cyrilzakka/clinical-trials huggingface dataset:
Drug Discrimination in Methadone-Maintained Humans Study 1

This study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. Each subject will receive 2-4 of the listed interventions.


Eligibility Criteria:
Inclusion Criteria:

1. Must be between the ages of 18-65.
2. Participation in the UAMS Substance Abuse Treatment Clinic Methadone Maintenance Program or the CATAR Clinic Little Rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry.
3. Subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. This would be defined as \< 3 missed methadone medications and missed \< 3 group or \<3 individual therapy sessions in the two months prior to study participation
4. Subjects must submit a urine sample negative for illicit drugs prior to study entry.
5. Subjects must be able to read and understand English.

Exclusion Criteria:

Exclusion criteria

1. Ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below).
2. Current diagnosis of other drug or alcohol physical dependence (other than tobacco).
3. History of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression)
4. Pregnancy, plans to become pregnant or inadequate birth control.
5. Present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested.
6. History of severe reaction to Narcan challenge, which may have been given as part of admission into the Methadone Maintenance Program or to reverse overdose.
7. Liver function tests greater than 3 times normal, BUN and Creatinine outside normal range, or thyroid function tests outside normal range.
8. EKG abnormalities including but not limited to: bradycardia (\<60 bpm); prolonged with QTc interval (\>420 msec); Wolff-Parkinson White syndrome; wide complex tachycardia; 2nd degree, Mobitz type II heart block; 3rd degree heart block; left or right bundle branch block.
IPS Differentiated Cardiomyocytes Vein Transplantation for Chronic Heart Failure

Based on the safety evaluation of primates, the best cell transplantation scheme was integrated. One patient with CHF caused by coronary heart disease, one patient with CHF caused by dilatation and one patient with CHF caused by Keshan disease were selected and treated with autologous iPS differentiated cardiomyocyte intravenous transplantation. The safety evaluation of human body was completed and combined with subjective and objective indexes respectively. Structural and functional indicators were used to evaluate the therapeutic effect of cell transplantation. The results of animal experiments confirmed the safety and effectiveness of intravenous myocardial cell transplantation, and clarified its possible mechanism.


Eligibility Criteria:
Inclusion Criteria:

* It accords with the diagnostic standard of chronic heart failure.
* The etiological diagnosis accords with the corresponding diagnostic standard.
* The age is 30\~80 years old.
* Cardiac function classification is III- grade IV.
* Signed informed consent.

Exclusion Criteria:

* Those who did not meet the diagnostic criteria and were included in the standard.
* Patients with severe dyspnea (such as COPD with pulmonary encephalopathy, upper gastrointestinal bleeding, etc.) accompanied by obvious hypoxemia and hemodynamic instability.
* Patients with severe primary diseases, such as liver and kidney diseases, hematological diseases, autoimmune diseases, malignant tumors, progressive diseases or diseases with poor prognosis, such as severe infection, severe water and electrolyte disorders, acid-base imbalance.
* Various infectious diseases.
* Participants in other clinical trials in the past two months.
Non-Invasive Ventilation After Extubation in Hypercapnic Patients

The purpose of this study is to assess the efficacy of noninvasive ventilation in the prevention of extubation failure and mortality in patients with chronic respiratory disorders and hypercapnic respiratory failure during spontaneous breathing.

Background and aims: Patients with chronic respiratory disorders, intubated and mechanically-ventilated in intensive care units (ICU), often exhibit hypercapnia during the spontaneous breathing trial prior to extubation; this is associated to increased incidence of extubation failure and mortality. We will assess the efficacy of noninvasive ventilation (NIV) in the prevention of extubation failure and mortality in these patients. Design: Prospective, randomized, controlled clinical trial with two groups: support with noninvasive ventilation, and conventional clinical management (control group). Subjects: Patients with chronic respiratory disorders, intubated and ventilated ³48 hours, with hypercapnia (PaCO2 \>45 mmHg) during the spontaneous breathing trial, ready to be extubated. Interventions: Random allocation into two groups: NIV immediately after extubation during 24 hours, on conventional clinical management. Clinical follow-up (incidence of extubation failure, reintubation, ICU and hospital mortality, 90-day survival, complications associated to mechanical ventilation, ICU and hospital length of stay). Analyses of data: Comparison between two groups (NIV and control) in non-paired data design: quantitative variables (t-test, Mann-Whitney test, ROC curves), qualitative or categorical variables (chi square, Fisher's exact test), and Kaplan-Meier estimate of survival curves).

Eligibility Criteria:
Inclusion Criteria:

* Chronic respiratory disorders with invasive mechanical ventilation
* Hypercapnic respiratory failure during successful spontaneous breathing trial

Exclusion Criteria:

* Face or cranial trauma or surgery
* Recent gastric or esophageal surgery
* Tracheostomy or other upper airway disorders
* Upper gastrointestinal bleeding
* Excess respiratory secretions
* Lack of collaboration
Biomarker-driven Therapy for Melanoma

Patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. The recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion.

The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.

Eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. Other inclusion criteria included age ≥ 18 years; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. Previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. Patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. The study is approved by the institutional research ethics board.

Molecular analysis is performed at the Max Planck Institute for Molecular Genetics Berlin and a comprehensive report is made available with 4-8 weeks. The molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. The recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. The recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly.

The main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not.

For patients treated according to the recommendations: Response rate and progression free survival at 6 months according to RECIST criteria.

Eligibility Criteria:
Inclusion Criteria:

* histologically proven metastatic melanoma failing standard treatments
* age ≥ 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* life expectancy ≥ 24 weeks
* adequate renal, liver, and bone marrow functions

Exclusion Criteria:

- history of cardiac disease or metastatic brain or meningeal tumors
Blackberry Polyphenol Intake and Fuel Management

Studies in animals have suggested that berry preparations or anthocyanin-rich berry extracts can reduce body fatness. Previous studies with tea catechins, which belong to the flavonoid class of chemicals as do anthocyanins, suggest that these compounds can alter fat oxidation, and this may be the mechanism by which body fatness is influenced by anthocyanin intake. Well-controlled studies in humans are lacking.


Eligibility Criteria:
Exclusion Criteria:

* Younger than 25 years old or older than 75 years old
* Female
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisinidione)
* Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
* Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
* Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
* Fasting triglycerides greater than 300 mg/dL
* Fasting glucose greater than 126 mg/dL
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanalamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
* Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
* Use of any tobacco products in past 3 months
* Use of oral or IV antibiotics during the month preceding the study
* Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
* Known (self-reported) allergy or adverse reaction to blackberries
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Hyperbaric Oxygen Therapy and SPECT Brain Imaging in Cerebral Decompression Illness

Chart review of patients who received hyperbaric oxygen therapy for cerebral decompression illness who also underwent SPECT brain blood flow imaging to see if SPECT brain imaging tracks and is consistent with the clinical condition of the patients.

SPECT brain imaging has been shown to be the most sensitive imaging modality for cerebral decompression illness. This study is a retrospective review of the PI's experience using SPECT brain imaging in the diagnosis and treatment of all phases of cerebral decompression illness over the past two decades. The purpose of the study is to see if the functional imaging is consistent with the clinical condition and cognitive testing. Chart review of symptoms, and physical exam findings will be compared before and after treatment to SPECT brain imaging radiological readings to assess concordance.

Eligibility Criteria:
Inclusion Criteria:

* All patients in the P.I.'s practice who underwent hyperbaric oxygen therapy for cerebral decompression illness in the previous two decades who also underwent SPECT brain blood flow imaging early in the course of treatment and following completion of hyperbaric oxygen therapy.

Exclusion Criteria:

* none
Osteoarthritis in Older Adults: Recovery of Mobility and Pain With a Topical Analgesic

Biofreeze® is a topical ointment that has menthol and alcamphor. Its analgesic effect lies in the stimulation of A and C fibers by cold and nociceptive stimulation, respectively, which is produced by menthol, apparently through the newly discovered receptor TRPM8 (Transient Receptor Potential melastatin-8) The aim of this study is to investigate if BIOFREEZE ® treatment (Performance Health Inc., Export, PA) improves symptoms associated with moderate knee osteoarthritis, which would decrease the immobility and isolation in older adults.


Eligibility Criteria:
Inclusion Criteria:

* Moderate osteoarthritis of the knee
* Age 60 to 80 years
* Ambulatory

Exclusion Criteria:

* Other conditions that affect mobility
* Severe chronic diseases such as cardiac or renal failure
* Cancer
* Presence of gout
* Cognitive impairment
CyberSenga: Internet-based HIV Prevention in Uganda

The investigators propose to design and test an Internet-based HIV prevention program for adolescents in Uganda.

HIV/AIDS is a major contributor to morbidity and mortality in Uganda. Despite aggressive advances in HIV prevention efforts, recent data suggest that HIV prevalence is increasing generally, and HIV knowledge, a direct contributor to behavior, is on the decline among young people specifically as compared to a decade ago.

The Internet is a promising mode of intervention delivery in resource poor-settings because the costs associated with scaling up are minimal; dissemination online is the same if one person or 100,000 people use the program. Just as important, it provides access to important health information in a stigma-free, anonymous atmosphere. Our recent data indicate that 45% of adolescents in Mbarara, Uganda have used the Internet, 78% of whom went online at least once in the previous week. Eighty-one percent of respondents in the same survey indicated they would go to an HIV prevention web site if it existed. Based upon these data, we propose to develop a culturally appropriate, Internet-based HIV prevention program designed specifically for Ugandan adolescents between the ages of 12 and 18 years. Our specific aims are as follows:

Specific Aim 1: Design a 6-hour, Internet-based HIV prevention program for adolescents. Content will be culturally tailored to the HIV preventive information, motivation, and behavioral skills needs of Ugandan adolescents.

Specific Aim 2: Test the intervention in a randomized controlled trial (n=500) among adolescents attending grades Secondary 1-4 (similar to US high school grades 8th - 11th) at day schools in Mbarara.

This project has the potential to develop low-cost and salable interventions to HIV transmission risk behaviors among adolescents in Uganda.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in grades Secondary 1 through 4 at a partner secondary school
* Having used a computer or the Internet at least once in the past year
* Not having been part of the intervention development activities
* Caregiver informed permission and adolescent informed assent

Exclusion Criteria:

* none
The Efficacy and Safety of Desensitation Regimen for Patients With High Titers of Anti-HLA Antibodies Prior to Allo-HSCT

Evaluation of the efficacy and safety of immunoadsorption or plasma exchange combined with rituximab and high-dose IVIG to reduce high titres of anti-HLA antibodies in patients prior to allogeneic haematopoietic stem cell transplantation

Approximately 10-21% of allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients have non-specific or donor-specific anti-HLA antibodies (DSAs) prior to transplantation. Patients with combined DSAs and mean fluorescence intensity (MFI) ≥ 5000 can lead to a significantly higher incidence of primary graft failure and graft dysfunction after transplantation, and increased transplant-related mortality (TRM). Meanwhile, a retrospective study at our centre found that patients with high titre non-specific antibodies (MFI ≥ 5000) present before cord blood transplantation had significantly higher TRM in the early post-transplantation period. Therefore, our centre intends to conduct a single-arm prospective cohort study to explore whether the desensitisation regimen of immunosorbent or plasma exchange combined with rituximab and high-dose IVIG before transplantation in allogeneic hematopoietic stem cell transplantation patients with high titres of anti-HLA antibodies can lower the antibody titres in the patient's body, reduce the incidence of transplant-related complications, and improve the prognosis of transplantation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects to undergo allo-HSCT
2. Age 14-60, No gender, No ethnicity
3. ECOG score ≤ 2
4. Population reactive antibody screening within 1 month prior to transplantation HLA-class I or class II antibody MFI ≥ 5000
5. No severe organ failure and no active infections
6. Subjects and their families voluntarily undergo anti-HLA antibody testing and antibody desensitisation treatment and sign an informed consent form

Exclusion Criteria:

1. Those with severe organ dysfunction or disease, such as severe disease and dysfunction of the heart, liver, kidneys and pancreas
2. Pregnancy
3. Subjects and/or authorised family members who refuse to accept antibody desensitisation treatment
4. Persons with any life-threatening disease, physical condition, or organ system dysfunction that, in the opinion of the investigator, may compromise the safety of the subject and place the results of the study at unnecessary risk
5. Persons with drug dependence,uncontrolled psychiatric disorders and persons with cognitive dysfunction
6. Participants in other clinical studies within 3 months
7. Those whom the investigator considers unsuitable for enrolment (e.g., subjects will not be able to adhere to examinations and treatments due to financial or other issues)
Nutrition, Physical Performance & Fitness in Indian School Children

The purpose of this study is to evaluate the effect of nutritional supplement on physical performance measures of apparently healthy school going children in India.

Nutritional status may be important in achieving optimal physical performance. There is evidence of significant improvements in physical fitness, aerobic capacity and anaerobic threshold of children and adolescents with nutritional intervention, albeit in children with initial sub-optimal nutritional status. This may be of particular relevance in developing countries like India, where there is limited data on physical fitness and a wide-spread prevalence of concurrent micronutrient deficiencies even in apparently normal school age children. The present study therefore, is designed to assess the effect of a nutritional supplement on the physical performance measures of school going children. This is a randomized, double blind placebo-controlled study of three treatment groups (1 test, 1 positive control (placebo) and 1 'no intervention') conducted in equal numbers of male or female children \[ages 7-11\] attending day schools in Bangalore. Subjects in the intervention (test and positive control) groups will receive study treatments (fortified or un-fortified nutritional powder) once a day for 4 months. The treatments will be administered under supervision on all school working days; for the weekend and other holidays, sachets will be provided for home consumption. At baseline and 4months, physical performance tests will be administered and blood sample drawn to assess nutritional status. Other selected outcome measures such as nutrition status and muscle strength/ endurance will also be assessed. It is hypothesized that after 4 months of intervention, children consuming fortified nutritional powder will have statistically significant improvements in physical performance/ fitness measures as compared to the two control groups.

Eligibility Criteria:
Inclusion Criteria:

* Boys and girls between ages 7-10.5 years
* Z score of height for age and weight for age of 0 to \< -3
* Good general health at screening
* Understands and is willing, able and likely to comply with all study procedures and restrictions
* Written informed consent from the parents/ guardians and writtent assent by the study participant

Exclusion Criteria:

* Severe anemia (Hb\<8 g% )
* Cardiovascular disease on clinical examination or history
* Any underlying respiratory disease with impairment of lung function
* Physical disability Children consuming nutritional supplements (tonics, syrups, tablets or chews) and/ or health food drinks on a regular basis
* Recent history \[3mo\] of serious infections, injuries and/ or surgeries
* Participation in any nutritional study in the last 1 year
* Indication that they are likely to move within the period of study intervention
* Any known food allergies like peanut allergy, gluten allergy
* Family members of an employee of the Sponsor or the study site.
Studying the Impact of a Medication Use Evaluation by the Community Pharmacist

In this intervention study, 75 Belgian community pharmacies each recruit 12 patients for an intermediate medication review. For each patient, the identified drug-related problems and subsequent interventions are registered using the PharmDisc classification. In a subset of Dutch speaking patients, a pretest-posttest single group design is used to measure the impact of this review on patient related outcomes using questionnaires. The primary outcome is the medication related quality of life, measured via the living with medicines questionnaire. Other patient reported outcomes include adherence, self-management, patient satisfaction, fall incidents and use of emergency healthcare services. Medication records are also collected to objectively measure adherence before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients should be 70 years or older
* Use five or more drugs on a regular basis (prescription or non-prescription drugs)
* Live in the ambulatory setting
* Obtain his medication from this pharmacy on a regular basis

Exclusion Criteria:

-