bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Megace F and Megace OS Under Fasting and Fed Conditions in Healthy Male Volunteers
Condition: Cachexia; Anorexia
MeSH terms: Anorexia; Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study of Megace F will be conducted to investigate pharmacokinetics and safety
      compared to Megace OS.

      Phase I study divided into 3 parts written as belows.

      Part 1 Megace F in fasting volunteers vs Megace F in fed volunteers Part 2 Megace F vs Megace
      OS in fed volunteers Part 3 Megace F vs Megace OS in fasting volunteers
    


Intervention name(s): Megace F; Megace OS
Intervention type(s): Drug; Drug
Intervention description(s): Megace F oral suspension; Megace oral suspension
Intervention MeSH terms: Megestrol Acetate; Megestrol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence of Two Somatropin Products (Norditropin® Versus Genotropin®) in Healthy Adult Volunteers
Condition: Genetic Disorder; Prader-Willi Syndrome; Growth Disorder; Idiopathic Short Stature; Healthy
MeSH terms: Dwarfism; Prader-Willi Syndrome; Genetic Diseases, Inborn; Growth Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in United States of America (USA). The aim of this trial is to
      examine the bioequivalence of Norditropin® versus Genotropin® in healthy adult volunteers.
    


Intervention name(s): somatropin; somatropin
Intervention type(s): Drug; Drug
Intervention description(s): A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen; A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Epidemiology of TST Change in Korea
Condition: Tuberculosis; Latent Tuberculosis
MeSH terms: Tuberculosis; Latent Tuberculosis
Study type: Observational

Summary: 
      TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC
      recommendation. Participants with chest radiograph showing active TB lesion are excluded from
      this study.
    

Detailed description: 
      Enroll criteria

        -  A term of whole military conscripts per year in one Reserve Force Battalion

        -  Military conscripts gather from all around area in Korea randomly

        -  Each participant undertake a chest X-ray (CXR) and blood tests including human
           immunodeficiency virus (HIV) at the start of initiatory training.

      Exclusion Criteria

        -  Chest X-ray suggesting active TB

        -  HIV positive in serology

      Design

        -  After giving informed consent, all participants receive one-step TST following standard
           procedures.

        -  The largest transverse diameter of induration is measured 48-72hr after injection.

        -  The investigator and these trained nurses were blinded to the status of their
           demographic characteristics.
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A term of whole military conscripts per year
Relative Bioavailability of ESK-001 Tablet Versus Liquid in Healthy Participants
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, in-house, open-label, crossover study in 15 healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.)
    

Intervention name(s): ESK-001; Rabeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablet or liquid; Oral Tablet
Intervention MeSH terms: Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized, Single Center Pilot Study Comparing Hyaluronic Acid to Vaginal Estrogen for Treatment of Genitourinary Syndrome of Menopause
Condition: Genitourinary Syndrome of Menopause (GSM)
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Non-hormonal alternatives for the treatment of genitourinary syndrome of menopause (GSM) are
      needed. In this proposed trial, patients who are diagnosed with GSM will be randomized to
      receive either a hyaluronic acid (HLA) vaginal insert or vaginal estrogen topical cream for
      12 weeks. There will be a baseline visit and an 12 week follow up visit, at which points the
      patient will undergo a detailed history and physical examination including a pelvic exam,
      vaginal pH sampling, vaginal cell sample for microscopic analysis, and will fill out a
      vulvovaginal symptom questionnaire (VSQ). These study arms will be analyzed to assess the
      efficacy of HLA as compared to the gold standard of vaginal estrogen to treat GSM symptoms.
    


Intervention name(s): Revaree; Estrace
Intervention type(s): Device; Drug
Intervention description(s): Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.; Vaginal estrogen cream, estradiol: 100mcg
Other intervention name(s): HLA Vaginal Insert; Vaginal estrogen cream
Intervention MeSH terms: Estrogens; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Chronic Circadian Disruption vs. Chronic Sleep Restriction on Metabolism
Condition: Aging; Sleep Restriction; Circadian Disruption
Study type: Interventional

Summary: 
      The overall objectives of the proposed study are to examine the consequences of chronic
      circadian disruption and chronic sleep restriction on metabolic function in healthy adults.
    

Detailed description: 
      It has long been recognized that sleep patterns change with age. A common feature of aging is
      the advance of the timing of sleep to earlier hours, often earlier than desired. These
      age-related changes are found in even healthy individuals who are not taking medications and
      who are free from sleep disorders. In addition to these sleep disturbances, many older
      individuals curtail their sleep voluntarily, reporting similar rates of sleep restriction
      (sleeping less than 7 or less than 6 hours per night) when compared to young adults. Whether
      voluntary or not, insufficient sleep has medical, safety and metabolic consequences. In fact,
      converging evidence in young adults suggests that sleep restriction per se may impair
      metabolism, and that reduced sleep duration is associated with weight gain, obesity,
      diabetes, cardiovascular disease, and mortality. An understanding of how the circadian and
      sleep homeostatic neurobiological processes responds to increasing homeostatic sleep
      pressure, and the effects of sleep restriction on metabolism at different ages, should
      provide information on the regulation of sleep and metabolism in aging, as well as direction
      for future treatments. In the present study, we will study the separate impacts of chronic
      sleep restriction (while minimizing circadian disruption) and chronic circadian disruption
      (while minimizing sleep disruption) and a poor diet on metabolism.
    

Intervention name(s): Circadian Disruption; Sleep Restriction; Control
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Following a baseline of adequate time in bed, study participants will spend 3 weeks on a daily jet-lag schedule (where each day is longer than 24 hours).; Following a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks).; Following a baseline of adequate time in bed, study participants will continue to have adequate time in bed and opportunity for sleep during each 24-hour day, for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Sleep; Aging; Metabolism; Circadian; Genetic; Alertness
Study to Evaluate the Safety and Immunogenicity of MG1109 in Healthy Adult Volunteers
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study was designed in two steps with Step 1, a single-center, double-blind, randomized
      clinical Pilot study and Step 2, a multi-center, single-blind, randomized clinical Pivotal
      study. The investigator evaluate the immunogenicity and safety of the investigational vaccine
      in the subjects during their participation in the study.
    

Detailed description: 
      MG1109 is purified, inactivated influenza viral antigen.
    

Intervention name(s): Step 1; Step 2
Intervention type(s): Biological; Biological
Intervention description(s): Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days; Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Avian influenza
Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel
      formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted
      healthy male subjects.
    

Detailed description: 
      The purpose of this study is to determine the bioavailability of 0.5mg dutasteride in a novel
      formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted
      healthy male subjects. This will be an open-label, single dose, randomized, two-period
      crossover study in healthy male subjects. Subjects will receive a single oral dose 0.5mg
      novel dutasteride formulation and a single oral dose 0.5mg dutasteride soft gel capsule in a
      fasted state. Each dose of the study medication will be separated by a 28-day washout period.
      Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.
      Safety will be assessed by measurement of blood pressure, heart rate, laboratory data, and
      review of adverse events. The study will enrol approximately 35 healthy male subjects to
      ensure that 30 subjects complete the study. The study will be conducted in the USA.
    

Intervention name(s): dutasteride; dutasteride
Intervention type(s): Drug; Drug
Intervention description(s): novel dutasteride; dutasteride soft gel capsule
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dutasteride; cross over study; bioavailability
Addressing Involuntary Movements in Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether fixed-doses of an investigational drug,
      SD-809 (deutetrabenazine), will reduce the severity of abnormal involuntary movements of
      tardive dyskinesia.
    


Intervention name(s): SD-809; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.; Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.
Other intervention name(s): deutetrabenzine; Austedo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms
Breathing Relaxation Exercise Heart Failure
Condition: Congestive Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The aim of the study is to determine the effect of breathing and relaxation exercises on
      dyspnea, fatigue and self-care level in heart failure patients.
    

Detailed description: 
      The Effect of Breathing and Relaxation Exercise on Dyspnea, Fatigue and Self-Care Level in
      Patients with Heart Failure: A Randomized Controlled Study It was planned according to
      CONSORT rules as a randomized controlled study to determine its effect on self-care level.

      The hypotheses of the research are as follows:

      a: Breathing exercise applied to HF patients has an effect on the mean dyspnea score. b:
      Breathing exercise applied to HF patients has an effect on the mean fatigue score. c:
      Breathing exercise applied to HF patients has an effect on self-care mean scores. d:
      Relaxation exercise applied to HF patients has an effect on the mean dyspnea score. e:
      Relaxation exercise applied to HF patients has an effect on the mean fatigue score.

      f: Relaxation exercise applied to HF patients has an effect on self-care mean scores.
    

Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): intervention group
Other intervention name(s): breathing and relaxation exercise
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The universe of the research; all heart failure patients. In order to determine the sample
        of the study, a similar study Lopes et al. (2018) considering the data obtained from the
        study, power=0.80, α=0.05 and β=0.20 were calculated. It was determined that 80% power
        could be reached if the study was conducted with at least 20 individuals in each group, at
        a significance level of p<0.05, with a medium effect size (ES: 0.5) in independent groups,
        with a 95% confidence interval. As a result of the calculation, taking into account the
        problems that may arise during the study process, it is planned to sample a total of 75
        patients, 25 patients in each group (intervention group (yoga breathing and progressive
        relaxation exercise group) and control group).
      
Keywords: heart failure, breathing exercise, relaxation exercise
Silicone Gel Versus Onion Extract Gel as Prevention for Postsurgical Scars
Condition: Hypertrophic or Keloid Scars
MeSH terms: Keloid
Study type: Interventional
Phase: Phase 3

Summary: 
      Hypertrophic or keloid scars develop for about 39% to 68% of patients after surgery. The
      subjective opinion of the patient regarding the scar will often constitute the standard for
      judging the success or failure of the procedure. Surgical scars are not only a cosmetic
      concern but they can also cause pain, itching, discomfort, contracture, and other functional
      impairment. Various treatment options exists for treating hypertrophic scars and keloids,
      including intralesional steroid injection, dermabrasion, pressure therapy, surgical excision,
      radiotherapy, cryotherapy, pulse dye, and carbon dioxide laser ablation. However, these
      treatments often require multiple visits and have limited success. Therefore, prevention and
      early recognition of hypertrophic scars and keloids are very important in their management.

      Among preventive treatments available, silicone gel and onion extract gel have been marketed
      as products to improve the appearance and texture of surgical scars. Despite its popularity,
      data demonstrating the efficacy of these gels are lacking. Furthermore, there is no
      comparative study of silicone gel and onion extract gel for preventing postsurgical
      hypertrophic or keloid scars. The investigators therefore conducted this randomized
      controlled trial to compare the efficacy of silicone gel and onion extract gel for the
      prevention of postsurgical hypertrophic scars. The investigators also compared patient
      compliance and side effect between two topical gels.
    


Intervention name(s): Silicone gel Kelo-cort™;; Onion extract gel Contractubex™
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
POCone-UBiT-IR300 Pediatric Comparison Study
Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare between the POCone® to the UBiT®-IR300 in measuring
      13CO2/12CO2 ratio in breath samples when used together with the BreathTek® UBT (urea breath
      test) Kit and the pUHR-CA web-based software program in identifying H. pylori infection in
      pediatric subjects.
    

Detailed description: 
      The same patients will be tested on both the POCone® and UBiT®-IR300. If the patients test
      positive for H. pylori, they will be given eradication medication and brought back in for a
      re-test.
    

Intervention name(s): Pranactin citric solution
Intervention type(s): Other
Intervention description(s): All patients were required to drink the pranactic citric solution to diagnose H.pylori.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Helicobacter pylori
Efficacy of Long Term Plavix Therapy Post Angioplasty
Condition: Percutaneous Coronary Intervention
Study type: Interventional

Summary: 
      1010 patients post stenting were enrolled to receive Plavix more than 12 months and less than
      that and rate of bleeding, complication and major cardiovascular adverse events ( MACE) were
      compared to evaluate safety and feasibility of long term Plavix therapy post stenting.
    

Detailed description: 
      1010 patients from registry of angioplasty and stenting in Shiraz and Baghiatolah hospital
      were enrolled and long term Plavix therapy more than and less than 12 months were compared
      between two groups of patients prospectively and rate of major adverse cardiovascular events
      ( MACE) (death, myocardial infarction, cerebrovascular accidents and revascularization) and
      rate of bleeding were compared between 2 groups.Syntax score and American heart association (
      AHA) score of coronary involvement were measured and MACE was compared to these scores.
    

Intervention name(s): plavix; plavix
Intervention type(s): Drug; Drug
Intervention description(s): taking plavix more than 12 months; taking plavix less than 12 months
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dual antiplatelet therapy; clopidogrel; percutaneous coronary intervention
Efficacy of Buscopan® in Comparison With 654-II (Anisodamine) in Acute Gastric or Intestinal Pain
Condition: Intestinal Diseases
MeSH terms: Intestinal Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to assess the efficacy of Buscopan® (hyoscine butylbromide) in
      comparison to 654-II (anisodamine)in acute gastric or intestinal spasm-like pain.
    


Intervention name(s): 654-II (anisodamine); Buscopan® (hyoscine butylbromide)
Intervention type(s): Drug; Drug
Intervention description(s): 10mg injection; 20mg injection
Intervention MeSH terms: Anisodamine; Scopolamine; Butylscopolammonium Bromide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Genes of Hypertension in African Americans
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases
Study type: Observational

Summary: 
      To identify genes contributing to hypertension in African Americans by focusing on the
      physiological pathways that determine arterial pressure.
    

Detailed description: 
      BACKGROUND:

      Since the mid 1990s, the investigators have extensively characterized African Americans for
      phenotypes related to cardiovascular and renal function. Based on recently completed genome
      scans, they have identified several chromosomal regions likely to contain genes influencing
      hypertension-related phenotypes in hypertensive, African American sib pairs. For several
      phenotypes, overlapping QTLs have also been identified in related studies in a genetically
      isolated French Canadian population and/or in homologous chromosomal regions in the F2 cross
      of Dahl-salt sensitive x normotensive Brown Norway rats.

      DESIGN NARRATIVE:

      The investigators will extensively phenotype 500 hypertensive and 500 normotensive African
      American subjects to conduct a genetic association study, using a single nucleotide
      polymorphism (SNP) genomic scan approach. To achieve a clear separation of blood pressures
      from hypertensive subjects, normotensive subjects will be selected from the lower third of
      the population-based blood pressure distribution. Hypertensive (BMI), and age. Inclusion of
      phenotypes is based on their relevance to the pathophysiology of hypertension and prior
      evidence of "heritability." Candidate genes for SNP analysis will be selected within
      chromosomal regions of two quantitative trait loci (QTLs) that they have previously
      demonstrated to be linked to hypertension-related phenotypes--a QTL for body mass index on
      chromosome 1 and a QTL for microalbuminuria on chromosome 18. SNP analyses will be carried
      out in 15 percent of the genes within each of these QTLs, and genes will be selected on the
      basis of their relevance to hypertension, including documented sequence conservation for
      blood pressure related QTLs with rat or mouse. The final goal of the project is to determine
      if distinct clusters of blood pressure related phenotypes can be identified that will permit
      stratification of hypertensive individuals into distinct subgroups to facilitate the analysis
      of the genetic determinants of hypertension and/or provide mechanistic leads to genes
      contributing to these traits.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        African Americans
      
Biospecimen description: 
      Blood cells and DNA