bioihbjkbjnl/mcl2 huggingface dataset:
A Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy
Condition: Moderate or Severe Hypoxic-ischemic Encephalopathy in Newborns
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Intervention: Infusion of autologous cord blood; Placebo
Intervention description: Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.; Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 35.0
Sex: All
Maximum age: 6 Hours
Healthy volunteers: No
Keywords: Hypoxic-ischemic encephalopathy; autologous cord blood cells; newborn infants

Summary:

      This study will test the safety and efficacy of an infusion of a baby's own (autologous)
      umbilical cord blood as compared with placebo in babies born with history and signs of
      hypoxic-ischemic brain injury.
    

Eligibility criteria:

        Inclusion Criteria:

          1. NICHD Neonatal Research Network Hypothermia Trial inclusion criteria

          2. Mothers must have consented or given verbal assent for cord blood collection at
             delivery, and cord blood must be available for volume and red blood cell reduction
             before 45 hours of age

          3. The infant must be able to receive at least one dose of autologous cord blood before
             48 hours of age

          4. All infants must have signs of encephalopathy within 6 hours of age

        Exclusion Criteria:

          1. Major congenital or chromosomal abnormalities

          2. Severe growth restriction (birth weight <1800 g)

          3. Opinion by attending neonatologist that the study may interfere with treatment or
             safety of subject

          4. Moribund neonates for whom no further treatment is planned

          5. Infants born to mothers are known to be HIV, Hepatitis B, Hepatitis C or who have
             active syphilis or CMV infection in pregnancy

          6. Infants suspected of overwhelming sepsis

          7. ECMO initiated or likely in the first 48 hours of life
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: GS-9674; Placebo to match GS-9674
Intervention description: Tablet administered orally once daily; Tablet(s) administered orally once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Non-alcoholic fatty liver disease (NAFLD); Fibrosis; GS-9674

Summary:

      The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in
      participants with nonalcoholic steatohepatitis (NASH).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Meets the following conditions:

               -  A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)

               -  Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
                  with ≥ 8% steatosis

               -  Screening magnetic resonance elastography (MRE) with liver stiffness ≥ 2.5
                  kilopascal (kPa) OR

               -  A historical liver biopsy within 12 months of screening consistent with NASH with
                  fibrosis, but not cirrhosis, and

               -  No documented weight loss > 5% between the date of the liver biopsy and
                  screening.

          -  Platelet count ≥ 150,000/mm^3

          -  Albumin ≥ 3.3 g/dL

          -  Serum creatinine ≤ upper limit of normal (ULN)

        Key Exclusion Criteria:

          -  Pregnant or lactating females

          -  Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)

          -  Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

          -  Cirrhosis of the liver

               -  Prior history of decompensated liver disease, including ascites, hepatic
                  encephalopathy, or variceal bleeding

          -  Body mass index (BMI) < 18 kg/m^2

          -  Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)

          -  International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

          -  Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Guanfacine to Improve Substance Use Outcomes in Women
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Intervention: Guanfacine; Behavioral Counseling
Intervention description: Guanfacine 3mg/day Versus Placebo; placebo
Intervention MeSH terms: Guanfacine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: double blind
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Hypothesis: Guanfacine (GUA) (3mg/day) will reduce drug craving, improve cognitive
      flexibility and result in associated lower drug use in women with substance use disorder
      (SUD) in an outpatient clinical setting.
    

Eligibility criteria:

        Inclusion Criteria:

          -  100 treatment seeking women

          -  Ages 18-70 years

          -  Body mass index (BMI) of 18-35

          -  Meet current DSM-V criteria for co-occurring SUDs, with primary DSM-V cocaine or
             primary DSM-V opioid use disorder AND co-occurring cannabis or alcohol or nicotine use
             disorders;

          -  Positive drug urine toxicology screens for primary addictive disorder during a 2-week
             intake assessment period

          -  Good health as verified by screening examination

          -  Able to read English and complete study evaluations

          -  Able to provide informed written and verbal consent

        Exclusion Criteria:

          -  Meet criteria for physiological dependence on alcohol requiring medical detoxification

          -  Regular use of anti-hypertensives, anti-arrythmics, antiretroviral medications, and
             medications that would interact with Guanfacine and be contraindicated as per study
             physician;

          -  Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal,
             current mania)

          -  Significant underlying medical conditions which in the opinion of study physician
             would preclude patient from fully cooperating or be of potential harm during the
             course of the study; Specifically hepatic and renal impairment as per liver enzymes at
             3X the normal limit, or BUN>50mg or BUN:Cr > 10:1.

          -  Hypotensive women with sitting blood pressure below 100/50 mmHG

          -  Women who are pregnant, nursing or refuse to use a reliable form of birth control

          -  EKG evidence at baseline screening of any clinically significant conduction
             abnormalities, including a Bazlett's QT c>470 msec for women.
HORIZANT (Gabapentin Enacarbil Extended-Release Tablets) for the Treatment of Alcohol Use Disorder
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: gabapentin enacarbil; Placebo
Intervention description: Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day; Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 346.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol use disorder; alcoholism; alcohol dependence; drinking alcohol

Summary:

      The purpose of this study is to determine whether gabapentin enacarbil is effective in the
      treatment of problems with alcohol.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must meet each one of the following inclusion criteria in order to be eligible for
        participation in the study:

          1. Be at least 21 years of age.

          2. Have a current (past 12 months) DSM-5 diagnosis of AUD.

          3. Have a BAC by breathalyzer equal to 0.000 when s/he signed the informed consent
             document (either just prior to or immediately after signing consent).

          4. Be seeking treatment for problems with alcohol.

        Additional will be evaluated in clinic.

        Exclusion Criteria:

        Evaluations will be conducted in clinic.
Safety and Efficacy of Cariprazine (RGH-188) in the Acute Exacerbation of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Cariprazine; Risperidone
Intervention description: Placebo was supplied in capsules.; Cariprazine was supplied in capsules; Risperidone was supplied in capsules
Intervention MeSH terms: Risperidone; Cariprazine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 732.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This is a study to evaluate the safety, efficacy, and tolerability of cariprazine (RGH-188)
      relative to placebo in adult patients (18-60 years of age) with acute exacerbation of
      schizophrenia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 60 years of age.

          -  Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
             criteria for schizophrenia (paranoid type, disorganized type, catatonic type, or
             undifferentiated type) based on a Structured Clinical Interview for DSM-IV (SCID).

          -  Total Positive and Negative Syndrome Scale (PANSS) score ≥ 80 and ≤ 120.

          -  Diagnosis of schizophrenia for at least 1 year.

        Exclusion Criteria:

          -  Abnormalities on physical examination or abnormal vital signs, electrocardiogram, or
             clinical laboratory values.

          -  First episode of psychosis.
Fluoxetine for Visual Recovery After Ischemic Stroke
Condition: Acute Stroke; Visual Field Loss
MeSH terms: Stroke; Ischemic Stroke
Intervention: Fluoxetine; Placebo
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute ischemic stroke; Homonymous hemianopia; Homonymous quadrantanopia; Visual field loss; Post-stroke recovery; Fluoxetine; Selective serotonin reuptake inhibitor

Summary:

      The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake
      inhibitor commonly used for depression, enhances visual recovery after an acute ischemic
      stroke.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MRI-confirmed acute ischemic stroke resulting in an isolated homonymous visual field
             loss.

        Exclusion Criteria:

          -  Known hypersensitivity to fluoxetine or other selective serotonin reuptake inhibitors

          -  National Institutes of Health Stroke Scale score greater than 5

          -  Premorbid modified Rankin Scale score greater than 2

          -  Premorbid monocular or binocular visual field deficits

          -  Premorbid retinopathy or optic neuropathy

          -  Premorbid depression

          -  History of cognitive impairment, dementia, or neurodegenerative disorder

          -  History of seizure disorder

          -  History of mania or hypomania

          -  History of hyponatremia

          -  History of angle-closure glaucoma or elevated intraocular pressure

          -  Current alcohol abuse or impaired liver function

          -  Current use of an antidepressant medication

          -  Current use of a medication likely to have an adverse interaction with fluoxetine

          -  Current use of a medication likely to impair post-stroke recovery

          -  Contraindication to MRI

          -  Pregnancy or lactation

          -  Hemorrhagic transformation of the index stroke, resulting in mass effect

          -  Enrollment in another clinical trial at the time of the index stroke
Effect of Inhaled TD-8236 on Allergen-induced Asthmatic Response
Condition: Asthma
MeSH terms: Asthma
Intervention: TD-8236; Placebo
Intervention description: The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.; The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: TD-8236; Asthma; Proof of concept

Summary:

      This will be a randomized, double-blind, placebo-controlled study. The study will use a
      three-period, six-sequence, complete-block, cross-over study design to characterize two doses
      of inhaled TD-8236 compared to placebo in subjects with mild asthma and a known response to
      an allergen. Each of the three periods will be 14 days, followed by a washout period before
      the next period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, 18 to 65 years of age

          -  Willing and able to give informed consent and comply with study requirements

          -  Documented physician-diagnosed asthma for ≥ 4 months prior to Screening

          -  Body mass index (BMI) ≥ 18.0 and ≤ 35.0 kg/m2 at Screening and weighs ≥ 50 kg at
             Screening.

          -  Women of child bearing potential must have a negative pregnancy test

          -  Males and females must use a highly efficient birth control method

          -  Pre-bronchodilator FEV1 ≥ 70% predicted

          -  Documented allergy to at least one common allergen

          -  Dual responder to inhaled bronchial challenges

          -  Additional inclusion criteria apply

        Exclusion Criteria:

          -  Positive for hepatitis A, B or C, HIV or tuberculosis

          -  Clinically significant abnormalities of laboratory evaluations

          -  Have abnormal ECG measurements

          -  Any sign of respiratory tract infection within 6 weeks of screening

          -  Have a current bacterial, parasitic, fungal or viral infection

          -  History of life-threatening asthma

          -  Uses or have used tobacco or nicotine-containing products within 6 months prior to
             screening

          -  Additional exclusion criteria apply
[F-18] Fluorothymidine PET/CT Imaging for Pelvic Cancers
Condition: Uterine Cervical Neoplasms; Endometrial Neoplasms; Anus Neoplasms; Rectal Neoplasms; Prostatic Neoplasms
MeSH terms: Neoplasms; Prostatic Neoplasms; Rectal Neoplasms; Uterine Cervical Neoplasms; Endometrial Neoplasms; Pelvic Neoplasms; Anus Neoplasms
Intervention: fluorothymidine F 18
Intervention description: A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: radiotherapy; Positron-Emission Tomography and Computed Tomography; chemotherapy; bone marrow

Summary:

      [F-18] Fluorothymidine PET imaging will be used to create a radiation therapy treatment plan
      to avoid active bone marrow in the pelvis. This will be done to evaluate if sparing bone
      marrow will help maintain blood counts. This would impact chemotherapy administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to understand and willingness to sign a written informed consent document.

          -  Recommended to undergo pelvic irradiation with concurrent chemotherapy.

          -  At least 18 years of age. Pediatrics would be best served by a protocol designed for
             their specific needs.

          -  Karnofsky Performance Status of at least 60% at time of screening.

          -  Life expectancy of greater than 6 months.

          -  Subject must have normal organ and marrow function (as defined below) within 30 days
             of study enrollment:

               -  leukocytes at least 3,000 / µL

               -  absolute neutrophil count of at least 1500 / µL

               -  platelets of at least 100,000 / µL

               -  creatinine equal to or less than the upper limit of normal

          -  not pregnant (as applicable)

        Exclusion Criteria:

          -  history of allergic reactions attributed to compounds of similar chemical or biologic
             composition to FLT

          -  an oncology research protocol requiring full pelvic radiation (i.e., 4 field box
             technique)

          -  uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  subjects taking nucleoside analog medications such as those used as antiretroviral
             agents.
Crossover Trial of AD109 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD109; Atomoxetine; R-oxybutynin; Placebo; Digit System Substitution Test
Intervention description: Oral administration before bed; Oral administration before bed; Oral administration before bed; Oral administration before bed; a neuropsychological test sensitive to brain damage, dementia, age and depression where numbers are assigned symbols. Under each digit the subject should write down the corresponding symbol as fast as possible. The number of correct symbols within the allowed time is measured.
Intervention MeSH terms: Oxybutynin; Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of AD109 versus its individual components or placebo in
      patients with obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.

          -  AHI 10 to <20, or AHI ≥20 if meets other PSG criteria

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery
             disease or cardiac failure) or hypertension requiring more than 2 medications for
             control. A medication for these purposes is defined by dosage form, such that a
             combination antihypertensive medication is considered 1 medication

          -  CPAP should not be used for at least 2 weeks prior to first study PSG

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.
Stereotactic Radiosurgery or Other Local Ablation Then Erlotinib in Epidermal Growth Factor Receptor (EGFR)
Condition: Non Small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Stereotactic Radiosurgery; Erlotinib
Intervention description: 21 Gy daily for 5 days; 150mg once daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: For all patients, all sites of progressive disease will be treated with local ablation (primarily stereotactic radiosurgery) followed by the EGFR-TKI erlotinib until disease progression.
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Non small cell lung cancer; EGFR mutant; Phase II; erlotinib; tarceva; cyberknife; Lineberger

Summary:

      - Progression free survival after locally ablative therapy and erlotinib in EGFR patients
      progressed after EGFR-TKI therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent

          -  18 years of age or older

          -  Histologically or cytologically confirmed stge IV EGFR-mutant NSCLC

          -  History of previous response to EGFR-TKI defined by a RECIST 1.1 criteria

          -  Progressive disease following EGFR-TKI therapy

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Adequate organ and marrow function

          -  Negative urine or serum pregnancy test for female patients

          -  Patients who can have children must agree to adequate contraception

        Exclusion Criteria:

          -  Unresolved chronic toxicities greater than 2, measured by CTCAE v4

          -  Treatment with any FDA approved or experimental cancer treatment following progression
             on EGFR-TKI

          -  Any history of previous greater than grade 3 toxicity attributable to erlotinib

          -  Pregnant or lactating female

          -  Any previous radiation to sites of planned Stereostatic Radiosurgery

          -  History of another malignancy

          -  Concomitant anticancer therapy, immunotherapy, or radiation therapy (within 4 weeks)

          -  Evidence of severe or uncontrolled systemic diseases

          -  Known hypersensitivity reaction or idiosyncrasy to erlotinib

          -  Psychological, familial, sociological, or geographical conditions

          -  Any other condition in investigator's opinion jeopardize compliance with protocol