bioihbjkbjnl/mcl2 huggingface dataset:
An Efficacy, Safety, and Tolerability Study for TA-7284 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of TA-7284
      compared with placebo in patients with type 2 diabetes.
    

Detailed description: 
      Type 2 diabetes mellitus (T2DM) is well recognized as a major public health problem that
      presents patients with a significant risk of complications including heart disease,
      retinopathy, nephropathy, and neuropathy. Various classes of orally administered
      antihyperglycemic agents have been developed for the treatment of T2DM and although
      individual agents may be highly effective for some patients, it is still difficult to
      maintain optimal glycemic control in most patients, resulting in high rates of morbidity and
      mortality in the diabetic population. This is a randomized, double-blind, placebo-controlled,
      parallel-group study to demonstrate the efficacy, safety, and tolerability of TA-7284
      compared with placebo in patients with T2DM, who are not optimally controlled on diet and
      exercise. The primary study hypothesis is that the study drug will be superior to placebo as
      assessed by the change in HbA1c from baseline. The patients will receive tablets of TA-7284,
      or placebo, once daily for 12 weeks.
    

Intervention name(s): TA-7284-Low; TA-7284-Low-middle; TA-7284-High-middle; TA-7284-High; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): TA-7284-Low; TA-7284-Low-middle; TA-7284-High-middle; TA-7284-High; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TA-7284; JNJ-28431754; Canagliflozin; Type 2 diabetes mellitus; Sodium Glucose Co-transporter (SGLT2 inhibitor)
Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet.
Condition: Raynaud's Disease
MeSH terms: Raynaud Disease
Study type: Observational

Summary: 
      Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will
      be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma
      will be studied. This research study is being done to better understand Raynaud's disease and
      to assess the role of blood flow measurement in diagnosing the disorder, specifically,
      through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow measurement
      software system owned by the study's sponsor, VasSol, Inc.
    

Detailed description: 
      The investigators propose to obtain volumetric flow data on 10 hands of patients with
      Raynaud's disorder and scleroderma at UIC rheumatology clinic and compare these results with
      previously established volumetric flow data for non-Raynaud's patients. Through this
      analysis, the invstigators will be able to better understand and correlate subjective and
      objective measures of both disease presentation and progression. Collection of cross
      sectional data will allow us to better address the following questions Is it possible to more
      precisely diagnose patients with Raynaud's disorder based on NOVA analysis as well as
      clinical findings

      Is it possible to stratify patients with Raynaud's disorder into categories which may allow:

      i. Prediction of disease course and prognosis ii. Prediction of response to specific
      treatment modalities (vasodilators vs anti-coagulation vs surgical or chemical denervation)
      The investigators propose to collect measurements of disease severity as well as functional
      assessment of patients Raynaud's and scleroderma in order to address the following questions
      c. Does NOVA flow and volume data correlate with measures of Raynaud's and scleroderma
      disease severity index d. Does NOVA flow and volume data correlate with OT assessment of hand
      functionality.
    

Intervention name(s): Nova Flow Procedure
Intervention type(s): Radiation
Intervention description(s): Evaluation of the diagnosis, and stratification of the severity of Raynaud's disorder in patients with scleroderma based on clinical and imaging data will allow creation of more precise diagnostic criteria as well as disease classification which may guide treatment practices. The study results will likely have no immediate benefit to the patients participating in the study, however may have a future impact diagnosis, stratification and ultimately treatment of patients with Raynaud's disorder. In addition, data collected in this study may provide insight into disease process and leading to future research endeavors.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will
        be asked to participate.
Physical Activity and Academic Achievement Across the Curriculum (A+PAAC)
Condition: Intelligence; Obesity
Study type: Interventional

Summary: 
      There is currently considerable interest in both improving academic achievement (No Child
      Left Behind) and reducing the rates of obesity and its associated negative health
      consequences in elementary school students. Increased physical activity (PA) offers a
      potential intervention to address both issues. Evidence is available which suggests an
      association of PA with both academic achievement and obesity, and an association between
      obesity and academic achievement.

      To provide increased PA while maintaining academic instruction time, we developed a program
      we call "Physical Activity Across the Curriculum" (PAAC) in which regular classroom teachers
      were trained to deliver academic lessons using moderate to vigorous physical activity (MVPA)
      for 20 minutes/d, 5 days/wk. This study is looking to compare academic achievement between
      students in elementary schools that participate in academic lessons taught through MVPA
      (PAAC) to students that do not (CON).
    


Intervention name(s): A+PAAC; CON
Intervention type(s): Behavioral; Behavioral
Intervention description(s): academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.; lessons taught by regular classroom teachers using traditional/regular sedentary lessons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: academic achievement; elementary school; physical activity; exercise
Evaluation of Harmonicity in Running Gait by the Use of Innovative Techniques of Video Analysis
Condition: Injuries
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      This study aims to demonstrate the use of a digital video analysis method to evaluate
      harmonicity of running gait, through an holistic approach.

      Furthermore, it explores the association of running gait harmonicity with running velocity
      and level of training and with running injuries risk .
    

Detailed description: 
      Aetiology of running related injuries is reported to be multifactorial but still not fully
      understood. Factors that impede the understanding of the mechanisms and aetiology of injury
      are the traditional segmental approach to the analysis of running gait and the lack of
      prospective studies.

      A more holistic approach to analysis of movement could permit a more in depth comprehension
      of the injured state, trough a changing of point of view. This holistic approach is based on
      the harmonic nature of running gait.

      Despite the everyday use of the term "harmonicity" within sporting domains, methods to
      measure running gait harmonicity is a theme still vaguely explored.

      Traditional methods evaluate the movement quality of the whole body based on the motion
      analysis of specific segments, that are supposed to sufficiently represent the entire body.
      The search for a method to analyse harmonicity of cyclic movements with a real holistic
      approach, is therefore still open.

      With these aims, an innovative video analysis method has been proposed, based on the measure
      of the frequency variation of the pixel brightness in the digital video of a cyclic movement.
    

Intervention name(s): Maximal incremental running test; Metabolic and movement analysis of running; Questionnaires
Intervention type(s): Diagnostic Test; Diagnostic Test; Other
Intervention description(s): Maximal incremental running test with measures of metabolic, spatio-temporal parameters and video recording with camera in the frontal plane.
video recording of frontal view, metabolic and spatio-temporal measures of three (self-selected speed, + and - 20 percentage of self-selected speed) 6 minutes running test monthly (12 months) follow-up questionnaire; Running analysis of three six minutes running test (self-selected speed, + and - 20% of the self-selected speed) by video recording with camera in the frontal plane, and acquisition of the metabolic and spatio-temporal parameters; Monthly follow-up questionnaire (12 months) about training habits and injuries
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        recreational runners
      
Keywords: running harmonicity; running related injuries
Effect of Gut Microbiota and Fecal Inflammatory Marker on Childhood Gastroenteritis
Condition: Clinical Infection; Microbial Colonization; Gastroenteritis; Inflammatory Response; Probiotics
MeSH terms: Communicable Diseases; Infections; Gastroenteritis
Study type: Observational

Summary: 
      Childhood gastroenteritis establishes gastrointestinal disease and increase the economic
      burden, and the pediatric population is especially vulnerable to these gastrointestinal
      infections. The aim of this study is to evaluate the role of intestinal microbiota and their
      relationship with childhood gastroenteritis.
    

Detailed description: 
      Childhood gastroenteritis establishes gastrointestinal disease and increase the economic
      burden, and the pediatric population is especially vulnerable to these gastrointestinal
      infections. According to a World Health Organization report in 2003, the median incidence of
      diarrhea for all children age under 5 years was 3.2 episodes per child-year, and this number
      has not changed significantly since 1980s. In Taiwan, the enteric pathogens associated
      mortality is low, but the social burden and economic costs are substantial because of the
      high incidence.

      Intestinal microflora are able to use the substances consumed in the diet: bacteria can
      transform complex polysaccharides and monosaccharides in short-chain fatty acids. Short-chain
      fatty acids are a source of energy for colonocytes and directly affect the storage of lipids
      and the absorption and metabolism of food, creating the so-called 'second meal effect'.

      Qualitative and quantitative alterations of commensal flora may result in various
      gastrointestinal and extraintestinal diseases. One of the first interactions these bacteria
      have when interacting with the intestinal epithelial cells lining the GI tact.

      The first aim of this study is to evaluate the role of intestinal microbiota and their
      relationship with childhood gastroenteritis. The second aim of this study is determining the
      inflammatory markers (such as fecal TNF-α, interleukin -6, calprotectin, lactoferrin) on the
      host of childhood gastroenteritis. The investigators try to seek to gain an advanced
      understanding effect of intestinal microbiota and fecal inflammatory marker in the childhood
      gastroenteritis.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with or without diarrhea less than three days, or healthy volunteers. The age of
        participants is from 6-month-old to 12-year-old.
      
Biospecimen description: 
      Bacteria DNA in feces of human
Disulfiram for Cocaine Abuse in Buprenorphine Treatment
Condition: Cocaine Dependence; Opioid Dependency
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are proposing a placebo-controlled clinical trial to evaluate the efficacy
      and potential mechanisms of action of disulfiram (versus placebo) for treating cocaine abuse
      in subjects with concurrent opiate dependence and cocaine abuse or dependence maintained on
      buprenorphine/naloxone combination.
    

Detailed description: 
      The Specific Aims and hypotheses for the proposed study are as follows:

        1. To compare the efficacy of disulfiram versus placebo for the treatment of buprenorphine
           maintained patients with concurrent opioid and cocaine dependence. Study hypothesis 1 is
           that disulfiram is superior to placebo.

        2. To evaluate whether dopamine-B-hydroxylase (DBH) genotypes associated with high,
           intermediate or low enzyme activity predict responses to disulfiram treatment of cocaine
           use in buprenorphine treated subjects. Study hypothesis 2 is that disulfiram efficacy is
           higher in subjects with low DBH compared to subjects with high DBH.

        3. To explore whether baseline measures of alcohol use predict response to disulfiram.
           Study Hypothesis 3 is that the effects of disulfiram on cocaine use are independent of
           the severity of baseline alcohol use.
    

Intervention name(s): Disulfiram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Disulfiram 250 mg per day; Placebo daily
Intervention MeSH terms: Disulfiram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Disulfiram; Buprenorphine; Cocaine dependence; Opioid dependence; Dopamine-Beta-Hydroxylase
The Effect of Gemfibrozil, Ketoconazole and Clarithromycin on the Amount of LY2409021 in the Bloodstream
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effect of gemfibrozil, ketoconazole, and
      clarithromycin on how much LY2409021 is found in the bloodstream and how long the body takes
      to get rid of it. The study is split into two parts, Part A and Part B. Participants in Part
      A are divided into two cohorts (groups). Each cohort will participate in two study periods.
      Period 1 involves a single dose of LY2409021. Period 2 involves either gemfibrozil or
      ketoconazole given daily for 21 days with LY2409021 given once on Day 4. Part A will last for
      51 days and will also involve screening within 27 days of the start of the study. Part B is
      only open to participants who successfully completed Part A of the study. Participants in
      Part B will receive clarithromycin given daily for 21 days with LY2409021 given once on Day
      4. Part B will last for 29 days and will also involve screening within 27 days of the start
      of the study.
    

Detailed description: 
      Part B was added to the trial in August 2013, per protocol amendment.
    

Intervention name(s): LY2409021; Gemfibrozil; Ketoconazole; Clarithromycin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Clarithromycin; Ketoconazole; Gemfibrozil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Dental Caries Prevention by a Natural Product
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to
      standard caries preventive measures for the prevention of new carious lesions in high caries
      risk patients.
    

Detailed description: 
      Research hypothesis (Null hypothesis):

      The present clinical trial will be conducted to reject or accept the null hypothesis that
      using Licorice extract mouth wash in addition to standard preventive measures will not differ
      from using standard preventive measures alone in preventing incidence of new carious lesions.

      PICOTS:

      P: Population with high caries risk patients

      I: Use of licorice.

      I2: Use of chlorhexidine

      C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning).

      O.1: Primary outcome is incidence of new carious lesions

      T: Time for measurement is 12 months

      S: A Randomized controlled clinical trial (Parallel study)
    

Intervention name(s): Licorice
Intervention type(s): Other
Intervention description(s): Natural herbal product
Other intervention name(s): Glycyrrhiza glabra Linn; Mulethi
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Reduced ER-QOL in Families After Congenital Cataract Surgery
Condition: Prospective Cross-sectional Study
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Children after congenital cataract surgery experience a lower quality of life and reduced
      functional vision. Their families have also been seriously affected. Investigators should pay
      more attention to them, and measures should be administered to families.
    


Intervention name(s): Yune Zhao
Intervention type(s): Procedure
Intervention description(s): Yune Zhao did congenital cataract surgeries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      It is becoming increasingly clear that North Americans prefer dietary approaches to enhance
      health in favour of pharmaceutical approaches. Although the consumption of various
      phytosterol (PS)-enriched foods have been shown to be effective in lowering plasma
      cholesterol in a variety of food matrices, the lipid-lowering potential of PS-enriched
      soymilk has not been investigated. Therefore, the objective of this investigation was to
      examine the lipid-lowering efficacy of a PS-enriched soymilk beverage in comparison to a 1%
      dairy milk control. Twenty-three hypercholesterolemic subjects (Total-cholesterol and
      LDL-cholesterol ≥ 5.0 and 3.5 mmol/L, respectively) consumed 3 tetrapacs per day of a
      phytosterol-enriched soy beverage providing 1.95g PS/d or a 1% dairy milk control. The study
      was conducted as a 28 d controlled dietary intervention according to a completely randomized,
      two-period cross-over design.
    


Intervention name(s): phytosterol enhanced soy based beverage; 1% milk
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cholesterol; plant sterols; cholesterol absorption
A Study to Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single-center, Randomized, Blinded, Placebo- and Active-controlled Crossover Study to
      Evaluate the Effect of Saroglitazar Magnesium on the QTc Interval in Healthy Volunteers
    

Detailed description: 
      Primary Objective: This is a Phase 1, single-center, blinded (with respect to saroglitazar
      magnesium and placebo administration), randomized, placebo- and active-controlled, 4-period
      crossover study to investigate the effect of single therapeutic and supra-therapeutic (5×)
      doses of saroglitazar magnesium on the corrected QT (QTc) interval in healthy subjects in
      compliance with the current version of the International Council for Harmonisation E14
      Guidelines.

      After confirmation of eligibility, 52 subjects (at least 16 will be females) will be randomly
      assigned to 1 of 4 treatment sequences using a William's design prior to study treatment
      administration on Day 1 of Period 1. Randomized subjects will receive each of the 4 study
      treatments across the 4 treatment periods separated by at least a 7-day washout period.
    

Intervention name(s): Saroglitazar magnesium 4mg; Placebos; Moxifloxacin 400mg; Saroglitazar magnesium 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally; 5 tablets of placebo to be administered orally; 1 tablet of 400 mg Moxifloxacin to be administered orally; 5 tablets of 4 mg Saroglitazar magnesium to be administered orally
Other intervention name(s): not any; not any; not any; not any
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity
Condition: Atrophy; Vaginal Diseases
MeSH terms: Vaginal Diseases; Atrophy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of ospemifene in
      postmenopausal women experiencing moderate to severe vaginal dryness and vaginal pain
      associated with sexual activity.
    


Intervention name(s): Ospemifene 60 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 60 mg/day oral dose of ospemifene for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed; oral dose of placebo,1 tablet/day, for 12 weeks - from Visit 2 (Randomization, Day 1) to Visit 4 (Week 12) plus Non-hormonal vaginal lubricant as needed
Other intervention name(s): Osphena®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Vulvar and vaginal atrophy in postmenopausal women; Menopausal symptoms; Vaginal atrophy; Urogenital atrophy