bioihbjkbjnl/mcl2 huggingface dataset:
GORE TAG® Thoracic Endoprosthesis - 45 mm for the Treatment of Aneurysms of the Descending Thoracic Aorta
Condition: Aortic Aneurysm, Thoracic
MeSH terms: Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Thoracic
Intervention: GORE TAG® Thoracic Endoprosthesis
Intervention description: Implant
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The objective of this study is to assess the safety and efficacy of the 45 mm TAG device in
      subjects with aneurysms of the descending thoracic aorta.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Presence of Descending thoracic aortic aneurysm deemed to warrant surgical repair

               -  Fusiform (≥50 mm), or

               -  Saccular (no diameter criteria)

          2. All proximal and/or all distal landing zone inner diameters between 37-42 mm

               -  Diameter taper between proximal and distal landing zones and the ability to use
                  devices of different diameters to compensate for the taper must be within device
                  sizing guide specifications

          3. Proximal and distal landing zone length greater than 2.0 cm

               -  Landing zone must not be aneurysmal, dissected, heavily calcified, or heavily
                  thrombosed

          4. Life expectancy > 2 years

          5. Subject is open surgical candidate defined as:

               -  Able to tolerate thoracotomy

               -  American Society of Anesthesiologists class I-IV (class V excluded)

               -  New York Heart Association class I-III or not applicable (class IV excluded)

          6. Male or infertile female

          7. Age greater than 21 years

          8. Able to comply with study protocol requirements, including follow-up

        Exclusion Criteria:

          1. Mycotic aneurysm

          2. Hemodynamically unstable aneurysm rupture

          3. Aortic dissection

          4. Planned occlusion of left carotid or celiac arteries

          5. Planned concomitant surgical procedure (other than left subclavian transposition), or
             major surgery within 30 days of treatment date

          6. Myocardial infarction or stroke within 6 weeks of treatment

          7. Pre-treatment creatinine > 2.0 mg/dL

          8. Degenerative connective tissue disease, e.g. Marfan's or Ehler-Danlos Syndrome

          9. Participation in another drug or device study within 1 year of treatment

         10. History of drug abuse within 6 months of treatment
Radiation Therapy in Treating Patients With Stage II or Stage III Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: High Dose brachytherapy boost; External beam radiotherapy
Intervention description: 19 Gy in two fractions (on day of placement and 6-24 hours later) before or after external beam radiotherapy, such that all study treatment occurs within 8 weeks.; 45 Gy as 1.8 Gy five days a week for five weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 129.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer

Summary:

      RATIONALE: Radiation therapy uses high-energy x-rays and other sources to damage tumor cells.
      Internal radiation therapy uses radioactive material placed directly into or near a tumor to
      kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving internal radiation therapy together
      with external-beam radiation therapy works in treating patients with stage II or stage III
      prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically confirmed, adenocarcinoma of the prostate, clinical stage T1c-T3b, N0,
             M0.

          2. Patient will have clinically negative nodes as established by imaging (pelvic computed
             tomography (CT), magnetic resonance imaging (MRI)).

          3. The patient will be clinically M0.

          4. Zubrod status 0-1.

          5. No prior pelvic or prostate radiation or chemotherapy for prostate cancer; induction
             hormonal therapy beginning ≤ 120 days prior to registration is acceptable.

          6. One of the following combinations of factors:

             Clinical stage T1c-T2c, Gleason score 2-6 and prostate-specific antigen (PSA) >10 but
             ≤ 20 Clinical stage T3a-T3b, Gleason score 2-6 and PSA ≤ 20 Clinical stage T1c-T3b,
             Gleason score 7-10 and PSA ≤ 20

          7. Patients must sign a study-specific consent form prior to registration.

        Exclusion Criteria:

          1. Stage T4 disease.

          2. Lymph node involvement (N1).

          3. Evidence of distant metastases (M1).

          4. Radical surgery for carcinoma of the prostate.

          5. Previous hormonal therapy beginning > 120 days prior to registration.

          6. Major medical or psychiatric illness which, in the investigator's opinion, would
             prevent completion of treatment and would interfere with follow-up.

          7. Prior transurethral resection of the prostate (TURP).

          8. Prior invasive malignancy(except non-melanomatous skin cancer) unless disease free for
             a minimum of 3 years (For example, carcinoma in situ of the oral cavity or bladder are
             permissible).

          9. Hip prosthesis.
Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: SOF; VEL; RBV
Intervention description: 400 mg tablet administered orally once daily; Tablet administered orally once daily; 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Ribavirin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 323.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatitis; Genotype 1; Genotype 3; Treatment experienced

Summary:

      The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
      tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
      in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)
      infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) ≥ 18 kg/m^2

          -  HCV RNA ≥ 10000 IU/mL at screening

          -  Prior treatment failure to a regimen including interferon with or without RBV

          -  HCV genotype 1 or 3

          -  Chronic HCV infection

          -  Cirrhosis determination

          -  Use of highly effective contraception methods if female of childbearing potential or
             sexually active male

        Exclusion Criteria:

          -  Current or prior history of clinically significant illness other than HCV

          -  Screening ECG with clinically significant abnormalities

          -  Prior exposure to HCV specific direct acting antiviral agent

          -  Pregnant or nursing female or male with pregnant female partner

          -  Chronic liver disease of non-HCV etiology

          -  Hepatitis B

          -  Active drug abuse

          -  Use of any prohibited concomitant medications
Docusate/Senna for the Treatment of Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Intervention: senna/docusate
Intervention description: Stimulant laxative
Intervention MeSH terms: Bismuth subsalicylate; Sennosides
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The aim of the study is to evaluate the efficacy of the stimulant laxative Senokot-S® for the
      treatment of diabetic gastroparesis. Senokot-S, and its metabolites, are thought to produce
      peristalsis, drive intraluminal fluid and electrolyte shifts, and have an irritant effect on
      the gut mucosa. These complex physiologic mechanisms appear may sufficiently promote stomach
      emp-tying, and thereby reduce or eliminate the severity of gastroparesis symptoms. In this
      open label study, participants will be randomized into high and low dose groups to assess for
      ideal dosing and tolerability. It is the overall goal of this study to select the most
      promising dose-strength for the treatment of mild through severe gastroparesis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-75 years, male and non-pregnant, non-lactating females

          -  Diagnosis of type 1 or type 2 diabetes mellitus

          -  Clinical diagnosis of diabetic gastroparesis

        Exclusion Criteria:

          -  Diagnosed idiopathic gastroparesis

          -  A history or inflammatory bowel disease, such as Crohn's disease or ulcerative colitis

          -  A history of bowel obstruction, current unexplained abdominal pain, or undiagnosed
             rectal bleeding

          -  Gastrointestinal cancer

          -  Any active cancer

          -  Prior gastric surgery

          -  End-stage heart disease, liver disease, lung disease

          -  Known or suspected drug abuse

          -  Any condition requiring use of daily narcotics

          -  Concurrent usage of mineral oil or products containing mineral oil

          -  Current or recent (within the last 3 months) usage of Senokot-S, docusate or senna
Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence
Condition: Methamphetamine Dependence
Intervention: Bupropion; Placebo
Intervention description: 150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.; Placebo
Intervention MeSH terms: Bupropion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 200.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects
      with methamphetamine dependence who report using methamphetamine 29 or less days during the
      30 days prior to the start of signing consent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI

          -  Must have at least 1 amphetamine or methamphetamine positive urine specimen after the
             start of screening and before randomization or provide information to verify recent
             use if a positive urine sample can't be obtained

          -  Must report using methamphetamine for 29 days or less during the 30 day period prior
             signing consent using the timeline follow-back method

          -  Must be willing and able to comply with study procedures

          -  Must be able to verbalize and understand consent forms and provide written informed
             consent

          -  Must be seeking treatment for methamphetamine dependence

        Exclusion Criteria:

          -  Please contact study site for more information
Hematopoietic Stem Cell Transplantation (HSCT) for Children With SCID Utilizing Alemtuzumab, Plerixafor & Filgrastim
Condition: Severe Combined Immunodeficiency
MeSH terms: Severe Combined Immunodeficiency; Immunologic Deficiency Syndromes
Intervention: Transplant Conditioning with Mobilization Only; Transplant Conditioning with Mobilization and Alemtuzumab
Intervention description: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant; Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant
Intervention MeSH terms: Plerixafor; Alemtuzumab; Lenograstim
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Maximum age: 3 Years
Healthy volunteers: No
Keywords: SCID; Transplant; Alemtuzumab; Plerixafor

Summary:

      The goal of this study is to develop a novel approach to hematopoietic stem cell
      transplantation for children with Severe Combined Immunodeficiency Disease (SCID) that
      eliminates the use of toxic chemotherapy conditioning and maximizes the likelihood of T and B
      cell immune reconstitution. Rather than classic chemotherapeutic agents, the investigators
      will utilize a targeted stem cell mobilizer, plerixafor, in combination with alemtuzumab, a
      monoclonal antibody. Correlative scientific questions will include: 1) efficacy and
      characteristics of host stem cell mobilization; and 2) alemtuzumab pharmacokinetics in very
      young children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with classic SCID phenotype (<400 CD3/ul or maternally engrafted and <10% of
             normal PHA lymphoproliferative response). Genotypic identification is preferable, but
             not required.

          -  Patients must have an acceptable stem cell donor (HLA matched relative, 9 or 10/10
             HLA-matched unrelated, or haplocompatible relative).

        Exclusion Criteria:

          -  Patients with "leaky" SCID syndromes, Omenn's Syndrome, reticular dysgenesis, ADA
             deficiency

          -  Lansky score <60%

          -  Patient with expected survival <4 weeks (including disseminated CMV infection
             involving lungs and/or CNS)
Omega-3 Fatty Acids for Hyperactivity Treatment in Autism Spectrum Disorder
Condition: Autism Spectrum Disorders; Hyperactivity
MeSH terms: Hyperkinesis; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Intervention: Omega-3 Fatty Acids; Placebo
Intervention description: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).; Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 57.0
Sex: All
Minimum age: 5 Years
Maximum age: 8 Years
Healthy volunteers: No

Summary:

      The proposed study is an internet-based, randomized, double-blind, placebo-controlled trial
      which will assess changes in hyperactivity in children ages five through eight with an autism
      spectrum disorders (ASD) and elevated levels of hyperactivity. In order to answer this
      question, this study will assess changes in hyperactivity as measured by the Aberrant
      Behavior Checklist (ABC) in children with ASD and elevated baseline levels of hyperactivity
      who are randomly assigned to use 1.3 grams of omega-3 fatty acids daily compared to placebo.
      The overwhelming majority of study procedures, including recruitment, informed consent,
      assessment of inclusion and exclusion criteria, and collection of baseline and outcome
      measures will take place over the internet.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Children who are participating in Interactive Autism Network (IAN) Research Families

          2. Diagnosis of (Autism Spectrum Disorders (ASD) by a professional and Social
             Communication Question (SCQ) score>12

          3. Age 5-8

          4. Aberrant Behavior Checklist - Hyperactivity subscale (ABC-H)>20

        Exclusion Criteria:

          1. Children in foster care and each parent must affirm that they are the biological or
             adoptive parent of the child

          2. Allergy to fish

          3. Bleeding disorder, current use of anticoagulant or anti-platelet therapy, or recent or
             planned surgery

          4. Any major medical illness that interferes with regular school attendance

          5. Current or recent (past six months) use of omega-3 fatty acid

          6. Siblings with ASD
Beta-blockade Effects on Memory for Cocaine Craving
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Intervention: Propranolol; Placebo
Intervention description: 40 mg administered once; administered once
Intervention MeSH terms: Propranolol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cocaine; cocaine-dependent; propranolol; craving; beta-blockade; cue exposure; drug; addiction; memory; addictive behavior

Summary:

      The purpose of this study is to examine the effects of propranolol versus placebo on
      responses to cocaine cues in cocaine dependent individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current cocaine dependence (within past month)

          -  Able to provide informed consent

          -  Use of birth control by female participants (barrier methods, surgical sterilization,
             IUD, or abstinence)

          -  Live within 50-mile radius of research site

          -  Consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours
             prior to inpatient admission and follow-up assessment

          -  Consent to random assignment to propranolol or placebo

        Exclusion Criteria:

          -  Women who are pregnant, nursing or are of childbearing potential and not
             practicing/using birth control

          -  Evidence or history of significant hematological, endocrine, cardiovascular,
             pulmonary, renal, gastrointestinal or neurological disease

          -  Significant liver impairment

          -  History of or current psychotic disorder, current severe major depressive disorder,
             bipolar affective disorder or a severe anxiety disorder

          -  Currently taking anti-arrhythmic agents, psychostimulants or other agents known to
             interfere with heart rate and skin conductance monitoring

          -  Known or suspected hypersensitivity to propranolol

          -  Individuals taking medications that could adversely interact with the study
             medication, including, but not limited to albuterol, insulin, or significant
             inhibitors of CYP2D6

          -  Individuals with bronchial asthma or chronic obstructive pulmonary disease
Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Lymphoma, Lymphoblastic
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Etoposide, cytarabine, vincristine, dexamethasone; methotrexate, teniposide, PEG-asparaginase; mitoxantrone, cyclophosphamide, mercaptopurine, vinblastine; L-asparaginase, erwinia asparaginase; chemotherapy, intrathecal chemotherapy, steroid therapy; Hematopoietic Stem Cell Transplant; Natural Killer (NK) Cell Transplant
Intervention description: See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.; See Detailed Description section for details of treatment interventions.
Intervention MeSH terms: Cytarabine; Dexamethasone; Dexamethasone acetate; Cyclophosphamide; Methotrexate; Etoposide; Etoposide phosphate; Vincristine; Asparaginase; Mitoxantrone; Mercaptopurine; Vinblastine; Pegaspargase; Teniposide; BB 1101
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Leukemia; Lymphoblastic; Acute; Lymphoma; Non-Hodgkin's

Summary:

      The main purpose of this study is to find out how well participants with relapsed or
      refractory ALL respond to treatment with an etoposide- and teniposide-based induction
      chemotherapy regimen and what the side effects are.

      Primary Objectives:

        -  To estimate the response rate for patients with refractory or relapsed ALL.

        -  To estimate the survival rate of patients with refractory or relapsed ALL treated with
           risk-directed therapy.
    

Eligibility criteria:

        Inclusion Criteria

          -  Childhood ALL in first relapse OR in first hematological relapse after an
             extramedullary relapse, OR not attaining a complete remission with frontline
             therapies, OR lymphoblastic leukemia in first relapse.

          -  Patients must be 21 years of age or younger

          -  Informed consent explained to and signed by parent/legal guardian.

        Exclusion Criteria

          -  Life expectancy less than 8 weeks

          -  Patients with mature B cell ALL