bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting
Condition: HER2+ Metastatic Breast Cancer (MBC)
MeSH terms: Breast Neoplasms
Intervention: neratinib; capecitabine; lapatinib
Intervention MeSH terms: Capecitabine; Lapatinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 621.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neratinib; Nerlynx

Summary:

      This is a randomized, multi-center, multinational, open-label, active-controlled, parallel
      design study of the combination of neratinib plus capecitabine versus the combination of
      lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2
      directed regimens in the metastatic setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged ≥18 years at signing of informed consent.

          -  Histologically confirmed MBC, current stage IV.

          -  Documented HER2 overexpression or gene-amplified tumor immunohistochemistry 3+ or 2+,
             with confirmatory fluorescence in situ hybridization (FISH) +.

          -  Prior treatment with at least two (2) HER2-directed regimens for metastatic breast
             cancer.

        Exclusion Criteria:

          -  Received previous therapy with capecitabine, neratinib, lapatinib, or any other HER2
             directed tyrosine kinase inhibitor.

        Note: There are additional inclusion and exclusion criteria. The study center will
        determine if you meet all of the criteria.
Tolerability and Efficacy of AM and PM Once Daily Dosing With Extended-release Guanfacine Hydrochloride in Children 6-12 With Attention-Deficit/Hyperactivity Disorder (ADHD) (The ADHD Tempo Study)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: extended-release guanfacine hydrochloride (SPD503); placebo; extended-release guanfacine hydrochloride
Intervention description: dosed in AM; dosed in the AM or PM; Dosed in the PM
Intervention MeSH terms: Guanfacine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 340.0
Sex: All
Minimum age: 6 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The primary purpose is to assess the efficacy of once daily dosing with optimized SPD503 (1,
      2, 3 and 4mg/day), dosed either in the morning or evening, compared to placebo, in children
      with ADHD as measured by change from baseline score at endpoint on the ADHD-RS-IV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  6-12 years old

          -  ADHD diagnosis

          -  ADHD-RS-IV minimum score of 28

          -  CGI-S score > or = 4

        Exclusion Criteria:

          -  Current, controlled or uncontrolled, comorbid psychiatric diagnosis

          -  Condition or illness which represent inappropriate risk to subject

          -  Known history or presence of structural cardiac abnormalities, serious heart rhythm
             abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events,
             or clinically significant bradycardia; orthostatic hypotension or controlled or
             uncontrolled hypertension

          -  Use of prohibited medication that have CNS effects or affect cognitive performance

          -  History of alcohol or substance abuse within 6 months

          -  Current use of medication that affect BP or heart rate

          -  Significantly overweight

          -  Weight of less than 55 lbs

          -  Known allergy to SPD503

          -  Abnormal urine drug and alcohol screen
Efficacy and Safety of Oral Febuxostat in Participants With Gout
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Febuxostat; Allopurinol
Intervention description: Febuxostat 40 mg, capsules, orally, once daily for up to 6 months.; Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.; Allopurinol 200 mg or 300 mg, capsules, orally, once daily for up to 6 months.
Dose is dependent on the subject's renal function. Subjects with normal renal function or mild renal impairment received 300 mg once daily; subjects with moderate renal impairment received 200 mg once daily.
Intervention MeSH terms: Allopurinol; Febuxostat
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 2269.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: tophi; hyperuricemia; uric acid; Drug Therapy

Summary:

      The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily
      (QD), to allopurinol in subjects with hyperuricemia and gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has one or more of the American Rheumatism Association criteria for the diagnosis of
             gout.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

          -  Must have a serum urate level greater than or equal to 8.0 milligram per deciliter
             (mg/dL).

        Exclusion Criteria:

          -  Have a severe, unstable, or life threatening medical condition that would likely
             prevent them from completing this study.

          -  Has a known body reaction to febuxostat, allopurinol, naproxen, any other
             non-steroidal anti-inflammatory drug (NSAID), aspirin, lansoprazole, colchicine, or
             any components in their formulation.

          -  History of xanthinuria.

          -  Alcohol consumption greater than 14/week.

          -  History of significant concomitant illness.

          -  Active liver or peptic ulcer disease.

          -  Has rheumatoid arthritis requiring treatment.

          -  Has estimated creatinine clearance less than 30 milliliter per minute (mL/min)
             calculated using the Cockcroft-Gault formula corrected for ideal body weight.

          -  Requires therapy with any other urate-lowering drug other than the study drug;
             long-term use of NSAIDs and COX-2 inhibitors; salicylates; thiazide diuretics;
             losartan; azathioprine; mercaptopurine; theophylline; intravenous (IV) colchicine;
             cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole;trimethoprim.
Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Intervention: Oxybutynin (Oxytrol, BAY839380)
Intervention description: Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)
Intervention MeSH terms: Oxybutynin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 855.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      With this study researchers want to gather information about the consumer use behavior of
      Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a
      prescription from a healthcare professional. An area of focus was on the potential benefits
      of an over-the-counter status for Oxytrol and on the ongoing use behavior of the consumers.
      Oxytrol is a thin, flexible, clear patch that is indicated for the treatment of overactive
      bladder a disease characterized by a collection of symptoms, including urinary frequency,
      urgency, and urge incontinence. The adhesive patch is placed on the skin to deliver Oxytrol
      through the skin into the bloodstream.
    

Eligibility criteria:

        Inclusion criteria:

          -  Female

          -  18 years of age or older

          -  Not pregnant or suspected to be pregnant

          -  Never trained or employed as a healthcare professional

          -  Neither the subject nor anyone in their household worked for a pharmaceutical company,
             a pharmacy, a managed care or health insurance company, a healthcare practice, or as a
             healthcare professional

          -  Had not participated in any market research study, product label study or clinical
             trial in the past 12 months

        Exclusion criteria:

          -  Symptoms of blood in the urine not related to menses

          -  Back pain and fever in conjunction with frequency or urgency and any of the following:
             dysuria, hematuria, or cloudy urine

          -  Narrow-angle glaucoma

          -  Pregnant (as determined by a urine pregnancy test among women of child bearing
             potential)

          -  Breastfeeding

          -  Known allergy to oxybutynin
Lamotrigine in Reducing Psychologic Side-Effect of Perioperative Ketamine
Condition: Reducing Psychological Side Effects of Ketamine
Intervention: Lamotrigine 300 MG; Placebo; Ketamine
Intervention description: 300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P<.05).; 300 mg of oral Placebo; 1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery
Intervention MeSH terms: Lamotrigine; Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomization without stratification
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: The Pharmacy will know the treatment
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Patient will receive lamotrigine vs. placebo with small sips of water. Lamotrigine reaches
      peak level 1-4 hours after oral administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 -65 Years of age

          -  Planned overnight hospital stay

        Exclusion Criteria:

          -  Pregnant and planning to become pregnant

          -  No known History of seizure

          -  No known History of Schizophrenia

          -  No known History of unstable angina

          -  Patients taking Antiepileptic medications

          -  Known history of Lamotrigine intake in past.

          -  Any history of allergic reaction to lamotrigine in the past.
Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat
Condition: Moderate to Severe Convexity of Submental Fat; Safety; Efficacy
Intervention: Deoxycholic Acid; Placebo
Intervention description: Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.; Phosphate buffered saline placebo for injection.
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objectives of this study are to explore the safety and efficacy of subcutaneous
      injections of Deoxycholic Acid relative to placebo, in the submental area in patients with
      mild or extreme fullness of the submental fat and ratings of 1 or 4.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female subjects, 18 to 65 years old

          -  Stable Body weight

          -  Body Mass Index (BMI) of ≤40.0 kg/m^2

          -  Acceptable volume of submental fat graded by clinician

          -  Dissatisfaction with the submental area expressed by the subject

          -  Signed informed consent form (ICF)

          -  SMF ratings of 1 or 4

        Exclusion Criteria:

          -  No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic
             agents)

          -  Presence of clinically significant health problems

          -  History of trauma associated with the chin or neck areas that in the judgment of the
             investigator may affect evaluation of safety or efficacy of treatment

          -  Body mass index ≤40 kg/m^2
Safety and Efficacy of BAY1192631 in Japanese Patients With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections
Condition: Skin Diseases, Infectious
MeSH terms: Infections; Communicable Diseases; Soft Tissue Infections; Skin Diseases, Infectious; Skin Diseases
Intervention: Tedizolid Phosphate (Sivextro, BAY1192631); Linezolid
Intervention description: BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.; Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.
Intervention MeSH terms: Linezolid; Tedizolid; Tedizolid phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 125.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Methicillin Resistant Staphylococcus Aureus,; Skin and soft tissue infection,; Bacteremia,; Tedizolid

Summary:

      The aim of this study is to see the efficacy and safety of BAY1192631 in Japanese patients
      with methicillin-resistant staphylococcus aureus (MRSA) (skin and soft tissue infections
      (SSTI) and SSTI-related bacteremia).
    

Eligibility criteria:

        Inclusion Criteria

          -  Suspected or confirmed Methicillin-resistant Staphylococcus aureus (MRSA) infection

          -  Japanese Male and female patients aged 18 years or above

          -  Diagnosis of Skin and soft tissue infection with MRSA either suspected or confirmed as
             the major cause of infection, with/without SSTI (skin and soft tissue
             infection)-derived MRSA bacteremia suspected

        Exclusion Criteria:

          -  Having received any systemic antibacterial potentially effective against MRSA for
             >/=24 hours within 3 days prior to the first infusion of a study drug, or having
             received/expected to receive the medication within 24 hours prior to the first
             infusion, unless antibacterial therapy for >/=72 hours proves to be ineffective on or
             lack appropriate potency (resistant) to MRSA.

          -  Moribund clinical condition such as death likely within the first 3 days of a study
             drug treatment

          -  History of significant allergy or intolerance to linezolid or BAY1192631

          -  Known or suspected human immunodeficiency virus (HIV) infection with a CD4+ T-cell
             count < 200/μL

          -  Chronic treatment with immunosuppressive drugs

          -  Active tuberculosis or non-tuberculous mycobacteriosis which need medical treatments

          -  Current or anticipated neutropenia with neutrophil count < 1,000/ mm^3

          -  Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >/= 8 times the
             upper limit of reference range OR moderate to severe hepatic disease with Child Pugh
             score >/=10.
Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
Condition: Renal Cell Carcinoma (RCC)
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Pembrolizumab; Epacadostat; Sunitinib; Pazopanib
Intervention description: Pembrolizumab 200 mg administered intravenously every 3 weeks.; Epacadostat 100 mg administered orally twice daily.; Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.; Pazopanib 800 mg administered orally once daily.
Intervention MeSH terms: Pembrolizumab; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal cell carcinoma; programmed cell death 1 (PD-1) inhibitor; indoleamine 2; 3-dioxygenase 1 (IDO1) inhibitor

Summary:

      The purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus
      epacadostat compared to sunitinib or pazopanib in participants with locally
      advanced/metastatic renal cell carcinoma (mRCC) with a clear cell component who have not
      received prior systemic therapy for their mRCC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic confirmation of locally advanced or metastatic RCC with a clear-cell
             component with or without sarcomatoid features.

          -  Must not have received any prior systemic therapy for their mRCC.

          -  Measurable disease based on RECIST v1.1.

          -  Archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor
             lesion as required.

          -  Karnofsky performance status ≥ 70%.

          -  Adequate organ function per protocol-defined criteria.

        Exclusion Criteria:

          -  Use of protocol-defined prior/concomitant therapy.

          -  Currently receiving or has received an investigational treatment as part of a study of
             an investigational agent or has used an investigational device within 4 weeks before
             randomization.

          -  History of severe hypersensitivity reaction to study treatments or their excipients.

          -  Active autoimmune disease that has required systemic treatment in past 2 years.

          -  Known additional malignancy that has progressed or has required active treatment in
             the last 3 years.

          -  Known active central nervous system metastases and/or carcinomatous meningitis.

          -  History of (noninfectious) pneumonitis that required steroids or current pneumonitis.

          -  History or presence of an abnormal electrocardiogram that, in the investigator's
             opinion, is clinically meaningful.

          -  Significant cardiac event within 12 months before Cycle 1 Day 1.
Study of the 2.25mm Sirolimus-Eluting Stent in the Treatment of Patients With Coronary Artery Lesions
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Intervention: CYPHER Sirolimus-eluting Coronary Stent
Intervention description: 2.25 Cypher Sirolimus-eluting Coronary Stent
Intervention MeSH terms: Sirolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main objective of this study is to assess the safety and effectiveness of the
      sirolimus-eluting Bx VELOCITYTM stent in reducing in-lesion restenosis in patients with de
      novo native coronary artery lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or non-pregnant female patients minimum 18 years of age

          2. Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society
             Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald
             Classification B&C, I-II) OR patients with documented silent ischemia;

          3. Target lesion is 20mm in length (visual estimate);

          4. Target lesion stenosis is >50% and <100% (visual estimate);

        Exclusion Criteria:

          1. Patient has experienced a Q-wave or non-Q-wave myocardial infarction with documented
             total CK >2 times normal within the preceding 24 hours and the CK and CK-MB enzymes
             remains above normal at the time of treatment;

          2. Has unstable angina classified as Braunwald III B or C, or is having a peri
             infarction;

          3. Documented Left ventricular ejection fraction 25%;

          4. Impaired renal function (creatinine > 3.0 mg/dl) at the time of treatment;
Continued Efficacy and Safety of Zoledronic Acid (q 4 Wks vs. q 12 Wks) in the 2nd Year of Treatment in Patients With Bone Metastases From Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Intervention: Zoledronic acid; Placebo
Intervention description: 4mg IV; Placebo to zoledronic acid
Intervention MeSH terms: Zoledronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 416.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer; zoledronic acid; bone metastases

Summary:

      Clinical trial in breast cancer patients with bone metastases pretreated for approximately 1
      year with a standard zoledronic acid regimen. Looking at the continued effectiveness and
      safety of giving zoledronic acid every 4 weeks versus every 12 weeks given over 1 year. This
      study is prospective, double-blind, stratified, multi-center, and two-arm.
    

Eligibility criteria:

        Inclusion Criteria:

        Female patients ≥ 18 years of age. Confirmed breast cancer with bone metastasis. Pretreated
        with Zometa®, or Aredia (pamidronate) or all sequential regimens of both, for a minimum of
        9 doses;

        Exclusion Criteria:

        Abnormal kidney function determined by serum creatinine levels. Current active dental
        problems including: ongoing infection of the teeth or jawbone; current exposed bone in the
        mouth; and current or prior diagnosis of osteonecrosis of the jaw.

        Recent (within 8 weeks) or planned dental or jaw surgery (e.g., extraction, implants).

        Diagnosis of metabolic bone disease other than osteoporosis (e.g., Paget's disease of
        bone).

        Known hypersensitivity to Zometa. Treatment with other investigational drugs within 30 days
        prior to randomization.

        Other protocol-defined exclusion criteria may have applied.