bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in
      adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
    


Intervention name(s): Lisdexamfetamine dimesylate; Methylphenidate Hydrochloride; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance; Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance; Daily oral dosing in the AM for 8 weeks
Other intervention name(s): LDX, Vyvanse, SPD489; OROS-MPH, Concerta
Intervention MeSH terms: Methylphenidate; Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
The Dynamics of Human Atrial Fibrillation
Condition: Atrial Fibrillation; Atrial Tachyarrhythmia
MeSH terms: Atrial Fibrillation; Tachycardia
Study type: Observational

Summary: 
      The study is conducted in patients with atrial fibrillation undergoing clinically prescribed
      ablation. The study hypothesis is that ablation at specific sites that are identified to
      'drive' the atrial fibrillation may improve the success of the ablation procedure.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects will be men and women of all races aged 21 to 80 years undergoing clinically
        indicated ablation of Atrial Fibrillation.
      
Keywords: Atrial Fibrillation; Ablation
Evaluation of the Benefits of FloraGLO™ Lutein on Skin Health
Condition: Aging; Wrinkle; Skin Elasticity; Healthy; Hydration
Study type: Interventional

Summary: 
      Therefore, the present study is designed to contribute to the body of literature by
      investigating the effect of 12-weeks of lutein supplementation on multiple parameters of skin
      health and appearance in healthy women.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, parallel twelve-week study of the
      performance of an oral test product to evaluate the effects of twelve weeks of lutein
      supplementation on skin health and appearance in healthy women. A seven-day washout period
      will precede the evaluation period. The subjects in each cohort will use consume one softgel
      of their assigned test product (treatment or placebo) daily in the morning with breakfast for
      12 weeks. Changes in skin condition and appearance as well as blood chemistry will be
      assessed using results from expert visual grading, instrumental assessments, skin and blood
      assays and subjective questionnaire responses. Subjects will be recruited during the winter
      season to account for seasonal variations of skin parameters.

      Evaluation points will occur pre-application (Baseline; Week 0) and after 42 and 84 days of
      use (D42, D84; Week 6, Week 12). Data will be collected on the following outcomes:

      1. Skin Hydration 2. Skin texture/smoothness 2. Reduction of facial fine lines and wrinkles
      3. Skin elasticity and firmness 4. Sagging skin, dry skin, skin tone, appearance from expert
      clinical grading and subjective questionnaire responses.

      6. Skin hydration 7. Skin collagen 8. Skin lipid content. 9. Skin Carotenoids
    

Intervention name(s): FloraGLO Lutein; Safflower Oil
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Lutein (FloraGLO™) in safflower oil; Safflower Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Parallel Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Early Therapy of Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension; Systemic Sclerosis
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension; Scleroderma, Systemic; Scleroderma, Diffuse
Study type: Interventional

Summary: 
      Exercise-induced increase of the pulmonary arterial pressure may be an early sign of
      pulmonary arterial hypertension. It has been shown that patients with normal pulmonary
      arterial pressure at rest but elevated pulmonary arterial pressure during exercise have a
      decreased exercise-capacity and may have a worse prognosis compared to patients with normal
      pulmonary arterial pressure values at rest and during exercise. According to the currently
      used definition pulmonary hypertension can be diagnosed if the mean pulmonary arterial
      pressure is higher than 25mmHg at rest or 30mmHg during exercise. In this study patients with
      a risk for pulmonary arterial hypertension (connective tissue disease) and increased
      pulmonary arterial pressure values during exercise are receiving a therapy with a dual
      endothelin receptor antagonist - bosentan, a therapy established for pulmonary arterial
      hypertension. The therapy effect is than compared to the recorded changes before the
      introduction of this therapy.
    

Detailed description: 
      Bosentan is an established therapy in pulmonary arterial hypertension, which may be diagnosed
      when the mean pulmonary arterial pressure is >25mmHg at rest or >30mmHg at exercise. Bosentan
      has shown efficacy, if mean pulmonary arterial pressure was elevated at rest. However, there
      are no data available of the effects of such a therapy, if the mean pulmonary arterial
      pressure is normal at rest but elevated during exercise. The purpose of this study is to
      provide additional data on this group of patients. Our hypothesis is that patients with
      exercise-induced pulmonary hypertension may show a gradual worsening of pulmonary
      hemodynamics and potentially a development of manifest pulmonary arterial hypertension
      (elevated resting pulmonary arterial pressure values) without treatment, while the
      introduction of Bosentan may improve hemodynamics and exercise capacity in this patient
      group.
    

Intervention name(s): Bosentan
Intervention type(s): Drug
Intervention description(s): 2x62.5mg for 4 weeks, then 2x125mg
Other intervention name(s): Tracleer
Intervention MeSH terms: Bosentan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to further evaluate the safety and seroprotective immune
      response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects
      11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
    

Detailed description: 
      This study will evaluate the safety and efficacy of two injections of HEPLISAV™ in subjects
      11 to 55 years old. About 200 subjects will be included in the study. Once subjects have been
      consented and screened, they will receive a total of two injections over a 28-day period,
      with follow-up visits at 8, 12 and 28 weeks. Safety and tolerability will be evaluated by
      occurrence of adverse events, periodic laboratory tests, vital signs, and local/systemic
      reactogenicity.

      Comparison: This study does not include a control treatment; all subjects will receive
      treatment with HEPLISAV™.
    

Intervention name(s): HEPLISAV
Intervention type(s): Biological
Intervention description(s): Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis B vaccine; HBV vaccine; Hepatitis B; Hepatitis; HBV; Vaccine; 1018; HBsAg
Basic Research Study to Examine the Relation Between Muscle Insulin Resistance and Lipid Production in the Liver.
Condition: Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      The purpose of this study is to examine the pathophysiology of insulin resistance and the
      relation to the metabolic syndrome in humans.
    

Detailed description: 
      In this study insulin resistant (IR), young offspring of parents with type 2 diabetes (18-46
      years) and healthy, lean elderly individuals (65-90 years) will undergo 1H/13C MRS
      measurements of liver and muscle lipid and glycogen content before and after a high
      carbohydrate meal challenge. Hepatic de novo lipogenesis will be determined as the
      incorporation of deuterium, from deuterium labeled water (2H2O), into plasma triglycerides 5.
      These metabolic studies will be performed in 3 sets: Study Part 1: Resting, Study Part 2:
      After 1 bout of exercise and Study part 3: After 6 weeks of exercise training. Since
      intra-abdominal obesity has been postulated to be at the core of the metabolic derangements
      and directly responsible for the atherogenic dyslipidemia associated with the metabolic
      syndrome, the investigators will also measure intra-abdominal fat content by magnetic
      resonance imaging (MRI).
    

Intervention name(s): Exercise Training
Intervention type(s): Other
Intervention description(s): Six weeks of exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insulin resistance; Exercise; de novo lipogenesis; NAFLD; Magnetic Resonance Spectroscopy
The Effect of Laughter Yoga on Hope and School Burnout
Condition: Laughter Therapy; Laughter Yoga; Hope; School Burnout
MeSH terms: Burnout, Psychological
Study type: Interventional

Summary: 
      This study aimed to evaluate the effect of laughter yoga on hope and school burnout among
      secondary school (8th Grade) students. The study hypothesized that laughter yoga would have
      an effect on hope and school burnout scores among secondary school students
    

Detailed description: 
      Purpose: The aim of the research was to examine the effects of laughter yoga on life hope and
      school burnout among secondary school (8th Grade) students.

      Methods: The study was conducted with 60 (30 in the intervention group, and 30 in the control
      group) students. The study population consisted of 8th grade students. Laughter yoga sessions
      were applied to the intervention group twice a week for 6 weeks. No intervention was offered
      to the control group. Data were collected by a socio-demographic questionnaire, school
      burnout inventory and Children's Hope Scale.

      Results: After laughter yoga, the intervention result showed a significant decrease in
      burnout (d=0.129; p < 0.001) and increase hope scores (d=0.556; p < 0.001) compared to the
      control group.

      Conclusion: The study reveals that laughter yoga affects students' burnout and hope levels.
      It is recommended to organize laughter yoga activities in schools to decrease burnout and
      increase hope of students.
    

Intervention name(s): Laughter yoga
Intervention type(s): Behavioral
Intervention description(s): Laughter yoga program was composed of four steps. The first step, which took 10 minutes, had warm-up exercises including gentle stretching and hand clapping. The second step, which included deep breathing exercises and hand clapping, took 5 minutes. The third step involved children's games and laughter exercises. The sessions included a combination of different laughter exercises. The last step, which included yoga nidra took 5 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
South Texas Early Prevention Studies PreK
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The South Texas Early Prevention Study-Prekindergarten (STEPS-PreK4) was a cluster randomized
      trial (CRT) of preschool children 4 years of age to test the effect of the Bienestar/NEEMA
      Coordinated School Health Program (BN CSHP) on childhood obesity prevalence prevention.
    

Detailed description: 
      The STEPS-PreK4 was a CRT where preschools, embedded within elementary schools, were the unit
      of randomization, intervention, and analysis. The study was designed for two years of
      intervention (pre-kinder to kindergarten) and four data collection periods (fall 2018, spring
      2019, fall 2019, and spring 2020). Due to the COVID-19 pandemic the study was stopped
      prematurely and only results from the first three periods will be presented.

      The two school districts where the study was conducted are located along the Texas-Mexico
      border in the county of Hidalgo. These school districts were selected because of the high
      poverty and health risk-factors levels.25 The preschools have two grade levels with children
      3 and 4 years of age. The present study targeted preschools with children 4 years of age.
      Demographics of the two school districts were similar, 99% Hispanic, 92% economically
      disadvantaged, and 42% identified as English as a second language.
    

Intervention name(s): STEPS-PreK
Intervention type(s): Behavioral
Intervention description(s): Intervention group received the BN CHSP, a Texas Education Agency (TEA)-approved CSHP. This health program was first piloted in schools located in low-income neighborhoods where enrollment was predominantly Black and Latino children. The Social-Ecological Model guided the BN CSHP design. This theory postulates that health behaviors are molded by individual, interpersonal, and environmental interactions. Thus, BN CSHP encompasses curricula from preschool to eighth grade and is designed to target the four environments that influence children's health behaviors: 1) Healthy Lifestyles Healthy Minds (Health), 2) Moving For Life (Physical Education), 3) Eat to Live (Child Nutrition/School Food Service), and 4) MyFamily/MiFamilia (Home).
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: There were three sequential data collection periods through the process.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prek children; obesity prevalence
Quetiapine Extended Release Depression Symptoms
Condition: Schizophrenia; Depression
MeSH terms: Depression; Depressive Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to
      Risperidone, considered as the reference drug for the treatment of depressive symptoms of
      schizophrenia.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine Extended Release; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day; Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
Other intervention name(s): Seroquel XR™; Risperdal
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schizophrenia; Depression; Quetiapine
Effect of Nutrition Bars on Satiety in Women
Condition: Hunger; Satiety
Study type: Interventional

Summary: 
      This study investigates nutrition bar consumption and possible impact on self-reported
      ratings of hunger and fullness compared to a control.
    

Detailed description: 
      Participant eligibility will be screened at visit 1. Test days will commence at 8 to 10 a.m.
      and visits two to four will be spaced four days apart. On visit days participants consume a
      nutrition bar; satiety and hunger ratings, blood samples are collected simultaneously over a
      three hour period. After completion, participants will complete gastrointestinal (GI)
      tolerability as well as Palatability and Adverse Events questionnaires.
    

Intervention name(s): Nutrition Bar
Intervention type(s): Other
Intervention description(s): Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Hunger; Fullness; Satiety; Nutrition bar; Crossover
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose,
      inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy
      subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be
      enrolled in this study.
    

Detailed description: 
      Up to seven cohorts of eight subjects each (up to a total of 56 subjects) will be enrolled.
      The eight subjects within each cohort will be randomized 6:2 to receive a single intravenous
      dose of TP-271 or placebo. The planned doses are:

      Cohort A: 0.15 mg/kg Cohort B: 0.45 mg/kg Cohort C: 1.0 mg/kg Cohort D: 2.0 mg/kg Cohort E:
      3.0 mg/kg Cohort F: 4.0 mg/kg Cohort G: 5.0 mg/kg

      Doses of IMP will be administered intravenously on the morning of Day 1 following an
      overnight fast (minimum 8 hours).

      During the Screening Period (within the 28 days prior to the subject receiving TP-271 or
      placebo) each subject will be assessed for eligibility. Each subject must sign and date an
      ICF prior to undergoing any study-related procedures.

      All cohorts will follow the same study design (Figure 1). On Day -1, subjects will be
      admitted to the study unit so their eligibility can be confirmed. Subjects will be required
      to stay overnight at the study unit on Day -1. On Day 1, eligible subjects will be enrolled
      and randomized to receive either TP-271 or placebo. Subjects will be required to stay at the
      study unit from Day 1 through Day 5 to assess safety and obtain required PK samples. On Day
      5, subjects will be discharged from the study unit. A final safety assessment will be
      performed once between Day 7 and Day 10 following the subject's dose of IMP.
    

Intervention name(s): TP-271
Intervention type(s): Drug
Intervention description(s): TP-271 is a novel, broad-spectrum tetracycline with potent activity against multidrug-resistant pathogens. It will be administered intravenously (IV) in doses ranging from 0.15 to 5.0 mg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Breast Cancer Risk Assessment Using Optical Breast Spectroscopy (OBS)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      This study aims to evaluate if a light based technique, called Optical Breast Spectroscopy
      (OBS) formerly known as Transillumination Breast Spectroscopy (TiBS), can be used to detect
      differences in breast tissue between high- and low-risk populations and within the high-risk
      population between BrCa1 or 2 carriers and non-carriers. These differences may include
      differences in breast tissue composition and metabolism at time of enrollment into the study
      (possibly reflecting changes occurring in adolescence) and in the rate of breast tissue
      change over time (possibly reflecting rate of tissue transformation from normal to ultimately
      malignant state).
    

Detailed description: 
      Preliminary data show Optical Breast Spectroscopy (OBS)has the ability to detect tissue
      differences with various pathologies and age-related changes in breast tissue over a two year
      period. In the present study, we want to determine whether OBS has the ability to detect
      optical differences between women who harbor a mutation in the breast cancer susceptibility
      gene, BrCa1 or BrCa2, and their age-matched controls (non-carriers). More specifically,
      possible differences in the breast tissue at time of enrollment into the study (reflecting
      changes potentially occurring in adolescence) and in the rate of breast tissue change over
      time (reflecting rate of tissue transformation from normal to ultimately malignant state).
      The overall goal is to develop a pre-screening technique to survey or monitor the risk of
      breast tissue and to advise the earliest point when imaging techniques (e.g. MRI) should be
      initiated or when more drastic primary prevention measures are recommended.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Cases are recruited from three participating high-risk screening centres: Familial Breast
        and Ovarian Cancer Programs at Mount Sinai Hospital and/or Princess Margaret Hospital
        (Toronto, Ontario, Canada), the Juravinski Cancer Center (Hamilton, Ontario, Canada) and
        Women's College Hsopital (toronto, Ontario, Canada). Controls are recruited from the
        respective geographical locations.
      
Keywords: Breast Cancer Risk; BRCA1; BRCA2; Breast Cancer Susceptibility gene; Optical Transillumination Spectroscopy; Transillumination Breast Spectroscopy
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Condition: Females Scheduled to be Treated Using the MC1.
Study type: Observational

Summary: 
      The objective of this study is to observe body contour changes following treatment using the
      MC1 device.
    

Detailed description: 
      The purpose of this research study is to observe body contour changes following treatment
      using the MC1 device. The MC1 System is FDA cleared for relief of minor muscle aches, pain
      and muscle spasm, temporary improvement in local blood circulation, and temporary reduction
      in the appearance of cellulite.
    

Intervention name(s): MC1 Ultrasonic Device
Intervention type(s): Device
Intervention description(s): Ultrasonic and zonal massage device.
Other intervention name(s): MC1; VASERShape
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to
        be treated using the MC1 device.
      
Keywords: MC1 VASER VASERShape