bioihbjkbjnl/mcl2 huggingface dataset:
Fesoterodine "add-on" Male Overactive Bladder Study
Condition: Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive
Intervention: Fesoterodine; Placebo
Intervention description: Fesoterodine 4mg or 8mg; Placebo
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 947.0
Sex: Male
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy and safety of fesoterodine on overactive bladder symptom improvement
      when added to ongoing alpha blocker treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men aged 40 years and above.

          -  On a stable and well-tolerated dose of an alpha-blocker prescribed for LUTS for at
             least 6 weeks prior to screening (Visit 1).

          -  Persistent symptoms of OAB with urinary frequency >=8 times/24 hours and
             micturition-related urgency episodes >=3 episode/24 hours.

        Exclusion Criteria:

          -  Contraindication to fesoterodine (antimuscarinics).

          -  Previous history of acute urinary retention requiring catheterization or severe
             voiding difficulties in the judgment of the investigator, prior to baseline.

          -  Unable to follow the study procedures, including completion of self-administered
             bladder diary and patient reported outcome questionnaires.
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: adalimumab; placebo
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 274.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis

Summary:

      The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese
      subjects with moderately to severely active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ulcerative colitis for greater than 90 days prior to Baseline.

          -  Active ulcerative colitis with a Mayo Score of 6-12 points at Baseline and endoscopy
             subscore of 2-3 during the Screening Period, despite concurrent treatment with at
             least one of the following (oral corticosteroids or immunosuppressants or both as
             defined below):

          -  Stable oral corticosteroid dose (prednisolone dose of ≥ 20 mg/day or equivalent) for
             at least 14 days prior to Baseline or stable oral corticosteroid dose (prednisolone of
             5 to less than 20 mg/day) for at least 40 days prior to Baseline. And/or

          -  At least a consecutive 90-day course of azathioprine or 6-mercaptopurine (6-MP) prior
             to Baseline, with a dose of azathioprine ≥ 50 mg/day or 6-MP ≥ 30 mg/day, or a dose
             that was the highest tolerated by the patient.

        Exclusion Criteria:

          -  History of subtotal colectomy with ileorectostomy or colectomy with ileoanal pouch,
             Koch pouch, or ileostomy for ulcerative colitis or was planning bowel surgery.

          -  Patients with disease limited to the rectum.

          -  Indeterminate colitis and/or Crohn's disease.

          -  Received any biological therapy (including infliximab) in the past.

          -  History of tuberculosis or malignancy.

          -  Pregnant women.

          -  Patients with positive C. difficile stool assay at Screening.

          -  Current diagnosis of fulminant colitis and/or toxic megacolon.
A Study To Evaluate The Effects And Safety Of Treatment, Treatment Withdrawal, Followed By Re-Treatment With CP-690,550 In Subjects With Moderate To Severe Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Intervention: CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention description: 10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design; 10 mg oral BID; 5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design; 5 mg oral BID
Intervention MeSH terms: Tofacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: OPT Retreatment; OPT; chronic; moderate; severe; treatment; safety; treatment withdrawal; retreatment; retreatment withdrawal; CP-690,550; Psoriasis Vulgaris; Plaque Psoriasis; tofacitinib; Xeljanz; nail psoriasis; Jak-inhibitor; oral treatment; Pruritus; Itch; DLQI; rebound; intermittent; retreat

Summary:

      The primary objectives of the study are to 1) compare the efficacy responses of CP 690,550 (5
      mg BID and 10 mg BID) versus placebo following 24 weeks of CP 690,550 treatment and
      subsequent withdrawal of active treatment at various timepoints during the 16 week double
      blind active or placebo treatment period; 2) evaluate the regain of efficacy responses of CP
      690,550 (5 mg BID and 10 mg BID) following 4 -16 weeks of CP 690,550 treatment withdrawal and
      subsequent re treatment; and 3) evaluate the safety and tolerability of CP 690,550 (5 mg BID
      and 10 mg BID) in subjects with moderate to severe chronic plaque psoriasis who are
      candidates for systemic therapy or phototherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years or older with diagnosis of plaque-type psoriasis (psoriasis vulgaris) for at
             least 12 months prior to first dose of study drug;

          -  Psoriasis Area and Severity Index (PASI) score of 12 or greater, AND Physician's
             Global Assessment (PGA) score of 3 (moderate) or 4 (severe); Psoriasis covering at
             least 10% of body surface area;

          -  No evidence of active or latent or inadequately treated infection with Tuberculosis or
             other serious infections.

        Exclusion Criteria:

          -  Non-plaque or drug induced forms of psoriasis;

          -  Cannot discontinue current oral, injectable or topical therapy for psoriasis or cannot
             discontinue phototherapy (Psoralen Ultraviolet A; Ultraviolet B).

          -  Any uncontrolled significant medical condition.
Effects of Titrated Oral Tolvaptan 15-60 mg Once Daily (QD) on Cognitive and Neurological Function in Elderly Hyponatremic Patients
Condition: Hyponatremia
MeSH terms: Hyponatremia
Intervention: Tolvaptan; Placebo
Intervention description: 15-60 mg oral tablet given once a day for 21 days.; Placebo tablet given once daily for 21 days
Intervention MeSH terms: Tolvaptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 57.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Hyponatremia; Cognitive; Neurological Function; Elderly

Summary:

      Demonstrate an improvement in the composite scores of validated neurocognitive tests in
      elderly subjects with chronic sub-clinical (i.e., asymptomatic) hyponatremia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women and men 50 years of age or older.

          -  Serum Sodium ≥123 and ≤ 134 mEq/L [mmol/L]at screening and baseline.

          -  Subjects with serum sodium concentrations ≥118 and ≤122 mEq/L[mmol/L] at screening and
             baseline may be entered into the trial based on consultation and approval from the
             study medical monitor.

        Exclusion Criteria:

          -  Conditions or history which may present a safety concern to the subject or their
             offspring or extreme susceptibility to hypotension with sudden fluid loss (aquaresis).

          -  Hyponatremia that is acute, easily reversible, artifactual, or due to a condition not
             associated with vasopressin excess or likely to respond to aquaretic therapy.

          -  Conditions associated with an independent imminent risk of morbidity and mortality.

          -  Conditions which may confound the assessment of endpoints, history of poor compliance,
             participation in a clinical trial believed by the PI or Sponsor likely to confound
             endpoint assessments.

          -  Conditions which may confound primary endpoints of cognitive function.
A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: Placebo; azelastine Hcl; azelastineHcl / fluticasone propionate; fluticasone propionate
Intervention description: placebo; azelastine Hcl 548 mcg; azelastine Hcl 548 mcg / fluticasone propionate 200 mcg; fluticasone propionate 200 mcg
Intervention MeSH terms: Fluticasone; Xhance; Azelastine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 832.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if two allergy medications (azelastine and
      fluticasone) are more effective than placebo or either medication alone (azelastine or
      fluticasone)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients 12 years of age and older with a 2 year history of moderate
             to severe seasonal allergic rhinitis

          -  Must be in generally good health

          -  Must meet minimum symptom requirements, as specified in the protocol

          -  Must be wiling and able to provide informed consent and to participate all study
             procedures

          -  Positive skin test to a prevalent spring allergen

        Exclusion criteria:

          -  On nasal examination,the presence of nasal mucosal erosion, nasal ulceration or nasal
             septal perforation

          -  Nasal disease likely to affect the deposition of the medication or evaluation, such as
             sinus infection, nasal polyps or severe deviated septum

          -  Nasal or sinus surgery within the previous 6 months

          -  Chronic sinus infection (more than 3 per year)

          -  Planned travel outside the study area during the study period

          -  Use of any investigational drug within 30 days of the first visit

          -  Hypersensitivity (bad reaction) to azelastine hydrchloride nasal spray (Astelin), or
             fluticasone propionate nasal spray (Flonase)

          -  Women who are not using an acceptable method or birth control

          -  Women who are pregnant or nursing

          -  Upper respiratory tract infection such as common cold, flu, sinus infection within 2
             weeks of first study visit

          -  Asthma or other lung diseases such as COPD. Mild asthma symptoms may be considered
             after consultation with the investigator

          -  Irregular heartbeat or other symptomatic heart conditions

          -  History of alcohol or drug abuse

          -  History of glaucoma

          -  Use of medications that could affect the study results
A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Lacosamide
Intervention description: Pharmaceutical Form: Oral tablets
Concentration: 50 mg
Route of Administration: Oral administration
Intervention MeSH terms: Lacosamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 17 Years
Healthy volunteers: No
Keywords: Lacosamide; Vimpat; Epilepsy; Partial onset seizures; Tonic-clonic seizures; Monotherapy; AED

Summary:

      Study is conducted to evaluate the long-term safety and tolerability of lacosamide (LCM) in
      patients receiving LCM in SP0994 [NCT01465997]. The study will enable collection of
      additional monotherapy safety data, and will facilitate access to treatment until commercial
      availability for monotherapy use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  An Institutional Review Board /Institutional Ethics Committee approved written
             Informed Consent Form (ICF) is signed and dated by the subject or by the parent(s) or
             legal representative. The ICF or a specific Assent form, where required, will be
             signed and dated by minors

          -  Subject/legal representative is considered reliable and capable of adhering to the
             protocol, visit schedule, and medication intake according to the judgment of the
             investigator

          -  Subject has completed the Termination Visit of SP0994 [NCT01465997] and has been
             treated with lacosamide monotherapy

        Exclusion Criteria:

          -  Subject is receiving any investigational drugs or using any experimental devices in
             addition to lacosamide (LCM)

          -  Subject experienced a seizure at the 3rd target dose (i.e. LCM 600 mg/day) during
             SP0994

          -  Subject required another Anti Epileptic Drug (AED) for the treatment of seizures

          -  Subject meets a "must" withdrawal criteria for SP0994

          -  Subject is experiencing an ongoing Serious Adverse Event from SP0994

          -  Female subject who is pregnant or nursing, and/or a woman of childbearing potential
             who is not surgically sterile, 2 year postmenopausal or does not practice one highly
             effective method of contraception, unless sexually abstinent, for the duration of the
             study
Follow-up of Rheumatoid Arthritis (RA) Moderate to Low Disease Activity Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol
Intervention description: 200 mg every two weeks
Certolizuimab Pegol 200 mg every two weeks Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis; Moderate to Low Disease Activity; Certolizumab Pegol

Summary:

      To continue to assess the clinical safety and efficacy of Certolizumab Pegol as add-on
      therapy with stable-dose Disease Modifying Anti-Rheumatic Drugs (DMARDs)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with established adult rheumatoid arthritis on Disease Modifying
             Anti-Rheumatic Drugs (DMARDs) therapy who were included in C87076 protocol and:

          -  either failed to achieve remission after 6 months of study treatment

          -  or flared after the 6 months of study treatment and completed the study (C87076
             [NCT00674362])

        Exclusion Criteria:

          -  All the concomitant diseases or pathological conditions that could interfere and
             impact the assessment of the study treatment

          -  Previous clinical trials and previous biological therapy that could interfere with the
             results in the present clinical trial
Use of Dexamethasone in Pediatric Asthma Exacerbations
Condition: Asthma
MeSH terms: Asthma
Intervention: Dexamethasone Sodium Phosphate Injection
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 318.0
Sex: All
Minimum age: 2 Years
Maximum age: 20 Years
Healthy volunteers: No
Keywords: Pediatric; Asthma; Exacerbation; Dexamethasone

Summary:

      The purpose of this study is to compare the efficacy of a single dose of dexamethasone vs.
      two doses of dexamethasone in mild and moderate asthma exacerbations pediatric patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 2 to 20 years, from all race and ethnicity groups, with a known history
             of asthma who present to the Emergency Department of Women and Children's Hospital of
             Buffalo with an acute exacerbation of mild or moderate asthma are potentially eligible
             for the study. Patients with severe asthma exacerbations will require intravenous
             steroid therapy, therefore, they will not be enrolled in the study. The investigators
             plan to enroll patients from winter of 2014 to fall 2016.

        History of asthma is defined by physician diagnosis of at least 1 prior episode of wheezing
        which responded to beta agonist medication.

        Mild asthma is defined as: Pediatric Asthma Score (PAS) of 5 to 7; Moderate asthma is
        defined as: PAS of 8 to 11; Severe asthma is defined as: PAS of 12 or more.

        Exclusion Criteria:

          -  Children who have one of the following conditions will be excluded from the study: are
             less than 2 years of age, have signs of severe exacerbation (Pediatric Asthma Score of
             more than 11), have used oral steroids in the last 2 weeks, have chronic lung disease
             (e.g., cystic fibrosis), have been given IV solumedrol, or vomit two doses of
             dexamethasone in emergency department.
Protein Kinase C (PKC) Inhibitor-Diabetic Retinopathy Phase 3 Study
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Intervention: ruboxistaurin; placebo
Intervention description: 32-mg tablet, orally, daily, up to 42 months; 1 tablet, orally, daily, up to 42 months
Intervention MeSH terms: Ruboxistaurin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 685.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is to test whether or not 32 milligrams (mg) of ruboxistaurin a day over three
      years will reduce vision loss associated with diabetic retinopathy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 or Type 2 diabetes mellitus

          -  18 years or older

          -  Meet specific requirements for diabetic retinopathy

          -  Free of severe or chronically disabling conditions, except diabetes, diabetic
             retinopathy and diabetic macular edema

          -  Hemoglobin A1c (HbA1C) ≤13.0%

        Exclusion Criteria:

          -  History of panretinal photocoagulation for diabetic retinopathy, conditions that might
             affect the progression of diabetic retinopathy, or unstable angina

          -  Investigators, site personnel directly affiliated with the study and their families

          -  Presence of eye disorders that may affect the progression of diabetic retinopathy or
             cause vision loss

          -  Presence of medical disorder, cancer, or elevated laboratory measurements that could
             represent a safety risk during the study

          -  Women who are pregnant, breastfeeding, intend to become pregnant, or who are sexually
             active without using an acceptable method of birth control
Rosuvastatin in Visceral Adiposity
Condition: Abdominal Obesity
MeSH terms: Obesity; Obesity, Abdominal
Intervention: Rosuvastatin; Placebo for rosuvastatin
Intervention description: 10 mg once daily; once daily
Intervention MeSH terms: Rosuvastatin Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 54.0
Sex: Male
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate whether 6 months treatment with the
      cholesterol-lowering drug rosuvastatin may reduce visceral fat tissue in obese middle aged
      men.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients between 40 and 65 years of age.

          -  Abdominal obesity

          -  Dyslipidemia

          -  Written informed consent.

        Exclusion Criteria:

          -  Uncontrolled hypertension

          -  Diabetes mellitus

          -  Severe liver disease

          -  Severely reduced renal function

          -  Uncontrolled endocrine disorders

          -  History of or ongoing malignant disease

          -  Patients with known myopathic disease

          -  Recent alcohol or drug abuse

          -  Weight loss or weight gain during the three months prior to screening.

          -  Ongoing treatment with statins

          -  Ongoing treatment with calcineurin-inhibitors

          -  Ongoing treatment with anti-inflammatory drugs

          -  Received an investigational drug within 30 days prior to screening.

          -  Strong clinical indication for statin treatment

          -  In the Principal Investigator's opinion, the patient has other clinically significant
             cardiac, oncologic, neurologic or psychiatric disease that could be adversely affected
             by Study participation.

          -  For any reason the patient is considered by the Principal Investigator to be an
             unsuitable candidate to participate in the Study.