bioihbjkbjnl/mcl2 huggingface dataset:
Combination of Irinotecan and Temozolomide in Children With Brain Tumors.
Condition: Glioma; Medulloblastoma
MeSH terms: Glioma; Medulloblastoma
Intervention: Irinotecan; Temozolomide
Intervention description: Irinotecan 10 mg/m^2 per day on days 1-5 and days 8-12 in repeated 3 week cycles; Temozolomide 100-125 mg/m^2 daily on days 1-5 in repeated 3 week cycles
Intervention MeSH terms: Irinotecan; Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 6 Months
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the rate of objective confirmed tumor response of irinotecan in
      combination with temozolomide in children with recurrent or refractory medulloblastoma and in
      children with newly diagnosed high-grade glioma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Cohort 1: Recurrent or refractory medulloblastoma in which current standard treatment
             approaches have failed; biopsy is not required for recurrent disease.

          -  Cohort 2: Newly-diagnosed high-grade glioma (World Health Organization [WHO] grade 3
             or 4)

          -  Life expectancy ≥ 3 months

        Exclusion Criteria:

          -  Diagnosis of brainstem glioma

          -  Concurrent administration of any other anti-tumor therapy

          -  Pre-existing uncontrolled diarrhea
Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Intermittent Explosive Disorder
Condition: Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: AVP-786; Placebo
Intervention description: oral capsules; oral capsules
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Intermittent Explosive Disorder; AVP-786

Summary:

      This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate AVP-786
      for the treatment of Intermittent Explosive Disorder (IED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of current Intermittent Explosive Disorder (IED) according to the Diagnostic
             and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, as solicited
             by the Structured Clinical Interview for DSM-5, Clinical Trials Version

          -  At least 3 IED days (at least 1 IED episode each day, as recorded by the participant)
             per week for the 2 consecutive weeks directly preceding baseline with 70% compliance
             during that time frame, as assessed by the investigator

          -  Score ≥ 12 on the Life History of Aggression scale at screening

          -  Score ≥ 6 on the Overt Aggression Scale - Modified Total Irritability at screening and
             baseline

          -  Score ≥ 4 on the modified Clinical Global Impression of Severity for IED at screening
             and baseline

        Exclusion Criteria:

          -  Diagnosis of major depressive disorder within 6 months of screening

          -  Significant symptoms of a depressive disorder or a Patient Health Questionnaire-9
             score ≥ 10 at screening

          -  Met only the DSM-5 A2 criterion for IED

          -  Lifetime history of schizophrenia, schizoaffective disorder, bipolar disorder,
             antisocial personality disorder, neurocognitive disorder, or mental retardation (DSM-5
             criteria)

          -  Recurrent IED episodes that are better explained by another mental disorder or
             attributable to another medical condition (e.g., head trauma, Alzheimer's disease) or
             to the physiological effect of a substance (e.g., a drug of abuse, a medication)
             (DSM-5 criteria)
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: ACC-001 + QS-21; ACC-001; QS-21; Placebo: Phosphate buffered saline
Intervention description: Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12; Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12; QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12; Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Intervention MeSH terms: Saponin QA-21V1
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 86.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Alzheimer's Disease; active immunization

Summary:

      To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active
      immunization, in patients with mild to moderate Alzheimer's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of probable Alzheimer's Disease with Mini-Mental State Examination (MMSE)
             score of 16-26 (except Germany: 21-26)

          -  Brain MRI consistent with Alzheimer Disease

          -  Concurent use of Chloniesterase inhibitor or memantine allowed if stable

          -  Other inclusion criteria apply

        Exclusion Criteria:

          -  Significant Neurological Disease other than Alzheimer's disease

          -  Major psychiatric disorder

          -  Contraindication to undergo brain MRI

          -  Clinically significant systemic illness

          -  Other exclusion criteria apply
[124I]FIAU PET-CT Scanning in Patients With Pain in a Prosthetic Knee or Hip Joint
Condition: Prosthetic Joint Infections
Intervention: [124I]FIAU
Intervention description: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.
Intervention MeSH terms: Fialuridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Phase II; FIAU; Fialuridine; Prosthetic; Joint; Infection; PET-CT

Summary:

      This protocol will evaluate the sensitivity and specificity of [124I]FIAU as a diagnostic
      imaging agent for the detection of prosthetic joint infections in patients.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males or females age >18 years

          2. Ability to provide informed consent

          3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6
             weeks of enrollment

          4. Need for operative intervention in the opinion of the surgeon to correct the pain in
             the prosthetic joint

          5. Prosthetic joint implant that has been in site for more than 3 months prior to
             enrolment

          6. Having adequate general health to be expected to tolerate surgery adn to survive for 6
             months from the time of informed consent

          7. Women must be either postmenopausal or surgically sterile

          8. Ability to return for all study assessments

          9. Clinically euthyroid, or on stable thyroid replacement therapy

        Exclusion Criteria:

          1. Subjects who are unable to comply with study requirements

          2. Indication, in the opinion of the principal investigator, for urgent surgery that
             would preclude the time needed for PET-CT scanning

          3. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy;
             neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic
             gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers
             [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and
             stroke-like syndrome [MELAS])

          4. Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate
             aminotransferase (AST) >5X ULN

          5. Creatinine clearance <30 mL/min

          6. Body mass that exceeds the rating of the CT table

          7. Hypersensitivity to iodine

          8. Any condition that would put the subject at reasonable risk in the opinion of the
             investigator
A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome
Condition: Sjogren's Syndrome
MeSH terms: Sjogren's Syndrome; Syndrome
Intervention: RSLV-132; Placebo
Intervention description: RNase Fc fusion protein; 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: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The present study will examine the role of circulating RNA complexed with autoantibodies and
      immune complexes and its role in activation of inflammatory pathways in patients with primary
      Sjogren's syndrome. The study will be conducted in a subset of Sjogren's patients who have
      elevated levels of autoantibodies and a pattern of elevated interferon-stimulated gene
      expression in blood cells. A number of biochemical and clinical parameters will be analyzed
      to determine the potential therapeutic utility of nuclease therapy in Sjogren's syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Meet 4 of 6 criteria of 2002 American-European Consensus Group (AECG) criteria for
             Primary Sjogren's Syndrome

          2. Presence of anti Ro autoantibodies

          3. Presence of interferon signature

        Exclusion Criteria:

          1. Use fo hydroxychloroquine within 30 days of baseline

          2. Use of cyclophosphamide within 180 days of baseline

          3. Use of oral corticosteroids greater than 10 mg/day

          4. Known IgG4-related disease
Prophylactic White Cell Transfusions Versus Therapeutic White Cell Transfusions in Patients With Leukemia
Condition: Leukemia
MeSH terms: Leukemia
Intervention: Prophylactic White Cell Transfusion; Therapeutic White Cell Transfusion
Intervention description: Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops; Radiated white blood cell transfusions daily only with infection (or persistent fever)
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No
Keywords: Acute myelogenous leukemia; AML; Undifferentiated and bi-phenotypic leukemia; High-risk myelodysplastic syndrome; Chronic myelogenous leukemia; Infection; Radiated Prophylactic White Cell Transfusions; Therapeutic Radiated White Cell Transfusion; prophylactic antibiotics

Summary:

      Patients with leukemia often have low white blood cell counts after chemotherapy, which puts
      them at greater risk for infection. The standard of care for preventing infections is to give
      these patients antibiotic, antifungal, and antiviral drugs during the time that white blood
      cell counts are low. However, many patients still develop infections during chemotherapy.
      Radiated white blood cell transfusions are a standard treatment once a patient develops a
      severe infection.

      The goal of this clinical research study is to learn if giving unirradiated white blood cell
      transfusions early in chemotherapy might delay or prevent infections in patients with
      leukemia. Researchers also want to learn more about the type and severity of any infections
      that do occur.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult and pediatric (=/> 2 years old) patients with a diagnosis of acute myelogenous
             leukemia (including undifferentiated and bi-phenotypic leukemia), or high-risk
             myelodysplastic syndrome, or chronic myelogenous leukemia in blast crisis who will
             receive first or second anti-leukemia therapeutic intent with chemotherapy, targeted
             therapy or hypomethylating agents

          2. Patients must sign an informed consent indicating they are aware of the
             investigational nature of this study, in keeping with the policies of the hospital.

        Exclusion Criteria:

          1. Patients with baseline (at start leukemia treatment) infection, defined as patients
             with a)fever and known positive cultures at the time of randomization; or b) chest or
             sinus computed tomography with findings suggestive of pneumonia or sinusitis; or c)
             one positive galactomannan test >/= 1 or two positive galactomannan text >/= 0.5 to 1

          2. Patients with Zubrod performance status >/= 3
Study to Investigate the Effects of Orteronel on the QT/QTc Interval in Patients With Metastatic Castration-Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Orteronel+Prednisone
Intervention description: Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic castrate resistant prostate cancer, mCRPC, orteronel, TAK-700, Phase 2, QT, QTc

Summary:

      The purpose of this phase 2, open-label, single-arm, multidose, multicenter study is to
      investigate the effects of Orteronel plus Prednisone on the QT/QTc interval in patients with
      Metastatic Castration-Resistant Prostrate Cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntary written consent

          -  Screening PSA ≥ 2ng/ml

          -  Patients must have a diagnosis of mCRPC

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Prior surgical or medical castration with testosterone at screening < 50 ng/dL

        Exclusion Criteria:

          -  Prior chemotherapy for prostate cancer within 6 months prior to screening. (Any prior
             therapy with cabazitaxel, mitoxantrone, or anthracyclines is exclusionary.)

          -  Documented central nervous system metastases

          -  Clinically significant heart disease

          -  Patients who have an abnormal 12-lead ECG result at screening including one or more of
             the following: QRS>110 ms, QTcF>480ms, PR interval>200 ms

          -  Patients who have a history of risk factors for TdP including unexplained syncope,
             known long QT syndrome, heart failure, angina, or clinically significant abnormal
             laboratory assessments

        Please note that there are additional inclusion and exclusion criteria. The study center
        will determine if you meet all of the criteria.

        Site personnel will explain the trial in detail and answer any question you may have if you
        do qualify for the study. You can then decide whether or not you wish to participate. If
        you do not qualify for the trial, site personnel will explain the reasons
OTO-201 for the Treatment of Otitis Externa
Condition: Otitis Externa
MeSH terms: Otitis; Otitis Externa
Intervention: OTO-201 (ciprofloxacin)
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 75.0
Sex: All
Minimum age: 6 Months
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Otitis externa; Swimmer's ear; Ear infection

Summary:

      This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa.
      Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study
      is designed to characterize safety, procedural factors and clinical effect of OTO-201
      administered in subjects with otitis externa.
    

Eligibility criteria:

        Inclusion Criteria includes, but is not limited to:

          -  Subject is a male or female aged 6 months to 80 years, inclusive

          -  Subject has a clinical diagnosis of unilateral otitis externa

          -  Subject or subject's caregiver is willing to comply with the protocol and attend all
             study visits

        Exclusion Criteria includes, but is not limited to:

          -  Subject has tympanic membrane perforation

          -  Subject has a history of known immunodeficiency disease

          -  Subject has fungal otitis externa, based on clinical signs
Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Certolizumab pegol (CZP); Certolizumab pegol (CZP); Certolizumab pegol (CZP)
Intervention description: Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received Placebo at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol (CZP) 200 mg at Weeks 0, 2 and 4.; Certolizumab pegol (CZP) 400 mg administered subcutaneously in a liquid formulation at Weeks 8, 12, 16, 20 and 24 relative to the start of the 6-week double-blind main study C87037 (NCT00291668) where subjects received certolizumab pegol 400 mg at Weeks 0, 2 and 4.
Intervention MeSH terms: Certolizumab Pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 16 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Certolizumab pegol; Cimzia; CZP

Summary:

      This is a multi-centre, open-label extension study in subjects who showed clinical response
      to induction therapy in the treatment of subjects with active Crohn's disease in the
      double-blind main study C87037 (NCT00291668).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who participated in main double-blind induction study C87037 (NCT00291668)
             and showed clinical efficacy

        Exclusion Criteria:

          -  Subjects who experienced aggravation of Crohn's disease during main double-blind
             induction study C87037 (NCT00291668) and required treatment change
Polestriding Versus Walking for Subjects With Poor Leg Circulation
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Intervention: Walking with poles; Walking exercise
Intervention description: Patients walked with poles, 20-45 minutes, 3 times/week for 24 weeks.; Patients walked for 20-45 minutes, 3 times/week for 24 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 146.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare the effects of polestriding (walking with poles) and
      traditional walking on physical endurance in subjects with poor circulation in their legs.
      Another goal is to evaluate the effectiveness of a walking program in increasing the amount
      of oxygen in the calf muscles and therefore improving overall physical activity and quality
      of life.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Peripheral Vascular Disease

          -  Cramping/Claudication Pain in legs while walking

          -  Ankle Brachial Index (measure of circulation by doppler) .90 or less

        Exclusion Criteria:

          -  Ulcers or sores on feet or legs

          -  Unable to walk or confined to a wheelchair

          -  Amputations or severe arthritis pain in shoulders, knees, or hips

          -  Medical conditions which would exclude subject from participating in an exercise
             program

          -  Vascular Surgery within the last six months, or planning vascular surgery
Ondansetron vs Prochlorperazine for Nausea and Vomiting in the Emergency Department
Condition: Nausea and Vomiting
MeSH terms: Emergencies; Nausea; Vomiting
Intervention: Prochlorperazine; Ondansetron
Intervention description: Patients receiving Prochlorperazine; Patients receiving Ondansetron
Intervention MeSH terms: Ondansetron; Prochlorperazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will compare the effect of prochlorperazine and ondansetron for the treatment of
      nausea and vomiting in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients presenting to the ED with at least one of the following

          -  Nausea

          -  Vomiting documented in the ED

        Exclusion Criteria:

          -  Previous treatment in the ED with Ondansetron, prochlorperazine, promethazine or
             metaclopramide

          -  Patients with missed last menstrual period

          -  Pregnancy

          -  Age < 18 years old

          -  Treatment with antineoplastic agents within 7 days prior to randomization

          -  Irritable bowel syndrome

          -  Gastroparesis

          -  Suspected gastrointestinal bleed

          -  Suspected intestinal obstruction

          -  Preexisting motor disorder (Restless-leg syndrome or Parkinson's disease)

          -  Traumatic brain injury upon admission to ED

          -  Intracranial hemorrhage upon admission to ED

          -  Patients unable to read, write or communicate in the English language

          -  Patients leaving the ED against medical advice