cyrilzakka/clinical-trials huggingface dataset:
Time Restricted Feeding (4-hour Versus 6-hour) for Weight Loss in Obese Adults

The aims of this proposal are to compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight and metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF.

Modest weight loss of 5-10% is sufficient to reduce metabolic disease risk in obese individuals. The first line of therapy prescribed for weight loss is daily calorie restriction (CR; 25% restriction every day). However, adherence to CR greatly diminishes after 4-6 weeks, due to subject frustration with constantly having to count calories and never being able to eat freely. In light of these issues with CR, another approach that limits timing of food intake, instead of number of calories consumed, has been developed. This strategy is termed time restricted feeding (TRF), and involves confining the period of food intake to 8 h/d (10 am to 6 pm) without calorie counting. Preliminary findings of 8-h TRF demonstrate modest weight loss and blood pressure reductions after 12 weeks. What remains unknown however, is whether shorter feeding windows during TRF (such as 4-h or 6-h feeding windows) can produce even greater weight loss in obese adults. Also of interest, is the impact of these shorter feeding windows on metabolic disease risk indicators (such as plasma lipids, blood pressure, and insulin resistance, inflammation and oxidative stress). Accordingly, the aims of this proposal are: AIM 1: To compare the effects of 4-h versus 6-h time restricted feeding (TRF) on body weight in adults with obesity; AIM 2: To compare the effects of 4-h versus 6-h TRF on metabolic disease risk factors in adults with obesity. To test the study objectives, a 10-week randomized, controlled, parallel-arm trial, divided into 2 consecutive periods: (1) 2-week baseline period; and (2) 8-week TRF weight loss period, will be implemented. Obese subjects will be randomized to 1 of 3 groups: (1) 4-h TRF, (2) 6-h TRF, or a no-intervention control group. This study will be the first randomized controlled trial to compare 4-h versus 6-h TRF on body weight and metabolic disease risk markers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* body mass index (BMI) between 30.0 and 49.9 kg/m2;
* age between 18 and 65 years; sedentary (light exercise less than 1 h per week) or moderately active (moderate exercise 1 to 2 h per week);
* weight stable for \>3 months prior to the beginning of the study (gain or loss \<4 kg);
* able to give written informed consent

Exclusion Criteria:

* Smoker; diabetic;
* taking weight loss medications;
* taking medication that requires eating food before (or with) the medication; history of eating disorders;
* night-shift workers;
* perimenopausal;
* pregnant women
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of CS0159 in Subjects With NASH

A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of CS0159 in subjects with Non-Alcoholic Steatohepatitis (NASH)

This will be a multicenter, double-blind, randomized, placebo-controlled, dose-ranging study to evaluate the safety, tolerability, PKs, and efficacy of CS0159 in the treatment of patients with NASH over 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the diagnosis of NASH.
2. Evidence of metabolic syndrome, except for those patients with biopsy-proven NASH.
3. Body mass index (BMI) \>25 kg/m2, NOTE: for Asian-Americans BMI \>23 kg/m2.
4. Stable use of other antidiabetic, weight loss, or lipid-modifying medications for at least 12 weeks prior to randomization.

Exclusion Criteria:

1. Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
2. Previous exposure to farnesoid X receptor (FXR) agonists 3 months prior to the first dosing.
3. Current or within 6 months of screening use of drugs associated with steatosis, including but not limited to eg, methotrexate, amiodarone, high-dose estrogen, tamoxifen, long term systemic steroids, anabolic steroids, valproic acid.
4. Prothrombin time international normalized ratio \>1.3, unless due to therapeutic anticoagulation.
5. Total bilirubin \>upper limit of normal (ULN; except for patients with Gilbert's syndrome with a normal direct bilirubin value and normal reticulocyte count).

   Platelet count \<140 000/mm³, absolute neutrophil count \<1500 cells/mm3, or total
6. white blood cells \<3000 cells/mm3.
7. Alanine aminotransferase and aspartate aminotransferase (AST) \>5 × ULN, or alkaline phosphatase (ALP) \>1.5 × ULN.
8. Weight changes \>10% in 6 months prior to screening, or weight changes \>5% from the screening MRI-PDFF to randomization or from the time of the diagnostic liver biopsy to randomization, whichever is longer.
9. Poorly controlled hypertension (systolic \>160 mm Hg, or diastolic blood pressure \>100 mm Hg - mean of 3 measurements).
10. Uncontrolled diabetes mellitus (hemoglobin A1c \>10.0% during screening).
Adalimumab for Inflammatory Osteoarthritis

We will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.

This is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. Primary endpoint is at 12 weeks and primary outcome is the OARSI responder index.

Eligibility Criteria:
Inclusion Criteria:

* Patient is 40 years of age or older.
* If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse
* If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative.
* Patient has a diagnosis of OA of the index knee according to American College of Rheumatology criteria, including radiological evidence of OA (Kellgren-Lawrence grades 2 or 3).
* Patient has had continual pain for at least 6 months prior to inclusion in the study. This includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an NSAID, acetaminophen/codeine combination (i.e. Tylenol No 2, 3, 4) taken at least 3 times daily
* Patient has had daily knee pain for the month preceding study enrolment.
* Patient has a summed pain score of 125-400mm (visual analog scale) on the WOMAC pain sub-scale in the index (more symptomatic) knee.
* Patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at Screening and Baseline.

Exclusion Criteria:

* Subject has a history of an allergic reaction or significant sensitivity to constituents of Adalimumab.
* Patient has a history of proven systemic arthritis such as rheumatoid arthritis.
* Patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee OA
* Patient has predominant patellofemoral disease
Nasopharyngeal Carcinoma (NPC) Axitinib

This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
* Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
* Disease must be not amenable to potentially curative radiotherapy or surgery.
* Measurable disease according to RECIST.
* Age 18 or above; ECOG performance 0 or 1.
* Adequate bone marrow, renal and hepatic reserve.

Exclusion Criteria:

* Presence of local recurrence
* Presence of neck lymph node recurrence invading vascular structure;
* Presence of central lung lesions involving major blood vessels;
* History of hemoptysis or epistaxis within 4 weeks;
* Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy;
* Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome;
* Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
Whole-Body Vibration Versus Gravity Force Stimulation on Postural Stability in Children With Down Syndrome

The purpose of the study is to compare the effect between of whole-body vibration and gravity force stimulation on postural stability in children with Down syndrome.

Down Syndrome (DS) is one of genetic disorders characterized by some common clinical and functional features. Most children with Down syndrome have deficits in postural stability or balance, co-ordination, gait, and functional mobility throughout childhood and adulthood. Postural control dysfunctions are the most common problems found in children with DS leads them to be more inactive, which contributes to functional mobility problems. Several techniques that involve proprioceptive, vestibular, and visual inputs are so beneficial to children with DS. Whole-body vibration (WBV) is one of the training methods that use high-frequency mechanical stimuli generated by a vibrating platform and transmitted through the body, leading to bone loading and sensory receptor stimulation. Gravity force stimulation (GFS) has a strong impact on the child's sensory system helping to normalize the system through exercises that send strong messages to the brain to regulate the tactile, proprioceptive and vestibular components. Hence, there is need to compare between the effects of whole-body vibration training and gravity force stimulation on postural stability in children with Down syndrome.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages will be ranged from 8 to 10 years old.
2. Functional hearing and vision.
3. Mild and moderate mental retardation with IQ level (50-70) determined by a psychiatric specialist in the school (IQ measured by Stanford-Binet intelligence scale)
4. Independent standing and walking.

Exclusion Criteria:

1. Synptomatic pain.
2. Musculoskeletal problems or/ atlanto-axial instability.
3. Rheumatic and congenital heart disease
4. History of previous surgical operation
5. Regular participation in any sport activities.
PANLAR's Latin American Registry of Rheumatic Patients Treated With Jak Inhibitors

This prospective, non-interventional, research registry is designed to study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).

There is scarce data on the real-world safety and effectiveness of Jak in Latin America. This registry will provide reliable data on the use of JAKi in LA, as will be a prospective study involving carefully selected rheumatologists and centers. Soon, a good number of copies of original JAKi will be available in LA, and it is important to keep track of the safety and effectiveness of this drugs in the real world.

The primary objective of the registry is to prospectively study the comparative safety and comparative effectiveness of approved Jak Inhibitors treatment for RA-PsA-SpA in a cohort of patients and theirs controls cared for by rheumatologists across Latin América (LA).

The registry will be a cohort study where cases will be patients with RA, PsA and SpA initiating any approved JAK inhibitor. To have an active control group, patients with RA, PsA o SpA initiating any other disease modifying antirheumatic drug (DMARD) (biologic or not biologic) will also be included in the registry.

It will be a Web based registry, where the investigators will include data related to the cases and controls. Data collected will include, demographics, disease characteristics, disease activity, past and current medications, comorbidities. At each visit adherence with the medications, adverse events, changes in medications, disease activity and disability will be assessed.Patients will be followed up at three months intervals, after inclusion in the registry and thereafter every 6 months during the next three years. Adverse events could be included at any time between visits if the investigator is notified.

Eligibility Criteria:
To be eligible for enrollment into the PREJAK Registry, a patient must satisfy all of the inclusion criteria and none of the exclusion criteria listed below.

Inclusion Criteria

The patient must be:

1. One of the following:

   1. Diagnosis with rheumatoid arthritis (RA) and initiating (prescribed or starting) a Januse Kinase inhibitors (JAKi) for the treatment of RA at the enrollment visit.
   2. Meet the ASAS criteria for axial spondyloarthritis (AxSpA), including radiographic or non-radiographic, and initiating (prescribe or starting) a JAKi for the treatment of AxSpA at the enrollment visit.
   3. Diagnosis with psoriatic arthritis (PsA) and initiating (prescribed or starting) a Januse Kinase inhibitors (JAKi) for the treatment of PsA at the enrollment visit.
2. At least 18 years age or older
3. Able and willing to provide written consent

Exclusion Criteria:

Patients who do not wish to participate or are unable to give informed consent
Impact of Vitamin D Supplementation on Cardiometabolic Risk Factors [The Daily D Health Study]

The purpose of this research is to determine what supplemental doses of vitamin D may be necessary to raise serum levels to optimal levels and how vitamin D supplementation and changes in vitamin D status impact cardiovascular risk factors in schoolchildren.

Research suggests that vitamin D, known mainly for its role in bone health, may have other roles in the body and that vitamin D deficiency may contribute to certain chronic diseases, such as cardiovascular disease. Recently, vitamin D has received growing attention due to the increased awareness of possible deficiencies among certain populations at risk of vitamin D deficiency. Most circulating 25-hydroxyvitamin D comes from exposure to UVB rays in natural sunlight. In 2010, the Institute of Medicine issued new recommendations that daily vitamin D intakes should be increased to 600 IU/day for children ages 1-18. However, even with these recommendations in place, roughly 20% of all children are below the recommended 20 ng/mL. Moreover, more than two-thirds of all children have levels below 30 ng/mL, including 80% of Hispanic children and 92% of non-Hispanic black children. Therefore, it is imperative to gain an understanding of: 1) what supplemental doses may be necessary for schoolchildren who are already at a disadvantage in achieving optimal levels of 25(OH)D due to factors such as living at a northern latitude, having high obesity rates, and where a large proportion of the population are Latino or African American; and 2) whether serum concentrations of 25(OH)D over 30 ng/mL in children prevent health risks.

Eligibility Criteria:
Inclusion Criteria:

* Subjects in 4th-8th grade
* Subjects must attend school where study is being conducted
* Subject and parent/guardian must give assent/consent to participate in study Related Requirements
* Subjects must complete all study visits (baseline, 3,6 and 12 months)
* Subjects must agree to be blinded

Exclusion Criteria:

* Subjects taking glucocorticoids
* Subjects not in 4th-8th grade
* Clinical diagnosis of Cystic Fibrosis
* Clinical diagnosis of Kidney disease
* Subjects currently taking a vitamin D supplement of \>1000 IU/day
* Subjects diagnosed with Irritable Bowel Syndrome (IBS)
* Clinical diagnosis of AIDS
* Clinical diagnosis of Sarcoidosis
* Clinical diagnosis of Epilepsy
Patient-reported, Health Economic and Psychosocial Outcomes in Friedreich Ataxia

The PROFA study is an international, multi-centric observational and validation study to assess the patient-reported, psychosocial and economic outcomes of patients with Friedreich Ataxia (FA). Eligible patients will be recruited from six study centers in Germany, Austria and France. Patients will complete a baseline assessment via face-to-face interviews at the study centers and multiple momentary follow-up assessments via a mobile-health app at home daily to monthly for six months. Study results will gain essential and in-depth insights into the daily life of patients with FA.

There is a lack of knowledge about the patient-reported, psychosocial, and economic impact of Friedreich's Ataxia (FA). The few previous studies were based on small sample sizes and annual cross-sectional data, limiting the generalizability of the results.

Therefore, the PROFA study aims

1. to assess the acceptability, feasibility, and usability of a mobile-health app for the collection of longitudinal real-time data,
2. to determine healthcare costs from a societal perspective that includes informal care productivity losses, to assess associated factors and to analyze the impact of evidence-based treatment on costs,
3. to validate measures of health-related quality of life (HRQoL), to assess patients' HRQoL and its fluctuation over time and identify associated factors,
4. to develop, validate and evaluate a new measure of hearing and speech disabilities' impact on patients' psychosocial health, and
5. to evaluate interaction effects between HRQoL, psychosocial health and economic outcomes in patients with FA.

Thus, the PROFA study will gain a comprehensive understanding of the individual, societal, and economic burden of FA, identifying determinants of health and social life and efficient use of healthcare resources. This is crucial to improve the treatment, care, and everyday life of FA patients and their families.

This validation and observational study will recruit patients from six study centers (Germany, France, and Austria). The data assessment will be based on (i) a baseline assessment via interviews at the study centers and (ii) a subsequent remote momentary data assessment via a mobile-health app on a daily to monthly basis for six months, covering assessments of ataxia severity, HRQoL, psychosocial health, speech and hearing disabilities, health services utilization, and specific health events. Descriptive and multivariate statistics will be used to describe the impact of FA on the patient-reported HRQoL, psychosocial health and economic outcomes.

Eligibility Criteria:
Inclusion Criteria:

* FA confirmed by molecular genetic testing
* Ataxia severity of ≤30 points according to the Scale of the Assessment and Rating of Ataxia (SARA)
* Access to a smartphone or tablet and able to operate the device
* Older than 12 years

Exclusion Criteria:

* Lack of ability to give consent
* Ataxia severity \>30 according to the Scale of the Assessment and Rating of Ataxia (SARA)
Increasing Adherence to Pulmonary Rehabilitation After COPD Related Hospitalizations (Pilot Study)

This pilot study will look at investigating barriers, facilitators, adherence and effectiveness of an interactive home-based pulmonary rehabilitation program and health coaching for patients who have recently been hospitalized for a COPD related cause.

Despite proven benefits, the proportion of people with COPD who receive Pulmonary Rehabilitation (PR) is very small. The current model of a center-based PR program fails to address the needs of many patients with COPD. The most common patient barrier to attendance is travel to center-based programs, particularly for frail patients with more severe COPD who need transportation assistance. Home-based, unsupervised PR has been proposed as an alternative model to hospital-based programs and has been found to be safe and effective.

In this pilot study researchers will investigate barriers, facilitators and adherence to a home-based pulmonary rehabilitation program after hospitalization. The results of this pilot study will inform the second part of this study as a randomized control study under a different grant (Study 2/R33). Both quantitative and qualitative methods will be used for the evaluation.

10 patients will be enrolled in this pilot study and allocated to a home-based PR in order to polish the intervention before the randomized portion of the study. This pilot is supported by a grant mechanism (R61) explicitly oriented to adjust the intervention and identify barriers for the next randomized portion of this study (Study 2) supported by a separate grant mechanism (R33).

Eligibility Criteria:
Inclusion Criteria

* COPD related hospitalization and eligible for PR
* Age 40+
* Confidence (score \> 5 in a self-efficacy question (1-10 scale): how confident you feel to use this system on a daily basis)

Exclusion Criteria

* Inability to walk (orthopedic-neurologic problems or confined to bed)
Balance Training in Diabetic Neuropathy

This study evaluates the efficacy of balance training in Diabetic Neuropathy. Control group will receive general exercises while Eperimental/ Interventional group will receive Balance exercises along with general exercises.


Eligibility Criteria:
Inclusion Criteria:

* Age group: 30-60 years
* Diabetes type II patients diagnosed with peripheral neuropathy by medical doctor for at least 5 years
* Neuropathy present (on the basis of Michigan Neuropathy Screening Instrument
* Have balance impairment ( evaluation on Berg Balance Scale)

Exclusion Criteria:

* Neuropathy due to other medical conditions like Vitamin deficiency, Hypothyroidism, Auto-immune/ demyelinating diseases
* Foot ulcers
* Lower limb amputee
* Vestibular diseases
* Retinopathy
* Cardiac problems
* Hemiplegia/ Stroke