cyrilzakka/clinical-trials huggingface dataset:
BMI Study for Children Ages 6-9 Years and Parents

The purpose of this study is to test the Fitwits office tool and games with 6-9 year old children and their parents to: 1) assist parent-child dyad with correct BMI status identification and understanding; 2) address nutrition, portion size, and activity cues; and, 3) track BMI trajectory over 12-month period.

The investigators will study parents' perceptions of their child's BMI before and after the Fitwits intervention with a primary goal of improving parents' ability to identify their child's actual BMI status (underweight, healthy weight, overweight, or obese). Secondary goals are to measure changes in behaviors and BMI trajectories with repetitive use of the Fitwits office tool.

The study design is a longitudinal non-randomized intervention study with four time points (baseline, 3, 6, and 12 months). The investigators will recruit family medicine residents, fellows, and faculty at the investigators' three family health centers and enroll 150 parent/guardians and children aged 6-9 years at well child visits, regardless of initial BMI.

The investigators will use electronic health record-generated BMI percentages, the physician-led Fitwits Office Tool as the intervention, and self-reported surveys for the parent-child dyad. Surveys will record the BMI understanding -pre- and post-Fitwits intervention at each visit.

The investigators will compare the intervention to a control group residency-based family health center with usual care for child/parent dyads presenting at well child care and 12 months later. At this site the investigators will survey for correct parent identification of the child's BMI category.

Eligibility Criteria:
Inclusion Criteria:

* Ages 6-9 regardless of BMI status

Exclusion Criteria:

* non-English-speaking
Inspiratory Muscle Training in Heart Failure

The aim of this study is to investigate the potential effects of inspiratory muscle training on cardiovascular, respiratory, physical, and psychosocial functions in patients with heart failure.

Heart failure is a syndrome that leads to decreased cardiac output, inflammation, increased catabolism, and prolonged immobilization, causing inspiratory muscle weakness. Cardiac rehabilitation is a well-known treatment approach in heart failure however, the participation rate in cardiac rehabilitation is low. Therefore, inspiratory muscle training may serve as an alternative approach in patients with heart failure.

Patients will be randomly allocated into the inspiratory muscle training group and control group. The inspiratory muscle training (IMT) group will carry out IMT sessions three days per week for 8 weeks by using an inspiratory threshold loading device. Each session will consist of seven cycles including 2 min of breathing on an inspiratory loading device followed by 1 min of rest and will last 21 min. IMT will be performed at the tolerable maximum load for each 2-min work interval and will be progressively increased over the 8 weeks. The control group will perform unloaded IMT by using an inspiratory threshold loading device during all training sessions. Data will be collected before and after the treatment by a masked outcome assessor.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of heart failure with reduced ejection fraction
* Clinically stable
* Functional class II-III according to the New York Heart Association functional classification
* Having inspiratory muscle weakness (MIP\<70%)
* Volunteer to participation

Exclusion Criteria:

* Congenital heart disease
* Severe valvular heart disease
* Cardiac device such as implantable cardioverter defibrillator or cardiac resynchronization therapy
* Neurological disease
* Conditions that may limit the physical mobility
Circadian RA Study in Rheumatoid Arthritis Subjects

Primary objective: To determine the changes in circadian activity rhythms and disease activity in rheumatoid arthritis (RA) patients from pre-treatment to one month after Enbrel initiation.

Secondary objectives:

* To determine if there is an association between changes in circadian rhythm and changes in disease activity in active RA after initiation of Enbrel
* To determine if the changes in circadian activity rhythms are associated with systemic inflammation in RA patients
* To determine changes in traditional sleep quality variables from pre-treatment to one month after Enbrel initiation in RA patients

Rheumatoid arthritis (RA) is a chronic and debilitating disease. However, the symptoms of RA show variation over the course of the day, with worsening symptoms in the morning. This worsening of symptoms in the morning is correlated with an increase in inflammation in the body.

Biologic therapies, such as Enbrel (etanercept), appear to improve energy, pain and quality of life in patients with RA, and these changes may occur before a doctor is able to detect changes during the patient's physical examination. It is possible that a patient's response to biological agents can be rapidly determined by assessing circadian activity (also called "rest-activity circadian rhythms" or RAR).

Currently, wrist actigraphy bands, which are worn for a period of time, can reliably provide information about RAR. Wrist actigraphy bands are small electronic devices worn on the wrist (similar to a watch) that records the subject's level of activity throughout the day. Studies in osteoarthritis and in rheumatoid arthritis have found subjects with joint pain to have significant differences in RAR, and disrupted RAR has been associated with disease activity.

This study will provide information about 24-hour circadian activity rhythms before and after 3-4 weeks of Enbrel treatment in study subjects with active rheumatoid arthritis. The study will assess patients who are starting on Enbrel that has been prescribed by their doctor.

Eligibility Criteria:
Inclusion Criteria:

* 6/28 tender and 6/28 swollen joints (e.g. active rheumatoid arthritis)
* CRP ≥ 1.5mg/L
* Insufficient response or intolerance to ≥1 disease modifying anti-rheumatic drug (DMARD) which must include methotrexate or hydroxychloroquine, or sulfasalazine or leflunomide and at stable dose for 4 weeks
* If taking Glucocorticoids, stable dose from 0-10mg a day for 2 weeks, and remain stable for the 4 week study
* Appropriate to start on a biologic agent for RA, as determined by patient's physician.

Exclusion Criteria:

* Prior use of a biologic agent for 4 weeks prior to the study
* Evidence of positive tuberculosis (TB) test, purified protein derivative (PPD) or Quantiferon or prophylactic treatment instituted 4 weeks before study, or hepatitis B core antibody
* No medical condition that would prevent completion of the study
Effectiveness of a Multidisciplinary Medication Review With Follow-up for Patients Treated With Coumarin Anticoagulants in Primary Care

The interdisciplinary collaboration between doctors, nurses and pharmacists, can facilitate the control of patients under treatment with coumarin anticoagulants, increasing their safety and effectiveness. On the other hand, the clinical utility of tools such as pharmacogenetics and the SAME-TT2R2 is unexplored. Based on the foregoing, it seems necessary to study the impact of the Program of medication review with follow-up in collaboration with doctors and nurses in primary care improves the degree of control of the patients under treatment with coumarin anticoagulants. Method: a randomized, controlled study for the main objective. Population and scope of study: Patients on treatment with coumarin anticoagulants with time in therapeutic range (TTR) according to the method of Rosendaal less than 70% in follow-up from primary care in a health area of the Arrabal Health Center (Zaragoza, Spain). Each patient will be followed by a period of 6 months. After this period, patients in the control group (CG) will receive the service of medication review with follow-up for a period of time equivalent (6 months). Intervention: Program of pharmacotherapy follow-up. Variables result: Stability of the INR, drug adherence, intake of vitamin K, knowledge of the patient on the use of acenocoumarol, associated costs, avoided costs, quality of life, satisfaction of patients and professionals involved. Statistical analysis and sample size: 204 patients. Multivariate analysis will be used and cost-effectiveness..


Eligibility Criteria:
Inclusion Criteria:

* Submit a TTR less than 70% in the last 6 months.

Exclusion Criteria:

* Not sign the informed consent.
* Present cognitive difficulties for the project.
Evaluating a Community-Led COVID-19 Testing Intervention to Address Mistrust

The goal of this study is to assess how community-led group discussions about health-related topics may alter beliefs and intentions regarding healthcare recommendations, such as COVID-19 testing and vaccination.

Eligible participants will be randomized to intervention or control group. Intervention group participants will meet virtually with other community member participants in small discussion groups once a week for one hour over the course of 12 weeks. The online discussion groups will be led by peer mentor facilitators and supported by a research team member. Discussion topics will include current events, COVID-19, and other health related topics. Control group participants will not meet in weekly discussion groups. At approximately the 0 month, 3 month, and 6 month time points, all participants will answer online surveys about health related topics. At the 3 month and 6 month time points, all participants will also be asked to self-administer a COVID-19 test that investigators provide. Finally, around the fourth month, intervention group participants will be invited to an online feedback session with the research team about participants' experiences in the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Resident of one of the 9 housing authority agencies
* Willing to participate in Zoom meetings and complete online assessments at baseline, 3-month, and 6-month timepoints
* Ability to read, speak, and understand English

Exclusion Criteria:

* None
Development of Method of Fructose Identification in Urine to Detect the Viral Infection

The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage. There will be 20 samples from the HIV-infected patients and 30 samples from the heath controls. The study will collect 10ml urine and examined fructose and fructose-diphosphate using the polarographic method.

The goal of this research is the attempt to implement a new research method based on modern electrochemistry successes, in particular the development of the polarographic method of fructose and fructose diphosphate identification and its implementation to detect the viral infection in early stage.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection

Exclusion Criteria:

* who are in highly active antiretroviral therapy(HARRT) therapy
Fertility Supportive Behavior Education Based On Watson's Theory Of Human Care

Infertile individuals frequently attempt behavioral changes to enhance the effectiveness of their treatment and improve fertility outcomes. Consequently, this study was designed to assess the impact of fertility supportive behavior education, grounded in Watson's Human Care Theory, on healthy lifestyle behaviors and the success rates of in vitro fertilization (IVF) in women with primary infertility


Eligibility Criteria:
Inclusion Criteria:

* Women have a diagnosis of primary infertility.
* Women over the age of 18 and under the age of 32.
* Women able to read and write in Arabic.
* The cause of infertility must be a male factor.
* Women who are undergoing assisted reproductive techniques, specifically İn Vitro Fertilization-Intracytoplasmatic Sperm Injection.
* Women using the same drugs and protocols for IVF treatment.
* Only women who receive a fresh embryo transfer during their IVF treatment included in the study.

Exclusion Criteria:

* Women who have problems with understanding or perception
* The presence of tubal, uterine or other infertility factors in women
* Women undergoing a frozen embryo transfer as part of their IVF treatment
* Women whose pregnancies do not continue or who are diagnosed with a fetal anomaly by the time the healthy lifestyle behaviors scale is re-administered after 3 months excluded from the study.
Prospective Interventional Study on Reversibility of Type 2 Diabetes Mellitus With Hypocaloric Diet

T2DM, a chronic progressive disorder has an epidemic status in India. Remission (HbA1c of \< 6.5% without any anti-diabetic medication) of T2DM is achievable with diet modifications in recently diagnosed obese T2D individuals. Studies suggest Very Low Calorie Diet (600 - 800kcal) and Low Calorie Diet-LCD (800 -1000 kcal) using Meal replacers (MR) are helpful. The investigators aimed to study the effects of LCD without any anti diabetic medication in intervention group and later comparing it with Control group (on standard medical treatment).

The objective is to study the effect of LCD in anthropometric , biochemical and NAFLD (Non Alcholic Fatty Liver Disease) parameters after 8 weeks and 24 weeks from enrollment.

Purposive sampling is used to enroll participants in the study. The LCD is a combination of one meal replacer and modified major meals. Calculated exchanges of food groups is taken care of in the other two major meals and snacks in between. Inorder to adhere compliance clinical (at baseline, after 8 weeks, after 24 weeks) as well as virtual visits through whatsapp, e-mails, SMS, phone calls (once a week during 8 weeks of intervention and further once a month upto 24 weeks) are scheduled. After 8 weeks of LCD, calorie is increased to 1200-1400 Kcal/day. In the control group the standard medical treatment is continued.

The data is collected in case report form and analysed using SPSS software by statistician.

Eligibility Criteria:
Inclusion Criteria:

* Patients with BMI ≥ 30 kg/m\^2
* DM history of less than 6 years.
* HBA1C of 6.5-8.5 %.
* On two or less than two diabetes medication.

Exclusion Criteria:

* Patients on Insulin
* Patients having any co morbidity like severe diabetic nephropathy, neuropathy and any other serious illness.
* Evidence of Type 1 diabetes, ketones and acidosis.
Cultural Arts Programme for Older Chinese

This study examines the effectiveness of an innovative cultural arts program in reducing depressive symptoms and age-related self-stigma among older Chinese as compared to service as usual through a randomized waitlist controlled trial.

Depressive symptoms are common among community-dwelling older people, and prevention and early detection can reduce the incidence of depressive disorders. However, internalized ageism and stigma of mental illness may disempower older people and impede help-seeking behaviors among those at risk of depression. Nonpharmacological interventions may reduce stigma, and among different approaches, arts-based programs are gaining attention because arts are deemed enjoyable, stigma-free, and conducive to mental health.

This study adopts a waitlist-controlled trial and examines the effectiveness of an innovative cultural art programme to combat internalised ageism and reduce depressive symptoms compared with service as usual. Community-dwelling older adults (age 60 years and over) at risk for depression will be recruited and randomised to receive cultural arts (experimental group) or service as usual (waitlist control group). Assessments will be administered by trained researcher(s) at baseline (T0), and completion of the 9-session intervention (T1). Effectiveness analyses will be based on changes in assessments at different time points between intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* aged 60 years or above;
* at risk for depression, i.e., Patient Health Questionnaire (PHQ-9) score under 10; or
* having at least one risk factor of depression, including frequent loneliness, lack of social interaction, lack of meaningful/enjoyable activities, chronic pain, more than four chronic diseases, or bereavement.

Exclusion Criteria:

* known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia;
* illiterate;
* physically frail; or
* significant suicidal risk.
Harnessing Macrophage Lysosomal Lipid Metabolism in Obesity (ATM)

The goal of this study is to evaluate the role of transcription factor EB (TFEB) in adipose (fat) tissue macrophages (ATM) in regulating adipose tissue and systemic metabolic function in obesity. The investigators will assess the differences in ATM lipid metabolism in people with metabolically abnormal obesity and lean individuals.

Both groups will have:

* screening visit
* imaging (body composition testing - dual-energy x-ray absorptiometry (DEXA) scans, magnetic resonance imaging \[MRI\] and magnetic resonance spectroscopy \[MRS\] scans)
* Overnight visit with intravenous infusion (IV), muscle, and fat tissue biopsies


Eligibility Criteria:
Inclusion Criteria :

* age: ≥18 but ≤70 years
* not pregnant or breastfeeding
* weight stable and sedentary before enrollment
* no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \[MAO\]-Type 2 Diabetes group)
* no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer)
* participants must fulfil all of the following group-specific inclusion criteria below:

Lean group:

* Body mass index (BMI) ≥18.5 but \<25.0 kg/m2
* Intrahepatic triglyceride (IHTG) content \<5%
* fasting blood glucose concentration: \<100 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
* Hemoglobin A1C (HbA1c) \<5.7 %

Metabolically normal obesity (MNO) group:

* BMI ≥30.0 but \<45.0 kg/m2
* IHTG content \<5%
* fasting blood glucose concentration: \<100 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl
* HbA1c \<5.7 %

Metabolically abnormal obesity (MAO)-insulin resistance and non-alcoholic fatty liver disease (NAFLD) group:

* BMI ≥30.0 but \<45.0 kg/m2
* IHTG content \>7.5%
* fasting blood glucose concentration: ≥100 but \<126 mg/dl
* blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl
* HbA1c: ≥5.7 but \<6.4 %

MAO-type 2 diabetes group:

* BMI ≥30.0 but \<45.0 kg/m2
* clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or HbA1c \>6.4 % without medication if not diagnosed and medically treated for diabetes

Exclusion Criteria:

- Individuals that do not meet all inclusion Criterion
Wearables and Cardiac Rehabilitation

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring recovering of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

The goal of this study is to collect wearable sensor data that the investigators hypothesize will be useful in future algorithm development for monitoring the recovery of participants enrolled in cardiac rehabilitation programs. Participants will be provided one or more smartwatches and/or smart rings to wear during a 14 week study which includes 2 weeks of baseline data collection and a 12-week, 36-session cardiac rehabilitation program. They will capture a pre-assessment 6 minute walk tests and a post-assessment 6 minute walk test. They will otherwise conduct standard cardiac rehabilitation program procedures and our sensors will capture data and sleep information throughout the study period.

This work will use data from cardiac rehabilitation, captured from smartwatches, and data from rest/sleep, captured from smartwatches and smartrings, to see if there are trends in recovery that can be modeled. Recovery is measured as an improvement in 6 minute walk test performance over the course of cardiac rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment in Cardiac Rehabilitation - eligible all-comers to Cardiac Rehabilitation
* Age 18 or older
* Native English speaker

Exclusion Criteria:

* Inability to wear one or more SmartWatches or Smartring
* Inability to walk unassisted
* Inability to participate in cardiac rehabilitation
* Inability to use a smartphone to aid in upload of remote data
* Lack of smartphone to use in the study
* There is a change in participant health such that the participant meets any of the exclusion criteria for this study during the course of the cardiac rehab sessions