bioihbjkbjnl/mcl2 huggingface dataset:
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Condition: Intermittent Explosive Disorder
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Intervention: Fluoxetine; Divalproex; Placebo
Intervention description: Fluoxetine capsules by mouth, up to 60 mg daily; Divalproex ER capsules by mouth, up to 3000 mg daily; Placebo capsules by mouth, up to 8 capsules daily
Intervention MeSH terms: Valproic Acid; Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 90.0
Sex: All
Minimum age: 21 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for
      the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder
      (IED).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Intermittent Explosive Disorder (IED)

          -  In good physical health

          -  Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening

          -  Willing and able to comply with the study requirements

        Exclusion Criteria:

          -  Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental
             retardation

          -  Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score
             higher than 18

          -  Current alcohol or drug abuse or dependence

          -  Active medical conditions that will interfere with the study

          -  Thymoleptic or neuroleptic treatments

          -  Presence of the following serious and active medical conditions: demyelinating or
             progressive degenerative disorders; central nervous system infection; progressive
             degenerative neurological disorder; ischemic heart disease; respiratory, renal, or
             liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy;
             Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a
             history of more than two febrile seizures prior to 1 year of age are eligible.

          -  Chronic, ongoing treatment with the following classes of medications: antidepressants,
             neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic
             narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics,
             non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat
             cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV
             antiviral agents

          -  Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started
             less than 3 months before study entry

          -  Hypersensitivity to fluoxetine or divalproex

          -  Pregnancy
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Trastuzumab; Taxane (docetaxel or paclitaxel)
Intervention description: 4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.; Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Trastuzumab; Taxane
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without
      a taxane for the first line treatment of metastatic breast cancer in women who have relapsed
      at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for
      HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading
      dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by
      3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or
      paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study
      treatment is until disease progression, and the target sample size is <100 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  at least 10 months of Herceptin treatment for HER2-positive early breast cancer;

          -  metastatic breast cancer >=12 months after discontinuation of Herceptin;

          -  measurable disease.

        Exclusion Criteria:

          -  previous chemotherapy for metastatic breast cancer;

          -  brain metastases;

          -  invasive malignancy other than metastatic breast cancer.
Curcumin in Treating Patients With Familial Adenomatous Polyposis
Condition: Familial Adenomatous Polyposis
MeSH terms: Colorectal Neoplasms; Nasopharyngeal Neoplasms; Adenomatous Polyposis Coli
Intervention: Curcumin; Laboratory Biomarker Analysis; Placebo
Intervention description: Given PO; Correlative studies; Given PO
Intervention MeSH terms: Curcumin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies curcumin in treating patients with familial
      adenomatous polyposis. Curcumin may prevent colorectal cancer in patients with a history of
      rectal polyps or colorectal neoplasia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with familial adenomatous polyposis who have undergone subtotal colectomy
             with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir),
             and patients with intact colons with 5 or more adenomas in the rectum-sigmoid or
             reservoir

          -  Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis
             without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy

        Exclusion Criteria:

          -  Female patients of childbearing age not on effective birth control

          -  Pregnant women

          -  White blood cell count (WBC) < 3500/ml

          -  Platelet count < 100,000/ml

          -  Blood urea nitrogen (BUN) > 25mg%

          -  Creatinine > 1.5mg%

          -  Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs), aspirin,
             curcumin, tumeric, calcium, vitamin D, green tea, or polyphenol E supplements for the
             duration of the trial

          -  Malignancy other than nonmelanoma skin cancer

          -  Active bacterial infection

          -  Patients with symptoms of active gastroesophageal reflux disease (GERD) (symptomatic
             despite medication or current erosive esophagitis on endoscopy)

          -  Patients with a history of peptic ulcer disease

          -  Patients on warfarin or plavix
Does Continued Use of Clopidogrel Into Surgery Cause Increased Perioperative Bleeding?
Condition: Clopidogrel
Intervention: Clopidogrel; Discontinue Clopidogrel
Intervention description: Continue home dose of clopidogrel into surgery; Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
Intervention MeSH terms: Clopidogrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: clopidogrel; general surgery

Summary:

      Patients who on taking clopidogrel are randomized to either continue clopidogrel into general
      surgery or discontinue clopidogrel 7 days before surgery. All patients resume clopidogrel
      after surgery. The investigators track the development of bleeding complications that may
      develop within 90 days of the surgery. Patients are medically cleared to be in either arm of
      the study by their cardiologist and surgeon. There is currently no evidence to support for or
      against the use continuation or discontinuation of clopidogrel prior to general surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  taking clopidogrel

          -  undergoing general surgery

          -  cleared by both cardiologist and surgery for randomized arm

        Exclusion Criteria:

          -  previous history of bleeding complications/bleeding disposition

          -  no capacity to consent
AC105 in Patients With Acute Traumatic Spinal Cord Injury
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Intervention: AC105; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Acute; Traumatic; SCI; Spinal Cord Injury

Summary:

      The principal aim of this study was to establish the feasibility of rapid administration,
      safety, and tolerability of AC105 in patients with acute spinal cord injury.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between 18 and 65 years of age, inclusive

          -  Acute traumatic SCI, at a neurological level between C4 and T11

          -  No evidence of penetrating or transection injury (e.g. caused by projectile or stab
             wound)

          -  Neurological ASIA Impairment Scale A, B or C

          -  Patient is able to provide written or verbal witnessed consent. If unable to provide
             either, consent may be provided by legally authorized representative (LAR)

          -  Patient is able to initiate treatment within time window of injury

        Exclusion Criteria:

          -  Known allergy or hypersensitivity to polyethylene glycol

          -  Mental impairment or other conditions that would preclude a reliable ASIA exam or
             adequate consent

          -  Positive urine pregnancy test result

          -  Serum creatinine level ≥ 2 mg/dL

          -  History or active renal failure or dialysis

          -  Mean arterial blood pressure < 60 mmHg despite vasopressor treatment

          -  On a current regimen of digoxin

          -  Chronic use of magnesium salts prior to the SCI (within 1week of presentation) and/or
             the use of magnesium salts in the acute care setting prior to the administration of
             investigational product

          -  Any other medical condition that, in the judgment of the investigator, would preclude
             provision of informed consent, make participation in the study unsafe, or unreasonably
             complicate follow-up or the interpretation of study outcome data or may otherwise
             interfere with achieving the study objectives

          -  In the judgment of the Investigator, cannot adequately provide informed consent, is
             likely to be non-compliant, or may be unable to cooperate with study requirements
Proton Beam Radiation Therapy for Intraocular and Periocular Retinoblastoma
Condition: Retinoblastoma
MeSH terms: Retinoblastoma
Intervention: Proton Beam Radiation Therapy; Ophthalmic EUA
Intervention description: Radiation given daily for 5 days in a row each week (except for Saturdays, Sundays, and holidays). The whole treatment will take about 4-6 weeks.; Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Healthy volunteers: No
Keywords: Children with retinoblastoma; Retinoblastoma; Pediatrics; Proton Beam Radiation Therapy; Radiation Therapy; Tumor of the Eye; Ophthalmic EUA; Examination under anesthesia; Bilateral retinoblastoma; Unilateral retinoblastoma; Extraocular disease; Intraocular procedure

Summary:

      The purpose of this trial is to evaluate proton beam radiation therapy as an alternative to
      external photon beam irradiation in children with retinoblastoma as a means of local tumor
      control and ocular retention.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Active or recurrent retinoblastoma patient eligible for treatment of external beam
             radiation therapy.

          2. A parent or guardian who can provide informed consent to a minor or child participant.

          3. No concurrent infection.

          4. No contraindication for repeated general anesthesia/sedation.

        Exclusion Criteria:

          1. Inability to return for multiple examinations under anesthesia.

          2. Medical contraindication for exams under anesthesia/sedation.

          3. Unreliable follow-up.
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Condition: Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Methotrexate; Vincristine; PEG-l-asparaginase; Dexamethasone; Rituximab
Intervention description: 200 mg/m^2 by vein on days 1 and 15.; 1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.; 2500 International units/m^2 by vein on days 2 and 16; 40 mg by vein or by mouth daily days 1-4 and 15-18.; Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.
Intervention MeSH terms: Dexamethasone; Rituximab; Methotrexate; Vincristine; Asparaginase; Pegaspargase
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No
Keywords: Acute lymphoblastic leukemia; ALL; Leukemia; Methotrexate; Vincristine; PEG-l-asparaginase; PEG asparaginase; Pegaspargase; Oncaspar; Polyethylene Glycol Conjugated Lasparaginase-H; Dexamethasone; Decadron; Rituximab; Rituxan

Summary:

      This goal of this clinical research study is to learn if the combination of methotrexate,
      pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients)
      can help to control ALL that has not responded to previous treatment or has come back after a
      response or chronic myeloid leukemia (CML).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in
             relapse or primary refractory; without viable stem cell transplant option. Patients
             with previously treated Philadelphia chromosome positive ALL will be also eligible;

          2. Chronic myeloid leukemia in blast phase

          3. Zubrod performance status </= 3;

          4. Adequate liver function (bilirubin </= 3.0mg/dl, unless considered due to tumor),and
             renal function (creatinine </= 3.0 mg/dl unless considered due to tumor;

          5. Age >/= to 1 year

          6. Understand and voluntarily sign an informed consent form.

          7. For pediatric patients (age >/= 1 year to </= 18 years), Lansky performance status
             >/=50

          8. For pediatric patients (age >/= 1 year to </= 18 years), second or greater relapse

        Exclusion Criteria:

          1. Pregnant patients

          2. Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic
             event with PEG-l-asparaginase or its components.
Interferon Gamma-1b in Friedreich Ataxia (FRDA)
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Intervention: Interferon Gamma-1b
Intervention description: Subjects will begin by taking 10 mcg/m2 of IFN-g-1b for the first two weeks of the study. Dose will be escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study. Finally, the dose will be escalated to 50 mcg/m2 of IFN-g-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
All doses will be administered via subcutaneous injection.
Intervention MeSH terms: Interferons; Interferon-gamma
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Friedreich ataxia; Interferon gamma-1b; FRDA

Summary:

      Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults
      for which there is presently no therapy. Recently, a study reported that interferon gamma
      (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with
      Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test
      whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of
      children with FRDA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with FRDA confirmed by genetic testing with 2 expanded
             Guanine-adenine-adenine repeats

          -  Females who are not pregnant or breast feeding, and who do not intend to become
             pregnant. Females of child-bearing potential must use a reliable method of
             contraception and must provide a negative urine pregnancy test at screening

          -  Stable doses of all medications, vitamins and supplements for 30 days prior to study
             entry and for the duration of the study

          -  Parent/guardian permission (informed consent) and child assent

        Exclusion Criteria:

          -  Any unstable illness that in the investigator's opinion precludes participation in
             this study

          -  Use of any investigational product within 30 days prior to enrollment

          -  Subjects with a history of substance abuse

          -  Presence of clinically significant cardiac disease

          -  History of hypersensitivity to IFN-g or E. coli derived products

          -  Presence of severe renal disease or hepatic disease

          -  Clinically significant abnormal White blood cell count, hemoglobin or platelet count

          -  Any subject planning a scheduled surgical procedure during the study
A Study of Abicipar Pegol in Japanese Patients With Neovascular Age-related Macular Degeneration
Condition: Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: abicipar pegol; ranibizumab; sham procedure
Intervention description: Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.; Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.; Sham procedure to the study eye at weeks 12 and 16.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a safety and efficacy study of abicipar pegol in patients with neovascular
      age-related macular degeneration to establish comparability between Japanese and
      non-Japanese.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ethnically Japanese

          -  Diagnosis of wet age-related macular degeneration in at least 1 eye

          -  Best corrected visual acuity of 20/32 to 20/320 in the study eye and 20/200 or better
             in the fellow eye

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or anaphylactic reaction to iodine or shellfish

          -  Cataract or refractive surgery within the last 3 months

          -  History of vitrectomy
Positional Therapy After Stroke
Condition: Sleep Apnea; Stroke
MeSH terms: Stroke
Intervention: Positional therapy including the use of a special pillow
Intervention description: Avoidance of supine sleep via a special pillow and other measures.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Stroke is the leading cause of adult disability and the third leading cause of death in the
      United States. Unfortunately, there are few therapies that have been proven to improve stroke
      outcome. Sleep apnea is an emerging stroke risk factor and has a well established association
      with higher mortality and poor functional outcome following stroke. Over half of acute stroke
      patients have sleep apnea, suggesting that it may be a important target for therapy.
      Attenuation of sleep apnea severity may result in improved stroke outcomes. However, the
      standard treatment for sleep apnea is not well-tolerated among stroke patients. An
      alternative treatment is avoidance of supine sleep. Supine sleep is very common in acute
      stroke patients, and therefore this treatment may have particular relevance to the stroke
      population. The proposed study will be conducted in two phases. The first phase is a
      randomized, crossover design in which acute stroke patients will be given positional
      treatment (to avoid supine sleep) on one night during their stroke hospitalization. This will
      be compared with another night of sleeping without positional therapy. The order of
      treatments (standard vs positional therapy) will be random. The first phase will demonstrate
      the proof of concept: that stroke patients given positional therapy to avoid supine sleep
      will (1) sleep less on their backs, and (2) will have improved sleep apnea parameters with
      positional therapy. In the second phase, those identified to have sleep apnea will be
      randomized to receive positional therapy at home for three months, or standard therapy. This
      second phase will demonstrate the adherence/feasibility of three months of positional
      therapy, and will allow us to estimate effect size based on a functional outcome measure. The
      data obtained from this pilot clinical trial are essential to plan a large efficacy study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18 or older

          -  Probable ischemic stroke within prior 14 days

        Exclusion Criteria:

          -  Any medical condition precluding the avoidance of supine posture or dictating the need
             for a particular position.

          -  Current use of CPAP (or other PAP), mechanical ventilation, or supplemental oxygen.