bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-493/ABT-530
Intervention description: Tablet; ABT-493 coformulated with ABT-530
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment-naïve; HCV Gentoype 2; Non-cirrhotic; Chronic Hepatitis C; HCV Gentoype 5; HCV Gentoype 4; HCV Gentoype 6; HCV Gentoype 1; Compensated cirrhotic; Treatment-experienced; HCV Gentoype 3

Summary:

      The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with
      the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection
      and chronic severe renal impairment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chronic hepatitis C virus (HCV) infection

          -  Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.

          -  Subject must be HCV treatment-naïve or have failed previous HCV treatment.

          -  Subjects with underlying chronic renal impairment (estimated glomerular filtration
             rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening,
             including those requiring dialysis).

          -  Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with
             cirrhosis must have documented compensated cirrhosis.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any excipients
             of the study drug.

          -  Female who is pregnant, planning to become pregnant during the study, or
             breastfeeding; or male whose partner is pregnant or planning to become pregnant during
             the study.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg) or
             anti-human immunodeficiency virus antibody (HIV Ab).

          -  HCV genotype performed during screening indicating co-infection with more than 1 HCV
             genotype; HCV GT3 infected, treatment-experienced subjects were excluded.

          -  Patients who failed a previous regimen containing protease inhibitor (PIs) and/or
             nonstructural protein 5A (NS5A) inhibitors.
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Fluocinolone Acetonide; Fluocinolone Acetonide
Intervention description: 0.5 mg fluocinolone acetonide intravitreal insert; 0.2 mg fluocinolone acetonide intravitreal insert
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert
      of fluocinolone acetonide for the treatment of diabetic macular edema
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >= 18 years with diabetic macular edema

          -  Diagnosis of diabetes mellitus types 1 or 2

          -  Best corrected visual acuity of ≥ 19 letters

          -  Retinal thickness > 250 microns by OCT

          -  Investigator is comfortable deferring macular laser treatment for 6 weeks

        Exclusion Criteria:

          -  Glaucoma, ocular hypertension, IOP >21 mmHg or concurrent therapy at screening with
             IOP lowering agents

          -  Retinal or choroidal neovascularization due to ocular conditions other than diabetic
             retinopathy

          -  Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months

          -  Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months

          -  Any ocular surgery within the last 3 months

          -  Retinal laser treatment within the last 3 months

          -  History of uncontrolled IOP elevation with steroid use that did not respond to topical
             therapy

          -  Any lens opacity which impairs visualization of the posterior pole
A Comparison of Prasugrel (CS-747) and Clopidogrel in Acute Coronary Syndrome Subjects Who Are to Undergo Percutaneous Coronary Intervention
Condition: Coronary Arteriosclerosis; Acute Coronary Syndromes
MeSH terms: Acute Coronary Syndrome; Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia; Syndrome
Intervention: Prasugrel; Clopidogrel
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13619.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The sponsors of this investigational drug are developing prasugrel (also known as CS-747) as
      a possible treatment for patients with acute coronary syndrome (heart attack or chest pain)
      who need, or are expected to need, a percutaneous coronary intervention (PCI; also called a
      balloon angioplasty). Prasugrel was compared with Clopidogrel to determine which drug is
      better at reducing deaths, future heart attacks, or stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A person who has been diagnosed with acute coronary syndrome and is to undergo a
             percutaneous coronary intervention.

          -  A person who is of the legal age of 18 and is mentally competent to provide a signed
             written informed consent.

          -  If a woman is of childbearing potential (i.e., before menopause), she must test
             negative for pregnancy and agree to use a reliable method of birth control.

        Exclusion Criteria:

          -  A person who has had an ischemic stroke within the last 3 months or a hemorrhagic
             stroke at any time in the past.

          -  A person who has active internal bleeding or has a history of a bleeding disorder.

          -  Individuals who are at an increased risk of bleeding based on laboratory criteria
             evaluated by the treatment physician or on medication that can cause bleeding.

          -  A person who has liver disease; for example, cirrhosis.

          -  A person who has a condition such as alcoholism, mental illness, or is drug dependent.

          -  A person who has cardiogenic shock, a refractory ventricular arrhythmia, or congestive
             heart failure (class IV).
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia (BPH) and Erectile Dysfunction (ED)
Condition: Benign Prostate Hyperplasia; Erectile Dysfunction
MeSH terms: Erectile Dysfunction; Prostatic Hyperplasia; Hyperplasia
Intervention: 5 mg Tadalafil; Placebo; 0.2 mg Tamsulosin
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Tadalafil; Tamsulosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 909.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see whether tadalafil can reduce the signs and symptoms in
      men with Erectile Dysfunction (ED) and Benign Prostatic Hyperplasia-Lower Urinary Tract
      Symptoms (BPH-LUTS) and improve their quality of life.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Present with a history of ED and signs and symptoms of BPH.

          -  Are sexually active with an adult female partner, and expect to remain sexually active
             with the same adult female partner for the duration of the study.

        Main Exclusion Criteria:

          -  Current treatment with nitrates.

          -  Prostate-specific antigen (PSA) greater than 10.0 nanogram (ng)/mL at 1st screening.

          -  PSA greater than or equal to 4.0 to less than or equal to 10.0 ng/mL at 1st screening
             if prostate malignancy has not been ruled out to the satisfaction of a urologist

          -  Suffering from other urinary disease like cancer, or infection

          -  Serious cardiovascular disease

          -  History of significant renal insufficiency
The Clinical Effect of MK0476 With Concomitant Administration of and Removal of Inhaled Beclomethasone in Asthmatic Patients (0476-029)
Condition: Asthma
MeSH terms: Asthma
Intervention: montelukast sodium; beclomethasone; Placebo inhaler; placebo tablet
Intervention description: 10 mg tablet taken once daily at bedtime for 16 weeks; 200 ug inhaled, taken twice daily for 16 weeks; placebo inhaler taken twice daily for 16 weeks; placebo tablet taken once daily at bedtime for 16 weeks
Intervention MeSH terms: Beclomethasone; Montelukast
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 642.0
Sex: All
Minimum age: 15 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: chronic asthma

Summary:

      This study will investigate the additive effect of montelukast (MK0476) taken along with
      inhaled beclomethasone versus inhaled beclomethasone alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients tested negative for pregnancy and agreed to use appropriate
             contraceptives through out the study

          -  Patient was a nonsmoker

          -  Patient was in good general health (except for asthma)

        Exclusion Criteria:

          -  Patient was hospitalized

          -  Patient was female who was less than 8 weeks postpartum or breast feeding

          -  Patient planned to move or vacation away during the study

          -  Patient had major surgery within 4 weeks the past 4 weeks

          -  Patient has donated blood or participated in a clinical trial within the past 4 weeks

          -  Patient was a regular user or recent abuser of alcohol or illicit drugs

          -  Patient was 40% over or under normal weight for height
Cytokine Removal in Cardiopulmonary Bypass Patients
Condition: Elective Cardiac Surgical Interventions
Intervention: CytoSorb
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by
      extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit,
      endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation,
      ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in
      systemic inflammation and the main producers of pro- and antiinflammatory cytokines.
      Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory
      homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6
      and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory
      response induces post surgical monocyte immunosuppression which is indicated by an impaired
      production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral
      circulation with increased lactate levels, pronounced fluid accumulation, increased need of
      vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning
      from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to
      decrease the inflammatory process have the potential to improve the perioperative course.

      Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for
      the first 36 hours after surgery and induces a decreased inflammatory response for up to 3
      days post surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  elective cardiac surgical intervention with an expected CBP duration >120 minutes

        Exclusion Criteria:

          -  Emergency procedures

          -  Heart transplantation

          -  Elective left ventricular assist device (LVAD) implantation

          -  Pulmonary thromendarterectomy

          -  Declined informed consent

          -  Serum creatinine > 2mg/dl

          -  Body mass index < 18

          -  Age < 18 years

          -  Pregnant woman

          -  Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has
             produced leukopenia

          -  Receiving antileukocyte drugs

          -  Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)

          -  CRP > 2mg/dl

          -  History of Stroke

          -  Bilirubin >2mg/dl
A Study of S6G5T3 in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: S6G5T-3; S6G5T-8
Intervention description: Once a day topical cream; Once a day topical cream
Intervention MeSH terms: Tretinoin; Benzoyl Peroxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 434.0
Sex: All
Minimum age: 9 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of S6G5T-3 compared to its vehicle when applied once daily for 12
      weeks in participants with acne vulgaris.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant must sign an Institutional Review Board (IRB) approved written informed
             consent for this study.

          2. Male and female 9 years of age and older.

          3. Have 2 or fewer cysts or nodules.

        Exclusion Criteria:

          1. More than 2 acne nodules or cysts (defined as an inflammatory lesion greater than or
             equal to 5 millimeter [mm] in diameter).

          2. Acne conglobata, acne fulminans and secondary acne (for example, chloracne,
             drug-induced acne).

          3. History of blood dyscrasia (for example, leukemia, haemophilia, sickle cell anemia,
             multiple myeloma).

          4. Underlying disease that requires the use of interfering topical or systemic therapy.

          5. Other dermatological conditions that require the use of interfering topical or
             systemic therapy or that might interfere with study assessments such as, but not
             limited to, atopic dermatitis, perioral dermatitis, or rosacea.
Randomized, Double-Blind, Multicenter, Placebo-Controlled Study Of Pregabalin For Pain Associated With Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathy, Painful
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Intervention: placebo; pregabalin; pregabalin
Intervention description: Dosage: placebo, oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose); Dosage: 300 mg/day (150 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose); Dosage: 600 mg/day (300 mg bid), oral administration, Treatment duration: 13 weeks (1-week titration and 12-week fixed dose)
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 314.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of pregabalin at 300 mg/day and 600 mg/day (BID) in
      patients with painful diabetic peripheral neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Visual Analogue Scale (VAS) of pain is higher than 40 mm.

          -  Diagnosis of type 1 or 2 diabetes mellitus for at least 1 year

        Exclusion Criteria:

          -  Malignancy within the past 2 years.

          -  Neurologic disorders unrelated to diabetic neuropathy that may confuse the assessment
             of neuropathy pain
A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; sitagliptin
Intervention description: albiglutide weekly subcutaneous injection + sitagliptin matching placebo; albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
Intervention MeSH terms: Sitagliptin Phosphate; rGLP-1 protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 507.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: sitagliptin; albiglutide; renal impairment

Summary:

      This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a
      weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired
      with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately
      controlled on their current regimen of diet and exercise or their antidiabetic therapy of
      metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic
      medications will be recruited into the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is
             experiencing inadequate glycemic control on their current regime of diet and exercise
             or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral
             antidiabetic medications

          -  BMI >/=20 kg/m2 and </=45 kg/m2

          -  Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)

          -  HbA1c between 7.0% and 10.0%, inclusive.

        Exclusion Criteria:

          -  History of cancer

          -  History of treated diabetic gastroparesis

          -  Current biliary disease or history of pancreatitis

          -  History of significant gastrointestinal surgery

          -  Recent clinically significant cardiovascular and/or cerebrovascular disease

          -  History of human immunodeficiency virus infection

          -  Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C

          -  Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks
             postpartum

          -  Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients,
             excipients of albiglutide, or Baker's yeast

          -  Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives,
             whichever is longer, before Screening or a history of receipt of an investigational
             antidiabetic drug within the 3 months before randomization or receipt of albiglutide
             in previous studies
A Study to Evaluate the Effects of BGF and GFF on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BGF; GFF
Intervention description: Treatment with Budesonide/Glycopyrronium/FormoterolFumarate; Treatment with Glycopyrronium/Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 23.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a randomised, controlled, two period cross-over, 4 weeks chronic dosing, study to
      evaluate the effects of Budesonide/Glycopyrronium/Formoterol Fumarate (BGF) and
      Glycopyrronium/Formoterol Fumarate (GFF) on airway dimensions.
    

Eligibility criteria:

        Inclusion Criteria:

        Subject must be 40 years to ≤80 years of age inclusive, at the time of signing the informed
        consent form at Visit 1.

          -  COPD Diagnosis: Subjects with an established clinical history of COPD

          -  Screening clinical laboratory tests must be acceptable to the Investigator.

          -  Screening ECG must be acceptable to the Investigator

          -  Individual Compliance: Subjects must be willing to remain at the study center as
             required per protocol to complete all visit assessments

          -  Patients should be on scheduled maintenance treatment with one or more inhaled
             bronchodilator therapies.

        Exclusion Criteria:

          -  As judged by the investigator, any evidence of significant diseases other than COPD,
             i.e., disease or condition which, in the investigator's opinion makes it undesirable
             for the subject to participate in the trial.

          -  Spirometry Performance:

               1. Subjects who cannot perform acceptable spirometry, i.e., meet ATS/ERS
                  acceptability criteria.

               2. Repeatability: Subjects who cannot perform technically acceptable spirometry in
                  accordance with ATS repeatability criteria

          -  Cancer: Subjects who have cancer that has not been in complete remission for at least
             five years.

          -  Substance Abuse: Subjects, who in the opinion of the Investigator, significantly abuse
             alcohol or drugs

          -  Subjects who in the opinion of the investigator are unable to abstain from prohibited
             medications including LABA/LAMAs/ICS