bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects
Condition: Healthy Volunteers
Intervention: Placebo; ASC-01
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Male
Minimum age: 20 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and
      sertraline Tablet in Japanese healthy male subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male volunteers aged 20 to 40 years.

          -  Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50
             kg.

        Exclusion Criteria:

          -  History of any clinically important disease or disorder which, in the opinion of the
             Investigator, may either put the volunteer at risk because of participation in the
             study.

          -  History or presence of gastrointestinal, hepatic, or renal disease or any other
             condition known to interfere with absorption, distribution, metabolism, or excretion
             of drugs.

          -  Any clinically significant abnormalities in the physical examination, clinical
             laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.
Intravaginal Artesunate for the Treatment of HPV+ High Grade Cervical Intraepithelial Neoplasia (CIN2/3)
Condition: Cervical Intraepithelial Neoplasia Grade 2/3; High-risk HPV (Any Strain)
MeSH terms: Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Intervention: Artesunate Suppositories
Intervention MeSH terms: Artesunate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cervical dysplasia; HPV; Treatment; preinvasive; cervix; vaginal suppository; Cornelia Trimble; abnormal pap; CIN

Summary:

      This phase I research protocol is designed to assess immunogenicity and clinical endpoints in
      patients with human papillomavirus (HPV) 16 cervical intraepithelial neoplasia (CIN)2/3. The
      protocol tests the use of artesunate in suppository formulation applied intravaginally in
      patients with cervical dysplasia (CIN2/3).

      The primary endpoint is to determine and evaluate the safety, tolerability, and feasibility
      of intravaginal administration of artesunate in health women with CIN2/3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years

          -  Capable of informed consent

          -  HPV-positive by DNA test

          -  Histologically confirmed CIN 2, CIN 3, or CIN 2/3

          -  Body weight ≥ 50 kg

          -  Immune competent

        Exclusion Criteria:

          -  Pregnant and nursing women

          -  HIV seropositive

          -  Active autoimmune disease

          -  Taking immunosuppressive medication

          -  Evidence of concurrent adenocarcinoma in situ

          -  Concurrent malignancy except for nonmelanoma skin lesions
Drug-Drug Interaction Study Between Colchicine and Ketoconazole
Condition: Pharmacokinetics
Intervention: Colchicine; Ketoconazole; Colchicine
Intervention description: A single dose of colchicine 0.6 mg administered alone at 7:30 a.m. on Day 1.; one 200 mg Ketoconazole tablet administered twice daily at 7:15 a.m. and 7:15 p.m. on Days 15-18 without regard to meals, then along with colchicine at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours; final dose of 200 mg administered at 7:15 p.m. on Day 19; A single dose of colchicine 0.6 mg administered along with ketoconazole at 7:15 a.m. on Day 19 after an overnight fast of at least 10 hours
Intervention MeSH terms: Ketoconazole; Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: blood levels over time;; pharmacokinetics;; healthy adult;; cytochrome p450

Summary:

      Ketoconazole is a potent inhibitor of the cytochrome P450 (CYP) 3A4 enzyme system, one of the
      enzyme systems responsible for the metabolism of colchicine. This study will evaluate the
      effect of multiple doses of ketoconazole on the pharmacokinetic profile of a single 0.6 mg
      dose of colchicine. A secondary objective is to evaluate the safety and tolerability of this
      regimen in healthy volunteers. All study subjects will be monitored for adverse events
      throughout the study period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-45 years of age, non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) greater than or equal to 18 and less than or equal to 32, inclusive

        Exclusion Criteria:

          -  Recent participation (within 28 days) in other research studies

          -  Recent significant blood donation or plasma donation

          -  Pregnant or lactating

          -  Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface
             antigen (HbsAg), or hepatitis C virus (HCV)

          -  Recent (2-year) history or evidence of alcoholism or drug abuse

          -  History or presence of significant cardiovascular, pulmonary, hepatic, gallbladder or
             biliary tract, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, neurologic, or psychiatric disease

          -  Subjects who have used any drugs or substances known to inhibit or induce cytochrome
             (CYP) P450 enzymes and/or P-glycoprotein (P-gp) within 28 days prior to the first dose
             and throughout the study

          -  Drug allergies to colchicine or ketoconazole or any other anti-fungal agent
Open Label, 4 Week Study of ITCA 650 in Adults With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: ITCA 650 (exenatide in DUROS)
Intervention MeSH terms: Exenatide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 30 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      evaluate the safety and tolerability of ITCA 650 in subjects with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes >6 months

          -  stable diet & exercise, metformin, TZD or met + TZD HbA1c >6.5% <10.0%

        Exclusion Criteria:

          -  prior treatment with exenatide

          -  history of pancreatitis

          -  history of medullary thyroid cancer or multiple endocrine neoplasia 2
Safety and Pharmacokinetics Study of Redosing EXPAREL in Healthy Volunteers
Condition: Healthy Volunteers
Intervention: EXPAREL
Intervention MeSH terms: Bupivacaine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety and pharmacokinetics of redosing EXPAREL
      via local subcutaneous infiltration in healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥18 years of age.

          -  American Society of Anesthesiologists (ASA) physical status 1 or 2.

          -  Female subjects must be surgically sterile, at least 2 years postmenopausal, or using
             a medically acceptable method of birth control. If of childbearing potential, must
             have a documented negative pregnancy test within 24 hours before the first study drug
             administration.

          -  Able to provide informed consent, adhere to the study visit schedule, and complete all
             study assessments.

        Exclusion Criteria:

          -  History of hypersensitivity or idiosyncratic reactions to amide-type local
             anesthetics.

          -  History of abnormal bleeding tendencies/clotting disorders.

          -  Regular use of anticoagulants (except for low dose aspirin for cardioprotection).

          -  Received any investigational drug within 30 days prior to study drug administration,
             and/or has planned administration of another investigational product or procedure
             during his/her participation in this study.

          -  Currently pregnant, nursing, or planning to become pregnant during the study or within
             1 month after study drug administration.

          -  Subjects with significant medical conditions or laboratory results that, in the
             opinion of the Investigator, would constitute a contraindication to participation in
             the study, or cause inability to comply with the study requirements.

          -  Received bupivacaine or other local anesthetic within 7 days of first study drug
             administration.
DSAP Treatment Comparison: 2% Lovastatin/ 2% Cholesterol vs 2% Lovastatin Alone
Condition: Actinic Porokeratosis
MeSH terms: Porokeratosis
Intervention: Lovastatin 2%, 2% Cholesterol Cream; Lovastatin 2% Cream
Intervention description: Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.; Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will analyze the effects of topical lovastatin/cholesterol vs topical lovastatin
      alone in patients with disseminated superficial actinic porokeratosis. Patients will be
      divided into two groups, topical lovastatin/cholesterol and topical lovastatin alone.
      Patients will apply topical treatment twice daily to lesions over the course of 12 weeks.
      Follow up will occur in the virtual setting and photographs will be used to document
      progress.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients 18 years and older with the diagnosis of disseminated superficial actinic
             porokeratosis.

        Exclusion Criteria:

          -  Patients with allergies or contraindications to lovastatin or cholesterol

          -  Female patients currently pregnant or lactating.

          -  Female patients with plans to become pregnant.

          -  Patients actively taking approved forms of long-term contraception (oral
             contraceptives, implantable intrauterine devices, or other hormone eluting implants)
             will be allowed to participate as long as they have no plan to become pregnant during
             the course of the study. A urine pregnancy test will be administered to these patients
             to confirm that they can be included in the study.

          -  Inability or unwillingness of subject or legal guardian/representative to give
             informed consent
Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure
Condition: Healthy
Intervention: MAP0004; IV Placebo (Saline); Placebo Inhaler; IV Dihydroergotamine Mesylate (DHE)
Intervention description: 1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol; IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol; Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.; IV DHE administered in Treatment A as per protocol
Intervention MeSH terms: Dihydroergotamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy volunteers

Summary:

      Compare the acute effects and tolerability of Dihydroergotamine Mesylate (DHE) delivered by
      Oral Inhalation (MAP0004) versus by intravenous (IV) infusion in healthy adult volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Able to provide a signed, executed written informed consent

          2. Healthy non-smoking adult volunteers: Male or Female subjects 18 to 45 years old

          3. Female subjects who are practicing adequate contraception

          4. Stable cardiac status

          5. Normal hemoglobin values

          6. Normal Echocardiogram

          7. Normal or not clinically significant 12-lead Electrocardiogram

          8. Demonstrated ability to properly use the Tempo® Inhaler

          9. Subject has not donated blood in the last 56 days

        Exclusion Criteria:

          1. Contraindication to dihydroergotamine mesylate (DHE)

          2. Use of any excluded concomitant medications within the 10 days prior to Visit 1

          3. History of hemiplegic or basilar migraine

          4. Participation in another investigational trial during the 30 days prior to Visit 1
Pharmacokinetics and Pharmacodynamics Trial With Linagliptin (BI 1356) 5mg in African American Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: linagliptin QD (once daily) for 7 days
Intervention description: dipeptidyl peptidase IV (DPP-4) activity will be measured as PD response to drug administration
Intervention MeSH terms: Linagliptin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The objective of this trial is to investigate the pharmacokinetics and pharmacodynamics of
      linagliptin (BI 1356) 5 mg administered orally in patients with Type 2 diabetes mellitus of
      African American origin.
    

Eligibility criteria:

        Inclusion criteria:

          1. Glycosylated haemoglobin >=7 and <= 10%

          2. Age >=21 and <= 65

          3. Body Mass Index >=18.5 and <=38 kg/m2

          4. African American origin

          5. Signed and dated informed consent prior to admission to the study

        Exclusion criteria:

          1. Any finding of the medical examination considered clinically relevant by the
             Investigator

          2. Clinically relevant concomitant diseases like renal insufficiency, cardiac
             insufficiency New York Heart Association (NYHA) II-IV, known cardiovascular disease
             including hypertension >160-100 mmHg (under current treatment), stroke and transient
             ischemic attack (TIA).

          3. Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular,
             metabolic, immunological or hormonal disorders besides type 2 diabetes

          4. Clinically relevant diseases of central nervous system or psychiatric disorders or
             relevant neurological disorders besides polyneuropathy

          5. Diagnosis of sickle cell anemia or known chronic anemia

          6. History of chronic or relevant infections (for example human immunodeficieny virus
             (HIV), Hepatitis B)

          7. History of relevant allergy/hypersensitivity

          8. Intake of drugs with a long half life (>24hours) within at least one month or less
             than 10 half lives of the respective drug prior to administration except allowed co
             medication

          9. Alcohol abuse, drug abuse

         10. Any laboratory value of clinical relevance that is outside an acceptable range

         11. Change of drug dosing of allowed co medication

         12. Any (electrocardiogram) ECG value outside the reference range and of clinical
             relevance.

         13. Fasted glucose >270 mg/dl or randomly determined blood glucose >400 mg/dl on two
             consecutive days during screening or wash out

         14. Serum creatinine above upper limit normal at screening
Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers
Condition: Healthy Volunteers
Intervention: Radiolabeled SPD557
Intervention description: A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1
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: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Radiolabelled; AME

Summary:

      Phase I study to evaluate the excretion of radioactivity, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of [14C]
      SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study
      is to investigate how and how quickly SPD557 or its break down products are excreted by
      analysing blood, faeces and urine samples collected during the study.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males ages 18 to 50 years

          -  Have a body mass index (BMI) of ≥18.5 and ≤30 kg/m2

          -  Subject is willing to comply with any applicable contraceptive and sperm donation
             requirements

        Key Exclusion criteria:

          -  Have participated in a [14C]-study within the last 6 months.

          -  Exposure to clinically significant radiation within 12 months prior to dose (for
             example, serial X-ray or computed tomography scans, barium meal, current employment in
             a job requiring radiation exposure monitoring).

          -  Male subjects who consume more than 21 units of alcohol per week or 3 units per day.

          -  Subjects who report typically having more than 2 bowel movements per day, less than 3
             bowel movements per week or those whose bowel habits have changed significantly within
             30 days
Study of Dalotuzumab (MK-0646) in Adults With Solid Tumors (MK-0646-009)
Condition: Neoplasm
Intervention: Dalotuzumab
Intervention description: IV infusion
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      This clinical study evaluates the safety, tolerability, pharmacokinetics, and immunogenicity
      of dalotuzumab (MK-0646) in participants with relapsed or refractory locally advanced or
      metastatic solid tumors using once weekly and once every other week dose infusion regimens.

      The primary study hypothesis is that administration of dalotuzumab as a once weekly and an
      every other week infusion will be generally safe and well tolerated
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has histologically- or cytologically-confirmed metastatic or locally advanced solid
             tumor(s) that has (have) failed to respond to standard therapy, or for which adequate
             standard therapy does not exist

          -  Has tumor(s) associated with insulin-like growth factor 1 receptor (IGF-1R) expression
             in the literature (e.g. prostate, pancreatic, colon, lung and breast)

          -  Has Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1

          -  Demonstrates adequate organ function

        Exclusion Criteria:

          -  Has had chemotherapy, radiotherapy, or biological therapy within 4 weeks (6 weeks for
             nitrosoureas or mitomycin C) prior to registration

          -  Is concurrently using growth hormone (GH), or growth hormone inhibitor

          -  Has any active central nervous system (CNS) metastases and/or carcinomatous meningitis

          -  Has any primary CNS tumor - any symptomatic ascites or plural effusion

          -  Has a history or current evidence of any clinically significant disease that might
             confound the results of the study, complicate the interpretation of the study results,
             interfere with the participant's participation, or pose an additional risk to the
             participant

          -  Is pregnant or breast-feeding