bioihbjkbjnl/mcl2 huggingface dataset:
Exercise and Bright Light Treatment: Effects on Body Weight and Composition
Condition: Obesity; Fatigue
MeSH terms: Fatigue
Study type: Interventional
Phase: Phase 2

Summary: 
      Bright light therapy has been used to safely and effectively treat conditions such as
      Seasonal Affective Disorder and to regularize sleep in patients with circadian rhythm
      disorder. Based on evidence of the link between bright light, serotonin, mood and
      carbohydrate metabolism, it has been suggested that bright light therapy can improve weight
      loss but the literature on the subject is sparse. Further, the literature suggests that apart
      from any changes in mood and carbohydrate metabolism, bright light may reduce the unpleasant
      side-effects of exercise and increase compliance to an exercise program.
    

Detailed description: 
      Objective: Increased physical activity is important given the concern over the growing rates
      of obesity. Bright light therapy has the potential to enhancing serotonin levels, impact on
      carbohydrate metabolism and reducing soreness and hyperthermia associated with physical
      activity. The aim of this study is to conduct a controlled investigation of the effects of
      bright light therapy and exercise on weight loss and body composition in overweight
      individuals.

      Research Methods and Procedures: Twenty-five overweight male and female subjects will be
      assigned to 6 weeks of moderate exercise with or without bright light treatment. Outcome
      measure included changes in body mass and body composition and ratings of mood, seasonality
      and sleep.
    

Intervention name(s): Bright Light Therapy; Exercise
Intervention type(s): Device; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: bright light treatment; exercise; body fat index; mood; sleep; fatigue
Weight Loss and Exercise in Obese, Physically Limited, Older Women and Men
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of weight loss and exercise on physical
      function, body fat and muscle mass, bone strength, and quality of life.
    

Detailed description: 
      Obesity causes serious medical complications and impairs quality of life. Moreover, in
      elderly persons, obesity can lead to frailty by exacerbating the decline in strength,
      endurance, balance and mobility associated with aging and physical inactivity. The primary
      objectives of the proposed research are to evaluate the independent and combined effects of
      weight loss and exercise on physical function, body composition, bone and muscle metabolism,
      and quality of life in frail, obese elderly men and women. The central hypothesis is that in
      frail obese elderly subjects, weight loss will improve physical function and quality of life,
      while the addition of exercise will not only augment improvement in these outcomes, but also
      attenuate the adverse effects of weight loss on bone and muscle masses. To test this
      hypothesis, 110 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30
      kg/m2) with physical frailty will be randomized to 4 treatment groups: 1) control, 2) 10%
      weight loss, 3) exercise training, and 4) 10% weight loss plus exercise training.
    

Intervention name(s): Diet; Exercise; Weight Loss and Exercise
Intervention type(s): Behavioral; Other; Other
Intervention description(s): 10 percent weight loss through diet and behavioral modification; Multicomponent (resistance, aerobic, balance) exercise three times a week; 10% weight loss through diet and exercise plus multicomponent exercise training three times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; aging; exercise; diet; weight loss; physical function; Obesity in the Elderly
A Study to Evaluate the Efficacy and Safety of VX-150 in Treating Subjects With Pain Caused by Small Fiber Neuropathy
Condition: Small Fiber Neuropathy
MeSH terms: Small Fiber Neuropathy
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group, multicenter
      study evaluating the efficacy of VX-150 for the treatment of pain caused by small fiber
      neuropathy.
    


Intervention name(s): VX-150; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received VX-150 1250 milligrams (mg) once daily (qd) orally for 6 weeks.; Participants received placebo matched to VX-150 for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preventive Intervention Against Lymphedema After Breast Cancer Surgery
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms; Lymphedema
Study type: Interventional

Summary: 
      This study will examine whether lymphedema after breast cancer surgery can be reduced. In a
      randomised controlled design the aim is to investigate whether an early intervention with
      progressive resistance training and close monitoring of arm swelling can reduce the incidence
      of lymphedema after breast cancer surgery.
    

Detailed description: 
      Lymphedema is a well known and much dreaded complication after breast cancer surgery. The aim
      in this study is to examine if lymphedema can be prevented with early progressive strength
      training focusing on the arm, and close monitoring of pre clinical lymphedema in the 1 year
      exercise period. The primary outcome is lymphedema, and secondary outcomes are pain,
      self-reported symptoms of swelling, sensory disturbance, physical and psychological
      functioning, fatigue, depression, anxiety and health related quality of life.

      158 patients operated for breast cancer with axillary node dissection, will be invited from
      three hospitals in Denmark, Sealand (Rigshospitalet, Ringsted Hospital, and Herlev Hospital),
      while on the surgical wards. Two weeks later upon consent they are recruited, baseline tested
      and randomized to either exercise intervention or usual care control.

      The exercise intervention consists of progressive resistance training, combined with a
      stretching programme, with a total duration of 60 minutes per session. The group attend
      supervised exercises twice a week and a once weekly home exercise programme of 45 to 60
      minutes duration. After 20 weeks, exercises are converted to home exercises, and they are
      monitored by a weekly sms-service. At 12 months, follow-up measurements are taken for both
      groups. Lymphedema is defined as 3% limb volume change from the baseline measurement.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): progressive resistance training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: breast cancer surgery; axillary lymph node dissection; resistance training; breast cancer related lymphedema
Theater in School Sex Education - a Randomized Controlled Study
Condition: Attitude; Sexual Behavior; Condom Use; Prevention; Chlamydia Infections; Safe Sex
MeSH terms: Infections; Chlamydia Infections
Study type: Interventional

Summary: 
      The study evaluated if interactive theater in school sex education affects student knowledge,
      attitudes and behavior regarding condom use. The intervention group got a play, value
      exercises, chlamydia games, condom school and interactive replay with professional actors and
      staff from a youth guidance center. The control group got standard sex education from school
      staff, based on the education guidelines of the Swedish National Agency for Education.
    

Detailed description: 
      The spread of chlamydia indicates that current preventive work with condoms is insufficient.
      Research shows that reasons behind increased chlamydia include youths taking more sexual
      risks, due to altered attitudes and sexual behaviors. Since only condoms protect against both
      sexually transmitted infections (STIs) and unwanted pregnancy, the goal of the World Health
      Organization (WHO) chlamydia prevention program is to increase condom use. Research suggests
      that school is the most important arena for sex education, reaching all youths early in life,
      when many values on sex and relationships are instilled. International studies on theater in
      sex education indicate effects like increased knowledge on the topic, and partially changed
      attitudes and behaviors among youths. Furthermore, several studies show that youths feel
      theater is a good method for sex education and a supplement to standard education.
    

Intervention name(s): SAFETY; Standard education
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cluster-randomized controlled trial with parallel assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chlamydia infections; condoms; theater,; sex education
A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants
Condition: Healthy Volunteer
Study type: Observational

Summary: 
      This is a single center non-interventional study in healthy participants for behavioral
      assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5
      participants and will study the implementation of the behavioral tests and identify potential
      issues. Part B will involve 30 participants and will study the test-retest reliability.
      Duration of participation for each participant will be 30 days for Part A (28 days screening
      period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2
      study visits of 2 days each separated by a period of 14 days).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Participants
      
Biospecimen description: 
      Whole blood for DNA extraction
A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Condition: Non-alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open for men and women with a liver disease called nonalcoholic steatohepatitis
      (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called
      BI 456906 helps patients with NASH and liver fibrosis. The study tests 3 different doses of
      BI 456906 to find the dose that helps best. Participants are put into 4 groups randomly,
      which means by chance. There are 3 groups that each receive a different dose of BI 456906 and
      there is 1 group that receives placebo. BI 456906 and placebo are given as an injection under
      the skin once per week. The placebo injection looks like the BI 456906 injection but does not
      contain any medicine.

      Participants are in the study for a little over 1 year (60 weeks). During this time, they
      visit the study site several times and have some video calls in addition. At the visits, the
      study doctors take different measurements. To see whether the treatment works, the doctors
      take a very small sample of liver tissue (biopsy) from each participant at the start and at
      the end of the study. They also examine the liver by ultrasound and MRI. The doctors also
      regularly check the general health of the participants.
    


Intervention name(s): BI 456906; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 456906; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase3 Study to Evaluate the Efficacy and Safety of MEDI3250 in Healthy Japanese Children Age 7 Years Through 18 Years
Condition: Healthy Japanese Children Age 7 Years Through 18 Years
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to gather the efficacy, safety and tolerability data in Japanese
      children 7 to 18 years of age that would support approval of MEDI3250 in Japan.
    

Detailed description: 
      This randomized, double-blind, placebo controlled, multicenter study will enrol 1008
      subjects. The study is designed to gather the efficacy, safety and tolerability data in
      Japanese children 7 through 18 years of age that would support approval of MEDI3250 in Japan.

      For children age 7 years through 18 years, the recommended dosage schedule for intranasal
      administration is 0.2 mL (0.1 mL per nostril). For children age 7 years through 8 years not
      previously vaccinated against seasonal influenza, a second dose should be given after an
      interval of at least 4 weeks.

      For the efficacy endpoint, data will be gathered on the incidence of laboratory-confirmed
      influenza-like illness in the two treatment arms. Laboratory-confirmed influenza-like illness
      would include cases of influenza diagnosed using culture-confirmation and/or PCR-based
      methods.

      For the safety and tolerability endpoint, data will be gathered on solicited symptoms, AEs
      and SAEs.

      Subject will be randomized 2:1 to receive MEDI3250 or placebo.
    

Intervention name(s): MEDI3250; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): MEDI3250; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Efficacy; Safety; Tolerability; MEDI3250; Japanese children
Purified Anthocyanins Supplementation in Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus，Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Anthocyanins, the water-soluble compounds that make plants appear different colors, have been
      shown to prevent insulin resistance, reduce the blood glucose and oxidative stress in
      rodents. The purpose of our study is to evaluate a potential protective effect of purified
      anthocyanins supplement on type 2 diabetes mellitus patients.
    

Detailed description: 
      The study was designed as a randomized, double-blind label, interventional study on patients
      with T2DM. The eligible Participants are randomly assigned to control and Anthocyanins
      supplement group. During the 12 weeks trial period,the participants were instructed to
      consume two anthocyanin capsules or placebo capsules twice daily (30 min after breakfast and
      supper).
    

Intervention name(s): Anthocyanin; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Extract of blueberry and huckleberry （MEDOX，http://www.medox.no/english）; starch
Other intervention name(s): natural purified anthocyanin; placebo capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Paediatric Use of the Abbott Sensor Based Glucose Monitoring System
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      Accuracy evaluation of the Abbott Sensor Based Glucose Monitoring System when used by
      children with diabetes.
    


Intervention name(s): Abbott Sensor Based Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects will wear the Abbott Sensor Based Glucose Monitoring System and will be asked to perform 4 blood glucose tests per day (pre-meal and before bedtime). Subjects will be asked to scan the sensor when each blood glucose test is performed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
In-home Versus Hospital Preoperative Training for Patients Undergoing Total Knee Replacement
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      In this work the importance of the potentiation and recovery of the balance with a
      physiotherapeutic intervention that begins in the early preoperative phase is compared with
      the conventional postoperative rehabilitation. The objective is to evaluate the influence of
      a muscle enhancement protocol in which a specific work of balance is included, with the
      physical benefits that this entails for the evolution of the patient. It also seeks to verify
      if the teaching and recommendation of exercises at home as preparation and conditioning for
      the intervention of ATR is effective, and to what extent, compared to a guided training in
      the hospital.
    


Intervention name(s): Preoperative training (hospital); Preoperative training (home)
Intervention type(s): Other; Other
Intervention description(s): Preoperative hospital training; Preoperative in-home training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this project is to evaluate in a randomized clinical trial, double-blind,
      controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938
      and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in
      children with mild / moderate persistent asthma .
    

Detailed description: 
      To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108
      CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial
      inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of
      markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on
      exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10);
      Interferon γ (IFN-γ).
    

Intervention name(s): Reuterin D3 drops; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 5 drops/day for 3 months; 5 drops/day for 3 months
Other intervention name(s): Lactobacillus reuteri DSM 17938 + Vit. D3
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bronchial Inflammation; Asthma; Childhood Asthma Control Test (C-ACT); Asthma Exacerbations
Safety, Tolerability and Pharmacokinetics of Efavirenz in HIV-Infected Children
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The primary purpose of this study is to find the dose of Efavirenz for young children. The
      safety and how the medication is tolerated will also be studied.
    


Intervention name(s): Efavirenz (EFV) + Didanosine (ddI) + Emtricitabine (FTC)
Intervention type(s): Drug
Intervention description(s): Oral Solution, Capsules or Tablets, Oral, once daily
Efavirenz (EFV) per weight-based dosing nomogram (max 720 mg)
Didanosine (ddI) 240 mg/m2 (max 400 mg)
Emtricitabine (FTC) 6 mg/kg (max 200 mg)
Where EFV oral solution is commercially available: 48 weeks or until 3rd birthday (whichever is longer);
Where EFV oral solution NOT commercially available: until 7th birthday or until able to swallow EFV capsules (whichever occurs first)
Other intervention name(s): Sustiva; BMS-561525
Intervention MeSH terms: Emtricitabine; Efavirenz; Didanosine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV, Pediatric
A Pilot Study of Therapist Guided Activity Practice for Depressive Symptoms
Condition: Depressive Symptoms
MeSH terms: Depression
Study type: Interventional

Summary: 
      There is literature to support both the need for and efficacy of brief interventions for
      depressive symptoms, particularly among college students.Brief behavioral activation
      interventions (BATD) have gained recognition as efficacious treatments for depression; yet a
      recent study evidenced a substantial (39%) non-response rate (Kuyken et al., 2017). In
      accordance with behavioral models of depression, the treatment involves increasing activity
      and positive experience, to break the negative reinforcement cycle maintaining depressed
      mood. Thus, strategies that may facilitate increasing activity may improve BATD outcomes. The
      objective of the current study is to examine whether briefly practicing a target activity
      during an activity planning session (modified single session of BATD) increases the
      likelihood of completing the activity during the upcoming week. We hypothesized that guided
      activity practice may improve self-efficacy within session and activity completion in the
      upcoming week. We further aim to explore whether activity completion mediates depressive
      symptom change.
    


Intervention name(s): Activity Planning; Therapist Guided Activity Practice
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The therapist will work with the participant to select a challenging, yet rewarding or value-driven activity that he/she can engage in 5x and monitor daily over the upcoming week.; The therapist will work with the participant to plan and carry out a brief in-vivo version of their goal/target activity. The therapist will guide the participant through the activity for approximately 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
Condition: Chronic Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether active repetitive transcranial magnetic
      stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive
      treatment of chronic migraine, compared to placebo repetitive transcranial magnetic
      stimulation.
    

Detailed description: 
      Patients with chronic migraine according to the criteria of the International Headache
      Society will be randomized to either active repetitive transcranial magnetic stimulation of
      the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic
      stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8
      sessions in the second month of treatment). Outcomes will be evaluated at baseline, after
      one, two months after treatment, and one month after end of treatment
    

Intervention name(s): 10Hz active rTMS; Placebo
Intervention type(s): Device; Device
Intervention description(s): 10Hz active rTMS delivered to the left dorsolateral prefrontal cortex; 10Hz placebo rTMS delivered to the vertex
Other intervention name(s): Repetitive transcranial magnetic stimulation; Repetitive transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine