bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Regular Consumption of Micronutrient Fortified Beverage on the Micronutrient Status of Indian Schoolchildren
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the impact of regular consumption of micronutrient
      fortified drink in improving nutritional and micronutrient status in Indian school children.
      The test beverage will be fortified with both, vitamins and minerals.
    


Intervention name(s): Non-Fortified Control Product; Micronutrient Fortified Test Product
Intervention type(s): Other; Other
Intervention description(s): Non-Fortified Control Beverage; Micronutrient Fortified Test Beverage
Intervention MeSH terms: Micronutrients; Trace Elements
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: micronutrient; healthy children; vitamins; minerals; cognition; physical performance; iron; Micronutrient status; Cognitive Performance
Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride
      toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2
      diabetic population.
    


Intervention name(s): Triclosan/copolymer/fluoride; Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.; Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.
Other intervention name(s): Total toothpaste; Fluorigard oral rinse
Intervention MeSH terms: Triclosan; Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Perifosine in Treating Patients With Metastatic or Recurrent Malignant Melanoma
Condition: Melanoma (Skin)
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who
      have metastatic or recurrent malignant melanoma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the efficacy of perifosine, in terms of response rate, in previously untreated
           patients with metastatic or recurrent malignant melanoma.

        -  Assess the toxicity of this drug in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral perifosine daily on days 1-21. Treatment repeats every 28 days for up
      to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who
      achieve a complete response (CR) or partial response (PR) receive 2 additional courses after
      documentation of CR or stable PR (i.e., no further tumor shrinkage).

      Patients are followed at 4 weeks and then every 3 months thereafter.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 12-18
      months.
    

Intervention name(s): perifosine
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent melanoma; stage IV melanoma
Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and
      efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in
      CF subjects 2 through 5 years of age.
    


Intervention name(s): ELX/TEZ/IVA; IVA
Intervention type(s): Drug; Drug
Intervention description(s): Fixed dose combination granules for oral administration.; Granules for oral administration.
Other intervention name(s): VX-445/VX-661/VX-770; elexacaftor/tezacaftor/ivacaftor; VX-770; ivacaftor
Intervention MeSH terms: Ivacaftor; Elexacaftor
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PET Imaging Study to Evaluate the mGlu5r Occupancy Following ADX48621 (Dipraglurant) Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label study, non-randomized, positron emission tomography (PET)study
      investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy
      subjects using [18F]-FPEB as the radiotracer.
    

Detailed description: 
      This is an open label study, non-randomized, positron emission tomography (PET) study
      investigating mGlu5 receptor occupancy after single or two oral dosing of ADX48621 in healthy
      subjects using [18F]-FPEB . The study consists of 2 parts.

      Part 1: A receptor occupancy dose curve will be obtained by using an adaptive design.
      Subjects will undergo two [18F]-FPEB PET imaging sessions: a baseline plus a scan after
      treatment with one dose of ADX48621. The second scan will be taken at Tmax for ADX48621 (1
      hour post dose). 100 mg will be the initial dose as this has been proven to be efficacious in
      a P2A study in Parkinson's patients. This is an open label study, non-randomized, positron
      emission tomography (PET)study investigating mGlu5 receptor occupancy after single or two
      oral dosing of ADX48621 in healthy subjects using [18F]-FPEB as the radiotracer.The maximum
      dose to be given will be 200 mg.

      Part 2: The time course of the receptor occupancy will be studied for the dose which gives
      70% receptor occupancy as determined in Part 1. Two subjects will receive 2 doses of ADX48621
      on 2 separate days and undergo three [18F]-FPEB PET imaging sessions: a baseline scan, post
      dose scan 1 and post dose scan 2. Subjects will be given ADX48621 one hour prior post dose
      scan 1. The 2nd dose will be given in the morning approximately 4-6 hours prior of the post
      dose scan 2. The post dose scan 2 will be performed in the afternoon. The maximum dose to be
      given will be 400 mg.
    

Intervention name(s): ADX48621; [18F]FPEB
Intervention type(s): Drug; Radiation
Intervention description(s): ADX4862, an investigational compound, is a potent, selective, negative allosteric modulator of the metabotropic glutamate receptor 5 (mGlu5 NAM).; radiotracer used for PET scanning
Other intervention name(s): dipraglurant
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Volunteers
Oral Microbiome and Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Observational

Summary: 
      This is a prospective population based study to examine the relationship of oral and
      pancreatic microbiome, and their functions, to pancreatic cancer risk.

      The identification of specific oral bacteria and their functional relationship to pancreatic
      cancer will advance scientific knowledge on the etiology of pancreatic cancer. This could
      provide a new microbially-based research paradigm, possibly leading to new drug targets for
      this disease. Second, the oral bacteria may serve as a readily accessible, non-invasive
      biomarker for subsequent pancreatic cancer risk, which help to identify people at high risk
      of this disease. Finally, the identified oral bacteria may lead to microbial prophylactic
      preventions, with antibiotic therapy aimed at eradicating the specific species associated
      with increased cancer risk or, alternatively, combined with probiotics to introduce species
      that are associated with a decreased cancer risk. Thus, the study outcomes will lead to
      actionable means for pancreatic cancer prevention.
    

Detailed description: 
      A history of periodontal disease and the presence of circulating antibodies to selected oral
      pathogens have been associated with increased risk of pancreatic cancer; however, direct
      relationships of oral microbes with pancreatic cancer have not been evaluated in prospective
      studies. Investigators examine the relationship of oral microbiota with subsequent risk of
      pancreatic cancer in a large nested case-control study.
    

Intervention name(s): 16S rRNA gene sequencing assay
Intervention type(s): Other
Intervention description(s): extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        361 incident adenocarcinoma of pancreas and 371 matched controls from two prospective
        cohort studies, the American Cancer Society Cancer Prevention Study II and the National
        Cancer Institute Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial.
      
Biospecimen description: 
      Using DNA extracted from oral samples from these cohorts, 16S rRNA genes were amplified and
      sequenced, followed by assignment of each sequence to a microbial taxa
A Randomized Trial of Interventions for Teenage Drivers With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      There is clear, converging evidence from multiple prospective studies with well-diagnosed
      adolescents with ADHD and comparison, non-ADHD adolescents, that teen drivers with ADHD have
      more accidents and other adverse driving outcomes. Available research indicates parental
      monitoring and limit-setting for adolescent drivers is one of the most effective
      interventions for preventing negative driving outcomes. For children with ADHD, interventions
      to promote parenting capacity to effectively oversee and intervene in teen driving will
      likely need to be intensive and require multiple treatment components. The present proposal
      aims to compare the standard care for teen drivers (driver's education classes and driving
      practice) to the Supporting a Teen's Effective Entry to the Roadway (STEER) program, that
      includes a parent-teen intervention, adolescent skill building, parent training on effective
      adolescent management strategies, joint parent-teen negotiations sessions, practice on a
      driving simulator, parental monitoring of objective driving behaviors, and the targeting of
      safe teen driving via contingency management strategies (i.e., parent-teen contracts). To
      facilitate teen and parent engagement the intervention will be preceded by a motivational
      interview. The specific aims of the proposal are to investigate the efficacy of the STEER
      program relative to a standard care group in a randomized clinical trial (N=172) on measures
      of objective driving outcome and parenting capacity. It is hypothesized that the STEER
      program will result in improved outcomes relative to the standard care group at the end of
      intervention and 6 and 12 month follow-up assessments.
    


Intervention name(s): CarChipPro; Driver's Education; STEER Program; Driving Simulator Practice
Intervention type(s): Device; Behavioral; Behavioral; Other
Intervention description(s): On board driving monitor; 10 Session License to Learn Program.; 8-session behavioral parent training and teen social skills/communication training program; Practice Driving on a driving simulator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ADHD; Driving; Behavior modification
Study of the Platelet Function During the Last Month of Pregnancy
Condition: Pregnancy
Study type: Interventional

Summary: 
      The objective is to compare women's platelet answer in the last month of pregnancy to women
      old enough to procreate, no pregnancy and without hormonal treatment.

      The hypothesis of research is that the decrease of platelet answer in pregnant women could
      not only limit the occurence of embolic accidents but also explain the lowest incidence of
      the arterial thrombosis in comparison with the venous thrombosis.
    

Detailed description: 
      This is a monocentric study comparing a group of pregnant women and a group of "no pregnancy"
      women.

      The goal of the present study is to determine the impact of pregnancy on platelet function.
      For this, the study propose to explore, in women in the last month of pregnancy, the ability
      of platelets to aggregate after activation by strong agonists but also their ability to
      adhere to a matrix and form thrombies.

      The study will include 30 pregnant and 30 "no pregnancy" control women, of childbearing age
      and not taking hormone therapy. From a blood sample, two types of examination will be
      implemented:

      A) In whole blood, we will evaluate the percentage of platelet adhesion to collagen matrix or
      fibrinogen and the volume of thrombies formed.

      B) In washed platelets and whole blood, we shall determine the percentage of aggregation
      after activation by different agonists and the amount of certain membrane markers of platelet
      activation. Furthermore, an assay of estradiol plasma will be made.
    

Intervention name(s): Blood sample
Intervention type(s): Other
Intervention description(s): In washed platelets and whole blood, study shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.
In whole blood, study will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed.
Other intervention name(s): Blood sample in pregnancy and no pregnancy women
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; platelets
Development of an Algorithm for Prediction of Onset of Hemodynamic Instability in Humans
Condition: Hemorrhagic Shock
MeSH terms: Shock, Hemorrhagic
Study type: Observational

Summary: 
      The purpose for this study is to measure the physiology of human undergoing a Lower Body
      Negative Pressure usea non-invasive low-power optical technique, near-infrared diffuse
      optical spectroscopy measurement and compare these measurement to standard monitoring
      procedures delineated in the Brooke Army Medical Center.

      The Brooke Army Medical Center can use near-infrared diffuse optical spectroscopy to provide
      functional physiologic tissue and organ information without ionizing radiation and without
      withdrawing any blood, in a cost-effective and rapid manner. Monitoring for the onset of
      circulatory shock in a wounded soldier on the battlefield is typically performed by
      measurement of arterial blood pressure, arterial oxygen saturation, or simple auscultation of
      the pulse. Shock is typically recognized by non-specific signs and subjective symptoms such
      as cold clammy skin, pallor, weak thready pulse, unstable vital signs, and diminished
      mentation.
    

Detailed description: 
      The near-infrared diffuse optical spectroscopy can measure tissue regions deeper below the
      skin surface and reports on larger tissue volumes in muscle and brain. The near-infrared
      diffuse optical spectroscopy instrument generate harmless amounts of low-level non-ionizing
      near-infrared ligh can measure the tissue absorption and scattering properties at depths of 1
      cm or more below the skin surface include larger tissue volumes in muscle and brain. The
      absorption properties of tissue provide and can determine absolute concentrations of
      deoxygenated hemoglobin, oxygenated hemoglobin, and water, as well as the total hemoglobin
      saturation.
    

Intervention name(s): Near-Infrared Diffuse Optical Spectroscopy
Intervention type(s): Device
Intervention description(s): Early predictor of hemorrhagic shock
Other intervention name(s): Near-Infrared Diffuse Optical Spectroscopy Imaging
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Army Medical Center, civilian and military
      
Keywords: trauma situations; Lower Body Negative Pressure (LBNP)
Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional
Phase: Phase 4

Summary: 
      Activity-related breathlessness (dyspnea) is the dominant symptom and persists despite
      optimal medical care in as many as 50% of patients with advanced chronic obstructive
      pulmonary disease (COPD). The objective of this project is to determine the underlying
      mechanisms of the activity-related breathlessness in patients with advanced COPD. To study
      the different pathways involved in causing breathlessness, we will compare the effects of two
      treatments, opiates with oxygen versus bronchodilators, which relieve breathlessness in
      different ways.
    

Detailed description: 
      Dyspnea arises during exercise in COPD patients when there is a mismatch between the
      ventilatory demand (largely dictated by chemical stimuli) and the capacity to respond to that
      demand (dictated by mechanical/muscular factors). Our preliminary studies have indicated that
      treatment with opioids in COPD patients can improve activity related dyspnea by reducing
      central respiratory neural drive and breathing frequency without a significant change in the
      respiratory mechanics. By contrast, a reduction in exertional dyspnea following inhaled
      bronchodilators in COPD was mainly related to an improved respiratory mechanics with
      increased inspiratory capacity, tidal volume, and inspiratory reserve volume etcetera. By
      comparing the physiological mechanisms of dyspnea relief during the opiate and bronchodilator
      therapy, we hope to gain new insights into the mechanisms of dyspnea in COPD by selectively
      manipulating inspiratory neural drive (nebulized opiates) and abnormal respiratory mechanics
      (nebulized bronchodilators) within the same individuals. As such, the primary objective of
      this study is to compare the effects of inhaled opiate with oxygen versus bronchodilator
      treatments on the intensity of dyspnea, electromyographic estimates of inspiratory neural
      drive and respiratory mechanics and their interactions during a standardized exercise test
      using a randomized, controlled, crossover design in patients with COPD.
    

Intervention name(s): Fentanyl Citrate; Combivent
Intervention type(s): Drug; Drug
Intervention description(s): 100 mcg fentanyl citrate will be inhaled via nebulizer; 0.5 mg ipratropium bromide + 2.5 mg salbutamol will be inhaled via nebulizer
Other intervention name(s): Inhaled fentanyl; Bronchodilator
Intervention MeSH terms: Fentanyl; Bronchodilator Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Expression of Longevity Genes in Response to Extended Fasting
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of fasting on physical changes associated
      with cardiovascular disease.
    

Detailed description: 
      Coronary heart disease (CHD) is the largest contributor to morbidity and mortality in the
      Western world and is associated with high-calorie diet, high body mass, and a variety of
      other factors. CHD can lead to myocardial infarction (MI) and other embolic events. A growing
      body of evidence suggests that relatively low caloric intake in the diets of a variety of
      animals increases longevity and preliminary evidence among humans indicates that such caloric
      restriction reduces risk factors for CHD, including cholesterol levels, blood pressure,
      glucose, and obesity. Caloric restriction has also been shown to alter the expression of
      certain genes, especially the forkhead box (FOX) O and sirtuin (SIRT) genes whose
      over-expression has been shown to increase longevity in animal models. Extended avoidance of
      caloric intake, also called fasting or short-term starvation, has been shown to increase
      expression of the FOXA genes that have similar sequence and function as the FOXO genes and
      that have been shown to increase longevity among animals regardless of FOXO function. We
      recently demonstrated that the risk of CHD was significantly lower among patients who
      reported a history of routine periodic extended fasting. The two primary hypotheses for this
      observation are that fasting may improve individual ability to control dietary intake or that
      fasting may initiate a cascade of protective mechanisms that preserve cellular and metabolic
      health.
    

Intervention name(s): Fasting First; Fed First
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 28±4 hours of water-only fasting followed by 28±4 hours fed; 28± 4 hours fed followed by 28± 4 hours of fasting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fasting; Short-term starvation; Diet; Coronary artery disease
A Study in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple doses of
      LY2439821 in Japanese patients with rheumatoid arthritis.
    


Intervention name(s): LY2439821; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Ixekizumab
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment