bioihbjkbjnl/mcl2 huggingface dataset:
Safety & Efficacy of Peginesatide for the Treatment of Anemia in Participants With Chronic Renal Failure Not on Dialysis
Condition: Chronic Renal Failure; Chronic Kidney Disease; Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic; Anemia
Intervention: peginesatide; peginesatide; Darbepoetin alfa
Intervention description: Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).; Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.; As prescribed, starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: anemia; chronic kidney disease; CKD; chronic renal failure; CRF; erythropoietin; EPO; erythropoiesis stimulating agent; ESA; Hematide™; hemoglobin; Hb; Hgb; Omontys; peginesatide; red blood cell; red blood cell production

Summary:

      The purpose of this study was to evaluate the safety and efficacy of peginesatide for the
      treatment of anemia in participants with chronic kidney disease, who are not on dialysis and
      not on erythropoiesis stimulating agent (ESA) treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Chronic renal failure with an estimated glomerular filtration rate < 60 milliliter per
             minute per 1.73m^2 and not expected to begin dialysis for at least 12 weeks.

          2. Two consecutive hemoglobin values ≥ 8.0 g/dL and < 11.0 g/dL within 4 weeks prior to
             randomization.

        Exclusion Criteria:

          1. Females who are pregnant or breast-feeding.

          2. Treatment with an ESA in the 12 weeks prior to randomization.

          3. Known intolerance to any ESA, parenteral iron supplementation, or pegylated molecule.

          4. Prior chronic hemodialysis or chronic peritoneal dialysis treatment.

          5. Known bleeding or coagulation disorder.

          6. Known hematologic disease or cause of anemia other than renal disease

          7. Poorly controlled hypertension

          8. Evidence of active malignancy within one year prior to randomization.

          9. A scheduled kidney transplant
A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: Tocilizumab (myeloma receptor antibody [MRA]) was supplied in sterile solution of 20 mg TCZ/mL for aseptic preparation of infusion bags for IV administration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 538.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, international multi-center extension study WA18695 was designed to assess
      the long term safety of tocilizumab in patients who had moderate to severe active rheumatoid
      arthritis (RA). Patients enrolled in the WA18695 study had previously received treatment in
      the 24-week, placebo-controlled, Phase III Study WA17822. Eligible patients were assigned to
      treatment with 8 mg/kg tocilizumab every 4 weeks for a maximum of 5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who have completed participation in the Phase III study WA17822 (NCT00106548)
             in adult rheumatoid arthritis.

        Exclusion Criteria:

          -  Treatment with any investigational agent since the last administration of study drug
             in WA17822.

          -  Treatment with intravenous (IV) gammaglobulin, plasmapheresis, or Prosorba column
             since the last administration of study drug in WA17822.

          -  Treatment with an anti-tumor necrosis factor or anti-interleukin-1 agent, or a T cell
             costimulation modulator since the last administration of study drug in WA17822.

          -  Previous treatment with any cell-depleting therapies.

          -  Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to
             baseline.
Bronchoscopic Intratumoral Chemotherapy for Small Cell Lung Cancer (SCLC)
Condition: Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Intervention: Cisplatin
Intervention description: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies
Intervention MeSH terms: Cisplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Healthy volunteers: No

Summary:

      This project proposes to use bronchoscopic intratumoral chemotherapy for small cell lung
      cancer in two fashions:

        1. to implement a prospective clinical trial to test the feasibility and efficacy of
           intralesional chemotherapy as consolidative therapy immediately following standard
           systemic chemotherapy and radiation therapy for patients with limited stage SCLC by
           comparing tumor growth and survival rates of the treatment group and compare the
           outcomes to historical controls

        2. to implement a prospective clinical trial to test the feasibility and efficacy as
           measured by tumor growth and survival rates of intralesional chemotherapy for patients
           with recurrent SCLC after standard treatment.
    

Eligibility criteria:

        Inclusion Criteria: Competent adult English speaking subjects

          -  With limited stage SCLC who have completed standard of care treatment who are
             responders with no evidence of disseminated disease other than CNS metastasis,

          -  With recurrent disseminated SCLC after standard of care treatment with symptoms
             related to central tumor obstruction,

          -  With recurrent limited stage SCLC with mediastinal/hilar recurrence not previously
             treated with intratumoral cisplatin

        Exclusion Criteria:

          -  Subjects who do not meet the inclusion criteria

          -  Subjects who, in the opinion of the investigator, are at risk undergoing a
             bronchoscopy
Assessment of Efficacy and Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Intervention: NKTR-118; NKTR-118; Placebo
Intervention description: 12.5 mg oral tablet once daily; 25 mg oral tablet once daily; Oral tablet once daily
Intervention MeSH terms: Naloxegol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 652.0
Sex: All
Minimum age: 18 Years
Maximum age: 84 Years
Healthy volunteers: No
Keywords: Non-Cancer-Related Pain, Opioid-Induced Constipation

Summary:

      The purpose of this study is to evaluate the effect and safety of NKTR-118 treatment of
      opioid-induced constipation in patients with non-cancer-related pain, including those
      patients that have inadequate response to laxative therapy (LIR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent prior to any study-specific procedures.

          -  Men and women who are between the ages of ≥18 and <85 years.

          -  Self-reported active symptoms of OIC at screening (<3 SBMs/week and experiencing ≥1
             reported symptom of hard/lumpy stools, straining, or sensation of incomplete
             evacuation/anorectal obstruction in at least 25% of BMs over the previous 4 weeks);
             and Documented confirmed OIC (<3 SBMs/week on average over the 2-week OIC confirmation
             period.

          -  Receiving a stable maintenance opioid regimen consisting of a total daily dose of 30
             mg to 1000 mg of oral morphine, or equianalgesic amount(s) of 1 or more other opioid
             therapies for a minimum of 4 weeks prior to screening for non-cancer-related pain with
             no anticipated change in opioid dose requirement over the proposed study period as a
             result of disease progression.

          -  Willingness to stop all laxatives and other bowel regimens including prune juice and
             herbal products throughout the 2-week OIC confirmation period and the 12-week
             treatment period, and to use only bisacodyl as rescue medication if a BM has not
             occurred within at least 72 hours of the last recorded BM.

        Exclusion Criteria:

          -  Patients receiving Opioid regimen for treatment of pain related to cancer.

          -  History of cancer within 5 years from first study visit with the exception of basal
             cell cancer and squamous cell skin cancer.

          -  Medical conditions and treatments associated with diarrhea, intermittent loose stools,
             or constipation.

          -  Other issues to the gastrointestinal tract that could impose a risk to the patient.

          -  Pregnancy or lactation.
Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.
Condition: Asthma
MeSH terms: Asthma; Emergencies
Intervention: Budesonide; albuterol; Ipratropium bromide; Prednisone
Intervention description: 2mg/dose by nebulizer, four doses over 3 hours; 2.5mg/dose by nebulizer, 7 doses over 6 hours; 2.5 mg, one dose; 60mg PO
Intervention MeSH terms: Prednisone; Budesonide; Bromides; Albuterol; Ipratropium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: acute, emergency department

Summary:

      To determine whether adding nebulized inhaled steroids to the standard care of acutely ill ED
      patients with refractory acute asthma helps improve forced expiratory volume at one second
      (FEV1) and decrease the need for hospitalization.
    

Eligibility criteria:

        Inclusion Criteria:

          -  FEV1<50% predicted after bronchodilator therapy, age 18-60, presenting to an emergency
             department with acute asthma

        Exclusion Criteria:

          -  other chronic lung disease, >15 pack years smoking
Evaluation of Evolocumab (AMG 145) Efficacy in Diabetic Adults With Hypercholesterolemia/Mixed Dyslipidemia
Condition: Hypercholesterolemia; Mixed Dyslipidemia; Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2; Hypercholesterolemia; Dyslipidemias
Intervention: Evolocumab; Placebo to Evolocumab
Intervention description: Administered by subcutaneous injection with an automated mini doser; Administered by subcutaneous injection with an automated mini doser
Intervention MeSH terms: Evolocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: diabetes; type 2 diabetes; high blood cholesterol; hypercholesterolemia; mixed dyslipidemia; high cholesterol; statin intolerant

Summary:

      The purpose of this study is to evaluate the effect of 12 weeks of subcutaneous evolocumab
      taken monthly compared with subcutaneous placebo taken monthly on low density lipoprotein
      cholesterol (LDL-C) in adults with type 2 diabetes mellitus and high blood cholesterol on a
      maximally tolerated oral dose of statin of at least moderate-intensity.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 years

          -  Type 2 Diabetes Mellitus

          -  Hemoglobin A1c < 10%

          -  Stable diabetes therapy

          -  Must be on maximally tolerated dose of statin of at least moderate Intensity

          -  Fasting triglycerides ≤ 600 mg/dL

          -  Not at LDL-C or Non-HDL-C goal.

        Exclusion Criteria:

          -  Moderate to severe renal dysfunction

          -  Uncontrolled hypertension

          -  Persistent active liver disease or hepatic dysfunction

          -  Has taken a cholesterylester transfer protein inhibitor in the last 12 months,

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary
             artery bypass graft or stroke within 3 months prior to randomization
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: Subcutaneous injection every 4 weeks (starting dose of 120, 200 or 360 micrograms, based on previous ESA therapy)
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 202.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy, safety and tolerability of once monthly
      administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis
      patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting
      dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of
      epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to
      maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the
      target sample size is 200 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  chronic renal anemia;

          -  regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for
             >=3 months;

          -  continuous iv maintenance epoetin alfa therapy with same dosing interval during
             previous 2 months.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension;

          -  significant acute or chronic bleeding;

          -  active malignant disease (except non-melanoma skin cancer).
Effects of SH T00658ID on Libido
Condition: Contraception; Libido
Intervention: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Microgynon; Placebo
Intervention description: Estradiol valerate (EV) and dienogest (DNG). Sequential 4-phasic regimen. Daily oral administration of one encapsulated SH T00658ID for 28 days per cycle, for 6 treatment cycles: Days 1-2, 3.0 mg EV; Days 3-7, 2.0 mg EV+2.0 mg DNG; Days 8-24, 2.0 mg EV+3.0 mg DNG; Days 25-26, 1.0 mg EV; Days 27-28, placebo, encapsulated for blinding purpose; Days 1 to 21: daily oral administration of one encapsulated Microgynon tablet; 0.03 mg ethinylestradiol (EE) + 0.15 mg levonorgestrel (LNG). Six 28-day treatment cycles.; Days 22 to 28: daily oral administration of one encapsulated placebo tablet. Six 28-day treatment cycles.
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 217.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Oral contraceptive; Sexual dysfunction; Libido

Summary:

      The aim of the study is to investigate whether women on oral contraceptives (OCs) suffering
      from acquired OC-associated female sexual dysfunction (FSD) for at least 3 months but no
      longer than one year will express the same level of sexual distress when taking SH T00658ID
      compared to Microgynon, the usual OC prescribed for women with OC-associated FSD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  OC-associated female sexual dysfunction (FSD) for at least 3 months but no longer than
             one year and willingness to continue OC use but to switch to SH T00658ID or Microgynon

          -  Combined score of the sexual desire and arousal domains of the FSFI questionnaire of
             18 or below at screening and baseline

        Exclusion Criteria:

          -  Contraindications for oral contraceptive use, for example but not limited to: presence
             or history of venous or arterial thrombotic / thromboembolic events, hypertension,
             presence or history of severe hepatic disease
Study of DU-176b, Prevention of Venous Thromboembolism in Patients After Hip Fracture Surgery
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism; Hip Fractures
Intervention: DU-176b (edoxaban); Enoxaparin sodium 20mg
Intervention MeSH terms: Enoxaparin; Enoxaparin sodium; Edoxaban
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 92.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Anticoagulants; Enoxaparin sodium; venous thromboembolism.; thromboembolism; Thrombosis; deep vein thrombosis; DU-176b; Edoxaban; factor Xa; hip fracture surgery; embolism

Summary:

      The objective of this study is to evaluate the safety and efficacy of DU-176b compared with
      enoxaparin sodium for the prevention of venous thromboembolism in patients after elective hip
      fracture surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who are scheduled to undergo surgery within 10 days for fracture of inner or
             outer femoral neck (trochanteric and subtrochanteric)

        Exclusion Criteria:

          -  Subjects with risks of hemorrhage

          -  Subjects with thrombolic risks

          -  Subjects who weigh less than 40 kg

          -  Subjects who are pregnant or suspect pregnancy, or subjects who want to become
             pregnant
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Condition: Hemorrhagic Stroke; Venous Thromboembolism; Deep Venous Thrombosis
MeSH terms: Stroke; Hemorrhagic Stroke; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Enoxaparin; Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization
Intervention description: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke; placebo standard therapy
Intervention MeSH terms: Enoxaparin
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hemorrhagic stroke; venous thromboembolism; prevention

Summary:

      Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism.
      Intermittent pneumatic compression combined with elastic stockings have been shown to be
      superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis
      after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are
      ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic
      stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism
      in patients with ICH because the use of anticoagulants may cause an enlargement of the
      hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and
      safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous
      intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated
      compression stockings and/or intermittent pneumatic compression and/or early mobilization)
      will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke
      onset.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intracranial spontaneous hemorrhage on brain CT scan

          -  Intracranial hemorrhage during treatment with oral anticoagulants

          -  Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for
             cerebellar hemorrhage).

        Exclusion Criteria:

          -  cerebral hemorrhage due to intracranial vascular malformation

          -  rebleeding on CT scan after 72 hours from stroke (before randomization)