bioihbjkbjnl/mcl2 huggingface dataset:
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ribociclib; letrozole
Intervention description: ribociclib + letrozole; ribociclib + letrozole
Intervention MeSH terms: Letrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HR-positive; HER2-negative; Advanced breast cancer; LEE011; ribociclib; letrozole; femara; CDK; CDK4; CDK6; CDK4/6; CDK4/6 inhibitor; Phase III; Phase IIIb; ER-positive; PR-positive; Postmenopausal; Premenopausal; Men

Summary:

      This study was a companion study to CLEE011A2404 which provided the opportunity for the
      collection of tumor tissue samples to better understand relevant mutations and the mechanisms
      responsible for resistance to treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent was to have been obtained prior to any baseline/screening
             procedures.

          -  Patients eligible for this companion sample collection protocol sample collection
             protocol must have met all inclusion in CLEE011A2404.

        Exclusion Criteria:

          -  Patients eligible for this companion sample collection protocol must not have met any
             of the exclusion criteria in the CLEE011A2404 study, in addition to the following:

          -  Patients without either fresh or archival tumor tissue accessible.
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab (75 mg); Secukinumab (150 mg); Placebo
Intervention description: Secukinumab (75 mg); Secukinumab (150 mg); Placebo
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 371.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankylosing spondylitis; AS; ASAS; inflammatory back pain

Summary:

      This study will assess the efficacy and safety of secukinumab in patients with active
      ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs,
      DMARDs and / or TNFα inhibitor therapy.
    

Eligibility criteria:

        Inclusion criteria:

          -  Male or non-pregnant, non-lactating female patients at least 18 years of age

          -  Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray)
             fulfilling the Modified New York criteria for AS (1984)

          -  Patients should have been on NSAIDs with an inadequate response

          -  Patients who are regularly taking NSAIDs as part of their AS therapy are required to
             be on a stable dose

          -  Patients who have been on an anti-TNFα agent (not more than one) must have experienced
             an inadequate response

        Exclusion criteria:

          -  Chest X-ray with evidence of ongoing infectious or malignant process

          -  Patients with total ankylosis of the spine

          -  Patients previously treated with any biological immunomodulating agents except for
             those targeting TNFα

          -  Previous treatment with any cell-depleting therapies

          -  Other protocol-defined inclusion/exclusion criteria may apply
Aflibercept Compared to Placebo in Term of Efficacy in Patients Treated With Gemcitabine for Metastatic Pancreatic Cancer
Condition: Pancreatic Neoplasm
MeSH terms: Pancreatic Neoplasms
Intervention: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®); Placebo; Gemcitabine
Intervention description: 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.; 4 mg/kg was administered intravenously (IV) over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle; 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles.
Intervention MeSH terms: Gemcitabine; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 546.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic pancreatic cancer; angiogenesis inhibitor; gemcitabine

Summary:

      The main objective of the study was to evaluate the effectiveness of aflibercept treatment by
      comparison to placebo in increasing the overall survival (OS) in participants with metastatic
      pancreatic cancer, treated with gemcitabine.

      The secondary objectives were to evaluate progression free survival, clinical benefit,
      overall response, safety and immunogenicity of aflibercept, in the two treatment arms (Arm 1:
      Aflibercept and Gemcitabine; Arm 2: Placebo and Gemcitabine).

      The study included an interim analysis of OS. In accordance with the study protocol, an
      interim analysis was performed for the purpose of futility and overwhelming efficacy. On the
      basis of the interim analysis, the Data Monitoring Committee (DMC) recommended that this
      study be terminated for futility based on predefined boundary rules.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cytologically or histologically confirmed evidence of epithelial cancer
             (adenocarcinoma) of the exocrine pancreas

          -  Metastatic disease

          -  No prior chemotherapy for pancreatic disease

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2

          -  Adequate renal, liver and bone marrow functions

        Exclusion Criteria:

          -  Less than 42 days elapsed from prior major surgery (28 days from other prior surgery)
             to the time of randomization

          -  Prior treatment with anti-VEGF or VEGF-Receptor-inhibitors

          -  Uncontrolled hypertension

          -  Pregnancy or breastfeeding

          -  Participant with reproductive potential (M/F) without effective method of
             contraception

        The above information is not intended to contain all considerations relevant to potential
        participation in a clinical trial.
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare PFS (progression-free survival) rate at 6
      months and at 1 year after randomization, of Nivolumab 480 mg every 4 weeks with nivolumab
      240 mg every 2 weeks in subjects with advanced/metastatic (Stage IIIb/IV) NSCLC (non-Sq and
      Sq).
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically or cytologically documented Squamous or non-Squamous Non-small cell
             lung cancer (NSCLC) (Stage IIIB/IV), or recurrent or progressive disease following
             multimodal therapy

          -  Patients must have received pre-study nivolumab for up to 12 months and have 2
             consecutive tumor assessments confirming Complete response (CR), Partial response
             (PR), or Stable disease (SD)

          -  Measurable disease before start of pre-study nivolumab treatment

          -  Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2

        Exclusion Criteria:

          -  Carcinomatous meningitis

          -  Untreated, symptomatic Central nervous system (CNS) metastases

          -  Symptomatic interstitial lung disease

        Other protocol defined inclusion/exclusion criteria could apply
Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children
Condition: Pneumococcal Vaccines
Intervention: 13vPnC; 13vPnC
Intervention description: 13vPnC will be administered by intramuscular injection at approximately 5 and 12 months of age.; 13vPnC will be administered by intramuscular injection at approximately 12 months of age.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 234.0
Sex: All
Minimum age: 140 Days
Maximum age: 392 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Subjects; Vaccines; Pneumococcal

Summary:

      The purposes of this study are to evaluate the safety of 13-valent pneumococcal Conjugate
      Vaccine (13vPnC) in children who have already been vaccinated with Prevenar. The study will
      also assess the immunological response (measure the amount of antibodies, i.e. proteins that
      fight off germs) produced by children after they have been given the 13-valent pneumococcal
      vaccine at 5 and 12 months or 12 months of age. In addition, reactions at the injection site
      will be assessed during the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy children previously immunized with 1 or 2 doses of Prevenar.

          -  Group 1: Male or female subjects between the age of >=140 and <=196 days of age at
             time of enrollment.

          -  Group 2: Male or female subjects between the age of >=336 and <=392 days of age at
             time of enrollment

          -  Available for entire study period.

        Exclusion Criteria:

          -  Previous reaction or contra-indication to pneumococcal vaccine or vaccine related
             component.

          -  Previous vaccination with licensed or investigational pneumococcal vaccine other than
             Prevenar.
Multiple Dose Dental Pain Study Of Ibuprofen Extended Release
Condition: Pain
MeSH terms: Toothache
Intervention: Ibuprofen 600 mg ER; Placebo
Intervention description: One 600 mg caplet dosed at 0, 12, 24 and 36 hours; One placebo caplet dosed at times 0, 12, 24 and 36 hours
Intervention MeSH terms: Ibuprofen
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Minimum age: 16 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: dental pain; multiple dose; ibuprofen; third molar extraction

Summary:

      The study hypothesis is that single and multiple doses of ibuprofen 600 mg ER caplets provide
      analgesic efficacy superior to placebo over 12-hour dosing intervals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 16 to 40 years of age

          -  Subjects who undergo surgical removal of at least two third molars

          -  One of which must be a partial or full bony mandibular impaction

          -  Subjects must have at least moderate baseline pain (a score of 2 on the categorical
             pain severity rating scale) confirmed by a score of at least 50 mm on the 100-mm
             visual analog scale-pain severity rating scale (VAS-PSR)

        Exclusion Criteria:

          -  Acute localized dental infection at the time of surgery that could confound the
             post-surgical evaluation

          -  Presence or history of any significant organ disease

          -  Use of prescription or OTC first generation antihistamines

          -  Females who are pregnant, lactating or of childbearing potential and not using a
             medically approved method to prevent pregnancy
A Long-Term Safety and Efficacy Study AGN-19920 in Patients With Persistent Erythema Associated With Rosacea
Condition: Erythema; Rosacea
MeSH terms: Rosacea; Erythema
Intervention: Oxymetazoline HCL Cream 1.0%
Intervention description: Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.
Intervention MeSH terms: Phenylephrine; Oxymetazoline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 440.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the long-term safety and efficacy of oxymetazoline hydrogen chloride
      (HCL) Cream 1.0% (AGN-199201) in patients with persistent erythema associated with rosacea.
    

Eligibility criteria:

        Inclusion Criteria:

        -Moderate to severe persistent facial erythema associated with rosacea.

        Exclusion Criteria:

          -  Current treatment with monoamine oxidase (MAO) inhibitors

          -  Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, scleroderma or
             Sjogren's syndrome.
A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Condition: Pulmonary Hypertension, Familial Persistent, of the Newborn
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Intervention: placebo; iv sildenafil
Intervention description: IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.; loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 59.0
Sex: All
Minimum age: 0 Days
Maximum age: 4 Days
Healthy volunteers: No
Keywords: persistent pulmonary hypertension; newborn; neonates; iv sildenafil; hypoxic respiratory failure and at risk of persistent pulmonary hypertension of the newborn

Summary:

      This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide
      treatment and reduce the failure rate of available treatments for persistent pulmonary
      hypertension of the newborn.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Neonates with persistent pulmonary hypertension of the newborn

          -  Age <=96 hours and >=34 weeks gestational age

          -  Oxygenation Index >15 and <60

          -  Concurrent treatment with inhaled nitric oxide and >=50% oxygen

        Exclusion Criteria:

          -  Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary
             resuscitation

          -  Expected duration of mechanical ventilation <48 hours

          -  Profound hypoxemia

          -  Life-threatening or lethal congenital anomaly
Study Evaluating the Efficacy and Safety of Idelalisib in Combination With Bendamustine and Rituximab for Previously Treated Chronic Lymphocytic Leukemia (CLL) (Tugela )
Condition: Chronic Lymphocytic Leukemia
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Idelalisib; Rituximab; Bendamustine; Placebo to match idelalisib
Intervention description: Idelalisib 150 mg administered orally twice daily; Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions; Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions; Placebo to match idelalisib administered orally twice daily
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride; Idelalisib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 416.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Zydelig; CLL; CAL-101; GS 1101; GS-1101; PI3K; Rituxan; Rituximab; Bendamustine; Leukemia; idelalisib

Summary:

      The primary objective of this study is to evaluate the effect of the addition of idelalisib
      (formerly GS-1101) to bendamustine + rituximab (BR) on progression-free survival (PFS) in
      participants with previously treated chronic lymphocytic leukemia (CLL)
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Previously treated recurrent CLL

          -  Measurable lymphadenopathy

          -  Requires therapy for CLL

          -  Has experienced CLL progression < 36 months since the completion of the last prior
             therapy

        Key Exclusion Criteria:

          -  Recent history of a major non-CLL malignancy

          -  Evidence of an ongoing infection

          -  CLL refractory to bendamustine

          -  Concurrent participation in another therapeutic clinical trial

        NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 734.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase
      inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's
      disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with an AChEI.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's current AChEI therapy is likely to be interrupted or discontinued during
             the study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
A Trial of Cranberry Capsules for Urinary Tract Infection Prevention in Nursing Home Residents
Condition: Bacteriuria
MeSH terms: Bacteriuria
Intervention: 2 cranberry capsules; Placebo
Intervention description: Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC); Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to cranberry or placebo capsules.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 185.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Urinary tract infection (UTI) is the most common infection in nursing home residents, and
      bacteriuria is the greatest trigger for antimicrobial therapy in the nursing home setting.
      The primary aim of this study is to test the efficacy of two oral cranberry capsules per day
      in the reduction of bacteriuria plus pyuria in female nursing home residents. These aims will
      be accomplished by conducting a double blind randomized placebo controlled efficacy trial of
      two oral cranberry capsules daily versus placebo in a cohort of Connecticut female nursing
      home residents.
    

Eligibility criteria:

        Inclusion Criteria:

          1. female residents;

          2. long term residents

          3. English speaking; and

          4. age ≥ 65 years.

        Exclusion Criteria:

          1. residents that are not expected to be in the nursing home for at least one month
             (i.e., short term rehabilitation, pending discharge, terminal [life expectancy < 1
             month]);

          2. residents who are on chronic suppressive antibiotic or anti-infective (i.e.,
             mandelamine) therapy for recurrent UTI;

          3. residents with end stage renal disease on dialysis (they do not regularly produce
             urine);

          4. residents unable to produce a baseline clean catch urine specimen for collection;

          5. residents on warfarin therapy because of a potential interaction of warfarin and
             cranberry juice;

          6. residents with a history of nephrolithiasis because cranberry may increase the risk of
             nephrolithiasis;

          7. have an indwelling bladder catheter in place;

          8. have an allergy to cranberry products;

          9. are being treated with cranberry products;

         10. residence <4 weeks.