bioihbjkbjnl/mcl2 huggingface dataset:
SSP-002358 Drug Interaction Study With Omeprazole
Condition: Healthy
Intervention: SSP-002358; SSP-002358 + omeprazole
Intervention description: 1 mg, oral, once; SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
Intervention MeSH terms: Omeprazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a drug interaction study evaluating whether blood plasma concentrations of
      SSP-002358-base are altered when SSP-002358 is taken together with omeprazole.
    

Eligibility criteria:

        Inclusion criteria:

          1. Age 18-55 years inclusive at the time of consent.

          2. Subject is willing to comply with any applicable contraceptive requirements of the
             protocol and is:

               -  Male, or

               -  Non-pregnant, non-lactating female

               -  Females must be at least 90 days post-partum or nulliparous.

        Exclusion criteria:

          1. Any current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal,
             malignancy or other conditions) that could affect the action, absorption, or
             disposition of the investigational product, or could affect clinical or laboratory
             assessments.

          2. Any known or suspected intolerance or hypersensitivity to the investigational product
             or omeprazole, closely related compounds, or any of the stated ingredients.
A Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro
Intervention description: Administered via SC injection; Administered via SC injection
Intervention MeSH terms: Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 56.0
Sex: All
Minimum age: 6 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 1 diabetes mellitus.

      There are 2 parts to this study. Part A is investigating how the body processes LY900014 and
      the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog) when study
      treatment is given by subcutaneous injection. Part B of the study is investigating how the
      body processes LY900014 and the effect of LY900014 on blood sugar levels compared to insulin
      lispro (Humalog) when study treatment is given by continuous subcutaneous insulin infusion
      (CSII) pump.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 40 days in each part.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants aged 6-64 with Type 1 Diabetes Mellitus (T1DM) for at
             least 1 year

          -  Have a glycated hemoglobin (HbA1c) less than (<)10.0 percent (%)

        Exclusion Criteria:

          -  Receiving any oral or injectable medication intended for the treatment of diabetes
             mellitus other than insulins in the 12 months prior to screening

          -  More than one episode of severe hypoglycaemia in the last 6 months

          -  Presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic, or
             gastrointestinal disease, proliferative retinopathy, uncontrolled celiac disease,
             uncontrolled hyperthyroidism or hypothyroidism, or adrenal insufficiency

          -  Have obvious clinical signs or symptoms of liver disease

          -  Have a history of renal impairment
A Family-based, Resilience-focused Intervention for War-affected Communities in North-eastern Democratic Republic of Congo
Condition: Psychological Distress
Intervention: Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention
Intervention description: A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 159.0
Sex: All
Minimum age: 7 Years
Maximum age: 99 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: community-based; war-affected; psychosocial support; family-focused; psychological distress; adolescents; Democratic Republic of Congo; family functioning; community functioning; daily functioning

Summary:

      The main research question of the study is whether a family-based, life-skills focused
      psychosocial intervention is effective in reducing psychological distress and stigma and
      improving inter-personal relations and functioning among war-affected children in the
      Democratic Republic of Congo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  War-affected

          -  eastern Democratic Republic of Congo

          -  Formerly abducted child or vulnerable child

        Exclusion Criteria:

          -  severe/violent behavioural problems

          -  severe learning difficulties
Effect of Tepotinib on PK of CYP3A Substrate Midazolam
Condition: Healthy
Intervention: Midazolam; Tepotinib
Intervention description: Participant received single oral dose of 7.5 mg midazolam tablet on Day 1 of treatment period 1 and Day 11 in treatment period 2.; Participants received single oral dose of 500 mg tepotinib film-coated tablet from Day 1 to 11 in treatment period 2.
Intervention MeSH terms: Tepotinib; Midazolam
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Sequential Assignment
Intervention model description: This is a single sequence cross-over trial.
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 44 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Tepotinib; Midazolam; Cytochrome P450; Pharmacokinetics

Summary:

      The study investigated the effect of tepotinib on the pharmacokinetics (PK) of the Cytochrome
      P450 (CYP) 3A substrate midazolam determined from concentrations of midazolam and its main
      metabolite 1-hydroxymidazolam in healthy participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants of non-child bearing potential

          -  Body weight between 50 to 100 kilogram (kg)

          -  Body mass index (BMI) between 18.5 and 29.9 kilogram per meter square (kg/m^2)

          -  Other protocol defined inclusion criteria could apply

        Exclusion Criteria:

          -  Participation in a clinical study within 60 days prior to first drug administration

          -  Whole blood donation or loss of greater than 450 milliliter (mL) within 60 days prior
             to first drug administration

          -  Any surgical or medical condition, or any other significant disease that could
             interfere with the study objectives, conduct, or evaluation

          -  Other protocol defined exclusion criteria could apply
An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: MK-0941; Placebo; LANTUS insulin
Intervention description: In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.
Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2.; 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.; LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Intervention MeSH terms: Insulin Glargine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type
      2 diabetics being treated with basal insulin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female (of non-childbearing potential) between 18 to 70 years of age

          -  Diagnosed with Type 2 Diabetes and currently being treated with basal insulin

          -  Smokers may participate, but they are limited to 10 cigarettes per day while at the
             clinic and must follow clinic smoking rules

        Exclusion Criteria:

          -  History of Type 1 diabetes

          -  Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12
             weeks prior to study start

          -  History of severe hypoglycemia

          -  Allergic to insulin
A Study to Evaluate the Effect of the Potent Cytochrome P-450 3A4 (CYP3A4) Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-954 in Healthy Adult Participants
Condition: Healthy Participants
Intervention: TAK-954; Itraconazole
Intervention description: TAK-954 Infusion; Itraconazole Capsule
Intervention MeSH terms: Itraconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Drug Therapy

Summary:

      The purpose of this study is to evaluate the effect of the potent CYP3A4 inhibitor
      itraconazole on the single-dose PK of TAK-954.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Is a man or woman (with no child bearing potential) aged 18 to 55 years, inclusive, at
             the Screening Visit.

          2. Has a body mass index (BMI) from greater than or equal to (>=) 18 and less than or
             equal to (<=) 30 kilogram per square meter (kg/m^2) and has a body weight greater than
             (>) 50 kilogram (kg) at the Screening Visit.

          3. Is a nonsmoker who has not used tobacco- or nicotine-containing products (example,
             nicotine patch) for at least 6 months before administration of the initial dose of
             trial drug/invasive procedure.

        Exclusion Criteria:

          1. Has a positive alcohol or drug screen.

          2. Had major surgery, donated or lost 1 unit of blood (approximately 500 milliliter (mL))
             within 8 weeks of the first dose of study drug.

          3. Has a history of alcohol consumption exceeding 2 standard drinks per day on average (1
             glass is approximately equivalent to: beer [354 mL/12 ounces], wine [118 mL/4 ounces],
             or distilled spirits [29.5 mL/1 ounce] per day).

          4. Consumes excessive amounts, defined as greater than 6 servings (1 serving is
             approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks,
             or other caffeinated beverages per day.

          5. Has a substance abuse disorder.
Study of Milademetan in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: Milademetan
Intervention description: Milademetan was administered orally once daily on Days 1 to 14 in a 28-day cycle.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Oncology; MDM2; Escalation with overdose control (EWOC)

Summary:

      This is a Phase 1, multicenter, open-label study to evaluate safety, tolerability and
      pharmacokinetics of milademetan in Japanese patients with relapsed or refractory acute
      myeloid leukemia. The milademetan initial dose will be Level 1: 90 mg. No increase in the
      milademetan dose will be made in the same participant. Dose-limiting toxicity associated with
      milademetan occurring at each level will be assessed, and the maximum tolerated dose (MTD)
      will be decided using a modified continuous reassessment method (mCRM).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Relapsed or refractory AML

          -  AML for which no standard treatment is available

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 2

        Exclusion Criteria:

          -  Acute Promyelocytic Leukemia

          -  Chronic myelogenous leukemia in blast crisis (BCR-ABL fusion gene positive)

          -  Presence of central nervous system involvement of leukemia or a history of primary
             central nervous system leukemia
A Study of The Effect of Hepatic Impairment on The Pharmacokinetics of Aleglitazar
Condition: Healthy Volunteer
Intervention: aleglitazar
Intervention description: single oral dose
Phase: Phase 1
Study type: Interventional
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This open-label study will assess the effects of hepatic impairment on the pharmacokinetics
      of a single oral dose of aleglitazar in subjects with mild or moderate hepatic impairment
      (Child-Pugh class A or B) and in matched control subjects with normal hepatic function.
      Subjects will receive a single oral dose of aleglitazar, with assessment of the
      pharmacokinetics of aleglitazar on Days 1-5. Anticipated duration of study for each enrolled
      subject is approximately 6 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female adults, 18-70 years of age inclusive

          -  Normal hepatic function or mild to moderate impaired liver function (Child-Pugh class
             A or B)

          -  Body mass index (BMI) 18 to 40 kg/m2 inclusive

          -  Females must be either surgically sterile, postmenopausal, or willing to use two
             reliable methods of contraception for the duration of the study and started 3 months
             before study start

        Exclusion Criteria:

          -  For subjects with hepatic impairment: evidence of progressive liver disease within the
             last 4 weeks, or biliary liver cirrhosis or other causes of hepatic impairment not
             related to parenchymal disorder and/or disease

          -  For healthy volunteers: positive test for hepatitis B or C, alcohol intake of more
             than 14 units per week, or history of clinically significant alcohol or drug abuse

          -  Acute infection or current malignancy requiring treatment

          -  History of clinically significant allergic disease or drug hypersensitivity

          -  Positive test for HIV-1 or HIV-2 at screening

          -  Participation in a clinical study with an investigational drug or new chemical entity
             within 2 months prior to screening

          -  Females who are pregnant or lactating
A Phase I Study to Assess the Safety of Pegcetacoplan (APL-2) as an Add-On to Standard of Care in Subjects With PNH
Condition: Paroxysmal Nocturnal Hemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Intervention: Pegcetacoplan
Intervention description: Complement (C3) Inhibitor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: PNH; Paroxysmal Nocturnal Hemoglobinuria; Complement inhibitor; Anemia; Hemoglobinuria; hematologic diseases; extravascular hemolysis (EVH); intravascular hemolysis (IVH); C3 inhibitor

Summary:

      This study will be the initial exploration of pegcetacoplan in patients with PNH. The
      assessments of the safety, tolerability, PK, and PD following administration of single and
      multiples doses of pegcetacoplan will guide decisions to further develop the drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female

          -  At least 18 years of age

          -  Weigh >55 kg

          -  Diagnosed with PNH

          -  On treatment with eculizumab (Soliris®) for at least 3 months

          -  Hb < 10 g/dL at screening OR have received at least one transfusion within 12 months
             prior to screening

          -  Platelet count of >30,000/mm3

          -  Absolute neutrophil count > 500/mm3

          -  Women of child-bearing potential (WOCBP) must have a negative pregnancy test at
             screening and must agree to use protocol defined methods of contraception for the
             duration of the study (see below)

          -  Males with female partners of child bearing potential must agree to use protocol
             defined methods of contraception (see below) and agree to refrain from donating sperm
             for the duration of the study

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Active bacterial infection

          -  Known infection with hepatitis B, C or HIV

          -  Hereditary complement deficiency

          -  History of bone marrow transplantation

          -  Participation in any other investigational drug trial or exposure to other
             investigational agent, device or procedure within 30 days

          -  Evidence of QTcF prolongation defined as > 450 ms for males and > 470 ms for females
             at screening

          -  Creatinine clearance (CrCl) < 50 mL/min (Cockcroft-Gault formula) at screening

          -  Breast-feeding women

          -  History of meningococcal disease

          -  No vaccination against N. meningitidis types A, C, W, Y and B (administered as two
             separate vaccinations), Pneumococcal conjugate vaccine or Pneumococcal polysaccharide
             vaccine 23 (PCV13 or PPSV23, respectively) and Haemophilus influenzae Type B (Hib)
             vaccination within 2 years prior to Day 1 (Visit 2) dosing.
Thrombosomes® in Bleeding Thrombocytopenic Patients
Condition: Thrombocytopenia; Hematologic Diseases; Bone Marrow Aplasia
MeSH terms: Thrombocytopenia; Hematologic Diseases; Anemia, Aplastic; Hemorrhage
Intervention: Thrombosomes
Intervention description: Freeze-dried platelets
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: thrombocytopenia; bleeding

Summary:

      The study evaluates the safety and potential early signals of efficacy of allogeneic
      Thrombosomes in bleeding thrombocytopenic patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults up to 74 y/o with any of following: acute leukemia (ALL or AML),
             myelodysplasia, aplasia, and/or therapy (chemotherapy or radiation) induced bone
             marrow aplasia or hypoplasia with thrombocytopenia (platelet count ≥ 5,000 and ≤
             70,000/μL) for a minimum of 2 days. May include bone marrow transplant or peripheral
             or cord blood stem cell recipients, but not subjects with Graft-vs-Host disease.

          -  Hospitalized patients (or willing to be hospitalized for 24 hours after Rx) with
             Modified WHO Grade 1 (subset) or Grade 2 Bleeding Score or at risk for same within 4
             weeks of screening. The Grade 1 subset includes patients who have either epistaxis,
             hematuria, oral petechiae, or bleeding at invasive or other wound sites.

          -  No platelet inhibitor drugs within 5 days prior to infusion and through Day 6
             follow-up period.

        Exclusion Criteria:

          -  History or condition related to thrombosis, embolism or vascular occlusion/ischemia,
             including but not limited to: transient ischemic attack, stroke, myocardial
             infarction, stent placement, valve replacement and/or repair

          -  Currently with an active acute infection, or suspected infection, a single oral
             temperature of ≥ 101° F or a temperature of ≥ 100.4°F sustained over a 1 h period in
             past 24 h. Subjects on prophylactic antibiotics are not excluded from study

          -  Coagulopathy or receiving anticoagulants that result in PT (prothrombin time) or aPTT
             (activated partial thromboplastin time) values greater than 1.3 X upper limit of
             normal or elevated D-dimer of decreased fibrinogen

          -  History of any inherited coagulation or platelet function, disorder or ITP (idiopathic
             thrombocytopenic purpura), TTP (thrombotic thrombocytopenic purpura), or HUS
             (hemolytic-uremic syndrome)

          -  Receipt of tranexamic acid or other antifibrinolytics within 48 hrs prior to infusion

          -  Treatment with an investigational drug within 1 month of infusion, other than for
             treatment of their underlying disease