bioihbjkbjnl/mcl2 huggingface dataset:
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PegIFN/RBV; PegIFN/RBV; BI201335; BI201335 24W; PegIFN/RBV; Bi 201335
Intervention description: PegIFN/RBV for 24 or 48w; PegIFN/RBV for 24 or 48w; BI201335 for 12w; BI201335 for 24w; PegIFN/RBV for 24 or 48w; BI 201335 for 24 w
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or
      24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation
      of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue
      PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or
      relapsers patients coinfected with HIV
    

Eligibility criteria:

        Inclusion criteria:

          1. Chronic hepatitis C (HCV) genotype 1 infection

          2. Chronic Human Immunodeficiency Virus (HIV) -1 infection

          3. HCV treatment naive or HCV treatment experienced but only relapsers

          4. Age 18 to 70 years

          5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy
             (HAART)

          6. Karnofsky score >70

          7. HCV viral load >1.000 IU/mL

        Exclusion criteria:

          1. HCV infection of mixed genotype (1/2, 1/3, 1/4)

          2. Evidence of acute or chronic liver due to chronic HCV infection

          3. Hepatitis B virus (HBV) infection with presence of HBs-Ag

          4. Active malignancy or history or malignancy within the last 5 years

          5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic
             growth factor or immunomodulatory treatment in 28 days prior enrolment.

          6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy,
             esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points
             according tho the Child-Turcotte-Pugh classification

          7. Hemoglobin </=11g/dL for women and </= 12 g/dL for men

          8. Patients with stable cardiac disease and Hemoglobin <12g/dL

          9. Known hypersensitivity to any ingredient of the study drugs
An Open-label Study to Determine the Efficacy and Safety of Topiramate in the Treatment of Tourette Syndrome.
Condition: Tourette Syndrome
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Topiramate (drug)
Intervention description: Topiramate 25 mg to 200 mg
Intervention MeSH terms: Topiramate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 7 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Previous studies using topiramate in Tourette subjects have shown that with the use of this
      medication subjects report that their tics get better. The purpose of this study is to study
      if topiramate improves the symptoms of Tourette syndrome, such as motor tics, or other
      associated symptoms such as attention or obsessive-compulsive problems.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must continue to meet the specific inclusion criteria outlined in either
             CAPSS-176 or CAPSS-198 to enroll in this protocol.

          -  Subjects must have completed the Double-Blind Phase or discontinued the Double-Blind
             Phase after a minimum of 6 weeks due to lack of efficacy (defined by a CGI improvement
             score of >6 [much worse or very much worse]) in either CAPSS-176 or CAPSS-198.

          -  Subjects or their parents/guardians, must be able to read and comprehend written
             instructions and willing to complete all scales and assessments required by this
             protocol.

          -  After full explanation of the study, subjects, or their parent/legally authorized
             representatives, must demonstrate their willingness to participate by signing an
             informed consent form. If applicable, pediatric subjects capable of giving assent must
             sign the assent form.

          -  Subjects must continue their current treatment for tics, treatment of comorbid
             symptoms or treatment of A-D/HD at the dose level established prior to entry in the
             Double-Blind Phase of CAPSS-176 or CAPSS-198.

        Exclusion Criteria:

          -  Subjects must continue to meet the specific exclusion criteria outlined in either
             CAPSS-176 or CAPSS-198 to enroll in this protocol.

          -  Subjects who have SGOT and/or SGPT levels greater than 2 times the upper limit of the
             normal range from the last visit in either CAPSS-176 or CAPSS-198 will not be
             permitted to enroll in the current study.
Avatrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Active Non-Hematological Cancers
Condition: Chemotherapy-induced Thrombocytopenia
MeSH terms: Thrombocytopenia
Intervention: Avatrombopag; Placebo Oral Tablet
Intervention description: Oral avatrombopag tablet; Placebo comparator tablet
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CIT; Thrombocytopenia

Summary:

      Phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and
      safety of avatrombopag in subjects with chemotherapy-induced thrombocytopenia receiving
      chemotherapy for the treatment of ovarian, lung (small cell and non-small cell) and bladder
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women greater than or equal to 18 years of age;

          -  A diagnosis of ovarian, lung (small cell or non-small cell) or bladder cancer
             requiring systemic chemotherapy

          -  Participant receiving a chemotherapy regimen given in a 21 or 28-day cycle, including
             1 or more of the following agents or class of agents:

               -  Nucleoside analog, including gemcitabine and fluorouracil;

               -  Carboplatin or cisplatin;

               -  Anthracycline; or

               -  Alkylating agent;

          -  Participant experienced severe thrombocytopenia, defined as 2 platelet counts <50 x
             109/L measured at least 24 hours apart, during the qualifying chemotherapy cycle, of
             their current chemotherapy regimen

          -  ECOG performance status <=2

        Exclusion Criteria:

          -  Participant has experienced >=Grade 2 CIT other than during the current chemotherapy
             treatment regimen within 6 months of Screening;

          -  Participant has any history of hematologic malignancies, including leukemia, myeloma,
             myeloproliferative disease, lymphoma, or myelodysplastic diseases;

          -  Participant has received >2 previous lines of chemotherapy or is receiving whole brain
             radiation during the study treatment period;

          -  Participant has a known medical history of genetic prothrombotic syndromes

          -  Participant has a history of arterial or venous thrombosis within 3 months of
             screening;

          -  Use of vitamin K antagonists;

          -  Participant has previously received a thrombopoietin receptor agonist or recombinant
             human thrombopoietin for the treatment of CIT within 3 months of screening
Pharmacoeconomic Consequences Of Analgesia in the Intensive Care Unit (ICU)
Condition: Analgesia
MeSH terms: Agnosia
Intervention: Remifentanil; Propofol
Intervention description: analgesia in medical and post-surgical Intensive Care Unit subjects requiring mechanical ventilation; conventional sedation in medical and post-surgical Intensive Care Unit subjects requiring mechanical
Intervention MeSH terms: Remifentanil; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: analgesia; Mechanical ventilation; pharmaco-economic; ICU

Summary:

      This study will be a multicentre randomized, open-label, phase IIIb study. This study will
      evaluate two different techniques of sedation: an analgesia based regimen with remifentanil
      versus a conventional sedation based regimen using propofol in subjects that require
      mechanical ventilation for at least 2 days in the ICU. The conventional sedation based
      regimen will consist of propofol combined with an opioid according to routine clinical
      practice (morphine, fentanyl, sufentanil or other as required) . The analgesia based regimen
      will consist of remifentanil, with propofol added on if required.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Medical and post-surgical patients admitted to ICU and requiring mechanical
             ventilation.

          -  Intubated subjects expected to require mechanical ventilation for longer than 48 hours
             after starting the study drug.

          -  Subjects requiring both analgesia and sedation with a regimen comprising a hypnotic
             agent and an opioid.

        Exclusion Criteria:

          -  Diagnosis: cardiopulmonary resuscitation (CPR) in the previous 24 hours or expecting
             to require major surgery within the next three days

          -  Subject who, in the judgement of the investigator, has a life expectancy of 2 days or
             refrained or refuses full life support, which would limit the care provided

          -  Concurrent medications:

               -  Requires or is likely to require neuromuscular blocking agents by continuous
                  infusion to facilitate mechanical ventilation

               -  Has or is likely to receive an epidural block during the treatment period
A Study for Evaluating the Efficacy and Safety of Zonisamide and Lamotrigine (Lamictal) for Subjects With Refractory Simple Partial, Complex Partial or Partial With Secondary Generalized Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Intervention: Zonisamide; Lamotrigine
Intervention description: Tablet once or twice daily orally for 16 weeks; Tablet once daily orally for 16 weeks
Intervention MeSH terms: Lamotrigine; Zonisamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Epilepsy; seizures

Summary:

      The purpose of this study is to evaluate the efficacy and safety of zonisamide for
      anti-epilepsy drugs (AEDs) treated subjects with refractory simple partial, complex partial
      or partial with secondary generalized seizures.
    

Eligibility criteria:

        Inclusion criteria:

          -  Subjects must sign and date the informed consent form

          -  Clinical diagnosis as refractory epilepsy

        Exclusion criteria:

          -  Progressive neurologic disease

          -  Serious psychiatric disease

          -  Hemolytic anemia

          -  G6PD (glucose-6-phosphate dehydrogenase) deficiency

          -  Acute intermittent porphyrias

          -  Subjects who have received study drugs (Zonisamide, Lamotrigine) in the past

          -  Drug or alcohol addiction

          -  Renal impairment (serum creatinine ≧ 1.5 mg/dl), or hepatic abnormality (ALT or AST >
             2x ULN)

          -  Stevens-Johnson syndrome

          -  Progressive exfoliative dermatitis

          -  Pregnant, lactating or of childbearing potential female

          -  Regularly taking oral contraceptives

          -  Hypersensitivity to study drugs

          -  Severe cardiac disease (New York Heart Association Functional Class III and IV)

          -  History of malignancy within 5 years

               -  Taking valproic acid within 7 days prior to screening

               -  Subjects with simple partial seizures without motor component
Sitagliptin Versus Glipizide in Participants With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency (MK-0431-063 AM1)
Condition: Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Sitagliptin; Glipizide; Placebo for Sitagliptin; Placebo for Glipizide
Intervention description: Participants with moderate renal insufficiency will receive two sitagliptin 25 mg tablets orally daily; participants with severe renal insufficiency will receive one sitagliptin 25 mg tablet orally daily; Participants will receive glipizide 2.5 mg (1/2 tablet) orally once daily up to 20 mg orally daily (10 mg twice daily); Participants with moderate renal insufficiency will receive 2 placebo for sitagliptin tablets orally daily; participants with severe renal insufficiency will receive 1 placebo for sitagliptin tablet orally daily; Participants will receive 1/2 tablet of placebo for glipizide orally once daily up to 2 tablets orally twice daily
Intervention MeSH terms: Sitagliptin Phosphate; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 426.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose
      levels in participants with moderate or severe renal insufficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has type 2 diabetes mellitus

          -  Has moderate or severe renal insufficiency

        Exclusion Criteria:

          -  Has type 1 diabetes mellitus or a history of ketoacidosis

          -  Is on a new weight loss program

          -  Has active liver disease

          -  Is on dialysis or is likely to need dialysis during the study
A Study to Determine the Efficacy and Safety of Albiglutide as Compared With Liraglutide.
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; liraglutide
Intervention description: albiglutide weekly subcutaneous injection; liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
Intervention MeSH terms: Liraglutide; rGLP-1 protein
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 841.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: GSK716155; liraglutide; albiglutide; open-label

Summary:

      This open-label study examines the efficacy and safety of albiglutide as compared with
      liraglutide in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 diabetes mellitus and experiencing inadequate glycemic control on
             their current regimen of metformin, TZD, SU, or any combination of these oral
             antidiabetic medications

          -  BMI >/=20kg/m2 and </=45 kg/m2

          -  Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)

          -  HbA1c between 7.0% and 10.0%, inclusive

          -  Female subjects of childbearing potential must be practicing adequate contraception.

        Exclusion Criteria:

          -  History of cancer

          -  History of treated diabetic gastroparesis

          -  Current biliary disease or history of pancreatitis

          -  History of significant GI surgery

          -  Recent clinically significant cardiovascular and/or cerebrovascular disease

          -  Hypertension

          -  History of human immunodeficiency virus infection

          -  History of or current liver disease or acute symptomatic infection with hepatitis B or
             hepatitis C

          -  History of alcohol or substance abuse

          -  Female subject is pregnant, lactating, or <6 weeks postpartum

          -  Known allergy to any GLP 1 analogue, liraglutide, other study medications' excipients,
             excipients of albiglutide, or Baker's yeast

          -  History of type 1 diabetes mellitus

          -  Contraindications (as per the prescribing information) for the use of either
             background or potential randomized study medications (e.g., liraglutide)

          -  Receipt of any investigational drug or liraglutide 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

          -  History or family history of thyroid disease
A Study Evaluating the Effectiveness of AMG 334 Injection in Preventing Migraines in Adults Having Failed Other Therapies
Condition: Episodic Migraine
MeSH terms: Migraine Disorders
Intervention: AMG334 (70 mg) Pre-Filled Syringe (PFS); Placebo Pre-Filled Syringe (PFS)
Intervention description: Two injections of AMG 334 70 mg (equaling 140 mg total dose) will be administered via subcutaneous injection; Subcutaneous injection of matching placebo
Intervention MeSH terms: Erenumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 246.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine; attack; headache; episodic; aura; AMG 334; CGRP receptor agonist; erenumab; adult

Summary:

      The purpose of this study is to determine if AMG 334 is effective in treating migraines in
      patients who have failed other preventive migraine treatments.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of migraine in the 12 months prior to screen

          -  4-14 days per month of migraine symptoms

          -  >=80% diary compliance during the Baseline period

          -  Failure of previous migraine prophylactic treatments

        Exclusion Criteria:

          -  >50 years old at migraine onset

          -  Pregnant or nursing

          -  History of cluster or hemiplegic headache

          -  Evidence of seizure or psychiatric disorder

          -  Score of over 19 on Beck Depression Inventory-2

          -  Active chronic pain syndrome

          -  Cardiac or hepatic disease
Long Term Follow-up Study of Safety and Efficacy of Botulinum Toxin Type A for the Treatment of Patients With Idiopathic Overactive Bladder With Urinary Incontinence
Condition: Overactive Bladder; Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive
Intervention: botulinum toxin Type A
Intervention description: Botulinum toxin Type A 100U or 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 829.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the long term safety and effectiveness of botulinum
      toxin type A in treating patients with idiopathic overactive bladder with urinary
      incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in preceding study 191622-095 (NCT00910845) or 191622-520 (NCT00910520)

        Exclusion Criteria:

          -  Females who are pregnant, nursing or planning a pregnancy

          -  Patient has any condition or situation which, in the Investigators opinion, would put
             the patient at risk from continuing treatment with botulinum toxin Type A
Safety and Efficacy of Difluprednate 0.05% for the Treatment of Anterior Uveitis
Condition: Endogenous Anterior Uveitis
MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis
Intervention: Difluprednate 0.05% ophthalmic emulsion; Prednisolone acetate 1.0% ophthalmic suspension
Intervention description: 1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment; 1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
Intervention MeSH terms: Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Difluprednate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 111.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to demonstrate that difluprednate 0.05% (Durezol) dosed 4 times
      daily is noninferior to prednisolone 1% (Pred Forte) dosed 8 times daily for the treatment of
      endogenous anterior uveitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of endogenous anterior uveitis in at least 1 eye.

          -  The presence of > 10 cells in the anterior chamber of at least one eye, and a flare
             score of > 2 in that same eye.

          -  Age 2 years or older on day of consent.

          -  Negative urine pregnancy test on Day 0 for females of childbearing potential who are
             not at least 1 year post-menopausal or surgically sterilized.

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Presence of endogenous anterior uveitis diagnosed for > 2 weeks prior to enrollment in
             the study.

          -  Presence of intermediate uveitis, posterior uveitis or panuveitis in either eye.

          -  Instillation of any topical corticosteroid or NSAID in the study eye within 7 days of
             instillation of study drug.

          -  History of glaucoma or clinically significant ocular hypertension in the opinion of
             the Investigator involving an IOP ≥ 21 millimeters mercury in either eye.

          -  History of steroid-induced elevation of intraocular pressure.

          -  Any confirmed or suspected active viral, bacterial or fungal keratoconjunctival
             disease in either eye.

          -  History of glaucoma or clinically significant ocular hypertension in the opinion of
             the Investigator involving an intraocular pressure (IOP) > 21 mmHg in either eye.

          -  Corneal abrasion or ulceration in either eye.

          -  Pregnancy or lactation.

          -  Other protocol-defined exclusion criteria may apply.