bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness of Two Blood Transfusion Strategies in Surgical Patients With Cardiovascular Disease
Condition: Anemia; Hematologic Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Thromboembolism; Pneumonia; Cerebrovascular Accident
MeSH terms: Stroke; Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Thromboembolism; Hematologic Diseases; Infarction
Intervention: Liberal (10 g/dL) Transfusion Strategy; Restrictive (Symptomatic) Transfusion Strategy
Intervention description: This transfusion strategy will maintains postoperative Hgb levels above 10 g/dL. This threshold strategy will use enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization.; Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 2016.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Blood Disease; blood transfusion

Summary:

      The purpose of this study is to compare liberal red blood cell transfusion therapy with
      restrictive red blood cell transfusion therapy in surgical patients with cardiovascular
      disease or risk factors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has undergone surgical repair for a hip fracture

          -  Has a postoperative Hgb level below 10 g/dL within three days of surgery

          -  Diagnosis of cardiovascular disease (e.g., coronary artery disease, congestive heart
             failure, stroke or transient ischemic attack, or peripheral vascular disease) or
             cardiovascular risk factors (e.g., diabetes mellitus, hypertension,
             hypercholesterolemia, tobacco use, or creatinine levels greater than 2.0 mg/dL)

        Exclusion Criteria:

          -  Unable to walk prior to hip fracture

          -  Declines blood transfusions

          -  Suffered multiple traumas

          -  Pathologic fracture of the hip due to malignancy

          -  Clinically recognized acute myocardial infarction within the 30 days prior to study
             entry

          -  Previously participated in the trial and fractured the other hip

          -  Symptoms associated with anemia (e.g., ischemic chest pain) or actively bleeding at
             the time of randomization
Efficacy and Safety of AMR101 (Ethyl Icosapentate) in Patients With Fasting Triglyceride (Tg) Levels ≥ 500 and ≤ 2000 mg/dL
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: AMR101 (ethyl icosapentate) - 4 g/day; AMR101 (ethyl icosapentate) - 2 g/day; Placebo
Intervention description: AMR101 (ethyl icosapentate) 4 capsules/day for 12 weeks (Weeks 1-12); AMR101 (ethyl icosapentate) 2 capsules/day with placebo 2 capsules/day for 12 weeks (Weeks 1-12); Placebo 4 capsules/day for 12 weeks (Weeks 1-12)
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 229.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertriglyceridemia; omega-3 fatty acids; statin; triglycerides; lipids; EPA; docosahexaenoic acid; fish; fatty acids; fibrates; niacin; lipid; atorvastatin; Lovaza; simvastatin; lovastatin; pravastatin; fluvastatin; rosuvastatin; Trilipix; Vytorin; Simcor; ezetimibe; Zetia; ethyl-EPA; ethyl icosapentate; Crestor; Zocor; Lipitor; Niaspan; LDL; HDL; cholesterol; dyslipidemia; VASCEPA; icosapent ethyl

Summary:

      The primary objective is to determine the efficacy of AMR101 (ethyl icosapentate) compared to
      placebo in lowering fasting triglyceride levels in patients with very high fasting
      triglyceride levels ≥ 500 and ≤ 2000 mg/dL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages >18

          -  Fasting triglyceride ≥500 mg/dL and ≤2000 mg/dL

          -  Provide written informed consent and authorization for protected health information
             disclosure

        Exclusion Criteria:

          -  Women who are pregnant or lactating, or planning to become pregnant

          -  Use of non-statin lipid-altering drugs which cannot be stopped including fibrates,
             niacin, fish oil and other products containing omega-3 fatty acids or other dietary
             supplements with potential lipid-altering effects

          -  History of pancreatitis

          -  History of bariatric surgery or currently on weight loss drugs

          -  Uncontrolled hypertension (BP > 160/100)

          -  HIV infection or on treatment with HIV-protease inhibitors, cyclophosphamide,or
             isotretinoin

          -  Consumption of more than 2 alcoholic beverages per day

          -  History of cancers (except if been disease free for >5 years OR history was basal or
             squamous cell skin cancer)

          -  Participation in another clinical trial involving an investigational agent in the last
             30 days

          -  Other parameters will be assessed at the study center to ensure eligibility for this
             study.
Buprenorphine Group Medical Visits in Primary Care
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Intervention: G-BMT; Treatment as usual; Buprenorphine
Intervention description: The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.; Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.; All participants will continue to receive maintenance treatment with buprenorphine-naloxone
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: opioid use disorder; group counseling; office-based buprenorphine treatment

Summary:

      The primary goal of this research is to improve the effectiveness of buprenorphine
      maintenance treatment (BMT) within primary care.

      Investigators propose that providing BMT as part of a group medical visit (instead of an
      individual visit) will improve treatment outcomes for patients with persistent opioid abuse,
      because members become accountable to the group, are exposed to beneficial habits of others
      (i.e. positive deviance), and can receive efficacious behavioral interventions concomitantly
      with medical management
    

Eligibility criteria:

        Inclusion Criteria:

          1. Currently receiving BMT at Montefiore community health center (CHC).

          2. Received BMT for 12 or more weeks.

          3. Persistent opioid abuse (positive toxicology for an unprescribed opioid at most recent
             test or in 50% or more of collected tests in the previous 6 months.)

          4. Fluent in English of Spanish

        Exclusion Criteria:

        1) Pregnancy
Study Of Sunitinib In Combination With Docetaxel Vs Docetaxel In Patients With Advanced Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Sunitinib malate; Taxotere
Intervention description: Sunitinib 37.5 mg daily by oral capsule in schedule 2/1 with Docetaxel 75 mg/m2 every 3 weeks or 37. 5 mg daily in continuous dosing (in absence of docetaxel); Docetaxel 100 mg/m2 every 3 weeks in the comparator arm
Intervention MeSH terms: Docetaxel; Sunitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 594.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: advanced breast cancer; sunitinib; docetaxel; Phase 3

Summary:

      This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of sunitinib
      combined with docetaxel versus docetaxel, administered as first-line treatment, in patients
      with unresectable locally recurrent or metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Breast cancer with evidence of unresectable locally recurrent, or metastatic disease

          -  Her-2 negative tumors

        Exclusion Criteria:

          -  Patients for whom docetaxel is contraindicated

          -  Clinical presentation of inflammatory carcinoma with no other measurable disease
16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Ankylosing Spondylitis
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Secukinumab; Secukinumab; Placebo
Intervention description: Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio; Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio; Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AIN457, ankylosing spondylitis, chronic inflammatory disease, inflammatory back pain, secukinumab, self-injection

Summary:

      The purpose of this study is to provide 16-week efficacy, safety and tolerability data versus
      placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.) self-administration
      with or without a loading regimen and maintenance dosing using pre-filled syringe (PFS) and
      to assess efficacy, safety and tolerability up to 2 years in subjects with active AS despite
      current or previous NSAID, non-biologic DMARD, or biologic anti-TNFα therapy.
    

Eligibility criteria:

        Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
        Modified NY Criteria (1984), inadequate response to NSAIDs.

        Exclusion criteria: pregnancy or lactation, on-going infectious or malignant process on a
        chest X-ray or MRI, previous exposure to IL-17 or IL-17R targeting therapies, previous
        exposure to any biological immunomodulating agent excluding TNF antagonists, previous cell
        depleting therapy.

        Other protocol-defined inclusion/exclusion criteria do apply.
Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: MR prednisone; Placebo
Intervention description: 1 x 5 mg daily; 1x daily
Intervention MeSH terms: Prednisone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Signs and Symptoms; Autoimmune Diseases; Joint Diseases; Arthritis; Connective Tissue Diseases; Arthritis, Rheumatoid; Rheumatic Diseases; Predniso(lo)ne

Summary:

      The purpose of the study is to compare the safety and efficacy, with regards to the signs and
      symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease
      Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented history of RA in agreement with ACR criteria

          -  DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater
             than or equal to 6 weeks prior to screening visit

          -  Duration of morning stiffness greater than or equal to 45 minutes

          -  greater than or equal to 4 swollen joints (out of 28)

          -  greater than or equal to 4 tender joints (out of 28)

        Exclusion Criteria:

          -  Suffering from another disease, which requires glucocorticoid treatment during the
             study period

          -  Synovectomy within 4 months prior to study start

          -  Use of glucocorticoids:

               -  Continued use of systemic glucocorticoids within 4 weeks prior to screening visit

               -  Intermittent use of glucocorticoids within 2 weeks prior to screening visit.

               -  Joint injections within 6 weeks prior to screening visit

               -  Topical glucocorticoids must be stopped at screening visit

          -  Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other
             compounds within 5 serum half lives prior to screening visit

          -  Pregnancy or nursing
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Condition: Liver Disease
MeSH terms: Liver Diseases
Intervention: HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate); Hepatic Venous Pressure Gradient (HVPG)
Intervention description: The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease; Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
Intervention MeSH terms: Cholic Acids
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing; HepQuant-SHUNT; Liver Function

Summary:

      This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt
      (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to
      Hepatic Venous Pressure Gradient testing in patients with liver disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Liver disease patient scheduled to have an Hepatic Venous Pressure Gradient (HVPG)
             procedure

          -  At time of enrollment, being between the ages of 18 and 75

        Exclusion Criteria:

          -  Concomitant treatment with both a beta blocker and an ACE inhibitor

          -  Concurrent hepatic malignancy. Patients with a history of treated HCC can be included
             if there is no evidence of recurrent disease at the time of this study.

          -  Unstable angina or history of myocardial infarction or congestive heart failure within
             6 months prior to enrollment into this study

          -  Renal insufficiency with chronic kidney disease stage 4 or 5 (GFR < 30 mL/min/1.73m2)

          -  Crohn's disease or any active intestinal inflammatory condition

          -  Having had an ileal resection

          -  Diabetic Gastroparesis

          -  Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed prior
             to HQ SHUNT testing.

          -  Inability to consent for one's self
Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: Pirfenidone; Placebo
Intervention description: 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.; Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
Intervention MeSH terms: Pirfenidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 344.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Idiopathic; Pulmonary; Fibrosis; Lung; Pirfenidone; InterMune

Summary:

      The purposes of this study are to assess the efficacy of treatment with pirfenidone 2403
      milligrams per day compared with placebo in patients with idiopathic pulmonary fibrosis
      (IPF)and to assess the safety of treatment with pirfenidone 2403 milligrams per day compared
      with placebo in patients with idiopathic pulmonary fibrosis.
    

Eligibility criteria:

        Primary Inclusion criteria:

          -  diagnosis of idiopathic pulmonary fibrosis

          -  40 to 80 years of age

          -  Forced Vital Capacity ≥ 50% predicted value

          -  carbon monoxide diffusing capacity (DLco) ≥ 35% predicted value

          -  either Forced Vital Capacity or carbon monoxide diffusing capacity (DLco) ≤ 90%
             predicted value

          -  no improvement in past year

          -  able to walk 150 meters in 6 minutes and maintain saturation ≥ 83% while on no more
             than 6 liters per minute supplemental oxygen

        Primary Exclusion criteria:

          -  unable to undergo pulmonary function testing

          -  evidence of significant obstructive lung disease or airway hyper-responsiveness

          -  in the clinical opinion of the investigator, the patient is expected to need and be
             eligible for a lung transplant within 72 weeks of randomization

          -  active infection

          -  liver disease

          -  cancer or other medical condition likely to result in death within 2 years

          -  diabetes

          -  pregnancy or lactation

          -  substance abuse

          -  personal or family history of long QT syndrome

          -  other IPF treatment

          -  unable to take study medication

          -  withdrawal from other IPF trials
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Dexamethasone; Prednisolone
Intervention description: depot intracameral; Prednisolone eye drops 1%
Intervention MeSH terms: Dexamethasone; Prednisolone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 194.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40
      years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion
      criteria will be randomized to 1 of 2 treatment groups

        -  A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone,
           equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;

        -  Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times
           daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp
           biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and
           specular microscopy endothelial cell count.
    

Eligibility criteria:

        Inclusion Criteria:

          -  undergoing cataract surgery

        Exclusion Criteria:

          -  glaucoma patient, pregnancy, allergy to dexamethasone
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Condition: Parathyroid Carcinoma; Primary Hyperparathyroidism
MeSH terms: Carcinoma; Parathyroid Neoplasms; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Primary
Intervention: KHK7580
Intervention description: oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in
      patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo
      parathyroidectomy or relapse after parathyroidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personally submitted written voluntary informed consent to participate in the study

          -  Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who
             are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

          -  Corrected serum calcium level is > 11.3 mg/dL at screening.

        Exclusion Criteria:

          -  Patients receiving cinacalcet hydrochloride within 2 weeks before screening

          -  Patients diagnosed with hypercalcemia associated with malignant tumors other than
             parathyroid carcinoma.

          -  Severe heart disease

          -  Severe hepatic dysfunction

          -  Uncontrolled hypertension and/or diabetes

          -  Treatment with an investigational product (drug or medical device) in a clinical study
             or any study equivalent to clinical study within 12 weeks before screening