bioihbjkbjnl/mcl2 huggingface dataset:
An Asian Study to Evaluate Efficacy and Safety of Oral Enzalutamide in Progressive Metastatic Prostate Cancer Participants
Condition: Progressive Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Enzalutamide; Placebo
Intervention description: Oral; Oral
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 395.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Enzalutamide; Androgen receptor; Prostate cancer; Xtandi

Summary:

      Purpose of the study was to assess the effect of enzalutamide on time to Prostate Specific
      Antigen (PSA) progression as compared to placebo in chemotherapy naïve participants with
      progressive metastatic prostate cancer who have failed androgen deprivation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate without neuroendocrine
             differentiation or small cell features

          -  Ongoing androgen deprivation therapy with a GnRH analogue or bilateral orchiectomy

          -  Progressive disease despite androgen deprivation therapy as defined by rising PSA
             levels or progressive soft tissue or bone disease

          -  No prior treatment with cytotoxic chemotherapy

          -  Asymptomatic or mildly symptomatic from prostate cancer

        Exclusion Criteria:

          -  Severe concurrent disease, infection, or co-morbidity that, in the judgment of the
             Investigator, would make the patient inappropriate for enrollment

          -  Known or suspected brain metastasis or active leptomeningeal disease

          -  History of another malignancy within the previous 5 years other than curatively
             treated non-melanomatous skin cancer

          -  History of seizure including febrile seizure or any condition that may predispose to
             seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss
             of consciousness requiring hospitalization).
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: ponesimod; teriflunomide
Intervention description: film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning; film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
Intervention MeSH terms: Teriflunomide; Ponesimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1133.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: relapsing multiple sclerosis

Summary:

      International clinical trial to compare ponesimod and teriflunomide in relapsing multiple
      sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

        Male and female subjects aged 18 to 55 years with established diagnosis of MS McDonald 2010
        with relapsing course from onset (i.e., RRMS and SPMS with superimposed relapses).

        Subjects must have active disease evidenced by one or more MS attacks with onset within the
        period of 12 to 1 months prior to randomization, or by two or more MS attacks with onset
        within the 24 to 1 months prior to randomization, or with one or more gadolinium-enhancing
        (Gd+) lesion(s) of the brain on an MRI performed within 6 months prior to randomization.

        Enrolled subjects must be ambulatory (EDSS score of up to 5.5 inclusive) and may be
        treatment-naïve or previously treated with MS disease modifying therapy.

        Exclusion Criteria:

        Subjects with significant medical conditions or therapies for such conditions (e.g.,
        cardiovascular, pulmonary, immunological, hepatic,ophthalmological conditions) or lactating
        or pregnant women are not eligible to enter the study.

        Subjects with contraindications to MRI or with clinically relevant medical or surgical
        conditions that, in the opinion of the investigator, would put the subject at risk by
        participating in the study are not eligible to enter the study.
Cetrorelix (CET) Pamoate Regimens in Patients With Symptomatic Benign Prostatic Hypertrophy (BPH)
Condition: Benign Prostatic Hypertrophy
MeSH terms: Prostatic Hyperplasia; Hypertrophy
Intervention: Cetrorelix 78 mg + 78 mg; Cetrorelix 78 mg + 52 mg; Placebo
Intervention MeSH terms: Cetrorelix
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 667.0
Sex: Male
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Cetrorelix

Summary:

      Benign Prostatic Hypertrophy (BPH) is a common and bothersome condition of aging men. It is
      characterized by an enlargement of the prostate occurring in human male over the age of 50
      which increases in prevalence with age, and among those aged 50 to 80, about 40% report
      moderate or severe urinary symptoms of prostatism. The aim of treatment is to improve
      patients' quality of life which primarily depends on the severity of the symptoms of BPH.
      Current treatments of BPH have a benefit / risk ratio which leaves room for improvement.

      For this study, study medication (Cetrorelix pamoate or placebo) is administered by injection
      in the buttocks (Intramuscular). All patients completing the double-blind portion (Week 0 to
      52) are eligible to receive the active drug during the open-label part of the study (Week 52
      to 90).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Benign Prostatic Hyperplasia, based on medical history

          -  Voiding symptoms

        Exclusion Criteria:

          -  Urgent need for prostate surgery or prior surgical treatment of the prostate or
             bladder

          -  Major organ dysfunction

          -  Eczema (atopic dermatitis) treated during the last 6 months

          -  Current or recent treatment with sexual hormone drugs or 5 α reductase inhibitors or
             botulinum toxin type a (Botox) within the last 6 months prior randomization or with α
             blockers or saw palmetto within the last 6 weeks prior to randomization

          -  Urologic disorders including neurogenic bladder dysfunction due to diabetes mellitus
             or documented neurologic disorder, urethral stricture disease or history of pelvic
             radiation therapy

          -  History of acute obstructive, infectious, or neurological disorders of the
             genitourinary tract within the last 3 months
A Study of Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Predialysis Patients Not Treated With ESA.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: sc every month (starting dose 1.2 micrograms/kg)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of subcutaneous methoxy
      polyethylene glycol-epoetin beta (Mircera) for the correction and maintenance of hemoglobin
      levels in predialysis patients with renal anemia who are not currently treated with
      erythropoietin stimulating agents (ESA). Eligible patients will receive monthly subcutaneous
      injections of Mircera at an initial recommended dose of 1.2 micrograms/kg. The anticipated
      time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  predialysis stage;

          -  no ESA therapy during previous 3 months.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension requiring hospitalization in previous 6 months;

          -  significant acute or chronic bleeding.
A Study of Avastin (Bevacizumab) Plus Crossover Fluoropyrimidine-Based Chemotherapy in Patients With Metastatic Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Chemotherapy; Bevacizumab
Intervention description: As prescribed; Bevacizumab, 5 mg/kg intravenously (IV) on days 1 and 14 of each 4 week cycle, or 7.5 mg/kg IV on days 1 and 22 of each 6 week cycle.
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 820.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of adding bevacizumab to crossover
      fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer who have
      experienced disease progression under first line treatment with standard chemotherapy plus
      bevacizumab. Participants will receive chemotherapy alone, or in combination with
      bevacizumab. The anticipated time on study treatment is until disease progression or
      unacceptable toxicity occurs. Participants are allowed to continue on bevacizumab, even after
      stopping chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >=18 years of age

          -  Metastatic colorectal cancer and disease progression

          -  Previously treated with first-line chemotherapy plus Avastin

          -  Eastern Cooperative Oncology Group (ECOG) performance status <=2.

        Exclusion Criteria:

          -  Diagnosis of progression of disease more than 3 months after last Avastin
             administration

          -  First-line patients with progression-free survival in first-line of <3 months

          -  Patients receiving less than 3 consecutive months of Avastin in first-line therapy

          -  Past or current history (within the last 2 years prior to treatment start) of other
             malignancies, except for curatively treated basal and squamous cell cancer of the skin
             or in situ cancer of the cervix

          -  Clinically significant cardiovascular disease within 6 months prior to start of study
             treatment

          -  Known central nervous system (CNS) disease, except for treated CNS metastases as
             defined by protocol
Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: AZLI; Placebo
Intervention description: AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily; Placebo to match AZLI administered via nebulizer three times daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and
      gram-negative airway infection. Participants received two 28-day courses of either Aztreonam
      for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a
      28-day off-drug period. Following the two blinded courses, all participants received a 28-day
      course of open-label AZLI then were followed for an additional 56 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/Female 18 years or older with non-CF bronchiectasis

          -  Chronic sputum production on most days

          -  Positive sputum culture for gram-negative organisms

          -  Must have met lung function requirements

        Exclusion Criteria:

          -  History of CF

          -  Hospitalized within 14 days prior to joining the study

          -  Previous exposure to AZLI

          -  Pregnant, breastfeeding, or unwilling to follow contraceptive measures for the study

          -  Must have met liver and kidney function requirements

          -  Continuous oxygen use of greater than 2 liters per minute (supplemental oxygen with
             activity and at night was allowed)

          -  Treatment for nontuberculous mycobacteria infection or active mycobacterium
             tuberculosis infection within 1 year of enrollment

          -  Other serious medical conditions.
ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Dacomitinib (PF-00299804); Active Comparator (erlotinib); Placebo erlotinib; Placebo PF00299804
Intervention description: Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing; Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing; placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.; placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 878.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: comparative study of PF-00299804 and Erlotinib; Double-Blind Phase 3 trial of TKI

Summary:

      This is a multinational, multicenter, randomized,double-blinded, Phase 3 study comparing the
      efficacy and safety of treatment with PF-00299804 to treatment with erlotinib in patients
      with advanced non-small cell lung cancer, previously treated with at least one prior regimen.
      Analyses of primary objective (Progression Free Survival) will be done in two co-primary
      populations as defined in the protocol.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Evidence of pathologically confirmed, advanced NSCLC (with known histology).

          -  Prior treatment with at least one and no more than two systemic therapy regimens (at
             least one must be standard chemotherapy for advanced NSCLC).

          -  Adequate tissue sample must be submitted prior to randomization for tumor biomarker
             analyses.

          -  Adequate renal, hematologic, liver function.

          -  ECOG PS of 0-2.

          -  Radiologically measurable disease.

        Exclusion Criteria:

          -  Small cell histology.

          -  Symptomatic brain mets or known leptomeningeal mets.

          -  Prior therapy with agent known or proposed to be active by action on EGFR tyrosine
             kinase or other HER family proteins.

          -  Uncontrolled medical disorders.
Instillation of Gemcitabine in Patients With Superficial Bladder Cancer
Condition: Bladder Neoplasms
MeSH terms: Urinary Bladder Neoplasms
Intervention: Gemcitabine; Placebo
Intervention description: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT); intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
Intervention MeSH terms: Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 355.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo-controlled Phase 3 multicenter study to assess the
      efficacy and safety of intravesical instillation of gemcitabine versus placebo immediately
      after transurethral resection of the bladder tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical evidence of superficial transitional cell carcinoma of the bladder

          -  Males or females at least 18 years of age

          -  Karnofsky Performance Status greater than or equal to 70%

          -  Patient compliance and geographic proximity that allow adequate follow-up

          -  Female patients with reproductive potential must use a reliable contraceptive method
             if appropriate (for example, intrauterine device [IUD], birth control pills, or
             barrier device) during the study. Female patients with reproductive potential must
             have a negative serum pregnancy test within 7 days of study enrollment.

          -  Signed informed consent.

        Exclusion Criteria:

          -  Clinical evidence of muscle-invasive or locally advanced bladder cancer

          -  Clinical evidence of upper urinary tract tumor

          -  Distant metastases

          -  Other malignancies within the last 2 years, except non-melanotic skin tumors,
             carcinoma in situ of the cervix or organ-confined prostate cancer after curative
             therapy

          -  Severe concomitant psychiatric disease

          -  Febrile, active infection

          -  Other serious concomitant disorders that would compromise the safety of the patient or
             his/her ability to complete the study according to the protocol, at the discretion of
             the investigator (for example, unstable angina pectoris, uncontrolled diabetes
             mellitus)
A 26-week Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart BID and Insulin Degludec OD Plus Insulin Aspart in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin in Need of Treatment Intensification With Mealtime Insulin
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: insulin degludec/insulin aspart; insulin degludec; insulin aspart
Intervention description: Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.; Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.; Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 274.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Africa, Europe and the United States of America (USA).

      The aim of the trial is to compare the difference in change in glycosylated haemoglobin
      (HbA1c) between insulin degludec/insulin aspart (IDegAsp) and/or oral anti-diabetic drugs
      (OADs) and insulin degludec (IDeg) plus insulin aspart (IAsp)and/or OADs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of type 2 Diabetes Mellitus at the discretion of the investigator for at
             least 26 weeks prior to screening (visit 1)

          -  Treatment with basal insulin for at least 12 weeks prior to randomisation with or
             without metformin, sulphonylurea (SU)/glinide, DPP-4 inhibitors,
             alfa-glucosidase-inhibitors

          -  HbA1c 7.0% - 10.0%

          -  Body mass index (BMI) less than or equal to 40.0 kg/m^2

        Exclusion Criteria:

          -  Treatment with glucose-lowering agent(s) other than those stated in the inclusion
             criteria

          -  Stroke; heart failure New York Heart Association (NYHA) class III or IV; myocardial
             infarction; unstable angina pectoris; or coronary arterial bypass graft or angioplasty

          -  Chronic disorder or disease which might jeopardise safety or compliance

          -  Malignant neoplasms

          -  Recurrent severe hypoglycaemia
The Acute Effects of the Angiotensin-converting Enzyme Inhibitor Enalaprilat on Flow Distribution
Condition: Hypertension; Congestive Cardiomyopathy
MeSH terms: Hypertension; Cardiomyopathies; Cardiomyopathy, Dilated
Intervention: Enalaprilat
Intervention description: Enalaprilat will be administered intravenously i.v. 0.005 - 0.01 mg/kg i.v. over 1 minute
Intervention MeSH terms: Enalaprilat; Enalapril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 2 Months
Maximum age: 5 Years
Healthy volunteers: No
Keywords: pediatric; hypertension; congestive cardiomyopathy; angiotensin-converting enzyme inhibitor; cardiac catheterization

Summary:

      The primary objective of this study is to study the acute effects of angiotensin-converting
      enzyme inhibitor (ACEI) on systemic, pulmonary and cerebral blood flow in post bidirectional
      cavopulmonary connection (BCPC) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BCPC patients at time of routine pre-Fontan catheterization

          -  Patients between the ages of 2 months and 5 years old

        Exclusion Criteria:

          -  Patients who have had ACEI therapy within 24 hours of the procedure