bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Exercise Training on Fine Motor Skills
Condition: Fine Motor Skills; Testosterone Concentration
Study type: Interventional

Summary: 
      Despite the importance of physical activity for adolescent physical development, the specific
      impact of different types of exercise training on fine motor skills and testosterone
      concentration is unknown. A primary aim of this study was to analyze the benefits of
      cardiovascular and coordinative exercise training on fine motor skills in an adolescent
      population. A second aim of our study was to determine the testosterone concentration after
      physical stress of cardiovascular and coordinative exercise training and if testosterone was
      related to fine motor skills among adolescents following an exercise training intervention.
    

Detailed description: 
      We assigned 135 adolescents (68 girls, 12-15 years of age) from Lithuania. Adolescents were
      assigned to one of three groups: control group (CON) (n = 46; 23 girls), coordinative
      exercise (CE) (n = 41; 22 girls), and cardiovascular exercise (CVE) group (n = 48; 23 girls).
      Participants performed all necessary tests according to the study protocol one week before
      the intervention. Adolescents were familiarized with the tests on a separate day before the
      first assessment. A second set of tests was performed one week after the 10-week exercise
      intervention.

      The exercise intervention period was 10 weeks. Exercises were led by a Physical Education
      teacher. Experimental groups had common physical education classes twice per week for 45
      minutes each, and additional exercise sessions were held three times per week for 45 minutes
      after school.
    

Intervention name(s): exercise training
Intervention type(s): Behavioral
Intervention description(s): Exercise training session for 45 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: school, cardiovascular exercise, coordinative exercise
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 To 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Condition: Clostridium Difficile
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate a clostridium difficile vaccine in healthy adults aged 50 to 85
      years, who will each receive 3 doses of vaccine. Subjects will receive their vaccine doses at
      either months 0, 1, and 3 or days 1, 8, and 30. Subjects will be divided into 2 age groups
      (50-64 and 65-85 years of age). The study will assess how safe and tolerable the vaccine is,
      and also look at subjects' immune response to the vaccine.
    


Intervention name(s): C. difficile vaccine with adjuvant; Placebo; C. difficile vaccine with adjuvant; placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.; Placebo administered at Month 0, 1, and 3.; C. difficile vaccine with adjuvant administered at day 1, 8, 30.; Placebo administered at Day 1, 8, and 30.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Study of Nasal Mucosa Histopathological Changes in Chronic Hypersensitivity Pneumonitis
Condition: Hypersensitivity Pneumonitis; Nasal Mucosal Disorder
MeSH terms: Pneumonia; Alveolitis, Extrinsic Allergic; Hypersensitivity
Study type: Interventional

Summary: 
      Background:Hypersensitivity pneumonitis (HP) is an interstitial lung disease that develops
      after inhalation of organic or inorganic antigens in susceptible individuals. The nasal
      mucosa is constantly exposed to these antigens that can irritate the respiratory mucosa.

      Objectives: to assess the burden of sinonasal symptoms in HP patients and to evaluate the
      nasal histopathology in those patients.
    


Intervention name(s): nasal endoscopy
Intervention type(s): Procedure
Intervention description(s): nasal endoscopy and mucosal biopsy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: hypersensitivity pneumonitis; nasal mucosa histopaholgical changes
Effect of Food on a Fixed Dose Combination Tablet of Canagliflozin and Metformin Immediate Release in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the absorption and distribution of a fixed-dose
      Combination (FDC) tablet of canagliflozin and metformin IR is affected when taken with food
      by healthy volunteers.
    

Detailed description: 
      This is an open-label (identity of study drug will be known to volunteers and study staff),
      single-center study to evaluate the oral bioavailability (ie, absorption and distribution
      within the body) and pharmacokinetics (blood levels) of a single dose of 1 fixed-dose
      combination (FDC) tablet of canagliflozin and metformin IR (abbreviated as 1 CANA/MET IR FDC
      tablet) when taken by healthy volunteers without food (in a fasting state) or with food (in a
      fed state). Healthy volunteers participating in the study will be randomly (by chance)
      assigned to receive Treatment A (1 CANA/MET IR FDC tablet taken by healthy volunteers in a
      fasting state) followed approximately 14 days later by Treatment B (1 CANA/MET IR FDC tablet
      taken by healthy volunteers in a fed state) or Treatment B followed approximately 14 days
      later by Treatment A.
    

Intervention name(s): A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state); B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.; Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Oral bioavailability; Canagliflozin (JNJ-28431754); Metformin IR
Safety and Efficacy of CJ Smallpox Vaccine in Previously Vaccinated Healthy Volunteers
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 3

Summary: 
      The currently available stock of smallpox vaccine would be insufficient in the face of an
      incident of smallpox attack. Thus, new manufacturing methods for smallpox vaccine are
      urgently needed because previous manufacturing methods using calf lymph are no longer
      acceptable in the view of current standards. Recently, CJ corporation in Republic of Korea
      has developed cell-culture derived smallpox vaccine (CJ-50300) which was manufactured by
      infecting MRC-5 cells. The aim of this clinical trial were to assess safety, reactogenicity,
      and immunogenicity of CJ-50300 in previously vaccinated healthy volunteers
    


Intervention name(s): smallpox vaccine CJ-50300
Intervention type(s): Drug
Intervention description(s): Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
Other intervention name(s): CJ-53300
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Smallpox vaccine efficacy
Safety Study of Thumb Orthoses in Osteoarthritis in the Base of the Thumb (BTOA)
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The prevalence of digital osteoarthritis varies according to whether a radiological or
      clinical definition is adopted.

      Interventions: Thumb orthoses to be worn at night and usual care vs usual care. Outcome
      measures: Pain at 1 month assessed on visual analog scale is the main outcome measure.
      Disability at 6 months (Cochin Hand Function Scale) and deformation at 1 year are the main
      secondary outcome measures.
    

Detailed description: 
      The prevalence of digital osteoarthritis varies according to whether a radiological or
      clinical definition is adopted. Radiologically defined osteoarthritis of the hand has been
      estimated to represent 38% of women and 24.5% of men over 66 years of age but higher
      prevalence of 60-70% has also been reported. Of patients with radiological signs, 20 to 40%
      become symptomatic. For patients over 55 years of age, the distal interphalangeal joints are
      the most prevalent site of osteoarthritis (20%) determined radiologically and clinically,
      followed by the base of the thumb (8%) and proximal interphalangeal joints (5%). This
      prevalence increases with age, and the incidence peaks in perimenopausal women.
      Osteoarthritis in the base of the thumb (BTOA) concerns the trapeziometacarpal joint, with a
      possible secondary location at the trapezotrapezoidial and scaphotrapezial joints. BTOA
      induces a closure of the first web, which in turn causes an alteration of the thumb-index
      pinch and therefore a limitation in hand function. Pain induced by the compression of the
      thumb column during pinching could also lead to functional disability. Effect of a simple
      intervention such as wearing rest thumb orthoses on pain and disability is unknown.
    

Intervention name(s): Thumb orthoses
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: trapezotrapezoidial; scaphotrapezial; thumb; pain; orthoses; Osteoarthritis in the BTOA concerns the trapezometacarpal joint
Study of Phenoptin to Increase Phenylalanine Tolerance in Phenylketonuric Children on a Phenylalanine-restricted Diet
Condition: Phenylketonurias
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this trial is to evaluate the ability of Phenoptin to increase
      phenylalanine (phe) tolerance in children with phenylketonuria who are following a
      phe-restricted diet.
    


Intervention name(s): Sapropterin Dihydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120-240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.; Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120-240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
Intervention MeSH terms: Verapamil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fitness, Activity and Lung Cancer Study
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the change in pulmonary function and exercise
      capacity in lung cancer patients after pulmonary resection. Furthermore, to study the effect
      of training on aerobic capacity, muscular strength, morbidity and survival. Physical activity
      level by accelerometers, body composition by DXA and quality of life will also be reported.
    

Detailed description: 
      Five year after surgery, all included patients will be reinvited to undergo a fourth health
      excame to study the long-term effects of exercise training on physical fitness, morbidity and
      survival.
    

Intervention name(s): Physical training; As usual
Intervention type(s): Other; Other
Intervention description(s): Physical training three times a week for 20 week including endurance and strength training compare to the "as usual" group as controls; Controls, not training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Pulmonary function; Maximal oxygen uptake; Cardiorespiratory fitness; High-intensity training; Surgery
Improving Cancer Patients' Insurance Choices
Condition: Cancer; Health Literacy; Health Insurance; Health Services Accessibility; Informed Decision Making
Study type: Interventional

Summary: 
      The goal of this research study is to find out if a decision aid (DA) created by
      investigators, I Can PIC, is effective in helping cancer patients make decisions about their
      health insurance. The investigators will evaluate I Can PIC compared to an attention control
      condition (existing website created by the American Cancer Society Cancer Action Network).
      The study hypothesis is that those randomly assigned to I Can PIC will have higher knowledge
      about health insurance terms and details, more certainty about the best health insurance plan
      for them, and more confidence in their health insurance decisions compared to those randomly
      assigned to the control condition.
    

Detailed description: 
      In a prior study, the investigators created a consumer-friendly online tool, Show Me Health
      Plans (SMHP), for those enrolling in health insurance in the ACA marketplace. I Can PIC was
      developed based on SMHP, with input from an advisory board, and incorporating feedback from
      semi-structured qualitative interviews with cancer survivors. The investigators created I Can
      PIC to focus on unique needs of cancer patients and survivors considering health insurance.
      In this study, the investigators will examine the effectiveness of I Can PIC by conducting a
      randomized experiment with 275 participants. The trial will compare the I Can PIC to an
      attention control website developed by the American Cancer Society Cancer Action Network.
      Primary outcomes include knowledge, decision self-efficacy, certainty about plan choice, and
      the match between plan choice and preferences. The investigators will also explore whether
      financial toxicity, cancer type, and time since diagnosis relate to outcomes.
    

Intervention name(s): I Can PIC
Intervention type(s): Behavioral
Intervention description(s): Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.
Other intervention name(s): Decision Aid (DA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Decision Making; Decision Support; Health Literacy
Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to
      compare the efficacy and safety of atomoxetine versus placebo in children and adolescents
      aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid
      oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an
      initial 3- to 28-day screening and washout phase, participants will be assigned to
      double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be
      succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will
      be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dosage form for the atomoxetine fast and slow titration arms consists of 2.5 mg, 10 mg, 20 mg, 25 mg, and 40 mg capsules. Double-blind treatment will consist of 3 capsules taken once per day for approximately 9 weeks.; Double-blind treatment will consist of 3 matching placebo capsules taken once per day by mouth for approximately 9 weeks.
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Teen Outreach Program in Chicago Public Schools
Condition: Sexual Behavior
Study type: Interventional

Summary: 
      The purpose of this study was to determine the impact of TOP® on sexual health behavior.
    

Detailed description: 
      The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools
      (CPS) with equal number of schools randomized to intervention and comparison groups for two
      cohort years. Students were administered a scannable paper survey at three time points:
      baseline, post-program and 1-year post program. The primary impact analysis used an
      intent-to-treat approach. Implementation of TOP® was assessed by conducting classroom
      observations. TOP® was delivered in a variety of classroom settings over the school year by
      facilitators from CPS and partner organizations.
    

Intervention name(s): Teen Outreach Program
Intervention type(s): Behavioral
Intervention description(s): TOP® is a positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels. The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes. TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
RCT to Compare Orlistat and Polyglucosamine for the Management of Overweight and Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      This trial compares two treatment methods:

        1. Orlistat 60 mg to be taken three times daily one capsule; indicated for weight loss in
           overweight adults. Important is also that it is taken along with a reduced-calorie and
           low-fat diet.

        2. Polyglucosamine tablets to be taken two times daily two tablets, taken with the two main
           meals with the highest fat content, indicated for weight maintenance and weight loss.
    


Intervention name(s): orlistat 60 mg; polyglucosamine
Intervention type(s): Drug; Device
Intervention description(s): In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets.; In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening).
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polyglucosamine; L 112; overweight,; obesity; orlistat; weight reduction
Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
Condition: Myopia; Hyperopia; Refractive Error
MeSH terms: Refractive Errors; Hyperopia
Study type: Interventional

Summary: 
      The purpose of this study was to compare three CE-marked daily disposable contact lenses for
      tear film stability as measured by pre-lens non-invasive keratograph break up time (PL
      NIK-BUT). Secondarily, contact lens surface wettability was assessed.
    

Detailed description: 
      Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a
      washout phase of at least 1 night between brands.
    

Intervention name(s): Nelfilcon A contact lenses; Omafilcon A contact lenses; Etafilcon A contact lenses
Intervention type(s): Device; Device; Device
Other intervention name(s): DAILIES® AquaComfort Plus®; Proclear® 1 day; 1-DAY ACUVUE® MOIST®
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Soft contact lenses; Daily disposable contact lenses; Tear Film Break Up Time; Contact lens wettability