cyrilzakka/clinical-trials huggingface dataset:
Quantification of Outcome Measures for Mind-body Interventions

The purpose of this study is to determine if participation in one of three different health management groups will elicit genomic and biochemical changes and decrease perceived stress levels and symptoms in healthy, stressed adults. The investigators expect that changes in self-reported psychological stress and symptoms will be directly linked to changes in biological indicators (genomic expression profiles and neuroendocrine and pro-inflammatory biomarkers).

This randomized, controlled trial will determine the relative strength of correlation between changes in stress outcome measures (self-report questionnaire, genomic expression, biochemical assay) in moderately to severely stressed healthy subjects randomized to one of three health education interventions at both end-intervention and at a 6-month long-term follow-up. This study will also determine which of the different outcome measures exhibit the greatest degree of sensitivity, reliability and consistency at both end-intervention and long-term follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Stress is chronic and ongoing with no resolution of the stressors within the timeframe of the study, with a minimum prior duration of 6 months.
* Able to provide informed consent and to understand written and spoken English.

Exclusion Criteria:

* Practice of yoga, meditation, guided imagery or other mind body techniques that elicit the RR, once per week for 45 min total or more within the last three months or less.
* Any current medical condition that would preclude their safe and effective practice of the yoga or meditation interventions.
* The presence of bipolar or psychotic disorders, or history of any other DSMIV Axis I disorder with active symptoms or treatment within the last 5 years, as determined by a structured clinical interview.
* Initiation of psychotherapy within 6 months of entering the study.
* Serious or unstable medical illness, including serious or unstable cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease.
* Patient deemed unable to complete protocol due to cognitive, psychiatric or other reasons.
* Pregnancy or planned conception over the course of the study (could confound biomarker values).
* Current use of the following medications: systemic corticosteroids, chronic (i.e., more than 3 days per week) use of anti-inflammatories (e.g., ibuprofen; currently or within the last 3 months), immunosuppressive or cytotoxic therapies (currently or within the last 12 months), and anabolic steroids.
* Current (within the last 6 months) psychoactive medications (e.g. antidepressants, mood stabilizers, antipsychotics, anxiolytics), with the exception of hypnotics, which will be permitted.
Scleral Response to Intraocular Pressure (IOP)

The study evaluated changes in the depth of the lamina cribrosa at different eye pressures.

Participants were glaucoma patients who during routine care were observed at different eye pressures. Images taken with an optical device that is routinely used in such patients were analysed.

Eligibility Criteria:
Inclusion Criteria:

* glaucoma patients

Exclusion Criteria:

* non-glaucoma patients
Tri Staple Technology Stapler Used in Gastric Bypass

The objectives of this clinical trial are to assess in a pilot setting the overall performance and safety of the Endo GIA™ Stapler with Endo GIA™ SULU with Tri-Staple™ Technology when used in a gastric bypass procedure.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be 18-65 years of age.
* The patient has a BMI of 40-60 kg/m2, or 35-40 kg/m2 with one or more of following comorbidities: sleep apnea, hypertension, hyperlipidemia, coronary artery disease, gastro esophageal reflux disease, osteoarthritis, and diabetes and eligible for gastric bypass.
* The patient must be willing and able to participate in the study procedures and able to understand and sign the informed consent.

Exclusion Criteria:

* The procedure is needed as revision bariatric surgery or the patient has had prior gastric surgery (nissen fundoplication, hiatal hernia, etc)
* The patient is pregnant.
* The patient has an active or history of, infection at the operative site.
* The patient is unable or unwilling to comply with the study requirements, follow-up schedule, or to give valid informed consent.
* Patient has an abdominal ventral hernia requiring mesh repair
* The patient has a history of clinically significant liver disease
* The patient has a history of drug or alcohol abuse within 2 years of enrollment
* The patient has a history of venous thrombosis or pulmonary embolism
* The patient has a history of coagulopathy
DEX vs SEVO in Congenital Heart Surgery

Anesthesia-related neurotoxicity in the developing brain is still a concern although evidence in humans is debatable. Moreover, it is unclear whether repeated and/or prolonged exposures are harmless and whether their effects are more pronounced in newborns and infants with brains more vulnerable to injury. One such specific group of patients is children with congenital heart disease (CHD). Nearly, half of the school-age survivors with CHD exhibit neurodevelopmental symptoms. It is thus important to elucidate whether any plausible neurotoxicity of the commonly used anesthetic agents can be observed in this population, and whether specific neuroprotective strategies can be demonstrated within the frame of a randomized controlled trial (RCT).

Animal data have shown that dexmedetomidine (DEX) induces neuroprotective effects only at well-adjusted doses. One major issue with trials of anesthetic neurotoxicity is the latency between the conduct of these studies and the assessment of neurodevelopmental outcome. In contrast, the use of biomarkers of neuronal injury could be extremely valuable. Serum Neurofilament Light (NfL) has been shown to be a sensitive and specific marker of neuronal injury and is associated with neurologic outcome of children with various pathologies. The investigators hypothesize that in congenital heart surgery, use of DEX as main anesthetic agent in conjunction with low dose sevoflurane results in less release of serum NfL and is thus potentially less neurotoxic compared to the current standard of care. The hypothesis is tested with a RCT including patients between 0 - 3y undergoing surgery with cardiopulmonary bypass. To avoid any neurotoxicity due to anesthetic overdose, intraoperative burst suppression will be avoided. In addition to postoperative comparison of serum NfL, postoperative electroencephalogram and neurodevelopmental outcome of both groups will be compared taking into consideration the genetic background.


Eligibility Criteria:
Inclusion Criteria:

* Patients up to 3 years
* Must undergo cardiac surgery with CPB

Exclusion Criteria:

* Preoperative chronic kidney disease (glomerular filtration rate of less than 30 ml/min per 1.73m2 for greater than 3 months)
* Preoperative cerebral hemorrhage, stroke or
* Preoperative seizures
* Abnormal preoperative cerebral ultrasound
* Preoperative Extracorporeal Life Support
* Preoperative sedated and intubated patients
* Preterm newborns (\< 32 W gestational age)
* Newborns weighing \< 2 kg
* Patients with Williams-Beuren syndrome.
Satiety Response After Mixed Fiber Doses

People who eat more dietary fiber have a lower body weight than people who eat less fiber. Potential mechanisms include greater feelings of satiety, reductions in food intake, changes in blood glucose, insulin, or gut hormones.

The investigators hypothesize that increasing doses of mixed fiber will influence satiety response, food intake, glucose, insulin, ghrelin, GLP-1, and PYY 3-36, in a dose-dependent manner, when given to subjects in muffins for breakfast.


Eligibility Criteria:
Inclusion Criteria:

* English speaking
* healthy men and women
* 18 and 65 years of age
* non-smoking
* not taking medications
* non-dieting (weight stable over last 3 months)
* BMI between 18 and 27
* able to give blood through an IV

Exclusion Criteria:

* irregular or erratic breakfast eating patterns
* food allergies to ingredients commonly found in muffins or pizza
* distaste for muffins or pizza
* BMI less than 18 or greater than 27
* weight change \> 5 kg in last 3 months (intentional or unintentional)
* cardiovascular disease
* diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* cancer in prior 5 years (except basal cell carcinoma of skin)
* renal or hepatic disease
* Crohns disease
* ulcerative colitis
* any other gastrointestinal conditions that may affect digestion or absorption
* recent bacterial infection (\< 3 months)
* chronic medication use
* history of drug or alcohol abuse in prior 6 months
* concurrent or recent intervention study participation
* vegetarians
* people who ate more than approximately 15 g of fiber per day
* pregnant or lactating women
* women with irregular menstrual cycles
Does Improving Insulation and Heating Improve Health?

The Housing, Heating and Health Study has enrolled 409 households with ineffective heaters, who have a child with asthma between 6 and 12 years.

In the winter of 2005, houses were insulated and baseline measures taken of indoor temperatures, nitrogen dioxide, with more intensive indoor air quality monitoring in a sub-sample of 33 homes.

Objective data are being collected on the household's health and energy usage. The households randomly assigned to the intervention group will have new heaters installed over the summer.

Results will be available after the follow-up data collection in 2006.

1. Introduction New Zealand houses are relatively poorly constructed and maintained for the temperate climate and most homes are heated to less than the WHO recommended minimum winter temperature of 18°C. Excess winter mortality is comparable to the levels in Portugal and Scotland. The Group's previous Housing, Insulation and Health Study has shown that insulating existing homes leads to a small but significant improvement in health and energy consumption, but raised the question as to whether installing more sustainable heating could increase these gains.
2. Study design

We have enrolled 409 households, who use either plug-in electric heaters or unflued gas heating, and where there is a child with asthma, aged between 6 and 12 years. In the winter of 2005, uninsulated houses were insulated and baseline measures taken of indoor temperatures in the living room and the child's bedroom, and levels of nitrogen dioxide. Intensive monitoring of indoor air quality is being carried out in a sub-sample of 33 homes. All members of the child's family have filled out detailed questionnaires of their health and the heads-of -household have completed a questionnaire on the characteristics of the household's energy usage. Objective measures are also being collected of the household's fuel bills, the child's attendance at school and the family's health care utilisation.

Households are randomised so that the intervention group will have their choice of new, more efficient and sustainable heaters (heat pumps, wood pellet burners, or flued gas heaters) that heat more of the house and which emit no internal emissions installed over the summer. In the winter of 2006, follow-up measures will be taken and then the control households will receive their choice of new heaters.

Eligibility Criteria:
Inclusion Criteria:

* Household has asthmatic child between 6 and 12, is living in study area, and will not be moving in the two years after applying to join the study.

Exclusion Criteria:

* Heating of good quality and comparable to heater that will be installed by the study
Food Intake and the Adolescent Brain

The brain plays an integral role in how and what people eat. However, the brain's contribution to overeating is not well understood during sensitive developmental periods such as adolescence, when excessive weight gain and obesity prevalence are a significant concern.The proposed study will use functional magnetic resonance imaging to examine how the brain's response to excess energy is related to overeating in adolescents with and without obesity.


Eligibility Criteria:
Inclusion Criteria:

* male or female
* 13-18 years-old
* resident of Colorado

Exclusion Criteria:

* weigh less than 88 pounds or have a BMI% rank of \<10% for age and sex;
* have a physician's diagnosis of metabolic syndrome or diabetes (Type 1 or 2);
* have a physician's diagnosis of anorexia nervosa or bulimia nervosa;
* currently taking anti-psychotic medications (not including anti-depressant or anti- anxiety medications);
* have a non-MRI safe device (e.g. pacemaker or defibrillator) or metal in the body (e.g. metal pins, shrapnel);
* experience symptoms of claustrophobia when in small or closed-off places;
* are pregnant or plan to become pregnant
A Smartphone Intervention for WIC Mothers to Improve Nutrition and Weight Gain During Pregnancy

The study will test the effectiveness of a smartphone-based behavior modification program adapted for use in Women, Infants, and Children program in a state-wide, randomized controlled trial in 432 low-income women enrolled in the Louisiana Women, Infants, and Children program.

The study is a multi-site randomized controlled trial, testing the effectiveness of the smartphone-based behavior modification program in pregnant women within the Louisiana Women, Infants, and Children program. Equal number of participants will be randomized to either the intervention or the control. Although the intervention itself lasts 24 weeks (only during pregnancy), women will be enrolled in this study for approximately 18 months, from the 10-16th week of pregnancy until 12 month postpartum follow-up. Study outcomes will be assessed at three visits during pregnancy (early, mid, and late,) and three visits postpartum (1, 6, and 12 months).

Eligibility Criteria:
Inclusion Criteria:

* Less than 16 weeks gestational age at screening visit
* Have a BMI of 18.5 to 40 kg/m2
* Expecting a singleton pregnancy
* Certified to receive Women, Infants, and Children services during current pregnancy
* Has smartphone with internet access
* Willing to be identifiable to other study participants in this study program

Exclusion Criteria:

* Smoking
* Drug or alcohol use
* Non-pregnancy related illness
* Hypertension at screening visit
* Current mental health issue or eating disorder
* Inability to complete a behavioral run-in task
* Plans to move out of the state in the next 18 months
Use of a Social Assistance Robot in a Population of Children Subjected to Prolonged Isolation

During the period of isolation of the hospitalized child, contacts between the child and his family are impaired. Being away from home as well as from the social and family circle can be harmful for the hospitalized child. It seems necessary to measure the impact of the use of such an assistance robot both on the user himself and his family. Thus, it seems relevant to scientifically validate the benefit of using such an assistance robot to break iatrogenic social isolation and to measure the impact of this use.


Eligibility Criteria:
Inclusion Criteria:

* Children hospitalized in the pediatric hemato-oncology department whose duration of isolation is estimated to be greater than two weeks.
* Children who have accepted the robot and whose parents have accepted its use in their home.
* Agreement of holders of parental authority for the inclusion of the hospitalized child.

Exclusion Criteria:

* Patient or two parents who do not have a sufficient level of French for research.
* Cognitive or motor disorders in children, not allowing the use of the robot and/or the carrying out of semi-structured interviews.
* Cognitive disorders in parents and/or siblings that do not allow semi-structured interviews to be carried out.
Esmadem Education Model on High-Risk Pregnant Women

Pregnancy is a normal and natural process in a woman's life. During this process, anatomical, physiological, biochemical and emotional changes are observed. During pregnancy, sometimes risk situations arise from the mother, sometimes from the fetus. the scope of prenatal care is high today, the main focus is on the physical aspects of care and medical measures. Midwives who provide holistic care should also address spiritual care. Therefore, the esmadem education model will be conducted to examine the effect of the spiritual coping, tolerance and depression of risky pregnancies.


Eligibility Criteria:
Inclusion Criteria:

Pregnant women aged 18-45 ,In the second trimester, Primiparous, Have sufficient communication skills, Literate, Can read and understand Turkish, Agree to participate in the research Continuing pregnancy school Having a risky pregnancy diagnosis according to the criteria in the Ministry of Health Pregnancy Risk Assessment Form and having been diagnosed as a risky pregnancy by a physician

Exclusion Criteria:

* Having any mental illness
Role of Mineralocorticoid Receptor in Diabetic Cardiovascular Disease

Aldosterone is a significant mediator of cardiovascular injury associated with heart failure and the cardiovascular benefits of mineralocorticoid receptor blockade are additive to those of angiotensin converting enzyme inhibitors or angiotensin II (ANGII) receptor blockers. This study will test the hypothesis that mineralocorticoid receptor (MR) antagonists exert beneficial cardiovascular effects, specifically by decreasing vascular injury and improving vascular function. A randomized, double-blind study will be conducted, in which participants with Type 2 Diabetes Mellitus will undergo a series of assessments to test heart, blood vessel, and kidney function at baseline, and after 2 and 6 months of treatment with one of the following drugs:

1. spironolactone
2. hydrochlorothiazide (HCTZ) plus potassium
3. placebo

In the event of insufficient funds, randomization to the placebo arm will be stopped and primary assessment of outcomes will occur at baseline and after 6 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years
* type 2 diabetes mellitus
* with or without hypertension

Exclusion Criteria:

* ischemic changes on resting electrocardiogram,
* clinical evidence of heart disease (angina, heart failure, unstable angina),cerebrovascular or peripheral vascular disease,
* significant cardiac arrhythmias,
* aortic stenosis,
* 2nd or 3rd degree atrio-ventricular block, sinus node disease, or symptomatic bradycardia,
* bronchospastic lung disease with active wheezing,
* known hypersensitivity to adenosine,
* hemoglobin A1C (HbA1c) \> 8.5%, \*
* gout (If not already taking HCTZ),
* the use of Rosiglitazone,\*\*
* estimated glomerular filtration rate (eGFR) \< 60 ml/min,
* serum potassium \> 5.0 mmol/L,
* use of potassium-sparing diuretics,\*\*
* current smoker,\*
* pregnancy,
* renal disease not related to diabetes mellitus,
* uncontrolled hypertension, systolic blood pressure (BP) \>160 mm Hg and diastolic BP \>100 mm Hg,\*
* use of cyclic hormone replacement therapy
* past intolerance of angiotensin-converting enzyme (ACE) inhibitor therapy
* other major medical illnesses. Participants with evidence of a previous myocardial infarction on the first adenosine-stimulated positron emission tomography (PET) study will be withdrawn from the study.
* Screening systolic blood pressure \< 105 mm Hg off of anti-hypertensive medications

  * Participants can enroll in study and proceed with in-patient evaluations if during the run-in period adjustments of medications, diet and habits lead to improved glucose control \[equivalent to HbA1c \<8.5%, controlled hypertension and cessation of smoking.

    * Participants who are currently taking these medications will not qualify for a screening visit. If medications were recently stopped by the participant's physician, he or she may be screened but the baseline assessment protocol must occur 3 months after stopping.
Tongxinluo Capsule for Coronary Microvascular Disease

To investigate the efficacy and safety of Tongxinluo in patients with microvascular angina pectoris. Long-term follow-up of 1 to 5 years will be performed to evaluate the effect of Tongxinluo on long-term adverse cardiovascular events in patients with coronary microvascular disease.


Eligibility Criteria:
Inclusion Criteria:

1. Repeated chest pain attacks with typical exertional angina pectoris or resting angina pectoris attacks;
2. Coronary normal or stenosis \< 20%;
3. Ischemic depression in ST segment during resting or exercise;
4. Blood flow reserve (CFR) of the anterior descending coronary artery \< 2.0;
5. Subjects or their guardians agreed to participate in this study.

Exclusion Criteria:

1. Previous myocardial infarction or PCI or CABG treatment;
2. A history of heart failure or LVEF \< 50%;
3. Severe arrhythmia;
4. Myocarditis, Pericardium Disease, Valvular Disease, or Cardiomyopathy;
5. A history of stroke within half a year;
6. Diabetes difficult to control;
7. Refractory hypertension or hypertension accompanied by left ventricular wall thickness \> 12 mm;
8. Familial hypercholesterolemia;
9. Takayasu arteritis, Kawasaki disease or coronary artery malformation;
10. Pregnant or nursing, or having the intention to give birth within one year;
11. Hepatic or renal dysfunction;
12. Other diseases which may cause serious risks to patients;
13. Requiring warfarin anticoagulant therapy; Taking potassium channel opener, CCB, ACEI drugs or traditional Chinese medicines;
14. Allergic to contrast agents or blood products;
15. Patients who participated in clinical research of other drugs within 3 months before being selected.
The Movement Program for an Active and Healthy Lifestyle in Adolescents

School is a favorable environment for the development of actions aimed at healthy behavioral changes. This project proposes to evaluate the effectiveness of an intervention program on aspects of lifestyle, with a focus on physical activity (PA) and reducing sedentary behaviors, and the relationship of these factors with the academic performance of students in the school from Florianopolis, SC, Brazil.

This is a randomized controlled intervention study enroling classes of 7th to 9th grade of fundamental education.

The intervention program will last for one year (about ten months), with three focuses: training of teachers, educational and environmental changes to behavior change.


Eligibility Criteria:
Inclusion Criteria:

Students of both sexes Students aged 12-15 years Students who are enrolled in 7-9 grade classes

Exclusion Criteria:

Students younger than 12 years-old and older than 15 years-old Students with uncompleted data at baseline and/or 10-months follow-up Students who dropout the school