bioihbjkbjnl/mcl2 huggingface dataset:
A Trial Comparing the Safety and Efficacy of Insulin Degludec and Insulin Glargine, With or Without OADs in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec; insulin glargine
Intervention description: Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.; Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 721.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of the trial is to
      compare the safety and efficacy of insulin degludec (IDeg) and insulin glargine (IGlar) with
      or without OADs (oral anti-diabetic drugs) excluding SUs (sulfonylureas)/glinides in subjects
      with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
        consent - Subjects fulfilling at least one of the below criteria: a) Experienced at least
        one severe hypoglycaemic episode within last year (according to the ADA (American Diabetes
        Association) definition, April 2013), b) Moderate chronic renal failure, defined as
        glomerular filtration rate 30 - 59 mL/min/1.73 m^2 per CKD-Epi (Chronic Kidney Disease
        Epidemiology Collaboration) by central laboratory analysis, c) Hypoglycaemic symptom
        unawareness, d) Exposed to insulin for more than 5 years, e) Recent episode of
        hypoglycaemia (defined by symptoms of hypoglycaemia and/or episode with low glucose
        measurement (below or equal to 70 mg/dL [below or equal to 3.9 mmol/L])) within the last 12
        weeks prior to Visit 1 (screening) - Type 2 diabetes mellitus (diagnosed clinically) for at
        least 26 weeks prior to Visit 1 - Current treatment with any basal insulin (OD or BID) ±
        any combination of OADs (metformin, DPP-4 inhibitor, alpha-glucosidase inhibitor,
        thiazolidinediones, and SGLT2-inhibitor) for 26 weeks or longer prior to Visit 1 For
        subjects on BID the total daily dose should be below 75 units - HbA1c (glycosylated
        haemoglobin) below or equal to 9.5 % by central laboratory analysis - BMI (body mass index)
        below or equal to 45 kg/m^2 Exclusion Criteria: - Treatment with a bolus insulin separately
        or contained in an insulin mix product within the last 26 weeks prior to Visit 1 - Use of
        any other anti-diabetic agent(s) than those stated in the inclusion criteria within the
        last 26 weeks prior to Visit 1
E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
Condition: Heartburn
MeSH terms: Heartburn
Intervention: rabeprazole sodium; placebo
Intervention description: Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.; Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Intervention MeSH terms: Rabeprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 619.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Heartburn; Rabeprazole

Summary:

      The purpose of this study is to investigate the safety and efficacy of rabeprazole 10 mg in
      treating frequent heartburn.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Male or female patients > 18 years of age.

          2. If female, not of childbearing potential by reason of surgery or menopause, or of
             childbearing potential, but using an approved method of contraception since the last
             menstrual period. Females of childbearing potential must have a negative serum
             pregnancy test before starting the study.

          3. Patients must report a history of heartburn at least two days per week over the past
             month.

        Key Exclusion Criteria:

          1. History of erosive esophagitis verified by endoscopy.

          2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.

          3. Patients who have a history of Barrett's esophagus or esophageal stricture.

          4. Evidence of any medical condition that may interfere with the conduct of the study,
             the interpretation of study results, or the health of the patient during the study.

          5. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2)
             blockers, or prokinetics. Prior intermittent use of these agents is permitted if they
             are discontinued at least three days prior to the run-in phase. The H2 blocker,
             cimetidine (Tagamet®), must be discontinued for at least seven days before the study
             drug is administered.
A Study of Erlotinib (Tarceva) After Surgery With or Without Adjuvant Chemotherapy in Non-Small Cell Lung Carcinoma (NSCLC) Patients Who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib; Placebo
Intervention description: 150 mg tablet; Placebo tablet
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Adjuvant Non-small Cell Lung Cancer; Tarceva; Early-stage Lung Cancer; Adjuvant; RADIANT; NSCLC; EGFR-positive tumor; Stage IB Non-small Cell Lung Cancer; Stage II Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer

Summary:

      This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill
      following complete surgical removal of the tumor with or without chemotherapy after surgery
      in Stage IB-IIIA NSCLC patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary tissue from patient's surgery must be epidermal growth factor receptor
             (EGFR)-positive by certain tests

          -  Patients may have up to 4 cycles of chemotherapy after surgery

          -  Complete removal of the tumor by surgery

          -  Able to start drug under the following timelines:

               -  6 months from the day of surgery for patients who get chemotherapy

               -  3 months from the day of surgery for those who do not get chemotherapy

          -  Confirmed diagnosis of Stage IB-IIIA NSCLC

          -  Patients must be accessible for follow-up visits

        Exclusion Criteria:

          -  History of prior radiotherapy for NSCLC either before or after surgery

          -  History of heart disease or uncontrolled heart arrhythmias within the previous year

          -  History of poorly controlled gastrointestinal (GI) disorders that could affect the
             absorption of study drug

          -  History of other cancer except certain skin or cervical cancers, patients who have had
             other cancer are eligible if they have remained disease free for at least 5 years

          -  Patients who have received chemotherapy for NSCLC before surgery

          -  Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with
             carcinoid tumors are not eligible.
Study of Meloxicam Capsules to Treat Osteoarthritis Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Meloxicam Test Capsules; Meloxicam Test Capsules; Placebo Capsules
Intervention MeSH terms: Meloxicam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 403.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Meloxicam [Test] Capsules are safe and
      effective for the treatment of osteoarthritis pain of the knee or hip.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Primary diagnosis of Functional Class I-III OA of the hip or knee

          -  Chronic user of nonsteroidal anti-inflammatory drugs (NDAIDs) and/or acetaminophen for
             OA pain

          -  Discontinued all analgesic therapy at Screening

          -  For women of child-bearing potential: a woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

        Exclusion Criteria:

          -  History of allergic reaction or clinically significant intolerance to acetaminophen,
             aspirin, or any NSAIDs, including meloxicam

          -  Requires continuous use of opioid or opioid combination products to control OA pain of
             the knee or hip

          -  Clinically significant unstable cardiac, respiratory, neurological, immunological,
             hematological, or renal disease

          -  Significant difficulties swallowing capsules or unable to tolerate oral medication

          -  Previous participation in another clinical study of Meloxicam Capsules or received any
             investigational drug or device or investigational therapy within 30 days before
             Screening
Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes.
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: semaglutide; Dulaglutide
Intervention description: Administered subcutaneously (s.c., under the skin) once-weekly.; Administered subcutaneously (s.c., under the skin) once-weekly.
Intervention MeSH terms: Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and the United States of America (USA). The aim of
      the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on
      to metformin in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed
        consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive)
        - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal
        tolerated dose documented in the patient medical record) for 90 days prior to screening
        Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant
        or is of child-bearing potential and not using an adequate contraceptive method (adequate
        contraceptive measures as required by local regulation or practice) - Any condition, which
        in the investigator's opinion might jeopardise subject's safety or compliance with the
        protocol - Treatment with any medication for the indication of diabetes or obesity other
        than stated in the inclusion criteria in a period of 90 days before screening. An exception
        is short-term insulin treatment for acute illness for a total of equal to or below 14 days
        - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50
        ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary
        Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60
        mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) -
        Subjects presently classified as being in New York Heart Association Class IV - Planned
        coronary, carotid or peripheral artery revascularisation on the day of screening -
        Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of
        malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and
        in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more
        than 14 consecutive days or on a frequent basis) known to affect weight or glucose
        metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Everolimus in de Novo Kidney Transplant Recipients
Condition: Kidney Transplantation
Intervention: Everolimus; Mycophenolate sodium; Cyclosporine; Steroids
Intervention description: Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.; Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.; Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.; Steroids were administered according to local clinical practice.
Intervention MeSH terms: Cyclosporine; Mycophenolic Acid; Everolimus; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Immunosuppression; Kidney transplantation; everolimus; safety

Summary:

      The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant)
      administration of everolimus after transplantation reduces the risk of wound healing
      complications in comparison with immediate administration in de novo renal transplant
      patients (proportion of patients without wound/surgical complications related to initial
      transplant surgery) between randomization and 3 months after transplantation.
    

Eligibility criteria:

        Key Inclusion criteria:

          -  Patients who are willing and able to participate in the study and who provide written
             informed consent before performing any study related procedure;

          -  Men or women ≥18 years at transplant;

          -  Recipients of 1st or 2nd single kidney transplant from deceased donor or living
             unrelated/related donor > 14 years;

        Key Exclusion criteria:

          -  Patients who are recipients of multiple organs transplant, including two kidneys;

          -  Historical or current peak PRA > 50%. Patients with already existing antibodies
             against the donor;

          -  Thrombocytopenia (platelets < 75,000/mm³), absolute neutrophil count <1,500/mm³,
             leucopenia (leucocytes < 2,500/mm³) or hemoglobin < 7 g/dL;

          -  Body mass index (BMI) > 30 Kg/m2;
A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
Condition: Eosinophils, Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Intervention: reslizumab
Intervention description: Reslizumab was provided in a pre-filled syringe.
Intervention MeSH terms: Reslizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 391.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label (OL) extension study to obtain additional long-term safety
      data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed
      dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who
      completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The
      study consists of a screening/baseline visit followed by a 36-week OL treatment period and a
      15-week follow-up period.
    

Eligibility criteria:

        Inclusion Criteria:

        • Patient with eosinophilic asthma who completed the treatment period of a double-blind,
        placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

        ~~ Additional criteria apply, please contact the investigator for more information

        Exclusion Criteria:

          -  Patient has received any reslizumab administration in any previous clinical trial
             other than Studies C38072-AS-30025 and C38072-AS-30027.

          -  The patient has any clinically significant, uncontrolled medical condition

          -  The patient has another confounding underlying lung disorder

          -  The patient has a known/diagnosed hypereosinophilic syndrome.

          -  The patient has a diagnosis of malignancy within 5 years of the screening visit,
             except for treated and cured non-melanoma skin cancers.

          -  The patient is a pregnant or lactating woman

          -  The patient is a current smoker (ie, has smoked within the last 6 months before
             screening) or has a smoking history ≥10 pack-years.

          -  The patient is currently using any systemic immunosuppressive or immunomodulatory
             agents other than OCS

          -  The patient has a history of allergic reaction or hypersensitivity to any component of
             the study drug.

          -  The patient has a history of an immunodeficiency disorder including human
             immunodeficiency virus (HIV).

               -  Additional criteria apply, please contact the investigator for more information
Safety and Efficacy Study of AA4500 (XIAFLEX™, Proposed Name) in the Treatment of Advanced Dupuytren's Disease
Condition: Advanced Dupuytren's Disease
MeSH terms: Dupuytren Contracture
Intervention: collagenase clostridium histolyticum
Intervention description: Up to five injections of AA4500 into cord(s) of the affected hand(s). Each injection was separated by at least 30 days.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a Phase 3, 9-month, open-label study conducted in the United States. Subjects with a
      diagnosis of advanced Dupuytren's disease in a metacarpophalangeal (MP) or proximal
      interphalangeal (PIP) joint that resulted in a fixed flexion deformity of at least one
      finger, other than the thumb, that was at least 20° as measured by finger goniometry and was
      suitable for evaluation and injection were enrolled.

      This study was designed to be part of the larger clinical program, for adult patients with
      Dupuytren's contracture with a palpable cord, where the data from 2 pivotal
      Placebo-Controlled studies (AUX-CC-857 (NCT00528606) and AUX-CC-859 (NCT00533273)) and 7
      non-pivotal studies were evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with a diagnosis of advanced Dupuytren's disease, with a fixed flexion
             deformity of at least one finger, other than the thumb, that had a contracture at
             least 20°, but not greater than 100° for MP (80° for PIP) joints, caused by a palpable
             cord.

          -  Had a positive "table top test," defined as the inability to simultaneously place the
             affected finger(s) and palm flat against a table top.

          -  Were naïve to AA4500 treatment or had received one or two injections of AA4500 for the
             treatment of advanced Dupuytren's disease in Auxilium Studies AUX-CC-851, AUX-CC-853,
             or AUX-CC-855.

          -  Were judged to be in good health.

        Exclusion Criteria:

          -  Had a chronic muscular, neurological, or neuromuscular disorder that affected the
             hands.

          -  Had received treatment for advanced Dupuytren's disease within 90 days of enrollment
             on the joint selected for the initial injection of AA4500, including surgery
             (fasciectomy or surgical fasciotomy), needle aponeurotomy/fasciotomy, or injection of
             verapamil and/or interferon.

          -  Had a known recent history of stroke, bleeding, a disease process that affected the
             hands, or other medical condition, which in the investigator's opinion, would make the
             subject unsuitable for enrollment in the study.
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: PF-06410293; Adalimumab
Intervention description: PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.; Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase 3; adalimumab; rheumatoid arthritis

Summary:

      The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab
      in combination with methotrexate in subjects with moderately to severly active rheumatoid
      arthritis who have had an inadequate response to methotrexate.

      In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
      subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
      treatment (PF-06410293) at home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4
             months.

          -  At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
             and baseline.

          -  Hs-CRP equal or greater than 8 mg/L.

          -  Must have received methotrexate for at least 12 weeks and been on a stable dose for at
             least 4 weeks prior to the first study dose.

        Exclusion Criteria:

          -  Evidence of untreated or inadequately treated latent or active TB.

          -  Evidence of uncontrolled, clinically significant diseases, including moderate or
             severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

          -  History of infection requiring hospitalization or parenteral antimicrobial therapy
             within 6 months prior to first dose of study drug.

          -  May have received no more than 2 doses of one biologic therapy (other than adalimumab
             or lymphocyte depleting therapy).

          -  Any second DMARD must be washed out prior to the first study dose.