bioihbjkbjnl/mcl2 huggingface dataset:
Cardiovascular Effects of Sporting Events
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Major sporting events may have adverse cardiovascular effects in subjects with coronary heart
      disease. We also hypothesized that the adverse cardiovascular effects of sporting events are
      a result of psychobiological processes including stress-induced hemodynamic changes,
      autonomic dysfunction and parasympathetic withdrawal, and inflammatory and prothrombotic
      responses, all of which may in turn promote myocardial ischemia.
    

Detailed description: 
      Observational studies suggest that exposure to sporting events may worsen symptoms of angina
      and trigger acute myocardial infarction. The mechanisms for this association are unknown. To
      date, there have been no controlled exposures in patients with coronary heart disease: an
      important population who may be particularly susceptible to the adverse cardiovascular
      effects of sporting events.

      In a randomized crossover controlled study, 38 patients with prior myocardial infarction will
      be exposed to sporting events or not. Myocardial ischemia will be quantified by ST-segment
      analysis using continuous 12-lead electrocardiography, and blood pressure change will be
      analyzed using ambulatory blood pressure monitoring. Autonomic function will be assessed by
      heart rate variability. Ischemic, inflammatory and prothrombotic markers will also be
      measured.
    

Intervention name(s): Exposure to sporting events; No exposure to sporting events
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Exposure to sporting events; No exposure to sporting events
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sporting events; stress; myocardial ischemia; ST-segment depression; blood pressure
Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses
Condition: Normal Subjects
Study type: Interventional

Summary: 
      This exploratory study aims at investigating the acute effects of artificially sweetened and
      sugar beverage consumption (as compared to water consumption) on acute hemodynamic and
      metabolic stress response.
    

Detailed description: 
      This single-center study included five visits. The first two visits (screening and
      familiarization) allowed checking the eligibility of the volunteers. In case of inclusion,
      the subjects were assigned to a sequence of three experimental conditions (water, sugar and
      artificial sweeteners), in a randomized, crossover design.

      The experimental test was divided into 5 stages:

        1. a 90 minutes baseline period (t=0-90 min),

        2. a 30-min mental stress (MS; t=90-120 min), consisting in 5-min periods of Stroop's color
           word conflict test alternated with 5-min periods of mental arithmetic test.

        3. a 30-min MS recovery period (t=120-150),

        4. a 3-min cold pressure test (CPT) was carried out, aiming at immersing one volunteer's
           forearm in an ice water container at 3°C,

      3) a 15-min CPT recovery period (t=120-150). 60 min after the beginning of the metabolic
      test, volunteers will drink 25 mL every 15 min, after 10-sec mouth rinsing, of either an
      artificially- or sugar-sweetened beverages or water (control).

      Hemodynamic stress responses will be measured by repeated blood pressure, heart rate and
      cardiac output. Repeated venous blood samples will allow to assess metabolic stress
      responses.

      Each condition (water, artificial sweeteners and sugar) will be preceded by a 2-day run-in
      period.
    

Intervention name(s): Ingestion of artificially-sweetened beverages; Ingestion of sugar-sweetened beverages; Ingestion of water
Intervention type(s): Other; Other; Other
Intervention description(s): From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing non nutritive sweeteners (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.; From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing sugar (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.; From t=60 to the end of the metabolic test, volunteers will ingest 7 water beverages (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: sweeteners; sugar; stress response
Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of
      lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in
      healthy male Chinese and Japanese subjects.
    


Intervention name(s): Lacosamide; Lacosamide; Lacosamide; Placebo 3; Placebo 4; Placebo 2
Intervention type(s): Drug; Drug; Drug; Other; Other; Other
Intervention description(s): 100 mg oral tablet, single dose; Lacosamide 2 X 100 mg tablet; Lacosamide 4 X 100mg tablet; Placebo - 3 tablets; Placebo - 4 tablets; Placebo - 2 tablets
Other intervention name(s): Vimpat®; Vimpat®; Vimpat®
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Vimpat; Pharmacokinetics; Healthy Japanese male; Healthy Chinese male
The Role of No-Calorie Beverages Within a Weight Loss Program
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      The no calorie drink study is looking for over 300 people to participate. The study is
      evaluating the effect of no calorie beverages on weight loss and weight maintained over time
      in people who drink diet beverages every day as compared to water only drinkers during the 1
      year study period.
    

Detailed description: 
      This investigation aims to test the hypothesis that the amount of weight lost and maintained
      over time in an intensive behavioral weight management program will be equivalent in subjects
      consuming beverages containing no calorie sweeteners as compared to water beverages.
    

Intervention name(s): 2 no calorie beverages per day; 2 water beverages per day
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly and monthly lifestyle weight loss/maintenance classes.; Weekly and monthly lifestyle weight loss/maintenance classes.
Other intervention name(s): 2 non-nutritive sweetened beverages per day; water only group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Obesity, weight loss, weight maintenance
Safety and Efficacy Study of A0001 in Subjects With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a double-blind, placebo-controlled study with two dose levels of A0001 given
      twice daily for 28 days. Potential subjects will be screened first to determine eligibility,
      after which they will be randomized to receive either a high dose of A0001, a low dose of
      A0001 or placebo for 28 days.

      Eligible subjects will return within 21 days of screening for the baseline visit and
      randomization to one of three potential treatments. The subjects will be required to take 3
      capsules of study medication in the morning with a morning meal and 3 capsules of study
      medication at night with an evening meal for 28 days. Additional visits to the clinic are
      planned for Day 14 and Day 28, at which time a number of clinical and biochemical assessments
      will be done.
    


Intervention name(s): alpha-tocopherolquinone (A0001); alpha-tocopherolquinone (A0001); placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 28 days of low dose (1.0 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.; 28 days of high dose (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.; 28 days of placebo oral capsules. Treatment taken twice daily with meals.
Intervention MeSH terms: Vitamin E; Tocopherylquinone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This was an open-label, non-randomized, multicenter, Phase 2 study evaluating the efficacy
      and safety of ABT-199 in 127 participants with relapsed or refractory chronic lymphocytic
      leukemia (CLL) after B-cell receptor signaling pathway inhibitors (BCR PI) treatment.
    


Intervention name(s): Venetoclax
Intervention type(s): Drug
Intervention description(s): Each dose of venetoclax was to be taken with approximately 240 mL of water within 30 minutes after the completion of breakfast or the participant's first meal of the day.
Other intervention name(s): ABT-199; VENCLEXTA®
Intervention MeSH terms: Venetoclax
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oncology; Chronic Lymphocytic Leukemia; Cancer of the blood and bone marrow
MOD-4023 (Long-Lasting Human Growth Hormone (hGH)) Study in Growth Hormone Deficient Adults (GHDA)
Condition: Adult Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to assess the safety, tolerability and Pharmacokinetics/ Pharmacodynamics
      (PK/PD) profile of three doses of MOD-4023 on a weekly regime and one dose on an
      every-other-week regime administered for a period of 4 weeks in Growth Hormone Deficient
      Adult (GHDA) patients who previously were on a stable r-hGH treatment. An additional
      extension period of 16 weeks once-weekly administration of MOD-4023 aims to confirm the dose
      selection for future trials.
    

Detailed description: 
      The study is a phase II, randomized, open-label, parallel, 4 active treatment arms study to
      evaluate the safety, tolerability and PK/PD profile of MOD-4023 in pre-treated, normalized,
      GHD adults.

      The study is conducted in 2 stages. Stage I is a 4-week treatment period with 4 different
      dose levels/dosing regimens.

      Stage II is a 16-week treatment-extension period in which all the patients will start with
      the same dose (derived from stage I) and will be dose titrated to maintain IGF-1 levels
      within the normal range.
    

Intervention name(s): MOD-4023; MOD-4023; MOD-4023; MOD-4023
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly; liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly; liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly; liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MOD-4023; Growth Hormone Deficient Adults; Phase II
COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
Condition: Heart Failure; Heart Failure, Systolic; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs.
      Enalapril on improvement in erectile function and ability in male patients with chronic heart
      failure with reduced ejection fraction and erectile dysfunction.
    

Detailed description: 
      The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving
      erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection
      fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide
      a thorough understanding of the impact of sacubitril/valsartan on male sexual function and
      therefore quality of life.
    

Intervention name(s): LCZ696; Enalapril matching placebo; Enalapril; LCZ696 matching placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets; Placebo to Enalapril 10 mg film-coated tablets; Enalapril 10 mg film-coated tablets; Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Intervention MeSH terms: Enalapril; Enalaprilat; Sacubitril and valsartan sodium hydrate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: heart failure; systolic heart failure; heart failure with reduced ejection fraction; erectile dysfunction; Enalapril; Enalaprilat; LCZ696; Sacubitril/valsartan
Depth of Anesthesia in Cardiac Surgery
Condition: Heart Valve Diseases
MeSH terms: Heart Valve Diseases
Study type: Interventional

Summary: 
      The aim of our study was to evaluate the significance of monitoring anesthetic depth for the
      conduct of anesthesia and the early postoperative period in patients subjected to surgical
      correction of combined valvular disorders.
    

Detailed description: 
      Our aim was to evaluate the effect of monitoring anesthetic depth on duration of
      postoperative mechanical ventilation and ICU stay after surgical correction of combined
      valvular disorders.
    

Intervention name(s): maintenance of anesthesia; maintenance of anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points; intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
Other intervention name(s): Controlled anesthesia depth; Controlled anesthesia depth
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: depth of anesthesia; valve surgery
GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
Condition: Chronic Inflammatory Small Bowel Disease
MeSH terms: Intestinal Diseases
Study type: Interventional

Summary: 
      Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or
      colostomy bags or having an ileal pouch and who meet the eligibility criteria will be
      enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples
      will be collected from: (i) fluids suctioned during standard endoscopy procedures /
      pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from
      stool samples collected by patients after pouch surgery.
    

Detailed description: 
      Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or
      colostomy bags or having an ileal pouch and who meet the eligibility criteria will be
      enrolled to this study during up to three years at up to 4 clinical sites. GI fluids samples
      will be collected from: (i) fluids suctioned during standard endoscopy procedures /
      pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from
      stool samples collected by patients after pouchsurgery.

      The samples will be collected into sealed plastic containers, clearly labeled with
      "Biohazard" stickers and patient's code and be kept on ice for up to 30min and then freezed
      in -20deg to -80deg.

      Characterization and quanification of small molecules- and protein biomarkers of GI diseases
      such as IBD will be performed.
    

Intervention name(s): Endoscopy procedures
Intervention type(s): Procedure
Intervention description(s): GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Music for Insomnia
Condition: Insomnia; Sleep Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine the effect of listening to music on sleep quality
      (subjective and objective), daytime dysfunction and neurophysiological arousal in patients
      with insomnia.
    

Detailed description: 
      Sleep problems are highly prevalent in modern society and poor sleep is associated with
      impaired physical and mental health with large costs for both individuals and society.
      Pharmacological treatment is recommended only for short-term use, and there is a need to
      study promising drug-free aids to improve sleep. Furthermore, the mechanisms of insomnia are
      not well understood. In the present project we will investigate if listening to music can
      improve sleep quality in persons suffering from insomnia. We will use a randomized controlled
      trial design including both subjective and objective measures of sleep.
    

Intervention name(s): Music; Audiobook
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants choice among 4 genres of music matched on music characteristics; Participants choice among 4 types of audiobooks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared With a Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet Under Fasting Conditions in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open-label, Single-dose, 2-Sequence, 2-Period, Crossover Study to Assess Safety
      and Pharmacokinetics of a Nateglinide/Metformin HCl Combined Tablet Compared with a
      Nateglinide 120 mg Tablet and Metformin HCl 500 mg Tablet under Fasting Conditions in Healthy
      Male Subjects
    


Intervention name(s): Nateglinide; Nateglinide/Metformin; Metformin
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Metformin; Nateglinide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of 8 mg Perindopril Tert-Butylamine / 2.5 mg Indapamide / 10 mg Amlodipine Tablets Versus 10 mg Perindopril Arginine / 2.5 mg Indapamide / 10 mg Amlodipine Film-Coated Tablets in Healthy Volunteers
Condition: Bioequivalence; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The present study is a comparative bioavailability study performed to assess bioequivalence
      between a Test medication (PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg
      indapamide / 10 mg amlodipine tablets manufactured by PrJSC "Pharmaceutical firm "Darnitsa"
      [Ukraine]) and a Reference medication (marketed medicinal product TRIPLIXAM® 10 mg /2.5 mg/10
      mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets
      [manufactured by Servier (Ireland) Industries Ltd]) in healthy adult volunteers under fasting
      conditions.
    


Intervention name(s): PERINDOPRES® TRIO, 8 mg perindopril tert-butylamine / 2.5 mg indapamide / 10 mg amlodipine tablets; TRIPLIXAM® 10 mg /2.5 mg/10 mg, 10 mg perindopril arginine / 2.5 mg indapamide / 10 mg amlodipine film-coated tablets
Intervention type(s): Drug; Drug
Intervention description(s): Oral, generic fixed-dose combination of perindopril tert-butylamine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).; Oral, innovative fixed-dose combination of perindopril arginine (angiotensin-converting-enzyme inhibitor for the treatment of high blood pressure and heart failure), indapamide (thiazide-like diuretic used in the treatment of hypertension and decompensated heart failure) and amlodipine (calcium channel blocker used to treat high blood pressure and coronary artery disease).
Intervention MeSH terms: Amlodipine; Perindopril; Indapamide
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Two-period, two-sequence, cross-over single dose study
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; perindopril; indapamide; amlodipine; healthy subjects; pharmacokinetics
An Ergonomic Training With Exercise Program for Work-related Musculoskeletal Disorders Among Hemodialysis Nurse
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      This study aimed to examine the effectiveness of the 12-week ergonomic intervention developed
      by Person-Environment-Occupation (PEO) model in improving musculoskeletal discomfort and
      muscle strength for hemodialysis nurses. The maintenance effects of the intervention were
      also evaluated after another 12-week follow-up.
    

Detailed description: 
      Methods A cluster experimental design was used to conduct this study. Participants were
      recruited from hemodialysis units at two medical centers in Taiwan and had complaints of
      work-related musculoskeletal disorders (WMSDs) within the past six months. By PEO model, the
      12-week intervention including ergonomic education and exercise program was designed based on
      the job contents of hemodialysis nurses. In the study period, we used a mobile massager app
      to reminder them and monitor their implementation of exercises. The outcome indicators were
      measured before and after intervention as well as the follow-up after another 12 weeks. A
      generalized estimating equations model was adopted to analyze the repeated measurements.
    

Intervention name(s): ergonomic training
Intervention type(s): Other
Intervention description(s): ergonomic education & exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care