bioihbjkbjnl/mcl2 huggingface dataset:
Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: ARQ-151 0.3% cream; ARQ-151 vehicle cream
Intervention description: ARQ-151 0.3% cream; ARQ-151 vehicle cream
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 442.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day
      for 56 days by subjects with chronic plaque psoriasis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants legally competent to sign and give informed consented and if appropriate
             assent as required by local laws

          -  Males and females ages 2 years and older (inclusive)

          -  Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for
             children) as determined by the Investigator

          -  Females of childbearing potential (FOCBP) must have a negative pregnancy test at
             Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must
             agree to use at least one form of highly effective contraception throughout the trial.

          -  In good health as judged by the Investigator, based on medical history, physical
             examination, serum chemistry labs, hematology values, and urinalysis.

          -  Subjects considered reliable and capable of adhering to the Protocol and visit
             schedule, according to the judgment of the Investigator.

        Exclusion Criteria:

          -  Planned excessive exposure of treated area(s) to either natural or artificial
             sunlight, tanning bed or other LED.

               -  Females who are pregnant, wishing to become pregnant during the study, or are
                  breast-feeding.

               -  Previous treatment with ARQ-151 or its active ingredient

               -  Subjects with any serious medical condition or laboratory abnormality that would
                  prevent study participation or place the subject at significant risk, as
                  determined by the Investigator.

               -  Subjects with a history of chronic alcohol or drug abuse within 6 months of
                  initiation of investigational product

               -  Subjects who are unable to communicate, read or understand the local language, or
                  who display another condition, which in the Investigator's opinion, makes them
                  unsuitable for clinical study participation
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: Telbivudine (LdT)
Intervention description: Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.
Intervention MeSH terms: Telbivudine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1869.0
Sex: All
Minimum age: 16 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is being conducted as an open-label, extended-term study for patients with chronic
      hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine

          -  Patient was not discontinued from previous Idenix-Sponsored study

        Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Patient is pregnant or breastfeeding

          -  Patient is co-infected with hepatitis C, hepatitis D or HIV

        Other protocol-defined exclusion criteria may apply
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Placebo; SM-13496; SM-13496
Intervention description: Placebo comparator; SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6; SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Intervention MeSH terms: Lurasidone 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: 525.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with Bipolar I Depression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who were fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provided written voluntary consent to
             participate in the study.

          -  Outpatients aged 18 through 74 years at the time of consent

          -  Patients meets DSM-IV-TR criteria for bipolar I disorder, most recent episode
             depressed (≥ 4 weeks and less than 12 months) without psychotic features.

        Exclusion Criteria:

          -  Patients with imminent risk of suicide or injury to self, others, or property.

          -  Patients who had been hospitalized because of a manic or mixed episode within 60 days
             prior to screening.

          -  Patients who are otherwise considered ineligible for the study by the investigator.
Multi-arm Intervention Diabetes Adherence Study
Condition: Diabetes
Intervention: Adherence information; Adherence information plus motivational interviewing
Intervention description: Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system.; Physicians, of the patients randomized to this arm, will have medication adherence information displayed when using the electronic prescribing system. Moreover, patients randomized to this arm will be recruited into a clinic run by pharmacists and nurses with delegated prescription power. The clinic personnel will use motivational interviewing techniques with patients to improve adherence to medications and/or to intensify medical treatment if adherence is optimal.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 1692.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: medication adherence; motivational interviewing

Summary:

      The purpose of this study is to compare the effectiveness of two different interventions to
      improve adherence to diabetes medications among patients with diabetes and poor metabolic
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 2 dispensings for oral medications used to treat diabetes and dyslipidemia in
             the last 18 month.

          -  At least one laboratory result for both glycated hemoglobin and LDL-cholesterol in the
             last 6 months.

          -  Average HbA1c ≥ 7% OR an average LDL ≥ 100 mg/d

          -  Continuous health plan enrollment currently and in the previous calendar year with no
             more than a 1 month lapse of coverage, and benefits that include both medical and
             pharmacy coverage.

        Exclusion Criteria:

          -  Patients who have been institutionalized in a nursing home or in a long-term care
             facility for more than 3 months in the preceding 18 month period.

          -  Participation in a disease management program
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection
Condition: Acetaminophen Overdose
MeSH terms: Drug Overdose
Intervention: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free); Acetadote
Intervention description: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours; Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
Intervention MeSH terms: Acetylcysteine; Edetic Acid; N-monoacetylcystine; Pentetic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Acetaminophen overdose; induced hepatotoxicity, liver injury

Summary:

      The primary purpose of this study is determine if a new formulation of Acetadote is at least
      as effective as the current formulation in the prevention and treatment of acetaminophen
      overdose related liver injury.
    

Eligibility criteria:

        Inclusion Criteria:

        1) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity

        Exclusion Criteria:

          1. History of allergy or hypersensitivity to acetylcysteine or any component of
             Acetadote.

          2. Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM)
             administration.

          3. Pregnant or nursing.

          4. Less than 12 years of age.

          5. Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
             >1000 U/L.

          6. Have a baseline International Normalized. Ratio (INR) > 2.0

          7. Be on dialysis or having existing renal injury such that the volume of the study drug
             administration would render the patient unsuitable for the study, in the opinion of
             the investigator.

          8. Have congestive heart failure such that the volume of the study drug administration
             would render the patient unsuitable for the study, in the opinion of the investigator.

          9. Inability to understand the requirements of the study. Subjects must be willing to
             provide written informed consent or consent of parent/legal guardian (as evidenced by
             signature on an informed consent document approved by an Institutional Review Board
             [IRB]), and agree to abide by the study restrictions. (If the subject is
             incapacitated, informed consent will be sought from a legally acceptable
             representative).

         10. Refusal to provide written authorization for use and disclosure of protected health
             information.

         11. Be otherwise unsuitable for the study, in the opinion of the Investigator.
Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Condition: Stomach Ulcer; Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Stomach Ulcer; Ulcer
Intervention: Lansoprazole; Gefarnate
Intervention description: Lansoprazole 15 mg, capsules, orally, once daily and gefarnate placebo-matching capsules, orally, twice daily for up to 6 to 24 months.; Gefarnate 50 mg, capsules, orally, twice daily and lansoprazole placebo-matching capsules, orally, once daily for up to 6 to 24 months.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole; Gefarnate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 366.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Curling Ulcer; Gastric Ulcer; Nonsteroid anti-inflammatory drug; Drug Therapy

Summary:

      The purpose of this study is to determine whether AG-1749 (lansoprazole), once daily (QD), is
      effective in preventing the recurrence of gastric and duodenal ulcers in patients receiving
      long term treatment with nonsteroid anti-inflammatory drug, compared to gefarnate, twice
      daily (BID).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient was on nonsteroid anti-inflammatory drug (NSAID) treatment on the day when
             consent was obtained, and requires the long-term continuous treatment even after
             treatment with the investigational drug is started.

          -  The patient was confirmed to have a history of gastric ulcer or duodenal ulcer.

        Exclusion Criteria:

          -  Endoscopically confirmed gastric and/or duodenal ulcers on Day 1.

          -  Endoscopically confirmed active upper gastrointestinal hemorrhage on Day 1.

          -  Current or past history of aspirin-induced asthma or hypersensitivity to NSAIDs.

          -  Past or planned surgery affecting gastric acid secretion.

          -  Clinically significant hepatic or renal disorder.

          -  Serious cardiac dysfunction, hypertension, or hematological disorder.
Study Evaluating Sirolimus in Kidney Transplant Recipients
Condition: Graft vs Host Disease; Kidney Transplantation
MeSH terms: Graft vs Host Disease
Intervention: sirolimus; cyclosporine; mycophenolate mofetil; corticosteroids; daclizumab
Intervention description: 15 mg loading dose, followed by 5 mg/day to achieve target trough levels of 10-15 ng/mL at months 1-6, then 8-12 ng/mL at months 7-12; Initial dose of 10 mg/kg/day, then twice daily to achieve target trough levels of 300-400 ng/mL at weeks 0-4; 200-300 ng/mL at months 1-2; 150-250 ng/mL at months 2-3; 100-200 ng/mL at months 3-6; 75-150 ng/mL months 6-12; 1 g twice daily; may be reduced to 750 mg BID for adverse events, or to 500 mg BID for persisting adverse events; As per center practice. By day 8 prednisolone tapered to 20 mg/day; by day 30 to 15 mg/day; by day 60 to 10 mg/day; after 4 to 6 months to 5-7.5 mg/day; IV: 1 mg/kg to a maximum of 100 mg/dose. 5 doses at 2, 4, 6, and 8 weeks after transplantation
Intervention MeSH terms: Cyclosporine; Sirolimus; Mycophenolic Acid; Cyclosporins; Daclizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney; Transplant

Summary:

      The purpose of this study is to compare the kidney function in patients who have received a
      transplanted kidney and were treated with the combination of sirolimus, daclizumab,
      mycophenolate and corticosteroids versus transplanted patients treated with cyclosporine,
      mycophenolate and corticosteroids.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Kidney transplantation

          -  Donor must be at least 60 years old.

        Exclusion Criteria:

          -  Current systemic infection

          -  Unstable angina or treatment for serious arrhythmia.

          -  Cancer within the previous 5 years.
Behavioral Modification and Vesicare Versus Vesicare Alone for Urge Incontinence in Patients With Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive; Urinary Incontinence, Urge
Intervention: Vesicare (solifenacin); Vesicare (solifenacin) plus behavioral modification
Intervention description: 5mg po qd; 5 mg dose po once daily plus behavioral modification
Intervention MeSH terms: Solifenacin Succinate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: urinary incontinence; overactive bladder; urinary frequency

Summary:

      This study will help determine if behavior modification performed in conjunction with oral
      Vesicare anticholinergic therapy is more effective for treating overactive bladder symptoms
      than oral Vesicare anticholinergic therapy alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female patients > 18 years of age

          -  OAB symptoms for > 3 months

          -  Symptoms defined as greater than 3 episodes/week of an uncontrolled urge to void
             causing incontinence.

          -  May or may not be accompanied by urinary frequency

          -  May be accompanied by stress urinary incontinence where stress incontinence does not
             predominate

        Exclusion Criteria:

          -  Male Patients

          -  Underlying cortical or spinal cord pathology including SCI, MS, or

          -  Parkinson's Disease

          -  Urinary retention with post-void residual > 150cc

          -  Current treatment or treatment within the last 3 months with anticholinergic
             medications

          -  Patients not able to complete the questionaires or voiding diaries in English

          -  Pregnancy

          -  Active urinary tract infections

          -  Bladder Cancer or unevaluated hematuria

          -  Known diagnosis of narrow angle glaucoma

          -  Severe constipation

          -  History of reduced renal function (CrCl<30ml/min)

          -  History of liver disease

          -  Current treatment with cytochrome P450 inhibitor medications
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
Condition: Primary Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brinzolamide ophthalmic suspension; Azopt®
Intervention description: dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks; dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Intervention MeSH terms: Brinzolamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic
      equivalence study with clinical endpoint.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or
             ocular hypertension in both eyes.

          -  Provide signed and dated informed consent in accordance with good clinical practice
             and local legislation prior to any study procedure.

          -  Be able and willing to follow study instructions and complete all required visits.

          -  Subject requires treatment of both eyes and is able to discontinue use of all ocular
             hypotensive medication(s) or switch ocular hypotensive medications and undergo
             appropriate washout period.

        Exclusion Criteria:

          -  Subjects with angle closure glaucoma

          -  Females who are pregnant, breast feeding, or planning a pregnancy.

          -  Females of childbearing potential who do not agree to utilize an adequate form of
             contraception.

          -  Current, or past history of, severe hepatic or renal impairment

          -  Current, or history within 2 months prior to baseline of, significant ocular disease

          -  Functionally significant visual field loss

          -  Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to
             any component of brinzolamide or sulfonamide therapy

          -  Subjects currently in another clinical trial
A Multicenter Extension Trial to Evaluate the Safety of Testosterone Gel
Condition: Adult Male Hypogonadism
MeSH terms: Hypogonadism
Intervention: Testosterone Gel (FE 999093)
Intervention MeSH terms: Testosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 145.0
Sex: Male
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a multicenter extension trial in adult hypogonadal males. The purpose of this study
      is to evaluate the safety of testosterone gel delivered using an applicator over an extended
      period of time.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of the Phase 3 protocol (NCT01665599)

        Exclusion Criteria:

          -  Use of another investigational product

          -  Use of any medications that could be considered anabolic or interfere with androgen
             metabolism

          -  Use of estrogens, gonadotropin releasing hormone agonists/antagonists, antiandrogens,
             or human growth hormone

          -  Use of another testosterone product

          -  Chronic use of any drug of abuse
Safety And Effectiveness Of Daily Dosing With Sunitinib Or Imatinib In Patients With Gastrointestinal Stromal Tumors
Condition: Gastrointestinal Stromal Tumor
MeSH terms: Gastrointestinal Stromal Tumors
Intervention: sunitinib malate; imatinib mesylate
Intervention description: 37.5 mg daily; 800mg daily
Intervention MeSH terms: Sunitinib; Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase IIIb study of patients with gastrointestinal stromal tumors who have had progressive
      disease while on 400 mg imatinib. Patients will be randomly assigned to either sunitinib 37.5
      mg daily or imatinib 800 mg daily. This study will find out the benefits and potential side
      effects of taking sunitinib or imatinib for approximately one year.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with gastrointestinal stromal tumors whose disease has progressed on imatinib
             400 mg daily.

        Exclusion Criteria:

          -  Current treatment with any chemotherapy other than imatinib.

          -  Current treatment with any dose of imatinib other than 400 mg