bioihbjkbjnl/mcl2 huggingface dataset:
Denosumab Fracture Intervention Randomized Placebo Controlled Trial in Japanese Patients With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Denosumab; Placebo; Alendronate sodium hydrate
Intervention description: Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).; Subcutaneous injection every 6 months for 24 months, followed by a 12-month period of denosumab (subcutaneously - every six months).; Oral tablet once a week for 24 months
Intervention MeSH terms: Denosumab; Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1262.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      Evaluate the efficacy and safety of denosumab in the treatment of involutional
      (postmenopausal and senile) osteoporotic subjects with prevalent fragility vertebral
      fracture(s)
    

Eligibility criteria:

        Inclusion Criteria:

          -  Involutional (postmenopausal and senile) osteoporosis with prevalent fragility
             vertebral fractures

        Exclusion Criteria:

          -  Any underlying condition,(other than BMD) that might have resulted in abnormal bone
             metabolism
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
Condition: Bleeding
Intervention: Andexanet; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 80.0
Sex: All
Minimum age: 50 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Andexanet alpha; Anticoagulation; Antidote; Rivaroxaban; Anti-fXa inhibitor; PRT4445; Xarelto; Reversal agent

Summary:

      The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the
      anticoagulation effect of Rivaroxaban.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Reasonably healthy men and women aged 50 to 75

        Exclusion Criteria:

          -  History of abnormal bleeding, active bleeding or risk factors for bleeding

          -  History of thrombosis or risk factors for thrombosis

          -  History of adult asthma or use of inhaled medications
Comparison of Telavancin and Vancomycin for Hospital-acquired Pneumonia Due to Methicillin-resistant Staphylococcus Aureus
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial; Healthcare-Associated Pneumonia
Intervention: Telavancin; Vancomycin
Intervention description: Telavancin 10 mg/kg/day IV for up to 21 days; Vancomycin 1 Gm administered every 12 hrs IV for up to 21 days
Intervention MeSH terms: Vancomycin; Telavancin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 771.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Study 0019 (NCT00124020) compares the safety and effectiveness of an investigational drug,
      telavancin, with vancomycin for the treatment of hospital-acquired pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical signs and symptoms consistent with pneumonia acquired after at least 48 hours
             of continuous stay in an inpatient acute or chronic care facility or acquired within 7
             days after being discharged from a hospitalization of greater than or equal to 3 days
             duration.

        Exclusion Criteria:

          -  Received more than 24 hours of potentially effective systemic (IV, IM or PO)
             antibiotic therapy for Gram-positive pneumonia immediately prior to randomization.
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
Condition: Crohn Disease
MeSH terms: Crohn Disease
Intervention: BI 695501; HUMIRA
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      The primary objective of this trial is to compare the clinical efficacy of BI 695501 with
      EU-approved Humira® in patients with active Crohn's disease (CD).

      Secondary Objectives:

      The secondary objectives of this trial are to compare the efficacy and safety of BI 695501
      with EU-approved Humira® across the induction and maintenance phases.
    

Eligibility criteria:

        Inclusion criteria:

          -  Males and females aged >=18 and =<80 years at Screening who have a diagnosis of
             moderate to severely active Crohn's Disease (CD), confirmed by endoscopy or radiologic
             evaluation, for more than 4 months with evidence of mucosal ulceration. Patients must
             have all of the following:

               -  Crohn's Disease Activity Index (CDAI) score of >=220 and =<450

               -  A diagnosis of Crohn's Disease (CD) confirmed by ileocolonoscopy during Screening

               -  Presence of mucosal ulcers in at least one segment of the ileum or colon and a
                  SES-CD score ≥7 (for patients with isolated ileal disease SES-CD score ≥4), as
                  assessed by ileocolonoscopy and confirmed by central independent reviewer(s)
                  before randomization

          -  Anti-tumor necrosis factor (TNF) patients or patients previously treated with
             infliximab who had initially responded and who meet one of the following criteria:

               -  Responded and developed secondary resistance due confirmed anti-infliximab
                  anti-drug antibody formation, which caused infliximab depletion

               -  Responded and became intolerant

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  Patients with ulcerative colitis or indeterminate colitis

          -  Patients with symptomatic known obstructive strictures

          -  Surgical bowel resection performed within 6 months prior to Screening or planned
             resection at any time while enrolled in the trial

          -  Patients with an ostomy or ileoanal pouch

          -  Patients with short bowel syndrome

          -  Patients who have previously used infliximab and have never clinically responded

          -  Patients who have previously received treatment with adalimumab, or who have
             participated in an adalimumab or adalimumab biosimilar clinical trial

          -  Further exclusion criteria apply
Characterization of 24 Hour Spirometry Profiles of Inhaled BI 1744 CL and Inhaled Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI1744) Low; Placebo (for olodaterol BI1744); Placebo (for Tiotropium); Olodaterol (BI1744) High; Tiotropium 18 mcg
Intervention description: Low dose inhaled orally once daily from Respimat inhaler; Placebo (olodaterol low and high dose)delivered by Respimat; Placebo (Tiotropium 18 mcg) delivered by HandiHaler; High dose inhaled orally once daily from Respimat inhaler; 18mcg inhaled once daily from Handihaler
Intervention MeSH terms: Tiotropium Bromide; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 108.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is intended to characterize the lung function profile of BI1744 in COPD patients
      where patients will perform pulmonary function tests at regular intervals for 24 hours at the
      end of a 6 week treatment period. Each patient will receive all four treatments.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients willing to participate with confirmed diagnosis of COPD

          -  40 years of age or older

          -  having a 10 pack year smoking history

          -  able to perform serial pulmonary function tests

          -  able to use both a Dry powder inhaler (DPI) and Respimat device

        Exclusion criteria:

          -  Significant other disease

          -  clinically relevant abnormal hematology, chemistry, or urinalysis

          -  history of asthma

          -  diagnosis of thyrotoxicosis

          -  paroxysmal tachycardia related to beta agonists

          -  history of MI within 1 year, cardiac arrhythmia, hospitalization for heart failure
             within 1 year

          -  active tuberculosis, cystic fibrosis, clinically evident bronchiectasis

          -  significant alcohol or drug abuse

          -  pulmonary resection

          -  taking oral beta adrenergics

          -  taking unstable oral steroids

          -  daytime oxygen

          -  enrolled in rehabilitation program

          -  enrolled in another study or taking investigational products

          -  pregnant or nursing women, women of child bearing potential not willing to use two
             methods of birth control

          -  those who are not willing to comply with pulmonary medication washouts
Efficacy and Safety of Everolimus (RAD001) Compared to Placebo in Patients With Advanced Neuroendocrine Tumors
Condition: Advanced Neuroendocrine Tumors of Pancreatic Origin
MeSH terms: Neuroendocrine Tumors
Intervention: Everolimus; Everolimus Placebo
Intervention description: A 10-mg dose of everolimus was given by continuous oral daily dosing of two 5-mg tablets.; a 10-mg dose of matching placebo to Everolimus was given by continuous oral daily dosing of two 5-mg tablets.
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 410.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase III; Advanced Neuroendocrine Tumor in adults; RAD001; NET; everolimus; mTOr; islet cell; neuroendocrine

Summary:

      The purpose of this study was to evaluate progression free survival in those participants
      assigned everolimus 10 mg/day plus Best Supportive Care versus those assigned to placebo plus
      Best Supportive Care in Advanced Neuroendocrine Tumors of pancreatic origin.
    

Eligibility criteria:

        Inclusion criteria:

          1. Patients must have advanced (unresectable or metastatic) biopsy-proven pancreatic NET

          2. Measurable disease by radiologic assessment

          3. Adequate blood work

          4. Performance Status 0-2 : Ability to be out of bed most of the time

          5. Adult male or female patients ≥ 18 years of age

          6. Women of childbearing potential must have a negative serum pregnancy test

          7. Written informed consent from patients must be obtained in accordance to local
             guidelines

        Exclusion criteria:

          1. Patients with severe kind of (poorly differentiated neuroendocrine carcinoma,
             high-grade neuroendocrine carcinoma, adenocarcinoid, goblet cell carcinoid and small
             cell carcinoma) cancer are not eligible

          2. Other chemotherapy, immunotherapy or radiotherapy within 4 weeks prior to starting
             this trial

          3. Hepatic artery procedure called embolization within the last 6 months (1 month if
             there are other sites of measurable disease), or cryoablation/ radiofrequency ablation
             of hepatic metastasis within 2 months of enrollment

          4. Prior therapy with the same kind of medication (mTOR inhibitors: sirolimus,
             temsirolimus, everolimus).

          5. Uncontrolled diabetes mellitus Patients who have any severe and/or uncontrolled
             medical conditions such as:

          6. Patients receiving chronic treatment with corticosteroids or another immunosuppressive
             agent

          7. Patients with a known history of HIV seropositivity

          8. No other prior or concurrent cancer at the time enrolling to this trial

        Other protocol defined inclusion/ exclusion criteria applied
A Study to Evaluate Safety, Tolerability, and Immunogenicity of an Investigational Zoster Vaccine In Subjects With a History of Varicella (Chickenpox)(V211-010)(COMPLETED)
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Intervention: Comparator: zoster vaccine live (Oka/Merck) refrigerated formulation; Comparator: zoster vaccine live (Oka/Merck) frozen formulation
Intervention description: 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Merck) refrigerated formulation at Day 1; 1 dose of 0.65-mL/dose subcutaneous injection of zoster vaccine live (Oka/Meck) frozen formulation at Day 1
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 368.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether the refrigerator-stable formulation of an
      investigational vaccine has a comparable immune response (the body's ability to protect
      against disease) and safety profile to that of the freezer-stable formulation of the vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Individuals who are at least 50 years of age or older with a history of varicella
             (chicken pox)

        Exclusion Criteria:

          -  Prior history of herpes zoster (shingles)

          -  Prior receipt of varicella or zoster vaccine

          -  Immunosuppressed
Safety and Efficacy of Intravenous Immunoglobulin IgPro10 in Patients With Primary Immunodeficiencies (PID)
Condition: Agammaglobulinemia; IgG Deficiency; Common Variable Immunodeficiency
MeSH terms: Agammaglobulinemia; IgG Deficiency; Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Intervention: Immunoglobulins Intravenous (Human)
Intervention description: Liquid formulation; treatment schedule every 3 or 4 weeks using an individualized regimen with a dose of 0.2 - 0.8 g IgG per kg bw
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 4 Years
Maximum age: 71 Years
Healthy volunteers: No
Keywords: Immunoglobulin Intravenous; Agammaglobulinemia; Hypogammaglobulinemia; Common variable immunodeficiency; Immunoglobulin G; Children

Summary:

      The objectives of this trial are the assessment of safety and efficacy of IgPro10 in patients
      with PID, and the assessment of tolerability of high infusion rates. To demonstrate safety,
      the number of infusions temporally associated with AEs, the rate, severity and relationship
      of all AEs and the vital sign changes during each infusion will be evaluated.
    

Eligibility criteria:

        Key Inclusion Criteria:

        Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia)
        who:

        Participated in the Phase III clinical study with intravenous IgPro10 (study number
        ZLB03_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)

        OR

        Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg
        IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were
        interested in participating in the Phase III clinical study with subcutaneous IgPro20
        (study number ZLB04_009CR) (referred to as 'new' subjects)

        Written informed consent

        Key Exclusion Criteria:

        Diagnosis of epilepsia

        Insulin dependent diabetes

        Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other
        immunosuppressive drugs

        History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure,
        severe hypertension
Phase 3 Study of MAP0004 in Adult Migraineurs
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Intervention: MAP0004; Placebo
Intervention description: MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.; Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Migraine

Summary:

      This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in
      adult migraineurs. Subjects will self administer study drug in the outpatient setting.
    

Eligibility criteria:

        Major Inclusion Criteria:

          -  Male or female between 18 and 65 years of age.

          -  History of episodic, acute migraine (with or without aura) with onset prior to 50

        Major Exclusion Criteria:

          -  Known allergy or sensitivity or contraindication to study drugs or their formulations

          -  History of chronic pulmonary disease, coronary artery disease (CAD), liver disease,
             kidney disease, seizures, stroke, or major psychiatric condition.

          -  Any condition that, in the opinion of the Investigator, would make the subject
             unsuitable for study participation
Efficacy Study of a Standardized Pollen Extract Preparation (Cernilton) to Treat Inflammatory Chronic Prostatitis-Chronic Pelvic Pain Syndrome (CP-CPPS)
Condition: Chronic Prostatitis; Chronic Pelvic Pain Syndrome
MeSH terms: Prostatitis; Syndrome; Pelvic Pain; Chronic Disease; Somatoform Disorders
Intervention: Cernilton; Placebo
Intervention description: Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 23 mg Extractum Pollens siccatum, 4 mg L-glutamate and 0.23 mg Stigmasterol per capsule for 12 weeks.; Oral placebo, 2 capsules every 8 hours with identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 139.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: chronic prostatitis symptom index; male; inflammatory; CP-CPPS; Cernilton; pelvic pain; symptoms

Summary:

      In this placebo controlled study the safety and efficacy of Cernilton, a standardized pollen
      extract, in men with inflammatory chronic prostatitis-chronic pelvic pain syndrome was
      investigated. The purpose of this study is to determine whether Cernilton is safe and
      effective in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  men between 18 and 65 years

          -  symptoms of pelvic pain for at least 3 months during the 6 months before study entry

          -  a score in the pain domain of the German validated version of the NIH chronic
             prostatitis symptom index (NIH-CPSI) of 7 or higher

          -  leukocytes of 10 or more in post prostate massage urine

        Exclusion Criteria:

          -  urinary tract infection

          -  acute bacterial or chronic bacterial prostatitis

          -  history of urethritis with discharge 4 weeks prior to study entry

          -  a history of epididymitis or sexually transmitted disease

          -  residual urine volume of more than 50 mL due to bladder outlet obstruction

          -  indication for or history of prostate surgery including prostate biopsy

          -  treatment with phytotherapeutic agents

          -  alpha-blocker agents or antimicrobial substances with prostatic penetration 4 weeks
             prior to study entry

          -  treatment with agents influencing intraprostatic hormone metabolism 6 months prior to
             study entry
Tapentadol (CG5503)
Condition: Osteoarthritis, Knee; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: oxycodone; placebo; tapentadol (CG5503)
Intervention description: 10, 20, 30, 40, 50mg twice a day (BID) during 15 weeks; matching placebo twice a day (BID) during 15 weeks; 50, 100, 150, 200, 250mg twice a day (BID) during 15 weeks
Intervention MeSH terms: Oxycodone; Tapentadol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1030.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Pain; Osteoarthritis, Knee; tapentadol; Pain Assessment

Summary:

      The purpose of this trial is to evaluate the effectiveness (level of pain control) and safety
      of orally administered tapentadol (CG5503) Extended Release (ER) (base) at doses of 100-250
      mg twice daily in patients with moderate to severe chronic pain due to osteoarthritis of the
      knee, in comparison with placebo and Oxycodone Controlled Release (CR).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with osteoarthritis of the knee based on the American College of
             Rheumatology (ACR) criteria and functional capacity class of I-III

          -  patients taking analgesic medications for at least 3 months prior to screening and/or
             dissatisfied with their current therapy

          -  Patients requiring opioid treatment must be taking daily doses of opioid-based
             analgesic, equivalent to <160 mg of oral morphine

          -  baseline score of greater than or equal to 5 on an 11-point numerical rating scale,
             calculated as the average pain intensity during the last 3 days prior to
             randomization.

        Exclusion Criteria:

          -  History of alcohol and/or drug abuse in Investigator's judgement

          -  history of significant liver insufficiency

          -  chronic hepatitis B or C, or HIV, presence of active hepatitis B or C within the past
             3 months

          -  life-long history of seizure disorder or epilepsy

          -  history of malignancy within past 2 years, with exception of basal cell carcinoma that
             has been successfully treated

          -  uncontrolled hypertension

          -  patients with severely impaired renal function

          -  patients with moderate to severly impaired hepatic function or with laboratory values
             reflecting inadequate hepatic function