cyrilzakka/clinical-trials huggingface dataset:
The Effect of Chan-Chuang Qigong on Fatigue, Exercise Capacity and Quality of Lifpatients With Heart Failure

This study aimed to investigate the impact of Chan-Chuang Qigong on fatigue, exercise capacity, quality of life, and heart function in heart failure patients. The study recruited 72 heart failure patients from a medical center in northern Taiwan for an experimental study. The participants were randomly divided into two groups: patients in experimental group was given twice daily, every 15 minutes Chan-Chuang qigong, control group received the regular care for heart failure patients. Data was collected using the Piper Fatigue Scale, a six-minute walking test, and the Minnesota Living with Heart Failure Questionnaire before the intervention as the baseline, and at the 4th, 8th, and 12th weeks during the intervention. It is hoped that through this study, we can understand the effect of Chan-Chuang qigong on improving fatigue, exercise capacity and quality of life in patients with heart failure, and provide an additional choice and reference for the treatment and care of patients with heart failure in the future, and recommend future treatment of heart failure.


Eligibility Criteria:
Inclusion Criteria:

1. at least 20 years of age.
2. Cardiology specialist diagnoses heart failure based on clinical examination
3. Heart failure classified as New York Heart Association class II (NYHA II)
4. Left ventricular ejection volume \<50% (HFmrEF and HFrEF)
5. According to the doctor's assessment, it is not appropriate to exercise
6. Clear consciousness and ability to communicate
7. Agree to participate in this study after explanation and sign the consent form

Exclusion Criteria:

1. Renal failure treated with hemodialysis
2. Severe arrhythmias, such as third-degree atrioventricular block, frequent ventricular pulses and heartbeats greater than 130 beats/min at rest
3. About to undergo coronary interventional surgery or cardiac surgery within 3 months
4. Coronary interventional surgery or cardiac surgery in the past 3 months
Environmental Assessment of Sleep in Youth

In this research study, investigators want to learn more about the factors that influence children's breathing during sleep and their sleep quality. Specifically, investigators are interested in factors that are related to risk of snoring, sleep apnea (a condition where breathing stops during sleep), and poor sleep quality.

Investigators are doing a research study to gather information to help better understand why snoring and sleep problems are so common in the community, and how the home and neighborhood environment impacts sleep in children. Investigators want to know if factors such as the quality of air, household dust, environmental noise, and family routines impact sleep and other health and behavioral factors associated with sleep.

Investigators want to test how sleep is influenced by factors such as: the quality of air inside and outside the child's home (including measuring pollution, second hand smoke, and dust); temperature and humidity; family routines and interactions; and characteristics of the home. Investigators will ask participants to come in for a one time visit for undergoing procedures as well as answering questions regarding general health, asthma and sleep. 10% of the participating children will have a second home assessment and sleep monitoring procedures performed 6 months after the initial home assessment.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years
* Children living (50% of the time or more) at their current residence for at least 1 month

Exclusion Criteria:

* Children with severe chronic diseases (e.g. cancer, genetic or congenital disorders interfering with mobility)
* Children with severe neurobehavioral, neurodevelopmental or psychiatric disorders requiring special assistance
* Children living in the current residence for \< 1 month will be not be eligible.
* Families who do not speak English or Spanish well enough to complete the neuropsychological measures, as validated versions in other languages are not available for all of the measures.
Japanese Study With Rimonabant in Obese Type 2 Diabetic Patients With Oral Anti-diabetic Drug

The primary objective of this study is to assess the efficacy of Rimonabant (SR141716) compared to placebo on change in HbA1c and on relative change in body weight over 52 weeks in obese type 2 diabetic patients on monotherapy inadequately controlled with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor).

The secondary objectives are:

* To evaluate the effect of Rimonabant compared to placebo on other parameters related to the glucose control, waist circumference, Body Mass Index and metabolic parameters;
* To evaluate the safety and tolerability of Rimonabant compared to placebo;
* To evaluate the pharmacokinetics of Rimonabant.

The total duration per patient will be approximately 69 weeks including a 52-week double-blind treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus patients on monotherapy with oral anti-diabetic drug (sulfonylurea or α-glucosidase inhibitor)
* HbA1C ≥ 7.0 % and ≤ 10.0 %
* Body Mass Index ≥ 25 kg/m²

Exclusion Criteria:

* Type 1 diabetes
* Within 12 weeks prior to screening visit: use of oral antidiabetic drugs (other than a sulfonylurea or alpha-glucosidase inhibitor) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
* Within 4 weeks prior to screening visit: administration of systemic long-acting corticosteroids or prolonged use (more than one week) of other systemic corticosteroids, change in lipid lowering treatment
* Secondary obesity
* Primary hyperlipidemia
* Positive serum pregnancy test in females of childbearing potential

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study of Clofarabine for Older Patients With Newly Diagnosed Acute Myelogenous Leukemia (AML) (CLASSIC II)

Clolar (clofarabine injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment regimens.

This study will evaluate the efficacy of clofarabine in elderly patients with acute myelogenous leukemia (AML) who are unlikely to benefit from treatment with intensive chemotherapy regimens (cytarabine and anthracycline based regimens) used in younger patients with AML.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AML (de novo, secondary or with an antecedent hematologic disorder \[AHD\])
* Age ≥ 60 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Presence of at least one adverse prognostic factor: Age ≥ 70 years; or AHD; or ECOG performance status of 2; or Intermediate or unfavorable (i.e., adverse) karyotype defined as any cytogenetic profile except the presence of any of the following:

  * t(8;21)(q22;q22)
  * inv(16)(p13;q22 or t(16;16)(p13;q22)
  * t(15;17)(q22;q12) and variants.
* Adequate renal and hepatic function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN; and Serum creatinine ≤ 1.0 mg/dL; if serum creatinine \> 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73 m\^2 as calculated by the Modification of Diet in Renal Disease (MDRD) equation
* Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 40% or left ventricular fractional shortening ≥ 22%

Exclusion Criteria:

* Diagnosis of acute promyelocytic leukemia
* Prior treatment with clofarabine
* Prior treatment for AML or an antecedent hematologic disorder
* Prior hematopoietic stem cell transplant (HSCT)
* Prior radiation therapy to the pelvis
* Investigational agent received within 30 days prior to the first dose of study drug
* Ongoing uncontrolled systemic infection
* Diagnosis of another malignancy, unless the patient has been disease-free for at least 5 years following the completion of curative intent therapy with the following exceptions: Patients with treated non-melanoma skin cancer, in-situ carcinoma or cervical intraepithelial neoplasia regardless of disease-free duration are eligible for this study if definitive treatment for the condition has been completed; Patients with organ-confined prostate cancer with no evidence of recurrent or progressive disease based on PSA value are eligible for this study if hormonal therapy has been initiated or a radical prostatectomy has been performed
* Clinical evidence of central nervous system (CNS) involvement
* Severe concurrent medical condition or psychiatric disorder that would preclude study participation
* Positive human immunodeficiency virus (HIV) test
A Phase I Dose Escalation Study of Synthetic Hypericin in HIV-Infected Patients With Less Than 300 CD4 Lymphocytes

To determine the maximum tolerated dose (MTD) of hypericin, to define the types of toxicities that may be observed, and to determine what doses of the drug are associated with improvements in virological and immunological surrogate markers of HIV infection. To determine the bioavailability of synthetic hypericin given in 2 percent benzyl alcohol solution.

Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.

Hypericin is unlike other drugs presently being used to treat AIDS patients. Hypericin shows anti-HIV activity in test tube experiments.

Each group of eight patients receives a given dose of hypericin by intravenous infusion. Doses are given three times per week for 8 weeks. When all eight patients at a dose level have been entered and four of the eight patients have completed 3 weeks of therapy without evidence of dose-limiting toxicity, additional patients may begin to receive drug at the next dose level. Concurrently, six patients wll participate in an oral-dosing bioavailability study. NOTE: The initial study was stopped secondary to an MTD being reached.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Prophylaxis for Pneumocystis carinii pneumonia (required for patients with CD4+ \< 200).
* Symptomatic treatment with analgesics, antihistamines, antiemetics, antidiarrheal agents, or other supportive therapy.
* Short courses (\< 10 days) with ketoconazole or fluconazole for oral candidiasis or acyclovir for herpes lesions.
* Topical medications such as clotrimazole troches or nystatin suspensions.

Concurrent Treatment:

Allowed:

* Blood transfusions.

Patients must have HIV infection with CD+4 lymphocyte count of \< 300 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded.

* Kaposi's sarcoma requiring systemic therapy.

Concurrent Medication:

Excluded:

* Continued use of opiates or drugs known to induce photosensitivity.

Patients with the following are excluded:

* Active or chronic opportunistic infection at time of study entry that required curative or suppressive therapy.
* Significant liver disease, orthostatic hypotension, cardiac disease, seizure disorder, lymphoma, hypotension.

Prior Medication:

Excluded:

* Zidovudine (AZT), dideoxyinosine (ddI), dideoxycytidine (ddC), interferon, other antiretroviral agents or immunomodulating drugs within 1 month prior to study entry. Ribavirin within 3 months of study entry.
* Ganciclovir (DHPG), antimycobacterial drugs, MAO inhibitors, hypertension-inducing, nephrotoxic, or hepatotoxic drugs within 14 days of entry.
* Cytotoxic chemotherapy within 1 month prior to study entry.

Active substance abuse.
Mumbai Worksite Tobacco Control Study

The investigators are designing and testing the effectiveness of an integrated tobacco control and occupational health (OH) intervention aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies in 20 manufacturing worksites in the greater Mumbai region of India.

Through 6 health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use.

Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced.

Eligibility Criteria:
Inclusion Criteria:

* Manufacturing worksites located in the Mumbai, Thane, or Raigad districts of India
* Employ at least 60% production workers/40% administrative staff OR at employ at least 200 production workers on staff. NOTE: We are defining "workers" as anyone who is on the company roster, regardless of whether they're permanent or contractual
* Companies must be autonomous decision-makers and allow us to function at their worksite
* Companies must be willing to provide us with a current employee roster

Exclusion Criteria:

* Employees do not speak English, Hindi, or Marathi
Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia

Bilateral pallidal stimulation is effective in the treatment of patients with generalised idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal stimulation in patients with post-anoxic generalised dystonia or non-generalised primary dystonia.

Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients with post-anoxic generalised dystonia or primary dystonia.

Eligibility Criteria:
Inclusion Criteria:

* Post-anoxic generalised dystonia
* Idiopathic non-generalised dystonia
* Disease duration \> 1 year

Exclusion Criteria:

* Contraindication to magnetic resonance imaging (MRI)
* Mini-mental status (MMS) \< 24
* Severe psychiatric disorder
The Impact of Clinical Pharmacist Intervention and Dapagliflozin As Add-On Therapy in the Management of Type 2 Diabetes Mellitus.

Diabetes mellitus is a progressive endocrine disease characterized by insulin deficiency with or without insulin resistance. Management of type 2 diabetes requires a comprehensive team following and monitoring the disease carefully. Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been shown to be an effective medication for the treatment of T2DM, and has been demonstrated to improve glycemic control. The investigators believe that enrolling clinical pharmacist intervention as a part of a multidisciplinary approach and dapagliflozin is necessary to provide better patient care in patients that are on dual or triple oral hypoglycemic agents other than dapagliflozin. Therefore, the hypothesis of this study is that the impact and tolerability of clinical pharmacist-led intervention can be comparable to add on dapagliflozin alone on glycemic control in the management of T2DM.

The study will be a three-arm prospective, randomized, controlled trial conducted in the Diabetes and endocrine center in Sulaymaniyah, Iraq. Participants will be randomly assigned to one of the following three groups. Group 1 receives dapagliflozin 10 mg as add-on therapy along with their standard dual or triple oral hypoglycemic medicines; group 2 receives clinical pharmacist-led intervention including dosage adjustment, dietary modification, education on the importance of adherence, strategies to improve adherence, and regular follow-up along with their standard dual or triple oral hypoglycemic medicines; group 3 is the standard therapy group when patients are receiving their standard dual or triple therapy only; and the duration of the study is 3 months. Glycemic control will be measured by measurement of HbA1c and fasting plasma glucose level after 3 months. Changes in body weight and BMI will also be done; in addition, compliance will be measured using a hill-bone compliance scale for high blood pressure medication applied to diabetic medication. The expected outcome includes improving both HbA1c and fasting plasma glucose levels in both groups compared to baseline and comparable improvement in parameters between the clinical pharmacist-led intervention group and dapagliflozin 10 mg add-on therapy group.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of type 2 diabetes mellitus having either dual or triple therapy, including (metformin, sulfonylurea, and/or DPP-4 inhibitors).
* HbA1c level between 7.0% and 10% and patients with HbA1c above 10% but refusing insulin therapy.
* Willing to provide informed consent.

Exclusion Criteria:

* Presence of comorbidities (e.g., severe renal impairment (eGFR \< 30 mL/min/1.73m²), thyroid dysfunction, liver dysfunction).
* Presence of type 1 diabetes mellitus.
* History of diabetic ketoacidosis.
* Pregnancy or breastfeeding.
* Cognitive impairment or inability to provide informed consent.
Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.

After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus and tacrolimus) will be discontinued and they will be placed on Myfortic® monotherapy for 2 years thereafter. After completion of two years of Myfortic® maintenance monotherapy, it will be weaned and subjects will be monitored over the subsequent twelve months, for the appearance of sensitization using panel reactive antibody (PRA) levels.

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients age 18-70 years of age.
2. Ability to provide written informed consent.
3. Mentally stable and able to comply with the procedures of the study protocol.
4. Any subject currently prescribed immunosuppressive medications or discontinuation of immunosuppressive medications indicated as per current protocol of islet transplantation.
5. History of at least one islet transplant.
6. Stimulated C-peptide \<0.3 ng/ml.

Exclusion Criteria:

1. Known history of untreated severe hyperlipidemia, obesity, or refractory hypertension
2. For female participants: Positive pregnancy test or presently breast-feeding.
3. History of active infection including hepatitis B, hepatitis C, HIV, or TB.
4. Any history of malignancy except for completely resected squamous or basal skin cell carcinoma.
5. Known active alcohol or substance abuse.
6. Severe co-existing history of cardiac disease, characterized by a history of any one of these conditions: recent myocardial infarction (within past 6 months), evidence of ischemia on functional cardiac exam within the last year, or left ventricular ejection fraction \<30%.
7. History of persistent elevation of liver function tests. SGOT (AST), SGPT (ALT), alkaline phosphatase or total bilirubin, with values \>1.5 times normal upper limits will exclude a patient.
8. Evidence of inter-current infection.
9. Active peptic ulcer disease
10. History on non-adherence to prescribed regimens including immunosuppression.
11. PRA ≥ 50% or evidence of significant sensitization to be determined at discretion of the investigator.
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

This 12-month study will evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia.

This is a single-site 12-month open-label randomized study comparing the efficacy of the FDA-approved long-acting formulation of aripiprazole lauroxil to the efficacy of oral aripiprazole among patients with a recent onset of schizophrenia, schizophreniform, or schizoaffective (depressed) disorder. All assessments and treatment will take place at the UCLA Aftercare Research Program (300 UCLA Medical Plaza, Los Angeles, CA 90095), which is a program that specializes in the treatment and study of individuals with a recent onset of schizophrenia. The primary goal is to evaluate the efficacy of aripiprazole lauroxil compared to oral aripiprazole in preventing the re-emergence of psychotic symptoms in patients with a recent onset of schizophrenia. All patients on oral medications will, at least initially, be treated with oral aripiprazole.

Eligibility Criteria:
Inclusion Criteria:

1. Is between 18 and 45 years of age, inclusive, at Screening.
2. Has a diagnosis of schizophreniform disorder, schizophrenia, or schizoaffective disorder, depressed type.
3. Has a first episode of a psychotic illness that occurred within the 24 months before entry.
4. Fluency (oral and written) in the English language.
5. Exhibits tolerability to ARI ORAL during the Stabilization period.
6. Resides within commuting distance of the UCLA Aftercare Research Program in a stable living situation where the patient can be located.
7. Agrees to abide by the contraceptive requirements of the protocol.
8. Additional criteria may apply

Exclusion Criteria:

1. Evidence of a known neurological disorder (e.g., epilepsy) or significant head injury.
2. Premorbid IQ less than 70.
3. Is currently pregnant or breastfeeding, or is planning to become pregnant during the study.
4. Is currently on a long-acting injectable antipsychotic medication and it is clinically contra-indicated to switch to oral aripiprazole.
5. History of poor or inadequate response to an adequate trial of oral or injectable aripiprazole.
6. Has received AL-LAI or IM depot aripiprazole within two months prior to Randomization.
7. Has alcohol or substance abuse as a prominent clinical problem or makes the primary diagnosis not possible to confirm.
8. Is currently being treated with clozapine.
9. Has participated in a clinical drug trial involving any drug within the past two months.
10. Has a current DSM-5 diagnosis of bipolar disorder, or schizoaffective disorder, bipolar type, based on the screening SCID.
11. Patient is an imminent danger to himself/herself.
12. History of neuroleptic malignant syndrome, malignant hyperthermia, or clinically significant tardive dyskinesia.
13. Additional criteria may apply.
A Phase 1 Trial To Assess The Safety And Pharmacokinetics Of Single, Ascending, Oral Doses Of Dimebon In Healthy Adults

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of Dimebon following single ascending doses. A formal single ascending dose study of this nature has not been performed to date in the Dimebon development program.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Subjects who display the CYP2D6 extensive, intermediate, ultra-rapid, or poor metabolizer statuses.

Exclusion Criteria:

* A known history of hypersensitivity or previous intolerance to Dimebon or other antihistamines.
* Subjects with any previous history of seizures, convulsions, epilepsy, or significant head injury.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).