bioihbjkbjnl/mcl2 huggingface dataset:
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hypothermia; Wounds and Injuries
Intervention: Arctic Sun; Magnesium Sulfate
Intervention description: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.; IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours.
Intervention MeSH terms: Magnesium Sulfate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Traumatic; Brain; Injury

Summary:

      The investigators hypothesize that hypothermia (body cooling) and additional magnesium
      sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.

      This is a study to compare the outcomes of patients with severe traumatic brain injury who
      have been allocated to one of the following three groups:

      Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have
      their core body temperature lowered to 34C Group 3 - Subjects will have their core body
      temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium
      sulfate.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult males or females ≥ 18 years of age

          2. Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS)
             ≤ 8

          3. In-hospital and screened within 7 hours of injury.

          4. Able to obtain legally effective written consent from authorized representative

          5. Patients who are intubated and on mechanical ventilation

          6. Admitted to ICU

        Exclusion Criteria:

          1. Bladder or rectal core temperature below 32C (89.6F) upon admission

          2. Clinical brain death

          3. Patients with open abdomens.

          4. Multiple orthopedic injuries (> 2 long bone fractures)

          5. Persistent hypotension (systolic blood pressure < 90mmHg)

          6. Persistent hypoxia (O2 Saturation < 94%)

          7. Persistent metabolic acidosis (Lactic acid > 5 mmol/L, arterial pH < 7.25)

          8. Positive serum pregnancy test

          9. Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial
             damage (as shown on ECG)

         10. History of abnormal renal function

         11. Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)

         12. Pediatric patients (< 18 years old)
Testing Palbociclib (PD-0332991) as a Potential Targeted Treatment in Cancers With CCND1, 2, 3 Amplification (MATCH-Subprotocol Z1B)
Condition: Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm
MeSH terms: Lymphoma; Neoplasms
Intervention: Palbociclib
Intervention description: Given PO
Intervention MeSH terms: Palbociclib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II MATCH treatment trial identifies the effects of palbociclib in patients whose
      cancer has genetic changes called CCND1, 2, or 3 amplification. Palbociclib blocks proteins
      called CDK4 and CDK6, which may stop cancer cell growth when CCND1, 2, or 3 amplifications
      are present. Researchers hope to learn if palbociclib will shrink this type of cancer or stop
      its growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have met applicable eligibility criteria in the Master MATCH Protocol
             prior to registration to treatment subprotocol

          -  Patients must have amplification of CCND1, 2, or 3, or another aberration, as
             determined via the MATCH Master Protocol

          -  Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment
             assignment and must have no clinically important abnormalities in rhythm, conduction
             or morphology of resting ECG (e.g. complete left bundle branch block, third degree
             heart block)

        Exclusion Criteria:

          -  Patients must not have known hypersensitivity to palbociclib or compounds of similar
             chemical or biologic composition

          -  Patients must not have breast cancer, mantle cell lymphoma or myeloma

          -  Patients with known or symptoms of left ventricular dysfunction will be excluded

          -  Patients must not have had prior treatment with palbociclib, ribociclib, abemaciclib
             or any other CDK4/6 inhibitors

          -  Patients must not be using drugs or foods that are known potent CYP3A4 inhibitors or
             inducers, or are CYP3A4 substrates with narrow therapeutic indices
Nitric Oxide in Myocardial Infarction Size
Condition: Acute Myocardial Infarction; ST Elevation MI; STEMI
MeSH terms: Myocardial Infarction; Infarction
Intervention: Nitric Oxide; Placebo
Intervention description: Nitric oxide for inhalation; Nitrogen gas (placebo) for inhalation
Intervention MeSH terms: Nitric Oxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: INOT44; NOMI

Summary:

      The purpose of this study is to assess whether or not inhaled nitric oxide can decrease
      myocardial infarction (MI) size at 48-72 hours in patients presenting with an ST segment
      elevation MI (STEMI) who undergo successful percutaneous coronary intervention.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute myocardial infarction and electrocardiographic evidence of ST elevation

          -  No clinical evidence of congestive heart failure

          -  All patients must undergo successful percutaneous coronary intervention for
             thrombolysis in myocardial infarction (TIMI) 0 or 1 coronary flow with resulting TIMI
             2 or 3 flow

          -  Greater than 18 years of age

          -  Signed Institutional Review Board (IRB) approved informed consent

        Exclusion Criteria:

          -  Prior myocardial infarction

          -  Requirement for urgent cardiac surgery

          -  Previous coronary artery bypass graft (CABG) or primary coronary intervention (PCI)

          -  Left bundle branch block

          -  Heart block that is expected to require a temporary pacemaker for greater than 72
             hours

          -  Prior use of thrombolytic therapy for the current event

          -  Unable to tolerate magnetic resonance imaging or unable to tolerate gadolinium
             contrast media, including patients with a calculated creatinine clearance less than 60
             ml/min/1.73m² Body Surface Area (BSA)

          -  Active or recent hemorrhage requiring an invasive procedure for evaluation or
             transfusion within 6 weeks prior to presentation, or hemorrhagic stroke within the 6
             weeks prior

          -  Neutropenia (WBC <2000 (mm)³), Anemia (HCT <30%, Thrombocytopenia (Thrombocytes
             <50,000 (mm)³). It is not necessary to confirm blood counts prior to start of study
             drug in the absence of clinical suspicion.

          -  Known or suspected aortic dissection.

          -  Prior history of pulmonary disease requiring chronic oxygen therapy.

          -  Pregnancy, lactating, and women of childbearing potential.

          -  Medical problem likely to preclude completion of the study.

          -  Use of investigational drugs or device within the 30 days prior to enrollment
A 4-week Study to Evaluate the Efficacy and Safety of HP-5000 in Subjects With Knee Osteoarthritis
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Diclofenac Sodium Active Topical Patch 1; Diclofenac Sodium Active Topical Patch 2; Placebo patch
Intervention description: HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s); HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s); Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 289.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      A 4-week, Randomized, Double-blind, Multicenter, Placebo-controlled Phase 2 Study to Evaluate
      the Efficacy and Safety of HP-5000 in Subjects with Osteoarthritis (OA) of the Knee
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 40 to 85 years with a clinical diagnosis of OA of the target knee
             according to the American College of Rheumatology (ACR) criteria, including:

          -  Symptoms for at least 6 months prior to screening, AND

          -  Knee pain in the target knee for 30 days of the preceding month (periarticular knee
             pain due to OA and not due to other conditions such as bursitis, tendonitis, etc.) AND

          -  The pain in the target knee required the use of nonsteroidal anti-inflammatory drugs
             (NSAIDs) either over the counter (OTC) per recommendation of a physician or
             prescribed.

        Exclusion Criteria:

          -  Body mass index (BMI) > 40

          -  Any subject who disobeyed the restriction of prohibited therapies (i.e., use rescue
             medication) during Screening Washout Period.

          -  Secondary OA of the knee (rheumatoid arthritis, gout, psoriasis, syphilitic
             neuropathy, ochronosis, metabolic or other primary bone disease or acute trauma).
Yoga in Treating Sleep Disturbance in Cancer Survivors
Condition: Fatigue; Cancer; Sleep Disorders
MeSH terms: Sleep Wake Disorders; Parasomnias; Dyssomnias; Fatigue
Intervention: Standard Care Control Condition; Yoga Intervention (YOCAS)
Intervention description: Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.; The Yoga for Cancer Survivors (YOCAS) intervention uses two forms of yoga: Gentle Hatha yoga and Restorative yoga. The YOCAS sessions are standardized, and each session includes physical alignment postures, breathing and mindfulness exercises. The intervention is delivered in an instructor taught, group format, twice a week for 75 minutes each time over 4 weeks for a total of eight sessions of yoga. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 410.0
Sex: All
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: cancer-related sleep disturbance; fatigue; sleep disorders

Summary:

      RATIONALE: Yoga may help improve sleep, fatigue, and quality of life in cancer survivors.

      PURPOSE: This phase II trial is studying how well yoga works in treating sleep disturbance in
      cancer survivors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of any type of cancer

          -  More than 1 primary cancer allowed

          -  Has undergone and completed all forms of standard treatment (surgery, chemotherapy,
             radiation therapy) within the past 2 to 24 months

          -  Patients can be on hormones such as Tamoxifen, or monoclonal antibodies like Herceptin

          -  Persistent sleep disturbance, as indicated by a response of ≥ 3 when asked to rate
             their sleep on an 11-point scale (0 is equivalent to no sleep disturbance and 10 is
             the worst possible sleep disturbance)

          -  Able to read English

          -  21 years of age or older

        Exclusion Criteria:

          -  No prior or concurrent regular (≥ 1 day/week) participation in yoga classes or
             maintain regular personal practice of any form of yoga within the past 3 months

          -  No diagnosis of sleep apnea

          -  No concurrent cancer therapy with the exception of hormonal therapy (e.g., tamoxifen
             citrate) or monoclonal antibodies (e.g., trastuzumab [Herceptin®])

          -  No metastatic cancer
Evaluation of the Safety and Effectiveness of the Kinamed Gem Ceramic Femoral Component for Total Knee Replacement
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: zirconia femoral component; cobalt chrome femoral component
Intervention description: total knee arthroplasty performed using implant with zirconia femoral component; total knee arthroplasty performed using implant with cobalt chrome femoral component
Intervention MeSH terms: Cobalt
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 4.0
Sex: All
Healthy volunteers: No
Keywords: total knee arthroplasty; osteoarthritis; ceramic bearing; zirconia

Summary:

      The aim of this study is to provide evidence that the safety and effectiveness of the ceramic
      femoral component of the Gem Total Knee System is similar to FDA approved implants used in
      total knee replacement surgery. The hypotheses to be tested are that the investigational and
      control groups are equivalent in terms of patient success rate and complication-free rate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Skeletally mature

          -  Primary TKA for osteoarthritis or post-traumatic arthritis of the knee joint

          -  Stable or reconstructable collateral and posterior cruciate ligaments

          -  Correctable deformity

          -  Intact quadriceps and hamstrings mechanisms

          -  Patella bone thick enough (at least 15 mm) after resection

        Exclusion Criteria:

          -  Previous TKA

          -  Bilateral knee arthritis

          -  Non-availability for follow-up

          -  Mental incompetence or confinement

          -  Patients being treated with other investigational devices for same disorder

          -  Infection

          -  Osteoporosis, acute renal failure, or other disorders known to affect bone quality

          -  Charcot's or Paget's disease

          -  Patient physical condition preventing use of appropriate size implant

          -  Disease conditions affecting blood supply to knee

          -  Insufficient bone quality or quantity

          -  Physical condition predisposing implant to extreme loads

          -  History of septic knee arthritis

          -  History of drug abuse
Study of Nivolumab Given Sequentially With Ipilimumab in Subjects With Advanced or Metastatic Melanoma (CheckMate 064)
Condition: Advanced or Metastatic Melanoma
MeSH terms: Melanoma
Intervention: Nivolumab; Ipilimumab
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 138.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of a sequential combination
      therapy of Nivolumab and Ipilimumab
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically confirmed unresectable Stage III or IV melanoma

          -  Treatment-naive or experienced disease recurrence or progression during or after one
             prior systemic regimen for advanced disease

          -  Measurable disease by Computed Tomography/Magnetic resonance imaging (CT/MRI) per
             Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Known BRAF V600 mutation status or consent to BRAF V600 mutation testing

          -  Sufficient tumor tissue accessible for baseline and post-treatment biopsies.

        Exclusion Criteria:

          -  Active central nervous system (CNS) metastases

          -  Carcinomatous meningitis

          -  Active, known or suspected autoimmune disease

          -  Condition requiring systemic treatment with either corticosteroids (>10 mg daily
             prednisone equivalent) or other immunosuppressive medications within 14 days of
             randomization

          -  Prior therapy with anti-Programmed Death-1 (PD1), anti-Programmed Death-Ligand 1
             (PD-L1), anti-PD-L2, anti-CD137, or anti-CTLA-4 (cytotoxic T lymphocyte antigen 4)
             antibody

          -  Prior treatment with other immunotherapies

          -  Prior therapy with BRAF inhibitor within 6 weeks of enrollment
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Teneligliptin 10mg; Teneligliptin 20 mg; Teneligliptin 40 mg; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 324.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: insulin resistance

Summary:

      The purpose of this study is to evaluate the efficacy and safety and to determine the
      appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with
      type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration
      once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment
      manner.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who are 20 - 75 years old

          -  Patients who are under dietary management and taking therapeutic exercise for diabetes
             over 12 weeks before administration of investigational drug

          -  Patients whose HbA1c is 6.5 - 9.5%

          -  Patients who were not administered drugs prohibited for concomitant use within 12
             weeks before administration of investigational drug.

        Exclusion Criteria:

          -  Patients with type 1 diabetes, diabetes mellitus caused by pancreas failure, or
             secondary diabetes (Cushing disease, acromegaly, etc)

          -  Patients with Class III/IV heart failure symptoms according to New York Heart
             Association (NYHA) functional classification

          -  Patients with serious diabetic complications

          -  Patients who are habitual excessive alcohol consumption.

          -  Patients with severe hepatic disorder or severe renal disorder.

          -  Pregnant, lactating, and probably pregnant patients, and patients who can not agree to
             contraception
Oral Rivaroxaban in Children With Venous Thrombosis
Condition: Venous Thrombosis
MeSH terms: Thrombosis; Venous Thrombosis
Intervention: Rivaroxaban (Xarelto, BAY59-7939); Active comparator; Rivaroxaban (BAY59-7939) suspension
Intervention description: Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.; Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).; Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
Intervention MeSH terms: Rivaroxaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find out whether rivaroxaban is safe to use in children and
      how long it stays in the body. There will also be a check for bleeding and worsening of blood
      clots.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children aged 6 to < 18 years with documented symptomatic or asymptomatic venous
             thrombosis treated for at least 2 months or, in case of catheter related thrombosis,
             treated for at least 6 weeks with LMWH (low molecular weight heparin), , fondaparinux
             and/or VKA (vitamin K antagonist).

          -  Informed consent provided and, if applicable, child assent provided

        Exclusion Criteria:

          -  Active bleeding or high risk for bleeding contraindicating anticoagulant therapy

          -  Symptomatic progression of venous thrombosis during preceding anticoagulant treatment

          -  Planned invasive procedures, including lumbar puncture and removal of non peripherally
             placed central lines during study treatment

          -  An estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2

          -  Hepatic disease which is associated with coagulopathy leading to a clinically relevant
             bleeding risk or ALT > 5x upper level of normal (ULN) or total bilirubin > 2x ULN with
             direct bilirubin > 20% of the total

          -  Platelet count < 50 x 10^9/L

          -  Hypertension defined as > 95th age percentile

          -  Life expectancy < 3 months

          -  Concomitant use of strong inhibitors of both cytochrome P450 isoenzyme 3A4 (CYP3A4)
             and P-glycoprotein (P-gp), i.e. all human immunodeficiency virus protease inhibitors
             and the following azole antimycotics agents: ketoconazole, itraconazole, voriconazole,
             posaconazole, if used systemically

          -  Concomitant use of strong inducers of CYP3A4, i.e. rifampicin, rifabutin,
             phenobarbital, phenytoin and carbamazepine