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NCT04776785
|
Effect of Self-Assembling Peptides on the Progression of Non-Cavitated Proximal Caries
|
The aim of this randomized controlled, double-blinded, split-mouth clinical trial was to evaluate the efficacy of self-assembling peptide P11-4 solution (Curodont™ Repair) with fluoride varnish on the progression of non-cavitated proximal caries compared to casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) with fluoride varnish (MI Varnish™) sodium fluoride (NaF) varnish (Profluorid® Varnish).
The study included 300 permanent molars belonging to 150 children, aged between 7 to 13 years old, who had two non-cavitated proximal carious lesions.
|
First, the subjects were randomly allocated to three main groups with 50 individuals in each. Then the carious lesions belonging to each subject were randomly assigned to two subgroups based on different treatment agents used: Group 1; P11-4+NaF/NaF, Group 2; P11-4+NaF/CPP-ACP+NaF, Group 3; CPP-ACP+NaF/NaF. Accordingly, test 1 lesions received P11-4+NaF combination, test 2 lesions received CPP-ACP+NaF varnish, and control lesions received NaF varnish alone. At the 6th and 12th months after the clinical applications, Profluorid® Varnish application was repeated for test 1 and control lesions, and MI Varnish™ application was repeated for test 2 lesions. At the end of the 12 months, carious lesion progression status was evaluated radiographically, by using independent visual reading, pair-wise visual reading, and digital subtraction radiography (DSR) methods.
|
Inclusion Criteria:
* Children who had two permanent molars with non-cavitated proximal carious lesions that included one in the right jaw and the other one in the left jaw, and in contact with neighboring teeth,
* Non-cavitated proximal carious lesions which is radiographically extending into either the outer half of the enamel (E1), the inner half of the enamel (E2) or the outer third of the dentin (D1),
* Children who had not any systemic disease that prevents the application,
* Cooperative children who allowed to radiographic examinations and clinical applications.
Exclusion Criteria:
* There is caries/restoration on the different surface of the tooth to be treated,
* There is caries/restoration on the contact surface of the tooth adjacent to the tooth to be treated,
* Non-cavitated proximal carious lesions which is radiographically extending into the middle third of the dentin (D2) or the inner third of the dentin (D3),
* There is cavitation on the proximal surface of the tooth to be treated,
* Non-cooperative children who had not allow to radiographic examinations and clinical applications,
* Children and parents who denied the participation in the follow-up appointments.
|
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] |
NCT04339062
|
Cemiplimab in AlloSCT/SOT Recipients With CSCC
|
In this research study, Cemiplimab is being evaluated as a treatment for advanced cutaneous squamous cell carcinoma in participants who have previously received an allogeneic hematopoietic stem cell transplant or kidney transplant.
- This research study involves the following drug(s):
* Cemiplimab
* Everolimus or Sirolimus
* Prednisone
|
* This an open-label, two cohort, phase I/II research study to evaluate the safety and effectiveness of Cemiplimab as a treatment for advanced cutaneous squamous cell carcinoma in participants who have received allogeneic hematopoietic stem cell or kidney transplants.
* The research study procedures include screening for eligibility, study treatment, participant evaluations and safety follow-up visits. It is expected that about 12 people will take part in this research study.
* Participants will be divided into two groups (cohorts) of allogeneic hematopoietic stem cell recipients or kidney transplants recipients.
* Allogeneic hematopoietic stem cell recipients will only receive the study treatment drug of Cemiplimab.
* Kidney transplant recipients will receive the study treatment drug of Cemiplimab along with the immunosuppressant drugs of Everolimus or Sirolimus and Prednisone to prevent kidney rejection.
The U.S. Food and Drug Administration (FDA) has approved Cemiplimab as a treatment option for patients with advanced cutaneous squamous cell cancer, but the FDA has not approved the use of Cemiplimab in participants who have received allogeneic hematopoietic stem cell transplants or kidney transplants in the past.
-- Cemiplimab is a type of drug called a monoclonal antibody. Antibodies are proteins naturally found in your blood that fight infections. A monoclonal antibody is a special kind of antibody that is manufactured as a medication to target specific proteins in the body that may be involved this type of cancer.
Cemiplimab is a human monoclonal anti-PD-1 antibody that works by blocking the programmed death-1 (PD-1), a cell receptor on immune cells that is involved in preventing immune cells from destroying other cells. Blocking the receptor is expected to help immune cells attack cancer cells.
|
Inclusion Criteria:
* Patients must have histologically confirmed, advanced or metastatic cutaneous squamous cell carcinoma (cSCC) with 1 or more measurable lesions (greater than or equal to 1 cm).
* A history of either (Cohort 1) allogeneic hematopoietic stem cell transplant (alloHSCT) and ≥ 2 years or 730 days from day 0 of their HSCT with adequate bone marrow function (see Section 3.1.6) and off of all systemic immunosuppression (topical agents permitted) for at least 3 months prior to enrollment; sequelae of chronic graft versus host disease (GVHD) is permitted (i.e. chronic dry eyes, sclerodermatous skin changes, etc.) if the patient is not on systemic immunosuppression, or (Cohort 2) a renal transplant with a functioning allograft (at least 6 months from allograft transplant) as determined by estimated glomerular filtration (GFR) rate (CKD-EPI equation \[40\], Appendix A) ≥30 mL/min, baseline proteinuria lower than 0.5 g/day (spot urine protein-creatinine ratio), and off antiproliferative immunosuppressive medications.
* Age 18 years or older.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%, see Appendix B).
* Participants must have adequate organ and marrow function as defined below:
* leukocytes ≥ 2,200/mcL
* absolute neutrophil count ≥ 1,000/mcL
* platelets ≥ 90,000/mcL
* total bilirubin within normal institutional limits (except in cases where Gilbert syndrome is known or suspected, where total bilirubin should be \< 3 mg/dL)
* AST(SGOT)/ALT(SGPT) ≤ 2.5 × institutional upper limit of normal
* creatinine ≤ 1.5 × institutional upper limit of normal OR
* estimated GFR ≥ 30 mL/min/1.73 m2 for participants with creatinine levels above institutional normal (CKD-EPI equation).
* urine protein/creatinine ratio \< 0.5 (equal to less than 500 mg of proteinuria per day)
* Ability to understand and the willingness to sign a written informed consent document.
* A prior history of acute GVHD that has resolved, or sequelae of chronic GVHD following allo-HSCT is permitted. Active acute GVHD patients are excluded.
* Women of childbearing potential (WOCBP) must agree to use at least 1 highly effective form of contraception (refer to Appendix C for examples). WOCBP should plan to use an adequate method to avoid pregnancy for up to 7 months (30 days plus the time required for cemiplimab to undergo five half-lives) after the last dose of investigational drug.
"Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche, who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), who is not postmenopausal, who is sexually active with a male partner. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
* Women of childbearing potential, as defined above, must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of cemiplimab.
* Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product. Women who are not of childbearing potential as defined above, and azoospermic men) do not require contraception. See Appendix C for further guidance on contraception
Exclusion Criteria:
* Participants who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have unresolved toxicities from prior anti-cancer therapy more than 4 weeks earlier, defined as not resolved to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version 5.0), grade 0 or 1.
* Participants who are receiving any other investigational agents.
* For Cohort 1 allo-HSCT patients enrolling to the study, corticosteroid doses \> 10 mg of prednisone daily or equivalent within 4 weeks of the first dose of PD-1 inhibitor are prohibited. For Cohort 2 renal transplant patients enrolling to the study, corticosteroid use is permitted if used as part of their immunosuppressive regimen for graft protection prior to enrollment.
* Existing significant autoimmune conditions. Patients with a history of Hashimoto thyroiditis who are stable on replacement hormone therapy are not excluded.
* Known human immunodeficiency virus carrier or a diagnosis of immunodeficiency. Any positive test result for hepatitis B virus or hepatitis C virus indicating presence of virus, e.g., Hepatitis B surface antigen (HBsAg, Australia antigen) positive, or Hepatitis C antibody (anti-HCV) positive (except if HCV-RNA negative).
* Kidney transplant recipients with active acute rejection.
* Allergy to cemiplimab or any of its components.
* Any prior exposure to the phosphoinositide 3-kinase inhibitor idelalisib.
* Subject who has been treated with immunotherapy. This includes prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways (including chimeric antigen receptor \[CAR\] T cell therapies). Prior topical or intralesional immunotherapies (e.g. imiquimod, talimogene laherparepvec) are allowed.
* Subject with known and untreated brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. However, baseline brain imaging is not required prior to enrollment in the study if patients are asymptomatic. Patients at least 4 weeks out from metastatic central nervous system (CNS) treatment are permitted to enroll, if they are asymptomatic, radiographically stable per the investigator, and on stable doses of anti-epileptic drugs (AEDs) and oral corticosteroids (for Cohort 1 only, the patient must be on 10 mg of prednisone daily equivalent dosing or less, see 3.2.2) at the time of enrollment.
* Participants receiving any medications or substances that are strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated list such as \[http://medicine.iupui.edu/clinpharm/ddis/table.aspx\]. Medical reference texts such as the Physicians' Desk Reference may also provide this information. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
* Known non-infectious pneumonitis or any history of interstitial lung disease.
|
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] |
NCT01799941
|
Safety, Tolerability and Effectiveness of Nuedexta in the Treatment of Pseudobulbar Affect (PBA)
|
The objectives of the study are to evaluate the safety, tolerability, and effectiveness of NUEDEXTA capsules containing 20 mg DM (Dextromethorphan)/10 mg Q (Quinidine) for treatment of Pseudobulbar Affect (PBA) in patients with prevalent conditions such as dementia, stroke, and traumatic brain injury (TBI)over a 12 week period.
|
This will be an Open-label, Multicenter, study in patients with PBA and dementia, stroke or TBI. Patients with a clinical diagnosis of PBA and who meet all other inclusion and exclusion criteria will be eligible to participate and receive NUEDEXTA for 12 weeks.
Males and females patients with a minimum age of 18 years, a clinical diagnosis of Pseudobulbar Affect and a documented diagnosis of neurologic disease or brain injury, will be enrolled in this study.
The primary effectiveness endpoint is the mean change in the Center for Neurologic Study-Lability scale (CNS-LS). Secondary objectives include measures to evaluate treatment outcomes.
|
Inclusion Criteria:
* Center for Neurologic Study-Lability Scale (CNS-LS)score of 13 or greater
* Clinical diagnosis of Pseudobulbar Affect (PBA)
* Documentation of Neurologic disease or brain injury
Exclusion Criteria:
* Unstable neurologic disease
* Severe dementia
* Stroke within 3 months
* Penetrating TBI
* Contraindications to Nuedexta
* Severe Depressive Disorder
|
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] |
NCT06223672
|
Essential Fats for Enhancing Cognitive Thinking (EFFECT) Study
|
The proposed research is a randomized crossover trial designed to assess changes in postprandial cognitive function and the gut-brain axis in adults with subjective cognitive complaints who consume 1 study snack per day for 1 week.
|
Study objective including
1. To measure the impact of dietary fats on postprandial cognitive function in adults who report subjective cognitive complaints.
2. To assess the effect of dietary fat consumption on the gut-brain axis in relationship to cognitive function.
|
Inclusion Criteria:
* Subjective cognitive impairment
* BMI ≥30 kg/m2
* HbA1C \<6.5%
Exclusion Criteria:
* Diagnosis og cognitive impairment or dementia
* Montreal Cognitive Assessment (MoCA) score of \<26
* Current or previous diagnosis of Diabetes or use of diabetes medications
* Current diagnosis of or current treatment of cancer other than non-melanoma skin cancer
* Gastrointestinal diseases or disorders (including pancreatic and gastric bypass surgery) where consumption of the study foods would be contraindication or where the disease or disorder could negatively affect nutrient absorption and/or would prevent participants from tolerating the study foods
* Hyperthyroidism diagnosis
* Food Allergy or intolerances
* Any dietary restriction where consumption of the study foods, study meals/snack or meal challenge or any ingredient would be contraindicated
* Use of some oil supplements in the past 4 weeks prior to enrolling
* Pregnancy and lactation
* Inability to access veins for venipuncture
* Antibiotic use in the past month
* Psychostimulant or nootropic medication use
* Current use of supplements or medications for weight loss or following a weight loss program
* Severe or uncontrolled autoimmune diseases
* Current or previous diagnosis of severe kidney failure, liver cirrhosis and some pulmonary diseases
* Heart disease events (including stroke or heart attack) within last 3 months prior to enrollment
* Alcohol or drug abuse
|
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] |
NCT03593824
|
The Visual Plasticity During Adversity and Prosperity in Infants With Congenital Cataracts
|
Phenotypic plasticity is the ability of individuals to change their phenotypic status when exposed to environmental variations. However, whether the plastic changes show differential susceptibility in adversity and prosperity is debated and the specific pattern of plasticity remains elusive.
Here the investigators address this question by tracking the phenotypes (functional, structural, physical, and attachment traits) in two groups of infants before and after visual deprivation: one group experienced a short duration of complete deprivation (extreme adversity) and the other group experienced a long durations of partial deprivation (watered-down adversity).
|
Inclusion Criteria:
* Diagnosis with dense or non-dense nuclear congenital cataract
Exclusion Criteria:
* no metabolic diseases, mental retardation or central nervous diseases
* had no history of inherited diseases
|
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] |
|
NCT02242149
|
Efficacy Study of Diacerein on Glycemic Control and Liver Fat in Type 2 Diabetes Subjects
|
This study is conducted to test the hypothesis that in uncontrolled type 2 diabetic adults treatment with diacerein will improve glycemic control and will reduce liver fat within a 24 month period.
|
Background: Recently, knowledge about diacerhein, an anthraquinone drug with powerful anti-inflammatory properties, revealed that this drug improves insulin sensitivity, mediated by the reversal of chronic subclinical inflammation. Amongst the numerous pathogenetic factors, oxidative stress and apoptosis of hepatocytes initiate many inflammatory processes and are involved in the progression of Non alcoholic fatty liver disease.
Aims:The aim is to evaluate the effect of treatment with diacerein in improvement of glycemic parameters (mean glycated hemoglobin, fasting blood sugar) and reduction of liver fat fraction.
Methods:Two-hundred patients will be randomly allocated either to treatment with diacerein plus their usual therapeutic regimen or to placebo for 24 months. Clinic, laboratory evaluation (including glycated hemoglobin, fasting blood sugar, creatinine, ferritin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), g-glutamyl transpeptidase, alkaline phosphatase, bilirubin, albumin, prothrombin time, platelet count, total cholesterol, high-density and low-density lipoprotein cholesterol and triglycerides and urinary albumin excretion rate no 24-hour urine collection) will be performed before and every 3 months until the end of study. Pro-Inflammatory cytokines, adiponectin and cytokeratin-18 were measured before, at 12 months and at the end of study. Liver fat fraction measurement using controlled attenuation parameter (CAP) by transient elastography. (Fibroscan) will be performed before and after the 12 and 24-month treatment, with the observers blinded to the allocation group.
|
Inclusion Criteria:
* Type 2 diabetes.
* Presence of liver steatosis diagnosed by ultrasound or transient elastography (Fibroscan®)
* Age 30-75 years.
* HbA1c 7.5- 9.5 for at least 8 weeks prior to screening.
* Stable diabetes therapeutic regimen consisting of either diet, oral hypoglycemic agents with or without insulin for 8 weeks prior to randomization.
Exclusion Criteria:
* Body mass index \> 40 kg/m2
* Serum creatinine ≥180mmol/L or estimated glomerular filtration rate \< 30 ml/min.
* Presence of any serious concomitant disease, such as a pulmonary disease or malignant disorders.
* Current daily alcohol ingestion ≥20 g.
* Hepatotoxic drugs.
* Presence of other chronic liver disease other than nonalcoholic fatty liver disease, including hepatitis B virus and hepatitis C virus infection, hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, autoimmune hepatitis.
* Women seeking pregnancy.
* Current use or previous use within 6 months of vitamin E or pioglitazone
|
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] |
NCT04660799
|
A Study on Pharmacokinetics (PK), Efficacy and Safety of Subcutaneous (SC) Versus Intravenous (IV) Rituximab, in Combination With CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) in Previously Untreated Participants With CD20 Positive Diffuse Large B-Cell Lymphoma (DLBCL)
|
This is a multicenter China-only study to investigate the PK, efficacy and safety of SC rituximab versus IV rituximab, both in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) in previously untreated participants with CD20 positive DLBCL. Participants will be randomized to receive eight cycles of rituximab SC or rituximab IV combined with six or eight cycles of standard CHOP chemotherapy. After the end of study treatment, participants will be followed-up every 3 months for 6 months.
|
Inclusion Criteria:
* Previously untreated CD20 positive diffuse large B-cell lymphoma (DLBCL)
* Participants with an International Prognostic Index (IPI) score of 1 to 5 or IPI score of 0 with bulky disease, defined as one lesion \>/=7.5 cm
* At least one bi-dimensionally measurable lesion defined as \>/=1.5 cm in its largest dimension on CT scan
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
* Left ventricular ejection fraction (LVEF) \>/=50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram
* A negative serum pregnancy test or a negative urine pregnancy test within 7 days prior to study treatment
* For men who are not surgically sterile, agreement to use a barrier method of contraception during the treatment period and until \>/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer, and agreement to request that their partners use an additional method of contraception
* For women of reproductive potential who are not surgically sterile, agreement to use adequate methods of contraception during the treatment period and until \>/=12 months after the last dose of rituximab SC or rituximab IV or according to institutional guidelines for CHOP chemotherapy, whichever is longer
* Adequate hematologic function confirmed within 14 days prior to randomization
Exclusion Criteria:
* Transformed non-Hodgkin's lymphoma (NHL) or types of NHL other than DLBCL and its subtypes according to World Health Organization classification
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
* Contraindication to any of the individual components of CHOP, including prior receipt of anthracyclines
* Prior therapy for DLBCL, with the exception of nodal biopsy or local irradiation or surgery for diagnosis
* Prior treatment with cytotoxic drugs or rituximab for another condition (e.g.,rheumatoid arthritis) or prior use of an anti-CD20 antibody
* Current or recent treatment with another investigational drug or participation in another investigational therapeutic study
* Ongoing corticosteroid use (\>30 mg/day of prednisone or equivalent)
* Primary CNS lymphoma, blastic variant of mantle cell lymphoma, or histologic evidence of transformation to a Burkitt lymphoma, primary mediastinal DLBCL, primary effusion lymphoma, and primary cutaneous DLBCL
* History of other malignancy that could affect compliance with the protocol or interpretation of results
* Evidence of significant, uncontrolled concomitant diseases including but not limited to significant cardiovascular disease or pulmonary disease
* Any of the following abnormal laboratory values: creatinine \>1.5 upper limit of normal (ULN), aspartate aminotransferase (AST) / alanine aminotransferase (ALT) \>2.5ULN, total bilirubin \>1.5ULN, prothrombin time - international normalized ratio (PT-INR) / partial thromboplastin time (PTT) / activated partial thromboplastin time (aPTT)\>1.5ULN
* Positive test results for chronic hepatitis B (HBV) and or hepatitis C (HCV) infection; Participants with occult or prior HBV infection (defined as negative HBsAg and positive total hepatitis B core antibody \[HBcAb\]) may be included if HBV DNA is undetectable; Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA
* Known history of human immunodeficiency virus (HIV)
|
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|
NCT03799497
|
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental
|
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.
|
Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.
|
Inclusion Criteria:
* Providing informed, dated and signed consent (for minors, consent must be signed by both parents)
* With medical insurance
* With normal vision
* Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18
* Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder
Exclusion Criteria:
* Pregnant or breast-feeding women
* With antecedent or current neurologic disease
* With antecedent or current ophthalmologic disease
* Contraindication for IRMf
|
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0.20102868974208832
] |
NCT04290130
|
Dynamic Neural Mechanisms of Audiovisual Speech Perception
|
Understanding speech is one of the most important functions of the human brain. We use information from both the auditory modality (the voice the of person we are talking to) and the visual modality (the facial movements of the person we are talking to) to understand speech. We will use intracranial encephalography to study the organization and operation of the brain during audiovisual speech perception.
|
Inclusion Criteria:
* must be undergoing neurosurgery for the treatment of a brain disorder
Exclusion Criteria:
* must have corrected-to-normal vision and hearing
|
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|
NCT05780385
|
Nasotracheal Intubation in Critically Ill.
|
The aim of this prospective randomized trail is to compare nasotracheal versus orotracheal intubation in critically ill patients. We aim to study:
* required sedation depth
* rate of spontaneous breathing
* extend and possibility of physiotherapy
* vasopressor and sedative drug doses
Participants are randomized 1:1 to receive either nasotracheal or orotracheal intubation.
|
In the intensive care unit endotracheal intubation and consecutive mechanical ventilation are required for different surgical procedures, examinations and interventions in the ICU or due to respiratory insufficiency. Commonly, intubation is performed orotracheally by direct laryngoscopy after preoxygenation and administration of narcotics and a muscle relaxant. When using this technique sedation is often necessary for tolerance of the orotracheal tube. To avoid the adverse side effects of sedation and mechanical ventilation as for example hypotension, barotrauma, ventilator associated pneumonia, etc., intubation via a nasotracheal approach might be favorable. Retrospective data show that nasotracheal intubation is associated with fewer sedatives, vasopressors, and a higher rate of spontaneous breathing. As there is a paucity of data concerning the use of nasotracheal intubation in the intensive care setting the investigators aim to compare the use of orotracheal and nasotracheal tubes in a prospective randomized trial, using sedation depth as primary outcome measure.
|
Inclusion Criteria:
* Age ≥ 18
* Patients requiring tracheal intubation during their intensive care stay.
Exclusion Criteria:
* orotracheal or nasotracheal route of intubation technically not possible (e.g. confirmed indication for awake fiberoptic intubation due to expected difficult airway)
* tracheal intubation indicated for deep sedation (e.g. treatment of elevated intracranial pressure)
* thrombocytopenia \< 50/nl or other risk factors for bleeding
* pregnant or breastfeeding women
* denial of consent
|
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] |
NCT01407237
|
Physiologic Investigation of the Renin Angiotensin Aldosterone Axis in HIV
|
The purpose of this study is to see if individuals with HIV-infection, particularly those with increased belly fat, have abnormalities in the renin angiotensin aldosterone axis. Renin, angiotensin, and aldosterone are hormones that regulate salt and water balance in the body, and they may also have effects on sugar metabolism and cardiovascular health. There is some evidence that individuals with HIV-associated abdominal fat accumulation may have increased aldosterone, which may contribute to abnormalities in sugar metabolism and increased cardiovascular disease seen in HIV. The purpose of this study is the measure renin, angiotensin, and aldosterone activity, as well as other hormonal axes, in people with and without HIV infection, and with and without increased belly fat. The investigators hypothesize that aldosterone will be increased in HIV-infected individuals compared to those without HIV-infection, and that aldosterone will be further increased in HIV-infected individuals with increased abdominal fat compared to those without abdominal fat accumulation.
|
Inclusion Criteria:
1. Stable use of antiretroviral therapy for at least 3 months (HIV group)
2. Age ≥ 18 and ≤ 65 years of age
Exclusion Criteria:
1. Antihypertensive use, including angiotensin converting enzyme inhibitors or angiotensin II receptor blocker use, diuretics, beta-blockers, calcium-channel blockers, potassium supplements, and spironolactone; and/or blood pressure (BP) \>140/90 at screen
2. Current or recent steroid use within last 2 months.
3. Known diabetes and/or use of antidiabetic medications
4. Creatinine \> 1.5 mg/dL
5. Potassium (K) \> 5.5 mEq/L
6. Hemoglobin (Hgb) \< 11.0 mg/dL
7. Alanine aminotransferase (ALT) \> 2.5 x upper limit of normal (ULN)
8. Thyroid disease/abnormal thyroid stimulating hormone (TSH)
9. Significant electrocardiographic abnormalities at screen such as heart block or ischemia
10. History of congestive heart failure, stroke, myocardial infarction, or known coronary artery disease (CAD)
11. For women: Pregnant or actively seeking pregnancy, or breastfeeding
12. Estrogen, progestational derivative, growth hormone (GH), growth hormone releasing hormone (GHRH) or ketoconazole use within 3 months.
13. Current viral, bacterial or other infections (excluding HIV)
14. Current cigarette smoker/use of nicotine (patch/gum) or current active substance abuse
|
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] |
|
NCT04554407
|
Study to Evaluate the Performance of a Sustained Vacuum System
|
The purpose of this study is to evaluate the performance of the SOMAVAC® 100 Sustained Vacuum System after oncologic resections.
|
Inclusion Criteria:
* Aged 21 years or older;
* Undergoing mastectomy (uni or bilateral), axillary node resection, or inguinal node resection;
* Capable of providing informed consent.
Exclusion Criteria:
* Pregnant or lactating females;
* Patients on steroids or other immune modulators known to impact healing;
* Patients who are likely to not complete the study;
* Patients who, in the opinion of the investigator, are unlikely to comply with the protocol;
* Patients who have participated in this trial previously and who were withdrawn;
* Patients with known allergies to contacting materials (i.e. latex, metal, etc.);
* Patients who received neoadjuvant chemotherapy or radiotherapy within the last 3 weeks.
|
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|
NCT04870775
|
Effectiveness of a Mindfulness Training Program for Hospital Workers During the Pandemic.
|
The aim of this study is to reduce the negative psychological impact of the pandemic on hospital workers through mindfulness training.
|
In the face of the recent health crisis, one group vulnerable to psychological consequences has been the hospital workers who have worked on the front line during the COVID-19 pandemic.
It is expected that subjects participating in Mindfulness training will decrease their psychopathological symptoms more than the control group.
The programa will be held in 8 sessions (1 per week) as follows:
SESSION 1:
Welcome Brief opening practice with anchoring or focus options. Presentation of mindfulness, what it is and what it is not, definition and available scientific evidence.
Guided reflection on what brought the people here. Introduction of participants and teacher. Standing yoga postures. Raisin meditation. Body scan practice Presentation of home practice Brief closing practice
SESSION 2:
Brief opening practice. Standing yoga postures. Body scanner practice Dialogue on the practices, in small groups first and then in the large group. Exercise of the 9 points: conditioning and creative response. Attentional photo sitting meditation. Presentation of the home practice Brief closing practice
SESSION 3:
Brief opening practice Meditation with attention to an attentional focus. Yoga postures on the floor Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of pleasant events, paying attention to how it has registered in the form of bodily sensations, thoughts and emotions.
Presentation of the home practice Brief closing practice
SESSION 4:
Brief opening practice Standing yoga postures Sitting meditation with attention to the unwanted, offering the option to pendulum, from unpleasantness to attentional focus.
Dialogue in small groups and then in the common room about the experience of the practices.
Review of the calendar of unpleasant events and connect the unpleasant experience with stress.
Brief explanation of stress physiology and reactivity. Presentation of home practice Brief closing practice
SESSION 5:
Brief opening practice. Standing yoga postures. Complete meditation alternating different focuses of attention to end with open awareness.
Dialogue in small groups and then in the common room about the experience of the practices, reflection on being in the middle of the course (achievements, expectations, challenges...).
Introduce mindfulness in any of the phases of the habit loop and in moments of reactivity. Concept of mindful pause.
Presentation of home practice Brief closing practice
SESSION 6:
Brief opening practice. Standing yoga postures. Full seated meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the practices, introducing reflections on engagement with the practice and its effects and challenges.
Guided reflection on a difficult communication situation and interactive dialogue from there.
Presentation of home practice Brief closing practice
SESSION 7:
Brief opening practice. Movement practice: encouraging simplicity and exploration of boundaries. Participants are invited to guide some of them.
Sitting meditation, with more silence and less guidance. Dialogue in small groups and then in the common room about the experience of the day's practice.
Reflection on how people relate to their environment and the choices people make around technology, social networking, media and what effects those choices have.
Presentation of home practice Brief closing practice
SESSION 8:
Brief opening practice. Body scanning practice Small group discussion and then in the common room about the home practice. Writing a letter to the "future self" after reflection on what the program is entailing.
Resources to continue with "the rest of your life", next steps. Group sharing of global experiences with the program Brief closing practice
RETREAT DAY In addition to the 8 sessions, a small silent retreat is held on a Saturday, which is a day of intensive practice (approximately 8 hours). On this day consecutive practices are performed, including some different sitting meditation such as mountain meditation, loving-kindness or lake meditation.
|
Inclusion Criteria:
* Working in a hospital
* Proficiency in the Spanish language
Exclusion Criteria:
* Have severe mental disorders.
|
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] |
NCT02820688
|
Concentration-Volume Relationship in Infraclavicular Block
|
This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomized into three groups. Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups
|
Although ultrasound guided infraclavicular nerve block is routinely used to provide anesthesia for almost all of the upper extremity surgeries, optimal volume and concentration of locak anesthetic to be administered is still a subject of debate. This prospective, randomized, double blind study aims to determine the optimal volume for adequate sensorial and motor blockade following an infraclavicular block. Patients will be randomly allocated into three groups. 81 patients (27 in each group) are planned to be enrolled in this study due to a power analysis performed (G-power ver 3.1). Using a constant dose of local anesthetics (45mg bupivacaine 180mg prilocaine), different volumes will be used in each of the groups (First group; 18mL, second group; 27mL, third group; 36mL). Onset, duration and quality of sensory and motor block will be compared for patients between groups Researchers who perform the block and assess the block quality and onset will be blinded to patients' groups. Patients will also be blinded to groups they are assigned.
|
Inclusion Criteria:
* Scheduled for upper extremity surgery with infraclavicular nerve block
Exclusion Criteria:
* Patient Refusal
* Patients younger than 18
* Patients with known local anesthetic allergies
* Patients with a BMI\>30
* Diabetic Patients
* Uncooperated Patients
* Patients with coagulopathy or recieving anticoagulant therapy
* Skin infection on injection site
* Patients diagnosed with sepsis or bacteremia
* Physiologic and emotional lability
* Surgeries that are expected to last longer than 3 hours
|
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] |
NCT00266188
|
Follow up of Post-repair Tetralogy of Fallot
|
Tetralogy of Fallot is the most frequent complex congenital heart malformation. Over the past five decades, surgical repair has been performed with respectable results. However, relevant postoperative residues frequently remain. Pulmonary insufficiency, in particular, has been identified as a factor limiting the right ventricular function and, accordingly, the quality of life and life expectancy.
With increasing use of cardiac MRI for both measurement of ventricular function and imaging of pulmonary arteries, residual defects have been discovered that were not detectable by echocardiography. There is mounting evidence of right ventricular pressure and volume stress in Fallot patients after surgical correction. At present, it is impossible to detect right ventricular insufficiency at an early stage. Hence, it is to be assumed that right ventricular insufficiency is underdiagnosed and therapeutic action frequently is initiated beyond the point of no return of ventricular function.
The objective of this study is the systematic collection of cross-sectional and longitudinal data from extensive standardised examinations, including MRI, echocardiography, pulmonary function and ergometry tests, ECG and quality of life assessments, in a large number of patients with surgically corrected tetralogy of Fallot, and the setup of a database. The data obtained are supposed to provide information on the long-term outcome of surgical correction, to help establish criteria for necessity and time of re-intervention or re-operation, and to assess the effectiveness of re-interventions and re-operations.
|
In the repair of tetralogy of Fallot, pulmonary insufficiency used to be tacitly accepted as a result of extensive transannular patching (TAP) and considered unobjectionable. In fact, this is well tolerated during the first postoperative years, but today there is increasing evidence that the resulting chronic volume stress to the right ventricle is harmful on the long run, in particular if there are stenoses of the pulmonary artery in addition. Such stenoses, partly due to distortions after shunt surgery, together with pulmonary insufficiency, lead to a combined volume and pressure load of the right ventricle. The chronic volume stress results in a decrease in biventricular function and exercise tolerance, associated with increasing electrical instability with frequent, mostly ventricular, dysrhythmias. This constellation brings about a significantly increased risk of cardiac death.
Pulmonary valve replacement can improve haemodynamics, exercise tolerance and dysrhythmia. However, it is still unclear, which criteria best indicate the need for re-operation or other re-intervention, such as balloon dilatations of peripheral pulmonary stenoses, and what may be the best point in time.
Cardiac MRI has been established as non-invasive method to quantify right and left ventricular function without radiation exposure. Correlating quantitative functional data to clinical conditions may permit the evaluation of factors that influence the long-term course after surgical repair of Fallot's tetralogy.
The objective of this study is to establish a broad database of cross-sectional and longitudinal (after one year) findings from extensive standardised examinations, including MRI, echocardiography, pulmonary function and ergometry tests, ECG, quality of life assessments performed and cardiac catheterisation, if indicated, on a large number of subjects with surgically corrected tetralogy of Fallot. The data obtained are supposed to determine parameters indicating beginning irreversibility of decreased cardiac function, to provide information on the long-term outcome of surgical correction, to help establish criteria for necessity and time of re-intervention or re-operation, and to assess the effectiveness of re-interventions and re-operations.
|
Inclusion Criteria:
* Written consent of the patient and/or the patient's legal representative
* Patients with tetralogy of Fallot (including pulmonary atresia with extreme form of VSD ) after corrective operation
* The corrective intervention has to date back to at least one year before study inclusion
* Ergospirometry and MRI examination can be carried out on an outpatient basis (i. e. patients are normally older than 8 years)
* Patients are not selected according to functional status, i. e. in terms of potentially necessary reintervention measures (e. g. cardiac catheter intervention, pulmonary valve replacement)
Exclusion Criteria:
* Lack of consent
* Tetralogy of Fallot or pulmonary atresia with VSD without corrective operation (or corrective operation that dates back to less than one year before)
* Pulmonary valve agenesia, DORV (if there is a distinct discontinuity between mitral valve and aortic valve)
* Associated severe heart defects (e. g. AV canal)
* Other clinically relevant diseases, such as malignant tumour or florid diseases (in the investigating physician's assessment)
* Patient is not able to perform ergospirometry (bicycle/treadmill) or contraindication exists
* Absolute MRI contraindication, e.g. cardiac pacemaker
* Pregnant and breast-feeding patients
* Lack of cardiac catheter findings (or MRI) before initial operation -
|
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] |
NCT02621047
|
Effect of Hepatic Impairment on the Pharmacokinetics of Alectinib
|
This is a multicenter, non-randomized, single-dose, open-label study conducted in male and surgically sterile or post-menopausal female participants with stable chronic hepatic impairment and in healthy participants matched by age, gender, and body weight to assess the effect of hepatic impairment on the pharmacokinetics of alectinib.
|
Inclusion Criteria:
All Participants
* Body mass index between 18 to 35 kilograms per square meter (kg/m\^2) inclusive and weight greater than (\>) 50 kilograms (kg)
* Female participants must be surgically sterile or post-menopausal
* Male participants and their partners of child-bearing potential must be willing to use 2 effective methods of contraception, one of which must be a barrier method
Participants with Hepatic Impairment
- Documented chronic stable liver disease (Child-Pugh Class A, B or C)
Exclusion Criteria:
All Participants
* Pregnant or lactating women, males with female partners who are pregnant or lactating, or women of child bearing potential
* Positive test for drugs of abuse or alcohol
* Participation in an investigational drug or device study within 45 days or 5 half-lives (whichever time period is longer) or 6 months for biologic therapies prior to study drug administration
* History of hypersensitivity to any of the additives in the alectinib formulation
* Participants under judicial supervision, guardianship, or curatorship
* History of severe drug-related allergic reactions or drug-induced hepatotoxicity
Healthy Participants
* Use of any medications (prescription or over-the-counter), within 2 weeks or 5 half-lives (whichever longer) prior to study drug administration
* Use of any herbal supplements or any metabolic inducers within 4 weeks, or 5 half-lives (whichever is longer) prior to study drug administration
Participants with Hepatic Impairment
* Positive screening test for human immunodeficiency virus (HIV)
* History of liver transplantation
* Hepatocellular carcinoma or acute liver disease
* Severe ascites at screening or admission to the clinic
* Recent history (past 2 years) or current severe hepatic encephalopathy (Grade 3 or higher)
* Any evidence of progressive liver disease within the last 4 weeks
* Presence of surgically created or transjugular intrahepatic portal systemic shunts
|
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] |
|
NCT01291680
|
Assessment of Central Pain in the Peripartum Period
|
Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome (FMS). FMS is characterized by the presence of both allodynia and hyperalgesia. FMS is also characterized by disturbances of the autonomic nervous system such as orthostatic intolerance, postural tachycardia etc. The effect of these conditions during gestation and post partum periods is not well known.
Parturition is a complex process which involves multiple endocrine and physiological changes within a short period of time. Severe pain is an important attribute of this natural process. The purpose of the current study is to evaluate the impact of chronic central pain on the process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a history of central pain, before the onset of active labor, will differ from women not demonstrating such traits; these women may require earlier higher does of analgesia, and may demonstrate increased hemodynamic lability during labor and delivery.
|
Chronic pain is common. Up to 10% of the Population has been estimated to suffer from chronic pain and up to 5% of the female population has been estimated to suffer from widespread, chronic pain and tenderness, thus fulfilling American College of Rheumatology (ACR) criteria for classification of fibromyalgia syndrome (FMS)(1;2). FMS is considered to represent a prototype of chronic pain which is mediated by the central nervous system, i.e. a condition in which chronic pain is the result of augmented pain processing (and diminished pain - inhibition) within the Central Nercous System (CNS) circuitry (3). Clinical characteristics which are suggestive of the presence of central, versus peripheral (nociceptive) or neuropathic pain, are a lifetime history of pain conditions, a diffuse, non- anatomical distribution of pain, a family history of chronic pain and the co-existence of additional "functional" symptoms such as chronic fatigue, disturbed sleep, irritable bowel etc.
The current paradigms accepted for the pathogenesis of central pain involve an imbalance of multiple neurotransmitters in the CNS, some inhibitory (e.g. serotonin, norepinephrine) others facilitatory (e.g. substance P) which govern the process of spinal pain transmission. Additional processing takes place at higher centers, such as the amygdala and thalamus (4).
FMS is characterized by the presence of both allodynia and hyperalgesia. In addition, medications which have been shown to be effective in FMS and similar conditions are different from those effective in acute pain or in other chronic pain conditions not characterized as central (e.g. malignancy - associated pain). Thus, opioids and Non Steroidal Anti-Inflammatory Drugs (NSAIDS) are relatively ineffective for the treatment of central pain (the former may even cause paradoxical hyperalgesia) (5) while medications which increase levels of norepinephrine and serotonin (NSRIs) are often effective. FMS is also characterized by disturbances of the autonomic nervous system such as orthostatic intolerance, postural tachycardia etc.(6) The effect of these conditions during gestation and post partum periods is not well known.
Parturition is a complex process which involves multiple endocrine and physiological changes within a short period of time. Severe pain is an important attribute of this natural process. The processes of labor, delivery and also the peripartum period are characterized by acute shifts in volume, loss of blood and additional forms of physiological stress and emotional distress.
The purpose of the current study is to evaluate the impact of chronic central pain on the process of parturition. Our hypothesis is, that women demonstrating signs, symptoms and a history of central pain, before the onset of active labor, will differ from women not demonstrating such traits; these women may require earlier higher does of analgesia, and may demonstrate increased hemodynamic lability during labor and delivery.
|
Inclusion Criteria:
* Pregnant women, week 39-41
* Ability to give written informed consent
Exclusion Criteria:
* Age under 18
* High risk pregnancy
* Not able to give written informed consent
|
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] |
NCT06185335
|
A Trial of the Safety and Efficacy of Single-Dose Administration of ANB-010 in Subjects With Hemophilia A
|
The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-010 in subjects with hemophilia A. The study will have a dose-escalation design with elements of phase I/II seamless adaptive design.
|
The study will be conducted in 2 stages:
Stage 1: pilot efficacy and safety study of different doses to select a potentially therapeutic dose for further study.
Stage 2: study of the efficacy and safety of ANB-010 at the selected potentially therapeutic dose.
The stage 1 design is typical of phase I clinical trials with a modified "3+3" design and dose escalation. Three subjects are to be sequentially included in each cohort, each of whom will recieved a pre-specified cohort dose of ANB-010 as a single inravenous infusion.
Subjects will be monitored for dose-limiting toxicity (DLT) events for 4 weeks after the drug infusion. The decision concerning dose escalation will be made at the Independent Data Monitoring Committee (IDMC) meetings.
At the second stage the main study period will include 6 subjects who will receive ANB-010 at the optimal dose selected based on the results of stage 1 data analysis.
|
Inclusion Criteria:
1. Male subjects aged ≥18 years at the time of signing the informed consent form.
3. Established diagnosis of hemophilia A with a documented history of endogenous FVIII activity ≤1% AND ≤2% at screening.
4. Therapy with FVIII concentrates for at least 150 exposure days.
Exclusion Criteria:
1. History of use of any gene therapy product.
2. Use of emicizumab within less than 6 months before the date of signing the ICF.
3. The presence of other blood or hematopoietic disorders other than hemophilia A.
4. Presence of AAV6 antibodies detected by ELISA.
5. BMI \<16 kg/m² or ≥35 kg/m².
6. Diagnosis of HIV infection.
7. HBV infection.
8. HCV infection.
9. Any active systemic infections or recurrent infections requiring systemic therapy at screening.
10. Any other disorders associated with severe immunodeficiency.
11. Relevant hepatic disorders or conditions that can be a symptom of existing liver disorder.
12. Malignancies with remission duration of less than 5 years at the time of signing the ICF, except for cured basal cell carcinoma.
|
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] |
NCT04929717
|
Social Media and Breastfeeding Self Efficacy
|
This study aimed to determine the effect of breastfeeding support on women's breastfeeding self-efficacy via social media. This study was conducted maternity unit at a state hospital in Turkey. Education and consulting about breastfeeding were given via WhatsApp application to women in the intervention group. Women in the control group receive only routine breastfeeding training.
|
The research was conducted as a randomized controlled trial. The stratified and permutation block randomization methods were used in the study. The personal information form and BSES-SF were administered to women in the hospital before the intervention. Breastfeeding education and counseling were provided via social media (WhatsApp) to support women for breastfeeding and to ensure the continuity of breastfeeding in the postpartum period. Breastfeeding education was given to women in the first four weeks after discharge from the hospital. The control group received the routine breastfeeding postpartum educational training given to all women by healthcare personnel as part of the hospital procedures. Except for routine breastfeeding training, no intervention was applied to the control group.
|
Inclusion Criteria:
* being primipara
* being 18 years of age or older
* using the WhatsApp social media application
* having a newborn with a weight of 2500 grams and above
* agreeing to participate in the study
Exclusion Criteria:
* being multiparity
* having a physical or mental health problem that would prevent breastfeeding
* preterm labor (before 37 weeks)
* difficult labor
* either mother or baby having a health problem after birth
* mother's substance use (drug, smoking or alcohol)
|
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] |
NCT03369197
|
Nasal Continuous Positive Airway Pressure Versus Standard Care During Procedural Sedation for Gastrointestinal Endoscopy
|
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds.
|
This study is a randomized controlled trial comparing oxygen delivery by nasal mask with continuous positive airway pressure versus standard care (nasal cannula or standard facemask) during propofol-based sedation for gastrointestinal endoscopy procedures to reduce the incidence of hypoxia. The primary outcome will be the rate of oxygen desaturation below 90% for ≥15 seconds. In addition, secondary measures will include evaluation of mechanism and degree of respiratory depression associated with hypoxia and hypoventilation by characterizing changes in minute ventilation, tidal volume, and respiratory rate as well as the rate and degree of airway obstruction. The investigators hypothesize that the addition of nasal continuous positive airway pressure in the intervention arm will lead to decreased obstruction as positive pressure will stent open the obstructed airway. Depth of anesthesia will be monitored by Bispectral Index and investigators hypothesize that the degree of hypoventilation, obstruction, and will be significantly lower in the intervention arm compared to the control arm. Further, the depth of anesthesia will be independent of total propofol dose received. While the primary outcome in this study is hypoxia, investigators also seek to marry end tidal carbon dioxide with minute ventilation and transcutaneous carbon dioxide measurement to better understand the total effects of sedation on respiration. Thus the study will also serve to evaluate which mode(s) of respiratory monitoring might be the best possible intervention to enhance safety during procedural sedation in the future. Further, investigators suspect that the amplitude of end tidal carbon dioxide will not predict the degree of respiratory depression seen with other monitors. In addition, investigators will measure serum short chain fatty acid concentrations as a predictor and possible mechanism for differences in individual variability in anesthesia induced respiratory depression.
|
Inclusion Criteria:
* Adult patients (≥ 18 years of age) undergoing colonoscopy, endoscopic gastroduodenoscopy, and endoscopic gastroduodenoscopy with biopsy and/or ultrasound, or combined upper and lower endoscopy procedure anticipated to last longer than 10 minutes in the Endoscopy Suite at the Johns Hopkins Hospital when the anesthetic plan is monitored anesthesia care with propofol-based anesthesia with a natural airway.
Exclusion Criteria:
* Left ventricular Assist Device
* Severe Pulmonary Hypertension
* Ejection fraction less than 35 percent
* Active Congestive Heart Failure Exacerbation
* Planned procedure is Balloon Enteroscopy or Endoscopic Retrograde Duodenoscopy.
* Topical lidocaine administration
* Pregnancy
* Previous enrollment in this study
|
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] |
NCT04614883
|
Analysis of Volatile Organic Compounds in Exhaled Air and in Sweat in the Context of Suspicion of COVID-19 Infection
|
In the context of the actual pandemia of the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) which requires a better diagnostic strategy for the management of patients.
The study of volatile organic compounds (VOC) detected in exhaled air or in sweat, is an innovative research area for respiratory diseases. The analysis of VOC can be done either by the technique of the mass spectrometry which allows the identification of each VOC in the exhaled air or by the technique of electronic nose, simpler and faster, which provides an idea of the general profile of the VOC without identifying them. The VOC have shown their interest in some situations, such as diagnostic or prognostic tool in patients followed for thoracic tumorous pathology or bronchial or pulmonary vascular diseases.
Moreover, it has recently been shown that properly trained dogs would be able to detect an olfactory signature of SARS-CoV-2 infection with a specificity greater than 90%; this olfactory signature corresponds to VOCs detectable by the flair of dogs (Nosaïs-Covid19 study).
Validation of the diagnostic value of VOC analyzes by non-invasive and rapid methods (electronic nose analysis or mass spectrometry; detection by the scent of dogs) for the rapid detection and early diagnosis of a SARS-CoV-2 infection warrants the performance of this clinical study.
|
Inclusion Criteria:
1. Patients
* Patents anaged at the Foch Hospital for suspected COVID-19 and any other patient whose management requires diagnosis of SARS-CoV-2 infection
* Patients aged 18 or over;
* Patients Fluent in French ;
* Patients with a signed consent form;
* Patients with a health insurance plan.
2. Healthy volunteers
* Foch Hospital staff asymptomatic for SARS-CoV-2 infection;
* Aged 18 yor over;
* Fluent in french;
* with a signed consent form;
* With a health insurance plan.
Exclusion Criteria:
* Pregnant woman
* Patient deprived of liberty by judicial or administrative decision
|
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] |
|
NCT03508349
|
Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
|
The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.
|
More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.
This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.
|
Inclusion Criteria:
* Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
* Willing to participate
Exclusion Criteria:
* • Pregnant women below the age of 18
* Not willing to participate
|
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] |
NCT03755102
|
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progression on Osimertinib.
|
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
|
Inclusion Criteria:
* Written informed consent
* Advanced biopsy-proven metastatic non-small cell lung cancer
* Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
* Prior treatment with osimertinib with response followed by disease progression
* No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
* Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation
* Measurable (RECIST 1.1) indicator lesion not previously irradiated
* Karnofsky performance status (KPS) \>/= 70%
* Age \>/= 18 years old
* Ability to swallow oral medication
* Adequate organ function
* AST, ALT \</= 3 x ULN
* Total bilirubin \</= 1.5x ULN
* Creatinine \</= 1.5x ULN OR calculated creatinine clearance \>/= 60ml/min
* Absolute neutrophil count (ANC) \>/= 1000 cells/mm3
* Hemoglobin\>/=8.0 g/dL
* Platelets \>/=75,000/mm3
Exclusion Criteria:
* Pregnant or lactating women
* Any radiotherapy within 1 week of starting treatment on protocol.
* Any major surgery within 1 weeks of starting treatment on protocol.
* Any evidence of active clinically significant interstitial lung disease
* Continue to have unresolved \> grade 1 toxicity from any previous treatment Treatment
* Patients with a known mechanism of resistance to osimertinib that will clearly not respond to dacomitinib therapy (i.e. known MET amplification, ALK fusion, RET fusion).
* Symptomatic brain metastases or leptomeningeal disease requiring escalating doses of steroids
|
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|
NCT00255216
|
Policosanol for the Treatment of Hypercholesterolemia
|
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba.
This study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH).
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
|
Policosanol, a compound derived from sugar cane wax and available in health food stores across the United States, is a popular non-prescription product for treating hypercholesterolemia. Policosanol has been used in Cuba since 1991 to treat high cholesterol. Virtually all of the published medical literature on policosanol has been authored by research groups in Cuba. According to the Cuban data, policosanol can lower total cholesterol, lower low-density lipoprotein cholesterol (LDL-C), and raise high-density lipoprotein cholesterol (HDL-C). Based on post-marketing surveys, this drug appears to be devoid of any biochemical, hematological, or clinical adverse effects.
Confirmation of this data on policosanol by scientifically rigorous experiments and trials in this country would provide a safe and effective therapeutic option for the treatment of hypercholesterolemia. Consequently, policosanol has the potential to become a valuable tool in the fight against coronary heart disease - a major cause of mortality in the United States.
This pilot study will assess the short-term safety and efficacy of policosanol in healthy adults who have a baseline LDL-C of 130-200. The recruitment population will be derived from primary care clinics consisting primarily of Caucasian and African-American patients. The primary outcome measurements will be the percentage change in LDL-C. Secondary outcomes will include changes in total cholesterol, HDL-C, triglycerides, C-reactive protein, and lipoprotein sub-particles. This will be the first known randomized clinical trial of policosanol in North America.
The data derived from this pilot study regarding the lipid lowering effects of policosanol will be used to support applications for further funding through institutions outside the Carolinas Healthcare System including the National Institute of Health (NIH). Future studies could include an assessment of the effects of policosanol on other markers for coronary heart disease and potential use in combination with current lipid medications. The overall goal is to perform a large multi-center clinical outcome trial to establish the precise clinical benefits of policosanol.
Summary: Demonstration of the lipid-lowering ability of policosanol is an initial step in providing a safe, cost-effective therapy for hypercholesterolemia, thereby advancing the treatment and prevention of cardiovascular disease in this country.
Specific Aim: To independently corroborate the lipid lowering effects of policosanol in a small pilot study.
Hypotheses: After 8 weeks of therapy policosanol 40 mg/day will:
1. Produce a statistically significant reduction in LDL-C compared to placebo.
2. Provide a statistically significant reduction in LDL particle number and C-reactive protein.
|
Inclusion Criteria
* Age ≥ 18 years
* Males, or females who are not pregnant and have a highly reliable contraception method (i.e. hormonal or surgical contraception)
* Baseline LDL-C between 130 and 200
Exclusion Criteria
* History of Coronary Artery Disease - Patients will be excluded if they have been told at any time that they have heart disease based on a history of abnormal EKG, stress test, or coronary catheterization.
* History of Cerebrovascular Disease - Patients with a history of stroke or TIA will be excluded from the study.
* History of Congestive Heart Disease - Patients will be excluded if they have a history of congestive heart failure, regardless of the underlying cause or stage of disease. This will be true even if patients do not have a history of coronary artery disease.
* History of Diabetes - Patients will be asked if they have ever been diagnosed with any type of diabetes in the past. All patients with diabetes including type I, type II, and gestational diabetes will be excluded.
* History of Renal Impairment - Any patient with a history of kidney problems including transient renal impairment or current renal insufficiency will be excluded.
* History of Uncontrolled Hypertension - If patients report a history of poorly controlled blood pressure, defined as systolic blood pressure consistently over 140 or diastolic blood pressure consistently greater than 90, they will be excluded. Blood pressure will be checked at the beginning of the study and patients will be excluded if the initial reading reveals a systolic blood pressure over 160 and/or a diastolic blood pressure over 100.
* History of Untreated or Clinically Evident Thyroid Disease - Patients will be excluded if they report a history of untreated thyroid disease or current symptoms of an untreated thyroid disorder.
* Currently taking medications or supplements with known or potential lipid-altering effects including: phytosterols, statins, cholestin, niacin, fibrates, psyllium fiber, bile acid sequestrants, diabetic medications, and weight control medications such as orlistat
* Currently having residual side effects from a previously discontinued lipid medication
* Pregnancy or breastfeeding
* Triglycerides \> 300 at baseline
* Patients with clinical atherosclerotic disease which would be considered a coronary heart disease risk equivalent per ATP III guidelines - including carotid artery disease, peripheral arterial disease, and abdominal aortic aneurysm.
* Patients with 2 or more cardiac risk factors and over 20% risk of coronary disease according to their 10- year Framingham risk assessment.
|
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] |
NCT04621955
|
Observational Study of Home Administration of Carfilzomib
|
The purpose of this study is to evaluate the feasibility of an at home administration program for carfilzomib patients.
|
In this observational study, the feasibility of an at home administration program for carfilzomib will be evaluated in patients with relapsed and/or refractory multiple myeloma having already received a minimum of 2 and a maximum of 6 full cycles of KRd (carfilzomib - lenalidomide - dexamethasone) in the hospital.
One treatment cycle of KRd consists of a 28-day period. Carfilzomib is administered intravenously as a 10 minute infusion, on two consecutive days, each week for three weeks (days 1, 2, 8, 9, 15 and 16), followed by a 12-day rest period (days 17 - 28). In combination with carfilzomib, lenalidomide is administered orally on days 1-21 and dexamethasone is administered orally on days 1, 8, 15 and 22 of the 28-day cycles.
Multiple myeloma is characterized by a recurring pattern of remission and relapse. Given the need for chronic treatment and good adherence, convenience and quality of life of the patients become important factors as well. As the majority of the multiple myeloma patients are elderly and the treatment schedule requires many hospital visits, this treatment schedule may impact the social and familial life of the patient.
If the patient accepts to participate in the home administration program:
* Administration of carfilzomib during cycle 1 and 2 will be performed in the hospital
* During cycle 3 until 6, carfilzomib will be administered on day 1 and15 in the hospital, while there will be home administration on days 2, 8, 9 and 16.
* On day 1 of each cycle, there will be asked to the patient to complete a short questionnaire about the quality of life and patients satisfaction during the home administration program of carfilzomib.
If the patient doesn't accept to participate in the home administration program:
-The patient can agree on one-time collection of data: patient characteristics (date of birth+gender) and reason for refusal to the home administration program.
|
Inclusion Criteria:
* Age ≥ 18 years
* Ability to understand the informed consent and willingness to provide an informed consent signature
* Signed and dated written informed consent available (for participation in the home administration program or for agreement on data-collection in case of refusal to participate (reasons for refusal))
* Diagnosis of a relapsed and/or refractory multiple myeloma (refractory meaning nonresponsive (stable or progressive disease) during treatment or disease progression within 60 days of treatment discontinuation)
* Patient on KRd treatment (according to reimbursement criteria) having already received a minimum of 2 and a maximum of 6 full cycles of KRd in the hospital
* Patient with good tolerance of KRd and expected to receive ≥ 6 cycles based on clinical assessment of the treating physician
* Patient willing to receive at home intravenous administration of carfilzomib (only for patients who accepted the home administration program of the study)
Exclusion Criteria:
* Lactating or pregnant females
* Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Program of lenalidomide are met and unless use effective contraception measures during and for one month following treatment. Male patients should use contraception and refrain form sperm donation for at least 90 days after the last dose of carfilzomib.
* Patients who already received carfilzomib home administration
* Any contra-indication for continuation of treatment with carfilzomib
|
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] |
NCT05948241
|
Online Psychological Support Group for Patients With Heart Failure and Depression
|
Heart failure is a chronic disease, being the second cause of death in Brazil. Currently, it is estimated that 6.4 million Brazilians suffer from this disease. The higher number of rehospitalization, lower survival of these individuals. There are recommendations from Societies of Cardiology for the inclusion of effective self-care for patients with chronic HF, intend greater control of symptoms, greater adherence to treatment and, consequently, decrease of rehospitalization. One of the pillars of self-care's education for chronic patients recommended by the Health Ministry is the management of the patient's emotional aspects. These have been undertreated in most studies. The prevalence of depression among patients with HF is high and ranges from 41% to 72%, and the assessment with the BDI-II, which is the gold standard used, is 67%. Patients with HF and depression have greater difficulty in adhering to treatment and poor maintenance of self-care. Also, they present 4 times more risk of rehospitalization/mortality. Faced with this problem, this project was designed, proposing an online psychological support group for patients with heart failure and depression, primarily aimed at improving self-care, adherence and secondarily at reducing the rates of depression and readmission.
|
Inclusion Criteria:
* Patients diagnosed with heart failure
* Age between 18 and 79 years B)
* After hospital discharge
* Depression (BDI-II score above 14 points)
* Acceptance of the Term of Consent;
Exclusion Criteria:
* Patients with dementia
* Communication barriers
* Octogenarians
* People unable to access the internet for the intervention
* Who declined to participate;
|
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] |
|
NCT06851923
|
Study of Visual Mecanisms Involved in Face Recognition
|
Since the 19th century, perception has been regarded as an inferential process in which sensory input is compared with prior knowledge, namely the internalised representation of the visual environment. This notion is central to the understanding of everyday perception and cognition in general, and is attracting much attention in various areas of psychology and cognitive neuroscience. However, it is unclear whether and how the primary visual refinement that is thought to underlie the convergence of bottom-up inputs with top-down prior knowledge applies to the processing of meaningful stimuli in our everyday lives. The investigators have shown that human face processing mechanisms are shaped by prior knowledge that the horizontal range of face information conveys the richest and most reliable cues. Furthermore, investigators' previous data suggest that the primary visual cortex is recruited during the progressive refinement of face representation. Using very high field neuroimaging, the present project proposes to follow the neural mechanisms underlying the cortical refinement of horizontal information in human face processing, and to study their contribution to behaviour.
|
Inclusion Criteria:
Participants will be screened (see annex 2) to ascertain they fit with all these inclusion criteria:
* Be between 18 and 50 years old,
* have normal eyesight or eyesight corrected with contact lenses,
* Have no neurological disorder,
* Not have had a skull fracture or head surgery,
* Have no chronic progressive illness or mental deficiency,
* Have no metal parts in their body (dental braces or pins, metal plates, pacemakers, implanted prostheses, etc.),
* Have no tattoos containing metallic particles or implanted jewellery (e.g. piercings) that cannot be removed,
* Not to have worked with metals,
* Do not take any medicines or substances that may affect brain function (e.g. drugs, energy drinks, alcohol),
* Not to be pregnant or breastfeeding.
* Do not be claustrophobic.
Exclusion Criteria:
Participants presenting a counter-indication (responding yes to one of the questions of the screening questionnaire, see annex 2) to participate will be excluded from participation.
Participants will be screened to ascertain they do not present any of these counter-indications to the participation to the MRI measurement. We will exclude people with these characteristics:
* Be younger than 18 or older than 50 years old,
* have poor eyesight,
* Have neurological disorder,
* have had a skull fracture or head surgery,
* Have a chronic progressive illness or mental deficiency,
* Have metal parts in their body (dental braces or pins, metal plates, pacemakers, implanted prostheses, etc.),
* Have tattoos containing metallic particles or implanted jewellery (e.g. piercings) that cannot be removed,
* have worked with metals,
* take medicines or substances that may affect brain function (e.g. drugs, energy drinks, alcohol),
* pregnant or breastfeeding.
* claustrophobic.
|
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] |
|
NCT00630708
|
Safety of Dual Blockage of Rennin-angiotensin System in Patients With Advanced Renal Insufficiency
|
The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
|
Interruption of the renin-angiotensin systerm (RAS) with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) slows the progression of chronic renal insufficiency in the presence or absence of diabetes. Even for advanced chronic renal insufficiency (stage 4 CKD), ACE inhibitors and ARBs can still provide renoprotection. Some clinical studies showed that dual RAS blockage seemed to enhance the antiproteinuric effect compared with single-agent ACE inhibitor or ARB and then improve renal survival. However, in the only one randomized controlled trial investigating the renoprotection of combined ACE inhibitor and ARB for mild or moderate chronic renal insufficiency (the mean creatinine value is 2.9mg/dl), the incidence of hyperkalemia was increased in combination therapy compared with monotherapy. Although increase of hyperkalemia was not statistical significant, it suggested that combination treatment of ACEI and ARB might increase the incidence of hyperkalemia in patients with advanced renal insufficiency. However, it is still undetermined whether combination treatment of ACE inhibitor and ARB is safe as an ACE inhibitor or ARB monotherapy in advanced non-diabetic chronic renal insufficiency (stage 4 CKD). The primary aim of the present study is to assess the safety of combined treatment of benazepril (an ACE inhibitor) or losartan (an ARB) in non-diabetic patients with advanced renal insufficiency.
|
Inclusion Criteria:
1. Serum creatinine concentration of 3.0 to 5.0 mg per deciliter (265 to 442 µmol/L)
2. Creatinine clearance of 15 to 30 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
3. non-diabetic renal disease
4. Persistent heavier proteinuria (defined by urinary protein excretion of more than 0.3g per day for three or more months without evidence of urinary tract infection or overt heart failure \[a New York Heart Association class of Ⅲ or Ⅳ\])
5. had not received ACE inhibitors or ARBs for at least two weeks before screening
Exclusion Criteria:
1. No history of allergic reaction to drugs, especially ACE inhibitors and/or ARBs
2. Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
3. Malignant hypertension (blood pressure \>180/120 mm Hg) or blood pressure \<110mm Hg without antihypertensive treatment
4. Treatment with drugs affecting serum potassium such as diuretic, β2 receptor blocker et al.
5. Treatment with corticosteroids, non-steroidal anti-inflammatory drugs, or immunosuppressive drugs, especially ciclosporin A
6. Myocardial infarction or cerebrovascular accident in the year preceding the trial
7. Nephrotic syndrome (albuminaemia less than 25 g/L)
8. Renovascular disease or connective-tissue disease
9. Obstructive uropathy
10. Immediate need for dialysis
11. Pregnancy or breastfeeding
|
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] |
NCT05729724
|
Effect of Pharmacological Interventions on Systolic Blood Pressure Drops (SynABPM 2 Proof-of-concept)
|
SynABPM 2 proof-of-efficacy is a retrospective, multicentre, observational study performed in patients affected by hypotensive reflex syncope who had performed two ABPMs, one before and another after any therapeutical intervention aimed to increase arterial blood pressure
|
24-hour ambulatory blood pressure monitoring (ABPM) is able to detect systolic blood pressure (SBP) drops that allow to discriminate patients with reflex syncope from controls. One episode of daytime SBP \<90 mmHg or one episode of daytime SBP \<100 mmHg, if mean 24-hour SBP is \<125 mmHg, is the best cut-off for the identification of reflex syncope patients with hypotensive susceptibility.
The hypothesis of the present proof-of-concept study is that a therapeutic strategy aimed to increase arterial blood pressure can prevent SBP drops and (hopefully) reduce syncope recurrences.
If the study hypothesis will be confirmed, the magnitude of increase of SBP needed to abolish SBP drops will be also assessed.
|
Inclusion Criteria:
Eligible patients were those who fulfilled all the following criteria:
* had received a diagnosis of reflex syncope
* had undergone an ABPM as part of the routine work-up of syncope in use in these hospitals that had shown one or more daytime SBP drop \<90 mmHg or one or more daytime drops \<100 mmHg in patients with average 24-hour SBP ≥125 mmHg
* had received instructions in order to abolish/reduce their antihypertensive therapy with the aim to prevent syncopal recurrences or had received active drug therapy, i.e., fludrocortisone, in order to increase their arterial blood pressure.
* had performed a second ABPM within 6 months from ABPM 1 in order to verify the effect of the prescribed change in therapy
Exclusion Criteria:
* Age \<18 years
* Symptomatic orthostatic hypotension (defined as a symptomatic fall in SBP ≥20 mm Hg or a SBP decrease to \<90 mmHg, as per the ESC guidelines;
* competing causes of syncope (i.e., syncope due to arrhythmias and structural cardiac diseases and non-syncopal causes of transient loss of consciousness as defined by ESC guidelines on syncope
* Severe structural heart disease, previous stroke or transient ischaemic attack
|
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] |
NCT06771544
|
Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
|
This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.
|
Inclusion Criteria:
* Age ≥18 years at the time of signing informed consent form (ICF)
* Patients must have unresectable Stage III or Stage IV non-ocular melanoma per American Joint Committee on Cancer 8th Edition Staging Criteria not amenable to local therapy
* Participants must have measurable disease by RECIST v1.1 criteria as assessed by investigator/ radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
* Participants must have Eastern Cooperative Group (ECOG) performance status score of 0, 1 or 2 at screening visit.
* Life expectancy of at least 12 weeks
* Adequate bone marrow, liver, and renal function
* Hemoglobin ≥8.0 g/dL
* Platelets ≥75/mm3
* ANC ≥1.5/mm3
* Creatinine Clearance ≥ 30mL/min Cockcroft-Gault CrCl, mL/min = (140 - age) × (weight, kg) × (0.85 if female) / (72 × Cr, mg/dL).
* AST and ALT less than 3 times the Upper Limit of Normal or less than 5 times the Upper Limit of normal with liver metastases. T Bilirubin \< 3.1 mg/dL.
* Recovered from toxicities of pembrolizumab, excluding endocrine toxicities
* Receipt of PD-1/PD-L1
* For melanoma patients: within 6 weeks (every 3 week dosing) or 9 weeks (every 6 week dosing) prior to the first dose of the investigational therapy
* Women of childbearing potential must have had a negative pregnancy test performed within 7 days prior to the start of treatment
* Females of childbearing potential and males must be willing and able to use an adequate method of contraception to avoid pregnancy for the duration of the study.
* Male and female participants of childbearing potential who are sexually active with a non-sterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of study intervention; cessation of birth control after this point shall be discussed with a responsible physician.
* Pregnant or lactating women are prohibited from enrolling in this study.
* Male participants are not allowed to donate sperm from the time of enrollment until 6 months after administration of study interventions.
Exclusion Criteria:
* Participants with a diagnosis of ocular or metastatic uveal melanoma
* Participants with a history of a malignant disease other than those being treated in this study. The following exceptions are permitted:
* Malignancies that were treated curatively and have not recurred within 2 years. Shorter intervals can be considered after discussion with the Principal Investigator.
* Completely resected basal cell and squamous cell skin cancers.
* Any malignancy considered to be indolent and that has never required therapy, such as chronic lymphocytic leukemia.
* Completely resected carcinoma in situ of any type
* Participants ineligible to be retreated with pembrolizumab due to a treatment-related AE while on a prior anti-PD(L)-1 regimen that led to discontinuation of that prior therapy and would thus prevent retreatment or with an immune-related adverse event (irAE) of grade 3 or greater
* Participants with known untreated or symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis. NOTE: Participants with previously treated brain metastases may participate provided ALL of the following apply:
* Treated CNS lesions are radiographically stable (without evidence of progression for ≥ 28 days prior to the first dose of study intervention) after intervention (eg, surgery and/or radiation).
* Neurologically stable and on stable dose of ≤ 10mg of prednisone equivalent steroids for at least 7 days prior to the first dose of study intervention.
* Investigational or standard immunotherapy (with exception of pembrolizumab, nivolumab, or relatlimab), chemotherapy or radiation within 6-9 weeks of the first dose of the investigational therapy (see Inclusion Criteria)
* Presence of B-RAF driver mutation without prior receipt of BRAF +/- MEK inhibitors, unless patient declines BRAF +/-MEK inhibition for any reason or is unable to tolerate BRAF and/or MEK inhibitors.
* Participants with a known history of chronic viral infections as indicated below. If patients do not have a known history, testing is not required during the screening period to confirm the patient has an active infection.
* Known HBV infection defined as hepatitis B surface antigen reactive. NOTE: Participants with HBV infection on stable anti-viral therapy for \> 4 weeks prior to the planned first study intervention and viral load confirmed as undetectable during Screening may be eligible.
* Known active HCV infection defined as detectable HCV RNA (qualitative) infection. NOTE: History of HCV is not exclusionary if participant has received curative treatment and viral load is confirmed as undetectable during Screening.
* Active HIV infection. Those with HIV infections on combination antiretroviral medications with stable CD4 count \>200/microliters as measured within screening time period. If the patient does not have a known history of HIV, then testing is not required during screening to confirm presence or absence of HIV.
* Positive serum pregnancy test
* Participants with out-of-range screening laboratory values as defined below. NOTE: Hematology evaluations must be performed \>7 days from any blood transfusion. Or blood product transfusion or from any dose of hematologic growth factor.
* Glomerular filtration rate (calculated using the Chronic Kidney Disease Epidemiology Collaboration formula) \< 30 mL/min
* Total bilirubin \> 1.5 × ULN; participants with Gilbert's syndrome are excluded if total bilirubin \> 3.0 × ULN; or direct bilirubin \> 1.5 × ULN
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST): \> 2.5 × ULN (\> 5 × ULN for participants with liver metastases)
* Albumin \< 3.0 g/dL
* Absolute neutrophil count \< 1.5 × 10\^9/L
* Absolute lymphocyte count \< 0.5 × 10\^9/L
* Platelet count \< 100 × 10\^9/L
* Hemoglobin \< 9 g/dL
* Participants with a history of allogeneic tissue/solid organ transplant
|
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] |
|
NCT02050672
|
Effect of Myoinositol Treatment of Spermatozoa on in Vitro Fertilization Outcome
|
In the present trial, the investigators aim to evaluate whether semen myo-inositol (MI) treatment is able to improve IVF outcomes.
In particular, retrieved oocytes will be randomly divided in two groups, one group will be inseminated with MI treated semen while the other will be inseminated with untreated semen.
|
Myo is synthesized from glucose-6-phosphate, it is a precursor of second messengers in the cell signaling pathways and it is involved in the regulation of intracellular calcium.
Literature data have demonstrated the MI play a crucial role in reproduction, indeed, oocyte and spematozoa are nursed in a medium congaing hig MI concentration.
Furthermore, it has been demonstrated that, in oligoasthenoteratozoospermic patients, in vitro incubation with 2 mg/ml of myo increase significantly the number of spermatozoa with high mitochondrial membrane potential (MMP). Moreover, it has been found that the in vitro fertilization rate is correlated with the percentage of high MMP spermatozoa.
|
Inclusion Criteria:
* couple counselled for IVF
Exclusion Criteria:
* cryopreserved sample
|
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] |
NCT04652544
|
Vitamin D Supplementation in Individuals With a Chronic Spinal Cord Injury
|
The main objective of this placebo-controlled randomized double-blinded study is to investigate the effect of vitamin D supplementation on vitamin D status (25(OH)D concentration in the blood) among individuals with a chronic spinal cord injury (SCI). Further, the effects of vitamin D supplementation on several other parameters (e.g. bone density and mood) are investigated, which could reveal positive secondary effects of supplementation that are especially relevant for clinical practice.
|
The purpose of this study is to evaluate the influence of vitamin D supplementation among individuals with chronic SCI. The primary aim is to study whether different dosages (24'000 IU/month or 48'000 IU/month) of vitamin D supplementation over 12 months will lead to differences in vitamin D status as well as differences in several other outcomes. The use of a placebo group supports the evaluation of dose-response effects of vitamin D supplementation on the primary outcome (vitamin D status) and secondary outcomes (including bone density and mood) that are not only supported by randomized controlled trial standards but also informative in clinical practice.
|
Inclusion Criteria:
* Informed Consent to the present study as documented by a signature
* Chronic (\> 3 years) traumatic or non-traumatic spinal cord injury with a sub-C4-level lesion
* Wheelchair dependency during activities of daily living
* vitamin D status \<75nmol/L
Exclusion Criteria:
* Contraindications to the investigational product
* Clinically relevant disorders,
* Pressure ulcer grade 3 or 4
* Pregnancy, breastfeeding
* Vitamin D supplementation (\> 400 IU/day) within the last 12 months
* Visiting a country with increased sun exposure (below the 37th parallel north) within the last month before study enrolment or during the study
* Fractures in both arms and/or both legs within the last five years
|
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] |
NCT01341483
|
Incidence of Male Pudendal Artery Stenosis in Suboptimal Erections Study
|
The purpose of this study is to determine the proportion of men with known or suspected coronary artery disease (CAD) and/or peripheral arterial disease (PAD) that have angiographic identifiable erectile related artery (ERA) atherosclerotic disease defined as at least one ERA stenosis greater than or equal to 50% (per core lab Quantitative Vascular Analysis - QVA).
|
Vascular insufficiency is a commonly cited cause of Erectile Dysfunction (ED) and the most common treatments of ED target aspects of the penile vasculature. Initial pharmacotherapy typically focuses on the penile microvasculature; however, surgical revascularization has also been used to treat ED caused by lesions in the internal iliac artery (IIA) and/or internal pudendal artery (IPA) and penile arteries. Anatomically, surgical revascularization connects the inferior epigastric artery to the dorsal artery of the penis or a combination of the dorsal artery and vein of the penis. The pudendal artery or deep artery of the penis is usually not the target of surgical bypass. Recent advances in percutaneous revascularization have sparked interest in penile revascularization to treat ED.
However, as this new percutaneous treatment modality evolves, several important clinical questions remain unanswered. Important among these are what is the normal angiographic anatomy of the erectile related arteries (ERA), and how do angiographic findings correlate with symptoms of ED? Also, how many men could possible benefit from percutaneous revascularization?
The normal IPA anatomy by contrast angiography is not well defined and there are no studies that correlate IPA findings with erectile function. While studies have been done on populations of men with suspected vasculogenic and chronic ED, no study has established the normal angiographic anatomy of the IPA or evaluated the prevalence of angiographic IPA occlusive disease.
Therefore, an angiographic prevalence study will assist in determining the population of men who could potentially benefit from percutaneous treatment of atherosclerotic IPA lesions.
|
Inclusion Criteria:
* Subject must be undergoing coronary or peripheral angiography for suspected or known coronary or peripheral atherosclerotic disease
* Subject must be male ≥ 35 and ≤ 70 years old
* Subject must provide written informed consent before any study-related procedures are performed
* Subject must agree to comply with study procedures and follow-up for the entire length of the study
Exclusion Criteria:
* Subject is unable to safely attempt sexual intercourse secondary to severe cardiac disease or other health condition
* Subject has a life expectancy of \< 12 months
* Subject's serum creatinine is \> 2.5 mg/dl
* Subject has known aorto-iliac occlusive disease, previous AAA endograft procedure or open surgical procedure
* Subject has history of prostatic carcinoma requiring surgery (i.e., prostatectomy), pelvic radiation, or hormonal/chemotherapy
* Subject has a history of myocardial infarction, stroke, life-threatening arrhythmia, or unstable angina requiring hospitalization within 3 months (90 days) prior to enrollment
* Subject has had exposure to PDE5 inhibitor (per subject's concomitant medication list) within the 72 hours prior to the scheduled baseline angiography
* Subject has a history of renal transplantation
* Subject has a penile implant
* Subject has become unstable or has received a maximum radiation dose, increased procedure time, and/or maximum contrast dose (in the Investigator's opinion) from the primary angiographic procedure that would compromise the safety of the subject by proceeding with enrollment into the IMPASSE study
|
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] |
NCT05033587
|
Study of AK105 With Anlotinib and Radiotherapy Adjuvant Therapy in MGMT Unmethylated Newly Diagnosed Glioblastoma.
|
This is a prospective, open-label single-arm, exploratory, two-stage design trial, aiming to investigate safety and efficacy of AK105 with anlotinib and radiotherapy adjuvant therapy in MGMT unmethylated newly diagnosed glioblastoma.
|
Glioblastoma is the most common and aggressive primary brain tumor in adults. Treatment usually involves surgery, after which chemotherapy and radiation therapy are used. The Central Brain Tumor Registry of the United States (CBTRUS) Statistical Report primary brain and other central nervous system tumors diagnosed in the United States in 2012-2016, glioblastoma accounted for 48.3% of primary malignant brain tumors.
The Stupp protocol has become standard of care for the treatment of newly diagnosed GBM, however, some MGMT unmethylated glioblastomas are still resistant to temozolomide.
Immunotherapy is being studied as treatment for the cancer, AK105 is a humanized monoclonal antibody that specially binds to PD-1. Anlotinib hydrochloride is a multi-target receptor tyrosine kinase inhibitor. Based on the mechanism study, tumor vascular abnormalities promote tissue hypoxia and increase lactic acid, thereby activating immunosuppression and inhibiting T cell function. Anti-angiogenic drugs enhance the infiltration of effector immune cells by inducing normalization of blood vessels and reducing immunosuppression.
|
Inclusion Criteria:
* The patient voluntarily joined the study and signed a written informed consent;
* Pathologically confirmed treatment-naïve glioblastoma with PCR tested MGMT unmethylated;
* The interval between the last biopsy or surgery is 4-6 weeks, and the surgical incision is healed well;
* According to Rano criteria, there are evaluable measurable disease;
* 18-70 years of age;
* Karnofsky performance status (KPS) ≥ 60; and estimated survival of at least 3 months;
* The main organ function to meet the following criteria:
1) routine blood test: HB≥90g/L(no blood transfusion in 14 days); ANC≥1.5×109/L; White blood cell counts≥3.5×109/L; PLT≥90×109/L; 2) blood biochemical test: ALT and AST ≤2.5×ULN(times the upper limit of normal) and if liver/bone metastases≤5×ULN; TBIL ≤1.5 ULN; Serum Cr≤1.5×ULN and CrCL≥60 ml/min; 3) APTT, INR and PT≤1.5×ULN;
* The woman patients of childbearing age who must agree to take contraceptive methods during the research and within another 6 months after it; who are not in the lactation period and examined as negative in blood serum test or urine pregnancy test within 7 days before the research.
Exclusion Criteria:
* Prior therapy with anti-angiogenic drugs, such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, surufatinib, regorafenib or fruquintinib ect, or with anti-PD-1(L1) or anti-CTLA-4 agents;
* Patients who get other monoclonal antibodies have severe hypersensitivity;
* Present or along with other malignancies within 5 years. Exceptions include cured basal cell carcinoma of the skin or in situ prostate cancer or in situ cervical cancer;
* Patients have any active autoimmune disease that required systemic treatment, including but not limited to autoimmune hepatitis, enteritis, vasculitis, nephritis; asthma that require bronchodilators for medical intervention. Exceptions include patients with vitiligo, psoriasis, alopecia or well-controlled type 1 diabetes but not required systemic treatment, or hypothyroidism with normal thyroid function after alternative treatment;
* In the past, there is a treatment toxicity of CTCAE5.0 ≥2 grade that has not been completely relieved (the adverse reaction grades in this article, unless otherwise specified, are defaulted to the CTCAE 5.0 standard);
* Immunodeficiency diagnosis or receiving chronic systemic steroid therapy (\>10mg/day prednisone or equivalent) or any other form of immunosuppressive therapy, and continued to be used within 2 weeks before the first dose in this study;
* Those with multiple factors affecting oral drugs (such as inability to swallow, post gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.);
* Imaging (CT or MRI) shows that the tumor has invaded or unclearly separated the large blood vessels;
* Patients with active bleeding, or unexplained persistent decline in hemoglobin should postpone their screening/enrollment until the bleeding stops and the investigator judges it to be safe;
* Within 4 weeks before the first dose in this study, patients with CTCAE5.0 grade 3+ bleeding; patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; on the premise that the international normalized ratio of prothrombin time (INR) ≤1.5, it is allowed to use low-dose warfarin (≤1mg/D), low-dose heparin (≤12000U /D) or low-dose aspirin (≤100mg/D) for preventive purposes;
* Within 4 weeks before the first dose in this study, patients with unhealed wounds, fractures, gastric and duodenal active ulcers, ulcerative colitis, or unresected tumors have active bleeding, or may be caused as determined by the researchers other conditions of gastrointestinal bleeding and perforation, have undergone major surgery (excluding vascular access surgery), inoculated with preventive vaccine or attenuated vaccine;
* Received the treatment of proprietary Chinese medicines with anti-tumor indications specified in the NMPA approved drug instructions within 2 weeks before the start of the study treatment(Including compound cantharidin capsules, Kangai injection, Kanglaite capsule/injection, Aidi injection, brucea javanica oil injection/capsule, Xiaoaiping tablet/injection, Huachansu capsule, etc.); or received drugs with immunomodulatory effects (including thymosin, interferon, and interleukin, except for local use to control pleural effusion or ascites);
* History of organ or blood transplantation;
* Patients have active diverticulitis, abdominal abscess, gastrointestinal obstruction;
* Patients with any severe and/or uncontrollable disease, including:
1) Patients with unsatisfactory blood pressure control (systolic blood pressure\>140 mmHg, diastolic blood pressure\>90 mmHg); 2)Within 6 months of the first administration patients with myocardial ischemia or myocardial infarction, arrhythmia that require treatment (including QTC ≥480ms), and grade ≥2 congestive heart failure; 3) active or uncontrolled serious infection (≥CTCAE5.0 Grade 2 infection), tuberculosis patients; 4) Known clinical history of liver disease, including viral hepatitis, carriers of hepatitis b virus must be excluded from active HBV infection, i.e., HBV DNA positive (\>2500 copy /mL or \>500IU/mL);known hepatitis c virus infection (HCV) and HCV RNA positive (\>1 x 10\^3 copy /mL), or other decompensated liver disease, chronic hepatitis requires antiviral treatment; 5) HIV test positive or Syphilis Testing RPR positive; 6) Diabetes is poorly controlled (fasting blood glucose (FBG) ≥10mmol/L); 7) Urine routines suggest that urine protein is ≥++, and the 24-hour urine protein quantification is more than 1.0 g;
* Those considered by the researcher to be unsuitable for inclusion.
|
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] |
NCT00656799
|
Dialysis of Sugammadex in Participants With Severe Renal Impairment (Study 19.4.333) (P05773)
|
The clinical trial objectives were to evaluate the dialysability of the sugammadex-rocuronium complex; it's safety and efficacy in participants with severe renal impairment.
|
The current trial was designed to evaluate the dialysability of the sugammadex-rocuronium complex in participants with severe renal impairment. A dose of 4.0 mg/kg sugammadex was administered 15 minutes after administration of 0.6 mg/kg rocuronium. Blood and dialysate samples were collected before, during and after hemodialysis/filtration, for calculation of clearance of sugammadex-rocuronium complex and assessment of rebound.
|
Inclusion Criteria:
* At least 18 years of age
* American Society of Anesthesiologists (ASA) Class \>=4
* Creatinine clearance (CLCR) \< 30 mL/min and clinical indication for dialysis
* Hospitalization at Intensive Care Unit (ICU) and scheduled for a (surgical) procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium
* Scheduled for a (surgical) procedure in supine position
* Written informed consent (of the legal representative)
Exclusion Criteria:
* Known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic dysfunction
* Known or suspected to have a (family) history of malignant hyperthermia
* Known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia
* Have already participated in a sugammadex trial
* Have participated in another clinical trial, not preapproved by NV Organon, within 30 days of study entry
* Females who are pregnant\*
* Females who are breast-feeding \* In females pregnancy will be excluded both from medical history and by a human chorionic gonadotropin (hCG) test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
|
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] |
NCT05195099
|
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
|
The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity and respiratory muscle strength.
vital capacity and respiratory muscle strength. In addition to increasing the sensibility of smell and taste, observing if there is a relationship between the decrease of these senses with the senses with appetite and whether appetite has normalised in post-SARS-CoV-2 patients. It is a randomised and blinded experimental study with a control group where the sample recruited will be 30 patients, with a range of of 30 patients, with an age range of 19-42 years, where they carried out an assessment of spirometry, modified Borg dyspnoea scales and modified Medical Research Council (MMRC), Singapure (MMRC), Singapore Smell and Taste Questionnaire (SSTQ) and weekly smell and taste questionnaire.
taste questionnaire.
|
Inclusion Criteria:
* age range between 18 and 42 years.
* patients with respiratory sequelae post Covid-19.
* patients with smell and taste sequelae post Covid-19.
Exclusion Criteria:
* Under 18 years old.
* Over 42 years old.
* Patients not diagnosed with Covid-19 (PCR positive).
|
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] |
|
NCT04417790
|
Utility of Lung Ultrasound in the Estimation of Extravascular Lung Water in Pediatric Population
|
Increased extravascular lung water (EVLW) may increase mortality and morbidity in cardiopulmonary pathology. Many factors can cause increased extravascular lung water and pulmonary edema after cardiac surgery. This includes left ventricular failure, acute mitral regurgitation; systemic inflammatory response post-cardiopulmonary bypass, left to right shunts, transfusion associated acute lung injury, acute respiratory distress syndrome(ARDS) and sepsis.
The clinical assessment of lung water ranges from auscultation to radiological methods to invasive measurements like dye dilution or thermodilution studies.
Lung ultrasonography is the newest modality for noninvasive assessment of extravascular lung water. Lung ultrasound has been validated against auscultation, chest X-rays, CT chest as well as the bedside gold standard, transpulmonary thermodilution in adults.
Critically ill children are more susceptible to complications and worsened outcomes from increased EVLW.
Lung ultrasound correlates with clinical and radiological endpoints, but has not been validated against invasive objective measures like transpulmonary thermodilution.
Evaluation of transpulmonary thermodilution setups in the pediatric population has shown different normal values and cutoffs compared to adults, possibly due to differential rates growth and development.
It is aimed to investigate the correlation of Lung ultrasound based indices of extravascular lung water to invasive measures, assess optimum cutoffs to appropriate clinical endpoints and evaluate their sensitivity and specificity.
|
Inclusion Criteria:
* aged under 12 years,
* undergoing elective cardiac surgery for cyanotic or acyanotic congenital heart disease,
* Aristotle score ≤9,
* with prior written informed consent
Exclusion Criteria:
* Neonates,
* Children with any chest wall deformity,
* children with known lung disease, active infection,
* those weighing less than 3.5 kg.
|
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|
NCT00081965
|
Acupuncture in Treating Hot Flashes in Women With Breast Cancer
|
RATIONALE: Acupuncture may help relieve hot flashes in women with breast cancer. It is not yet known whether acupuncture is more effective than a placebo in treating hot flashes in women with breast cancer
PURPOSE: This randomized clinical trial is studying acupuncture to see how well it works compared to a placebo in treating hot flashes in women with breast cancer.
|
OBJECTIVES:
Primary
* Determine whether acupuncture, compared to placebo, reduces the incidence of hot flashes in women with breast cancer.
Secondary
* Determine the long-term effects of acupuncture on hot flashes.
OUTLINE: This a randomized, placebo-controlled, multicenter study. Patients are stratified according to concurrent treatment with selective estrogen receptor modulators, gonadotropin-releasing hormone analogs, or aromatase inhibitors (yes vs no), concurrent use of hot flash medication or selective serotonin reuptake inhibitors (SSRIs) (yes vs no), baseline hot flash frequency (\> 7 per day), and menopausal status at diagnosis (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms.
* Arm I (treatment): Patients receive 8 acupuncture treatments over 4 weeks.
* Arm II (control): Patients receive 8 placebo acupuncture treatments over 4 weeks. Beginning at week 7, patients are offered 8 true acupuncture treatments over 4 weeks.
Patients in both arms complete a "hot flash" diary for 1 week before treatment and then periodically during and after treatment.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
|
DISEASE CHARACTERISTICS:
* Diagnosis of breast cancer (including in situ disease)
* Must be receiving treatment for breast cancer at Memorial Sloan Kettering Cancer Center (MSKCC) or its regional site (Commack)
* Has an average of 3 or more hot flashes a day during 1 week of baseline diary recording
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Pre- or postmenopausal
* Karnofsky performance status 70-100%
* Ambulatory
* No skin infection
PRIOR CONCURRENT THERAPY:
* More than 3 weeks since prior and no concurrent treatment with any of the following during the 6 week evaluation period of the trial:
* Surgery
* Initiation of a new chemotherapy regimen
* Initiation of immunotherapy
* Initiation of radiotherapy
* Initiation or cessation of hormonal therapy
* More than 6 weeks since prior acupuncture treatment (6 months for acupuncture specifically for the treatment of hot flashes)
* No concurrent pharmacological treatment for hot flashes unless dose has been stable for 4 weeks
* No concurrent selective serotonin reuptake inhibitors (SSRIs) unless dose has been stable for 4 weeks
|
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0.44099563360214233,
-0.3965654969215393,
-0.35225215554237366,
0.8780653476715088,
0.23194465041160583,
0.2898710370063782,
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] |
NCT03680092
|
Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation
|
The purpose of this study is to investigate whether the combination of cyclophosphamide and abatacept versus the treatment used in standard of care will reduce the incidence of moderate and severe chronic graft-versus-host disease (GVHD) following hematopoietic stem cell transplantation. GVHD occurs when the cells from your donor (the graft) see your body's cells (the host) as different and attack them.
|
The experimental GVHD prophylaxis arm consists of cyclophosphamide and abatacept. Cyclophosphamide induces apoptosis of activated T cells and abatacept (CTLA4Ig) blocks activation of T cells by inhibiting the co-stimulatory signal.
Compared to the standard-of-care control arm, the experimental arm is much more convenient and expected to be associated with fewer toxicities.
In addition there is a great theoretical potential for immunological synergy between cyclophosphamide and abatacept for inducing post-transplant immunologic tolerance that clinically might translate into less GVHD without increase in relapse Patients will be randomized 1:1 to the experimental vs the standard of care arm. Randomization will be done prior to the use of any conditional therapy.
The two arms will be stratified by disease (acute leukemia vs others) and donor type (MRD vs MUD/MUD vs Haplo) in an effort to keep them balanced.
The conditioning regimen for both arms will be mainly Busulfan/Fludarabine (A Total Body Irradiation based conditioning regimen will be allowed for diseases such as ALL)
The GVHD prophylaxis regimen on the experimental arm will consist of high dose Cyclophosphamide on Days +3 and +4 followed by abatacept for 6 months.
The GVHD prophylaxis regimen on the standard of care arm will consist of methotrexate on Days +1,+3, +6 and +11 and tacrolimus for patients with a 10/10 matched related or unrelated donor and of high dose cyclophosphamide on Days +3 and +4 followed by tacrolimus and mycophenolate for patients with a haploidentical donor.
|
Inclusion Criteria:
* High risk hematologic malignancy justifying the need for an allogeneic hematopoetic stem cell transplantation: AML, ALL, CML in accelerated or blast phase, MDS/MPN, NHL, Hodgkin lymphoma, and multiple myeloma
* Creatinine clearance \> 40
* Adequate hepatic function
* Normal cardiac function (EF \> 50%)
Exclusion Criteria:
* Patients with hematologic malignancies for which transplant is not the only curative option, such as AML with good or intermediate cytogenetics or molecular markers in CR1 or CML in chronic phase
* Inability to identify an 10/10 HLA-Matched Donor (related or unrelated) or a haploidentical donor
* Active malignant disease relapse
* Active, uncontrolled infection, uncontrolled cardiac angina, symptomatic congestive heart failure
* Life expectancy \<3 months
* Pregnancy or lactation
* Patients may not be receiving any other investigational agents in the last 28 days
* Patients with chronic myeloid leukemia in first chronic phase
|
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] |
NCT05252013
|
The Impact of Broad Bean Hull on Blood Glucose Control and Gut Health
|
This study aims to assess the effects of broad bean hull (BBH) consumption on blood glucose and gut health. Broad bean (Vicia faba) is widely cultivated in Scotland, with the UK being the most significant European producer. The seed coat (hull or testa) is removed during broad bean processing. This is a significant secondary product that is largely discarded. Preliminary work showed that this material is comparable to wheat bran and is rich in fibre (49%) and protein (18%). Additionally, it showed a rich phytochemical profile and lower fat and carbohydrate content than wheat bran. Experiments also showed that BBH inhibited the activity of alpha-amylase and alpha-glucosidase enzymes, suggesting anti-diabetic properties. Overall, these results showed that BBH is a secondary crop product having potential as a functional food for humans. Therefore, the objective of this study is to assess in vivo in humans the physiological and functional effects of BBH. Using an acute phase randomised controlled crossover design, the study will assess how consuming BBH fortified breads affects plasma glucose and gut health. The study will recruit 18 volunteers, normal-overweight, aged 18-75 years, who habitually consume low amounts of fruits and vegetables (≤3 portions/day). The volunteers will attend two identical stand-alone intervention sessions lasting three days each following the screening. The order of the intervention sessions will be randomised. On the day before each intervention session, the participants will provide a baseline faecal sample and have a continuous glucose monitoring sensor (CGMS) attached. They will be also be given a standardised dinner. On the next morning, following a 10-12 hr fast, an indwelling antecubital cannula will be inserted, and a blood sample will be taken for measuring baseline levels of metabolites. The volunteers will be given a standardised portion of the BBH or control bread to consume, and further blood samples taken for the subsequent four hours. Breath samples will also be taken at the same time points for measuring gastric emptying. The volunteers will be provided with all the meals for the rest of the day and the subsequent two days. These will include two portions per day of either the BBH or control bread. The meals will be standardised for energy and macronutrients. The volunteers will be instructed to return to the Human Nutrition Unit on the fourth morning and provide a second faecal sample and remove the CGMS. Blood samples will be analysed for systemic bioavailability and metabolism of test meal components, glucose regulatory hormones and breath samples for quantifying gastric emptying. The faecal samples will be analysed for gut bioavailability and metabolism of test meal components, microbial counts, composition, and water content.
|
The study aims to confirm in vivo the effects of consuming broad bean hull on blood glucose control and gut health. Although in vitro evidence is promising, its benefits remain confirmed in vivo in humans. No studies have previously attempted to assess the impact of broad bean hull consumption on glycaemic and gut health outcomes in humans. Therefore, this study will be novel and provide useful information on the potential of using BBH as a functional food for human health.
From a health perspective, it is essential to establish the bioavailability and metabolism of dietary constituents in humans. Certain metabolites are absorbed early in the gastrointestinal tract, whereas others are transported to the colon, where they are extensively metabolised by the gut microbiota. This study will characterise the bioactive metabolites present in the plasma and faecal samples obtained. This will inform on their availability to the systemic circulation and their excretion profiles.
Using targeted quantitative analysis (LC-MS and GC-MS), metabolites and their in vivo concentrations will be measured. The principal metabolites analysed will be those produced by the phenylpropanoid pathway and protein and carbohydrate metabolism products. These will include derivatives and metabolites of the simple phenols, benzoic acids, phenolic acids, phenylacetic acids, phenypropionic acids, phenylpyruvic acids, phenyllactic acids, mandellic acids, phenolic dimers, acetophenones, benzaldehydes, cinnamaldehydes, benzyl alcohols, cinnamyl alcohols, indoles, isoflavones, coumarins, chalcones, flavanones, flavones, flavonols, anthocyanidins.
Furthermore, short-chain fatty acids will be analysed in the participants' faecal samples. It has been shown that many of these compounds are bioactive and exhibit anti-oxidant and anti-inflammatory activity at in vivo concentrations. Therefore, these studies will provide important information on bioavailability and metabolism and correlate the indices with health biomarkers.
In addition, compounds such as the carcinogenic heterocyclic amines, genotoxic nitrosamines, indoles, polyamines, bile acids, and other protein metabolites considered detrimental to human health will also be measured. It is likely, the carbohydrate and phytochemical content of plant proteins may also protect against the formation of these toxic and potentially carcinogenic protein by-products.
|
Inclusion Criteria:
* Healthy males and females
* Aged 18-75 years old.
* BMI 23-35 kg/m2
* HbA1c \<6.5%
* Total cholesterol ≤ 7 mmol/l
Exclusion Criteria:
* Glucose 6 Phosphate Dehydrogenase deficiency
* Diagnosed for chronic diseases; thyroid disorders, metabolic/genetic diseases, diabetes and disorders of glycaemic control; cardiovascular disease; irritable and inflammatory bowel disorders.
* Women with polycystic ovaries syndrome (PCOS)
* Women who are lactating or breastfeeding, pregnant
* On prescription medications known to affect metabolism, including hormonal contraceptives and thyroid medications, and hormonal replacement therapy
* Have taken a course of antibiotics in the past four weeks
* Allergic/intolerant to foods provided in the study
* Diagnosed for high blood pressure and on prescription medications such as Ramipril
* Alcohol and/or other substance abuse
* Smoking and the use of e-cigarettes, nicotine patches and nicotine gums
* Physically active at a competitive level
* Usually not consuming significantly more than five portions of fruits and vegetables per day
* Poor venous access
|
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] |
NCT04750291
|
Management of Popeye Sign With Botulinum Toxin After Bicepstenotomy
|
Double-blinded randomized controlled trial with 20 people of whom 10 will receive a placebo infiltration and 10 an infiltration with botulinum toxin type A for cramping pain after arthroscopic tenotomy of the long head of the biceps tendon.
|
Title: Management of Popeye sign with botulinum toxin after tenotomy of the long head of the biceps tendon: a double-blinded randomized controlled trial Précis: Double-blinded randomized controlled trial with 20 people. Randomization in 2 arms of 10 people. 3 visits will be planned with a meantime of 3 months after the infiltration with botulinum toxin type A (BTX-A) or placebo that will be administered at the 2nd visit.
Objective: The primary objective is to assess the effectiveness of an infiltration with botulinum toxin in the biceps muscle after tenotomy of the long head of the biceps tendon for pain and disability reduction.
Endpoint: The primary endpoint is a pain reduction as measured by the Visual Analogue pain scale (VAS) and a reduced disability as measured by the quick DASH (Disabilities of the Arm, Shoulder and Hand).
Population: 20 people who underwent an arthroscopic tenotomy of the long head of the biceps tendon and are having post-operative pain in the biceps muscle.
Phase: 4
Number of Sites enrolling participants: single center study in AZ Delta Roeselare
Description of Study Agent: botulinum toxin type A (Botox®) 100 International Units by intramuscular injection
Study Duration: From March 2021 till December 2022
Participant Duration: 3 months
|
Inclusion Criteria:
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Have had arthroscopic tenotomy of the long head of the biceps tendon without rotator cuff repair, acromioclavicular joint resection or glenoid labrum repair
* Having bicipital pain that started after the tenotomy
Exclusion Criteria:
* under 18 years of age
* over 65 years of age
* pregnancy or lactation
|
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] |
NCT04173845
|
Double Randomized and Placebo Controlled Trail of Tianqi Pingchan Granule to Prevent Levodopa-Induced Dyskinesia
|
A randomized, double-blind, placebo-controlled multicenter clinical trial was used to observe the effectiveness, safety and side effects of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia, so as to determine the clinical efficacy of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia.
|
The aim of this clinical trail is to evaluate the effect of Tianqi Pingzhan Granule in the prevention of levodopa induced dyskinesia in adults. All patients included in the study should meet the inclusion criteria. Half of participants will receive Tianqi Pingzhan Granule, while the other half will receive a placebo of Tianqi Pingzhan Granule. All participants will be assigned to either the active group or the control group randomly. During the clinical trail both doctors and patients are double-blind except serious adverse events occurred.
|
Inclusion Criteria:
Patients with PD aged 30-85，have at least the following two conditions:
1. Dosage of Levodopa ≥ 400mg/d;
2. Grade of H\&Y≥3;
3. risk score of dyskinesia\>4;
Exclusion Criteria:
1. PD patients with dyskinesia;
2. Taking other Chinese medicines against Parkinson's disease;
3. pregnant and lactating women;
4. Impaired cognitive function (according to pre-entry MMSE score):
secondary education level: MMSE \<24 points; primary education level \<20 points; illiterate \<17 points;
5. accompanied by a history of mental illness;
6. impaired liver and kidney function;
7. accompanied by severe other systemic diseases;
8. Previous traditional Chinese medicine preparations or serious adverse reactions
9. Before the enrollment, the EKG showed obvious abnormalities and required clinical intervention.
10. PD related brain surgery
11. Patients who are participating in other clinical studies or has participated other clinical studies within 30 days before
12. Patients unable to cooperate with the survey
|
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] |
NCT01546428
|
A Phase I Study of INC280 in Japanese Patients With Advanced Solid Tumors
|
INC280 will be administered to Japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. The trial will assess the safety and tolerability and determine the maximum tolerated dose (MTD) on INC280
|
Inclusion Criteria:
* Advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available.
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
* Good organ (hepatic, kidney, BM) function at screening/baseline visit.
Exclusion criteria:
* Symptomatic CNS metastases that are neurologically unstable or requiring increasing doses of steroids to control CNS disease.
* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of INC280.
* Undergone a bone marrow or solid organ transplant.
* Women who are pregnant or breast feeding.
Other protocol-defined inclusion/exclusion criteria may apply
|
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|
NCT01980927
|
Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association Atlas Correction
|
A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the treatment of headache, it has not been formally studied using clinical trials. There is some data indicating that NUCCA correction can increase intracranial compliance. This intracranial compliance can be measured by a magnetic resonance imaging (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope to show that the correction of an atlas misalignment will increase intracranial compliance in subjects with migraine.
|
Inclusion Criteria:
* Patients must be 18-65 years of age.
* Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
* Have migraine with or without aura.
* Have between 10-26 headache days per month over the last 4 months.
* Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
* Have at least 8 days per month with pain of levels greater than or equal to 4/10 for part of the day, or have attacks successfully treated with migraine specific medication.
* Be candidates suitable for NUCCA therapeutic intervention because of atlas displacement as assessed by NUCCA investigator.
* Subjects on acceptable pharmacological prophylaxis must either remain on a stable dose throughout the study, or stop the prophylactic medication one month before entering the baseline period.
Exclusion Criteria:
* Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
* Headache on more than 26 days per month.
* Acute medication overuse as defined by the International Classification of Headache Disorders.
* Pregnancy or lactation
* Severe cervical spine degeneration as assessed by cervical spine x-ray.
* Claustrophobia or any condition that contraindicates an MRI scan
* A history of cardiovascular disease, cerebrovascular disease, brain surgery, or other central nervous system disorder.
* Other chronic pain disorder which might interfere with headache assessment or study procedures.
* A history of significant hypo- or hypertension as determined by the investigator.
* Subject on a beta-blocker, calcium channel blocker, or other medication which the investigator considers might alter cerebral vascular regulation. Triptans are allowed, but must not be taken within 24 hours (48 hours for frovatriptan) before an MRI study.
* A history of substance abuse or dependence within 1 year.
* Current participation in a research study or within the last 30 days.
* Any spinal chiropractic care outside of the study protocol is prohibited during the baseline and treatment period.
* Use of botulinum A within 4 months of study entry.
* A history of significant head or neck trauma (as judged by the investigator) within the year prior to study entry.
|
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] |
|
NCT04561635
|
Effects of Multiple-micronutrients Supplementation on Growth and Iron Status of Indigenous Children in Malaysia
|
Child undernutrition is largely attributed to inadequate nutrition including micronutrient deficiency. Undernutrition is prevalent among indigenous children as compared to the general population. This cluster randomized controlled trial aimed to determine the effect of multiple-micronutrients supplement (MMS) on growth and iron status of Orang Asli (indigenous group in Peninsular Malaysia) young children (6 to 24 months) in Selangor. MMS is a blend of 15 micronutrients in powder form that can be used for home fortification of foods for young children. A total of 98 children recruited in this study with 49 children randomly assigned for each intervention (IG) and control group (CG). At baseline, all children were normal in weight-for-age (WAZ\>-2SD), length-for-age (LAZ\>-2SD), weight-for-length (WLZ\>-2SD) and blood haemoglobin (\>11g/dL). IG was supplemented with three sachets of MMS each week i.e. every other day for 12 months and received health and nutrition advice. CG only received health and nutrition advice. Both groups were assessed for body weight, length and dietary intake at baseline, month 3, 6, 9, 12 of intervention, and 3 months post intervention. Blood haemoglobin was assessed at baseline, month-12 of intervention and 3 months post intervention. Compliance to MMS was measured in IG. The primary outcomes were weight, length, WAZ, LAZ, WLZ and haemoglobin, while the secondary outcome was dietary intake. The independence sample t-test and the chi-square test were used to determine the difference in the baseline variables between the groups. ANOVA using General Linear Model (GLM) for repeated measures was performed to determine the difference in the growth measures z scores, haemoglobin, energy, nutrients and food group within and between the groups over the period of the study. Per protocol analysis was performed. This study hypothesized that there were significant differences in the changes (before and after MMS intervention) related to growth \[(weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ)\]; iron status (haemoglobin concentration); and dietary intake (energy, nutrients and food group intakes) between intervention and control groups.
|
1. Study Objectives This study was undertaken to determine the effect of Multiple micronutrients supplement (MMS) on the nutritional status of Orang Asli (indigenous people in Peninsular Malaysia) children (6 to 24 months) in Selangor. This study assessed growth (weight, length, WAZ, LAZ, WLZ) and iron status (haemoglobin concentration) of children as primary outcomes, while the secondary outcome included dietary intake (energy, nutrients and food groups) of children.
2. Study Location This study was conducted in Orang Asli (OA) communities in Selangor, Peninsular Malaysia. The specific communities were identified with the assistance of Department of Orang Asli Development Selangor (JAKOA). The majority of residents are Temuan (78%), followed by Mah Meri (15%), Semai (2%) and mixed (5%). This study included only the Temuan tribe as study population.
3. Study Design This was a cluster randomized controlled trial. Villages as clusters were randomly allocated into either intervention or control group. All households in each cluster were included in the trial.
4. Sample Size A formula for mean difference between two groups was used for sample size calculation. The sample size was calculated to have 80% chance of detecting a mean difference in length of 0.56 cm or more with an estimated standard deviation of 0.31. An additional 50% was applied to the calculation of sample size to account for withdrawal and non-compliance. Hence, the total number of respondents per group was 49.
5. Sampling Procedure There were 74 OA clusters (villages) in Selangor. Screening of clusters were conducted according to inclusion and exclusion criteria of clusters. Upon screening, 17 non-Temuan clusters and 6 Temuan clusters were excluded from this study. Temuan cluster is defined as having at least 80% of the households in the village are of Temuan ethnicity. The remaining 51 Temuan clusters were then randomly assigned either to the intervention or control group by considering the distance and geographical locality of the clusters. A total of 22 clusters were randomly allocated to the intervention group, while 29 clusters randomly allocated to the control group. There were 7 small clusters in the control group which grouped into 2 clusters as the small clusters have a small number of young children.
Screening assessment of children then were conducted in clusters (that obtained consent from head of villages) based on the lists of children aged between 6 to 24 months given by the head of villages. All listed children were screened according to inclusion and exclusion criteria of children. Upon screening, 68 children in four clusters of intervention group, and 102 children in seven clusters of control group were excluded as not meeting the inclusion criteria of children. Based on the screening assessment, the total number of children recruited initially was 98 children, with 49 children in each of the two groups.
6. Selection of Clusters (Villages) and Children Approval by JAKOA was obtained prior to the selection of clusters (villages). OA villages were visited by investigator and a research assistant to conduct the selection of clusters based on inclusion and exclusion criteria. Head of villages were interviewed to obtain information on majority of households' ethnicity and availability of child/children aged between 6 to 24 months. For Temuan cluster that has at least one child aged between 6 to 24 months old, the head of villages were given an invitation letter, letter of study approval by JAKOA and information of the study. The head of villages were briefed about the purpose, benefits and potential risks of the study to the children. They were given the opportunity to ask for further details if they were not clear about the given explanation. Consent from the head of villages were obtained after the briefing. List of households with children aged between 6 to 24 months was then given to the investigator by the head of villages for the selection of children.
7. Treatments The intervention group was supplemented with three sachets of MMS in powder form each week for every other day for a period of 12 months. Each sachet containing 1 g consisting of ten vitamins and five minerals. The amount of each micronutrient provided by MMS was mostly ≥ 42% of the Malaysian Recommended Nutrient Intake, (RNI). This was adequate to meet the daily nutrient requirement of children in addition to nutrients provided by daily complementary foods. The MMS was manufactured by DSM Singapore Industrial Pte. Ltd. It was in powder form and to be sprinkled over a cooked meal or dissolved in a drink for the child. The intervention group was visited weekly in first 2 months and two-weekly in the following months to distribute and monitor the supplementation of MMS. Written instruction for using and storing the MMS in simple language with visuals was given prior to the supplementation. The intervention group also received health and nutrition advice delivered by investigator at 3, 6 and 9 months after supplementation begins. The control group received health and nutrition advice that were similar to intervention group and delivered at 3, 6 and 9 months after the study began.
8. Measurements 8.1 Demographic and Socioeconomic Information Demographic and socioeconomic information were obtained through face-to-face interview with parents/ caregivers using a pre-tested questionnaire and assistance from a local translator. Age of children was calculated from childbirth date that obtained from birth certificate or child health record. Data were collected prior to the intervention as baseline data.
8.2 Anthropometry Birth weight and length of children were obtained from child health record. Body weight and length of children were measured at baseline, 3, 6, 9, 12 and 15 months after supplementation begins. Weight and length of children were measured using Tanita Digital Weighing Scale HD 325 (to the nearest 0.1 kg) and Recumbent Measuring Board (to the nearest 0.1cm), respectively using standard procedures. All measurements were taken twice, and the average value were used as final data. Age, weight and length of the children were translated into three indices of weight-for-age, length-for-age and weight-for-length. WHO Anthro program version 3.2.2 was used to estimate the Z scores for weight-for-age (WAZ), length-for-age (LAZ) and weight-for-length (WLZ). Z score was used to distinguish between normal and underweight (WAZ \<-2), stunted (LAZ \<-2) and wasted (WLZ \<-2) children according to WHO classifications.
8.3 Haemoglobin Haemoglobin level was assessed using finger-prick blood method. A staff nurse conducted the assessment using a portable HemoCue®201+ Analyzer. Haemoglobin assessment was performed at baseline, 12 and 15 months of study.
8.4 Dietary Intake Dietary intake was assessed using a standard 24-hour diet recall questionnaire at baseline, 3, 6, 9, 12 and 15 months. This assessment involved face-to-face interview with parents/ caregivers to obtain information on time, types and amount of foods and beverages consumed by children during the 24 hours prior to the interview. Household measurements (e.g. cups, teaspoons, plates, bowls) were used to assist parents/ caregivers in estimation of portion sizes of consumed foods and beverages. Dietary intake data was analysed using a computerized dietary analysis program, Nutritionist Pro. The USDA Food Database was used in this software for dietary analysis.
8.5 Child Vaccination, Infection and Household Sanitation and Hygiene History of child vaccination, infection and household sanitation and hygiene were assessed using a standard questionnaire at 12 months of study (end of the intervention). History of child vaccination was obtained from child health record. Assessments of child infection history involved face-to-face interview with parents/ caregivers to obtain information on common infections in children in the preceding two weeks. Interview with parents/ caregivers were conducted as well to obtain information on household sanitation and hygiene.
8.6 Compliance to MMS Every week, parents/ caregivers in intervention group were given a pack which contains 3 sachets of MMS to be taken by their children in a week. After a week, the parents/ caregivers were required to return the empty sachets (including unused or half used) to the investigator. Compliance to MMS was measured by dividing the total number of empty sachets with a total number of distributed sachets for the 3, 6, 9 and 12-months periods.
8.7 Adverse effect of MMS Any adverse effect was assessed during a weekly visit. The information was obtained through a weekly face-to-face interview with the parents/ caregivers.
9. Study Withdrawal Children who withdrew the study were visited several times and attempts were made to persuade the parents/ caregivers to continue with the study. Withdrawals were recorded in Case Report Form to determine percentage of the participants who withdrew for reasons related to the intervention or those who missed at random.
10. Ethics Approval and Funding The study protocol was approved by the Ethics Committee for Research Involving Human Subjects (JKEUPM) of Universiti Putra Malaysia. Permission to conduct the study in Orang Asli communities was obtained from the Department of Orang Asli Development (JAKOA). Written informed consent was obtained from parents /caregivers who agree to participate in the study. This study was funded by a research grant from Universiti Putra Malaysia (GP-IPS/2016/9514200).
11. Data Analysis Data were analyzed using 'Statistical Package for Social Sciences' programme for Windows version 22.0. Categorical data were described using count and percentage. All numerical data were tested for normality of distribution and were presented as mean and standard deviation. Non-parametric tests were used whenever the assumptions of normality and/ or homogeneity of variances were not met. Logarithmic conversion was performed for data not normally distributed. Per protocol analysis was performed, and children who withdrew from the study, noncompliant, and has missing outcomes were excluded from analysis.
The independence sample t-test was used to determine the difference in the mean of continuous variables between the intervention and control groups, while for categorical variables the Pearson's chi-square test was used. Paired t-test was conducted to assess changes in outcomes variables within each group (intervention and control) between baseline and 12 months as well as 15 months follow-up. ANCOVA using General Linear Model for repeated measures was performed to determine the effects of intervention between the groups on main and specific outcomes. Demographic and socioeconomic characteristics of both groups such as gender of children, age of children at selected time points, education of mothers and baseline measures were controlled in the analysis. Differences between groups were considered statistically significant at p\<0.05 using two-tailed tests.
|
Inclusion Criteria:
* Aged between 6 to 24 months old; and
* Normal weight-for-age (WAZ \> -2SD), length-for-age (LAZ \> -2SD) and weight-for-length (WLZ \> -2SD); and
* Normal haemoglobin level (\> 11.0g/dL).
Exclusion Criteria:
* Has/ had history of chronic diseases e.g. failure to thrive and/or metabolic or endocrine disorders; and
* Has history of congenital and/or acquired neurological condition; and
* Under treatment for communicable diseases such as Tuberculosis, HIV.
|
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] |
NCT01712048
|
Submucosal Injection EMR vs. Underwater EMR for Colorectal Polyps
|
The aim of this study is to compare the efficacy and safety of two standard methods of polypectomy (polyp removal), submucosal injection-assisted endoscopic mucosal resection (EMR) and full water emersion (without submucosal injection) EMR, for large colorectal polyps.
|
The endoscopic resection of benign colon polyps (polypectomy) plays a vital role in the prevention of colo-rectal cancer. While, small pedunculated polyps are removed with ease, large flat lesions pose a greater challenge. As a result, special techniques have been developed to assist in the removal of these difficult polyps.
During conventional colonoscopy with polypectomy, the colon lumen is insufflated with air, which flattens polyps and thins the wall of the colon. These two factors increase the risk of procedural complications such as bleeding and perforation. In order to counter these drawbacks a technique, which involves the injection of saline into the submucosal area beneath the polyp, is commonly used for the resection of large flat polyps. Theoretically, the injection creates a "safety cushion" that reduces the risks of accidental ensnarement of the muscularis propria, which can lead to iatrogenic perforation and thermal injury to the deeper tissue layers. However, the submucosal injection technique is cumbersome in patients with particularly large polyps as multiple injections are often necessary, which can blur the line between normal and abnormal tissue.
Water emersion colonoscopy is a well-established alternative to conventional "air" colonoscopy and is in fact preferred by many endoscopists. Studies have shown that using water instead of air decreases the discomfort of colonoscopy, measured by the amount of sedative and pain medication used, time to complete the colonoscopy, and recovery time, and increases cecal intubation rates. Interventional Endoscopy Services (IES) at CPMC has taken the concepts of water emersion colonoscopy one step further in order to developed a novel method of "underwater" EMR. This technique was inspired by the observation that the muscularis propria of the colon retains its native thickness (1-2 mm) and circular configuration during underwater EUS examination. Furthermore, water immersion "floats" mucosal lesions away from the deeper wall layers, eliminating the need for a "safety cushion" created by submucosal injection. One drawback to the underwater technique is that in the case of poor preps, residual feces in the colon is suspended in the water, interfering with visualization. Additionally, the use of water often causes soiling of the gurney as a result of water seepage from the rectum during the procedure, which requires additional sanitary attention during the procedure.
|
Inclusion Criteria:
* Patients age \>18 years that are scheduled for endoscopic resection of large colo-rectal lesions who consent to this study.
Exclusion Criteria:
* Patients unable to provide informed consent.
* Patients with lesions showing adenoma invasion into the muscularis propria on EUS.
* Patients without at least one colo-rectal lesions ≥ 20mm.
|
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] |
NCT05062226
|
GMP Case Studies of Tolerance, Safety and Acceptability in PKU and TYR
|
Three new protein substitutes have been developed to help with compliance in PKU and TYR patients, which are powdered protein substitutes, low in Phe and, low in Phe and Tyr respectively, with a mixed balance of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fats and micronutrients for the dietary management of PKU and TYR.
This series of case-studies will evaluate the acceptability, compliance, gastrointestinal tolerance and safety of the three GMP-based products for PKU and TYR in 45 patients with PKU and TYR, in both adults and children over 3 years (15 patients per product). The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple specialist metabolic centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies. A series of case studies is undertaken due to the rarity of these conditions and the difficulty in recruiting these patients to trials.
|
Phenylketonuria (PKU) and Tyrosinaemia (TYR) are rare inherited metabolic disorders of amino acid metabolism requiring dietary management. PKU is characterised by an inability to metabolise the essential dietary amino acid phenylalanine (Phe) into tyrosine (Tyr). As such, without appropriate management, PKU can lead to extremely elevated levels of Phe within the blood and brain, which can be detrimental to neurological health. The dietary management of PKU involves restricting dietary sources of Phe. Tyrosinaemia (TYR) is characterised by the inability to metabolise the dietary amino acid Tyr. If left uncontrolled, TYR can lead to serious hepatic, renal and neurological complications. The dietary management of TYR involves restriction of dietary sources of Tyr and Phe (as Phe is converted into Tyr). The dietary management of PKU and TYR involves restricting dietary protein intake to promote optimal metabolic control, whilst meeting all other amino acid and nutrient requirements. As Phe and Tyr are present in significant quantities in nearly all dietary proteins, this usually requires a very low protein diet from food, supplemented with a Phe-free (for PKU) or Phe- and Tyr-free (for TYR) amino acid-based protein substitute. However, compliance with the diet is often poor, with patients commonly going "off diet" during adolescence and in adulthood. This can lead to entirely preventable, lifelong mental and physiological impairments. Reasons for non-compliance often revolve around the strong taste of amino acid-based protein substitutes, alongside the inability to conform to the normal eating habits of peers.
Three new protein substitutes have been developed to help with compliance in PKU and TYR patients, which are powdered protein substitutes, low in Phe and, low in Phe and Tyr respectively, with a mixed balance of glycomacropeptide (GMP), essential and non-essential amino acids, carbohydrates, fats and micronutrients for the dietary management of PKU and TYR. The protein in GMP-based products for PKU and TYR are based on GMP, a peptide isolated from milk during cheese manufacturing and the only known naturally derived protein source low in Phe and Tyr. The GMP is supplemented with appropriate quantities of other amino acids which are naturally low or not present in GMP, as well as carbohydrates and fats. This differs from traditional formulae which are based wholly on individual, synthetically produced amino acids to provide the source of dietary nitrogen, supplemented with vitamins and minerals. Studies to date have illustrated that PKU patients who replace their regular Phe-free amino acid-based formula with GMP-based foods may have better diet compliance, prefer the taste and may have improved blood Phe control.
This series of case-studies will evaluate the acceptability, compliance, gastrointestinal tolerance and safety of the three GMP-based products for PKU and TYR in 45 patients with PKU and TYR, in both adults and children over 3 years (15 patients per product). The case study will last 29 days in total, including a 1-day baseline period followed by a 28-day intervention period. The case studies will be conducted across multiple specialist metabolic centres in the UK, to meet the UK ACBS and GMS requirements for acceptability studies. A series of case studies is undertaken due to the rarity of these conditions and the difficulty in recruiting these patients to trials.
|
Inclusion Criteria:
* Male or female
* Over 3 years of age
* Diagnosed with classical or variant type phenylketonuria, or tyrosinaemia (as appropriate)
* Have been compliant in taking at least one protein substitute, providing at least 10g protein equivalents, for at least 1 month prior to trial commencement
* Have a prescribed daily Phe or Phe and Tyr allowance for PKU or TYR respectively
* Written or electronic informed consent from patient, and/or from parent/caregiver if applicable
Exclusion Criteria:
* Currently prescribed Sapropterin or similar tetrahydrobiopterin based medication
* Pregnant or lactating
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients, including milk and soy
* Investigator concern around willingness/ability of patient or parent/caregiver to comply with protocol requirements
|
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] |
NCT01465633
|
Bioavailability Investigations of Thyronajod Mite Tablets of Dosage Strengths 50 μg Levothyrox-ine/75 μg Iodine, and 100 μg Levothyroxine/75 μg Iodine vs. a Levothyroxine Drinking-Solution: A Randomised Cross Over Study in Healthy Male Individuals. Currently: 50 μg/ 75 μg Tablets
|
The purpose of this study is to measure the area under the curve (AUC0-48h; extent of systemic availability) and the maxi-mum concentrations (Cmax) of total serum levothyroxine (TT4, bound and free fraction) after a single pharmacological dose of 600 μg administered as tablets also containing iodine supple-ments vs. the same dose of levothyroxine administered as a reference solution without iodine.
|
Inclusion Criteria:
* Euthyroid men
* Age: 18 - 50
* Normal values for fT4 und TSH
* Good state of health
Exclusion Criteria:
* Thyroid function disorders in terms of subclinical or overt hyper- or hypothyroidism
* History of thyroid function disorders
* Focal or diffuse autonomies of the thyroid gland
* Thyroid nodules \>1 ml according to sonographic examination
* Any acute or chronic illness
* Dermatitis herpetiformis
|
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] |
|
NCT00801957
|
Equivalence of the Response to Vaccination of Tacrolimus Ointment to a Steroid Ointment Regimen in Children With Atopic Dermatitis
|
Seven-month study in pediatric patients (2-11 years) with moderate to severe AD who were considered to benefit from vaccination to prevent invasive disease caused by Neisseria meningitides serogroup C.
|
At the week 1 visit, the patients were vaccinated with a protein-conjugated vaccine against meningitis. All patients received a challenge at the month 6 visit with a low dose of meningo polysaccharide vaccine. A control group of healthy subjects (not suffering from atopic dermatitis) received only the vaccination and the challenge dose.
|
Inclusion Criteria:
* Patients with moderate to severe atopic dermatitis and in need for treatment
* Patients require vaccination to prevent invasive disease caused by Neisseria meningitidis serogroup C
Exclusion Criteria:
* Patients have known hypersensitivity to macrolides, tacrolimus and any component of the vaccine
* Patients have an acute severe febrile illness, genetic epidermal barrier defect such as Netherton's syndrome or generalized erythroderma, a skin infection on the affected and to be treated area
* Patients have already received a meningo polysaccharide or conjugated vaccine against meningitis
|
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] |
NCT06757179
|
The ELYAR (Elysium Against Rhinitis) Project
|
Acute rhinitis is an inflammatory process that primarily affects the nasal mucosa, with a high incidence in the pediatric population and a morbidity rate of 6-8 episodes annually during the first two years of schooling (1). It is one of the most common conditions causing discomfort and debilitation in children, compromising their quality of life, negatively affecting social interactions, school performance, and sleep quality. In most cases, the origin is viral and the course is seasonal, with higher incidence in the autumn and winter seasons (1).
More than 100 viral strains are known to be responsible for this condition, among which Rhinoviruses are considered the most widespread and contagious (2). Symptoms, which typically begin 1-2 days after infection, include nasal congestion, nasal breathing obstruction, rhinorrhea, sneezing, coughing, headache, malaise, and sometimes mild fever, with complete remission generally occurring within 8-10 days (2).
The therapeutic approach is exclusively symptomatic, mainly aimed at reducing nasal obstruction. Literature indicates that nasal irrigation with saline solution is the most useful treatment for cleansing the nasal passages, thinning nasal secretions, and allowing for easier elimination; in the presence of fever, antipyretics may be useful (3).
Given these premises, the aim of this clinical study was to evaluate the therapeutic efficacy of an isotonic saline solution containing mullein, thyme, propolis, and long-chain polyphosphates, which are known for their natural properties to promote nasal secretion fluidity, reduce inflammation, and improve the functionality of the upper respiratory mucosa (4). In addition, more recent pre-clinical data suggested that this formulation exerts an antiviral action characterized by inhibition of virus replication (Rhinovirus and SARS-CoV-2) and an anti-inflammatory action through modulation of NF-Kb signaling in cultured human nasal respiratory epithelial cells. These effects are also associated with antibacterial action thanks to mullein and thyme.
|
Inclusion Criteria:
* Caucasian subjects of both sexes,
* aged between 4 and 14 years;
* diagnosis of acute rhinitis based on the presence of ≥3 of the following symptoms that had onset within the last 24 hours: rhinorrhea, nasal congestion, nasal obstruction, sneezing, pharyngodynia, cough;
* in addition to ≥1 of the following signs/symptoms: headache;
* fever; malaise; burning eyes; myalgia;
* written informed consent obtained from the parents of the participants and from the participants themselves if older than 6 years.
Exclusion Criteria:
* non-Caucasian ethnicity; age \<4 and \>14 years; known hypersensitivity/allergy to any component of the dietary supplement;
* previous diagnosis of severe nasal septal deviation or any other condition that could cause nasal obstruction, such as nasal polyps;
* history of nasal or sinus surgery that could affect symptom scores; use of antibiotics, corticosteroids, or antihistamines within 2 weeks prior to the study; participation in other studies;
* conditions that made compliance with the protocol unlikely.
|
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] |
|
NCT03235960
|
Efficacy of Glass-ionomer Fissure Sealants
|
Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
|
Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.
|
Inclusion Criteria:
* at least one recently erupted permanent molar with sound pits and fissures
* healthy patients
* possibility to perform a dental treatment
* willing to participate in the study
Exclusion Criteria:
* teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system
* medically compromised patients
* non cooperative patients
* not willing to participate in the study
|
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] |
NCT03976583
|
Remineralization Potential of Pearl Powder Compared to CPP-ACP on Enamel White Spot Lesions
|
The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate.
|
The aim of this study is to evaluate the remineralization potential of pearl powder on early ('white spot') lesions in enamel in orthodontic patients compared to casein phosphopeptide-amorphous calcium phosphate. The remineralisation potential will be assessed both visually and by standardised photographic image analysis. the follow up will be up to 12 months.
|
Inclusion Criteria:
* Males or females.
* Age: 12-25 years old.
* Patients with good oral hygiene.
* Co-operative patients who show interest to participate in the study.
Exclusion Criteria:
* Patients with bad oral hygiene.
* Lack of patient's approval and compliance.
* Presence of abnormal oral, medical, or mental condition.
* Patients who are allergic to milk products.
* Pregnant and lactating women.
|
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] |
NCT04449679
|
Real-Time Monitoring of Chemotherapy Side-Effects in Patients With Gastrointestinal Cancers, RT-CAMSS Study
|
This trial tests new methods and materials for the real-time chemotherapy-associated side effects monitoring support system (RT-CAMSS) in patients with gastrointestinal cancers undergoing chemotherapy. RT-CAMSS is a monitoring support system that provides patients with evidence-based information and side-effect management and coping skills, emotional support and validation, and proactive care via text messages and questionnaires as they undergo chemotherapy.
|
PRIMARY OBJECTIVES:
I. Develop and refine a real-time chemo-associated side effects monitoring support system (RT-CAMSS) using interactive text messaging (TXT) for patients with gastric, esophageal, pancreatic and colorectal cancer during chemotherapy.
II. Assess the feasibility and engagement of the RT-CAMSS in a 2-month pilot study.
III. To gather preliminary data on the impact of RT-CAMSS on patient's quality of life and symptom distress.
OUTLINE:
PHASE I: Patients participate in an audio-recorded focus group or one-on-one interview over 40 minutes either in-person, over the phone, or electronically. Patients receive sample text messages and questionnaires generated from the RT-CAMSS to generate reaction, discussion, and scenarios.
PHASE II: Patients receive RT-CAMSS over 2 months or until chemotherapy is discontinued, whichever is earlier. RT-CAMSS consists of text messages addressing knowledge about specific cancer type and chemotherapy, side-effect prevention, suggestions of lifestyle behavioral changes and emotional support, and preparation for surgery. Patients then record their symptoms through answering a series of questionnaires and receive tailored feedback according to their answers, including a consultation with a nurse.
After completion of study, patients are followed up at 1 and 2 months.
|
Inclusion Criteria:
* Patients diagnosed with gastric, esophageal, pancreatic or colorectal cancer
* Scheduled to start intravenous (IV) chemotherapy or has started IV chemotherapy
* Able to read and understand English
* Able to provide signed and dated informed consent form
* Have a mobile device with text message capability
* Know or willing to learn how to use text messaging
Exclusion Criteria:
* \< 18 years of age
* Cognitive impairment documented in the electronic medical record (EMR), biological variables (sex)
|
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] |
NCT04779008
|
Long-term Remote Ischemic Preconditioning Improves Myocardial Perfusion and Prognosis of Patients After CABG
|
Remote Ischemic preconditioning (RIPC) has been reported to improve myocardial microcirculation, promote collateral circulation recruitment, and improve myocardial perfusion in patients.Two large randomized controlled trials demonstrated a perioperative cardioprotective effect of RIPC (reduced troponin levels), but did not find that a single preoperative RIPC improved long-term outcomes of coronary artery bypass grafting(CABG).The effect of a single RIPC before CABG may be too short. This study aims to investigate whether long-term RIPC improved myocardial perfusion in patients 3 months and 6 months after CABG surgery , and to detect changes in blood vascular endothelial growth factor, Nitrc Oxide, adenosine，and Endothelin-1, and to observe MACCE event rates at 12 months.
|
A total of 210 patients were randomly divided into three groups according to the inclusion and exclusion criteria, with 70 patients in each group.
Experimental Group 1:
The patient underwent one RIPC (Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff air vehicle to 200 mmHg) 1 hours before surgery, then normal surgery, and RIPC was performed on the second day after surgery and every day after surgery, which lasted for 1 year.
Experiment Group 2:
Patients underwent once RIPC 1 hours before surgery, and then normal medical procedures were performed with no additional intervention.
Control group:
Patients did not receive any additional intervention. All patients were evaluated in three ways. First: 7days and 3 months after surgery , the quantitative examination of myocardial blood flow was conducted to observe the improvement of myocardial blood perfusion.
Second: The changes in the concentrations of vascular colorectal growth factor, Nitrc Oxide, adenosine, and endothelin-1.
Third, patients were evaluated for 6 months and 12months MACCE incidence (cardiovascular death, Nonfatal myocardial infarction, unplanned revascularization, and stroke).
|
Inclusion Criteria:
* Three coronary artery lesions, CABG surgery was planned
Exclusion Criteria:
* The patients could not tolerate ripc;
* peripheral vascular disease affecting upper limbs
* Acute myocardial infarction complicated with cardiogenic shock，in recent 30 days,
* Emergency cases
* Severe structural heart disease and severe arrhythmia ；
* The uncontrolled systolic blood pressure and diastolic blood pressure of severe hypertension were 180 mmHg and 120 mmHg respectively;
* Severe liver, renal and pulmonary disease
* Mental disorder can't cooperate;
* Inability to give informed consent；
* Patients on glibenclamide or nicorandil, as these medications may interfere with RIC
* pregnant;
|
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] |
NCT05013645
|
Evaluation of Skin Hydration in Adults With Dry Skin Using a Moisturizer With an Added Sterilized Probiotic
|
Double-blind placebo-controlled clinical trial to evaluate the effectiveness of a sterilized probiotic on skin health and hydration in adults with dry skin.
The goal of the study is to determine if the addition of a skin-conditioning probiotic to a standard gel product will moisturize the skin, support a healthy skin microbiome, and be readily tolerated by adults with dry skin.
|
Inclusion Criteria:
1. Provision of a signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability to attend study visits for the duration of the study
3. English-speaking
4. 18-90 years of age
5. Score of a 2 or higher in one of the four areas assessed on the Dry Skin Area and Severity Index (DASI)
Exclusion Criteria:
1. Current self-reported pregnancy or active intent to conceive
2. Current lactation
3. Fever within 7 days of study enrollment
4. Self-reported use of systemic antibiotics (oral or injectable) in the past 6 weeks.
5. Any clinically significant medical or psychological disorder, condition, or disease that in the opinion of the investigator exposes the subject to unacceptable risk by participating in the study or interferes with the subject's ability to complete the study.
|
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] |
|
NCT03079895
|
Thrive Care: Internet CBT for Depression
|
This project will study the effectiveness of computerized cognitive behavioral therapy (CBT) in reducing depression symptoms. The design is a two-arm randomized controlled trial comparing (i) control arm, which is treatment as usual with (ii) treatment arm, which is treatment as usual plus computerized CBT. The primary outcome measure is change in depression symptom severity. The name of the computerized CBT program to be used in the study is Thrive.
|
Population:
* As identified in Epic, Kaiser Permanente Southern California (KPSC) Fontana Family Medicine patients with a depression diagnosis recorded during the prior week (rolling basis).
* Target study enrollment: 150 participants per arm (300 total)
Recruitment:
* Kaiser Permanente (KP) will send eligible patients a postal letter inviting them to participate in study. Interested patients will be directed to the Enrollment/Assessment Website, a website to be developed by vendor Waypoint Health Innovations. The recruitment letter will contain (i) a description of the study, (ii) the web address for the Enrollment/Assessment Website, (iii) the patient's Study Identifier (ID).
* Additionally, KP will send eligible patients for whom KP has an email address an email inviting them to participate in the study.
Screening and Enrollment (Enrollment/Assessment Website):
* A patient interested in applying to the study will visit the Enrollment/Assessment Website and input his/her unique Study ID. The website will verify that the entered Study ID is on a pre-loaded list. If valid, the patient may continue to screening assessments.
* Patient will complete the 9-item Patient Health Questionnaire (PHQ-9) depression symptom assessment. Patients with eligible PHQ-9 scores may continue to Informed Consent page.
* The Informed Consent (IC) page will contain (i) the Informed Consent text including contact information for any questions patient may have; (ii) fields for first name, last name, date of birth, email address, and phone number; (iii) a check box labeled "I understand the above information and agree to participate..." (or similar); and (iv) a "submit" (or similar) button.
* To enroll in the study, the patient must complete all fields, check the box, and click submit button. The website will validate that every field has been completed and that the phone number and email fields have the correct format (e.g. [email protected] for the email field).
* If all fields are complete, the website will store the Study ID, first name, last name, date of birth, email address, and phone number that patient entered into the website. They will be stored in an encrypted database for use by researchers.
* Additionally, the website will store the complete Informed Consent page (including Informed Consent text, first name, last name, date of birth, email address, phone number, and checked box) in a single encrypted record, timestamp it, and place a digital certificate on it. The digital certificate will allow us to prove that no one tampered with any part of the IC document after the participant clicked submit.
* The website automatically randomizes participants to treatment or control arm. Participants continue in website to baseline assessments.
* After baseline assessments, control arm participants go to a page in the Enrollment/Assessment Website telling them to expect assessment again in 2 months, while treatment arm participants will be given instructions for enrolling in Thrive.
* Researchers would have access to the completed IC forms to print and/or mail to patients who request a copy.
* Weekly, KP research coordinator will review new participants' study ID, name, and date of birth (DOB) the participant entered to ensure they match KP records. Individuals who entered information that does not reasonably match KP records would be removed from the study.
Coaching:
• KP will send each treatment arm participant four emails encouraging them to use Thrive, with the exception that the second email will be replaced by a phone call from KP for patients who have not achieved a minimum level of activity in Thrive at that point.
Endpoint and Follow-up Assessments:
• KP will ask each study participant to visit Enrollment/Assessment Website 2 and 6 months after study enrollment to complete assessments.
|
Inclusion Criteria:
* Per EPIC (or other system) records, clinical depression was addressed during the prior week by a KPSC Fontana Family Medicine physician , reflected by an ICD-9 or ICD-10 diagnosis of Depression, Major Depressive Disorder, Dysthymia, Adjustment Disorder with Depressed Mood, and Depression Not Otherwise Specified. This does not have to be the patient's first depression diagnosis.
* Screening Patient Health Questionnaire (PHQ-9) score of ≥5 as measured in Assessment Website (see Section 4 for information on Assessment Website)
Exclusion Criteria:
* History or current diagnosis indicating any Schizophrenia spectrum or other psychotic disorder, any Neurocognitive disorder, Delirium, Bipolar disorder, Intellectual disability, or Personality disorder, or any active substance abuse, as defined by DSM-5
* Member is not proficient in English
* Member answered "more than half the days" or "nearly every day" on the Patient Health Questionnaire ninth item and did not subsequently answer (regarding suicidal ideations) "Yes" to the question "are you sure you can stay safe?"
|
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] |
NCT01221779
|
Chronic Aphasia - Improved by Intensive Training and Electrical Brain Stimulation
|
The purpose of this study is to determine if non-invasive electrical brain stimulation can enhance the out of intensive language therapy in chronic aphasia
|
Stroke is the leading cause of death and disability worldwide. Given the increasing average lifespan worldwide, the incidence and prevalence of patients with stroke will dramatically increase in the future. One of the most frequent and devastating conditions after stroke is aphasia, which affects language production and comprehension. High-frequent intensive speech-and-language therapy is currently the treatment of choice in chronic aphasia. However, despite its general effectiveness, treatment effect sizes are only low to moderate. Thus, there is a pressing need to explore novel training-adjuvant therapies to enhance treatment efficacy. Moreover, very little is known about the neurobiology of treatment-induced recovery in chronic aphasia. This is the prerequisite to improve existing and/or develop new treatment paradigms.
Thus, in the present project we aim to assess whether the outcome of intensive language training can be enhanced by adjuvant non-invasive brain stimulation. We will be using anodal transcranial direct current stimulation (atDCS) that has previously been shown to enhance (a) language and motor learning in healthy subjects and (b) motor recovery in stroke patients. Specifically, in a longitudinal group comparison design, two matched groups of patients with chronic anomia will receive two weeks of intensive language training with or without atDCS. Treatment effects will be assessed immediately after the two week intervention period and several months after the end of the training. We will also use functional and structural magnetic resonance imaging (MRI) to elucidate language network changes in the two groups.
|
Inclusion Criteria:
* right-handedness
* single first time left-hemisphere stroke
* fluent- or non-fluent chronic aphasia (more than six months post-stroke)
* anomia (PR\>10 and PR\<60 Aachen Aphasia Naming Subtest)
* native German Speaker
Exclusion Criteria:
* more than one stroke
* alcoholism, severe psychiatric conditions, other neurological conditions
* other non-treated medical problems, severe microangiopathy
* pregnancy
|
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] |
NCT06087731
|
Efficacy and Safety of Tocilizumab for TAO
|
This study aims to evaluate the efficacy and safety of tocilizumab treating Thyroid Associated Ophthalmopathy.
|
Thyroid Associated Ophthalmopathy(TAO) is one of autoimmune orbital diseases characterized by enlargement of the extraocular muscles and increase in fatty or/and orbit connective tissue volume affecting the appearance and visual function of the eyes. In TAO pathogenesis, orbital fibroblasts are activated by autoantibodies against the thyrotropin receptor TSHR and the insulin-like growth factor-1 receptor. The fibroblasts then secrete interleukin-6 (IL-6), macrophage chemoattractant protein-1, and transforming growth factor-ß. In orbital preadipocyte fibroblasts, IL-6 increases expression of the thyrotropin receptor TSHR, and the orbital volume is relative to IL-6 mRNA expression. Thus, IL-6 may have several roles in the pathogenesis of TAO. Tocilizumab, a recombinant humanized IgG1 monoclonal antibody against IL-6 receptors, is FDA-approved for the treatment of rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis with a good toleration. The investigators carry this perspective cohort study to evaluate the efficacy of tocilizumab in TAO.
|
Inclusion criteria:
Age 18-70 years old
* Clinical diagnosis of Thyroid-associated ophthalmopathy
* Euthyroid status at least 1 months before baseline.
* No previous specific therapy for TAO, except for local measures
* Written informed consent is obtained
Exclusion criteria:
* Uncontrolled diabetes or hypertension
* Renal or hepatic insufficiency.
* Infectious diseases (HIV, HBV,TB and so on)
* History of mental/psychiatric disorder
* Other ocular diseases or fundus diseases.
* Any previous systemic medications or surgery for the treatment of TAO
* Pregnant or lactating females.
* Intolerability of tocilizumab
|
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] |
NCT02236481
|
Clinical Study to Evaluate the Efficacy of Anakinra in Patients With Rheumatoid Arthritis and Diabetes
|
The TRACK \[Treatment of Rheumatoid Arthritis and Comorbidities with Kineret (anakinra)\]-study: a randomized, open-label multicenter study assessing the efficacy of anakinra in lowering HbA1c (glycated hemoglobin) as well as changes in DAS28 in Rheumatoid Arthritis (R.A.) patients with type 2 diabetes (T2D) Authors: R. Giacomelli,(A,B) P. Cipriani (A) and P. Ruscitti (A) on behalf of the TRACK study-group; (A) University of L'Aquila, L'Aquila, Italy; Background: Interleukin-1 (IL-1) plays a pivotal role in R.A., joint erosion and cartilage destruction.(1) Anakinra (a recombinant form of the naturally occurring IL-1 receptor antagonist (IL-1Ra), which blocks the activity of both IL-1α and IL-1β) has shown in a number of RCTs (2-6) to be effective in the treatment of R.A., in monotherapy,(2,4) as well as associated to methotrexate (MTX).(3,5,6) IL-1β plays also an important role in the pathogenesis of T2D: Glucose has been shown to induce IL-1β hypersecretion through inflammasome activation, while IL-1β induces impairment of β-cell secretory function and β-cell apoptosis.(7) In prediabetic subjects, the expression of IL-1Ra is induced by IL-1β and reflects the body's response to counterbalance increased IL-1β activity.(7) Levels of IL-1Ra tend to rise up to 6 years before the diagnosis of T2D.(8,9) IL-1Ra has been successfully used as a marker for the risk of developing T2D in subjects with metabolic syndrome.(10) As a clinical proof of concept, IL-1 inhibition with anakinra in patients with T2D has shown to improve the secretorial function of beta-cells as well as to lower the ratio of proinsulin/insulin and glycated hemoglobin/hemoglobin significantly, favoring glycemic control and possibly reducing the severity and prevalence of the associated complications of this disease.(11) Summarizing, IL-1 inhibition with anakinra has a clinical impact on R.A. as well as T2D. As from 6-10% of Italian R.A. patients have also T2D, this trial aims at investigating the impact of IL-1 inhibition on both diseases. Very recent data also show that T2D is a predictor of response to anakinra-treatment in R.A. patients,(12) which furthermore justifies the use of anakinra in this subset of R.A. patients. Objectives: \[Primary\] To evaluate the change in HbA1c between baseline, 3 months, 6 months, 1 year and at last follow up of 2 years from the beginning; \[Secondary\] To evaluate the efficacy on controlling signs \& symptoms of R.A., assessing the remission rate at 3 months, 6 months, 1 year and at follow up (2 years), using the evaluation scale of disease activity on 28 joints, DAS28 and SDAI improvements from baseline conditions over time points, according to EULAR response criteria. Methods: 200 patients in 28 Italian centers with active R.A. refractory to treatment with methotrexate and T2D will be enrolled and randomized to receive either 100mg of anakinra once daily by subcutaneous injection or any anti-TNF-alfa drug treatment. \[84 subjects will be required in each treatment arm to reach 90% power with an alpha error of 0.05 to detect a mean difference between the study arms of 0.25 percentage points of HbA1c . The assumed difference of HbA1c is rather conservative when compared to previously published changes in T2D patients (11).\] Anti-diabetic treatment is required to be unchanged for at least one month prior to enrolment. Patients will be invited to maintain dietary habits and lifestyle during the study period. Further details can be viewed on the trials website after subscription.(13) References: (1) Arend \& Dayer, Adv. Imm. 1993; 54: 167-227. (2) Bresnihan, Arthritis Rheum. 1998; 41: 2196-2204. (3) Cohen, Arthritis Rheum. 2002; 46: 614-624. (4) Nuki, Arthritis. Rheum. 2002; 46: 2838-2846. (5) Cohen, ARD 2004; 63: 1062-1068. (6) Cohen, Rheumatology 2004; 43: 704-711. (7) Donath, Nat. Rev. Immunol. 2011; 11: 98-107. (8) Herder, Diabetes Care 2009; 32: 421-423. (9) Carstensen, Diabetes 2010; 59: 1222-1227. (10) Luotola, J. Intern. Med. 2011; 269: 322-332. (11) Larsen, NEJM 2007; 356: 1517-1526. (12) Missler-Karger, EULAR 2013, Abs. FRI0219. (13) http://www.anakinra-ra-diabetes.org/ Disclosure: This trial is receiving support from Swedish Orphan Biovitrum AB according to the Italian law decree 17 December 2004. (B) speaker fees
|
Inclusion Criteria:
* male and female patients aged ≥ 18 years;
* previous diagnosis of RA with criteria of the American College of Rheumatology (ACR) / European League Against Rheumatism (EULAR);
* Diagnosis of Diabetes Mellitus type II according to the American Diabetes Association (ADA) criteria since at least 6 months;
* Patients with an inadequate response to previous treatment with methotrexate (determined on the basis of the evaluation of the physician);
* BMI \<35
* Glycated hemoglobin \> 7% \<10%
* Minimum score Disease Activity Score-28 (DAS 28) \> 3.2
* For patients previously treated with a biologic drug, wash out of the treatment for at least 1 month prior to enrollment;
* For patients in treatment with hypoglycemic drugs at enrollment, no change of the hypoglycemic treatment in terms of type of drug and dosage, for a period of at least 3 months before enrolment
* For patients in therapy with other drugs at baseline, no change in terms of drug administered and the dosage regimen for a period of at least 1 month prior to enrollment;
* Absence of signs and symptoms related to ischemic heart disease
* Signature of written Informed Consent Form.
Exclusion Criteria:
* DM2 diagnosed since more than 10 years;
* Ongoing Acute infection or chronic infection, which has one or more of following:
* Increased levels of C-reactive protein \> 30 mg / L
* fever
* Ongoing treatment with antibiotics ;
* Chronic granulomatous infections (ie. tuberculosis diagnosed by radiography or by laboratory tests)
* History of recurrent infections or presence of diseases that induce to infections;
* C-peptide values \<0.5 ng / mL ( 0.1665 nmol / L)
* presence of neutropenia ( WBC \< 2000/mm3 ) or anemia (hemoglobin \< 11g/dL for man and 10g/dl for the woman) ;
* presence of one or more contraindication indicate in SmPC of study drug (anakinra);
* presence of one or more contraindication indicate in SmPC of control drug (inhibitors of TNF -alpha ; ATC L04AB);
* presence of one or more contraindications to treatment with methotrexate ;
* previous ischemic attack or myocardial infarction;
* heart failure NYHA class III or IV;
* hepatic or progressive liver disease ( values of ALAT / ASAT increased by at least two -fold compared to normal limits );
* pregnant, or women not using contraceptive measures;
* breast-feeding;
* participation in another clinical study up to 6 months before randomization;
* depressive syndrome or other serious psychiatric illness that, in the opinion of the physician, may preclude participation in the study;
* presence of known malignancy ;
* Clinically significant history of alcohol abuse or drug addiction , that, in the opinion of the physician, may preclude participation in the study;
* any condition that, in the opinion of the physician, precludes the possibility of using the study drug (anakinra , Kineret ) or the control drug (inhibitors of TNF alpha; L04AB ATC ) in compliance with SmPC indications ;
* any other condition or laboratory parameter that , in the opinion of the physician, precludes the subject's participation in the study.
|
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|
NCT04552483
|
Effects of Early Use of Nitazoxanide in Patients With COVID-19
|
Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms.
Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.
|
SARITA-2 is a multicenter, randomized, placebo-controlled, parallel, -blinded, interventional, treatment clinical trial with two arms, which aims to study the impact of nitazoxanide in the early phase of the COVID-19 (Coronavirus Disease-19).
Experimental group: 196 patients received nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients received placebo 8/8 hours for 5 days.
Population: 392 Patients with COVID-19, confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease.
Calculation of the sample size was based on a previous study which demonstrated that 78% of Covid-19 patients in group 4 (Hospitalized without oxygen therapy), according to the WHO ordinal classification, experienced complete resolution of symptoms after receiving placebo.10 In the present trial, patients were classified as group 2 (Symptomatic and independent), and a greater degree of recovery as measured by symptom-free days (80%) was expected even after placebo. Thus, assuming an 11% increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo, we would need approximately 196 patients per experimental group, admitting a beta error of 15% and alpha error of 5%, for a total n of 392 patients. Calculation of the sample size was done by G\*Power 3.1.9.2 (Universität Düsseldorf, Düsseldorf, Germany).
|
Inclusion Criteria:
* Clinical scenario compatible with infection by the SARS-CoV-2 \[Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue)
* Beginning 1 to 3 days before inclusion in the study
* Age equal or superior to 18 years
* Willingness to receive study treatment
* Providing written and informed consent or the same consent signed by a family member
Exclusion Criteria:
* Negative result of RT-PCR for SARS-COV2 collected on admission
* Impossibility to use oral medications
* History of severe liver disease (Child Pugh C class)
* Previous renal failure
* Severe heart failure (NYHA 3 or 4)
* COPD (GOLD 3 and 4)
* Neoplasia in the last 5 years
* Known autoimmune disease
* Individuals with known hypersensitivity to study drug
* Previous treatment with the study medication during the last 30 days
* Clinical suspicion of tuberculosis and bacterial pneumonia
|
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] |
NCT04884724
|
Adaptive Dance Exercise Program on Trunk Control, Balance and Functional Mobility in Cerebral Palsy
|
The human body needs a system to control and coordinate its action plan in order to perform an effective action. This system works irregularly or inappropriately in people with Cerebral Palsy (CP). An alternative to controlling these disorders is automatic movement modulation such as dance. Dance, whose main purpose is to achieve a satisfying motor performance, increases motor learning with sensory, perceptual and emotional components. Although the effects of dance therapy on functionality, balance and participation in people with CP have been previously examined in the literature, it has been reported that the evidence is insufficient and more studies are needed. The aim of this study is to examine the effects of adaptive dance exercise program on trunk control, balance and functional mobility in children and adolescents with Cerebral Palsy.
|
Inclusion Criteria:
* Diagnosed with Cerebral Palsy
* Volunteer
* Ages between of 6-18 years
* Gross Motor Function Classification System (GMFCS) Level 1 and Level 2
* To have cognitive skills to understand and apply adaptive dance exercises to be given.
Exclusion Criteria:
* Participants diagnosed with Cerebral Palsy having cognitive disorders
* Participants diagnosed with Cerebral Palsy having vision or hearing problems
* Participants diagnosed with Cerebral Palsy have a history of trauma such as botox or muscle relaxation operation and / or fracture at least 6 months before participating in the study.
|
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] |
|
NCT06379867
|
A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects
|
Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects.
|
Inclusion Criteria:
1. Ability to understand and comply with protocol requirements and is willing voluntarily sign written ICF.
2. Healthy participants at age from 18 to 45 years old (inclusive) at Screening.
3. Male body weight ≥50 kg, female body weight ≥45 kg, with a body mass index BMI of 19\~28 kg/m2 (inclusive).
4. Left Ventricular Ejection Fraction (LVEF)≥50%.
Exclusion Criteria:
1. Past or present clinically significant systemic disease as judged by the Investigator including, but not limited to psychiatric, neurologic, pulmonary, respiratory, cardiac, gastrointestinal, genitourinary, renal, hepatic, metabolic, endocrinologic, hematological, or autoimmune disorders.
2. History of allergy to egg or egg products, soybean or soy products.
3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. History of allergy to HSK3486 or moxifloxacin or its investigational product excipients, or history of specific allergies (asthma, urticaria, eczema, etc.), or history of tendinitis or tendon rupture due to moxifloxacin or any other quinolone drug.
4. Clinically significant infection/injury/disease within 1 month prior to dosing.
5. Current or recent (\< 6 months from screening) hepatobiliary disease.
6. Current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
7. Family history of sudden death at \<50 years of age.
8. History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeats or palpitations, clinically significant head injury.
9. Pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, or conditions that could interfere with the absorption, metabolism, and/or excretion of study drug (e.g., history of bariatric surgery or intestinal bypass surgery; simple uncomplicated appendectomies and hernia repairs are allowed, but cholecystectomy is not allowed).
10. Positive test results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antigen/antibody combination test.
11. Subjects with previous or suspected difficult airway (e.g., modified Mallampti score III-IV, congenital microglossia, mandibular dysplasia), or respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea syndrome; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion or cough within 1 week prior to baseline.
12. Knowledge of any kind of cardiovascular disorder/condition/procedure known to increase the possibility of QT prolongation or history of risk factors for TdP (e.g., heart failure, hypokalemia, hypomagnesemia, congenital Long QT syndrome, or family history of Long QT Syndrome.
13. Laboratory tests at screening or baseline judged clinically significant by the investigator, including, but not limited to, ALT or AST \> 1.2 ×ULN (the upper limit of the reference range at screening or baseline), direct bilirubin \> ULN (congenital nonhemolytic hyperbilirubinemia \[e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable), creatine kinase (CK) \> ULN (one repeat test allowed), thyroid stimulating hormone (TSH) outside normal range (0.75 to 5.6 mIU/L) , serum potassium outside normal range (3.5 to 5.3 mmol/L).
14. Rest sitting vital sign results abnormal and clinically significant at screening or baseline, ear temperature outside normal range, diastolic blood pressure ≥ 90 mmHg or systolic blood pressure ≥ 140 mmHg, HR \< 55 beats/min or \> 100 beats/min (test can be repeated once according to investigator's judgment).
15. Oxygen saturation (SpO2) below 95% at baseline.
16. Abnormal 12-lead ECG at screening or baseline (any test abnormality), including any of the following:
1. QTcF \> 450 ms
2. QRS \> 110 ms
3. PR \> 200 ms
4. Second or third-degree AV block
5. Any rhythm other than sinus rhythm of clinical significance.
17. Estimated Glomerular Filtration Rate (eGFR) \< 90 mL/min (estimated using MDRD equation).
18. Participation in another clinical study of an investigational drug (or medical device) within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or previous participation in any other clinical trial related to HSK3486.
19. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening, platelets within 6 weeks prior to screening, or receive blood products within 2 months prior to admission to a the investigational site.
20. Sperm and egg donation program from screening period to 90 days after study end.
21. Pregnant or lactating women or those with positive pregnancy test results. Male or female subjects of childbearing potential do not agree to use an effective method of contraception from the time of signing ICF until 90 days after leaving the investigational site after the last dose (see Appendix 6 for details of specific contraceptive methods).
22. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing or during the clinical trial.
23. Use or intend to use of any prescription, nonprescription, vitamin, herbal, or nutraceutical within 14 days prior to dosing or during the clinical trial.
24. Smoking (≥ 5 cigarettes per day) within 6 months prior to screening, or inability to quit smoking during the trial.
25. Positive alcohol breath test, or regular drinking within 6 months prior to dosing or during the trial, i.e. drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit =360 mL beer or 45 mL spirits or 150 mL wine at 40% alcohol).
26. Positive urine drug abuse screening (morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine), or history of drug abuse, drug dependence within 6 months prior to screening, or drug use within 3 months prior to screening.
27. Subjects who tested positive for COVID-19 during screening.
28. Eating fruits or foods affecting metabolic enzymes, such as grapefruit (citrus), pomelo, etc., within 7 days prior to screening; and not abstaining from the above beverages, fruits or foods during the study period.
29. Previous chronic excessive consumption (more than 8 cups per day, 1 cup =250 mL) of tea, coffee or caffeinated beverages, or intake of caffeine and/or purine-rich foods or beverages (e.g. coffee, tea, chocolate, caffeinated carbonated beverages, cola, etc.) within 48 hours prior to screening, or refusal to stop drinking tea, coffee and/or caffeinated beverages during the trial.
30. Performing or unwilling to refrain from strenuous physical activity, which could cause muscle aches or injury, including contact sports, at any time from 3 days prior to dosing through the end-of-study visit.
31. Subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease).
32. Any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety or efficacy of the study drug according to the study protocol (e.g., poorly compliant subject, poorly vascular condition, allergies to medical plastics/latex).
|
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] |
|
NCT00412932
|
An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension
|
This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
|
Inclusion Criteria:
1. Males or Females greater than 65 years of age
2. Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
3. The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg.
4. Patients with a mean daytime (8am-4pm) systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than or equal to 199 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.
Exclusion Criteria:
1. History of stroke or transient ischemic attack (TIA) within the last one year.
2. History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
3. Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg).
4. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome.
5. Type I diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
7. Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
8. Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.
|
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|
NCT02236949
|
Sustainability of a Knowledge Translation Intervention to Improve Paediatric Pain
|
The purpose of this research study is to evaluate the effectiveness of short refresher sessions. "Pain Practice Change Boosters" given at regular intervals to sustain improved pain process (assessment and management) and clinical outcomes (pain intensity) achieved during a 15 month knowledge translation intervention, Evidence-based Practice for Improving Quality (EPIQ), in 8 children's hospitals in Canada; and to determine the factors that affect that sustainability. The CIHR Team in Children's Pain (2006-2011) evaluated the effectiveness of the EPIQ intervention in 32 hospital units (4 units at each hospital site). 16 hospital units were allocated to the intervention group and 16 units continued with standard care. The current study focuses on the 16 hospital units that implemented the EPIQ intervention only.
|
This is an 8 hospital repeated measures Randomized Controlled Trial design using a centrally controlled cluster random allocation of units with stratification by hospital. The sample consisted of the 16 hospital units that implemented the EPIQ intervention in the CIHR Team in Children's Pain study. Randomization was restricted so there was one intervention unit and one standard care unit at each site. Outcomes were measured at 3 time points:12 months after the completion of the EPIQ intervention: Baseline (Time 1); 12 months following the implementation of the Booster intervention (Time 2); and 36 months following the implementation of the Booster intervention (Time 3), including the frequency and proportion of children receiving pain assessment and management strategies, children's pain intensity during painful procedures, and health care professionals' perceptions of the context of sustainability.
|
Inclusion Criteria:
Hospitals met the following inclusion criteria in at least four patient care units:
* distinct geographic location and administrative structure;
* minimum of 15 beds per unit;
* care for children exposed to painful procedures for diagnostic or therapeutic purposes; and
* implementation of pharmacological and non-pharmacological interventions to manage pain.
The 16 participating hospital units had implemented the EPIQ intervention in the CIHR Team in Children's Pain study. Patients in the participating hospital units were eligible to be included in the determination of the pain practice and clinical outcomes if they:
* were between 32 weeks gestational age at birth and 18 years;
* received skin breaking procedures; and
* were admitted to the unit for \>24 hours.
Surveys used to determine factors influencing sustainability were administered to health care professionals in all participating units, who had at least 1 year of professional experience, had worked on the unit for at least 6 months, and spoke English or French.
|
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] |
NCT05739760
|
Impact of Cuddle and Calm Booklets on Parent-Child Emotional Connection a Nurture-based Children's Book
|
Children's social and emotional development is affected by their relationship with their parents. The goal of the study is to test an intervention that guides parents and children to strengthen their relational health and navigate difficult situations. This study will begin in the well-child visit in the pediatric department at MetroHealth Medical Center. Pediatricians will invite families to enroll in the study, then study personnel will administer two illustrated poem books called "Cuddle and Calm," a poetry book with tips on how to strengthen the parent-child relationship, or "Health and Safety," a poetry book with tips on how to avoid injuries. This intervention is based on the construct of emotional connection as studied by Martha G Welch MD, who developed the Welch Emotional Connection Screen (WECS) along with Amie Hane PhD. The WECS-Parent Report (WECS-PR) is a likert scale parent-report screen with items regarding the domains featured in the WECS.
|
The parent-child relationship affects the child's socio-emotional development and the parent's stress. The purpose of this study is to test a behavioral intervention designed to guide parents and children on how to strengthen their relational health and navigate challenging interactions. This intervention will involve a unique experience in the well-child visit in the pediatric department (either virtually or in-person) at Metrohealth Medical Center, in which pediatricians will invite families to participate in the study. Then, study personnel will administer either "Cuddle and Calm," an illustrated poetry book that feature tips on how to promote the relationship between parents and their children, or "Health and Safety," an illustrated poetry book that features tips on how to navigate risky injuries. The approach is based on the construct of emotional connection as studied by Dr. Martha Welch's Nurture Science Program of Columbia University Irving Medical Center. They developed the Welch Emotional Connection Screen (WECS), an assessment that allows parent-facing professionals to rate the emotional connection of a mother-child relationship in just a few minutes of observed interaction, and shows preliminary predictive properties when performed in the first year of life. The WECS-Parent Report (WECSPR) is a Likert-scale parent-report screen with items regarding the domains featured in the WECS. All consenting subjects will complete WECS-PR, a tantrum survey before and after administration of the booklets to determine the impact of the reading material.
|
Inclusion Criteria:
* Children between 18 months and 6 years old and their mothers or grandmothers, if primary caregiver, scheduled for a well visit.
Exclusion Criteria:
* Refusal to consent
* Inability to access internet; not having an email address.
|
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] |
NCT06420388
|
2% Lidocaine Gel in Reducing Postoperative Pain Following Haemorrhoidectomy
|
The study is a randomized, double-blind, controlled trial evaluating the efficacy of 2% lidocaine gel in reducing postoperative pain and analgesic consumption after haemorrhoidectomy. 222 patients undergoing Ferguson haemorrhoidectomy will be randomly assigned to receive either 2% lidocaine gel or a non-anaesthetic lubricant gel control. Pain scores using a visual analog scale (VAS) will be assessed at 12 and 24 hours, and 2, 3, and 7 days postoperatively. Analgesic consumption will also be measured.
|
Title: Efficacy of 2% Lidocaine Gel in Reducing Postoperative Pain and Analgesic Consumption Following Haemorrhoidectomy: A Randomized, Double-Blind, Controlled Trial Objective: To assess the effect of 2% lidocaine gel on postoperative pain intensity and analgesic consumption following haemorrhoidectomy.
Study Design: This study is a single-center, randomized, double-blind, controlled trial. Patients will be randomly assigned in a 1:1 ratio to receive either 2% lidocaine gel or a non-anaesthetic water-based lubricant gel (control) using a computer-generated randomization list. The randomization will be stratified by hemorrhoid grade (III or IV). The study medication will be prepared by the hospital pharmacy and provided in identical, pre-filled syringes to ensure blinding of participants and investigators.
Intervention: The intervention group will receive 5 mL of 2% lidocaine gel, while the control group will receive 5 mL of a non-anaesthetic water-based lubricant gel. The study medication will be applied to the perianal region three times per day for 7 days following surgery. Patients will be instructed on the proper application technique and will be provided with a diary to record the time and date of each application.
Outcome Assessment: Postoperative pain will be assessed using a 100 mm visual analog scale (VAS), with 0 representing no pain and 100 representing the worst imaginable pain. Pain scores will be recorded at 12 and 24 hours, and 2, 3, and 7 days after surgery. Patients will also record their analgesic consumption in a diary, including the type, dose, and frequency of analgesics used. Postoperative complications, such as bleeding, infection, or urinary retention, will be assessed by the treating surgeon at each follow-up visit.
Sample Size: A sample size of 222 patients (111 per group) was calculated based on a power of 80%, a significance level of 0.05, and an expected difference in mean VAS scores of 15 mm between the groups, with a standard deviation of 30 mm.
|
Inclusion Criteria:
* Age 18 years or older
* Diagnosed with Grade III or IV hemorrhoids
* Candidate for Ferguson haemorrhoidectomy
Exclusion Criteria:
* Not a candidate for Ferguson haemorrhoidectomy
* Recurrent hemorrhoidal disease
* Concurrent anal pathology diagnosed preoperatively, including:
* Anal fistula
* Anal fissure
* Anal polyp
* History of diabetes mellitus
* History of liver cirrhosis
* History of inflammatory bowel disease
* Documented neuropathy
* Coagulation disorders
* Currently on anticoagulants
* Documented allergy to any of the drugs included in the protocol
|
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] |
NCT01972061
|
Foot/Hand Neuromodulation for Overactive Bladder (OAB)
|
The purpose of this study is to determine if electrical stimulation of the foot is effective in the treatment of overactive bladder conditions.
|
Foot neuromodulation is designed to treat OAB conditions by electrically stimulating the somatic afferent nerves in the foot using skin surface electrodes. The foot stimulation is non-invasive, can be performed at home, and has no adverse effects. Foot neuromodulation therapy will likely be accepted by more patients and have the potential to make a broader impact on the improvement of OAB conditions.
|
Inclusion Criteria:
1. 18 year old men and women and older
2. Currently having overactive bladder (OAB) symptoms, i.e. urgency, frequency, or incontinence
3. No evidence of neurological disorder or urinary tract infection, i.e. clinically diagnosed as idiopathic OAB
Exclusion Criteria:
1. Pregnant women in their late pregnancy phase will be excluded because the increasing size of the baby/uterus may cause overactive bladder.
2. Patients with implanted electrical stimulators such as pacemaker will be excluded for potential interference with the TENS stimulator.
3. Patients who are allergic to Cipro or Bactrim will be excluded from the CMG study.
|
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] |
NCT06068881
|
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation
|
The purpose of this research study is to learn about the effectiveness and safety of the study drug, tazemetostat, in adults with relapsed/refractory follicular lymphoma whose tumours do not have an "EZH2 gain-of-function" genetic mutation. Follicular lymphoma is a blood cancer. It affects white blood cells called lymphocytes. White blood cells normally help to fight infections, but when you have follicular lymphoma, the blood cells can form tumours in your body. 'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2" mutation who have no satisfactory alternative treatment options.
This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2 gain-of-function" genetic mutation and who previously received therapies commonly used in the U.S. in your body.
'Relapsed/refractory' follicular lymphoma means the disease has either not improved or is getting worse (progressing) during or after previous treatment.
Tazemetostat already has approval in the United States for the treatment of adult patients with relapsed/refractory follicular lymphoma with or without the "EZH2 gain-of-function" mutation who have no satisfactory alternative treatment options. This study is being conducted to better understand the effectiveness in patients whose tumours do not have an "EZH2" genetic mutation and who previously received therapies commonly used in the U.S.
In this study, all participants will receive the study drug. It will be taken by mouth (orally), as a tablet, twice daily. The sizes and number of tumours according to scan results will be collected as well as results of safety tests (such as physical examinations and laboratory tests).
The study consists of 4 periods:
* Screening period may take up to 4 weeks and require at least 1 visit.
* Treatment period will require 2 visits for each of the first 2 months, followed by 1 visit every month for the remainder of the first 12 months, followed by 1 visit every 3 months (except for women of childbearing potential \[WOCBP\], who will continue to have a pregnancy testing every month) until unacceptable toxicity, disease progression, or the start of new systemic anticancer therapy, whichever is first.
* Safety follow-up period will last for 1 month after the last dose of tazemetostat, and it will end with 1 visit or telephone call.
* Long-term follow-up period is only for participants who stop taking tazemetostat while their disease continues to respond; this period will last until disease progression, start of new cancer treatment, or death from any cause, whichever is first, and will require a visit every 3 months.
Tazemetostat will be provided to participants who tolerate it for as long as their disease does not progress.
Participants may be transferred to another study or program after about 2 years for continued treatment with tazemetostat or for long-term follow-up. Patients may withdraw consent to participate at any time.
|
Inclusion Criteria:
* At least 18 years of age, inclusive, at the time of signing the informed consent form
* Histologically confirmed follicular lymphoma (FL) grades 1, 2, or 3A
* Previously treated with ≥1 prior systemic chemotherapy, immunotherapy, or chemo-immunotherapy consistent with those used in a US population, including but not limited to bendamustine, obinutuzumab, rituximab plus lenalidomide. Patients with only 1 prior line of therapy should not be eligible for available combination or monotherapies
* Documented relapsed, refractory, or progressive disease (PD) after treatment with systemic therapy (refractory defined as less than PR or as PD \<6 months after last dose)
* Measurable disease as defined by Lugano Classification
* Have provided sufficient tumour tissue block or unstained slides for EZH2 mutation and copy number gain (CNG) testing
* Wild-type EZH2 (ie, lacking GOF mutation). Note: If EZH2 GOF mutation status is known from site specific testing, WT patients can be enrolled with documentation of the testing, and additional archival tumour tissue or fresh lymph node biopsy taken before starting tazemetostat will be required for confirmatory testing of EZH2 GOF mutation status at study-specific laboratories. If EZH2 GOF mutation status is unknown, the results of central testing confirming wild-type (WT) EZH2 mutation status on an archival tumour sample, or a fresh lymph node biopsy is required before enrolment. (Archival tumour tissue collected within 15 months before the first dose is preferred, where feasible.)
* Eastern Cooperative Oncology Group (ECOG) performance status ≤2
* Adequate time between prior anticancer therapy and first dose of tazemetostat as follows:
* Cytotoxic chemotherapy: At least 21 days.
* Noncytotoxic chemotherapy (eg, small molecule inhibitor): At least 14 days.
* Monoclonal and/or bispecific antibodies or chimeric antigen receptor (CAR) T: At least 28 days.
* Radiotherapy: At least 6 weeks from prior radioisotope therapy; at least 12 weeks from 50% pelvic or total body irradiation.
* Adequate liver function, by all of the following criteria:
* Total bilirubin ≤1.5 × the upper limit of normal (ULN) except for unconjugated hyperbilirubinemia of Gilbert's syndrome.
* Alkaline phosphatase (ALP) (in the absence of bone disease), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) ≤3 × ULN (≤5 × ULN if the patient has liver metastases).
* Adequate renal function: Calculated creatinine clearance ≥30 mL/minute per the Cockcroft and Gault formula
* Adequate bone marrow function, by all of the following criteria:
* Absolute neutrophil count (ANC) ≥1000/mm3 (≥1.0 × 109/L) if no lymphoma infiltration of bone marrow OR ANC ≥750/mm3 (≥0.75 × 109/L) with bone marrow infiltration: Without growth factor support (filgrastim or pegfilgrastim) for at least 14 days.
* Platelets ≥75,000/mm3 (≥75 × 109/L), evaluated at least 7 days after last platelet transfusion.
* Haemoglobin ≥9.0 g/dL, though may receive transfusion
* Adequate coagulation, by both of the following criteria (NOTE: In patients with thromboembolism risk, prophylactic anticoagulation, or antiplatelet therapy at investigator discretion, is recommended):
* International normalized ratio (INR) ≤1.5 × ULN
* Activated partial thromboplastin time (aPTT) ≤1.5 × ULN (unless on warfarin, then INR ≤3.0).
* Women of childbearing potential (WOCBP) must have 2 negative pregnancy tests (beta-human chorionic gonadotropin \[β-hCG\] on-site urine or serum tests with a minimum sensitivity of 25 mIU/mL or equivalent units of β-hCG) during screening. The second of these screening pregnancy tests
Exclusion Criteria:
* Grade 3b FL, mixed histology FL, or FL that has histologically transformed to DLBCL.
* Malignancies other than FL.
* Any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or myeloproliferative neoplasm (MPN)
* Any prior history of T-cell lymphoblastic lymphoma (LBL)/T-cell acute lymphoblastic leukaemia (ALL)
* Major surgery within 4 weeks before the first dose of study intervention.
* Significant cardiovascular impairment.
* Prolongation of corrected QT interval using Fridericia's formula (QTcF) to ≥480 msec at screening or history of long QT syndrome
* Venous thrombosis or pulmonary embolism within 3 months before starting tazemetostat. Note: Patients with deep vein thrombosis/pulmonary embolism greater than 3 months before treatment are eligible but recommended to receive prophylaxis
* Uncontrolled active infection requiring systemic therapy
* Active viral infection with human immunodeficiency virus (HIV)
* History of hepatitis B or C, unless they have adequate liver function as defined by inclusion criteria and are hepatitis B surface antigen negative with undetectable hepatitis B virus (HBV) DNA and/or have undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) if HCV antibody positive
* History of solid organ transplant
* Prior exposure to tazemetostat or other inhibitor(s) of EZH2
* Taking medications that are known strong CYP3A inhibitors and strong or moderate CYP3A inducers (including St. John's wort)
* Pregnant or lactating/breastfeeding
|
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|
NCT06604000
|
Goal Management Training (GMT) for Improvement of Cognitive Control Function After Acquired Brain Injury
|
The goal of this clinical trial is to investigate predictors of treatment outcome, and the effect of individual treatment components of Goal Management Training (GMT) for improvement of cognitive control function in people with acquired brain injury (ABI).
Primary aim: To identify demographic, clinical and cognitive predictors of treatment response in Goal Management Training after acquired brain injury (ABI)?
Secondary aims: To investigate the effects of a) extended cuing (via a smartphone) and b) a booster module?
* All included participants will receive Goal Management Training in groups of 4-6 patients, as implemented in a rehabilitation hospital setting (St. Olavs Hospital, Trondheim University Hospital). The standard treatment ("GMT Usual") consists of 10 sessions, delivered as 2 sessions a day, one day per week, over 5 weeks.
* All participants will be asked to complete self-report measures and performance-based cognitive testing at baseline (T1), immediately after the main treatment period (T2), at 6 months (T3), and 1 year (T4) after treatment.
* After baseline assessment, 50% of participants will be randomized to receive extended cuing through a smartphone application ("GMT Cuing") - intended to facilitate the effect of between-session tasks (homework) completed by the participants. These participants will, in addition to the standard treatment, on a daily basis receive a message that says "STOP" as a reminder to do their home assignments.
* After completion of the 10 GMT sessions and the first post-treatment assessment immediately after the main treatment period, 50% of the participants will be randomized to receive an additional booster module ("GMT Boost") 3 months after the last ordinary GMT module - intended to facilitate a prolonged treatment response. The remaining 50% will receive no booster module ("GMT No Boost")
* Randomization will be carried out on treatment group-level (all patients in the same group receive the same treatment). The total anticipated sample size is N = 116 patients.
* The Global Executive Composite (GEC) score derived from BRIEF-A will be used as the primary outcome measure. A selection of other included measures will be used as secondary outcome measures.
|
The Global Executive Composite (GEC) score derived from BRIEF-A will be used as the primary outcome measure. A selection of other included measures will be used as secondary outcome measures. Data will be analyzed based on an intention-to-treat approach. Penalized linear regression by the elastic net approach (a combination of the Lasso and Ridge regression approaches) will be used to identify demographic, clinical and cognitive predictors of outcome at 6 months after treatment (T3), which is the primary aim of the study. For the secondary aim of investigating the differences in outcome for primary and secondary outcomes between "GMT Cuing" and "GMT Usual", and between "GMT Boost" and "GMT No Boost", linear mixed models (LMMs) will be used. Data for all time points will be included, but of primary interest are differences at T2 (immediately after treatment) for assessing the effect of cuing, and at T3 (6 months after treatment) for the effect of boosting. The LMMs can account for within-subject correlations due to repeated measurements. In addition, the investigators will perform exploratory moderation and mediation analyses across both treatment groups. For the penalized regression models, complete case analyses will be performed as long as the number of missing observations is small. Otherwise, imputation will be considered, but imputation is not straightforward for variable selection models. Linear mixed models can handle missing data for the outcome variable. Considering multiple testing linked to several secondary outcomes, p-values will be interpreted with care rather than using a formal p-value adjustment. Results will be interpreted according to the magnitude of the group difference (effect size) as well as the p-values. Data will be analyzed using IBM SPSS, STATA and R.
|
Inclusion Criteria:
* Patients aged 18-65 with acquired brain injury with no concomitant diseases minimum 12 months' post-injury/surgery, reporting cognitive control problems by structured interview or clinical performance measures.
Exclusion Criteria:
* Non-fluency in Norwegian Language
* Major psychiatric disorder or reported ongoing alcohol or substance abuse.
* Premorbid neurological disease or insult and/or comorbid neurological disease.
* Aphasia or other specified language problems causing potential communication problems.
* Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with training or estimated IQ \< 85
|
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] |
NCT00918671
|
Medication-overuse Headache: 4 Years Follow up
|
From 1 January 2004 to 31 December 2006 64 individuals with probable medication overuse headache were included in a randomized, 1-year open-labeled, multicentre study to evaluate the effect of early introduction of prophylactic treatment compared to abrupt withdrawal and with a control group (ClinicalTrials.gov number NCT00159588). In this follow-up, randomized patients still alive 4 years after primary inclusion time will be invited to a follow up interview, evaluating the headache complaints and the proportion of recurrent medication overuse.
|
The participants will be interviewed by telephone or consult the study doctor completing a headache diary for at least 1 month before attending the visit.
|
Inclusion Criteria:
* Randomized during the initial trial during 2004-2006.
|
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] |
NCT05501548
|
Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer
|
This is a study to evaluate the safety and clinical activity of the combination of olaparib and high-dose IV ascorbate, as second or later line of therapy, in castration resistant prostate cancer patients with no known DNA repair gene mutations (DDRm). In brief, the primary endpoint is PSA50 response , defined by a 50% reduction in PSA from baseline . The secondary endpoints are assessing the PSA doubling time, radiographic and PSA PFS, safety and tolerability as defined by the incidence of grade 3 to 5 toxicities, and measuring overall survival.
|
Inclusion Criteria:
* Have metastatic castration-resistant prostate cancer (prostate cancer progressing by PSA (rise by 25% on prior therapy) or imaging despite castrate levels of testosterone \[\<50 ng/dL\] using standard measures of progression defined by Prostate Cancer Working Group3)
* Have a minimum PSA of 1 ng/mL
* Have a pathological diagnosis of prostate carcinoma
* Patients should continue receiving continuous hormonal ablation with surgical or medical castration with baseline testosterone \<50ng/dL
* Patients may be receiving bone-targeted agents
* May have received multiple lines of therapy including radium 223, sipuleucel T, and up to 2 lines of chemotherapy (One of 2 lines may be for hormone sensitive metastatic prostate cancer or both can be for castration resistant).
* Age \>= 18
* Have ECOG performance status 0-1 (Appendix A)
* Be able to take oral medication and willing to consider a port for ease of administration of ascorbate
* Must have progressed on one systemic line of treatment (can include LHRH agonist/antagonist or orchiectomy and one additional line of therapy (abiraterone, enzalutamide, apalutamide, darolutamide, docetaxel, etc))
* Have normal organ and marrow function measured within 28 days prior to administration of study treatment as defined below:
* Absolute neutrophil count \>1.5 x 109/L
* Platelets ≥ 100,000/mm³
* Hemoglobin ≥ 9g/dL with no blood transfusion in the past 28 days
* Total bilirubin ≤ 1.5 ULN
* AST (SGOT)/ALT(SGPT) ≤ 2.5 x ULN (≤5x ULN if with known liver metastases provided bilirubin is normal
* Creatinine ≤ 1.6 x ULN (for patients with ≥1.6 x ULN, calculated or measured creatinine clearance must be ≥ 60 mL/minute (Cockcroft-Gault)
* Men of reproductive potential and those who are surgically sterilized (i.e. post- vasectomy) must agree to practice effective barrier contraception that has an expected failure rate of \<1% during and for 6 months after discontinuation of study treatment. Female partners should also use a highly effective form of contraception (\[see Appendix C for acceptable methods\]) if they are of childbearing potential.
* If condoms are used as a barrier contraceptive, a spermicidal agent should be added to ensure that pregnancy does not occur
* Have the ability to understand, and have given written informed consent before performance of any study-related procedures not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion Criteria:
* Have a known DNA repair mutation (minimum list of genes that must be mutation negative for inclusion: ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D, RAD45L). In addition, patients who have not completed germline and somatic testing to rule out such a mutation are ineligible until they have completed testing. If tissue or liquid ctDNA sequencing was not previously done, testing using the Foundation One liquid biopsy test or an equivalent FDA-approved test is acceptable as standard of care.
* DNA repair mutation variant of unknown significance (VUS) allowed
* Have had known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days.
* No prior olaparib, rucaparib, or other PARP inhibitor
* Have had major surgery within 2 weeks of dosing of investigational agent
* Have had palliative radiation or another biological cancer therapy within 2 weeks prior to the first dose of study drug (2 week wash out required)
* Patients receiving any systemic chemotherapy or radiotherapy within 3 weeks prior to study treatment
* Have received other investigational drugs within 14 days prior to enrollment.
* Is expected to require chemotherapy or radiation for pain palliation in the next 12 weeks.
* Have used or plan concomitant use of the following medications in the past 6 months prior to enrollment: 5-alpha reductase inhibitors unless subject has been taking stable dose of medication for prior 6 months
* Concomitant use of known strong CYP3A inhibitors (eg. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (eg. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting study treatment is 2 weeks. See the following link for a complete list of known CYP3A inhibitors: https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
* Concomitant use of known strong (eg. phenobarbital, enzalutamide, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort ) or moderate CYP3A inducers (eg. bosentan, efavirenz, modafinil). The required washout period prior to starting study treatment is 5 weeks for enzalutamide or phenobarbital and 3 weeks for other agents. See the following link for a complete list of known CYP3A inhibitors:https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and-drug-interactions-table-substrates-inhibitors-and-inducers
* Have moderate or severe cardiovascular disease:
* Has the presence of cardiac disease, including a myocardial infarction within six months prior to study entry, unstable angina pectoris, New York Heart Association Class III/IV congestive heart failure, or uncontrolled hypertension.
* Resting ECG indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg., unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QTc prolongation \>500 ms, electrolyte disturbances, etc.), or patients with congenital long QT syndrome.
* Have 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
* Other malignancy unless curatively treated with no evidence of disease for \>5 years except adequately treated non-melanoma skin cancer
* Persistent toxicities (\>Common Terminology Criteria for Adverse Event (CTCAE) grade 2) caused by previous cancer therapy, excluding alopecia
* Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
* Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on High Resolution Computed Tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
* Patients with known active hepatitis (i.e. Hepatitis B or C)
* Previous allogenic bone marrow transplant or double umbilical cord blood transplantation (dUCBT)
* Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
|
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] |
|
NCT06777082
|
Role of RPL8 Protein Alterations in High-grade Serous Ovarian Carcinoma
|
Background and rationale of the study:
From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreover, its mRNA expression is positively correlated with its genetic amplification-an observation not previously reported or studied in the literature. RPL8 is a structural component of the large ribosomal subunit, which is involved in protein synthesis. Based on this, and our preliminary data, we hypothesize that RPL8 amplification may play a role in ovarian cancer development. Understanding the impact of RPL8 amplification in ovarian cancer could provide new insights into the biology of this poorly understood cancer.
Study objectives:
The main objective of this project is to determine whether RPL8 can be used as a biomarker both for risk assessment and for patient stratification in choosing the most appropriate therapeutic option. Specifically, we aim to study:
1. The relationship between the genetic status of RPL8 and clinical outcomes.
2. The contribution of RPL8 amplification to treatment response.
Type of human tissue under study:
The analyses will be conducted on tumor tissue samples obtained from ovarian cancer resections. Some samples have already been collected and stored at the IRCCS, while others are yet to be gathered.
Type of investigation:
* Expression analysis of RPL8, C-MYC, and related genes (RT-PCR, ddPCR, WB, IHC).
* Gene copy number analysis and mutation screening (ddPCR and similar molecular techniques).
* Analysis of possible associations between pathological data, follow-up data, and therapeutic response outcomes in patients.
Analysis methodology:
Data on the genetic status, expression, and subcellular localization of RPL8 and C-MYC will be correlated with categorical and continuous variables related to the patients' medical history and clinical status. Differences between categorical variables will be analyzed using analysis of variance (ANOVA), the Mann-Whitney test, or the Kruskal-Wallis test, depending on whether data distribution is normal or not (assessed via the Kolmogorov-Smirnov test). Correlations between continuous variables will be evaluated using Pearson or Spearman tests, again based on data distribution.
|
Background and rationale of the study:
From our preliminary analyses of a dataset on patients with high-grade serous ovarian carcinoma (HGSOC), available in the online database The Cancer Genome Atlas, we found that the gene encoding ribosomal protein L8 (RPL8) is amplified at a high frequency (\~30%) in HGSOC. Moreover, its mRNA expression is positively correlated with its genetic amplification-an observation not previously reported or studied in the literature. RPL8 is a structural component of the large ribosomal subunit, which is involved in protein synthesis. Based on this, and our preliminary data, we hypothesize that RPL8 amplification may play a role in ovarian cancer development. Understanding the impact of RPL8 amplification in ovarian cancer could provide new insights into the biology of this poorly understood cancer.
Study objectives:
The main objective of this project is to determine whether RPL8 can be used as a biomarker both for risk assessment and for patient stratification in choosing the most appropriate therapeutic option. Specifically, we aim to study:
1. The relationship between the genetic status of RPL8 and clinical outcomes.
2. The contribution of RPL8 amplification to treatment response.
Type of human tissue under study:
The analyses will be conducted on tumor tissue samples obtained from ovarian cancer resections. Some samples have already been collected and stored at the IRCCS, while others are yet to be gathered.
Type of investigation:
* Expression analysis of RPL8, C-MYC, and related genes (RT-PCR, ddPCR, WB, IHC).
* Gene copy number analysis and mutation screening (ddPCR and similar molecular techniques).
* Analysis of possible associations between pathological data, follow-up data, and therapeutic response outcomes in patients.
Analysis methodology:
Data on the genetic status, expression, and subcellular localization of RPL8 and C-MYC will be correlated with categorical and continuous variables related to the patients' medical history and clinical status. Differences between categorical variables will be analyzed using analysis of variance (ANOVA), the Mann-Whitney test, or the Kruskal-Wallis test, depending on whether data distribution is normal or not (assessed via the Kolmogorov-Smirnov test). Correlations between continuous variables will be evaluated using Pearson or Spearman tests, again based on data distribution.
General characteristics of the study population:
Inclusion criteria:
* Age ≥ 18 years.
* Diagnosis of high-grade (3 or 4) serous ovarian carcinoma, either at onset or recurrence.
* Signed informed consent to participate in the study.
Exclusion criteria:
* Ovarian tumors of histological types other than serous.
* Other primary tumor types.
Study Design retrospective (on archival material) + prospective
|
Inclusion Criteria:
* Age ≥ 18 years.
* Diagnosis of high-grade (3 or 4) serous ovarian carcinoma, either at onset or recurrence.
* Signed informed consent to participate in the study.
Exclusion Criteria:
* Ovarian tumors of histological types other than serous.
* Other primary tumor types.
|
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] |
NCT04086901
|
Dose Escalated Adaptive RadioTherapy in Definitive Chemo-radiotherapy for Esophageal Cancer
|
In Denmark, 1000 new cases of esophageal and gastro-esophageal junction cancer occur every year. Surgery is the primary treatment for patients with localized disease who are considered medically and technically operable. For patients deemed non-resectable, definitive chemoradiotherapy is the treatment of choice, but despite treatment with curative intent, these patients have a poor prognosis, with a median survival of less than 20 months and a 5-year survival at 15-25% in clinical studies
This study will examine the effect of escalation of increasing the radiation dose to the most Positron Emissions Tomografi (PET) avid part of the tumour and lymph nodes compared to a standard uniform dose distribution.
|
In Denmark, there are almost 900 new cases of oesphageal and gastro-esophageal junction (GEJ) cancer per year, with a 5-year survival rate below 20% for the entire group and a 5-year survival rate of approximately 40% for the curatively treated patients.
Surgery is the primary treatment for patients with localized disease who are considered medically and technically operable. For patients deemed non-resectable, definitive chemoradiotherapy is the treatment of choice, but despite treatment with curative intent, these patients have a poor prognosis, with a median survival of less than 20 months and a 5-year survival at 15-25% in clinical studies.
Survival is affected by several factors like stage, gender and comorbidity, but also by lack of local and regional tumour control. Several studies examined pattern of failure in patients with oesophageal cancer treated with definitive chemoradiotherapy. Most patients experience local failure, and most local failures were located in the Gross Tumor volume (GTV). These findings imply that future therapeutic strategies should focus on improving local control in order to increase successful treatment outcome, although care should be taken to ensure that this does not come at the cost of excess treatment related toxicity.
Strategies to overcome in-GTV failures include radiotherapy-sensitizing agents and dose escalation, the latter has been evaluated in several studies with heterogeneous results.
The role of Positron Emissions Tomografi/ComputerTomografi (PET/CT) in radiotherapy planning has been examined and the diagnostic value of PET/CT in oesophageal cancer is widely accepted, whereas the role in assessing tumour response to treatment is less well established. Flour-Deoxy-Glucose (FDG)-PET scans allow for measurement of changes in tumour cell metabolism that precede changes in tumour size, and reduction in FDG uptake during neoadjuvant therapy has been correlated with favourable outcomes in patients with oesophageal cancer.
PET-positive areas have been suggested as suitable targets for dose-escalation strategies, since studies suggested that high FDG uptake on pre-treatment PET/CT identifies tumour sub-volumes that are at greater risk of recurrence after chemoradiotherapy in patients with locally advanced oesophageal cancer.
The major concern in a dose escalation study is severe and potentially lethal normal tissue complications. Oesophageal cancer irradiation usually results in irradiation of the oesophagus, lungs and heart due to the anatomical tumour location, which may result in acute toxicities dominated by radiation pneumonitis and esophagitis (leading to inappropriate nutricial intake). Late toxicities include oesophageal fistula/ulcers, cardiac events, pulmonary fibrosis, or even deaths related to radiation exposure. Dose gradients between the target and normal tissue may be sharp, in order to limit the norml tissue dose and hence the risk of unacceptable toxicity, while maintaining high doses to the tumour.
Current study Previous studies have suggested that escalating the radiation dose to the GTV may provide improved local control, but requires great caution in relation to normal tissue irradiation to avoid unacceptable side effects. The investigators propose a study approach where both requirements will be met. FDG-PET scans will be used to identify and delineate the tumour sub-volumes with the highest tracer uptake to guide the dose-escalation. The dose to the GTV will be escalated to a high dose (63Gray (Gy) in the FDG-PET avid areas in the primary tumour and 60 Gy in the lymph nodes) while Clinical target volume (CTV) and Planning target volume (PTV) will be treated with standard dose. The patients will be randomized between this dose-escalated arm and a standard arm with 50Gy in 25 fractions. The total number of fractions will be 25 in both arms. Dose escalation will be limited by normal tissues constraints.
The study will be conducted with modern state-of-the-art radiotherapy techniques, including advanced dose calculation algorithms, daily image guidance, and adaptation of the treatment plan during treatment if needed. The participating centres must implement and comply with a quality assurance program in order to maintain high treatment quality in the study.
|
Inclusion Criteria:
The patients must meet all of the following inclusion criteria to be included in the study:
* Patients with histologically verified squamous cell or adenocarcinoma (including signet cell carcinoma) of the oesophagus or GEJ.
* Multi-Disciplinary Team (MDT) assessment and treatment recommendation; deemed nonresectable and/or inoperable.
* TNM stage (8th edition): cT1-4a or cN+, cM0-1 (M1 disease limited to metastatic lymph nodes)
* Age ≥18 years.
* Performance status ≤2.
* Adequate cardiac, lung and renal function measured according to local guidelines.
* Adequate laboratory findings:
* haematological: haemoglobin \> 90 g/L, absolute neutrophil count (ANC) ≥ 1,5 x 109/L, platelets ≥ 75 x 109/L
* hepatic: bilirubin ≤ 1.5 x ULN, ALAT ≤ 3 x ULN
* renal: creatinine ≤ 1.5 x ULN
* Suitability to undergo curatively intended chemoradiation therapy.
* Ability to adhere to procedures for study and follow-up.
* Women must present a negative pregnancy test. Fertile men and women must use effective contraception. Fertile women included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after.
* Signed informed consent to participate in the study, including acceptance that dose plan and scans will be stored in a national dose plan bank, and the remaining data stored in a central database.
* A standard plan for radiotherapy with homogenous 50 Gy / 25 fractions, meeting all dose constraints for normal tissue, must be achievable.
Exclusion Criteria:
Patients who will meet one or more of the following exclusion criteria cannot be included in this study:
* Prior oncological treatment or surgical resection for the present disease
* Broncho-pulmonary fistula verified by bronchoscopy
* Any other active malignancies which may compromise study protocol or endpoints except for basal or squamous cell skin cancer
* Any unstable systemic disease (including clinically significant cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease)
* Symptomatic peripheral neuropathy greater than grade 1 (CTCAE version 4.03)
* Any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial
* Severely decreased lung function
|
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] |
NCT04168775
|
Peak Inspiratory Flow Rates in Patients With COPD
|
Recent studies have reported that some Chronic Obstructive Pulmonary Disease (COPD) patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaken to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, Patient-Reported Outcomes (PRO), body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation.
|
Recent studies have reported that some COPD patients may have a suboptimal ability to generate a sufficient inspiratory effort to achieve adequate lung delivery of inhaled medications through dry powder inhalers. Sparse data is available about the inspiratory capacity of these patients in the home setting, whether clinically stable or when experiencing worsened respiratory symptoms outside the acute care setting. This study is undertaking this study to better understand the proportion of patients with suboptimal peak inspiratory flow rate (sPIFR) measurements amongst COPD patients receiving dry powder inhaler(s) (DPI) in the ambulatory setting. Further, the study will characterize PIFR over time, the variability of PIFR measurements, and the associations with potential predictors (demographics, clinical, PRO, body position, and device) as well as exacerbations frequency and change in PIFR around period of exacerbation. To complete these aims, 120 participants will be enrolled in a 6 month study to perform PIFR measurements and respiratory questionnaires at home.
|
Inclusion Criteria:
* Age \> 50 years-old
* Spirometry-confirmed diagnosis of COPD (FEV1/FVC \<0.70)
* Global initiative for Chronic Obstructive Lung Disease (GOLD) II-IV based on spirometry results
* COPD Assessment Test (CAT) score \> 10
* For high resistance DPI, baseline PIFR \< 90 L/min (InCheck DIAL®) and \>=30 L/min; for medium resistance DPI, PIFR ≤ 90 L/min (InCheck DIAL®) and \>=60 L/min. Handihaler is a high resistance DPI. Examples of medium resistance DPI: Anoro, Incruse, Breo Ellipta®, Advair® Diskus® DP or Wixela® Inhub®
* History of smoking tobacco products \> 10 pack years
* Prescribed at least one daily maintenance DPI with no change in prescription within the four weeks prior to the Enrollment Visit
* One or more exacerbations of COPD requiring systemic corticosteroids within last 2 years
Exclusion Criteria:
* Inability to demonstrate proper technique for the InCheck DIAL® device
* Inability to achieve minimum PIFR for prescribed DPI(s) at screening/enrollment visit (\< 30 L/min for e.g., Handihaler® (High resistance DPI), \< 60 L/min for Ellipta® (Medium resistance DPI))
* Inability to perform spirometry to meet American Thoracic Society standards
* Neuromuscular disease associated with weakness
* Any condition that, in the opinion of the site investigator, would compromise the subject's ability to participate in the study.
* Pneumothorax within the past 4 weeks
* For those participants who will require spirometry (i.e., if they have not had it within the past 3 months): Participants who present with a myocardial infarction or eye, chest or abdominal surgery within six weeks of baseline can be rescreened after the six week window has passed
|
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] |
NCT01927978
|
Using "PET Response Criteria in Solid Tumors (PERCIST)" in Evaluating Response to Neoadjuvant Chemoradiotherpy for Esophageal Cancer
|
This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Purpose:
1. The incremental staging information by using 18F-FDG PET
2. The impact of the PET results on the patients' subsequent therapy planning
3. To compare treatment response using RECIST criteria and FDG PET results.
|
Background: Esophageal cancer is one of the leading malignancies in Taiwan. Accuracy tumor staging can direct to appropriate therapy planning and provide prognostic implications. Positron emission tomography (PET) with \[18F\]-fluoro-2-deoxy-D-glucose (FDG) has been shown to have better N staging and prognostic stratification abilities than conventional imaging modalities, such as endoscopic ultrasonography (EUS) and CT.
Purpose: This study is aimed to evaluate the effectiveness of 18F-FDG PET in the initial staging, therapy planning, and therapeutic response monitoring for esophageal cancer patients.
Method: Patients with pathological proven esophageal cancer, age 20-90 year-old, will be included in this study. Each patient will receive a baseline PET study. For those patients who received pre-operative CCRT, another PET will be performed 1-4 weeks after completion of CCRT.
Primary outcome: 1. The incremental staging information by using 18F-FDG PET 2. The impact of the PET results on the patients' subsequent therapy planning 3. To compare treatment response using RECIST criteria and FDG PET results.
Secondary outcome: To correlate the PET response rate and the patients' disease free survival and overall survival.
|
Inclusion Criteria:
1. Age：20-90 years old
2. Histological proved esophageal cancer
3. ECOG performance status 0-2
4. written informed consent signed
Exclusion Criteria:
1. prior chemotherapy or treatment for other systemic anti-cancer agent(s)
2. pregnant or intend to be pregnant
3. other malignancies known
4. other concurrent cancer treatment
|
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] |
NCT03300362
|
Improved Novel VaccIne CombinaTion InflUenza Study
|
A Phase IIb randomised, participant-blinded, placebo-controlled, multi-centre phase IIb efficacy study in 2030 volunteers aged 65 and over. The study will assess the safety and efficacy of the co-administration of a viral vectored vaccine, MVA- NP+M1, and the annual recommended licensed inactivated influenza vaccine (IIV). Within the main cohort 100 participants will be recruited to an immunology sub-cohort.
|
The efficacy of current seasonal influenza vaccines is limited in the face of antigenic mismatch between circulating viral strains and those in the given vaccine. Additionally vaccination in older adults, a major target group for vaccination, prevents laboratory-confirmed influenza in only 30-40% compared to 70-90% in young adults. The hypothesis in this Phase IIb efficacy study is that a new vaccine MVA-NP+M1 with licensed inactivated influenza vaccine (IIV) in the older age group will be able to induce immune responses that protect individuals against influenza illness, severity of symptoms and reduce viral shedding, thereby increasing the protection conferred by seasonal influenza vaccine alone. A total of 2030 participants who are 65 years of age or over and eligible for annual seasonal influenza vaccination and provide informed consent will be recruited to the study. Potential volunteers will be mailed an invitation to take part by their GPs or recruited by local advertisements. Participants will be randomised to receive either MVA- NP+M1 with licensed IIV or saline placebo with licensed IIV. In the first 28 days after vaccination, participants will record adverse events using an electronic or paper diary. The participants will be contacted by telephone 1 day and 7 days post-vaccination to enquire about any serious adverse events and support follow up. During influenza season participants will record weekly whether or not they have had an influenza like illness (ILI). For every ILI episode experienced, the participants will record the severity of their symptoms daily. Among the participants, a total of 100 volunteers (50 in each group) will be recruited into an immunology sub-cohort. They will have blood samples collected on the day of vaccination, 1 week, 3 weeks and 26 weeks post-vaccination for monitoring of laboratory adverse events and immunogenicity purposes.
|
Inclusion Criteria:
* Volunteer is willing and has capacity to provide written informed consent for participation in the trial (in the Investigator's opinion).
* Male or female adults, aged 65 years and above
* Able and willing (in the Investigator's opinion) to comply with all study requirements
* Willing to allow the investigators to discuss the volunteer's medical history with their General Practitioner
* Eligible to receive seasonal influenza vaccine
Exclusion Criteria:
* Any history of anaphylaxis in reaction to vaccination or history of allergic reactions likely to be exacerbated by any component of the vaccine (e.g. egg allergy)
* Ongoing terminal illness with a life expectancy estimated to be approximately \<6 months.
* Continuous use of oral anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)
* Any other significant disease, disorder or finding (including blood test results), which, in the opinion of the Investigators, would either put the volunteer at risk because of participation in the study, or may influence the result of the study
* Participation in another clinical trial of an investigational medicinal product in the 30 days preceding enrolment, or planned use during the study period
* Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data
* Receipt of annual seasonal influenza vaccine prior to enrolment (for the same influenza season volunteers are recruited in)
* Not willing to comply with study procedures
|
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] |
NCT02927730
|
The Correlation Between Clinical Diagnosis of Retained Placenta And Histology
|
The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology. Secondly, to assess different clinical parameters that are likely related to accuracy of the diagnosis of RPOC
|
Background:
Retained products of conception (RPOC) are a common and treatable complication after delivery or termination of pregnancy. The reported incidence in the literature is around 1% of all pregnancies. Most often, diagnoses are made on clinical basis and there is only scarce information available related to the correlation between the clinical and pathological diagnosis of RPOC. The gold standard for diagnosis of RPOC is based on histopathological confirmation of chorionic villi in tissue derived from the uterus. Once RPOC is diagnosed on a clinical basis, several treatment options are available, including expectant management, pharmacological treatment, and surgical interventions. Given the risks associated with surgical interventions, accurate diagnosis is vital. Guidelines at Maccabi Health Care Organization mandate that hysteroscopic removal of suspected RPOC should be performed only after approval by a Gynecological Surgical Preauthorization committee. Based on the activity of this committee and starting 2011, Maccabi has developed a database on certain gynecologic-surgical procedures including hysteroscopic removal of suspected RPOC.
Purpose of the study:
The main purpose is to evaluate the correlation in qualitative and quantitative manner between clinical diagnosis of retained placenta and histology.
Expected results:
70% correlation between the clinical and pathological diagnosis of RPOC.
Methods:
Establishing a dedicated database which includes demographic, clinical and histological data of women who have undergone hysteroscopic removal of suspected RPOC and statistical assessment of correlations.
Significance:
Determination of the correlation between clinical suspicion and histological diagnosis of retained placental tissue Finding clinical parameters that may increase the accuracy of this diagnosis and will help to prevent unnecessary procedures.
|
Inclusion Criteria:
* Women who diagnosed clinically with RPOC
* women who prefomed therapeutic hysteroscopy under the diagnosis of RPOC
Exclusion Criteria:
* Women who underwent hysteroscopy presumptive diagnosis of RPOC without documentation of pathological results were excluded.
* Women who have not performed / recorded sonography test before the hysterocpy.
|
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] |
NCT04400890
|
Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
|
Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.
|
This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.
200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.
|
Inclusion Criteria:
* Outpatients who test positive for infection with SARS-CoV-2.
* Age ≥45 years
* Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
* Symptom duration ≤ 10 days, or \<72 hours of new respiratory symptoms.
* Patient must have access to the internet or a smartphone to complete surveys.
* English-speaking patients
Exclusion Criteria:
* Diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician
* Asymptomatic patients (e.g. patients who were screened without symptoms but tested positive)
* Known or suspected liver disease or Hepatitis C
* Known kidney disease with estimate Glomerular Filtration Rate (eGFR) \<60
* Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window.
* Allergy to grapes or rice.
* Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF))
* Currently pregnant
* Hospitalization
|
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] |
NCT00415948
|
Myeloperoxidase and Multi-Markers In the Diagnosis of Diagnoses of Acute Coronary Syndrome (MIDAS) - Sample Procurement
|
The purpose of the study is to procure blood samples from patients who present to the Emergency Department with suspected ACS (Acute Coronary Syndrome).
|
This is a prospective, multi-center, observational, and sample procurement study of adult subjects presenting to an Emergency Department (ED) in whom ACS is in the differential diagnosis. Subjects must present to one of the participating EDs within 6 hours or less from the time of symptom onset, and must have experienced at least 30 minutes of chest discomfort. Those ED patients with possible ACS who meet the inclusion/exclusion criteria will be approached for study enrollment by trained research personnel.
The patient's diagnostic work-up and treatment will continue per the standards of the treating institution. As indicated by their clinical presentation, all subjects in the study will have objective cardiac testing for evidence of coronary artery disease (CAD) during or in close proximity to the index ED visit or hospital admission. For this study, objective cardiac testing will consist of one of the following tests: exercise treadmill, coronary angiography, myocardial stress imaging, stress magnetic resonance imaging (MRI), sestamibi scan, or dobutamine echocardiogram. Cardiac events and procedures, such as angioplasty-stenting and coronary artery bypass surgery (CABG), will be recorded during the index ED visit, hospitalization and post-hospital follow-up period. Subjects will have a 30-day and 6-month follow-up contact by phone to collect this information on cardiac events, procedures, and survival.
|
Inclusion Criteria:
* Age 18 years or older at time of enrollment
* Patient presenting to the ED within 6 hours or less from symptom (chest discomfort consistent with possible ACS) onset
* Patient experiencing at least 30 minutes of chest discomfort, consistent with possible ACS, from time of symptom onset; patients who have symptoms of shorter duration due to pharmacologic intervention may be included
* Physician plans to perform objective cardiac testing as defined by the protocol
Exclusion Criteria:
* Patient (or legal representative) unable or unwilling to provide informed consent
* Patient (or legal representative) refusal of medical record review or telephone follow-up at 30 days or 6 months
* Patient (or legal representative) refusal of multiple blood sample collection over the study period
* Prisoners or other institutionalized individuals
|
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] |
NCT05801861
|
Modulating Goal-directed Navigation Using Noninvasive Brain Stimulation
|
Our specific aim is to examine the effects of TMS on spatial processing during goal-directed navigation. In these experiments the investigators will utilize a scalp-recorded brain oscillation called right posterior theta that is believed to index the sensitivity of the parahippocampal cortex to spatial context. Here the investigators will asked whether this electrophysiological signal can be modulated up or down using TMS while participants engage in virtual navigation tasks, and if so, whether it would affect the spatial encoding of rewards and subsequent choices during task performance.
|
The design is primarily a randomized control-trial design (3 sessions), testing the effects of 10-Hz rTMS and single-pulse TMS on spatial processing during goal-directed navigation tasks. Subjects will be randomly assigned to an active or sham group. All participants will be asked to complete two TMS sessions within two weeks. For the active TMS group, participants will be scanned using a 3 Tesla MRI system and will receive a structural (T1) and diffusion-weighted imaging (DWI) scan (Session A). For each subsequent TMS session, the TMS coil will be placed 1cm above the scalp over a right parietal region displaying maximum connectivity patterns with the parahippocampal cortex. Subjects will be randomly assigned to a 10-Hz rTMS protocol or single-pulse TMS protocol. At the start of the first TMS session (Session B), participants will be fitted with an EEG cap and engage in a virtual T-maze reward task. In this task, subjects will be asked to choose the left or right alley of the maze, and after their response, they will received a reward stimulus (apple or orange) which will indicate whether the participant will receive 5 or 0 cents on that trial. For the 10-Hz group, the task will be divided into 2 blocks (225 trials per block). At the start of Block 1, the robotic arm will position the TMS coil \<1 cm over the right parietal target. Next, 50 rTMS pulses will be delivered at 110% of participants' rMT at 10-Hz continuously over the target immediately before every 10 trials of the T-maze. A total of 2250 pulses will be delivered and 450 T-maze trials completed. For the single-pulse group, the T-maze task will be divided into 2 blocks (225 trials per block). For the first block, a single TMS pulse will be delivered at 110% of participants' rMT over the TMS target immediately following trial-to-trial feedback and at the peak phase of the evoked theta oscillations (closed-loop). Following 10 trials of single-pulse, subjects will complete 5 trials with no TMS (total 150 TMS trials, 75 no-TMS trials). For the second block, a single TMS pulse will be delivered over the TMS target immediately following trial-to-trial feedback and at the trough phase of the evoked theta oscillation (peak and trough order will be counterbalanced across subjects). Following 10 trials of single-pulse, subjects will complete 5 trials with no TMS (total 150 TMS trials, 75 no-TMS trials). A total of 300 TMS trials and 150 no-TMS trials of the T-maze task will be performed. At the end of Session B, participants will be scheduled to return to the laboratory to complete Session C on a separate day. At the start of the second TMS session (Session C), participants will be fitted with an EEG cap and engage in the Linear Track Maze. During the encoding phase of this task, subjects will be presented with five distinct landmarks (pillars) along the track. Each time they reach a landmark, they stop for 500 ms and an apple (a reward, 5 cents) or an orange (no reward, 0 cents) appears. Only one landmark is associated with a reward. Following the encoding phase, the recall phase starts and subjects are shown both old and new landmarks. Subjects are instructed to indicate via button press which of these pillars was accompanied by a reward and earn the reward by correctly identifying the reward pillar. Recall performance will be assessed using d-prime, which represents how well subjects were able to recall the correct reward location. In total, subjects perform 200 trials across four blocks (50 trials each), resulting in a duration of roughly 30 minutes. For each block of the encoding phase, a single TMS pulses will be delivered at either at the peak, trough, ascending, descending phase of the evoked theta oscillation following the onset of the reward stimulus. (phase target order will be counterbalanced across blocks and subjects). The investigators will then test the effect of phase stimulation on recall performance as assed using d-prime. Identical protocols will be applied to the Sham groups with the exception that the TMS coil will be targeted at electrode position P4 and flipped 180 degrees, preventing pulses from hitting the scalp.
|
Inclusion Criteria:
1. Be between the ages of 18 and 55 years old.
2. Not received substance abuse treatment within the previous 30 days.
3. Be in stable mental and physical health.
4. If female, test non-pregnant.
5. No evidence of focal or diffuse brain lesion on MRI.
6. Be willing to provide informed consent.
7. Be able to comply with protocol requirements and likely to complete all study procedures.
Exclusion Criteria:
1. Contraindication to MRI (e.g., presence of metal in the skull, orbits or intracranial cavity, claustrophobia).
2. Contraindication to rTMS (history of neurological disorder or seizure, increased intracranial pressure, brain surgery, or head trauma with loss of consciousness for \> 15 minutes, implanted electronic device, metal in the head, or pregnancy).
3. History of autoimmune, endocrine, viral, or vascular disorder affecting the brain.
4. History or MRI evidence of neurological disorder that would lead to local or diffuse brain lesions or significant physical impairment.
5. Life time history of mental disorders such as: Bipolar Affective disorder (BPAD), Schizophrenia, Post-traumatic Stress disorder (PTSD) or Dementia or Major Depression.
uninterruptable central nervous system medication.
|
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] |
NCT03285373
|
This Study Observes the Use of New Oral Anticoagulants (NOACs) in Patients With a Heart Rhythm Disorder in Spain
|
The primary objective of the study is to describe the usage of NOACs in patients with NVAF, in the hospital setting, based on the baseline characteristics at the time of first NOAC initiation.
|
Inclusion Criteria:
* The patient is willing and provides written informed consent to participate in this study
* The patient is at least 18 years of age
* The patient has a diagnosis of non-valvular atrial fibrillation (NVAF)
* The patient is on treatment with NOAC according to its approved local SmPC and has initiated his first NOAC starting from November 2016
Exclusion Criteria:
-if the current participating patient participate in any clinical trial of a drug or device will be excluded
|
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] |
|
NCT05558007
|
Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients
|
To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.
|
Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.
The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction.
BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function).
Thus, this study aims to evaluate efficacy, safety and tolerabilty of BZ371A on the recovery of erectile function of patients that were underwent Radical Prostatectomy.
|
Inclusion Criteria:
1. Men between the ages of 40 and 65 years;
2. Exclusive heterosexual men, regardless of race or social class.
3. RP due to prostate cancer without metastasis;
4. RP performed less than 60 days before the screening visit;
5. Erectile function prior to normal RP, defined as IIEF questionnaire with more than 22 points in domain A;
6. Stable sexual partner (more than 2 months prior to RP), and intention to maintain the relationship during the study.
7. Continuous use of 5mg Tadalafil from the 30th up to the 60th day after RP.
Exclusion Criteria:
1. Prostate cancer in TNM stage classified as T3 or T4.
2. Perineal and/or open RP;
3. Necessity of other therapy for prostate cancer than RP, including radiation therapy or hormone therapy;
4. Uncontrolled diabetes at screening visit (HbA1C \> 10%);
5. Prior spinal cord injury with lower limb paralysis;
6. Current male hormone use, or hypogonadism, defined by total testosterone below 8 nmol/L (2300 pg/mL) or total testosterone between 8 and 11 nmol/L (2300 and 3170 pg/mL) and free testosterone \< 220 pmol/L (\< 64 ng/dL);
7. Patients with current depression, characterized by use or need for use of antidepressants.
8. Presence of genital lesions (such as severe penile fibrosis or Peyronie's disease) or active sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, HPV, and others) that impair analysis of local adverse effects on the genitalia;
9. Use of topical medications in the genital region that may interfere in the IP evaluation, as well as in its absorption or drug interaction;
10. Possession of penile prosthesis;
11. History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patient with heart diseases (including history of angina and/or heart failure) and nephropathies;
12. Current use of nitrates, such as propatilnitrate (Sustrate®), isosorbide (Monocordil®, Cincordil®, Isordil®), nitroglycerin (Nitradisc®, Nitroderm TTS®, Nitronal®, Tridil®) and isosorbitol dinitrate (Isocord®);ketoconazole; ritonavir; and rifampicin.
13. Findings on ECG and/or laboratory tests that, in the Investigator's criteria, are considered significant and offer risk to the research volunteer's participation or may hinder the study analyses;
14. BP outside the limits considered safe: SBP below 90 mmHg or above 170 mmHg; or DBP below 50 mmHg or above 100 mmHg, except situations such as "white coat syndrome";
15. Diseases that can cause priapism, such as sickle cell anemia, multiple myeloma, or leukemia;
16. Histroy of priapism, defined as painful erection from up to 6 hours.
17. Current relevant diarrhea, defined as duration over four weeks, association with abdominal pain or dysabsortive syndrome, or presence of mucus, pus, or blood in the stool;
18. Known hypersensitivity to tadalafil and/or BZ371A;
19. History of symptomatic Lactose intolorence such as: the necessity of enzymatic treatment, abdominal distension or diarrhea when ingesting products or supplements with lactose;
20. Low adhsesion to 5mg Tadalafil use, characterized by the use of \<80% of the pills between the 30th and 60th day post PR;.
21. Pregnant or lacting partner.
22. Partner in childbearing age which does not accept to get exposed to the treatment
23. Any disease, condition or physical finding that the Investigator considers significant and that increases the risk of the research subject's participation or may interfere with the results, including severe debilitating illness, presence of cancer other than prostate cancer, severe mental illness persistent medication abuse;
|
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] |
NCT05349032
|
Assessing the Bioavailability of Leading Phytonutrient Products
|
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. The study will secondarily look at inflammatory markers in the urine to determine any change.
|
This study will primarily test various phytonutrient-based supplements to see which gets absorbed into the body the best. 120 mg of curcumin from brands Meriva, CurcElite, Lonvida, UltraCur, NovaSol. The study will secondarily look at inflammatory markers in the urine to determine any change.
|
Inclusion Criteria:
* Age and gender
Exclusion Criteria:
* Cannot take any phytonutrient or curcumin supplement five days prior to commencement.
|
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] |
NCT04091477
|
Impact of Neuropsychological Alteration of Patients With Eating Disorders
|
Eating disorders are multifactorial disorders currently conceptualized in a biopsychosocial model, but pathophysiology remains relatively unknown, and robust etiological models to guide treatment are therefore lacking. Different endophenotypes and neurocognitive vulnerability factors have been found in eating disorders including decision making abnormalities. The investigators hypothesize that decision making abnormalities are associated with a lower level of functioning and quality of life which could lead to social and interpersonal difficulties. The investigators also hypothesize that these anomalies are associated with a particular clinical profile (more restrictive profile, more hyperactivity, less insight on the disease and desire for care ...).
|
The investigators will recruit a total of 200 patients with an eating disorder in the university hospital of Montpellier.
Participation consists of a one-day visit with a multidisciplinary assessment. No action is specific to research. This is the usual management of patients with eating disorders addressed to our department.
|
Inclusion criteria :
* Patient with an eating disorder according to DSM-V criteria
* Patient aged from 15 to 65 years
* Patient who performs the day-hospital evaluation
* Patient affiliated to a French social security system
* Patient able to understand the nature, the aim and the methodology of the study For minor one of the legal guardians gave his consent
Exclusion criteria:
* Patient in an unstable somatic state (eg severe metabolic disorder making impossible or unreliable neuropsychological assessments)
* Patient's refusal to participate
* Patient protected by law (guardianship or curatorship)
* Pregnant or nursing women. A dosage of βHCG will be performed to ensure the absence of pregnancy.
|
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] |
NCT00462579
|
Risk Factors for Carbapenem-resistant Acinetobacter Baumannii
|
It has been demonstrated that panresistant strains of Acinetobacter species may be selected by antibiotic use \[4\], may be transmitted from person to person \[5\], and may be passed via environmental contamination \[6\]. Surveillance for panresistant Acinetobacter species should be a priority, given the lack of antibiotic options for the treatment of these infections. There are currently no data on the antibiotic susceptibility of Acinetobacter species or on the rates of panresistant organisms. The elucidation of potential risk factors for resistant strains of Acinetobacter is therefore an important task, and the use of alternative antibiotics should be considered in ICUs where these strains are endemic.
|
The elucidation of potential risk factors for resistant strains of Acinetobacter is therefore an important task, and the use of alternative antibiotics should be considered in ICUs where these strains are endemic.he following information will be collected: age, sex, occupation, hospital location at the time of positive culture (ER, medical ward, ICU etc), date of positive culture, prior hospitalization, receipt of outpatient dialysis, home care or other regular medical care (eg, outpatient chemotherapy), presence of invasive devices, receipt of antibiotics, including their type and whether they were adequate for the resistance profile of the organism, prior positive microbiologic cultures, time and location of positive cultures, underlying diseases and severity of illness, presence of urinary or intravascular devices, recent immunomodulative therapies or radiation therapy, physical exam findings, laboratory and radiographical data, antimicrobial usage within 30 days of onset of the infection, microbiological data and resistance patterns, choice of antibiotics once organism identified, bacteriological outcomes, laboratory results, demographic information, medications, clinical outcome,gender, height, weight, ethnicity, and past medical history. We will collect information retrospectively.
|
Inclusion Criteria:
* Positive cultures of carbapenem-resistant acinetobacter baumannii
Exclusion Criteria:
* Not meeting inclusion criteria
|
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] |
NCT05298917
|
Influence of Silicone Hydrogel Extended Contact Lens Wear on Corneal Sensitivity
|
Soft contact lens wear reduces the amount of oxygen reaching the eye, which may have an influence on corneal sensitivity. The aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.
|
Contact lens wear may have an influence on corneal sensitivity, by three mechanisms: hypoxic, mechanical and inflammatory. Extended silicone hydrogel contact lens wear increases the risk of infections. A change in corneal sensitivity may be considered as an indicator for change in corneal physiology. It is there the aim of this study is to measure corneal sensitivity with means of liquid jet esthesiometry at baseline and after 6 days of continuous, extended contact lens wear.
|
Inclusion Criteria:
* no contact lens wear three days before first visit
* corneal radius between 7.4 and 8.0; if corneal radius \>8.0, corneal diameter must be at least 12 mm; if corneal radius \< 7.4, corneal diameter must be \< 12.0
* OSDI score no higher than 13 points
Exclusion Criteria:
* systemic disease that may have an influence ocular healtjh
* active ocular disease and no history of ocular surgery
|
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] |
NCT00036647
|
OSI-774 (Tarceva) in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
|
The purpose of this study is to determine if OSI-774 will improve overall survival of patients with incurable stage IIIB/IV non-small cell lung cancer compared to standard of care. OSI-774 is a new type of drug under evaluation called an epidermal growth factor receptor (EGFR). OSI-774 is an investigational drug that has not yet been approved by the U.S. Food and Drug Administration (FDA).
|
* Clinical diagnosis of stage IIIB or IV non-small cell lung cancer.
* Must have evidence of disease (clinical or radiological).
* Have failed 1 but no more than 2 prior chemotherapy regimens, have recovered from any side effects and have not had any chemotherapy for at least 21 days.
* If the patient has had surgery, the surgery was at least 2 weeks ago.
* Patients whose cancer has spread to their brain or central nervous system are eligible, providing that they have been on stable dose of steroids for at least 4 weeks and are free of symptoms.
* If the patient received radiation therapy, treatment was at least 4 weeks ago.
|
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] |
|
NCT00918983
|
Clinical Evaluation of NX-1207 for the Treatment of Benign Prostatic Hyperplasia (BPH)
|
This study will evaluate the safety and efficacy of a 2.5 mg dose of NX-1207 for the treatment of BPH (benign prostatic hyperplasia) as compared to placebo.
|
Inclusion Criteria:
1. Provide signed informed consent prior to enrolment in the study
2. IPSS ≥ 15
3. Prostate Volume ≥ 30 mL ≤ 70 mL
4. Qmax \< 15 mL/sec based on a minimum void of 125 mL
5. Agree not to use any other approved or experimental BPH or OAB medication anytime during the study
Exclusion Criteria:
1. History of illness or condition that may interfere with study or endanger subject
2. Use of prescribed medications that may interfere with study or endanger subject
3. Presence of a median lobe of the prostate
4. Previous surgery or MIST for treatment of BPH
5. Post-void residual urine volume \> 200 mL
6. PSA ≥ 10 ng/mL; prostate cancer must be ruled out (negative biopsy) for PSA ≥ 4 ng/mL
7. Participation in a study of any investigational drug or device within the previous 90 days
8. Prostate cancer
|
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|
NCT03087903
|
A Study of Grape Seed Extract in Asymptomatic Non-Metastatic Prostate Cancer Patients with Rising PSA
|
Patients will take 150 mg of GSE product by mouth twice daily and will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year.
|
Patients will take 150 mg of GSE product by mouth twice daily in the form of 75 mg capsule of Leucoselect Phytosome preparation; total oral dosage is 300 mg GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits and patients must not have a doubling of their PSA (compared to baseline) by 3 months in order to continue on study. Patients who meet criteria to continue on study will be treated until disease progression or for one year (whichever comes first).
|
Inclusion Criteria:
1. Written informed consent has been obtained.
2. Adults \> or = 18 years of age.
3. Histologically confirmed prostate adenocarcinoma.
4. Evidence of rising PSA, on 2 separate occasions, at least one week apart. Baseline PSA must be ≥ 0.2 ng/mL at the time of screening. Radiographic evidence of disease is not allowed.
5. Patients must have sufficient PSA time points prior to enrollment (a minimum of 3 PSA levels within a six month period) to calculate a baseline PSA doubling time.
6. Patients must not be on active LHRH agonist/antagonist therapy and must have testosterone level \> 50 ng/dL.
7. Patients must not be on active anti-androgen therapy or 5-alpha reductase inhibitors. Patients on stable dose of 5-alpha reductase inhibitors for benign prostatic hypertrophy for at least 12 months may continue. They must withdraw from the study if this is stopped while on study.
8. Patients who are candidates for local salvage therapy must have had this option pursued or discussed; and the patient must have either declined salvage therapy or was deemed not to be a candidate for salvage therapy.
9. Patients who have PSA recurrence after local salvage therapy may participate in this study.
10. Patients with hormone sensitive disease who received prior androgen deprivation therapy as part of primary/salvage local treatment or patients receiving intermittent androgen deprivation therapy will be allowed to participate.
11. Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
12. Adequate hematologic function (absolute neutrophil count \[ANC\]≥1,500 cells/µL; hemoglobin ≥9 g/dL, platelets ≥75,000/µL).
13. Adequate renal function (serum creatinine ≤ 2X the upper limit of normal (ULN)
14. Adequate hepatic function (total bilirubin ≤ 2 x upper limit of normal \[ULN\], alanine aminotransferase \[ALT\]≤ 3xULN, aspartate aminotransferase \[AST\]≤3 x ULN).
15. Patients can continue taking what they are taking at the time they start on the study, but agree not to start any new (over the counter) herbal supplement on regular basis during study duration.
16. Prior chemotherapy for prostate cancer (upfront, adjuvant, etc.) is allowed as long as it was not given for hormone-refractory disease.
Exclusion Criteria:
1. Patients who are on active surveillance for untreated localized disease may not participate in this study.
2. Inability to swallow gelatin capsules, or any medical condition that interferes with normal gastrointestinal absorption.
3. Major surgery, radiation, or treatment with any other investigational drug within 2 weeks of study treatment.
4. Documented hypersensitivity reaction to any product with GSE (see complete list in Appendix 1).
5. Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
6. Symptomatic prostate cancer as determined by cancer-related pain requiring narcotic pain medication.
7. History of another cancer is exclusionary unless it is believed to be likely cured or is unlikely to be fatal in the next 3 years (e.g. squamous cell carcinoma, superficial bladder cancer, chronic lymphocytic leukemia, etc).
8. Very fast PSA doubling time of less than 4 weeks, if the absolute PSA is \> 2 ng/mL.
9. Known allergy/intolerance to soy, phosphatidycholine or any other constituents of grape seed extract.
|
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] |
NCT03315286
|
Validation of SHADE a Mobile Technology for Monitoring of Ultraviolet Exposure
|
This study will evaluate the safety and effectiveness of Shade for the management of UV-induced skin complications and data collected from this study will be used to support the proposed indications for use.
|
The incidence of non-melanoma skin cancers, due to increased ultraviolet (UV) exposure, has increased by 300% over the past 2 decades. The innovative UV sensor, Shade, is designed to help people manage their UV exposure by quantifying their UV exposure levels through a linked smartphone application. In order to validate the effectiveness of Shade, we propose conducting a study communicating the level of UV exposure and correlating it with the development of actinic keratosis (AK), a precancerous lesion of the skin. We will recruit patients with multiple repeat AK's, as this population continues to develop AKs every year. We will include renal transplant patients. The risk of developing squamous cell carcinoma (SCC) in renal transplant patients is 65 times higher than normal patients. They are an ideal patient population for this study. We will evaluate the UV monitor's effectiveness in decreasing the number of AKs over a summer. This randomized partially blinded study will recruit 120 patients with a recent history of AK lesions and evaluate the incidence of new AKs after one summer. We will perform a control versus study group analysis. Half of the subjects (study group) will be randomly assigned to use the sensor along with its smartphone application, while the other half (control group) will receive standard of care treatment involving counseling to avoid sun exposure. Subjects will have regular standard of care visits with the dermatologist who will follow the number of actinic keratosis via clinical exam and photography. The primary outcome will be a statistically significant reduction by at least 25% of the cumulative number of newly occurred AK lesions between the control and the study group over one summer, counted at enrollment and follow-up. In subjects at one study site, skin DNA damage will also be assessed using cyclobutane pyrimidine dimers (CPD) levels measured by ELISA in both sun exposed (cheek) and sun protected skin (buccal mucosa) in both the study and control groups. Secondary outcomes will look at clinical decreases by 25% in CPD levels after using the sensor.
|
Inclusion Criteria:
* between 18-80 years of age
* given a diagnosis of actinic keratosis in the past year and/or has had a history of \>5 actinic keratosis over the past 5 years
* has a compatible smartphone ((Apple version \>= 7, Android version \>= 4.4.2; no Jitterbug or Samsung Galaxy J3)
* willing to commit to dermatology visits (including standard of care visits) every 3 months for 6 months
Exclusion Criteria:
* received UV therapy within the past 6 months
* work/lifestyle incompatible with wearing a UV sensor over the course of 1 year
* has difficulty controlling UV exposure
* has a medical condition judged incompatible with the study by the enrolling physician including the presence of an ICD or an existing plan for extended inpatient treatment
* has received field therapy (i.e., entire face or scalp) for the treatment of actinic keratosis (i.e., topical imiquimod, 5-fluorouracil, photodynamic therapy) in the past 3 months
* is an employee or direct relative of an employee of the investigational site or study sponsor
|
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] |
NCT06801665
|
FMT+ QL1706+bevacizumab+ XELOX As First-line Treatment for Advanced MSS-type Colon Cancer with Liver Metastasis
|
The investigators plan to initiate a prospective, multicenter, phase II study, recruiting 30 patients with advanced colon cancer patients with liver metastasis who have not received prior treatment. This study plans to reconstruct intestinal microecology through fecal microbiota transplantation (FMT), and combine with QL1706+Bevacizumab+XELOX to enhance the anti-tumor immune effect at the same time, thereby improving the prognosis of colon cancer patients with liver metastasis.
|
This is a prospective, single-arm, multi-center, exploratory clinical study. Patients with previously untreated, newly diagnosed advanced colon cancer with liver metastasis, who could be diagnosed by histological or cytological means, ECOG PS 0-1, excluded Ras, Raf wild type left colon and rectum, excluded dMMR/MSI-H. Eligible subjects who met the inclusion criteria were screened and signed informed consent.
FMT was performed 2 days before treatment with QL1706, bevacizumab, and chemotherapy. QL1706， bevacizumab, and chemotherapy (XELOX) were administered every 3 weeks according to the patient's body surface area. A total of 6 cycles were performed. Subsequent maintenance therapy was at the discretion of the investigator.
RECIST v1.1 was used for tumor evaluation every 6 weeks during treatment. NCI-CTCAE 5.0 was used for safety assessment every 3 weeks. Adverse events were recorded throughout the study to 90 days after the end of treatment. Treatment continues until disease progression, subject withdraws informed consent, loss of follow-up, or death. Patients should provide 10ml whole blood samples and fecal samples at baseline, after two cycles of treatment, after four cycles of treatment, before maintenance treatment for the detection of efficacy prediction markers (each cycle is 21 days).
|
Inclusion Criteria:
1. Histological or cytological confirmed advanced colon cancer with liver metastasis.
2. Signed written informed consent.
3. Have not received anti-tumor treatment.
4. According to the investigators assessment, at least one measurable target lesion defined by RECIST v1.1.
5. Patients of both sexes, aged ≥18 years and ≤75 years.
6. ECOG PS 0-1;
7. Expected survival time ≥ 3 months;
8. Have adequate organ and bone marrow function, laboratory examination within 7 days prior to enrollment meets the following requirements, as follows:
1) Blood routine: ANC ≥ 1.5 × 10\^9/L, Platelet count ≥ 100 × 10\^9/L, HGB ≥100 g/L (no blood transfusion or erythropoietin dependence within 14 days); 2) Liver function: TBIL ≤1.5 x ULN; ALT/AST ≤ 5 x ULN; ALP ≤5×ULN; 3) Renal function: Cr ≤1.5×ULN, or creatinine clearance ≥50 mL/min: Urine routine results showed urinary protein \< 2+; 4) Coagulation function: INR or PT ≤1.5 x ULN. 9.For female subjects of reproductive age, a urine or serum pregnancy test should be performed and the result is negative 3 days prior to receiving the initial study drug administration.
10. For women of childbearing potential (WOCBP): agreement to refrain from heterosexual intercourse or use contraception.
11. For men: agreement to refrain from heterosexual intercourse or use a condom, and agreement to refrain from donating sperm.
Exclusion Criteria:
1. Suffered from other malignancies in the past 5 years, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ and papillary thyroid carcinoma.
2. Patients requiring elective surgery during the trial.
3. Patients who cannot take oral drugs, or have conditions that the investigator determines to significantly affect gastrointestinal absorption, such as chronic diarrhea, intestinal obstruction, etc., and are not suitable for treatment.
4. Patients during pregnancy (positive pregnancy test) or lactation.
5. Central nervous system metastasis or meningeal metastasis.
6. Uncontrollable bone metastasis, or patients at risk of fracture, requiring surgery, local radiation therapy.
7. Patients with active infection requiring systemic anti-infection treatment.
8. Patients with a history of immunodeficiency, including those who are positive for HIV antibody tests.
9. Patients with known, active autoimmune diseases.
10. Patients with uncontrolled active hepatitis B, patients with hepatitis C virus infection (HCV antibody positive).
11. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: severe arrhythmia, acute coronary syndrome within 6 months, congestive heart failure, aortic dissection, stroke, and T IA history.
12. Severe bleeding events occur within half a year, or high bleeding risk factors such as active digestive tract ulcers and esophageal and gastric varices due to liver cirrhosis.
13. Patients with diabetes who cannot be stably controlled by drugs (including insulin).
14. Mental or language disorders that prevent communication with the patient;
15. Patients participating in another clinical trial.
16. MSI-H/ d MMR without immunotherapy; left colorectum of Ras, Raf wild-type.
17. The investigator believes that the subject has other serious systemic diseases or other conditions that make him unsuitable for participation in this trial.
|
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0.1530362367630005,
0.3206270635128021,
-0.354131281375885,
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0.2534358501434326,
0.3937021493911743,
0.7514580488204956,
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] |
NCT01430962
|
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration Performed Under General Anesthesia Versus Moderate Sedation
|
The purpose of the study is to determine if there are any differences in yield or safety of Endobronchial Ultrasound-guided Transbronchial Needle Aspiration (EBUS-TBNA) (a type of bronchoscopy with biopsy) performed under general anesthesia versus moderate sedation.
|
Inclusion Criteria:
* All patients over the age of 18, evaluated by pulmonary physician that require EBUS TBNA for sampling of hilar and/or mediastinal lymphadenopathies or masses
* Patients should be considered eligible to undergo either CS or GA, without contraindications for either one of them, based on the assessment by the pulmonologist who will perform EBUS-TBNA
Exclusion Criteria:
* Pregnancy or breastfeeding women
* Patients deemed poor candidates for general anesthesia by the evaluating physician (e.g., severe coronary artery disease, COPD with FEV1 \< 1 liter, uncontrolled hypertension, increased intracranial pressure, reaction to anesthetics)
* Previous reaction to medications routinely used in conscious sedation
* Patients with history of intolerance to either general anesthesia or conscious sedation
* Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
|
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] |
|
NCT04723251
|
The Gratitude Gallery - A Positive Psychology Intervention
|
This study will assess the feasibility and acceptability of a positive psychology intervention, The Gratitude Gallery, for increasing gratitude in adults.
The study hypothesizes that participants will find the activity feasible and acceptable and complete the intervention as directed. The project also hypothesizes that those that complete the intervention will show an increase in self-reported gratitude, as well as a decrease in symptoms of anxiety and depression.
|
Inclusion Criteria:
* Able to read/understand English and give consent
* Owns a smart phone capable of taking pictures
* Willing and able to comply with all aspects of study procedures
* PHQ-9 score greater or equal to 5 but less or equal to 14 with no suicidal ideation
* Generalized anxiety disorder (GAD-7) score greater or equal to 0 but less or equal to 9
* No plan to initiate a new program that could increase positive affect during the study period (e.g., psychotherapy, new exercise regimen, meditation classes)
* If on medication then stable (at least 3 months) on dose or not on medication
Exclusion Criteria:
* Having a psychotic disorder active suicidality or severe depressive or anxiety symptoms
* Other factors that at the discretion of the investigators that would adversely affect study participation
|
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|
NCT00699920
|
Cohort Study in Uganda Comparing Artesunate + Amiodaquine (Coarsucam) Versus Artemether + Lumenfantrine (Coartem) in the Treatment of Repeated Uncomplicated Plasmodium Falciparum Malaria Attacks
|
Primary objective is to demonstrate the non-inferiority of PCR (Polymerase Chain Reaction) adjusted adequate clinical and parasitological response at Day 28 of Coarsucam versus Coartem, based on the first malaria attack of each patient.
Secondary objectives:
For the first attack:
To compare the 2 groups of treatment in terms of:
* Day 42 efficacy
* Parasitological and fever clearance
* Clinical and Biological tolerability
* Evolution of gametocyte carriage
For attack 2nd and following:
To compare the 2 groups of treatment in terms of:
* Day 28 and Day 42 clinical and parasitological effectiveness
* Clinical and Biological tolerability
* Proportion of patients without fever at Day 3
* Proportion of patients without parasites at Day 3
* Evolution of gametocyte carriage
* Compliance
During the total follow up of the cohort:
To compare the 2 groups of treatment in terms of:
* Treatment incidence density
* Impact of repeated treatment on clinical and biological tolerability
* Impact on anaemia
* Impact on Hackett score.
|
Inclusion Criteria:
Specific inclusion criteria for initial enrollment:
* Confirmed mono infection with Plasmodium falciparum, with parasite density ≥2000 asexual forms per µl of blood,
Inclusion criteria for each attacks:
* Body weight ≥5 kg
* Able to be treated by oral route
* Fever (axillary temperatur ≥37.5 degrees Celsius) at D0 or history of fever within the previous 24 hours
* Confirmed Plasmodium falciparum infection with positive paratesimia
* Haemoglobin value ≥5.0 g/dl
Exclusion Criteria:
Specific exclusion criteria for initial enrollment:
* Patient participating in another ongoing clinical trial
* Allergy to one of the investigational medicinal products
* History of hepatic and (or) haematological impairment during treatment with amodiaquine
* History of cardiac disease
* Concomitant febrile illness
Exclusion criteria for each attacks:
* Presence of at least one danger sign of malaria: recent history of convulsions (1-2 within 24h), unconsciousness state, lethargy, unable to drink or breast feed, vomiting everything, unable to stand/sit due to weakness
* Severe concomitant disease or known disturbances of electrolyte balance such as hypokalaemia or hypomagnesaemia
* Intake of medication metabolized by cytochrome CYP 2D6 (e.g. metoprolol, flecainide, imipramine, amitriptyline, clomipramine) at the time of inclusion
* Intake of drugs known to inhibit CYP 2A6 (e.g. methoxsalem, pilocarpine, tranylcypromine) and/or 2C8 cytochromes (e.g. trimethoprim, ritonavir, ketoconazole, montelukast, gemfibrozil) at the time of inclusion
* Intake of medication known to prolong the QTc interval, such as class IA and III antiarrythmics, neuroleptics, antidepressant agents, certain antibiotics including drugs in the macrolide class, fluoroquinolones, imidazole and triazole, antifungal agents, certain non-sedative anthistamines (terfenadine, astemizole) and cisapride at the time of inclusion
* Patient having received artesunate + amiodaquine or artemether + lumefantrine at suitable dosage within the previous 2 weeks.
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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|
NCT04494438
|
Rituximab for Idiopathic Nephrotic Syndrome
|
Open-label, randomized, controlled trial due to value whether the monoclonal antibody rituximab is non-inferior to steroids in maintaining remission in juvenile forms of SDNS.
The investigators will enroll 30 pediatric patients affected by idiopathic nephrotic syndrome, who have been in treatment with steroids for at least one year. The lowest dose of drug required to maintain a stable remission will be between 0.4 and 0.7 mg/ kg/ day.
This trial provides an initial run-in phase of one month during wich remission will be achieved by means of a standard oral prednisone course. Once remission has been achieved children will be randomized in a parallel arm open label RCT to continue prednisone alone for one month (control) or to add a single intravenous infusion of rituximab (375 mg/m2 - intervention). Prednisone will be tapered in both arms after one month.
|
Inclusion Criteria:
* Age between 1 and 16 years.
* Steroid-dependent idiopatic nephrotic syndrome for a minimum of 6 to a maximum of 12 months at the time of study entry, regardless of disease duration.
* Low-dose steroid dependence (between 0.4 and 0.7 mg/ kg/ day)
Exclusion Criteria:
* Positivity of autoimmunity tests (ANA, nDNA, ANCA) or reduced C3 levels
* Histological pattern suggestive for congenital anomalies (diffuse mesangial sclerosis without IgM deposits, cystic-like tubular dilations, evidence of mithocondrial damage on electronic microscopy.
* Histological pattern not correlated with idiopathic nephrotic syndrome in the pediatric age (membranous glomerulonephritis, lupus nephritis, diffuse and/or localized vasculitis, amyloidosis).
* Evidence of homozygous or heterozygous mutations in podocitary genes commonly involved in the pathology (NPHS1, NPHS2, WT1).
* Estimated glomerula filtration rate (eGFR) \< 60ml/min.
* Presence of circulating IgM against HCV, HBV, parvovirus or mycoplasm.
|
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] |
|
NCT04088123
|
Impact of Anti-platelet Drug Exposure on Platelet mRNA Splicing in Healthy Subjects
|
The purpose of this pilot study is to determine how the anti-platelet drug, ticagrelor, impacts platelet mRNA splicing after a single loading dose in 10 healthy participants. These results will be valuable in that they will help inform our analysis of platelet RNA splicing after a thrombotic event.
|
There is nothing known on how differential splicing in platelets is impacted by of P2Y12 inhibition by anti-platelet agents. Consequently, the focus of this longitudinal pilot study will be to determine the impact of a single ticagrelor loading dose (180 mg), our "model" anti-platelet drug, on platelet RNA splicing in 10 healthy individuals.
It will test the hypothesis that ticagrelor exposure does not significantly alter platelet mRNA splicing. It will involve administering a single loading dose (180 mg) of ticagrelor to healthy volunteers.
|
Inclusion Criteria:
* 18 - 70 years-old
* Speak and understand English
Exclusion Criteria:
* History of blood clotting/bleeding disorders
* Current medications that are CYP3A4 inhibitors/inducers
* Current medications that their pharmacokinetics is impacted by ticagrelor (i.e. simvastatin, lovastatin, digoxin) per FDA recommendations.
* Diagnosed with arterial or venous thrombosis
* Active cancer diagnosis
* Pregnant
* Hepatic impairment including active hepatitis infection or cirrhosis
* Current hormonal contraception
* Currently taking aspirin or anti-platelet drugs. If patient has recently taken an NSAID, the last dose should have been discontinued based established criteria
|
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] |
NCT00792610
|
The Hepatitis B Vaccine Booster Response Among the Youth Who Had Completed Neonatal Hepatitis B Vaccines
|
At the time of the present study, the necessity for booster vaccinations for the prevention of hepatitis B(HB) 15 years post-vaccination in the group of young adults who have become seronegative for HB markers after complete neonatal HB vaccination was in question. A booster vaccination strategy may lead to a significant economic impact on national health care resources, and the costs/benefits must therefore be carefully evaluated. Unfortunately, the data to support such analyses are lacking. Because an increased risk of HB infection is anticipated when adolescents enter into young adulthood through becoming sexual active, breakthrough infections such as fulminant HB might be the main concern instead of the risk of chronic HB carriage. To address this issue, this study aimed to measure the booster responses after HB vaccination in seronegative young adults who had completed neonatal HB vaccines in Taiwan before.
|
This cohort study was conducted between October 2007 and Jan 2009. The target population was subjects aged 18-23 years who were born after 1984 when the Taiwanese national HB vaccination program was launched. Their vaccination records must have shown a completed neonatal HB vaccination, and they were seronegative for all three HB viral markers including HBsAg(Hepatitis B surface antigen), anti-HBc(core antibody against Hepatitis B), and anti-HBs(Surface antibody against Hepatitis B) within 2 years of entry into the study and at study entry. They were recruited through a Student's Health Center Clinic referral, Bulletin Board System posts, and Web-broadcast invitation. The neonatal HB vaccination records were verified through linkage to the Taiwan Center for Disease Control databank. Signed informed consent was obtained from all the participants and their parents or guardians. Pregnant females, persons with a previous history of allergy to HB vaccines, or allergy to yeast were excluded. First 3 months are screen phase to recruit college students for assay of hepatitis B viral markers. Seronegative subjects were approached for enrollment into receiving hepatitis B vaccine booster afterwards.
All participants were tested for HB markers at enrollment, even if they had been tested in the previous months, to confirm their status. A questionnaire was completed at enrolment to record sociodemographic factors including age, gender, self reported family history of hepatitis B carriers, self reported blood type, and so on. The participants then received three intramuscular doses of HB vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20 microgram/ml/vial, GlaxoSmithKline, Belgium) at baseline and at the 1st and 6th month follow-up visits. Their anti-HBs status was checked at baseline, 7-10 days, 1 month, 6 months, and 7 months following the first dose of HB vaccine. Adverse effects associated with the vaccine were also reported within one week after each Engerix-B injection.
|
Inclusion Criteria:
1. aged 18-23 years
2. the youth born after July 1984 who have received a hepatitis B virus markers checkup within 2 years including HBsAg, core antibody against hepatitis B(anti-HBc), and surface antibody against hepatitis B (anti-HBs) and the results are all negative for these 3 viral markers.
3. Participants should agree to sign inform consent. For younger than 20 years old subjects, one of their parents also help the participate review and sign the inform consent.
4. Participants are willing to receive 3 doses of Hepatitis B vaccines without payment.
5. General condition is in good health judged by the doctor
Exclusion Criteria:
1. Allergy to Hepatitis B vaccines or yeast
2. pregnancy
|
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] |
NCT01869036
|
Use of Caudal Anesthesia Supplemented With Morphine in Children Undergoing Renal Surgery
|
The aim of this study is to test an efficacy and safety of supplemented by Morphine caudal anesthesia in children who undergo renal surgery in our department.
|
The kidney surgery is a significant part of surgical armamentarium in pediatric urology. The common operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy.
One of the main goals in the postoperative period is to provide a painless recovery following by early mobilization of the child and early discharge home. Caudal anesthesia has become a gold standard in the renal surgery providing painless postoperative period, allowing earlier child feeding and speedy recovery. However some researchers have pointed out that caudal anesthesia with supplemented with Marcaine may provide painless postoperative period only for a very limited period of time and required additional painkiller therapy during postoperative period. Caudal anesthesia supplemented with Morphine has demonstrated their benefits in children who undergo infraumbilical surgery.
|
Inclusion Criteria:
* children who are scheduled for renal surgery from two months age to puberty
* operations are open and laparoscopic pyeloplasty, partial nephrectomy open and laparoscopic and laparoscopic nephrectomy
Exclusion Criteria:
* malignancy
|
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] |
NCT02206503
|
Cyclophosphamide With Biochemical Progression During Lenalidomide-Dexamethasone Treatment for Relapsed/Refractory Multiple Myeloma (MM)
|
This study evaluates the efficacy of the addiction of Cyclophosphamide to Revlimid-low dose dexamethasone (Rd) in relapsed/refractory Multiple Myeloma patients, who experienced a biochemical progression, without CRAB, during Rd treatment.
|
This protocol is a phase II multicenter, open label study designed to determine whether the addiction of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. Patients will be evaluated at scheduled visits in up to 3 study periods: pre-treatment, treatment and long-term follow-up (LTFU).
The pre-treatment period includes: screening visits, performed at study entry. After providing written informed consent to participate in the study, patients will be evaluated for study eligibility. The screening period includes the availability of inclusion criteria described above. Subjects who meet all the inclusion criteria will be enrolled.
The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle.
During the LTFU period, after development of confirmed progression disease (PD), all patients are to be followed for survival every 1-3 months via telephone or office visit.
|
Inclusion Criteria:
* Patient with relapse/refractory multiple myeloma who experienced biochemical progression, without CRAB, during treatment with Rd. CRAB means the presence of organ damage, multiple myeloma related (renal impairment and/or anemia and/or new bone lesions and/or hypercalcemia). It is sufficient one of the previous signs for defining the presence of CRAB. Biochemical progression means: positivization of serum/urine immunofixation for patients who reached a complete remission with Rd treatment or at least 25% increment of monoclonal component in serum/urine for patients who reached at least a stable disease (SD).
* Patient exposed to previous therapy included Lenalidomide, Thalidomide, Bortezomib and/or autologous stem cell transplantation (ASCT) and in treatment with Rd.
* Patient is, in the investigator(s) opinion, willing and able to comply with the protocol requirements.
* Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to their future medical care.
* Female patient is either post-menopausal or surgically sterilized or, if at childbearing potential, must: understand that the study medication could have an expected teratogenic risk.
* Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhea. This applies unless the subject commits to absolute and continued abstinence confirmed on a monthly basis. The following are effective methods of contraception\*:
* Implant\*\*
* Levonorgestrel-releasing intrauterine system (IUS)\*\*
* Medroxyprogesterone acetate depot
* Tubal sterilisation
* Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
* Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
* Combined oral contraceptive pills are not recommended. If a subject was using combined oral contraception, she must switch to one of the methods above. The increased risk of venous thromboembolism (VTE) continues for 4 to 6 weeks after stopping combined oral contraception.
* \*\*prophylactic antibiotics should be considered at the time of insertion particularly in patients with neutropenia due to risk of infection.
* Agree to have a medically supervised pregnancy test with a minimum sensitivity of 25 mills International Units on milliliter (mIU/ml) not more than 3 days before the start of study medication once the subject has been on effective contraception for at least 4 weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* Agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. These tests should be performed not more than 3 days before the start of next treatment. This requirement also applies to women of childbearing potential who practice complete and continued abstinence.
* † A female subject or a female partner of a male subject is considered to have childbearing potential unless she meets at least one of the following criteria: Age
≥50 years and naturally amenorrhoeic for ≥ 1 year (amenorrhoea following cancer therapy does not rule out childbearing potential), premature ovarian failure confirmed by a specialist gynaecologist, previous bilateral salpingooophorectomy or hysterectomy, xy genotype, Turner's syndrome or uterine agenesis.
* Male subjects must:
* Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if their partner is of childbearing potential and has no contraception.
* Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
* All subjects must:
* Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
* Agree not to share study medication with another person and to return all unused study drug to the investigator.
* Patient who obtain at least a SD with Rd treatment and experienced a biochemical progression without CRAB, during the treatment itself.
* Patient has a Karnofsky performance status ≥ 60%.
* Patient has a life-expectancy \> 6 months.
* Patients must have a adequate cardiac function.
* Patients must have adequate pulmonary function.
* Patient has the following laboratory values within 14 days before Baseline (day 1 of the Cyclophosphamide):
* Platelet count ≥ 50 x 109/L or ≥ 25 109/L if bone marrow involvement is ≥ 50% of plasma cells in bone marrow biopsy.
* Absolute neutrophil count (ANC) ≥ 1.0 x 109/L or ≥ 0,5 109/L x if bone marrow involvement is ≥ 50% of plasma cells in bone marrow biopsy.
* Corrected serum calcium ≤ 14 mg/dL (3.5 mmol/L).
* Aspartate transaminase (AST): ≤ 2.5 x the upper limit of normal (ULN).
* Alanine transaminase (ALT): ≤ 2.5 x the ULN.
* Total bilirubin: ≤ 1.5 x the ULN.
* Calculated or measured creatinine clearance: ≥ 30 mL/minute.
Exclusion Criteria:
* Patients with newly diagnosed multiple myeloma.
* Patients who relapsed from multiple myeloma with signs of organ damage related to disease (CRAB).
* Any serious medical condition, including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if he or she participates in this study or confounds the experimental ability to interpret data from the study.
* Pregnant or lactating females.
* Prior history of malignancies, other than multiple myeloma, unless the subject has been free of the disease for ≥ 3 years. Exceptions include the following: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast, incidental histological finding of prostate cancer (TNM stage of T1a or T1b).
|
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] |
NCT01356446
|
Checklist Application and Mortality
|
The study investigates the impact of the implementation of a surgical checklist on the mortality 30 days and 90 days after surgery. Patients scheduled for elective surgical procedures (excluding cardiac surgery) lasting at least 15 minutes are eligible. Surgery is performed in a single tertiary care center. The study is an open trial before and after intervention (implementation of the checklist "safe surgery saves lifes").
|
Inclusion Criteria:
* elective surgery in general or regional anesthesia lasting \> 15 min
Exclusion Criteria:
* urgent / emergent surgery
|
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