bioihbjkbjnl/mcl2 huggingface dataset:
Flaxseed Compared With Placebo in Patients With Hypercholesterolemia
Condition: Familial or Severe Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to determine if thirty grams per day of flaxseed consumption for 4
      weeks could potentially reduce the serum lipid levels in children and adolescents with
      familial or severe hypercholesterolemia compared to those on placebo.
    

Detailed description: 
      The proposed study is a 4 week randomized, double-blind, placebo-controlled clinical trial.
      Participants will be recruited from the pediatric lipid disorder clinic at the Hospital for
      Sick Children, which provides consultations to and management of children with primary lipid
      abnormalities. Patients that meet the study criteria will be approached during their
      routinely scheduled clinic visits, until the sample size (N=30) be reached. Patients will
      randomly be assigned to the intervention or the placebo group. The intervention group will be
      given muffins and breads containing ground flaxseed. Two muffins and one slice of bread will
      be consumed per day to provide a total of 30g flaxseed to the experimental group. The control
      group will be given muffins and breads containing whole wheat flour in place of flaxseed.
      Participants will be instructed to eat one muffin for breakfast, one muffin as an afternoon
      snack, and one slice of bread as an evening snack every day for a 4-week period. The muffins
      and breads use in the study will be baked by an independent baker.
    

Intervention name(s): flaxseed; whole wheat flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks; 1 muffin for breakfast, 1 muffin for afternoon snack and 1 slice of bread for evening snack every day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: flaxseed; hypercholesterolemia; children
The Effect of Yoga Practice on Pain Intensity, Menstruation Symptoms and Quality of Life in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea; Pain, Menstrual; Quality of Life
MeSH terms: Dysmenorrhea; Pain
Study type: Interventional

Summary: 
      The aim of this randomized controlled study is to evaluate the effect of yoga practice on
      pain intensity, menstruation symptoms and quality of life in nursing students with primary
      dysmenorrhea. The hypothesis of this study is that yoga reduces pain and menstrual symptom
      severity and improves quality of life.
    

Detailed description: 
      In the study, 52 students will be randomly assigned to intervention (yoga) and control
      groups. The researcher will provide information about the purpose of the study and the study
      process by interviewing all the students in the sample online. All students participating in
      the study, who are in the yoga or control group of the study, will be given a data collection
      form as a pre-test by the researcher.

      Hatha yoga will be applied to the students (n = 26) in the yoga group in the study.
      Considering the studies conducted with these students, it is planned to practice Hatha yoga
      for 60 minutes twice a week for three menstrual cycles (12 weeks). Yoga practice will be done
      online by the researcher Aslıhan Aksu (A.A.), who has a Yoga Alliance-approved yoga
      instructor certificate, on the determined days and times using appropriate platforms. In the
      control group (n=26), no intervention will be made for 12 weeks. The results will be
      collected through data collection forms before the yoga practice and after the 12-week yoga
      practice is completed. The data collection forms applied to all students in the yoga and
      control groups at the beginning of the study will be applied to the control group again at
      the end of 12 weeks. The primary expected result of the study is the effect of yoga on
      students' menstrual pain intensity. The secondary expected results of the study are to
      determine the effect of yoga on students' menstrual symptoms and quality of life.
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, parallel, two arm, randomized controlled clinical trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: yoga; menstrual pain; menstrual symptoms; quality of life; nursing students; primary dysmenorrhea
Internet-Delivered Cognitive Behaviour Therapy for Adolescent Depression
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether tailored internet-administrated cognitive
      behaviour therapy (CBT) is a feasible approach in the treatment of depressive symptoms and
      comorbid anxiety symptoms.
    

Detailed description: 
      As above
    

Intervention name(s): Tailored Internet-administrated CBT-Treatment
Intervention type(s): Behavioral
Intervention description(s): Guided internet-delivered CBT with chat sessions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rosiglitazone (Extended Release Tablets) As Monotherapy In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      Rosiglitazone (RSG) has been tested and is approved as a treatment for type II diabetes
      mellitus, a disease that occurs when the body ineffectively uses glucose. RSG XR, the
      investigational drug, is an extended-release form of RSG. This study tests whether RSG XR
      safely provides benefit to people with mild to moderate Alzheimer's disease (AD). RSG XR is a
      new approach to AD therapy and this study tests whether one's genes alter the effectiveness
      of RSG XR. Glucose is used by cells to make energy that they need to live. Changes in the
      ability of cells to use of glucose can lead to diseases like diabetes. Glucose levels may be
      lower in the brains of AD patients, and their brain cells may also use glucose less well than
      in unaffected people. The proper function of brain cells may be critical to memory and
      thought. If brain cells use glucose poorly, this might impact AD. Drugs that help brain cells
      properly use glucose may help a person maintain normal memory and thinking. Data suggesting
      that RSG may help AD patients was first seen in a small study at the Univ. of Washington and
      then from a larger international GSK study. In the first study, those receiving RSG once
      daily for 6 months scored better on 3 tests of memory and thought than those who did not
      receive RSG. In the GSK study, those that benefited most from therapy with RSG XR had a
      specific genetic pattern. They lacked the gene that caused them to produce apolipoprotein E
      e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent,
      or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE
      e3 version of the gene from one parent. Subjects with one copy of the APOE e4 gene remained
      fairly stable while those with two copies of APOE e4 continued to worsen during the 6-month
      treatment. This study will directly test the effect of RSG XR on people who either have or
      lack the APOE e4 gene.
    

Detailed description: 
      A 24-week, double-blind, double-dummy, randomized, parallel-group study to investigate the
      effects of rosiglitazone (extended release tablets), donepezil, and placebo as monotherapy on
      cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate
      Alzheimer's disease. (REFLECT-1)
    

Intervention name(s): Rosiglitazone
Intervention type(s): Drug
Intervention description(s): XR (extended release) oral tablets
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: apolipoprotein E; monotherapy; cognition; mild; rosiglitazone; Alzheimer's disease; moderate
Hypoglycemic Effects of Fermented Red Ginseng in Subject With Impaired Fasting Glucose or Type 2 Diabetes
Condition: Impaired Glucose or Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study was conducted to investigate the effects of daily supplementation of fermented red
      ginseng (FRG) on glycemic status in subjects with impaired fasting glucose (IFG) or type 2
      diabetes.
    

Detailed description: 
      This study was a 4 weeks, randomized, double-blind, placebo-controlled trial. Forty-two
      subjects with IFG or type 2 diabetes were randomly allocated to 2 groups to consume placebo
      or FRG three times per day for 4 weeks. Fasting and postprandial glucose profiles during meal
      tolerance test were assessed before and after the intervention.
    

Intervention name(s): Fermented Red Ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Fermented red ginseng 2.7g/day for 4 weeks; Placebo 2.7g/day for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
COVAXIN in a Pediatric Cohort
Condition: SARS-CoV2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is designed to evaluate the safety, reactogenicity and immunogenicity of three
      groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of
      the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart.

      Data will be un-blinded to the third party bio-statistician and an interim analysis will be
      performed on day 56 for Immunogenicity, Safety and submitted to CDSCO.
    

Detailed description: 
      Study design: A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety,
      Reactogenicity and Immunogenicity, of the Whole-Virion Inactivated SARS-CoV-2 Vaccine
      (COVAXIN®) in Healthy Volunteers ages ≤18 to ≥2 Years.

      A total sample size of 525 healthy volunteers.

      The study is designed to evaluate the safety, reactogenicity and immunogenicity of three
      groups ages ≤18 - >12, ≤12 ->6, ≤ 6 - >2 years of healthy volunteers who receive two doses of
      the whole virion inactivated SARS-CoV-2 virus vaccine (COVAXIN®) 28 days apart.

      Group1: A total of 175 healthy volunteers ages ≤18->12, years will be enrolled in this group
      and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day
      28+2.

      Group 2: A total of 175 healthy volunteers ages ≤12->6, years will be enrolled in this group
      and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day
      28+2.

      Group 3: A total of 175 healthy volunteers ages ≤6-> 2 years will be enrolled in this group
      and will receive two doses of BBV152 vaccine through intramuscular route on Day 0 and Day
      28+2.

      Data will be un-blinded to the third party bio-statistician and an interim analysis will be
      performed on day 56 for Immunogenicity, Safety and submitted to CDSCO.

      Immunogenicity analysis: A total of 5 ml of blood is collected at days 0, 28+2, 56±7, 118±7
      and 208±7. SARS-CoV-2 test will be conducted at the time of screening using RT-PCR and ELISA
      method.
    

Intervention name(s): COVAXIN
Intervention type(s): Biological
Intervention description(s): Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)
Intervention model: Single Group Assignment
Intervention model description: Open label
Masking: None (Open Label)
Primary purpose: Prevention
Treatment of Non-Gestational Acute Uterine Bleeding: A Randomized Trial
Condition: Uterine Hemorrhage; Menorrhagia
MeSH terms: Uterine Hemorrhage; Menorrhagia; Hemorrhage
Study type: Interventional

Summary: 
      To determine the relative efficacy of multidose medroxyprogesterone acetate (MPA, Provera)
      and a multidose, monophasic combination oral contraceptive in the treatment of
      hemodynamically stable women with non-gestational, acute uterine bleeding.
    

Detailed description: 
      Acute uterine bleeding, unrelated to pregnancy, is a relatively common problem that causes
      many reproductive-aged women to requite emergent medical and/or surgical intervention.
      Although the traditional approaches have generally been surgical in nature, many
      practitioners utilize medical methods to arrest the bleeding. However, despite widespread
      use, there exists a paucity of information regarding the effectiveness, side-effects, and
      patient satisfaction associated with the commonly-used medical regimens. (b) The purpose of
      the study is to compare the efficacy of multidose medroxyprogesterone acetate and a
      multidose, monophasic combined oral contraceptive in the treatment of hemodvnamically-stable
      women with non-gestational, acute uterine bleeding.

      (c) Non-pregnant, hemodynamically-stable, reproductive-aged, women, over the age of IS, who
      present either to the emergency area or to KP practitioner's offices with acute uterine
      bleeding, will be considered for eligibility. If, following a full exam and medically
      appropriate investigations medical management is deemed appropriate, they will be approached
      by a member of the investigating team for possible inclusion into the study. Following
      informed consent, patients will be randomized to receive either medroxyprogesterone acetate
      (20 mg three times daily for 7 days) or monophasic oral contraceptive containing I mg of
      norethindrone and 35 ug of ethinyl estradiol (three dines daily for seven days). Following
      the seven days of therapy, those randomized to MPA will continue with 20 mg per day for three
      weeks while those randomized to oral contraceptives will take one pill per day for three
      weeks, each completing a total of four weeks of therapy. The primary outcome will be the
      number of days until cessation of bleeding. Other outcomes measured will include pad and
      tampon counts, and hemoglobin levels. Chi square tests and student t will be used to evaluate
      differences between the two treatment groups. The hope is that this study will elucidate on
      the efficacy of the two regimens.
    

Intervention name(s): Provera; Combination Birth Control pills
Intervention type(s): Drug; Drug
Intervention MeSH terms: Medroxyprogesterone Acetate; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute uterine bleeding
Efficacy of Core Stabilization Exercises in Women With Stress and Mixed Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      In our study, we aimed to evaluate the effects of core stabilization exercises added to
      traditional Kegel exercises on incontinence and quality of life in women with stress and
      stress dominant mixed urinary incontinence.
    


Intervention name(s): Core stabilization exercises with Kegel exercises; Kegel exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Core stabilization exercise program consists of two phases: teaching the basic movement (contraction of the Transversus abdominis and other muscles with diaphragmatic breathing) and incremental exercises added to the basic movement. The basic movement will be studied before each exercise and then the specified exercises will be added. The physiatrist will teach the exercise program to the patients. The first 6 of the 12 exercises classified according to the degree of difficulty will be performed for 5 weeks, and the next 5 weeks will be moved to the other 6 exercises. The exercises will be performed at least 3 days a week, with 10 repetitions of each movement, and the program will last for 10 weeks. Compliance with the exercise program will be questioned over the phone, and patients will be evaluated with a follow-up form before the study, at the 10th week, and at the 20th week. In addition, the Kegel exercise program specified in the other group will be applied.; Kegel Exercises The exercise will start as 2 sets of 10 repetitions in the morning and evening, and after getting used to it, it will be increased to 3 sets of 10 repetitions per day.
The patient, lying on his back with his knees bent, feet slightly apart from each other, will try to lift the breech, urinary tract opening and vagina on the pelvic floor by counting to 5, and should not tighten your abdominal and leg muscles, and should not hold your breath while doing this exercise.
In this way, he will count up to 5 while contracting, then he will relax by counting to 10 (after getting used to it, the holding time will be increased to 10 seconds).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stress urinary incontinence; incontinence rehabilitation; incontinence exercises; core stabilization exercises
Addressing Origins of the Opioid Epidemic by Improving Prescribing for Opioid-Naive Patients
Condition: Opioid Use; Opioid-Related Disorders; Opioid Abuse; Prescription Drug Abuse and Dependency
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional

Summary: 
      Risk of long-term opioid dependence increases with initial opioid dose/duration, but despite
      recent Centers for Disease Control and Prevention (CDC)-endorsed minimum doses for initial
      opioid prescription, primary care providers are likely to overprescribe. In this quality
      improvement project, primary care departments at Weill Cornell and the Institute for Family
      Health (federally qualified health center in New York City) will implement an unobtrusive
      "nudge" in their electronic prescribing software to promote the CDC-endorsed low doses for
      all opioids. In the evaluation, we will employ a quasi-experimental design with rigorous
      interrupted time series analysis methods to assess the effect of the "nudge" on prescribing
      rates. The analysis will be performed at the provider level, with deidentified physician data
      and a limited data set (fully deidentified except for date of prescription) of patient-level
      data.
    

Detailed description: 
      The two participating institutions, WCMC (Weill Cornell Medical College) and IFH (Institute
      for Family Health), intend to redesign the e-prescribing interface to create a minor "nudge"
      to encourage prescribers to prescribe the minimum dose set by the 2016 CDC guideline for
      opioid-naive patients in 2018. The change to the e-prescribing system is that after a
      prescriber chooses the drug they wish to prescribe, the minimum recommended dosage from the
      CDC guidelines will be displayed. The prescriber can choose to change the dosage by
      overwriting in the field box. The changes to the prescriber system will be implemented at two
      Weill Cornell clinical organizations: Weill Cornell Internal Medicine Associates (WCIMA) and
      Weill Cornell Medical Associates (CMA), and at all locations at our collaborating institution
      IFH (Institute for Family Health). Weill Cornell and IFH will provide data for the analysis,
      which will be conducted by the co-investigators on this protocol. The project will assess
      data pre- and post- implementation to study prescribing patterns.
    

Intervention name(s): Default Prescribing Change
Intervention type(s): Other
Intervention description(s): In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.
Intervention model: Single Group Assignment
Intervention model description: This is a interrupted time series study model with one study group.
Masking: None (Open Label)
Primary purpose: Other
Safety and Dose Escalation Study of Zinc Supplementation in Critically Ill Children
Condition: Critical Illness
MeSH terms: Critical Illness
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the study is 1) to determine whether administration of intravenous zinc to
      critically ill children is safe, and 2) to determine an appropriate dose of zinc
      supplementation.
    

Detailed description: 
      Our recently published studies in children with septic shock demonstrated that pediatric
      septic shock is characterized by large scale repression of genes that either directly depend
      on normal zinc homeostasis or directly participate in zinc homeostasis. Functional validation
      studies demonstrated that nonsurvivors of pediatric septic shock have abnormally low serum
      zinc concentrations. A follow-up pilot study in a general population of critically ill
      children demonstrated that the presence of low plasma zinc concentrations is a prevalent
      problem in critically ill children. In addition, low plasma zinc concentrations correlate
      inversely with indices of inflammation and directly with the number of organ failures. These
      preliminary data, coupled with the expected safety of zinc supplementation, provided the
      rationale for a double blinded, prospective, placebo-controlled trial of zinc supplementation
      in critically ill children, with the two primary study endpoints to assess efficacy being
      highly clinically relevant: reduction of the lymphopenia rate and improvement of glucose
      homeostasis. Although the proposal was well-received, the primary concern precluding funding
      of this trial were lack of safety and dosing data for intravenous zinc. We have therefore
      developed a proposal for a Phase I/II study of safety and pharmacokinetics to address these
      concerns. It is anticipated that data generated through this proposal will provide the
      necessary preliminary data to re-submit our application for an interventional efficacy trial
      of zinc supplementation in critically ill children
    

Intervention name(s): Zinc sulfate
Intervention type(s): Drug
Intervention description(s): Zinc sulfate 200 mcg/ml in Normal Saline
Intervention MeSH terms: Zinc Sulfate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other