bioihbjkbjnl/mcl2 huggingface dataset:
An Implantable Microstimulator for the Chronic Treatment of Refractory Urinary Urge Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Urge
Intervention: bion
Intervention description: battery powered microstimulator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Incontinence; Refractory; Urinary; Urge; Stimulation; Nerve; Microstimulator; Neuromodulation

Summary:

      This clinical trial is being conducted to investigate the safety and effectiveness of a new
      device designed to treat urinary urge incontinence in those patients who have tried and
      failed two or more conservative therapies.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Age 18 years and above.

          2. Diagnosed with urinary urge incontinence.

          3. Have no reported history of urethral obstruction/stricture, bladder calculi or bladder
             tumor.

          4. Have normal upper urinary tract function.

          5. Be capable of giving informed consent.

          6. Be capable and willing to follow all study related procedures.

        Key Exclusion Criteria:

          1. Have any active implantable device regardless of whether stimulation status is ON or
             OFF.

          2. Are pregnant as confirmed by a urine pregnancy test or plan to become pregnant during
             the following 12 months period.

          3. Less than one year post partum and/or are breast-feeding.

          4. Have any passive implant that contains metal or electrically conductive materials.

          5. Have conditions requiring Magnetic Resonance Imaging (MRI) evaluation.

          6. Have conditions requiring diathermy procedures.

          7. Have an inability to operate the bion Remote Control and bion Recharging System either
             by self or caregiver.

          8. Have diabetes with peripheral nerve involvement or have severe uncontrolled diabetes.

          9. Have history of coagulopathy or bleeding disorder.

         10. Have a history of pelvic pain as primary diagnosis.

         11. Have anatomical restrictions such that the study device placement is not possible.

         12. Are currently participating or have participated within the past 30 days in any
             clinical investigation involving or impacting urinary or renal function.

         13. Have a life expectancy of less than 1 year.

         14. Cannot independently comprehend and complete the QoL questionnaires.
A Reader Study to Assess Accuracy and Reliability of Flortaucipir F 18 Positron Emission Tomography (PET) Scan Interpretation
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: flortaucipir F 18
Intervention description: No study drug will be administered.
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.
Masking: None (Open Label)
Masking description: PET scans were obtained in an open-label fashion.
Enrollment: 242.0
Sex: All
Healthy volunteers: No
Keywords: flortaucipir F 18; Positron Emission Tomography; 18F-AV-1451; Diagnostic imaging; Tau imaging

Summary:

      This study will evaluate the performance of physician readers trained to read
      flortaucipir-PET (positron emission tomography) scans.
    

Eligibility criteria:

        Scan Reader Criteria (5 total):

          -  Board-certified in radiology or nuclear medicine

          -  Professional experience interpreting PET scans

          -  Naive to study protocol

          -  No previous training or exposure to Avid Flortaucipir F 18 read methodology

        Scan Criteria:

        - Previous enrollment in Study A05 confirmatory cohort (NCT02016560), or A16 (NCT02516046)

        Scan Study Population Criteria for FR01 (A05 confirmatory cohort):

          -  Cognitively-impaired

          -  mild cognitive impairment (MCI) or dementia with suspected neurodegenerative cause

          -  mini-mental status exam (MMSE) score of 20-27, inclusive

        Scan Study Population Criteria for FR01 (Study A16):

          -  Subjects at end of life (less than or equal to 6 months)

          -  Imaged with flortaucipir F18 and came to autopsy
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; Placebo
Intervention description: QAW039 once daily; Placebo once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 704.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: QAW039, uncontrolled asthma

Summary:

      A randomized, multicenter, double-blind, placebo- controlled parallel-group study to
      determine the efficacy and safety of QAW039, compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
      uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
      second (FEV1) at the end of 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

          -  Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
             ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
             antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
             and the doses have been stable for at least 4 weeks prior to Visit 1.

          -  FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
             years.

          -  Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
             of the placebo run- in period.

          -  Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
             period.

          -  Demonstrated reversible airway obstruction.

          -  Asthma control questionnaire (ACQ) score ≥ 1.5.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days, whichever is longer.

          -  A resting QTcF (Fridericia) ≥450 msec (male) or

             ≥460 msec (female).

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
             >2 mg of pitavastatin.

        Other protocol-defined inclusion/exclusion criteria may apply.
Comparison of Lens Care Regimens With a Silicone Hydrogel Lens (Emerald)
Condition: Myopia
MeSH terms: Myopia
Intervention: ClearCare; Optifree Replenish
Intervention description: contact lens care system; contact lens care system
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 30.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to evaluate and compare, on a daily wear basis, the performance
      of two contact lens care solutions when used with silicone hydrogel soft contact lenses with
      regards to comfort and dryness symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

        A person is eligible for inclusion in the study if he/she:

          1. Is at least 17 years of age and has full legal capacity to volunteer.

          2. Has read, understood and signed an information consent letter.

          3. Is willing and able to follow instructions and maintain the appointment schedule.

          4. Is presently using either bi-weekly or monthly replacement lenses.

          5. Has symptoms of ocular dryness as determined by specific pre-screening criteria.

          6. Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual
             vision correction.

          7. Has clear corneas and no active ocular disease.

          8. Has had an ocular examination in the last two years.

        Exclusion Criteria:

        A person will be excluded from the study if he/she:

          1. Is an asymptomatic lens wearer.

          2. Is a daily disposable contact lens wearer.

          3. Is a current extended wear contact lens wearer.

          4. Currently uses one of the study lens care regimens.

          5. Has any clinically significant blepharitis.

          6. Has undergone corneal refractive surgery.

          7. Is aphakic.

          8. Has any active ocular disease.

          9. Has any systemic disease affecting ocular health.

         10. Is using any systemic or topical medications that may affect ocular health.

         11. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.

         12. Is participating in any other type of clinical or research study.
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: Entecavir (ETV); Adefovir (ADV)
Intervention description: Tablets, Oral, 1 mg once daily, 96 weeks from the time the last patient is randomized; Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized
Intervention MeSH terms: Entecavir; Adefovir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 195.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: hepatic decompensation

Summary:

      This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg
      QD in patients who have chronic hepatitis B infection and hepatic decompensation. The
      patients are treated for 96 weeks after the last subject is randomized.
    

Eligibility criteria:

        Inclusion

          -  Child-Pugh (CP) score >= 7

          -  Hepatitis B virus (HBV) viremia

        Exclusion

          -  Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN)

          -  Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV)
             coinfection
An Evaluation of Exenatide and Rosiglitazone in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: exenatide; rosiglitazone
Intervention description: subcutaneous injection, 5mcg or 10mcg, twice a day; oral tablet, 2mg or 4mg, twice a day
Intervention MeSH terms: Exenatide; Rosiglitazone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: diabetes; exenatide; rosiglitazone; Amylin; Lilly

Summary:

      This protocol is designed to evaluate the metabolic effects of adding exenatide,
      rosiglitazone, or both to an existing regimen of metformin in subjects with inadequate
      glycemic control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HbA1c of 6.8% to 10.0%, inclusive.

          -  Body mass index (BMI) of 25 kg/m^2 to 40 kg/m^2, inclusive.

        Exclusion Criteria:

          -  Have participated in this study previously, or have received exenatide, pramlintide
             acetate, GLP-1 analogs, or dipeptidyl peptidase-IV (DPP-IV) inhibitors

          -  Have participated in an interventional, medical, surgical, or pharmaceutical study (a
             study in which an experimental, drug, medical, or surgical treatment was given) within
             30 days of study start. This criterion includes drugs that have not received
             regulatory approval for any indication at the time of study start.

          -  Treated with any of the following medications:

               -  Thiazolidinedione within 5 months of screening;

               -  Sulfonylurea within 3 months of screening;

               -  Metformin/sulfonylurea combination therapy within 3 months of screening;

               -  Alpha-glucosidase inhibitor within 3 months of screening;

               -  Meglitinide within 3 months of screening;

               -  Insulin for more than 1 week within the 3 months prior to screening.

               -  Symlin (pramlintide acetate) injection or Byetta (exenatide) injection at any
                  time

               -  Chronic (more than 2 weeks) or recent (within 4 weeks of study start) use of a
                  drug that directly affects gastrointestinal motility

               -  Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid
                  therapy (excluding topical and inhaled preparations) or have received such
                  therapy within the 4 weeks immediately preceding study start

               -  Regular use of a medication with addictive potential such as an opiate, narcotic,
                  or tranquilizer

               -  Systemic antineoplastic agent

               -  Systemic transplantation medication

               -  Drugs for weight loss, including over-the-counter medications, within the 4
                  months prior to study start
BLOOM-DM: Behavioral Modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus
Condition: Obesity
MeSH terms: Obesity; Diabetes Mellitus; Overweight
Intervention: Lorcaserin 10 mg once daily (QD); Lorcaserin 10 mg twice a day (BID); Matching Placebo
Intervention description: Lorcaserin 10 mg tablet each morning and placebo tablet each evening for a duration of 52 weeks.; Lorcaserin 10 mg tablet each morning and evening for a duration of 52 weeks.; Matching placebo tablet each morning and evening for a duration of 52 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 604.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: obesity; weight loss; lorcaserin; APD356; BLOOM-DM; hypertension; dyslipidemia; sleep apnea; glucose tolerance; cardiovascular disease; Arena

Summary:

      The purpose of this study is to assess the weight loss effect of lorcaserin during and at the
      end of 1 year of treatment in overweight and obese patients with Type II diabetes mellitus
      treated with metformin, sulfonylurea (SFU), or either agent in combination with other oral
      hypoglycemic agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overweight/obese men and women with type 2 diabetes mellitus that is managed with oral
             anti-hyperglycemic agent(s).

          -  Body mass index (BMI) 27 to 45 kg/m2, inclusive.

          -  Ability to complete a 1 year study

        Exclusion Criteria:

          -  Pregnancy

          -  Use of insulin in any form, exenatide (Byetta) or pramlintide (Symlin) within 3 months
             prior to screening

          -  History of symptomatic heart valve disease

          -  Serious or unstable current or past medical conditions
A Phase 3 Safety and Efficacy Study of Fovista® (E10030) Intravitreous Administration in Combination With Lucentis® Compared to Lucentis® Monotherapy
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: E10030; ranibizumab; E10030 sham intravitreal injection
Intervention description: Pressure on the eye with a syringe with no needle
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 627.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Wet AMD; choroidal neovascularization; Fovista®; E10030; Lucentis®

Summary:

      The objectives of this study are to evaluate the safety and efficacy of intravitreal
      administration of Fovista® administered in combination with Lucentis® compared to Lucentis®
      monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related
      macular degeneration (AMD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects of either gender aged ≥ 50 years

          -  Active subfoveal choroidal neovascularization (CNV) secondary to AMD

          -  Presence of sub-retinal hyper-reflective material (SD-OCT)

        Exclusion Criteria:

          -  Any prior treatment for AMD in the study eye prior to the Day 1 visit, except oral
             supplements of vitamins and minerals

          -  Any prior intravitreal treatment in the study eye prior to the Day 1 visit, regardless
             of indication (including intravitreal corticosteroids)

          -  Any intraocular surgery or thermal laser within three (3) months of trial entry. Any
             prior thermal laser in the macular region, regardless of indication

          -  Subjects with subfoveal scar or subfoveal atrophy are excluded

          -  Diabetes mellitus
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers
Condition: Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Intervention: Tadalafil; Placebo
Intervention description: 5 mg taken by mouth once daily for 12 weeks; By mouth once daily for 12 weeks
Intervention MeSH terms: Tadalafil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 318.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Prostate; BPH; Benign Prostatic Hyperplasia; BPH-LUTS; LUTS; Phosphodiesterase Inhibitors; tadalafil; alpha blockers

Summary:

      The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to
      men who are currently taking a medication called an alpha blocker for the treatment of benign
      prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that
      the bladder is not completely emptied after urination).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to
             starting the study.

          -  Have not taken the following treatments within the indicated duration and agree not to
             use at any time during the study:

               1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations)
                  for at least 4 weeks prior to receiving study medication.

               2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior
                  to receiving study medication.

               3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks
                  prior to receiving study medication.

          -  If taking finasteride or dutasteride, must have been taking treatment for at least 6
             months.

        Exclusion Criteria:

          -  Currently receiving alpha-blocker therapy for the treatment of hypertension.

          -  History of symptoms associated with orthostasis, including recurrent episodes of
             dizziness, lightheadedness, loss of consciousness, or syncope.

          -  Treated with nitrates for any cardiac conditions.

          -  Have had any of the following in the past 90 days: Heart attack, also known as a
             myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft
             surgery); Had a procedure to open up blood vessels in the heart known as angioplasty
             or stent placement (percutaneous coronary intervention).

          -  Have problems with kidneys, liver, or nervous system

          -  Have uncontrolled diabetes

          -  Have prostate cancer, are being treated for cancer or have clinical evidence of
             prostate cancer (PSA greater than 10 ng/ml at the start of study).

          -  Have had a stroke or a significant injury to brain or spinal cord.
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
Condition: Chronic Hepatitis C Virus (HCV) Infection Genotype 1
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267; ABT-333; Ribavirin (RBV)
Intervention description: Tablet for oral use; Tablet for oral use; Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.
Intervention MeSH terms: Ritonavir; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1596.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Hepatitis C Genotype 1; Compensated Cirrhosis; Cirrhosis; Naive; Hepatitis C; Hepatitis C Virus; Treatment-Experienced; Relapser; Null responder; Non responder

Summary:

      The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated
      with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without
      ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females at least 18 years old at screening

          2. Females must be post-menopausal for more than 2 years or surgically sterile or
             practicing acceptable forms of birth control

          3. Chronic hepatitis C, genotype 1 infection

          4. Males must be surgically sterile or agree to practice acceptable forms of birth
             control

          5. Screening laboratory result indicating HCV genotype 1 infection

        Exclusion Criteria:

          1. Use of contraindicated medications within 2 weeks of dosing

          2. Abnormal laboratory tests

          3. Current or past clinical evidence of Child-Pugh B or C classification or history of
             liver decompensation

          4. Confirmed presence of hepatocellular carcinoma

          5. History of solid organ transplant