bioihbjkbjnl/mcl2 huggingface dataset:
Modifying the Home Television Watching Environment
Condition: Obesity; Body Weight Changes
MeSH terms: Body Weight; Body Weight Changes
Study type: Interventional

Summary: 
      The purpose of this study is to determine if limiting television (TV) and computer time will
      result in a stabilization or smaller increase in body mass index (BMI), lower energy intake,
      and increased physical activity in 4-7 year old obese (>85th BMI percentile) children over
      two years.
    

Detailed description: 
      There is a positive correlation between obesity and television watching in adults and
      children. And, television watching, controlling for current obesity, is a predictor of future
      obesity. Almost half of all children watch 3 or more hours of television each day. The
      American Academy of Pediatrics recommends that children watch no more than 1-2 hours each
      day.

      Families will be randomized to one of two conditions. Half the families will be taught to use
      the TV Allowance to reduce their child's TV and computer use by one-half over a six month
      period and the other half will use the device to monitor TV watching (control group). This
      study uses TV Allowance units to monitor home television watching, video game playing, and
      computer use. The TV Allowance can also be used to limit the amount of TV and computer use by
      programming it to allow a specific number of hours for each family member. Heights, weights,
      food intake, and physical activity will be measured at baseline and every six months. The
      purpose of this study is to determine if limiting television and computer time will result in
      a stabilization or smaller increase in BMI, lower energy intake, and increased physical
      activity in 4-7 year old obese (>85th BMI percentile) children over two years.
    

Intervention name(s): Behavior modification
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; television; child obesity; Reduce TV; Usual control
Prospective Metabolic Monitoring of Youth and Adults With Bipolar Disorder
Condition: Bipolar Disorder; Youth; Adults
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      Background: Most psychotropic medications that are effective in the treatment of Bipolar
      Disorder (BD) are associated with endocrine-metabolic changes (EMCs). To date, there is no
      long-term study in BD that has examined specifically the association of inflammation with
      EMCs in BD. Specific aims: 1) to identify predictors of EMCs among adolescents and adults
      with BD who are being started on a medication ; 2) to compare change in EMCs in youth and
      adults treated for BD; 3) to measure change in EMCs associated with use of different
      medications for BD. Research Design: Participants: 30 adolescents (14-18 years old) with BD
      and 30 adults (19-65 years old) with BD. Measures: Blood levels of biomarkers that are
      associated with EMCs will be measured.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Thirty adolescent participants with BD (type I, II, or not otherwise specified), and 30
        adult participants with BD will be enrolled. Participants with BD will be recruited from
        the Youth and Adult Mood Disorder Clinics. Psychiatry Division staff will identify patients
        who meet the study criteria during weekly treatment team meetings. New referrals will also
        be screened to identify potential participants.
      
Keywords: Bipolar Disorder; Youth; Adults; Endocrine-metabolic changes
Camp NERF: Methods of a Summer Nutrition Ed Rec & Fitness Program to Prevent Unhealthy Weight Gain in Children
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity; Weight Gain
Study type: Interventional

Summary: 
      The primary aims of this research project are to:

        1. Evaluate the efficacy of Camp NERF to improve child nutrition, physical activity, mental
           health, and anthropometric outcomes.

        2. Evaluate the efficacy of Camp NERF to improve caregiver self-efficacy for establishing
           healthy family nutrition and physical activity practices, amount of physical activity,
           and BMI.

        3. Evaluate the efficacy of Camp NERF to improve youth mentor nutrition, physical activity,
           and anthropometric outcomes.
    

Detailed description: 
      Background: The number of obese children in the US remains high, which is problematic due to
      the mental, physical, and academic effects of obesity on child health. Data indicate that
      school-age children, particularly underserved children, experience unhealthy gains in BMI at
      a rate nearly twice as fast during the summer months. Few efforts have been directed at
      implementing evidence-based programming to prevent excess weight gain during the summer
      recess.

      Methods: Camp NERF is an 8-week, multi-component (nutrition, physical activity, and mental
      health), theory-based program for underserved school-age children in grades Kindergarten -
      5th grade coupled with the USDA Summer Food Service Program. Twelve eligible elementary
      school sites will be randomized to one of the three programming groups: 1) Active Control
      (non-nutrition, physical activity, or mental health [4H curricula]); 2) Standard Care
      (nutrition and physical activity); or 3) Enhanced Care (nutrition, physical activity, and
      mental health) programming. Anthropometric, behavioral, and psychosocial data will be
      collected from child-caregiver dyads pre- and post-intervention. Site-specific
      characteristics and process evaluation measures will also be collected.

      Discussion: This is the first, evidence-based intervention to address the issue of weight
      gain during the summer months among underserved, school-aged children. Results from this
      study will provide researchers, practitioners, and public health professionals with insight
      on evidence-based programming to aid in childhood obesity prevention during this particular
      window of risk.
    

Intervention name(s): Enhanced Care; Standard Care; Active Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): 8-week (nutrition, physical activity, and mental health) summer curriculum/program; 8-week (nutrition and physical activity) summer curriculum/program; 8-week (non-nutrition, physical activity or mental health) summer curriculum/program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Use of Virtual Reality Devices for Vestibular Rehabilitation
Condition: Virtual Reality
Study type: Interventional

Summary: 
      The aim of this study is to investigate the superiority of virtual reality-supported
      vestibular rehabilitation exercises over conventional vestibular rehabilitation exercises in
      patients with complaints such as vertigo, loss of balance, falling, and gait imbalance.
    


Intervention name(s): Virtual Reality; Traditional home exercises
Intervention type(s): Device; Other
Intervention description(s): Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.; Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Nab-Paclitaxel and Gemcitabine in Subjects With Previously Untreated Stage IV Pancreatic Cancer
Condition: Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD)
      of OMP-59R5 in combination with nab-paclitaxel and gemcitabine followed by a Phase 2,
      multicenter, randomized, placebo-controlled portion to evaluate the efficacy and safety of
      OMP-59R5 in combination with nab-paclitaxel and gemcitabine in subjects with previously
      untreated stage IV pancreatic cancer.
    


Intervention name(s): OMP-59R5; Gemcitabine; Placebo; Nab-Paclitaxel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): OMP-59R5 administered intravenously; administered intravenously; administered IV; administered intravenously
Other intervention name(s): Abraxane
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Newly diagnosed Stage IV Pancreatic Cancer
The Safety and Efficacy of Escitalopram in Pediatric Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Depression affects approximately 2.5% of children and 8% of adolescents. Escitalopram is the
      S-enantiomer of citalopram. Both escitalopram and citalopram are selective serotonin reuptake
      inhibitors (SSRIs) and are used to treat depression in adults. This study is designed to
      provide a systematic evaluation of the safety and efficacy of escitalopram in the treatment
      of depressed pediatric patients, 12 to 17 years of age. Patients completing the study will be
      eligible to enter an open-label extension study.
    


Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escitalopram 10mg per day for three weeks, 10-20mg per day for up to the remaining 5 weeks; Placebo once daily for up to 8 weeks
Other intervention name(s): Lexapro (TM)
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression; Adolescents; Escitalopram; Pediatrics
Drug Interaction Study of MGL-3196 With Clopidogrel
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether the single and multiple-dose
      pharmacokinetics (PK) of MGL-3196 are affected by co-administration with clopidogrel in
      healthy subjects.
    


Intervention name(s): MGL-3196; Clopidogrel
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally on the morning of Day 1; Multiple-dose administration of 100 mg MGL-3196 on Day 6 until Day 14; After one-day washout period after Day 1, loading dose of 300 mg clopidogrel administered on Day 3 and then, at approximately the same time each morning, 75 mg clopidogrel administered on Days 4 to 11
Intervention MeSH terms: Clopidogrel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of a Single Dose of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      A Dose Escalating Study of PRS-060 Administered by Oral Inhalation or IV Infusion in Healthy
      Subjects
    

Detailed description: 
      PRS-060 is a new drug being developed for treatment of asthma. The main purpose of this study
      is to investigate the safety, tolerability and pharmacokinetics of single ascending doses of
      PRS-060 in healthy subjects
    

Intervention name(s): PRS-060; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug; PRS-060 Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single Group Assignment This is a phase 1, dose escalating study to assess safety, tolerability, and PK of a single dose of PRS-060 administered by oral inhalation or IV infusion to healthy male and female subjects. This study will be conducted utilizing a single-blind, randomized, dose-escalating design.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Asthma; Anticalin; PRS-060; Healthy Volunteers; Pieris; IL-4 receptor alpha; IL-13; IL-4
The Effect of Cycling Off Criteria During Pressure Support Ventilation in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The investigators' aim is to study the effect of cycling off criteria during pressure support
      ventilation in COPD patients at two levels of PEEP and PSV.
    

Detailed description: 
      In this study two levels of cycling off criteria at two levels of PEEP and PSV were tested in
      term of gas exchange, respiratory mechanics, work of breathing and patient comfort.
    

Intervention name(s): mechanical ventilation
Intervention type(s): Procedure
Intervention description(s): evaluated the effect of two different cycling off criteria on breathing pattern, respiratory effort, and gas exchange in patients with chronic obstructive pulmonary disease
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gas exchange; pressure support ventilation; respiratory mechanics; COPD patients
The Efficacy and Safety of DWP16001 Compared to Placebo in the Treatment of Type 2 Diabetes Mellitus.
Condition: T2DM (Type 2 Diabetes Mellitus)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of DWP16001 compared to
      placebo in the treatment of type 2 diabetes mellitus.
    


Intervention name(s): DWP16001
Intervention type(s): Drug
Intervention description(s): DWP16001 A mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intra-Individual Comparison of Sirolimus and Paclitaxel Coated Stent (FRE-RACE Study)
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this study is to assess the safety and effectiveness of the Sirolimus
      eluting Cypher Select(TM) stent in reducing angiographic in-stent late loss in de novo native
      coronary lesions as compared to the TAXUS(TM) Paclitaxel-eluting stent in patients presenting
      with two or more coronary artery stenoses (prospective, randomized, intra-individual
      comparison).
    

Detailed description: 
      This is a prospective, 2 arm, randomized, multicenter Phase III study (6 centers).

      A total of 110 patients with at least two de novo native coronary artery lesions (lesion A,
      lesion B) ≤ 30 mm in length and ≥ 2.25 mm to < 3.0 mm in diameter by visual estimate will be
      enrolled. Patients will be randomized for implantation of the sirolimus eluting Cypher
      Select(TM) Balloon-Expandable Stent or to the TAXUS(TM) Paclitaxel-eluting stent for lesion A
      and B.
    

Intervention name(s): Paclitaxel-eluting TAXUS(TM); Sirolimus eluting Cypher Select(TM)
Intervention type(s): Device; Device
Intervention description(s): TAXUS(TM) Paclitaxel-eluting stent; Sirolimus eluting Cypher Select(TM) stent
Intervention MeSH terms: Sirolimus; Paclitaxel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: coronary artery disease; coronary intervention; drug eluting stent implantation; Cypher - Stent; Sirolimus; Taxus - Stent; Paclitaxel
Training Study to Characterize Biomarkers to Chickenpox and Yellow Fever Vaccines
Condition: Healthy
MeSH terms: Yellow Fever
Study type: Interventional

Summary: 
      It is thought that vaccines trigger innate inflammatory responses to induce antigenspecific
      adaptive immunity (the desired effect), but excessive inflammation may lead to serious
      inflammatory complications or unwanted side effects. Currently there is a lack of reliable
      biomarkers (a measurable biological response that predicts something) able to predict severe
      inflammation and this has resulted in the development of several vaccines being terminated
      and the withdrawal of some licensed vaccines which were associated with inflammatory
      complications.

      This study is part of the BIOVACSAFE project which is a 5year €30M project funded by the
      Innovative Medicine Initiative. The project involves a series of clinical studies using
      licensed vaccines as benchmarks to generate clinical data on inflammation and identify
      biomarkers that can be used to predict acceptable reactogenicity. The target is to identify
      biomarkers that can predict the occurrence of beneficial and detrimental effects in response
      to a vaccine. Such biomarkers could be used in future vaccine development programs to
      optimize selection of vaccine candidates with a profile that will be unlikely to generate
      worrisome safety signals once they are in generalized use.

      This study is one in a series of "training" studies which will each use different licensed
      vaccines that are prototypical representatives of a class of vaccine used in a particular
      target population. Forty eight subjects will be randomised into three groups to receive: A)
      Varicella zoster vaccine (n = 20), B) Yellow Fever vaccine (n = 20), C) Saline placebo (n =
      8). Following a screening visit, participants will undergo a seven day residential visit
      which will include immunization and intensive monitoring of physiological (e.g. heart rate,
      oral temperature, blood pressure) metabolic and immune (innate and adaptive) parameters. This
      visit will be followed up by four outpatient visits with further monitoring and blood
      samples.
    


Intervention name(s): Varicella-zoster virus; Yellow Fever Vaccine; Placebo
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): Varilrix; Stamaril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: To identify; biomarkers; of vaccine safety; Volunteers
PMCF Study to Evaluate Performance and Safety of "LUXIDROPIN BABY & JUNIOR"
Condition: Ocular Discharge
Study type: Interventional

Summary: 
      Children's tear film and ocular surface are increasingly exposed to environmental factors.
      The tear film is the most important barrier protecting the eye from external insults such as
      pollen, dust, sand. If a foreign substance is not washed away by the tear film, it eventually
      reaches the ocular surface resulting in eye irritation, ocular secretions, and/or allergic
      response. Primary intervention is aimed at avoiding allergens and using eye lubricants to
      facilitate the washout of the foreign substance. It is also recommended to regularly clean
      the children's eyes to avoid infections. Topical medications are usually recommended only in
      the presence of infectious conjunctivitis.

      Ocular secretions are also commonly observed in newborn babies. Neonatal ocular discharge is
      often related to congenital nasolacrimal duct obstruction (CNLDO) which normally occurs
      within the first weeks of age. CNLDO (also known as dacryostenosis) results from a congenital
      abnormality of the lacrimal drainage system in the form of a membranous obstruction of the
      nasolacrimal duct of one or both eyes. In most cases, blocked tear ducts open spontaneously
      within the first 6-12 months of age. Traditionally, management of CNLDO consists of frequent
      lacrimal sac massages and regular cleaning of the eyes. Topical antibiotic therapy is
      indicated only with the clinical evidence of infection.

      For these reasons, an interventional, non-comparative, single-center Post Marketing Clinical
      Follow-up (PMCF) study was planned to evaluate the performance and safety of "LUXIDROPIN BABY
      & JUNIOR" used to facilitate the removal of ocular secretions in pediatric subjects.

      The objectives of the PMCF study are confirmation of the performance, collection of
      additional safety data regarding expected adverse events and detection of potential
      unexpected adverse events associated with the use of "LUXIDROPIN BABY & JUNIOR" according to
      the Instructions for Use (IFU).

      Each pediatric subject whose parent(s)/legal guardian signed an Informed Consent Form (ICF),
      will enter the screening and baseline phase (the 2 visits will coincide) during which
      baseline procedures will be completed.

      At baseline visit (V0), "LUXIDROPIN BABY & JUNIOR" will be administered to the enrolled
      subject.

      The patient will perform 2 on-site visits: V0 and V2/EOS. To monitor the safety, 1 phone
      contact is planned (V1) to check for potential adverse events and concomitant medications
      intake.
    


Intervention name(s): Saline eye drops
Intervention type(s): Device
Intervention description(s): Ocular drops used to facilitate the removal of ocular secretions in pediatric subjects
Intervention MeSH terms: Ophthalmic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment