cyrilzakka/clinical-trials huggingface dataset:
Peace-Building Interventions for Israeli and Palestinian Youth

The investigators expect an intervention that focuses on actual dialogue and familiarity with members of the other culture, discussion of empathy, generosity, and kindness, and focus on adaptive and reciprocal modes of conflict resolution will alter both physiological, behavioral, and mental response to the pain of the other, increase empathy, and reduce hostility.

We hypothesized that the intervention will impact perspective taking (PT) on the national conflict, reducing the tendency to view justice only on one's side. Such increase in PT would initiate a chain leading to greater behavioral empathy.

Second, we hypothesize that change in oxytocin (OT) levels and empathic behavior (less withdrawal and tension and more synchrony) would be impacted by the intervention and the degree to which it altered youth PT on the conflict.

Finally, we suggest a 3-path model charting the multi-dimensional pathways leading to behavioral empathy toward outgroup member. First, individual differences in OT functionality will shape empathy so that youth with higher OT levels at pre-intervention and greater PT will show more empathic dialogue at post-intervention. Second, dispositional cognitive empathy, as tested by the Interpersonal Reactivity Index questioner (IRI), at pre-intervention will predict higher behavioral empathy at T2, both directly and as mediated by reduction in ethnocentric attitudes following the intervention. Finally, we hypothesize that the intervention will influence empathy by initiating a chain that begins with increasing PT, which, in turn, will lead to reduction in tension during interaction with outgroup, and culminating in greater empathy during face-to-face encounters

Eligibility Criteria:
Inclusion Criteria:

* jewish israeli
* arab israeli
* lives in the center of israel
* both parents agree to participation

Exclusion Criteria:

* no mental disorder
* no neurological-developmental disorder
Eculizumab Therapy for Chronic Complement-Mediated Injury in Kidney Transplantation

This study is designed to assess the effectiveness of eculizumab in recipients of kidney transplantation with donor-specific antibodies (DSA) and worsening kidney function and to assess if eculizumab improves endothelial cell injury in the kidney.

The investigators hypothesize that complement inhibition with eculizumab will reduce allograft injury, resulting from less complement-mediated injury of endothelial cells and less endothelial cell activation.

This study will address the clinical challenge that currently exists in the management of kidney transplant recipients who have developed de novo DSA, have deteriorating graft function, yet have no established treatment alternative.

This is a randomized, open-label, pilot intervention trial. Post transplant patients with deteriorating renal function (defined as 20% reduction in GFR) will be screened for the development of DSA and biopsied for the presence of C4d deposition. All patients with DSA and those meeting inclusion/exclusion criteria will undergo protocol renal biopsy and will be assessed for C4d deposition. Participants will be randomized to treatment with eculizumab plus standard of care (SOC) or SOC only. Randomization will be stratified by C4d status (C4d+/C4d-) with 10 subjects (7 eculizumab, 3 SOC only) in each stratum.

Eculizumab is an antibody that has been developed to inhibit the complement protein C5. Eculizumab will be delivered via IV according to the following schedule:

* Eculizumab Induction 600mg IV every 7 days for 4 doses
* Eculizumab 900mg IV 7 days later
* Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients greater than 6 months from the date of transplant
* Must be on standard immunosuppression: tacrolimus, mycophenolate mofetil, prednisone and have stable tacrolimus trough levels over past 3 months
* Deteriorating renal function, as defined by 20% reduction in GFR (MDRD calculation)
* Presence of DSA, as defined as MFI \> 1100
* Renal biopsy demonstrating no diffuse, irreversible end-stage organ injury (i.e. stage IV Fibrosis)
* Renal biopsy demonstrating C4d deposition (stratum 1) or no C4d deposition (stratum 2)

Exclusion Criteria:

* History of CMV, BK, HSV or other viral infections
* History of chronic, recurrent bacterial infections
* Evidence of tubulitis on renal biopsy or other morphological features of acute cellular rejection or acute humoral rejection
* Renal biopsy demonstrating diffuse, irreversible end-stage organ injury
* Absolute GFR \< 25 (MDRD calculation)
* Inability to provide informed consent
* History of poor vascular access
* Refusal to use double barrier contraception during study participation
* Patients actively enrolled in other clinical trials
Amniotic Membrane in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome (CTS) is the most frequent mononeuropathy. CTS is more frequent in females than in males, it has been associated to work activities, hormone exposure and obesity. Although its primary treatment is conservative, there is strong evidence that patients who retard surgery are more prone to develop worse outcomes. Surgery to treat CTS consists in liberating carpal tunnel in order to ameliorate median nerve symptoms; however, more than 20% of patients who undergo surgery have recurrent CTS (RCTS). RCTS is due to a fibrotic process in the site of the surgery. Amniotic membrane (AM) is the inner layer of the placenta which has been used to treat different pathologies. AM transplantation (AMT) has demonstrated to significantly inhibit inflammation and fibrosis. Therefore, the aim of the present study was to determine the effect of AMT in CTS surgery. The present is a randomized, open labeled, controlled clinical study. The investigators included patients with recent diagnosis of CTS and divided into two groups. The experimental group received AMT concomitantly with conventional surgery; whilst, the control group received only the conventional surgery. Clinical status of patients measured with the BCTQ questionaire was the main outcome. Both groups showed similar BCTQ punctuation at the beginning of the study. However, the results of the experimental group were significantly better than those from the control group through time, until the finish of the study. None of the patients presented complications or adverse effects related to the AMT. These results indicate that AMT is a secure and suitable treatment for CTS presenting better clinical outcomes at one-year follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Patients with recent CTS diagnosis
* Patients that undergo CTS surgery
* Patients that accept to participate in the study
* Patients that sign informed consent

Exclusion Criteria:

* Patients with recurrent CTS diagnosis;
* Patients with concomitant hand/arm comorbidities
* Patients with any systemic disease that comprises muscles and bones
* Collagenopathies
* Systemic lupus erythematosus
A Phase 2 Study Evaluating JCPyV-specific T Cell Therapy for PML

This is a randomized, double-blinded, Phase 2 trial in patients with PML due to JCPyV. Patients will receive treatment with a matched virus-specific T-cell product (CE VST01-JC) or placebo, and will then be monitored for response to therapy.

Progressive multifocal leukoencephalopathy (PML) is a demyelinating disease of the central nervous system caused by JC polyomavirus (JCPyV) occurring in immunocompromised patients who face a disease that is usually progressive and often fatal (Padgett 1971; Tan 2010). Annually, it is estimated that 4,000 people develop PML in the United States and Europe combined (NORD 2015).

This is a randomized, double- blinded, Phase 2 trial in patients with PML due to JCPyV. Patients will receive treatment with a matched virus-specific T-cell product (CE VST01-JC) or placebo, and will then be monitored for response to therapy. The study is designed to evaluate whether CE-VST01-JC infusions will slow and ultimately halt neurological progression in patients with PML compared with placebo as evaluated by modified Rankin Score (mRS).

Eligibility Criteria:
* Male or female subjects aged 18 years or older, with actively progressing PML confirmed by MRI and JCPyV present in CSF or in brain biopsy tissue (diagnosis confirmed according to algorithm diagnostic criteria for PML developed by the American Academy of Neurology).
Predictors of Weight Loss and Metabolic Health After Bariatric Surgery

In this prospective study the investigators aim to identify preoperative predictors of improvement of metabolic health and weight loss after bariatric surgery focusing on inflammation, insulin sensitivity (in a subgroup of patients), glucoregulatory determinants, psychological traits, feeding behavior characteristics and cardiorespiratory fitness

Obesity is the result of a complex interplay between genetic and epigenetic predisposition, environment, physical activity, nutrition and psychology. It is a debilitating disorder and a risk factor for the development of metabolic disorders such as dyslipidaemia, hypertension and hyperglycaemia as well as certain cancers. Bariatric surgery has proven to be the most effective treatment for morbid obesity with established long-term results of weight loss, remission of comorbid conditions and the improvement of Quality of Life (QoL). However, variability in these results after bariatric surgery is well known. Identifying preoperative predictors of postoperative weight loss and metabolic health is of clinical priority. Predictors could help further improve the efficacy of care for obesity by tailoring treatment to the individual, based on their predicted response and therefore optimize outcome after bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Patient is ≥ 18 and ≤ 75 years old
* BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
* Scheduled for primary bariatric procedure: Roux-en-Y gastric bypass (RYGB) or Sleeve Gastrectomy (SG)
* Stable weight 3 months prior to inclusion weight (\<10% change in body weight for 3 months prior to assessments)

In order to be eligible to participate in the subgroup of this study, we will use the following inclusion criteria:

* Ability to provide informed consent
* Patient is ≥ 18 and ≤ 75 years old
* BMI ≥ 40 kg/m2 or ≥ 35 kg/m2 with obesity related comorbidity
* Patients scheduled for RYGB
* Patients who are insulin resistant (impaired fasting glucose (\> 5.6 mmol/L) or fasting insulin \> 74 pmol/L)
* Postmenopausal women (to prevent bias due to the effect of sex hormones on insulin sensitivity)

Exclusion Criteria:

* Any actual medical condition except for obesity related health issues or well treated hypothyroidism
* Pregnancy anticipated in the first two years following surgery

A potential subject who meet the following criteria will be excluded from participation in the subgroup of this study:

* Coagulation disorders and/or use anticoagulants
* Use of any medication except for statins, antihypertensives (except for Angiotensine converting enzyme (ACE)- or angiotensin receptor blockers) and thyroid hormone
* Diabetes mellitus type 2
Tenofovir in HIV/HBV Coinfection

The purpose of the study is to compare the effectiveness of 3 different treatment regimens in reducing or clearing the Hepatitis B Virus in patients infected with HIV and Hepatitis B (co-infection)

A randomised multi-centre trial of tenofovir vs lamivudine vs tenofovir/lamivudine in antiretroviral naïve subjects with HIV/HBV co-infection over 48 weeks (Clinical Trial A). Plus, a 12 week viral kinetic sub-study comparing a sub-group of the patients on Clinical Trial A with a group of therapy naïve HBV mono-infected subjects (Substudy A1)

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Documented HIV infection (positive serology for HIV-1 and detectable HIV-1 RNA)
* Age 18 - 70 years
* HBV DNA \> 105 copies/ml
* HBsAg positive \>6 months or HBsAg positive and anti HB core IgM negative
* Creatinine \<= 2.0mg/dl (\<= 0.2 mmol/L)
* Platelet count \>= 50,000/mm
* HIV-1 antiretroviral therapy naïve
* No prior exposure to anti-HBV agents (LAM, adefovir, TDF) although prior IFN treatment allowed

Exclusion Criteria:

* HCV-RNA positive or Anti-HAV IgM positive
* Acute hepatitis (serum ALT \> 1000 U/L)
* Active opportunistic infection
* Other causes of chronic liver disease identified (autoimmune hepatitis, hemochromatosis, Wilsons disease, alfa-1-antitrypsin deficiency)
* Concurrent malignancy requiring cytotoxic chemotherapy
* Decompensated or Child's C cirrhosis
* Alfa-fetoprotein (AFP) \> 3X ULN (unless negative CT scan or MRI within 3 months of entry date)
* Pregnancy or lactation
* Any other condition which in the opinion of the investigator might interfere with compliance or outcome of the study
HR Chest CT Visual Scoring, Spirometry and Health Related Quality of Life in Evaluating Severity of ILD Patients

To establish a simplified approach for assessment of severity of interstitial lung disease by evaluating the relationship between HRCT findings, the clinical severity score,spirometry and quality of life.

The interstitial lung diseases are a group of parenchymal pulmonary disorders that affect the interstitium causing progressive fibrosis of lung tissue. These disorders characterized by dyspnea aggravated by exertion . This group of diseases is associated with substantial morbidity and mortality. Thus, a multi-disciplinary approach including clinical, pathological, and radiological correlation is required to reach accurate assessment. The high-resolution computed tomography \[HRCT\] images of the chest are considered the main platform for the diagnostic approach .High-resolution CT (HRCT) scans offer the possibility of measuring disease severity more accurately and sensitively by focusing on fibrotic changes. HRCT images illustrate the presence and extent of parenchymal abnormalities including: reticular opacities, ground-glass opacities, traction bronchiectasis and honeycombing. Most patients with suspected ILDs are likely to undergo complete Pulmonary Function Testing. Usually there is restrictive pulmonary function with decreased TLC (Total Lung Capacity) , FVC (Forced Vital Capacity), FEV1 (Forced Expiratory Volume in One Second) and a normal or increased FEV1/FVC ratio.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted at Chest Department or presented to our out patient clinic with clinical diagnosis of Interstitial Lung Diseases among both sexes

Exclusion Criteria:

* patients under 18 years old.
* pregnant patients.
* patients with a history of previous lung resections.
* presence of bronchial carcinoma or lobar consolidation.
* patients contraindicated to perform pulmonary function will be excluded.
Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease

The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion criteria:

* Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion
* COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)
* Age between 40 and 80 years

Exclusion criteria:

* Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)
* History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease
* History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays
* History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)
* Body mass index \>40kg/m2
* History of diabetes mellitus, measured fasting glucose \> 11 mmol/L
* History of Hypercholesterolemia, measured total cholesterol \> 8 mmol/L
* Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy
* Neutropenia, anemia (Hb \< 8 g/100mL)
* History of chronic renal failure, serum creatinine \> 176 micromol/L (2.0mg/dL)
* Creatine kinase \> 3 times the upper limit of normal (ULN)
* Acute or chronic liver disease (serum transaminases \> 3 times the ULN)
* Pregnancy (oral examination and blood test prior to inclusion)
* Active abuse of drugs or alcohol, poor compliance anticipated
* Statin use within the last 4 weeks prior to study start or previously clear indication for statin use
* Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin
* History of malignant disease of any kind within 5 years prior to inclusion.
* History of uncontrolled hypothyroidism
* Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion.
* Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid
A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe).

Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks.

The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart.

Women can only take part in the study if they are not able to become pregnant.


Eligibility Criteria:
Inclusion Criteria:

* Males or females of non-childbearing potential.
* Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b):

  1. Age 40 years or older at the time of signing informed consent and history of ASCVD
  2. Age above 50 years at the time of signing informed consent and with ASCVD risk
* Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening.
* Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants
* Participants must be on maximally tolerated dose of statins.
* Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.

Exclusion Criteria:

* Treatment with PCSK9i therapy (alirocumab or evolocumab within 90 days prior to screening) or PCSK9 siRNA therapy (inclisiran within 12 months prior to screening).
* Fasting triglyceride above 4.52 mmol/L (above 400 mg/dL) as measured by the central laboratory at screening.
* Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
* Renal impairment with eGFR less than 30 ml/min/1.73 m2 as measured by the central laboratory at screening
Remote Observed Dosing to Increase Suboxone Compliance

The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of using remote compliance monitoring in buprenorphine (Suboxone®) treatment for opiate dependence. To that end, 10 opiate dependent subjects will be recruited through the University of Pennsylvania's Treatment Research Center, an outpatient substance abuse treatment facility. All subjects will receive buprenorphine (Suboxone®) (16 mg/day, adjusted as needed according to individual requirements).


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily provide written informed consent prior to the conduct of any study-related procedure
* Male or female, 18 to 65 years of age,
* Meet DSM-IV criteria for current opioid dependence
* Females of childbearing potential and fertile males must use a reliable means of contraception
* Owns a smartphone with forward facing camera that allows for use of Skype

Exclusion Criteria:

* University of Pennsylvania student, employee, or affiliate
* Current diagnosis of AIDS
* Presence of AST and/or ALT equal to or 3X upper limit of normal
* Total bilirubin and/or creatinine equal to or 1.5X upper limit or normal
* Current diagnosis of chronic pain requiring opioids
* Pregnant or lactating females
* Previous hypersensitivity or allergy to buprenorphine or EVA-containing substances
* Current use of agents metabolized through CYP 3A4 such as azole antifungals (e.g. ketoconazole), macrolide antibiotics (e.g. erythromycin), and protease inhibitors (e.g. ritonavir, indinavir, saquinavir)
* Meet DSM-IV criteria for current dependence on any psychoactive substances other than opioids or nicotine (e.g. alcohol, sedatives)
* Current use of benzodiazepines other than physician prescribed
* Significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent
* Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study; and/or any pending legal action that could prohibit participation and/or compliance in study procedures
* Participated in a clinical study within the previous 8 weeks
Study to Evaluate Drug Levels of Various Solid Gastro-retentive Formulations of Deucravacitinib (BMS-986165) in Healthy Participants

The purpose of this study is to identify drug levels of gastro-retentive (GR) formulations which prolong retaining time in the stomach of deucravacitinib (BMS-986165) in Healthy Participants.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and healthy females according to the assessment of the Investigator.
* Body mass index of 18.0 kg/m\^2 through 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of first dose) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion.
* History of any significant drug allergy.
* Other protocol-defined Inclusion/Exclusion criteria apply.