bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, and Immunogenicity of the Adjuvanted Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to < 72 Months of Age
Condition: Influenza Disease
MeSH terms: Influenza, Human
Intervention: Trivalent split influenza vaccine (TIV); MF59-adjuvanted trivalent influenza vaccine (aTIV); Licensed comparator trivalent split influenza vaccine (comparator TIV)
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 6104.0
Sex: All
Minimum age: 6 Months
Maximum age: 72 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Adjuvanted Trivalent Subunit Influenza Vaccine; vaccine; influenza; adjuvant; MF-59; pediatric

Summary:

      This Study Aims to Evaluate the Safety, Tolerability, and Immunogenicity of the Adjuvanted
      Trivalent Subunit Influenza Vaccine and the Non-Adjuvanted Trivalent Subunit Influenza
      Vaccine Compared to the Non-Adjuvanted Trivalent Split Influenza Vaccine in Children 6 to <
      72 Months of Age.
    

Eligibility criteria:

        Inclusion Criteria:

        1.Children 6 months to 72 months of age.

        Exclusion Criteria:Children

          1. Who had been hospitalized at the time of enrollment

          2. Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or
             chicken protein

          3. Who had known impairment of the immune function

          4. Who had fever interfering with normal daily activities at the time of enrollment

          5. Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28
             days (for live vaccines) prior to enrollment in the study

          6. Concomitant participation in another clinical study

          7. Who had surgery planned during the study period that in the investigator's opinion
             would have interfered with the study visits schedule.
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Condition: Ocular Inflammation
MeSH terms: Cataract; Inflammation
Intervention: ISV-303; DuraSite Vehicle
Intervention description: 0.075% bromfenac in DuraSite dosed BID; DuraSite vehicle dosed BID
Intervention MeSH terms: Bromfenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 268.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of
      topical administration of ISV-303 compared with Durasite Vehicle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subjects age 18 or older scheduled for unilateral cataract surgery with
             posterior chamber intraocular lens implantation

          -  If a female is of childbearing potential, the subject must agree to and submit a
             negative pregnancy test before any protocol-specific procedures are conducted. The
             subject must use effective contraception for the duration of the study. Post
             menopausal is defined as having no menses for at least 12 consecutive months

          -  Signature of the subject on the Informed Consent Form

          -  Willing to avoid disallowed medications for the duration of the study

          -  Willing and able to follow all instructions and attend all study visits

          -  Able to self-administer the IMP (or have a caregiver available to instill all doses of
             study drugs )

          -  Additional inclusion criteria also apply

        Exclusion Criteria:

          -  Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the
             IMP or any of the procedural medications

          -  Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a
             positive pregnancy test

          -  Currently suffer from alcohol and/or drug abuse

          -  Prior (within 30 days of beginning study treatment) or anticipated concurrent use of
             an investigational drug or device

          -  A condition or a situation, which in the investigator's opinion may put the subject at
             increased risk, confound study data, or interfere significantly with the subject's
             study participation

          -  Additional inclusion criteria also apply
A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Intervention: Mycophenolate mofetil (MMF); Cyclophosphamide, Maintenance Phase; Cyclophosphamide, Induction Phase; Prednisone
Intervention description: 1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.; 0.5-1 g/m^2 IV pulse once every 3 months; 0.5 - 1 g/m^2 IV pulse once per month; 1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Cyclophosphamide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the efficacy of CellCept [0.5-2 grams per day (g/day) orally (p.o.)]
      and cyclophosphamide [0.5-1 grams per square meter (g/m2) quarterly] as maintenance treatment
      for patients with lupus nephritis. All patients will receive induction treatment with
      cyclophosphamide (0.5-1g/m2 monthly) for 6 months, and will then be randomized to the
      maintenance phase of the study for a further 6 months, followed by 6 months of treatment-free
      follow-up. The anticipated time on study treatment is 12 months.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  diagnosis of systemic lupus erythematosus and lupus nephritis (class III, IV or V).

        Exclusion Criteria:

          -  patients who have received cytotoxic drugs in previous 8 weeks;

          -  systemic infections;

          -  hepatitis B or C, or HIV.
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: ELX/TEZ/IVA; TEZ/IVA; IVA
Intervention description: FDC tablet for oral administration.; Fixed-dose combination (FDC) tablet for oral administration.; Mono tablet for oral administration.
Intervention MeSH terms: Ivacaftor; Elexacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 176.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX,
      VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with
      cystic fibrosis (CF) who are homozygous for F508del.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Homozygous for the F508del mutation (F/F)

          -  Forced expiratory volume in 1 second (FEV1) value ≥40% and ≤90% of predicted mean for
             age, sex, and height

        Key Exclusion Criteria:

          -  Clinically significant cirrhosis with or without portal hypertension

          -  Lung infection with organisms associated with a more rapid decline in pulmonary status

          -  Solid organ or hematological transplantation

        Other protocol defined Inclusion/Exclusion criteria may apply
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: mesalamine; mesalamine
Intervention description: mesalamine 2.4 g/day (400 mg tablet) for 6 weeks; mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Intervention MeSH terms: Mesalamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg
      tablet) versus Asacol 2.4 g/day (400 mg tablet
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmed diagnosis of ulcerative colitis

        Exclusion Criteria:

          -  a history of allergy or hypersensitivity to salicylates or aminosalicylates;

          -  a history of extensive small bowel resection
Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment
Condition: Type 2 Diabetes
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Saxagliptin; Placebo
Intervention description: 2.5 mg once daily oral dose; Placebo
Intervention MeSH terms: Saxagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 572.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: DPP-4 inhibitors; HbA1c; incretins; Renal Impairment

Summary:

      Saxagliptin is a new investigational medication being developed for treatment of type 2
      diabetes. This study is designed to test the efficacy of once daily saxagliptin in renally
      impaired patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with type 2 diabetes

          -  Documented history of CrCl <50 ml/min within the 3 months prior to enrollment

          -  HbA1c ≥7.0% and ≤11.0%

        Exclusion Criteria:

          -  Type 1 diabetes, history of diabetic ketoacidosis or hyposmolar non-ketonic coma

          -  Previous or current treatment with any DPP-IV inhibitor and/or GLP-1 mimetic.
Long-Term Open-Label, Safety Study Of Sitaxentan Sodium In Japanese Pulmonary Arterial Hypertension Patients
Condition: Hypertension, Pulmonary
MeSH terms: Pulmonary Arterial Hypertension; Hypertension, Pulmonary; Hypertension
Intervention: Sitaxentan
Intervention description: sitaxentan sodium 100 mg
Intervention MeSH terms: Sitaxsentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: sitaxentan sodium pulmonary hypertension

Summary:

      The safety and efficacy at 100 mg once daily for oral dose of sitaxentan sodium were
      demonstrated in the STRIDE clinical trial program. Sitaxentan sodium was approved in the EU,
      Canada and Australia. In this study, the long-term safety and efficacy after administrations
      of sitaxentan sodium at a dose of 100 mg alone or in combination with another medication will
      be investigated in Japanese PAH patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject who completed the B1321052 study as planned.

        Exclusion Criteria:

          -  Has uncontrolled systemic hypertension as evidenced by sitting systolic blood pressure
             >160 mm Hg or sitting diastolic blood pressure >100 mm Hg at Screening.

          -  Has hypotension defined as systolic arterial pressure <90 mm Hg after sitting for 5
             minutes at Screening.
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
Condition: Metastatic Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: MM-398; 5 Fluorouracil; Leucovorin
Intervention description: Arm A: MM-398 120 mg/m2 IV Q3W
Arm C: MM-398 80mg/m2 IV Q2W; Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks; Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
Arm C: Leucovorin 400 mg/m2 IV every 2 weeks
Intervention MeSH terms: Leucovorin; Fluorouracil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 417.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic cancer; MM-398; PEP02; Metastatic pancreatic cancer; Gemcitabine refractory pancreatic cancer; Second line pancreatic cancer treatment; Pancreatic cancer post gemcitabine therapy

Summary:

      The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil
      (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic
      pancreatic cancer patients who have progressed on prior gemcitabine based therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas

          -  Metastatic disease

          -  Documented disease progression after prior gemcitabine based therapy

          -  KPS >/= 70

          -  Adequate bone marrow function

          -  Adequate hepatic function

          -  Adequate renal function

        Exclusion Criteria:

          -  Active CNS metastasis

          -  Clinically significant GI disorders

          -  Severe arterial thromboembolic events less than 6 months before inclusion

          -  NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled
             blood pressure

          -  Active infection or uncontrolled fever

          -  Pregnant or breast feeding patients
Studying the Effects of Administration of Polyunsaturated Fatty Acids (PUFAS) of Omega-3 Series in Nicotine Dependence
Condition: Tobacco Dependence; Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Omega 3; Placebo
Intervention description: Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.; mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
Intervention MeSH terms: Mineral Oil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 20 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco dependence; tobacco treatment; omega 3 series; polyunsaturated fatty acids

Summary:

      Nicotine dependence may prolong the exposure to toxic substances that cause various diseases.
      The Central Nervous System (CNS) is consisted by a large amount of Polyunsaturated Fatty
      Acids (PUFAS) from omega-3 serie. Omega-3 takes part in several actions, including the
      modulation of dopaminergic neurotransmission. In its deficiency is detected a hypofunctioning
      of the mesolimbic and mesocortical pathway, related to the reward system, involved on the
      context of nicotine dependence. Treatment using dietary supplementation with omega-3 shows
      improvements in several diseases, including mood disorders such as anxiety and depression.
      The investigators hypothesis is that supplementation with these fatty acids can restore the
      levels of omega-3 and could decrease nicotine dependence. The investigators objective is to
      investigate a possible association between increased serum levels of omega-3 and the
      reduction in nicotine dependence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy smokers; age between 20 and 60 years; score in Fagerström Test for Nicotine
             Dependence (FTND) up to 5 points (FTND > 5); high motivation to stop smoking (accessed
             by Richmond Test)

        Exclusion Criteria:

          -  psychiatric disorders; taking psychoactive medications; history of alcohol and/or
             other drugs abuse or dependence;
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)
Condition: Central Retinal Vein Occlusion
MeSH terms: Retinal Vein Occlusion
Intervention: Sham injection; Ranibizumab 0.5 mg
Intervention description: Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.; Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
Intervention MeSH terms: Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 252.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CRVO, macular edema, vision impairment, retinal vein occlusion, ranibizumab

Summary:

      Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients
      with visual impairment due to macular edema secondary to CRVO
    

Eligibility criteria:

        Inclusion Criteria for study and fellow eye:

        • Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a
        BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.

        Exclusion Criteria:

          -  Pregnant or nursing women or women of child bearing potential unless using an
             effective contraception

             - Stroke or myocard infarction within 3 months prior to study

          -  History of malignancy within the past 5 years

          -  Uncontrolled hypertension

          -  Active infection or inflammation in any eye

          -  use of corticosteroids for at least 30 days in the last 6 months

          -  treatment with anti-angiogenic drugs in any eye within last 3 months

          -  Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months
             respectively
A Study of LY2189265 in Japanese Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY2189265; Placebo; Liraglutide
Intervention MeSH terms: Liraglutide; Dulaglutide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 492.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: GLP-1

Summary:

      The purpose of this trial is to examine the efficacy and safety of once-weekly LY2189265 in
      participants with type 2 diabetes mellitus who are not taking oral antidiabetic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who have had a diagnosis of type 2 diabetes mellitus before screening.

          -  Participants who have been Oral Antihyperglycemic Medication (OAM)-naïve (diet and
             exercise only) or been taking OAM monotherapy except for thiazolidinedione (TZD) and
             are willing to discontinue this medication. Participants taking OAM monotherapy must
             complete 8-week washout period prior to randomization.

          -  Participants who are OAM naïve with a screening glycosylated hemoglobin (HbA1c) value
             of 7.0% to 10.0% and randomization HbA1c value of 7.0% to 10.0%, or who are taking OAM
             monotherapy with screening HbA1c value of 6.5% to 9.0% and randomization HbA1c value
             of 7.0% to 10.0%.

          -  Participants who have a body mass index (BMI) of 18.5 kilograms per meter squared
             (kg/m^2) to 35.0 kg/m^2.

        Exclusion Criteria:

          -  Participants who have a diagnosis of type 1 diabetes.

          -  Participants who have previously been treated with any other glucagon-like peptide-1
             (GLP-1) analog.

          -  Participants who have been receiving more than half of the maximum dose of
             sulfonylureas at screening.

          -  Participants who have been currently taking insulin or TZD, or have had previous
             insulin or TZD treatment within 3 months before screening.

          -  Participants who have obvious clinical signs or symptoms of pancreatitis, a history of
             chronic pancreatitis or acute pancreatitis at screening, as determined by the
             investigator. Participants who have a serum amylase concentration ≥3 times the upper
             limit of the reference range and/or a serum lipase concentration ≥2 times the upper
             limit of the reference range, as determined by the central laboratory at screening.

          -  Participants who have self or family history of medullary C-cell hyperplasia, focal
             hyperplasia, or medullary thyroid carcinoma (MTC).