cyrilzakka/clinical-trials huggingface dataset:
Exercise is Medicine for Patients With CKD

The investigators plan to integrate and tailor the existing Exercise is Medicine framework, an evidence-based multi-level intervention program developed by the American Society of Sports Medicine, for the care of patients with advanced chronic kidney disease. In this pilot randomized control trial, investigators will compare the effects and feasibility of two intervention arms designed to start and maintain physical activity in this high-risk population (Group 1: physical activity assessment, brief counseling session + physical activity wearable versus Group 2: Group 1 intervention components + referral to a free, community-based, EIM practitioner led group exercise program).

Persons on dialysis are physically inactive, with most reporting activity levels below the fifth percentile of healthy age-matched groups. Physical inactivity in turn increases the risk for functional decline and mortality in this vulnerable population. The investigators propose a pragmatic clinical trial for an exercise intervention among persons transitioning to dialysis. The investigators will use an existing framework - Exercise is Medicine (EIM) - developed by the American College of Sports Medicine. The investigators will randomize 98 persons from two regions-Atlanta and Bay Area-in two intervention arms with incremental levels of clinical-community integration: physical activity assessment during Nephrology clinical visit, brief counseling at pre-dialysis education and physical activity wearable (group 1) versus group 1 intervention components plus a referral to a free, EIM practitioner-led group exercise program over 16 weeks (group 2; 8 week core intervention; 8 week follow up). The investigators will assess efficacy by comparing between group differences in minutes/week of (measured) moderate intensity physical activity. To evaluate implementation, investigators will use questionnaires and exit interviews for assessing barriers to referral, participation and retention along the path of the intervention; investigators will use cost-utility analyses to assess scalability. Further the investigators will have a plan for dissemination of the intervention by partnering with insurance providers and both for-profit and non-profit dialysis organizations. The overall goal is to inform the development of a practical, cost-conscious intervention that addresses barriers to physical activity commonly faced by persons on dialysis, and can be delivered as a "package" to interested practices.

Eligibility Criteria:
Inclusion Criteria:

* - eGFR \< 30 ml/min/1.73m2
* Age ≥30 and ≤80 years
* Noncompliance with physical activity guidelines
* Not in precontemplation stage
* Non-wheelchair bound
* Able to provide informed consent in English or Spanish
* Anticipated to be living in the area over the next 36 weeks

Exclusion Criteria:

* - Inability to provide consent in English
* Diagnosed mental health disorder
* Alcohol or drug abuse
* No fixed address or contact details
* Unstable angina or unstable arrhythmias
* Lack of access to internet
* Any concern not otherwise stated by patient's nephrologist
Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation

This is an open, single-arm, phase I/phase II clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Relapsed Refractory (R/R) adult acute lymphoblastic leukemia bridging allogeneic hematopoietic stem cell transplantation.

This trial openly recruited 50 patients into the group and were given CAR-T treatment. Patients participating in clinical trials will be tested and evaluated in terms of treatment safety, efficacy, and response duration. As assessed by clinicians, adult B-ALL patients who meet the enrollment criteria, after adequate communication, the patient or family members voluntarily join the clinical study, and are willing to bridge allogeneic hematopoiesis within 3 months after enrollment using CAR-T therapy。

Eligibility Criteria:
Inclusion Criteria:

1. Be diagnosed a kind of Relapsed or Refractory Haematopoietic and Lymphoid Malignancies:
2. ECOG score≤2;
3. To be aged 1 to 65 years;
4. More than a month lifetime from the consent signing date.

Exclusion Criteria:

1. Serious cardiac insufficiency, left ventricular ejection fraction\<50%;
2. Has a history of severe pulmonary function damaging;
3. Merging other progressing malignant tumor;
4. Merging uncontrolled infection;
5. Merging the metabolic diseases (except diabetes);
6. Merging severe autoimmune diseases or immunodeficiency disease;
7. Patients with active hepatitis B or hepatitis C;
8. Patients with HIV infection;
9. Has a history of serious allergies on Biological products (including antibiotics);
10. Has acute GvHD on allogeneic hematopoietic stem cell transplantation patients after stopping immunosuppressants a month;
11. Pregnancy or lactation women;
12. Any situation that would increase dangerousness of subjects or disturb the outcome of the clinical study according to the researcher's evaluation.
Effects of Crossover Point Exercise on Depression, Anxiety and Stress in Chinese Postmenopausal Women

To analyze the effects of the Crossover Point (COP) Exercise Program on Chinese postmenopausal women.

This is a randomized clinical trial of single-blind with 2 arms (control group and experimental group), in which a pre-treatment-posttest design has been used.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women without incapacitating chronic disease or contraindications to exercise
* baseline mental health
* no severe chronic diseases or exercise contraindications
* ability to understand the research details and voluntarily sign the informed consent form.

Exclusion Criteria:

* Women with undetermined menopause；
* BMI \<18.5 kg/m2 or BMI \>28 kg/m2
* uncontrolled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>110 mmHg)
* life-threatening illness with a prognosis of \<5 years
* currently receiving estrogen therapy
* currently taking medication that may affect psychological testing
* contraindications to exercise
A Pilot Study To Evaluate the Efficacy of Response Guided Therapy of Peginterferon Alfa Plus Ribavirin in the Treatment of Patients With HCV/HBV Co-Infection

This is an open label, randomized-controlled, comparative trial. HBV and HCV dually infected patients with negative hepatitis B e antigen (HBeAg) were enrolled in the study. The definition of HBV and HCV dual infection included seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA. Eligible subjects were randomized into 2 groups at treatment initiation. Subjects who were randomized into the genotype guided therapy (GGT) group received Peg-IFN and standard dose RBV (1200 mg/day) for 48 weeks in subjects infected with HCV genotype 1 or Peg-IFN and low dose RBV (800 mg/day) for 24 weeks in subjects infected with HCV genotype 2/3; the patients were then followed for 6 months. For subjects who were randomized into the response guided therapy (RGT) group, the duration of Peg-IFN and RBV therapy was abbreviated to 24 weeks in subjects with HCV genotype 1, a pre-treatment low viral load (LVL, \< 400000 IU/mL) and RVR (defined asHCV RNA \<50 IU/mL at 4th week of therapy); the duration was 16 weeks in subjects with HCV genotype 2/3 and RVR.


Eligibility Criteria:
Inclusion Criteria:

* seropositivity of HCV antibody (anti-HCV) and HBsAg for more than 6 months, together with positive serum HCV RNA.
* negative HBeAg
* serum alanine aminotransferase (ALT) levels between 1-10-fold of the upper limit of normal (ULN)
* treatment naive or had previously failed interferon monotherapy.

Exclusion Criteria:

* decompensated liver disease (Child-Pugh score ≥ 7)
* Pregnant or breast-feeding women
* serum creatinine ≥ 2 mg/dL
* evidence of alcoholism or drug abuse
* any other known disease that was not suitable for Peg-IFN therapy.
A Study to Evaluate the Efficacy and Safety of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to assess the effect of reldesemtiv versus placebo on functional outcomes in ALS.

COURAGE-ALS is a Phase 3, double-blind, randomized, placebo-controlled trial of reldesemtiv in patients aged 18 to 80 with ALS.

The screening and qualification period for the trial will be no more than 21 days in duration. Approximately 555 eligible ALS patients will be randomized (2:1) to receive the following dose of reldesemtiv or placebo (stratified by riluzole use/non-use and edaravone use/non-use) for the first 24 weeks (double-blind, placebo-controlled period):

* 300 mg reldesemtiv twice a day for a 600 mg total daily dose (TDD)
* Placebo twice daily

At the end of the 24-week double-blind, placebo-controlled period, patients will transition to the active drug period, where all patients will receive the following dose of reldesemtiv for the next 24 weeks:

* 300 mg reldesemtiv twice a day for a 600 mg TDD for patients who were not down titrated during the 24 weeks of blinded dosing
* 150 mg reldesemtiv twice a day for a 300 mg TDD for patients who were down titrated during the 24 weeks of blinded dosing

Eligibility Criteria:
Key Inclusion Criteria:

* Males or Females between the ages of 18 and 80 years of age, inclusive
* Diagnosis of familial or sporadic ALS (defined as meeting the laboratory-supported probable, probable, or definite criteria for ALS according to the World Federation of Neurology El Escorial criteria). Patients who meet the possible criteria are eligible if they have lower motor neuron findings; those who have purely upper motor neuron findings are ineligible.
* First symptom of ALS ≤ 24 months prior to screening. The qualifying first symptoms of ALS are limited to manifestations of weakness in extremity, bulbar, or respiratory muscles.
* ALSFRS-R total score ≤ 44 at screening. Patients with a total score of 45 or higher may be rescreened 60±7 days following the original screening date.
* Upright FVC ≥ 65.0% of predicted for age, height, sex and ethnicity at screening according to Global Lung Initiative equation
* Must be either on riluzole for ≥ 30 days prior to screening or have not taken it for at least 30 days prior to screening
* Must have completed at least 2 cycles of edaravone at the time of screening or have not received it for at least 30 days prior to screening
* Able to swallow whole tablets

Exclusion Criteria:

* eGFRCysC \< 45.0 mL/min/1.73 m2 at screening
* Urine protein/creatinine ratio \> 1 mg/mg (113 mg/mmol) at screening
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3-times the upper limit of normal (ULN)
* Total bilirubin (TBL), direct or indirect bilirubin above the ULN.
* Cognitive impairment, related to ALS or otherwise that impairs the patient's ability to understand and/or comply with study procedures and provide informed consent
* Other medically significant neurological conditions that could interfere with the assessment of ALS symptoms, signs or progression.
* Has a tracheostomy
Digital Application Usage for Adherence of Patients Undergoing Robotic Assisted Radical Prostatectomy Following Oncological and Postoperative Functional Outcomes

Prostate cancer (PC) is the most common non-skin tumor in men and the second leading cause of death from cancer in Brazil. It accounts for 13.8% of deaths from cancer in males, similar to what happens with breast cancer in females, corresponding to 15.8% of cancer deaths in women. Mobile applications, software developed for smartphones and tablets used for many different purposes (games, communication, entertainment etc) have become important tools of mHealth (Mobile Health in Portuguese - mobile health) as they allow remote support to patients or self-promotion of health care. It has been used globally to assist in the treatment and control of various diseases such as diabetes, physical inactivity, and many others. In oncology there are several applications developed to assist in the monitoring and treatment of various cancers such as gastric and breast cancer. So far it has not developed an application for follow-up of patients with PC, to capture data on satisfaction of post-treatment patient regarding the comorbidity of surgery, and also loyalty and adherence of patients to follow-up in offices allowing a possible intervention it is done at the right time. Nor was made compared to assess whether there is benefit in using this application. Thus, the objective of this work is to develop an application for smartphones facing the postoperative follow-up of patients undergoing robotic radical prostatectomy and compare adherence to treatment compared to accompanied by traditional way patient. In addition, we will evaluate the progress of the IPSS, ICIQ and IIEF-5 compared to preoperatively in patients undergoing prostatectomy robotic radical.


Eligibility Criteria:
Inclusion Criteria:

* patients having a diagnosis of prostate cancer who are undergoing robotic radical prostatectomy for treatment of the disease and who accept to participate in the study by signing the informed consent term.

Exclusion Criteria:

* Patients who refused to participate in the study
COMT Activity and Hypnotizability

Hypnosis is an effective pain management tool for surgery that can reduce opioid use up to 40%. COMT single nucleotide polymorphisms (SNPs) can predict pain sensitivity and opioid use perioperatively, and may also be associated with hypnotizability or response to hypnotic analgesia. Analyzing COMT haplotypes from DNA extracted from saliva or blood using a giant magnetoresistive (GMR) nanotechnology platform may be faster, less expensive, and at least as accurate as pyrosequencing. This study aims to validate a multi-SNP point-of-care (POC) GMR assay for the rapid genotyping of SNPs predictive of COMT activity, and test the feasibility of using COMT activity as a biomarker for hypnotizability and/or response to hypnotic analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in one of 3 specific hypnosis trials
* Enrollment is by invitation only

Exclusion Criteria:

* Participants in the prior trials who declined to be contacted for future research.
Diabetes Nutrition Algorithms - Sugars: Galactose- and Fiber-induced Metabolic Improvement in the Dietetic Treatment of Type 2 Diabetes

In animal models and retrospective studies, certain food components such as sugars and fiber have been detected as potential agents to influence development and progress of type 2 diabetes.

The DiNA study prospectively investigates, if non-soluble non-fermentable fibers (vs. soluble ones) and galactose (vs. palatinose) are capable to improvement metabolic parameters in patients with long-term type 2 diabetes and intensive insulin treatment.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes, insulin-dependent
* high insulin resistance

Exclusion Criteria:

* accompanying disease, medication or metabolic disorder, which interact with glucose metabolism or eating behavior (e.g. renal insufficiency, major cardial insuffiency, untreated hypothyreosis, corticoid treatment, depression and other psychiatric disorders...)
Efficacy and Safety Study of Policosanol

The purpose of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction

100 selected elderly patients with endothelial dysfunction were randomized to two groups,Group1:received policosanol 20mg qd;Group2:received placebo 20mg qd；endothelial function was tested by peripheral arterial tonometry(PAT) before and after 6 months' treatment with policosanol or placebo respectively; Endothelial dysfunction is defined as reactive hyperemia index(RHI)\< 1.67; The aim of this study is to assess the clinical efficacy and safety of policosanol on elderly patients with endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 60 years old；
2. Patients with endothelial dysfunction
3. Provision of informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Acute myocardial infarction ,severe trauma , major operation or stroke within six months;
2. Tumor or inflammatory diseases
3. Known allergies to policosanol
4. Life expectancy less than 1 year
5. secondary dyslipidemia 6.taking other experimental medicine within six months;
A Study of RD14-01 in Patients With Advanced Solid Tumors

This study will evaluate the safety and tolerability of RD14-01, a ROR1-targeted CAR T-cell therapy, in patients with ROR1+ advanced solid tumors.

This single-arm, open-label, dose-escalation and dose-expansion study will evaluate the safety and tolerability of RD14-01, ROR1-targeting CAR T cells, in adults with ROR1+ advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old and \< 70 years old, gender unlimited;
2. Patients with locally advanced or metastatic solid tumors confirmed by histopathology or cytology;
3. Subjects who failed or were intolerant to standard treatment, or lacked effective treatment;
4. ROR1+ by central laboratory immunohistochemistry (IHC);
5. Adequate organ and marrow function;
6. At least one measurable lesion as per RECIST v1.1;
7. Estimated survival ≥3 months;

7.Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1; 8.Ability to understand and provide informed consent.

Exclusion Criteria:

1. Prior treatment with any agent targeting ROR1;
2. Received anti-tumor therapy within 4 weeks prior to the start of treatment, including chemotherapy, radiotherapy, targeted therapy, etc. (excluding preconditioning);
3. Presence of active central nervous system (CNS) metastasis;
4. There is or has been a history of severe cardiovascular disease;
5. There is an uncontrolled pleural, abdominal or pericardial effusion
6. HIV-positive, active acute or chronic HBV or HCV, or active tuberculosis;
7. Pregnant or breast-feeding females;
8. There is a known or suspected failure to comply with the study protocol (for example, alcohol abuse, drug dependence, or psychological disorders) or any condition that the investigator believes may increase the subjects' risk or interfere with the results of the test.
Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

In this interventional cohort study, the investigators aim to evaluate retinal vascular function as assessed by optical coherence tomography angiography, fundus photography and dynamic vessel analysis in patients who share microvascular involvement of their pathology (e.g. chronic kidney disease, cardiac decompensation, neuronal small vessel disease and glaucoma) and age-matched healthy controls. Plasm and skin samples for comparative proteomics and transcriptomics are also taken.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a confirmed or suspect diagnosis of glaucoma based on intra-ocular eye pressure, visual field defect and structural optic nerve changes, regardless their age.
* Adult patients with chronic kidney disease regardless their age.
* Adult patients with heart failure with preserved ejection fraction (HFpEF), regardless their age: symptomatic heart failure with Left Ventricle Ejection Fraction \> 50% AND BNP \> 35 pg/ml (or NT-proBNP\>125 pg/ml) OR signs of diastolic dysfunction according to the European Society of Cardiology guidelines 2016
* Adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age.
* People without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age
* Capable and willing to participate (informed consent)

Exclusion Criteria:

* Diabetes
* Personal medical history of retinal neovascularization.
* Unable or unwilling to give consent
Improving Hypertension Control in East and Central Harlem

This hypertension project is evaluating strategies developed to target problems underlying lack of blood pressure control among treated but uncontrolled hypertensive patients in East and Central Harlem.

The hypertension project will tailor improvement strategies to the problems identified as underlying underuse among treated but uncontrolled hypertensive patients in East and Central Harlem, New York City. Along with the communities' 6 major health providers, we will first combine qualitative and quantitative methods to identify specific patient, provider, and system problems, and customize interventions to address them. In a randomized controlled trial, we will then randomly assign 480 patients among 4 arms: nurse management, blood pressure monitors alone, usual care, and peer led chronic disease self-management course. During the 18-month trial, patients self-monitor their blood pressure or attend a self-management course, or nurse managers will assess patients' needs, counsel them, address any access barriers, and follow up with regular telephone contacts; convey information, including blood pressures from patients' self-monitoring, between patients and physicians to inform possible medication changes; and ameliorate any systems problems. We will assess differences in blood pressure reductions among the 4 arms as the primary outcome, and in quality of life, patient satisfaction, costs, and cost-effectiveness as secondary outcomes. The findings will provide new knowledge about the relationship between these changes and patient and clinician knowledge, attitudes, and behaviors. The educational course is designed to teach patients tools for managing their chronic illness which will empower them to improve their overall health and is specifically tailored for patients living with asymptomatic chronic illnesses and will emphasize communication with health care providers. In partnership with community organizations and the policymakers, we will disseminate successful findings within these communities and throughout the state and the nation.

Eligibility Criteria:
Inclusion Criteria:

Male and female, English or Spanish speaking African American and/or Hispanic patients with uncontrolled hypertension who have been seen in either the Cardiology clinic, Internal Medicine Associates (IMA) or Geriatric clinic at least twice in a given year at least 18 years of age.

Exclusion Criteria:

This study is about hypertension control among African Americans and Hispanics, these are the ethnic groups with disparities in CVD that we want to improve so other races are excluded. The study is for adults with hypertension; therefore, we are excluding anyone who is under 18 years of age.