bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Sofosbuvir Plus Ribavirin in Adults With Chronic HCV Infection
Condition: Chronic HCV Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis C
Intervention: Sofosbuvir; RBV; PEG
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
Intervention MeSH terms: Sofosbuvir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 687.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objectives of this study are to evaluate the efficacy, safety and tolerability of
      treatment with sofosbuvir (SOF)+ ribavirin (RBV), with or without Pegylated interferon alfa
      (Peg-IFNα-2a/ PEG)) in participants with chronic genotype (GT)-1, 2, 3, and 6 Hepatitis C
      virus (HCV) infection.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  HCV treatment-naive (HCV genotype 1, 2, 3 or 6), defined as no prior exposure to any
             interferon (IFN), RBV, or other approved or experimental HCV-specific direct-acting
             antiviral agent, or HCV treatment-experienced (HCV genotype 1, 2, 3, or 6 only) with
             medical records that include sufficient detail of prior treatment with IFN to allow
             for categorization of prior response as either IFN Intolerant, non-responder, or
             experiences viral breakthrough or relapse

          -  HCV infection documented by anti-HCV antibody test, genotyping test, or liver biopsy

        Key Exclusion Criteria:

          -  Current or prior history of any clinically-significant illness (other than HCV)

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of a non-HCV etiology

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
Condition: Glaucoma, Open-Angle; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle; Hypertension
Intervention: bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy); Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution
Intervention description: One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.; One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
Intervention MeSH terms: Timolol; Brimonidine Tartrate; Bimatoprost; Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 192.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and efficacy of Triple Combination Therapy compared with
      Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary
      open-angle glaucoma or ocular hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ocular hypertension or primary open-angle glaucoma in each eye

          -  Requires treatment with IOP-lowering medication in both eyes

        Exclusion Criteria:

          -  Required chronic use of ocular medications during the study other than study
             medication

          -  Use of any corticosteroids within 30 days

          -  History of any prior eye surgery, except for uncomplicated eye surgery performed more
             than 6 months before the Screening visit

          -  Anticipated wearing of contact lenses during the study
Effect of rFVIIa on Peri-operative Blood Loss in Patients Undergoing Major Burn
Condition: Burns
MeSH terms: Burns
Intervention: Recombinant Factor VIIa; Placebo
Intervention description: intravenous infusion of Factor VIIa; intravenous infusion of placebo (sterile water)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Burns

Summary:

      The purpose of the study is to see if a medication (Recombinant Coagulation Factor VIIa or
      NovoSeven), normally used to stop bleeding in persons with a bleeding disorder, will lower
      the amount of blood lost during burn surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female

          -  Burn wounds

          -  18-65 years of age

          -  Scheduled excision of burn wound of at least 20 percent TBSA

        Exclusion Criteria:

          -  Age greater than 65 years

          -  History of blood coagulation disorders

          -  Taking anti-coagulation medication

          -  Contraindication for heparin therapy

          -  Pregnant or nursing females

          -  Unstable angina

          -  MI within the last 6 months

          -  Recent of diagnosis of DVT, stroke within the last 6 months

          -  Renal failure requiring dialysis or creatinine clearance less than 25 ml/min

          -  Religious prohibition to blood transfusion

          -  Have received rFVIIa during current hospitalization

          -  Previous enrollment in this study
Clopidogrel Optimal Loading Dose Usage to Reduce Recurrent EveNTs/Optimal Antiplatelet Strategy for InterventionS
Condition: Acute Coronary Disease; Angina Unstable
MeSH terms: Coronary Disease; Coronary Artery Disease
Intervention: Clopidogrel; acetylsalicyclic acid (ASA)
Intervention description: oral administration; oral administration
Intervention MeSH terms: Clopidogrel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25086.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: platelet aggregation inhibitors; acute coronary disease; percutaneous coronary

Summary:

      The purpose of this study is to evaluate whether a higher dosage of clopidogrel with aspirin
      (two doses) will decrease the risk of ischemic complications (cardiac death (CV death),
      myocardial infarction (MI), stroke) after a percutaneous coronary intervention (PCI).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with acute coronary disease with clinical symptoms and at least
             electrocardiogram changes or cardiac enzymes elevated

        Exclusion Criteria:

          -  Use of anticoagulants within 10 days with an international normalized ratio (INR) >
             1.5 or planned use during the hospitalisation period

          -  Administration of clopidogrel > 75 mg prior to randomization

          -  Contraindication to clopidogrel or aspirin

          -  Active bleeding or significant risk of bleeding
Evaluate Clinical Research From Commerical Oral Care Products
Condition: Gingival Diseases
MeSH terms: Gingival Diseases
Intervention: Fluoride; Triclosan/Fluoride; Chlorhexidine Gluconate
Intervention description: Brush twice daily; Half mouth toothbrushing twice daily for 4 days; Mouth rinsing twice a day for 4 days
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Triclosan; Fluorides; Sodium Fluoride; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of
      commercial oral care products.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female volunteers 18-65 years of age

          -  Good general health

          -  Must sign informed consent form

          -  Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.

          -  No history of allergy to personal care consumer products, or their ingredients,
             relevant to any ingredient in the test products as determined by the dental/medical
             professional monitoring the study.

        Exclusion Criteria:

          -  Subjects unable or unwilling to sign the informed consent form.

          -  Medical condition which requires pre-medication prior to dental visits/procedures

          -  Moderate or advanced periodontal disease or heavy dental tartar (calculus) requiring
             more than one visit of cleaning sessions

          -  2 or more decayed untreated dental sites at screening.

          -  Other disease of the hard or soft oral tissues.

          -  Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).

          -  Use of medications that can currently affect salivary flow.

          -  Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.

          -  Pregnant or nursing women.

          -  Participation in any other clinical study within 1 week prior to enrollment into this
             study.

          -  Allergy to chlorhexidine

          -  Use of tobacco products

          -  Subjects who must receive dental treatment during the study dates.

          -  Current use of Antibiotics for any purpose.

          -  Presence of an orthodontic appliance.

          -  History of allergy to common dentifrice ingredients.

          -  Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; ZD4054; Placebo
Intervention description: intravenous infusion given every three weeks; 10 mg oral once daily dose; placebo oral tablet once daily
Intervention MeSH terms: Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1494.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hormone Resistant Prostate Cancer; Endothelin A Receptor Antagonist; Endothelin A; Endothelin A antagonist

Summary:

      Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054
      (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone
      resistant prostate cancer (HRPC).

      This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can
      further improve survival compared with docetaxel alone.

      ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread
      by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054
      (Zibotentan) in hormone resistant prostate cancer patients with bone metastases compared with
      docetaxel.

      All patients participating in this clinical trial will receive docetaxel chemotherapy, which
      is a commonly used chemotherapy to treat prostate cancer in addition to other existing
      prostate cancer therapies.

      Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive
      placebo in addition to docetaxel and other prostate cancer therapy. By participating in this
      trial there is a 50% chance that patients will receive an agent that may further slow the
      progression of the tumour.

      No patients will be deprived of standard prostate cancer therapy.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who answer TRUE to the following criteria may be eligible to participate in this
        trial.

          -  Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has
             spread to the bone (bone metastasis)

          -  Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment

          -  Currently receiving treatment with surgical or medical castration

        Exclusion Criteria:

        Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.

          -  Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior
             targeted cancer therapies are permitted if received during a previous clinical trial.

          -  Suffering from heart failure or had a myocardial infarction within last 6 months

          -  A history of epilepsy or seizures
Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; exenatide
Intervention description: One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly; One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
Intervention MeSH terms: Exenatide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 813.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Europe and North and South America. The aim of the trial is to
      investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended
      release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with
      type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes
        treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose
        and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum
        dose allowed according to national label) for at least 90 days prior to screening. Stable
        is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91
        mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are
        pregnant, breast-feeding or intend to become pregnant or are not using an adequate
        contraceptive method throughout the trial including the 5 week follow-up period (adequate
        contraceptive measures as required by local law or practice) - Any chronic disorder or
        severe disease which, in the opinion of the investigator, might jeopardise subject's safety
        or compliance with the protocol - Treatment with glucose lowering agent(s) other than
        stated in the inclusion criteria in a period of 90 days before screening. An exception is
        short-term treatment (7 days or less in total) with insulin in connection with
        inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening
        calcitonin value equal to or above 50 ng/L (pg/mL) - Personal or family history of
        medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) -
        Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60
        ml/min/1.73 m^2 per modification of diet in renal disease (MDRD) formula (4 variable
        version) - Acute coronary or cerebrovascular event within 90 days before randomisation -
        Heart failure, New York Heart Association (NYHA) class IV
Study to Evaluate the Safety and Efficacy of USL261 (Intranasal Midazolam) in Patients With Seizure Clusters
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: USL261; Placebo
Intervention MeSH terms: Midazolam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 292.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Epilepsy; seizure clusters; acute repetitive seizures; rescue treatment; ARTEMIS

Summary:

      The purpose of this study is to examine the safety and effectiveness of USL261 for the
      outpatient treatment of seizure clusters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has a competent, adult caregiver who can recognize and observe the subject's seizure
             cluster episodes

          -  Has an established diagnosis of partial or generalized epilepsy that includes the
             following:

               -  A documented history of seizure clusters lasting a minimum of 10 minutes

               -  Seizure cluster pattern is observable, stereotyped, and recognizably different
                  from the subject's other non-cluster seizure activity (if any)

               -  A second seizure in the seizure cluster typically occurring within 6 hours from
                  the time of cluster recognition

               -  A seizure cluster pattern composed of multiple (≥ 2) partial or generalized
                  seizures

               -  A seizure cluster pattern established > 3 months before Visit 1

               -  A frequency of ≥ 3 seizure clusters during the year before Visit 1

               -  At least 1 seizure cluster occurring ≤ 4 months before Visit 1

               -  Seizure cluster pattern is confirmed by a central reviewer

          -  Currently on a stable regimen of anti-epileptic drugs (AEDs) with no changes in type
             of AEDs since Visit 1 and for ≥ 7 days before Visit 2, with or without intermittent
             use of benzodiazepines at a constant dose

          -  Weight is 40 kg to 125 kg, inclusive

        Exclusion Criteria:

          -  Has a neurological disorder that is likely to progress in the next year

          -  Has severe chronic cardio-respiratory disease

          -  Has had psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1

          -  Has a history of their stereotypical seizure cluster progressing to status epilepticus
             within the 2 years before Visit 1

          -  Has a history of acute narrow-angle glaucoma.

          -  Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before
             Visit 1 or a suicide attempt in the past 5 years

          -  Currently using a vagal nerve stimulator (VNS) unless the device has been implanted
             for at least 6 months and the setting stable for 4 weeks before Visit 1
The Effect of the Interaction of Glucagon and Insulin on Endogenous Glucose Production in Humans
Condition: Healthy
Intervention: 0.4mU Insulin followed by withdrawal period followed by 0.8mU study; 0.8mU Insulin followed by withdrawal period followed by 0.4mU study
Intervention description: Clamp study with insulin infused at 0.4 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.8 mU/Kg/min; Clamp study with insulin infused at 0.8 mU/Kg/min, followed by a 2 week withdrawal period followed by a clamp study with insulin infused at 0.4 mU/Kg/min
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this research is to help understand the relative importance of changes in
      insulin secretion (which lowers glucose) and changes in glucagon (which raises glucose) to
      regulate metabolism and the body's ability to make glucose.
    

Eligibility criteria:

        Inclusion Criteria:

          -  We will recruit 15 otherwise healthy subjects using intramural and local extramural
             advertising after approval from the Mayo Clinic Institutional Review Board.
             Individuals who express interest in participating will be invited for a screening
             visit. Individuals with a BMI < 19 or > 28 kg/m2 will be excluded from the study to
             avoid potential confounding effects that may result from extreme leanness or from
             obesity. Subjects will have no known systemic illness, taking any medication that
             could affect glucose metabolism and no history of upper gastrointestinal surgery.

        Exclusion Criteria:

          -  Subjects < 18 years of age or > 40 years of age will not be studied to minimize the
             potential confounding effects of age on glucagon and insulin action. The subjects will
             not be taking medications that affect glucose metabolism (to be determined by PI) and
             have no history of chronic illness or upper gastrointestinal surgery. We are seeking
             to recruit subjects who do not have diabetes (fasting glucose <100mg/dL).
Comprehensive Add on Study in Japan
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Linagliptin; Linagliptin; Metformin; Metformin; Linagliptin; Linagliptin; Linagliptin
Intervention description: Linagliptin once daily; Linagliptin once daily; Metformin twice or three time per day; Metformin twice or three time per day; Linagliptin once daily; Linagliptin once daily; Linagliptin once daily
Intervention MeSH terms: Metformin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 574.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the safety and efficacy of linagliptin
      (5mg / once daily) given for 52 weeks as add-on therapy to patients with type 2 diabetes
      mellitus and insufficient glycaemic control despite diet, exercise, and treatment with one
      approved antidiabetic drug.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus

          2. Male and female patients on diet and exercise regimen who are treated with one
             antidiabetic drug

        Exclusion criteria:

          1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism

          2. Impaired hepatic function

          3. Glitazone, glinide, and sulfonylurea group: renal failure or renal impairment defined
             as estimated glomerular filtration rate <30 ml/min (severe renal impairment) at Visit
             1, Biguanide group: renal failure or renal impairment defined as estimated glomerular
             filtration rate <60 ml/min (moderate renal impairment) at Visit 1

          4. Treatment with anti-obesity drugs