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NCT00171223
|
An Extension Study to Determine the Efficacy and Safety of STI571 in Participants With Chronic Myeloid Leukemia Who Are Refractory to or Intolerant of Interferon-Alpha
|
During the Core Phase of the study, participants received STI571 at a dose of 400 milligrams (mg) daily for up to 12 months. Participants completing 12 months of therapy were eligible to continue treatment in the Extension Phase of the study provided that, in the opinion of the investigator, they had benefited from treatment with STI571 and there were no safety concerns.
|
Inclusion Criteria:
Participants included in the study were:
* Consenting males or females greater than or equal to (≥)18 years of age with Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).
* With a documented failure of interferon-alpha (IFN) or an IFN-containing therapy, characterized as resistance or refractoriness defined as any of the following:
* Hematologic Resistance - Failure to achieve a complete hematological response (CHR), lasting for at least 1 month despite 6 or more months of IFN or an IFN-containing regimen, in which IFN was administered at a dose of at least 25 million international units (MIU) per week. During this treatment period the cumulative duration of hydroxyurea therapy may not have exceeded 50% of the treatment period with the IFN-containing regimen.
* Cytogenetic Resistance - Bone marrow cytogenetics showing ≥65% Ph+ after one year of IFN-based therapy,
* Cytogenetic Refractoriness - An increase in the Ph+ chromosome in BM cells by at least 30 percentage points (e.g. from 20% to 50%, or from 30% to 60%) confirmed by two samples at least 1 month apart, or an absolute increase to ≥65%,
* Hematologic Refractoriness - A rising white blood cell count (WBC) \[to a level ≥20 x 10\^9/L confirmed by two samples taken at least two weeks apart\] for participants achieving a complete hematologic response while receiving IFN or an IFN-containing regimen. This regimen must have included IFN at a dose of at least 25 MIU administered per week. During this treatment period the cumulative duration of hydroxyurea therapy may not have exceeded 50% of the treatment period with the IFN-containing regimen.
In this report all refractory populations were referred to as "relapsed" populations.
* With a documented intolerance to IFN therapy defined as a ≥Grade 3 non-hematologic toxicity persisting for at least one month, for participants receiving IFN or an IFN- containing regimen. IFN was to be administered at a dose of at least 25 MIU/week. Participants who were intolerant of IFN were to have been diagnosed ≥6 months prior to the time of entry into the study.
Exclusion Criteria:
Participants excluded from the study were:
* Females of childbearing potential without a negative pregnancy test prior to the initiation of study drug. Barrier contraceptive precautions were to be used throughout the trial in both sexes.
* With serum bilirubin and creatinine concentrations more than twice the upper limit of the normal range (ULN).
* With serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) more than twice the ULN.
* With \>15% of blasts or basophils in peripheral blood (PB) or bone marrow (BM).
* With ≥30% of blasts plus promyelocytes in PB or BM.
* With a platelet count of less than (\<)100 x 10\^9/L.
* With an Eastern Cooperative Oncology Group (ECOG) Performance Status Score ≥3.
* Receiving busulfan within 6 weeks of Day 1.
* Receiving treatment with IFN or cytosine arabinoside (Ara-C) within 14 days of Day 1.
* Receiving treatment with hydroxyurea within 7 days of Day 1.
* Receiving other investigational agents within 28 days of Day 1.
* With prior marrow or stem cell transplantation.
|
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|
NCT04165265
|
The Use of Web-app Constant-Care in Patients With Acute Severe Ulcerative Colitis Treated With Rescue Therapy
|
The primary aim is to evaluate if introduction of eHealth in its form of the web application Constant-Care (https://ibd.constant-care.com) could reduce the length of hospitalization in patients with acute severe Ulcerative Colitis treated with infliximab. This is relative to historical controls extracted from medical records.
Patients will self-measure on the web-application while hospitalized as well as after discharge. At the web-application different questionnaires are filled out and a fecal calprotectin (FC) analysis is performed on a smartphone. The final follow up is one year after admission.
|
Consecutive inclusion of patients hospitalized at North Zealand University Hospital (NOH) in Denmark between December 2019 and June 2020 with the diagnosis acute severe Ulcerative Colitis (UC) (expected 14-28 patients). The included patients will be matched with historical controls 1:3 (matched on age and sex). Controls will be extracted from medical records (2015-2019). Only historical controls who meet the inclusion criteria as well as receive Infliximab rescue therapy, when admitted to hospital due to the diagnosis acute severe UC, are included. This means that patients, who are responders to high dose glucocorticoids are excluded as historical controls.
At Day 0 all the included UC patients will receive an introduction and their own personal login to the Constant-Care (CC) web-application (Two Factor Authentication) as well as receive standard treatment with IV glucocorticoids. When the patients have received an introduction to CC, they will register their disease activity; Simple Clinical Colitis Activity index (SCCAI). This tool captures the patient's illness experience (Patient-Reported Outcomes, PROs). Furthermore, the patients are introduced and assisted with Fecal Calprotectin (FC) testing kit (CalproSmart). For this analysis, patients will receive a personal login to CalproSmart.
Beside the CC monitoring initiated at Day 0, the patient will be followed through standard monitoring (DSGH guidelines) such as vital parameters daily (minimum three times a day), conventional FC Elisa (send to Hvidovre), blood samples and the frequency of bowel movements. In addition, fecal samples will be collected from all patients to microbiome analysis for future use (I Suite nr: 03719, ID no: NOH-2015-017). A separate written informed consent is collected when patient want to participate in future research with microbiome analysis. Furthermore, the patients' medical history, disease course and Montreal classification will be examined. At follow-up (week 52) it is considered if the patient had a colectomy.
While hospitalized patients register in CC everyday as well as perform the FC test with CalproSmart. This is continued until discharge or whenever the patient is categorized as "green". A patient is classified as "green" when either SCCAI or FC are in the green zone (cut-off values: SCCAI; ≤ 2 (green), \> 2 - 5 (yellow) and \> 5 (red), FC; ≤ 200 mg/kg (green), 201-600 mg/kg (yellow), \> 600 (red)).
On or around Day 3 it is considered if patient is a responder to the initial treatment with glucocorticoids. In case only partial or no response is observed the patient is considered rescue therapy (Infliximab, IFX) if no contraindications are present. This divides the patients in two arms; responders and partial/non-responders.
Both groups will continue daily registration in CC and perform FC test while admitted to hospital or until classified as "green". After discharge the responder group will register in CC and perform FC on demand in case of relapse in disease. At follow up (week 52) responders will register in CC and perform the FC test.
Partial/non-responders will, after discharge, register in CC and perform FC test once every week in the following 7 weeks. Afterwards registration is done on demand in case of relapse in disease. A final registration in CC and FC test is done at follow up.
In CC, patients will register: SCCAI, S-IBDQ, WEB-DI and FC via CalproSmart.
|
Inclusion Criteria:
* Patients with the diagnosis acute severe UC/IBDU, ECCO guidelines; Bloody diarrhea ≥ 6/day plus minimum one of following: Pulse \> 90/min, Temperature \> 37.8 °C, Hemoglobin \< 105 g/l, ESR \> 30 mm/h, CRP \> 30
* Hospitalized at NOH, Hillerød
* UC patients receiving IV glucocorticoids
* UC patients who can read, speak and understand Danish
* Have a smartphone
* UC patients who can manage going on Internet
* Above 18 years of age
Exclusion Criteria:
* Any present enteric infection
* Receiving per oral glucocorticoids
* Contraindications for IFX therapy, including;
1. Former inadequate response to IFX
2. Disease relapse in spite of current treatment with IFX
3. Intolerance or unacceptable side-effects to IFX
4. Active or latent TB
5. Cardiac failure (NYHA III or IV)
6. Demyelinating disorders
* Former gastrointestinal surgery
* UC patients with any severe mental disturbance and/or alcohol/other drug abuse
* UC patients with language barrier
* Below 18 years of age
|
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] |
NCT05424601
|
Intervention in a Small-scale Study of Game Based Cognitive Change Skills
|
This activity will have the objectives of preliminary testing user satisfaction, the feasibility of the platform and its preliminary efficacy
|
Preliminary efficacy will be tested in an emotion-regulation framework. Children included in this study will be allocated to play Level 4 of the REThink game on cognitive change or to no intervention Control condition. Children and adolescents in the intervention group will be distributed afterwards in two groups: with or without ecological momentary intervention (EMI) using the PsyPills app for following-up with the cognitive change ER personalized strategy reminder during a real exam situation. Outcomes considered will be stress reactivity (both subjective and physiological) using EMA before, during and after the test (Colombo et al., 2020), and cognitive change, namely irrational and rational beliefs, and reflective functioning improvements.
|
Inclusion Criteria:
* children and adolescents between 10 and 16 years old
* provided written parental consent
* able to access mobile/internet applications on their device
Exclusion Criteria:
* Intellectual disability or physical limitations precluded the use of the computer program
* Had a major mental health disorder
|
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] |
NCT00285883
|
Directly Observed Therapy in High Risk Populations in Newark, NJ
|
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center and be given Directly observed therapy.
|
30 patients with poor antiretroviral therapy compliance will be identified from our pool of patients at Saint Michael's Medical Center. Consent will be obtained, their regimens will be switched to QD based on previous therapies and resistance patterns if available. Patients will be placed on direct observed therapy.Each patient will be placed on Fortovase/Ritonavir (1600mg/100mg)QD plus two or three NRTIs based on a phenotypic baseline testing to a protease inhibitor. Patients will visit the office at baseline, weeks 1, 4, 8, 12, 16, 24, 32, 40, and 48. Patients will also be visited daily by the social worker (or designee) to observe patients taking their antiretroviral therapy for 6 months. After six months of direct observed therapy patients will be given a diary card to record administration of medications and the social worker ( or designee) will visit the home twice weekly. If the patient experiences a change in therapy secondary to virologic failure, the patient will return to baseline visit for the new once a day regimen. Virologic failure will be defined as \< .5 log drop between each visit or \> 400 copies/mL at week 24 on two separate occasions at least 14 days apart
|
Inclusion Criteria:
1. Men and Women \> 18 years of age with a confirmed HIV-1 diagnosis 2. CD4 count \<350 and or history of opportunistic infection 3. HIV PCR \>55000 and \>55,000 on one occasion in last 12 months 4. Patients with poor compliance (Poor compliance will de defined as taking less than 80 percent of prescribed medication 5. Patients with mental illness, HIV dementia, substance abuse or social factor prohibiting compliance 6. Willingness to sign informed consent or legal guardian
-
Exclusion Criteria:
1. ALT/AST \> 5X ULN
2. CReatinine \>2.0 -
|
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] |
NCT02006589
|
Bioavailability Study of Candesartan Cilexetil 8mg Tablet Under Fasting Conditions
|
This will be an open-label, randomized, single dose, two-way crossover study. Each subject will participate in both treatment periods and will receive single oral doses of candesartan cilexetil (GW615775) and reference candesartan cilexetil (ATACAND™); the treatment periods will be separated by a washout period of at least 7 days and no greater than 14 days. This study aims to determine the relative bioavailability of an 8mg test formulation tablet of candesartan cilexetil (GW615775) compared to an 8mg reference tablet of candesartan cilexetil in healthy adult subjects. ATACAND is a registered trademark of the AstraZeneca group of companies.
|
Inclusion Criteria:
* Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
* Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the Investigator in consultation with the GSK Medical Monitor if required agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
* Body weight \>= 50kg and body mass index within the range 19 - 24.9 kilogram per square meter (kg/m\^2) (inclusive).
* A female subject is eligible to participate if she is of: Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy for this definition, "documented" refers to the outcome of the investigator's/designee's review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records; or postmenopausal defined as 12 months of spontaneous amenorrhea in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) \> 40 milli-international units (MIU) per milliliter (mL) and estradiol \<40 pigogram per mL (pg/mL) (\<147 picomole per liter) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the contraception methods in protocol if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment. For most forms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method; Child-bearing potential with negative pregnancy test as determined by serum and urine human chorionic gonadotropin (hCG) test at screening or prior to dosing and Agrees to use one of the contraception methods listed in Protocol for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until the follow-up contact visit.or has only same-sex partners, when this is her preferred and usual lifestyle.
* Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Protocol. This criterion must be followed from the time of the first dose of study medication until the follow-up contact visit.
* Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Alanine transaminase, alkaline phosphatase and bilirubin \<= 1.5x upper limit of normal (ULN) (isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
* Based on single or averaged corrected QT interval (QTc) of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QT duration corrected for heart rate by Fridericia's formula (QTcF) \<450 milliseconds (msec) .
Exclusion Criteria:
* Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* History of regular alcohol consumption within 6 months of the study defined as: An average weekly intake of \>21 units for males or \>14 units for females. One unit is equivalent to 8 gram of alcohol: a half-pint (approximately 240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
* History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or GSK Medical Monitor, contraindicates their participation.
* Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
* Any subject with a systolic BP\<95 millimeters of mercury (mmHg) or with a recent history of postural symptoms
* A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
* Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
* A positive pre-study drug/alcohol screen.
* A positive test for Human immunodeficiency virus (HIV) antibody.
* Pregnant females as determined by positive serum hCG test at screening or prior to dosing.
* Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
* Lactating females.
* The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
* Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
|
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|
NCT06792604
|
Host Genome Methylation: a Screening Tool in Anal Cancer Detection
|
In January 2023, the first recommendations for anal cancer screening were issued by the French National Society of Coloproctology (SNFCP). These were the world's first national recommendations for anal cancer screening for at-risk patients, not limited to people living with HIV. They are based on screening for papillomavirus type 16 (HPV16) as the first line of defence, followed by reflex cytology in the event of a positive HPV16 smear and a proctological examination. In the event of abnormal cytology or proctological examination, high-resolution anoscopy (HRA) should be performed, but access to it is limited by the number of proctologists with the expertise to carry out this examination and the cost of the equipment. The development of biological markers could enable only patients at high risk of high-grade dysplasia/anal cancer to be referred for HRA.
As part of the AIN3 cohort, we demonstrated that the markers ZNF582 and ASCL1, studied on anal smears taken when patients were included in the cohort, showed a significantly higher level of methylation in patients who subsequently progressed to anal cancer.
The aim of this project is to test, in real-life conditions, the contribution of these methylation markers in the triage of asymptomatic patients eligible for anal cancer screening according to the SNFCP guidelines (MSM over 30 years of age living with HIV, women with a history of vulvar lesions or vulvar, women patients who have had a solid organ transplant for more than 10 years and extension to men patients who have had a solid organ transplant for more than 10 years).
|
I. Current state of knowledge on the pathology
In 2020, 30,000 cases of squamous cell carcinoma of the anus were reported worldwide. These cancers affect women in 2/3 of cases. They are fairly rare in the general population, with an age-standardised incidence rate of 0.35 per 100,000 person-years (p.a.) in men and 0.57 in women.
The population of men who have sex with men (MSM) living with HIV is at greater risk of anal cancer: studies in 2012 reported an 80-fold increase in the relative risk compared with the non-HIV-infected male population. This population is also more exposed to anal HPV infections, which adds to the dysimmunity associated with HIV infection. As a result, this population was already the subject of specific recommendations concerning anal canal cancer screening based on cytology. A recent meta-analysis has stratified the risk of anal cancer in different populations. It confirms the excess risk of anal cancer in the MSM population living with HIV (up to 100 per 100,000 pa in MSM living with HIV aged over 45).
It has also identified other groups at risk of anal cancer. A higher incidence rate of anal cancer in women who have already had cervical or vulvovaginal cancer is clearly established. But this meta-analysis by Clifford et al. shows a different stratification of anal cancer risk according to the type of previous HPV-induced cancer. Thus, the incidence rate of anal cancer is highest in the case of a history of vulvar cancer, equal to 50 per 100,000 pa, whereas it is close to 10 per 100,000 pa in the case of a history of vaginal or cervical cancers. Another group at risk of anal cancer is made up of immunosuppressed people not infected with HIV, and in particular solid transplant recipients, with different incidence rates of anal cancer depending on the type of transplant and above all the time since the transplant.
Overall, incidence rates of anal cancer, regardless of sex, are higher in high-income countries. In 2018, 1,532 new cases of anal cancer were reported in women in France, corresponding to an incidence rate of 2.4 per 100,000 woman-years, and 479 new cases in men, corresponding to an incidence rate of 0.8 per 100,000 man-years. As in many high-income countries, an overall increase in the incidence of this cancer has been observed in France, both in women (+3.4% and +5.7% between 1990 and 2018 and between 2010 and 2018 respectively) and in men (+1.5% and +3.3% between 1990 and 2018 and between 2010 and 2018 respectively). Trends by age for anal cancer show an increase in the number of cases, mainly in women aged 50 and 60.
Analysis of human genome methylation in anal swabs is a promising biomarker for anal cancer risk. Methylation is an epigenetic physiological phenomenon that regulates the expression of certain genes. The viral oncoproteins E6 and E7 of high-risk oncogenic HPVs (notably HPV16) have been shown to induce activation or increased expression of the cellular enzymes responsible for these methylation phenomena. As a general rule, hypermethylation of gene promoters leads to their inactivation. Repression of genes involved in the antiviral or anti-tumour response may contribute to immune escape, whereas hypermethylation inducing repression of tumour suppressor genes favours the cancerous process.
With regard to anal cancer, two studies demonstrated that the methylation markers previously developed for the cervix were not discriminatory for anal cancer. Subsequently, cross-sectional analysis of anal biopsies at different stages (normal cytology, low-grade or high-grade lesions, cancer) has revealed methylation markers specific to anal carcinogenesis in anal biopsies (invasive tissue sampling).
These markers are extremely promising, and methylation could therefore constitute a robust predictive marker of progression to an invasive lesion, and would therefore be a decisive factor in the decision of invasive treatment versus surveillance.
II. State of knowledge on reference procedures
The evolution of anal pre-cancerous lesions is less well described than that of cervical lesions due to the absence of screening programmes to date.
For the first time, the American ANCHOR study of nearly 5,000 PLHIV demonstrated the impact of treatment of high-grade lesions, with a 57% reduction in the rate of cancer in the treated arm (incidence 173 per 100,000 pa vs 402 per 100,000 pa in the simple surveillance arm). Following this study, recommendations for screening for precancerous anal lesions in asymptomatic at-risk populations are beginning to emerge.
In January 2023, the French National Society of Colo-Proctology (SNFCP) issued recommendations for anal cancer screening of asymptomatic individuals in three at-risk populations: MSM living with HIV aged over 30, women with a history of pre-cancerous lesion or cancer of the vulva and women who have received a solid organ transplant for more than 10 years. These recommendations target populations with an incidence of anal cancer greater than 40 per 100,000 pa according to the meta-analysis by Clifford et al. In this context, screening for anal cancer is based on primary HPV16 screening, in particular by anal self-sampling and, if positive, an anal smear for cytology and a standard proctology examination. In the event of abnormal cytology, patients will be referred for a proctology consultation with high-resolution anoscopy (HRA).
There are few proctologists in France who carry out AHR examinations, and waiting times for consultations are already very high. The major stumbling block to the introduction of anal cancer screening is the anticipated worsening of the overcrowding of AHR examinations and proctology consultations. For example, a recent meta-analysis reported a prevalence of 27% to 35% of HPV16 infection in the anal region of MSM living with HIV. The development of triage tools enabling only those patients most at risk of high-grade anal dysplasia to be referred for this examination is therefore crucial.
The aim of this new study is to validate the predictive capacity of anal smear methylation markers for screening patients at risk of progressing to high-grade dysplasia and to define appropriate thresholds in this sample, including patients targeted by the new SNFCP screening recommendations and therefore with no history of AIN3 lesions.
III. Hypothesis
This study is based on the hypothesis that the level of methylation of the markers ASCL1 and ZNF582 will be predictive of the risk of asymptomatic patients developing high-grade anal lesions and therefore anal cancer.
|
Inclusion Criteria:
1. Adults (age ≥ 18 years)
2. Eligible for anal cancer screening according to the SNFCP guidelines (with extension to men who have received solid organ transplants for more than 10 years):
* MSM (men who have sex with men) aged over 30 living with HIV
* Patients who have received a solid organ transplant for more than 10 years
* Women with a history of vulvar lesions or vulvar cancer
Non-inclusion Criteria:
1. Proctological follow-up for a current high-grade anal lesion or cancer
2. Pregnant or breastfeeding women
3. Subject deprived of liberty or under legal protection
4. Non-affiliation with social security system
5. Refusal to participate expressed by the patient
Exclusion Criteria :
1) Refusal of anal self-sampling on inclusion
|
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] |
NCT01221246
|
Efficacy and Safety Study of GM602 in Patients With Acute Middle Cerebral Artery Ischemic Stroke Within 18 Hours
|
The purpose of this research study is to determine whether the investigational drug GM602, is effective and safe in the treatment of ischemic stroke (strokes caused by a blood clot blocking the flow of blood through one, or more of the blood vessels supplying the brain) when administered up to 18 hours after symptoms begin.
|
Stroke is a serious and life threatening disease. About 85% of all strokes are ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The thrombolytic drug tissue plasminogen activator (tPA) is the only early treatment for acute ischemic stroke approved by the FDA. Treatment with tPA must be administered within three hours of the stroke onset. Furthermore, tPA treatment carries a recognized risk of bleeding in the brain. GM602 is an investigational drug that may act as a neuroprotectant in patients who have had a stroke. It is thought to stop cell death and reduce inflammation in the injured area of the brain. This study is designed to evaluate the safety and efficacy of GM602 administered intravenously to patients in three consecutive daily doses of 320 mg/dose or 480 mg/dose, the initial dose administered within 18 hours after onset of acute ischemic stroke in the Middle Cerebral artery region.
|
Inclusion Criteria:
* \> 18 years old
* Be eligible for MRI or CT scan
* Have suffered acute ischemic stroke in the middle cerebral artery (MCA) distribution, as verified by the Screening diffusion-weighted imaging (DWI) abnormality and Screening perfusion-weighted imaging pressure-work index (PWI ) abnormality
* Have NIH Stroke Scale (NIHSS) score total score of 9-20 inclusive at screening
* Have suffered acute ischemic stroke within 18 hours
* Have been functionally independent with a Modified Rankin Score (mRS) of 0 or 1 prior to suffering stroke
* Patients who received tPA or FDA approved mechanical device can also enroll
* completed informed consent form
Exclusion Criteria:
* Have history of stroke in the past 3 months
* Cannot be evaluated using MRI/CT
* Have stroke of the brainstem or cerebellum
* Have clinical presentation consistent with acute MI by EKG criteria (STEMI) at screening
* Have hemorrhage revealed by CT or MRI scan
* Have \> 1/3 MCA territory HYPER intensity as seen on MRI OR \>1/3 MCA territory HYPO intensity as seen on CT
* Have blood sugar level \>400 mg/DL or\<50 mg/dL
* Have kidney disease, creatinine \> 2.0
* Have had recent (within 90 days) serious head trauma or head trauma with loss of consciousness
* Have any prior history of seizure
* Have clinically relevant pre-existing neurological deficit (Historical Rankin score ≥ 2)
* Have any other known clinically significant medical disorder (cardiovascular, hepatic, renal, endocrine, respiratory, immunological, cancer, AIDS)
* Life expectancy of less than 6 months due to comorbid conditions
* Women of child bearing potential who are pregnant or breast-feeding or unable to practice birth control during the study period
* Have participated in any other trial of an investigational agent within 90 days prior to screening
* Informed consent cannot be obtained
* Unable to participate in study visits
|
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] |
NCT04160910
|
5HTP Regulation Of Asthma In Children
|
The purpose of this study is to learn more about if taking a supplement called 5-hydroxytryptophan (5HTP) can improve breathing and anxiety symptoms related to asthma. To help learn more subjects will either be assigned to a group that is taking the supplement (5HTP) or a group that is taking a placebo. This will be decided randomly. Later in the study subjects will crossover to the other group.There are 5 study visits over the course of about 12 weeks.
|
The objective of this study is to test the hypothesis that over-the-counter amino acid supplement 5HTP (isolated from the plant Griffonia Simplifolia) reduces human allergic lung responses and consequently improves lung function. The primary outcome is the change in FEV1. We anticipate the 5HTP at the proposed doses will improve lung function as in preclinical studies that used clinically relevant 5HTP. Secondary outcomes will be blood eosinophil counts and reduced symptoms for anxiety/depression, as seen in changes in the anxiety-depression scores from questionnaires (CES-DC \& SCARED). The results from these studies have the transformative potential to influence approaches to improve lung function and asthma-associated anxiety/depression.
* Aim 1: Test that 5HTP improves lung function in children with allergic asthma
* Aim 2: Test that 5HTP reduces eosinophil numbers in the blood and nasal fluid of patients with asthma from Aim 1
* Aim 3: Test that 5HTP decreases lung inflammation, increases cortisol and prolactin without altering systemic plasma concentrations of 5HTP, serotonin, 5-hydroxyindoleacetic acid (5-HIAA), and dopamine
|
Inclusion Criteria:
* Age 8-18 Years of Age
* Mild to Moderate Asthma based on ATS guidelines
* Positive Allergy Test (positive skin or serum IgE)
* Weight ≥ 70 lbs (32 kg)
* CES-DC cut-off ≥ 15 (total score range is 0 to 60) or SCARED cut-off
* 25 (total score range is 0 to 142)
* Ability to comply with study visits and study procedures
* Informed Consent by participant and if applicable the parent or legal guardian
Exclusion Criteria:
* Currently taking a SSRI
* Taking a leukotriene inhibitor (montelukast, Zileuton)
* Severe Asthma Based on ATS Guidelines
* Taking a biologic medication (omalizumab, mepolizumab, benralizumab, dupilumab)
* Medical History of Adverse Reaction to 5HTP
* Physical findings that would compromise the safety of the study or the quality of the study data
|
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] |
NCT04744584
|
Medication Reconciliation in Pulmonary Hypertension
|
Pulmonary hypertension (PH) is a life threatening condition. In PH, pulmonary arterial hypertension (PAH) and chronic thrombo-embolic chronic pulmonary hypertension (CTEPH) are two rare diseases requiring specific and complex drug management. In France ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. Anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.
|
Medication reconciliation (MR) will be done for patients hospitalized in the French referral center for PH for PAH or CTEPH. Detected medication errors will be tracked and fixed by the physician before the end of hospitalization. A synthesis of new/stopped and modified treatments will be given to the patient as well as his related healthcare professionals (community pharmacist and general practioner) to ensure the maintaining of the new therapeutic management and the understanding of drugs modification. To compare the potential decrease of medication errors promoted by MR, a retrospective MR will be also done for patients without MR at 1st hospitalization but at the next one (3 to 12 months after).
|
Inclusion Criteria:
* Patient affiliated or entitled to a social security scheme
* At least 18 years old
* Patient with enlightened information of the study and not opposed with it.
* For patient without MR: patient hospitalized for the first re-evaluation of PAH or CTEPH within 12 months following the first assessment hospitalization (ie: first right heart catheterization at bicetre Hospital).
* For patient with MR: patient hospitalized for first assessment (first right heart catheterization at bicetre Hospital) of PAH or CTEPH
Exclusion Criteria:
* Patient suffering from another form of PH
* Patient under guardianship or curator
* Inability to give information to the patient either due to language barrier or to cognitive impairment
* Patient hosted in institution on discharge from hospital (follow-up care and long-term rehabilitation)
* Patient with a life expectancy of less than 1 year
* Patient on transplant list
* Patient refusal
* Length of stay \< 48 hours
|
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] |
NCT03111485
|
Effect of Long-acting Levodopa on Obstructive Sleep Apnea in Parkinson's Disease
|
This trial will assess whether long-acting levodopa taken at night improves obstructive sleep apnea (OSA) in patients with Parkinson's disease (PD), as compared with placebo.
|
Participants with Parkinson's disease and sleep apnea will take long-acting levodopa and placebo at bedtime for 2 weeks each, in a randomized order, with a 2-week washout period in-between. Sleep studies will be done at the end of each period. The primary outcome will be the apnea-hypopnea index change from baseline to on-medication, comparing active medication to placebo. Other outcomes will include other polysomnographic parameters such as oxygenation measures and sleep architecture variables, as well as the Epworth Sleepiness Scale, the Montreal Cognitive Assessment, the Parkinson's disease sleep scale and the Unified Parkinson's Disease Rating Scale. Adverse events will be closely monitored.
|
Inclusion Criteria:
1. Diagnosis of idiopathic PD consistent with the UK Brain Bank;
2. Presence of OSA on screening PSG, as defined by an AHI ≥ 15/h (moderate to severe OSA);
3. Stable regimen of anti-PD medication for 4 weeks prior to entry into the study, and no planned change during the study
Exclusion Criteria:
1. Other major neurological disorder;
2. Already taking long-acting levodopa (at any time of day);
3. Taking short-acting levodopa at bedtime or during the night;
4. Any contraindication to long-acting levodopa (see below);
5. Severe levodopa induced dyskinesias;
6. Already on or requiring treatment for restless legs syndrome ;
7. Body mass index \>35 kg/m2;
8. Intercurrent upper respiratory tract infection;
9. Other known cause of OSA (e.g. craniofacial malformation);
10. Active treatment of OSA (CPAP, dental appliance or other), unless willing to stop treatment 2 weeks prior to start and during the duration of the study.
|
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] |
NCT00122278
|
Headache in the Emergency Department (ED) - A Multi-Center Research Network to Optimize the ED Treatment of Migraines
|
Migraines are a specific type of headache that frequently recur and are very painful. Although there are many medications that are effective against migraines, none of these medications cure 100% of migraines. Another problem with migraines is that although many times they get better after intravenous (IV) treatment in the emergency room (ER), about 1/3 of the time migraines recur the next day. The purpose of this research project is to see if adding a medication called dexamethasone to standard ER therapy will help patients get better quicker and stay pain-free more often than if they receive placebo.
|
Parenteral Corticosteroids as Adjuvant Therapy for Migraine Headaches:
A. Overview/Aims: Five million Americans present to emergency departments (ED) annually with headaches \[1\]. The majority of these patients have migraine headaches \[2,3\]. Parenteral medications of proven benefit for acute migraines include the triptans \[4\], dopamine-receptor antagonists \[5-11\], non-steroidals \[12\], and dihydroergotamine \[13\]. Although these distinct classes of medication are often effective for the treatment of acute migraines, their use is complicated by treatment failures \[4,9,14\], recurrence of headache \[15,16\], and side effects \[17\], all of which are of concern for patients with migraines \[18\]. The ideal medication, which would rapidly alleviate migraine pain without any recurrence of pain or side effects, has not yet been identified.
The role of corticosteroids in acute migraines is ill-defined. Although used in patients with intractable migraines, this class of medication is not widely used in typical migraine attacks. However, limited clinical data suggest that corticosteroids decrease the rate of recurrent headaches \[19-21\] and might decrease the pain of an acute attack \[22\]. Further research is needed to define the role of corticosteroids in the ED treatment of acute migraine headaches.
Specific Aim: The specific aim of this study is to determine the efficacy of ten milligrams of parenteral dexamethasone as adjuvant therapy for the emergency department treatment of migraine headaches.
Primary Hypothesis: Twenty four hours after medication administration, a greater percentage of migraine subjects who received dexamethasone will have:
* sustained pain-free headache relief; and
* no headache-related functional impairment when compared to subjects who receive placebo.
Both groups will also receive the standard of care.
Secondary Hypothesis: Two hours after medication administration, a greater percentage of migraine subjects who received dexamethasone will be headache pain-free, when compared to subjects who receive placebo.
B. Background and Significance:
Despite standard treatment, a large percentage of emergency migraineurs continue to suffer from headaches after ED discharge. Recurrent or persistent headaches rated as moderate or severe in intensity occurred in 14-43% of subjects 24 hours after discharge in ED-based migraine clinical trials \[20,23,24\]. In a Canadian population, 45% of headache patients reported headache-related functional impairment within 24 hours of ED discharge \[16\].
Some reports indicate that corticosteroids decrease the rate and intensity of recurrent migraine headaches \[19-21\]. However, the investigators could not find any corticosteroid clinical trials using recommended measures and outcomes \[25\] in a migraine population. To the best of their knowledge, no controlled clinical trial has tested the efficacy of corticosteroids as primary migraine-abortive therapy.
Although the pathogenesis of migraine headaches is incompletely understood, a sterile neurogenic inflammation is felt to be key to the pain generating pathway that occurs in acute migraines \[15\]. Corticosteroids theoretically mitigate this inflammation and decrease the pain and duration of acute migraine attacks.
One dose of intravenous dexamethasone has been well-tolerated in migraineurs \[20\]. If this medication proves to have efficacy for migraines, then this would represent a substantial contribution to headache medicine, an effective tool in the armamentarium of emergency physicians, and a cheap and safe method to decrease the pain and suffering of ED migraine patients.
C. Methods:
C1. Overview: This will be a randomized, double-blind, placebo-controlled clinical research trial testing the efficacy of intravenous dexamethasone sodium phosphate as adjuvant therapy for acute migraine headaches. All subjects will receive standard-of-care migraine-abortive medication for their migraines. In addition, they will receive either ten milligrams of intravenous dexamethasone sodium phosphate or a comparable amount of placebo. Subjects will be followed by telephone 24 hours after medication administration.
C2. Study Sites: Study sites will include the emergency departments of Montefiore Medical Center, Jacobi Medical Center, New York Presbyterian Hospital, St. Luke's Medical Center, Bellevue Medical Center, and Kings County Medical Center.
C3. Selection of Participants: The attending emergency physician will refer all adult patients who present with a chief complaint of headache during the regular hours of the data collectors. Under the supervision of the site investigators, the data collectors will inform patients about the study and ask for their consent to participate in this study as human subjects. The data collectors will include in this study any patient who has a migraine headache as defined by the International Headache Society (IHS-2003 1.1 migraine without aura; 1.2 migraine with aura). Patients will also be included if they have an IHS probable migraine (IHS-2003 1.6.1 \& 1.6.2) \[26\] that has lasted between 72 and 168 hours. In other words, patients will also be included if their headache meets all IHS migraine criteria except that the duration of the headache has been between 73 and 168 hours. These probable migraine patients will be included because they represent a substantial subset of ED primary headache patients (Friedman, et. al., unpublished data) and because the majority of patients with a disabling probable migraine and a history of similar headaches will respond to migraine-specific medication \[27\].
Patients will be excluded if the emergency physician intends to perform a lumbar puncture in the ED because lumbar puncture has an independent association with 24 hour headache pain scores. Patients will be excluded for persistent objective focal neurologic deficits, as determined by the attending physician, for fear of mistaking a stroke for a complicated migraine, or for signs and symptoms concerning for other causes of malignant secondary headache such as meningitis, subarachnoid hemorrhage, carotid dissection, or intracranial mass. Patients will also be excluded for temperatures greater than 100.3 degrees, pregnancy or lactation, or allergy or intolerance to any of the study medications. Patients can only enroll once. Patients over the age of 64 will be excluded, for fear of increased risk of adverse reactions to study medications and increased risk of secondary headaches. Patients who do not meet enrollment criteria will have basic demographic and headache variables recorded.
C4. Randomization and Blinding: Randomization is to be done by the research pharmacist at Montefiore Medical Center in blocks of six using computer generated random number tables available online. The randomization will be stratified by study site. In an order determined by the random number tables, the pharmacist will insert medication into vials and place these vials into sequentially numbered brown paper research bags. The research bags will be distributed by express courier in batches of six to the investigators at each site. The research bags will be stored at each site in a locked location accessible to the data collectors. When a subject has been identified, the contents of each research bag will be administered by a clinical nurse. Assignment will be known only by the research pharmacist. However, the assignment will accompany each research bag, sealed in a small manila envelope, in case a medical emergency mandates that the assignment be revealed.
C5. Measures:
C5a. Categorical Scale: As a primary measure, this trial will use the four point descriptive scale recommended for use in migraine research \[25\]. On this scale, subjects are asked to characterize their migraine pain as "none, mild, moderate or severe".
C5b. Disability Scale: A descriptive categorical scale will be used to characterize the subject's headache-related disability. On this scale, subjects describe their disability as "1) none; 2) mildly impaired (having a little bit of difficulty doing what I usually do); 3) moderately impaired (having a great deal of difficulty doing what I usually do and can only do very minor activities); or 4) severely impaired (requiring bed rest)" \[25\].
C5c. Numerical Rating Scale for Pain: An 11-point verbal numerical rating scale for pain will be a secondary measurement tool for this trial. On this scale, subjects are asked to describe their pain as a number between zero and ten, with zero being no pain and ten being the worst pain imaginable. This scale has been shown to perform comparably to a visual analog scale, while being easier to administer \[28\].
C6.Outcomes: The primary outcome will be the percentage of subjects who achieve and maintain a "headache pain free" state. Persistent "headache pain free" is the recommended outcome for migraine clinical research \[25\]. Subjects will be considered to have fulfilled the primary outcome if they achieve a pain free state in the ED and maintain this throughout the 24 hour period after receiving study medication. The alternate primary outcome will be the number of subjects who report no headache-related disability for the period of time after ED discharge. The major secondary outcome will be the percentage of subjects who report a "headache pain-free" status two hours after medication administration.
Other secondary outcomes include rates of sustained headache relief (moderate or severe pain becoming and maintaining a level of mild or none), two-hour NRS change (NRSbaseline-NRS2hours), 24 hour NRS change (NRSbaseline-NRS24hours), need for rescue medication before two hours, need for analgesic medication after discharge from the ED, associated symptoms (specifically: weakness, drowsiness, dizziness), unscheduled visits to a medical provider within 24 hours of medication administration, and the percentage of patients who answer affirmatively to the question "Do you want to receive the same medication the next time you come to the ED?"
C7. Data Collection, Data Entry, and Back-Up: Data entry and follow-up of subjects will be accomplished by taking advantage of the research infrastructure in place at the Department of Emergency Medicine of the Albert Einstein College of Medicine. Five full-time research assistants and one research clerk are funded by the department. The research assistants are medical technician level, full-time employees who have extensive clinical research experience and have passed required research ethics courses. These research assistants staff the Montefiore ED during all operational hours.
The initial data collection process will be performed by the data collectors at each individual site. These data collectors will be different in each ED, depending on the resources at the individual ED. At Montefiore and Jacobi, the data collectors are salaried, trained, technician level employees, who have passed required research ethics courses. The data collectors will be trained for this particular study by the principal investigator and site investigators. Their training will include mock patient encounters. The data collectors will use a standardized data collection instrument to collect baseline information, pain scores, and side effects in the ED. After the ED data have been obtained, the data collection instrument will be photocopied and faxed to a dedicated research clerk in the Department of Emergency Medicine at Albert Einstein College of Medicine. The receiving fax machine is a private fax machine secured in an office behind two locked doors.
The research clerk will be responsible for obtaining the 24 hour follow-up information. At a time pre-arranged with the subject prior to the subject's discharge from the ED, the research clerk will call the subject and obtain 24 hour follow-up information by reading questions off of the data collection instrument. Twenty-four hour follow-up to be done during non-business hours will be performed by Montefiore's research assistants, who cover the ED 24 hours a day, seven days every week. These research assistants will retrieve the faxed data collection instruments, obtain the follow-up information, and then return the data collection instruments to the research clerk.
The research clerk will enter all data into SPSS data entry V.11. Completed data collection instruments will be sent to a second research clerk who will enter the data a second time into the same SPSS program. After every ten subjects have been entered, data will be backed up and stored on three different computers on two distinct campuses. Prior to all analyses, the two data sets will be compared. Discrepancies will be corrected using the initial data collection instrument as the source. The original version of each data collection instrument will be kept in a locked cabinet at its original site.
C8. Medications: In addition to study medication or placebo, all subjects will receive standard migraine abortive therapy. The optimal migraine-abortive/analgesic medication for ED patients with acute migraine headaches has not yet been defined, so the investigators have chosen intravenous metoclopramide, an effective, safe, widely-available, and economical dopamine receptor antagonist, as the migraine treatment for this trial. Parenteral dopamine-antagonists are recommended for use in the ED29 and are used more commonly than triptans in the ED setting \[1,16\]. Metoclopramide has been shown to be at least as effective as subcutaneous sumatriptan at reducing pain \[7,8\] with comparable two hour activity limitations \[30\]. The investigators will use 20 milligrams of intravenous metoclopramide, a moderate dose when compared to their previous work \[23,30\]. In addition to metoclopramide, each subject will also receive 25mg of diphenhydramine to prevent akathisia and other extra-pyramidal reactions to the metoclopramide \[31\]. This combination of metoclopramide and diphenhydramine is commonly used in the ED setting and does not cause significant drowsiness or impairment of activities in migraineurs at two hours \[30\]. The investigators view the potential anti-migraine effect of diphenhydramine \[32\] as added benefit for their subjects. Metoclopramide, diphenhydramine, and the study medication will be placed into a 50cc bag of normal saline and administered as a slow intravenous drip over twenty minutes.
Subjects who require rescue medication for persistent headache will receive another 20mg of intravenous metoclopramide. This additional dose of metoclopramide is part of an ED-based protocol that has demonstrated a high rate of pain relief and patient satisfaction with a minimum of side effects \[23,30\].
Subjects who require more pain medication will receive a combination of ibuprofen and oral opiates at the discretion of the treating physician.
All subjects will be discharged from the ED with two 400mg tablets of ibuprofen to be taken as needed for recurrence of headache. Ibuprofen is an effective migraine treatment \[9\].
C9. Interim Analysis, Stopping Rules and Sample Size Calculation: An interim analysis will be performed to detect an overwhelming superiority of the intervention. A data monitoring committee will convene after 126 subjects have been enrolled. The committee will look for a statistically significant difference in the primary outcome or a discrepancy in the rate of adverse effects (measured by rate of hospitalization for presumed adverse reaction to medication). The medications used in this study are well-known to the medical community and commonly used. Neither the disease nor the medications cause mortality or significant permanent disability. Therefore, although the investigators will monitor the adverse effects that occur during this trial, they do not anticipate that this will have a significant effect on the outcome.
There are many different approaches to calculation of significance criteria that can be used in interim analyses, and thus might be used to terminate a trial before the complete data are collected. The investigators have chosen an intermediate approach, based on the O'Brien-Fleming procedure \[33\] and set the interim test criterion at 0.01, and the final test criterion at 0.04. Using a criterion for significance of 0.04 and a 2-tailed test, this study will require 100 subjects in each group, for a total of 200 subjects, to have power of 80% to yield a statistically significant result. This computation assumes that the difference in persistent headache pain-free proportions is 0.20, specifically, 0.30 versus 0.50 (the rate of persistent headache pain-free 24 hours after ED discharge in a previous similarly-dosed metoclopramide trial was 30% \[30\]). The clinical effect being sought is comparable to a number needed to treat of five, the largest number needed to treat believed important to discover for this self-limited disease process. The interim analysis will have adequate power (0.80) to discover a statistically significant difference (alpha=0.01) if the difference between the two groups is 30% (.60 versus .30).
C10. Co-Variates: The following variables will be assessed:
C10a. Cutaneous Allodynia: Cutaneous allodynia is felt to be a marker of more intractable migraines \[34\] and can be tested for by lightly rubbing a 4 x 4 piece of gauze on the face of the subject \[35\]. The data collectors will assess each subject for cutaneous allodynia prior to the administration of medication.
C10b. Duration of Headache: Although likely to be collinear with allodynia, this co-variate might be associated with intractable 24 hour headaches \[20\].
C10c. Pre-Medication: In previous work, although 25% of the investigators' population took no analgesic medication prior to presentation to the ED, this co-variate did not confound the association between study medication and persistent pain-free \[30\]. Nevertheless, the investigators will record all migraine-relevant medications used by their subjects prior to ED presentation, group these by class, and determine if this co-variate has a relationship with the primary outcomes.
C11d. Aura: The investigators know of no documented association between aura and corticosteroids, but this subject has been inadequately explored.
C11e. Prophylactic Medications: In previous work \[30\], only a small minority of ED migraineurs were on prophylactic medication. However, these patients represent a sub-set of migraineurs with more severe disease.
C11f. Chronic Migraines: Only a small minority of ED migraineurs can be classified as chronic (Friedman, unpublished data). However, these patients represent a sub-set of migraineurs at high risk of recurrent 24 hour headaches.
C11g. Medication-Rebound Headaches: This diagnosis has been inadequately explored in the ED setting and consists of complicated headache patients. The investigators will not exclude these patients from this study because they are likely to benefit from this intervention \[21\].
C11h. Site: To account for site-specific differences from influencing the results, subjects from each site will be randomized in blocks of six to prevent unequal representation of a particular site in either arm. This will prevent any one site from overly influencing the study.
C11i. Race/Ethnicity: This will be based on subject's report. The significance of this co-variate for this study is unknown.
C11j. Age: This will be recorded. The significance of this co-variate for this study is unknown.
C12k.Gender: This will be recorded. The significance of this co-variate for this study is unknown.
C12. Analysis: The data will be analyzed in an "intention-to-treat" manner. Once a patient is randomized and receives the dexamethasone, their pain scores will be included in the 24-hour analysis regardless of whether or not they received rescue medication or completed the protocol. However, lost-to-follow-up subjects will be excluded from the primary analysis (a sensitivity analysis will be conducted in which lost-to-follow-up subjects are assumed to have a poor outcome). Study enrollment will continue until the pre-determined number of subjects have completed the primary endpoint. Chi-square analysis will be used to compare rates. Students t-tests will be used to compare mean differences in pain scores. Multivariate regression models will be used to analyze the influence of the co-variates discussed above, particularly allodynia, duration of headache, and use of medication prior to ED presentation. Briefly, evidence of confounding will be sought by looking for an association between the heterogeneous variable and both the independent (study medication) and dependent (pain status) variables. Between-group differences will be expressed as means or proportions, bounded by 95% confidence intervals (95% CI).
References:
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2. Bigal M, Bordini CA, Speciali JG. Headache in an emergency room in Brazil. Sao Paulo Med J 2000; 118:58-62.
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4. Akpunonu BE, Mutgi AB, Federman DJ, et al. Subcutaneous sumatriptan for treatment of acute migraine in patients admitted to the emergency department: a multicenter study. Ann Emerg Med 1995; 25:464-9.
5. Bigal ME, Bordini CA, Speciali JG. Intravenous chlorpromazine in the emergency department treatment of migraines: a randomized controlled trial. J Emerg Med 2002; 23:141-8.
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7. Friedman B, Corbo J, Lipton R, et al. Metoclopramide Versus Sumatriptan for the ED Treatment of Migraines. Neurology 2005.
8. Esteban-Morales A, Chavez PT, Martinez CGR, Zuniga AS. Respuesta clinica de metoclopramida en comparacion con sumatriptan en el tratamiento de ataques agudos de migrana. Revista de la Sanidad Militar Mexico 1999; 53:36-40.
9. Tek DS, McClellan DS, Olshaker JS, Allen CL, Arthur DC. A prospective, double-blind study of metoclopramide hydrochloride for the control of migraine in the emergency department. Ann Emerg Med 1990; 19:1083-7.
10. Silberstein SD, Young WB, Mendizabal JE, Rothrock JF, Alam AS. Acute migraine treatment with droperidol: A randomized, double-blind, placebo-controlled trial. Neurology 2003; 60:315-21.
11. Seim MB, March JA, Dunn KA. Intravenous ketorolac vs intravenous prochlorperazine for the treatment of migraine headaches. Acad Emerg Med 1998; 5:573-6.
12. Meredith JT, Wait S, Brewer KL. A prospective double-blind study of nasal sumatriptan versus IV ketorolac in migraine. Am J Emerg Med 2003; 21:173-5.
13. Winner P, Ricalde O, Le Force B, Saper J, Margul B. A double-blind study of subcutaneous dihydroergotamine vs subcutaneous sumatriptan in the treatment of acute migraine. Arch Neurol 1996; 53:180-4.
14. Ellis GL, Delaney J, DeHart DA, Owens A. The efficacy of metoclopramide in the treatment of migraine headache. Ann Emerg Med 1993; 22:191-5.
15. Goadsby PJ, Lipton RB, Ferrari MD. Migraine--current understanding and treatment. N Engl J Med 2002; 346:257-70.
16. Ducharme J, Beveridge RC, Lee JS, Beaulieu S. Emergency management of migraine: is the headache really over? Acad Emerg Med 1998; 5:899-905.
17. Hardman J, Limbird L. Goodman and Gilman's the pharmacological basis of therapeutics, 9th ed. New York: McGraw-Hill, Health Professions Division, 1996.
18. Lipton RB, Hamelsky SW, Dayno JM. What do patients with migraine want from acute migraine treatment? Headache 2002; 42 Suppl 1:3-9.
19. Krymchantowski AV, Barbosa JS. Dexamethasone decreases migraine recurrence observed after treatment with a triptan combined with a nonsteroidal anti-inflammatory drug. Arq Neuropsiquiatr 2001; 59:708-11.
20. Innes G, Macphail I, Dillon E. Dexamethasone prevents relapse after emergency department treatment of acute migraine: a randomized clinical trial. Canadian Journal of Emergency Medicine 1999; 1.
21. Gallagher RM. Emergency treatment of intractable migraine. Headache 1986; 26:74-5.
22. Monzillo P, Nemoto P, Costa A, Sanvito W. Tratamento Agudo Da Crise De Enxaqueca Refrataria Na Emergencia. Arq Neuropsiquiatr 2004; 62:513-518.
23. Corbo J, Esses D, Bijur PE, Iannaccone R, Gallagher EJ. Randomized clinical trial of intravenous magnesium sulfate as an adjunctive medication for emergency department treatment of migraine headache. Ann Emerg Med 2001; 38:621-7.
24. Cameron JD, Lane PL, Speechley M. Intravenous chlorpromazine vs intravenous metoclopramide in acute migraine headache. Acad Emerg Med 1995; 2:597-602.
25. Tfelt-Hansen P, Block G, Dahlof C, et al. Guidelines for controlled trials of drugs in migraine: second edition. Cephalalgia 2000; 20:765-86.
26. Classification and diagnostic criteria for headache disorders, cranial neuralgias and facial pain. Headache Classification Committee of the International Headache Society. Cephalalgia 1988; 8 Suppl 7:1-96.
27. Lipton RB, Cady RK, Stewart WF, Wilks K, Hall C. Diagnostic lessons from the spectrum study. Neurology 2002; 58:S27-31.
28. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med 2003; 10:390-2.
29. Kelly AM. Migraine: pharmacotherapy in the emergency department. J Accid Emerg Med 2000; 17:241-5.
30. Friedman BW, Corbo J, Lipton RB, et al. A trial of metoclopramide vs sumatriptan for the emergency department treatment of migraines. Neurology 2005; 64:463-8.
31. Drug Consult. St. Louis: Mosby, Inc., 2005.
32. Swidan SZ, Lake AE, 3rd, Saper JR. Efficacy of intravenous diphenhydramine versus intravenous DHE-45 in the treatment of severe migraine headache. Curr Pain Headache Rep 2005; 9:65-70.
33. O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics 1979; 35:549-56.
34. Burstein R, Collins B, Jakubowski M. Defeating migraine pain with triptans: a race against the development of cutaneous allodynia. Ann Neurol 2004; 55:19-26.
35. Ashkenazi A, Sholtzow M, Young WB. Prevalence of Dynamic Mechanical (Brush) Allodynia in MIgraine (Abstract). Neurology 2004; 62:A83.
|
Inclusion Criteria:
* Migraine with or without aura; probable migraine without aura
Exclusion Criteria:
* Secondary headache
* Allergy, contraindication or intolerance to study medication
|
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] |
NCT02742623
|
A Non-interventional Study on Xarelto for Treatment of Venous Thromboembolism (VTE) and Prevention of Recurrent VTE in Patients With Active Cancer
|
This study aims to collect patient reported outcomes and assess treatment satisfaction in active cancer patients treated with rivaroxaban for VTE (venous thromboembolism).
|
Inclusion Criteria:
* Adult female and male patients with active cancer other than fully treated basal-cell or squamous-cell carcinoma of the skin (active cancer defined as the diagnosis or treatment of cancer in the previous \< 6 months or recurrent or metastatic cancer)
* Patients that have been treated with standard of care anticoagulation (Low Molecular Weight Heparin / Vitamin K Antagonist) for treatment of DVT and/ or PE (index VTE event) and/ or prevention of recurrent DVT and PE for at least 4 weeks prior to inclusion in the study
* Patients for whom the decision was made to start rivaroxaban for treatment of DVT and/ or PE and/ or prevention of recurrent DVT and PE
* Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
* Patients who are willing to participate in this study (signed informed consent)
* Patients who are available for follow-up with a life expectancy \>6 months
Exclusion Criteria:
* The contra-indications according to the local marketing authorization must be considered
* Patients who developed an index VTE event despite chronic anticoagulant therapy
* Patients receiving apixaban, edoxaban or dabigatran or any investigational drug as the initial therapy for the index VTE event
* Patients participating in an investigational program with interventions outside of routine clinical practice with exception of oncology investigational trials
|
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|
NCT01523197
|
Auto-trilevel Ventilator for Patients With Overlap Syndrome
|
Obstructive Sleep Apnea Syndrome (OSAS) and chronic obstructive pulmonary disease (COPD) are two diseases that often coexist and are called overlap syndrome(OS). Compared to single OSAS, OS patients are more susceptible to serious hypoxia and hypercapnia especially during sleep, and are much more likely to result in pulmonary hypertension and cor-pulmonal.
With a more flexible expiratory positive airway pressure (EPAP), auto-trilevel ventilation may be superior to fixed bilevel positive airway pressure (BiPAP) ventilation in both removing residual obstructive sleep apnea hypopnea events and correcting hypercapnia simultaneously. The overall purpose of this study is to compare the curative effects between fixed BiPAP and auto-trilevel ventilations on OS patients.
|
The contradiction in treatment for overlap syndrome is how to improve hypercapnia because of narrower difference between inspiratory positive airway pressure (IPAP) and expiratory positive airway pressure (EPAP), and meanwhile to eliminate apnea and popnea events which may easily occur at the end of expiration For ordinary Bipap ventilator. If the IPAP is set to higher, the patients may feel discomfort, if the pressure difference between IPAP and EPAP is too narrow or the expiratory positive airway pressure (EPAP) too high, hypercapnia may occur. If the EPAP is too low, redusual apnea and hypopnea event may become common.
Auto-trilevel ventilation, with a lower airway pressure at the beginning of expiration to prevent hypercapnia and a higher airway pressure at the end of expiration to prevent residual apnea events, should be able to provide a novel ventilation mode with a higher efficacy and lower average airway pressure for overlap syndrome. To prove the hypothesis, comparison is made between ordinary BiPAP and auto-Trilevel ventilation modes during treatment for patients with overlap syndrome.
In this study, the investigators compare the changes of related indexes including apnea hypopnea index、minimal pulse oxygen saturation、arousal index, sleep quality,PaCO2 and sleepiness scores) before and on treatment. Meanwhile, curative effects will be compared between BiPAP and auto-Trilevel ventilation modes. The investigators will analyze the changes and then confirm our hypothesis.
|
Inclusion Criteria:
1. Patient or legal representative of the patient is willing and able to sign an approved informed consent and privacy protection authorization in the United States.
2. Subject is \>18 years old.
3. Diagnosed overlap syndrome(OSAS and COPD). 4. Expected to tolerate the ventilator therapy .
Exclusion Criteria:
1. Patient is currently enrolled in another clinical study which may confound the result of this study.
2. Patient for who inform consent cannot be obtained.
3. Patients with a history of cerebrovascular accident within the 6 months prior to this study.
4. Patients with acute or chronic renal failure, diabetes and severe lung diseases.
5. Patients with unstable angina.
6. Patient who is of pregnant or during lactation period.
7. Patients with a history of injury or surgery within 6 months prior to the study.
|
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] |
NCT06910826
|
Visual Education for Spinal Anesthesia Acceptance
|
Primary outcome: To determine the incidence of spinal anesthesia preference after exposure to the visual information catalog.
Secondary outcomes: To analyze independent (age, education, profession, previous experiences) and dependent (fear, anxiety) factors influencing patient choices.
|
Inclusion Criteria:
* Aged 18-45
* who are undergoing elective cesarean sections
* and classified as ASA I-II according to the American Society of Anesthesiologists (ASA) scale
Exclusion Criteria:
* patients under 18 or over 45 years old,
* emergency cesareans,
* preeclampsia,
* cardiovascular disorders,
* fetal abnormalities,
* those not receiving spinal anesthesia or converted to general anesthesia during surgery,
* those who refuse to participate in the study,
* hospital clinical or administrative staff,
* patients with psychiatric disorders
|
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|
NCT03062891
|
Sleep Treatment Outcome Predictors: A Pilot Study (STOP-pilot)
|
Insomnia occurs frequently causing a substantial burden to society (1). Historically, insomnia has been considered as secondary to a handful of other psychiatric disorders, such as depression and anxiety - but it is now clear that this disorder is associated with a wide range of psychiatric conditions and may actually precede and predict their development and severity (e.g. 2). Treating insomnia has been posited to hold the promise of reducing or preventing the development of co-morbid problems - although this possibility needs to be rigorously tested.
Cognitive behavioural therapy (CBT) is an effective treatment for disturbed sleep, specifically insomnia, in adults (3) and is recommended by NICE for the management of long-term sleep problems. This treatment is more accessible than ever before given recent ground-breaking internet initiatives - such as the Sleepio programme (see: https://www.sleepio.com/home/), which was developed by one of the collaborators (Colin Espie) and has yielded encouraging results (4).
Despite the importance of CBT for treating disturbed sleep and the finding that it leads to a good outcome for the majority of sufferers, some people fail to respond to this treatment. For example, research cited on the Sleepio website notes that around 70% of those with even very long term sleep difficulties experience long-term improvements from the treatment, meaning that 30% do not (see 4). Understanding more about who does and does not respond holds the promise of improving or tailoring treatments for insomnia.
The study proposed here builds on recent work by one of the researchers who has been exploring demographic (5), clinical (e.g. 6) and most uniquely genetic (e.g. 7); and epigenetic (e.g. 8) predictors of psychological treatment response (coining the term Therapygenetics, see, 7). While these predictors are individually only likely to explain a small proportion of the variance of treatment outcome, understanding these multiple risks and their interaction is the best way to consider this issue. The study addressed here is a pilot study, necessary to demonstrate feasibility of utilising a sleep intervention application in an unselected sample of young adults, prior to applying for grant funding to undertake a larger but similar behavioural genetics study in the future.
The main aim of this pilot study is to test the feasibility of the study design, by investigating whether unselected participants show an improvement in sleep quality after taking the intervention. Participation and drop out rates as well acceptability of the intervention in a non-clinical population will also be investigated.
Research Questions:
1. Does the online CBT intervention improve sleep quality in a non-clinical, unselected sample?
2. How feasible is it to run this study on a non-clinical sample? This will include investigating response rate, participant drop-out, and treatment accessibility.
The investigators will also offer perform preliminary investigations into:
3. Does improving sleep quality have implications for associated phenotypes? Specifically the investigators will examine symptoms of anxiety, depression, attention-deficit hyperactivity disorder (ADHD), psychosis, and well-being.
4. Which demographic, clinical, genetic, and epigenetic factors predict treatment outcome for sleep problems?
Research questions 3) and 4) will be primary aims in the main study, but will constitute secondary aims in the pilot study as there won't be the statistical power to fully address these questions.
|
Inclusion
* Female
* Aged 18 plus
* Psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
Exclusion
* Male
* Under 18
* Not a psychology student (undergraduate or postgraduate) at one of three London universities involved in the study.
|
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] |
|
NCT00846989
|
Efficacy, Tolerability and Safety of RKI983 (0.05% & 0.10%) vs Xalatan in Patients With POAG or Ocular Hypertension
|
This purpose of this study is to access the efficacy, tolerability and safety of RKI983 (0.05% and 0.10%) ophthalmic solution bid versus once daily latanoprost 0.005%, in patients with POAG or ocular hypertension.
|
Inclusion Criteria:
* Females must be post-menopausal or surgically sterile, or must use concomitantly two acceptable forms of effective contraception
* Clinical diagnosis of POAG or OH
* For study eyes not previously treated with anti-glaucoma medications
* IOP must be ≥ 22 mm Hg at least at two assessment time-points at Screening, and
* IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline, and
* IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Screening and Baseline assessment time-points.
* Or for study eyes previously treated with anti-glaucoma medications
* IOP must be ≥ 14 mm Hg and ≤ 24 mm Hg at least at two assessment time-points at Screening.
* IOP must be ≥ 22 mm Hg at least at two assessment time-points at Baseline (after wash-out)
* IOP must be ≥ 20 mm Hg and ≤ 36 mm Hg at all Baseline assessment time-points
Exclusion Criteria:
* History of or current clinically significant ocular conditions in either eye that would contraindicate the use of an investigational drug or latanoprost (e.g. active intraocular inflammation), or that might affect interpretation of the results of the study.
* History or presence of clinically significant medical problems that contraindicate the use of an investigational drug or latanoprost, including but not limited to:
* Uncontrolled hypertension with systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg measured at more than one blood pressure reading at Screening or Baseline;
* myocardial infarction within the 3 months period prior to randomization;
* active severe viral infections such as active encephalitis, meningitis, hepatitis, herpes simplex, or herpes zoster (minor viral upper respiratory infections such as colds do not require exclusion.)
* Presence of moderate or severe (grade 2 or 3) conjunctival hyperemia in the study eye at Baseline Visit.
* Argon laser trabeculoplasty or any prior IOP lowering surgery in the study eye.
* Ocular surgery in the study eye within 3 months prior to the Screening Visit.
Other protocol-defined inclusion/exclusion criteria may apply
|
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] |
|
NCT05352932
|
Establishment of Clinical Staging of Chronic Pancreatitis Based on Histopathology of Pancreatic Duct Biopsy
|
This study intends to establish the clinical staging of chronic pancreatitis based on histopathology through pancreatic duct biopsy technology.
|
Chronic pancreatitis (CP) is an inflammatory disease that can causes progressive fibrosis of pancreatic tissue and eventually leads to damage of pancreatic exocrine and endocrine. According to statistics, the prevalence of CP in China is 13/10 million, which is still increasing. Pancreatic duct stones are the most important pathological changes of CP. More than 50% of patients with CP are accompanied by pancreatic duct stones, which can lead to pancreatic duct obstruction, hypertension and tissue ischemia. Removal of pancreatic duct stones under Endoscopic retrograde cholangiopancreatography (ERCP) are the first choice.
Pathological features of CP include pancreatic parenchymal atrophy and interstitial fibrosis resulting from chronic inflammatory damage. Although there are numerous criteria for clinical staging and severity grading of CP, they all have their own limitations, and none of them have been validated by randomized controlled trials. There is also no clear definition of the clinical stage and severity of CP in the guidelines for the diagnosis and treatment of CP. According to the "Clinical Guideline: Chronic Pancreatitis" issued by the American College of Gastroenterology in 2020, histopathology is the "gold standard" for the diagnosis of CP.
In the past ten years, the technology of mother-daughter scope has developed rapidly. The duodenoscope is used as the mother scope, and the cholangiopancreatoscope is used as the daughter scope. The optical fiber or digital imaging system carried by the daughter scope can directly observe the internal situation of the pancreatic and bile ducts. The channel allows the endoscopist to precisely biopsy the wall of the main pancreatic duct with a biopsy forceps. This technology improves the predicament of pancreatic tissue biopsy in the past, allowing ERCP treatment in patients with CP and pancreatic tissue biopsy to be carried out simultaneously.
|
Inclusion Criteria:
* Patients with chronic pancreatitis or idiopathic recurrent acute pancreatitis;
* In line with the indications for ERCP treatment.
Exclusion Criteria:
* suspected to have malignant tumors;
* history of pancreatic surgery or gastrojejunostomy (Billroth II);
* bile duct stricture secondary to cholangitis or chronic pancreatitis;
* acute pancreatitis exacerbation or acute exacerbation of chronic pancreatitis;
* coagulation dysfunction (INR≥1.5 or platelet count≤50×10\^9/L);
* pregnant or breastfeeding women;
* patients who refused to participate in the study.
|
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] |
NCT06512376
|
Hereditary Cerebral Small Vessel Diseases Registry-Trial Ready Cohort
|
We took hereditary cerebral small vessel disease (hCSVD) patients as our main subjects, aiming to establish a platform for a comprehensive evaluation and long-term follow-up. Deeply explore the pathophysiological mechanism of hCSVD, which may render the theoretical basis for the treatment and management of hCSVD.
|
Cerebral Small Vessel Disease is a series of clinical, imaging, and pathological syndromes caused by a variety of risk factors affecting cerebral arterioles, arterioles, capillaries, and venules, accounting for 20% of stroke and 45% of dementia.
Although the incidence rate of hereditary small cerebral vascular disease is low, because of its early onset, high disability rate, and lack of effective treatment, it also brings a heavy burden to the patients and their families. Therefore, it is important to study the pathogenic gene, pathogenesis, clinical characteristics, and imaging manifestations of hereditary cerebrovascular disease to provide a theoretical basis for the treatment and prevention of hereditary cerebrovascular disease in the future.
This multi-center, prospective, continuous, registry study, runs from 2022 to 2027. The study is expected to recruit 100 subjects, according to the sample size design of the registry study.
We recruited patients with the hereditary cerebral small-vessel disease (hCSVD) intending to establish a platform for a comprehensive assessment and long-term follow-up by collecting genetics, imaging, and clinical symptoms of the primary disease and its relatives. With long-term follow-up of the development and prognosis of imaging and clinical symptoms combined with genetics, we will work on the correlation between genes and phenotype and deeply explore the pathophysiological mechanism of hCSVD, which may render the theoretical basis for the treatment and management of hCSVD.
|
Inclusion Criteria:
1. All ages, male or female
2. Carriers of the pathogenic genes mutation (mutation with unknown clinical significance/ suspected pathogenic mutation/ pathogenic mutation) of hCSVD confirmed by the gene tests, including but not limited to NOTCH3, HTPA1, CTSA, GLA, TREX1, COL4A1/2, or highly-suspected hCSVD2
3. CSVD related abnormalities on brain MRI, any 1 or more of:
1. White matter hyperintensities, Fazekas score3 ≥1
2. ≥1 newly-occurred lacunar infarcts
3. ≥1 old lacunar infarcts
4. ≥3 cerebral microbleeds
4. Informed consent signed
Exclusion Criteria:
1. Diagnosis of mental disorders according to DSM-V and unable to be compliant to the research
2. Patients with life expectancy less than one year due to any advanced disease, e.g., malignant tumor
3. Patients unable to return for follow-up visits due to some reasons
|
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] |
NCT05848557
|
mSaada: A Mobile Health Tool
|
In the R21 phase of this project, investigators will: (1) work with key stakeholders and local and international developers to finalize the mSaada platform, building on the existing prototype to add patient and specimen tracking functionality; and (2) carry out a pilot to identify the patient, provider and health system factors necessary to design a trial to evaluate mSaada effectiveness in assisting community health volunteer-led home-based HPV screening, and implementation factors. Investigators will carry out a six-month pilot of mSaada with community units in two health facilities providing HPV-based screening, and use performance metrics including system usage rates, workflow observations and qualitative data to guide the planning of a to determine effectiveness.
In the R33 phase of the project, investigators plan to: (1) conduct an 18-month c-RCT across 12 health facilities to determine the impact of mSaada on cervical cancer screening uptake, treatment acquisition and cervical cancer knowledge levels among women in the community; and (2) measure the requisite implementation factors for mSaada effectiveness, sustainability, and scale-up. The rigorous study design will allow us to determine the clinical impact of mSaada, ensure the local and regional infrastructure has the capacity necessary for sustainability and develop strategies for widespread implementation and scale-up. Collaboration with key stakeholders from the Kenya Ministry of Health will facilitate the development of a long-term sustainability plan as the country moves toward HPV-based cervical cancer screening. Investigators anticipate the mSaada platform will play a pivotal role in facilitating the introduction of HPV-based screening programs that can reach women in settings with limited health care infrastructure.
|
R21 Aim 1 Community health volunteers (CHVs), facility providers and supervisors, Ministry of Health officials
Inclusion Criteria:
* 18 years or older
* be employed by a government clinic
* be working in cervical cancer screening
Exclusion Criteria:
* Does not understand the study purpose and details
* Is not willing to provide informed consent
Women
Inclusion Criteria:
- between 30 and 65 years old
Exclusion Criteria:
* Does not understand the study purpose and details
* Is not willing to provide informed consent
Aim 2 Community health volunteers (CHVs)
Inclusion Criteria:
* 18 years or older
* be employed by a government clinic
* be working in cervical cancer screening
Exclusion Criteria:
* Does not understand the study purpose and details
* Is not willing to provide informed consent
Women
Inclusion Criteria:
* between 30 and 65 years old
* intact cervix and uterus
* able to provide informed consent.
Exclusion Criteria:
* Does not understand the study purpose and details
* Is not willing to provide informed consent
R33
Eligibility criteria for women participants include:
1. reside within Kisumu County,
2. have access to government health facilities with capacity to provide HPV testing,
3. are eligible for cervical cancer screening per the Kenya Ministry of Health guidelines (women who are between ages 30-65 and have an intact uterus and cervix) and
4. ability to provide informed consent.
Eligibility criteria for CHV participants include:
1. reside within Kisumu County,
2. work in government health facilities that deliver cervical cancer screening and treatment to women, and 3) ability to provide informed consent.
|
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] |
|
NCT05085444
|
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
|
A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma
|
Autoimmune diseases only show local pathological damage, but more often systemic lesions. If not diagnosed and treated in time or poorly controlled, a risk of disability or even death as the course of the disease progresses. Studies have shown that B cells can present their own antigens to autoimmune T cells to promote the release of inflammatory factors, or they can differentiate into plasma cells to release autoantibodies, and play an important role in the occurrence and progression of autoimmune diseases. In recent years, it has become a major research focus to deplete B cells in patients or inhibit B cell function. This research focuses on CAR-T cells killing B cells. This fully reflects the application prospects of CAR-T cells in autoimmune diseases.
Based on the current research progress, our center intends to conduct research on the safety and effectiveness of CD19/BCMA CAR-T cells in the treatment of refractory scleroderma
|
Inclusion Criteria:
1. Scleroderma with positive CD19/BCMA expression , and the conventional treatment is not effective and (or) no effective treatment
2. Estimated survival time\> 12 weeks;
3. Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up;
4. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion Criteria:
* Subjects with any of the following exclusion criteria were not eligible for this trial:
1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids;
7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
8. Other uncontrolled diseases that were not suitable for this trial;
9. Patients with HIV infection;
10. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study
11. Platelets ≥30×10E9/L, and absolute lymphocyte count ≥1.0×10E9/L
12. Methylprednisolone (maximum dose 1mg/kg) or prednisone (maximum dose 1.25mg/kg) instead of immunosuppressive agents to control the disease.
|
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] |
NCT06539481
|
Open Label Trial Studying the Safety and Effectiveness of ILUVIEN® (190μg) in Children and Adolescents, Who Have Recurrent Non-infectious Uveitis Affecting the Posterior Segment of the Eye.
|
The main aim is to test how safe and effective the medicine ILUVIEN® (190μg) is for children and adolescents, who have non-infectious uveitis that keeps coming back and affects the back of the eye.
The main thing Alimera wants to find out is how well the implant works for treating non-infectious uveitis in the back of the eye. Treatment success will be measured after 6 months of using the implant.
The treatment will be considered successful if two things happen:
1. No swelling in the back of the eye called cystoid macular oedema;
2. A decrease in the cloudiness inside the eye, called vitreous haze, by at least two levels compared to how it was before the treatment, or the vitreous haze is completely gone.
Participants will:
1. Receive a single treatment with ILUVIEN®, which is a tiny tube that is to be implanted in the eye and releases low levels of the corticosteroid (fluocinolone acetonide) in the eye for up to 36 months.
2. Be followed for 36 months for checkups and tests
|
Inclusion Criteria:
* Males and females of ≥6 and \<18 years of age at time of consent
* Non-infectious posterior, intermediate or panuveitis in the study eye with a history of recurrence ≥1 per year as assessed by the Investigator
* Uveitis in the study eye not adequately controlled by the preferred standard of care due to intolerable adverse effects or poor response, in the judgment of the Investigator
* Treatment with systemic corticosteroid or other systemic therapies given for at least 3 months within the previous 12 months prior to Day 1
Exclusion Criteria:
* History of intraocular surgery in the study eye within 90 days of the screening visit.
* Hypersensitivity to FA or any component of ILUVIEN®
* History of any form of glaucoma or ocular hypertension in study eye, unless study eye has been previously treated with an incisional IOP-lowering surgical procedure at least 90 days prior to the screening visit and that procedure has resulted in stable IOP in the normal range (10-21 mmHg)
* Increased intraocular pressure \>25 mmHg or that required treatment including increases in medications, surgery (other than drainage surgery), or hospitalisations, within 4 weeks prior to baseline that, in the opinion of the Investigator, would pose an unacceptable risk to the patient participating in the study
|
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] |
|
NCT02034565
|
Phase 1 Bioavailability Study of Apixaban Solution Formulation Relative to Apixaban Tablets in Healthy Subjects
|
The purpose of this study is to assess the oral bioavailability of Apixaban solution formulation (Treatment B, 10 mg as 25 mL x 0.4 mg/mL) relative to Apixaban tablets (Treatment A, 10 mg as 2 x 5 mg tablets) in healthy subjects.
|
Inclusion Criteria:
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion Criteria:
* Any significant acute or chronic medical illness or relevant trauma (e.g., history of chronic hypertension, bacterial endocarditis, hemorrhagic stroke, motor vehicle accident resulting in significant head trauma or internal injuries)
* History or evidence of abnormal bleeding or coagulation disorder (e.g., easy bruising or gingival bleeding, prolonged bleeding after dental extraction, postpartum, or after trauma, wounds or surgery)
|
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] |
|
NCT02964091
|
Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World
|
The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.
|
This is an open-label single arm study that will evaluate the antiviral efficacy, safety and tolerability of ledipasvir/sofosbuvir fixed dose combination administered for 12 weeks in HCV treatment-naive and treatment-experienced participants with chronic genotype 1 or 4 HCV infection. Approximately 240 participants will be enrolled and treated with sofosbuvir (SOF) 400 mg/LDV 90 mg fixed dose combination (FDC) one tablet once daily for 12 weeks in the SHARED 1 study. Sixty additional participants will be enrolled in the SHARED 2 sub-cohort with laboratory monitoring blinded to study clinicians.
|
Inclusion Criteria:
* patients that are willing and able to provide written informed consent
* age ≥ 18 years
* HCV RNA ≥ 103 IU/mL
* HCV genotype 1 or 4
* screening ultrasound excluding hepatocellular carcinoma (HCC)
* acceptable laboratory values (hemoglobin ≥8.0 g/dL, platelet count ≥40,000/mm3; AST, ALT, and alkaline phosphatase ≤10 × ULN; creatinine clearance ≥30 mL/min)
* general good health
* ability to comply with study procedures
* HIV-infected patients must have completed at least 6 months of any approved HIV antiretroviral therapy (ART) per Rwanda National Guidelines 2013, have been taking for at least 2 weeks prior to screening ART compatible with SOF/LDV (efavirenz, rilpivirine, raltegravir, dolutegravir, emtricitabine, lamivudine, zidovudine, tenofovir), have screening HIV RNA \< 200 copies/mL, and have screening CD4 T-cell count of ≥100 cells/µL
Exclusion Criteria:
* current or history of clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage)
* active tuberculosis
* other clinically-significant illness (except HCV and/or HIV) or any other major medical disorder
* active Hepatitis B infection
* difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
* any IFN-containing regimen within 8 weeks prior to screening or any prior exposure to HCV-specific direct-acting antiviral agent (other than a NS3/4A protease inhibitor and SOF), current pregnancy or breastfeeding, and active drug or alcohol use or dependence
|
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] |
NCT01552356
|
Pazopanib Hydrochloride in Treating Patients With Advanced or Refractory Solid Tumors
|
This phase I trial studies the side effects and the best dose of pazopanib hydrochloride in treating patients with solid tumors that has spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or does not respond to treatment (refractory). Pazopanib hydrochloride may prevent the growth of new blood vessels that tumors need to grow. Studying samples of blood in the laboratory from patients receiving pazopanib hydrochloride may help doctors learn more about the effects of the body on the drug. It may also help doctors understand how well patients respond to treatment.
|
PRIMARY OBJECTIVES:
I. To assess the feasibility and safety of individualizing pazopanib (pazopanib hydrochloride) monotherapy based upon attained pazopanib plasma concentrations so as to achieve desired target pazopanib plasma concentration in the highest possible fraction of treated patients.
SECONDARY OBJECTIVES:
I. To assess whether patient cytochrome P450 (CYP) or other polymorphisms may correlate with attained pazopanib levels in response to standard pazopanib dosing.
II. To assess whether patient trough pazopanib levels attained 24 hours after initiation of 800 mg daily fasting may predict steady state trough pazopanib levels after 14 days of pazopanib administration.
III. To assess whether patient trough pazopanib levels may correlate with observed pazopanib toxicities.
OUTLINE: This is a dose-escalation study.
Patients receive pazopanib hydrochloride orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Course length can be extended to 56 days at the discretion of the treating physician after 12 courses (1 year) of treatment on study.
After completion of study treatment, patients are followed up for 3 months.
|
Inclusion Criteria:
* Histologic proof of cancer which is now not amenable to alternative curative or clearly superior standard treatment options
* Measurable disease
* Hemoglobin (Hgb) \>= 8.0 g/dL
* Absolute neutrophil count (ANC) \>= 1,500/uL
* Platelet (PLT) = 100,000/uL
* Activated partial thromboplastin time (APTT) \< 1.2 times upper limit of normal (ULN); (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
* International normalized ratio (INR) \< 1.2 times ULN; (Note: use of warfarin is prohibited; low molecular weight heparin is allowed, so long as these criteria are met)
* Direct bilirubin =\< 1.5 X upper limit of normal (ULN) (subjects with Gilbert's syndrome and elevations of indirect bilirubin only are eligible)
* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 2.5 X ULN
* Creatinine =\< 1.5 times ULN OR measured creatinine clearance of \>= 60 mL/min 1.73 m\^2
* Urine protein/creatinine ratio \< 1 or 24-hour urine \< 1 gram
* \< Grade 2 hypo/hyperkalemia
* \< Grade 3 hypo/hypercalcemia
* \< Grade 3 hypo/hyperphosphatemia
* \< Grade 3 hypo/hypermagnesemia
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
* Ability to provide informed consent
* Willing to return to Mayo Clinic for follow up
* Life expectancy \>= 84 days (3 months)
* Willingness to provide mandatory blood samples for pazopanib drug level assessments required for dosage adjustments, as well as for required pharmacogenomic studies
* Women of childbearing potential only: negative serum pregnancy test done =\< 14 days prior to registration
Exclusion Criteria:
* Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
* Corrected QT interval (QTc) \>= 480 msec and/or receiving any concomitant medications that are associated with a risk of QTc prolongation and/or torsades de pointes; NOTE: these medications should be discontinued or replaced with drugs that do not carry these risks
* Subjects with any of the following cardiovascular conditions within the past 6 months
* Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
* Admission for unstable angina
* Myocardial infarction
* Cardiac angioplasty or stenting
* Coronary artery bypass graft surgery
* Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
* Arterial thrombosis
* Symptomatic peripheral vascular disease
* Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
* Active cardiac arrhythmia (except sinus arrhythmia, atrial fibrillation, asymptomatic premature ventricular contractions \[PVCs\])
* Ejection fraction \< institutional lower limit of normal (LLN) and/or history of cardiomyopathy
* Receiving a medication with known risk of torsades de pointes; the following medications are specifically prohibited: amiodarone, arsenic trioxide, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, disopyramide, dofetilide, dolasetron, droperidol, erythromycin, halofantrine, haloperidol, ibutilide levomethadyl, mesoridazine, methadone, pentamidine, pimozide, procainamide, quinidine, sotalol, sparfloxacin, and thioridazine; patients should be watched carefully for indications of torsades de pointes, such as syncope; performing additional electrocardiograms (EKGs) on subjects who must take one or more of these medications is not required; however, additional investigations, including EKGs, may be performed as per the treating physician's judgment
* Blood pressure (BP) \> 140 mmHg (systolic) and \> 90 mmHg (diastolic); initiation or adjustment of BP medication is permitted prior to registration provided that the average of three BP readings at a visit prior to registration is \< 140/90 mmHg
* Any of the following prior therapies:
* Chemotherapy =\< 28 days prior to registration
* Mitomycin C/nitrosoureas =\< 42 days prior to registration
* Immunotherapy =\< 28 days prior to registration
* Biologic therapy =\< 28 days prior to registration
* Radiation therapy =\< 28 days prior to registration
* Radiation to \> 25% of bone marrow
* Failure to fully recover from acute, reversible effects of prior chemotherapy (other anti-neoplastic therapy) and radiation therapy
* Subjects with known brain metastases
* Any of the following:
* Pregnant women
* Nursing women
* Men or women of childbearing potential who are unwilling to employ adequate contraception
* Other concurrent chemotherapy, immunotherapy, radiotherapy, or any ancillary therapy considered investigational (utilized for a non-Food and Drug Administration \[FDA\]-approved indication and in the context of a research investigation); Note: concomitant use of zoledronic acid, pamidronate or denosumab is allowed (and can be initiated while patients are on study therapy at investigator discretion)
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
* Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 counts \< 200
* Receiving any other investigational agent
* Other active malignancy =\< 3 years prior to registration; EXCEPTIONS: non-melanotic skin cancer or carcinoma-in-situ of the cervix; NOTE: if there is a history or prior malignancy, they must not be receiving other specific treatment (e.g. hormonal or chemotherapy) for their cancer
* Prior use of pazopanib (prior use of other kinase inhibitors allowed)
* Receiving any medications or substances that are strong or moderate inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) (indinavir, nelfinavir, atazanavir, ritonavir, clarithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, saquinavir, telithromycin, aprepitant, erythromycin, fluconazole, grapefruit juice, verapamil, diltiazem); use of the aforementioned strong or moderate inhibitors is prohibited \< 7 days prior to registration
* Receiving any medications or substances that are inducers of CYP3A4 (efavirenz, nevirapine, carbamazepine, modafinil, phenobarbital, phenytoin, pioglitazone, rifabutin, rifampin, St. John's wort); use of the aforementioned inducers is prohibited =\< 7 days prior to registration
* Receiving mitotane within 6 months of enrolling on the study
* Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:
* Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills
* Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
* Active peptic ulcer disease
* Malabsorption syndrome
* Any of the following conditions:
* Serious or non-healing wound, ulcer, or bone fracture
* Current use of therapeutic warfarin; Note: low molecular weight heparin is allowed; prothrombin time (PT)/partial thromboplastin time (PTT) must meet the inclusion criteria
* History of bleeding disorder, including patients afflicted with hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding
* History of hemoptysis in excess of 2.5 mL (1/2 teaspoon ) within 8 weeks prior to first dose of study drug
* Poorly controlled depression or anxiety disorder, or recent (=\< 6 months) suicidal ideation
* HIV-positive patients on combination antiretroviral therapy; appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated
* Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including
* Active peptic ulcer disease
* Known intraluminal metastatic lesions
* Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
* History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment
|
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] |
NCT05365659
|
IKS03 in Patients with Advanced B Cell Non-Hodgkin Lymphomas
|
This first-in-human study will evaluate the recommended dose for further clinical development, safety, tolerability, antineoplastic activity, immunogenicity, pharmacokinetics and pharmacodynamics of IKS03, a CD19 targeting antibody-drug conjugate, in patients with advanced B cell non-Hodgkin lymphoma (NHL).
|
The study will consist of 2 parts: dose-escalation (Part 1) and dose-expansion (Part 2). The dose-escalation part (Part 1) of the study is to evaluate the safety and tolerability of increasing dose levels of IKS03 to establish a recommended dose for expansion (RDE); and the dose-expansion part (Part 2) of the study is to further evaluate the safety, pharmacokinetics/pharmacodynamics, and efficacy of IKS03 at the RDE.
|
Inclusion Criteria:
1. Males or females, ≥ 18 years of age
2. Part 1: documented B cell NHL (any subtype except Burkitt lymphoma, Waldenström macroglobulinemia, chronic lymphocytic leukemia); previously confirmed CD19-positive if feasible
3. Part 2: documented B cell NHL (subtypes to be determined); confirmed CD19-positive; possible expansion cohorts may include:
1. Diffuse large B cell lymphoma (including germinal center B cell type, activated B cell type)
2. Follicular lymphoma (including duodenal-type follicular lymphoma)
3. Mantle cell lymphoma
4. B cell lymphomas not specified
4. If B cell NHL subtype likely to have bone marrow involvement must be willing to undergo bone marrow biopsy in the event of an on-study complete response to confirm response
5. NHL that is relapsed, refractory to, or intolerant of existing therapy(ies) with known curative potential, or for which no standard therapy is available; must have received at least 2 prior lines of systemic therapy
6. Must be in need of systemic treatment and not require immediate cytoreductive therapy
7. Part 1: measurable or non-measurable disease
8. Part 2: measurable disease according to The Revised Criteria/Lugano Classification
9. Part 1: screening tumor biopsy requested, but optional; Part 2: patient must agree to screening tumor biopsy
10. ECOG performance status 0 or 1; anticipated life expectancy ≥ 10 weeks
11. Women of childbearing potential and fertile men agreeing to use two effective methods of contraception (including a highly effective method of contraception); women beginning 2 weeks prior to the first dose, men beginning prior to the first dose, and both continuing until 8 months after the last dose of study drug; male patients must also agree to refrain from sperm donation during this period.
12. Ability to understand and give written informed consent
Exclusion Criteria:
1. Women who are pregnant or intending to become pregnant before, during, or within 8 months after the last dose of study drug; women who are breastfeeding
2. Patients documented to be CD19-negative
3. Central nervous system (CNS) lymphoma, leptomeningeal infiltration, or spinal cord compression not controlled by prior surgery or radiotherapy; symptoms suggesting CNS involvement
4. Part 2: History of another malignancy within 2 years, with the exception of:
1. Treated, non-melanoma skin cancers
2. Treated carcinoma in situ (e.g., breast, cervix)
3. Controlled, superficial carcinoma of the urinary bladder
4. T1a or b prostate carcinoma treated according to standard of care, with PSA within normal limits
5. Papillary thyroid carcinoma Stage I treated surgically for cure
5. Any of the following hematologic abnormalities at baseline (transfusion allowed \> 5 days previous):
1. Hemoglobin \< 8.0 g/dL
2. Absolute neutrophil count \< 1,000 per mm3
3. Platelet count \< 75,000 per mm3
6. Any of the following laboratory abnormalities at baseline:
1. Total bilirubin \> 1.5 × upper limit of normal (ULN); \> 3 × ULN if with Gilbert's Syndrome
2. AST or ALT \> 3 × ULN; \> 5 × ULN if due to hepatic involvement by tumor
3. Estimated GFR ≤ 60 mL/min corrected for BSA
4. Albuminuria defined as urine albumin to creatinine ratio \< 30 mg/g or \< 3 mg/mmol) by spot urine albumin
7. Any of the following coagulation parameter abnormalities at baseline unless on a stable dose of anticoagulant therapy for a prior thrombotic event:
1. PT or INR \> 1.5 × ULN; \> 3× ULN if anticoagulated)
2. PTT \> 1.5 × ULN; \> 3× ULN if anticoagulated
8. Any of the following laboratory abnormalities at baseline aimed at assessing renal function:
1. Estimated glomerular filtration rate (eGFR) ≤ 60 mL/min, corrected for BSA.
2. Albuminuria defined as urine albumin to creatinine ratio (UACR) ≥ 30 mg/g or ≥ 3 mg/mmol by spot urine albumin
9. Patients with:
1. Active thrombosis, or a history of deep vein thrombosis or pulmonary embolism, within 4 weeks unless adequately treated and stable
2. Active uncontrolled bleeding or a known bleeding diathesis
10. Significant cardiovascular disease or condition, including:
1. Congestive heart failure or angina pectoris requiring therapy
2. Ventricular arrhythmia requiring therapy or other uncontrolled arrhythmia
3. Severe conduction disturbance (e.g., 3rd degree heart block)
4. QTc interval ≥ 480 milliseconds
5. Left ventricular ejection fraction below the lower limit of normal or \< 50% by MUGA scan or echocardiogram
6. Class III or IV cardiovascular disease according to the New York Heart Association Functional Classification
7. History of acute coronary syndromes (e.g., MI, unstable angina), coronary angioplasty, stenting, or bypass within 6 months
11. Significant liver disease, including:
1. Non-infectious hepatitis
2. Hepatic cirrhosis (Child-Pugh Class B and Class C)
12. Significant pulmonary disease or condition, including:
1. Significant symptomatic COPD, as assessed by the Investigator
2. History or any current evidence on imaging studies of interstitial lung disease, pulmonary fibrosis
3. History of pulmonary inflammatory disease, pneumonitis, ARDS
4. History of pneumonia within 6 months
13. Significant corneal disease or condition, including history of or current evidence of keratitis
14. Clinically significant CNS disease or condition including PML, epilepsy, vasculitis, or neurodegenerative disease. Also including TIA or stroke within 6 months
15. Known HIV infection or AIDS
16. Active hepatitis B virus or hepatitis C virus infection
17. Any other serious/active/uncontrolled infection, any infection requiring parenteral antibiotics, or unexplained fever \> 38ºC within 2 weeks
18. Autoimmune disease or condition requiring systemic steroids or other immunosuppressive medications
19. Unresolved Grade \> 1 AE associated with any prior antineoplastic therapy (except persistent Grade 2 alopecia, peripheral neuropathy, decreased hemoglobin, neutropenia, lymphopenia, hypomagnesemia, and/or endocrine end-organ failure being adequately managed by HRT)
20. Known or suspected hypersensitivity to any of the excipients of formulated study drug
21. Inadequate recovery from a surgical procedure, or a major surgical procedure within 4 weeks
22. Any other serious, life-threatening, or unstable preexisting medical condition, including significant organ system dysfunction, or clinically significant laboratory abnormality(ies)
23. A psychiatric disorder or altered mental status that would preclude understanding of the informed consent process
Drugs and Other Treatments to be Excluded:
1. Receipt of:
1. Any CD19-targeted therapy within 3 months
2. Any tumor vaccine within 6 weeks (must have progressed if previously received)
2. Prior autologous/allogeneic CAR-T therapy if known to be CD19-negative after
3. Any other antineoplastic agent for the primary malignancy without delayed toxicity within 4 weeks or 5 plasma half-lives, whichever is shortest (except nitrosoureas and mitomycin C within 6 weeks)
4. Any other investigational treatments within 4 weeks
5. Drugs known to impair renal function, including:
1. NSAIDS within 3 days
2. Aminoglycoside antibiotics, amphotericin B, etc. within 1 week
3. Bisphosphonates within 1 month
6. Prior solid organ transplant
7. Allogeneic HSCT within 6 months, or:
1. If receiving immunosuppression
2. If with active evidence of GVHD
8. Autologous hematopoietic stem cell transplantation (HSCT) within 3 months
9. Radiotherapy:
1. To target lesions within 4 weeks unless progression of the lesion has been documented
2. To non-target lesions within 1 week
10. Live/live-attenuated vaccines against infectious diseases within 4 weeks
11. Immunosuppressive or systemic glucocorticoid therapy (\> 10 mg prednisone daily or equivalent) within 2 weeks
12. Prophylactic use of hematopoietic growth factors within 1 week
13. Herbal therapies and supplements within 2 weeks
14. Strong inhibitors of cytochrome P450 within 2 weeks
|
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] |
NCT03895476
|
To Measure Pain Perception Following De-Epithelized Free Gingival Graft Harvesting
|
This randomized clinical comparative study will evaluate the postoperative pain following the FGG graft harvest procedure technique covered by four different methods for coverage of the palatal donor site.
|
This study will compare the application of :
* hemostatic collagen sponge
* collagen sponge sealed with abio-adhesive material
* Platelet rich fibrin
* physical barrier (stent) on the palatal donor sites with the purpose of which one of these will result in least postoperative pain after epithelialized gingival graft (EGG) harvesting.
|
Inclusion Criteria:
* English speaking
* At least 18 years old- 70 years old
* Must be a patient of the UAB Dental School
* Able to read and understand informed consent document
* Patients needing soft tissue graft with teeth that have miller class I or II recession (\>=2mm) on the facial aspects
* Presence of periodontally healthy teeth at the recipient site.
* Ability of the participants to maintain good oral hygiene
* Patient not pregnant or breastfeeding
* Not taking medications known to cause gingival enlargement
Exclusion Criteria:
* Non-English speaking
* Less than 18 years old, older than 70 years old
* Smokers/tobacco users
* Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
* Patients that have severe gingival recession (Miller class III and IV) or \< 2 mm.
* Presence of periodontal disease at the recipient site.
* Poor oral hygiene
* Patient pregnant or breastfeeding
* Taking medications known to cause gingival enlargement
|
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] |
NCT02288260
|
RuSsian RegisTry of Acute CoronaRy SyndromE TreAtMent and Approach in Dual Antiplatelet Therapy
|
This NIS is a multi-centre, observational, descriptive, cross-sectional study including all consecutive patients with Acute Coronary Syndrome (ACS) and a single-arm, prospective, longitudinal cohort study which will include patients hospitalized for ACS and who are with ticagrelor on discharge from hospital.
|
Inclusion Criteria:
* Part A,B: Subjects whose data have been entered in the Russian ACS Registry
* PART A,B: Discharged from hospital after MI with ST-segment elevation (STEMI), MI NST segment elevation (NSTEMI) or Unstable angina. Hospitalized during 24 hours of ACS symptoms onset
* Part B: Patients on ticagrelor at the time of discharge from hospital
Exclusion Criteria:
* The existence of serious / severe concomitant diseases which can in the short term (i.e. within 6 months) limit the duration of life
* Current participation in a clinical trial with a non-licensed investigational medicinal product
|
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] |
|
NCT06654635
|
Ultrasound Guided Rhomboid Intercostal Plane Block Versus Thoracic Erector Spinae Plane Block in Upper Abdominal Surgery
|
The aim of the work is to evaluate the analgesic efficacy of ultrasound guided rhomboid intercostal plane block versus ultrasound guided thoracic erector spinae block in patients undergoing upper abdominal surgery.
|
Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period.
The improved safety and efficacy that ultrasound brings to regional anesthesia helped promote its use and realize the benefits that regional anesthesia has over general anesthesia, such as decreased morbidity and mortality, superior postoperative analgesia, cost-effectiveness, decrease postoperative complications and an improved postoperative course .
|
Inclusion Criteria:
* Patients aged 21-65 years.
* Both gender.
* American Society of Anesthesiologists (ASA) classification I-II.
* Presented for elective upper abdominal surgery.
Exclusion Criteria:
* Patients refused to participate.
* Patients with known or suspected allergy to the used medication.
* Patients with preoperative chronic pain.
* Patients with major cardiac, renal, respiratory, or hepatic disease.
* Patients with potential risk of coagulopathy.
* Obese patients with body mass index (BMI) \>35.
|
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] |
NCT04263571
|
Hepcidin as a Predictor for the IVI Mediated Increase in Haemoglobin Levels
|
The study is a multidisciplinary study, which involves all kind of medical specialties. Patients, who are scheduled for elective surgery, will be seen at a multidisciplinary anaesthesia/Patient Blood Management (PBM) clinic and screened for anaemia prior to surgery. Anaemic patients will eventually be treated with 500mg of iron isomaltoside.
|
Hgb levels, standard iron parameters and hepcidin will be assessed. Additional parameters that might influence Hgb or IVI levels will be documented.
All main analyses will be pre-defined in detail in a statistical analysis plan. In order to analyse the responsiveness to IVI, the change in Hgb levels from PBM clinic to day 0 will be analysed using multivariable regression models. The association of change in Hgb and hepcidin will be analysed adjusting for potentially confounding factors as age, gender or number of days from PBM clinic to surgery. The correlation of hepcidin and standard iron parameters will be assessed. Based on the increase in Hgb levels, responders to IVI will be defined. The definition of good- bad responder in terms of delta Hgb levels depends on the time between IVI substitution and surgery. ROC analyses will be performed and potential predictors (e.g. hepcidin, ferritin) will be compared concerning the area under the ROC curve (AUC).
|
Inclusion Criteria:
* informed consent
* iron deficiency anemia
* elective surgery planned during the next 4 to 28 days
Exclusion Criteria:
* Contraindications for an IV iron Infusion severe infections, hepatocellular carcinoma, liver metastases, acute severe asthma, a simultaneous oral iron medication, another IV iron preparation, iron overload, chronic renal failure and regular IV iron substitution
* Pregnancy or lactation
* Allergy against iron
* chronic renal failure on dialysis
* iron overload
|
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] |
NCT05085158
|
Pathogen Detection in HIV-infected Children With Non-malarial Febrile Illnesses Using Metagenomic Sequencing
|
In Uganda, 130,000 children (0-14 years of age) were living with HIV in 2018. Last year, nearly 450 infants acquired HIV every day; most of them during childbirth and these are at extremely high risk of dying in the first two years of life from treatable infections which present with fever. While fevers are commonly attributed to malaria, most fevers in African children are not due to malaria and clinicians are challenged by the similar clinical features of wide spectrum of potential aetiologies. The prevalence of treatable causes of non-malarial febrile illnesses in children in Africa has been reported to be 45%.
|
Rapid diagnostic tests (RDTs) for malaria have highlighted the decreasing proportion of malaria-attributable illness in endemic areas. Unfortunately, once malaria is excluded, there are few accessible diagnostic tools to guide the management of severe febrile illnesses in low-resource settings. RDTs for non-malarial tropical infections currently rely on detection of host antibodies against a single infectious agent yet their sensitivities and specificities are inherently limited. It should be noted that causes of non-malarial febrile illnesses (NMFIs) in HIV-infected children in Uganda remains scarce. There's minimal guidance on how to manage HIV-infected children with NMFIs. Thus, it is important that other causes of fever in African children be better characterized to facilitate optimization of diagnostic and therapeutic algorithms.
Considering these limitations, there is a pressing need for sensitive pathogen-detection-based approaches such as shotgun metagenomics sequencing (sMGS). Ultimately, in the near future, integration of whole-genome based approaches such as long-read sequencing technologies to tropical fevers is urgently needed to improve management of severe and treatable infections especially among the vulnerable groups such as HIV-infected children and adolescents presenting with NMFIs.
This project aims to utilise sMGS to characterize microbial pathogens in HIV-infected Ugandan children and adolescents admitted to Baylor College of Medicine Children's Foundation - Uganda with NMFIs and associated clinical presentations or comorbidities.
|
Inclusion Criteria:
Study population will include a total of 200 (100 who are \<5 years and 100 who are 6-to-14 years, including equal number of female and male study participants) HIV-infected Ugandan children and adolescents admitted with non-malarial febrile illnesses (NMFIs) to Baylor College of Medicine Children's Foundation - Uganda.
Exclusion Criteria:
Critically ill patients will not be recruited.
|
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] |
NCT04050046
|
Noninvasive Brain Stimulation to Enhance Cognitive Training in Older Adults
|
This research study explores the feasibility of pairing computer-based cognitive training (CBCT) with transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation, in order to enhance and preserve mental skills in older adults. The investigators aim to enhance participants ability to perform tasks of memory, attention, processing speed and other areas of cognition. Additionally, researchers are interested in the ability of the brain to adapt to change-neuroplasticity. Neuroplasticity is thought to impact how individuals respond to cognitive training and tDCS. In order to look at individual differences in neuroplasticity transcranial magnetic stimulation (TMS), a noninvasive brain stimulation technique, will be used. Individual responses to TMS can be used as a marker of neuroplastic changes in brain function, in order to reveal the relationship between brain plasticity and tDCS-induced changes in cognitive ability.
|
Promising evidence suggests that cognitive training regimens may have some beneficial effects on cognition in older adults. However, the improvement from computer-based cognitive training (CBCT) diminish over time which highlights a fundamental challenge for CBCT interventions. Transcranial direct current stimulation (tDCS) can enhance certain cognitive skills, particularly when stimulation is combined with rehearsal of relevant behaviors. Importantly, these benefits have been shown to persist up to 2 months after the intervention.
This study will lay the groundwork for larger scale studies that will combine CBCT with neuromodulation, potentially leading to the development of a persistent, transferrable, multimodal technique to preserve cognition in older adults. In this study, participants will be randomly assigned to receive either real or sham tDCS for 5 consecutive days in conjunction with CBCT. The participant's cognition will be assessed with a neuropsychological assessment at baseline, 1 week, 2 weeks, and 2 months in order to determine any changes.
Additionally, transcranial magnetic stimulation (TMS) will be used to characterize the relationship between baseline differences in brain plasticity and cognitive changes induced by tDCS+CBCT. The effects of TMS on cortical activity have been shown to depend on a variety of neuroplasticity-related mechanisms. In this study, changes in motor physiology (called motor evoked potentials (MEPs)) induced by TMS will be used. Stimulation of the motor cortex with TMS induces robust, transient, and readily quantifiable changes in motor excitability, which are sensitive to changes in the mechanisms of neuroplasticity. Investigators hypothesize that individual variability in brain plasticity, measured by changes in MEP response to TMS, will predict the degree of cognitive benefit afforded by tDCS+CBCT.
Study Visits:
---------------- Visit 1 - Consent and Screening (2 hours) Review enrollment documents and conduct baseline neuropsychological assessment
---------------- Visit 2 - Visit 5 - tDCS + CBCT (30 minutes) Subjects will receive either real or sham stimulation along with cognitive training
--------------- Visit 6 - tDCS + CBCT \& Follow-up (3 hours) Subjects will receive either real or sham stimulation along with cognitive training \& follow-up neurospychological assessment
--------------- Visit 7 - TMS (3 hours) Subjects will receive TMS in order to induce MEPs
------------ Visit 8 - 2 week follow-up (1 .5 hours) Follow-up neuropsychological assessment
----------- Visit 9 - 2 month follow-up (1.5 hours) Follow-up neuropsycological assessment
|
Inclusion Criteria:
* Normal cognition
* English as their native language
Exclusion Criteria:
1. . History of neurological disorders
2. . History of head injury with unconsciousness lasting more than 5 minutes
3. . History of psychiatric disorders
4. . Currently abusing alcohol or drugs (prescription or otherwise)
5. . History of epilepsy or seizures within the past 6 months
6. . Previous brain surgery
7. . Pacemaker
|
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] |
NCT00390871
|
Acute Neurological ICU Sedation Trial (ANIST)
|
Dexmedetomidine (Precedex, Hospira) is a "super" selective alpha2-agonist - 8-10x more avid binding to alpha2 receptors than clonidine - and may have particularly favorable characteristics as a continuous i.v. infusion sedative for critically ill neuroscience patients. Its combination of anxiolysis, analgesia, without undue lethargy may make it an ideal agent where frequent neurological examinations are important. Unclear, however, is whether Precedex is superior to current common i.v. sedation protocols, and if there are any undue concerns of this agent on cerebral physiology and cortical stimulation.
|
Dexmedetomidine has shown promise in small case series to be an efficacious sedative agent in the intensive care unit (ICU) setting, in both post-surgical and medical patients. A recent publication reported on the efficacy in a small series of medical patients (n=12), but as part of the exclusion criteria were any serious nervous system trauma or direct central nervous system (CNS) pathology.
A potential advantage of dexmedetomidine as a sedative agent compared to current popular classes of drugs, particularly propofol, benzodiazepines, and narcotics, is the nominal effect on reduction of level of arousal. Experience suggests that this agent may induce effective degrees of sedation without concomitant loss of attentive behavior and cognition following low levels of auditory or tactile stimulation. Thus, neurological assessment may be preserved while achieving the goal of a non-agitated or anxious patient. Additionally, the combination of both sedative/anxiolytic and analgesic action of dexmedetomidine may permit single drug use for both sedation and pain control during the post-operative and medical ICU period.
The cerebral effects of alpha2-agonists have been modestly studied in the clinical environment, and only in normal volunteers. As expected, cerebral blood flow decreased following initiation of the sedative, coincident with the expected diminishment of global cerebral metabolism. No studies have evaluated dexmedetomidine in patients suffering from neurological injury, the very population that may most benefit from the agent's sedative characteristics. Thus, it is imperative that a safety \& efficacy study be carried out in a population of both medical and post-operative neuroscience patients. From an intraoperative perspective, dexmedetomidine has been effectively used as a sedative for both awake and sedation cases. Some evidence suggests prolonged cognitive deficits may persist beyond the sedative action of the drug.
One concern in the neuroscience patient population is laboratory evidence that alpha2-agonists may lower the seizure threshold. Such data has been shown for both clonidine and dexmedetomidine.
Therefore, to provide a comprehensive evaluation leading to successful safety and efficacy data for this sedative, it will be important to perform the following three studies. All three studies will be done concurrently but enrollment between the three studies will be mutually exclusive.
Objective 1: Evaluation of Quality of Sedation: Does dexmedetomidine provide superior sedative characteristics relative to current standard agents in patients with neurological dysfunction? The metrics for such a study will include -
1. Pharmacodynamic ease of sedation: time to goal, required nursing interventions to goal;
2. Quality \& consistency of sedation: ability to examine the patient, number of required titration interventions;
3. Rapid weaning: time to off and no residual effect both hemodynamic and neurologic;
4. Systemic hemodynamic alterations requiring drug infusion adjustment or medical intervention;
5. Side effect and toxicity of sedative infusion: neurological dysfunction - cognitive, motor, sensory; electrolyte/hematological/metabolic disturbances, alteration of drug levels.
Objective 2: Alteration of Cerebral Physiology: Does Dexmedetomidine alter intracranial physiology either in a favorable or unfavorable manner? The metrics for such a study will include -
1. Measures of intracranial pressure (ICP), mean arterial pressure (MAP), cerebral perfusion pressure (CPP);
2. Cognitive neurological state;
3. Cerebral saturation (venous) or direct cerebral oximetry (oxygen tissue level) in a subset population with specific intracranial device.
|
Objective 1: Inclusion Criteria:
Neuroscience patients in the Neuro Critical Care Unit (NCCU) who are:
* 18-80 years of age;
* Mechanically ventilated patients;
* Requiring continuous sedation for a minimum of 9-11 hours (depending on whether or not pt is post-operative), yet frequent neurological examinations or Patients with a Nursing Instrument for Communication of Sedation Score (NICSS) \> 0
* Patient or family able to provide consent.
* Considered to have guarded yet stable neurological state. Not fluctuating intracranial pressure (ICP), cerebral perfusion pressure (CPP), or ongoing known cerebral ischemia if ICP monitoring in place.
Objective 1: Exclusion Criteria:
* Pregnancy.
* ICP\> 30 mm Hg despite therapy if ICP monitored.
* CPP \<70 mm Hg if monitored.
* Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
* Neuromuscular paralysis.
* Non-functional cognitive exam - not following commands.
* Renal insufficiency: Serum Creatinine \>2.0 mg/dl or estimated Cr Clearance \<40.0 ml/min.
* Hepatic disease: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \> 300, or international normalized ratio (INR) \> 1.7 not on anticoagulants.
* Severe chronic obstructive pulmonary disease (COPD) with baseline arterial partial pressure of carbon dioxide (pCO2)\>50.
* Suspected alcohol or substance withdrawal.
* Hypotension - requiring pressor therapy to maintain baseline adequate CPP or mean arterial pressure (MAP).
* Cardiac arrhythmia - sinus bradycardia (HR \<60), atrial fibrillation (\>6 PVC's/min)
* Bradycardia- heart rate less than 60 beats per minute.
* Patient does not require mechanical ventilation.
Objective 2: Inclusion Criteria:
Critically ill neuroscience patients who are:
* 18-80 years of age;
* Mechanically ventilated;
* Require Intracranial Pressure (ICP) monitoring by either subarachnoid bolt (SA bolt), or by an Intra-Ventricular Catheter (IVC).
* Amenable for placement of intra-cerebral oxygen sensor or jugular bulb catheter.
* Have glaucoma coma score (GCS) score \> 5 that requires sedation.
* Requiring continuous sedation for minimum of 9-11 hours (depending on whether or not pt is post-operative) , yet frequent neurological examinations every 1-2 hours or Patients with a NICSS score \> 0
* Patient or family able to provide consent.
Objective 2: Exclusion Criteria:
* Pregnancy;
* ICP\> 30 mm Hg despite therapy; 3) CPP \<70 mm Hg;
* Occurrence of: new cerebral stroke, hemorrhage, or change in edema by CT, increase in ICP if monitored.
* Continuous neuromuscular paralysis
* Renal insufficiency: Serum Creatinine \>2.0 mg/dl or estimated Cr \<40.0 Clearance ml/min.
* Hepatic disease: AST, ALT \> 300, or INR \> 1.7 not on anticoagulants.
* Severe COPD with baseline arterial pCO2\>50.
* Suspected alcohol or substance withdrawal.
|
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] |
NCT06907667
|
Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2
|
Immune response to influenza vaccine in patients with chronic renal insufficiency.
|
Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.
There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.
In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.
On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.
|
Inclusion Criteria:
* Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR \< 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
* Age ≥ 18 years;
* Indication for influenza vaccination;
* Express free and informed consent.
Exclusion Criteria:
* Known hypersensitivity to influenza vaccine or egg proteins;
* Previous influenza vaccination for the current season;
* Current infection;
* Current acute illness;
* Treatments with a major impact on vaccine response:
* Treatment of rejection within the previous 3 months;
* Renal transplantation with induction performed within the previous 6 months;
* Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
* Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
* Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
* Subjects not affiliated to Social Security.
|
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] |
NCT03011606
|
Robotic Surgery After Focal Ablation Therapy
|
The toxicity of traditional prostate cancer therapies including radical surgery and external beam radiation is well known. This has prompted a move towards focal therapy where only the cancerous part of the prostate is treated.
To date, studies have demonstrated very promising outcomes following focal therapy with the majority of men maintaining their urinary and sexual function after therapy.
In a small proportion of men, disease recurs after focal therapy. The optimal treatment for men with recurrent disease after focal therapy is yet to be defined. Patients may undergo further focal therapy to the recurrent disease, undergo radiation therapy, whole-gland therapy using a minimally invasive approach such as High Intensity Focused Ultrasound (HIFU) or cryotherapy. Alternatively patients may undergo radical surgery where the whole prostate is removed.
To date, the side-effects or toxicity of any treatment for recurrent prostate cancer after focal therapy has not been formally studied.
Traditionally, the side effects of surgery and radiation therapy performed in patients that have already undergone previous prostate cancer treatment have been considerable with high rates of urinary incontinence and erectile dysfunction. However, as focal therapy leaves a significant area of the prostate untreated, the investigators believe surgery after focal prostate therapy will be associated with a much lower incidence of urinary and sexual dysfunction.
The aim of the RAFT study is to characterise the side effects of prostate cancer surgery in men that have undergone prior focal ablation therapy. In addition, the investigators wish to perform a number of basic science studies to attempt to better understand why the patient has experienced recurrent prostate cancer after focal therapy.
|
Inclusion criteria:
1. Willingness to provide informed consent
2. Males aged 18 years and over
3. Histological confirmed recurrent/residual adenocarcinoma of the prostate with Gleason score following primary focal prostate cancer ablation therapy. Biopsy must have been performed within 6 months of screening for the study
4. Prior focal ablation therapy using either High Intensity Focused Ultrasound (HIFU), Cryotherapy, brachytherapy, electroporation or Photodynamic therapy
5. Serum Prostate Specific Antigen (PSA) must be below 20
6. Absence of metastatic disease
7. Life expectancy ≥ 10 years
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. MRI imaging to suggest urinary sphincter has not been incorporated in prior ablation therapy
Exclusion Criteria:
1. Serious co-existing medical illness such as chronic active autoimmune disease (within the last 6 months).
2. Other active malignancy over the last 5 years that has required systemic therapy excluding:
1. Adjuvant therapy in the curative setting
2. Non-melanoma skin cancer
3. superficial transitional cell carcinoma
3. No willingness to comply with the procedural requirements of this protocol
4. Coagulopathy/ Cirrhosis
5. Severe obesity defined as a BMI greater than 45
6. Inability to tolerate general anaesthesia
7. Prior pelvic fracture
8. Extensive tethering of the rectum caused by prior ablation therapy
|
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] |
|
NCT01464333
|
Special Investigation (Long-term Investigation) in Patients With Crohn's Disease
|
This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.
|
Inclusion Criteria:
* Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen
* Patients with no past- or present malignant tumors
* Patients who are not currently receiving Humira
Exclusion Criteria:
* None.
|
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] |
|
NCT01635491
|
Gastrointestinal Transit Times and Motility in Healthy Volunteers Obtained by Motilis-3D-transit
|
The purpose of this study is to describe gastrointestinal motility and transit times in healthy subjects by using Motilis 3D-Transit and to compare the total gastrointestinal transit time (GITT) to GITT obtained using radioopaque markers.
The investigators end points are to measure the transit times through different segments of the gastrointestinal canal,e.g. gastric emptying, small intestine, total GITT.
The study is descriptive and is designed to test and evaluate the usefulness of the Motilis 3D-Transit system. The investigators hypothesize, that with the system transit times through different segments of the gastrointestinal canal can be measured.
The design is made for evaluating the transit times, the inter-subject reproducibility and comparison with gold standard for colonic transit time measurement.
The investigators have chosen to include 20 healthy volunteers.The study is descriptive and therefore power calculation is not needed.
|
Inclusion Criteria:
* Healthy Volunteer
* Signed informed consent obtained
* Fasted since midnight
Exclusion Criteria:
* Subject has known GI related symptoms complaints or GI diseases, including swallowing disorders
* Subject has cancer or other life threatening diseases or conditions
* Subject is pregnant
* Subject has undergone abdominal surgery
* Subject has abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Subject's bowel movements are irregular
* Subject has known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Subject has cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Subject takes any medication affecting GI motility
* Subject having MRI within the next four weeks
|
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] |
|
NCT04577326
|
Mesothelin-targeted CAR T-cell Therapy in Patients With Mesothelioma
|
This study will test the safety of MSLN-targeted CAR-T cells at different doses to find the safest dose to give to people with MPM. The researchers want to see what effects, if any, the study treatment has on people with this type of cancer. This study is the first time that an MSLN-targeted CAR-T cell treatment with an anti-PD1 component is being given to people.
|
Inclusion Criteria:
1. Aged ≥18 years
2. Karnofsky performance status ≥70%
3. Pathologically confirmed MPM
1. Epithelioid or biphasic histologic diagnosis provided that ≥10% of the tumor expresses MSLN by IHC analysis
2. Patients with peritoneal mesothelioma with pleural involvement are eligible only if there is radiographic and pathologic confirmation of mesothelioma in the pleural cavity and ≥10% of the tumor expresses MSLN by IHC analysis.
4. Previously treated with at least 1 treatment regimen
5. Measurable or evaluable disease (disease is considered evaluable but not measurable if it does not meet the eligibility criteria for mRECIST but is a manifestation of malignancy that can be followed qualitatively as an indicator of disease progression or treatment response)
6. Chemotherapy, targeted therapy, or radiotherapy must be completed at least 7 days before leukapheresis.
a. CPI must be completed at least 21 days before leukapheresis.
7. Chemotherapy, targeted therapy, or therapeutic radiotherapy must be completed at least 14 days before administration of T cells.
1. Palliative radiotherapy can be completed 2 days before lymphodepletion. Immunotherapy with CPI must be completed at least 42 days before administration of T cells.
9. Any major thoracic (thoracotomy with lung or esophageal resection) or abdominal (laparotomy with organ resection) operation must have occurred at least 28 days before study enrollment. Patients who have undergone diagnostic VATS or laparoscopy can be included in the study.
10. All acute toxic effects of any previous therapeutic or palliative radiotherapy, chemotherapy, or surgical procedures must have resolved to grade 1 (CTCAE v5.0).
11. Lab requirements (hematology):
a. Absolute neutrophil count ≥1.5 K/mcL b. Platelet count ≥100 K/mcL
12. Lab requirements (serum chemistry):
a. Bilirubin ≤1.5x upper limit of normal (ULN) b. Serum alanine aminotransferase and serum aspartate aminotransferase (ALT/AST) level ≤5x ULN c. Serum creatinine level ≤1.5x ULN or creatinine \>1.5x ULN but calculated clearances of \>60 by Cockcroft-Gault Equation
13. Negative screen for infectious disease markers including Hepatitis B core antibody, Hepatitis B surface antigen, Hepatitis C antibody, HIV 1-2 antibody, HTLV 1-2 and Syphilis (rapid plasma regain profile) Note - Patients with history of prior hepatitis B virus (HBV) infection are eligible if the HBV viral load is undetectable. Patients with a history of hepatitis C virus (HCV) infection who were treated for hepatitis C and cured are eligible if hepatitis C viral load is undetectable.
14. Life expectancy at the time of screening ≥4 months
Exclusion Criteria:
1. Patients receiving therapy for concurrent active malignancy
a. Patients receiving treatment for in situ skin malignancies are not excluded.
2. Patients who received prior CAR T-cell therapy
3. Untreated or active central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Patients with a history of treated CNS metastases are eligible if all the following criteria are met:
1. Presence of measurable or evaluable disease outside of the CNS
2. Radiographic demonstration of improvement upon completion of CNS-directed therapy and no evidence of interim progression between completion of CNSdirected therapy and the screening radiographic study
3. Completion of radiotherapy ≥8 weeks before the screening radiographic study
4. Discontinuation of corticosteroids and anticonvulsants ≥4 weeks before the screening radiographic study
4. History of seizure disorder
5. Active autoimmune disease that has required systemic treatment in the past year (with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
a. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
6. Patients who are receiving daily systemic corticosteroids that are above physiological doses for any reason or who are under immunosuppressive or immunomodulatory treatment
7. Patients with the below cardiac conditions:
1. New York Heart Association stage III or IV congestive heart failure
2. Myocardial infarction ≤6 months before enrollment
3. History of myocarditis
4. Serious uncontrolled cardiac arrhythmia, unstable angina, or uncontrolled infection
8. Patients with left ventricular ejection fraction ≤40%
9. Patients with active interstitial lung disease/pneumonitis or a history of interstitial lung disease/pneumonitis requiring treatment with systemic steroids
10. Baseline pulse oximetry \<90% on room air at the screening timepoint
11. Pregnant or lactating women
a. Subjects and their partners with reproductive potential must agree to use an effective form of contraception during treatment and for 1 year following treatment.
12. Known active infection requiring antibiotic treatment 7 days before the start of treatment (Day 0). Note: treatment can be delayed at the discretion of the treating physician to allow the patient to recover from the infection.
13. Administration of live, attenuated vaccine within 8 weeks before the start of treatment (Day 0) and for 100 days following treatment.
14. Any other medical condition that, in the opinion of the PI, may interfere with a subject's participation in or compliance with the study
15. Any patient deemed to be noncompliant by the study team for administration of a high risk treatment agent and for close follow-up after treatment as required by the protocol
16. Patients with known hematologic malignancy requiring treatment in the preceding 5 years or a known history of lymphoid malignancy.
|
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|
NCT03606551
|
EXD-959 Orthodontic Brackets and EXD-961 Related Instruments Trial
|
The purpose of this study is to assess the performance of the EXD-959 self-ligating ceramic bracket system using EXD 961 instruments in the treatment of orthodontic malocclusion. The information gained in this study and other studies will be used to evaluate the clinical performance of the bracket system during orthodontic treatment and to substantiate marketing claims for the bracket system, open/close instrument and de-bonding instrument.
|
This prospective case-series study will evaluate the performance of the EXD-959 ceramic bracket system at baseline (BL), 4, and 6 months post-baseline, and at the time that each subject has their study brackets debonded (approx. 4 to 24 months). Bond failures and adverse events will be tracked throughout the entire study. A total of 78 study subjects will be enrolled in this study (30 new and 48 intercept cases). The patients will be recruited from a total of 6 participating study sites.
Self-Ligating (SL) Practitioners: The sponsor will recruit 4 orthodontist-investigators who have experience using and currently use self-ligating style orthodontic brackets.
Ligating (L) Practitioners: The sponsor will recruit 2 orthodontist-investigators who do NOT currently use self-ligating style orthodontic brackets in their practices. These will be practitioners who currently use brackets that require that either metal or elastomeric ties are used to secure the archwire into the bracket-slots.
Five new and 8 intercept subjects, who meet the inclusion/exclusion criteria and consent/assent to participate, will be enrolled at each study site (n = 13 per site).
* New patient subjects who are just initiating full orthodontic treatment will have their premolars, canines, and incisors bonded with the EXD-959 brackets, using the related EXD-961 instruments, according to the manufacturer's IFU. Their remaining teeth will be bonded with the brackets of the orthodontist's choice. Three of the 5 new patients recruited may be patients that the orthodontist will choose to initiate treatment with the EXD-959 study brackets being applied to the upper teeth only. Having this option will allow the investigators to recruit subjects with deeper over-bites where their standard of care would be to apply esthetic brackets on the upper teeth and metal brackets on the lower teeth.
* Intercept patient subjects: Eight subjects will be recruited from patients who are currently undergoing orthodontic treatment. Their existing treatment will be intercepted. They will have the brackets currently on their upper and lower premolars, canines, and incisors debonded and replaced with the EXD-959 study brackets, preferably using the related EXD-961 instruments, according the manufacturer's IFU. Three of 8 new intercept patients recruited may have treatment initiated on upper teeth only.
* In order to evaluate rotation correction, torque control, bracket and bracket- door durability, and debonding experiences two types of intercept patients will be targeted:
* Intercept - progress: this group will include a minimum of three patients at each study site who have moved into rectangular wires; and in whom, the orthodontist- investigator believes they will be able to evaluate rotation corrections. For example, rotation correction of the upper central incisor which will test the width of the bracket's holding points in situations that have wide teeth and greater inter-bracket distance.
* Intercept-finishing: this group will include a minimum of three patients per study site who are estimated to be within 4 months of completing their orthodontic treatment; and in whom, the orthodontist-investigator believes they will be able to evaluate both torque control and debonding experiences.
As long as they recruit a minimum of 3 subjects in each intercept category, each orthodontist-investigator can then determine the total number of subjects recruited in each of the progress- and finishing-intercept groups in order to reach a total of 8 subjects. For example, at one site they might recruit 3 progress and 5 finishing subjects, while another site might recruit 4 progress and 4 finishing subjects.
In both SL and L practitioners the EXD-959 bracket system will be used in conjunction with the archwires prescribed by the treating orthodontists according to their respective treatment philosophies.
The study patients, treating orthodontists, and orthodontic staff who interact with the study subjects, the EXD brackets, and the EXD instruments will provide feedback related to specific attributes of the product at defined time-points, using the study documents provided by the study sponsor.
|
Inclusion Criteria:
1. Able to understand and willing to voluntarily sign the consent/assent form(s);
2. Willing and able to return to the study facility for scheduled visits and recalls;
3. Have permanent dentition including first molars, premolars, canines, and incisors erupted;
4. Teeth have sound, non-carious buccal enamel, free from white-spot lesions; and,
5. Have good oral hygiene as determined by the orthodontist/dental hygienist.
For intercept patients only:
6. Currently have brackets on their teeth; and,
7. Have begun treatment with rectangular archwires; or, who are in their finishing stage of orthodontic treatment (i.e. they have 3 to 4 months of treatment remaining).
Exclusion Criteria:
1. Currently participating in another clinical study.
2. Difficulty being compliant with study visits, such as those planning or having extensive travel commitments or who lack transportation.
3. Have mental, emotional, or developmental disabilities.
4. Have a complex/surgical case.
5. Have a deep overbite that would result in their maxillary incisor teeth occluding with the ceramic brackets on the mandibular teeth that cannot be avoided.
6. Need essential dental care, i.e., for broken teeth, grossly carious or abscessed teeth.
7. Have dental prostheses/implants that will interfere with projected teeth movement.
8. Have known allergies to product ingredients (e.g. methacrylate resin materials, nickel, chromium).
9. Have a medical or oral condition that, in the investigator's judgement, may compromise the subject's safety or interfere with the conduct and outcome of the study.
|
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] |
NCT01817946
|
Myotubular Myopathy Genetic Testing Study
|
Myotubular myopathy (XLMTM) is an X-linked disorder caused by mutations in the myotubularin gene (MTM1). The clinical spectrum is variable and ranges from individuals who require a wheelchair and full time breathing support to those who are able to walk and breathe on their own. Symptoms of myotubular myopathy include long faces, facial weakness with eye muscle weakness, breathing support with a muscle biopsy demonstrating central nucleated fibers. These symptoms may be caused by mutations or changes in the MTM1, BIN1 (bridging integrator 1), DNM2 (dynamin 2) and RYR1 (ryanodine receptor 1) genes. However, the majority are caused by mutations in the MTM1 gene. Some patients with symptoms consistent with myotubular myopathy who initially have negative testing of the MTM1 gene were later found to have a unique type of change in the MTM1 gene. This unique change, called a deletion or duplication, can be found with a different type of genetic test called a CGH (comparative genomic hybridization) array.
Investigators do not know how frequent deletions and duplications are in patients with X-linked myotubular myopathy. Recently, there have been advances in identifying potential treatments for XLMTM. The next step will be to proceed with clinical trials of potential treatments. In order to be ready for clinical trials, it is important that investigators find the specific genetic change that is causing XLMTM in people with this diagnosis. This study will attempt to find changes in the MTM1 gene in individuals who have clinical symptoms consistent with a diagnosis of XLMTM. Participants will be asked to enroll in the CMDIR (Congenital Muscle Disease International Registry), complete a brief clinical survey, provide access to medical records, and provide a saliva or blood sample for genetic testing. Results of genetic testing will be communicated to participants by the physician specified in the consent by the signing person.
Study Hypothesis:
Not all individuals with a clinical diagnosis of XLMTM have access to genetic testing. Investigators know that deletions and duplications of the MTM1 gene can cause XLMTM. Investigators will find more individuals with XLMTM by performing genetic testing of the MTM1 gene, including CGH array for deletions and duplications.
|
* Prospective participants will complete registration in the CMDIR.
* The CMDIR genetic curator will review CMDIR data for study eligibility.
* If eligible, participant will be called and consented to participate in the study.
* Sequencing can be done with a saliva sample. However, if this method does not detect a mutation or change in the MTM1 gene, a further test, called CGH Array, has to be performed. For the CGH Array test, a saliva sample may deliver a clear result in terms of a deletion/duplication mutation. In the event, CGH Array with the saliva sample does not provide a result, a the blood sample is necessary to repeat CGH Array.
* The study participant will receive a kit and instructions for saliva specimen collection for genetic testing from the CMDIR in the mail.
* If a mutation or change in the MTM1 gene could not be found by genetic testing and CGH Array with a saliva sample, the study participant will receive a second kit in the mail from the CMDIR with instructions for a blood draw to be used for CGH Array.
* The family will coordinate collection of the saliva specimen or a local blood draw, if necessary, and will be responsible for mailing the specimen in a pre-paid parcel to the University of Chicago. There will be a $40 reimbursement for the cost of the blood draw. Mailing the specimen to the testing site is at no cost for the participant. A two-week turn-around from receipt of the kit to sending it to the testing laboratory is requested.
* Genetic testing will start with standard sequencing of the MTM1 gene, isolated from the saliva specimen, followed by CGH Array if sequencing of the MTM1 gene isolated from the saliva sample or further from a blood sample if a variant consistent with the symptoms could not be detected using the saliva sample.
* Test results will be 1) reported to a physician specified by the study participant and 2) uploaded into the study participant's profile in the CMDIR and 3) if concurrently enrolled in the Beggs Laboratory or other IRB-approved clinical study, test results will also be made available to that study provided appropriate informed consent has been given.
|
Inclusion Criteria: Patient eligibility will be determined by the CMDIR genetic curator using the following prioritization protocol.
1. Males and females in the US and Canada who have a known mutation in the MTM1 gene identified in a research lab and never confirmed in a clinical CLIA (Clinical Laboratory Improvement Amendments) -certified laboratory.
2. Male and female patients in the US and Canada who meet 2 of 3 of the following criteria: + clinical history, + family history, + centronucleation on muscle biopsy (no signs of nemaline rods or cores). Clinical history includes: post-natal breathing support (not necessarily continued after first month), length above 90% for EGA (estimated gestational age), facial characteristics (narrow facies), facial weakness (ophthalmoplegia, excessive saliva with need for suctioning).
3. Males and females in the US and Canada who present with XLMTM symptoms and no genetic mutation in the MTM1 gene found with conventional sequencing, requiring CGH array deletion/duplication testing.
4. Age range: One month - no maximum age.
5. Individual is registered with the CMDIR.
6. Written study consent provided by parent/caregiver (affected individual's age less than 18 years or for those individuals greater than 18 years with learning disabilities or inability to physically access consent) or affected individual (age greater than 18 years)
Exclusion Criteria:
1. Carrier testing for asymptomatic mothers.
|
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] |
NCT03603236
|
Evaluation of the Possible Relationship Between Preeclampsia and Periodontal Disease
|
The primary objective of the study is to assess the incidence and severity of the periodontal infection of patients with preeclampsia.
The secondary objective of the study is to analyze the relationship between preeclampsia and periodontal infection, using clinical, biochemical and microbiological methods.
|
Preeclampsia is identified as an important cause for mother and newborn mortality. Inspite of extensive research, the exact etiological relations have not been established.
Periodontal disease is a subclinical and persistent infection source which induces the systemic inflammatory reactions and increases the risk of preeclampsia. It is believed that the results will set light to the etiology of preeclampsia and will help to develop strategies to prevent the disease.
|
Inclusion Criteria:
* pregnant women with preeclampsia
* 37. weeks of pregnant women with no history of preterm labor
Exclusion Criteria:
* Genitourinary infection,
* pregnancy or pre-pregnancy hypertension,
* HIV infection,
* diabetes mellitus,
* multiple pregnancy, preterm labor / low birth weight,
* smoker and alcohol use history,
* IVF pregnancy,
* placental, cervical and uterine anomalies,
* pregnancy with intrauterine growth retardation,
* pregnancies with congenital or chromosomal fetal anomalies,
* significant vaginal bleeding,
* infertility stories,
* drug addicts,
* poor socioeconomic level
|
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] |
NCT05464550
|
Role of Self-focused Attention in Depression
|
Using a task measuring the tracking of eye movements, the aim of this study is to demonstrate that individuals suffering from depression focus their attention more on their reflection in the screen after recalling a failure (and this all the more so as their depressive symptomatology is strong) .
|
Inclusion Criteria:
* patients with depressive disorders according to the Diagnostic and statistical Manual of Mental Disorders (DSM-V) criteria
* Men or women, aged 18 to 60
* patients without mental impairment
* patients without neurological impairment (epilepsy, encephalopathy, head trauma)
* patients with a sufficient command of French
* free patients, without guardianship or curators or subordination
* patients benefiting from coverage by a social security scheme or benefiting from it through a third party in accordance with the French law on biomedical research
* obtaining oral non-objection by the patient after clear and honest information about the study
* Patient with normal or corrected vision without rigid contact lenses
Exclusion Criteria:
* patients with an intelligence quotient \< 70
* patients aged \< 18 years or \> 60 years
* patients with mental impairment
* patients with neurological impairment (epilepsy, encephalopathy, head trauma)
* patients who do not speak French well enough
* patients hospitalized under duress
* patients without social security
* Patient wearing rigid contact lenses
|
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] |
|
NCT02591940
|
Proof of Concept of Model Based Cardiovascular Prediction
|
CARDIOPROOF is a proof-of-concept project that consolidates the outcomes of previous virtual physiological human (VPH) projects and checks the applicability and effectiveness of available predictive modelling and simulation tools, validating them in interrelated clinical trials conducted in three European centres of excellence in cardiac treatment (from Germany, Italy and the UK). CARDIOPROOF focuses on patients with aortic valve disease and aortic coarctation, which, if left untreated, can ensue irreversible heart failure. As a result treatment becomes mandatory, but optimum timing and the best type of treatment still remain difficult to determine. With more than 50.000 interventions per year within the EU, the diseases addressed by CARDIOPROOF have a significant socio-economic impact. Present clinical guidelines are highly complex and rely mostly on imaging diagnostics and clinical parameters, without benefiting, as yet, from patient-specific disease modelling based prediction. CARDIOPROOF goes beyond the current state of the art by conducting validation trials aimed at covering and comparing the complete spectrum of cardiovascular treatment, predicting the evolution of the disease and the immediate and mid-term outcome of treatment. Operational clustering is going to provide a seamless clinical solution that applies different modeling methods to realize the potential of personalised medicine taking into account user-friendliness as a key component of clinical usability. CARDIOPROOF's goal is to provide first-hand data on comparative cost-effectiveness and clinical efficacy of the most advanced VPH approaches compared to conventional diagnostics and treatment algorithms, thus accelerating the deployment of VPH methods in clinical environments, and bring to maturity holistic patient-specific computer-based predictive models and simulations.
|
Inclusion Criteria:
* patients with the need for surgical or interventional treatment with Aortic Coarctation
* patients with the need for aortic valve disease surgery
* both according to current treatment guidelines
Exclusion Criteria:
* contraindications for MRI
|
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] |
|
NCT06323070
|
Effects of Watermelon or Low-fat Cookie Consumption on Wellness
|
The objective of the proposed research is to determine the effects of fresh watermelon consumption on physiological indicators of wellness regarding sexual, skin and gut health in adults.
|
Inclusion Criteria:
* Generally healthy subjects
* BMI 20-40 kg/m2
Exclusion Criteria:
* Smoker
* Pregnant woman
* Required antibiotics use
* Required dietary supplement use
* Required medication of metabolic disorders, mental health and sexual health
* Allergy to watermelon or wheat
|
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] |
|
NCT04875689
|
Laser Therapy on Chronic Knee Joint Osteoarthritis Patients PATIENTS
|
Knee osteoarthritis is the most common condition presented in physiotherapy OPD.LASER therapy is new treatment option and to find out its effects in knee osteoarthritis is need of the hour. With this research one can find out best treatment program for knee osteoarthritis patients which can be shared with other community members. If there will be added effect of LASER treatment in reducing the visits or stays it will be a cost effective option. this study will help to find better management option for patients with knee osteoarthritis.
This study will address the scarcity of research on this topic in Pakistan and will help to raise awareness among patients about the effects of LASER THERAY.
|
Osteoarthritis (OA) is a degenerative joint disease characterized by the loss of articular cartilage, subchondral bone remodeling, joint space narrowing and the formation of bone spurs. The initiation of cartilage breakdown is stimulated by mechanical stress or injury and the degenerative process progresses slowly over many years. In the advanced stage of OA, the abnormal remodeling of cartilage and subchondral bone results in the formation of osteophytes at the joint surface and margins, which irreversibly destroys the affected joint. Obesity, previous trauma, female gender and older age are considered the most common risk factors for knee OA. The prevalence of radiographic KOA for all age groups and found a value of 27.3 % for women and 21.0 % for men.Clinical manifestations include joint pain, stiffness, decreased range of motion (ROM), muscle weakness, proprioceptive changes, difficulties in activities of daily living (ADL) such as walking, climbing / descending stairs and housekeeping\[5\]Many physical therapy agents such as ultrasound\[6\], electrical stimulation, strengthening exercise\[8\]and thermal therapy\[9\] have been introduced.
Because of the non-invasiveness and advantage of inciting nearly no adverse side effects, low-level laser therapy (LLLT) has been widely used to relieve pain in different musculoskeletal disorder. It also promotes fibroblasts, collagen synthesis, cell oxygen recovery, and bone remodeling. Laser efficacy depends on 4 factors of wavelength, duration of treatment, dose, and areas of the application.Low level laser therapy induces photochemical physiological actions in living tissues at the cellular level. Some of these effects include cellular oxygenation, release of neurotransmitters associated with pain modulation and release of anti-inflammatory, endogenous mediators. LLLT consists of a monochromatic light source without any thermal effect that stimulates reparative properties in human cartilage. Moreover, it has an analgesic effect, although the mechanisms through which this occurs remain uncertain. The suggested mechanisms include: increased mitochondrial ATP and tissue oxygenation, increased levels of neurotransmitters implicated in pain modulation (such as serotonin) and anti-inflammatory effects. Study stated that the reduction in pain through using LLLT might be due to mechanisms such as physiological effects mediated by photochemical actions at cellular level in animal or human tissue, and through increased levels of the neurotransmitters implicated in pain modulation, such as serotonin. Some researchers have also concluded that LLLT has an effect on joint cartilage regeneration, achieved through proliferation of chondrocytes and synthesis and secretion of extracellular matrix.
A study on "Effect of laser therapy on chronic osteoarthritis of the knee in older subjects" showed that there was a significant reduction in VAS and pain intensity, an increase in isometric muscle strength and range of motion of the knee as well as increase in physical functional ability in three treatment groups.
A study on "Efficacy of low-level laser therapy on pain and disability in knee osteoarthritis: systematic review and meta-analysis of randomized placebo-controlled trials" showed that LLLT reduces pain and disability in KOA at 4-8 J with 785-860 nm wavelength and at 1-3 J with 904 nm wavelength per treatment spot.
A study on "effectiveness of low-level laser therapy in patients with knee osteoarthritis: a systematic review and meta-analysis" this study indicated that low level laser therapy has neither early nor later benefits in reducing pain or improving function in patients with KOA.
A study on "The Effect of Low Level Laser Therapy on Pain and Range of Motion of Patients With Knee Osteoarthritis" showed that the effectiveness of low-power laser in reducing pain and improving the range of motion in patients with knee osteoarthritis is similar to the effectiveness of the placebo laser. Low-power laser is recognized as an appropriate medical modality to treat knee osteoarthritis in animals and humans and can be used along with acupuncture or exercise.
A study on Effect of low level laser therapy (904nm) and static stretching in patients with knee osteoarthritis: a protocol of randomized controlled trial showed that the The European League Against Rheumatism (EULAR) recommendations indicate stretching exercises as an adjunctive treatment.
|
Inclusion Criteria:
* • The study includes female patients with chronic knee OA
* The study includes patients from the age of 40 years and 65 years
* The study includes patients with Grade II and III OA of knee
* Patients having no other physical and mental issues
Exclusion Criteria:
* • The study excludes male patients
* Patients with lab results abnormal (inflammatory and infectious disease, malignant tumor)
* Patients with arterial coagulation blockage in lower limbs.
* Usual contraindication for laser therapy
* Patient's undergone surgery of knee
|
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] |
NCT02680899
|
Adolescent Mental Health InSciEd Out
|
The study herein seeks to determine whether students undergoing InSciEd Out curriculum in mental health and addiction (called My Mind, My Body) experience changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
|
Integrated Science Education Outreach (InSciEd Out) is one novel program that seeks to promote scientific and health literacy through fostering scientific inquiry. The guiding premise of InSciEd Out's health promotion arm is a concept called Prescription Education (PE), which uses science education as a direct and early intervention for disease behaviors. The underlying hypothesis of InSciEd Out PE is that a student who lives a scientific experience in his or her own voice (undergoes true inquiry-based science) will be empowered to elect healthier behaviors in any targeted health paradigm. PE's proposed mechanism of change is that inquiry-based science catalyzes transitions from knowledge to understanding to attitudes to intents to actual behavioral change.
InSciEd Out partnership with the the school in this study began in Spring of 2013 with a projected health promotion arm targeting mental health and addiction. The current iteration of the partnership commenced in Summer of 2014 under the annual InSciEd Out summer internship. This internship led to creation of grades 7 and 8 curriculum in mental health and addiction. Version 1 of this curriculum was piloted last year. A revised version of the curriculum will be implemented in Spring of 2016. Although there are education-specific metrics for assessment already built into program evaluation of InSciEd Out, there are currently no clinically relevant inventories in place to specifically probe efficacy of the lesson plans upon key mental health outcomes.
The study herein is the establishment of clinically relevant inventories around implemented InSciEd Out curriculum in mental health and addiction (called My Mind, My Body). These inventories are selected to measure student changes in their mental health-related knowledge, attitudes, and help-seeking behavioral intentions. The research group hypothesizes that students undergoing InSciEd Out mental health and addiction curriculum will exhibit pre-post increases in mental health literacy, decreases in mental health stigmatization, and increases in mental health help-seeking behavioral intentions.
|
Inclusion Criteria: Partner school students who do not opt out of and assent to the study
Exclusion Criteria: Partner school students opting out of or not assenting to the study
|
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] |
NCT02495740
|
E-Bike Versus Classic Bike Intervention Trial
|
The effects of active commuting with an e-bike, as compared with a "classic" bike, on cardiorespiratory fitness and vascular health are largely unknown. To assess whether active commuting with an e-bike or a classic bike increases peak oxygen consumption (VO2peak) in untrained and overweight individuals.
|
Riding an electrically assisted bicycle (e-bike) is thought to be suitable to increase physical activity in daily life, to promote health, and to increase cardiorespiratory fitness in normal-weight individuals. The positive effect of commuting to work by a normal bike on cardiorespiratory fitness has been shown to be an important predictor of cardiovascular mortality in previous studies. We thought to improve maximal oxygen uptake by commuting to work by e-bike vs. classic bike. Besides cardiorespiratory fitness we assessed arterial stiffness as brachial-ankle pulse wave velocity as an independent predictor of cardiovascular events and all-cause mortality.
|
Inclusion Criteria:
body mass index 25-35 kg/m2, and willingness to commute to work by e-bike or by normal bike at least 3 times per week with a one-way distance of ≥ 6 km.
Exclusion Criteria:
cycling as a leisure-time activity, active commuting to work or exercise training more than once per week within 4 weeks before the start of the study, uncontrolled cardiovascular diseases limiting cardiorespiratory fitness, stage II arterial hypertension (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 95 mmHg), renal diseases, uncontrolled diabetes mellitus (HbA1c \> 6.5%), or active malignancy or chemotherapy during the past 6 months.
|
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] |
NCT04527458
|
Case Fatalities in Hospitalised COVID-19 Patients in the UK
|
This study will investigate how the case fatality in hospitalised patients with COVID-19 has changed throughout the pandemic. It will also explore possible mechanisms that could be driving these changes. This analysis will enhance our understanding of the virus, which will be important for researchers and clinicians to respond appropriately.
|
Inclusion Criteria:
* All patients admitted with a proven or high likelihood of COVID-19
|
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|
NCT00169091
|
Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
|
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
|
This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.
|
Inclusion Criteria:
* RDC diagnosis of schizophrenia
* Men and women, without regard to race/ethnicity,
* Aged 18-45
* Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of \> 21 (on a 0 - 6 scale);
* Require treatment with neuroleptic drugs on a clinical basis;
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
* Be within the first episode of a psychotic disorder;
* Have a history of neuroleptic treatment of \< 12 weeks;
* Likely to remain in the study for 2 years.
Exclusion Criteria:
* Substance dependence in the last six months
* History of seizure or blood dyscrasia
* Major medical illness
* Pregnancy or Lactation
|
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] |
NCT02502253
|
BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)
|
Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and thus represent a worthy target for secondary prevention interventions.
There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes and type 2 diabetes) increase risk of incident cognitive impairment and possibly AD, and evidence that the neurons of the AD brain are in fact insulin resistant with diminished glucose uptake under physiological conditions. Thus, persons with MCI and prediabetes or type 2 diabetes may be at particular risk of incident cognitive impairment and AD.
A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose does not improve cognitive (or other health) outcomes in older persons with peripheral insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI and metabolic risk factors, and a drug targeting insulin resistance with good blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While there is a phase III study of intranasal insulin targeting this strategy, nutraceuticals offer a low-tech solution that would be more suitable to future secondary prevention trials in MCI.
Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical preparations grape seed polyphenolic extract (GSE), and resveratrol that contain abundant concentrations of polyphenols. The investigators have found that oral BDPP administration was associated with improved cognition and brain plasticity long-term potentiation (LTP) in mouse models of metabolic syndrome and AD, as well as lowering brain amyloid and tau burden in an AD mouse model2-4. The investigators have demonstrated excellent absorption of oral BDPP in a small study in humans and similarly excellent CSF penetration of oral BDPP in rats, but it is crucial to demonstrate safety and CSF penetration of oral BDPP in humans to assess its potential as a treatment for MCI and prediabetes or type 2 diabetes.
|
Inclusion Criteria:
* Age 50-90 years inclusive
* Amnestic MCI
* Impaired fasting glucose (IFG), defined by American Diabetes Association criteria (fasting blood sugar between 100 and 125 mg/dl) or clinically stable type 2 diabetes
* Knowledgeable informant (KI) who spends at least 5 hours/week with the participant and can provide information about the participant's psychosocial functioning
Exclusion Criteria:
* Deemed too unstable medically or neurologically to safely enroll in trial of research medication
* Type 1 Diabetes Mellitus
* Diagnosis of dementia due to Alzheimer's disease
|
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|
NCT04069390
|
evaluatioN de la perfOrMAnce De Capteurs E-textiles
|
The NOMADE study has a dual purpose:
* Test the performance of new types of sensors that are likely to integrate Bioserenity devices and will therefore improve them.
* Test the performance of the sensors of Bioserenity CE devices and their advanced versions
Different EC and non-CE models of Neuronaute and Cardioskin may be tested in this study.
|
Bioserenity develops innovative solutions, using smart clothing that can be used in hospitals or homes, in short or long term. Without wires, these washable textiles allow, in particular, the measurement of biophysiological signals via a recording box, while allowing the participant the freedom to continue his daily activities.
In order to perfect Bioserenity products, new types of non-invasive sensors will be integrated to offer a new range of multimodal and polygraphic products. Moreover, in order to optimise the already EC devices, they have evolved slightly in terms of textile and software.
Participants will perform at least one recording session with one of the study devices, Neuronaute or Cardioskin. After that, they can hold other meetings if they wish. For this they will not be specially summoned, they will have to volunteer when they wish to participate. The model and type of Bioserenity device (Neuronaute or Cardioskin) may change depending on the session. The recording context may also change. Throughout the duration of the study, whether participants wish to participate regularly or not, they will in all cases be limited to two participation sessions per week. They can stop at any time, without having to justify themselves. The investigation centre will adapt to the availability of the participants and their willingness to participate: the aim is to generate them no constraints.
During recording, subjects may be asked to do small, simple exercises, which differ depending on the recorded signal. Sometimes the exercises can be repeated with a non-invasive device of the market, with minimal risks and constraints, in order to be able to perform a comparison of signals
The principal aim evaluate the performance of Cardioskin or Neuronaute device sensors over short-term recording periods.
The secondary aim is to evaluate the performance of Cardioskin or Neuronaute device sensors over long-term recording periods.
|
Inclusion Criteria:
* Male, female at least 18 years
* Membership of a social security scheme
Exclusion Criteria:
* Minors
* Refusal of consent
* Allergy to one of the components of Bioserenity products, including:Polyamide (other polymers),Polyester,Elasthanne,Polyethylene/polyopropylene (other polymers),Titanium,Silicone,Silver/Copper,Other synthetic materials
* Allergy to one of the components present in commercial electrodes (gel electrode type Kendall 530 or similar; or electrodes type Ag/Agcl; or other electrodes containing in particular: acrylate/polyacrylate, acrylic acid, Impedimed electrodes, etc.)
* Allergy to one of the components in an electroconductive cream for sensors (Elefix, Ten20 and similar biocompatible product)
* Known allergy to one of the components in a commercial EEG helmet (neoprene, elastomer, silicone, etc.)
* Sensory disorders that make the participant insensitive to pain
* Motor or mental disorders that prevent the participant from expressing pain
* Behavioural disorders that make the participant excessively agitated or aggressive
* Person protected
|
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] |
NCT05595993
|
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache
|
To investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).
|
Inclusion Criteria:
* Age 18 to 65 years of age upon entry into screening
* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
* ≥ 4 monthly headache days on average across the 3 months prior to screening
* Provision of informed consent prior to initiation of any study-specific activities/procedures.
Exclusion Criteria:
* \> 1 mild traumatic injury to the head
* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
* History of moderate or severe injury to the head
* History of whiplash injury
* History of craniotomy
* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
* Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
|
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|
NCT00588094
|
Dose Augmented Rituximab and ICE for Pts With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell NHL
|
The purpose of this research is to study a treatment program for patients with aggressive lymphoma that has come back after initial or first therapy (called relapsed) or that has not responded to first therapy (called refractory). Since 1993, we have used a combination of chemotherapy known as ICE (Ifosfamide, Carboplatin, and Etoposide) for your type of lymphoma. In many patients, this treatment helps the disease to shrink before giving high-dose therapy and autologous stem cell transplant (ASCT). Only patients who respond to these types of treatments have a chance of their disease going away (remission) with an ASCT. In 1999, we studied the same treatment but added another medicine for your type of lymphoma, Rituximab (Rituxan), to the ICE treatment (RICE). More patients had lymphoma shrinkage from this treatment (chemosensitive disease) than with ICE alone. These patients then received high dose therapy and autologous stem cell transplant and have an improved chance of having a remission.
ICE chemotherapy is standard chemotherapy used at Memorial Sloan-Kettering Cancer Center. However, it is different in this study because of the higher doses. We are testing higher doses of RICE treatment for patients in this study.
In our current study in Hodgkin's lymphoma, we are giving these higher doses of ICE (called augmented ICE) to patients who also have higher risk. We hope to show in this study that by using Rituximab and augmented ICE that we can improve your ability to achieve a remission (that is, to have the disease go away).
|
The purpose of this study is to determine if dose escalation of the rituximab-ICE (RICEesc) program can improve the overall response rate of patients with primary refractory or poor risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with peripheral blood progenitor cells (PBPCs) collected after cycle 2.
A two-stage design will be employed, such that the study will be terminated if in the first cohort of patients it appears that the overall response rate is \<50% or if \>25% patients fail to mobilize at least 2 x 106 CD34+ cells/kg.
|
Inclusion Criteria:
* Histologic diagnosis of the one of the following B cell aggressive lymphomas, confirmed by an MSKCC pathologist: Diffuse Large, Immunoblastic, Mantle cell, Anaplastic Large Cell, De novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive.
* Tumors must stain positive for CD20.
* Primary refractory disease proven by biopsy or fine needle aspiration (cytology) of an involved site
* Relapsed diffuse large, immunoblastic, anaplastic, de novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive proven by biopsy or fine needle aspiration (cytology) of an involved field site and at least two of the three following risk factors: LDH\> upper limit of normal, KPS \< 80%, Stage III or IV disease.
* All mantle cell lymphoma patients in first relapse
* Failure of doxorubicin or mitoxantrone containing front-line therapy
* Bidimensionally measurable disease.
* Cardiac ejection fraction of greater than 50%, measured since last chemotherapy.
* Serum creatinine \<1.5 mg/dl; if creatinine \>1.5 mg/dl then the measured 12- or 24-hour creatinine clearance must be \>60 ml/minute.
* ANC\>1000/µl and Platelets\>50,000/µl
* Total bilirubin \< 2.0 mg/dl in the absence of a history of Gilbert's disease.
* Females of childbearing age must be on an acceptable form of birth control.
* Age between 18 and 72
* HIV I and II negative.
* Patients or their guardians must be capable of providing informed consent.
Exclusion Criteria:
* Any lymphoma subtype other than those described among the inclusion criteria.
* All patients with relapsed diffuse large, immunoblastic, anaplastic, de novo transformation of follicular lymphoma, or classical Hodgkin's lymphoma which is CD20 antigen positive disease who have \<2 of following risk factors: LDH\> upper limit of normal, KPS \< 80%, Stage III or IV disease.
* History of second-line chemotherapy
* Presence of CNS involvement.
* Prior treatment with carboplatin, cisplatin, ifosfamide, or etoposide
* Hepatitis B surface antigen positive.
* Known pregnancy or breast-feeding.
* Medical illness unrelated to NHL, which in the opinion of the attending physician and/or principal investigator will preclude administering chemotherapy safely.
* History of any malignancy for which the disease-free interval is \<5 years, excluding curatively treated cutaneous basal cell or squamous cell carcinoma and carcinoma in-situ of the cervix
|
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] |
NCT01798069
|
Impact of Narrative Medicine (Workshop Reflexive Writing)
|
Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reflexive writing "dedicated to medical students on the satisfaction of standardized patients.
Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: Participants will be randomized in two groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.
A program of Narrative Medicine in Class-led instruction "workshop reflexive writing "vs "workshop reading medical publication".
Outcome: The primary endpoint will be the satisfaction of standardized patient relative to the empathy of the medical students. The secondary endpoints will be the empathy of the medical students; recommendation of the student by the standardized patients to friends or relatives; students' satisfaction.
Potential interests: The investigators believe that the workshop "reflexive writing" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.
|
Inclusion Criteria:
* All students in the fourth year of medical school have chosen for their first 2 quarters to complete an internship in clinical hospital departments (i.e. where direct contact with patients)
Exclusion Criteria:
* All students refusing to participate in the study.
* All students repeaters.
|
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] |
|
NCT04762186
|
Viable Human SARS-CoV-2 Specific T Cell Transfer in Patients at Risk for Severe COVID-19
|
Monocentric open phase I (dose escalation component), followed by a multi-center, randomized, phase II component benchmarking IMP+SoC against SoC
|
The clinical trial will consist of a phase I and a phase II part. The main trial objective in the phase I part is to determine the recommended phase II dose (RP2D) of viable human SARS-CoV 2-specific T cells by evaluation of safety and tolerability.
In the phase II part, the primary objective is to gain first data on efficacy of adaptive therapy with viable human SARS-CoV-2-specific T cells. This will be a randomized, prospective feasibility trial.
Details to phase II will be updated after completion of phase I.
|
Inclusion Criteria:
* Age 18 years or above
* Written informed consent from the trial subject has been obtained
* Willing to follow contraception guidelines
* Tested positive for SARS-CoV-2 by PCR \<72 hours after swab
* A maximum of 14 days between onset of symptoms and enrollment
* WHO score 5 OR
* WHO score 4 with at least one additional risk factor for disease progression
* Acceptable risk factors are:
* Radiographically proven lung infiltrates
* Immunosuppression either by malignant disease or it's treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression
* Immunosuppressive drugs or steroids at a prednisolone equivalent of \<1 mg/kg BW)
* Receipt of an autologous transplant within the last 5 years
* Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression
Exclusion criteria:
* Participation in any other clinical trial of an experimental agent treatment
* Active GvHD or history of GvHD
* History of CAR-T-Cell Therapy
* COVID-19 WHO ordinal scale ≥6
* Anticipated life-expectancy \<72 hours
* Expected duration of hospital stay \<72 hours
* Sepsis-induced leukopenia or thrombocytopenia (leukocytes \<1,000/µl or platelets \<50,000/µl). If the cytopenias result from underlying hematologic disease or its treatment this will not be regarded as exclusion criterion
* CT pneumonia score ≥13 \[50\]
* Any Steroids ≥1 mg/kg Prednisolon-equivalent/kg BW, besides 6 mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19
* Pregnant or breast feeding
* Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject's safe participation in and completion of the study
* Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion
* Known hypersensitivity to iron dextran
* Known pre-existing human anti-mouse antibodies (HAMAs)
* ontraindication against mandatory protocol-inherent comedication(s): antihistamine and/or acetaminophen
* Failure to use highly-effective contraceptive methods. The following contraceptive methods with a Pearl Index lower than 1% are regarded as highly-effective:
* Oral hormonal contraception ('pill')
* Dermal hormonal contraception
* Vaginal hormonal contraception (NuvaRing®)
* Contraceptive plaster
* Long-acting injectable contraceptives
* Implants that release progesterone (Implanon®)
* Tubal ligation (female sterilization)
* Intrauterine devices that release hormones (hormone spiral)
* Double barrier methods
* This means that the following are not regarded as safe: condom plus spermicide, simple barrier methods (vaginal pessaries, condom, female condoms), copper spirals, the rhythm method, basal temperature method, and the withdrawal method (coitus interruptus).
* Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator
* Legally incapacitated persons
* Persons held in an institution by legal or official order
|
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] |
NCT04430894
|
KRDI in Transplant-Eligible MM
|
This research study is testing the efficacy of an experimental drug combination for people with newly diagnosed multiple myeloma that are eligible for a stem cell transplant.
The names of the study drugs involved in this study are:
* Carfilzomib
* Isatuximab
* Lenalidomide
* Dexamethasone
|
This is a phase II study to evaluate the efficacy of once weekly carfilzomib, lenalidomide, dexamethasone, and isatuximab (KRDI) in patients with newly diagnosed, transplant-eligible multiple myeloma. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. The study treatment portion of this study is comprised of an induction phase and a maintenance phase.
* Induction Phase :
* All participants will receive the same study drugs (carfilzomib, isatuximab, lenalidomide, and dexamethasone) for up to 8 cycles. Each cycle is 28 days in length.
* All participants will perform stem cell collection after 4 cycles of therapy. Based on the recommendation participants may or may not proceed to an autologous stem cell transplant (SCT) as part of induction therapy.
* Maintenance Phase: During maintenance, participants will receive the study treatment for up to two years after induction until progressive disease or unacceptable toxicity
It is expected that about 50 people will take part in this research study.
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug combination to learn whether the drug combination works in treating a specific disease.
"Investigational" means that the drug combination is being studied.
The U.S. Food and Drug Administration (FDA) has approved carfilzomib or isatuximab as a treatment for relapsed/refractory multiple myeloma.
The FDA has also approved lenalidomide and dexamethasone as a treatment option for transplant-eligible multiple myeloma.
However, the FDA has not approved the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone as an approved regimen. The combination is considered to be investigational for the treatment of individuals with newly diagnosed multiple myeloma.
|
Inclusion Criteria:
* Subject must be at least 18 years of age.
* Subject must have documented multiple myeloma satisfying the CRAB criteria and measurable disease defined as:
* Monoclonal plasma cells in the bone marrow ≥10% or presence of a biopsy-proven Plasmacytoma.
* Measurable disease as defined by any of the following:
* IgG myeloma: Serum monoclonal paraprotein (M-protein) level ≥.5 g/dL or urine M-protein level ≥200 mg/24 hours; or
* IgA, IgM, or IgD multiple myeloma: serum M-protein level ≥0.25 g/dL or urine M-protein level ≥200 mg/24 hours; or
* Light chain multiple myeloma: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio.
* Sixty percent or greater clonal plasma cells on bone marrow examination.
* Serum involved / uninvolved free light chain ratio of 100 or greater, provided the absolute level of the involved free light chain is at least 100 mg/L (a patient's "involved" free light chain - either kappa or lambda - is the one that is above the normal reference range; the uninvolved light chain is the one that typically is in, or below, the normal range).
* More than one focal lesion on magnetic resonance image (MRI) that is at least 5 mm or greater in size.
* Newly diagnosed and considered candidate for high-dose chemotherapy with stem cell transplant.
* Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
* Subject must have pretreatment clinical laboratory values meeting the following criteria during the Screening Phase:
* hemoglobin ≥ 7.5 g/dL (≥ mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted);
* absolute neutrophil count ≥1.0 x 109/L (granulocyte colony stimulating factor \[GCSF\] use is permitted);
* platelet count ≥70 x 109/L for subjects in whom \<50% of bone marrow nucleated cells are plasma cells; otherwise platelet count \>50 × 109/L (transfusions are not permitted to achieve this minimum platelet count)
* aspartate aminotransferase (AST) ≤2.5 x upper limit of normal (ULN);
* alanine aminotransferase (ALT) ≤2.5 x ULN;
* total bilirubin ≤2.0 x ULN, except in subjects with congenital bilirubinemia, such as Gilbert syndrome (direct bilirubin ≤2.0 x ULN)
* creatinine clearance ≥30 mL/min
* corrected serum calcium ≤14 mg/dL (≤3.5 mmol/L); or free ionized calcium \<6.5 mg/dL (\<1.6 mmol/L).
* Women of childbearing potential must commit to either abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control simultaneously. This includes one highly effective form of contraception (tubal ligation, intrauterine device \[IUD\], hormonal \[birth control pills, injections, hormonal patches, vaginal rings or implants\] or partner's vasectomy) and one additional effective contraceptive method (male latex or synthetic condom, diaphragm, or cervical cap). Contraception must begin 4 weeks prior to dosing. Reliable contraception is indicated even where there has been a history of infertility, unless due to hysterectomy or bilateral oophorectomy.
* A man who is sexually active with a woman of childbearing potential must agree to use a latex or synthetic condom, even if they had a successful vasectomy. All men must also not donate sperm during the study, for 4 weeks after the last dose of lenalidomide, for 90 days after the last dose of carfilzomib, and for 4 months after the last dose of isatuximab.
* A woman of childbearing potential must have 2 negative serum or urine pregnancy tests at Screening, first within 10 to 14 days prior to dosing and the second within 24 hours prior to dosing.
* Each subject (or their legally acceptable representative) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Subject must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, as referenced in the ICF.
Exclusion Criteria:
* Any potential subject who meets any of the following criteria will be excluded from participating in the study.
* Subject has a diagnosis of primary amyloidosis, monoclonal gammopathy of undetermined significance, or smoldering multiple myeloma. Monoclonal gammopathy of undetermined significance is defined by presence of serum M-protein \<3 g/dL; absence of lytic bone lesions, anemia, hypercalcemia, and renal insufficiency related to the M-protein; and (if determined) proportion of plasma cells in the bone marrow of 10% or less. Smoldering multiple myeloma is defined as asymptomatic MM with absence of related organ or tissue impairment end organ damage.
* Subject has a diagnosis of Waldenström's disease, or other conditions in which IgM M-protein is present in the absence of a clonal plasma cell infiltration with lytic bone lesions
* Subject has prior or current systemic therapy or SCT for MM, with the exception of an emergency use of a short course (equivalent of dexamethasone 40 mg/day for a maximum 4 days) of corticosteroids before treatment.
* Subject has a history of malignancy (other than MM) within 5 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 5 years).
* Subject has had radiation therapy within 14 days of enrollment.
* Subject has had plasmapheresis within 28 days of enrollment.
* Subject is exhibiting clinical signs of meningeal involvement of MM.
* Subject has known chronic obstructive pulmonary disease (COPD) (defined as a forced expiratory volume \[FEV\] in 1 second \<60% of predicted normal), persistent asthma, or a history of asthma within the last 2 years (intermittent asthma is allowed). Subjects with known or suspected COPD or asthma must have a FEV1 test during screening.
* Subject is known to be seropositive for history of human immunodeficiency virus (HIV) or known to have active hepatitis B or hepatitis C.
* Subject has any concurrent medical or psychiatric condition or disease (eg, active systemic infection, uncontrolled diabetes, acute diffuse infiltrative pulmonary disease) that is likely to interfere with the study procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this study.
* Subject has clinically significant cardiac disease, including:
* myocardial infarction within 1 year before enrollment, or an unstable or uncontrolled disease/condition related to or affecting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association Class III-IV;
* uncontrolled cardiac arrhythmia (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] Version 4 Grade ≥2) or clinically significant ECG abnormalities;
* screening 12-lead ECG showing a baseline QT interval as corrected by Fridericia's formula (QTcF) \>470 msec.
* uncontrolled hypertension
* Subject has known allergies, hypersensitivity, or intolerance to corticosteroids, monoclonal antibodies or human proteins, or their excipients (refer to respective package inserts or IB) or known sensitivity to mammalian-derived products.
* Subject has plasma cell leukemia (according to World Health Organization \[WHO\] criterion: ≥20% of cells in the peripheral blood with an absolute plasma cell count of more than 2 × 109/L) or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
* Subject is known or suspected of not being able to comply with the study protocol (eg, because of alcoholism, drug dependency, or psychological disorder). Subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject (eg, compromise the well-being) or that could prevent, limit, or confound the protocol specified assessments.
* Subject is a woman who is pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study within 30 days after the last dose of lenalidomide or carfilzomib, or within 4 months after the last dose of isatuximab. Or, subject is a man who plans to father a child while enrolled in this study, within 4 weeks after the last dose of lenalidomide, within 90 days of the last dose of carfilzomib, or within 4 months after the last dose of isatuximab.
* Subject has had major surgery within 2 weeks before enrollment or has not fully recovered from surgery, or has surgery planned during the time the subject is expected to participate in the study. Kyphoplasty or vertebroplasty is not considered major surgery.
* Subject has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before enrollment or is currently enrolled in an interventional investigational study.
* Subject has contraindications to required prophylaxis for deep vein thrombosis and pulmonary embolism.
* Incidence of gastrointestinal disease that may significantly alter the absorption of oral drugs.
* Peripheral neuropathy ≥ Grade 2 on clinical examination during the screening period.
* Systemic treatment with strong inhibitors of CYP1A2 (fluvoxamine, enoxacin), strong inhibitors of CYP3A (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobartital), or use of Ginkgo biloba, St. John's wort within 14 days before the first dose of study treatment.
|
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] |
NCT00207090
|
Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer
|
The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.
|
Inclusion Criteria:
* Up to three prior chemotherapy regimens
* Measurable or non-measurable disease
* Available for treatment and follow-up
Exclusion Criteria:
* Neuropathy
* Uncontrolled cardiovascular disease
* Refusal to participate in genetic analysis
|
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] |
|
NCT00420121
|
European Society of Cutaneous Lupus Erythematosus (EUSCLE)
|
Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of the study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with CLE.
|
Methods: A core set questionnaire has been developed in the course of the "European Society of Cutaneous Lupus Erythematosus (EUSCLE)", and a total of 40 patients (32 females, 8 males) in two centres, Germany and Sweden, were included in this study. Results: CLE was diagnosed in 39 individuals (5 with acute CLE, 10 with subacute CLE, 13 with chronic CLE, and 18 with intermittent CLE) and one individual presented with a systemic manifestation of the disease. Furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified CLASI were examined. Interestingly, 75% of the patients with CLE showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. Laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-Ro/SSA in 12 and positive anti-La/SSB antibodies in 8 cases. The predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). Conclusions: The new core set questionnaire enables the clinician to characterize the different skin manifestations involved in CLE and to evaluate disease activity and reasonable treatment modalities. Furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. In the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with CLE.
|
Inclusion Criteria:
* systemic or cutaneous lupus erythematosus confirmed by histological analysis
* written informed consent available prior to any study-procedures
Exclusion Criteria:
* patients with conditions that are contrary to the above mentioned criteria
|
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] |
NCT05646303
|
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
|
The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are:
* Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
* Is treatment with psilocybin and therapy safe for participants?
Participants will
* Attend 13 study visits
* Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
* Record their daily alcohol consumption on study specific device
Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.
|
Inclusion Criteria:
* Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
* Expressed a wish to reduce or stop alcohol consumption.
* Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
Exclusion Criteria:
* Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score \>19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
* Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
* History of hallucinogen use disorder, or any use in the past 1 year, or \>25 lifetime uses.
|
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|
NCT04474951
|
Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies
|
The main purpose of this study is to evaluate the impact of food supplements (herbal remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea. Secondary aims of the trial are to evaluate the impact of these supplements on the quality of life and to evaluate their tolerability profile.
|
Inclusion Criteria:
* Male or Female ≥ 18 years
* Karnofsky Performance Scale (KPS) ≥ 90%
* Breast or Gynecological cancer
* Informed consent signed before every procedure study specific, on day 1 of therapy cycle
* Inclusion Criteria Arm 1: presence of grade 1 anemia as per CTCAE 4.0 criteria; patients on treatment with anti-CDK 4/6 or PARP Inhibitors or in adjuvant therapy with hormone therapy
* Inclusion Criteria Arm 2: presence of fatigue of any grade; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane
* Inclusion Criteria Arm 3: presence of nausea of any grade, without vomiting; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane
Exclusion Criteria:
* Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment
* Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical hypothyroidism not compensated by replacement therapy; Persistent insomnia
* Arm 3: patients with evidence of anxiety or anxious-depressive syndrome
|
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] |
|
NCT02822547
|
Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults
|
Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks
|
Inclusion Criteria:
* History of HBsAg positive for more than 6 months
* HBeAg-positive or HBeAg-negative within 8 weeks
* Serum AST or ALT ≥ 80 IU/L
* HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10\^5 copies/mL (or 20,000 IU/mL)
* HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10\^4 copies/mL(or 2,000 IU/mL)
Exclusion Criteria:
* History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
* Prior treatment of interferon
* Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
* Other chronic liver disease or decompensated liver disease
* platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3
* Pregnant or lactating woman
* History of Organ transplantation
* Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
|
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] |
|
NCT00336921
|
Alfuzosin for Treating Acute Urinary Retention
|
The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).
|
Inclusion Criteria:
* First episode of painful AUR related to BPH requiring catheterization
* Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization
Exclusion Criteria:
* Participated in another investigational study within 3 months before recruitment
* Suspect bladder neuro-dysfunction unrelated to etiology;
* Single Bladder neck disease;
* Acute/chronic prostatitis;
* Diagnosed prostate carcinoma;
* Suspected prostate carcinoma diagnosed by ultrasound wave;
* Surgical history of prostate and urethra;
* Diagnosed/suspected abnormality in urethra structure;
* Bladder stone;
* Blood urine retention caused by any reason;
* Residual volume less than 500 ml
* Residual volume more than 1500 ml
* AUR not due to BPH
* Parkinson's disease
* Insulin dependent diabetes
* Known/suspected multiple sclerosis;
* Stroke/MI within 6 months prior to enrolment;
* AST, ALT and Creatinine \> 1.5x upper limit; neutrophil \< 3,000/mm³; platelet \< 100,000/mm³;
* Unstable/severe heart failure;
* History of postural hypertension/hypotension;
* Known hypersensitivity to α-receptor blocker;
* Suspected/diagnosed expansible nerval disease;
* Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
* Treatment with α1-receptor blocker within 1 month prior to enrolment;
* Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
* Treatment with Disopyramide
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
|
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|
NCT05266053
|
Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections
|
There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome.
The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections
|
Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\~4-6 weeks postoperative) to rate scar quality.
|
Inclusion Criteria:
* Scheduled or non-labor repeat cesarean delivery
* One or more prior cesarean section(s) with prior pfannenstiel incision scar
* Gestational age \> 23 weeks
* Age 18 and older
Exclusion Criteria:
* Patients with malignancy in the wound bed or margins of the wound
* Non-enteric and unexplored fistulas
* Necrotic tissue with eschar present
* Exposed arteries, veins, nerves or organs
* Exposed anastomotic sites
* Cellulitis or evidence of active infection
* Known allergy to adhesive tape
* Patient unwilling to follow-up
* Contraindication to NPWT
* Bleeding disorder
* Therapeutic anticoagulation
* Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient)
* Prior irradiated skin
|
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] |
NCT04741126
|
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury
|
To determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. Previous studies were designed to target only a small sample. Level and American Spinal Cord Injury Association (ASIA) scale were not specified so this study covers this aspect.
|
The previous studies show that the partial control of the muscle necessary for cough, which varies with motor level, proportionately improves the patient's ability to cough volitionally. Spinal cord injury also affects mucus clearance, the peak flow meter was used to assist the ability of cough and they also measure the peak cough flow (PFC).In the literature for the airway clearance, the following techniques were used, incentive spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure. There is increasing interest in strategies such as interval training that may provide a tolerable training load while maintaining an effective stimulus for adaptation. Manually assisted cough technique is used to enhance the cough strength, to help with mucus secretion it can be carried out in lying, side-lying, or sitting positions.it is important that clear secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection and complication can be reduced which improve the quality of life. Manually assisted cough is a technique using strong arms to assist cough. This may be providing help in neuromuscular disease or spinal cord injury with weak respiratory and abdominal muscle.
|
Inclusion Criteria:
* The patient with incomplete cervical spine injury at C4, C5,
* bronchitis,
* shortness of breath having Peak cough flow (PCF) less than 50% and
* ASIA impairment scale C \&D
Exclusion Criteria:
* The patient with upper cervical,
* thoracic, and
* lumbar spine injury,
* diagnosed with TB,
* degenerative diseases,
* surgical conditions, and
* complete spinal cord injury.
|
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] |
NCT05356234
|
Ignite Study of the Jewish Family and Children's Service of the Suncoast, Inc.
|
The goals of the program are to help struggling fathers and father figures improve the parent-child relationship, sustain healthy marriages and relationships (and help those who are single identify ways to enter into safe and supportive relationships that may ultimately lead to marriage), and identify and support fathers in their economic stability and employment objectives. These outcomes will be achieved through a series of workshops addressing responsible parenting and marriage and relationships as well as a complement of employment services and comprehensive case management. Additional services needed by participants will be identified and provided either through wraparound programming provided by JFCS or through collaborative agreements with local partner agencies. Additionally, Ignite will incorporate a comprehensive employment program combining both job and career advancement.
|
In each full year of the grant, this program will serve a minimum of 250 community-based fathers or expectant fathers (custodial or noncustodial) who are age 18 and older and who have a child or children under the age of 24. While the program will be targeted to fathers, mothers may also be served, as might individuals who play a father figure role such as adoptive fathers, foster fathers, grandfathers, etc. Ignite will serve the geographic area of Sarasota, Manatee, and Charlotte counties on the Gulf Coast of Florida. The goals of the program are to help struggling fathers and father figures improve the parent-child relationship, sustain healthy marriages and relationships (and help those who are single identify ways to enter into safe and supportive relationships that may ultimately lead to marriage), and identify and support fathers in their economic stability and employment objectives. These outcomes will be achieved through the provision of a series of workshops addressing responsible parenting and marriage and relationships as well as a complement of employment services and comprehensive case management. Additional services needed by participants will be identified and provided either through the extensive wraparound programming provided by JFCS or through collaborative agreements with local partner agencies.
Additionally, Ignite will incorporate a comprehensive employment program combining both job and career advancement. This will help fathers in crisis reach improved financial stability, which will in turn improve the ability of individual participants to be better parents and better partners, furthering the goals to foster more stable parent-child relationships and promote healthy marriages in the region. Nationwide 35% of children live in single parent families. Growing up in a single-parent family increases a child's risk of growing up poor, becoming a teen parent, dropping out of school, and disconnecting from the labor market. Coupled with its successful history of providing healthy marriage programming, JFCS as an agency is well-positioned to help families in crisis (both due to current economic conditions and in more long-term tenuous situations) become more stable and self-sufficient. Notable within our local demographic data is a significantly higher than average rate of unemployment and higher percentages of income in the past 30 days less than $500. Understanding the inextricable link between financial security and family stability, Ignite is truly targeting and reaching the most vulnerable individuals based solely on economic risk factors.
|
Inclusion Criteria:
1. Adults age 18 or older
2. Have a child or children under the age of 24
3. Interested in improving the parent-child relationship, sustain healthy marriages and relationships, and economic stability and employment objectives
4. Resides in Sarasota, Manatee, and Charlotte counties on the Gulf Coast of Florida
Exclusion Criteria:
1. Under age 18
2. Does not reside in Sarasota, Manatee, and Charlotte counties on the Gulf Coast of Florida
|
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] |
NCT05078736
|
Effects of Moderate Intensity Intermittent and Moderate Intensity Continuous Training on Hyperlipdemia
|
This project will be a Randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done, subject following eligibility criteria from milestone gym Sialkot, will randomly allocated in two groups via lottery method, baseline assessment will be done, Group A participants will receive baseline treatment along with moderate intensity intermittent training, and Group B participants will receive baseline treatment along with moderate intensity continuous training. Pre and post intervention assessment will include lipid profile test and Vo2 max rating of perceived exertion (RPE), and post data will be analyzed by using SPSS version 25.
|
Hyperlipidemia is a condition with high levels of fat in the blood, such as cholesterol and triglycerides. Hyperlipidemia is most commonly associated with high-fat diets, sedentary lifestyle, obesity and diabetes. The aim of the current study is to find the effectiveness of moderate intensity intermittent training and moderate intensity continuous training in women with hyperlipidemia. It will be a Randomized control trial and screening will be done as per the inclusion criteria of women having 30-40 years of age with hyperlipidemia. Participants with the history of any serious cardiac condition, musculoskeletal injury, and any type of systemic issue will be excluded.
Participants will be randomly allocated into two groups, Group A will receive moderate intensity intermittent training consist of running for 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery and Group B will receive moderate intensity continuous training consist of running continuously for 5 km at 70% of maximal aerobic speed for 5 weeks including exercise training of 3 days/week. Participants in both groups will be assessed with Lipid profile (fasting triglycerides, High Density Lipoproteins, Low density Lipoproteins) before and after the intervention.
VO2 max, rating of perceived exertion (RPE) Step Test: The step test is designed to measure a person's aerobic fitness. Participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's recovery rate during the minute immediately following the step test exercise.
Modified Borg scale: MBS is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.
|
Inclusion Criteria:
* Women.
* Age 30-40 years.
* Hyperlipidemia
Exclusion Criteria:
* With another serious cardiac condition.
* With any musculoskeletal injury.
* With any systematic condition.
|
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] |
NCT03120845
|
Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
|
Aim :to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
|
Aim to compare incidence of post-operative pain and apical healing after single-visit versus two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity tests and radiographically all teeth showed a small and irregular radiolucency at the tooth apex. Working length was established with EAL and confirmed radiographically. Reciprocating files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a lubricant.
|
Inclusion Criteria:
1. The aims and requirements of the study were freely accepted;
2. Treatment was limited to patients in good health;
3. All teeth had nonvital pulps and apical periodontitis, with or without a sinus tract;
4. A negative response to hot and cold pulp sensitivity tests;
5. Presence of sufficient coronal tooth structure for rubber dam isolation;
6. No prior endodontic treatment on the involved tooth
7. No analgesics or antibiotics were used five days before the clinical procedures began.
Exclusion Criteria:
1. Patients who did not meet inclusion requirements;
2. Patients who did not provide authorization for participation;
3. Patients who were younger than 16 years old;
4. Patients who were pregnant;
5. Patients who were diabetic;
6. Patients with a positive history of antibiotic use within the past month;
7. Patients whose tooth had been previously accessed or endodontically treated;
8. Teeth with root resorption,
9. Immature/open apex, or a root canal in which patency of the apical foramen could not be established were all excluded from the study. Teeth with periodontal pockets deeper than 4 mm also were excluded of the study.
|
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] |
NCT05642286
|
Clinical Study of Endovascular Interventional Surgical Instrument Control System and Related Consumables in Percutaneous Coronary Intervention
|
The goal of this study is to evaluate the safety and effectiveness of endovascular interventional surgery instrument control system （ALLVAS®robot）and supporting consumables for coronary artery interventional surgery.
Participants will will complete coronary intervention surgery with the assistance of robot system（ALLVAS®robot）, and evaluate the effect of the use effect of robots and clinical treatment after surgery
|
Interventional therapy plays an important role in the treatment of coronary heart disease. At present, the main treatment methods still rely on human hands, and there are some defects, including but not limited to hand shaking and visual error. The use of robots may partly circumvent the above shortcomings.
This study is to evaluate the safety and effectiveness of ALLVAS®robot for coronary artery interventional surgery.
|
Inclusion Criteria:
1. Patients who voluntarily participate in and sign the informed consent form, and can cooperate to complete the whole trial process;
2. aged over 18 and under 75;
3. After coronary CT angiography (CTA) or coronary angiography (DSA), the investigator judged that the patients who needed interventional blood supply reconstruction (target vessel diameter ≥ 2.5mm and lesion stenosis ≥ 70%).
Exclusion Criteria:
1. Acute myocardial infarction occurred within 7 days;
2. The target vessel has received coronary intervention within 30 days;
3. Restenosis in stent of target vessel;
4. Patients with bifurcation lesions whose target vessel branches need to be protected but cannot protect the collateral branches;
5. Hemodynamic instability (including low blood pressure or use of vasopressors to maintain blood pressure;)
6. Three vessel lesions;
7. The target vessel was diagnosed as coronary chronic occlusive disease (CTO) or left main artery stenosis or severe calcification requiring pretreatment;
8. Perforation, dissection or aneurysm of the proximal vessel of the target vessel;
9. Echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%;
10. Stroke or transient ischemic attack (TIA) occurred within 30 days;
11. Peptic ulcer or gastrointestinal bleeding within 90 days;
12. Estimated glomerular filtration rate eGFR (ckd epi)\<30 ml/min/1.73 m2;
13. Platelet count\<50 × 109/L or \> 700 × 109/L； White blood cell count \< 3 × 109/L;
14. Women who are in pregnancy or lactation or have a pregnancy preparation plan during the trial period;
15. People with allergy history or contraindication to antiplatelet drugs, anticoagulants, anesthetics, contrast agents, stent materials and their coating drugs;
16. Severe infections difficult to control;
17. Those who have mental diseases or mental disorders and cannot be described normally;
18. Emergency operation is required for any reason;
19. Those who have participated in clinical trials of other drugs or medical devices within 3 months before screening;
20. The investigator believes that there are other circumstances that are not suitable for this clinical trial.
|
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] |
NCT05531786
|
Phase I/II Study of Pacritinib, A JAK2/IRAK1/CSF1R Inhibitor, in Refractory Chronic Graft-Versus-Host Disease (cGVHD) After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
|
Background:
Chronic graft-versus-host disease (cGVHD) is an immune system disorder that can occur in people who have had a stem cell transplant. cGVHD can affect multiple organs and increase risk of disability and death. New treatments are needed to treat cGVHD after stem cell transplant.
Objective:
To test a drug (pacritinib) in people with moderate or severe cGVHD that has not responded to previous treatment.
Eligibility:
People aged 18 years and older with moderate or severe cGVHD that has not responded to 2 or more lines of previous treatment.
Design:
Participants will be screened. They will have blood and urine tests. They will have tests of their heart and lung function. They may also have a CT scan. Some may have other specialized tests.
Participants will take the study drug at home every day. Pacritinib is a capsule taken by mouth. The study doctor will determine the dosage and schedule.
Participants will keep a medication diary. They will record the date and time of each drug dose and any missed doses.
Participants will visit the clinic every 2 weeks for the first 4 months. Then they will visit the clinic once every 4 weeks. They will have blood and urine tests. During some visits, other screening tests will be repeated, and participants will fill out questionnaires about their quality of life. Photographs may be taken of skin rashes and joints affected by cGVHD.
Participants will give saliva samples. Optional biopsies may be taken of the skin and mouth.
Participants will take pacritinib for 6 to 12 months if no side effects develop. Follow-up visits will continue for up to 2 years.
...
|
Background:
* Chronic GVHD (cGVHD) is a multi-organ disorder characterized by immune dysregulation, impaired organ function, and decreased survival for hematopoietic stem cell transplantation (HSCT) patients.
* The JAK-STAT pathway plays an important role in immune cell development and function, including antigen presenting cells, B- and T-cells, and its activation leads to a cascade promoting a proinflammatory cytokine milieu.
* Pacritinib is a JAK2/IRAK1/CSF1R/FLT3 inhibitor, with an established safety and efficacy profile in the treatment of myeloproliferative neoplasms (myelofibrosis) and of acute GVHD.
* Pacritinib s immunomodulatory effects suggest therapeutic benefit for cGVHD, without abrogating the graft-versus-leukemia effect after HSCT.
Objectives:
* Phase I: to determine the safety of pacritinib in participants with refractory cGVHD
* Phase II: to determine the efficacy of pacritinib in participants with refractory cGVHD
Eligibility:
* Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria.
* cGVHD that did not respond to at least two prior lines of systemic therapy.
* Age greater than or equal to18 years.
* If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on stable or tapering doses in the preceding 4 weeks.
* Participants must have adequate organ and marrow function.
Design:
* This Phase I/II study will use a modified 3+3 dose-escalation design, with two planned dose levels of pacritinib, followed by a small efficacy evaluation in a randomized phase II design.
* Pacritinib will be given taken orally once or twice daily (based on dose level) on days 1- 28 of a 28-day cycle.
* Pacritinib treatment will continue for up to 12 months. cGVHD response will be evaluated at 6 weeks, and 3, 6, 9 and 12 months from the start of pacritinib. All participants will be followed through 2 years post-initiation of pacritinib.
* Total maximum number of participants to be enrolled is 30, with accrual ceiling set at 50 participants.
|
-INCLUSION CRITERIA:
1. Moderate or severe cGVHD (after allogeneic hematopoietic stem cell transplantation) diagnosed and staged per NIH criteria
2. cGVHD that did not respond to greater than or equal to 2 lines of prior systemic therapy.
Disease that has failed prior systemic therapy will be defined as follows:
a) For prior corticosteroid-containing regimens, disease that:
i) recurs after achievement of a CR, or
ii) progresses after achievement of a PR, or
iii) progresses after at least 1 week of prednisone equivalent of 1 mg/kg/day, or
iv) is stable and persistent after at least 4 weeks of a prednisone equivalent of 0.5 mg/kg/day
OR,
b) For other systemic therapies, disease that:
i) recurs after achievement of CR, or
ii) progresses after achievement of a PR, or
iii) is stable and persistent despite 4 weeks of therapeutic dosing of systemic therapy
3. Karnofsky performance score greater than or equal to 60%
4. Age \>=18 years.
5. If participant is taking systemic therapy for cGVHD at the time of enrollment, they must be on a stable or tapering dose in the preceding 4 weeks.
6. Participants must have adequate organ and marrow function as defined below:
* absolute neutrophil count \>=1,000/mcL
* platelets \>=50,000/mcL
* total bilirubin \<=1.5 X institutional upper limit of normal
OR
\<=3 X institutional upper limit of normal in participants with Gilbert s syndrome
* AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal
* creatinine clearance \>=50 mL/min/1.73 m\^2 per Cockroft-Gault
7. Primary malignancy for which the participant received transplant has been in complete clinical remission and stable for 3 months prior to enrollment on study.
8. Individuals of child-bearing potential (IOCBP) and individuals able to father a child with a partner able to become pregnant who are sexually active must agree to use one (1) highly effective (e.g., intrauterine device \[IUD\], surgical) or two (2)effective forms of contraception (e.g., barrier method) at study entry, for the duration of study treatment, and for at least 90 days after last study drug exposure.
9. Ability of participant to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA:
1. Acute GVHD that is active as defined by exhibiting current signs or symptoms of disease without any chronic GVHD (classic and late-acute GVHD per NIH consensus criteria); participants with a clinical presentation consistent with overlapping acute GVHD with concurrent chronic GVHD will be eligible
2. Treatment with ruxolitinib, or ibrutinib within the for \<= 14 days prior to treatment initiation.
3. Active HIV-1 (detectable HIV viral load), or Hepatitis B (HBV) and/or Hepatitis C (HCV) infection (positive HBV or HCV viral load in the setting of positive HBV core antibody or surface antibody or HCV antibody).
4. Participants with the following cardiac conditions at screening:
* symptomatic congestive heart failure
* unstable angina pectoris
* uncontrolled cardiac dysrhythmias
* QTc(F) prolongation \>450 ms or other factors that increase the risk for QT prolongation (i.e., heart failure, or a history of long QT interval syndrome).
5. Left ventricular ejection fraction \<= 50% by transthoracic echocardiogram (TTE) at screening.
6. Participants with poor pulmonary function as defined by a forced expiratory volume in the first second (FEV1) \<= 39% calculated using the USA-ITS-NIH equation.
7. Participants with evidence of ongoing hemorrhage, active signs/symptoms of bleeding, or history of severe bleeding complications in the one year prior to enrollment.
8. Concurrent treatment with any other investigational agents.
9. Concurrent use of strong CYP3A4 inducers or inhibitors, must stop 2 weeks prior study drug initiation.
10. Known hypersensitivity to JAK inhibitors.
11. Participants who are unwilling to accept blood transfusions.
12. Pregnancy or breastfeeding.
13. Participants with any active, uncontrolled viral, bacterial, or fungal infection are excluded.
14. Other malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix or breast which requires active treatment.
15. Uncontrolled intercurrent illness evaluated by history, physical exam and chemistries or situation that would limit compliance with study requirements.
|
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] |
NCT00572403
|
Risk Factors Contributing to the Development of Microalbuminuria
|
This research project will look at the relationship between baseline variables, and the new onset of microalbuminuria and the response to treatment with an angiotensin receptor blocker, losartan, in a cohort of 246 early hypertensives and normotensives who are being brought back for a 4-5 year follow up visit as part of a continuing project. We hypothesize that the new onset of microalbuminuria is associated with higher blood pressure levels at baseline and 1 year as well as being associated with elevated left ventricular mass index. The rate of new onset microalbuminuria in non-diabetics is not established and this prospective study will provide data.
|
The primary objective of this research project is to determine risk factors related to the development of microalbuminuria. The secondary objective is to determine whether uric acid levels at the final visit are correlated with the onset of microalbuminuria. Of participants returning for a 4-5 year follow up visit as part of a continuing project, we will examine the proportion that have developed microalbuminuria. Subjects found to have microalbuminuria will be offered therapy with the ARB losartan and will be followed at three months to determine if there has been a reduction in levels.
|
Inclusion Criteria:
* participation in the Double Exposure study
* elevated microalbuminuria
|
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] |
NCT02731417
|
Acupuncture Treatment for Post-partum Urinary Retention
|
There are no set national guidelines for the management of postpartum bladder. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention with reports of spontaneous restoring of micturition in all of the patients. The investigators aimed at examining if acupuncture is a useful tool to treat postpartum urinary retention.
|
Urinary retention is a common and frustrating complication in women during the immediate postpartum period. Physiologic changes in the bladder that occur during pregnancy predispose patients to develop symptomatic retention of urine during the first hours to days after delivery.
Postpartum urinary retention has a reported incidence ranging from 1.7 to 17.9 percent. Up to 5% of these women may have significant and longer lasting dysfunction, which if not recognised in the early peripartum period, may lead to bladder distension and overflow incontinence with significant long-term bladder dysfunction. Factors associated with postpartum urinary retention include: (1)Nulliparous women. (2) Prolonged labour, especially a prolonged second stage. (3)Assisted/instrumental delivery. (4)Perineal injury. (5)Caesarean section. (6)Regional analgesia.
Treatment begins with supportive measures to enhance the likelihood of micturition, such as ambulation, privacy, and a warm bath. If these measures are not successful, catheterization is usually performed.
There are no set national guidelines for the management of postpartum bladder care as yet. There is little evidence on the management of postpartum urinary retention and many hospitals have implemented their own postpartum bladder care protocols.
Acupuncture has been implemented as an alternative course of treatment for urinary retention in several chinese medical centers over the years with reports of spontaneous restoring of micturition in all of the patients.
A prospective study including all patients with postpartum urinary retention meeting the study criteria will be recruited. All patients will be required to give their informed consent. All patients will undergo a pre-treatment and post-treatment ultrasound recording the residual urine volume.
After the pre-treatment ultrasound acupuncture will be performed according to the following: 1) The points Sanyinjiao (SP 6) and Zusanli (ST 36) on the right side will be punctured 1/5-2 cm deep and moderate stimulation will be applied. 2) The needles will be retained for 30 minutes after achieving Qi and will be manipulated once every 3-5 minutes. After 30 minutes of acupuncture treatment, the patient will have an opportunity to void. If the patient is successful in voiding a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is less than 100 ml acupuncture treatment will be considered a success. If the patient is not successful at voiding during the hour after acupuncture treatment, a post-treatment ultrasound recording the residual urine volume will be performed. If the post-void residual (PVR) urine volume is greater than 100 ml, acupuncture treatment will be considered a failure and the patient will be catheterized.
|
Inclusion Criteria:
* Patients with postpartum urinary retention with either difficulty having voluntary micturition or a post-void residual (PVR) urine volume greater than 100 ml. confirmed by ultrasonography.
Exclusion Criteria:
* Patients with dermatitis over the acupuncture points,
* active urinary tract infection, prior use of anti-cholinergic drugs, cholinergic drugs, and alpha blockers.
|
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] |
NCT00125476
|
Effects of Exercise Training on Diastolic Heart Function in Postmenopausal Women
|
This study is a prospective follow-up study to the Dose-Response to Exercise in Women (DREW) study. In DREW, 450 overweight, sedentary postmenopausal women were randomly assigned to either a non-exercise control group or to 1 of 3 weekly physical activity groups. The DREW study is evaluating the dose-response of exercise training in regard to changes in multiple cardiac risk factors. This study will measure diastolic heart function in a subset of the DREW population in order to examine the relationship between dose response, changes in physical activity, and diastolic function. Diastolic heart function will be assessed using both traditional and novel echocardiographic measures.
|
BACKGROUND:
Congestive heart failure (CHF) has become the number one reason for hospitalization in the United States. Diastolic heart dysfunction is becoming increasingly recognized as a significant factor in the etiology of CHF. Of the total affected population, 70% of patients with diastolic heart failure are female, the majority of which are elderly. There is currently no effective pharmacological therapy for the treatment of diastolic heart dysfunction. Existing cross-sectional studies and limited training trials supporting the hypothesis that exercise may improve diastolic function have only studied men. There is a need for more properly controlled and adequately powered studies examining the effect of exercise training on diastolic function, particularly in populations at high risk for CHF, such as sedentary, postmenopausal women with elevated blood pressure.
DESIGN NARRATIVE:
A total of 215 sedentary, postmenopausal women at moderate risk for cardiovascular disease will be randomly assigned to receive either exercise training or no exercise for six months. This study will measure diastolic heart function using novel echocardiographic measurements, such as pulmonary vein flow pattern, tissue Doppler, and color M-mode mitral inflow propagation velocity. The study will also measure the left ventricular mass.
|
Inclusion Criteria:
* Physically inactive for 6 months prior to study entry; defined as sedentary and having an energy expenditure of less than 35 kcal(kgˉ¹)(dayˉ¹)
* Postmenopausal and fits one of the following criteria: over 55 years old and no natural menses for at least 5 years; less than 55 years old and no natural menses for at least 2 years and a serum follicle stimulating hormone (FSH) level greater than 40 mIU/ml; hysterectomy with documentation of bilateral oophorectomy; less than 55 years old with a hysterectomy but no documentation of bilateral oophorectomy and with an FSH level greater than 40 mIU/ml and estradiol level less than 25 pg/ml
* If taking hormone replacement therapy, must have been on a stable dose for at least 6 months, and must maintain the same dosage of the same medication throughout the study
* Body mass index between 25 and 40 kg/m²
* Systolic blood pressure between 120 and 159 mm Hg and diastolic blood pressure no greater than 99 mm Hg
* Fasting plasma glucose level less than 126 mg/dl
* Physically capable of exercise
Exclusion Criteria:
* Currently taking any antihypertensive medications
* Current or history of significant cardiovascular diseases or disorders, including arrythmias; myocarditis; cardiomyopathy; congestive heart failure; stroke or transient ischemic cerebral attacks; peripheral vascular disease with intermittent claudication; acute, chronic, or recurrent thrombophlebitis; and Stage II or III hypertension
* Current or history of total cholesterol level of at least 240 mg/dl with LDL-C level of at least 160 mg/dl or triglyceride levels of at least 300 mg/dl
* Current or history of hematologic disorders, including anemias, bleeding disorders, chronic thrombotic disorders, or hypercoagulable states
* Recent blood donation within the 6 weeks before study entry (participants also will be asked to refrain from blood donation during the study)
* Weight loss of 20 or more kilograms within the year prior to study entry
* Hospitalization for mental illness within 5 years of study entry or score of at least 10 on the Center for Epidemiological Studies Depression scale (CESD)
* Plans to be out of the city for more than 4 weeks over the next 6 months
* Other significant medical conditions, including the following: chronic or recurrent respiratory, gastrointestinal, neuromuscular, neurological, or psychiatric conditions; musculoskeletal problems interfering with exercise; autoimmune or collagen vascular diseases; immunodeficiency diseases or a positive HIV test; malignancies within 5 years of study entry, with the exception of skin cancer that is therapeutically controlled; endocrine and metabolic disorders; or any other medical condition or disease that is life-threatening or that may interfere with or be aggravated by exercise
|
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] |
NCT01731132
|
DIU-QoL. Quality of Life Evaluation in Intrauterine Device Users.
|
Knowledge about the impact on quality of life of women initiating IUD in the Spanish population at baseline and after 12 months of use.
|
Inclusion Criteria:
* 18-49 years old female.
* Women who is visited by a gynecology or primary care physician and starts contraception with an IUD/IUS.
* Women that has not used hormonal contraception in any form in the last 3 months.
* Women who have no problems listening, reading or writing.
* Women who gives their written consent to participate in the study.
Exclusion Criteria:
* Women who have contraindications to use IUDs.
* Women with previous experience with IUDs.
* Women who initiates the use of IUDs for other purposes other than contraception.
* Woman who is participating in a clinical trial at the time of initiating the study.
|
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|
NCT03610997
|
Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia
|
Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.
|
Anisometropia is a condition in which one eye has a significantly different refractive error from the other and commonly leads to the development of refractive amblyopia in the affected eye. High isoametropia is the condition in which both eyes have high refractive error and commonly leads to bilateral refractive amblyopia if untreated. Amblyopia is the condition in which vision does not develop fully in the brain due to disuse or misuse of one or both eyes. Typically, in high anisometropia, a contact lens in the eye with the stronger refractive error and/or glasses must be used to correct the refractive error. Commonly, infants and children with this condition refuse to wear the contact lens or glasses because the other eye sees normally. There are other problems in treating high anisometropia with glasses. One is aniseikonia, the condition of image size disparity between the two eyes. This causes difficulty for the brain of the affected person to fuse the images from the two eyes because the image from one eye is much larger than that from the other eye. This results in asthenopia (eye fatigue) and sometimes even diplopia. If the anisometropia is severe, significant amblyopia will result in the eye with the stronger refractive error and, if not treated at an early age, permanent and potentially severe vision loss will result.
In high isoametropia, contact lenses or glasses must likewise be used in order for normal vision to develop. Most children with isoametropia will wear glasses well because they cannot see well without them. By contrast, children with developmental delays, chromosomal abnormalities, autism, or attention deficit hyperactivity disorder and high isoametropia very commonly will not wear the needed refractive correction due to strong tactile aversion to anything touching their face or head. If the refractive error is high, significant bilateral (isoametropic) amblyopia will result and, if not treated at an early age, permanent and potentially severe vision loss will result.
PRK can normalize high refractive errors and potentially reduce or eliminate the amblyopia in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity. Secondary outcomes are stability of refractive correction, and corneal health.
|
Inclusion Criteria:.
* Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months.
* Anisometropic group:
* The anisometropia must be at least 3.00 diopters.
* The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children
* Isoametropic group
* Myopia must be at least -4.00 diopters in both eyes
* Hyperopia must be at least +4.00 diopters in both eyes
* Astigmatism must be at least +2.50 diopters in both eyes.
Exclusion Criteria:
* History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation.
* History of known collagen disorder
* History of known corneal ectasia
* History of previous herpes simplex keratitis
* Corneal thickness of less than 450u
|
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] |
NCT05571176
|
KetaMoHydBup: Pharmacokinetic Interaction of S-ketamine, Morphine, Hydromorphone and Buprenorphine
|
S-ketamine is often administered as a part of multimodal analgesia to reduce postoperative pain and postoperative opioid consumption. Current data indicates that ketamine may be useful for patients with prior use of opioids whereas the benefit for opioid-naive patients is less clear. However, different opioids have variable pharmacokinetic characteristics. Therefore, it is important to evaluate S-ketamine's effect on the pharmacokinetics of opioids.
|
S-ketamine is often used as a part of multimodal analgesia to reduce postoperative pain and opioid consumption, in part by mitigating opioid tolerance and opioid-induced hyperalgesia. However, there are mixed results concerning the effect of ketamine for this indication. Different opioids have various pharmacokinetic characteristics. Ketamine is known to inhibit the liver UGT2B7-enzyme, that is responsible for e.g., morphine metabolism. Therefore, it is important to investigate whether there is a clinically important pharmacokinetic interaction between S-ketamine and opioids metabolized via liver UGT2B7 enzyme. These opioids include morphpine, hydromorphone and buprenoprhine.
|
Inclusion Criteria:
* written informed consent
* age 18-45 years
* healthy
* Normal values in the following laboratory assessments: Hb, P-ALAT, P-AFOS, P-GT, P-creatinine, P-K, P-Na, chemical sample for urine (U-KemSeul). Pregnancy test (P-hCG-tot) must be negative.
* Urine sample for detection of any illegal drugs must be negative (U-Huum-PS)
* Normal EKG
* Normal blood pressure
* No prior use of illicit drugs
Exclusion Criteria:
* Tendency/predisposition to illicit drug use, illicit drug use in history
* Abnormal EKG
* smoking
* use of oral contraceptives
* pregnancy, lactation
* participating in a less tha 3 months ago
* Blood donation less than 3 months ago
* The subject's peripheral veins are hardly visible (predisposing difficulties in cannulation)
* weight less than 50 kg, body mass index (BMI) less than 18,5 or over 30
|
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] |
NCT03185715
|
Oocyte Recipient's Decision in the Number of Embryos to be Transferred
|
Multiple pregnancies are considered an ART complication. The only effective way to reduce its incidence is to transfer a single embryo. Nonetheless, there is some reluctance among the patients to accept this strategy. In IVF/ICSI programs, it has been demonstrated that, after receiving the information about the similar cumulative live birth rate after single embryo transfer (SET) and double embryo transfer (DET) and the obstetric and perinatal risks of multiple pregnancy, a significant number of patients opt for SET. Up to date, no comparable studies have been published in oocyte recipients. The aim of this study is to evaluate if the information given to the patients influence their preference on the number of embryos to be transferred. It also seeks to identify factors which determine the initial preference and factors which can explain a hypothetic change in this preference.
|
Inclusion Criteria:
* Patients under their first oocyte or embryo donation cycle.
* Sufficient knowledge of Spanish to fill out questionnaires.
Exclusion Criteria:
* Patients with a medical indication for single embryo transfer (e.g. Turner syndrome, uterine surgeries, cardiovascular risk).
* Having had previous oocyte or embryo donation cycles.
* Insufficient knowledge of Spanish.
|
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] |
|
NCT05337358
|
Clinical Performance of Fiber Reinforced FRC Base and Bonded CAD/CAM Resin Composite Endocrowns Versus Conventional Lithium Disilicate Endocrowns in Posterior Teeth (1y Randomized Clinical Trial).
|
In patients with endodontically treated molar teeth indicated for endocrown, will the fiber reinforced FRC base and bonded CAD/CAM resin composite endocrowns restorations have a similar clinical performance to the conventional lithium disilicate endocrown over one year?
|
Inclusion Criteria:
* Patients with good oral hygiene
* Patients having one or more endodontically treated molars that need prosthetic restoration.
* Molars should have enough tooth structure for endocrown restoration with minimum 3 walls with thickness not less than 1.5 mm and gingival step placed supragingival
* Fully erupted molars
* Molars free of developmental defect
* Healthy periodontium
* Absence of periapical pathosis
* Acceptable endodontic treatment and proper bone support
Exclusion Criteria:
* Patients with bad oral hygiene
* Patients with active periodontal disease
* Patients with missing teeth opposing to the area intended for restoration
* Patients with parafunctional habits or psychiatric problems or unrealistic expectation.
|
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|
NCT01436864
|
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
|
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
|
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is the main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
|
Inclusion Criteria:
* Signed the Informed Consent Form;
* Age ≥ 50 years of either gender;
* Total lesion size ≤ 30 mm2 of the study eye;
* BCVA score of the study eye between 73 and 19 letters;
* Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
* BCVA score of the fellow eye ≥ 19 letters.
Exclusion Criteria:
* Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
* Subretinal hemorrhage area≥ 50% of total lesion size;
* Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
* Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
* Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
* Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
* Previous ophthalmologic operations in the study eye;
* Current active inflammation or infection in either eye;
* Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* Current systemic administrations which may lead to toxicity in the crystalline lens;
* History of allergy or current allergic response;
* History of surgery within one month preceding enrollment;
* Infectious diseases need systemic administration;
* Systemic autoimmune diseases;
* Any uncontrolled clinical disorders;
* Patients of child-bearing potential do not adopted adequate contraception methods;
* Pregnant or nursing women;
* Patients should be excluded in the opinion of investigators;
|
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] |
NCT00355901
|
An Observational Follow-up Study for Subjects Receiving Salvage Therapy After Previous Treatment in a Visilizumab Study for Intravenous Steroid-Refractory Ulcerative Colitis
|
To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.
|
Inclusion Criteria:
* Previous participation in a visilizumab study of IVSR-UC.
* Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.
Exclusion Criteria:
* Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
* For U.S. sites, unwilling or unable to provide authorization to use protected health information.
|
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] |
|
NCT01450592
|
Study To Assess the Dietary Carbohydrate Content of Indian Diabetic Population
|
The study is designed as an interventional (as blood investigations will be done) dietary survey of diabetic \& non-diabetic population sample of India to understand \& compare dietary patterns among them.The study objective is to find out amount of carbohydrate content of daily diet of diabetic population study . This study does not intend to study the effect of any drugs. There will be 2 groups : Type 2 diabetics and non diabetic population. The study will begin after the study approval by ethics committee. The subject will involved after they sign the consent form. The study involves general examination of patients, collection of data like history of disease, interview by dietitian with the help of questionnaire, blood investigations (only in diabetic population only) and glycaemic control status of only diabetic population.The study is planned to be enroll 800 subjects (400 in each groups) from 10 study centers spread across India. The study data will be analyzed with appropriate statistical methods.
|
Inclusion Criteria:
* Diabetic Population
* Patients willing to provide signed \& dated informed consent and comply with study
* Indian diabetic population diagnosed with T2DM for at least 12 months
* Male and non pregnant female with age18 years or more
* Non-Diabetic Population
* Indian non-diabetic population who are not following any diet plan or dietary advice
* Patients willing to provide signed \& dated informed consent and comply with study requirements.
* Male and non pregnant female with age 18 years or more
* Non-diabetic population should be matched in terms of age, sex and centre
Exclusion Criteria:
* Patient unwilling to comply with the study procedures.
* Pregnant \& lactating women
* History of cardiovascular event within the previous six months.
* Patients with specific co morbidities, which may impact the patients diet, e.g malignant diseases, advanced dementia, Parkinson's disease and others.
* Suffering from chronic diseases including but not limited to chronic renal failure, chronic liver disease that might interfere with participation in the study as per physician discretion.
* Patients on weight management plan e.g. low carbohydrate diet which includes dietary modifications or dietary alterations.
|
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|
NCT01361113
|
Neoadjuvant Pazopanib in Renal Cell Carcinoma
|
This study will be a single arm phase II clinical trial of 8 weeks of daily, oral neo-adjuvant pazopanib prior to nephrectomy in 39 evaluable patients with histologically confirmed localized renal cell carcinoma (RCC).
|
The primary objective of this study is to determine the objective response rate Complete Response + Partial Response(CR+PR) associated with neoadjuvant pazopanib at 8 weeks as defined via Response Evaluation Criteria in Solid Tumors (RECIST1.1). The investigators will also estimate the recurrence free survival (RFS), specifically the 1 and 2 year rates, with recurrence defined via RECIST1.1, and characterize the safety issues. Finally, this study also includes a number of exploratory analyses designed to evaluate potential correlations between RFS and; serum levels of cytokine and angiogenesis factor (CAF).
|
Inclusion Criteria:
* Age ≥ 18 years with radiographic evidence of nonmetastatic renal cell carcinoma
* Histological verification of clear cell renal cell carcinoma (-Clinical stage 2 (7 cm) or greater with localized disease
* No evidence of extranodal metastatic disease
* Appropriate candidate for surgery
* The Eastern Cooperative Oncology Group (ECOG) Performance status of 0-1
* Adequate organ function
* Serum calcium, magnesium, potassium within normal limits, or if outside of normal limits, must be deemed clinically insignificant by the Investigator.
* No known coagulopathy
* Ability to read and follow instructions
* Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of pazopanib treatment and both men and women must be willing to use adequate contraception.
* Able to provide written, informed consent
* Blood and urine samples must be provided from all subjects for biomarker analysis before and during treatment with pazopanib
Exclusion Criteria
* Known or suspected allergy to pazopanib
* Inability to swallow or retain oral medication
* Prior malignancy Exception: Subjects who have had another malignancy and have been disease-free for three years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
* Unable or unwilling to discontinue use of prohibited medications at least 7 days prior to the first dose of study drug and for the duration of the study.
* Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including
* History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
* History of any one or more cardiovascular conditions within the past 6 months
* Hypertension \[defined as systolic blood pressure (SBP) of ≥140 mmHg OR diastolic blood pressure (DBP) of ≥ 90 mmHg in spite of optimal medical management.
* Evidence of active bleeding or bleeding diathesis.
* Any serious and/or unstable pre-existing medical (especially hepatic disease), psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
* Prior major surgery or trauma within 28 days prior to first dose of pazopanib and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major).
* Pregnant or breastfeeding; breastfeeding may not resume for 14 days after the last dose of pazopanib
* Prior treatment with any of the following anti-cancer therapies for treatment of their RCC:
* radiation therapy, surgery or tumor embolization
* chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy
* Baseline Corrected QT Interval (QTc) \>480 msec or other clinically significant baseline ECG abnormality
|
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] |
NCT04476147
|
The Impact of Frailty on Thrombosis of Elderly Patients With NVAF （FTE-NVAF）
|
This study aims to investigate the use of anticoagulants in elderly patients with non-valvular atrial fibrillation (NVAF) and the incidence of frailty in elderly patients with NVAF. After two years follow-up, we observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
|
Inclusion Criteria:
* ≥65yr
* Confirmed non-valvular atrial fibrillation (NVAF) diagnosis with ECG or Holter
* fulfilled CHA2DS2-VASc, HAS-BLED and Fried Scale
* patients agreed and provided informed consent
Exclusion Criteria:
* valvular atrial fibrillation
* cardiac surgery related atrial fibrillation
* acute disease related atrial fibrillation
* patients not fulfilled all the exam and text，or not accept the follow-up
|
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|
NCT04554394
|
CellFX System for the Treatment of Cutaneous Non-Genital Warts
|
This prospective, non-randomized, multicenter pivotal study is designed to evaluate the safety and effectiveness of the CellFX System in patients with cutaneous non-genital warts on all areas of the body, excluding the face.
|
The study will enroll healthy adult subjects with a minimum of two cutaneous non-genital warts, excluding the face, with each wart lesion not exceeding 10 x 10mm. One of the warts for each subject will be untreated and will serve as the subject's internal control. Macrophotography of all study warts will be captured along with Investigator assessments using the Wart Measurement Scale (WMS) and lesion measurements for wart reduction. All subjects will be followed at 7, 30, 60, 90 and 120-days post-initial CellFX treatment. All wart lesions are eligible for re-treatment up to 3 times over the course of the study. Adverse events will be documented.
|
Inclusion Criteria:
* Subjects must be at least 21 and not older than 80 years of age
* Subjects must be able to read and speak English or Spanish
* Subjects must sign a written informed consent to participate in the study, prior to any study related procedures
* Subject must have a minimum of two cutaneous non-genital warts, each not exceeding 10 x 10mm
* Subject is willing to undergo all study-mandated procedures
* Subject agrees to refrain from using all other wart removal products or treatments (topical medication including over-the-counter medications) during the study period
Exclusion Criteria:
* Subject has an implantable electronic medical device. (pacemaker, implantable cardioverter defibrillator, etc.)
* Subject has cochlear implants
* Subject has an active systemic infection or history of an infection in the designated treatment area within 90 days of enrollment
* Subject has a history of and/or current tinnitus
* Subject is known to be immune-compromised
* Subject is taking a blood thinning medication (Antiplatelet, Anticoagulation, Factor Xa Inhibitor, etc.)
* Subject has Type 1 Diabetes and is insulin dependent
* Subject has a known allergy to Lidocaine or Lidocaine-like products
* Subject is a member of a vulnerable population including individuals employed by the Sponsor, clinic site, or entity associated with the conduct of the study
* Subject has a comorbidity or condition which may reduce compliance with this protocol, including follow-up visits
* Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device)
|
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] |
NCT05257642
|
Testing the Efficacy of REThink Main Game-based ER Strategies on the Stress Reactivity
|
This activity will aim to test the comparative efficacy of the main game-based emotion-regulation abilities training of the REThink online game: cognitive change, biofeedback and problem-solving in reducing stress reactivity of the children and adolescents
|
Children included in this study (aged 8-16 years, G\*Power estimated N=98) will be allocated to one of the three experimental conditions (cognitive change, biofeedback and problem-solving game based training based on the REThink online game levels), or no intervention Control condition. All children will be exposed afterwards to psychosocial stress in the form of peer rejection "ball toss" task. It will be measure both game-based skills outcomes, and EMA stress reactivity outcomes.
|
Inclusion Criteria:
children and adolescents between 8 and 16 years provided written parental consent
Exclusion Criteria:
Intellectual disability or physical limitations precluded the use of the computer program
|
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] |
NCT02275013
|
Levosimendan Administration and Outcome in Cardiac Surgery
|
To assess the effects on outcome of levosimendan with respect to timing of its administration on the postoperative course of high-risk cardiac surgery patients in a retrospective observational study.
|
Inclusion Criteria:
* patients undergoing cardiac surgery between 2006 and 2013
* levosimendan administration within 24 hours of postoperative ICU admission
Exclusion Criteria:
* patients younger than 18
|
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|
NCT04474964
|
Focal Radiotherapy Plus Low Dose Craniospinal Irradiation Followed by Adjuvant Chemotherapy in WNT Medulloblastoma.
|
This clinical study is going to be done on a type of brain tumor in children called Medulloblastoma. The WNT pathway type of medulloblastoma is considered to be low risk and have the best outcomes in terms of survival. With the current standard of care for this type of medulloblastoma it is believed by the investigators that we are over treating the disease and increasing the long term side effects of these children. Several groups in the world are testing de-intensification of treatment in this favourable subset of children who experience long term late side effects of therapy. By reducing the dose to the craniospinal axis and keeping the total tumor bed dose the same in this study the investigators are expecting to reduce some of the late side effects of craniospinal irradiation without compromising disease control and survival.
|
WNT pathway medulloblastomas have the best prognosis amongst all four subgroups with 5-year overall survival exceeding 90%. Overall medulloblastoma is more common in males. They can occur at all ages, but, are uncommon in infants. They are mostly uniform in their genetic aberrations, histological pattern, and clinical presentation. The WNT pathway is involved in regulating embryonal development in the brain. They are frequently described as having CTNNB1 mutations, nuclear immunohistochemical staining for β-catenin, and monosomy six (deletion of one copy of chromosome 6 in the tumor). Thus monosomy 6 in conjunction with nuclear β-catenin accumulation is considered a sensitive and specific marker for WNT pathway medulloblastoma they are typically located in the midline vermian region filling up the fourth ventricle and infiltrating the brain stem consistent with their proposed cell of origin from the dorsal brainstem nuclei. The immediate impact of enhanced understanding of molecular biology has led to biologically driven next-generation clinical trials in newly diagnosed medulloblastoma. Given the excellent long-term survival outcomes in WNT-pathway medulloblastoma and potential for significant late toxicities with currently prevalent doses of CSI (23.4-36Gy), it has been hypothesized that further reduction of dose or in certain cases avoidance of CSI would translate into reduction in late morbidity of treatment.
In our first generation FOR-WNT study, the investigators had avoided upfront CSI and treated the tumor-bed alone with focal conformal radiotherapy in low-risk WNT-pathway medulloblastoma followed by 6-cycles of adjuvant systemic chemotherapy. However, early experience from our own study and similar results from another study (primary chemotherapy approach completely avoiding radiotherapy) suggests an unduly increased risk of relapse - spinal leptomeningeal or supratentorial if CSI is avoided and local recurrence at primary site too if radiation is completely avoided. Given the excellent long-term survival outcomes in WNT-pathway medulloblastoma treated with currently prevalent doses of CSI (23.4-36Gy), presence of significant late toxicities with such doses, but the increased risk of relapse with avoidance of CSI and/or local irradiation, the investigators hypothesize that further moderate reduction of CSI dose to 18Gy/10fx keeping the primary-site dose to 54Gy/30fx would translate into a meaningful reduction in late morbidity of treatment without compromising disease control or survival. Thus, the investigators herewith propose the second-generation study (FOR-WNT 2) to include low-dose CSI (18Gy/10fx) plus tumor-bed boost (36Gy/20fx) for a total primary site dose of 54Gy/30fx without concurrent chemotherapy followed by standard 6-cycles of adjuvant systemic chemotherapy.
|
Inclusion Criteria:
* Age more than 3 years and less than 16 years.
* Newly diagnosed WNT pathway medulloblastoma.
* Post-surgery residual disease less than 1.5 cm2 on post-operative MRI brain.
* No evidence of metastatic disease in the brain, spine or cerebral spinal fluid (CSF) assessed by MRI of the brain/spine and lumbar puncture for CSF cytology.
* Fit for initiation of adjuvant treatment within 6-weeks of surgery
Exclusion Criteria:
* Age Less than 3 and more than 16 years.
* Molecular subgroup other than WNT pathway.
* Post-surgery residual disease more than 1.5cm2 on post-operative imaging.
* Evidence of any metastatic disease in the brain, spine or CSF.
* Previous history of radiotherapy or chemotherapy prior to study enrollment.
* Not fit for initiation of adjuvant treatment within 6 weeks of surgery.
* Not willing for consent/assent.
|
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] |
NCT02057822
|
Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months
|
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
|
The ocular surface may be the seat of an inflammatory process in many pathology as vernal keratoconjunctivitis. It has been shown that inflammatory cytokines produced by the cells themselves and the constituent cells of the target organ, are the main factors that cause inflammation. The main objective of our study was to compare the concentration of 40 cytokines in vernal keratoconjunctivitis and in control subjects.
|
Inclusion Criteria:
* Childrens between 3 and 18 years
* Affiliated at system of French social security
* Signed by the holders of parental authority of the sheet and written consent to participate in this study
* First consultation at Clermont-Ferrand Hospital for vernal keratocunjunctivitis
Exclusion Criteria:
* Subject suffering from acute or chronic eye disease in which the physician investigator resound with the results: uveitis, glaucoma, retinopathy
* Subject who had undergone eye surgery
* Subject having an infection the day of collection: ENT, digestive, urinary
* Subject with cancer, mental illness or any other condition in which the physician investigator sound informed consent and / or the results
* Pregnant subject
* Subject with contact lenses
* Subject who judged by the investigating physician not enough cooperating to allow a safe collection
|
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] |
NCT04094233
|
Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise
|
Dietary NO3 is found in high concentrations in green leafy vegetables and beets. Studies weighing the action of NO3 for ergogenic purposes have found metabolic improvement in skeletal muscle during exercise in hypoxia, lowering blood pressure and increased workload at anaerobic threshold. In a way, the use of nitrate in combination with exercise may assist in autonomic adaptation to multiple stimuli, such as rest, during exercise and during the recovery period. HRV is one of the most practical methods for analyzing the physiological functioning of the ANS, both in the pathological condition of the individual and in the induction of other variables. peak-R (RRI) of consecutive heart beats. This study aims to evaluate the effect of beet extract supplementation in combination with submaximal strength exercise on heart rate variability and cardiovascular parameters of physically active individuals. It is a double-blind randomized crossover clinical trial.
|
An anamnesis of the participants will be made before the research. Essential information such as name, gender, age, height, BMI will be collected. Anthropometric measurements will be acquired according to the recommendations. Volunteers will be properly informed about the procedures and objectives of this study.
From a pre-established randomization, on the first day of collection volunteers will be allocated to group I (Placebo) or group II (Beet Extract). In the first intervention the volunteers allocated in group I will take a capsule containing 600mg of starch, at the end of this will be provided another capsule containing 600mg of beet extract for the second intervention. Conversely, group II volunteers will ingest a capsule containing 600mg of beet extract in the first intervention, and at the end of the experiment, another capsule containing 600mg of starch will be provided.
Research participants will be advised to consume the capsules within 2 hours of the procedure, adequate time for digestion, absorption and effect on the body. Prior to testing will be asked about the use of caffeine or any other type of substance that is described in the study inclusion and exclusion criteria. Then the collection will proceed.
Participants' blood pressure will be measured before (Rest) and after submaximal strength exercise during the first recovery time (REC1- 00-05 minutes) at 5 1-minute intervals using an aneroid sphygmomanometer (Premium®). and stethoscope (Rappaport®). Korotkoff's first and fifth phase readings were adopted as systolic and diastolic blood pressure, respectively.
Resistance exercise will be performed by performing movements that recruit lower limbs, emphasizing the quadriceps, posterior leg and buttocks. Training intensity will be defined by a subjective test of 1 repetition maximum (1RM). The evaluation will take place at a time before (at least 72 hours) to the data collection, aiming to pre-define and standardize the load that will be used on the day of the experiment. In this sense, the individuals will be oriented to test the load in the 4 proposed physical exercises in a total of 10 maximum repetitions, obtaining 75% of 1 maximum repetition (75% 1RM).
Leg Press 45º - 4 sets x 10 repetitions (75% 1RM) Extender Chair - 4 sets x 10 reps (75% 1RM) Abductor Chair - 4 sets x 10 repetitions (75% 1RM) Guided Squat - 4 sets x 10 repetitions (75% 1RM
|
Inclusion Criteria:
* Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
* Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
* Do not use any medication that may interfere with cardiac autonomic modulation
* Do have no skeletal muscle damage.
Exclusion Criteria:
* Smoking patients
* As well as individuals who have already used anabolic steroids
* Cardiorespiratory diseases
* Neurological disorders
* Other known compromises that prevent the subject from performing the procedures.
|
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] |
NCT04919057
|
Robotic Radical Perineal Prostatectomy Study
|
Radical perineal prostatectomy (RPP) was the first approach utilized for the removal of the entire prostate gland for prostate cancer. In the minimally invasive surgery era, the robotic-assisted laparoscopic prostatectomy (RALP) was first described in the early 2000s, and has become the mainstay of prostatectomy in Hong Kong and many parts of the world. Incorporating the robotic technology into the technique of RPP has been studied recently. Some preliminary data showed that such approach resulted in a better functional outcome in continence and erectile function. Our study aims at assessing the safety and effectiveness of robotic RPP in prostate cancer management.
|
Radical perineal prostatectomy (RPP) was the first approach utilized for the removal of the entire prostate gland for prostate cancer \[1\]. It continued to be the favoured approach for radical prostatectomy for several decades before the description of the radical retropubic prostatectomy (RRP) by Walsh in 1970s, who has refined the anatomical retropubic approach \[2\]. In the minimally invasive surgery era, the robotic-assisted laparoscopic prostatectomy (RALP) was first described in the early 2000s \[3\]. With time, the robotic retropubic approach became one of the most common approaches for prostate removal in prostate cancer patients. In parallel with the implementation of robotic surgery in retropubic prostatectomy, a revival in interest was experienced for the RPP approach in its role for the management of localized prostate cancer. In 2003, Resnick reported a cohort of RPP with reasonable operative times and cancer control concluding that the procedure was safe and effective \[4\]. Janoff and Parra noted that in comparison to RRP, patients undergoing RPP had less postoperative discomfort, shorter return of bowel function and hospital stay with a decreased transfusion rate \[5\]. Incorporating the robotic technology into the technique of RPP, Kaouk et al. performed robotic RPP in four patients with localized prostate cancer using a multi-arm da Vinci Surgical system (Intuitive Surgical Inc., Sunnyvale, CA). The procedures were successfully completed applying a robotic perineal approach with patients discharged within 48 hours \[6\]. Tugku et al reported their clinical experience with 15 patients who underwent robotic RPP \[7\]. Early continence rate was shown to be 40% at urethral catheter removal and 94% at third months postoperatively. Furthermore, a study was performed by the same group comparing outcomes of robotic RPP versus transperitoneal RALP \[8\]. Eighty patients (40 robotic RPP vs 40 RALP) with localized prostate cancer were included in the study. Continence rates were 94% in the robotic RPP and 72% in the RALP (p = 0.001) group at the 6th-month follow-up. In terms of erectile function, the rates favoured robotic RPP at 3, 6, and 9-month follow-ups with 44%, 66%, and 75%, respectively. In addition, compared with conventional RALP, robotic RPP would offer an advantage for those patients who had previous intra-abdominal surgery. Moreover, not having the need of putting the patients into steep Trendelenburg position is another potential benefit of robotic RPP over conventional RALP. In this study, we evaluate the early oncological outcome and objective functional outcome of patients undergoing robotic RPP for the treatment of localized prostate cancer.
|
Inclusion Criteria:
* Men aged between 40 - 80 years
* Localized prostate cancer without obvious lymph node or distant metastases
Exclusion Criteria:
* Clinical T stage T3 or above
* Prostate size \>80 ml
* Patients with previous treatment of prostate cancer
* Patients with previous surgery on the prostate
* Patients with active urinary tract infection
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Patients who fail to give informed consent
|
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] |
NCT03475420
|
Post-Treatment Surveillance in Lung Cancer
|
There are 13.7 million Americans currently living with a history of cancer. With continued improvements in cancer treatment and increasing life expectancy, this number is expected to reach nearly 18 million within the next decade. The care of these cancer patients, including surveillance during the post-treatment survivorship phase, is an increasingly important major health care concern and expenditure. As the fourth leading diagnosis among cancer survivors, lung cancer is emerging as a chronic problem that currently affects over 450,000 Americans and is expected to grow by nearly 20% by 2022.
Lung cancer is the second most common cancer in the United States. Of the estimated 182,550 patients newly diagnosed with non-small cell lung cancer (NSCLC) this year, approximately 35% will present with localized disease and be eligible for curative resection. For patients with limited NSCLC, surgical resection is the most effective method of controlling the primary tumor and provides the best opportunity for cure. A recent analysis by this group demonstrated that the number of lung cancer resections has increased over the past decade, with over 45,000 lung cancer resections performed annually in the US.
This research will address a critical gap in knowledge because the optimal approach to post-treatment surveillance following lung cancer resection is unknown. The intensity of recommended surveillance visits ranges from every 3 months during the first two years to an annual visit. Imaging modalities range from CT scans to chest radiographs to no routine imaging for asymptomatic patients. The reason for these significant differences is a lack of quality data on lung cancer surveillance and clinical guidelines based largely on small retrospective analyses and expert opinion.
The National Cancer Data Base (NCDB) provides real world national lung cancer resection and surveillance data on over 70% of newly diagnosed lung cancers from more than 1,500 institutions. This study will compare the effectiveness of the three most common surveillance intensities (CT scans every 3 months vs. 6 months vs. annually) on the stakeholder selected outcome of survival. All analyses will be risk adjusted for differences in patient characteristics at baseline, including tumor characteristics, patient age, comorbid disease, and other potential confounders. Analyses will also be adjusted for the competing risk of death.
|
This study will use a special study of the National Cancer Database to develop a cohort of NSCLC survivors undergoing surveillance. Cox proportional hazards regression and competing risk analyses will compare the effectiveness of the three most common surveillance intensities (3 months vs. 6 months vs. annually) on survival.
There is also a plan to engage cancer survivors to guide the development of our study comparators, outcomes and demonstration of results.
|
Inclusion Criteria:
* Men or Women
* Diagnosis of surgically resected lung cancer
* American Joint Committee On Cancer (AJCC) stages I-III
Exclusion Criteria:
-
|
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0.1535695344209671,
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0.2999074161052704,
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] |
NCT05978362
|
Value of Capsular Repair for Latarjet
|
The purpose of the study is to evaluate the occurrence of osteoarthritis (YES/NO) by radiography.
|
This is a prospective, comparative, longitudinal, randomized, single-blind, multicenter study.
This study will validate preliminary results on a technique associating capsular repair with abutment according to Latarjet in the treatment of shoulder instabilities. It may help reduce the risk of osteoarthritis and thus allow patients to maintain a healthy, stable and painless shoulder for longer.
|
Inclusion Criteria:
* Patient, male or female, over the age of 18
* Patient with shoulder instability with risk factors for recurrence (ISIS score \> 3), requiring surgical stabilization by abutment
* Affiliated patient or beneficiary of a social security scheme
* Patient having been informed and having given his free, informed and written consent.
Exclusion Criteria:
* Patient with history of surgery for instability of the same shoulder
* Patient presenting contraindications to the realization of a postoperative scanner
* Patient whose physical and/or psychological health is severely impaired, which according to the investigator may affect the compliance of the study participant
* Patient participating in another clinical research or in a period of exclusion from another research still in progress at the time of inclusion
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
* Pregnant, breastfeeding or parturient woman
* Patient hospitalized without consent.
|
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] |
NCT02373384
|
The Predictors of Successful Oral Dissolution Therapy in Radiolucent Renal Stones; A Prospective Evaluation
|
The aim of the study is to evaluate the predictors of success of oral dissolution therapy in radiolucent renal stones in a large series of patients from a tertiary referral center in order to define the optimum case scenarios where oral dissolution therapy could be implemented.
|
Patients with renal stones, seen through the outpatient clinic in the urology department or post primary intervention for renal stones, will be assessed to see if the patient satisfies all inclusion and exclusion criteria. Patients who are meeting these criteria will be asked to participate in this prospective study. If they agree, they will be asked to sign an informed consent.
Baseline patients' assessment will include;
* Full history taking including
* Previous stone history regarding presentation and management
* Previous trial oral dissolution therapy for renal stones and their compliance to the treatment
* Previous GIT surgery
* History of chronic medical or metabolic illness e.g; DM
* Clinical examination including
o Body mass index (BMI)
* Laboratory investigations including;
* Urine analysis (urine PH)
* 24 hours urine testing for uric acid and citrate
* Urine culture
* Serum creatinine
* Random blood sugar (RBS)
* Serum uric acid
* Serum calcium, phosphorus and magnesium.
* Initial radiological evaluation will include
* Renal ultrasonography (US)
* Plain X-rays to exclude the presence of calcification in the targeted stone.
* Non Contrast Computed Tomography (NCCT) on the abdomen and pelvis.
* MAG3 diuretic renogram
(All NCCT studies will be performed with multislice helical CT scanners, NCCT images will be obtained from above the kidneys through the bladder base. For each renal stone, its location will be recorded, its size will be measured using the largest dimension from length (L), width (W) and height (H) on axial and coronal reformat images. Its mean density will be recorded by measurement using region of interest just smaller than the stone. Associated hydronephrosis proximal to the stone will be also evaluated (Nakada et al 2000).)
Patient will receive the allocated instructions and medications
Patients' follow up (The aim at follow up is to monitor the urinary PH with adjustment of the dose of potassium citrate and also to assess the compliance of the patients regarding the dietary recommendations and the medications)
* After 2 weeks, 4 weeks, 8 weeks and 12 weeks.
- the most important parameter will be assessed is the urinary PH every two weeks. The target urinary PH should be kept between6.5 to 7.0, the dose of potassium citrate should be adjusted to achieve this value.
* Patients' compliance to medications intake and the instruction of fluid intake and dietary modification.
|
Inclusion Criteria:
* Patients' criteria:
1. Ability to give informed consent.
2. Age more than 18 years.
3. Absence of significant hydronephrosis, serious urinary tract infection, congenital anomalies or distal ureteric obstruction in the affected renal unit.
4. Normal cardiac, hematological, and renal functions.
* Stone criteria:
1. Primary or recurrent renal stone.
2. Patients with residual renal stones after primary intervention whether open surgery, endoscopic or ESWL.
3. Peripheral calyceal stones or stone in the renal pelvis with no significant hydronephrosis.
4. Stone size less than 3 cm in maximum diameter
5. Stones with radiodensity less than 600 Hounsefield units attenuation in Non Contrast Computed Tomography (NCCT).
Exclusion Criteria:
* Patients' criteria:
1. Inability to give informed consent.
2. Age less than 18 years
3. Patients with unremitting pain or serious urinary tract infection.
4. Presence of significant hydronephrosis, congenital anomalies or distal ureteric obstruction in the affected renal unit.
5. Abnormal cardiac, hematological or renal functions.
* Stone criteria:
1. Obstructing stone in the renal pelvis with significant hydronephrosis.
2. Assumption of presence of calcium stones by presence of calcification in the stone in plain X-rays.
-
|
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] |
NCT02126280
|
Monocyte Activation in Preclinical Atherosclerosis
|
The study of proinflammatory and anti-inflammatory cytokines and chemokines expression profiles in human monocytes to identify new effective biomarkers that have the best diagnostic potential in asymptomatic atherosclerosis.
|
This project is the first step in creating a method for assessing an individual activity of macrophages. The problems addressed in the project are socially significant because of the high incidence of life-threatening diseases and their effects in the population. The method of evaluation of monocyte-macrophages activity in human blood will be based on the analysis of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory activity of macrophages. The most informative panel of cytokines and chemokines obtained during the project can be further used to create effective diagnostic tests.
|
Inclusion Criteria:
* men and women aged 40 to 74 years
* arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm Hg, diastolic blood pressure \<90 mm Hg)
* absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
Exclusion Criteria:
* personal history of transient ischemic attacks
* personal history of chronic diseases demanding permanent drug administration (more than 2 month per year)
* personal history of life-threatening diseases
* indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system
|
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] |
NCT02149966
|
A Phase I Study of AG-348 in Healthy Volunteers
|
This is a dose escalation study that will be conducted in healthy volunteers. Multiple cohorts of volunteers will receive ascending (increasingly higher) oral doses of AG-348 daily for 14 days to evaluate the safety and tolerability of multiple oral doses of AG-348, the pharmacokinetics (PK) of multiple doses of AG-348, and the pharmacodynamic profile of AG-348 with specific biomarkers assessed in the blood.
|
Inclusion Criteria:
* Healthy adult male or female subjects 18 - 60 years, in good general health who are able to understand consent and complete all study procedures.
* Female subjects of non-child bearing potential (surgically sterile or post-menopausal as confirmed by age \[over 50 years\], amenorrhea for ≥12 consecutive months and FSH).
* Male subjects who are not vasectomized must agree to use contraception up to 30 days after dosing.
* Subjects with body weight ≥50 kg; BMI ≥18.5 and ≤32 kg/m2.
* Subjects who are non-smokers and have not used nicotine-containing products for at least 3 months prior to screening.
* Subjects must be willing to refrain from caffeine- or xanthene-containing products (coffee, tea, chocolate) for 48 hours prior to dosing through discharge from the clinical facility.
* Subjects must agree to refrain from strenuous exercise starting 72 hours prior to admission through final follow-up visit.
* Subjects must refrain from use of alcohol starting 7 days (14 days for red wine) prior to admission through final follow-up visit.
* Subjects must agree not to donate blood products for duration of study participation.
Exclusion Criteria:
* Subjects who have previously received AG-348.
* Subjects with clinically relevant screening laboratory tests.
* Female subjects who are not post-menopausal.
* Subjects with recent use of prescription, over the counter (OTC), herbal and/or dietary medications and/or supplements.
* Male subjects with QTcF interval ECG \> 450 msec,or female subjects with QTcF interval ECG \> 470 msec.
* Subjects with a history of a serious mental illness.
* Subjects with a clinically relevant medical history or pre-existing medical condition that would interfere with the absorption, metabolism or excretion of the study drug.
* Subjects with a history of any primary malignancy (cancer). Exceptions are certain skin cancers, cervical cancer in situ or other cancers that have been curatively treated without evidence of disease for a minimum of 1 year.
* Subjects with glucose-6-phosphate-dehydrogenase (G6PD) deficiency.
* Subjects who are positive for hepatitis B, hepatitis C or HIV.
* Subjects who have undergone surgery 6 months prior to screening.
* Subjects who have a history of illicit drug use or alcoholism within the last year.
* Subjects who are participating in other concurrent clinical trial of an investigational drug, or have received another investigational agent within the last 2 months.
* Subjects with any conditions which would make the subject unsuitable for enrollment, or could interfere with the subject's participation in or completion of the study.
|
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] |
|
NCT04469764
|
Abemaciclib for the Treatment of Recurrent Ovarian or Endometrial Cancer
|
This phase II trial studies how well abemaciclib works in treating patients with ovarian or endometrial cancer that has an activation of the CDK4/6 pathway and that has come back (recurrent). Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving abemaciclib may work better for the treatment of recurrent ovarian and endometrial cancer.
|
PRIMARY OBJECTIVE:
I. To obtain an estimate of the proportion of patients' progression-free at 16 weeks (16 week progression free survival \[PFS\] rate) in patients with recurrent ovarian (including fallopian tube and primary peritoneal) or recurrent endometrial cancer following treatment with abemaciclib as a molecularly matched targeted therapy.
SECONDARY OBJECTIVE:
I. To assess objective response rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST), progression free survival (PFS) and safety following treatment with abemaciclib as a molecularly matched targeted therapy.
EXPLORATORY OBJECTIVES:
I. To explore the relationship between response to abemaciclib and somatic gene alterations that lead to CDK4/6 activation in ovarian cancer.
II. To explore the relationship between response to abemaciclib and hormone receptor expression levels as well as somatic gene alterations that lead to CDK4/6 activation in endometrial cancer.
OUTLINE:
Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Patients with tumors that are hormone receptor positive also receive anastrozole or letrozole per standard of care. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 30 days, and then every 12 weeks up to 1 year.
|
Inclusion Criteria:
* Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) cancer or endometrial cancer
* Molecular tumor board confirms that patient's archival ovarian cancer tumor specimen has been assessed using standard of care genomic profiling and demonstrates CDK4/6 activation features
* Molecular tumor board confirms that patient's archival endometrial cancer tumor specimen has been assessed using standard of care genomic profiling and is of endometrioid histology, has positive hormone receptor expression and lack of Cyclin E gene (CCNE) amplification or retinoblastoma susceptibility gene product (RB) loss
* At least one prior chemotherapy regimen for the treatment of recurrent ovarian or endometrial cancer
* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and study initiation
* Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and study initiation
* The patient is able to swallow oral medications
* Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Informed consent must be obtained in writing for all patients prior to performing study/screening procedures and prior to registration into the study
* Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L
* Platelets \>= 100 x 10\^9/L
* Hemoglobin \>= 8 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion
* Total bilirubin =\< 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin =\< 2.0 times ULN and direct bilirubin within normal limits are permitted
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN
* Female participants of childbearing potential must have a negative serum pregnancy test within 7 days of the first dose of abemaciclib and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib
Exclusion Criteria:
* Anticipation of immediate need for a major surgical procedure (e.g., impending bowel obstruction, gastrointestinal perforation) or radiation therapy during the trial
* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri or breast
* Treatment with chemotherapy, surgery, blood products, or an investigational agent within 3 weeks of trial enrollment
* Any of the following within 6 months prior to trial registration: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism
* Unstable brain metastases or carcinomatous meningitis
* Patient of child-bearing potential is evidently pregnant or is breast feeding. A woman with child bearing potential is defined as not surgically sterile or being post-menopausal for less than 6 months
* Patient of child-bearing potential is not willing to use adequate contraceptive precautions. Adequate effective method of contraception are those which result in low failure rates, less than 1% per year, such as non-hormonal intrauterine device (IUD), condoms, sexual abstinence or vasectomized partner
* The patient has serious preexisting medical condition(s) that would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea)
* The patient has active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]. Screening is not required for enrollment
* The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
* Current use or anticipated need for: Food or drugs that are known strong CYP3A4 inhibitors (i.e. grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, posaconazole, erythromycin, clarithromycin, tilithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir, nefazodone, diltiazem, and delaviridine)
* Other severe acute or chronic medical or psychiatric condition, or significant laboratory abnormality requiring further investigation that may cause undue risk for the patient's safety, inhibit protocol participation, or interfere with interpretation of trial results, and in the judgment of the investigator would make the patient inappropriate for entry into this trial
|
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] |
NCT06680349
|
Two Anti-CD20 Regimens for Fibrillary Glomerulonephritis
|
This study aims to evaluate the clinical and histological effects of two rituximab-based regimens in fibrillary glomerulonephritis.
|
Inclusion Criteria:
-Fibrillary glomerulonephritis (biospy proven defined by optical microscopy, immunofluorescence and electron microscopy studies with demonstration of the DNAJB9 protein)
Exclusion Criteria:
* previous treatment with anti-CD20; pregnant; unable to consent. other concomitant GN.
|
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] |
|
NCT04571086
|
FAPI-PET for Tumor Detection
|
This is a prospective observational trial investigating correlation with histopathology, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI in patients receiving this imaging modality for tumor staging or restaging as part of clinical care.
|
68-Ga-fibroblast-activation-protein-inhibitors (68-Ga-FAPI) are novel Positron emission tomography (PET) tracers that were recently introduced for the imaging of patients with various cancer diseases. The fibroblast-activation-protein (FAP) is highly expressed in carcinoma-associated fibroblasts (CAFs) in the stroma of various tumor entities. The aim of this registry study is to collect data on FAPI expression, positive predictive value, detection rate, reproducibility and impact on clinical management of 68-Ga-FAPI PET/CT or PET/MRI on patients receiving this imaging modality at initial diagnosis or restaging as part of clinical care.
|
Inclusion Criteria:
1. FAPI-PET scheduled for staging or restaging as part of clinical routine for proven or suspected malignancy
2. Age ≥ 18 years.
Exclusion Criteria:
1. Patient cannot give consent for the study
2. Patient can not lie flat or tolerate FAPI PET imaging
3. Unwillingness or inability to comply with study and follow-up procedures
4. Condition of patient which is critical to participate in this study in the discretion of the investigators
5. Pregnant, lactating, or breast feeding women.
|
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] |
NCT03183050
|
MEND 2: Making Treatment Decisions Using Genomic Testing
|
Clinical guidelines for women with early stage breast cancer integrate genomic tumor profiling tests such as the Oncotype DX Recurrence Score to refine recurrence estimates and systemic therapy selection when combined with existing markers. Guidelines suggest that the 25% with a high Score benefit from chemotherapy and the 50% with a low Score can safely avoid chemotherapy. Many challenges remain to maximize the benefits of testing prior to release of trial results in the next year. Strong clinical communication can impact proximal outcomes of patient comprehension, treatment preferences and satisfaction, involvement in care decisions as well as longer-term outcomes of treatment adherence and QOL. These proximal outcomes can be influenced by patient activation interventions utilizing a question prompt list (QPL). In the context of patients receiving Oncotype DX testing, the QPL could allow them to better understand the rationale for their oncologist's treatment recommendation, what it means for managing their disease, and encourage alignment of treatment preferences and selection with the Recurrence Score. Research is conducted in two phases to test the feasibility and impact of the QPL. In Phase 1, the draft QPL will be revised based on in-depth interviews with patients (N=20) and medical oncologists (N=10). Phase 2 will be a single-arm trial (N=75) to demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes.
|
Breast cancer is the most common cancer among US women, with more than 230,000 new diagnoses and 40,000 deaths each year, along with decrements in quality of life. Half of all newly-diagnosed patients are affected with estrogen-receptor positive, early-stage disease. Clinical guidelines for these women integrate genomic tumor profiling tests such as the Oncotype DX® Recurrence Score to refine recurrence estimates and systemic therapy selection when combined with existing markers. Thousands of women receive testing each year. While these women should all receive hormonal therapy, guidelines suggest that the 25% with a high Score benefit from additional chemotherapy and the 50% with a low Score can safely avoid chemotherapy. Appropriate treatment for the 25% of women with intermediate Recurrence Scores remains unclear until clinical trial (TAILORx) results are released in the next year.
Despite continuing dissemination, many challenges remain to maximize the benefits offered by testing and refined treatment selection. TAILORx results will continue to strengthen the evidence for clinical utility and increase testing rates. An effective intervention should be ready to respond to this increasing need. Communication can influence more proximal outcomes, including patient comprehension of their disease and its treatments, treatment preferences and satisfaction, involvement in care decisions as well as longer-term outcomes of treatment adherence and quality of life. This trial will test the feasibility and impact of a patient activation intervention to support effective integration of the Recurrence Score into clinical encounters and treatment decisions. Patient activation interventions utilizing a question prompt list (QPL) can impact proximal outcomes of preferences, comprehension, satisfaction and involvement. Women with newly-diagnosed breast cancer will be recruited to a single-arm trial to demonstrate feasibility and preliminarily assess the impact of the QPL on key outcomes. Aims are to:
Aim 1. Examine intervention feasibility. Feasibility will be examined in 3 areas: 1) patient and oncologist acceptability, 2) participant recruitment and retention, and 3) intervention dosage and fidelity.
Aim 2. Evaluate intervention effects on comprehension and treatment preferences. 2a: Participants will demonstrate significant increases in comprehension about their disease and its treatments from pre- to post-QPL. 2b: Participants will be more likely to report Score-concordant preferences from pre to post-QPL.
Aim 3. Assess potential intervention mechanisms on comprehension, preferences and satisfaction. 3a: Patient comprehension and satisfaction will be higher following encounters with greater shared decision making, greater perceived communication quality, and more frequent discussion of risks/benefits of treatments. 3b: Patient preferences will likely be more Score-concordant following encounters with greater shared decision making, greater perceived communication quality, and more frequent discussion of risks/benefits of treatments.
|
Inclusion Criteria:
* Women aged 40-75 who receive Oncotype DX testing are eligible.
Exclusion Criteria:
* Cognitive impairment that precludes informed consent and inability to converse in English given the focus on communication in this study. Clinical communication between providers and patients with limited English proficiency is beyond the scope of this work.
|
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] |
NCT05944718
|
Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa
|
Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour.
In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs.
This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in South Africa.
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3 Study Design As this study is a PrCT the study aspects will be embedded in the normal clinical care delivery of diabetes care in the selected clinics (see section 3.2, Scientific Rational for Selection of Study Design). Introducing only 1 additional clinic visit and 1 additional qualitative visit for study related procedures. The primary outcome measure, HbA1c, will be assessed through the HbA1c testing that is already used in these clinics. It is important to note that the type of HbA1c test (i.e.: laboratory-based vs point-of-care) per participant must remain constant during the study, this is because of variability of performance between various HbA1c testing platforms.
3.1 General Design This is a three-arm pragmatic randomized control study. The expected duration of study participants involvement in the study is 15 months, this consists of 9 months of intervention with a follow up visit 6 months post the last interventional study visit. There will be 6 total study visits for all participants.
* Arm 1 is those participants randomized to use of CGM in a continuous fashion; CGM use for the duration of 9 months.
* Arm 2 is those participants randomized to intermittent use of CGM; CGM use for 4 time points consisting of 2 weeks of CGM use each, for the duration of 9 months.
* Arm 3 is those participants randomized to standard of care; regular use of self-monitoring of blood glucose (SMBG) for the duration of 9 months.
For all participants the first study visit will consist of:
1. Enrolment including ICF,
2. Baseline surveys including demographics, the Glucose Monitoring Satisfaction Survey (GMSS-T1D), HRQOL surveys, and diabetes distress score survey.
3. Randomized assignment to study arm,
4. Blood draw for HbA1c testing (if not already done in the previous 1 month).
Those participants randomized to Arm 1 and Arm 2 will receive an education session on the CGM, be provided with the CGM, and be guided how to self-apply the CGM during enrolment visit.
During all Study Follow Up visits participants will have blood drawn for HbA1c testing, complete a brief survey to capture any hospitalizations and/or hypoglycaemic events related to diabetes complications that occurred between study visits.
Additionally, during Study Follow up visit C participants will complete the Glucose Monitoring Satisfaction Survey (GMSS-T1D), diabetes distress score survey, and an acceptability survey. During Study Follow up visit D, participants will complete the HRQOL surveys and diabetes distress score survey. During Study Follow up visit E participants will complete the Glucose Monitoring Satisfaction Survey (GMSS-T1D), diabetes distress score survey, and HRQOL surveys.
Detailed explanation of the study visits per arm are outlined below by arm in section 3.1.1, 3.1.2, 3.1.3
Qualitative methods used across all arms will consist of focus group discussions (FGDs) among the participants and caregivers of participants. Approximately 15 participants above the age of 18 years old will be selected from each arm (n=45, 3 FGD in total) and approximately 15 participants age range of 11 to 17 years old will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGD to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding participant perceptions towards their current glucose monitoring devices and quality of life. To capture the perspectives of care givers of children and adolescents living with T1 diabetes 15 caregivers will be selected from each arm (n=45, 3 FGD in total) to participate in arm specific FGDs to take place 30 to 35 weeks after study enrolment started. These FGDs will focus on understanding care giver perspectives towards their minor's glucose monitoring devices and quality of life from the perspective of the care giver as well as their perceptions towards the quality of life for their minor.
Qualitative methods will also be used to gather perceptions from the healthcare providers regarding their perceptions surrounding the feasibility and acceptability of use of CGMs in their settings. This will consist of a semi-structured interviews (SSI) of selected HCW (n=10 total) to be conducted after week 36 after study enrolment started.
3.1.1 Arm 1 Continuous use of CGM For those in Arm 1 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants.
1. Enrolment visit: For those randomized to Arm 1 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing (where this is standard of care) and be guided how to self-apply the CGM during enrolment visit.
2. Study Follow up A: The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. Participants in Arm 1 will be provided with 6 additional CGMs to continually use the CGM devices until their third study visit (Study Follow up B) to take place 12 weeks after enrolment.
3. Study Follow up B: At the third study visit participants will see the clinician and review the CGM data from the period of time in between second study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that they continually use the CGM devices until their fourth study visit (Study Follow up C) to take place at 24 weeks after enrolment.
4. Study Follow up C: At the fourth study visit participants will see the clinician and review the CGM data from the period of time in between third study visit and current, blood will be drawn for HbA1c testing, and the participant will be provided with 6 additional CGMS such that the continually use the CGM devices until their fifth study visit (Study Follow up D) to take place at 36 weeks after enrolment.
5. Study Follow up D: At the fifth study visit participants will see the clinician and review the CGM data from the period in between fourth study visit and current, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up C.
6. Study Follow up E: At the sixth and final study visit which takes place at 58 weeks after enrolment study participants will see the clinician and blood will be drawn for HbA1c.
3.1.2 Arm 2 Intermittent use of CGM For those in Arm 2 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants.
1. Enrolment visit: For those randomized to Arm 2 they will receive an education session on the CGM, be provided with the CGM, blood will be drawn for HbA1c testing, and be guided how to self-apply the CGM during enrolment visit.
2. Study Follow up A: The second study visit will take place 1 week after the enrolment visit. During this second visit the participant will see the clinician and review the CGM data from the first week. During Study follow up A participants in Arm 2 will be provided 1 CGM to use starting 1 week before their third study visit (Study Follow up B) to take place at 12 weeks after enrolment.
3. Study Follow up B: At the third study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up A, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A and 1 week before their fourth study visit (Study Follow up C) to take place at 24 weeks after enrolment.
4. Study Follow up C: At the fourth study visit participants will see the clinician and review the CGM data from the preceding week before Study follow up B, blood will be drawn for HbA1c testing, and the participant will be provided with 1 additional CGM such that the participant uses the CGM for the week directly following Study follow up A, and 1 week before their fifth study visit (Study Follow up D) to take place 36 weeks after enrolment.
5. Study Follow up D: At the fifth study visit participants will see the clinician and review the CGM data from the week preceding Study Follow up D, blood will be drawn for HbA1c testing and the participant will be provided with 1 additional CGM to use for the week following Study follow up D.
6. Study Follow up E: At the sixth and final study visit which takes place at 58 weeks after enrolment study participants will see the clinicals and blood will be drawn for HbA1c.
3.1.3 Arm 3 Standard of Care For those in Arm 3 there will be 6 study visits for all participants. There will be an additional visit for a FGD among a subset of participants. Participants will follow the standard of care at each clinic.
1. Enrolment visit: Those participants randomized to Arm 3 will undergo blood drawn for HbA1c testing.
2. Study Follow up A: The second visit will take place 1 week after the enrolment visit. Participants will see their clinician at the enrolment visit as per SoC
3. Study Follow up B: The third study visit will take place at 12 weeks after enrolment, participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
4. Study Follow up C: The fourth study visit will take place at 24 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c testing.
5. Study Follow up D: The fifth study visit will take place at the end of 35 weeks after enrolment. Participants will see the clinician as per SoC. Blood will be drawn for HbA1c.
6. Study Follow up E: The sixth and final study visit will take place at 58 weeks after enrolment. participants will see the clinician as per SoC. Blood will be drawn for HbA1c. After completion of study participation, those in Arm 3 will be offered 1 CGM to use such that they can experience CGM use. Those participants who accept the CGM will be provided with an education session on CGM use before application.
3.2 Scientific Rationale for Study Design As this study intendeds to generate evidence to inform policy and decision makers on the potential benefits of use of CGM in South Africa a pragmatic, rather than an explanatory, randomized control study design was selected \[9\]. A PrCT design was selected as the study aims to understand the impact of CGM use in as close to real world settings as possible. A classically designed randomized control trial with overly strict study criteria and processes may lead results that are not directly translatable to real world experience, while a classical RCT may have strong internal validity often RCTs are criticized for a lack of external validity, therefore a PrCT design was selected to balance internal and external validity \[12\]. A PrCT design may "provide more realistic effect size estimates and enhance translation of research findings into clinical practice".
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Inclusion Criteria:
* Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply:
People living with T1 diabetes with HbA1c current levels ≥10% within the last 3 months (and at least 2 HbA1c ≥10% within the last 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics.
* Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply:
• The child/adolescent that the person is a care giver to is enrolled in the study.
* Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply:
* Healthcare provider at the study sties engaged in diabetes care provision related to the study.
Exclusion Criteria:
* Participants are excluded from the Study if any of the following exclusion criteria apply:
* People living with T1 diabetes under 4 years old as this the minimum age for use of CGM as per the CGMs used in this study manufacturer instructions.
* People diagnosed with T1 diabetes within the last 2 years.
* People who have used a CGM in the last 6 months prior to enrollment.
* People who anticipate that they would have access to a CGM through means outside this study during the duration of the study (15 months).
* People living with Type 2 diabetes.
* Known pregnancy at the time of study enrolment.
* People who are not willing to agree to Freestyle Libre T\&Cs
|
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] |
NCT06681428
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Rising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers
|
The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
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Inclusion Criteria:
Potential subjects are required to meet all of the following criteria for enrollment into the study.
1. At least 18 years old, inclusive.
2. Presence of a DFU, Wagner Grade 1, extending through the dermis provided it is below the medial aspect of the malleolus.
3. The index ulcer (ulcer to be evaluated in the study) will be the largest ulcer if two or more DFUs are present with the same Wagner grade and will be the only one evaluated in the study. If other ulcerations are present on the same foot, they must be more than 2 cm distant from the index ulcer.
4. Index ulcer has been present for greater than 4 weeks prior to SV1 and less than 1 year, as of the date the subject consents for study.
5. Index ulcer is a minimum of 1.0 cm2 and a maximum of 25 cm2 at SV1 and TV1.
6. Within 3 months of SV1, adequate circulation to the affected foot as documented by a dorsal transcutaneous oxygen measurement (TCOM) or a skin perfusion pressure (SPP) measurement of ≥ 30 mmHg, or an Ankle Branchial Index (ABI) between 0.7 and 1.3 using the affected study extremity. As an alternative, arterial Doppler ultrasound can be performed evaluating for biphasic dorsalis pedis and posterior tibial vessels at the level of the ankle or a TBI (Toe Brachial Index) of \> 0.6 is acceptable.
7. The target ulcer has been offloaded for at least 14 days, prior to TV1.
8. Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers or abstinence) during the course of the study and undergo pregnancy tests.
9. Subject understands and is willing to participate in the clinical study and can comply with weekly visits.
10. Subjects must have read and signed the IRB approved ICF before screening procedures are performed.
Exclusion Criteria:
Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent treatment.
1. Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes
2. Index ulcer, in the opinion of the investigator, is suspicious for cancer and should undergo an ulcer biopsy to rule out a carcinoma of the ulcer
3. Index ulcer is infected
4. Subjects with a history of more than two weeks of treatment with immune-suppressants (including systemic corticosteroids \>10mg daily dose), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within 1-month prior to first SV1, or who receive such medications during the screening period or who are anticipated to require such medications during the course of the study
5. Subjects on any investigational drug(s), Investigational products, or therapeutic device(s) within 30 days preceding SV1
6. History of radiation at the ulcer site (regardless of time since last radiation treatment)
7. Index ulcer has been previously treated or will need to be treated with any prohibited therapies
8. Subjects with a previous diagnosis of HIV or Hepatitis C
9. Presence of any condition(s) which seriously compromises the subject's ability to complete this study or has a known history of poor adherence with medical treatment
10. Osteomyelitis or bone infection of the affected foot as verified by x-ray within 30 days prior to the first screening visit. (In the event of an ambiguous diagnosis, the Principal Investigator will make the final decision)
11. Subject is pregnant or breast-feeding
12. Presence of diabetes with poor metabolic control as documented with an HbA1c \>12.0 within last 90 days
13. Subjects with end stage renal disease as evidenced by a serum creatinine ≥3.0 mg/dL within 6 months of enrollment
14. Presence of acute Charcot Neuroarthropathy to the affected limb
15. Index ulcer that has reduced in area by 30% or more after 14 days of SOC from SV1 to the TV1/Randomization visit
|
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|
NCT00424944
|
Safety of Recombinant Hybrid GMZ 2 [GLURP + MSP 3] Blood Stage Malaria Vaccine
|
The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 40 adult male Gabonese volunteers will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters.
This is the first time this product will be tested in Africa
|
Background. GMZ2 is a recombinant hybrid of the Glutamate Rich Protein (GLURP) and the Merozoite Surface Protein 3 (MSP 3).This product has been developed at Sate Serum Institute in Denmark and Bacth released by Henogen of Belgium. The phase Ia trial in malaria naive volunteers is currently ongoing in Germany, at Tuebingen University. This phase Ia trial will establish safety of the vaccine and also select the best dosage (10, 30 or 100 µg). The dosage with the best safety and immunogenicity profile will be recommended for the phase Ib trial in Gabon.
2. Study Design This will be a single center, randomized, blinded and controlled study involving 40 adult male volunteers. The entire study duration will be 16 months with each participant remaining 13 months in the study.There will be 15 scheduled hospital visits and 11 scheduled field worker home visits. The Rabies vaccine will be used as control vaccine.
3. Objectives:
- The primary objective of this trial to evaluate the safety of 3 doses of GMZ2 when administered on Days 0, 28 \& 56, adjuvanted with aluminum hydroxide in healthy Gabonese adults.
- Secondary objectives include the following: (i). To assess the humoral response to the vaccine antigens GLURP and MSP3 by measuring the antibody response by ELISA and IFA.
(ii). To assess the cellular immune response by profiling the Th1/Th2-type cytokines after 24 and 48 hours stimulation.
|
Inclusion Criteria:
* Adult male Gabonese 18-45 years inclusive at the time of screening
* Residing in Lambarene for the duration of the study
* Separate written informed consent obtained before screening and study start respectively
* Available to participate in follow-up for the duration of study (13 months)
* General good health based on history and clinical examination
Exclusion Criteria:
* Previous vaccination with a investigational vaccine or a rabies vaccine
* Use of a investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first study immunization, or planned use up to 30 days after the third immunization
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first immunization. This includes any dose level of oral steroids or inhaled steroids, but not topical steroids
* Confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* Confirmed or suspected autoimmune disease
* History of allergic reactions or anaphylaxis to immunizations or to any vaccine component
* History of serious allergic reactions to any substance, requiring hospitalization or emergent medical care,or history of allergy to vaccines components
* History of splenectomy
* Laboratory evidence of liver disease (alanine aminotransferase \[ALT\] greater than 1.25 times the upper limit of normal of the testing laboratory).
* Laboratory evidence of renal disease (serum creatinine greater than the upper limit of normal of the testing laboratory, or more than trace protein or blood on urine dipstick testing).
* Laboratory evidence of hematologic disease (absolute leukocyte count 3.5-11/µL, absolute lymphocyte count 560-5280/µL, platelet count 120,000-400,000/µL, or hemoglobin 10.0-16.5g/dL).
* Administration of immunoglobulins and/or any blood products within the three months preceding the first study immunization or planned administration during the study period.
* Simultaneous participation in any other interventional clinical trial
* Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, malnutrition, or any other clinical findings that in the opinion of the clinical investigator may increase the risk of participating in the study
* Other condition that in the opinion of the clinical investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol.
|
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