bioihbjkbjnl/mcl2 huggingface dataset:
STP206 for the Prevention of Necrotizing Enterocolitis (NEC)
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Intervention: STP206; Control
Intervention description: Live Biotherapeutic; Sterile Water
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 103.0
Sex: All
Minimum age: 1 Day
Maximum age: 4 Days
Healthy volunteers: No

Summary:

      This study is a sequential dose escalation study to assess the safety, tolerability, and
      preliminary NEC-preventative efficacy of two doses of STP206 versus control in very low birth
      weight and extremely low birth weight neonates.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Neonates with birth weights between 2000-500g for Part A and 1500-500g for Part B

          2. Ability to start treatment within four days after birth.

          3. Gestational age between 23 and 32 weeks at birth

          4. Obtaining of informed consent from the subject's mother after full understanding of
             the study purpose and procedures.

          5. Parents who agree to allow the Principal Investigator and his/her staff to follow the
             procedures and assessments required by the protocol

        Exclusion Criteria:

          1. Infants with, or at high probability for, early onset sepsis (positive blood cultures
             or with clinical/histological chorioamnionitis with the expectation of empirical
             antimicrobial therapy for ≥5 days)

          2. Infants with persistent pulmonary hypertension of the newborn (PPHN)

          3. Congenital or chromosomal anomalies

          4. Congenital or acquired gastrointestinal pathology that preclude feeds soon after birth
             (e.g. cleft lip is not an exclusion criterion, but a duodenal atresia is)

          5. Infants in extremis to whom no further intensive care is offered by attending
             neonatologist (e.g., infant being provided only hospice/comfort care)

          6. Other conditions of the infant which, in the opinion of the attending neonatologist,
             preclude participation

          7. Positive maternal HIV status

          8. Participation in another interventional clinical trial

             For Part A of the study, the following additional exclusion criterion will apply:

          9. Small for gestational age neonates, i.e. neonates that weigh less that the 10th
             percentile for their gestational age according to the Estimated Fetal Weight
             Percentile Chart
Topical Sirolimus for the Treatment of Pachyonychia Congenita (PC)
Condition: Pachyonychia Congenita
MeSH terms: Pachyonychia Congenita; Nails, Malformed
Intervention: 1% sirolimus cream (TD201 1%)
Intervention description: 1% sirolimus cream (TD201 1%)
Intervention MeSH terms: Sirolimus
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 15.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: pachyonychia congenita

Summary:

      A study to evaluate safety and efficacy of topical sirolimus to treat plantar keratoderma in
      adults with PC. Subjects may receive either placebo or treatment with at least 1 foot
      receiving topical sirolimus at some time. For certain phases of the study treatment
      assignment to the right and left foot will be randomized in a double blind fashion. Blood
      levels will test systemic absorption of sirolimus. Other safety and efficacy measures will be
      taken through the 39-week study duration. Funding Source - FDA OOPD
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects must:

          -  Be capable of understanding the purpose and risks of the study and sign a written
             Informed Consent Form (ICF)

          -  Be male or female ≥ 16 years of age at the time of the screening visit

          -  Have a confirmed diagnosis of PC by genotyping (e.g., familial) and clinically
             correlated painful keratoderma.

          -  Have roughly symmetrical calluses of similar severity on the plantar surface of both
             feet

          -  Women of childbearing potential must have a negative serum pregnancy test

          -  Subjects, whether male or female, with reproductive potential and who are sexually
             active must agree to use double-barrier contraception methods

        Exclusion Criteria:

        A Subject with any of the following criteria is not eligible for inclusion in this study:

          -  Use of other investigational drugs within 30 days of the screening visit and/or has
             not recovered from any side effects of prior investigational drugs or procedure in the
             affected area (e.g., a biopsy)

          -  Significant condition in the dermatologic treatment area such as trauma, or nonhealing
             chronic wound

          -  Pregnant or nursing (lactating) female, or a positive serum pregnancy test

          -  Active infection either systemic or local near the site of treatment requiring chronic
             or prolonged use of antimicrobial agents

          -  Known immunodeficiency including: Hepatitis A; Hepatitis B; Hepatitis C; Human
             Immunodeficiency Virus (HIV)

        Prior and Current Treatment

          -  Unable to be discontinued from drugs known to either be inducers or inhibitors of
             CYP3A4/5 enzymes

          -  Unable to be discontinued from drugs known to be P-glycoprotein inhibitors
A Study of Evacetrapib (LY2484595) in Participants With Hepatic (Liver) Impairment
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Intervention: Evacetrapib
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of the drug gets into the bloodstream and
      how long it takes the body to remove it when given to participants with hepatic (liver)
      impairment compared to participants with normal hepatic function. Information about any side
      effects that may occur will also be collected. This study will last approximately 28 days,
      not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants have given written informed consent approved by the ethical review board
             (ERB) governing the site

          -  Female participants should be of non-childbearing potential

          -  Have a body mass index (BMI) of 18 to 40 kilograms per square meter (kg/m^2)

          -  Healthy participants have normal hepatic function as determined by medical history,
             physical examination, and other screening procedures

          -  Individuals with hepatic impairment classified as Child-Pugh score A, B, or C (mild,
             moderate, or severe impairment)

        Exclusion Criteria:

          -  Has had esophagus variceal bleeding within 3 months of check-in

          -  Have the need to take medications that may interfere with how the liver removes the
             drug

          -  Have evidence of cancer in the liver

          -  Consumes excessively large amounts of drinks with caffeine or alcohol
Colonizing Neurogenic Bladders With Benign Flora
Condition: Spinal Cord Injury; Urinary Tract Infection
MeSH terms: Urinary Tract Infections; Spinal Cord Injuries; Urinary Bladder, Neurogenic
Intervention: Insertion of urinary catheters coated with E. coli 83972
Intervention description: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Healthy volunteers: No
Keywords: biofilm; clinical trial; Escherichia coli; urinary catheter

Summary:

      The purpose of the research is to determine whether we can get harmless bacteria to live in
      the bladders of persons with spinal cord injury who practice intermittent bladder
      catheterization. We will also look at whether having the harmless bacteria in the bladder
      prevents urinary tract infections from occurring.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients followed at the MEDVAMC who have sustained spinal cord injury > 12 months earlier,
        suffer from neurogenic bladder, practice intermittent bladder catheterization, and who have
        had at least 1 symptomatic UTI in the past will be enrolled.

        Exclusion Criteria:

        Exclusion criteria will include obstructive urolithiasis, indwelling bladder or nephrostomy
        catheters, supravesical urinary diversion, vesicoureteral reflux, active malignancy,
        uncontrolled diabetes mellitus, AIDS, requirement for immunosuppressive medication, or
        current antibiotic therapy. Women of childbearing age must have a negative pregnancy test
        before enrolling in the study, and they must utilize effective birth control methods during
        the study and for 3 months after the study is concluded.
A Study of Insulin Peglispro in Healthy Male Japanese Participants
Condition: Healthy Volunteers
Intervention: Insulin Peglispro
Intervention MeSH terms: Insulin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate how the body processes the study drug known as
      insulin peglispro and how the study drug affects blood sugar in healthy male Japanese
      participants. This study will also evaluate safety of the study drug. The study will last up
      to 46 days for each participant, not including screening.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants are overtly healthy male Japanese.

          -  Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square
             meter (kg/m^2), inclusive.

        Exclusion Criteria:

          -  Participants have known allergies to insulin peglispro or related compounds.

          -  Participants have a fasting venous blood glucose >108 milligrams per deciliter (mg/dL)
             (>6 millimoles per liter [mmol/L]).
Behavioral and Neuroimaging Changes After Cognitive Rehab in Traumatic Brain Injuries (TBI) and Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment; Alzheimer's Disease; Traumatic Brain Injury
MeSH terms: Alzheimer Disease; Brain Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction
Intervention: Mnemonic strategy training (MST); Repeated exposure (XP); Subtracting Cues training
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Enrollment: 82.0
Sex: All
Minimum age: 18 Years
Maximum age: 88 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: cognitive rehabilitation; explicit memory training; mild cognitive impairment; Alzheimer's disease; traumatic brain injury; veterans

Summary:

      Memory deficits are common after traumatic brain injuries (TBI) and are characteristic of
      various forms of dementia, such as Alzheimer's disease and its common precursor mild
      cognitive impairment (MCI). This project intends to assess the efficacy of cognitive
      rehabilitation in these patient populations. We will also use neuroimaging (functional
      magnetic resonance imaging - fMRI) to assess changes in brain activity that occur following
      cognitive rehabilitation.
    

Eligibility criteria:

        Inclusion Criteria:

        General inclusion criteria (all patients):

          -  A minimum of 12 years of education or attainment of a Graduation Equivalency Diploma;

          -  All medications stable for approximately 3 months;

          -  No history of severe mental illness;

          -  No current untreated alcohol or substance abuse/dependence;

          -  English as native and preferred language;

          -  MRI-compatible if taking part in fMRI studies 7) Able to give informed consent.

        MCI Inclusion Criteria:

          -  Diagnosis of amnestic MCI based on criteria set forth by Petersen (2004).
             Additionally, other potential causes of cognitive deficit ruled out by the referring
             physician;

          -  55 years of age or older.

        TBI Inclusion criteria:

          -  History of a mild to moderate TBI;

          -  No history of other neurological disease or injury;

          -  A minimum of 6 months and maximum of 5 years post-onset of TBI;

          -  18 - 45 years old.

        Exclusion Criteria:

          -  History of neurological disease or injury (other than TBI)

          -  History of severe mental illness

          -  Current untreated alcohol or substance abuse

          -  Other conditions may exclude; please discuss with contact
To Assess the Pharmacokinetics, Safety and Tolerability of Selumetinib in Patients With Hepatic Impairment and Healthy Subjects
Condition: Solid Tumors
MeSH terms: Liver Diseases
Intervention: Selumetinib 50mg; Selumetinib 25mg
Intervention description: HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1; Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase I, healthy, pharmacokinetic, hepatic impairment

Summary:

      A study to assess the pharmacokinetics, safety and tolerability of Selumetinib (AZD6244,
      ARRY-142886) in patients with hepatic impairment and healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria for all participants:

          1. Subjects will be males or females (non-childbearing potential) aged 18 years or more
             and with a weight of at least 45 kg and a BMI between 18 and 40 kg/m2 inclusive.

             Inclusion Critera only for hepatic impaired patients:

          2. Subjects with stable liver cirrhosis and hepatic impairment for at least 3 months
             prior to the start of the study.

             Inclusion Criteria only for healthy volunteers:

          3. Subjects must be in good health, as determined by a medical history, physical
             examination, 12-lead ECG, clinical laboratory evaluations, and an ophthalmic
             examination performed before the administration of the investigational product.

        Exclusion Criteria for all participants:

          1. Subjects of Japanese or non-Japanese Asian ethnicity

          2. Any one parent or grandparent (maternal or paternal) is Japanese or non-Japanese Asian
             (eg, China, Taiwan, Korea, Philippines, Thailand, Vietnam, and Malaysia). Asian
             Indians are acceptable.

          3. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks
             of the first administration of the investigational product

          4. Subjects who smoke more than 10 cigarettes or the equivalent in tobacco per day.

             Exclusion criteria for hepatic impaired patients only

          5. Undergone liver transplantation. -
Understanding Dexmedetomidine In Infants Post-Operative From Cardiac Surgery
Condition: Hypoplastic Left Heart; Tetralogy of Fallot; Tricuspid Atresia
MeSH terms: Tetralogy of Fallot; Hypoplastic Left Heart Syndrome; Tricuspid Atresia
Intervention: Dexmedetomidine
Intervention description: Dosage levels: Dose Level 1: Loading dose 0.35mcg/kg and CIVI 0.25mcg/kg/hr Dose Level 2: Loading Dose of 0.7mcg/kg and CIVI 0.5mcg/kg/hr and Dose Level 3: Loading Dose 1 mcg/kg and CIVI 0.75 mcg/kg/hr.
Intervention MeSH terms: Dexmedetomidine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 1 Month
Maximum age: 24 Months
Healthy volunteers: No
Keywords: Postoperative from cardiac surgery; Dexmedetomidine

Summary:

      This study is being conducted to determine what dexmedetomidine does to the body and in turn,
      what how the body handles the medication. This medication, for the purpose of this trial, is
      used as a short-term sedative for infants who are immediately post-operative from cardiac
      surgery and have a breathing tube and are breathing with the assistance of a mechanical
      ventilator or breathing machine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be greater or equal to one month or less than or equal to 24 months of
             age.

          -  Post operative from cardiac surgery with tracheal intubation/mechanical ventilation in
             the immediate post-op period.

          -  Planned tracheal extubation within 24 hours post-operatively.

          -  Adequate renal function(1-12 months old creatinine less than or equal to 0.6mg/dL and
             >12 months to 24 months creatinine < or= to 1.0mg/dL)

          -  Adequate liver function(Total bilirubin < or= 1.5mg/dL and ALT 1-12 months < or = to
             165 U/L and > 12 months to 24 months < or = to 90 U/L)

          -  Isolated heart surgery

          -  Informed consent

        Exclusion Criteria:

          -  Patients who have received another investigational drug within the past 30 days.

          -  Receiving continuous infusions of muscle relaxants in the postoperative setting.

          -  Patients whoo have a positive blood culture without a subsequent negative culture or
             other evidence of ongoing serious infection.

          -  Patients, who, int he opinion of the investigator may not be able to comply with the
             safety monitoring requirements of the study.

          -  Patients who show signs or symptoms of elevated intracranial pressure.

          -  Post-operative hypotension based on age.

          -  Preexisting bradycardia based on age.

          -  Heart block

          -  Weight < 5kg

          -  Patients, who in the opinion of the investigator, are not appropriate candidates for
             an investigational drug study.
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin
Condition: Skin Manifestations
MeSH terms: Skin Manifestations
Intervention: adapalene cream 0.1% and adapalene lotion 0.1%; adapalene lotion 0.1%
Intervention description: adapalene cream 0.1% - apply once daily on one side of the face for 3 weeks; adapalene lotion 0.1% - apply once daily on the opposite side of the face for 3 weeks
Intervention MeSH terms: Adapalene
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1%
      to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3)
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females aged 18 years and older

          -  Subjects with healthy skin as determined by the clinical grader

        Exclusion Criteria:

          -  Subjects with a degree of skin pigmentation that interferes with the reading of skin
             reactions.

          -  Subjects with a condition or who are in a situation, which in the investigator's
             opinion may put the subject at risk, may confound study results, or may interfere with
             the subject's participation in the study.

          -  Subjects with known allergy to one of the components of the study drugs (refer to the
             package insert for Differin® Cream 0.1% and the investigator's brochure for Differin®
             Lotion 0.1%).

          -  Subjects who have participated in another investigational drug or device research
             study within 30 days of enrollment.

          -  Subjects with a washout period for topical treatment on the treated area less than 1
             week for corticosteroids and/or 4 weeks for retinoids.

          -  Subjects with a washout period for systemic treatment less than 1 week for medications
             that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months
             for retinoids.

          -  Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or
             rosacea on the area to be treated.

          -  Subjects who foresee unprotected and intense UV exposure during the study (mountain
             sports, UV radiation, sunbathing, etc.)
4 Week Treatment With Three Oral Doses of BI 10773 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773 low dose; placebo to BI 10773; BI 10773 medium dose; BI 10773 high dose
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 78.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Primary objective: safety and tolerability of BI 10773 in male and female patients with type
      2 diabetes Secondary objective: pharmacokinetics and pharmacodynamics of BI 10773
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and postmenopausal or hysterectomised female patients with type 2 diabetes

          -  Age >18 and < 70 years

          -  BMI >18.5 and <40 kg/m2

        Exclusion Criteria:

          -  Antidiabetic treatment with insulin or glitazones or with more than one oral
             hypoglycaemic agent;

          -  Fasted blood glucose > 240 mg/dl (>13.3 mmol/L) or a blood glucose level above 400
             mg/dl (22.2 mmol/L) postprandially;

          -  HbA1c > 8.5 %