bioihbjkbjnl/mcl2 huggingface dataset:
Dabigatran Etexilate in Extended Venous Thromboembolism (VTE) Prevention After Hip Replacement Surgery
Condition: Thromboembolism; Arthroplasty, Replacement, Hip
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate; dabigatran etexilate; enoxaparin
Intervention description: daily dose 150 mg once daily, half a dose on the day of surgery; daily dose 150 mg once daily, half a dose on the day of surgery; 40 mg once daily
Intervention MeSH terms: Enoxaparin; Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 3494.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to determine the comparative efficacy and safety of two oral
      regimens of dabigatran etexilate, compared to a standard subcutaneous regimen of enoxaparin,
      in prevention of venous thromboembolism in patients with primary elective total hip
      replacement surgery.
    

Eligibility criteria:

        Inclusion criteria

        Inclusion criteria (selected):

          -  Patients (18 years or older) scheduled to undergo a primary, unilateral, elective
             total hip replacement

          -  Written Informed Consent

        Exclusion criteria

        Exclusion criteria (selected):

          -  Patients with an excessive risk of bleeding, for example because of history of
             bleeding diathesis major surgery or trauma within the last 3 months history of
             haemorrhagic stroke or any of the following intracranial pathologies: bleeding,
             neoplasm, AV malformation or aneurysm clinically relevant bleeding or gastric /
             duodenal ulcer within the last 6 months treatment with anticoagulants within 7 days
             prior to joint replacement surgery or anticipated need during the study treatment
             period thrombocytopenia.

          -  Active malignant disease or current cytostatic treatment

          -  Known severe renal insufficiency

          -  Liver disease expected to have any potential impact on survival, or elevated AST or
             ALT > 2x upper limit of normal

          -  Recent unstable cardiovascular disease or history of myocardial infarction within the
             last 3 months

          -  Pre-menopausal women who are pregnant or nursing, or are of child-bearing potential
             and are not practising or do not plan to continue practising acceptable methods of
             birth control

          -  Allergy to radio opaque contrast media or iodine, heparins (incl. heparin induced
             thrombocytopenia) or dabigatran

          -  Contraindications to enoxaparin

          -  Participation in a clinical trial during the last 30 days
Follow-on Protocol of Pitavastatin Versus Simvastatin in Patients With Hypercholesterolemia or Dyslipidemia and Coronary Heart Disease Risk Factors
Condition: Hypercholesterolemia; Dyslipidemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia; Dyslipidemias
Intervention: pitavastatin; simvastatin
Intervention MeSH terms: Simvastatin; Pitavastatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 178.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypercholesterolemia; dyslipidemia; CHD; pitavastatin; simvastatin; 2 or more risk factors for coronary heart disease; combined dyslipidemia

Summary:

      This is a sixteen-week follow-on and 28 week single-blind extension study for patients who
      participated in study NK-104-304.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed NK-104-304 (NCT 00309738)

          -  Hypercholesterolemia or combined dyslipidemia

          -  2 or more risk factors for coronary heart disease (CHD)

        Exclusion Criteria:

          -  Withdrawn or terminated from NK-104-304 (00309738)
Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery
Condition: Prevent Bleeding in Major Surgery
MeSH terms: Von Willebrand Diseases
Intervention: human VWF/FVIII concentrate
Intervention description: intravenous infusion. Dose based on subject's individual invivo-recovery
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      Proportion of surgeries in which the primary endpoint (overall assessment) is classified as
      success.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with congenital VWD (von Willebrand Disease)

          -  Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical
             procedure

        Exclusion Criteria:

          -  Known coagulation disorder other than VWD

          -  Known history of, or suspected VWF or FVIII inhibitors

          -  Subjects with hepatic liver disease

          -  Known or suspected hypersensitivity or previous evidence of severe side effects to
             wilate or other VWF/FVIII concentrates

          -  Pregnant women in the first 20 weeks of gestation
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Condition: Axial Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Intervention: Ixekizumab; Placebo
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Ixekizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 303.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing; nonradiographic spondyloarthritis

Summary:

      The main purpose of this study is to evaluate the safety and efficacy of the study drug known
      as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants
      with nonradiographic axial spondyloarthritis (nonrad-axSpA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are ambulatory.

          -  Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the
             2009 Assessment of Spondyloarthritis International Society (ASAS) classification
             criteria.

          -  Have a history of back pain ≥3 months with age at onset <45 years.

          -  Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating
             scale (NRS) at screening and baseline.

          -  Have objective signs of inflammation by presence of sacroiliitis on MRI and/or
             presence of elevated C-reactive protein (CRP).

          -  In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory
             drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.

          -  If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

          -  Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

        Exclusion Criteria:

          -  Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.

          -  Have received any prior, or are currently receiving treatment with biologics, tumor
             necrosis factor inhibitors or other immunomodulatory agents.

          -  Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus
             Calmette-Guerin (BCG) within the past year.

          -  Have an ongoing or serious infection within the last 12 weeks or evidence of active
             tuberculosis.

          -  Have a compromised immune system.

          -  Have any other serious and/or uncontrolled diseases.

          -  Have either a current diagnosis or a recent history of malignant disease.

          -  Have had major surgery within 8 weeks of baseline, or will require surgery during the
             study.

          -  Are pregnant or breastfeeding.

          -  Have evidence of active anterior uveitis (an acute episode) within the last 42 days
             prior to baseline randomization.
Evaluation of Safety and Efficacy of PDP-716
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Intervention: Brimonidine Tartrate Ophthalmic Suspension; Brimonidine Tartrate Ophthalmic Solution
Intervention description: PDP-716; Three Times Brimonidine Tartrate Ophthalmic Solution
Intervention MeSH terms: Brimonidine Tartrate; Ophthalmic Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 682.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      The study will be conducted to evaluate the efficacy and safety of topical administration of
      PDP-716 compared with brimonidine tartrate ophthalmic solution.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Be male or female, of 2 years of age or older

          2. Have open-angle glaucoma or ocular hypertension in both the eyes

          3. Be able and willing to follow study instructions and complete all required visits.

        Exclusion Criteria:

          1. Females who are pregnant/lactating.

          2. Have uncontrolled systemic disease which might interfere with the study

          3. Any known allergy or sensitivity to the study medications or their components

          4. Any other clinically relevant abnormality
A Long-Term Study of JNS007ER in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Paliperidone extended-release (JNS007ER)
Intervention description: Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks.
Intervention MeSH terms: Paliperidone Palmitate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 228.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Schizophrenia; JNS007ER; Paliperidone extended-release

Summary:

      The purpose of this study is to assess the safety of JNS007ER 3-12 mg once daily in patients
      with schizophrenia over a long term period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients diagnosed with schizophrenia

          -  Patients who have given their own consent in writing to participate in the study

          -  Patients untreated with antipsychotics within 28 days before the screening test

          -  Patients who have completed Study JNS007ER-JPN-S31, or those who continued the study
             at least up to the evaluation at 2 weeks and subsequently discontinued the study due
             to insufficient efficacy

          -  Patients participating in Study JNS007ER-JPN-S31 and whose ratio of treatment to the
             evaluation at 2 weeks is ≥75%

        Exclusion Criteria:

          -  Patients diagnosed with a mental disease other than schizophrenia

          -  A total PANSS score > 120 at baseline

          -  Substance-related disorders

          -  Parkinson's disease complications

          -  Current or a past history of convulsive disease such as epilepsy

          -  Current or a past history of cerebrovascular accident

          -  Diabetes mellitus

          -  Significant hepatic or renal impairment

          -  Significant cardiovascular disorders

          -  Abnormal results of hematological examination, blood chemistry test and urinalysis at
             screening

          -  Pregnant women, breast-feeding mothers, and patients who wish pregnancy during the
             study period or those whose pregnancy test at screening was positive

          -  Contraindications to risperidone products

          -  Patients who discontinued Study JNS007ER-JPN-S31 due to an adverse event not related
             to the underlying disease

          -  Patients judged inadequate by the investigator to participate in the study
Effect of Teriparatide Compared to Risedronate on Back Pain in Women With a Spine Fracture Caused by Osteoporosis
Condition: Osteoporosis, Postmenopausal; Back Pain; Spinal Fracture
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Back Pain; Fractures, Bone; Spinal Fractures
Intervention: teriparatide; risedronate; placebo; placebo
Intervention description: 20 ug/day, subcutaneous, 18 months; 35 mg/once weekly, oral, 18 months; once weekly, oral, 18 months; daily, subcutaneous, 18 months
Intervention MeSH terms: Teriparatide; Risedronic Acid; Etidronic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 712.0
Sex: Female
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine if daily teriparatide reduces back pain more
      effectively than weekly risedronate in women with osteoporosis who have chronic back pain due
      to a spinal bone fracture.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women 45 years or older. No period for at least two years.

          -  History of back pain that started at least 2 months prior to the initial visit (likely
             due to spinal bone fracture determined by investigator).

          -  Minimum of one moderate spinal bone fracture.

          -  Beginning pain level of at least four on an eleven point scale.

          -  Bone Mineral Density (BMD) must meet criteria

          -  Able to read, understand, and administer self-questionnaires.

          -  Be willing and able to use a pen-injector to deliver the medication.

        Exclusion Criteria:

          -  Are at increased risk for osteosarcoma.

          -  Have an active or suspected diseases that affects bone metabolism other than
             osteoporosis.

          -  Participants that already know that they will require procedures to repair their
             spinal bone fractures.

          -  Abnormal values of certain lab tests.

          -  Anything that would make it difficult to determine if the back pain was due to the
             fracture.

          -  Poor medical or psychiatric condition.

          -  Alcohol or drug abuse within a year of the study start.

          -  Certain malignant neoplasms in the 5 years prior to enrollment.

          -  Active liver disease or clinical jaundice.

          -  Significantly impaired renal function.

          -  History of nephrolithiasis or urolithiasis within 2 years prior to enrollment.

          -  Known contraindication or intolerance to risedronate and/or teriparatide therapy.

          -  Treatment with oral strontium or certain therapeutic doses of fluoride.
A Study of Embeda (Kadian NT, ALO-01) in Subjects With Pain Due to Osteoarthritis of the Hip or Knee
Condition: Osteoarthritis; Chronic Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Hip; Chronic Pain
Intervention: ALO-01 (Morphine Sulfate Plus Naltrexone Hydrochloride Extended Release); Placebo
Intervention description: capsules, up to 80 mg bid; capsules, bid
Intervention MeSH terms: Naltrexone; Morphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 547.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: hip; knee; pain; osteoarthritis; OA; Kadian; Alpharma; naltrexone; Opioid; morphine; Embeda; ALO-01

Summary:

      The purpose of this study is to evaluate the efficacy of Kadian NT (ALO-01) compared with
      placebo for treating moderate to severe chronic pain over a 12 week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject is 21 years of age or older

          -  Subject is either not of childbearing potential OR subject must use an acceptable
             method of birth control if of childbearing potential

          -  Negative pregnancy test if female of childbearing potential

          -  Subject is in general good health

          -  Subject required treatment of joint pain within the last 90 days

          -  Subject has primary diagnosis of osteoarthritis (OA) of the hip or knee

        Exclusion Criteria:

          -  Subject has a documented history of allergic reaction or intolerance to morphine or
             other opioids

          -  Subject is pregnant or breast-feeding

          -  Subject is receiving systemic chemotherapy

          -  Subject has a history of drug abuse/dependence/misuse or alcohol abuse/dependence

          -  Subject has history of major depressive disorder not controlled with medication

          -  Subject has any chronic pain syndrome (i.e., fibromyalgia) that may interfere with the
             symptoms of OA

          -  Subject has active gastrointestinal disease, with the exception of gastroesophageal
             reflux disease (GERD)

          -  Subject has a documented history of rheumatoid arthritis, uncontrolled inflammatory
             arthritis or non-steroidal anti-inflammatory drug (NSAID)-dependent inflammatory
             arthritis
Trial of Netarsudil for Prevention of Corticosteroid-induced Intraocular Pressure Elevation
Condition: Fuchs' Endothelial Dystrophy; Bullous Keratopathy
MeSH terms: Fuchs' Endothelial Dystrophy
Intervention: Netarsudil; Placebo
Intervention description: netarsudil opthalmic solution 0.02%; Placebo eye drops
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Cornea transplant recipients who are using topical corticosteroids long-term to prevent
      transplant rejection will be randomized to use netarsudil or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age; male or female patient undergoing Descemet membrane
             endothelial keratoplasty; patient is able and willing to administer eye drops; patient
             is able to comprehend and has signed the Informed Consent form; patient is likely to
             complete the nine-month course of the study.

        Exclusion Criteria:

          -  A patient exhibiting pre-operative intraocular inflammation; a patient with a known
             sensitivity to any of the ingredients in the study medications; a patient who has a
             condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the
             investigator's opinion may put the patient at significant risk, may confound the study
             results, or may interfere significantly with the patient's participation in the study;
             a patient with abnormal eyelid function; a patient that is exhibiting active corneal
             ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis;
             a patient who has been diagnosed with uncontrolled glaucoma, prior aqueous shunt or
             trabeculectomy, or with preoperative intraocular pressure > 22 mm Hg in the potential
             study eye; presence of any ocular disease that would interfere with the evaluation of
             the study treatment (however, patients with a history of cystoid macular edema,
             age-related macular degeneration, corneal neovascularization, and other
             non-interfering comorbidities may be enrolled); a patient with a history of
             non-compliance with using prescribed medication; a patient who is concurrently
             involved in or participated in another randomized clinical trial within 30 days prior
             to enrollment in this study; patients who are pregnant or planning to become pregnant
             within the duration of the study.
Clinical Trial of Traditional Chinese Diaoshi Jifa Therapy of Meniere's Disease
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Intervention: Diaoshi Jifa therapy plus the Western medical treatment.; drug
Intervention description: Diaoshi Jifa treatment; the Western medical treatment alone.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Dizziness; Meniere's disease; Diaoshi Jifa therapy

Summary:

      The hypothesis of this study is that DiaoShi Jifa reduces the symptoms, such as dizziness in
      patients with Meniere's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical diagnosis of probable Meniere's disease

          2. Must be able to receive manual treatment

          3. Dizziness Patients receiving other treatment longer than 5 days before entering the
             study.

        Exclusion Criteria:

          1. Patients with critical illness of internal medicine and surgery

          2. Patients with spinal disease or other conditions that cannot receive manual treatment.