cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of a Virtual Pediatric Cardiac Rehabilitation Program or Telerehabilitation in Children with Heart Disease

Cardiac telerehabilitation is a much-needed pediatric therapy; however, a lack of randomized controlled trials has limited the development of and reimbursement for this valuable service. Through this prospective, randomized controlled trial, the investigators aim to demonstrate the safety and efficacy of PCTR in a clinically diverse population of children and adolescents with heart disease.

This is a single center, prospective, randomized, controlled pilot of a pediatric cardiac telerehabilitation program in adolescents with acquired or congenital heart disease.

Because of the known benefits of exercise, controls were offered the opportunity to participate in the intervention group after completing the 12 weeks in the control group.

Participants were randomized in a 2:1 ratio (intervention: control) to maximize participation in the exercise intervention. Participants were from three core populations: primary or secondary pulmonary hypertension (PH), structural congenital heart disease (CHD), and post-orthotopic heart transplant (OHT). PCTR was "semi-supervised", where one day per week the participant exercised one-on-one with a physical therapist or exercise physiologist via virtual platform and 2 days per week they exercised independently. Participants wore an activity tracker with heart rate monitoring 24 hours a day and a single lead, chest-based electrocardiogram (ECG) device while exercising. A physician or program director reviewed ECGs after all sessions. An adult had to be available in case of an emergency during each session. Controls received weekly check-ins and a Fitbit but did not receive a formal exercise prescription. All participants underwent baseline and post-study assessments including the cardiopulmonary stress test (CPET) and questionnaires and wore their Fitbits for the duration of the study.

Compliance was measured by attendance of Zoom appointments, Fitbit activity data, Wellue single lead electrocardiogram (ECG) data, and self-reported activity performed. Efficacy was measured by CPET results, validated questionnaire data and activity levels as determined by Fitbit data.

Eligibility Criteria:
Inclusion Criteria:

* Age 10 -25 yrs
* Not participating in organized sports of physical fitness programs
* Able to follow basic directions and express symptoms
* Dx of pulmonary hypertension, congenital heart disease, and transplant programs
* Clinically stable as deemed by the referring cardiologist

Exclusion Criteria:

* Clinical instability as demonstrated by recent medication escalation (within 3 months prior to starting the program)
* Hemodynamic instability
* Significant arrhythmia or ST segment or T wave abnormalities
* End-tidal carbon dioxide less than 20 mmHg with exercise, or exercise-induced symptoms that would limit ability to participate in the intervention safely
The Effect of Semaglutide on Bone Turnover in Patients With Increased Risk of Bone Fracture

The hypothesis for this study is that the GLP-1Ra Semaglutide has a positive effect on the balance between build-up and degradation as well as the strength of the bones in men and women aged 40-85 years at increased risk of bone fractures. Treatment involves injection of Semaglutide 1.34 mg/ml once a week or corresponding volume of placebo once a week for 52 weeks. The effect will be measured by bone markers in blood samples, bone scans, bone tissue tests (bone biopsy), and direct bone strength measured by microindentation at the start and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* T-score \<-1 in hip or lower back, assessed by DXA scan and / or
* Low-energy fracture within the last 3 years

Exclusion Criteria:

* T-score \<-2.5 in hip or lower back, assessed by DXA scan, although these individuals may be included if they prefer to participate or are not candidates for conventional therapy, e.g., by eGFR \<35 or adverse reaction (influenza-like symptoms, allergic reaction, etc.) to, e.g., bisphosphonate therapy
* Diabetes type 1 and 2
* Heart failure similar to NYHA Class IV
* Primary hyperparathyroidism
* Vitamin D deficiency (\<25 nM) (re-test after substitution acceptable)
* Known disorders affecting bone metabolism, e.g., uncontrolled thyrotoxicosis, severe renal impairment (eGFR \<20) or liver function (baseline phosphatase higher than twice upper limit (105 U/L)), rheumatism, celiac disease, hypogonadism, severe COPD, hypopituitarism, Cushing's disease
* Antiresorptive or bone anabolic drugs for the last 12 months
* Use of anabolic steroids in the previous year
* History of pancreatitis
* Allergy to the medicines used
* Inability to give informed consent
* BMI \<20 kg / m2
Prescription Medication Interactions

This study will examine the effects of doses of opioid/placebo and doses of sedative/placebo, alone and in combination. The primary outcomes are related to pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) to determine the interaction effects of these compounds.

Gabapentin and oxycodone are commonly used in combination for the treatment of chronic pain. Gabapentin is now widely misused/abused with studies indicating that gabapentin abuse is especially common among individuals with opioid misuse. The nature of gabapentin's abuse-related effects have been described in case reports and online as sedative-like and opioid-like, with descriptive reports including sedation, euphoria, talkativeness and increased energy. Despite their widespread co-administration both for licit and illicit purposes, no controlled psychopharmacological studies to our knowledge have directly examined the effects of oxycodone (or another opioid agonist) and gabapentin in combination. This study's objective is to characterize the subjective effect profile of gabapentin, examine the interaction between gabapentin and oxycodone, and assess the acute analgesic response to gabapentin and oxycodone, alone and in combination, across a range of doses for each drug.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults, ages 18-55
* Current non-medical use of opioids and sedatives

Exclusion Criteria:

* Physical dependence on opioids, alcohol, or benzodiazepines/sedatives/hypnotics
* Seeking treatment for drug use
* Significant medical problems
Effect of Beet-root Juice and PBM Treatments on Muscle Fatigue

The goal of this randomized counterbalanced repeated measures study is to test beet-root juice supplementation and red light therapy augment forearm muscle endurance in apparently healthy older adults over 65 years of age. The main questions seek to answer the following question:

Does beet-root juice supplementation improve forearm muscle endurance compared to a placebo supplement?

Does red light therapy improve forearm muscle endurance compared to a sham light exposure?

Does beet-root juice supplementation in combination with red light therapy improve forearm muscle endurance compared to a placebo-sham light control?


Eligibility Criteria:
Inclusion Criteria:

* Self-reports performing at least 30 minutes of light to moderate intensity physical activity 3 times per week for the last three months

Exclusion Criteria:

* Currently smoke
* Have smoked within the last 6 months
* Are taking taking supplements known to increase blood nitrate levels
* Have a known kidney disease
* Have a known liver disease
* Have a known thyroid condition
* Have a known gastritis condition
* Are taking medications that are known to cause complications with nitrate supplementation
* Have known or reported joint pain within the dominant hand
Treatment, Parallel Assignment, Double Blind (Subject, Outcomes Assessor), Efficacy Study

The purpose of this study is to determine whether electroacupuncture is effective in the treatment of overactive bladder.

Patient registry: Participants experiencing overactive bladder will be recruited from hospital outpatients and clinic-community. the diagnosis was made by the urologists. the random number table was generated by the Computer.

Sample size: According to the preliminary experiment combined the literature. Sample size is based on the primary outcome. The first step: one-tailed test: the electroacupuncture group vs Solifenacin group is 79.5% VS 54.8%( α=0.05, β=0.20, n=51). The second step: two-tailed test :the electroacupuncture group vs Placebo group is 54.5% VS 20.9%,(α=0.05, β=0.20, n=37). To combine the first and second step, 51 cases in each group are needed. Allowing for a 10% dropout, 57 cases in each group are needed. So we set the sample size is 60.

Quality control

1. Strict training on staff participating in the trial.
2. Rigorous control of the process of randomization.
3. Specific inclusion and exclusion criteria.
4. Strict outcome assessors and statisticians.
5. The standard of the drugs, acupuncture apparatus, inspection equipment are consistant.
6. Outcome assessment, completion of case report forms and data management will be under strict supervision.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of overactive bladder.
2. Frequent micturition.（average urinary frequency of ≥8 voids per day）
3. No relevant drug use within 2 weeks and no acupuncture treatment within 1 month before the study; not in other clinical trials.
4. Self-reported bladder symptoms ≥3 months
5. Capable of giving informed consent .
6. Capable and willing to follow all study-related procedures

Exclusion Criteria:

* Frequent micturition and urinary urgency are secondary to other diseases.
* Clinical diagnosis of simple stress urinary incontinence.
* Patients with urinary track infection and vagenal infection.
* Patients with implantable pelvic stimulator.
* Current use of electric therapy on pelvic area/back/legs.
* Current use of clostridium botulinum therapy on vesical or pelvic muscles.
* participation in any clinical inverstigation involving or impacting gynecological/urinary/renal function.
* Suffering from severe cardiac/hepatic/renal injury or cognitive disorder/aphasia/ dysphrenia/malnutrition, or in poor perform status and unable to cooperate.
* Patients in gestation and in lactation period.
* Patients in coagulation disorders or taking anticoagulation drugs.
* People with cardiac pacemaker or metal allergy.
* Patients having got eletroacupunture therapy or solifenacin in 4 weeks before the study.
* Patients are afraid of needles.
Following of Atmospheric Pollution Exposure During Pregnancy and Effects on Health

The SEPAGES couple-child cohort is coordinated by an Inserm (French National Institute of Health and Medical Research) team of environmental epidemiology. SEPAGES cohort is based on the general population and aims to cover several areas of environmental health research, including endocrine disruptors and air pollutants.

The main objectives is to quantify the impact of pollution during pregnancy and the first years of life on three main health outcomes : growth, respiratory health and neuro-development ; and to better understand the biological mechanism (such as genetic analysis to study the role of environmental factors on genes expression as well as the role of genetic factors on health). The objective is to include 500 families.

SEPAGES is a new type of longitudinal couple-child cohort with repeated clinical examinations during pregnancy and childhood, extensive collection of repeated biological samples from both parents and the child, use of new technologies to assess exposure to air pollution (GPS, personal dosimeter etc.) Throughout the study (during pregnancy and the first years of the child's life), clinical examination and many biological tests (urine, blood, hair) are performed. Exposure to different environmental factors are made several times during pregnancy and the first years of the child's life thanks to personal dosimeters, GPS and accelerometers. During labor and childbirth a number of samples are taken (placenta, tissues, blood, urines, hair, meconium and breast milk). Finally, during the study a number of evaluation questionnaires are given to volunteers via a computer platform in order to have a better understanding of the environment in which they are living.

The SEPAGES cohort follows the rule of the biomedical research. Informed consents are signed by both the father and the mother during the inclusion visit which takes place in the hospital. All ethical and data privacy agreements had been obtained : a favorable opinion was issued by the Comité de Protection des Personnes (CPP) on November 13th, 201 and by the CCTIRS (Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé) on January 09th, 2014. The study was authorised by the Agence Nationale de Sécurité du Médicament(ANSM), on Decmber 17th, 2013 and by the Comité Nationale de l'Informatique et des Libertés (CNIL) on June 26th, 2014.

Eligibility Criteria:
Inclusion Criteria:

* pregnant women
* \< 19 gestational weeks
* \> 18 years old
* living in the area of Grenoble
* planning to give birth in one of the four maternities located in Grenoble

Exclusion Criteria:

* not speaking French
* no access to the French social security
Multicenter iTBS Neuromodulation for PTSD Treatment

The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex (M1) as adjunct treatment for PTSD patients. The primary outcome measure includes changes in PTSD symptom severity, with secondary outcome measures focusing on negative moods improvements, quality of life and social/occupation functioning and functional connectivity of the brain.

The proposed study aims to evaluate the efficacy of intermittent theta-burst transcranial magnetic stimulation (iTBS) targeting primary motor cortex as adjunct treatment for PTSD patients.

Compared to traditional repetitive transcranial magnetic stimulation (rTMS), iTBS strategy usually delivers large amounts of pulses in a shorter time period, and its equal efficiency has been demonstrated in several psychiatric disorders such as major depressive disorder (MDD). Through this adequately randomized and sham-controlled study of iTBS for PTSD, this work will provide an alternative and potentially more potent stimulation target for clinical PTSD treatment. This study will also provide a comprehensive assessment of this treatment strategy towards improvements in symptoms, quality of life and brain functioning in PTSD.

The ultimate goal of this study is to develop a non-invasive brain stimulation approach targeting a novel site for alleviating symptoms and improving life quality for PTSD patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 to 65 years old
* Right handedness
* Have a diagnosis of PTSD meeting DSM-5 criteria
* CAPS-5 score\>35
* Under stable medication for at least four weeks
* Capable of independently reading and understanding study materials and providing informed consent.

Exclusion Criteria:

* Current (or past if appropriate) significant neurological or medical disorder, or lifetime history of 1) seizure disorder; 2) primary or secondary CNS tumors; 3) stroke; or 4) cerebral aneurysm.
* Primary psychotic disorder, bipolar I disorder, major depressive disorder, or personality disorders
* Lifetime history of attempted suicide or HAMD-17 suicide item (item 3) ≥ 3 points
* Implanted device (deep brain stimulation) or metal in the brain; a pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos if choose to do fMRI
* Previous experience of rTMS
* Pregnancy/lactation, or planning to become pregnant during the study
* Current under psychological or other physical treatments
Natriuretic Peptides and Metabolic Risk in Obesity

The investigators are examining:

1. the relationships of insulin levels and natriuretic peptide hormone levels, and
2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown of fat

in healthy lean and otherwise healthy obese individuals.

The cardiac natriuretic peptide hormonal system may protect against the development of cardiometabolic risk. Epidemiologic studies have shown that in relatively healthy individuals without heart failure, low natriuretic peptide levels are associated with unfavorable cardiometabolic phenotypes, including higher blood pressure, obesity, higher insulin levels, and diabetes mellitus. Understanding the mechanisms behind the "natriuretic peptide deficiency" of obesity would illuminate an important way in which obesity interacts with the cardiovascular system.

The investigators propose a prospective cross-over design in 40 healthy lean and otherwise healthy obese individuals. The investigators propose the following specific aims and hypotheses:

Aim 1: To study the effect of hyperinsulinemia on the response of the natriuretic peptide system to salt loading.

Hypothesis 1: Hyperinsulinemia will suppress natriuretic peptide levels in both obese and lean individuals.

Aim 2: To examine the effect of an intravenous infusion of natriuretic peptide on acute markers of lipolysis.

Hypothesis 2: An intravenous infusion of natriuretic peptide will raise acute markers of lipolysis in both obese and lean individuals.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18-50 years
* BMI 18 to \<25 kg/m2 (lean group, N=20) or BMI 30 to \<40 kg/m2 (obese group, N=20)

Exclusion Criteria:

* Current use of antihypertensive medications
* Current use of glucocorticoids, metformin, or any antidiabetes medications
* Prior or current cardiovascular disease, renal disease, or liver disease
* Diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled)
* Atrial fibrillation
* Bleeding disorder or anemia
* Elevated LFTs
* estimuated GFR \< 60 ml/min
* Abnormal sodium or potassium level
* Positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding
Wheat Bioactives and Immune Function

The purpose of this research was to understand the effects of bioactive compounds found in wheat cereal on human immunity. Subjects came in for a baseline blood draw, consumed whole wheat bran cereal daily for 21 days, and returned for a final blood draw. Immune function assays were performed at both sampling times. It was predicted that eating wheat bran would benefit immune function.

Healthy individuals, between 18 and 50 years of age, were recruited by flyer and word of mouth on the University of Florida campus and in the surrounding area, in May of 2010. Eligible subjects were randomly assigned to one of two experimental groups, to consume either 50 grams or 100 grams of whole wheat bran cereal daily, for three weeks. Blood was drawn from fasting subjects before consumption (baseline) and after three weeks of cereal consumption. Peripheral blood mononuclear cells (PBMC) were isolated and cultured with a broad based mitogen and autologous serum for 10 days. PBMC were stained with fluorochrome-conjugated antibodies on Day 0 and Day 10 of culture, at each blood draw. Data was acquired by flow cytometry and analyzed. Overall compliance was assessed using self-reported data and by counting left-over bags of cereal.

Eligibility Criteria:
Inclusion Criteria:

* generally healthy
* aged 18-65

Exclusion Criteria:

* chronic health problems
* high blood pressure
* BMI greater than 25
* vegan
Study of Ravulizumab in Pediatric Participants With HSCT-TMA

This study will evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of ravulizumab administered by intravenous infusion to pediatric participants, from 1 month to \< 18 years of age, with HSCT-TMA. The treatment period is 26 weeks, followed by a 26-week off-treatment follow-up period.


Eligibility Criteria:
Inclusion Criteria:

1. ≥ 28 days of age up to \< 18 years of age at the time of signing the informed consent.
2. Received HSCT within the past 12 months.
3. Diagnosis of TMA that persists for at least 72 hours after initial management of any triggering agent/condition.
4. A TMA diagnosis based on meeting the laboratory-based criteria during the Screening Period and/or ≤14 days prior to the Screening Period.
5. Body weight ≥ 5 kilograms at Screening or ≤7 days prior to the start of the Screening Period (date of consent).
6. Female participants of childbearing potential and male participants with female partners of childbearing potential must use highly effective contraception.
7. Participants must be vaccinated against meningococcal infections if clinically feasible. Participants who cannot receive meningococcal vaccine should receive antibiotic prophylaxis. Participants \<18 years of age must be re-vaccinated against Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae if clinically feasible.
8. Participants or their legally authorized representative must be capable of giving signed informed consent or assent.

Exclusion Criteria:

1. Thrombotic thrombocytopenic purpura (TTP) evidenced by ADAMTS13 deficiency.
2. Known Shiga toxin-related hemolytic uremic syndrome as demonstrated by positive test.
3. Positive direct Coombs test indicative of a clinically significant immune-mediated hemolysis not due to TMA.
4. Clinical diagnosis of disseminated intravascular coagulation (DIC).
5. Known bone marrow/graft failure for the current HSCT.
6. Diagnosis of veno-occlusive disease (VOD) which is unresolved at the time of Screening.
7. Human immunodeficiency virus (HIV) infection.
8. Unresolved meningococcal disease.
9. Presence of sepsis requiring vasopressor support.
10. Pregnancy or breastfeeding.
11. Hypersensitivity to murine proteins or to 1 of the excipients of Ravulizumab.
12. Any ongoing or history of medical or psychological conditions unrelated to HSCT-TMA that could increase the risk to the participant or confound the outcome of the study.
13. Respiratory failure requiring mechanical ventilation.
14. Previously or currently treated with a complement inhibitor.
15. Participation in an interventional treatment study of any therapy for TMA.
Trial of Variable Dialysate Bicarbonate

QTc prolongation and premature ventricular contractions (PVCs) are common in hemodialysis (HD) patients and are associated with sudden cardiac death.

It is known that higher dialysate bicarbonate is associated with more QTc prolongation during HD sessions.

This study aims to assess the effects of lower (30 mEq/L) versus higher (35 mEq/L) dialysate bicarbonate in adult maintenance HD patients admitted to the hospital.

The investigators will randomly assign subjects to lower versus higher dialysate bicarbonate concentrations during their hospital stay for up to a maximum of six HD sessions or until their hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

* prevalent end-stage renal disease, on maintenance HD \> 90 days
* age ≥ 18 years old
* thrice weekly HD

Exclusion Criteria:

* hemoglobin \< 8.0 g/dL
* pregnancy
* any physical, mental or medical condition which limited the ability to provide written informed consent