bioihbjkbjnl/mcl2 huggingface dataset:
Nilotinib Versus Standard Imatinib (400/600 mg Every Day (QD)) Comparing the Kinetics of Complete Molecular Response for Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Pts With Evidence of Persistent Leukemia by Real-time Quantitative Polymerase Chain Reaction (RQ-PCR)
Condition: CHRONIC MYELOGENOUS LEUKEMIA
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Nilotinib; Imatinib
Intervention description: Supplied in 200 mg capsules; Supplied in 100 mg and 400 mg capsules
Intervention MeSH terms: Imatinib Mesylate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: MYELOGENOUS; LEUKEMIA; Chronic Phase; CML

Summary:

      The primary goal of this study was to determine the rate of confirmed best cumulative
      complete molecular response (CMR) within the first year of study therapy with imatinib or
      nilotinib. The study also explored the impact and significance of the achieved CMR on patient
      outcomes (progression free survival (PFS), event free survival (EFS) and overall survival
      (OS), characterized the kinetics of CMR achieved in both treatment arms and after the
      cross-over.
    

Eligibility criteria:

        Inclusion Criteria:

        Diagnosis of chronic myeloid leukemia associated with BCR-ABL quantifiable by RQ-PCR
        Documented CCyR by bone marrow or BCR-ABL<1% IS in the past 12 months Persistent disease
        demonstrated by two PCR positive tests 3 months apart both during the past 6 months.

        Treatment with imatinib for at least 2 years with 400 mg or 600 mg and a stable dose No
        other current or planned anti-leukemia therapies

        Exclusion Criteria:

        Patient has evidence of rising PCR (a confirmed >1 log increase in previous 6 months)
        Patient has received another investigational agent within last 6 months or tyrosine kinase
        inhibitors (TKIs) other than imatinib Prior allogeneic stem cell transplantation

        Impaired cardiac function including any one of the following:

        Inability to monitor the QT interval on electrocardiogram (ECG) Long QT syndrome or a known
        family history of long QT syndrome. Clinically significant resting brachycardia (<50 beats
        per minute) QTc > 450 msec on baseline ECG (using the QTcF formula). If QTcF >450 msec and
        electrolytes are not within normal ranges, electrolytes should be corrected and then the
        patient re-screened for QTc Myocardial infarction within 12 months prior to starting study
        Other clinically significant uncontrolled heart disease (e.g. unstable angina, congestive
        heart failure or uncontrolled hypertension) History of or presence of clinically
        significant ventricular or atrial tachyarrhythmias Administration of cytokine therapy (e.g.
        G-CSF, GM-CSF or SCF) within 4 weeks prior to study entry
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Intervention: Intramuscular route of active treatment; Intravenous route of active treatment
Intervention description: IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.; IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1023.0
Sex: All
Healthy volunteers: No
Keywords: Status Epilepticus; Emergency Medical Services; Anticonvulsants; Drug Administration Routes; Seizures

Summary:

      The goal of this non-inferiority trial is to determine which type of routine care is the best
      for paramedics to stop someone from seizing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Paramedics or reliable witnesses verify 5 minutes of either continuous seizure
             activity or of repeated convulsive seizure activity where the patient does not regain
             consciousness (operationally defined as meaningful speech or obeying commands) between
             seizures.

          -  Patient is still seizing at the time of paramedic treatment with study medications.

          -  Estimated weight equal to or greater than 13 kg.

          -  Subject to be transported to a RAMPART participating hospital.

        Exclusion Criteria:

          -  Major trauma as the precipitant of the seizure

          -  Hypoglycemia (as defined by local EMS protocol or a glucose < 60 mg/dL)

          -  Known allergy to midazolam or lorazepam

          -  Cardiac arrest or heart rate (HR) <40 beats per minute

          -  Sensitivity to benzodiazepines

          -  Medical alert tag marked with "RAMPART declined"

          -  Prior treatment of this seizure with diazepam autoinjector as part of another study

          -  Known pregnancy

          -  Prisoners
LATINO Study: A Study of Mircera for the Maintenance Treatment of Dialysis Patients With Chronic Renal Anemia.
Condition: Anemia
MeSH terms: Anemia
Intervention: methoxy polyethylene glycol-epoetin beta [Mircera]
Intervention description: 120, 200 or 360 micrograms sc or iv monthly, starting dose
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will assess the efficacy and safety of Mircera when administered once
      monthly, subcutaneously or intravenously, for the maintenance of hemoglobin levels in
      dialysis patients with chronic renal anemia. Patients currently receiving maintenance
      treatment with epoetin alfa will receive monthly injections of Mircera with a starting dose
      (120, 200 or 360 micrograms) derived from the dose of epoetin alfa they were receiving in the
      week preceding study start. The anticipated time on study treatment is 3-12 months, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients, >=18 years of age;

          -  chronic renal anemia;

          -  hemodialysis or peritoneal dialysis, with same mode of dialysis for >=3 months before
             and throughout screening period;

          -  stable maintenance epoetin alfa therapy for past 2 months.

        Exclusion Criteria:

          -  transfusion of red blood cells during previous 2 months;

          -  poorly controlled hypertension requiring interruption of epoetin alfa in past 6
             months;

          -  acute or chronic bleeding during previous 2 months.
Pharmacokinetic Comparison Of All FK-506 Formulations
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Intervention: Prograf vs Envarsus XR vs Astagraf XL; Prograf vs Astagraf XL vs Envarsus XR
Intervention description: prograf vs Envarsus XR vs Astagraf XL; Prograf vs Astagraf XL vs Envarsus XR
Intervention MeSH terms: Tacrolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the pharmacokinetic parameters of three different
      formulations of tacrolimus.

      Eligible patients will be treated with all three formulations in a pre-defined sequence.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Renal transplant recipients, males or females, of 18 years of age or above.

          2. Able to participate and willing to give written informed consent and to comply with
             study visits and restrictions.

          3. Able to understand English.

          4. Patients having received a primary or secondary renal transplant

        Exclusion Criteria:

          1. Evidence of acute rejection episode within the past three months prior to screening.

          2. Recipients of organ transplants other than kidney.

          3. Patients who are known to be HIV positive.
Phase III Study of Vinflunine Plus Methotrexate Versus Methotrexate Alone in Patients With Head and Neck Cancer
Condition: Recurrent or Metastatic Head and Neck Carcinoma
MeSH terms: Carcinoma; Squamous Cell Carcinoma of Head and Neck
Intervention: Vinflunine; Methotrexate
Intervention MeSH terms: Methotrexate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 459.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Vinflunin; Vinflunin + Methotrexate; Metastatic Squamous Cell Carcinoma of the Head and Neck

Summary:

      For patients relapsing after platinum-based therapy, few data are available. The current use
      of cetuximab associated with radiotherapy in localized disease and associated with
      platinum-based chemotherapy in the first-line setting stresses the need for new therapeutic
      options at later stages of SCCHN.Vinca-alkaloids demonstrated activity in SCCHN. Vinflunine
      demonstrated superior antitumour activity to vinorelbine in preclinical animal models. Recent
      preliminary phase I results of the vinflunine plus methotrexate combination in SCCHN, based
      on a clinical review, show encouraging antitumour activity and an acceptable safety profile.
      Therefore the combination of vinflunine and methotrexate appears a promising salvage regimen
      after platinum failure.

      The present study has been designed as a multicenter, randomised phase III study which will
      compare the combination of IV vinflunine with methotrexate to methotrexate alone in SCCHN
      patients having failed platinum-based therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed recurrent and/or metastatic squamous cell
             carcinoma

          -  Documented progressive disease after chemotherapy for locoregionally advanced or
             recurrent/metastatic SCCHN which included a platinum derivative

          -  Measurable or non measurable disease

          -  adequate haematological, hepatic and renal functions

          -  WHO performance status < 1

        Exclusion Criteria:

          -  Nasopharyngeal carcinoma

          -  History of brain or leptomeningeal involvement

          -  Albumin level < 35 g/L

          -  Patients with weight loss ≥ 5% within the last 3 months

          -  Grade > 2 peripheral neuropathy at study entry

          -  "Third space" fluids (pleural effusion, ascites, massive edema)

          -  Prior treatment with vinca-alkaloids and methotrexate
Ultrasound Guided Supraclavicular Nerve Block
Condition: Local Anesthetic
Intervention: Ropivacaine; Mepivacaine
Intervention description: ropivacaine (15 ml).; One syringe will contain mepivacaine (15 ml)
Intervention MeSH terms: Ropivacaine; Mepivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: surgery for arm hand or elbow; mepivacaine; ropivacaine; hand surgery; elbow surgery; forearm surgery

Summary:

      This study will test the hypothesis that sequential injection of 1.5% mepivacaine followed 90
      seconds later by 0.5% ropivacaine in ultrasound guided supraclavicular block provides a
      quicker onset and a longer duration of analgesia than an equi-dose mixture of the two local
      anesthetics.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing upper extremity procedures suitable for supraclavicular
             anesthesia, including but not limited to oHand surgery oForearm surgery oElbow surgery

          -  Age between 18 and 70 years

        Exclusion Criteria:

          -  Contraindications to supraclavicular block

               -  Coagulopathy

               -  Infection at the needle insertion site

               -  Severe chronic obstructive pulmonary disease (COPD)

               -  Contralateral pneumothorax or diaphragmatic paralysis

          -  Pregnancy

          -  Preexisting neuropathy involving the surgical limb

          -  Routine opioid use

          -  Inability to attain adequate ultrasound images in the supraclavicular area
Treatment of Children and Adolescents With Growth Failure Associated With Primary IGF-1 Deficiency
Condition: Growth Disorders
MeSH terms: Growth Disorders; Failure to Thrive
Intervention: rh IGF-1 (mecasermin)
Intervention description: Patients from untreated arm for prior study MS301 (NCT00125164) were randomized to a dose of either 80 or 120 mcg/kg twice daily. For patients receiving active treatment in previous study MS 301 (NCT00125164), they started on a dose of 80 or 120 mcg/kg twice daily based on the dose reached at end of the previous study. Following a protocol amendment in May 2009, all patients were switched to once daily doses of 160 µg/kg, escalated to a targeted maximum dose of 240 µg/kg.
Intervention MeSH terms: Mecasermin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 4 Years
Maximum age: 15 Years
Healthy volunteers: No
Keywords: Insulin-like Growth Factor Deficiency; IGF-1; Short Stature

Summary:

      This is an extension study to Tercica study MS301 (NCT00125164) and is intended to collect
      long term safety and efficacy data on the continued use of recombinant human insulin-like
      growth factor-1 (rh IGF-1) in children and adolescents treated for primary IGF-1 deficiency
      (IGFD). The secondary objective is to use the data collected to learn more about the
      relationship of IGF-1 exposure to the promotion of normal growth and pubertal development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Parents or legally authorized representatives must give signed informed consent before
             any trial related activities are conducted

          -  Where required, assent of the subject will be appropriately documented prior to any
             study related activities

          -  Completion of assessments at Visit 9 (Month 120 of Study MS301 [NCT00125164])

        Exclusion Criteria:

          -  Incomplete participation in MS301 (NCT00125164)

          -  Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1
             injection) or its formulation

          -  Development or presence of a chronic condition except as approved by the Medical
             Monitor

          -  Pregnancy

          -  Any social or medical condition that, in the opinion of the investigator, would be
             detrimental to either the subject or the study
A Study of Vinflunine Plus Gemcitabine Versus Paclitaxel Plus Gemcitabine in Patients With Advanced Breast Cancer
Condition: Advanced Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Vinflunine+Gemcitabine; Paclitaxel+Gemcitabine
Intervention description: Vinflunine 320 mg/m² IV on day 1 and.Gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks; paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1
Intervention MeSH terms: Paclitaxel; Gemcitabine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1004.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The combination of vinflunine and gemcitabine in advanced breast cancer in comparison to
      paclitaxel and gemcitabine is based on the following points: the significant antitumour
      activity of vinflunine in metastatic breast cancer (MBC) as single agent after
      anthracycline-taxane exposure and recent phase I study results of the vinflunine plus
      gemcitabine is at least additive and both drugs have a distinct mechanism of action; since
      taxanes have been approved in the adjuvant setting and are widely used in the treatment of
      early breast cancer it is worthwhile to assess new combination chemotherapy regimens as first
      line therapy for metastatic breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  female patients

          -  18 years or older but less than 75 years old

          -  histologically/cytologically confirmed breast cancer

          -  documented locally recurrent or metastatic breast cancer

          -  HER-2 negative or unknown

          -  prior neo- and/or adjuvant anthracycline-based chemotherapy

          -  measurable or non-measurable disease according to Response Evaluation Criteria In
             Solid Tumors (RECIST) 1.0

          -  adequate haematological, hepatic and renal functions

          -  ECG without any clinically relevant abnormality

        Exclusion Criteria:

          -  known or clinical evidence of brain metastases or leptomeningeal involvement

          -  history of second primary malignancy

          -  patients having as sole tumour lesion: malignant effusion, lymphangitis, cystic
             lesion, bone lesion, and any other lesion not assessed by imaging techniques or colour
             photography

          -  pre-existing motor/sensory grade > 1 peripheral neuropathy

          -  prior therapy with vinca alkaloids and/or gemcitabine

          -  history of severe hypersensitivity to vinca alkaloids and/or gemcitabine or
             contraindication to any of these drugs

          -  pregnancy or breast feeding
An Open-label, Long-term Study of Telmisartan Plus Amlodipine Fixed-dose Combination
Condition: Hypertension
MeSH terms: Hypertension
Intervention: telmisartan40/amlodipine5; telmisartan80/amlodipine5
Intervention MeSH terms: Amlodipine; Telmisartan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 259.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To assess the long term safety and efficacy of telmisartan plus amlodipine FDC in patients
      with essential hypertension who failed to control their BP with either monotherapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with essential hypertension

          2. Outpatient

        Exclusion Criteria:

          -  Patients whose SBP >=180 mmHg or DBP >=110 mmHg at the end of treatment visit of the
             double-blind treatment period in the "non-responder trials"

          -  Patients who have met any of the exclusion criteria defined in the "non-responder
             trials"
Trial to Assess Parkinson's Disease (PD) Symptom Control to Four Doses of Rotigotine in a Transdermal Patch
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Rotigotine; Placebo; Rotigotine; Rotigotine
Intervention description: 2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks; 4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks; Placebo transdermal patch applied daily; 6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks; 8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 514.0
Sex: All
Minimum age: 30 Years
Healthy volunteers: No
Keywords: Parkinson's disease; rotigotine; patch; transdermal; dopamine agonist; off time; Neupro

Summary:

      The purpose of this study is to show Rotigotine dose response at four doses of Rotigotine
      used with L-dopa in treating advanced stage Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  PD greater than 3 years

          -  Stable dose L-dopa but symptoms not adequately controlled and have "off" time

          -  Able and willing to complete diary on specific days

        Exclusion Criteria:

          -  Previous use of rotigotine or Neupro

          -  Atypical Parkinson's syndrome

          -  Pallidotomy

          -  Thalamotomy

          -  Deep brain stimulation

          -  Fetal tissue transplant

          -  Dementia

          -  Psychosis

          -  Hallucinations

          -  Epilepsy

          -  Renal or hepatic dysfunction

          -  Clinically relevant cardiac dysfunction

          -  Symptomatic orthostatic hypotension

          -  Skin sensitivity to adhesives or unresolved contact dermatitis

          -  History of chronic alcohol or drug abuse

          -  Pregnant or of child-bearing potential

          -  Impulse control disorder
Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: Fostamatinib Disodium
Intervention description: Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this study was to assess the long term safety of fostamatinib in
      subjects with persistent/chronic ITP
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued
             early due to lack of response.

          -  Able and willing to give written informed consent

        Exclusion Criteria:

          -  Discontinued participation in Study C935788-047 or Study C935788-048 for any reason
             other than lack of response

          -  Poorly controlled hypertension during Study C935788-047 or Study C935788-048

          -  Significant infection, an acute infection such as influenza, or known inflammatory
             process