bioihbjkbjnl/mcl2 huggingface dataset:
T and B Cell Response to Avian Flu Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Observational

Summary: 
      The purpose of this substudy study is to evaluate the types of cells involved in fighting
      infection to the A/H5N1 (avian flu virus) vaccine. A maximum of 30 healthy adults ages 18-64
      years, enrolled at Stanford University Hospital and participating in another clinical trial
      (DMID Protocol 04-062) will be enrolled into this substudy to collect additional samples of
      blood for testing before and approximately one week after each vaccination.
    

Detailed description: 
      A human vaccination trial involving influenza A/H5N1 vaccine with different adjuvants is
      being conducted in a healthy adult population aged 18-64 years (DMID 04-062) to test the
      safety, reactogenicity, and immunogenicity of monovalent inactivated influenza A/H5N1 vaccine
      when given with either alone (no adjuvant), or given along with either alum or MF59. Two
      doses of the vaccine/adjuvent will be administered day 0 and day 28. This study is linked to
      DMID protocol 04-062. This protocol is a substudy to collect additional blood samples to
      specifically evaluate the cell-mediated immune responses generated from the vaccine. Primary
      goals of this study are 1) to establish reproducible, functional cell-mediate immune response
      assays to evaluate the magnitude and functional capacity of B cells, NK cells and T cells
      responding to monovalent subvirion H5 influenza vaccine 2) to evaluate the percent of
      subjects demonstrating B cell, NK cell, CD8+ and/or CD4+ response. The secondary goal of this
      study is to examine and compare the adjuvant effect of Alum or MF59 compared to no adjuvant
      on cell mediated immune responses.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy adults male and female ages 18-64 years, participating in another clinical trial
        (DMID Protocol 04-062)
      
Biospecimen description: 
      blood
    
Keywords: vaccine, influenza, A/H5N1, CMI, sub-study
Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effect of acid reducing agents (an antacid and an H2-receptor antagonist
      and a proton pump inhibitor) on palbociclib bioavailability in the presence of food.
    


Intervention name(s): palbociclib commercial free base; famotidine; rabeprazole; palbociclib commercial free base; antacid; antacid
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 125 mg oral capsule single dose; 20 mg oral tablet 10 hours before and 2 hours after palbociclib; 2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib; 125 mg oral capsule single dose; 30 mL orally once (2h before palbociclib); 30 mL orally once (2h after palbociclib)
Other intervention name(s): Pepcid; Aciphex; Mi-Acid Maximum Strength Liquid; Mi-Acid Maximum Strength Liquid
Intervention MeSH terms: Palbociclib; Rabeprazole; Famotidine; Anti-Ulcer Agents; Aluminum hydroxide, magnesium hydroxide, simethicone drug combination; Aluminum Hydroxide; Magnesium Hydroxide; Antacids; TEMPO
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioavailability; antacid; rabeprazole; famotidine; palbociclib
Study to Investigate the Effect of Atorvastatin on the Pharmacokinetic Properties of Telmisartan/S-amlodipine
Condition: Essential Hypertension; Hyperlipidemia
MeSH terms: Essential Hypertension; Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of Atorvastatin on the pharmacokinetic
      properties of Telmisartan/S-amlodipine
    


Intervention name(s): Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg; Telmisartan 80mg and S-amlodipine 5mg
Intervention type(s): Drug; Drug
Intervention description(s): Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
Atorvastatin 40mg: 1 tablet, oral, once daily, 2days
over the period I & II(cross-over); Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
over the period I & II(cross-over)
Intervention MeSH terms: Niacin; Amlodipine; Telmisartan; Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Telminuvo; Telmisartan; S-amlodipine; Atorvastatin; pharmacokinetics; Healthy volunteers
Effects of Inhibition of NO-Synthesis on Renal Hemodynamics and Sodium Excretion in Patients With Essential Hypertension and Healthy Controls
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The study tests the hypothesis that systemic and renal nitric oxide synthesis is changed in
      essential hypertension by investigating the effects of a non selective nitric oxide inhibitor
      on renal hemodynamics and sodium excretion in patients with essential hypertension. The
      results are compared with a group of healthy subjects.
    

Detailed description: 
      The study investigates the effects of Ng-monomethyl-L-arginine (L-NMMA) on:

        1. renal hemodynamics (renal plasma flow and glomerular filtration rate)

        2. renal sodium excretion

        3. lithium clearance and fractional lithium excretion

        4. plasma levels of vasoactive hormones

        5. blood pressure and heart rate
    

Intervention name(s): Ng-monomethyl-L-arginine (drug)
Intervention type(s): Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Keywords: hypertension; nitric oxide; renal hemodynamics
A PK Study to Evaluate PUR0200 and a Reference Product in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare drug blood levels of multiple formulations of inhaled
      PUR0200 to each other and to the reference product with and without oral charcoal.
    

Detailed description: 
      The purpose of this study is to compare 5 different formulations of PUR0200 to the reference
      product. All formulations will be inhaled. In 6 of the 7 study periods either PUR0200 or the
      reference product will be inhaled under fasting conditions without oral charcoal. In the 7th
      study period, half of the subjects will receive reference with oral charcoal and the other
      half will receive reference product without oral charcoal.
    

Intervention name(s): PUR0200; Reference Product
Intervention type(s): Drug; Drug
Intervention description(s): PUR0200 dry powder inhalation; Dry Powder Inhalation Reference Product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
An Evaluation Of The Fitting Success Rate Of Senofilcon A Soft Contact Lenses In Three Designs.
Condition: Myopia
MeSH terms: Seizures; Myopia
Study type: Interventional

Summary: 
      This study will compare the on-eye fitting characteristics of three types of contact lenses.
      Each lens pair will be worn for 30 to 45 minutes before assessment and the results will be
      compared to mathematically calculated fitting characteristics.
    

Detailed description: 
      This will be an approx. 40-60 subject, one-day, double-masked, randomised, repeated measures
      study. Each subject will wear the three lens types bilaterally in random succession, a total
      of six lenses will therefore be worn by each subject (3 per eye).
    

Intervention name(s): First pair Senofilcon A contact lens; Second pair Senofilcon A contact lens; Third pair Senofilcon A contact lens
Intervention type(s): Device; Device; Device
Intervention description(s): Fit assessment of the first pair contact lenses.; Fit assessment of the second pair of contact lenses.; Fit assessment of the third pair of contact lenses.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject will wear the three contact lens types bilaterally in random succession
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Contact lens; The Young Theory
Effect of Inflammasome Inhibitor on hsCRP in Patients After PCI
Condition: NLRP3; hsCRP; Percutaneous Coronary Intervention
Study type: Interventional
Phase: Phase 4

Summary: 
      Coronary artery disease (CAD) comprises the major contributor to a global epidemic of
      cardiovascular disease. Patients with CAD undergoing percutaneous coronary intervention (PCI)
      have a high-risk for adverse clinical outcomes.

      Residual inflammatory risk (RIR) in patients with CAD after standardized treatment is the
      main cause of adverse events such as recurrent myocardial infarction, stroke, and death,
      which has gained much interest in recent years. Inflammation plays an important role in the
      development of CAD. However, several randomized controlled clinical studies (RCT) of
      anti-inflammatory treatments ended in failure previously. Since 2017, the success of three
      large-scale RCTs (CANTOS, COLCOT and LoDoCo2) points to targeting the NLRP3 - IL-1 β- IL-6
      pathway for anti-inflammatory treatment of CAD. The inhibition of this pathway eventually
      leads to the decrease of high-sensitivity C-reactive protein (hsCRP), consistent with an
      anti-inflammatory effect. Therefore, the change of hsCRP may serve as a biomarker to screen
      anti-inflammatory drugs in this pathway.

      Targeting the NLRP3 - IL-1 β- IL-6 pathway with monoclonal antibodies is limited by high
      prices of the biological agents. Thus, researchers focused on the upstream molecule NLRP3.
      Currently, NLRP3 inhibitors that are clinically available include colchicine , tranilast and
      oridonin. Although several studies have indicated the effective effects of colchicine in CAD,
      the other two NLRP3 inhibitors lack sufficient data on anti-inflammatory treatment of CAD.
      Therefore, we intend to use NLRP3 inhibitors (colchicine, tranilast and oridonin) to treat
      patients after PCI for 4 weeks, compare the changes of hsCRP, and explore the effectiveness
      and safety of these different drugs, and screen the optimal anti-inflammatory drugs for
      coronary heart disease.
    


Intervention name(s): Colchicine; Tranilast; Oridonin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 tablet (0.5mg) / time, once a day; 1 capsule (0.1g) / time, 3 times a day; 2 tablets (0.5g) / time, 3 times a day;
Intervention MeSH terms: Tranilast; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate The Impact on Skin Quality Attributes by Juvederm® Volite Injection on Healthy Volunteers
Condition: Healthy Adults; Skin Enhancement
Study type: Interventional

Summary: 
      To evaluate the impact on skin quality attributes, including physical measurements and gene
      and protein expression (histological and genomic analysis), following administration of
      Juvéderm® VOLITE in the volar forearms of healthy volunteers.
    


Intervention name(s): Juvederm® VOLITE
Intervention type(s): Device
Intervention description(s): 1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Electrodermal Patterns of Arousal in Children
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Observational

Summary: 
      The purpose of this study was to explore the feasibility of detecting physiological patterns
      of arousal to sensory inputs in children with and without Autism Spectrum Disorder (ASD).
      Accordingly, two questions directed this methodological research investigation: (1) Is there
      a relationship between rest (tonic) and response (phasic) patterns of arousal among typically
      developing children and children with ASD?, and (2) Is there a difference in EDA response to
      sensation between typically developing children and children with ASD?
    

Detailed description: 
      This methodological research design is a prospective exploratory test-retest design assessing
      the relationship between tonic and phasic Electrodermal Activity (EDA) variables. EDA during
      rest and in response to a variety of sensations was measured using skin conductance.
      Descriptive statistics summarized EDA dependent variable data using skin conductance response
      (SCR) magnitude, SCR amplitude, skin conductance level (SCL), non-specific response (NSR) and
      habituation (HAB). The data was used to assess the relationship between tonic and phasic
      patterns of arousal and compare response patterns between groups using the Sensory Challenge
      Protocol (SCP) in children with ASD and typically developing children (TD).
    

Intervention name(s): Sensory Challenge Protocol
Intervention type(s): Other
Intervention description(s): Measurement of electrodermal activity in response to sensation
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of boys between the ages of 4 - 11 years with and without a diagnosis
        of Autism Spectrum Disorder were recruited from private and public New Jersey Schools,
        Barpak Occupational Therapy clinic, Bergenfield, New Jersey and Seton Hall University
        campus.
Cardiovascular (CV) Risk Evaluation In Type 2 Diabetes Subjects
Condition: Type 2 Diabetes Mellitus; CV Risk
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The primary objective of this study is to assess the total CV risk in patients with type 2
      diabetes and also to assess the impact of rosiglitazone in the total CV risk and the
      parameters of metabolic syndrome.
    


Time perspective: Prospective
Keywords: Type 2 diabetes; CV risk; rosiglitazone; AVANDIA
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) Who Met Severity Classification III
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the efficacy of 60mg of MCI-186 via
      intravenous drip once a day in patients with ALS whose severity is classified as grade III,
      based on the changes in the revised ALS functional rating scale (ALSFRS-R) scores after 24
      weeks administration in double-blind, placebo-controlled manner. And in addition, this study
      will be performed to examine the safety of MCI-186 to ALS patients who met severity
      classification III.
    


Intervention name(s): MCI-186; Placebo of MCI-186
Intervention type(s): Drug; Drug
Intervention description(s): Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; Two ampoules of Placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
Other intervention name(s): Edaravone; Radicut
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic lateral sclerosis; free radical scavenger
Comparison of Coagulation Factors During Laparoscopic Cholecystectomy
Condition: Gall Stone Disease; Polyp
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional

Summary: 
      Pneumoperitoneum is formed with CO2 during laparoscopic abdominal operations. Effect of
      pneumoperitoneum on coagulation factors is not well known. In our study the investigators
      aimed to compare the general anesthesia(GA) and combined spinal-epidural anesthesia (CA)
      during laparoscopic cholecystectomy(LC) with effect on coagulation factors.

      Fifty patients will be randomly assigned to either the Laparoscopic cholecystectomy under
      Combined anaesthesia (25 patients) or Laparoscopic cholecystectomy under general anaesthesia
      (25 patients). All patients has symptomatic gall stone disease or polyp of gall bladder.
    

Detailed description: 
      Objective of study : The aim of this study was to compare general anesthesia (GA) and
      combined (epidural and spinal) anesthesia (CA) for laparoscopic
      cholecystectomy(LC).Laparoscopic cholecystectomies are usually performed under general
      anesthesia. Studies involving cholecystectomies with regional anesthesia recently published.
      During regional anesthesia pneumoperitoneum is performed with lower pressure(10mmHg CO2).
      Patients can not tolerate higher intraabdominally pressure. Thera are very few studies
      involving the effect of pneumoperitoneum on coagulation factors. In our study the
      investigators separate the patients into 2 groups. Group1:10 mmHg pressure, laparoscopic
      cholecystectomy under general anesthesia ; Group2 : 10 mmHg pressure, laparoscopic
      cholecystectomy under Combined Spinal-Epidural Anesthesia The investigators performed
      standard conventional laparoscopic cholecystectomy procedure with 10mmHg pressure in both
      groups. The investigators aimed to investigate Prothrombin Time(PT), activated partial
      thromboplastin time(aPTT), thrombin time(TT), D-dimer and fibrinogen levels preoperative,
      postoperative 1st hour and 24th hour respectively.
    

Intervention name(s): Combined anaesthesia; General anaesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic cholecystectomy under 10 mmHg pressure; Laparoscopic cholecystectomy under 10 mmHg pressure
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: D-dimer; Fibrinogen; Laparoscopic cholecystectomy
Sensory Perception of Sweet Flavors in E-Cigarette
Condition: Smoking
Study type: Interventional

Summary: 
      Despite the explosive popularity of sweet flavored electronic cigarettes, there is little
      empirical evidence regarding how "sweet" flavors interact with different levels of nicotine
      to reduce its perceived bitterness and harshness, and thereby increase its appeal and
      additive potential. This study will serve to fill this knowledge gap through empirical
      psychophysical data that will determine the association between sweet flavor and nicotine and
      its link to the acceptance and rejection of vaped nicotine.
    

Detailed description: 
      We will recruit current, healthy e-cigarette users between the ages of 18-35.This study will
      require 1 visit to the Oregon State University campus to partake in a 1 hour (approximate)
      testing session. During the testing session, participants will be asked to puff commercial
      e-cigarettes containing 9 commercially available e-liquid preparations.
    

Intervention name(s): E-cigarettes with varying concentrations of nicotine & flavor
Intervention type(s): Other
Intervention description(s): Subjects will be asked to vape various e-cigarettes containing e-liquids at three concentrations of nicotine and sweet flavor (9 stimuli per subject).
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess Plasma Ammonia Time-Normalized Area Under the Curve and Rate of Ureagenesis in Healthy Adult Subjects
Condition: Ornithine Transcarbamylase Deficiency
MeSH terms: Ornithine Carbamoyltransferase Deficiency Disease
Study type: Observational

Summary: 
      The objective of the study is to characterize 24-hour plasma ammonia levels, characterize
      urea production rates in healthy normal subjects.
    

Detailed description: 
      During Part 1, eligible subjects will be asked to participate in 3 inpatient visits, each
      lasting up to 3 days (Day -1 to Day 2). Each visit will assess 24-hour ammonia levels in
      plasma and rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate.
      Sodium acetate is used as a tracer to measure the rate of ureagenesis.

      During Part 2, eligible subjects will be asked to participate in 1 inpatient visit, lasting
      up to 3 days (Day -1 to Day 2). The visit will assess 24-hour ammonia levels in plasma and
      rate of urea production for 4 hours following ingestion of [1-13C]sodium acetate. Sodium
      acetate is used as a tracer to measure the rate of ureagenesis.
    

Intervention name(s): No Intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy Volunteers at a Phase 1 unit
      
Biospecimen description: 
      Urine and plasma