bioihbjkbjnl/mcl2 huggingface dataset:
Chewing Gum Use to Reduce Post-operative Ileus in Pediatric Patients
Condition: Post Operative Ileus
MeSH terms: Ileus
Intervention: Chewing Gum
Intervention description: The use of chewing gum as a preventive measure for post-operative ileus
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 41.0
Sex: All
Minimum age: 5 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Post operative ileus; Gastrointestinal surgery; Chewing gum

Summary:

      Post- operative ileus refers to the time after surgery before coordinated electromotor bowel
      function resumes. It's treatment and prevention may signify an elevated hospitalization cost
      and the exposure to the patient to adverse effects of drugs.

      The current clinical trial has as primary objective to prove the efficacy of chewing gum as a
      preventive measure of post-operative ileus in pediatric patients after gastrointestinal
      surgery through the determination of the time the patient takes to tolerate oral intake, pass
      flatus, present bowel movements and the time of hospital stay.

      Patients will be assigned either to the case group (chewing gum + standard treatment) or to
      the control group (standard treatment), in both of them time from the end of surgery to the
      moment the patient presents first bowel movement, passes flatus, tolerates oral intake (any
      type of food) and is discharged from hospital; will be measured in hours and then analyzed to
      determine the validity of these data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pediatric patients who underwent any type of gastrointestinal surgery.

        Exclusion Criteria:

          -  Patients unable to chew

          -  Patients unable to swallow

          -  Patients whose clinical status is critical

          -  Patients with gastrointestinal motility disorders not associated with GI surgeries.

          -  Patients unable to follow directions about the use of chewing gum
Carvedilol (25 mg) in 24 Fed, Healthy, Adult Subjects
Condition: Healthy
Intervention: Carvedilol 25 mg tablets; COREG® 25 mg tablets
Intervention description: 1 x 25 mg; 1 x 25 mg
Intervention MeSH terms: Carvedilol
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Bioequivalence; Healthy Subjects

Summary:

      The objective of this randomized, single-dose, two-way crossover evaluation is to compare the
      relative bioequivalence of a test carvedilol formulation (TEVA Pharmaceuticals USA) to and
      equivalent oral dose of the commercially available carvedilol (COREG®, SmithKline Beecham
      Pharmaceuticals) in a test population of 24 adult individuals under fed conditions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Sex: Male of Female; similar proportions of each preferred.

          -  Age: At least 18 years.

          -  Weight: Minimum of 120 pounds and a BMI (body mass index) of less than 30.

        Exclusion Criteria:

          -  Subjects not complying with the above inclusion criteria must be excluded from the
             study.

          -  In addition, any one of the conditions listed below will exclude a subject from the
             study.

          -  History of treatment for alcoholism, substance abuse, or drug abuse within the past 24
             months

          -  History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other
             serious illness.

          -  History of treatment for any gastrointestinal disorder within the past five (5) years.

          -  History of, or presence of, asthma

          -  History of peripheral vascular disease

          -  History of heart failure

          -  History of pre-existing cardiac arrythmias associated with tachycardia

          -  History of severe sensitivity to allergens, requiring urgent medical treatment.

          -  Females who are pregnant or lactating

          -  History of hypersensitivity to carvedilol, or any beta adrenergic blocking drug.

          -  Conditions upon screening which might contraindicate or require that caution be used
             in the administration of carvedilol, including:

          -  sitting systolic blood pressure below 100 mmHg, or diastolic pressure below 60 mmHg.

          -  Heart rate less than 60 beats per minute after a 5-minute rest in a seated position.

          -  Inability to read and/or sign the consent form.

          -  Treatment with any other investigational drug during the four (4) weeks prior to the
             initial dosing for this study.

          -  Subjects who smoke or use tobacco products or are currently using nicotine products
             (patches, gums,etc.) Ninety (90) days abstinence is required.

          -  subjects who have donated blood within four (4) weeks prior to the initial dosing for
             this study.
Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: EGT0001474; Placebo
Intervention description: Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.; Placebo capsules to match EGT0001474
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus Type 2

Summary:

      The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how
      much of the drug gets into the blood and how long it takes the body to get rid of it) of
      single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also
      evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or females between the ages of 18 to 70 diagnosed with Type 2 diabetes.

          -  Body mass Index (BMI) between 18 kg/m2 and 37 kg/m2.

          -  HbA1c levels between 6.5 and 9.0 (inclusive) where the upper limit of normal for the
             HbA1c assay is 6.4% or 6.2-9.0% (inclusive) where the upper limit of normal for the
             HbA1c assay is 6.1% and fasting plasma glucose between 110 and 240 mg/dL (inclusive)
             while on diabetic medications.

          -  If taking drugs for diabetes, must be medically able and willing to discontinue
             diabetes medications for the duration of the study.

          -  Female subjects must be surgically sterilized or postmenopausal.

          -  Non-smoker for at least 3 months.

          -  Negative alcohol screen.

        Exclusion Criteria:

          -  Type 1 diabetes.

          -  Use of insulin therapy or oral antidiabetic medication other than metformin,
             sitagliptin or a sulfonylurea.

          -  Sitting blood pressure above 150/95 mmHg on 2 evaluations at least 10 minutes apart at
             screening.

          -  Treatment with an investigational drug within 30 days or 7 half-lives, whichever is
             longer.

          -  Previous treatment with EGT0001474.

          -  Vaccination within 30 days prior to the first dose of study medication.
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: LY2127399 (Tabalumab); Placebo
Intervention description: Administered subcutaneously; Administered subcutaneously
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 32.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will evaluate the safety and tolerability of multiple doses of LY2127399
      (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment
      period. All participants will be followed for up to 12 weeks after the last study drug
      administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have given written informed consent

          -  Women must not be pregnant, breastfeeding or be at risk to become pregnant during
             study participation

          -  Diagnosis of RA

          -  Active RA

          -  Current, regular use of Methotrexate, at a stable dose

          -  Body weight between 40 and 105 kilograms (kg), inclusive

        Exclusion Criteria:

          -  Use of excluded medications (reviewed by study doctor)

          -  Have medical findings which, in the opinion of the study doctor, put participant at an
             unacceptable risk for participation in the study

          -  Have had recent or ongoing infection which, in the opinion of the study doctor put
             participant at an unacceptable risk for participation

          -  Evidence of tuberculosis

          -  Have systemic inflammatory condition other than RA
A Study of LY2605541 and Glargine in Participants With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY2605541; Insulin Glargine
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study has 2 parts. Each participant will receive a daily injection of LY2605541 during
      one treatment period and a daily injection of insulin glargine during one treatment period.
      Each treatment period is 2 to 3 weeks and is followed by a procedure to lower blood sugar
      levels to see how the body recovers after each treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 1 diabetic for more than 1 year with glycated hemoglobin (HbA1c) less than 9%

          -  Otherwise fit and healthy

          -  Nonsmoker

        Exclusion Criteria:

          -  Taking medication or supplements other than insulin to control diabetes

          -  Suffered a hypoglycemic event in the last 12 months that required hospitalization or
             has poor awareness of hypoglycemia
A Study of LY110140 in Healthy Japanese Male Participants
Condition: Healthy Volunteer
Intervention: LY110140; Placebo
Intervention description: Administered orally as capsules; Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm
Intervention MeSH terms: Fluoxetine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 56.0
Sex: Male
Minimum age: 20 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purposes of this study are to look at safety, how well the study drug (LY110140) is
      tolerated, and how much of the study drug gets into the blood stream when given as single
      dose (SD) and multiple doses (MD) to healthy Japanese male participants. Participants will
      participate in SD portion for approximately 6 weeks and in MD portion for approximately 10
      weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy Japanese males (as determined by medical history and physical
             examination) who agree to use a reliable method of birth control during the study and
             for 3 months following the last dose of the investigational product.

          -  Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2),
             inclusive, at the time of screening.

          -  Have given written informed consent approved by Lilly and the ethical review board
             (ERB) governing the study site.

        Exclusion Criteria:

          -  Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the
             opinion of the investigator, increases the risks associated with participating in the
             study such as, a Bazett's corrected QT (QTcB) interval >450 milliseconds (msec).

          -  Have any lifetime history of a suicide attempt, or have suicidal ideation or, any
             suicidal behavior within the last month, or who are at significant risk to commit
             suicide, as judged by the investigator using the Columbia Suicide Severity Rating
             Scale (C-SSRS).

          -  Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the
             study.
Pharmacokinetics Study of MCI-186 in Subjects With Mild or Moderate Hepatic Impairment
Condition: Hepatic Impairment; Healthy
MeSH terms: Liver Diseases
Intervention: MCI-186
Intervention description: 30 mg of edaravone will be administered intravenously over 60 minutes
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the pharmacokinetics of MCI-186 after a single intravenous infusion of 30mg/hour in
      subjects with mild or moderate Hepatic impairment compared to subjects with normal hepatic
      function
    

Eligibility criteria:

        Inclusion Criteria:

        All subjects

          -  Able to provide written informed consent to participate in this study after reading
             the ICF

          -  Subjects is able to understand and willing to cooperate and comply with the Protocol
             restrictions and requirements.

          -  A body weight of ≥45 kg in males or ≥40 kg in females and a body mass index ranging
             from 18 to 30 kg/m2

        Hepatic impaired subjects (in addition)

          -  A Child-Pugh score of 5 or 6 for subjects with mild hepatic impairment, and between 7
             and 9, inclusive, for subjects with moderate hepatic impairment

          -  Chronic and stable hepatic impairment

        Healthy subjects (in addition)

          -  Subject with normal hepatic function

          -  Good health and free from clinically significant illness or disease

        Exclusion Criteria:

        All subjects

          -  Presence or history of severe allergy to food, or any medicinal product or relevant
             excipient that is of clinical significance

          -  Subjects were previously administered MCI-186.

          -  Positive urine drug screen (if not due to concomitant medication) or alcohol test

          -  History of drug abuse

          -  Presence of alcohol abuse

          -  Presence of active infection requiring antibiotics

          -  Positive test for human immunodeficiency virus (HIV) antigen/antibody

          -  Uncontrolled, or untreated hypertension defined as systolic blood pressure (SBP)>160
             mmHg and/or diastolic blood pressure (DBP)>100 mmHg

          -  eGFR <60 mL/min/1.73m2

        Hepatic impairment subject (in addition)

          -  Subjects with severe ascites

        Healthy subject (in addition)

          -  History or presence of any parenchymal hepatic disease

          -  Positive test for hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody
             (HCVAb)
Blood Sample Collection Study for Pharmacogenomic Characterization of Participants That Previously Received Namilumab in M1-1188-002-EM (PRIORA, [NCT01317797]) Study
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: No Intervention
Intervention description: No study drug will be administered in this study.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug therapy

Summary:

      The purpose of this study is to obtain blood samples from up to 14 participants who
      previously received namilumab in the previous study M1-1188-002-EM (PRIORA, [NCT01317797]) to
      correlate genetic markers with clinical outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

        1. The participant (or, when applicable, the participant's legally acceptable
        representative) voluntarily signs and dates a written, informed consent form and any
        required privacy authorization prior to the initiation of any study procedures.

        Exclusion Criteria:

          1. Did not receive namilumab during the PRIORA study (A phase Ib double-blind, placebo
             controlled, randomized, dose-escalating study).

          2. Participants without any response time point recorded 4-week after the last dose of
             namilumab and beyond this time point

          3. Participants who were excluded from post-hoc analysis due to protocol violations
             during the previous PRIORA study.
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Condition: Anemia of Prematurity
MeSH terms: Premature Birth
Intervention: feed during blood transfusion
Intervention description: babies receiving the intervention are fed during the PRBC transfusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 25 Weeks
Maximum age: 38 Weeks
Healthy volunteers: No
Keywords: anemia; prematurity; blood flow velocity; superior mesenteric artery; intestinal blood flow in premature infants

Summary:

      The purpose of the study is to see if a blood transfusion changes how fast blood flows to the
      intestines of a premature baby. Blood flow is measured by an ultrasound test. The
      investigators also look to see if the blood flow to the intestines depends on whether the
      baby feeds or doesn't feed during the blood transfusion.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age
             at enrollment

          2. First infant of twin gestation born at 25-32 weeks gestation who requires a blood
             transfusion; if both infants require transfusion on the same day the larger infant
             will be enrolled.

          3. Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60
             cc/kg/day

          4. A planned packed red blood cell transfusion, as per the clinical team, for anemia

          5. Infant is very likely to require a blood transfusion according to the attending
             neonatologist.

        Exclusion Criteria:

          1. Known congenital anomalies of the heart, brain, kidneys or intestine

          2. Chromosomal abnormality

          3. Intrauterine growth restriction at < 3% for weight at birth since this has been shown
             to alter mesenteric BFV and the post-prandial hyperemia

          4. Twin to twin transfusion sequence

          5. Higher order multiples

          6. Patent ductus arteriosus known to be present or currently being treated

          7. History of definite necrotizing enterocolitis Bell Stage 2 or greater

          8. Concurrent treatments with antibiotics or steroids

          9. Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential
             feeds

         10. Concurrent enrollment in another randomized trial

         11. Infants discharged or transferred to another facility without having received a PRBC
             transfusion will be excluded post-hoc.
A Study of [¹⁴C]-LY3202626 in Healthy Male Participants
Condition: Healthy
Intervention: [¹⁴C]-LY3202626
Intervention description: Administered as solution by mouth
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of the specially prepared study drug,
      LY3202626, containing radiolabeled carbon [¹⁴C] gets into the blood stream and how long it
      takes the body to get rid of it.

      Information about any side effects that may occur will also be collected.

      Participants will stay at a clinical research unit (CRU). The study will last about 28 days
      (check in to follow-up) for each participant.

      This study is for research purposes only and is not intended to treat any medical condition.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are overtly healthy males, as determined by physical examination, clinical laboratory
             tests, medical history and electrocardiogram (ECG)

          -  Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m²)
             inclusive at screening

        Exclusion Criteria:

          -  Have participated in a [¹⁴C]-study within the last 6 months prior to admission for
             this study

          -  Regularly use known drugs of abuse and/or show positive findings on urinary drug
             screening

          -  Have consumed grapefruits or grapefruit-containing products, Seville oranges or
             Seville orange-containing products, star fruits or star fruit-containing products
             within 7 days prior to dosing or intend to consume during the study

          -  Have a history of constipation or have had acute constipation within 3 weeks prior to
             admission

          -  Are currently or have been smokers or users of tobacco or nicotine replacement
             products within the 3 months prior to admission and/or have positive cotinine at
             screening or check-in

          -  Exposure to significant diagnostic, therapeutic, or employment-related radiation
             within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans,
             barium meal, current employment in a job requiring radiation exposure monitoring)