bioihbjkbjnl/mcl2 huggingface dataset:
An Interactive Internet Intervention for Adults With Insomnia
Condition: Insomnia; Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the efficacy of an interactive Internet intervention for adult
      insomnia (Sleep Healthy Using the Internet; SHUTi) to that of a static educational website to
      improve sleep, mood related symptoms, perceived health status, and overall quality of life.
    

Detailed description: 
      Insomnia is defined by complaints of poor sleep, as well as difficulties initiating and/or
      maintaining sleep more than 3 nights/week for more than 6 months. Insomnia may contribute to
      daytime fatigue, impaired performance, confused thinking and judgment, and difficulty with
      work and personal tasks. Cognitive behavioral therapy (CBT) has been found to have
      significant short- and long-term benefits for people with insomnia. Access to CBT for many
      people, however, is limited, due to the high cost of treatment and a limited number of
      trained professionals. Delivering CBT for insomnia via the Internet could help make it more
      widely available. This study will compare the effectiveness of an online CBT intervention in
      improving sleep, mood, and quality of life in people with insomnia to that of a static
      educational website.

      Participants in this study will be randomly assigned to receive the online CBT intervention
      or the static patient education website. The intervention period will last for 9 weeks.
      During the intervention period, participants assigned to the patient education website will
      be given content addressing strategies for dealing with insomnia. Those assigned to use the
      Internet intervention will review interactive, tailored content specific to the user's
      difficulties. Participants will complete questionnaires and two weeks of daily sleep diaries
      about their symptoms at four time points - at the beginning of the study, immediately after
      completing the 9 week program, 6 months later, and 12 months later.
    

Intervention name(s): Internet Intervention; Patient Education Website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will spend 1-2 hours each week for 9 weeks using the Internet intervention. Users will complete daily sleep diaries as well as interactive tutorials covering the topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the program they will receive tailored instructions for how to improve their sleep.; Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.
Other intervention name(s): Sleep Healthy Using the Internet (SHUTi)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: sleep; insomnia; internet; CBT
Telephone Physical Activity Intervention in Obese Youth
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of a telephone-based physical
      activity (PA) intervention in obese adolescents attending a Health Weight Comprehensive
      Clinic. Secondary aims focus on increasing the amount of change in obesity markers, namely
      waist circumference and BMI z-scores. The investigators hypothesize the following: 1.The
      telephone-based PA intervention will increase PA levels above the mail group; and 2. The
      telephone-based PA intervention will provide changes in waist circumference and BMI z-scores
      above the mail group.
    

Detailed description: 
      Obesity rates in youth have tripled over the past 20 years. Physical activity aids in weight
      loss and is critical for weight maintenance. Further, physical activity has other
      physiological and psychological benefits. Obese youth often see specialists for weight loss
      treatment. Treatment in a pediatric population uses a multi-component approach, but physical
      activity if often overlooked. Combining physical activity information with physician care and
      nutritional information could improve weight loss and the overall health of these obese
      children.
    

Intervention name(s): physical activity
Intervention type(s): Behavioral
Intervention description(s): physical activity counseling sessions will occur by telephone weekly for 2 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: physical activity; obesity; adolescents; telephone; BMI; body mass index
Enhancing Panic and Smoking Reduction Treatment With D-Cycloserine
Condition: Nicotine Addiction; Panic Attack
MeSH terms: Tobacco Use Disorder; Panic Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of the current study is to evaluate the efficacy of d-cycloserine in augmenting
      treatment of smoking cessation for individuals with panic attacks. The investigators
      hypothesize that individuals receiving DCS (versus those receiving placebo) will evidence
      greater smoking abstinence rates and decreased panic symptoms after receiving a combined
      CBT-based treatment for smokers with panic attacks.
    


Intervention name(s): d-cycloserine; Pill Placebo; Nicotine replacement therapy; Panic and Smoking Reduction Treatment
Intervention type(s): Drug; Drug; Drug; Behavioral
Intervention description(s): d-cycloserine is a medication thought to be associated with fear extinction.; All participants will receive Nicoderm CQ®, 24-hour transdermal nicotine patches and will be educated about the use of the patch at the session immediately prior to quit date. They will be instructed to apply one patch daily, beginning on quit date (week 5). Participants will use the 3-step tapering Nicoderm process (21-mg, 14-mg, and 7-mg). This regimen has been used in previous trials with a similar formulation of the patch (Fiore, 2000). A meta-analysis found no differences in outcome between 16- or 24-hour patches (Fiore et al., 1994). Participants who continue to smoke or lapse after quit day will not be instructed to discontinue the patch until their smoking level reaches 4 cigarettes/day for 4 days. Smokers who lapse during treatment will be encouraged to set a new quit date and continue their cessation attempt.; PSRT incorporates elements of standard smoking cessation treatment (i.e., counseling plus NRT) with procedures for reducing panic and enhancing tolerance to withdrawal sensations. Written therapist and patient manuals will be used and followed at all times to ensure standardized delivery of the treatment. Interventions that uniquely focus on addressing panic, fears and intolerance of anxiety, bodily-related sensations, and affect-relevant withdrawal symptoms include: (1) interoceptive exposure; (2) corrective information about anxiety and cognitive interventions designed to teach patients alternatives to catastrophic misinterpretations of the sensations and their feared consequences; and (3) situational exposure.
Other intervention name(s): d-cycloserine; DCS; sugar pill; patch, NRT, nicoderm,; PSRT, CBT, cognitive behavioral therapy, panic reduction, smoking cessation
Intervention MeSH terms: Cycloserine; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Trial of Two Techniques for Gingival Displacement
Condition: Poor Aesthetic of Existing Restoration of Tooth
Study type: Interventional
Phase: Phase 1

Summary: 
      Regardless of the selected technique for dental impression, gingival displacement is an
      essential procedure specially when making impressions of subgingival finishing lines, because
      a moisture-free sulcus is a requirement for an effective impression.

      The objective of this randomized clinical study is to evaluate the efficacy of the
      conventional and cordless gingival displacement (GD) techniques.
    

Detailed description: 
      On conventional technique we normally use a cord for gingival displacement. On the other
      hand, on cordless technique do not require this need.
    

Intervention name(s): Gingival displacement
Intervention type(s): Procedure
Intervention description(s): Gingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b
      administered by subcutaneous injection; compared to placebo in patients with IPF who are
      unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g
      1b group or a placebo group.
    


Intervention name(s): Interferon-gamma 1b
Intervention type(s): Drug
Intervention description(s): 200 mcg, SQ, 3x per week
Intervention MeSH terms: Interferons; Interferon-gamma
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: lung; IPF
Safety, Tolerability, and Pharmacokinetic Study of EVP-6124 in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Central Nervous System Diseases
MeSH terms: Nervous System Diseases; Central Nervous System Diseases; Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study in patients with schizophrenia is designed to provide preliminary evidence of the
      safety, tolerability, and pharmacokinetics as well as the effects on cognitive function of 2
      doses of EVP-6124 compared with placebo when given with the patient's usual antipsychotic
      medication.
    

Detailed description: 
      Study drug will be supplied as capsules and will be orally administered once daily for a
      total of 21 days. Eligible subjects will be admitted to an inpatient study unit on Day -6
      (six days before the first dose of study drug is administered) and will remain confined to
      the inpatient study unit throughout the dosing phase. Safety assessments, PK sampling, and
      cognitive testing will be performed.
    

Intervention name(s): EVP-6124 (0.3 mg/day); EVP-6124 (1.0 mg/day); Placebo; Antipsychotic therapy
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.; EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.; Matching placebo was administered as one capsule per day for 21 days.; Concomitant therapy with antipsychotic medication (aripiprazole [10 to 30 mg/day], olanzapine [10 to 20 mg/day], paliperidone [3 to 12 mg/day], or risperidone [2 to 16 mg/day]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.
Intervention MeSH terms: Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Schizoaffective; CNS
A Study Assessing the REG1 Anticoagulation System Compared Heparin in Subjects With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the REG1 anticoagulation
      System in Acute Coronary Syndrome (ACS) patients undergoing cardiac catheterization.
    

Detailed description: 
      Primary Outcome Bleeding Secondary Outcome Ischemia
    

Intervention name(s): REG1; Heparin
Intervention type(s): Drug; Drug
Intervention description(s): IV form, bolus dose. May be redosed. Control agent given as single re-dose at completion of intervention; IV dose per standard of care at the local institution
Other intervention name(s): unfractionated heparin; low molecular weight heparin
Intervention MeSH terms: Heparin; Calcium heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACS; Acute Coronary Syndrome; Catheterization
Effects of Karate in Adolescents With Down Syndrome
Condition: Down Syndrome
MeSH terms: Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      This randomized control study will investigate the health outcomes of adolescents with Down
      Syndrome who participate in a karate class as measured by ALPHA fitness testing and various
      PROMIS parent proxy questionnaires to assess participants mobility, physical activity, and
      overall affect.
    

Detailed description: 
      Adolescents with Down syndrome suffer from a set of health problems including heart disease,
      sleep disturbances, and obesity. Their decreased cardiovascular fitness and exercise capacity
      limits their ability to perform activities of daily living. Exercise interventions in this
      population of children have been shown to improve muscle strength, balance, and
      cardiovascular fitness. Prior research has helped better define physical activity barriers in
      this population which include: requiring parental supervision, lack of accessible programs,
      seasonal activities and reduced physical skills of the child. Karate is an indoor activity
      that can be performed at different skill levels without parental involvement. The
      investigators hypothesize that adolescents with Down syndrome who participate in karate will
      show improved health outcomes compared to those who did not participate. Furthermore, the
      investigators hypothesize that the majority of participants will continue the activity
      outside of the research window. This randomized controlled trial will enroll 30 adolescents
      with Down syndrome. Participants will be randomly assigned to a 3 month karate program or the
      control group with no intervention. Measurements are taken at baseline, 3 months, and 6
      months using validated ALPHA fitness testing and in addition parents will complete PROMIS
      questionnaires to assess overall participant's activity level, mobility, and generalized
      affect. An independent statistician will analyze the groups. This research will help
      physicians provide adolescents with Down syndrome appropriate recommendations for an
      individualized physical activity regimen that does not have similar limitations to other
      exercise programs.
    

Intervention name(s): PKSA karate class
Intervention type(s): Other
Intervention description(s): Participants will attend at least 20/24 PKSA karate classes over a 12 week period, completing standard karate training lessons. Participants will also be encouraged to practice on their own at home.
• Participants must attend at LEAST 20/24 classes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
To Assess the Effect of Lorcaserin Hydrochloride on Energy Metabolism and Food Intake
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of lorcaserin on energy metabolism and
      food intake in obese and overweight patients.
    


Intervention name(s): Placebo; Lorcaserin 10mg BID
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Splanchnic and Systemic VLDL-TG and FFA Balance
Condition: NAFLD; NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      To determine differences between NAFLD and NASH subjects with respect to hepatic FA
      metabolism (uptake, oxidation, and re-esterification) and hepatic VLDL-TG secretion and
      peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects
      with NAFLD and 8 with NASH (biopsy proven) will be studied in the overnight fasted state.
      VLDL-TG stable isotope will be used in combination with hepatic vein catherization to
      directly measure splanchnic VLDL-TG uptake and secretion. FFA (palmitate) tracers as well as
      adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate
      turnover and flexibility as well as tissue specific substrate handling during fasting and
      hyperinsulinemic conditions.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        8 obese subject men with NAFL (MR spectroskopi, fibro scanner) (BMI > 28).

        - 8 obese subject men with NASH (MR spectroskopi, fibro scanner) (BMI > 28). age between
        40-70 years.
Effect of Weight Loss and Exercise on Liver and Muscle Fat in Obese Elderly
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effect of weight loss and exercise on liver and
      muscle fat.
    

Detailed description: 
      Obesity causes serious medical complications and impairs quality of life. Moreover, both
      aging and obesity cause metabolic and physical dysfunction. The primary objectives of the
      proposed research are to evaluate the independent and combined effects of weight loss and
      exercise on Intrahepatic and Intramyocellular fat in obese elderly men and women. The central
      hypothesis is that in obese elderly subjects, weight loss will improve metabolic and physical
      function while the addition of exercise will not only augment improvement in these outcomes,
      but also attenuate the adverse effects of weight loss on bone and muscle masses. To test this
      hypothesis, 20 elderly (65-85 years old) obese men and women (body mass index [BMI] > 30
      kg/m2) with physical frailty will be randomized to 2 treatment groups: 1)10% weight loss, 2)
      10% weight loss plus exercise training.
    

Intervention name(s): weight loss and exercise; weight loss
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 10% weight loss through diet and exercise plus multicomponent exercise training three times a week; 10 percent weight loss through diet and behavioral modification
Other intervention name(s): lifestyle modification; lifestyle change
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obesity; aging; exercise; diet; weight loss; physical function; Obesity in the Elderly
Internet-based Parent Training for Parents of Children With Externalising Behavior Problems
Condition: Behavior Problem; Parenting
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      The study aims to evaluate the efficacy of a 5-week, therapist-guided, internet-delivered
      parent management training program (BIP SAMBA) targeting children aged 5 - 11 years with
      externalising behavior problems. The study is a randomised controlled trial with parents of
      N=30 children participating. The intervention BIP SAMBA is compared with a waitlist control
      condition. Participants in the control condition will be crossed over to the active treatment
      after 5 weeks. The primary outcome measure is the Eyberg Child Behavior Inventory (ECBI) at
      the post treatment (5 weeks after baseline assessment).
    


Intervention name(s): BIP SAMBA
Intervention type(s): Behavioral
Intervention description(s): Behavioral parent management training
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DDI Study to Investigate Interaction Between Amikacin and POL7080
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study.
      Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or
      combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects.
      The study consists of an eligibility screening period, up to 3 treatments periods and a
      follow-up visit.
    


Intervention name(s): POL7080; Amikacin; POL7080 + Amikacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 7 doses of POL7080 alone over 2.5 days; 3 doses of Amikacin alone over 2.5 days; 7 doses of POL7080 and 3 doses of Amikacin over 2.5 days
Intervention MeSH terms: Amikacin; Murepavadin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment