bioihbjkbjnl/mcl2 huggingface dataset:
Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: SU011248; Chemotherapy
Intervention description: SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.; The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.
Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
Docetaxel - 75-100 mg/m2 every 3 weeks
Paclitaxel - 175-200 mg/m2 every 3 weeks
Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare progression free survival for SU011248 [sutent
      (sunitinib malate)] versus standard of care therapy in patients with previously treated,
      advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast
      cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Recurrent or metastatic breast cancer

          -  Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative
             status

          -  Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease
             setting

          -  Relapse following adjuvant chemotherapy within 6 months of last treatment and/or
             received one or two chemotherapy regimens for advanced disease

        Exclusion Criteria:

          -  More than two chemotherapy regimens for advanced disease

          -  Uncontrolled/symptomatic spread of cancer to the brain
A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: ALX-0061; Placebo; Tocilizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 251.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is:

      - To assess the efficacy and safety of dose regimens of ALX-0061 monotherapy administered
      subcutaneously (s.c.) to subjects with active rheumatoid arthritis (RA).

      The secondary objectives of this study are:

        -  To assess the effects of ALX-0061 on quality of life, the pharmacokinetics (PK),
           pharmacodynamics (PD), and immunogenicity of ALX-0061 and to explore potential dose
           regimens for ALX-0061 monotherapy, based on safety and efficacy, for further clinical
           development.

        -  To obtain parallel descriptive information concerning the efficacy and safety of
           tocilizumab (TCZ) s.c. in the same clinical trial RA population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA (according to the 2010 EULAR/American College of Rheumatology (ACR)
             classification criteria) for at least 6 months prior to screening, and ACR functional
             class I-III.

          -  Received previous or current treatment with methotrexate (MTX), and is considered
             intolerant to MTX, or for whom continued treatment with MTX is inappropriate or has
             contraindications for MTX use.

          -  Subjects must not have received MTX for at least 4 weeks before first administration
             of the study drug.

          -  Have active RA with at least 6 swollen and 6 tender joints(66/68 joint count) at the
             time of screening and baseline

          -  Others as defined in the protocol

        Exclusion Criteria:

          -  Have been treated with DMARDs (Disease Modifying Antirheumatic Drugs)/systemic
             immunosuppressive drugs during the 4 weeks, or 12 weeks for hydroxychloroquine,
             chloroquine, or leflunomide (except when an adequate wash-out procedure for
             leflunomide was completed), prior to first administration of study drug.

          -  Have received approved or investigational biological or targeted synthetic DMARD
             therapies for RA (including tumor necrosis factor alpha-inhibitors, abatacept,
             rituximab, or Janus kinase [JAK]-inhibitors) less than 6 months prior to screening.

          -  Have a history of toxicity, non-tolerance, primary non-response or inadequate response
             to a biological therapy, or targeted synthetic DMARDs (including JAK inhibitors), for
             RA.

          -  Have received prior therapy blocking the interleukin-6 (IL-6) pathway, at any time.

          -  Others as defined in the protocol.
Study of Enzastaurin Versus Placebo With Pemetrexed for Participants With Advanced or Metastatic Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: enzastaurin; placebo; pemetrexed
Intervention description: 1125 milligrams (mg) loading dose then 500 mg, oral, daily Cycle 1 (28 days), subsequent cycles 21 days, until disease progression; oral, daily; 500 milligrams per square meter (mg/m^2), intravenous (IV), day 8 Cycle 1 (28 days), day 1 subsequent cycles (21 days), until disease progression
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the combination of enzastaurin and pemetrexed
      can extend survival time without progression of disease for participants who have advanced or
      metastatic non-small cell lung cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Laboratory confirmed diagnosis of NSCLC with locally advanced or metastatic disease
             which cannot be cured.

          -  Participants must have disease which progressed after 1 prior systemic cytotoxic
             chemotherapy regimen for advanced disease.

          -  At least 1 measurable lesion.

          -  Must have stopped all previous systemic therapies for cancer for at least 2 weeks
             prior to enrollment.

          -  Must be able to follow study guidelines and be able to show up for appointments.

        Exclusion Criteria:

          -  Treatment within the last 30 days with a drug that has not received regulatory
             approval for any indication at the time of study entry.

          -  Previous treatment with enzastaurin or pemetrexed.

          -  Concurrent administration of any other antitumor therapy.

          -  Inability to swallow tablets.

          -  Pregnant or breastfeeding.
Prevention of Clostridium Difficile-associated Diarrhea by Daily Intake of Kefir
Condition: Clostridium Difficile Infection; Diarrhea
MeSH terms: Clostridium Infections; Diarrhea
Intervention: kefir
Intervention description: 4 ounces of kefir 3 times a day, with or without food.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      This study is being conducted to investigate the potential benefits of probiotic intake for
      preventing antibiotic associated diarrhea and Clostridium difficile infection in patients
      undergoing a systemic antibiotic treatment. The primary research question is: can daily
      intake of kefir, a yogurt-like food containing probiotics, reduce the incidence of diarrhea
      and Clostridium difficile infection in patients during antibiotic treatment?
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who have:

          -  Been admitted to the medical unit on 7 West at St. Luke's Hospital (Duluth, MN)

          -  Been prescribed a systemic antibiotic of any kind (administered by oral or parenteral
             route), but have not yet started the regimen

          -  Consented to be randomized and take part in the study and are adults greater than 19
             years of age

        Exclusion Criteria:

        Patients who are/have:

          -  Tube feeding

          -  Undergoing dialysis and other renal treatment

          -  An existing C. difficile infection

          -  A recent history of C. difficile infection (within the last 3 months)

          -  A recent history of antibiotic use (within the last 3 months)

          -  Inflammatory bowel disease, Crohn's disease, or other chronic gastrointestinal
             syndrome

          -  A history of acquired of genetic immunodeficiencies; active, acute or chronic serious
             infections (i.e., viral hepatitis, HIV/AIDS), or autoimmune disorders

          -  Undergoing gastrointestinal surgery, radiation, or cytotoxic chemotherapy

          -  Allergy to milk protein
Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Condition: Paroxysmal Nocturnal Hemoglobinuria
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria; Eculizumab; PNH; Japan

Summary:

      A study to assess the safety and efficacy of eculizumab in Japanese patients with hemolytic
      PNH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Japanese individuals at least 12 years of age

          -  Diagnosis of PNH > 6 months

          -  At least one transfusion in the past 2 years for anemia or anemia-related symptoms

          -  LDH level ≥ 1.5 x upper limit of normal within 12 weeks

          -  Presence of a glycosylphosphatidylinositol (GPI)-deficient red blood cell (RBC) clone
             (type III cells) by flow cytometry of ≥10%

          -  Negative serum pregnancy test for women of child-bearing potential

        Exclusion Criteria:

          -  Platelet count < 30,000/µL

          -  Absolute neutrophil count ≤ 500/µL

          -  Known or suspected hereditary complement deficiency

          -  History of hematopoietic stem cell transplant

          -  History of meningococcal disease
Controlled Trial of 3,4-Diaminopyridine (3-4DAP) in Lambert-Eaton Myasthenic Syndrome (LEMS)
Condition: Muscle Weakness
MeSH terms: Muscle Weakness; Paresis
Intervention: 3-4 Diaminopyridine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 45 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: fluctuating muscle weakness; hyporeflexia; autonomic Dysfunction

Summary:

      The main purpose for this study is to provide access to 3,4 DAP, a drug which has
      demonstrated to be effective in treating weakness associated with Lambert-Eaton Myasthenic
      Syndrome. LEMS is a rare autoimmune cause of a defect in neuromuscular transmission. The
      disorder is clinically characterized by fluctuating muscle weakness, hyporeflexia and
      autonomic dysfunction.
    

Eligibility criteria:

        Inclusion Criteria: -Male or female majority between 45 and 60 years of age

          -  diagnosed with Lambert-Eaton Myasthenic Syndrome.

          -  subjects must be taking full dose of pyridostigmine

        Exclusion Criteria: - does subject have a history of liver problems?

          -  does subject have a history of prolonged QTc syndrome (which is a condition where
             there is prolongation between the start of the Q wave and the end of the T wave in the
             heart's electrical cycle).
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940
Condition: Pain
Intervention: AZD1940; Naproxen; Placebo
Intervention description: 800ug oral administration; 500mg oral administration; Placebo given pre-surgery
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesic effect; Molar extraction

Summary:

      The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by
      the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of
      AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive
      the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,
      will be allowed if a need for additional painkillers would arise. A number of patients will
      receive Naproxen as control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for surgical removal of one partial or complete impacted mandibular
             third molar.

          -  Provision of signed informed consent.

          -  Healthy males or non-fertile females.

        Exclusion Criteria:

          -  History of somatic disease/condition, which may interfere with the objectives of the
             study, as judged by the investigator.

          -  History of previous or ongoing psychiatric disease/condition including psychosis,
             affective disorder, anxiety disorder, borderline state and personality disorder
             according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder,
             4th edition.
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Intravenous Brivaracetam in Subjects >= 1 Month to < 16 Years of Age With Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Pharmaceutical form: Solution for iv injection
Route of administration: intravenous use
Concentration: 10 mg/ml
Intervention MeSH terms: Brivaracetam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 1 Month
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Epilepsy; Brivaracetam; Briviact; Open-label; pediatric; intravenous

Summary:

      The purpose of the study is to evaluate the pharmacokinetics (PK), safety, and tolerability
      of brivaracetam (BRV) administered intravenously (iv) in subjects >= 1 month to < 16 years of
      age with epilepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female from >= 1 month to < 16 years of age. For subjects who are < 1 year
             from birth and who were preterm infants, the corrected gestational age should be used
             for this entry requirement

          -  Weight >= 3 kg (6.6 lbs)

          -  Diagnosis of epilepsy

          -  Acceptable candidate for venipuncture and intravenous (iv) infusion

          -  Treatment with >=1 anti epileptic drug (AED; including BRV) without a change of dose
             regimen for at least 7 days prior to Screening

          -  No treatment with vagus nerve stimulation (VNS), OR the subject is being treated with
             VNS and the settings have been constant for >=7 days prior to Screening

          -  For female subjects: not of childbearing potential, OR of childbearing potential and
             not sexually active/negative pregnancy test, OR of childbearing potential and sexually
             active/negative pregnancy test/uses medically acceptable contraceptive methods

        Exclusion Criteria:

          -  Subject has previously received iv Brivaracetam (BRV) in this study

          -  Subject is being treated with BRV at a dose >5mg/kg/day (rounded) or >200mg/day for
             subjects with body weights >40kg

          -  Subject requires or is likely to require a change in concomitant antiepileptic drug(s)
             (AED[s]), dose of concomitant AED(s), or formulation of AED(s) during the 7 days prior
             to the intravenous (iv) pharmacokinetic (PK) Period

          -  Subject is likely, in the opinion of the Investigator, to require rescue medication
             during the Initiating Oral BRV (IOB) Treatment or iv PK Periods

          -  Subject has experienced generalized convulsive status epilepticus in the 28 days prior
             to Screening or during the Screening Period
Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Intervention: Ciprofloxacin (Cipro, BAYQ3939); Placebo
Intervention description: Inhalation of 32,5mg Ciprofloxacin inhaled twice a day; Inhalation of matching placebo twice a day
Intervention MeSH terms: Ciprofloxacin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ciprofloxacin; Airway infection; Bronchiectasis

Summary:

      The purpose of this study is to find out if bacterial load in the airways can be reduced
      after inhalation of ciprofloxacin for 28 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a proven and documented diagnosis of non-cystic fibrosis idiopathic or
             post pneumonic bronchiectasis

          -  Stable pulmonary status and stable regimen of standard treatment at least for the past
             30 days

        Exclusion Criteria:

          -  Forced Expiratory Volume 1 < 35% or > 80%

          -  Allergic bronchopulmonary aspergillosis

          -  Immunodeficiency disease requiring immunoglobulin replacement

          -  Inflammatory bowel disease
3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid for Consolidation of Second or Greater Remission of High-Risk Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: 3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid
Intervention description: 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles .Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage.
Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started after cycle 2.
Intervention MeSH terms: Tretinoin; Isotretinoin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 46.0
Sex: All
Minimum age: 18 Months
Healthy volunteers: No
Keywords: GM-CSF; MAB 3F8; RETINOIC ACID (CIS-9 & 13); 09-160

Summary:

      The purpose of this study is to find out what effects, good and/or bad, the combination of
      3F8 and GM-CSF has on the patient and the cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of NB as defined by a) histopathology (confirmed by the MSKCC Department of
             Pathology), or b) BM metastases or MIBG-avid lesion(s) plus high urine catecholamine
             levels.

          -  High-risk NB as defined by risk-related treatment guidelines1 and the International NB
             Staging System,89 i.e., stage 4 with (any age) or without (> or = to 18 months of age)
             MYCN amplification, MYCN-amplified stage 2 or stage 3 (any age), or MYCN-amplified
             stage 4S.

          -  The patients are in >2nd CR/VGPR, including no measurable MIBG-avid soft tissue tumor
             assessable for response.

          -  Signed informed consent indicating awareness of the investigational nature of this
             program.

        Exclusion Criteria:

          -  Creatinine > 3.0 mg/dL

          -  ALT, AST and Alkaline Phosphatase > 5.0 times the upper limit of normal

          -  Bilirubin > 3.0 mg/dL

          -  Patients with grade 3 or higher toxicities (using the CTCAE v34.0) related to cardiac,
             neurological, pulmonary or gastrointestinal function as determined by physical exam.
             Patients must have normal blood pressure for age.

          -  Progressive disease

          -  History of allergy to mouse proteins

          -  Active life-threatening infection.

          -  Human anti-mouse antibody (HAMA) titer >1000 Elisa units/ml.

          -  Inability to comply with protocol requirements.
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
Condition: Idiopathic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombocytopenic, Idiopathic
Intervention: rituximab [MabThera/Rituxan]
Intervention description: 1000mg iv on days 1 and 15
Intervention MeSH terms: Rituximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm study will evaluate the efficacy and safety of MabThera monotherapy in
      patients with refractory, relapsing or chronic idiopathic thrombocytopenic purpura (ITP).
      Patients will receive infusions of MabThera 1000mg i.v. on days 1 and 15. 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;

          -  refractory, relapsing or chronic idiopathic thrombocytopenic purpura;

          -  stable therapy during 3 weeks prior to study entry.

        Exclusion Criteria:

          -  newly diagnosed ITP (<6 weeks);

          -  prior treatment with MabThera;

          -  active bleeding requiring platelet transfusion within 7 days prior to entry into
             study.