bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate Taste and Relative Bioavailability of Two Microsphere Formulations of Crizotinib in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to estimate the relative bioavailability and palatability
      of 2 new crizotinib formulations to the commercially available crizotinib formulated capsule
      at a 250 mg dose administered under fasted conditions in adult healthy participants.
      Additionally, this study aims to assess the safety and tolerability of crizotinib 250 mg
      single dose in 4 formulations when given fasted, with high fat meal, or with a proton pump
      inhibitor in healthy participants. Finally, this study will explore the effect of food or
      proton pump inhibitor on the pharmacokinetics of the 2 new crizotinib formulations.

      We hypothesize 1 of the 2 new crizotinib formulations will have improved relative
      bioavailability and palatability than the formulated capsule under fasted or fed conditions
      with or without a proton pump inhibitor.
    


Intervention name(s): Treatment A; Treatment B; Treatment C; Treatment D; Treatment E; Treatment F; Treatment G; Treatment H
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single 250 mg crizotinib dose as coated microsphere 1 (cMS1) formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.; A single 250 mg crizotinib dose as coated microsphere 2 (cMS2) formulation will be administered on the morning of Day 1 after overnight fast of at least 10 hours.; A single 250 mg crizotinib dose as FC formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.; A single 250 mg crizotinib dose as OS will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.; 250 mg crizotinib as cMS1 formulation will be administered with high-fat, high-calorie meal after an overnight fast of at least 10 hours.; 250 mg crizotinib as cMS2 will be administered with a high-fat, high-calorie meal after an overnight fast of at least 10 hours.; 40 mg esomeprazole will be administered
1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS1 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.; 40 mg esomeprazole will be administered
1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS2 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Adult; Bioavailability; Crizotinib; Drug Interactions; Esomeprazole; Humans; Microsphere; Pharmacokinetics; Safety; Taste
Cognitive Benefits of Aerobic Exercise Across the Age Span
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that aerobic exercise leads improved
      cognitive function accompanied by increases in gray matter density and changes in functional
      magnetic resonance imaging (fMRI) patterns of task-related activation.
    

Detailed description: 
      While animal and human studies indicate cognitive benefits from aerobic exercise across the
      lifespan, the great majority of controlled exercise studies in humans have been restricted to
      elderly individuals. Those studies have indicated that enhancing aerobic capacity has a
      beneficial effect on cognition. One study suggests that this benefit is seen particularly for
      executive control processes, precisely the processes affected by aging. These improvements
      have been accompanied by increases in gray matter density and changes in functional magnetic
      resonance imaging (fMRI) patterns of task-related activation. The goal of the proposed study
      is to extend the investigation of the beneficial effects of aerobic exercise to younger
      individuals, and to compare these effects in young and old.

      In this application the study team propose to conduct a study in which 270 sedentary but
      otherwise healthy and cognitively intact individuals in the 20-68 year age range are
      randomized to two training conditions, aerobic exercise and stretching/toning, to be
      completed at YMCAs and YMHAs in New York City. Participants will be assessed for aerobic
      capacity, cognitive task performance, and by structural MRI, resting cerebral blood flow
      scans (arterial spin labeling) and cognitive activation fMRI studies at study entry and after
      6 months of training.

      The study also proposes two complementary approaches to investigating the neural correlates
      of the beneficial effects of aerobic exercise on cognition: 1) imaging -- a combination of
      structural, metabolic, and cognitive activation fMRI studies to evaluate the neural
      substrates of the effect of aerobic exercise on cognition will be used. 2) important
      correlates -- the effects of apolipoprotein E (APOE) genotype, inflammatory markers and
      cognitive reserve on the cognitive effects of aerobic exercise will be explored.
    

Intervention name(s): aerobic training; stretching/toning
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 24 weeks of aerobic training, 4X/week; stretches and toning exercises designed to promote flexibility and improved core strength
Other intervention name(s): Training, aerobic; Exercises, stretches and toning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: cognitive function; fMRI; apoE; inflammatory markers; exercise
Dose-response Relationship of Mustard Flour Footbaths in Healthy Volunteers
Condition: Thermogenesis by Different-dosage Mustard Flour Footbaths
Study type: Interventional

Summary: 
      A study to explore whether different dosages of mustard flour in footbaths cause different
      effects on warmth development as well as on general well-being and the autonomic nervous
      system.
    

Detailed description: 
      This is a blinded, four-arm randomized controlled trial with crossover design to explore the
      dose-response relationship of footbaths with different dosages of mustard flour in healthy
      volunteers, compared to a placebo control (footbath with warm water only). The main focus is
      on thermogenesis and warmth distribution, as assessed by high-resolution infrared
      thermography and questionnaire data before, during and after the intervention. In addition,
      effects on the autonomic nervous system are assessed by measuring various parameters of heart
      rate variability and pulse wave analysis.
    

Intervention name(s): 3-g mustard footbath; 6-g mustard footbath; 12-g mustard footbath; Warm water only
Intervention type(s): Other; Other; Other; Other
Intervention description(s): A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.; A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.
Intervention MeSH terms: Mechlorethamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Mustard flour footbaths; Dose-response relationship; Thermogenesis; Infrared thermography; Heart rate variability; Healthy volunteers
The Impact of Snacks Which Vary Nutritionally in Their Satiating Potential on Measures of Appetite Control
Condition: Lack of Satiety; Hyperphagia
MeSH terms: Hyperphagia
Study type: Interventional

Summary: 
      The current study will examine the effect of almond consumption (0.9g/kg dose) compared to an
      energy and weight matched comparator food or no food on measures of appetite control
      including appetite sensations, energy intake and food hedonics.
    

Detailed description: 
      Some individuals exhibit a weak satiety response to food and may be susceptible to
      overconsumption. Snack foods can be substantial contributors to daily energy intake, with
      different types of snacks exerting potentially different effects on satiety per calorie
      consumed. The current study will compare the effect of consuming different snack foods on
      measures of appetite control including appetite sensations, energy intake and food hedonics
      in women with a weak satiety response.

      In a crossover design, female participants will consume three different mid-morning snacks:
      raw almonds, savoury crackers or water. Appetite sensations, energy intake, food reward and
      craving will be assessed under controlled laboratory conditions. Satiety responsiveness will
      be determined using the satiety quotient (SQ).
    

Intervention name(s): Almonds; Cheese Savouries
Intervention type(s): Other; Other
Intervention description(s): Whole raw almonds provided as a mid-morning snack - 0.9g\kg; Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Bowel Prep Acceptance in Clinical Practice
Condition: Colonoscopy: Bowel Preparation
Study type: Observational

Summary: 
      Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure
      depends on an adequate visualization of the mucosa of the colon.There is strong evidence that
      the quality of bowel preparation is inversely correlated with the interval between the end of
      the assumption of the purgative and the start of colonoscopy (shorter intervals are
      associated with higher levels of preparation).Recent studies have shown that split dose prep
      significantly improves the quality of bowel cleansing. In light of these data, both the
      American College of Gastroenterology (ACG) and the European Society of Gastrointestinal
      Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel
      cleansing. Despite these recommendations, the uptake of schemes in divided doses appears
      clearly underused in actual clinical practice. In particular, in Italy only a few centers
      routinely adopt the regime split as their first choice for the preparation for
      colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not
      entirely clear, but probably in part reflecting gastroenterologists' concerns about potential
      elements that theoretically could make it less acceptable to the patient (get up early in the
      morning, potential problems during the journey from home to the hospital) The hypothesis of
      the study is that many patients would still be willing to accept these potential drawbacks if
      they were adequately informed about the positive impact of the scheme in divided doses on the
      effectiveness of bowel preparation, which results in higher reliability of the examination,
      shorter duration of the procedure, and less risk of rescheduling the exam in the near future
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        population undergoing colonoscopy
Evaluate the Effect of Osteo Introducer System in Total Hip Arthroplasty
Condition: Joint Disease
MeSH terms: Joint Diseases
Study type: Interventional

Summary: 
      Osteo introducer system is the instruments used in minimal invasive THA. This study will
      compare the minimal invasive THA using the osteo introducer system and THA using common
      instruments, to show the non-inferiority of osteo introducer system in safety and efficacy of
      THA surgery.
    


Intervention name(s): Minimum invasive total hip arthroplasty; Common total hip arthroplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Minimum invasive total hip arthroplasty using the osteo introducer system; Common total hip arthroplasty using common instruments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: total hip arthroplasty; minimal invasive
Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone.
Condition: Mouth, Edentulous
MeSH terms: Mouth, Edentulous
Study type: Interventional

Summary: 
      The purpose of this study is to test two standard of care techniques of placing dental
      implants, and to compare how people's bones and gums respond to two different depths at which
      implants are placed.
    

Detailed description: 
      The purpose of this study is to test epicrestal and subcrestal placement of dental implants,
      and to compare how people's bones and gums respond to two different depths at which implants
      are placed.
    

Intervention name(s): Ankylos dental endosseous implants-Sub-crestal; Ankylos dental endosseous implants-Epi-crestal
Intervention type(s): Device; Device
Intervention description(s): Implants placed subcrestally; Implants placed Epi-crestally
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a split mouth study design in which the same patient was used for both arms.
Masking: Single (Investigator)
Primary purpose: Treatment
The Relation Between Plasma Irisin Level and Endothelial Dysfunction in Type 2 Diabetes
Condition: Irisin; Endothelial Dysfunction; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      Irisin is a signaling protein that is released into the blood from skeletal muscle after
      proteolysis of the membrane protein FNDC5 . FNDC5, encoded by the Fndc5 gene. Irisin activity
      on subcutaneous white adipose tissue, both in culture and in vivo, stimulated UCP1 expression
      and induction of brown adipocytes in white adipose tissue depots, a process known as white
      fat ''browning''. Irisin increases total energy expenditure in animal models, and irisin
      expression in mice fed a high fat diet resulted in a significant improvement in glucose
      tolerance and a reduction in fasting insulin levels. Collectively, these data suggest that
      decreased serum irisin levels may be associated with the development of insulin resistance
      and Type 2 diabetes. Indeed, some studies showed that irisin levels were decreased in newly
      diagnosed Type 2 diabetes.

      Endothelial dysfunction is an early physiological event in atherosclerosis. However, to date,
      no data are available on the relationship between circulating irisin and endothelial
      dysfunction in diabetes. Therefore, the investigators hypothesized that circulating irisin
      level is associated with endothelial dysfunction.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        From July 2013 to Dec 2013, a total of 200 Chinese Han newly diagnosed type 2 diabetic
        patients were selected. They had been referred to our hospital and were aged 40～70 years.

        During the same period, 50 healthy subjects (all from medical staff in our hospital) were
        selected as control subjects.
Minocycline for Treatment of Posttraumatic Stress Disorder in Veterans
Condition: PTSD
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the safety and efficacy of adjunctive minocycline treatment in
      veterans with PTSD.
    

Detailed description: 
      This is a 12-week, open-label pilot study in which adjunctive minocycline will be
      administered to approximately 15 veterans diagnosed with PTSD.
    

Intervention name(s): Minocycline
Intervention type(s): Drug
Intervention description(s): Minocycline capsule
Other intervention name(s): Minocycline hydrochloride capsule
Intervention MeSH terms: Minocycline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Minocycline; PTSD
Autonomic Regulation Trial (ART)
Condition: Infarction, Myocardial
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The purpose of this study was to develope and evaluate a new method for risk stratification
      which predicts high mortality risk in patients with cardiac disease based on simultateous
      examination of high resolution ECG, continuous arterial pressure and a breathing signal.
    


Time perspective: Prospective
Keywords: AUTONOMIC NERVOUS SYSTEM; Assessment, Risk
Study of the Efficacy and Safety of NPC-15 for Sleep Disorders of Children With Neurodevelopmental Disorders
Condition: Sleep Disorders; Neurodevelopmental Disorder
MeSH terms: Sleep Wake Disorders; Parasomnias; Neurodevelopmental Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy on sleep latency with electronic sleep
      diaries and the safety of NPC-15.
    

Detailed description: 
      This study will be a multicenter and open label trial. The trial has three phases; the
      screening phase, treatment phase and post-treatment phase. The screening phase comprises a
      screening visit where subject's initial eligibility will be evaluated. During open label
      treatment phase, all patients will be administered NPC-15 1 mg, 2 mg or 4 mg on the basis of
      their doctors' judgements.
    

Intervention name(s): NPC-15
Intervention type(s): Drug
Intervention description(s): NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.
Other intervention name(s): Melatonin
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Melatonin; NPC-15; Sleep disorders; Neurodevelopmental disorder; Sleep latency; DSM-5
Effect of Pioglitazone on Endothelial Function in Premenopausal Women With Uncomplicated Systemic Lupus Erythematosus
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study aims to investigate the effect of pioglitazone (30 mg/day) on endothelial
      function in premenopausal women with SLE (systemic lupus erythematosus). Patients with
      hypertension, endocrine, hepatic or renal diseases will not be included, or pregnant /breast
      feeding women. This is a randomized, double blind, placebo controlled study.
    

Detailed description: 
      SLE (systemic lupus erythematosus) is characterized by accelerated atherosclerosis. The risk
      of suffering an acute myocardial infarction among premenopausal women with SLE is 50 times
      higher than control women of the same age. Insulin resistance and hyperinsulinemia are
      frequent in SLE. Lipid metabolism in SLE, as in other insulin resistant states, is
      characterized by high triglycerides, low HDL-cholesterol, normal LDL cholesterol (or slightly
      increased) and an increase in LDL's susceptibility to oxidation.

      All these alterations can produce endothelial dysfunction which is present in SLE patients.
      Pioglitazone is a PPAR (peroxisome proliferator activated receptor) gamma agonist that can
      potentially improve insulin resistance, with a positive effect on the lipid profile (lowering
      of triglycerides, and a discrete increase in HDL-C) and improve endothelial function.

      Patients will be randomized to receive either placebo or pioglitazone 30 mg/day during a
      period of 12 weeks. Endothelial function will be assessed by Positron Emission Tomography
      (PET).
    

Intervention name(s): pioglitazone; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg tablet QD (taken once daily); tablet taken once a day
Other intervention name(s): actos; zactos
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: lupus; HDL particles; endothelial function; pioglitazone
Impact of Therapist Change on Dropout in a Naturalistic Sample of Inpatients With Borderline Pathology Receiving DBT
Condition: Borderline Personality Disorder; PostTraumatic Stress Disorder; Psychotherapy; Dropout
MeSH terms: Stress Disorders, Post-Traumatic; Personality Disorders; Borderline Personality Disorder
Study type: Observational

Summary: 
      Participants with Borderline pathology (≥ 3 DSM-IV-criteria) receiving an inpatient
      Dialectical Behavior Therapy (DBT) program completed a quality assurance questionnaire set
      assessing demographic information and pretreatment psychopathology during the days of their
      inpatient stay. Beyond that, changes of therapists were documented.
    


Intervention name(s): Dialectical Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For this study, all patients aged from 18 to 65, discharged from our personality disorder
        inpatient unit between December 2012 and August 2016, and fulfilling three or more criteria
        for BPD as defined by DSM-IV (Borderline Personality characteristics; BPC) were considered
        (n = 89).