bioihbjkbjnl/mcl2 huggingface dataset:
Tryptophan Requirement of Healthy School Age Children
Condition: Healthy
Study type: Interventional

Summary: 
      Our objective is to determine the requirement for the amino acid tryptophan in school age
      children using the indicator amino acid technique.
    

Detailed description: 
      Seven healthy children will participate in the study. The children will participate as an
      outpatient basis with study days carried out in the Physiological Research Unit at the
      Hospital of Sick Children, Toronto, Canada. Inclusion criteria include: being healthy, not
      taking any medications, no recent weight changes, no history of significant illness, willing
      to participate in the study. Exclusion criteria were the presence of illness, significant
      weight change, not acceptance of the diet. Prior to enrolment, each subject will have to fill
      3 days food record form to ensure his or her normal dietary behavior. The study will be
      explained to subjects and their parents/guardians, benefits and potential risks will be
      explained as well and written assent, from the children, and consent from parents will be
      obtained. Subjects will receive financial compensations. Each subject will receive
      compensation for participation. Each parent/guardian will be reimbursed for the
      transpiration/parking expenses and a meal each study day.
    

Intervention name(s): tryptophan
Intervention type(s): Dietary Supplement
Intervention description(s): graded levels of tryptophan will be given to each subject
Intervention MeSH terms: Tryptophan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: requirements; amino acid; tryptophan
The Effect of Citric Flavonoid on Endothelial Function
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      This randomized, double-blind, placebo-controlled, parallel study aims to determine the
      6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and
      intestinal health as assessed by investigation of endothelial function, blood pressure and
      heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh
      subjects.

      Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum
      levels of specific metabolites of the study product.
    


Intervention name(s): Capsule containing citrus flavonoid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polyphenols; Endothelial function; Gut barrier function
Amylin and Glucagon-Like Peptide-1 (GLP-1): Influence on Gastric Emptying, Appetite and Food Intake in Humans
Condition: Diabetes
Study type: Observational

Summary: 
      The aim of this proposal is to dissect the mechanisms controlling gastric emptying, appetite
      and food intake in humans, and to obtain new knowledge to fight obesity on a pharmacological
      basis.
    

Detailed description: 
      The objective of the present study is to elucidate the mechanisms behind the effects of
      glucagon-like peptide-1 (GLP-1) on gastric emptying, appetite and food intake. The first
      GLP-1 based anti-diabetic therapy was approved by the FDA in 2005 and is now on the market in
      the United States. The strong glucose-dependent insulinotropic property of GLP-1 is a highly
      attractive feature in the pursue of optimal glycaemic control in type 2 diabetes. Moreover,
      the potential of GLP-1 to reduce gastric emptying, appetite and food intake makes it an
      attractive tool in the fight against obesity, a pandemic condition that often leads to type 2
      diabetes, and several companies are developing weight lowering drugs based on GLP-1.
      Interestingly, another peptide, amylin, exerts very similar effects on gastric emptying,
      appetite and food intake in humans. Amylin is found in insulin-rich granules in pancreatic
      beta-cells and is co-secreted with insulin upon insulinotropic stimuli. Currently, it is not
      known whether the inhibiting effects of GLP-1 on gastric emptying, appetite and food intake
      are directly mediated by GLP-1, or if the effects are secondary to the robust insulin
      responses, and thereby amylin responses, elicited by GLP-1. The objective of the present
      study is therefore to further elucidate the mechanisms of these effects in order to
      strengthen the development of anti-diabetic drugs with potential weight lowering
      capabilities.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 1 diabetes and matched healthy control subjects
      
Keywords: Amylin; GLP-1; gastric emptying; appetite and food intake
N2001-03: CEP-701 in Treating Young Patients With Recurrent or Refractory High-Risk Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: CEP-701 may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth.

      PURPOSE: This phase I trial is studying the side effects and best dose of CEP-701 in treating
      young patients with recurrent or refractory high-risk neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose of CEP-701 in pediatric patients with recurrent or
           refractory high-risk neuroblastoma.

        -  Determine the dose-limiting toxicity of this drug in these patients.

        -  Determine the pharmacokinetic behavior of this drug in these patients.

      Secondary

        -  Determine the degree of TrkB tyrosine kinase inhibition activity present in the serum of
           patients treated with this drug.

        -  Correlate the degree of TrkB tyrosine kinase inhibition activity in these patients with
           dose level, pharmacokinetics, and antitumor activity data of this drug.

        -  Determine the antitumor activity of this drug in these patients.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Patients receive oral CEP-701 twice daily* on days 1-5, 8-12, 15-19, and 22-26. Courses
      repeat every 28 days in the absence of disease progression or unacceptable toxicity.

      NOTE: *On day 1 of course 1 only, patients receive oral CEP-701 once instead of twice.

      Cohorts of 3-6 patients receive escalating doses of CEP-701 until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity. Once the MTD is determined, the dose level is
      expanded up to 9 patients.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): lestaurtinib
Intervention type(s): Drug
Intervention description(s): Given orally twice daily x 5 consecutive days followed by a two day rest. 28 days = 1 treatment course. Courses repeated indefinitely without gap provided patient has recovered course from toxicities and no DLTs. Dose level assigned according to the planned dose escalation schedule.
Other intervention name(s): CEP-701
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent neuroblastoma
The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.
    

Detailed description: 
      To suggest DBT for specific populations, compare the overall survival rate of women with
      digital mammography (DM) to the DBT screening for women with particular characteristics.
    

Intervention name(s): DBT; DM
Intervention type(s): Device; Device
Intervention description(s): Image with digital breast tomosynthesis; Image with digital mammography
Other intervention name(s): Digital Breast Tomosynthesis; Digital Mammography
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals were diagnosed with breast cancer according to the International Disease
        Classification Criteria from September 2011 to December 2015.
      
Keywords: breast cancer
Safety and Efficacy of Hormone Therapy With Letrozole in Postmenopausal Women With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to assess the safety and efficacy of neoadjuvant hormone therapy
      with letrozole in postmenopausal women with estrogen- and/or progesterone-receptor positive
      primary breast cancer on tumour regression to permit breast conserving surgery.
    


Intervention name(s): letrozole
Intervention type(s): Drug
Intervention description(s): 2.5mg letrozole once-daily
Other intervention name(s): Femara, FEM345
Intervention MeSH terms: Letrozole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Letrozole; Breast Conserving Surgery; NeoAdjuvant; Early Breast Cancer
Comparison of Active and Passive Static Stretching in Delayed Onset of Muscle Soreness of Recreational Body Builders
Condition: Sports Physical Therapy
MeSH terms: Myalgia
Study type: Interventional

Summary: 
      To find out the better treatment options from active and passive static stretching in delayed
      onset of muscle soreness in recreational body players.
    

Detailed description: 
      After registering participant's randomization will be done through sealed envelope method and
      will be allocated in both groups equally. Group 1 will receive passive static stretching
      while group 2 will receive active static stretching. All subjects will be assessed before the
      intervention through likert muscle soreness scale, Numeric Rating Pain Scale and range of
      motion for Shoulder, elbow, and wrist by a Goniometer. After that all subjects will perform
      eccentric exhaust weight exercises in the gym of all mentioned joints, three sets at each
      joint. Before giving the intervention they will assess of all mentioned parameters. Group 1
      groups will perform passive static stretching and group 2 will perform active static
      stretching. At the end of the intervention participants will be assessed again using the same
      parameters. Statistical analysis will be carried out to compare the outcomes measures of both
      groups.
    

Intervention name(s): Active and passive static stretching exercises
Intervention type(s): Other
Intervention description(s): Different group of muscles will be stretched one by one, tricep brachii, bicep brachii, wrist exentsor etc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Active Stretching; PassiveStretching; Recreational body players
Exercise,Metabolic Syndrome and Weight Regain (Echocardiography Substudy)
Condition: Metabolic Syndrome; Obesity
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      We plan to test the hypothesis that patients with metabolic syndrome will have impaired left
      ventricular diastolic parameters. These parameters will be measured before and after a stress
      test at the end of a 3 month period of exercise training and a 10% weight loss.
    

Detailed description: 
      Patients must have 2 of the 5 criteria for metabolic syndrome and be able to exercise in a
      monitored setting for 45 min 5 times a week.
    

Intervention name(s): Stress Echocardiography
Intervention type(s): Procedure
Intervention description(s): Echocardiography was performs prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: metabolic syndrome; obesity; exercise
Effectiveness of Family Group Interventions for People With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The mutual support group intervention would significantly improve the families' burden of
      care, functioning and social support, reduce the patients' severity of symptoms and
      re-hospitalizations, and reduce the demands for utilization of family services, when compared
      with the standard care group.
    

Detailed description: 
      Family interventions in schizophrenia have shown positive effects on patients but little
      attention has been paid to their effects on family members, particularly those in non-Western
      countries. This multi-site randomized controlled trial evaluated the effectiveness of a
      bi-weekly, 12-session, family-led mutual support group for Chinese caregivers of
      schizophrenia sufferers over 36 months, compared with a family psychoeducation group program
      and standard psychiatric care. It was conducted with 114 families of outpatients with
      schizophrenia in Hong Kong of whom 38 were assigned randomly to a mutual support group, a
      psychoeducation group, or standard care. Families' psychosocial health status and patients'
      symptom severity and length of re-hospitalizations at recruitment, one-month, 18-month, and
      36-month post-intervention were compared between groups.
    

Intervention name(s): mutual support group; psychoeducation group; Standard care
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): bi-weekly, 12-session, family-led mutual support group; bi-weekly, 12-session, family psychoeducation group; Routine mental health care services provided by the outpatient clinic and related agencies for families of people with schizophrenia
Other intervention name(s): FMSG; FPGP; Usual psychiatric care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: mutual support group; psychoeducation group; family caregivers; schizophrenia
Effect of Supplementation of Bioactive Compounds on the Energy Metabolism of People Living With HIV / AIDS
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Among the many changes associated with the impact of HIV and the long-term use of
      antiretroviral therapy, metabolics are important because they are important risk factors for
      the development of cardiovascular diseases. The objective of the present study is to evaluate
      the effect of the supplementation of curcumin, on the oxidation of resting energetic
      substrates in HIV / AIDS patients. The sample will be composed of adults living with HIV /
      AIDS on antiretroviral therapy for at least 6 months. Supplements will be made separately for
      30 days and will be evaluated before and after the intervention the following parameters:
      body composition, energy metabolism, biochemical parameters and a structured anamnesis. Food
      consumption and the level of physical activity of the volunteers will be controlled.
    

Detailed description: 
      The study is characterized as a double-blind randomized clinical trial. Participants in the
      study will be adults living with HIV / AIDS who undergo regular clinical follow-up at some
      Specialized HIV / AIDS Care Service.

      The sample will consist of 20 volunteers, 10 in the experimental group (GE) and 10 in the
      control group (CG). Participants will be randomly assigned to one of the groups by lottery by
      a researcher not participating in the study. The researcher responsible, as well as the
      volunteers, will not be aware of which participants are in the GE or the GC.

      The study will be carried out in the Movement Laboratory of the Physical Education Department
      of the Federal University of Rio Grande do Norte.
    

Intervention name(s): Curcumin; Placebo of Curcumin
Intervention type(s): Dietary Supplement; Other
Intervention description(s): The intervention will consist of the supplementation of curcumin for 30 days. Curcumin supplementation will be done by administration of 2 doses of 500mg of the product BioMor Curcumin® which is composed of 95% standardized extract of the root extract of Curcuma longa.; The intervention will consist of the placebo administration curcumin for 30 days.
The Curcumin placebo will be given in 2 doses of 500mg per day.
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Physical Activity and Bone Mineral Density in Children and Adolescents With Chronic Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      This study is an observational study. The purpose of this study is to assess the relationship
      between bone health and daily physical activity in children and adolescents with inflammatory
      bowel disease (IBD). Reduced bone mineral density is a common complication in pediatric IBD.
      Physical activity is an important determinant of health throughout the whole lifespan.
      Engaging in regular moderate-to-vigorous physical activity has important health benefits.
      Based on available evidence, the investigators hypothesize that daily moderate-to-vigorous
      physical activity could improve bone health (ie bone mineral density) in children and
      adolescents with IBD.
    

Detailed description: 
      To carry out this study, 120 patients (age ≥6 and <18 years at the screening visit) will be
      enrolled in this observational study. After obtaining the informed consent from the parents
      and the patient, the followings will be performed: clinical examination by a physician,
      dual-energy X-ray absorptiometry to assess bone density mineral and body composition,
      collection of a blood sample to assess the inflammatory status of the IBD patient. The
      patient will be asked also to fill in a questionnaire in order to assess quality of life. He
      will wear an accelerometer during 7 consecutive days for assessing daily physical activity in
      free living conditions. The main objective is to assess the relationship between daily
      physical activity and bone health in children and adolescents with IBD. The secondary
      objectives are to assess the relationship between daily physical activity and: 1) body
      composition and 2): quality of life in IBD children and adolescents. To our knowledge, this
      study is the first to assess the relationship between bone health and daily physical activity
      in IBD children and adolescents.
    

Intervention name(s): multiple examinations
Intervention type(s): Device
Intervention description(s): biological,clinical, X-ray, DXA, accelerometry assessment
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Children and Adolescents With Inflammatory Bowel Disease: Crohn´s disease and Ulcerative
        colitis
      
Keywords: Physical activity; Bone health; Pediatrics; Bone
Attention Control Training for PTSD Related to Combat or Interpersonal Violence
Condition: PTSD
Study type: Interventional

Summary: 
      Participants will complete a pre and post training psychological assessment. Participants
      will be assigned to attention control training or the comparison stimuli computer task in a
      double-blind randomized control trial design. Both computerized dot probe tasks display two
      stimuli on a computer screen, one above the other, followed by a small right or left arrow
      appearing in the location vacated by one of the stimuli. Participants are required to respond
      as quickly as they can by pressing the indicated right or left arrow on their computer
      keyboard without compromising accuracy. Participants complete 6 training sessions.
    


Intervention name(s): Attention Control Training; Comparison Task
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).; Neutral- neutral stimuli prior to response task
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Preoperative Evaluation of Airway
Condition: Obesity; Difficult Intubation
Study type: Interventional

Summary: 
      Evaluation of airway markers of patients who have undergone obesity surgery.
    

Detailed description: 
      The investigators evaluated the airway parameters recorded preoperatively for patients with
      BMI> 30 who were undervent bariatric surgery between 2015-2018 in terms of difficult airway.
    

Intervention name(s): obese patients
Intervention type(s): Other
Intervention description(s): underwent bariatric surgery
Intervention model: Sequential Assignment
Intervention model description: retrospective clinical trial
Masking: None (Open Label)
Primary purpose: Screening
Keywords: difficult airway, obese patient,