bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Hydrochlorothiazide 50mg Tablets Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of hydrochlorothiazide 50 mg tablet of Ohm
      Laboratories (A subsidiary of Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg
      tablet of IVAX Pharmaceuticals, USA in healthy, adult, human, male subjects under fasting
      condition
    

Detailed description: 
      The study was conducted as an open label, balanced, randomised, two-treatment, two-period,
      two- sequence, single-dose, crossover bioavailability study comparing hydrochlorothiazide 50
      mg tablet, containing 50 mg of hydrochlorothiazide of Ohm Laboratories (A subsidiary of
      Ranbaxy pharmaceuticals USA) with hydrochlorothiazide 50 mg tablet, containing 50 mg of
      hydrochlorothiazide of IVAX Pharmaceuticals, in healthy, adult, human, male subjects under
      fasting condition.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical,
      serology parameters and urine analysis) at base line. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study. In addition serum electrolytes Sodium,
      Potassium and Chloride were measured on admission and at the discharge of each period.

      A total of 36 subjects were randomized to receive single oral dose of hydrochlorothiazide 50
      mg tablet and 31 subjects completed both the periods of the study.
    

Intervention name(s): hydrochlorothiazide 50 mg tablet
Intervention type(s): Drug
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence hydrochlorothiazide 50 mg tablet fasting conditions
ICATA Asthma Mechanistic Study
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The purposes of this study are to determine the effects of omalizumab on cells involved in
      the allergic response, to evaluate predictors of response to omalizumab, and to determine
      whether response to omalizumab therapy is influenced by the environment. A subset of
      inner-city children and adolescents currently enrolled in Inner-City Anti-IgE Therapy for
      Asthma (a clinical trial of omalizumab) will be enrolled in this study.
    

Detailed description: 
      Immunoglobulin E (IgE) is important in the development of allergic responses and may
      determine asthma severity. Omalizumab is a man-made monoclonal antibody that directly blocks
      the cause of allergic reactions. There are three main objectives to this study. The first is
      to gain an understanding of how omalizumab affects cells involved in the immune response. The
      second objective is to determine whether response to omalizumab is influenced by exposure to
      environmental factors, including allergens and viral infections. The third objective is to
      determine what clinical markers can be used to determine which patients would most benefit
      from omalizumab therapy. This study will evaluate the immune and allergic responses of
      inner-city children with moderate to severe asthma who are receiving omalizumab or placebo as
      part of a parallel study (Inner-City Anti-IgE Therapy for Asthma, ICAC-08, NCT00377572).

      Nasal secretions will be collected from all participants at the beginning of this study,
      toward the middle of the study, and with each asthma exacerbation requiring a clinical visit.
      Some participants will participate in either the basophil or T-cell studies and associated
      procedures. These studies require blood collection at five study visits. Sputum collection
      will occur at four study visits. Those participants involved in the basophil studies will
      also undergo skin testing at three study visits.
    

Intervention name(s): Omalizumab
Intervention type(s): Biological
Intervention description(s): Subcutaneous injections of omalizumab will be administered every 2 or 4 weeks along with standardized asthma care for 60 weeks, beginning with the Randomization Visit, as a part of ICATA (ICAC-08, NCTNCT00377572).
Intervention MeSH terms: Omalizumab
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inner-city children and adolescents ages 6 to 20 with asthma who are currently enrolled in
        the ICATA Clinical Study
      
Biospecimen description: 
      Blood samples, sputum, and nasal secretions
    
Keywords: Immunoglobulin; IgE; Omalizumab
Assessment of Novel Sound Changing Principles in Hearing Instruments to Determine Their Application - Sonova2018_31
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      A methodical evaluation of sound changing principles in CE-labelled Sonova brand hearing
      instruments (e.g. Phonak hearing instruments) is intended to be conducted on hearing impaired
      participants. These sound changing principles are enabled by respective hearing instrument
      technologies and hearing instrument algorithms. The aim of the study is to investigate and
      asses strength and weaknesses of these sound changing principles in terms of hearing
      performance to determine their application in hearing instruments (Phase of development).
      Objective laboratory measurements will be carried out. This will be a controlled, single
      blinded and randomised active comparator clinical evaluation which will be conducted mono
      centric at Sonova AG Headquarter based in Stäfa
    


Intervention name(s): Bolero B90-SP
Intervention type(s): Device
Intervention description(s): Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment Each participant will be treated with each test condition in a randomized order.
Masking: Single (Participant)
Primary purpose: Treatment
Study of 2 Doses of HRV Vaccine Given Concomitantly With Routine EPI Vaccinations Including OPV in Healthy Infants
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objectives of this study is to determine vaccine efficacy against severe rotavirus
      (RV) gastroenteritis (GE) during the period starting from 2 weeks after Dose 2 until one year
      of age.
    

Detailed description: 
      The study has two groups: Group HRV and Group Placebo. Two oral doses administered to healthy
      infants who are 6-12 weeks of age at the time of Dose 1, according to a 0, 1 to 2-month
      schedule. Routine EPI vaccinations are given at the discretion of the investigator and
      according to local National Plans of Immunisation schedule in each participating country.
    

Intervention name(s): 2-dose oral live attenuated G1P[8] human rotavirus vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Effect of Bariatric Surgery on Kidney Function
Condition: Obese Subjects Who Will Undergo Gastric By-pass Surgery
Study type: Interventional

Summary: 
      Primary hypothesis:

      A large reduction in weight is not associated with a change in accurately measured glomerular
      filtration rate (GFR) (51Chromium ethylenediaminetetraacetic acid plasma clearance
      (51Cr-EDTA)).

      Secondary hypothesis:

      A large reduction in weight is associated with a greater change in estimated GFR (The
      Modification of Diet in Renal Disease (MDRD-formula)) than in accurately measured GFR.

      Other formulas for estimated GFR (Cockcroft Gault, Chronic Kidney Disease Epidemiology
      Collaboration (CKD-EPI), CKD-EPI with cystatin C) are better correlated with accurately
      measured GFR.
    


Intervention name(s): Gastric by-pass surgery
Intervention type(s): Procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Home-based vs. Clinic-based Rehabilitation on Sensorimotor, Cognition, Daily Function, and Participation
Condition: Chronic Stroke
Study type: Interventional

Summary: 
      The purpose of this study was to compare the treatment effects of home-based or clinic-based
      bilateral training with and without mirror feedback programon on physiological markers,
      sensorimotor, cognition, daily functions, and participation among patients with chronic
      stroke.
    


Intervention name(s): bilateral training with and without mirror feedback
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Role of Intima-media Thickness in Determining Arteriogenic Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Observational

Summary: 
      Erectile dysfunction.
    

Detailed description: 
      The intima media thickness is increasingly used as a surrogate end point of vascular outcomes
      in clinical trials aimed at determining the success of interventions that lower risk factors
      for atherosclerosis and associated diseases (stroke, myocardial infarction and peripheral
      artery diseases, like disease of cavernosal artery). The investigators hypothesized that the
      IMT of cavernosal artery would add to the predictive value of vasculogenic erectile
      dysfunction risk and outcomes. This study seeks to evaluate these hypotheses with our
      experience, investigating the predictive accuracy of Cavernosal Doppler ultrasound findings
      for discriminating patients with vasculogenic erectile dysfunction.
    

Intervention name(s): Penile Duplex
Intervention type(s): Device
Intervention description(s): Measuring intima media thickness
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Erectile dysfunction pateints
Prolonged Sitting on Responses to Short-Term Exercise Training
Condition: Atherosclerosis; Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Interventional

Summary: 
      Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT)
      after acute exercise. This study will evaluate the effect of prolonged sitting on response to
      a HFTT after a short term training period.
    


Intervention name(s): Prolonged sitting with exercise; Active walking with exercise.
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will commit to sitting more than 11 hours per day and taking less than 5000 steps per day while participating in exercise training.; Subjects will commit to sitting less than 5 hours per day and taking more than 10000 steps per day while participating in exercise training.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to either the sitting plus exercise or walking plus exercise.
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Properties of Nalmefene in Subjects With Renal Impairment and in Healthy Subjects
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate if renal impairment will have an impact on the pharmacokinetics of nalmefene
    


Intervention name(s): Nalmefene 18 mg
Intervention type(s): Drug
Intervention description(s): One single oral dose of 18 mg
Other intervention name(s): Selincro®
Intervention MeSH terms: Nalmefene
Intervention model: Single Group Assignment
Masking: None (Open Label)
Effects of High-intensity Interval Aerobic Training on Balance, Walking Capacity, and Quality of Life in Patients With Sub-acute Stroke
Condition: Stroke, Ischemic; Cerebrovascular Accident
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional

Summary: 
      Hemiplegia is one of the most common sequelae of stroke. Stroke is the leading cause of
      disability in adults all around the world. Stroke survivors can suffer several neurological
      impairments and deficits which have an important impact on patient's quality of life and
      which increase the costs for health and social services. After stroke, impairments in ADLs
      and functional status, deterioration in health related quality of life can be seen.

      The purpose of this study is to Determine the effect of Aerobic exercise training on Balance,
      Walking capacity and quality of life in sub-acute stroke.
    


Intervention name(s): High intensity Interval Training
Intervention type(s): Other
Intervention description(s): All the participants underwent 5 weeks of High intensity interval training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cerebrovascular accident; Treadmill Training; High-intensity interval training; Walking capacity.
Response of United Kingdom (UK) Infants to a Reduced Primary Schedule With Meningococcal C and Pneumococcal Conjugate Vaccines
Condition: Pneumococcal Infections; Meningococcal Infections
MeSH terms: Infections; Communicable Diseases; Pneumococcal Infections; Meningococcal Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the immune responses of UK infants after one or two
      doses of pneumococcal conjugate vaccine or one or two doses of three different types of
      meningococcal conjugate vaccine given at either two and three or two and four months of age.
    


Intervention name(s): menjugate; Men C conjugate vaccine; Men C conjugate; Men C Conjugate; Men C conjugate; Men C conjugate
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): men C conjugate vaccine; men C conjugate vaccine; men C conjugate vaccine; men C conjugate vaccine; men C conjugate vaccine; men C conjugate vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae; Neisseria meningitidis
Uremic Pruritus, Cytokines and Polymethylmethacrylate Artificial Kidney
Condition: Uremia; Pruritus
MeSH terms: Pruritus
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Uremic pruritus is one of the common complications in long-term dialysis
      patients. In general, many factors including xerosis, elevated serum calcium, phosphate,
      calcium-phosphate product, hyperparathyroidism and inadequate dialysis may contribute to it.
      Recently, researchers reported that immuno-hypothesis with high serum level of cytokines
      could be the cause of uremic pruritus. Polymethylmethacrylate (PMMA) artificial kidney (AK)
      has been reported to adsorb more serum cytokines than other high flux artificial kidneys.

      Methods: In July 2006, 30 patients with severe uremic pruritus from 300 chronic hemodialysis
      patients in a single center entered this prospective study. Their dialyzers were changed to
      PMMA AK for 4 weeks. The severity of pruritus was evaluated every week using the results of a
      questionnaire (pruritus score). Laboratory assays including pre-dialysis serum blood urea
      nitrogen, creatinine, β2-microgblubulin (β2M), calcium, phosphate, intact parathyroid hormone
      (iPTH), total CO2, ferritin, hematocrit, high sensitivity C-reactive protein (hsCRP), IL-1,
      IL-2, IL-6, IL-18, TNF-α, KT/V and β2M clearance were measured before and at the end of 4
      weeks of PMMA AK use.

      Expected Results:To prove the PMMA membrane could improve the uremic pruritus and to reveal
      the effect of PMMA membrane on serum level of possible factors contributing to uremic
      pruritus.
    


Intervention name(s): Hemodialysis with Polymethylmethacrylate Artificial Kidney
Intervention type(s): Procedure
Intervention MeSH terms: Polymethyl Methacrylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Uremic Pruritus; Cytokines; Polymethylmethacrylate Artificial Kidney; Hemodialysis
Imaging and BioFluid Biomarkers in Amyotrophic Lateral Sclerosis
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a multicenter, 18-month study, which aims to identify imaging and biofluid biomarkers
      in people with ALS to expand the understanding of ALS pathology, treatment targets, disease
      progression, and anatomical differences between different disease phenotypes. This pilot
      project is tailored to produce imaging tools that will allow researchers to conduct future
      ALS clinical trials more efficiently which may in turn impact the pace for ALS drug
      discovery.
    

Detailed description: 
      In this trial, approximately 200 subjects will participate in this study from 2 Northeast ALS
      Consortium (NEALS) centers in the United States. Fifty (50) ALS participants will be age and
      gender matched to 50 participants with no known neurological disorder (healthy controls). Of
      these, twenty five (25) ALS participants will be age (±5 years) gender and binding affinity
      (TSPO) matched to 25 healthy controls.

      During the enrollment period 200 participants will be screened and 100 participants will
      ultimately be scanned. There will be a maximum allowed time of 45 days between the screening
      and baseline visits (1st scan). All 100 subjects will undergo MRI scanning and clinical
      assessment at the Baseline Visit. Healthy control participants will have no further follow-up
      visits once they have completed their participation in the screening and baseline visits.
      Only 50 subjects from this sample will undergo PET scanning. The ALS participants will return
      for follow-up MRI scanning and clinical assessments every three months and follow-up PET
      scanning every 6 months over a 12-month period.
    

Intervention name(s): [18F] GE-180
Intervention type(s): Drug
Intervention description(s): PET Tracer Ligand
Other intervention name(s): ligand; PET Tracer
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 200 subjects will be screened and approximately 100 subjects will be
        enrolled. Fifty (50) subjects will be diagnosed with possible, probable, probable-lab
        supported, or definite ALS, fifty (50) subjects will have no known neurological disease.
      
Biospecimen description: 
      iPSC Line Generation, DNA, Inflammatory Markers, Plasma, CSF
    
Keywords: Biofluid; ALS; MRI; PET; Imaging; Biomarkers; Amyotrophic Lateral Sclerosis; TRACK ALS; pathology
Motivating Campus Change Project Pilot Study
Condition: Drinking Behavior
MeSH terms: Drinking Behavior
Study type: Interventional

Summary: 
      This study tests the optimization and delivery feasibility of personalized feedback
      interventions to address harmful alcohol use among college students.
    

Detailed description: 
      This study builds upon the latest alcohol intervention literature to develop and test the
      next wave of personalized feedback interventions (PFIs) to address harmful alcohol use among
      college students. The purpose of this research is to determine optimal configuration of PFIs
      to take advantage of the clarity and initial impact of single-component PFIs and greater
      effect size and duration of personalized multi-component PFIs. The Investigators seek to
      increase and evaluate engagement with the PFI and text-message materials and boost innovation
      of both content and process of the intervention. In addition to PFI content and delivery, the
      investigators will use qualitative and quantitative methods to determine personal relevance
      of the chosen high-risk events among a sample of students who engage in heavy episodic
      drinking to better understand duration of PFI effects impacted by fluctuations in drinking
      associated with high-risk events. Prior interventions have targeted drinking in general or a
      single high-risk drinking event (e.g., Spring Break), but have not targeted both general and
      event-specific drinking together. These enhanced intervention effects, could have a
      significant impact on risks associated with college student drinking, and can be rapidly
      disseminated and implemented on campuses nationwide to address the public health problem
      posed by heavy episodic drinking among college students.

      This study conducts a screening/baseline assessment to collect quantitative data on high risk
      drinking situations and related norms and screens participants for eligibility for the Pilot
      Feasibility Study. The purpose of the Pilot Feasibility Study is to test the feasibility of
      sending participants web-based personalized feedback targeting their general drinking
      behavior in a single dose (Simultaneous) versus broken up into 4 components administered one
      week apart (Sequential) with half of participants in each group also being randomly selected
      to receive a text message booster component targeting drinking during their upcoming birthday
      celebration.
    

Intervention name(s): Simultaneous Post Feedback Intervention Delivery; Sequential Post Feedback Intervention Delivery; Text Message Boosters
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Simultaneous PFI delivery after baseline survey; Sequential PFI delivery over 3 weeks after baseline survey; Text message boosters on PFI content during week of high risk drinking event
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of LY3478045 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study in healthy participants is to learn more about the safety of
      LY3478045 and any side effects that might be associated with it. The study will also measure
      how much LY3478045 gets into the bloodstream and how long it takes the body to get rid of it.

      This study has two parts: Part A (one dose) will last about six weeks and Part B (more than
      one dose) will last about eight weeks for each participant.
    


Intervention name(s): LY3478045; Placebo; Atorvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science