bioihbjkbjnl/mcl2 huggingface dataset:
Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis; CD
MeSH terms: Crohn Disease; Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases
Intervention: Bacteriotherapy
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 12 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Crohns Disease; Ulcerative Colitis; Inflammatory Bowel Disease; IBD

Summary:

      In this study, the investigators want to see if Bacteriotherapy (also referred to as stool
      transplantation) improves the symptoms and decreases inflammation in children with
      Inflammatory Bowel Disease (IBD). Examples of IBD are Crohn's Disease and Ulcerative Colitis.
      Additionally, researchers want to learn whether this experimental therapy delays the need for
      starting additional medications to treat pediatric IBD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Children ages 12-21 years old with a diagnosis of mild to moderate Ulcerative Colitis
             or Crohn's Disease

          -  Willing parent to donate stool for the transplant

        Exclusion Criteria:

          -  Severe Disease

          -  History of intra-abdominal abscess, intra-abdominal fistula or stricturing

          -  History of other systemic diseases

          -  The patient has received TNF inhibitors to treat their IBD within two months of
             transplant
A Phase 1 Single/Multiple Dose Study Of PF-06293620 To Assess Safety, Tolerability And Pharmacokinetics In Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo; PF-06293620; Placebo
Intervention description: subcutaneous, single dose 0.3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous, single dose 1.0 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 3 mg/kg; Subcutaneous normal saline single dose; Subcutaneous single dose 6 mg/kg; Subcutaneous normal saline single dose; Intravenous infusion single dose 1 mg/kg; Intravenous infusion normal saline single dose; Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57); Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57); Subcutaneous injection multiple dose TBD mg (Days TBD); Subcutaneous injection normal saline multiple dose (Days TBD)
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 84.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: first in human; single dose; multiple dose; escalation; safety study; Type 2 Diabetes Mellitus

Summary:

      A first in human study to determine the safety, tolerability and pharmacokinetics of single
      and multiple ascending doses of PF-06293620 in subjects with Type 2 Diabetes Mellitus
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women of non-childbearing potential with Type 2 Diabetes Mellitus

          -  Subjects on stable doses of metformin >/= 1500 mg daily (SAD cohorts) or >/= 1000 mg
             daily (MAD cohorts) x 30 days prior to screening

          -  HbA1c 7-10% (SAD Cohorts) or 6.5-10% (MAD cohorts) inclusive at screening

          -  Fasting C-peptide >1.12 ng/mL (SAD cohorts) or >/= 0.8 mg/mL (MAD cohorts) at
             screening

        Exclusion Criteria:

          -  History of Type 1 diabetes mellitus

          -  Evidence of diabetic complications with significant end-organ damage

          -  History of chronic pancreatitis or at high risk for pancreatitis

          -  Poorly controlled hypertension

          -  History of cardiovascular or cerebrovascular event or procedure
NAPLS Omega-3 Fatty Acid Versus Placebo Study
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Intervention: Omega-3 Long Chain Fatty Acid; Placebo
Intervention description: : The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.; The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 127.0
Sex: All
Minimum age: 12 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Prodromal; Schizophrenia; Psychosis; Omega

Summary:

      The overall goal of the present study is to determine whether Omega-3 Fatty Acids potentially
      prevent onset of psychosis and improve clinical symptoms and functional outcome in youth and
      young adults at elevated clinical risk for schizophrenia and related disorders. The specific
      aims are: (1) To determine whether the rate of progression to psychosis is lower during six
      months of treatment with Omega-3 Fatty Acids compared to six months of treatment with
      placebo, (2) To determine whether Omega-3 Fatty Acids are more efficacious than placebo for
      prodromal symptoms, negative symptoms, and functioning, (3) To assess the safety and
      tolerability of Omega-3 Fatty Acids in this population, and (4) To conduct analyses of
      neuroimaging, neurocognitive, electrophysiological and other ancillary data to explore
      mechanistic explanations for the hypothesized benefits of Omega-3 Fatty Acids on clinical and
      functional outcomes (e.g., increases in white matter integrity and processing speed).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be included if they are treatment-seeking patients between the ages of
             12 and 30 who meet diagnostic criteria for a possible prodromal syndrome and are part
             of the ongoing NAPLS study.

        Exclusion Criteria:

          -  use of antipsychotic medication in the previous month.

          -  concomitant medical or neurological illness.

          -  history of significant head injury.

          -  alcohol or drug abuse (excluding nicotine) in the past month or dependence in the past
             three months.

          -  screening full scale estimated IQ < 80.

          -  active suicidal or homicidal ideation.

          -  pregnancy or lactation.

          -  allergies to seafood or seafood related products or no history of seafood consumption
Empa/Lina FDC Food Effect Study (Japan)
Condition: Healthy
Intervention: empagliflozin/linagliptin FDC
Intervention description: empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet
Intervention MeSH terms: Empagliflozin; Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Male
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The trial will be performed as an open-label, randomised, single-dose, two-sequence crossover
      design for the assessment of effect of food on bioavailability of empagliflozin / linagliptin
      fixed dose combination (FDC) tablet.
    

Eligibility criteria:

        Inclusion criteria:

          -  Healthy male subjects age >=20 and <=45 years; body weight: >=50 kg and <=80 kg; body
             mass index: >=18.0 and <=25.0 kg/m2

          -  Without any clinically significant findings and complications on the basis of a
             complete medical history, including the physical examination, vital signs (blood
             pressure (BP), pulse rate (PR), body temperature)

          -  Signed and dated written informed consent prior to admission to the trial in
             accordance with the Good Clinical Practice (GCP) and the local legislation

        Exclusion criteria:

          -  Any finding of the medical examination (including blood pressure, pulse rate and
             electrocardiogram) deviating from normal and of clinical relevance

          -  Further exclusion criteria apply
A Safety Study of LY2886721 Multiple Doses in Healthy Subjects
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: LY2886721; Placebo
Intervention description: 5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days; Administered orally as capsules, daily for 14 days
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 study in healthy subjects to evaluate the safety and tolerability of
      LY2886721 multiple doses, how the body handles the drug, and the drug's effect on the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy men and non-childbearing potential women

          -  Body mass index between 18.0-32.0 kilograms per square meter (kg/m^2)

          -  Are reliable and willing to make yourself available for the duration of the study and
             are willing to follow study procedures and research unit policies

        Exclusion Criteria:

          -  Taking over-the-counter or prescription medication with the exception of vitamins or
             minerals

          -  Smoke more than 10 cigarettes per day

          -  Drink more than 5 cups of caffeine containing beverages (for example, coffee, tea) per
             day
A Study to Investigate the Effect of Rifampicin on the PK of Multiple Doses of Balovaptin In Healthy Volunteers
Condition: Healthy Volunteers
Intervention: Balovaptan; Rifampicin
Intervention description: In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.
In Period 2, balovaptan was administered as a qd dose on Days 7 to 16.; In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.
Intervention MeSH terms: Rifampin; Balovaptan
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was a single-center, non-randomized, open-label, one-sequence, two-period,
      within-subject study to investigate the effects of multiple doses of rifampicin on the PK and
      safety of multiple doses of balovaptan in healthy subjects. The study was conducted at 1 site
      in the Netherlands.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and female subjects. Healthy status is defined by absence of evidence of
             any active or chronic disease following a detailed medical and surgical history, a
             complete physical examination including vital signs, 12-lead ECG, hematology, blood
             chemistry, urinalysis, and serology.

          -  Body Mass Index of 18 to 30 kg/m2, inclusive.

          -  For women of childbearing potential: agreement to use at least 2 acceptable
             contraceptive methods during the treatment period and for 90 days after the last dose
             of study drug.

          -  For men: agreement to use contraceptive measures, and agreement to refrain from
             donating sperm until 90 days after the last dose of study drug.

        Exclusion Criteria:

          -  Female subjects who are pregnant or lactating.

          -  Any condition or disease detected during the medical interview/physical examination
             that would render the subject unsuitable for the study, place the subject at undue
             risk or interfere with the ability of the subject to complete the study in the opinion
             of the Investigator.

        Rifampicin-related Exclusion Criteria:

          -  Subjects diagnosed, or suspected of having porphyria, and subjects with first-degree
             relatives diagnosed, or suspected of having porphyria.

          -  Known hypersensitivity to rifampicin
A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Intervention: LY3819253; Placebo
Intervention description: Administered IV.; Administered IV.
Intervention MeSH terms: Bamlanivimab
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to test the safety and tolerability of LY3819253 when it is
      given by injection into a vein to participants hospitalized with COVID-19. Blood tests will
      be done to check how much LY3819253 is in the bloodstream and how long the body takes to
      eliminate it. Participation could last about 8 weeks and may include up to 15 visits in the
      hospital or the home.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are hospitalized or in the process of being admitted to hospital and have an initial
             laboratory determination of current COVID-19 infection less than or equal to (≤)72
             hours prior to randomization

          -  Are men or non-pregnant women

          -  Women of childbearing potential must agree to use at least one highly effective form
             of contraception for the entirety of the study

          -  Agree to the collection of nasopharyngeal swabs and venous blood

        Exclusion Criteria:

          -  Require mechanical ventilation or anticipated impending need for mechanical
             ventilation

          -  Received convalescent COVID-19 plasma treatment prior to enrollment

          -  Were resident in a nursing home or long-term care facility immediately prior to
             current hospitalization

          -  Suspected or proven serious, active bacterial, fungal, viral, or other infection
             (besides COVID-19) that in the opinion of the investigator could constitute a risk
             when taking investigational product

          -  Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air
             at rest at randomization.
A Phase 1 Single Ascending Dose and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of VBP15 in Healthy Adult Subjects
Condition: Healthy
Intervention: VBP15; Placebo
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: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Safety; tolerability; pharmacokinetics; adult; volunteers

Summary:

      The purpose of this study is to examine the safety, tolerability, and PK of various
      increasing single and multiple doses of VBP15 in healthy adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For the Single Ascending Dose Study (SAD): Male subjects, ages 18 to 65 years,
             inclusive.

          -  For the Multiple Ascending Dose Study (MAD): Male subjects or female subjects of
             nonchildbearing potential ages 18 to 65, inclusive.

        Exclusion Criteria:

          -  For the MAD Study: Women of childbearing potential.

          -  Clinically significant abnormal laboratory parameters
Study of Oral ALXN1840 at 2 Dose Strengths in Healthy Adults
Condition: Healthy
Intervention: ALXN1840
Intervention description: Participants received ALXN1840 at Hour 0 on Day 1 of the dosing period.
Intervention MeSH terms: Tetrathiomolybdate; Choline
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: ALXN1840; Enteric-coated tablet; Pharmacokinetics; Pharmacodynamics; Healthy

Summary:

      To assess the relative bioavailability of ALXN1840 administered orally as a single
      enteric-coated (EC) tablet (reference, Treatment A) versus three EC tablets (test, Treatment
      B).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight ≤ 100 kilograms (kg) and body mass index within the range 18-25 kg/meter
             squared, inclusive, at Screening.

          -  Negative serum pregnancy test at Screening and Day -1 for all women of childbearing
             potential.

          -  Willing to adhere to contraception requirements.

          -  Satisfactory medical assessment with no clinically significant or relevant
             abnormalities.

        Exclusion Criteria:

          -  Current or recurrent/chronic disease

          -  Positive test for hepatitis B surface antigen or human immunodeficiency virus antibody
             at Screening.

          -  Acute or chronic hepatitis C virus infection.

          -  History of hypersensitivity to ALXN1840 or its excipients or any significant allergic
             reaction.

          -  Use of prescription medications (excluding oral contraceptives) within 14 days prior
             to dosing on Day 1, except with prior approval of the Sponsor.

          -  Participation (that is, last protocol-required study visit) in a clinical study within
             90 days before initiation of dosing on Day 1.

          -  Serum ceruloplasmin value outside of the normal range at Screening

          -  Female participants who were breastfeeding.

          -  Prior exposure to ALXN1840.

          -  Major surgery or hospitalization within 90 days prior to dosing on Day 1.
Estimation Of Effect Of Ketoconazole On Pharmacokinetics Of Crizotinib In Healthy Volunteers
Condition: Healthy
Intervention: crizotinib; ketoconazole; crizotinib
Intervention description: Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.; Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16.; Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.
Intervention MeSH terms: Ketoconazole; Crizotinib
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: crizotinib; healthy volunteers; ketoconazole; pharmacokinetics; single dose

Summary:

      The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the
      single dose pharmacokinetics of crizotinib in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female of non-child bearing potential subjects between the ages of
             18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
             identified by a detailed medical history, full physical examination, including blood
             pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110
             lbs).

        Exclusion Criteria:

          -  Subjects with evidence of disease, conditions affecting drug absorption, treatment
             with other investigational drug within 30 days, history of regular alcohol
             consumption, and use of prescription , nonprescription drugs and dietary supplement
             within 7 days, and blood donation of 500 mL within 56 days.
Sitagliptin Dose Comparison Study in Patients With Type 2 Diabetes (MK-0431-077)(COMPLETED)
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin phosphate; sitagliptin phosphate; Comparator: Placebo
Intervention description: sitagliptin 100 mg tablets q.d. (once daily) for 7 days.; sitagliptin 200 mg tablets q.d. (once daily) for 7 days.; sitagliptin 100 mg & 200 mg matching Placebo tablets q.d. (once daily) for 7 days.
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to assess the safety and efficacy of sitagliptin 100mg compared to sitagliptin 200mg
      in patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has Type 2 Diabetes

          -  Patient is between the ages of 30-65 years

          -  Patient is not on an antihyperglycemic agent (AHA) (glycosylated hemoglobin [A1C]
             7-10% ), or is on oral single AHA or low-dose combination therapy (A1C 6.5-9.5%).

        Exclusion Criteria:

          -  Patient has Type 1 Diabetes

          -  Patient has been treated with sitagliptin, vildagliptin, or other similar drugs or has
             been treated with exenatide in the past 3 months

          -  Patient has taken insulin within the past 3 months