bioihbjkbjnl/mcl2 huggingface dataset:
Tear Fluid Levels of Loteprednol Etabonate Ophthalmic Gel 0.5% Following a Single Instillation
Condition: Pharmacokinetics
Intervention: LE Gel
Intervention description: Single drop of LE Gel 0.5% administered to the study eye on visit 2
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 1
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To assess the levels of loteprednol etabonate (LE) in tear fluid following a single topical
      instillation of LE ophthalmic gel 0.5% formulation to healthy volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be healthy volunteers with physiologically normal anterior segments not
             exhibiting clinically significant biomicroscopy findings.

          -  Subjects must have a best-corrected visual acuity of 20/20 or better in each eye.

          -  Subjects must have no active ocular disease or allergic conjunctivitis.

          -  Subjects must have a Schirmer test (without anesthesia) of ≥ 10mm in 5 minutes.

          -  Subjects must not be using any topical ocular medications or systemic medication other
             than acetaminophen.

          -  Male subjects or female subjects who are not of childbearing potential. Female
             subjects are considered to not be of childbearing potential if they are postmenopausal
             for at least 12 months or permanently sterilized (eg, tubal occlusion, hysterectomy,
             bilateral salpingectomy)

        Exclusion Criteria:

          -  Subjects having an intraocular pressure less than 5 mmHg or greater than 22 mmHg or
             any type of glaucoma.

          -  Subjects with a history of ocular trauma, infection, or inflammation within the last 3
             months.

          -  Subjects having any contraindication to the use of, or known sensitivity or allergy
             to, the study drug(s) or their components.

          -  Subjects wearing contact lenses on the day of Visit 2 and/or Visit 3 of the study

          -  Subjects having, at the Investigator's discretion, the presence of any significant
             illness that could be expected to interfere with the study.
Ascending Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Evolocumab (AMG 145) in Adults With Hyperlipidemia on Stable Doses of a Statin
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Intervention: Evolocumab; Placebo
Intervention description: Administered by subcutaneous injection; Administered by subcutaneous injection
Intervention MeSH terms: Evolocumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: AMG145; Multiple Dose; Statin; Ascending

Summary:

      The purpose of the study is to evaluate the safety and tolerability of multiple doses of
      evolocumab when given as an add-on to stable statin therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women ages 18 to 70 years (inclusive) at the time of screening with
             hyperlipidemia

          -  Body mass index (BMI) ≥18 and ≤ 35 kg/m^2 at the time of screening

          -  Low-density lipoprotein cholesterol (LDL-C) level of 70-220 mg/dL (inclusive) at
             screening as measured by direct assay

          -  For Cohorts 1-5: On a stable dose of rosuvastatin (Crestor) < 40 mg/day, atorvastatin
             (Lipitor) < 80 mg/day, or simvastatin (Zocor) 20-80 mg/day for ≥ 1 month prior to
             enrollment and expected to remain on this dose for the remainder of the study

          -  For Cohort 6: On a stable dose of rosuvastatin (Crestor) 40 mg/day or atorvastatin
             (Lipitor) 80 mg/day for ≥ 1 month prior to enrollment and expected to remain on this
             dose for the remainder of the study

          -  For Cohort 7: Diagnosis of heterozygous familial hypercholesterolemia, based on a
             score of ≥ 9 points using the World health Organization (WHO) criteria

        Exclusion Criteria:

          -  Diagnosis of homozygous familial hypercholesterolemia

          -  History of heart failure, coronary artery bypass graft, or cardiac arrhythmia

          -  History of acute coronary syndrome (e.g. myocardial infarction, hospitalization for
             unstable angina) or percutaneous coronary intervention, within 12 months prior to
             enrollment

          -  Planned cardiac surgery or revascularization

          -  Known aortic, peripheral vascular or cerebrovascular disease (including history of
             stroke or transient ischemic attack)

          -  Diabetes mellitus with any of the following:

               1. known microvascular or macrovascular disease

               2. HbA1c > 8.0% at screening

               3. use of any hypoglycemic medication other than metformin

          -  Uncontrolled hypertension (systolic blood pressure ≥ 150 or diastolic blood pressure ≥
             90 mmHg) either on or off therapy at screening or at baseline
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501
Intervention description: Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001.
After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Acute myeloid leukemia; WT1

Summary:

      The purpose of this study is to assess the safety of OCV-501 in patients with AML who
      completed the Study 311-10-001 and were judged that there was no relapse by any inspections
      in the end of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients who completed the Study 311-10-001 and were judged that there was no relapse
             by any inspections in the end of the study.

          -  Patients who are capable of giving informed consent

        Exclusion Criteria:

          -  Patients failed to discontinue the Study 311-10-001 even though patients met the
             discontinuation criteria.

          -  Patients who have participated in any other clinical trials , excluding the Study
             311-10-001).
Study to Evaluate Menses Induction in Women Administered Proellex
Condition: Amenorrhea
MeSH terms: Amenorrhea
Intervention: Placebo; Proellex
Intervention description: Placebo, 1 capsule daily for five days; Proellex, one 3, 6, 12 or 25 mg capsule daily for five days
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menstruation

Summary:

      The purpose of this study is to determine the oral dose level at which the investigative
      drug, Proellex, is able induce menstruation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical laboratory tests within normal ranges

          -  A normal menstrual period of 26-30 days

          -  Desiring not to become pregnant

          -  Agreeing to use a double barrier method of birth control for the duration of the trial

        Exclusion Criteria:

          -  Post-menopausal status

          -  Aamenorrhea or dysfunctional uterine bleeding

          -  Subjects demonstrating any clinically significant medical condition rendering the
             subjects infertile or marginally fertile

          -  Subjects with a Body Mass Index (BMI) below 18 or over 39
Crizotinib Plus Pembrolizumab In Alk-Positive Advanced Non Small Cell Lung Cancer Patients
Condition: ALK-positive Advanced NSCLC
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Crizotinib; Pembrolizumab
Intervention description: To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks; To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
Intervention MeSH terms: Pembrolizumab; Crizotinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: crizotinib; pembrolizumab; ALK-positive NSCLC; Lung Cancer; ALK-translocated NSCLC; Non Small Cell Lung Cancer

Summary:

      The purpose of this study has 2 phases, a Dose Finding Phase will determine the maximum
      tolerated dose . The Dose Expansion Phase will explore the safety, tolerability, and
      anti-tumor activity of the combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proved diagnosis of locally advanced recurrent or
             metastatic non-squamous NSCLC that is not suitable for local curative treatment.

          -  Alk-positive NSCLC as determined by a test that is approved or validated for use as a
             companion diagnostic test.

          -  No prior systemic therapy for metastatic disease.

          -  Adjuvant chemotherapy more than 12 months prior to study enrollment.

          -  Measurable disease as per RECIST 1.1

          -  ECOG PS 0 or 1.

        Exclusion Criteria:

          -  Prior exposure to ALK receptor tyrosine kinase inhibitor, anti-PD1, anti-PDL1 or any
             drug targeting T-cell checkpoint pathways.

          -  known diagnosis of immunodeficiency or is receiving systemic steroid therapy or other
             form of immunosuppressive therapy within 7 days of clinical trial treatment.

          -  Active autoimmune disease that has required systemic treatment in the past 3 months.

          -  History of extensive disseminated interstitial fibrosis or any grade of interstitial
             lung disease.
A Study of Evacetrapib in Participants With Abnormal Cholesterol
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Intervention: Evacetrapib
Intervention description: Administered orally
Intervention MeSH terms: Evacetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 101.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: abnormal cholesterol

Summary:

      The main purpose of this study is to measure how much of the drug gets into the blood stream
      and how long it takes the body to get rid of it when given once a day for 12, 24, and 52
      weeks to participants with abnormal amounts of cholesterol and/or fat in the blood stream.
      Information about any side effects that may occur will also be collected.

      This study will also evaluate how the study drug reacts in the body when given once a day for
      12, 24 and 52 weeks and how the body responds and returns to normal when the treatment is
      complete. The relationship between study drug and the results from the how the study drug
      reacts in the body may be explored, if needed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy participants or have stable medical conditions that, in the
             investigator's opinion, will not significantly alter the disposition of the drug, will
             not place the participant at increased risk by participating in the study, and will
             not interfere with interpretation of the data and meets one of the following criteria:

               -  Elevated low-density lipoprotein cholesterol (LDL-C) greater than 100 milligrams
                  per deciliter (mg/dL), OR

               -  Low high-density lipoprotein cholesterol (HDL-C) less than 45 mg/dL (men); less
                  than 50 mg/dL (women), OR

               -  Hypercholesterolemia on stable statin therapy for at least 3 month

          -  Have a body mass index (BMI) of 18 to 37 kilograms per square meter (kg/m^2),
             inclusive, at screening

        Exclusion Criteria:

          -  Have known allergies or intolerance to evacetrapib, related compounds

          -  Have history of recurrent rashes or chronic skin conditions

          -  Have significant history of or current chronic, active inflammatory conditions

          -  Have history or current evidence of significant neurological disorder

          -  Have long-standing diabetes that is insulin requiring

          -  Have history of or current symptoms of malabsorption syndromes, history of gastric
             bypass surgery
Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation
Condition: Medium-chain Acyl-CoA Dehydrogenase (MCAD) Deficiency
Intervention: Ravicti
Intervention description: Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day
Intervention MeSH terms: Glycerol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Medium-chain acyl-CoA dehydrogenase deficiency; MCAD deficiency; MCADD; ACADM deficiency; MCADH deficiency; 985A>G mutation; K304E mutation; Ravicti; glycerol phenylbutyrate

Summary:

      This is a medical research study to test a medication in adult patients with a disease called
      medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the
      985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is
      currently FDA approved for the treatment of urea cycle disorders. Previous research suggests
      that Ravicti may also be effective in the treatment MCAD deficiency. This study will
      investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD
      deficiency caused by having at least one copy of the 985A>G mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  confirmation of a diagnosis of MCAD deficiency

          -  at least one copy of 985A>G MCAD mutation

          -  ability to follow protocol

        Exclusion Criteria:

          -  positive pregnancy test

          -  currently breastfeeding

          -  currently taking any medication for which there is a potential drug interaction with
             Ravicti, includes corticosteroids, valproic acid, haloperidol, and probenecid

          -  liver or kidney insufficiency
Safety, Tolerability and Pharmacokinetics of Liraglutide-depot in Healthy Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide-depot; placebo
Intervention description: Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.; Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).
Intervention MeSH terms: Liraglutide
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate the safety, tolerability and pharmacokinetics (exposure in the body) of
      liraglutide-depot in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) between 20 and 35 kg/m^2 (both inclusive) with a body weight of
             at least 60 kg

          -  Apart from being obese (BMI above 30 kg/m^2) the subject has to be considered
             generally healthy

        Exclusion Criteria:

          -  Medical history of, or presence of, cancer, diabetes or any clinically significant
             cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrine,
             haematological, dermatological, venereal, neurological, psychiatric diseases or other
             major disorders

          -  Clinical or laboratory findings which suggest that the subject cannot be considered
             generally healthy

          -  Prescription medicine and non-prescription medicine with few exceptions

          -  Current and prior history of alcohol or drug abuse

          -  Current smoking of more than 5 cigarettes per day

          -  Mental incapacity, language barriers, or unwillingness to comply with the protocol
A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
Condition: Healthy
Intervention: Nasal Glucagon; Glucagon
Intervention description: Administered intranasally.; Administered SC.
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon
      (NG). The study drug was delivered into the participant's nostril (intranasally) or was given
      as an injection just under the skin (subcutaneously) once in each of four study periods. The
      study lasted about 23 days for each participant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00
             kg/m².

          -  Light-, non- or ex-smokers.

          -  Have no clinically significant diseases captured in the medical history or evidence of
             clinically significant findings on physical examination and/or clinical laboratory
             evaluations (hematology, biochemistry, ECG and urinalysis).

        Exclusion Criteria:

          -  Presence of any nose piercings.

          -  History of significant hypersensitivity to glucagon or any related products (including
             excipients of the formulations) as well as severe hypersensitivity reactions (like
             angioedema) to any drugs.

          -  Presence of significant gastrointestinal, liver or kidney disease, or any other
             conditions known to interfere with the absorption, distribution, metabolism or
             excretion of drugs or known to potentiate or predispose to undesired effects.

          -  Presence of significant cardiovascular, pulmonary, hematologic, neurological,
             psychiatric, endocrine, immunologic or dermatologic disease.

          -  Presence of clinically significant findings on nasal examination and bilateral
             anterior rhinoscopy.

          -  Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following
             a 12-hour fasting period.

          -  Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before
             each dosing.
Evaluation of Safety, Tolerability, and Antiviral Activity of ACH-0143102 Plus Ribavirin In Treatment-naive Hepatitis C Virus Infection Genotype 1b Participants
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis; Hepatitis, Chronic
Intervention: ACH-0143102; Ribavirin
Intervention MeSH terms: Ribavirin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to evaluate the safety, tolerability, and efficacy of 12 weeks
      of treatment with ACH-0143102 and ribavirin in genotype 1b (GT1b), treatment-naive, hepatitis
      C virus (HCV) participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females aged 18 years and older.

          -  Clinical diagnosis of hepatitis C with GT1b.

          -  Chronic hepatitis C treatment-naive participants.

          -  Interleukin 28B genotype CC.

          -  HCV ribonucleic acid > 10,000 international units/milliliter at screening.

          -  Female participants must be willing to use 2 effective methods of contraception during
             the dosing period and for 6 months after the last dose of ribavirin.

          -  Male participants must be willing to use an effective barrier method of contraception
             throughout the dosing period and for 6 months after the last dose of ribavirin. Male
             participants must agree not to donate sperm while enrolled in the study and for 6
             months after the last dose of ribavirin.

          -  Willing to participate in all study activities and all study requirements.

        Exclusion Criteria:

          -  Body mass index > 36 kilograms/meter squared.

          -  Pregnant or nursing females.

          -  Clinically significant laboratory abnormalities at screening.

          -  Previous participation in a clinical trial with protease inhibitor and/or
             non-structural protein 5A inhibitor.

          -  Human immunodeficiency virus infection or other liver diseases.

          -  Positive hepatitis B surface antigen.

          -  Liver cirrhosis.

          -  Uncontrolled psychiatric disease.

          -  Clinical evidence of chronic cardiac disease.

          -  History of malignancy of any organ system within 5 years.