bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Glucose on Ocular Blood Flow
Condition: Coronary Vasospasm
MeSH terms: Coronary Vasospasm
Study type: Observational

Summary: 
      The primary objective is to assess the effect of glucose on retinal vascular diameter in
      otherwise healthy vasospastic subjects compared to non-vasospastic controls.

      The secondary objective is to compare the effect of glucose also on choroidal blood flow in
      otherwise healthy vasospastic subjects with non-vasospastic controls.
    

Detailed description: 
      It is known that a glucose load can induce an increase in ocular blood flow. Acute
      hyperglycemia increases retinal vessel diameters in animals and humans. The purpose of this
      study is to compare the effect of glucose on the ocular blood flow in vasospastics and
      nonvasospastics. Body core temperature depends on basal metabolism. Peripheral
      vasoconstriction is a physiological way to preserve core temperature of the body. The
      etiology of primary vasospastic syndrome is unknown and potentially represents simply a
      reaction to a defective metabolism. Based on this hypothesis, vasospastics are expected to
      show a different vascular reaction to glucose.

      On both study days, after an overnight fast, the subjects will be seated for 30 minutes in
      the Lab and local tropicamide will be applied for pupil dilatation. After stabilisation of
      blood pressure Retinal vessel diameter and choroidal blood flow will be assessed. Baseline
      blood glucose levels will be measured. Afterwards study substance (75 gram of Glucose or
      Aspartate) will be applied in 3 dl of water. One and a half hour later, the vascular
      measurements will be repeated. Ath the end of hemodynamic assessments, blood sugar level will
      be measured again.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy vasospastic subjects, healthy non-vasospastic subjects
      
Keywords: glucose; vasospasm; RVA; LDF; vasospastic subjects; non-vasospastic subjects
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Condition: Gram Positive Infection; Concurrent Antibiotic Treatment
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a research study designed to look at the pharmacokinetics (distribution, breakdown,
      and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years
      who have infections that are caused by a specific group of bacteria (called Gram-positive
      bacteria).
    


Intervention name(s): daptomycin
Intervention type(s): Drug
Intervention description(s): i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.
Other intervention name(s): Cubicin
Intervention MeSH terms: Daptomycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Topical Omega-3 Fatty Acids (REMOGEN® OMEGA) in the Treatment of Dry Eye
Condition: Dry Eye Syndromes
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the efficacy of REMOGEN® OMEGA in reducing
      Dry Eye Syndrome (DES) symptoms.
    


Intervention name(s): REMOGEN OMEGA; Povidone
Intervention type(s): Device; Device
Intervention description(s): Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.; Artificial tears: preservative-free eye drops containing 2% povidone.
Intervention MeSH terms: Povidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: tear film; omega-3 fatty acids; eye drops
A Study of EndoChoice's Upper&Lower Endoscopic Systems Utilizing a Full Spectrum Optical Technology
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      EndoChoice's FUSE System enables a wider view range via 1-2 additional cameras (depending on
      the model). These optical properties are to be examined and reviewed in this trial (mainly
      usability and safety)
    

Detailed description: 
      EndoChoice Full Spectrum Optical Technology (FSOT) in gastrointestinal endoscopy enables a
      330 degree field of view. FSOT powers EndoChoice's FDA, CE and AMAR (Israeli medical device
      authority) approved Endoscopic systems (Gastroscope and Colonoscope). The intent of this
      study is to evaluate the safety, performance and usability of additional versions of FSOT-
      powered gastroscopes and colonoscopes.
    

Intervention name(s): Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)
Intervention type(s): Device
Intervention description(s): The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Investigate the Interaction Between Givosiran and a 5-probe Drug Cocktail in Patients With Acute Intermittent Porphyria (AIP)
Condition: Acute Intermittent Porphyria (AIP); Acute Hepatic Porphyria (AHP); Porphyria, Acute Intermittent; Acute Porphyria
MeSH terms: Porphyria, Acute Intermittent; Porphyrias, Hepatic; Coproporphyria, Hereditary; Porphyria, Erythropoietic; Porphyrias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of givosiran on the pharmacokinetics of
      the 5-probe cocktail of midazolam, caffeine, losartan, omeprazole, and dextromethorphan, and
      their metabolites, in asymptomatic patients with Acute Intermittent Porphyria.
    


Intervention name(s): Givosiran; 5-probe cocktail
Intervention type(s): Drug; Drug
Intervention description(s): single dose of givosiran by subcutaneous (sc) injection; includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RNAi therapeutic; Porphyria; Acute Hepatic Porphyria (AHP); Acute Intermittent Porphyria (AIP)
The Relationship Between COVID-19 Anxiety Level and Emotional Eating in Individuals With Metabolic Syndrome
Condition: Metabolic Syndrome; Emotional Eating; COVID-19
MeSH terms: COVID-19; Metabolic Syndrome; Syndrome
Study type: Observational

Summary: 
      The aim was to determine the coronavirus anxiety levels and emotional eating status of cases
      with diagnosis of MetS according to diagnostic criteria published by the International
      Diabetic Federation (IDF) in 2005 and healthy individuals with similar BMI to MetS subjects.
    

Detailed description: 
      The aim was to determine the coronavirus anxiety levels and emotional eating status of cases
      with diagnosis of MetS according to diagnostic criteria published by the International
      Diabetic Federation (IDF) in 2005 and healthy individuals with similar BMI to MetS subjects.
      This study was completed with the descriptive, cross-sectional and relational screening
      model. The full sampling method was used in the study. The study was completed with 105
      individuals with metabolic syndrome attending the diet clinic and 109 healthy individuals
      without MetS diagnosis also attending the diet clinic. Collection of data used anthropometric
      measurements and biochemical findings, blood pressure and a survey form, the Coronavirus
      Anxiety Scale (CAS) and Emotional Eating Scale (EES).
    

Intervention name(s): A survey form was applied to individuals included in the study face-to-face.
Intervention type(s): Procedure
Intervention description(s): This study was completed with a descriptive, cross-sectional and relational screening model
Other intervention name(s): This survey form; Biochemical findings (glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR).; Blood pressure was measured and recorded.; The coronavirus anxiety scale (CAS) and emotional eating scale (EES) were applied.
Intervention MeSH terms: Insulin
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Power analysis was performed using the G*Power (v3.1.9) program to determine the number of
        samples. According to Jacob Cohen's effect size coefficients, it was calculated that there
        should be at least 105 people in the groups for α=0.05 and 1-β=0.95 (95% power) levels,
        assuming that the evaluations between the two independent groups would have a medium effect
        size (d=0.5).
      
Biospecimen description: 
      glucose, HDL, LDL, total cholesterol, triglycerides, CRP, HbA1c, insulin, HOMA-IR
    
Keywords: Metabolic Syndrome; COVID-19; Eating
A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to determine the dose response and duration of action of GSK2190915 in
      mild asthmatic adult subjects who experience exercise-induced bronchoconstriction.
    

Detailed description: 
      This study is intended to determine the dose response and duration of action of GSK2190915 in
      mild asthmatic adult subjects who experience exercise-induced bronchoconstriction. Subjects
      will be invited to complete a screening visit, during which time exercise induced
      bronchoconstriction must be demonstrated, defined as a decrease between 20-40% in FEV1
      compared to baseline immediately following exercise challenge. Eligible subjects will
      complete a randomized, double-blind, five-way crossover study. Subjects will be randomized to
      a single dose of either 10 mg, 50 mg, 100 mg, 200 mg GSK2190915, or placebo during each
      treatment period. Each treatment period will last 2 days and will include various assessments
      following exercise challenge at 2, 9.5, and 24 hours post dose. A minimum 7 day washout
      between treatment periods will be required. Regardless if a subject completes or prematurely
      withdraws from the study, a follow up visit will be completed 7-21 days following last dose.
    

Intervention name(s): Placebo; GSK2190915
Intervention type(s): Drug; Drug
Intervention description(s): The current study will include a placebo arm to allow for a valid evaluation of adverse events attributable to GSK2190915 versus those independent of GSK2190915.; This study will assess FEV1 at various intervals following exercise challenge in subjects who have been administered a single dose of 10 mg, 50 mg, 100 mg, or 200 mg GSK2190915, compared to a placebo control.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Asthma, Exercise Induced Asthma, Exercise Induced Bronchospasm
Study Examining PrEP-001 in Healthy Subjects
Condition: Influenza A H3N2
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2 study, looking at the prophylactic efficacy, safety and tolerability to a repeated
      nasal dose of study drug after being infected with Influenza A/Perth/16/2009 (H3N2) virus.
    

Detailed description: 
      Screening took place up to 90 days before quarantine. Volunteers completed an informed
      consent and underwent screening assessments to determine their eligibility.

      There were 2 study groups:

      Cohort A: (Sentinel): determined the Challenge Virus infection rate after inoculation with
      Influenza Virus on Day 0. There was 12 subjects (open label, no randomisation) invited to
      attend Quarantine on Day -2 or -1.

      Cohort B: Examined the prophylactic efficacy, safety and tolerability of PrEP-001 compared to
      placebo (randomised 1:1). Subjects attended on Day -4/-3, dosed with PrEP-001 or Placebo on
      Day -2 AND Day-1 and then challenged with virus (volume confirmed from Cohort A) on Day 0.

      Volunteers remained in quarantine unit for 8 days after inoculation.

      At day 28, end of study visit, volunteers seen and assessed by a study physician for
      well-being, on-going symptoms and adverse events.
    

Intervention name(s): PrEP-001; Placebo Comparator
Intervention type(s): Drug; Other
Other intervention name(s): JNJ-43260295-AAM; G-004
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Extinction Learning in Adults With Tourette Syndrome
Condition: Tourette Syndrome; Habit Reversal Training; Tic Disorders; Tics; Comprehensive Behavioral Intervention for Tics
MeSH terms: Tourette Syndrome; Tic Disorders; Syndrome
Study type: Interventional

Summary: 
      Aversive sensory phenomena such as premonitory urges play a central role in the behavioral
      treatment model of tics. Extinction learning and extinction recall are learning processes
      implicated within this model, but are still understudied for individuals with Tourette
      syndrome (TS). This study examines extinction learning and extinction recall in adults with
      TS using an experimental task. This study will also explore the relationship between
      extinction processes (i.e., extinction learning and extinction recall) and treatment outcomes
      with behavior therapy. Findings from this investigation will be used to update the behavioral
      treatment model, which serves as the basis for evidence-based behavioral interventions.
    


Intervention name(s): Habit Reversal Training
Intervention type(s): Behavioral
Intervention description(s): Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Extinction Learning; Comprehensive Behavioral Intervention for Tics; Behavior Therapy; Habit Reversal Training; Tourette's Disorder
Fish Oil and Green Tea Extract in Preventing Prostate Cancer in Patients Who Are at Risk for Developing Prostate Cancer
Condition: Precancerous Condition; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Precancerous Conditions
Study type: Interventional

Summary: 
      RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing,
      or coming back. The use of fish oil and/or green tea may prevent prostate cancer.

      PURPOSE: This randomized clinical trial is studying how well a fish oil and/or green tea
      supplement works in preventing prostate cancer in patients with prostatic intraepithelial
      neoplasia or who are at risk for developing prostate cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the cancer preventing effects of fish oil supplementation and green tea
           extract use on markers of alteration in lipid metabolism in prostate tissue samples.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      stratified according to age (under 65 vs 65 and over). Patients are randomized to 1 of 4
      treatment arms.

        -  Arm I: Patients receive oral fish oil three times daily and oral green tea extract twice
           daily.

        -  Arm II: Patients receive an oil placebo three times daily and oral green tea extract
           twice daily.

        -  Arm III: Patients receive oral fish oil three times daily and a placebo twice daily.

        -  Arm IV: Patients receive an oil placebo three times daily and another placebo twice
           daily.

      Treatment in one of the above-listed arms continues for up to 20 weeks in the absence of
      disease progression or unacceptable toxicity.

      All patients undergo a prostate biopsy on the last day of study treatment.

      After completion of study treatment, patients receive a follow-up phone call at/around 30
      days later.

      PROJECTED ACCRUAL: A total of 144 patients will be accrued for this study.
    

Intervention name(s): green tea catechin extract; fish oil; placebo; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other; Other
Intervention description(s): Given orally 2 times/day; Given orally 3 times/day; Given olive oil placebo orally 3 times/day; Given green tea placebo orally 2 times/day
Other intervention name(s): Polyphenon E; omega-3 fatty acid, n-3 fatty acid, omega-3 polyunsaturated fatty acid, omega-3 PUFA; PLCB, olive oil; PLCB
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: prostate cancer; precancerous condition
Application of Ultrasound Integrated Precision Diagnosis Technology in Prevention of Kidney Disease and Its Progress
Condition: Diagnostic Imaging; Diagnosis; Kidney Disease
MeSH terms: Kidney Diseases; Disease
Study type: Observational

Summary: 
      In this study, a prospective, randomized and controlled clinical study would be carried out
      to establish Ultrasound Integrated Precision Diagnosis Technology with elastography as the
      core technology to evaluate renal injury and repair comprehensively and accurately, and to
      improve the clinical diagnosis chance of renal injury (or renal fibrosis).

      Combined with the dynamic changes of biomarkers (inflammatory factors, cytokines secreted by
      immune cells, etc.) after kidney injury, the research on the prognosis of kidney disease with
      ultrasound elastography technology as the core would be explored, which aims to provide a
      scientific basis for the application of Ultrasound Integrated Precision Diagnosis Technology.
    


Intervention name(s): Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)
Intervention type(s): Diagnostic Test
Intervention description(s): Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        For A on C group:18-70 years old patient who can cooperate with breath-holding,
        breath-holding and breath-exhaling movements, and communicate without obstacles, signed
        informed consent and with abnormal renal pathology or glomerular filtration rate(GFR) (15
        <GFR<90 ml/min.1.73 m2) or proteinuria > 1 g/24 h due to any cause.

        For fDGF in kidney transplantation patient :18-65 years old patient who can cooperate with
        breath-holding, breath-holding and breath-exhaling movements, and communicate without
        obstacles, signed informed consent and received Kidney transplant recipients in our
        hospital from May 2019 to November 2019.
      
Keywords: Ultrasound Elastography; Ultrasound Integrated Precision Diagnosis Technology; Acute on Chronic Kidney Disease; Kidney transplantation; kidney fibrosis
The Influence of Oxytocin on the Processing of Social Contact
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Social touch can convey the most potent and salient of socio-emotional signals. While the
      hypothalamic peptide oxytocin (OXT) has been identified as a key neurochemical mediator of
      grooming in some other social species, its modulatory influence on human interpersonal touch
      is unknown. The investigators expect that OXT augments the hedonic value of touch and that
      this behavioral effect is paralleled at the neural level by an increased response in brain
      areas mediating rewarding aspects of social touch.
    


Intervention name(s): Placebo; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): intranasal application, sodium chloride solution, 3 puffs per nostril; 24 IU Oxytocin, intranasal application 45 min prior to the experiment
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Oxytocin; fMRI
a Low-residue Diet for Bowel Preparation
Condition: Colon Polyp; Colorectal Adenoma
MeSH terms: Adenoma
Study type: Interventional

Summary: 
      Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve
      better bowel preparation quality compared with a self-prepared LRD. However, up to now, there
      has been no widely acceptable standard of LRD for bowel preparation. Moreover, these
      prepackaged LRD adopted in previous studies mainly consisted of traditional foods without
      further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically
      designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD
      on bowel preparation for colonoscopy with self-prepared LRD by patients.
    


Intervention name(s): Prepackaged Low-residue diet; Self-prepared Low-residue diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.; Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Bowel preparation; Polyp; adenoma
The Effect of Diet Composition on Performance, Expenditure, Blood Lipids, and Appetite Hormones in Highly Trained Cyclists
Condition: Endurance Cycling Performance
Study type: Interventional

Summary: 
      This study employs a crossover design to evaluate the effect of two different diets (high
      carbohydrate vs. ketogenic) and corresponding test meals on endurance exercise performance,
      energy expenditure including resting metabolic rate and thermic effect of food, postprandial
      responses of blood lipids, glucose and appetite hormones, and cognitive function and mood
      states.
    

Detailed description: 
      Traditionally, a high carbohydrate diet is recommended for elite endurance athletes and
      sub-elite, highly trained recreational athletes competing in endurance events. However,
      recently the ketogenic diet (extremely low carbohydrate content) has become popular in these
      populations. The effect on endurance exercise performance, energy expenditure, postprandial
      blood profiles, and cognitive function and mood states requires further investigation.

      In this study, highly trained recreational cyclists and triathletes will adhere to each diet
      (high-carbohydrate and ketogenic) for 14 days in a crossover design. Experimental trials at
      baseline and after each diet will evaluate endurance cycling performance (time trial),
      resting energy expenditure, the thermic effect of food of test meals corresponding in
      composition to each diet, postprandial responses of blood lipids, glucose and appetite
      hormones, and cognitive function and mood states.
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Participants will consume each diet for 14 days in a crossover design.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science