bioihbjkbjnl/mcl2 huggingface dataset:
The Model Building and Empirical Research of Eye Health Interventions for Children
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Eye Health Intervention can obviously
      reduce and delay myopia onset and development and improved the awareness rate of knowledge
      apparently .
    


Intervention name(s): eye health education
Intervention type(s): Behavioral
Intervention description(s): give a lecture and issue knowledge manual for children and parents ,6 months once , 2.5 years
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: myopia
Pharmacokinetic and Exploratory Electrocardiogram (ECG) Study
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen
      of 4.8 mg over 6 hours. In addition it will compare the electrocardiogram (ECG) changes, if
      any, from this dosing regimen to that of a single dose of moxifloxacin 400 mg, a positive
      control for the corrected QT interval (QTc) prolongation.
    

Detailed description: 
      This study will characterize the pharmacokinetics of colchicine after an oral dosing regimen
      of 4.8 mg over 6 hours. In addition, it will determine whether or not there is a trend toward
      effect of this high dose regimen on the electrocardiogram (ECG), mainly the corrected QT
      interval (QTc), via comparison to a 400 mg dose of moxifloxacin, a positive control for QTc
      prolongation. Eighteen healthy, non-smoking, non-obese, non-pregnant adults between the ages
      of 18 to 55 years of age will be randomized in a double blind fashion to either the
      colchicine or moxifloxacin treatment groups. On the day prior to the study (Day -1), subjects
      will receive colchicine and moxifloxacin placebos according to the same schedule and
      conditions as will be present during the study, and baseline ECG's will be determined by 24
      hour 12-lead Holter monitoring. On Day 1, after a minimum 10 hour overnight fast, subjects
      enrolled in the colchicine treatment group (N=15) will receive two 0.6 mg capsules (plus one
      dose moxifloxacin placebo) followed by an additional 0.6 mg colchicine dose (plus one dose
      moxifloxacin placebo) every hour for 6 additional doses; subjects in the moxifloxacin
      treatment group will receive placebo doses matching the colchicine treatment group over the
      first 5 hours, then 400 mg moxifloxacin (plus one dose colchicine placebo) at the 6 hour
      point. Fasting will continue for 4 hours after the first dose at which time a standardized
      meal will be served. Blood will be drawn from all participants at times sufficient to
      adequately define the pharmacokinetics of colchicine. During the study, continuous 24-hour
      ECG monitoring via 12-lead Holter monitor will be performed. Triplicate ECG records will be
      extracted from 5 minute observation periods throughout the 24 hours post dose. Finally, all
      study subjects will be monitored for adverse effects throughout the entire study period.
    

Intervention name(s): Colchicine; Moxifloxacin
Intervention type(s): Drug; Drug
Intervention description(s): two 0.6 mg capsules (1.2 mg dose) followed by an additional 0.6mg capsule every hour for 6 additional doses; 400 mg capsule at the 6 hour point
Other intervention name(s): COLCRYS TM
Intervention MeSH terms: Moxifloxacin; Colchicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: healthy
Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-groups of Patients Suffering From Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial will be conducted as a prospective, randomized, multinational, multicenter,
      double-blind, placebo and active controlled trial in 4 parallel-groups of patients suffering
      from seasonal allergic rhinitis.
    


Intervention name(s): Mometasone; Azelastine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Mometasone furoate nasal spray (50 mcg per actuation); Azelastine hydrochloride nasal spray (140 mcg per actuation); Placebo nasal spray
Intervention MeSH terms: Mometasone Furoate; Azelastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
First Time in Human Study (FTIH) With Positron Emission Tomography (PET)
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study described in the present protocol consists of two sections. Part A is the first
      administration into man to evaluate the safety, tolerability and pharmacokinetics of single
      ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled
      design in healthy male and female (of non-childbearing potential) subjects. Part B will be an
      open-label design in healthy male subjects to assess the GSK1144814 neurokinin-1 (NK1)
      receptor occupancy by positron emission tomography (PET) scanning with [11C]-GR205171
    

Detailed description: 
      GSK1144814 is a dual neurokinin-1 (NK1) and neurokinin-3 (NK3) antagonist with the potential
      to treat schizophrenia & depression.

      This study described in the present protocol consists of two sections. Part A is the first
      administration into man to evaluate the safety, tolerability and pharmacokinetics of single
      ascending doses of GSK1144814. The study is a single-blind, randomised, placebo-controlled
      design in healthy male and female (of non-childbearing potential) subjects. Part B will be an
      open-label design in healthy male subjects to assess the GSK1144814 NK1 receptor occupancy by
      positron emission tomography (PET) scanning with [11C]-GR205171.
    

Intervention name(s): GSK1144814; GSK1144814; GSK1144814
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose.; Single dose which may be split in up to three divided doses given 2 to 3 hours apart.; Single dose that may be split in up to three divided doses given 2 to 3 hours apart.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; safety; positron emission tomography (PET); single ascending dose
Bioequivalence Between WE 941 OD and Brotizolam (Lendormin®) Taken With Water in Healthy Adult Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The bioequivalence of WE 941 OD tablets prepared in oral disintegrating tablet form and
      brotizolam conventional tablets (Lendormin® tablets), both taken with water, was evaluated in
      healthy adult male subjects.
    


Intervention name(s): WE 941 OD tablets; Brotizolam
Intervention type(s): Drug; Drug
Other intervention name(s): Lendormin®
Intervention MeSH terms: Brotizolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Detection of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Activity in Rectal Tissues From Human Subjects
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      This is a pilot study. The purpose of the study is to facilitate the development of a new
      biomarker of cystic fibrosis transmembrane conductance regulator (CFTR) function using rectal
      tissue.
    

Detailed description: 
      CF research has advanced to the point where small molecule agents have been developed to
      overcome the underlying genetic defects caused by CFTR mutations.

      There is a critical need to develop new sensitive biomarkers of CFTR function and
      biochemistry that can be used in early phase clinical trials to demonstrate biologic effects
      of investigative agents in vivo. Intestinal Current Measurement (ICM) from rectal biopsy
      samples is an assay that has been proven to be sensitive and specific for CFTR function. This
      method and site of investigation is particularly attractive, since CFTR is expressed at high
      levels in the rectum, it is not altered by disease manifestations, and the tissue can be
      studied ex vivo, providing more flexibility in the nature of the techniques to detect and
      quantify CFTR activity.

      This study will aid in the development of new biomarkers in human rectal tissue for use in CF
      clinical trials. Testing compounds that are designed to restore function to disease-causing
      CFTR genes and proteins will provide an opportunity to improve and standardize techniques in
      the acquisition and measurement of CFTR activity in rectal biopsy specimens.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Non-CF subjects: Adults undergoing endoscopic procedures (colonoscopies) who meet the
        eligibility criteria.

        CF subjects: Adults with a diagnosis of CF who meet the eligibility criteria. CF subjects
        can include both patients who will be undergoing endoscopic (colonoscopies) and
        nonendoscopic procedures requiring anesthesia or sedation as a part of clinical care (e.g.,
        sinus surgery, central line placement), or CF subjects not undergoing planned
        surgical/anesthetic procedures.
      
Biospecimen description: 
      Rectal biopsy
    
Keywords: cystic fibrosis; cystic fibrosis transmembrane conductance regulator; biomarkers; Intestinal Current Measurement
Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD)
      characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.
    


Intervention name(s): HSK7653 10 mg; HSK7653 25 mg; HSK7653 50 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, HSK7653 10 mg Q2W, 12 weeks; Tablet, HSK7653 25 mg Q2W, 12 weeks; Tablet, HSK7653 50 mg Q2W, 12 weeks; Tablet, 0 mg Q2W, 12 weeks
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cruciferous Vegetable Intake and Histone Status in Screening Colonoscopy Patients
Condition: Colon Cancer
MeSH terms: Colonic Neoplasms
Study type: Observational

Summary: 
      This research study will assess cruciferous vegetable intake in patients presenting for
      screening colonoscopy and correlate intake with histone status and histone deacetylace (HDAC)
      expression in tissue biopsy specimens and peripheral blood mononuclear cells (PBMCs). The
      investigators will also measure sulforaphane (SFN) metabolites in blood as a biomarker of
      cruciferous vegetable intake.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients scheduled for screening colonoscopy
      
Biospecimen description: 
      Protein lysate and RNA obtained from de-identified normal colon biopsy specimens are stored
      at -80 degree centigrade.
    
Keywords: Colon cancer; Prevention; Cruciferous vegetables; Histone status
Therapeutic Ultrasound in the Treatment of Migraine
Condition: Migraine; Ultrasound
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      Headache affects the daily quality of life of patients. It has been reported that headaches
      may be associated with neck muscles, neck movements and trigger points in the neck Drug and
      non-drug treatments can be used today in the treatment of headaches. Various physical
      therapies are applied to cranial and cervical regions in non-drug therapies. Therapeutic
      ultrasound, Transcutaneous Electrical Nerve Stimulation (TENS), Hotpack and manipulation are
      some of them.This is a randomised placebo- controlled trial to determine the efficacy of the
      therapeutic ultrasound in the treatment of migraine.
    

Detailed description: 
      Evidence from controlled studies suggests that non-invasive physical therapies may help
      prevent headaches. Therapeutic ultrasound studies have generally been used in combination
      with other physical therapies.

      Therapeutic ultrasound is known to act in two different ways, thermal and non-thermal. With
      thermal effect, it is possible to reduce pain and joint joints and increase local blood flow,
      while stimulating tissue regeneration, soft tissue repair, blood flow regulation in chronic
      ischemic tissues and protein synthesis with nonthermal effect. In addition, its effect on
      inflammation accelerated repair by affecting cell activities, altering platelet membrane
      permeability, leading to the release of serotonin and accelerating wound healing.

      The aim of this study is to determine whether therapeutic ultrasound is superior to placebo
      ultrasound in the treatment of migraine.
    

Intervention name(s): therapeutic ultrasound; placebo ultrasound
Intervention type(s): Device; Device
Intervention description(s): Patients in the ultrasound group will be administered to the posterior neck region for 5 minutes in pulsed mode (pulse rate 1: 1) at 1 MHz, 1.5 W / cm2. The treatment will be done 5 days a week for a total of 10 days; When the ultrasonic device is in the closed position, the ultrasonic probe will be applied for 5 minutes in the posterior neck region of the patients. The treatment will be done 5 days a week for a total of 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized,placebo- controlled, double blind
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: migraine, therapeutic ultrasound, pain, disability
Valuation of Variable Dose of Docosahexanoic Acid for the Improvement of the Parameters of Male Fertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional

Summary: 
      Sperm parameters will be examined before DHA (DHA=Docosahexanoic Acid) consumption, after one
      months and after 2 months taken Docosahexanoic Acid or placebo.
    

Detailed description: 
      Prospective, randomized, double blind, placebo-controlled intervention study within
      individuals. Assisted reproduction unit and academic research laboratory. One hundred an
      eighty human semen samples from 60 infertile patients of IVI Sevilla clinic were finally
      included. Assessment of oxidative stress, apoptosis, lipid peroxidation, mitochondrial
      membrane potential, DNA fragmentation and standard sperm parameters before and after
      supplementation with different DHA doses (0.5, 1 and 2 g) or placebo for 1 and 3 months.
    

Intervention name(s): DHA; Placebo
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Docosahexaenoic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Docosahexanoic Acid,; DNA fragmentation; male fertility; Sperm parameters improvements
Blood Pressure Responses to Different Exercise Modes in Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The purposes of this study were to compare blood pressure responses of the same target heart
      rate on different exercise modes in patients with coronary artery diseases (CAD) and to
      compare the effects of blood pressure responses after exercise training.

      The investigators will recruit 30 subjects with CAD who are referred to phase II
      cardiopulmonary rehabilitation exercise training. The subjects performed the treadmill or
      stationary bicycle exercise randomly.
    

Detailed description: 
      Considering cardiopulmonary rehabilitation intensity is often setting by heart rate
      clinically, and only few study focused on exercise responses patients with CAD, the purposes
      of this study were to compare blood pressure responses of the same target heart rate on
      different exercise modes in patients with CAD and to compare the effects of blood pressure
      responses after exercise training.

      This is a crossover trial study. The investigators will recruit 30 subjects with CAD who are
      referred to phase II cardiopulmonary rehabilitation exercise training. After at least 3 times
      of familiar with the cardiopulmonary rehabilitation training machine, the subjects performed
      the treadmill or stationary bicycle and exercise to personalized target heart rate for 10
      minutes, take a rest until the heart rate recover to the resting heart rate, and then
      repeated the exercise in another exercise mode. The test order will be random. After at least
      12 times of cardiopulmonary rehabilitation training, the test will be performed again.
    

Intervention name(s): exercise
Intervention type(s): Other
Intervention description(s): The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: coronary artery disease; blood pressure; rehabilitation; exercise mode
Low-Dose Ketamine in Children With ADNP Syndrome
Condition: ADNP Syndrome
MeSH terms: Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase 2A, single dose, open-label study to evaluate the safety, tolerability, and
      efficacy of a low-dose, 40-minute infusion into the veins (intravenous infusion or "IV") of
      ketamine in children with ADNP syndrome (Activity-Dependent Neuroprotective Protein). The
      study team will enroll 10 participants, ages 5 to 12, at Mount Sinai. The study participation
      is expected to last 4 weeks and will include 5 scheduled clinic visits in order to complete
      safety monitoring, clinical assessments, and biomarker collection. At the conclusion of this
      study, the study team expects to demonstrate the safety and tolerability of low-dose ketamine
      in children with ADNP syndrome. Additionally, the study team anticipates identifying
      meaningful signals of efficacy in clinical outcome measures using RNA and DNA sequencing to
      analyze ADNP protein expression and DNA methylation profiles, a natural process by which
      methyl groups are added to the DNA to change its activity, in order to assess sensitivity to
      change with low-dose ketamine treatment and inform future phase 3 studies. Ketamine is not
      currently approved by the Food and Drug Administration to treat this syndrome, but it is
      approved for use in children in other situations, for example in anesthesia.
    


Intervention name(s): Ketamine
Intervention type(s): Drug
Intervention description(s): A single 40-minute intravenous infusion
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ketamine; ADNP; Activity-Dependent Neuroprotector Protein; Chromosome Disorders; Chromosome Aberrations
Weight Outlooks by Restriction of Diet and Sleep
Condition: Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether chronic moderate sleep restriction effects
      the amount of body fat and lean mass loss, and calorie expenditure, in individuals who are
      participating in a dietary weight loss program.
    

Detailed description: 
      Participants will be randomly assigned to an 8-week program of either restricted diet alone,
      or restricted diet with restricted sleep for 5 days a week. The total expected duration of
      participation is approximately 3 months.
    

Intervention name(s): Calorie restriction only; Sleep & calorie restriction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.; Participants randomly assigned to this group will be instructed to reduce their total time in bed by 90 minutes 5 days a week, in addition to restricting their dietary intake to approximately 95% of their resting metabolic rate.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: body composition; anthropometry
Effects of Epicatechin on Functional Capacity, Skeletal Muscle Structure and Diastolic Function in Patients With Heart Failure With Preserved Ejection Fraction (HFPEF)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The major goal of this proposal is to characterize the ability of epicatechin which a
      component of dark chocolate to improve the

        1. structural and functional features of skeletal muscle (SkM)

        2. exercise capacity (as assessed by VO2 max)

        3. parameters of diastolic heart function (as assessed by echocardiography)

      We propose that a 3 month treatment with epicatechin (through CocoaVia® capsules) will lead
      to a significant improvement in exercise capacity and diastolic function.
    

Detailed description: 
      Patient Inclusion/Exclusion Criteria:

        1. New York Heart Association Class II/III HF with preserved ejection fraction (EF) of
           >50%.

        2. Nonsmokers

        3. Subject not taking Coumadin, Xarelto, Prasugrel or Pradaxa. Patients on Plavix for drug
           eluting stent will not be excluded.

        4. Ages between 40-65. We will exclude any women of child bearing potential
    

Intervention name(s): CocoaVia
Intervention type(s): Dietary Supplement
Intervention description(s): CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
Other intervention name(s): Epicatechin consumption
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: with preserved ejection fraction of >55%
A Safety, Tolerability and Pharmacokinetic Study of ABT-102 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      three different strengths of an investigational product dosed twice a day over 7 days in
      healthy subjects.
    


Intervention name(s): ABT-102; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BID tablets, 7 days of treatment; BID tablets, 7 days of treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment