bioihbjkbjnl/mcl2 huggingface dataset:
A Randomized Controlled Trial Comparing Safety and Efficacy of Carboplatin and Paclitaxel Plus or Minus Sorafenib (BAY 43-9006) in Chemonaive Patients With Stage IIIB-IV Non-Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small Cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nexavar (Sorafenib, BAY43-9006) + carboplatin + paclitaxel; Carboplatin plus Paclitaxel
Intervention description: Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.; Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Carboplatin; Sorafenib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 926.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non-Small Cell Lung Cancer; NSCLC

Summary:

      A randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel
      plus or minus sorafenib in chemonaive patients with stage III-IV non-small cell lung cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage IIIB (with effusion) or Stage IV NSCLC any histology

          -  No prior chemotherapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

          -  Greater than or equal to 18 years of age

          -  Life expectancy at least 12 weeks

          -  Adequate bone marrow, liver and renal function

        Exclusion Criteria:

          -  Prior systemic anti cancer therapy

          -  Known brain metastasis. Patients with neurological symptoms should undergo at computed
             tomography (CT) scan/magnetic resonance imaging (MRI) of the brain to exclude brain
             metastasis

          -  Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events
             (CTCAE) Grade 2 within 4 weeks of first dose of study drug

          -  Thrombotic or embolic events including Transient ischemic attack (TIA) within the past
             6 months

          -  Uncontrolled hypertension

          -  Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of
             study drug

          -  Major surgery within 4 weeks

          -  Evidence or history of bleeding diathesis or coagulopathy
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Condition: Cushing's Disease
MeSH terms: ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion
Intervention: Pasireotide
Intervention MeSH terms: Pasireotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cushing's Disease; pasireotide; SOM230

Summary:

      This study will evaluate the safety and efficacy of two different doses of Pasireotide in
      patients with de novo or recurrent/persistent Cushing's Disease.
    

Eligibility criteria:

        Inclusion criteria

          -  18 years or greater

          -  Confirmed diagnosis of ACTH-dependent Cushing's disease

          -  Not considered candidate for pituitary surgery

        Exclusion criteria

          -  History of pituitary irradiation in the last 10 years

          -  Cushing's syndrome not caused by pituitary tumor

          -  Patients with active malignant disease (cancer) in the last 5 years

          -  Women who are pregnant or lactating

        Other protocol-defined inclusion/exclusion criteria apply.
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Stannous fluoride; Sodium monofluorophosphate
Intervention description: Test dentifrice containing 0.454% SnF; Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice
      daily brushing of a toothpaste containing stannous fluoride in comparison to marketed
      (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous
      fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed
      (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with self-reported history of dentinal hypersensitivity lasting more than
             6 months but not more than 10 years.

          -  Participants with minimum of 20 natural teeth.

          -  At screening, a minimum of two accessible teeth (incisors, canines, premolars) that
             meet all of the following criteria.

               1. Teeth showing signs of facial/cervical gingival recession and/or signs of erosion
                  or abrasion.

               2. Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.

               3. Teeth that are determined to be sensitive by the subject following a 1 second air
                  blast to the cervical margin.

        Exclusion Criteria:

          -  Presence of chronic debilitating disease which, in the opinion of the investigator,
             could affect study outcomes.

          -  Any condition which, in the opinion of the investigator, causes dry mouth.

          -  Tooth with evidence of current or recent caries, or reported treatment of decay in 12
             months of screening.

          -  Participant using of a desensitising dentifrice within 6 weeks of screening
Combination Therapy for the Treatment of Bipolar Disorders
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Intervention: Lithium; Lamotrigine; Divalproex; Placebo
Intervention description: Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent /L (mEq/L).; Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.; Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.; Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum dose of 200 mg per day.
Intervention MeSH terms: Lamotrigine; Valproic Acid; Lithium Carbonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      This study will compare triple and double drug regimens in the treatment of patients with
      depression, hypomania, or mania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Bipolar I or II Disorder

          -  Meet criteria for rapid cycling, defined as four or more episodes over the past 12
             months

          -  Meet criteria for a major depressive episode

        Exclusion Criteria:

          -  History of intolerability of lithium, divalproex, or lamotrigine
Study on Efficacy, Pharmacokinetics, and Safety of Two Subcutaneous Injections of Triptorelin Embonate 6 Month Formulation in Patients With Advanced Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Triptorelin embonate 22.5 mg
Intervention MeSH terms: Triptorelin Pamoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: Male
Healthy volunteers: No

Summary:

      The primary purpose of this study is to evaluate the efficacy of triptorelin embonate 22.5 mg
      6-month formulation administered by the subcutaneous (under the skin) route in:

        -  achieving castrate levels of testosterone (< 1.735 nmol/L) on Day 29 [i.e., 28 days
           after investigational medicinal product (IMP) injection], and

        -  in maintaining serum testosterone castrate levels from Month 2 (Day 57) to end of Month
           12 (Day 337) in participants with advanced prostate cancer.
    

Eligibility criteria:

        Summary Inclusion Criteria:

          -  Meets protocol-specified criteria for qualification and contraception

          -  Is willing and able to remain confined in the study unit for the entire duration of
             each treatment period and comply with restrictions related food, drink and medications

          -  Voluntarily consents to participate and provides written informed consent prior to any
             protocol-specific procedures

        Summary Exclusion Criteria:

          -  Has history or current use of over-the-counter medications, dietary supplements, or
             drugs (including nicotine and alcohol) outside protocol-specified parameters

          -  Has signs, symptoms or history of any condition that, per protocol or in the opinion
             of the investigator, might compromise: 1) the safety or well-being of the participant
             or study staff; 2) the safety or well-being of the participant's offspring (such as
             through pregnancy or breast-feeding); 3) the analysis of results
Assessment of Efficacy and Safety of Ruxolitinib in Participants With COVID-19-Associated ARDS Who Require Mechanical Ventilation (RUXCOVID-DEVENT)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Placebo; Ruxolitinib
Intervention description: Placebo administered BID approximately 12 hours apart; Ruxolitinb administered BID approximately 12 hours apart
Intervention MeSH terms: Janus Kinase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blinded
Enrollment: 211.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cytokine storm; COVID-19; ARDS; SARS-CoV-2; ruxolitinib; pneumonia

Summary:

      The purpose of this study is to evaluate the efficacy and safety of ruxolitinib in the
      treatment of participants with COVID-19-associated Acute Respiratory Distress Syndrome (ARDS)
      who require mechanical ventilation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant or guardian health proxy must provide informed consent before any study
             assessment is performed.

          -  Male or female participants aged ≥ 12 years.

          -  Participants with coronavirus (SARS-CoV-2) infection confirmed ≤ 3 weeks prior to
             randomization by any test with local regulatory approval.

          -  Participants who are intubated and receiving mechanical ventilation due to
             COVID-19-associated ARDS and have a PaO2/FiO2 of ≤ 300 mmHg within 6 -hours of
             randomization.

        Participants with lung imaging showing bilateral or diffuse pulmonary infiltrates on chest
        x-ray or CT scan.

        Exclusion Criteria:

          -  Known history of hypersensitivity to any drugs or metabolites of similar chemical
             classes as ruxolitinib.

          -  Presence of severely impaired renal function defined by estimated creatinine clearance
             < 15 mL/min measured or calculated by Cockcroft-Gault equation or calculated by the
             updated bedside Schwartz equation. Participants must not be receiving CRRT or
             intermittent hemodialysis at screening.

          -  In the opinion of the investigator, unlikely to survive for > 24 hours from
             randomization.

          -  Suspected active uncontrolled bacterial, fungal, viral, or other infection (besides
             COVID-19).

          -  Currently receiving ECMO.

          -  Participant may not be sharing a ventilator, or co-ventilating, with any other
             patient.

          -  Treatment with anti-IL-6, IL-6R, IL-1RA, IL-1β, or GM-CSF antagonists, or a BTK
             inhibitor, within 7 days of randomization.

          -  Treatment with a JAK inhibitor within 30 days of randomization.

          -  Participants who are on long-term use of antirejection or immunomodulatory drugs.

          -  Pregnant or nursing (lactating) women.
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: Etrasimod; Placebo
Intervention description: Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks; Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Ulcerative Colitis; Etrasimod; APD334; UC

Summary:

      The purpose of this study is to determine whether oral etrasimod is a safe and effective
      treatment in adult Japanese participants with moderately to severely active ulcerative
      colitis (UC). This study is an extension of study APD334-302 (NCT03996369). Participants will
      continue with the same blinded treatment assigned in Study APD334-302 for a total treatment
      duration of 52 weeks (12 weeks in Study APD334-302 plus 40 weeks in Study APD334-308).
    

Eligibility criteria:

        Inclusion Criteria:

        Participants with moderately to severely active ulcerative colitis (UC) are eligible to
        enroll into this study if they fulfill all of the following:

          -  Must have completed the Week 12 visit of Study APD334-302

          -  Ability to provide written informed consent or assent (parent or legal guardian must
             provide consent for a participant < 20 years of age or as required per local
             regulations who has assented to participate in the study) and to be compliant with the
             schedule of protocol assessments. Enrollment of participants < 20 years should be
             conducted only if acceptable according to local laws and regulations.

          -  Both men and women subjects agree to use a highly effective method of birth control if
             the possibility of conception exists

        Exclusion Criteria:

        Participants who meet any of the following exclusion criteria will not be eligible for
        enrollment into the study:

          -  If the Investigator considers the participant to be unsuitable for any reason to
             participate in the study

          -  Participants requiring partial or total colectomy during the APD334-302 study

          -  Participants requiring treatment with prohibited concomitant medications
Primary Sclerosing Cholangitis With Oral Vancomycin by the Study of Its Antimicrobial and Immunomodulating Effects
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Intervention: Oral Vancomycin
Intervention MeSH terms: Vancomycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Inflammation of the bile ducts; biliary scarring; obstruction

Summary:

      Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PSC Diagnosis: Liver biopsy and/or imaging (MRCP, ERCP, CT, or US

          -  Colonoscopy within 1 year or starting of study

          -  2 groups:

               1. IBD (Inflammatory bowel disease) and PSC: details of extent and type of IBD

               2. No IBD and PSC, but positive p-ANCA or ASCA serologies indicating possible IBD.

        Exclusion Criteria:

          -  Allergy to Vancomycin

          -  PSC not associated with IBD or NO positive IBD antibodies (p-ANCA [anti- neutrophil
             cytoplasmic antibody] or ASCA [anti-Saccharomyces cerevisiae antibody])

          -  Cholangiocarcinoma

          -  On oral or topical (enemas or suppositories) corticosteroids,topical mesalamine, or
             biologics (infliximab, adalimumab, certolizumab).
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Intervention: GSP 301 NS; Olopatadine HCl NS; Mometasone furoate NS; GSP 301 Placebo NS
Intervention description: FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days; 2 sprays in each nostril twice daily for 14 days
Intervention MeSH terms: Mometasone Furoate; Olopatadine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1180.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Seasonal Allergic Rhinitis

Summary:

      Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to
      individual monotherapies (comparators) as well as the efficacy of these monotherapies
      (comparators) versus placebo NS over 14 days of study treatment
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 12 years and older inclusive of either sex.

          2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit
             [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring
             allergy season (tree/grass pollen)

          3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for
             the AM assessment at the Screening Visit (Visit 1).

        Exclusion Criteria:

          1. Pregnant or lactating women.

          2. Plans to travel outside the known pollen area for the investigative site for > 24
             hours during the last 7 days of run in period.

          3. History of anaphylaxis and/or other severe local reaction(s) to skin testing.

          4. History of positive test for HIV, Hepatitis B or Hepatitis C infection.

          5. Documented evidence of acute or significant chronic sinusitis or chronic purulent
             postnasal drip.

          6. Subjects with an active pulmonary disorder or infection.

          7. Subjects with posterior subcapsular cataracts or glaucoma
Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: SM-13496
Intervention description: 40 or 80 mg once daily orally
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 284.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The study evaluates the long term safety and efficacy of SM-13496 in patients with
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are considered by the investigator eligible for the present study with no
             significant safety concerns

          -  Patients who are fully informed of and understand the objectives, procedures, and
             possible benefits and risks of the study and who provide written voluntarily consent
             to participate in the study

        Exclusion Criteria:

          -  Patients who are planning pregnancy for the expected duration of the study

          -  Patients who are otherwise considered ineligible for the study by the investigator
Effectiveness Study of Nivolumab Compared to Chemotherapy in Patients With Relapsed Small-cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Nivolumab; Topotecan; Amrubicin
Intervention MeSH terms: Nivolumab; Topotecan; Amrubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 569.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the overall survival of nivolumab versus chemotherapy
      in subjects with relapsed SCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed small cell lung cancer (SCLC)

          -  Subjects with either limited or extensive disease stage at the initial diagnosis

          -  Must have recurrence or progression after platinum-based first-line chemotherapy or
             chemoradiation therapy for the treatment of limited or extensive disease stage SCLC

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

        Exclusion Criteria:

          -  Untreated or symptomatic central nervous system (CNS) metastases

          -  Prior therapy with anti-PD-1, anti-PDL1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody

          -  Inadequate hematologic or hepatic function