bioihbjkbjnl/mcl2 huggingface dataset:
APRiCOT-L: Study to Evaluate Efficacy and Safety of Apricoxib With Erlotinib in Patients With Non-small Cell Lung Cancer
Condition: Recurrent Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: apricoxib/erlotinib; erlotinib/placebo
Intervention description: apricoxib: 100 mg tablets, 400mg/day
erlotinib: per package insert; erlotinib: per package insert
placebo: 100 mg tablets, 400 mg/day
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will compare the anti-tumor efficacy of apricoxib and erlotinib with placebo and
      erlotinib as measured by time to disease progression to test the hypothesis that down
      regulation of COX-2 and EGFR pathways in patients with up-regulated COX-2 expression in tumor
      will have a clinical benefit compared with erlotinib alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically determined Stage IV NSCLC including Stage IIIb (pleural effusion)

          -  Failed at least one prior platinum-based chemotherapy for Stage IIIb or Stage IV
             NSCLC. Patients receiving platinum-based chemotherapy only given in an adjuvant
             setting are not eligible.

          -  Measurable disease by RECIST

          -  Greater than or equal to 18 years of age

          -  ECOG PS of 0 or 1

        Exclusion Criteria:

          -  Radiation therapy within 2 weeks; chemotherapy within 3 weeks; non-cytotoxic
             investigational agents within 4 weeks of initiating study treatment

          -  Evidence of NYHA class III or greater cardiac disease

          -  History of MI, stroke, ventricular arrhythmia, or symptomatic conduction abnormality
             within 12 months

          -  Known HIV infection or AIDS

          -  Symptomatic CNS metastases

          -  Pregnant or nursing women

          -  Hypersensitivity or intolerance to erlotinib, sulfonamides, aspirin, or other NSAIDs.

          -  History of upper GI bleeding, ulceration, or perforation

          -  Prior history of COX-2 inhibitor therapy for the treatment of metastatic NSCLC

          -  Previous anti-EGFR kinase therapy
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
Condition: Breast Neoplasms; Neoplasms
MeSH terms: Breast Neoplasms; Neoplasms
Intervention: neratinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 136.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: phase 2; HER2+ breast cancer; monotherapy neratinib; HKI-272; Neratinib; Nerlynx; PB-272

Summary:

      The purpose of this study is to learn whether neratinib is safe and effective in treating
      women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic diagnosis of breast cancer and current stage IIIB, IIIC, or IV

          -  Progression following at least 6 weeks of standard doses of Herceptin (Arm A only)

          -  Over-expression of HER2

          -  Tumor tissue available and adequate for analysis at screening

          -  At least one measurable lesion

        Exclusion Criteria:

          -  Prior treatment with Herceptin (Arm B only)

          -  More than 4 prior cytotoxic chemotherapy regimens

          -  Subjects with bone or skin as the only site of measurable disease

          -  Inadequate cardiac function

          -  Major surgery, chemotherapy, radiotherapy, investigational agents or other cancer
             therapy within 1 week of treatment day 1

          -  Active central nervous system metastases

          -  Pregnant or breastfeeding women

          -  Inability to swallow the HKI-272 capsules
A Randomized Double Blind Vehicle Controlled Dose Ranging Parallel Design Multiple Site Clinical Study
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: DSXS1411; Placebo
Intervention description: DSXS (Taro Pharmaceuticals Inc.); Placebo (vehicle) (Taro Pharmaceuticals Inc.)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The objectives of this study are to evaluate the therapeutic efficacy and safety of DSXS and
      a Placebo in patients with moderate to severe scalp psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or non-pregnant, non-lactating females age 12 and older.

          -  Clinical diagnosis of moderate to severe scalp psoriasis, defined by a Investigator's
             Global Assessment score of at least 3 at screening.

        Exclusion Criteria:

          -  Under 12 years of age.

          -  Patients whose scalp and/or non-scalp psoriasis necessitates systemic or other
             concomitant topical therapies during the study.

          -  Has a scalp skin condition that would interfere with the diagnosis or assessment of
             plaque psoriasis of the scalp.
Safety Study of Apixaban in Recent Acute Coronary Syndrome
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome; Syndrome
Intervention: Apixaban; Apixaban; Placebo; Apixaban
Intervention description: Tablets, Oral, 2.5 mg, twice daily, 26 weeks; Tablets, Oral, 10 mg, once daily, 26 weeks; Tablets, Oral, 0, twice daily, 26 weeks; Tablets, Oral 10 mg, twice daily, 26 weeks
Intervention MeSH terms: Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1741.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of this clinical research study is to determine whether apixaban will be safe in
      people who have recently had unstable angina or a heart attack.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Recent (< = 7 days) Acute Coronary Syndrome (ACS).

          -  Clinically stable on optimal treatment

        Key Exclusion Criteria:

          -  High bleeding risk.

          -  Ongoing anticoagulant use.

          -  Need for chronic (>3 months) daily nonsteroidal anti-inflammatory drug (NSAID) or
             chronic high dose acetylsalicylic acid (ASA) use (>325 mg/day
Study to Evaluate the Effect of GBT440 Administered to Subjects With IPF on Supplemental Oxygen at Rest
Condition: Idiopathic Pulmonary Fibrosis; Hypoxemia
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Hypoxia
Intervention: GBT440
Intervention description: GBT440: Capsules which contain GBT440 drug substance in Swedish orange
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 45 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Idiopathic pulmonary fibrosis; hypoxemia; oxygen

Summary:

      This is an open label study in which eligible IPF subjects who are using supplemental oxygen
      at rest will receive GBT440 orally daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of IPF.

          -  Receiving supplemental oxygen for use at rest.

          -  Weight ≥ 40 kg.

          -  Male or female of child bearing potential willing and able to use highly effective
             methods of contraception from study start to 30 days after the last dose of study
             drug.

        Exclusion Criteria:

          -  FEV1/FVC < 70%

          -  History of other interstitial lung diseases.

          -  Subject plans to begin or has commenced pulmonary rehabilitation within 30 days of
             screening.

          -  Corticosteroid (> 10 mg per day of prednisone or an equivalent) administered for 7
             days or longer, within 30 days of screening.

          -  Participated in another clinical trial of an investigational drug (or medical device)
             within 30 days or 5-half-lives, whichever is longer, prior to screening, or is
             currently participating in another trial of an investigational drug (or medical
             device).

          -  Female who is breast-feeding or pregnant

          -  Current smoker or history of smoking within 3 months from screening
Metoclopramide Versus Placebo for GJ Placement
Condition: Radiation Exposure; Enteral Nutrition
Intervention: Metoclopramide 5 MG/ML Injectable Solution; Saline
Intervention description: A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.; A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.
Intervention MeSH terms: Metoclopramide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Interventional Radiology; Metoclopramide; Gastrojejenostomy

Summary:

      The goal of this study is to determine whether use of promotility agents to stimulate gastric
      peristalsis can reduce fluoroscopy time and procedure time during gastrojejunostomy (GJ)
      tubes placement in interventional radiology (IR). The investigators hypothesize that
      increased gastric peristalsis will aid in advancing a guidewire through the pylorus, a time
      consuming and tedious step required during GJ tube placement. In order to maximize scientific
      rigor and clinical practice impact, the investigators aim to answer this question through a
      blinded, randomized, placebo controlled trial.

      Specific Aim 1: To test the hypothesis that a single dose of IV metoclopramide immediately
      prior to GJ tube placement reduces the fluoroscopy time required to advance a guidewire
      through the pylorus.

      Specific Aim 2: To determine whether a single dose of IV metoclopramide immediately prior to
      GJ tube placement reduces total procedure fluoroscopy time, air kerma and total procedure
      time.

      Specific Aim 3: To assess the safety of a single dose of promotility agent prior to GJ tube
      placement by assessing rates of adverse events in the periprocedural period in patients
      receiving IV metoclopramide versus placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  undergoing de novo GJ placement as part of their routine clinical care

        Exclusion Criteria:

          -  Patient pregnant

          -  Contraindications to metoclopramide including:

               -  allergic reaction

               -  pheochromocytoma

               -  QTc prolongation

               -  history of seizure disorder

               -  extrapyramidal symptoms
Adjunctive Ganaxolone Treatment (Part A) in TSC Followed by Long-term Treatment (Part B)
Condition: Tuberous Sclerosis
MeSH terms: Tuberous Sclerosis; Sclerosis
Intervention: Ganaxolone
Intervention description: titration followed by maintenance and extension period
Intervention MeSH terms: Ganaxolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 2 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      To assess preliminary safety and efficacy of ganaxolone as adjunctive therapy for the
      treatment of primary seizure types in patients with genetically- or clinically-confirmed
      TSC-related epilepsy through the end of the 12 week treatment period.
    

Eligibility criteria:

        Inclusion Criteria (Part A):

          -  Clinical or mutational diagnosis of TSC

          -  Failure to control seizures despite appropriate trial of 2 or more ASMs at therapeutic
             doses.

          -  Have at least 8 countable/witnessed primary seizures during the 4-week baseline period
             with at least 1 primary seizure occurring in at least 3 of the 4 weeks of baseline.

        Inclusion Criteria (Part B)

        • Patients have experienced ≥ 35% reduction in primary seizure frequency during the Part A
        treatment period compared to the 4-week Baseline Period.

        Exclusion Criteria (Part A):

          -  Previous exposure to GNX

          -  Pregnant or breastfeeding

          -  Concurrent use of strong inducers or inhibitors of cytochrome P450 (CYP)3A4/5/7. Any
             strong inhibitor or inducer of CYP3A4/5/7 must be discontinued at least 28 days before
             Visit 2, study drug initiation. This does not include approved ASMs.

          -  Patients who have been taking felbamate for less than 1 year prior to screening

          -  Patients who test positive for tetrahydrocannabinol (THC) or non-approved cannabidiol
             (CBD) via plasma drug screen

          -  Chronic use of oral steroid medications, ketoconazole (except for topical
             formulations), St. John's Wort, or other IPs is not permitted

          -  Have an active CNS infection, demyelinating disease, degenerative neurological
             disease, or CNS disease deemed progressive. This includes tumor growth which in the
             opinion of the investigator could affect primary seizure control

          -  Patients with significant renal insufficiency, estimated glomerular filtration rate
             (eGFR) < 30 mL/min (calculated using the Cockcroft-Gault formula or Pediatric GFR
             calculator or Bedside Schwartz), will be excluded from study entry or will be
             discontinued if the criterion is met post baseline

          -  Have been exposed to any other investigational drug within 30 days or fewer than 5
             half lives (whichever is shorter) prior to the screening visit
Study Evaluating The Safety And Efficacy Of PF-03049423 In Subjects With Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: PF-03049423; PF-03049423; PF-03049423; Placebo
Intervention description: 1 mg of PF-03049423 daily for 90 days; 3 mg of PF-03049423 daily for 90 days; 6 mg of PF-03049423 daily for 90 days; Placebo of PF-03049423 daily for 90 days
Intervention MeSH terms: 3-(4-(2-hydroxyethyl)piperazin-1-yl)-7-(6-methoxypyridin-3-yl)-1-(2-propoxyethyl)pyrido(3,4-b)pyrazin-2(1H)-one
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 181.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Phase 2 Ischemic stroke Safety and efficacy

Summary:

      The purpose of this study is to evaluate the safety and tolerability of PF-03049423 following
      multiple dose administration to subjects with ischemic stroke. The study will also evaluate
      the efficacy of PF-03049423, relative to placebo, in subjects with ischemic stroke following
      90 days of therapy. The study will also explore the relationship between PF-03049423
      concentration and blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of ischemic stroke with an onset within 72 hours prior to start of study
             agent administration, male or female.

          -  Supratentorial ischemic stroke involving the cortex documented by neurological exam
             and confirmed by MRI.

          -  Stroke involving upper extremity.

          -  Subjects who received thrombolytic therapy may be enrolled and the use of antiplatelet
             is acceptable.

        Exclusion Criteria:

          -  Any other severe acute or chronic medical or psychiatric condition besides the stroke.

          -  Women of child bearing potential.

          -  Uncontrolled hypertension.
An Investigational Immuno-Therapy Safety and Efficacy Study of Multiple Administration Regimens for Nivolumab Plus Ipilimumab in Subjects With Renal Cell Carcinoma
Condition: Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Opdivo; Yervoy
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 104.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate safety and efficacy of different administration
      regimens of nivolumab plus ipilimumab in subjects with renal cell carcinoma.
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Advanced Renal Cell Carcinoma

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

          -  Must have at least 1 lesion with measurable disease

        Exclusion Criteria:

          -  Subjects with active central nervous system metastases

          -  Subjects who received prior therapy with checkpoint inhibitor

          -  Subjects with active, known or suspected autoimmune disease

        Other protocol defined inclusion/exclusion criteria could apply
Open-Label Study of the Safety and Immunogenicity of HEPLISAV™ Hepatitis B Virus Vaccine
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Intervention: HEPLISAV
Intervention description: Intramuscular (IM) injections 0.5mL on Day 0 and Week 4
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 11 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatitis B vaccine; HBV vaccine; Hepatitis B; Hepatitis; HBV; Vaccine; 1018; HBsAg

Summary:

      The purpose of this study is to further evaluate the safety and seroprotective immune
      response of a new investigational hepatitis B virus (HBV) vaccine, HEPLISAV™, in subjects
      11-55 years old. The primary hypothesis is that HEPLISAV™ is well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to give written informed consent

          -  Women of childbearing potential must be willing to consistently use a highly effective
             method of birth control

        Exclusion Criteria:

          -  Women who are pregnant or breastfeeding

          -  Any previous HBV infection

          -  Previous vaccination (1 or more doses) with any HBV vaccine

          -  Any previous autoimmune diseases

          -  Are at high risk for recent exposure to HBV, Hepatitis C Virus (HCV) or Human
             Immunodeficiency Virus (HIV)

          -  Received any blood products or antibodies within 3 months prior to study entry

          -  Ever received an injection with DNA plasmids or oligonucleotides

          -  Received any vaccines within 4 weeks prior to study entry

          -  Received any other investigational medicinal agent within 4 weeks prior to study entry
Study of Nasal Insulin to Fight Forgetfulness - Long-acting Insulin Detemir - 120 Days (SL120)
Condition: Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: Saline; Insulin detemir; Insulin
Intervention description: Saline, administered intranasally twice per day for a 16 week duration; 20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day); 20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Detemir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 50 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Memory; Intranasal insulin; Alzheimer's disease; Mild Cognitive Impairment

Summary:

      The study will examine the effects of intranasally administered long-acting insulin detemir
      on cognition in persons with Alzheimer's disease (AD) or amnestic mild cognitive impairment
      (aMCI). The rationale for these studies is derived from growing evidence that insulin
      contributes to multiple brain functions, and that insulin dysregulation can contribute to AD
      pathogenesis. Thus, therapies aimed at restoring normal insulin signaling in the CNS may have
      beneficial effects on brain function. Intranasal administration of insulin increases insulin
      signaling in the brain without raising peripheral levels and causing hypoglycemia. Insulin
      detemir is an insulin analogue that may have better action in brain than other insulin
      formulations because of its albumin binding properties. The investigators will test the
      therapeutic effects of intranasally-administered insulin detemir in a study in which
      participants will receive insulin detemir, regular insulin, or placebo over a four month
      period. The investigators will test the hypothesis that insulin and insulin detemir will both
      improve memory and daily functioning in persons with AD/aMCI compared with placebo, but that
      insulin detemir will have the greatest effect.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 50-89

          -  Diagnosed with mild cognitive impairment, or mild/moderate AD

        Exclusion Criteria:

          -  Excessively high or low blood pressure, heart rate

          -  Pre-existing diabetes not controlled by exercise/diet

          -  Previous/current use of insulin

          -  Significant elevations in lipids, liver enzymes

          -  Menstrual period within the last 12 months

          -  Significant neurological or medical disorder (other than AD)

          -  Significant use of nasal decongestants

          -  Current use of anti-psychotic, anti-convulsive, anxiolytic, glucocorticoids, or
             sedative medications