bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Bioequivalence (BE) and the Food Effect of TAK-438ASA Tablet
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate BE between a single-dose of TAK-438ASA tablet
      versus a single-dose combination of TAK-438 tablet 10 milligram (mg) and aspirin
      enteric-coated tablet 100 mg in Japanese healthy adult men (Study 1), and to evaluate the
      effects of food on the pharmacokinetics of TAK-438ASA tablet in Japanese healthy adult men
      (Study 2).
    

Detailed description: 
      The drug under investigation in this study is called TAK-438ASA. TAK-438ASA is being tested
      in Japanese healthy adult men. This study consists of two studies to evaluate bioequivalence
      (Study 1) and the effects of food (Study 2). Study 1 (split into a Pilot phase and a Pivotal
      phase) will look at bioequivalence between a single-dose of TAK-438ASA tablet versus a
      single-dose combination of TAK-438 tablet 10 mg and aspirin enteric-coated tablet 100 mg.
      Study 2 will look at the effects of food on the pharmacokinetics of TAK-438ASA tablet.

      The study will enroll up to 440 participants in total (Study 1 + 2). For Study 1, 12
      participants per group (24 participants in total) will be randomly assigned (by chance, like
      flipping a coin) to one of the two treatment groups for the pilot study to estimate the
      sample size of Pivotal study. After pilot study, 202 participants as a maximum per group (404
      participants in total) will be randomly assigned to one of the two treatment groups:

        -  TAK-438ASA tablet (Period 1) + TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 2)

        -  TAK-438 10 mg tablet and Aspirin 100 mg tablet (Period 1) + TAK-438ASA tablet (Period 2)

      For Study 2, 6 participants per group (12 participants in total) will be randomly assigned
      (by chance, like flipping a coin) to one of the two treatment groups:

        -  TAK-438ASA tablet (Fasted condition) + TAK-438ASA tablet (Fed condition)

        -  TAK-438ASA tablet (Fed condition) + TAK-438ASA tablet (Fasted condition) This
           single-center trial will be conducted in Japan. The overall time to participate in this
           study is approximately 18 days. Participants will make two visits to the clinic and be
           hospitalized for eight days in total.
    

Intervention name(s): TAK-438ASA; TAK-438; Aspirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-438ASA tablet.; TAK-438 tablet.; Aspirin enteric-coated tablet.
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug Therapy
Bioequivalence Study of Rivaroxaban
Condition: Embolism, Atrial Fibrillation and Venous Thrombosis
MeSH terms: Atrial Fibrillation; Thrombosis; Embolism; Venous Thrombosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are to establish the bioequivalence between rivaroxaban tablet
      15 mg and rivaroxaban granule formulation 15 mg, and to assess the safety and tolerability of
      rivaroxaban 15 mg in healthy adult male subjects.
    


Intervention name(s): Rivaroxaban (BAY 59-7939); Rivaroxaban (Xarelto, BAY 59-7939)
Intervention type(s): Drug; Drug
Intervention description(s): Rivaroxaban granule15mg for one day; Rivaroxaban tablet15mg for one day
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zinc Supplementation in Pediatric Sepsis
Condition: Zinc in Pediatric Sepsis
MeSH terms: Sepsis; Toxemia
Study type: Interventional
Phase: Phase 2

Summary: 
      a single blinded randomized controlled clinical trial that was conducted to evaluate the role
      of zinc supplementation in improving the outcome of infants and children with sepsis in
      pediatric intensive care unit.
    

Detailed description: 
      a single blinded randomized controlled clinical trial that was conducted to evaluate the role
      of zinc supplementation in improving the outcome of infants and children with sepsis in
      pediatric intensive care unit.

      The study included 72 cases that were randomly divided into 2 groups

      A- Group A (Zinc treated group):

      Included 36 cases who received oral zinc sulfate supplementation at doses ranging from 10 mg
      (infants) to 20 mg (under-five children) of elemental zinc per day, a dosage that is safe in
      these children.

      B- Group B:

      Included 36 cases who didn't receive zinc sulfate supplementation.

      Method of randomization:

      The cases were randomly divided into two groups using the closed envelope technique. The
      numbers from 1 to 72 were written in flat pieces of papers and put in closed envelopes that
      were randomly distributed to the participants.

      The cases with the odds number were allocated to the zinc treated group while the cases with
      the even numbers were allocated to the other group.
    

Intervention name(s): oral zinc sulfate
Intervention type(s): Drug
Intervention description(s): Oral zinc sulfate at dose 10 to 20 mg daily for 10 days
Intervention MeSH terms: Zinc Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine
Condition: Invasive Pneumococcal Disease
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to evaluate the immune response to 13-valent
      pneumococcal conjugate vaccine (13vPnCV) in children who as infants received either a
      complete series of PnCV versus a combination of PnCV and pneumococcal polysaccharide vaccine
      (PSV). This study is also intended to evaluate the safety of the 13vPnC.
    

Detailed description: 
      Follow-up measure for the EMEA supporting a Type II variation for Prevenar (PCV7) label
    

Intervention name(s): 13-valent pneumococcal conjugate vaccine (13vPnC); Blood draw
Intervention type(s): Biological; Procedure
Intervention description(s): 0.5 mL intramuscular injection; Collection of 10 mL of blood
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Other
Keywords: Immune response; pneumococcal conjugate vaccine; polysaccharide
A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized, parallel-group, open-label study will evaluate the effect of Actemra
      (tocilizumab) on vaccination in patients with active rheumatoid arthritis who have an
      inadequate response to methotrexate and who have had an inadequate clinical response or were
      intolerant to treatment with one or more anti-tumor necrosis factor (anti-TNF) therapies.
    


Intervention name(s): tocilizumab; methotrexate; 23-Valent Pneumococcal Polysaccharide Vaccine; Tetanus Toxoid Adsorbed Vaccine
Intervention type(s): Biological; Drug; Biological; Biological
Intervention description(s): Intravenous repeating dose; A stable dose of between 7.5 and 25 mg/week, oral or parenteral.; Intramuscular or subcutaneous injection; Intramuscular injection
Other intervention name(s): RoActemra; Actemra; Pneumovax
Intervention MeSH terms: Methotrexate; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dermatological Assessment of Primary Dermal Irritability Accumulated and Sensitization of Hyaluronic Nasal Spray
Condition: Sensitivity, Contact
MeSH terms: Dermatitis, Contact
Study type: Interventional

Summary: 
      Evaluate the potential of Primary Dermal Irritability, Accumulated Dermal Irritability and
      Dermal Sensitization, of health products through the application of Patch Test, proving the
      safety of the product for topical use. The study will be conducted with a Brazilian sample in
      which 65 research participants will be included. Depending on the results, the present study
      may support the claim: dermatologically tested.
    


Intervention name(s): Hyaluronic Nasal Spray
Intervention type(s): Other
Intervention description(s): Health care product - nasal application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Visual Field Defect Estimation Using Sequentially Optimized Reconstruction Strategy on Healthy and Glaucoma Subjects
Condition: Glaucoma, Open-Angle
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Observational

Summary: 
      Perimetry is a well-established method that is used to measure the visual field functions of
      humans. Commercially available products, such as the OCTOPUS 900 (Haag-Streit AG, Koeniz,
      Switzerland), are commonly used for assessing the visual field. Such devices are of critical
      value for patients suffering of glaucoma and neuro-ophthalmic conditions. The operating
      principle is to sequentially present light stimuli of different intensity at different
      locations within the visual field in an automatic way. Algorithms that select what locations
      and intensities to present over time are called strategies. These have the goal to provide
      both a fast and accurate estimation of the visual field function.

      Recently, new strategies were developed that are faster and equally accurate as the
      strategies used today. The technological advancement of these new methods lies primarily in
      the ability to estimate location sensitivities without observing them directly but by
      leveraging previously queried locations. For this the investigators plan to implement the
      next generation of perimetry strategies into an OCTOPUS 900 and to test it in healthy
      subjects and glaucoma patients.
    


Intervention name(s): Visual field testing
Intervention type(s): Diagnostic Test
Intervention description(s): Standard Automated Perimetry using a perimeter is one of the most commonly used techniques for measuring perceived visual ability of a subject. For a given eye, it provides quantitative measurements of visual function represented as a 2D spatial visual field map. It is of great clinical importance for diagnosing and monitoring glaucoma and detecting neurological conditions.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy subjects and subjects with Primary open-angle-, pseudoexfoliation- or primary
        angle-closure glaucoma
Evaluation of the Ovarian Reserve in Infertile Patients With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational

Summary: 
      Comparison between Ovarian reserve markers in patients with minimal/mild endometriosis and
      patients with tubal factor infertility
    

Detailed description: 
      Comparison between Ovarian reserve markers (laboratory or us) in patients with minimal/mild
      endometriosis and patients with tubal factor infertility including:

      Cycle Day 2 or 3 FSH and E2, Serum AMH and antral follicular count
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Group I : patients with minimal or mild endometriosis (I or II) as proven by laparoscopy
        (n=20).

        Group II: (control group) patients with tubal obstruction without endometriosis (n=20).
Effects of Weight on Inflammation and Colon Cancer Risk
Condition: Colorectal Cancer
MeSH terms: Inflammation
Study type: Observational

Summary: 
      An observational study designed to compare colonic cytokine concentrations in lean versus
      obese individuals
    

Detailed description: 
      An observational study was performed on 43 individuals undergoing routine screening
      colonoscopy, some of whom were lean and some who were obese. They had weight, height, and
      waist-hip ratio measured at the time of colonoscopy and had additional colonic biopsies to
      measure colonic cytokines.
    

Intervention name(s): no intervention
Intervention type(s): Other
Intervention description(s): there is no intervention in this study
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        43 generally healthy adults of both genders undergoing routine screening colonoscopy at
        Tufts Medical Center
      
Keywords: obesity; inflammation; cancer risk
Focus On Stiffness Reduction, Endothelial Function and Autonomic Nervous System
Condition: Arterial Stiffness; Endothelial Function; Autonomic Nervous System; Acute Coronary Syndrome; Arterial Hypertension
MeSH terms: Hypertension; Acute Coronary Syndrome
Study type: Observational [Patient Registry]

Summary: 
      Myocardial infarction is related with endothelial function, arterial stiffness and autonomic
      nervous system dysfunction, but also with arterial hypertension. Hypertension by itself is
      also related with endothelial function, arterial stiffness and autonomic nervous system
      dysfunction.

      Primary aim of study is to investigate how complex cardiac rehabilitation influence
      endothelial function, arterial stiffness and autonomic nervous system activity according to
      presence or absence arterial hypertension.

      Secondary aim is to obtain correlation between methods for the assessment of particular
      disorders and intercorrelation between different disorders for example endothelial function
      and autonomic nervous system activity.
    

Detailed description: 
      We expect that in study groups PWV will improve better that in control group. 5% of the limit
      value of p <0.05.

      We expect that in study groups AASI will improve better that in control group. 5% of the
      limit value of p <0.05.

      We expect that in study groups AI will improve better that in control group. 5% of the limit
      value of p <0.05.

      We expect that time and frequency parameters of HRV will increase in study group. 5% of the
      limit value of p <0.05.

      We expect that parameters of HRT will improve in study group. 5% of the limit value of p
      <0.05.

      We expect improvement in RHI in study group. 5% of the limit value of p <0.05.
    

Intervention name(s): comprehensive cardiac rehabilitation
Intervention type(s): Other
Intervention description(s): Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient after troponin-positive acute coronary syndrome (ACS) with or without arterial
        hypertension.
      
Biospecimen description: 
      VEGF-A, ADMA, NT-proBNP, creatinine, uric acid, LDL, HDL, total cholesterol, trigliceride,
      ALT,GGTP, CRP, fibrinogen,
    
Keywords: Arterial stiffness,; endothelial function,; autonomic nervous system,; acute coronary syndrome,; arterial hypertension,; pulse wave velocity,; augmentation index,; arterial stiffness index,; heart rate variability,; heart rate turbulence,; vascular endothelial growth factor,; asymmetric dimethylarginine
Armodafinil in Binge Eating Disorder (BED)
Condition: Binge Eating Disorder; Overweight; Obese
MeSH terms: Overweight; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to study the effectiveness, tolerability and safety of
      armodafinil in outpatients with binge eating disorder.
    


Intervention name(s): Armodafinil; Armodafinil; Matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): flexible dose 150-250mg/day; 150-250mg/day; flexible dose; Placebo comparator
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
Condition: Pulmonary Hypertension, Persistent, of the Newborn
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Observational

Summary: 
      This single center study will monitor the developmental progress of PPHN patients who
      received iv sildenafil in study A1481276. Two visits will be conducted, at 12 and 24 months
      following the end of study drug infusion.
    

Detailed description: 
      This study will monitor developmental progress of PPHN patients for 2 years following study
      treatment, using Bayley III and Hammersmith tools. Data will be explored with descriptive
      statistics.
    

Intervention name(s): non-interventional
Intervention type(s): Other
Intervention description(s): non-interventional
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric patients who took part in study A1481276 following PPHN treatment with IV
        sildenafil
      
Keywords: PPHN; development progress after PPHN; developmental progress after sildenafil.
Calcium, Protein and Gut Hormones
Condition: Obesity; Diabetes
Study type: Interventional

Summary: 
      Gut hormones have therapeutic potential in the prevention and treatment obesity and type 2
      diabetes (T2D). Milk protein and calcium can each potentiate gut hormones following meal
      ingestion in humans. However, these nutrients may interact synergistically (and with other
      minerals in milk) such that specific co-ingestion of these nutrients is required to obtain
      the full therapeutic potential for metabolism and energy balance. This proposal is to perform
      a pilot study on the effect of co-ingesting Capolac® plus protein on circulating gut hormone
      responses.
    

Detailed description: 
      Participants will be asked to arrive to the laboratory between 08:00 and 10:00 am after not
      eating for between 8-14 hours i.e. in a fasted state (water intake is permitted and
      encouraged). Participants will then be given one of three test drinks: 1) calcium citrate
      (1000 mg); 2) milk mineral supplement (equating to 1000 mg calcium); or 3) milk mineral
      supplement (equating to 1000 mg calcium) plus whey protein hydrolysate (50 g). Each of these
      drinks will also contain 500 mL of water and artificial sweetener (80 mg sucralose).

      Blood samples will be taken before, and at 15, 30, 45, 60, 90 and 120 minutes after ingestion
      of the test drink to determine the concentrations of gut hormones (GIP, GLP-1 and PYY)
      circulating in the bloodstream. We will also ask participants to complete an appetite
      questionnaire at baseline and every 30 minutes after ingestion of the test drink to assess
      their appetite sensations. After the 120-minute time point, we will remove the cannula and
      the trial day will be complete.
    

Intervention name(s): Calcium Citrate; Milk Mineral Supplement; Whey Protein Hydrolysate
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 1000 mg calcium as calcium citrate; Milk Minerals containing 1000 mg calcium; 50 g whey protein hydrolysate
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Calcium citrate, dairy product, whey protein, appetite, metabolism
Clinical Research Study to Evaluate Selegiline in the Treatment of Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Selegiline is superior to placebo in improving psychological and physical functioning in
      patients with Borderline Personality Disorder.
    

Detailed description: 
      Borderline Personality Disorder (BPD) is a chronic disorder occurring in 2-3% of the
      population. BPD is accompanied by high levels of co-existing psychiatric and physical
      disorders. One key predictor is persistent and recurring major depressive disorder.

      Since BPD is most closely linked with mood disorders and depression in particular, the use of
      antidepressant medications to treat the disorder is logical. However, to date, there are no
      FDA approved treatments for BPD. The American Psychiatric Association's Treatment Guidelines
      for Borderline Personality Disorder recommend antidepressants as a primary treatment of the
      disorder.

      Earlier trials using antidepressants that increase certain brain chemicals, such as,
      serotonin and noradrenalin have shown efficacy in controlling the mood swings of the illness
      for many people. These studies also document efficacy in controlling physical disorders,
      including headaches, migraines, irritable bowel, neurodermatitis (skin rash), fibromyalgia,
      premenstrual syndrome, and tempomandibular joint dysfunction (TMJ).

      group of antidepressants known as monoamine oxidase inhibitors (MAOIs) have also been shown
      to be effective in BPD patients. The oral form of these medications was accompanied by
      dietary restrictions, potential drug interactions, blood pressure changes and weight gain.

      Selegiline, a MAOI antidepressant, was put into a skin patch delivery system (transdermal)
      that reduced the side-effect profile. Trials without placebo control showed many individuals
      with BPD benefit from the selegiline skin patch. This trial will look at individuals on the
      selegiline and placebo to make sure the selegiline is or is not effective in treating BPD.
    

Intervention name(s): Selegiline; Placebo (for Selegiline)
Intervention type(s): Drug; Drug
Intervention description(s): The Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks.; Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch
Other intervention name(s): Emsam
Intervention MeSH terms: Selegiline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Anxiety; Headaches; Migraines; Irritable Bowel Syndrome IBS; Neurodermatitis; Fibromyalgia; Premenstrual Syndrome PMS; Temporomandibular Joint Dysfunction TMJ