bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Evaluate The Effect Of Food On How Tasocitinib (CP-690,550) Is Absorbed And Moves Through The Body Following Oral Administration Of Tasocitinib (CP-690,550) Tablets To Healthy Subjects
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, a 10 mg tasocitinib (CP-690,550) tablet will be administered to healthy
      subjects on two separate dosing occasions. On one occasion the tasocitinib (CP-690,550)
      tablet will be administered in a fasting condition; On the other occasion the tasocitinib
      (CP-690,550) tablet will be administered in a fed condition following a standard breakfast
      meal. The amount of tasocitinib (CP-690,550) in the blood will be measured at various times
      over 24 hours following each dosing occasion and compared to evaluate for any differences.
    

Detailed description: 
      To evaluate the effect of food on the pharmacokinetics of tasocitinib (CP-690,550).
    

Intervention name(s): Treatment A; Treatment B; Treatment B; Treatment A
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.; Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.; Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.; Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy subjects; Food Effect Study
A Long Term Extension of Study NC19453 Evaluating Safety and Efficacy of RO4607381
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This 2 arm study will assess the long term safety and efficacy of RO4607381 in patients with
      coronary heart disease or a coronary heart disease (CHD) risk equivalent who have completed
      study NC19453. Patients eligible to participate in the extension study will continue on the
      treatment they were originally assigned to ie RO4607381 (900mg po) or placebo daily, with
      concomitant daily atorvastatin (10 to 80mg po). The anticipated time on study treatment is 6
      months post study NC19453, and the target sample size is approximately 100 individuals.
    


Intervention name(s): dalcetrapib (RO4607381); placebo
Intervention type(s): Drug; Drug
Intervention description(s): 900mg po daily for 24 weeks; po daily for 24 weeks
Intervention MeSH terms: Dalcetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalency Study of Anastrozole 1 mg Under Fasted Conditions
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The objective of this study was to prove the bioequivalence of Anastrozole Tablet under
      fasted conditions.
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): 1 mg tablet
Other intervention name(s): ARIMIDEX
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioabsorbable Versus Durable Polymer Drug Eluting Stent (DES): a Meta-analysis
Condition: Restenosis; Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain.
      Thus the investigators planned a meta-analysis to compare outcomes of BP-DES versus PP-DES in
      obstructive coronary artery disease.
    

Detailed description: 
      Evidence supporting use of bioabsorbable polymer drug eluting stents (BP-DES) is uncertain.
      Previous studies suggested that BP-DES are at least as effective as durable polymer drug
      eluting stents (PP-DES). Thus the investigators planned a meta-analysis to compare outcomes
      of BP-DES versus PP-DES in obstructive coronary artery disease. Medline and Web databases
      were searched for studies comparing BP-DES and PP-DES for obstructive coronary disease,
      reporting rates of overall mortality, target lesion revascularization (TLR), myocardial
      infarction (MI), binary restenosis and late lumen loss (LLL) with a follow-up ≥ 6 months.
      Odds ratios (ORs) will be computed from individual studies and pooled according to a fixed
      effect (e.g. inverse variance weighting) or random effect model in case of statistical
      heterogeneity. Given the a priori heterogeneous nature of the observational analyses,
      separate subgroup analysis of studies with PLA bioabsorbable polymer loaded with biolimus A19
      (BP-BES) is prespecified.
    

Intervention name(s): percutaneous coronary intervention with stent
Intervention type(s): Procedure
Intervention description(s): patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients with coronary artery disease with indication to percutaneous coronary intervention
Pharmacokinetics, Safety, and Tolerance Study of Single Dose Administration of Risperidone ISM®
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will comprise two dosing periods in two different cohorts of healthy volunteers.
      The investigators will begin with a single dosage period I (1 injection of 25 mg of
      Risperidone for each subject); single dosage period II, different from the previous one (1
      injection of 37.5 mg of Risperidone for each subject), in a second group of healthy
      volunteers different from the first group will not start until after a preliminary analysis
      has been made of the safety data and plasma concentration data are known for the formulation
      of prolonged release Risperidone using the ISM® technology.
    


Intervention name(s): ISM®
Intervention type(s): Drug
Allocation: Non-Randomized
Masking: Single
Primary purpose: Treatment
A Phase I Study of Osilodrostat (LCI699) in Healthy Volunteers and Subjects With Impaired Renal Function
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To characterize the pharmacokinetics of LCI699 following a single oral dose in adult subjects
      with various degrees of impaired renal function.
    


Intervention name(s): osilodrostat
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal impairment, osilodrostat, LCI699
Comparison of the Effect of NN5401 With the Effect of NN1250 and Insulin Aspart in Type 1 Diabetics
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to compare the blood
      glucose lowering effect of NN5401(insulin degludec/insulin aspart (IDegAsp)) with NN1250
      (insulin degludec (IDeg)) and insulin aspart (IAsp) in subjects with type 1 diabetes where
      the trial participant will receive one single dose of each trial product in varying order.
    


Intervention name(s): insulin degludec; insulin degludec/insulin aspart; insulin aspart
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Insulin degludec single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).; Insulin degludec/insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).; Insulin aspart single-dose of 0.5 U/kg body weight injected subcutaneously (under the skin).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Condition: Morbid Obesity; Liver Fat
MeSH terms: Obesity, Morbid
Study type: Interventional

Summary: 
      Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat
      content and size thereby improving surgical outcomes. This study aims to investigate whether
      a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat
      further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI).
      The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further
      than the conventional food pre-operative diet.
    

Detailed description: 
      The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at
      baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either
      Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will
      reassess at week 6.
    

Intervention name(s): Liquid formula low-calorie diet (LCD); Roux-en-Y gastric bypass (RYGB); Control diet
Intervention type(s): Dietary Supplement; Procedure; Other
Intervention description(s): The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.; Participant went through Roux-en-Y gastric bypass (RYGB) surgery
Other intervention name(s): LCD; LED; Cambridge Weight Plan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: morbid obesity; gastric bypass; bariatrics; diet; caloric restriction; liver fat; appetite
Escitalopram in Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a short-term study to evaluate the efficacy, safety, and tolerability of escitalopram
      in adult patients (18 to 65 years of age) with moderate to severe depression. Patients
      completing the study may be eligible to enter a long-term open-label extension study with
      escitalopram.
    


Intervention name(s): Escitalopram; Placebo; Escitalopram
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Escitalopram low dose, oral administration, once daily dosing for 8 weeks.; Placebo, oral administration, once daily dosing for 8 weeks; Escitalopram high dose, oral administration, once daily dosing for 8 weeks
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Major Depressive Disorder; Escitalopram
Lurasidone - A 6-week Study of Patients With Bipolar I Depression (Monotherapy)
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical study is designed to test the hypothesis that lurasidone is effective,
      tolerable, and safe for the treatment of patients with bipolar I depression
    


Intervention name(s): lurasidone; lurasidone; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day; lurasidone 20 mg/day for Days 1-7; Placebo Comparator
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Bipolar I, Depression
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease
Condition: Coronary Artery Disease; Endothelial Function
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall
      mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in
      the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown
      that ticagrelor increases adenosine concentration, by interfering with its red blood cells'
      uptake and by inducing the release of ATP which is then converted to adenosine. Recent
      studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that
      ticagrelor increases the coronary blood flow in response to intravenous adenosine
      administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may
      influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method
      (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating
      endothelial dysfunction and has been found to positively correlate with flow mediated
      dilatation (FMD).

      This is prospective, randomized study with a crossover design, which will be conducted in
      patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a
      3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:

        -  Ticagrelor 90mg twice a day for the next 15 days or

        -  Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients
           wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement
           will be repeated at Day 15 and then treatment crossover will be performed for the next
           15 days (without an intervening washout period). At Day 30 patients will be subjected
           again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken
           from the patients in Day 0 for genotyping control.
    


Intervention name(s): Ticagrelor; Prasugrel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ticagrelor; prasugrel; endothelial function
Role of Skin Tests for the Diagnosis of Immediate Hypersensitivity Reactions Due to Iodinated Contrast Media
Condition: Hypersensitivity
MeSH terms: Hypersensitivity; Hypersensitivity, Immediate
Study type: Interventional

Summary: 
      The purpose of this trial is to study the diagnostic role of skin test in immediate reactions
      to iodinated radiocontrast media.
    


Intervention name(s): Skin tests with radiocontrast media
Intervention type(s): Procedure
Intervention description(s): Skin prick tests and intradermal test will be performed in patients with a history of immediate reactions to iodinated radiocontrast media
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Contrast media skin test; Skin test; hypersensitivity; contrast media
Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women
Condition: Obesity
Study type: Interventional

Summary: 
      The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on
      body weight, basal metabolic rate and macronutrient intake. In a crossover double masked
      model, 30 volunteers will be randomized into two groups, half of them will initiate the
      experiment by taking 2 "placebo" muffins daily for 3 weeks (Placebo phase) and the remnant
      volunteers will take 2 "gluten" muffins for 3 weeks (Gluten phase). After one day of wash
      out, the volunteers will be transferred for the other phase to complete 3 more experimental
      weeks.
    

Detailed description: 
      The objective is to evaluate in eutrophic women the impact of intake of moderate amounts of
      wheat gluten on body weight basal metabolic rate and possible relation to macronutrient
      intake. For this, 30 volunteers will kept on a restricted diet in gluten-free foods of 6
      weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as
      well as a 24-hour food register, to evaluate the average food and gluten daily intake. The
      volunteers will be randomized into two groups, half of them will initiate the experiment by
      taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will
      take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers
      will be transferred for the other phase to complete 3 more experimental weeks. During these 6
      experimental weeks, all volunteers will be instructed to exclude any food containing gluten
      from their diet. The test food (gluten and placebo muffins) will be produced in the
      Laboratory of Dietetic Technique of the School of Nursing of the Federal University of Minas
      Gerais and delivered weekly to each volunteer. Placebo test foods is a corn-based muffin of
      about 45g. In the Gluten muffins, 10g of corn is replaced by 10g of gluten (corresponding to
      7.5g of gluten protein). Each volunteer will be instructed to take 2 (placebo or gluten)
      muffin/day. To evaluate diet adherence and signs and symptoms of intolerances, volunteers
      will fill a questionnaire weekly, informing about the consumption of the test food, eventual
      intake of food containing gluten, and the presence of gastrointestinal signs and symptoms
      such as constipation, diarrhea, nausea or vomiting etc.
    

Intervention name(s): Gluten test food
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: crossover double masked model
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of Acetaminophen With Codeine and Ibuprofen for Children With Injuries
Condition: Pain
Study type: Interventional

Summary: 
      We compared the pain relief of acetaminophen with codeine versus ibuprofen for children ages
      5-18 years who came to the Pediatric Emergency Department with injuries to their arms or
      legs.
    

Detailed description: 
      We conducted a randomized, double-blinded equivalence trial. Pediatric Emergency Department
      patients 5-18 years of age with acute extremity pain received acetaminophen-codeine (1 mg/kg
      as codeine) or ibuprofen (10 mg/kg). They provided Color Analog Scale pain scores at baseline
      and at 20, 40, and 60 minutes after medication administration. The primary outcome measured
      was the difference in changes in pain score at 40 minutes, compared against a previously
      described minimal clinically significant change in pain score of 2 cm. Additional outcomes
      included need for rescue medication and adverse effects.
    

Intervention name(s): ibuprofen; acetaminophen with codeine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Ibuprofen; Codeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: child; pain; analgesics
Safety, PK, and Efficacy of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure With Reduced Ejection Fraction
Condition: Heart Failure With Reduced Ejection Fraction
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      -  To evaluate pharmacokinetics (PK) of omecamtiv mecarbil in Japanese subjects with heart
           failure (HF) with reduced ejection fraction

        -  To evaluate the safety and tolerability of oral omecamtiv mecarbil
    

Detailed description: 
      This study was conducted by Amgen as the IND holder, with Cytokinetics as a collaborator. Due
      to the termination of the collaboration agreement between Amgen and Cytokinetics in May 2021
      and subsequent transfer of the omecamtiv mecarbil IND from Amgen to Cytokinetics,
      Cytokinetics is now listed as the sponsor.
    

Intervention name(s): 25 mg Omecamtiv Mecarbil; Placebo; 37.5 mg Omecamtiv Mecarbil; 50 mg Omecamtiv Mecarbil
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): oral tablet; oral tablet; oral tablet; oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart Failure
Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular
      disease even in the absence of hypertension. However, there are few data regarding the impact
      of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients
      with OSA as well as the impact of treatment with continuous positive airway pressure.
    


Intervention name(s): CPAP; CPAP
Intervention type(s): Device; Device
Intervention description(s): Control - no treatment; CPAP: The airway pressure will be determined by an overnight sleep study titration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; Blood Pressure; PreHypertension; Masked Hypertension
A Quality of Life and Safety Study With Pimecrolimus Cream, 1% in Children (Age 2-12 Years) With Atopic Dermatitis
Condition: Atopic Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will evaluate the safety and effect of pimecrolimus cream 1% on quality of life of
      caregivers of South African children with mild to moderate atopic dermatitis (AD).
    


Intervention name(s): Pimecrolimus cream 1%
Intervention type(s): Drug
Other intervention name(s): Elidel
Intervention MeSH terms: Pimecrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic eczema; Pimecrolimus; Children; Quality of life; Safety; Atopic dermatitis