bioihbjkbjnl/mcl2 huggingface dataset:
High-Dose Sequential Therapy and Single Autologous Transplantation for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Cyclophosphamide; Etoposide; Melphalan; Carmustine; Filgrastim
Intervention description: Cyclophosphamide as a white powder in 100 mg, 200 mg and 500 mg vials, to be dissolved in ~250 mL of saline or D5W and infused IV over 2 hours; 100 mg etoposide as 5 mL solution in clear ampules for injection.; Melphalan as single-use glass vials of freeze-dried melphalan hydrochloride (equivalent to 50 mg of melphalan), to be reconstituted in 0.9% sodium chloride solution to not greater than 0.45 mg/mL, and administered within 1 hour of constitution.; Carmustine as a powder for reconstitution in 100 mg vials, to be reconstituted with 3 mL sterile dehydrated ethanol and D5W. Carmustine should be dissolved in 500 mL of 5% dextrose in water (D5W) and infused IV over 2 hours.; Filgrastim in vials of 300 µg or 480 µg at a concentration of 300 µg/mL, to be given as a daily subcutaneous injection.
Intervention MeSH terms: Cyclophosphamide; Melphalan; Carmustine; Etoposide; Etoposide phosphate; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study uses a sequence of high-dose chemotherapy drugs and a stem cell transplant to
      treat multiple myeloma. The study is being performed to evaluate the efficacy and side
      effects of treatment. Specifically, the study is designed to reduce the risk of interstitial
      pneumonitis.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Stage II to III multiple myeloma, or progression after initial treatment of Stage I
             disease; early or relapsed

          -  Age 18 to 75 years.

          -  Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center.

          -  Patients with amyloidosis may be eligible for this trial, with approval by the
             Principle Investigator.

          -  Patients must have a Karnofsky performance status > 70%.

          -  Aspartate aminotransferase (AST) must be < 2 x upper limit of normal (ULN)

          -  Alanine aminotransferase (ALT) must be < 2 x ULN

          -  Total bilirubin < 2 mg/dL.

          -  Serum creatinine < 2.0 or 24-hour creatinine clearance ≥ 60 mL/min.

          -  Patients must be HIV-negative.

          -  Patients must provide signed, informed consent.

        EXCLUSION CRITERIA

          -  Severe psychological or medical illness

          -  Prior autologous hematopoietic cell transplantation

          -  Pregnant

          -  Lactating women

          -  Smoldering multiple myeloma,

          -  Monoclonal gammopathy of unknown significance or primary amyloidosis will be excluded
             from this study
Treatment With Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Metastatic Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu -J591)
Intervention description: Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) consisting of J591 chelated at a specific activity of 12-15 mCi of 177Lu per mg of antibody plus sufficient non-radiolabeled, non-DOTA-conjugated ("naked") J591 to achieve a total antibody dose of 20 mg. Each dose will be administered by an IV infusion at a rate not to exceed 5 mg/min.
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate Cancer

Summary:

      The purpose of this study is to find out how effective 177Lu -J591 is in the treatment of
      patients with metastatic, androgen-independent prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of prostate adenocarcinoma.

          -  Metastatic prostate cancer progressive on imaging studies and/or rising PSA despite
             adequate medical or surgical castration therapy.

          -  Progressed following discontinuation of anti-androgen therapy, if received.

          -  Serum testosterone < 50 ng/ml

        Exclusion Criteria:

          -  Use of corticosteroids and/or adrenal hormone inhibitors within 4 weeks of treatment.

          -  Use of PC-SPES within 4 weeks of treatment.

          -  Use of red blood cell or platelet transfusions within 4 weeks of treatment.

          -  Use of hematopoietic growth factors within 4 weeks of treatment.

          -  Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.

          -  Bone scan demonstrating confluent lesions involving both axial and appendicular
             skeleton.

          -  Prior radiation therapy encompassing >25% of skeleton.

          -  Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®,
             Quadramet®).

          -  Active angina pectoris or NY Heart Association Class III-IV.

          -  History of deep vein thrombophlebitis and/or pulmonary embolus within 3 months of
             study entry.

          -  Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or
             hematological organ systems which might preclude completion of this study or interfere
             with determination of causality of any adverse effects experienced in this study.

          -  Prior monoclonal antibody therapy with the exception of ProstaScint®

          -  Prior investigational therapy (medications or devices) within 6 weeks of treatment.

          -  Known history of HIV
High-Dose Cyclophosphamide for Steroid Refractory GVHD
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Intervention: Cyclophosphamide
Intervention MeSH terms: Cyclophosphamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 75 Years
Healthy volunteers: No
Keywords: graft versus host disease

Summary:

      RATIONALE: High-dose cyclophosphamide may be an effective treatment for acute
      graft-versus-host disease that did not respond to steroid therapy.

      PURPOSE: This phase II trial is studying the side effects, best dose, and how well high-dose
      cyclophosphamide works in treating patients with acute graft-versus-host disease that did not
      respond to steroid therapy.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed acute graft-versus-host disease (GVHD) ≥ clinical grade II,
             that is steroid refractory

               -  Steroid refractory GVHD is defined as GVHD that has progressed (increasing in
                  grading) despite 49 hours of treatment with methylprednisolone of ≥ 2.0 mg/kg OR
                  GVHD that has failed to improve (no change in grading stage) despite 4 days of
                  treatment with methylprednisolone of ≥ 2.0 mg/kg

          -  Prior allogeneic hematopoietic stem cell transplantation using either bone marrow,
             peripheral blood stem cells, or cord blood OR prior donor lymphocyte infusion required

          -  Evidence of myeloid engraftment

          -  No chronic GVHD

        PATIENT CHARACTERISTICS:

          -  ECOG (Eastern Cooperative Oncology Group) performance status (PS) 0-2 OR Karnofsky PS
             60-100%

          -  ANC (absolute neutrophil count) > 500/mm³

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Must be geographically accessible

          -  No allergy or intolerance to cyclophosphamide or mesna

          -  No HIV positivity

          -  No mechanical ventilation

          -  No active bleeding (excluding gastrointestinal bleeding) or history of hemorrhagic
             cystitis

          -  No other uncontrolled illness including, but not limited to, the following:

               -  Ongoing or active infection

               -  Medical condition precluding patient from stopping azoles (e.g., fluconazole,
                  itraconazole, or voriconazole) or other adequate antifungal therapy during
                  cyclophosphamide administration

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Psychiatric illness/social situations that would preclude compliance

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics
Acute Pain Study Following Bunionectomy
Condition: Pain
MeSH terms: Acute Pain
Intervention: Hydrocodone/Acetaminophen Extended Release; Placebo
Intervention description: Placebo tablet
Intervention MeSH terms: Acetaminophen; Acetaminophen, hydrocodone drug combination; Hydrocodone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study was to evaluate analgesic efficacy and safety of
      hydrocodone/acetaminophen extended release compared to placebo in the treatment of moderate
      to severe pain following bunionectomy.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects who were in general good health, experiencing moderate to severe pain following
        bunionectomy

        Exclusion Criteria:

          -  Subjects who underwent Base wedge osteotomy and / or Long-Z Hart bunionectomy
             procedures

          -  Drug allergies to hydrocodone, acetaminophen

          -  Clinically significant or uncontrolled medical disorders or illness - history of drug
             or alcohol abuse / addiction
Microscopic Fluorescence-guided Vestibular Schwannoma Resection Using Fluorescein Sodium and YELLOW 560
Condition: Vestibular Schwannoma
MeSH terms: Neurilemmoma; Neuroma, Acoustic
Intervention: Fluorescein Sodium; YELLOW560 filter
Intervention description: Intravenous administration 1 mg/kg initial dosing if insufficient additional doses of 1 mg/kg may be administered.; Integrated fluorescence module serves to make fluorescent areas visible to assist in visualizing tumor during the resection.
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Paraganglioma; Head and Neck Schwannoma

Summary:

      The purpose of this study is to see if there is benefit to using an IV contrast called
      AK-Fluor® and a microscope filter called YELLOW560 when surgically removing a vestibular
      schwannoma, Meningioma, Head and Neck Paraganglioma, or Head and Neck Schwannoma.
    

Eligibility criteria:

        Inclusion Criteria

          -  Patient with a suspected VS

          -  Recurrent VS with prior microsurgical resection or radiation therapy

          -  Clinical indication for microsurgical resection

        Exclusion Criteria

          -  History of allergy to FS

          -  History of renal failure

          -  Pregnant women

          -  Those with inability to give informed consent

          -  Prisoners and inmates
A Trial of Sertraline in Young Children With Autism Spectrum Disorder
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Sertraline Liquid Placebo; Sertraline
Intervention description: Liquid placebo given in parallel to active medication; Active medication
Intervention MeSH terms: Sertraline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 58.0
Sex: All
Minimum age: 24 Months
Maximum age: 72 Months
Healthy volunteers: No
Keywords: Autism Spectrum Disorder; Behavior; sertraline; treatment

Summary:

      This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old
      inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant
      will receive a series of tests at both the beginning and end of the study. The researchers
      hope to show improvements in language and social deficits.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for
             Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment
             such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic
             Interview-Revised.

          -  Subject between the ages of 24-72 months of age.

          -  A reliable parent or caregiver who can report the side effects and communicate
             effectively with the research team.

          -  Stable medications during the two months prior to enrollment.

          -  Currently receiving interventions in the community or school for Autism Spectrum
             Disorder

        Exclusion Criteria:

          -  Current or past Selective Serotonin Reuptake Inhibitor treatment.

          -  Other serious co-morbid medical disorders affecting brain function and behavior,
             including uncontrolled seizures.
Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension
Condition: Tourette Syndrome in Children; Tourette Syndrome in Adolescence
MeSH terms: Tourette Syndrome; Syndrome
Intervention: Ecopipam
Intervention description: Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.
Intervention MeSH terms: Ecopipam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Open Label
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Tourette Syndrome

Summary:

      This study was an international, multicenter, open-label, long term extension study
      evaluating the safety of ecopipam tablets for the treatment of children and adolescent
      subjects with Tourette Syndrome.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up
             Visit within the last 30 days (or longer with permission of the medical monitor)
             without a major reportable protocol deviation and must be someone the Investigator
             feels would benefit from continued participation.

        Exclusion Criteria:

          -  Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder,
             schizophrenia, major depressive disorder).

          -  Unstable medical illness or clinically significant lab abnormalities.

          -  Risk of suicide.

          -  Pregnant or lactating women.

          -  Moderate to severe renal insufficiency.

          -  Positive urine drug screen.

          -  Certain medications that would lead to drug interactions.
Efficacy and Safety Study of MCI-196 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MCI-196; Placebo of MCI-196 Tablet
Intervention description: Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg); Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
Intervention MeSH terms: Bile Acids and Salts
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 183.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes; anion-exchange resin

Summary:

      The objective of this study is to evaluate the efficacy of MCI-196 in patients with Type 2
      Diabetes based on the changes in blood glucose-related parameters and safety after 12 weeks
      administration in double-blind, placebo-controlled manner. And in addition, the changes in
      lipid-related parameters are examined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients whose fasting blood glucose levels during the observation period are between
             130mg/dL and 200mg/dL.

          -  Patients whose HbA1c is 7.0% or above during the observation period.

        Exclusion Criteria:

          -  Patients with serious cardiac, hepatic or renal complications.

          -  Patients with serious diabetic complications.

          -  Patients with complete biliary obstruction or ileus.

          -  Pregnant, lactating, and probably pregnant patients, and patients who can not agree to
             contraception.
Study to Evaluate the Safety and Efficacy of NKTR-102 in Patients With Metastatic or Locally Advanced Breast Cancer
Condition: Tumor; Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: NKTR-102; NKTR-102
Intervention description: NKTR-102 given on a q14 day schedule; NKTR-102 given on a q21 day schedule
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, two-arm, 2-stage, Phase 2 study of NKTR-102 in patients
      with metastatic or locally advanced breast cancer whose disease has failed prior taxane-based
      treatment in the metastatic setting.

      Patients will be randomized 1:1 into one of two treatment arms. NKTR 102 will be administered
      at a dose level of 145 mg/m2 in both arms. In Arm A, NKTR-102 will be given on a q14d
      schedule. In Arm B, NKTR-102 will be given on a q21d schedule. Approximately 70 patients may
      be evaluated in this study with approximately 35 patients enrolled in each treatment arm.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Inoperable metastatic or locally advanced breast cancer

          2. No more than 2 prior chemotherapy regimens given in a metastatic or locally advanced
             setting and prior treatment in the metastatic setting must have included a taxane

        Exclusion Criteria:

          1. Patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to Day 1 of Cycle 1

          2. Patients who have had any major surgery within 4 weeks prior to Day 1 of Cycle or
             minor surgery within 2 weeks prior to Day 1 of Cycle 1
Study of BMS-754807 Combined With Letrozole or BMS-754807 Alone in Patients With Hormone Receptor-Positive Breast Cancer and Resistance to Non-Steroidal Aromatase Inhibitors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: BMS-754807; letrozole
Intervention description: Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity; Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity
Intervention MeSH terms: Letrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate oral doses of BMS-754807 in combination with
      letrozole or BMS-754807 alone are safe and efficacious in locally advanced or metastatic
      hormone receptor positive breast cancer subjects who have progressed with prior non-steroidal
      aromatase inhibitor treatment.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Postmenopausal women with hormone receptor-positive and HER-2 negative breast cancer

          -  Disease progression following non-steroidal aromatase inhibitor treatment

        Exclusion Criteria:

          -  Known symptomatic brain metastasis

          -  Medical condition requiring chronic steroids

          -  History of Type 1 or 2 Diabetes

          -  Uncontrolled or significant cardiovascular (CV) disease

          -  Concomitant second malignancies
Effect of Antioxidant Vitamins on Coagulopathy and Nosocomial Pneumonia After Severe Trauma
Condition: Coagulopathy; Nosocomial Pneumonia
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia; Hemostatic Disorders; Blood Coagulation Disorders
Intervention: Vitamin C; Vitamin E; Saline (for Vitamin C); Placebo (for Vitamin E)
Intervention description: 0.9% saline administered to mimic Vitamin C; Sugar pill administered to mimic Vitamin E
Intervention MeSH terms: Vitamins; Ascorbic Acid; Vitamin E; Tocopherols; Tocotrienols; alpha-Tocopherol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 11.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the effect of antioxidant vitamins (vitamins C and
      E) on the development of coagulation derangements and nosocomial pneumonia after severe
      trauma in patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult trauma patients admitted to the emergency department at the University of
             Alabama at Birmingham (UAB) Hospital

          -  Blunt or penetrating injury

          -  UAB highest trauma activation

        Exclusion Criteria:

          -  Age < 19 years of age

          -  Patients with known bleeding diathesis or who are concurrently taking anticoagulant
             medication

          -  Patients with known liver disease

          -  Minor patients

          -  Pregnant patients (known or suspected pregnancy)

          -  Patients who are incarcerated

          -  Patients who lack a surrogate
Effect of Pasireotide Long Acting Release (LAR) on Gonadotroph Adenomas
Condition: Gonadotroph Adenomas
MeSH terms: Adenoma
Intervention: pasireotide LAR
Intervention description: pasireotide LAR 80 mg IM once a month
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pituitary tumor; endocrine

Summary:

      The purpose of this study is to determine if administration of pasireotide LAR for one year
      to three patients with gonadotroph adenomas and elevated serum FSH concentrations will reduce
      the serum follicle-stimulating hormone (FSH) to normal and reduce the adenoma size.
    

Eligibility criteria:

        Inclusion Criteria:

          -  gonadotroph adenoma

        Exclusion Criteria:

          -  visual impairment attributable to the adenoma

          -  radiation therapy

          -  active gallbladder disease

          -  uncontrolled diabetes