bioihbjkbjnl/mcl2 huggingface dataset:
Rehabilitation of Adolescents and Young Adults With Congenital Heart Diseases
Condition: Heart Defects, Congenital; Adolescent; Young Adult
MeSH terms: Heart Diseases; Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      The investigators aim to measure the impact of a rehabilitation program in congenital
      cardiology in terms of health related quality of life. The orginality of the rehabilitation
      program consists in its design : initial hospitalizationfor a short period of time (5 days)
      at the rehabilitation center, followed by 11 weeks of rehabilitation at home under the
      supervision of a specialized sports trainer.
    

Detailed description: 
      Adolescents and adults with congenital heart disease (CHD) have reduced exercise capacity
      compared to the general population, even for "simple" heart disease.

      Regular physical activity is known to reduce the risk of acquired heart disease.

      Cardiac rehabilitation programs have been largely developed to manage adult coronary and
      heart failure patients, which is not yet the case routinely in patients, adults and children,
      carriers of DC.

      The investigators assume that patients who participate in this program will improve their
      quality of life compared to controls.

      The orginality of the rehabilitation program consists in its design : initial
      hospitalizationfor a short period of time (5 days) at the rehabilitation center, followed by
      11 weeks of rehabilitation at home under the supervision of a specialized sports trainer .
    

Intervention name(s): Cardiac rehabilitation
Intervention type(s): Other
Intervention description(s): Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cardiac rehabilitation
Masking: None (Open Label)
Primary purpose: Other
Keywords: cardiac rehabilitation; Congenital heart diseases; Heart defects, congenital; Adolescent; Young adult; Physical activity; Cardio-pulmonary exercice test; Oxygen uptake; Muscular deconditioning; Patient education as topic; Quality of life; Health Knowledge, Attitudes, Practice
Bioequivalence Study of Pantoprazole Sodium DR Tablets 40 mg of Dr. Reddy's Laboratories Limited Under Fasting Condition
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the single dose bioavailability of pantoprazole sodium 40 mg delayed release
      tablets (Dr. Reddy's Laboratories Ltd, India) with Protonix® 40 mg delayed release tablets
      (Wyeth Laboratories, USA) in 42 (+ 4 standby) healthy, adult, human subjects under fasting
      conditions.
    

Detailed description: 
      This is a Open label, balanced, randomized two-treatment, two-period,two-sequence, crossover
      bioequivalence study with at least 07 days washout period between each drug administration
      under fasting conditions.42 (+4 standby) healthy, adult, human subjects were enrolled. A
      single oral dose of40 mg of pantoprazole delayed release tablet will be administered along
      with 240 mL of drinking water after an overnight fast of at least 10 hours in each period.
    

Intervention name(s): Pantoprazole Sodium
Intervention type(s): Drug
Intervention description(s): Pantoprazole Sodium DR Tablets 40 mg
Other intervention name(s): Protonix DR Tablets 40 mg
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Appendectomy Versus no Appendectomy With Cesarean Section
Condition: Cesarean Delivery; Appendectomy
Study type: Interventional

Summary: 
      Women having cesarean section will be divided into two groups - cesarean section alone or
      cesarean section with appendectomy. The purpose is to see if the appendectomy can be done
      without adding any complications to the maternal post-operative course. The hypothesis is
      that there is no increased incidence of wound infection, post-operative morbidity or longer
      hospital stay associated with elective appendectomy at the time of Cesarean Section.
    

Detailed description: 
      Even though the incidence of appendicitis has decreased significantly since the advent of
      antibiotics, the disease process is still quite ubiquitous in many patient populations. The
      incidence of appendicitis in women over 20 and under 50 years of age is significant. The
      annual incidence of appendicitis in women aged 17 to 64 years of age is 1.9 per 1000. In the
      population aged 15 to 19 years of age, the risk of developing appendicitis is 1 in 99 in each
      year of this 4-year period. Diagnosing appendicitis in pregnancy poses a great challenge for
      the obstetrician because the appendix is displaced during pregnancy, nausea is common in
      pregnancy, direct abdominal signs are variable as well. The incidence of proven appendicitis
      approximates 1 in 1500 deliveries. Maternal and fetal mortality and morbidity are increased
      when appendicitis is associated with pregnancy, and the risks rise significantly if
      perforation and peritonitis occur. Fetal loss, which is between 10 and 20% in most reports,
      is mainly due to preterm labor or intrauterine death, particularly when perforation occurs.
      There are three main reasons to perform an incidental appendectomy (at the time of cesarean
      section): To reduce future mortality and morbidity from appendicitis in women of childbearing
      age; to eliminate undiagnosed incidental pathology in the appendix; and to eliminate the
      appendix from diagnostic consideration when the patient presents with abdominal or pelvic
      complaints. There will be 100 subjects taking part in the study. Standard post operative care
      will be administered with the only difference in the two groups being the operative procedure
      (appendectomy or no appendectomy).
    

Intervention name(s): Appendectomy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Cesarean section; Appendectomy
A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This multiple dose study will assess the safety, tolerability, pharmacokinetics and
      pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)-
      infected participants. The primary hypothesis is that administration of grazoprevir for 7
      days is sufficiently safe and well tolerated in HCV-infected males.
    


Intervention name(s): Grazoprevir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days; Placebo tablet, orally, once a day for 7 days
Intervention MeSH terms: Grazoprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the safety and tolerability of dabigatran etexilate capsules in a small group
      of eight adolescent patients.
    


Intervention name(s): dabigatran etexilate
Intervention type(s): Drug
Intervention description(s): 2.14 mg/kg BID to a max 150 mg BID
Intervention MeSH terms: Dabigatran
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study Assessing the Safety, Tolerability, and Pharmacokinetics of SEP-363856 in Male and Female Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral
      dose study designed to evaluate the safety, tolerability, and pharmacokinetic (PK) profiles
      of SEP-363856 and its metabolite SEP-363854 in male and female subjects with schizophrenia.
    

Detailed description: 
      This is a single-center, randomized, single-blind, placebo-controlled, ascending single oral
      dose study designed to evaluate the safety, tolerability, and PK of SEP-363856 and its
      metabolite SEP-363854 in male and female subjects with schizophrenia. This study will
      determine the maximum-tolerated dose (MTD) for a single oral dose of SEP-363856, and
      characterize the plasma PK profiles of SEP-363856 and its metabolite SEP-363854 in male and
      female subjects with schizophrenia.

      For each of the dose-escalation cohorts, 12 subjects (9 active subjects and 3 placebo
      subjects) will receive a single oral dose. An attempt will be made to have at least one-third
      of subjects in each cohort be female.

      Each cohort will be comprised of 12 subjects (9 active, 3 placebo). Within each cohort,
      subjects will be randomized to receive either SEP-363856 (active) or matched placebo in a 3:1
      ratio.

      The planned dose levels that will be evaluated are:

        -  Cohort 1: A single oral 25 mg dose of SEP-363856 or matched placebo.

        -  Cohort 2: A single oral 50 mg dose of SEP-363856 or matched placebo.

        -  Cohort 3: A single oral 100 mg dose of SEP-363856 or matched placebo.

        -  Cohort 4: A single oral 150 mg dose of SEP-363856 or matched placebo.
    

Intervention name(s): SEP-363856; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SEP-36385625 as a single oral dose of 25, 50, 100, and 150 mcg; single oral dose placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective disorders
Turmeric Anti-Inflammatory and Cell-Damage Trial
Condition: Healthy Adults
Study type: Interventional

Summary: 
      This trial will be conducted for the BBC. The aim of the project is to assess if consuming
      the spice turmeric every other day, in the amount consumed in a curry, can reduce cell damage
      and inflammation. The results of the project will be used to inform the TV program Trust Me
      I'm a Doctor.
    

Detailed description: 
      100 volunteers will be recruited for a 6 week intervention. The study group will be divided
      into 3 arms, each with approximately. 33 participants; one arm will receive a placebo
      capsule, one arm will receive a capsule with 400mg of curcumin (corresponding to two
      teaspoons of turmeric powder). These treatments are done double-blind. A third arm is 'open
      label', these volunteers will receive a bag with at least 135g turmeric and be asked to add
      two teaspoon to their food. Participants will be asked to supplement their diet with turmeric
      (powder, capsule or placebo) every other day for six weeks.

      Participants will be asked to attend the NU-Food research facility on 3 occasions. The first
      will be a screening session where participants will be given the option to discuss the
      project with a researcher. Participants will complete a screening questionnaire and sign an
      informed consent form. On the next visit, participants will arrive at the research facility
      at a pre-arranged time and firstly have their height and weight measured. Participants will
      then give 10ml of blood via venepuncture and asked to provide a 10ml spot urine sample. After
      this participants will be randomly allocated a treatment group (placebo, turmeric capsule or
      turmeric powder) and given instructions on dosage. After a 6 week treatment period,
      participants will return to the research facility, have their height and weight measured then
      give a second 10ml venous blood sample and provide a final spot urine sample. Each visit will
      take around 20 minutes.

      The main outcomes of the trial are oxidative stress and inflammation tests which will be
      conducted by PB bioscience and an assessment of DNA methylation by University College London.
      Proteomics analysis will be conducted on Urine samples.
    

Intervention name(s): Placebo comparator; Curcumin; Turmeric powder
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
EXCEL-II DES to Treat the Patients With de Novo Coronary Artery Lesions. (CREDIT-III)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Observational [Patient Registry]

Summary: 
      The study aims to further assess the safety, efficacy and the performance of its delivery
      system of the new generation Sirolimus-eluting stent of JWMS up to five years.
    

Detailed description: 
      1. A prospective, a single set, multicenter clinical trial;

        2. The primary in situ in patients with coronary heart disease;

        3. The center of: 28 (the actual number of center shall prevail);The plan selected 621
           patients;(where the total number of cases in 2.25 mm specification not less than 30
           cases, 5 cases each specification of not less than 2.25 mm.)

        4. Clinical follow-up time points: 1 months, 6 months, 12 months and 18 months of a year
           and 2 years to 5 years follow-up; This test by an independent coronary angiography core
           laboratories, data management and statistical center, clinical end points to judge
           committee and clinical monitoring of all relevant clinical and imaging data collecting,
           sorting, statistical analysis and judgement.All the selected patients within five years
           continuous follow-up tracking (phone or outpatient follow-up), to observe the happening
           of adverse events to the forward of the second generation of EXCEL drug-eluting stents
           (des) system security to make more accurate and credible evaluation.
    

Intervention name(s): EXCEL-II biodegradable polymer sirolimus-eluting stent
Intervention type(s): Device
Intervention description(s): EXCEL-II biodegradable polymer sirolimus-eluting stent implantation
Intervention MeSH terms: Sirolimus
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the Patients With de Novo Coronary Artery Lesions
      
Biospecimen description: 
      According to the CREATE (Multi - Center Registry of Excel Biodegradable Polymer Drug Eluting
      Stent) registration results show that ExcelTM drug-eluting stents implanted an average of 12
      months, target lesion (TLF) the failure rate of 6.7%.Will this study expected target lesion
      group stent failure rate estimate of 6.7%, the target is 9.5%;Test hypothesis: bilateral
      0.05% 0.05%, master degree, clinical follow-up requirements is more than 95%, this research
      need at least 829 patients, remove the CREDIT II randomized controlled study can provide the
      number of cases of test group 208 examples, this study still need to be included in the 621
      patients.
    
Keywords: DES; CAD; EXCEL-II; JWMS; PCI
High Dose Vitamin B1 to Reduce Abusive Alcohol Use
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 4

Summary: 
      B1AS tests the hypothesis that increased vitamin B1 (thiamine) intake can repair brain
      systems damaged by alcohol and help people with alcohol problems control their alcohol use. A
      strong, man-made form of thiamine (Benfotiamine) is used to increase blood thiamine to much
      higher levels than can be achieved using normal vitamin supplements. Drinking patterns are
      examined over 6 months of continued supplement use. Men and women with a recent history of
      alcohol problems are eligible to participate.
    

Detailed description: 
      B1AS is a randomized, double-blind placebo-controlled clinical trial of the effectiveness of
      Benfotiamine at reducing abusive drinking patterns in individuals with recent alcohol
      problems. Subjects consume 4 tablets of Benfotiamine (600 mg) or placebo daily for 6 months.
      Monthly follow-ups track alcohol use and alcohol-related problems over the 6 months. Blood
      tests are also conducted to determine the frequency of an inherited abnormality in thiamine
      processing that may be related to the risk of developing alcoholism.
    

Intervention name(s): Benfotiamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Benfotiamine 600 mg; Placebo
Intervention MeSH terms: Benphothiamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcoholism; Benfotiamine; Thiamine
Testing an Internet-Based Intervention for Preventing Eating Disorders
Condition: Eating Disorders
MeSH terms: Feeding and Eating Disorders
Study type: Interventional

Summary: 
      This study will examine the ability of an Internet-based program to prevent college-aged
      women from developing eating disorders.
    

Detailed description: 
      Approximately 2% to 4% of college-aged women suffer from eating disorders (EDs), and many
      more are at risk of developing them. A previous Internet-based intervention called Student
      Bodies (SB), which focused on body image concerns, was effective in reducing risk factors for
      EDs among college-aged women. However, the original SB program did not account for certain
      other risk factors, such as depression and compensatory behaviors like self-induced vomiting,
      over-exercising, or use of diuretics. Image and Mood (IaM) is an enhanced version of the SB
      program and takes into account depressive symptoms and the use of compensatory behaviors.
      This study will examine whether IaM will reduce ED risk factors in a large population of
      college women who are at high risk of developing EDs.

      Participation in this study will last 10 weeks. Participants will be randomly assigned to
      either receive the IaM program or be placed on a wait list. The IaM program, which will be
      delivered through the Internet, will provide information about nutrition, exercise, body
      image, and coping skills-including examples and exercises. It will also include an online
      message board monitored by a study psychologist. Each week the IaM participants will monitor
      their behavior, keep a journal about their experiences, and answer self-report
      questionnaires. Assessments of eating disorder symptoms; weight and shape concerns;
      depressive symptoms; and incidence of substance abuse, anxiety, or depressive disorders will
      be completed post-treatment and at 1- and 1.5-month follow-ups. Those assigned to the wait
      list will complete these assessments and then receive the IaM program after the last
      follow-up.
    

Intervention name(s): Image and Mood (IaM) program
Intervention type(s): Behavioral
Intervention description(s): A 10-week Internet-based intervention focused on (1) identifying and challenging automatic thoughts in order to improve body image and reduce negative affect, (2) developing adaptive emotion and behavior regulation skills associated with preventing disordered eating and negative affect, and (3) teaching relapse prevention skills. The program includes an online discussion group moderated by a study clinician.
Other intervention name(s): Student Bodies+
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Bulimia Nervosa; Binge Eating; Binge-Eating Disorder
The Value of the Trendelenburg Position During Routine Colonoscopy: A Pilot Study.
Condition: Colonoscopy
Study type: Interventional

Summary: 
      Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and
      remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at
      the tip, through the colon. The insertion process can be difficult in some patients,
      resulting in an uncomfortable and lengthy procedure.We postulate that raising the foot of the
      bed so that the stretcher forms a 15 degrees angle with the floor ("Trendelenburg position")
      may make the colonoscopy easier and more comfortable to the patient.
    

Detailed description: 
      Colonoscopy is a procedure commonly performed to screen for colon cancer and to look for and
      remove colon polyps. It involves inserting a flexible tube, equipped with a video-camera at
      the tip, through the colon. The insertion process can be difficult in some patients,
      resulting in an uncomfortable and lengthy procedure. Colonoscopy procedures are typically
      started with the patient positioned on their left side. If there is later difficulty
      advancing the colonoscope, the patient is shifted to other positions (e.g. back, right side,
      prone). We postulate that raising the foot of the bed so that the stretcher forms a 15
      degrees angle with the floor ("Trendelenburg position") may make the colonoscopy easier and
      more comfortable to the patient. This is a position commonly used in gynecologic surgery.
      This is a pilot project for us to gain experience with doing colonoscopy this way. The
      enrolled patient will be assigned randomly to 2 groups: one in the standard left lateral
      position and one in the 15 degree Trendelenberg position. We will be collecting data
      regarding the procedure from each group in the form of questionnaire and data sheet which
      will be filled during or at the conclusion of the procedure.
    

Intervention name(s): Trendelenburg position; Standard care
Intervention type(s): Procedure; Procedure
Intervention description(s): The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination; The patient will be placed in the standard horizontal position
Other intervention name(s): Head-Down Tilt
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Uptake and Acceptability of Home-use of Mifepristone for Medical Abortion
Condition: Termination of Pregnancy
Study type: Interventional

Summary: 
      The primary aim of this study is to assess the acceptability of home-use mifepristone for
      termination of pregnancy among women who choose it and their providers. The investigators'
      secondary aims are to assess rates of follow-up, adherence, efficacy, complications, lost
      productivity, and to estimate the minimum proportion of women who choose home-use over clinic
      use of mifepristone.
    


Intervention name(s): Mifepristone
Intervention type(s): Drug
Intervention description(s): home administration of mifepristone
Intervention MeSH terms: Mifepristone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research