bioihbjkbjnl/mcl2 huggingface dataset:
COSOPT (Timolol/Dorzolamide Combination) Normal Tension Glaucoma Study (MK0507A-161)(COMPLETED)
Condition: Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Intervention: timolol/dorzolamide combination
Intervention description: Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
Intervention MeSH terms: Timolol; Dorzolamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A study to evaluate the effect of the 12-week treatment with timolol/dorzolamide combination
      eyedrops (COSOPT) on decrease in intraocular pressure (IOP) at 2 hours after the study drug
      administration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have not been treated with a glaucoma medication within 6 weeks prior to
             study participation after diagnosis with primary open-angle glaucoma

          -  Patients with primary open-angle glaucoma based on gonioscopy

          -  Patients with normal tension glaucoma diagnosed based on accompanying optic disc
             cupping and reappearance of visual field defect corresponding to retinal nerve fiber
             layer defect.

          -  Subjects with < 22 mm Hg of diurnal IOP measured using Goldmann applanation tonometer
             (every two hours between 9 a.m. and 5 p.m.)

        Exclusion Criteria:

          -  Patients with another type of glaucoma but primary open-angle glaucoma

          -  Patients treated with other glaucoma medications within 6 weeks prior to study
             participation

          -  Patients with a history of chronic ocular inflammation or recurrent ocular
             inflammation

          -  Patients using contact lenses

          -  Patients who are allergic to timolol or dorzolamide

          -  Patients with a history of any of the following COSOPT (timolol/dorzolamide
             combination) contraindications:

               -  Reactive airway diseases

               -  Sinus bradycardia, second or third degree atrioventricular block, overt cardiac
                  failure, cardiogenic shock

               -  Severe renal impairment

          -  Patients with a history of significant ocular trauma or intraocular surgery within 6
             months before participating the study, or intraocular laser surgery within 3 months
             before the participating the study

          -  Patients with a history of a corneal disease

          -  Patients who are using steroid or used the drug for more than 2 weeks within 12 months
             before participating the study

          -  Pregnant women
Vascular Impairment in Type II Diabetes Mellitus With Co-morbid Obstructive Sleep Apnea
Condition: Sleep Apnea, Obstructive; Diabetes Mellitus
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Continuous positive airway pressure; Sham continuous positive airway pressure
Intervention description: CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).; CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The investigators will examine the possible synergistic effects of obstructive sleep apnea
      (OSA) and type II diabetes mellitus (DM) on vascular functioning by performing a two-part
      investigation:

        -  A cross-sectional study comparing subjects with OSA+DM, OSA only, DM only, and healthy
           controls.

        -  A three-month randomized placebo-controlled trial of continuous positive airway pressure
           (CPAP) in subjects with OSA+DM.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OSA subjects: apnea-hypopnea index >=10 and <100

          -  DM subjects: clinical diagnosis of DM and glycated hemoglobin < 8.0%

        Exclusion Criteria:

          -  Hematocrit < 32

          -  Pregnancy

          -  Infectious/collagen vascular/hepatic or renal/cardiopulmonary disease
The Biological Activity of Cediranib (AZD2171) in Gastro-Intestinal Stromal Tumours(GIST).
Condition: Gastrointestinal Stromal Tumors; Soft Tissue Sarcomas
MeSH terms: Sarcoma; Gastrointestinal Stromal Tumors
Intervention: AZD2171
Intervention description: 45 mg oral tablet once daily dose
Intervention MeSH terms: Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cancer; tumour; advanced cancer; Metastatic Gastro-Intestinal Stromal Tumours; gastro-intestinal cancer; RECENTIN

Summary:

      To determine the anti-tumour activity and biological effects of cediranib (AZD2171) at a dose
      of 45mg, primarily in Gastrointestinal Stromal Tumour (GIST) patients who are resistant to
      imatinib mesylate (current standard therapy) and also in patients with metastatic Soft Tissue
      Sarcoma (STS) resistant to standard therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological confirmation of GIST which is resistant or intolerant to
             imatinib mesylate, or metastatic STS, which is refractory to standard therapies or for
             which no standard therapy exists

        Exclusion Criteria:

          -  Patients with type I insulin-dependent diabetes or poorly-controlled type II
             insulin-independent diabetes.

          -  Patients with a history of poorly controlled high blood pressure
Maintenance Study Including Re-induction Therapy for Patients Who Did Not Show a Clinical Effect in Study C87037 (NCT00291668)
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol; Certolizumab pegol; Certolizumab pegol
Intervention description: Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 10, 12, 16, 20, 24, 28 and 32 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Certolizumab pegol (CZP) 400 mg at Weeks 0, 2 and 4.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 16 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Crohn's Disease; CDP870; Certolizumab pegol; CZP

Summary:

      This 26-week extension study evaluates the efficacy and safety of certolizumab pegol
      administered subcutaneously every 4 weeks (dosed at Weeks 16, 20, 24, 28 and 32) in subjects
      with active Crohn's disease who had no clinical response at Week 6 to induction therapy in
      the 6-week double-blind main study, C87037 (NCT00291668), but subsequently showed clinical
      response at Week 14 to repeated induction therapy (dosed at Weeks 8, 10 and 12) in this
      extension study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who gave written informed consent and who did not show clinical efficacy at
             Week 6 of the double-blind main study (NCT00291668) [reduction in Crohn's Disease
             Activity Index (CDAI) score of ≥100 points from Week 0, or remission (CDAI ≤150)]

        Exclusion Criteria:

          -  Subjects who experienced aggravation of Crohn's Disease during the double-blind main
             study (NCT00291668) and required treatment change
A Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Participants With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Imsidolimab; Placebo
Intervention description: Humanized Monoclonal Antibody; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 123.0
Sex: All
Minimum age: 12 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: LI-36 Receptor; Interleukin 36; Imsidolimab

Summary:

      Efficacy and Safety of Imsidolimab in Participants with Acne Vulgaris
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of moderate to severe facial AV

          -  Facial IGA) score of 3 (moderate) or 4 (severe)

          -  At least 20 and no more than 100 inflammatory lesions on the face

          -  No more than 100 non-inflammatory lesions on the face.

          -  No more than 5 nodules (≥5 millimeter [mm]) on the face

        Key Exclusion Criteria:

          -  A participant with acne fulminans or conglobate or secondary acne will be excluded.
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
Condition: Macular Edema; Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Fluocinolone Acetonide; Fluocinolone Acetonide
Intervention description: 0.2 µg/day; 0.5 µg/day
Intervention MeSH terms: Fluocinolone Acetonide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Macular edema secondary to RVO

Summary:

      This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with
      macular edema secondary to RVO.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central
             retinal vein occlusion (CRVO)

          -  Central subfield thickness > 300 μm

          -  BCVA of ≥ 24 and ≤ 68 letters

          -  Males and non-pregnant females 18 years and over

        Exclusion Criteria:

          -  Macular edema secondary to any condition other than RVO

          -  Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in
             the study eye

          -  Cystic intraretinal hemorrhage involving the fovea in the study eye that is
             responsible for vision loss

          -  Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with
             IOP-lowering agents)

          -  Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF
             therapy since the diagnosis of RVO in the study eye

          -  Any change in systemic steroid therapy within 3 months of screening

          -  History of vitrectomy in the study eye
Safety and Efficacy Study of Adjunctive Antiplatelet Therapy Prior to Primary PCI in Patients With STEMI
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Intervention: placebo; PRT060128 Potassium
Intervention description: administration of iv bolus prior to angiography; administration of iv bolus prior to angiography
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: STEMI; ACS

Summary:

      Safety and efficacy of adjunctive antiplatelet therapy prior to primary percutaneous
      intervention (PCI) in patients with ST-Elevation Myocardial Infarction (STEMI)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Persistent ST elevation ≥ 1mm (≥ 0.1mV) in two contiguous limb leads OR ≥ 2 mm (≥
             0.2mV) in two contiguous precordial leads, AND chest pain ≥ 20 minutes with onset
             within 6 hours of hospital presentation.

        Exclusion Criteria:

          -  Cardiogenic shock (systolic blood pressure < 90 mm Hg requiring vasopressor or
             hemodynamic support)

          -  Uncontrolled hypertension defined as any measured systolic blood pressure (SBP) > 180
             mm Hg or diastolic blood pressure (DBP) ≥ 110 mm Hg after the time -- History or
             symptoms of a congenital or acquired bleeding disorder or vascular malformation.

          -  Recent gastrointestinal bleeding within the last 30 days.

          -  Known thrombocytopenia (platelet count < 100,000/mm3).

          -  Any treatment with a fibrinolytic agent within the last 7 days.
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Condition: Colon Cancer; Precancerous Condition; Rectal Cancer
MeSH terms: Precancerous Conditions
Intervention: acetylsalicylic acid; placebo; laboratory biomarker analysis
Intervention description: Given orally; Given orally; Correlative study
Intervention MeSH terms: Aspirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 79.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial is studying how well aspirin works in preventing colorectal
      cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of
      certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.
    

Eligibility criteria:

        Criteria:

          -  No active or metastatic cancer within the past 6 months

          -  Scheduled to undergo colonoscopy for colonic neoplasia surveillance

          -  Hemoglobin >= 12.0 g/dL

          -  Platelet count >= 120,000/mm^3

          -  AST or ALT =< 1.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase =< 1.5 times ULN

          -  Bilirubin =< 1.5 times ULN

          -  BUN =< 40 mg/dL

          -  Glomerular filtration rate >= 45 mL/min

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No coagulopathy

          -  No anemia

          -  No history of peptic ulcer disease or gastrointestinal hemorrhage

          -  No history of cerebrovascular accident

          -  No uncontrolled hypertension

          -  No history of intolerance or allergy to aspirin or to NSAIDs

          -  No liver disease as manifested by signs or symptoms of cirrhosis

          -  No endoscopic or radiographic evidence of portal hypertension

          -  No active colitis by endoscopy

          -  No history of inflammatory bowel disease

          -  No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or
             transient ischemic attack)

          -  No untreated helicobacter pylori infection

          -  History of significant colonic neoplasia, defined as 1 of the following:

               -  Adenoma within the past 6 years

               -  Colorectal cancer within the past 6 years

               -  Known adenoma on present exam

               -  Histologically confirmed polyps seen on imaging

          -  INR =< 1.5

          -  At least 6 months since prior cancer treatment

          -  No other concurrent acetylsalicylic acid (aspirin)-containing products or
             non-steroidal anti-inflammatory drugs (NSAIDs)

          -  No concurrent systemic corticosteroids

          -  No other concurrent anticoagulants or antiplatelet agents

          -  No concurrent investigational drugs
Safety and Tolerability of Modafinil for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Modafinil
Intervention description: subjects attend clinic for the first week in order to receive meds; oral, 200mg/day doses for three days for initiation doses; increased to oral 400mg/day for the remainder of the trial (weeks 2-6); washout period during week 7
Intervention MeSH terms: Modafinil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This 7 week, open-label pilot clinical trial will examine the safety and tolerability of
      modafinil up to 400mg/day as a potential treatment to reduce methamphetamine use in
      methamphetamine-dependent volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18-65 years old

          -  not currently enrolled in a treatment program

          -  subjects must have a history of methamphetamine use with recent use confirmed by a
             positive urine toxicology screen for amphetamines during the month prior to study
             entry

          -  subjects must meet DSM-IV criteria for amphetamine dependence as assessed by the
             substance abuse section of the Structured Clinical Interview for DSM-IV (SCID)

          -  women of childbearing age must have a negative pregnancy test to enroll in this study,
             agree to monthly pregnancy testing, and agree to use appropriate forms of birth
             control for the duration of the study

        Exclusion Criteria:

          -  current diagnosis of alcohol, opiate, or sedative physical dependence

          -  ill health (e.g., major cardiovascular, renal, endocrine, hepatic disorder)

          -  history of schizophrenia, or bipolar type I disorder

          -  present or recent use of over-the-counter or prescription psychoactive drug or drug(s)
             that would be expected to have major interaction with drug to be tested

          -  medical contraindication to receiving study medications (e.g., allergy to modafinil,
             treatment with cyclosporine, clomipramine, or desipramine)

          -  Current suicidality or psychosis

          -  liver function tests (i.e., liver enzymes) greater than three times normal levels

          -  pregnancy or breastfeeding
A Study of the Safety and Effectiveness of Canagliflozin (JNJ-28431754) in Promoting Weight Loss in Overweight and Obese Patients Who do Not Have Diabetes
Condition: Obesity
MeSH terms: Obesity; Overweight
Intervention: Canagliflozin (JNJ-28431754); Placebo
Intervention description: One 50 mg, 100 mg, or 300 mg over-encapsulated tablet orally (by mouth) once daily for 12 weeks.; One matching placebo capsule orally once daily for 12 weeks.
Intervention MeSH terms: Canagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 376.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Obesity; Overweight; Weight loss; Anti-Obesity Agents; Human

Summary:

      The purpose of this study is to test the safety and effectiveness of JNJ-28431754 in
      promoting weight loss in patients who are overweight or obese and who do not have diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI >=30 kg/m2 and <50 kg/m2 or a BMI >=27 kg/m2 and <50 kg/m2 in the presence of
             controlled hypertension and/or treated or untreated dyslipidemia

          -  Must have a stable weight, i.e., increasing or decreasing not more than 5% in the 3
             months before screening

          -  Serum creatinine <=1.5 mg/dL for men and <=1.4 mg/dL for women at screening

          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels within 2
             times the upper limit of normal (ULN) and bilirubin within the normal range, unless
             the findings are consistent with Gilbert's disease

          -  fasting plasma glucose PG <7.0 mmol/L (126 mg/dL) at screening

        Exclusion Criteria:

          -  A history of hereditary glucose-galactose malabsorption or primary renal glycosuria

          -  An established diagnosis of diabetes mellitus or treatment with glucose lowering drugs
             at screening

          -  A history of reactive hypoglycemia or of symptomatology possibly due to hypoglycemia

          -  Fasting triglyceride level >6.78 mmol/L (600 mg/dL) at screening

          -  History of obesity with a known cause (e.g., Cushing's disease)