bioihbjkbjnl/mcl2 huggingface dataset:
The KP Personal Shopper: A Pilot to Improve the Impact of Dietary Advice
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Randomized trial of grocery-store based nutrition counseling visits for weight management vs.
      in-office visits. The investigators will test pre- and post-intervention individual-level
      dietary quality, knowledge, self-efficacy around dietary choice, and cost of shopping,
      measuring difference between intervention and control arms. At the study's end, the
      investigators will also conduct focus groups with a subset of 20 patients (10 from each arm)
      and do a structured interview with the dietitian to better understand the feasibility,
      strengths and shortcomings of this approach. Patients who complete the main portion of the
      trial will be randomly selected for recruitment into a focus group and consented separately
      for that focus group at the end of the study.

      The investigators hypothesize that, compared to office-based visits, the KP Personal Shopper
      visits will result in higher member diet quality scores, better nutritional knowledge scores,
      higher self-efficacy and confidence around food purchasing decisions, and more favorable
      perception of the visit by both dietician and member. The KP Personal Shopper approach may
      also result in increased grocery store costs for some members. Long-term, the investigators
      hypothesize that improvements in member perception, knowledge and dietary quality will lead
      to improved health outcomes.
    


Intervention name(s): KP Personal Shopper Visits; In-Office Dietitian Visits
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care.; Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dietary advice; Nutritional knowledge; Self-efficacy; Nutrition
Paclitaxel and Capecitabine in Treating Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of paclitaxel and capecitabine in treating
      women who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the safety, response rate, and efficacy of combination therapy with
      paclitaxel and capecitabine as first or second line therapy in women with metastatic breast
      cancer.

      OUTLINE: This is a multicenter study. Patients receive paclitaxel IV over 3 hours on day 1
      and capecitabine orally twice daily on days 1-14. Treatment repeats every 21 days in the
      absence of disease progression or unacceptable toxicity. Patients are followed for survival
      status every 3 months upon completion of treatment.

      PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.
    

Intervention name(s): capecitabine; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Capecitabine
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Effects of TOT on Performance, Independence and Fatigue in Children With Cancer
Condition: Childhood Cancer; Performance; Functional Independence; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      This study aims to explore the effects of Task-Oriented Training (TOT) on occupational
      performance, activities of daily living and fatigue of children in pediatric oncology clinic.

      Hypothesis: There is no effect of TOT on occupational performance and satisfaction in
      children with childhood cancer. There is no effect of TOT on functional independence in daily
      living activities in children with childhood cancer. There is no effect of TOT on fatigue
      levels in children with childhood cancer.
    


Intervention name(s): task-oriented training (TOT); conventional occupational therapy (COT)
Intervention type(s): Other; Other
Intervention description(s): The study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting.; The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.
Other intervention name(s): TOT; COT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: childhood cancer; fatigue; functional independence; occupational performance; task-oriented training
Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)
Condition: Coronary Artery Disease; Coronary Artery Stenosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Coronary Stenosis
Study type: Interventional

Summary: 
      BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute
      clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary
      artery lesions.
    


Intervention name(s): Percutaneous Coronary Intervention
Intervention type(s): Device
Intervention description(s): Implanttaion fo the DREAMS 2G Scaffold
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DREAMS 2G; Scaffold; Drug Eluting Absorbable Metal Scaffold; Coronary Artery Disease
A Study to Assess the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamics of JNJ-64179375 in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the safety and tolerability of JNJ-64179375 in
      Part 1 and 2.
    


Intervention name(s): JNJ-64179375 0.3 mg/kg; JNJ-64179375 1.0 mg/kg; JNJ-64179375 2.5 mg/kg; Placebo; JNJ-64179375 (Dose to be Determined)
Intervention type(s): Drug; Drug; Drug; Other; Drug
Intervention description(s): JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.; JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).; JNJ-64179375 2.5 mg/kg IV infusion on Day 1.; Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).; JNJ-64179375 IV infusion (Dose to be determined).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pilot Study of Bioequivalence of Cudafol(R) and Diprivan(R) Administered as Single Intravenous Doses in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate pharmacokinetic/pharmacodynamic equivalence and safety and tolerability of single
      doses of Cudafol(R) and Diprivan(R) in healthy subjects.
    


Intervention name(s): Cudafol(R) (propofol, 1% [10 mg/mL]); Diprivan(R) (propofol, 1% [10 mg/mL])
Intervention type(s): Drug; Drug
Intervention description(s): Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes; Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effect of Exercise Training on Obstructive Sleep Apnea Syndrome Severity
Condition: Sleep Apnea Syndromes; Sleep Apnea, Obstructives
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
Study type: Interventional

Summary: 
      Sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. It
      does multiply tenfold the occurrence of vascular events, particularly stroke. While
      Continuous Positive Airway Pressure (CPAP) is currently the Gold standard treatment to
      prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term
      adherence to CPAP is a significant problem and search for alternative treatment is essential.

      The investigators hypothesize that long-term exercise training would allow to reduce
      significantly sleep apnoea syndrome severity. Thus, in this study, the investigators will
      compare evolution of Apnoea Hypopnea Index (AHI) in an exercise trained group performed
      through in a national based non-profit organization (Fédération Française d'éducation
      Physique et de Gymnastique Volontaire (FFEPGV)) using a medical established program
      (NeuroGyV) during nine months against a control group receiving only standard dietetic and
      physical activity counseling.
    


Intervention name(s): Training; Control
Intervention type(s): Other; Other
Other intervention name(s): NeuroGyV program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Sleep Apnea Syndromes; Sleep Apnea, Obstructives; Training
APEX: Adiposity Prevention by Exercise in Black Girls
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To determine whether a one year afternoon exercise program will reduce adiposity in African
      American girls, ages 8 to 10.
    

Detailed description: 
      BACKGROUND:

      Obese children who engage in vigorous exercise programs show beneficial effects on total body
      percent fat (percent BF) and visceral adipose tissue (VAT); however, little is known about
      how to prevent accretion of total body or visceral adiposity in high risk youths, such as
      African-American (AA) females.The project has important health implications for two reasons,
      as follows. There is a dearth of information concerning the effects of exercise interventions
      in school and community settings. If the study shows that an afternoon exercise program
      reduces accretion of general and visceral adiposity and has a favorable impact on fitness and
      health in a population that is at high risk of obesity, then schools may be encouraged to
      implement similar interventions to prevent juvenile obesity and associated health problems.

      The study was awarded in response to a Program Announcement on Physical Activity and
      Cardiopulmonary Health released in October 1994 jointly by the NHLBI, the National Institute
      of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing
      Research.

      DESIGN NARRATIVE:

      The design involves randomization of 200 African American girls, eight to 10 years of age
      into intervention or control groups. After one year, the groups are compared to test the
      primary hypothesis that a one year afternoon exercise program will reduce accretion of
      general and visceral adiposity in these girls. Then the girls will switch group assignments
      for the next year. The pattern of data over the three time points will show what happens over
      a two year period in which the youths are, or are not, involved in the exercise program. The
      measurements will include: (1) percent body fat with dual-energy x-ray absorptiometry; (2)
      visceral adipose tissue (VAT) with magnetic resonance imaging; (3) cardiovascular fitness
      with a multi-stage treadmill test; (4) cardiovascular disease (CVD) risk factors (i.e., the
      ratio of total to high density lipoprotein cholesterol, insulin, systolic blood pressure, and
      fibrinogen); (5) free-living exercise and diet; (6) psychosocial variables (i.e.,
      self-efficacy and self-concept); (7) sexual maturation; (8) anthropometric measures. The
      exercise program will be implemented in neighborhood schools for 90 minutes each weekday
      afternoon. Transportation will be provided if needed. Sessions will include motor skill
      instruction and aerobic exercises.
    

Intervention name(s): Exercise
Intervention type(s): Behavioral
Applying the "New Authority" Model in the Treatment of Poorly Controlled Diabetic Adolescents and Their Families
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      It is presumed that families of poorly controlled diabetic adolescents (type 1) would benefit
      from parents' counselling, guided by "the New Authority" model.
    

Detailed description: 
      "The New Authority" model has been shown to be helpful in risk behaviors such as children's
      violence and school refusal. It is assumed the model would prove helpful in the risk behavior
      of lack of adherence to diabetes treatment regimen. The treatment is give to parents only,
      without the adolescent's participation. It is predicted to improve self care, parents'
      monitoring, family conflict and parents' helplessness.
    

Intervention name(s): experimental protocol treatment "The New Authority"
Intervention type(s): Behavioral
Other intervention name(s): "The New Authority" model
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: diabetes; type 1; adolescents; parents counselling
Study to Investigate Safety, Tolerability and Pharmacokinetics of AZD2423 Multiple Doses in Healthy Japanese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423
      in young and elderly healthy Japanese volunteers.
    


Intervention name(s): AZD2423; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral solution; oral solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: safety, tolerability, pharmacokinetics, AZD2423, Japanese
Generalized Anxiety Disorder Adjunct Study
Condition: Anxiety; Anxiety Disorders; Anxiety Neuroses; Anxiety States
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL)
      when added to standard selective serotonin reuptake inhibitor (SSRI) /
      serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the
      treatment of Generalized Anxiety Disorder in patients with partial or no response to
      SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with
      placebo
    


Intervention name(s): Placebo; quetiapine fumarate XR
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Generalized anxiety disorders; anxiety; adjunct treatment in anxiety; anxiety disorder; partial or non-responder in anxiety
Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of dexlansoprazole,
      once daily (QD), in pediatric subjects with symptomatic Gastroesophageal Reflux Disease.
    

Detailed description: 
      Gastroesophageal Reflux Disease (GERD) is a condition of several causes resulting in the
      backward flow of gastric contents into the esophagus through the lower esophageal sphincter.
      The prevalence of GERD in the pediatric population is increasingly becoming recognized and
      documented. It is a disease that may persist through adulthood, with symptoms in older
      children and adolescents similar to those seen in adults.

      Younger children generally present with extra-esophageal manifestations, regurgitation, and
      epigastric pain, while older children and adolescents typically present with adult-type GERD
      symptoms of heartburn and regurgitation. Treatment for GERD is aimed at improving symptoms
      and healing esophageal inflammation.

      Takeda Global Research & Development Center, Inc. (TGRD) developed dexlansoprazole delayed
      release capsules as a new therapy for treating acid related disorders including symptomatic
      non-erosive GERD, healing of erosive esophagitis (EE) and maintenance of healed EE.

      Dexlansoprazole delayed release capsules have not been studied in subjects younger than 12
      years of age. This study is designed to evaluate the safety of dexlansoprazole delayed
      release capsules in the pediatric population (1 to 11 years old) and to determine if the PK
      profile of dexlansoprazole in subjects 1 to 11 years of age is similar to that in adults
      given a similar dose.

      Subjects who satisfy the screening evaluation and Inclusion/Exclusion Criteria may be
      enrolled in the study. Eligible subjects will be assigned to one of three treatment groups.
      Attempts will be made to enroll an equal number of male and female subjects in each treatment
      group.
    

Intervention name(s): Dexlansoprazole; Dexlansoprazole; Dexlansoprazole
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.; Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days; Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
Other intervention name(s): Kapidex; TAK-390MR; Dexilant; Kapidex; TAK-390MR; Dexilant; Kapidex; TAK-390MR; Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Gastroesophageal Reflux; Erosive Esophagitis; Pharmacokinetics; Pediatrics; Drug Therapy
Study to Evaluate ASN002 in Subjects With Moderate To Severe Chronic Hand Eczema
Condition: Chronic Hand Dermatitis
MeSH terms: Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      Randomized double-blind/placebo study to evaluate the efficacy of ASN002 in subjects with
      severe chronic hand eczema.
    

Detailed description: 
      This is a placebo controlled study where subjects with severe chronic hand eczema will be
      randomized (1:1:1) to receive ASN002 at 40 mg, 80 mg, or placebo once daily for 16 weeks
      (Part A). Then, in Part B, subjects who were assigned to placebo in the first part of the
      study will receive the highest dose of ASN002 (80 mg) for the rest of the treatment period
      (up to Week 32). The subjects who were assigned ASN002 in the first part of the study will
      continue on the same assigned treatment dose during the second part of the study (Week 16 to
      Week 32). The total treatment period of 32 weeks will be followed by a 4 week follow-up
      period.This study will also characterize the pharmacokinetics and pharmacodynamics of ASN002
      through blood sampling and three or four biopsies from subjects who consent.
    

Intervention name(s): ASN002; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Daily dose of ASN002 for 32 weeks; Daily dose of Placebo Oral Tablet for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: eczema; hand eczema; hand dermatitis
Comparison of 30% Metformin and 2% Nicotinamide Lotion With Kligman Formula in the Treatment of Melasma
Condition: Melasma
MeSH terms: Melanosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment
      of Melasma
    

Detailed description: 
      A comparative study to evaluate Efficacy and tolerability of new lotion in the treatment of
      Melasma.
    

Intervention name(s): Metformin and Nicotinamide vs Kligman Formula
Intervention type(s): Drug
Intervention description(s): Comparison of 30% Metformin and 2% Nicotinamide lotion with kligman formula in the treatment of Melasma
Intervention MeSH terms: Niacinamide; Niacin; Nicotinic Acids; Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of 3 behavioral weight loss
      programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined
      approach which includes university-based treatment followed by Weight Watchers.
    


Intervention name(s): Standard behavioral weight loss treatment; Weight Watchers; Combined Treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Participants will receive 12 months of university-based behavioral weight loss treatment; Participants will receive 12 months of Weight Watchers; Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Alendronate Sodium Tablets 70 mg of Dr. Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioequivalence of Alendronate Sodium 70 mg of
      Dr. Reddy's and Fosamax Tablets 70 mg of Merck & Co.
    

Detailed description: 
      Open label, balanced, randomized, two-treatment, two-sequence, two-period, single-dose,
      crossover oral bioequivalence study of Alendronate sodium 70 mg tablets of Dr Reddy's
      Laboratories Limited, India and Fosamax® tablets of Merck & Co., Inc., USA, in healthy,
      adult, human subjects under fasting conditions.
    

Intervention name(s): Alendronate Sodium Tablets, 70 mg
Intervention type(s): Drug
Intervention description(s): Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.
Other intervention name(s): Fosamax Tablets 70 mg
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Alendronate Sodium; crossover