cyrilzakka/clinical-trials huggingface dataset:
Vancomycin Treatment in Recurrent PSC in Liver Transplant Patients

The purpose of the study is to investigate the safety and efficacy of oral vancomycin in patients with recurrent Primary Sclerosing Cholangitis (PSC) after liver transplantation. The primary endpoint is looking at the effect of the drug on liver function tests, an important surrogate of PSC disease activity at 12 weeks on treatment. Secondary endpoints include a decrease in liver function tests at 1 year, changes in bilirubin and adverse events. Effective treatment at the onset of PSC recurrence may lead to decreases in disease progression, recurrent liver failure, and repeat liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

1. History of prior orthotopic liver transplant or liver and kidney transplant.
2. Recurrent PSC confirmed by clinical labs (AST/ALT greater than 19 or ALKP greater than normal), imaging (MRCP or ERCP), and/or liver biopsy consistent with recurrent PSC.
3. No clinical evidence of liver transplant rejection and stability of post-transplant immune suppression dosing for three months prior to enrollment in the study
4. No changes to therapy for inflammatory bowel disease for at least three months prior to enrollment (for patients with history of IBD)
5. Patients on ursodiol must have been on a stable dose for two weeks prior to enrollment and dose must be stable for the remainder of the clinical trial.
6. All patients with inflammatory bowel disease must have had a colonoscopy within a year prior to enrollment
7. No antibiotics for 2 months before starting vancomycin
8. No probiotics for 1 month prior to starting vancomycin or during study period

Exclusion Criteria

1. Allergy to vancomycin
2. Pre-existing advanced malignancies
3. Pregnancy or Lactation
4. Inability to provide consent
5. Findings suggestive of liver disease of other etiology such as chronic alcoholic liver disease, chronic hepatitis B or C infection, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis, Wilson's disease, or congenital biliary disease.
6. Current biliary obstruction
7. Active infection
8. Involvement in any other investigational study
Multicenter, Prospective, Real World Study of Camrelizumab in Cross-line Treatment of Non-small Cell Lung Cancer

To explore the effectiveness and safety of Camrelizumab based cross-line therapy for patients with advanced NSCLC in the real world


Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent and volunteered to join the study
2. Aged \>=18 years
3. Patients with stage IIIb, IV, or relapsed non-small cell lung cancer diagnosed cytologically or histopathologically as EGFR/ALK-
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
5. At least one measurable lesion (according to RECIST 1.1)
6. No prior systemic therapy for advanced/metastatic NSCLC
7. contraception

Exclusion Criteria:

1. Those who are allergic to drug treatment；
2. Patients who were also treated with other immunodrugs or therapies；
3. Patients who are participating in other intervention studies；
4. Patients with other malignant tumors at the same time；
5. Pregnant or lactating women；
6. The investigator did not consider the patients eligible to participate in the study under any other circumstances.
Gene Expression Changes of Brain Tissue in Human Temporal Lobe Epilepsy With Hippocampal Sclerosis

Epilepsy is a common neurological disease, manifested in the sudden abnormal discharge of neurons leading to short-term brain dysfunction, has become the neurology after headache the second most common disease. In China, the prevalence of epilepsy is about 4.7-8.5 per 1,000, and more than 400,000 new cases of epilepsy are developed each year. Of these, 30% of patients were treated with ineffective medication, developing into a drug-incurable epilepsy that required surgery and other treatments. The most common type of epilepsy is temporal lobe epilepsy, while the common complication in temporal lobe epilepsy is hippocampal sclerosis, which often requires surgical removal. The incidence of inner temporal lobe epilepsy associated with hippocampal sclerosis is increasing, but its exact cause and specific pathogenesis are still unclear, so clarifying its pathogenesis will contribute to the understanding of temporal lobe epilepsy and the improvement of surgical procedures. This study is intended to get single-cell transcriptome as well as spatial transcriptome data of temporal lobe and hippocampus samples. By studying gene expression change associated with epilepsy and hippocampus sclerosis, we intended to find possible prognostic-related molecules and to deepen understanding of pathological changes in epilepsy at the molecular level.


Eligibility Criteria:
Inclusion Criteria:

* Patients confirmed in our hospital as having temporal lobe epilepsy and intending surgery to remove temporal lobe and hippocampal tissue;
* Volunteer to participate in this clinical trial, comply with the requirements of this clinical trial and sign an informed consent form.

Exclusion Criteria:

* Chronic diseases of the central nervous system other than temporal lobe epilepsy;
* Other patients that are not suitable for this clinical trial determined by the researchers;
Optimization Study of the Wraparound Care for Youth Injured by Violence Program

This study is an optimization study to evaluate how a wraparound program for youth who have been injured by violence helps to change violence related attitudes and beliefs, change individual risk factors for violence and reduce the risk of future injury due to violence. Wraparound care involves linking the youth with a support worker who will work with the youth to develop positive support networks and help them link with services that address risk factors towards future violence.

In Canada, violence is the most common reason for youth (aged 12- 24) to visit an emergency department (ED) and the leading cause of hospitalization among males aged 20 to 24. Injury is a chronic, recurring disease. In Winnipeg, Canada, 20% of youth injured by violence visited the same ED in the next year with a repeat injury due to violence. Currently the standard of care for this vulnerable population is to discharge them from our EDs with no effort to prevent the next injury.

There are 5 components key to implementing wraparound care for youth who are at risk of violence. The 1st component is the establishment of a relationship between support worker and youth at the time of injury - i.e. during a teachable moment. The 2nd component is that the support worker has extensive "lived experience". Many youth affected by violence have been marginalized by society and have significant trust issues with figures of traditional power (i.e. doctors, social workers etc.). It is imperative that the support worker establish trust quickly and act as a role model. The 3rd component is that the care program is individualized for and by each youth. The support worker helps the youth to define their own goals and the steps required to achieve them. The 4th component is to provide trauma-informed care. Trauma-informed care is an approach used by caregivers that acknowledges the current and past traumas a person may have experienced and helps the person heal and build a sense of control over their lives. The final component is the opportunity to access community supports within their own culture.

Eligibility Criteria:
Inclusion Criteria:

1) Age 14 - 24, and 2) Presentation with an injury due to violence (defined as an injury inflicted by someone else and one caused by a gunshot wound, stab wound, blunt object, or bodily force).

Exclusion Criteria:

1) Unable to consent due to language or brain injury, 2) Sexual assault, 3) Child Abuse, 4) Self-Inflicted Injury, or 5) Transfer from hospital \> 1 hr from Winnipeg, Canada
Yangxinshi Tablet Intervention for Exercise Capacity in Patients With Chronic Coronary Syndrome

This study is a prospective, multicentre, randomized, open-label, blinded-endpoint clinical trial to evaluate the efficacy and safety of Yangxinshi tablets in the treatment of patients with chronic coronary syndrome (CCS).

This study plans to enrol 1200 CCS patients. A central randomized control group will be set up. The experimental and control groups will be populated at a 3:1 ratio. In addition to basic medication, the experimental group will be given Yangxinshi tablets (three tablets each time, three times a day); the control group will be given basic medication only. The treatment period is 24 weeks. The primary efficacy indicator is the 6-minute walking distance (6MWD).

Eligibility Criteria:
Inclusion Criteria:

1. age 18-75 years;
2. CCS patients in stable condition and clearly diagnosed by coronary artery imaging (at least one vessel stenosis ≥ 50%): stable angina, ischaemic cardiomyopathy, asymptomatic or stable symptoms, occult coronary heart disease, acute coronary syndrome (ACS), or \>3 months after coronary revascularization;
3. moderately to severely limited exercise tolerance: the maximum 6MWD is \< 450 m, or the metabolic equivalent (MET) as measured by treadmill cardiopulmonary exercise testing is \< 5 METs;
4. voluntary participation and signing of informed consent.

Exclusion Criteria:

1. absolute or relative contraindications for the treadmill cardiopulmonary exercise test or 6-minute walk test (6MWT);
2. serious primary diseases, mental diseases, or malignant tumours that affect lifespan;
3. pregnancy, intended or suspected pregnancy, miscarriage, breastfeeding, or delivery in the last 6 months;
4. subjects not suitable for this study in the opinion of the researchers, such as subjects who are participating in other drug clinical trials or intervention studies.
A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies

The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \[DM\] or polymyositis \[PM\]).

Idiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.

DM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.

These disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.

This study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.

The study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.

There will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Participants that completed a qualifying study through Week 52.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation.
* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).
* Current use of any prohibited concomitant medication(s).
* Active bacterial, viral, fungal, mycobacterial or other infections.
* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.
* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Combination Chemotherapy in Treating Patients With Stage IIIB or Stage IV Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

OBJECTIVES: I. Compare the duration of symptom control, time to disease progression, survival, and quality of life in patients with stage IIIB or IV non-small cell lung cancer treated with 3 versus 6 courses of mitomycin, vinblastine, and cisplatin.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by stage of disease (stage IIIB vs IV). Patients are randomized to 1 of 2 treatment arms: Arm I: Patients receive cisplatin IV over 4 hours, mitomycin IV, and vinblastine IV on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during course 3. Arm II: Patients receive chemotherapy as in arm I. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Mitomycin is not administered during courses 3 and 5. Quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm I and after completion of 4, 5, and 6 courses for those in arm II. Patients may receive radiotherapy beginning after completion of chemotherapy.

PROJECTED ACCRUAL: A total of 310 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage IIIB or IV non-small cell lung cancer that is not eligible for surgery or radical radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod-WHO 0-2 Life expectancy: Not specified Hematopoietic: Hemoglobin greater than 10 g/dL WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Liver function tests no greater than 2 times normal (unless due to metastatic disease) Renal: Creatinine clearance greater than 60 mL/min EDTA clearance greater than 60 mL/min Other: No serious, uncontrolled, concurrent medical illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior conventional chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics Surgery: See Disease Characteristics
Effects of Training Combined With a Small Financial Incentive on Reducing Alcohol Consumption

The existing alcohol intervention studies are mainly conducted in developed countries, few studies have focused on alcohol consumption among ethnic minority migrant people in developing countries. To address this gap, the investigators aim to evaluate the effects of a brief intervention combined with a small financial incentive on alcohol consumption and health outcomes among the migrated population in Liangshan Prefecture. This study was conducted in Liangshan Prefecture for two reasons: first, Liangshan is a region located in the southwestern of Sichuan province and is populated by Yi minority, and the average income in Liangshan is just about two-thirds of the national average income. Second, a study found that the drinking rate of the Yi minority (47.9%) is higher than that of other regions in China.

The aim of this paper is to provide an overview of alcohol consumption among the ethnic populations in China and to test the feasibility and efficacy of small financial incentives with brief advice intervention targeting the reduction of harmful drinking behaviors among poor people.


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Age\<18 and Age\>65
* Scores of AUDIT\<8
* Do not speak mandarin
* Less than three-months residence at Xichang
* Income not calculated by hour wage or piece-rate wage
* Those who have previous abstinence experience, epilepsy, liver disease, and is using sedative drugs
Preclinical Imaging Biomarkers of Alzheimer's Disease Neuropathology in Young Adults With Youth-onset Diabetes: a Proof-of-concept Study

The goal of the study is to characterize preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes, and an age-similar group of young adults without diabetes.

The goal of the current proof-of-concept study is to characterize brain structural, functional, and molecular imaging biomarkers of preclinical Alzheimer's Disease and related dementias (AD/ADRD) neuropathology in a selected group of young adults with youth-onset diabetes (Y-DM; type 1 diabetes \[T1D\], n=5; type 2 diabetes \[T2D\], n=5) from the SEARCH for Diabetes in Youth study cohort, and an age-similar group of young adults without diabetes (n=5). This study will quantify structural and functional imaging biomarkers of AD/ADRD neuropathology via magnetic resonance imaging by assessing gray matter (GM) volume/cortical thickness, as well as GM and white matter (WM) microstructure, resting state functional network connectivity (rsfMRI), and cerebral blood flow (CBF) and WM hyperintensity volume. This study will additionally quantify brain tau density via positron emission tomography as the gold-standard measure of preclinical AD/ADRD neuropathology.

Eligibility Criteria:
Inclusion Criteria:

* Part of the SEARCH for Diabetes in Youth study cohort or
* Age 18-40
* Without diabetes

Exclusion Criteria:

* Head trauma with loss of consciousness \>30 minutes
* Claustrophobia
* Metal in the body
* Major psychiatric disorder (eg. schizophrenia, bipolar, and major depression)
* Neurological conditions affecting cognition (eg. epilepsy)
* Stroke
* If female, breastfeeding, plan to become pregnant or are pregnant
Balloon Expandable Transcatheter Aortic Valve Implantation Without Predilation of the Aortic Valve

There is limited experience for the balloon expandable THV (transcatheter heart valve) on the need for predilation (ballon aortic valvuloplasty, BAV). Therefore we aim to verify results of a small case series published by Wendler et. al. to examine hard endpoints such as the incidence of cerebrovascular complications, paravalvular leakage and operative outcomes in a multicenter registry.

We aim to compare the implantation of balloon expandable transcatheter heart valves with or without predilation with respect to procedural outcomes (VARC2).

Prior to the deployment of transcatheter heart valves (THV), balloon aortic valvuloplasty (BAV) is usually performed under rapid right ventricular pacing (burst \>180 bpm) with the induction of a functional cardiac arrest for up to 30 seconds. Aortic valve predilation is aiming at facilitating the crossing of the aortic annulus, accurate valve positioning and does also provide information on the anatomy of the valve complex. However, BAV has been shown to have a number of potentially detrimental effects, such as:

* Functional cardiac arrest induced by rapid pacing leads to transient coronary, cerebral, and renal ischemia.
* In patients with a reduced left ventricular ejection fraction (LVEF), prolonged cardiac depression after rapid pacing is observed and may result in hemodynamic failure and systemic inflammatory response syndrome (SIRS). Both are associated with a high periprocedural mortality.
* BAV has been identified as a major source of thrombotic and valvular material and increases the risk for coronary obstruction with subsequent myocardial infarction and stroke.
* The local trauma in the left-ventricular outflow tract caused by BAV may potentially contribute to aortic root rupture.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for TAVI as to the Edwards THV IFU
* Eligible for TABI with AND without BAV
* Signed informed consent

Exclusion Criteria:

* Logistic EuroSCORE I \>50%
* Mitral or tricuspid valvular insufficiency (\> grade II)
* Previous aortic valve replacement
* Uncontrolled atrial fibrillation
* Left ventricular or atrial thrombus by echocardiography
* Recent cerebrovascular event (within the last 3 months)
* High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
Effectiveness of Lifestyle Counseling Versus Physical Therapy on Chronic Low Back Pain

Background:

Low back pain is the leading cause of disability, affecting the quality of life and work productivity.

It is the most common reason for seek medical help and advice. Low back pain creates huge economical burden worldwide. To date, most ( 90%) of low back pain cases are not clinically defined with no preferred medical treatment

1. Study objectives:

   To prove that consulting using the "Stage of change" model for daily physical activity will lead to long term improvement of pain, disability and well-being parameters of those suffering from chronic low back pain, people age 25-55, when compared to conventional Physical Therapy.
2. Study hypotheses:

   The intervention groups vs. Physical Therapy group will demonstrate that the following parameters will improve after: 3 months, one, two and five years.
   1. Pain reduction.
   2. Less disability - improvement in daily activities.
   3. Better feeling of health and well-being.
   4. Increased and better compliance to daily sport activities.
   5. BMI reduction.
   6. Reduction of cigarette smoking.
   7. Reduction of usage of anti-analgesics and anti-inflammatory medications.
   8. Reduction in number of visits to Physical Therapy clinics due to low back pain.
3. Methods:

The present Randomized intervention study that will include 220 healthy individuals, males and females aged 25-55 years old suffering from chronic or recurrent low back pain, with or without radiation to the legs that were referred to Maccabi Healthcare Services Physical Therapy clinics in the Sharon district in Israel.

These individuals will be randomized to one of the following two groups:

1. Conventional Physical Therapy.
2. Physical Therapy focused on healthy lifestyle using the "Stage of Change" model.

Non-dependent observer will follow-up on the outcome parameters via phone calls and filling the questionnaire's with the relevant study participants following 3 months, 1 year, 2 and 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 25-55 years old
* Chronic / recurrent low back pain (over 3 months)
* With or without radiation

Exclusion Criteria:

* Rheumatoid disease
* Tumors
* Fibromyalgia
* Back surgery
* Road / work accidents
* Non Hebrew speaking
* Pregnancy