bioihbjkbjnl/mcl2 huggingface dataset:
Pacritinib Versus Best Available Therapy to Treat Myelofibrosis
Condition: Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: Pacritinib; Best Available Therapy
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 327.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelofibrosis; Post-Polycythemia Vera Myelofibrosis; Post-Essential Thrombocythemia Myelofibrosis; Primary Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; Bone Marrow Disease; Hematologic Disease; Splenomegaly; Pacritinib; MPN-SAF; MPN-SAF TSS; Anemia; Myeloproliferative Neoplasm; Spleen volume; Thrombocytopenia; SB1518

Summary:

      Phase 3, randomized, controlled study to evaluate the safety and efficacy of oral pacritinib
      compared to Best Available Therapy (BAT) in patients with primary or secondary myelofibrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Intermediate -1 or -2 or high-risk Myelofibrosis (per Passamonti et al 2010)

          -  Palpable splenomegaly ≥ 5 cm on physical examination

          -  Total Symptom Score >13 on the MPN-SAF TSS 2.0, not including the inactivity question

          -  Patients who are platelet or red blood cell transfusion-dependent are eligible

          -  Adequate white blood cell counts (with low blast counts), liver function, and renal
             function

          -  No spleen radiation therapy for 6-12 months

          -  Last therapy for myelofibrosis was 2-4 weeks ago, including any erythropoietic or
             thrombopoietic agent

          -  Not pregnant, not lactating, and agree to use effective birth control

        Exclusion Criteria:

          -  Prior treatment with a JAK2 inhibitor

          -  History of (or plans to undergo) spleen removal surgery or allogeneic stem cell
             transplant

          -  Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel
             disease, chronic diarrhea, or constipation

          -  Cardiovascular disease, including recent history or currently clinically symptomatic
             and uncontrolled: congestive heart failure, arrhythmia, angina, QTc prolongation or
             other QTc risk factors, myocardial infarction

          -  Other malignancy within last 3 years other than certain limited skin, cervical,
             prostate, breast, or bladder cancers

          -  Other ongoing, uncontrolled illnesses (including HIV infection and active hepatitis A,
             B, or C), psychiatric disorder, or social situation that would prevent good care on
             this study

          -  Life expectancy < 6 months
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer
Condition: Cancer; Carcinoma; Castrate-Resistant Prostate Cancer; Prostate Cancer; Tumors
MeSH terms: Prostatic Neoplasms
Intervention: Denosumab
Intervention description: 60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Androgen deprivation therapy for non-metastatic prostate cancer

Summary:

      The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3
      years under the 20040138 Amgen study and 2 years on this study) denosumab administration as
      measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who
      previously received denosumab for non-metastatic prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be currently participating in the 20040138 Amgen study

          -  Subjects must sign the informed consent before any study specific procedures are
             performed.

        Exclusion Criteria

          -  Subjects with any prior diagnosis of bone metastasis

          -  Known hypocalcemia

          -  Developed sensitivity to mammalian cell derived drug products during the 20040138
             study

          -  Currently receiving any investigational product other than denosumab or having
             received any investigational product during the 20040138 study

          -  Any disorder that, in the opinion of the investigator, may compromise the ability of
             the subject to give written informed consent and/or comply with study procedures
A Study To Evaluate the Long-Term Safety, Tolerability and Effect on Disease Course
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Disease Progression
Intervention: Laquinimod
Intervention description: One capsule containing 0.6 mg laquinimod to be administered orally once daily.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 839.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Relapsing Multiple Sclerosis

Summary:

      The purpose of this study is to make laquinimod 0.6 mg available for all subjects who
      completed the placebo-controlled MS-LAQ-301 study according to the protocol and to evaluate
      the long-term safety, tolerability and effect on disease course of daily oral laquinimod 0.6
      mg in subjects with relapsing multiple sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects must have completed the Termination visit of MS-LAQ-301 (completion of all
             Termination visit activities) according to the MS-LAQ-301 protocol.

          2. Women of child-bearing potential must practice an acceptable method of birth control
             [acceptable methods of birth control in this open label extension phase include:
             surgical sterilization, intrauterine devices, oral contraceptive, contraceptive patch
             (or hormone-releasing vaginal ring), long-acting injectable contraceptive, partner's
             vasectomy or double-barrier method (condom or diaphragm with spermicide)] during the
             study and up to 30 days after the last dose of the study drug..

          3. Subjects must be willing and able to comply with the protocol requirements for the
             duration of the study.

          4. Subjects must be able to comprehend, sign and date a written informed consent prior to
             entering the MS-LAQ-301E study.

        Exclusion Criteria:

          1. Premature discontinuation from the MS-LAQ-301 study, for any reason.

          2. Pregnancy [according to urine dipstick β-HCG test performed at Baseline (Month 0E)
             visit] or breastfeeding.

          3. Subjects with clinically significant or unstable medical or surgical condition
             detected or worsened during the MS-LAQ-301 study, which preclude safe participation
             and completion of the MS-LAQ-301E study. Acute exacerbation of MS will not exclude
             participation in the MS-LAQ-301E study.

          4. Use of inhibitors of CYP3A4 within 2 weeks prior to baseline visit (V0E, Month 0E).
A Study of Raltegravir in a Diverse Cohort of HIV-Infected Patients (0518-055)
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: Comparator: raltegravir
Intervention description: 400 mg tablets taken twice daily. Total treatment period is 48 weeks.
Intervention MeSH terms: Raltegravir Potassium
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      A study to test the safety and effect of twice daily raltegravir in a diverse cohort of
      patients currently infected with human immunodeficiency virus (HIV), where at least 50% are
      African American and at least 25% are female, either having received antiretroviral drugs
      before or not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient is HIV positive

          -  Patient agrees to use (or have their partner use) birth control as defined by the
             study doctor

        Exclusion Criteria:

          -  If female, pregnant or breastfeeding

          -  Patient has used an investigational agent in the last 30 days

          -  Patient has acute hepatitis

          -  Patient has received MK0518 (raltegravir) before

          -  Patient has used another experimental HIV-integrase inhibitor
Effect of pH and Fluoride Concentration of Dentifrices on Caries Control
Condition: Dental Fluorosis; Dental Caries
MeSH terms: Dental Caries; Fluorosis, Dental
Intervention: Low fluoride and conventional dentifrices with different pH
Intervention description: Comparison of different dentifrice fluoride concentrations and pH on caries control
Intervention MeSH terms: Fluorides
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 315.0
Sex: All
Minimum age: 2 Years
Maximum age: 4 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dentifrices; Fluoride; Nails; Plaque

Summary:

      This study aims to assess the overall effect of pH and fluoride concentration of liquid
      dentifrices in the control of children dental caries of a fluoridated area, through visual
      inspection and the quantitative light-induced fluorescence (QLF) method. Toenail F
      concentration of a subsample of the children enrolled will be evaluated, in order to assess F
      bioavailability from these formulations and the evaluation of the concentration of fluoride
      incorporated into the biofilm will be done 6 months after initiation of the dentifrices use.
    

Eligibility criteria:

        Inclusion Criteria:

          -  >= 2 years and <= 4 years

          -  Not having participated in any other clinical study within 3 months prior to
             selection;

          -  Not having very large carious lesions or dentin sensitivity during the study (if this
             occurs, the child will be referred for treatment);

          -  Signature of informed consent by the parents

        Exclusion Criteria:

          -  Using orthodontic appliances
Safety and Efficacy of Aliskiren 300 mg, 150 mg and 75 mg in Patients With Essential Hypertension Compared to Ramipril 5 mg
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: Aliskiren; Ramipril
Intervention description: Aliskiren; comparator
Intervention MeSH terms: Ramipril
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1613.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hypertension, Aliskiren, Ramipril

Summary:

      This study is designed to investigate the efficacy, safety and tolerability of aliskiren 300
      mg, 150 mg and 75 mg when compared to ramipril 5 mg in patients with essential hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have msDBP ≥ 90 mmHg and < 110 mmHg at the visit immediately prior to
             Visit 3

          -  Patients must have msDBP >OR= 95 mmHg and < 110 mmHg at Visit 3

          -  Patients must have an absolute difference of < or =10 mmHg in their mean sitting
             diastolic blood pressure (msDBP) from Visit 2 to Visit 3

        Exclusion Criteria:

          -  Severe hypertension (grade 3 WHO classification; msDBP >or= 110 mmHg and/or msSBP >or
             = 180 mmHg).

          -  History or evidence of a secondary form of hypertension.

          -  History of transient ischemic cerebral attack within 12 months of visit 1.

          -  Current angina pectoris requiring pharmacological therapy (other than those patients
             on a stable dose of oral or topical nitrates)

          -  Type 1 or Type 2 diabetes mellitus with glycosylated hemoglobin (HbA1c) > 8% at Visit
             1.

          -  Known or suspected contraindications to the study medications, including history of
             allergy to ramipril or other ACE Inhibitors.

        Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Tolerability of FCM vs Standard of Care in Treating Iron Deficiency Anemia in Chronic Kidney Disease Patients
Condition: Anemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose; Standard Medical Care (SMC)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 513.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      The Objective of this study is to study the safety of FCM in patients with anemia caused by
      chronic kidney failure
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female 18 to 85 years of age

          -  NDD-CKD Patients

          -  TSAT </= 25%

          -  Hgb </= 11.5

          -  Ferritin </= 300

          -  HD-CKD Patients

          -  TSAT </= 30%

          -  Hgb </= 12

          -  Ferritin </= 500

        Exclusion Criteria:

          -  Previous participation in a FCM trial

          -  Known Hypersensitivity to FCM

          -  History of anemia other that anemia due to chronic renal failure

          -  Current history of GI bleeding

          -  Received IV Iron within the last 30 Days

          -  Anticipated need for surgery

          -  Malignancy history

          -  AST or ALT greater than normal

          -  Received an investigational drug within 30 days of screening

          -  Pregnant or sexually active females who are not willing to use an effective form of
             birth control
0.25% Bupivacaine Versus a Mixture of 0.25% Bupivacaine and 1.3 % Liposomal Bupivacaine in Patients Undergoing Tka
Condition: Anesthesia
Intervention: Exparel; 0.25% bupivacaine
Intervention description: 1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty; 0.25% bupivacaine in patients undergoing total knee arthroplasty
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 25.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Total Knee arthroplasty; bupivacaine; anesthesia

Summary:

      Total knee and hip replacements are some of the most common orthopedic procedures that
      require aggressive postoperative pain management. This management helps us to improve
      clinical outcomes such as participation in early physical therapy, hospital discharge, and
      patient satisfaction. Based on the recent anatomical evidence and the investigator's
      knowledge of the complexity of the knee joint innervation the investigator proposes a new
      regional anesthesia technique that provides a complete sensory blockade and better analgesia
      while preserving the quadriceps strength and avoiding the potential for foot drop caused by
      inadvertent blockade of the common peroneal nerve.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients undergoing unilateral total knee replacement due to OA or rheumatoid
             arthritis

          -  Ages 40- 80 years old

          -  American Society of Anesthesiologists class I-III

        Exclusion Criteria:

          -  Refusal or absolute medical contraindication to peripheral nerve block

          -  refusal or absolute medical contraindication to spinal anesthesia

          -  conversion of spinal anesthesia to general anesthesia is obtained

          -  inability to cooperate

          -  allergy to any drug used in this study

          -  daily intake of opioids (tramadol, morphine, oxycodone, methadone, fentanyl)

          -  alcohol dependence or use of any illegal drugs within the last month

          -  inability to perform the mobilization test and timed up and go (TUG) test
             pre-operatively
An Extension Study of WA19926 of the Long-Term Safety of Tocilizumab (RoActemra/Actemra) in Patients With Early Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Tocilizumab
Intervention description: 8 mg/kg administered intravenously (IV) every 4 weeks for 104 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, single arm, multicenter long-term extension study of WA19926 evaluated the
      safety and efficacy of tocilizumab (RoActemra/Actemra) in participants with moderate to
      severe rheumatoid arthritis who completed the 104-week WA19926 core study. Eligible patients
      received tocilizumab 8 mg/kg intravenously every 4 weeks for up to 104 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult participants, >/= 18 years of age

          -  Participants who complete their last WA19926 core study visit (Week 104) and who may
             benefit from study drug treatment according to the Investigator's assessment

          -  No current or recent adverse event or laboratory finding preventing the use of the
             study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit

          -  Women of childbearing potential must agree to use adequate contraception as defined by
             protocol during the treatment period

        Exclusion Criteria:

          -  Pregnant females

          -  Participants who have withdrawn prematurely from the WA19926 core study for any reason

          -  Treatment with any investigational agent or cell-depleting therapies since the last
             administration of study drug in WA19926

          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,
             or a T-cell costimulation modulator since the last administration of study drug in
             WA19926

          -  Immunization with a live/attenuated vaccine since the last administration of study
             drug in WA19926

          -  Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other
             than rheumatoid arthritis

          -  Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than
             rheumatoid arthritis

          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal
             antibodies, including tocilizumab and its excipients

          -  Evidence of severe uncontrolled concomitant disease or disorder

          -  Known active or history of recurrent infections

          -  Active tuberculosis requiring treatment in the previous 3 years

          -  History of alcohol, drug or chemical abuse since inclusion in the WA19926 study
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Condition: Heart Decompensation
MeSH terms: Heart Failure
Intervention: Nesiritide; Placebo
Intervention description: 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs; matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
Intervention MeSH terms: Natriuretic Peptide, Brain
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Decompensation; Dyspnea; Heart failure; Nesiritide; Decompensated; ADHF

Summary:

      The purpose of this study is to find out if nesiritide (a human B-type natriuretic
      peptide/hBNP) as compared to placebo, plus the usual treatment for acute decompensated heart
      failure, helps to improve breathing difficulties, reduce heart failure readmissions to
      hospitals, and helps patients live longer.
    

Eligibility criteria:

        Inclusion Criteria:

        Hospitalized for the management of acute decompensated heart failure (ADHF) or diagnosed
        with ADHF within 48 hours after being hospitalized for another reason; Diagnosis of ADHF is
        defined as dyspnea (difficulty breathing) at rest or dyspnea with minimal activity.

        Exclusion Criteria:

        At high risk for hypotension (low blood pressure); Acute coronary syndrome as primary
        diagnosis; History of cardiac valvular stenosis, restrictive cardiomyopathy, hypertrophic
        cardiomyopathy, or pericardial tamponade; Previous enrollment in a nesiritide study;
        Persistent, uncontrolled hypertension (SBP [systolic blood pressure] >180 mmHg).