bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Certolizumab Pegol in Combination With Methotrexate in the Treatment of Disease Modifying Antirheumatic Drugs (DMARD)-naïve Adults With Early Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Certolizumab Pegol + Methotrexate (MTX); Placebo + Methotrexate (MTX)
Intervention description: Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.
On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).
CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.
The MTX treatment is to remain between 15-25 mg/week.; 1 syringe of Placebo every 2 Weeks and MTX.
The MTX treatment is to remain between 15-25 mg/week.
Intervention MeSH terms: Certolizumab Pegol; Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 359.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Certolizumab Pegol - Cimzia; Rheumatoid Arthritis

Summary:

      This study is intended to evaluate the efficacy and safety of Certolizumab Pegol (CZP) in
      combination with Methotrexate (MTX) for sustaining clinical response achieved in study RA0055
      Period 1 [NCT01519791]. Subjects entering this study RA0055 Period 2 achieved sustained Low
      Disease Activity at Week 52 in study RA0055 Period 1.
    

Eligibility criteria:

        Inclusion Criteria:

        - Those subjects in previous study RA0055 Period 1 who are in sustained LDA (defined as
        DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1

        Exclusion Criteria:

        - Those subjects in previous study RA0055 Period 1 who are NOT in sustained LDA (defined as
        DAS28[ESR] ≤ 3.2 at Weeks 40 and 52) at Week 52 in previous study RA0055 Period 1
Open-label Extension Study of Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in Neovascular ("Wet") Age-related Macular Degeneration (AMD)
Condition: Neovascular Age-related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Intravitreal Aflibercept Injection 2mg
Intervention MeSH terms: Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Eyes; Neovascular; Macular Degeneration; Retina; AMD; VEGF Trap-Eye; Best Corrected Visual Acuity

Summary:

      The primary objective is to assess long-term safety and tolerability of Intravitreal
      Aflibercept Injection (IAI; EYLEA®; BAY86-5321) in patients with neovascular AMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participation in Study VGFT-OD-0605 through week 96.

          -  In the opinion of the investigator, the study eye has neovascular AMD and may continue
             to require treatment.

        Exclusion Criteria:

          -  Presence of any condition that would jeopardize the patient's participation in this
             study.

          -  Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to
             practice adequate contraception throughout the study.
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
Condition: Endometriosis
MeSH terms: Endometriosis
Intervention: Elagolix
Intervention description: Elagolix tablets administered orally
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 506.0
Sex: Female
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Endometriosis associated pain; Elagolix; Gonadotropin-Releasing Hormone Antagonist; Dysmenorrhea (DYS); Non-Menstrual Pelvic Pain (NMPP)

Summary:

      A randomized study evaluating the continued safety and efficacy of elagolix in the management
      of moderate to severe endometriosis-associated pain in pre-menopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed the 6 month Treatment Period in pivotal study M12-665 (NCT01620528)

          -  Agrees to use required birth control methods during the study through Month 6 of the
             Post-treatment Follow-up period

        Exclusion Criteria:

          -  Clinically significant gynecological condition

          -  Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine,
             femoral neck or total hip

          -  Plans to become pregnant in the next 18 months
A Study Comparing Denosumab vs. Zoledronic Acid for the Treatment of Bone Metastases in Breast Cancer Subjects.
Condition: Bone Metastases
MeSH terms: Neoplasm Metastasis; Bone Neoplasms; Bone Marrow Diseases
Intervention: Denosumab; Zoledronic Acid
Intervention description: Q4W 120 mg denosumab SC injection and 4 mg zoledronic acid (Zometa) placebo IV over a minimum of 15 minutes; Q4W 4 mg zoledronic acid IV over minimum 15 minutes and 120 mg denosumab placebo SC
Intervention MeSH terms: Zoledronic Acid; Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 2049.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Fractures; Compressions; Bisphosphonates; Bone metastases; Breast cancer; Skeletal; Radiation; Surgery to Bone

Summary:

      The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in
      the treatment of bone metastases in subjects with advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults with histologically or cytologically confirmed breast adenocarcinoma

          -  radiographic evidence of at least one bone mets

          -  Easter Cooperative Oncology Group status of 0, 1 or 2;

          -  adequate organ function

        Exclusion Criteria:

          -  Current or prior IV bisphosphonate administration

          -  current or prior oral bisphosphonates for bone mets

          -  life expectancy of less than 6 months
Pediatric Open-Label Extension Study of Etanercept in Patients With Plaque Psoriasis
Condition: Pediatric Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: Etanercept
Intervention description: Open-label at a dose of 0.8 mg/kg (up to an intended dose of 50 mg) given once weekly by subcutaneous injection
Intervention MeSH terms: Etanercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Healthy volunteers: No
Keywords: Immunex; Amgen; Pediatric,; plaque psoriasis; clinical trial

Summary:

      The purpose of this study is to evaluate the long-term safety and efficacy of etanercept in
      pediatric patients with moderate to severe psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Enrollment on previous Amgen study 20030211 (NCT00078819)

        Exclusion Criteria:

          -  Serious or clinically significant adverse event on Amgen study 20030211 related to
             etanercept
Frozen ProQuad Administered Concomitantly Versus Nonconcomitantly With Other Pediatric Vaccines
Condition: Measles; Mumps; Rubella; Varicella
MeSH terms: Rubella
Intervention: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live; Comparator: Tripedia; Comparator: Comvax; Comparator: Varivax; Comparator: M-M-R II
Intervention description: A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL intramuscular injection (at Day 0 or Day 42); A single 0.5 mL intramuscular injection (at Day 0 or Day 42); A single 0.5 mL subcutaneous injection at Day 0; A single 0.5 mL subcutaneous injection at Day 0
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1913.0
Sex: All
Minimum age: 12 Months
Maximum age: 15 Months
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the safety and immunogenicity of ProQuad when administered
      concomitantly and nonconcomitantly with Tripedia and Comvax.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good health

          -  Negative clinical history of varicella, zoster, measles, mumps, rubella, diptheria,
             tetanus, pertussis, invasive Hib disease and hepatitis B

          -  Had completed either a 2-dose primary series of PedvaxHIB or COMVAX or any 3-dose
             primary series of a licensed Hib vaccine

          -  Had received 2 or 3 doses of any hepatitis B vaccine or COMVAX prior to entry into
             trial

        Exclusion Criteria:

          -  Previous receipt of measles, mumps, rubella or varicella vaccine either alone or in
             combination

          -  Any immune impairment or deficiency

          -  Recent household, daycare or school exposure to invasive Hib disease or hepatitis B

          -  Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to
             vaccination

          -  Vaccination with an inactive vaccine with in the past 14 days

          -  Vaccination with a live vaccine within the past 30 days

          -  Receipt of immune globulin, blood transfusion or blood-derived product in the past 3
             months

          -  Recent history of fever or underlying medical problems
Resuscitation Outcomes Consortium (ROC) Prehospital Resuscitation Using an Impedance Valve
Condition: Heart Arrest
MeSH terms: Heart Arrest
Intervention: Impedance Threshold Device (ITD); Sham ITD; Analyze early; Analyze later
Intervention description: Use of Impedance Threshold Device (ITD); Sham ITD; Upon EMS arrival at the scene of a non-traumatic cardiac arrest, an assessment of the cardiac rhythm is done to determine whether a defibrillatory shock is required.; Upon EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is given prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 11738.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac arrest; cardiopulmonary resuscitation

Summary:

      The purpose of this study is to look at two different treatments during a cardiac arrest that
      occurs outside of the hospital and whether either or both treatments will increase the number
      of people who live to hospital discharge. A cardiac arrest is when the heart stops pumping
      blood to the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All persons of local age of consent or older who suffer non-traumatic cardiopulmonary
             arrest outside of the hospital in the study communities with defibrillation and/or
             delivery of chest compressions provided by emergency medical service (EMS) providers
             dispatched to the scene and do not meet any of the exclusion criteria.

        Exclusion Criteria:

        Common:

          -  Do not attempt resuscitation (DNAR) orders

          -  Blunt, penetrating, or burn-related injury

          -  Patients with exsanguinations

          -  Known prisoners

          -  Known pregnancy

          -  Non-ROC EMS agency/provider

        For Analyzing Late versus Early

          -  EMS-witnessed arrests

          -  Non-EMS rhythm analysis (AED placed by police or lay responder is an exclusion but CPR
             by lay or other non-EMS responders is not)

        For ITD:

          -  Tracheostomy present

          -  CPR performed with the mechanical compression "Autopulse" device.
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Istradefylline
Intervention description: Oral istradefylline (KW-6002) 20 or 40 mg once daily.
Intervention MeSH terms: Istradefylline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 504.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's Disease; levodopa; end of dose wearing off; OFF time

Summary:

      This is an, open-label, long-term safety extension for patients in North America who have
      completed the prior istradefylline study 6002-INT-001.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of study 6002-INT-001

          -  Not of childbearing potential

        Exclusion Criteria:

          -  Cancer within 5 years of enrollment

          -  ALT/AST levels > 2.5 times ULN
Aflibercept in Combination With Docetaxel in Metastatic Androgen Independent Prostate Cancer
Condition: Prostatic Neoplasms; Neoplasm Metastasis
MeSH terms: Prostatic Neoplasms; Neoplasms; Neoplasm Metastasis
Intervention: Aflibercept; Placebo (for aflibercept); Docetaxel; Prednisone or Prednisolone
Intervention description: 25 mg/ml solution
6 mg/kg, 1-hour IV on Day 1 of each 3-Week cycle; Sterile aqueous buffered solution identical to aflibercept
1-hour IV on Day 1 of each 3-Week cycle; Marketed formulation
75 mg/m², 1 hour IV on Day 1 of each 3-week cycle (immediately after Aflibercept or placebo); Marketed formulation
5 mg twice daily PO from day 1 continuously
Intervention MeSH terms: Prednisone; Prednisolone; Docetaxel; Aflibercept
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1224.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic; prostate; cancer

Summary:

      Primary objective was to demonstrate overall survival improvement with aflibercept compared
      to placebo in patients receiving docetaxel / prednisone for metastatic androgen-independent
      prostate cancer (MAIPC).

      The secondary objectives were:

        -  To assess the efficacy of aflibercept compared to placebo on other parameters such
           prostate-specific antigen (PSA) level, cancer related pain, progression free survival
           (PFS), tumor-based and skeletal events and health-related quality of life (HRQL);

        -  To assess the overall safety in both treatment arms;

        -  To determine the pharmacokinetics of intravenous (IV) aflibercept in this population;

        -  to determine immunogenicity of IV aflibercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically- or cytologically-confirmed prostate adenocarcinoma;

          -  Metastatic disease;

          -  Progressive disease while receiving hormonal therapy or after surgical castration;

          -  Effective castration.

        Exclusion Criteria:

          -  Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except
             adjuvant/neoadjuvant treatment completed >3 years ago;

          -  Prior treatment with Vascular Endothelial Growth Factor (VEGF) inhibitors or VEGF
             receptor inhibitors;

          -  Eastern Cooperative Oncology Group (ECOG) performance status >2.

        The above information is not intended to contain all considerations relevant to a patient's
        potential participation in a clinical trial.
Study of the Safety and Effectiveness of Esmirtazapine in Participants With Chronic Primary Insomnia (P05706)
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Intervention: Esmirtazapine; Placebo
Intervention description: Esmirtazapine maleate was provided as tablets for oral use containing either 1.5, 3.0, or 4.5 mg of active compound. In addition, tablets contain the following excipients: hydroxypropyl cellulose, maize starch (United States Pharmacopeia [USP] name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.; Placebo tablets containing the following excipients: hydroxypropyl cellulose, maize starch (USP name: corn starch), magnesium stearate, and lactose monohydrate. Tablets were administered orally once daily about 30 minutes prior to bedtime.
Intervention MeSH terms: Mirtazapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 526.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if esmirtazapine (Org 50081) is a safe and
      effective treatment for insomnia. It was anticipated that esmirtazapine would increase mean
      Total Sleep Time (TST) as recorded in sleep diaries relative to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has signed written informed consent after the scope and nature of the investigation
             was explained to them

          -  Has difficulty falling asleep, maintaining sleep or has early morning awakenings

        Exclusion Criteria:

          -  Significant medical or psychiatric illness causing sleep disturbances

          -  Has a history of bipolar disorder or family (immediate family) of suicide

          -  Has sleep disorder such as sleep related breathing disorder, restless leg syndrome,
             narcolepsy

          -  Has significant other medical illness such as acute or chronic pain, heart, kidney or
             liver disease within the last year

          -  Currently diagnosed or meets the criteria for Major Depressive Disorder (MDD) or has
             been treated for MDD with the last 2 years

          -  Substance abuse, excessive use of alcohol (as determined by the physician) or drug
             addiction within the last year.
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Intervention: LNG-IUS; Hysterectomy
Intervention description: LNG-IUS releasing 25 microg of levonorgestrel; operation
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 236.0
Sex: Female
Minimum age: 35 Years
Maximum age: 49 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: randomized controlled trial; menorrhagia; LNG-IUS; hysterectomy

Summary:

      A randomised study including 236 women referred for essential menorrhagia to five university
      hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life
      issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with
      LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary
      outcome measures were health related quality of life (HRQoL), other measures of psychosocial
      well-being (anxiety, depression, sexual functioning), and costs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  heavy menstrual bleeding

          -  35-49 years

          -  were menstruating

          -  had completed their family size

          -  were eligible for both treatments

        Exclusion Criteria:

          -  submucous fibroids

          -  endometrial polyps

          -  ovarian tumours or cysts,

          -  cervical pathology

          -  urinary and bowel symptoms or pain due to large fibroids

          -  lack of indication for hysterectomy

          -  history of malignancies

          -  menopause

          -  severe depression

          -  metrorrhagia as a main complaint

          -  previous treatment failure with LNG-IUS

          -  severe acne

          -  uterine malformation
Study Comparing Budesonide Hydrofluoroalkane (HFA) vs Chlorofluorocarbon (CFC) Pressurized Metered Dose Inhalers (pMDI) in Patients With Mild to Moderate Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide HFA; Budesonide CFC
Intervention description: standard daily inhaled dose; standard daily inhaled dose
Intervention MeSH terms: Budesonide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Asthma hyperreactivity

Summary:

      This study is being carried out to see if budesonide with HFA is effective, safe and well
      tolerated compared with budesonide CFC. Budesonide HFA has been already given in other
      research studies, in both healthy volunteers and subjects with asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients suffering from stable, persistent, mild to moderate asthma as defined by
             Global Initiative for Asthma (GINA) Guidelines and for whom FEV1 > 60 %

          -  ICS taking ≤ 1000 μg BDP per day, or equivalent

          -  Methacholine PC20 < 4 mg/mL

        Exclusion Criteria:

          -  Known or suspected hypersensitivity to budesonide or any other constituents of the
             budesonide HFA pMDI or budesonide CFC pMDI.

          -  Currently a smoker or who has ceased smoking within 6 months of Visit 1.

          -  Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma
             therapy in the previous three months.

          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or bronchiectasis