bioihbjkbjnl/mcl2 huggingface dataset:
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Linagliptin; Linagliptin Placebo; Glimepiride
Intervention description: 5mg once daily; 0 mg placebo comparator for part 1 of study (to 18 weeks); 1-4mg for part 2 of study (weeks 19-52)
Intervention MeSH terms: Glimepiride; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Efficacy of BI 1356 compared to placebo in patients for whom metformin therapy is
      inappropriate (intolerability, contraindication). The second part of the study looks at the
      safety of BI 1356 in this patient population with longer term treatment in comparison to a
      sulfonylurea drug (glimepiride)
    

Eligibility criteria:

        Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and
        insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate
        (intolerability or contraindication)

        Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6
        months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or
        anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment
        current treatment with systemic steroids change in dosage of thyroid hormones hereditary
        galactose intolerance
Open-Label Extension Treatment With Etanercept (TNFR:Fc) for Participating Patients in Etanercept (TNFR:Fc) Clinical Trials
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Etanercept
Intervention description: Adult Rheumatoid Arthritis (RA) patients on etanercept (TNFR:Fc) with well controlled arthritic symptoms will continue on the etanercept (TNFR:Fc) dose administered in their original protocol of enrollment. All other adults will receive 50 mg per week as two 25 mg subcutaneous (SC) injections at separate sites, either on the same day or 3 or 4 days apart. Pediatric patients ages 4 to 17 years will receive a 0.8 mg/kg per week dose (up to a maximum of 50 mg per week).
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 639.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: Rheumatoid Arthritis, Etanercept, Long-term Safety, Enbrel

Summary:

      This study was designed to provide all adult and pediatric arthritis patients (placebo and
      etanercept(TNFR:Fc) treated) who have participated in clinical trials with etanercept
      (TNFR:Fc) the opportunity to receive continued treatment with etanercept (TNFR:Fc). The
      primary objective of this study is to examine safety parameters.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previous enrollment in Immunex protocols

          -  No clinically significant adverse events thought to be due to etanercept (TNFR:Fc)
             during previous treatment.

          -  Negative serum pregnancy test not more than 14 days before the first dose of study
             drug in females of childbearing potential.

          -  No more than one NSAID at a dose not greater than the maximum recommended dose and
             stable for at least two weeks prior to administration of etanercept (TNFR:Fc).
             Exclusion Criteria: - Previous receipt of TNFR:Fc (p55), antibody to TNF, anti-CD4
             antibody, or diphtheria IL-2 fusion protein.

          -  Receipt of investigational drugs or biologics (other than TNFR:Fc [p75]) within 1
             month prior to the first dose of etanercept (TNFR:Fc) in this study.

          -  Receipt of DMARDs or methotrexate (except patients from 16.0014) within two weeks
             prior to the first dose of etanercept (TNFR:Fc) in this study.

          -  Receipt of cyclophosphamide within six months prior to the first dose of (etanercept
             (TNFR:Fc) in this study.

          -  Receipt of cyclosporin within two weeks prior to the first dose of etanercept
             (TNFR:Fc) in this study.
A Study of Rituximab (MabThera®/Rituxan®) in Patients With Rheumatoid Arthritis and Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Rituximab; Placebo; Methylprednisolone; Methotrexate; Folic acid or folate
Intervention description: Rituximab was supplied as a sterile liquid for iv administration.; Placebo was supplied as a sterile liquid in single-use vials for iv administration.
Intervention MeSH terms: Folic Acid; Methylprednisolone; Rituximab; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This 3 arm study assessed the efficacy of rituximab (MabThera®/Rituxan®) in the prevention of
      progression of structural joint damage in participants with active rheumatoid arthritis who
      had an inadequate clinical response to methotrexate. Participants were randomized to receive
      rituximab 500 mg intravenously (iv), rituximab 1000 mg iv, or placebo iv on days 1 and 15
      every 24 weeks in the main study; all participants received concomitant methotrexate at a
      stable dose of 12.5-25 mg/week throughout the study. Further courses of rituximab were
      provided to eligible participants. Structural joint damage was assessed by magnetic resonance
      imaging (MRI) at baseline and at intervals during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, 18-80 years of age.

          -  Active rheumatoid arthritis for ≥ 3 months and ≤ 10 years.

          -  Evidence of erosive disease and/or clinical synovitis in a signal joint.

          -  Inadequate response to 12.5-25 mg/week methotrexate for ≥ 12 weeks.

        Exclusion Criteria:

          -  Rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid
             arthritis. - Any surgical procedure within 12 weeks prior to baseline.

          -  Previous treatment with a biologic agent or with a B cell modulating or cell depleting
             therapy.
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: botulinum toxin Type A; Normal Saline (Placebo)
Intervention description: Botulinum toxin Type A injection into the detrusor.; Placebo (Normal Saline) injection into the detrusor.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will assess the safety and efficacy of botulinum toxin Type A for the treatment of
      urinary incontinence overactive bladder in patients with a spinal cord injury or multiple
      sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord
             injury or multiple sclerosis

          -  Inadequate response to anticholinergic medication used to treat overactive bladder.

          -  Neurological respiratory impairment and abnormal pulmonary function test results

        Exclusion Criteria:

          -  History or evidence of pelvic or urologic abnormality

          -  Previous or current diagnosis of bladder or prostate cancer

          -  Symptomatic or untreated urinary tract infection at time of enrollment
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b; Ribavirin
Intervention description: In the previous treatment protocol (P02538 Part 1), peginterferon alfa-2b was administered at a dose of 60 μg/m^2 by subcutaneous injection weekly for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).; In the previous treatment protocol (P02538 Part 1), ribavirin was administered at a dose of 15 mg/kg/day orally in two divided doses for up to 48 weeks. No treatment was administered on the current follow-up study (P02538 Part 2).
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 94.0
Sex: All
Minimum age: 3 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants
      who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin
      (RBV) and who completed the follow-up in the P02538 Part 1 study (NCT00104052). No study drug
      therapy will be administered during the P02538 Part 2 study. Durability of virologic response
      will be assessed for participants who attained sustained virologic response (SVR) in Part I
      of this study by performing annual Hepatitis C Virus ribonucleic acid (HCV-RNA) testing. In
      addition, this study will characterize long-term safety in all participants who received
      PEG-IFN plus RBV treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Informed consent must be obtained from the participant or the participant's parent or
             legal guardian prior to any long-term follow-up study-related procedures. According to
             local laws and/or IRB/IEC requirements, participants may also need to provide written
             assent.

          -  The participant must have received at least one dose of peginterferon alfa-2b and
             ribavirin in the Protocol No. P02538 study.

          -  The participant must have completed the 24-week post-treatment follow-up in the P02538
             Part 1 study. All participants whether sustained responders, relapsers, or
             nonresponders are eligible to participate.

        Exclusion Criteria:

          -  Concurrent participation in any other clinical study.

          -  Retreatment with any antiviral or immunomodulatory drug for chronic hepatitis C after
             completion of, or discontinuation from, the treatment phase of the P02538 Part 1
             study.

          -  Any condition that in the opinion of the Investigator would make the participant
             unsuitable for enrollment.
A Study to Evaluate the Effect of Dapagliflozin on Blood Glucose Level and Renal Safety in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin 10 mg; Matching Placebo for Dapagliflozin
Intervention description: Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy; Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to determine whether dapagliflozin can improve
      (decrease) blood glucose values in patients with Type 2 diabetes and moderate renal
      impairment.This study will be conducted at approximately 100 centres from countries across
      North America and European regions. It is planned to randomize a total of 302 patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female or male aged ≥18 years and <75 years.

          -  History of T2DM for more than 12 months.

          -  Inadequate glycemic control, defined as HbA1c ≥7.0% and ≤11%

          -  Stable anti-diabetic treatment regimen

          -  Renal impairment: CKD 3A

        Exclusion Criteria:

          -  Women of childbearing potential who are unwilling or unable to use an acceptable
             method to avoid pregnancy for the entire study period.

          -  History of diabetic ketoacidosis or hyperosmolar nonketotic coma.

          -  Severe uncontrolled hypertension defined as SBP ≥180 mmHg and/or Diastolic Blood
             Pressure (DBP) ≥110 mmHg

          -  Any of the following Cardiovascular (CV)/Vascular Diseases within 3 months of prior to
             signing the consent at visit 1:

        Myocardial infarction, Cardiac surgery or revascularization(CABG/PTCA), Unstable angina,
        Unstable heart failure (HF), HF New York Heart Association (NYHA) Class IV,Transient
        ischemic attack (TIA) or significant cerebrovascular disease, Unstable or previously
        undiagnosed arrhythmia.

          -  History of any biopsy or imaging verifying intercurrent kidney disease (such as
             glomerular nephritis or sign of renal artery stenosis) other than diabetic nephropathy
             or diabetic nephropathy with nephrosclerosis.

          -  Significant hepatic disease, including, but not limited to, chronic active hepatitis
             and/or severe hepatic insufficiency.

          -  Ongoing treatment with any SGLT2-inhibitor, GLP-1 analogue, or rapid/short acting
             insulins at screening.

          -  Participation in another clinical study with an Investigational Product (IP) during
             the last 30 days prior to signing the consent at visit 1.
Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Ublituximab; Ibrutinib
Intervention description: Administered as an IV infusion; Administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 126.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study evaluates the effect of the addition of ublituximab, a novel monoclonal antibody,
      to ibrutinib compared to ibrutinib alone on antitumor activity, as measured by the overall
      response rate (ORR = CR [complete response] + PR [partial response]) in previously treated
      Chronic Lymphocytic Leukemia (CLL) participants with high-risk cytogenetic features. Half of
      the participants will receive ublituximab in combination with ibrutinib, while the other half
      will receive ibrutinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously treated Chronic Lymphocytic Leukemia (CLL) requiring treatment

          -  At least one high-risk cytogenetic feature defined by the presence of 17p deletion,
             11q deletion and/or p53 mutation

          -  Eastern Cooperative Oncology Group (ECOG) score of 0 to 2

        Exclusion Criteria:

          -  Any major surgery, chemotherapy or immunotherapy within the last 21 days

          -  Evidence of hepatitis B virus, hepatitis C virus or known human immunodeficiency virus
             (HIV) infection

          -  Autologous hematologic stem cell transplant within 3 months of study entry. Prior
             Allogeneic hematologic stem cell transplant is excluded

          -  Transformation of CLL to aggressive Non-Hodgkin's Lymphoma (NHL) (Richter's
             transformation)

          -  Previous therapy with ibrutinib, or any drug that specifically inhibits Bruton's
             tyrosine kinase (BTK)
Pharmacodynamic Bioequivalence of Metered Dose Inhalers of Albuterol Sulfate in Patients With Stable Mild Asthma
Condition: Mild Persistent Asthma
MeSH terms: Asthma
Intervention: methacholine chloride; placebo ProAir HFA; ProAir HFA; Lupin albuterol HFA MDI; placebo Lupin albuterol HFA MDI
Intervention MeSH terms: Albuterol; Procaterol; Methacholine Chloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test
      product to the reference product, using bronchoprovocation (methacholine challenge testing)
      in adult patients with stable mild asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and non-pregnant female subjects (18-65 years of age)

          -  Stable mild asthmatics based on National Asthma Education and Prevention Program
             (NAEPP) guidelines.

          -  Forced Expiratory Volume in 1 second ( FEV1) ≥ 80% of predicted. Airway responsiveness
             to methacholine demonstrated by a pre-albuterol dose (baseline) PC20 ≤ 8 mg/ml.

          -  Nonsmokers for at least 1 year prior to the study and a maximum smoking history of
             five pack-years (the equivalent of one pack per day for five years).

          -  Written informed consent.

        Exclusion Criteria:

          -  Conditions which could alter airway reactivity to methacholine (e.g., pneumonia, upper
             respiratory tract infection, lower respiratory tract, viral bronchitis and/or
             sinobronchitis) within six weeks preceding the screening visit.

          -  History of seasonal asthma exacerbations, in which case the patient should be studied
             outside of the relevant allergen season.

          -  History of cystic fibrosis, bronchiectasis or other respiratory diseases.

          -  History of cardiovascular, renal, neurologic, liver or endocrine dysfunction, or
             chronic condition that could put the safety of the patient at risk during the study or
             affect the efficacy and safety analyses during the study.

          -  Treatment in an emergency room, urgent care center, or hospitalization for acute
             asthmatic symptoms within the past 6 months or need for daily oral corticosteroids
             within past 3 months.

          -  Known intolerance or hypersensitivity to any component of the albuterol metered dose
             inhaler (MDI).
Study of Citicoline for the Treatment of Traumatic Brain Injury (COBRIT)
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Intervention: Placebo; citicoline
Intervention description: Drug Placebo Inactive twice a day given orally or enterally. The first dose is given within 24 hours of injury and treatment continues until 90 days or until the 90-day outcome assessment.; 1000 mg twice a day orally or enterally. The first dose is within 24 hours of injury and treatment continues for 90-days or until the 90-day outcome assessment.
Intervention MeSH terms: Choline; Cytidine Diphosphate Choline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1213.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: traumatic brain injury; cognition; behavioral outcome; functional outcome; treatment; early intervention; citicoline

Summary:

      The Citicoline Brain Injury Treatment (COBRIT) is a randomized, double-blind, placebo
      controlled, multi-center trial of the effects of 90 days of citicoline on functional outcome
      in patients with complicated mild, moderate and severe traumatic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Non-penetrating traumatic brain injury.

          2. Age 18 (19 in Alabama) - 70 years.

          3. GCS criteria on/off paralytics as specified in protocol

          4. Reasonable expectation of completion of outcomes measures at a network center at six
             months post-injury.

          5. Able to swallow oral medication or, if unable to swallow, a gastric tube or peg are
             placed by 23 hours after injury.

          6. Reasonable expectation of enrollment within 24-hour time window.

          7. English-speaking

        Exclusion Criteria:

          1. Intubated patients with GCS motor score = 6 and not meeting CT criteria.

          2. Bilaterally fixed and dilated pupils

          3. Positive pregnancy test, known pregnancy, or currently breast feeding

          4. Evidence of diseases that interfere with outcome assessment

          5. Current acetylcholinesterase inhibitor use (Appendix 1)

          6. Imminent death or current life-threatening disease

          7. Currently enrolled in another study

          8. Prisoners
Efficacy and Safety in Patients With Type 2 Diabetes Mellitus, Cardiovascular Disease and Hypertension
Condition: Type 2 Diabetes Mellitus; Cardiovascular Disease; Hypertension; Inadequate Glycaemic Control
MeSH terms: Hypertension; Cardiovascular Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period; Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 922.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: dapagliflozin; diabetes; cardiovascular disease; hypertension

Summary:

      This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight
      and blood pressure, when added to patients existing medications and how it compares with
      their usual treatment without added dapagliflozin. Safety data will be collected and analysed
      to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have
      diabetes, cardiovascular disease and hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes mellitus.

          -  Cardiovascular disease

          -  Hypertension

        Exclusion Criteria:

          -  Patients with type 1 diabetes or diabetes insipidus

          -  Patients with 3 or more oral anti-hyperglycaemic drugs with or without insulin and/or
             poorly controlled diabetes

          -  Any clinically significant illness, which would compromise the patient's safety and
             their participation in the study