bioihbjkbjnl/mcl2 huggingface dataset:
ACTIVATE: Standard Worksite Health Program vs. Activated Consumer
Condition: Evidence of Improved Health Status
Study type: Interventional

Summary: 
      A 3-year, randomized, controlled trial comparing a traditional worksite health promotion
      program and an activated consumer program on health practices, health status and patient
      activation measures.
    

Detailed description: 
      The design is a cluster, randomized controlled trial of two companies with three arms in each
      company. The arms include two control groups (one from each company), two intervention groups
      using a standard health promotion intervention, and two intervention groups that constitute
      using an activated consumer intervention. The standard intervention includes educational
      offerings to address health behaviors. The activated consumer intervention offers shorter
      education sessions and includes decision tools and skills development for working with heath
      care providers to better manage health and clinical conditions. Variables include health risk
      assessments, clinical measures such as lipids, blood pressure, body mass index, and tobacco
      use, perception of health care consumer practices, claims costs, and absenteeism analysis.
    

Intervention name(s): Counseling in use of health care; Counseling in diet, exercise; Control
Intervention type(s): Behavioral; Behavioral; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Cognitive Behavioral Treatment of Pediatric Trichotillomania
Condition: Trichotillomania
MeSH terms: Trichotillomania
Study type: Interventional

Summary: 
      This study will compare the effectiveness of cognitive-behavior therapy (CBT) to a minimal
      attention control (AC) condition for treatment of pediatric trichotillomania (TTM).
    

Detailed description: 
      TTM is a persistent impulse control disorder in which the individual acts on urges to pull
      out his or her own hair. Onset typically occurs by adolescence, and TTM is often associated
      with significant functional impairment and distress. CBT is a type of psychotherapy designed
      to change problematic behaviors and thinking. It includes self-monitoring of hair-pulling
      urges and homework assignments to practice the use of cognitive and behavioral strategies.

      Participants are assigned randomly to receive either CBT or AC for 8 weeks. Participants
      assigned to CBT receive weekly 1-hour sessions of CBT for 8 weeks; participants assigned to
      AC receive 6 telephone contacts and 2 in-person sessions for 8 weeks. After 8 weeks, CBT
      participants who respond to treatment enter Phase II, which lasts an additional 8 weeks and
      includes 4 in-person maintenance sessions. AC participants who are still symptomatic after 8
      weeks are offered CBT.
    

Intervention name(s): Cognitive-Behavior Therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive-behavior Therapy; Minimal Attention Control
Healthy Kids-Houston: A Community Childhood Obesity Intervention Program
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The collaborative study is to determine the effectiveness of an after-school community-based
      program to prevent obesity among minority children.
    

Detailed description: 
      Childhood obesity is a major health issue in the United States, particularly among minority
      children. An integrated after-school program that offers structured and fun physical
      activities with nutrition and behavior lessons in community centers operated by the Houston
      Parks and Recreation Department might prevent obesity among minority children who live in the
      neighborhood.
    

Intervention name(s): Healthy Kids-Houston program; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Children receive 90 minutes of after-school structured physical activities and 30 minutes of nutrition and behavior lessons twice a week during three 6-week sessions at the community centers. The 6-week sessions take place once in the fall, once in early spring and once in late spring.; Children do not receive the Healthy Kids-Houston behavior modification program but will participate in the regular after-school enrichment programs offered by the community centers.
Other intervention name(s): Healthy Kids-Houston curriculum
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Minority children; Community intervention program; Lifestyle changes; Physical activities; Nutrition lessons; Behavior modification
A Study to Compare a New Drug for Type 2 Diabetes to Placebo and to a Treatment Already Available for Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to compare the safety and effectiveness of the study drug
      known as LY2944876 to exenatide extended-release and placebo in participants with type 2
      diabetes mellitus. All drugs will be given by an injection under the skin. Participants
      remain on stable doses of metformin, as prescribed by their personal investigator if they
      were on metformin at study entry. Participants' involvement in the study is expected to last
      about 30 weeks.
    

Detailed description: 
      The study will include a 12 week blinded treatment period, where neither the participant nor
      the investigator will know to which treatment each individual is assigned. Thereafter follows
      a 12 week period where participants and the investigator will know which treatment they are
      assigned to. Participants' on LY2944876 and on exenatide extended-release continue treatment
      in this period, those who received placebo will be followed without treatment.
    

Intervention name(s): LY2944876; Exenatide extended-release; Placebo; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC; Administered SC; Administered SC; Oral
Intervention MeSH terms: Metformin; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Weight loss
Treatment of Binge Eating in Obese Patients in Primary Care
Condition: Obesity; Binge Eating
MeSH terms: Bulimia; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will test the effectiveness of two empirically-supported but distinct treatments
      for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure
      self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy
      for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered
      alone and in combination in a primary care setting.
    


Intervention name(s): Sibutramine; Placebo; Self-help CBT + Sibutramine; Self-help CBT + Placebo
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): 15 mg daily; Daily; Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily; Cognitive behavioral treatment manual for binge eating Placebo daily
Other intervention name(s): Meridia
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Binge eating; Sibutramine; Self-help; Primary care
MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a phase 1, randomized, double-blind, placebo-controlled, sequential parallel group,
      MAD study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of four
      once-weekly subcutaneous doses of PB-119 to subjects with T2DM.
    

Detailed description: 
      Dose levels of 25 µg, 50 µg, 100 µg and 200 µg with a dosing regimen of once weekly for 4
      consecutive weeks will be evaluated
    

Intervention name(s): PB-119 injection; PB-119 injection placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: placebo-control , parallel
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of Ventilatory Strategies During Laparoscopic Surgery
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      Atelectasis involving declive areas often occurs during general anesthesia and may persist
      postoperatively. This phenomenon could be amplified by pneumoperitoneum and Trendelenburg
      position. Hypothesis: To evaluate whether the shape of the airway pressure-time curve, Stress
      Index (SI), during constant flow inflation can lead ventilator setting during general
      anesthesia.
    


Intervention name(s): First arm: patients ventilated with zero end expiratory pressure; Patients ventilated with Positive End Expiratory Pressure; Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atelectasis; laparoscopic surgery; anesthesia; mechanical ventilation; Prevent; shape of the airway; pressure-time curve
Add-on Sodium Nitroprusside to Treatment as Usual in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      In spite of the numerous studies on schizophrenia, its etiology and physiopathology remain
      unknown. Evidence suggests a possible implication of nitric oxide (NO) in schizophrenia. NO
      is a gas with unique chemistry and influences the release of neurotransmitters, learning,
      memory and neurodevelopment. Recent studies that investigated the role of NO in patients with
      schizophrenia found evidence that points to a disruption in NO-mediated neurotransmission in
      schizophrenia. Accordingly, we believe that the administration of sodium nitroprusside, an NO
      donor, will ameliorate schizophrenia symptoms.
    


Intervention name(s): Sodium nitroprusside; Glucose solution
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion of 0,5 mcg/kg/min for 240 minutes; Intravenous infusion of glucose solution 5% for 240 minutes
Intervention MeSH terms: Nitroprusside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Nitric oxide; Sodium nitroprusside
"Self-consciousness and the Inter-subjective Body"
Condition: Anorexia Nervosa
MeSH terms: Anorexia; Anorexia Nervosa
Study type: Interventional

Summary: 
      The purpose of this study is to demonstrate that bodily self-consciousness is subjectively
      and inter-subjectively constituted and that some dimensions of the bodily self-consciousness
      are impaired in Anorexia nervosa.
    

Detailed description: 
      Anorexia nervosa is a severe psychiatric disorder, with high level of mortality. Anorexic
      patients often experience a serious disturbance in body and their own shape perception.

      We hypothesize that bodily self-consciousness is co-constituted by four subjective dimensions
      which are all inter-subjectively open: in encountering others, one's body is experienced as

        1. objectified,

        2. the bearer of inter-subjective feelings,

        3. an inter-subjective agent and

        4. the anchor of an inter-subjectively negotiated perspective.

      Across several experiments, we sought to determine which dimension of bodily
      self-consciousness is altered in Anorexia Nervosa compared to healthy subjects.
    

Intervention name(s): Joint perception task; Body Shape Questionnaire; Measure of the heart rate
Intervention type(s): Other; Behavioral; Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Bodily self-consciousness; intersubjective body; Anorexia Nervosa; Joint perception task; Interoceptive awareness
Living With Cervical Cancer: Assessing Utilities Associated With Common Treatment Complications
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The objective of this study is to establish patient preferences in regards to common
      complications of cervical cancer treatments, and to compare these preferences to those of
      medical providers who care for cervical cancer patients. These preferences will be determined
      via a interview using the Standard Gamble, which is a well-recognized method for establishing
      utilities.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patient Population: Patients ≥18 and <61 years old who were diagnosed with early cervical
        cancer (stages I and II) at least 3 years prior to the interview. We cannot limit our
        population to stage IB2 patients and meet our accrual goals due to the rarity of the
        disease. Patients with stages I and II cervical cancer are included because they have the
        potential to be exposed to the same treatment complications as patients with stage IB2
        disease. Patients of all health statuses will be accepted.

        Provider Population: Providers who care for patients with cervical cancer at the University
        of Wisconsin, including: gynecologic oncologists, radiation oncologists, physician's
        assistants and nurses. Providers must be ≥18 and <61 years old in any health status.
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths
Condition: Coronary Artery Disease; Autonomic Nervous System Disease; Blood Pressure; Heart Rate
MeSH terms: Nervous System Diseases; Autonomic Nervous System Diseases; Primary Dysautonomias; Coronary Artery Disease
Study type: Interventional

Summary: 
      Introduction: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting
      lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage
      extract promote beneficial health effects due to their nutritional properties. Objective: to
      analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise
      recovery in coronary heart disease patients. Methods: men diagnosed with ischemic coronary
      artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic
      exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart
      rate reserve (HRR), followed by 25 minutes at intensity 60% of FCR and for a final 30 minutes
      of recovery in the supine position. Before each exercise protocol, all volunteers will
      consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will
      also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of
      each supplementation will be done randomly. Cardiorespiratory parameters and heart rate
      variability (HRV) will be assessed at different times throughout the experimental procedure.
      To analyze the moments (rest versus recovery), the Bonferroni post-test will be used for
      parametric distribution or the Dunn post-test for non-parametric distribution. Statistical
      significance will be calculated at 5% for all analyses.
    


Intervention name(s): Placebo Protocol; Protocol Beet; Protocol Resveratrol; Protocol Beet and Resveratrol
Intervention type(s): Other; Other; Other; Other
Intervention description(s): ingestion of 500 mg of starch following 30 minutes of exercise (treadmill); ingestion of 500 mg of beet extect following 30 minutes of exercise (treadmill); ingestion of 500 mg of resveratrol following 30 minutes of exercise (treadmill); ingestion 500 mg of beet extect and 500 mg of resveratrol following 30 minutes of exercise (treadmill)
Other intervention name(s): 500 mg of starch; 500 mg of beet extract; 500 mg of resveratrol; 500 mg of beet extect and 500 mg of resveratrol
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
LAEH Formulation Nasal Spray to Reduce Viral Load
Condition: Coronavirus Disease
MeSH terms: Coronavirus Infections
Study type: Observational [Patient Registry]

Summary: 
      The Covixyl-V LAEH Nasal Spray's safety and efficay is clinically tested for use in subjects
      with COVID-19 infection.

      A randomized, double-blind, multi-center study is conducted to evaluate the efficacy and
      safety of ethyl lauroyl arginate hydrochloride (LAEH) formulation versus a matching placebo
      formulation administered as a nasal spray to reduce viral load from nasal area of subjects
      with coronavirus disease 2019 (COVID-19).
    

Detailed description: 
      The primary endpoint for this study was the comparison of change in viral load in RT-PCR
      Test.

      Proportion of COVID-19 infection-free subjects between the two treatment arms was followed.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        In the study, 33 subjects were screened and 3 of them failed in screening tests. Total 30
        subjects were enrolled in the study. Out of these 30 enrolled subjects, 15 subjects were
        randomized to Covixyl-V group and 15 subjects were randomized to placebo group
Transmission of Mother-Infant Stress Communication
Condition: Stress
Study type: Observational

Summary: 
      The central aim of this study is to assess mother-infant communication via behavioral,
      physiological, and affective indices under conditions where distal stressors may not be
      directly detectable by the infant.
    

Detailed description: 
      This investigation examines a distal maternal stressor on the quality of interaction in
      mother-infant dyadic communication. Assessments include behavioral, physiological, and
      affective indices under conditions where distal stressors may not be directly detectable by
      the infant. The present research examines mother-infant interactions to test the hypothesis
      of whether maternal stress may be transduced to their infants via multiple pathways. The
      secondary aim is to explore effective emotion regulation strategies for the mother as
      potential buffers to stress and additionally reducing early life stress effects on the
      infant's regulatory development.

      While the emotion regulation literature posits that reappraisal may be associated with
      decreased in physiological and psychological stress, this type of regulation strategy may be
      ineffective when interfacing with discrimination. The regulation strategy needs to be
      titrated to the stressor in order to be effective. These findings will have notable social,
      clinical, and psychological significance,
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Community sample of women (ages 18-40) with infants ages 4-9 months
      
Keywords: mother-infant dyadic regulation; stress; psychophysiology; emotion regulation
GS 5885 Administered Concomitantly With GS-9451, Tegobuvir and Ribavirin (RBV) in Chronic Genotype 1 Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this phase 2 study is to determine whether 30 mg or 90 mg of GS-5885 when
      given with GS-9451, Tegobuvir and Ribavirin (RBV) for 12 or 24 weeks is effective, safe and
      tolerable in the treatment of Chronic Genotype 1 HCV Infection.
    


Intervention name(s): GS-5885; Tegobuvir; GS-9451; ribavirin tablet; GS-5885
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet, 30 mg QD; capsule, 30 mg BID; tablet, 200 mg QD; (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet, 90 mg QD
Intervention MeSH terms: Ribavirin; Ledipasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; HCV RNA; Polymerase inhibitor; Protease inhibitor; Treatment naïve; GS-5885; GS-9451; Tegobuvir
Study of the Cerebral Bases of Tool Use and Tool Evolution
Condition: Healthy
Study type: Interventional

Summary: 
      Tool use is considered to be the hallmark of complex cognitive adaptations that humans have
      achieved trough evolution, that provides an adaptive advantage to the human species. Even if
      nonhuman species do use tools too, human tool use is much more complex and sophisticated.
      Besides, only humans can make their tools evolve by improving them. If Man has special
      abilities for tool use, it has to be grounded in a specific neuroanatomical substrate. Humans
      and nonhumans share a similar prehension system located within the superior parietal lobe and
      the intraparietal sulcus. However, there is a human specificity : the surpramarginal gyrus
      within the left inferior parietal lobe is unique to Man, and could play a central role in
      tool use and tool evolution.

      This project aims to study the neural correlates of human tool use with functional Magnetic
      Resonance Imaging (fMRI), to precise the cognitive mechanisms through which humans are able
      to use tools. We also wish to study what are the cognitive abilities that allow us to make
      our tools evolve by improving them, and the neural correlates associated.
    


Intervention name(s): fMRI
Intervention type(s): Other
Intervention description(s): Imaging examination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Tool; fMRI; neuroimaging; Evolution