bioihbjkbjnl/mcl2 huggingface dataset:
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate (+) metformin hydrochloride; Comparator: pioglitazone
Intervention description: sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period; pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 517.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No

Summary:

      A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used
      medication in patients with type 2 diabetes
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient is inadequately controlled and not on treatment with insulin or oral
             antihyperglycemic therapy

        General Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12
             weeks

          -  Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin)
             over the prior 3 years
Treatment of Refractory Status Epilepticus
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: propofol; thiopental/pentobarbital
Intervention description: liquid, mg/kg.h, titrated after EEG; liquid, mg/kg.h, titrated after EEG
Intervention MeSH terms: Pentobarbital; Thiopental; Propofol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Refractory status epilepticus,; coma-induction,; treatment,; propofol,; barbiturates,; efficacy,; safety.

Summary:

      The purpose of this study is to determine whether propofol or barbiturates should be
      preferred in the treatment of status epilepticus (continuous seizure activity) refractory to
      2 standard antiepileptic agents.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with refractory status epilepticus not due to cerebral anoxia, needing coma
             induction for clinical management.

        Exclusion Criteria:

          -  Age < 16 years old.

          -  Known pregnancy.

          -  Cerebral anoxia as SE etiology.

          -  Epilepsia partialis continua (simple partial SE).

          -  Known intolerance to the study drugs.

          -  Known mitochondrial disorder, hyperlipidemia, or significant rhabdomyolysis.
Safety/Efficacy Study of Oxycodone HCl/Niacin to Treat Pain After Bunionectomy
Condition: Pain
Intervention: Placebo; Acurox 5/30 mg; Acurox 7.5/30
Intervention description: 2 tablets every 6 hours for 48 hours; 2 tablets every 6 hours for 48 hours; 2 tablets every 6 hours for 48 hours
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids; Oxycodone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 405.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain

Summary:

      The purpose of this study is to determine whether oxycodone HCl and niacin are effective in
      the treatment of pain following bunionectomy surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is male or female at least 18 years of age

          -  For women of child-bearing potential: woman who is not pregnant and not nursing, and
             who is practicing an acceptable method of birth control

          -  Patient is scheduled to have a bunionectomy

          -  Patient must be willing to stay at the study site for at least 48 hours from the
             initial dose of study medication post-surgery

        Exclusion Criteria:

          -  Patient has a current disease or history of a disease that will impact the study or
             the patient's well-being

          -  Patient has used or intends to use any of the medications that are prohibited by the
             protocol

          -  Patient has a history of drug or alcohol abuse or dependence, or patient has a
             positive urine drug screen

          -  Patient is hypersensitive to any of the medications to be used in the study

          -  Patient has taken another investigational drug within 30 days prior to Screening
Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)
Condition: Visual Impairment; Macular Edema; Central Retinal Vein Occlusion
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Retinal Vein Occlusion; Edema
Intervention: Ranibizumab; Dexamethasone implant and sham injections
Intervention MeSH terms: Dexamethasone; Ranibizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Visual impairment; macular edema; Central retinal vein occlusion; Dexamethasone implant; Ranibizumab

Summary:

      This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone
      implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a
      pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with
      sham injections PRN afterwards.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with visual impairment due to macular edema following CRVO

          -  Diagnosis of CRVO at maximum 6 months prior to Screening

          -  BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

        Exclusion Criteria:

          -  Media clarity, pupillary dilation and patient cooperation not sufficient for adequate
             fundus photographs

          -  Central retinal thickness (CRT) < 250 µm in the study eye

          -  Prior episode of RVO in the study eye

          -  Active formation of new vessels in the study eye

          -  Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline

          -  IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if
             they have undergone glaucoma treatment

          -  Improvement of > 10 letters on BCVA between Screening and Baseline

        Other protocol-defined inclusion/exclusion criteria may apply
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
Condition: Pain
MeSH terms: Toothache
Intervention: Acetaminophen; Placebo Control
Intervention description: Acetaminophen Caplet - single dose; 0 mg Caplet - single dose
Intervention MeSH terms: Acetaminophen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 540.0
Sex: All
Minimum age: 16 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg
      and acetaminophen 1000 mg in dental surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be at least 16 and less than 51 years of age

          -  Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30

          -  Must have up to four of their back teeth (third-molars) pulled

        Exclusion Criteria:

          -  Cannot be allergic to acetaminophen (Tylenol)

          -  Cannot be pregnant (or planning to be pregnant) or nursing a baby

          -  Cannot have any other medical conditions that the investigator determines might
             compromise your safety or the study results
Persistence of Antibodies After Meningococcal Vaccine PF-06866681 in Healthy Children
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Intervention: Blood Sampling
Intervention description: At 2, 3, 4, 5, 6 years after booster vaccination.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 184.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; Immunogenicity; Children; Neisseria meningitidis; Long-term antibody persistence; Safety; Serogroups A, C, W-135, and Y

Summary:

      The purpose of this study is to evaluate the long-term antibody persistence as well as safety
      of GSK Biologicals' MenACWY-TT vaccine versus Meningitec up to 6 years after booster
      vaccination administered in healthy 5 year old children in the study MENACWY-TT-048 EXT: 039
      Y2, 3, 4, 5 (NCT00955682), who were primed with the same vaccine in the study MENACWY-TT-039
      (NCT00474266) at 12 through 23 months of age.
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects must satisfy ALL the following criteria at study entry:

          -  Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion
             of the investigator, can and will comply with the requirements of the protocol.

          -  A male or female who has received primary and booster vaccination with the MenACWY-TT
             or Meningitec vaccines in studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT: 039
             Y2, 3, 4, 5 (112036), respectively.

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

        Exclusion Criteria:

        The following criteria should be checked at the time of study entry. If ANY exclusion
        criterion applies, the subject must not be included in the study:

          -  Child in care.

          -  History of meningococcal disease.

          -  Administration of a meningococcal polysaccharide or a meningococcal polysaccharide
             conjugate vaccine outside of studies MENACWY-TT-039 (109670) and MENACWY-TT-048 EXT:
             039 Y2, 3, 4, 5 (112036).

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination.

          -  Bleeding disorders, such as thrombocytopenia, or subjects on anti-coagulant therapy.
SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis
Condition: Exocrine Pancreatic Insufficiency; Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Exocrine Pancreatic Insufficiency; Fibrosis
Intervention: Liprotamase; porcine (pig) PERT
Intervention description: oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement; oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 7 Years
Healthy volunteers: No

Summary:

      Liprotamase powder is a non-porcine, soluble and stable mixture of three digestive enzymes
      including lipase, protease, and amylase. The purpose of the present study is to provide
      additional efficacy and safety data compared to approved, porcine-derived, enterically-coated
      and encapsulated pancreatic enzyme replacement therapy. The primary efficacy endpoint of the
      study will be comparative efficacy measured as the change in the coefficient of fat
      absorption (CFA) in Cystic Fibrosis patients with exocrine pancreatic insufficiency (EPI).

      Liprotamase is stable in stomach and digestive fluids allowing administration in a variety of
      convenient formulations and with a number of foods without enteric coating.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Cystic Fibrosis based on presentation, genotype and/or sweat chloride

          -  Fecal elastase <100 mcg/g stool

          -  Minimum Coefficient of Fat (CFA) at screening while on stable PERT therapy

          -  Good nutritional status

        Exclusion Criteria:

          -  History or diagnosis of fibrosing colonopathy

          -  Distal intestinal obstruction syndrome in 6 months prior to screening

          -  Receiving enteral tube feedings

          -  Chronic diarrheal illness unrelated to pancreatic insufficiency

          -  Liver abnormalities, or liver or lung transplant, or significant bowel resection

          -  Forced expiratory volume in 1 second (FEV1) <30%
Pulmonary Rehabilitation Before Lung Cancer Resection
Condition: Non-small Cell Lung Cancer (NSCLC); Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Neoplasms; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: education; rehabilitation; pedometer; education; surgery
Intervention description: pulmonary rehabilitation participant manual; pulmonary rehabilitation; receive a pedometer; receive a pamphlet with exercises plus the standard course of care; patients undergo surgery
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a study funded by the National Institute of Health. The rationale for the need of
      this research is the lack of any well proven risk-reducing intervention that may decrease the
      morbidity of lung cancer resection in patients with COPD or that may improve their quality of
      life trajectory, a meaningful outcome in the overall disease progression. The proposed
      intervention is unique as it combines exercise and behavioral interventions that were pilot
      tested in a randomized single-blinded controlled design in the proposed population and proved
      feasible and potentially effective. The aim is to test the effect of the proposed
      rehabilitation on length of stay, pulmonary complications and quality of life trajectory.
    

Eligibility criteria:

        1. Patient is scheduled to undergo NSCLC resection: video assisted thoracoscopy (VATS) or
             open thoracotomy for: limited resection, lobectomy, or pneumonectomy. Surgery must not
             be scheduled to take place < 3 weeks after registration.

          2. Patient has a doctor diagnosis of COPD.

          3. Patient is a current or ex-smoker with a smoking history of ≥ 10 pack years.
             (Calculated by multiplying the number of packs of cigarettes smoked per day by the
             number of years the person has smoked. For example, 1 pack-year is equal to smoking 20
             cigarettes (1 pack) per day for 1 year, or 40 cigarettes per day for half a year, and
             so on).

          4. Age ≥ 18 yrs
Controlled Myelofibrosis Study With Oral Janus-associated Kinase (JAK) Inhibitor Treatment-II: The COMFORT-II Trial
Condition: Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis
Intervention: Ruxolitinib; Best Available Therapy (BAT)
Intervention description: 5 mg tablets packaged as 60-count in high-density polyethylene bottles; Prescribing and usage per respective package inserts
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 219.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis

Summary:

      This was an open label, randomized study comparing the efficacy and safety of randomized 2:1
      Ruxolitinib tablets versus best-available therapy, as selected by the investigator. The
      purpose was to compare the efficacy, safety and tolerability of Ruxolitinib
      (INC424/INCB018424) given twice daily to the best-available therapy, in subjects with primary
      myelofibrosis (PMF), post polycythemia vera myelofibrosis (PPV-MF) or post essential
      thrombocythemia myelofibrosis (PET-MF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be diagnosed with PMF, PPV-MF or PET-MF according to the 2008 World
             Health Organization criteria

          -  Subjects with MF requiring therapy must be classified as high risk OR intermediate
             risk level 2 according to the prognostic factors defined by the International Working
             Group

          -  Subjects with an ECOG performance status of 0, 1, 2 or 3

          -  Subjects with peripheral blood blast count of < 10%.

          -  Subjects who have not previously received treatment with a JAK inhibitor

        Exclusion Criteria:

          -  Subjects with a life expectancy of less than 6 months

          -  Subjects with inadequate bone marrow reserve as demonstrated by specific clinical
             laboratory counts

          -  Subjects with any history of platelet counts < 50,000/µL or ANC < 500/µL except during
             treatment for a myeloproliferative disorder or treatment with cytotoxic therapy for
             any other reason

          -  Subjects with inadequate liver or renal function

          -  Subjects with clinically significant bacterial, fungal, parasitic or viral infection
             which require therapy

          -  Subjects with an active malignancy over the previous 5 years except specific skin
             cancers

          -  Subjects with severe cardiac conditions

          -  Subjects who have had splenic irradiation within 12 months
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ABP 798; Rituximab (US); Rituximab (EU)
Intervention description: Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 311.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This trial is designed to determine what effects the human body has on the investigational
      medicine, ABP 798, and what effects the body has on the investigational medicine after you
      have been given it, and if this is comparable to what is seen for the licensed medicine,
      rituximab, in patients with moderate or severe RA.

      This study will also assess if the investigational medicine is safe and effective in treating
      moderate or severe RA compared to the licensed medicine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men or women ≥ 18 and ≤ 80 years old

          -  Subjects must be diagnosed with rheumatoid arthritis for at least 6 months before
             baseline

          -  Active RA defined as ≥ 6 swollen joints and ≥ 6 tender joints at screening and
             baseline and at least one of the following at screening:

               -  erythrocyte sedimentation rate (ESR) ≥ 28 mm/hr

               -  serum C-reactive protein (CRP) > 1.0 mg/dL

          -  Subjects must be taking methotrexate (MTX) for ≥ 12 consecutive weeks and on a stable
             dose of MTX 7.5 to 25 mg/week for ≥ 8 weeks prior to receiving the investigational
             product (IP), and be willing to remain on a stable dose throughout the study

          -  Subject has no known history of active tuberculosis

        Exclusion Criteria:

          -  Class IV RA, Felty's syndrome or history of prosthetic or native joint infection

          -  Major chronic inflammatory disease or connective tissue disease other than RA, with
             the exception of secondary Sjögren's syndrome

          -  Use of commercially available or investigational biologic therapies for RA as follows:

               -  anakinra, etanercept within 1 month prior to first dose of IP

               -  infliximab, abatacept, tocilizumab, golimumab, certolizumab within 3 months prior
                  to first dose of IP

               -  other experimental or commercially available biologic therapies for RA within 3
                  months or 5 half-lives (whichever is longer) prior to first dose of IP

          -  Previous receipt of rituximab or a biosimilar of rituximab

        Other Inclusion/Exclusion criteria may apply
A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol); Calcium Supplement 500 mg; Referred-Care Model
Intervention description: FOSAVANCE 5600 international units (IU)(Alendronate Sodium 70 mg/Vitamin D 5600 IU) combination tablet once weekly for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).; Calcium supplied locally by the investigator (containing 500 mg
calcium supplement) daily for 52 weeks (unless the patient's dietary intake of
calcium exceeds 1000 mg per day).; Usual treatment for osteoporosis chosen and prescribed by patients' own physicians for 6 months (Week 26) during the base period and an additional 6-month extension period (Week 52).
Intervention MeSH terms: Cholecalciferol; Vitamin D; Alendronate; Calcium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 515.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      A study designed to see if the study drug will increase blood levels of vitamin D, bone
      mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of
      falls as compared to women receiving standard care for osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  65 years or older

          -  Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or
             hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic
             sites including lumbar spine, total hip, and femoral neck sites

          -  Postmenopausal

          -  Low levels of vitamin D as measured 25-hydroxyvitamin D

          -  Has fallen at least once within the past 12 months

        Exclusion Criteria:

          -  Unable to stand or sit upright for at least 30 minutes

          -  Has a bone disorder other than osteoporosis

          -  Contraindication to the use of FOSAVANCE