bioihbjkbjnl/mcl2 huggingface dataset:
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition
Condition: Urinary Bladder, Neurogenic
MeSH terms: Urinary Bladder, Neurogenic
Intervention: Fesoterodine PR 4 mg; Fesoterodine PR 8 mg; Fesoterodine PR 8 mg; Oxybutynin; Fesoterodine PR; Fesoterodine BIC 2 mg; Fesoterodine BIC 4 mg
Intervention description: Fesoterodine 4 mg tablet once daily for 24 weeks; Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.; Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.; Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.; Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.; Fesoterodine BIC 2 mg tablet once daily for 24 weeks.; Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
Intervention MeSH terms: Fesoterodine; Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 181.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: neurogenic detrusor overactivity; neurogenic bladder; neuropathic bladder; neurologic disease; fesoterodine

Summary:

      The objective of the study is to find out if the medicine fesoterodine is a useful treatment
      in children with bladder muscle overactivity caused by a neurological condition. Children
      will be aged 6 to 17 years old. This is done by finding out how well it works, what the body
      does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It
      will be compared with the medicine oxybutynin, which is already available for treating the
      condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 6 to 17 years old

          -  Subjects with stable neurological disease and neurogenic detrusor overactivity

          -  Subjects using clean intermittent catheterization may participate

        Exclusion Criteria:

          -  Concomitant medications which may increase the risk to subjects or confound study
             results

          -  Other medical conditions which may increase the risk to subjects or confound study
             results

          -  Contraindications to the use of fesoterodine or oxybutynin
Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Condition: Esophagitis, Reflux; Esophagitis, Peptic
MeSH terms: Esophagitis; Esophagitis, Peptic
Intervention: Dexlansoprazole MR; Dexlansoprazole MR; Placebo
Intervention description: Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to six months.; Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to six months.; Dexlansoprazole placebo-matching capsules, orally, once daily for up to six months.
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 451.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erosive Esophagitis

Summary:

      The purpose of this study is to assess the ability of once-daily (QD) treatment with
      Dexlansoprazole modified-release (MR) 60 mg and 90 mg and placebo in maintaining healing of
      erosive esophagitis (EE).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have successfully completed the Phase 3 Study T-EE04-084 (NCT00251693)
             or TEE04-085 (NCT00251719); and have healed esophageal erosions proven by endoscopy.
             Complete healing was assessed for change in LA Esophagitis Classification grades A, B,
             C, or D to healed (defined as anything less than the criterion for Grade A). The
             subject was counted as healed if endoscopy findings did not meet the Grade A
             criterion.

        Exclusion Criteria:

          -  Use of prescription or nonprescription proton pump inhibitors (PPIs), histamine (H2)
             receptor antagonists, sucralfate, misoprostol, or prokinetics throughout the study

          -  Use of antacids (except for study supplied) throughout the study.

          -  Subjects using drugs with significant anticholinergic effects such as tricyclics who
             cannot stay on a stable dose throughout the study.

          -  Need for continuous anticoagulant therapy.
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
Condition: Anemia
MeSH terms: Diabetic Nephropathies; Anemia
Intervention: Epoetin beta
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 170.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of anemia correction with NeoRecormon on cardiac structure
      and function in patients with early diabetic nephropathy. The anticipated time on study
      treatment is 1-2 years and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  type 1 or type 2 diabetes;

          -  stable glycemic control for >=3 months;

          -  diabetic nephropathy.

        Exclusion Criteria:

          -  women who are pregnant, breastfeeding, or unwilling to use a reliable contraceptive
             method;

          -  previous treatment with erythropoietin or other erythropoietic substance;

          -  nondiabetic renal disease, nephrotic syndrome;

          -  blood transfusion within the 3 months prior to enrollment;

          -  administration of any investigational drug within 30 days preceding the study start,
             and during the study.
Two-year Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Condition: Overweight; Obesity
MeSH terms: Obesity; Overweight
Intervention: Semaglutide; Placebo (Semaglutide)
Intervention description: Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks; S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 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: 304.0
Sex: All
Healthy volunteers: No

Summary:

      This study will look at the change in body weight from the start to the end of the study.
      Researchers will compare the weight loss in people taking semaglutide (a new medicine) to
      people taking "dummy" medicine. In addition to taking the medicine, participants will also
      have talks with study staff about healthy food choices, how the participant can be more
      physically active and what participants can do to lose weight. Participants will either get
      semaglutide or "dummy" medicine - which treatment the participant gets is decided by chance.
      Participants will need to take 1 injection once a week. The study medicine is injected with a
      thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about
      2 years. The participants will have 19 clinic visits and 15 phone calls with the study
      doctor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age more than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index (BMI) more than or equal to 30 kg/m^2 or more than or equal to 27
             kg/m^2 with the presence of at least one of the following weight-related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion criteria:

          -  HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory
             at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records
Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: CP-690,550; CP-690,550; Disease-modifying antirheumatic drug
Intervention description: Oral tablets administered at a dose of 5 mg BID for 24 months; Oral tablets administered at a dose of 10 mg BID for 24 months; Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months
Intervention MeSH terms: Antirheumatic Agents; 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: 956.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: oral JAK inhibitor; MTX; DMARD; clinical trial; joint diseases; autoimmune diseases; anti-Inflammatory agents; rheumatic diseases

Summary:

      This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to
      methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This
      study will also compare the safety of CP-690,550 with methotrexate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with moderate to severe RA (Rheumatoid Arthritis) who have not been treated
             with methotrexate.

          -  Diagnosis of RA based on the American College of Rheumatology 1987 revised criteria.

          -  Active disease as defined by both >=6 tender or painful joints on motion and >= 6
             joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a
             C-reactive protein (CRP) concentration > 7 mg/dL

        Exclusion Criteria:

          -  Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White
             blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count
             <100 x 109/L

          -  History of any other rheumatic autoimmune disease other than Sjogren's syndrome

          -  No malignancy or history of malignancy

          -  History of infection requiring hospitalization, parenteral antimicrobial therapy, or
             as otherwise judged clinically significant by the investigator, within the 6 months
             prior to the first dose of study drug

          -  No chronic liver disease, recent or active hepatitis or other contraindication to
             methotrexate therapy
Colchicine For Prevention of Perioperative Atrial Fibrillation in Patients Undergoing Thoracic Surgery Pilot Study
Condition: Atrial Fibrillation; Thoracic Surgery
MeSH terms: Atrial Fibrillation
Intervention: Colchicine 0.6 mg; Placebo Colchicine
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 100.0
Sex: All
Minimum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this pilot study is to determine the feasibility of comparing colchicine to
      placebo for the prevention of new onset atrial fibrillation in patients undergoing general
      thoracic surgery and establish the foundation for a large, multi-centre, clinical trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients ≥55 years of age undergoing intra-thoracic surgery for a resection of
             tumor in lung.

        Exclusion Criteria:

          -  In AF prior to surgery*,

          -  Undergoing minor thoracic interventions/ procedures (i.e., chest tube insertion,
             needle pleural/lung biopsies, or minor chest-wall surgeries), or

          -  With contraindications to colchicine (i.e., allergy, or myelodysplastic disorders or
             estimated glomerular filtration rate [e-GFR] <30 mL/min/1.73m)

               -  Clarification: Patients with history of AF who are in sinus rhythm during
                  enrollment will be eligible for recruitment. Patients who have no history of AF
                  and are found to be in AF at the time of enrollment will not be eligible.
Long-term Efficacy and Safety of V0034 CR 01B Cream in Patients With Moderate-to-severe Uremic Xerosis
Condition: Uremic Xerosis
Intervention: V0034CR01B; V0034CR01B vehicle
Intervention MeSH terms: V0034CR
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 237.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary objective:

      To demonstrate the long-term efficacy (response to treatment during initial therapy, time to
      relapse without treatment, durability and lesional recurrence during maintenance therapy) of
      V0034 CR 01B cream on uraemic xerosis in the real-life setting.

      Secondary objectives:

        1. To assess the local tolerance of V0034 CR 01B after long-term use

        2. To assess the patient benefit and acceptability of V0034 CR 01B
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients of both sexes, of at least 18 years of age

          2. Women of childbearing potential having a reliable contraceptive method

          3. Patients undergoing maintenance renal dialysis (MRD), i.e. either haemodialysis or
             peritoneal dialysis, due to chronic renal failure

          4. Patients whose xerosis is related to their renal insufficiency status (uraemic
             xerosis)

          5. Patients suffering from xerosis with a severity score of at least two, on at least one
             of the five tests areas (right lower leg, left lower leg, forearm with no
             arterio-venous shunt, chest, dorsum of the neck)

        Exclusion Criteria:

          1. Patients under 18 years of age

          2. Women with childbearing potential having a positive pregnancy test at baseline

          3. Patients undergoing renal dialysis for another reason than chronic renal insufficiency

          4. Patients whose xerosis is due to another reason than their MRD status

          5. Patients suffering from mild xerosis (i.e. score less than two on all the xerotic test
             areas)

          6. Patients with a known history of allergy to one of the ingredients contained in the
             test product

          7. Patients with an intercurrent condition which may interfere with a good conduct or the
             study parameters of the study

          8. Patients treated with any other emollient/moisturising topical preparation within the
             seven days prior to study entry

          9. Patients who participated in a study within the three months prior to study entry

         10. Patients who are not affiliated to health insurance

         11. Patients who are not able or willing to follow the study instructions -
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: tocilizumab [RoActemra/Actemra]; tocilizumab [RoActemra/Actemra]; Nonbiologic DMARDs of investigator's choice
Intervention description: 8 mg/kg intravenous every 4 weeks for 24 weeks; 4 mg/kg every 4 weeks for 24 weeks; Nonbiologic disease-modifying antirheumatic drugs (DMARDs) As prescribed
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 886.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of
      tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had
      inadequate response to or are unable to tolerate DMARDs. The protocol incorporates risk
      mitigation strategies developed in partnership with the FDA to manage known and potential
      risks associated with the treatment of tocilizumab. Patients will be randomized to receive
      tocilizumab either 4 mg/kg intravenous (iv) or 8 mg/kg iv with concomitant non-biologic
      DMARDs, or 8 mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of
      6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample
      size is 500-1000 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  moderate to severe active rheumatoid arthritis for >6 months;

          -  inadequate clinical response or unable to tolerate current or prior biologic or
             non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;

          -  Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4

          -  body weight </=150kg

          -  current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to
             baseline;

        Exclusion Criteria:

          -  history of autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis;

          -  functional class IV as defined by the American College of Rheumatology (ACR)
             Classification of Functional Status in rheumatoid arthritis;

          -  treatment with rituximab within 6 months before screening;

          -  intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv)
             corticosteroids within 12 weeks prior to screening;

          -  known active current or history of recurrent infections, or any major episode of
             infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of
             screening, or oral antibiotics within 2 weeks prior to screening.
Disease Management for Smoking Cessation
Condition: Smoking Cessation
Intervention: High intensity disease management; Low intensity disease management; Comparison group; Bupropion
Intervention description: Health education mailings, 6 motivation interviews/counseling; Health education mailings, one motivation interview/counseling; Health education mailings; Buproprion or Nicotine Replacement Therapy
Intervention MeSH terms: Bupropion; Nicotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 750.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary aim of this study is to assess the effectiveness of both high and low intensity,
      disease management programs for smoking. The hypotheses are to compare abstinence from
      cigarettes, the number of quit attempts, and smokers motivation at 24 months between
      participants receiving high and low intensity disease management and those receiving usual
      care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over the age of 18

          -  Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days

          -  Speak English

          -  Their regular physician is a participating physician

          -  Working home telephone or cellular phone

        Exclusion Criteria:

          -  Women who are pregnant or planning to become pregnant in the next two years

          -  Plan on moving within two years

          -  Display signs of dementia or other mental disorders

          -  Live with a smoker already enrolled
A Double-blind Study to Assess the Efficacy and Safety of Denosumab Produced by Two Different Processes in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Denosumab (CP2); Denosumab (CP4)
Intervention description: Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.; Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 394.0
Sex: Female
Minimum age: 55 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: postmenopausal osteoporosis; osteoporosis; postmenopausal; denosumab; women

Summary:

      This study will compare the effect of denosumab produced by two different manufacturing
      processes on bone mineral density at the lumbar spine in postmenopausal women with
      osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent prior to any study-specific
             activities/procedures

          -  Ambulatory postmenopausal women.

          -  Age 55 years or older

          -  Screening BMD value equivalent to a T-score less than or equal to -2.5 at the lumbar
             spine, total hip, or femoral neck.

        Exclusion Criteria:

          -  Administration of osteoporosis treatments or bone active treatments within specific
             timeframes

          -  Vitamin D deficiency

          -  Diseases and conditions that affect bone metabolism (e.g., hypo/hyper-parathyroidism;
             hypo/hyperthyroidism, unless stable and well-controlled)

          -  Contraindications to denosumab therapy (e.g., hypocalcemia)