bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacodynamic Study of Cilostazol in Healthy Volunteers
Condition: Healthy
Intervention: Cilostazol; Acetylsalicylic acid; Clopidogrel
Intervention MeSH terms: Aspirin; Cilostazol; Clopidogrel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 77.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      The primary objective of this study is to investigate the effects of Cilostazol,
      Acetylsalycylic acid and Clopidogrel alone as well as combinations of
      Cilostazol/Acetylsalicylic acid and Cilostazol/ Clopidogrel on ex-vivo Platelet Function (PF)
      testing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Caucasian male subjects

          -  Able to read, to write and to fully understand German language

          -  Provision of written informed consent before screening and baseline

          -  BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg,
             inclusive

          -  Good general health as determined by the investigator by medical history, physical
             examination, vital signs, electrocardiogram, baseline and safety lab

        Exclusion Criteria:

          -  Personal or family history of bleeding disorders, or reasonable suspicion of vascular
             malformations, including aneurysms

          -  Known predisposition to bleeding (e.g. active peptic ulceration, recent (within 6
             month) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled
             hypertension)

          -  Use of antibiotics within thirty (30) days prior to screening and until baseline visit

          -  Clinically significant abnormalities in medical history, physical examination, vital
             signs, electrocardiogram, baseline and safety lab

          -  Supine pulse rate > 100 beats/min or <50 beats/min

          -  Systolic blood pressure <100 or >140 mmHg

          -  Diastolic blood pressure <50 or >90 mmHg

          -  Concomitant use of any other medication including over-the-counter preparations
A Phase 1B Study to Investigate the Safety and Preliminary Efficacy for the Combination of Dasatinib Plus Nivolumab in Patients With Chronic Myeloid Leukemia
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Intervention: Dasatinib; Nivolumab
Intervention MeSH terms: Nivolumab; Dasatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to find a dose of Nivolumab that can be safely added to
      Dasatinib in patients with Chronic Myeloid Leukemia.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com.

        Inclusion Criteria:

          -  Confirmed diagnosis of Chronic Myeloid Leukemia in Chronic Phase or Accelerated Phase
             :

               -  With historically documented Ph+ cells

               -  ≥2 prior Tyrosine Kinase Inhibitors (TKI) therapies for CML

               -  Currently progressing, resistance to or with a suboptimal response to their most
                  recent therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) Score 0 - 1

        Exclusion Criteria:

          -  Blast phase CML

          -  Known Abl-kinase mutation resistant to Dasatinib (e.g. T315I or T315A)
Effects of the NO-synthase Inhibitor VAS203 on Renal Function in Healthy Volunteers
Condition: Renal Function Impairment in Healthy Volunteers
Intervention: VAS203; Saline
Intervention description: Infusion of NO-Synthase inhibitor VAS203; Infusion of saline
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Analysis of the effect of the NO-Synthase inhibitor VAS203 (6 hours infusion of 10 mg/kg) on
      renal function and perfusion in 16 healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Informed consent in writing available.

          2. Willing and able to comply with all requirements of the study.

          3. Male, 18 and 45 years (inclusive).

          4. Subject has a body weight between 60 kg and 100 kg, extremes included.

          5. BMI 18 to 27 kg/m2.

          6. Non-smoker

          7. Serum creatinine within reference range (≤1.2 mg/dL) and Cockroft-Gault Clearance > 90
             ml/min

          8. Good general health as judged by the Investigator, as determined by medical history,
             physical examination, vital signs (systolic and diastolic blood pressure and pulse
             rate) and clinical laboratory parameters (clinical chemistry, hematology, and
             urinalysis)

        Exclusion Criteria:

          1. Clinically significant abnormalities in physical examination, vital signs or clinical
             laboratory parameters (according to the Investigator's judgment).

          2. Serum glutamate oxaloacetate transaminase or glutamate-pyruvate transaminase > 2-times
             above the upper limit of normal range.

          3. Subject with Cockcroft-Gault clearance < 90 ml/min.

          4. Clinically significant history of cardiovascular disease or any known present
             cardiovascular disease.

          5. History of clinically significant neurological, gastrointestinal, renal, hepatic,
             psychological, pulmonary, metabolic, endocrine, hematological, or other major
             disorders.

          6. Office blood pressure at screening higher than 160/100 mmHg, or lower than 95/55 mmHg.

          7. Office heart rate at screening after at least 5 minutes outside the range of 50- 99
             beats per minute (inclusive).

          8. Concomitant use of OTC medication within 1 week prior to dosing, except use of
             paracetamol (up to 2 g/day).

          9. Participation in any other clinical study within 30 days prior to inclusion in this -
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
Condition: Alcohol Use Disorder
MeSH terms: Alcoholism; Alcohol Drinking
Intervention: Pregnenolone300; Pregnenolone500; Placebo
Intervention description: 300mg; 500mg; placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind, placebo-controlled, parallel design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double-blinded
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Maximum age: 68 Years
Healthy volunteers: No

Summary:

      To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the
      role of neuroactive steroids in individuals with alcohol use disorder (AUD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female individuals, ages 18 to 68.

          -  Subjects must meet current Diagnostic and Statistical Manual of Mental Disorders 5th
             edition (DSM-V) criteria for alcohol use disorder; documented positive urine
             toxicology screen for alcohol at intake or collateral information from family members,
             significant others, room-mates etc., on recent use.

          -  Subject has voluntarily given informed consent and signed the informed consent
             document.

          -  Able to read English and complete study evaluations.

        Exclusion Criteria:

          -  Women who are pregnant, or nursing or are of childbearing potential and not practicing
             an effective means of birth control.

          -  Meet current criteria for use disorder on another psychoactive substance, such as,
             heroin, amphetamines, hallucinogens/Phencyclidine (PCP), excluding alcohol and
             nicotine.

          -  Any current use of opiates or past history of opiate use disorder (assessed via urine
             toxicology and self report).

          -  Current use of any psychoactive drugs (urine toxicology), including anxiolytics,
             naltrexone or antabuse.

          -  Any psychotic disorder or current Axis I psychiatric symptoms requiring specific
             attention.

          -  Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac
             pathology which in the opinion of study physician would preclude patient from fully
             cooperating or be of potential harm during the course of the study.

          -  Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
A Study to Compare the Pharmacokinetics of Belatacept Using Active Pharmaceutical Ingredient Manufactured by Process E Relative to Process C
Condition: Renal Transplantation
Intervention: Process E Belatacept; Process C Belatacept
Intervention MeSH terms: Abatacept
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 491.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of the study is to compare the Pharmacokinetics (PK) of Process E belatacept
      relative to Process C belatacept in Healthy subjects
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed Informed Consent

          2. Target population: Healthy males and females.

          3. Males and females, ages 18 to 55 years, inclusive.

          4. Women of child bearing potential (WOCBP) with negative serum or urine pregnancy test

          5. Women must not be breastfeeding

          6. Men and WOCBP must agree to follow instructions for contraception

        Exclusion Criteria:

          1. History of TB, malignancy, any other chronic or acute infecton or disease.

          2. History of acute or chronic medical illness

          3. Evidence of organ dysfunction or any clinically significant deviation from normal in
             physical examination, vital signs, ECG or clinical laboratory determinations beyond
             what is consistent with the target population.

          4. History of allergy to belatacept or related compounds -
Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), and Usability of Abaloparatide-solid Microstructured Transdermal System (sMTS) in Postmenopausal Women With Low Bone Mineral Density (BMD)
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Bone Diseases, Metabolic
Intervention: abaloparatide-sMTS
Intervention description: Abaloparatide-sMTS is a drug-device combination product consisting of the drug abaloparatide coated onto an sMTS array for transdermal administration of abaloparatide.
Intervention MeSH terms: Abaloparatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: Female
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: postmenopausal osteoporosis; transdermal delivery; microstructure patch; abaloparatide

Summary:

      This was an open-label, single-center study to evaluate the usability of abaloparatide-sMTS
      by participants with low BMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal for at least 2 years

          -  BMD T-score based on the female reference range <-1.0 and >-5.0 at the lumbar spine
             (L1-L4) or hip (femoral neck or total hip) by dual energy X-ray absorptiometry (DXA)

          -  Good general health as determined by medical history and physical exam (including
             vital signs, and has a body mass index up to 33 kilograms/square meter (kg/m^2)

          -  Laboratory tests within the normal range including serum calcium (albumin-corrected),
             intact parathyroid hormone (PTH), serum phosphorus, alkaline phosphatase, and thyroid
             stimulating hormone

          -  Serum 25-hydroxyvitamin D values ≥ 20 nanograms per milliliter (ng/mL)

        Exclusion Criteria:

          -  History of prior external beam or implant radiation therapy involving the skeleton,
             other than radioiodine

          -  History of bone disorders other than postmenopausal osteoporosis (such as Paget's
             disease)

          -  History of cancer within the last 5 years (with the exception of basal cell or
             squamous cancer of the skin)

          -  History of Cushing's disease, hypo or hyperparathyroidism, or malabsorptive syndromes
             within the past year

          -  Prior treatment with PTH, PTH-related peptide-derived drugs, or bone anabolic
             steroids, including abaloparatide, teriparatide, or PTH (1-84)

          -  Prior treatment with intravenous bisphosphonates at any time or oral bisphosphonates
             within the past year (12 months). Participants who have received a short course of
             oral bisphosphonate therapy (3 months or less) may be enrolled as long as the
             treatment occurred 6 or more months prior to enrollment

          -  Prior treatment with an investigational drug or device within the past 3 months or 5
             half-lives of the investigational drug, whichever is longer
The Interaction of Flavor With Nicotine Form in Adult Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine form; E-cigarette experimental flavor
Intervention description: participants will receive 36mg/ml nicotine salt and freebase nicotine; Participants will receive menthol and tobacco flavored e-cigarettes
Intervention MeSH terms: Nicotine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 20.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study seeks to elucidate the impact of e-cigarette flavor on subjective effects and
      nicotine exposure from e-cigarettes containing different forms of nicotine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 21 years old, able to read and write, use of combustible

        Exclusion Criteria:

        -
A Phase I Trial to Assess the Effects of Food and Formulation on PK of KPT-330 in Patients With Sarcoma
Condition: Sarcoma
MeSH terms: Sarcoma
Intervention: KCP-330
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Bone sarcoma; Soft-tissue sarcoma; Sarcoma; KPT-330; Food; Effects; Selinexor

Summary:

      The purpose of this research study is to find out more information such as: to determine the
      effects of high and low fat foods on the pharmacokinetics (PK) of oral KPT-330 tablets and to
      compare PK of capsules and tablets in Arms 1 and 2; to evaluate tumor response in sarcoma
      participants in Arm 3; to compare the PK of 60 milligrams (mg) of the new, 2nd generation
      tablet formulation and 60 mg of the selinexor suspension formula to the current, 1st
      generation tablets.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must have histologically confirmed soft tissue or bone/cartilage sarcoma.
             Patients with sarcoma of small round blue cell tumor types are allowed.
             Gastrointestinal stromal tumors (GIST) are excluded.

          2. Patients must have received at least one prior anticancer regimen for metastatic
             disease unless there is no other therapy available and evidence of progressive disease
             on study entry. Patients with stable disease will be included if there has been
             failure to respond to another drug(s) within the previous 3 months

        Exclusion Criteria:

          1. Patients with known liver metastases

          2. Radiation, chemotherapy, immunotherapy, any other systemic anticancer therapy or
             participation in an investigational anti-cancer study ≤ 3 weeks prior to initiation of
             therapy

          3. Patients with known brain metastasis

          4. Patients with any gastrointestinal dysfunctions that could interfere with the
             interpretation of the food effect data

          5. Patients with known intolerance to low or high fat meals

          6. In the opinion of the investigator, patients who are significantly below their ideal
             body weight
A Study of LY900014 in Participants With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY900014; Insulin Lispro
Intervention description: Administered SC; Administered SC
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: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to compare LY900014 with insulin lispro (Humalog) in
      participants with type 2 diabetes mellitus. The study will be conducted in participants with
      type 2 diabetes on insulin injection therapy to investigate how the body processes LY900014
      and the effect of LY900014 on blood sugar levels compared to insulin lispro (Humalog).

      Screening is required within 28 days prior to the start of the study. For each participant,
      the total duration of the clinical trial will be between 3 and 8 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 2 Diabetes Mellitus (T2DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

          -  Have a history or current cardiovascular, respiratory, hepatic, renal,
             gastrointestinal, endocrine (apart from T2DM), hematological, or neurological
             disorders capable of significantly altering the absorption, metabolism or elimination
             of drugs; of constituting a risk when taking the investigational product; or of
             interfering with the interpretation of data

          -  Have a history of renal impairment

          -  Have a history of deep vein thrombosis of the leg or repeated episodes of deep leg
             vein thrombosis in first-degree relatives

          -  Have proliferative retinopathy or maculopathy and/or severe neuropathy
A Meal Test Study of LY900014 in Participants With Type 1 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Lispro; Insulin Aspart; Insulin Aspart
Intervention description: Administered SC; Administered SC; Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Two forms of insulin lispro (LY900014 and Humalog®) and two forms of insulin aspart
      (NovoRapid® and Fiasp®) will be given to trial participants with diabetes mellitus type 1 by
      injection under the skin. The study will assess how fast the active ingredient (insulin
      lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove
      it. A test meal will be given to trial participants to assess the course of the blood sugar
      lowering effect of the investigational products. The safety and tolerability of LY900014 will
      also be assessed. Screening is required within 14 days prior to the lead in. For each
      participant, the study will last up to 91 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are male or female participants with Type 1 Diabetes Mellitus (T1DM) for at least 1
             year

          -  Have a body mass index (BMI) of 18.5 to 35.0 kilogram per meter square (kg/m²)

          -  Have a glycated hemoglobin (HbA1c) less than (<)9.0 percent (%)

          -  Have had no episodes of severe hypoglycaemia in the last 6 months

        Exclusion Criteria:

        - Have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal,
        endocrine (apart from T1DM), hematological, or neurological disorders capable of
        significantly altering the absorption, metabolism or elimination of drugs; of constituting
        a risk when taking the investigational product; or of interfering with the interpretation
        of data