bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Clinical Study With Investigational Compound LTT462 in Adult Patients With Specific Advanced Cancers.
Condition: Ovarian Neoplasms; Non-Small-Cell Lung Carcinoma; Melanoma; Other Solid Tumors
MeSH terms: Carcinoma, Non-Small-Cell Lung; Ovarian Neoplasms
Intervention: LTT462
Intervention description: ERK Inhibitor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: LTT462; ERK; MAPK; solid tumor

Summary:

      A phase I study of LTT462 in patients with advanced solid tumors that harbor MAPK pathway
      alterations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient (male or female) ≥12 years of age

          -  ECOG (Eastern Cooperative Oncology Group) performance status ≤1

          -  Must have progressed following standard therapy, or for whom, in the opinion of the
             Investigator, no effective standard therapy exists, is tolerated or appropriate.

          -  Patients must be willing and able to undergo study required biopsies.

          -  Presence of at least one measurable lesion according to RECIST v1.1.

          -  Documented MAPK pathway alteration

        Exclusion Criteria:

          -  Prior treatment with ERK inhibitors.

          -  History or current evidence of retinal vein occlusion (RVO) or current risk factors
             for RVO.

          -  Any medical condition that would, in the investigator's judgment, prevent the
             patient's participation in the clinical study due to safety concerns or compliance
             with clinical study procedures.

          -  Patients receiving proton pump inhibitors (PPI) which cannot be discontinued 3 days
             prior to the start study treatment and for the duration of the study.

          -  Patients with malignant disease other than that being treated in the study.

          -  Clinically significant cardiac disease.

        Other protocol-defined exclusion criteria may apply.
Bioequivalence of Two Lispro Formulations
Condition: Healthy Volunteers
Intervention: Insulin lispro A; Insulin lispro B
Intervention description: 20 units (U) subcutaneously (SC).; 20 U subcutaneously (SC).
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 21 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: insulin; lispro

Summary:

      This study will compare how the body treats 2 different forms of insulin lispro and how they
      affect blood sugar levels.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Are healthy males or females.

          -  Body mass index (BMI) between 18.5 and 29.9 kilograms per meter squared (kg/m^2)

          -  Are nonsmokers.

          -  Have normal blood pressure and pulse rate, a normal electrocardiogram (ECG), and
             clinical laboratory test results within normal reference range at screening.

        Exclusion Criteria:

          -  History of first-degree relatives known to have diabetes mellitus.

          -  Evidence of significant active neuropsychiatric disease.

          -  Evidence of an acute infection with fever or infectious disease.

          -  Intend to use over-the-counter or prescription medication (apart from vitamin/mineral
             supplements, occasional paracetamol, or birth control methods).

          -  Have used systemic glucocorticoids within 3 months prior to entry into the study.

          -  Have donated blood of 1 unit or more within the last 3 months prior to study entry.

          -  Excessive alcohol intake

          -  Have a fasting venous blood glucose (FBG, plasma) >6 millimoles/liter (mmol/L) at
             screening.

          -  Have positive hepatitis B surface antigen.
A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: alendronate sodium+vitamin D combination; Comparator: alendronate; Comparator: Vitamin D
Intervention description: A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.; A single dose tablet of 70mg alendronate in one treatment period of each sequence.; Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Alendronate; Vitamins
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 318.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate the bioequivalence of alendronate in combination with vitamin D
      compared to alendronate alone and the bioequivalence of vitamin D in combination with
      alendronate compared to vitamin D alone.

      This was an open-label, randomized, 2-part, crossover study. Each participant participated in
      one part of the study only (i.e., each participant participated only in Part I or only in
      Part II). Participants entered the study sequentially within each part of the study. A
      washout of at least 12 days separated each treatment period within each part of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or nonpregnant female age 18 to 85 years

          -  female of childbearing potential on appropriate method of contraception and not
             nursing

          -  Body Mass Index (BMI) less than or equal to 30 kg/m2

          -  subject is in good health

        Exclusion Criteria:

          -  mental or legal incapacitation

          -  received bisphosphonate treatment within 3 months of enrollment.

          -  unable to sit or stand upright for at least 2 hours

          -  unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours
             prior and 36 hours after study drug administration

          -  unwilling to limit alcohol consumption to no more than 2 drinks per day

          -  unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day
             or equivalent.

          -  unwilling to refrain from smoking during the study
Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Capecitabine; Docetaxel; Gemcitabine
Intervention description: Will be give on days 8-21; Will be given on days 1 and 8,; A fixed dose rate will be give on days 8 and 15.
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Pancreatic Cancer

Summary:

      The primary purpose of this study is to define the maximum tolerated dose of combination
      docetaxel, gemcitabine, and capecitabine in patients with pancreatic cancer. Adverse effects
      will be measured in study participants. In addition, researchers will assess data about
      preliminary efficacy in patients with this treatment approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adenocarcinoma of the pancreas

          -  no prior chemo except adjuvant

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

          -  peripheral neuropathy </= Gr. 1

        Exclusion Criteria:

          -  Pregnant/lactating females

          -  Uncontrolled heart disease, diabetes, psychiatric disorder

          -  Therapeutic doses of Warfarin
Safety Study of Dasatinib With Bortezomib (Velcade®) and Dexamethasone for Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Dasatinib; Bortezomib; Dexamethasone
Intervention description: Tablets; oral; approximately 2 years on study, depending on response; 50 mg once daily (QD), 100 mg QD, 140 mg QD; Powder; intravenous; approximately 2 years on study, depending on response; 1.0 mg/m^2 QD, 1.3 mg/m^2 QD; Tablets; oral; approximately 2 years on study, depending on response; 20 mg QD
Intervention MeSH terms: Dexamethasone; Bortezomib; Dasatinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and tolerability of dasatinib with
      bortezomib in the treatment of relapsed or refractory multiple myeloma.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Confirmed diagnosis of multiple myeloma with measurable disease

          -  Evidence of relapsed or refractory disease and at least 2 prior therapies for multiple
             myeloma

          -  Eastern Cooperative Oncology Group Performance Status of 0 - 2

          -  Last treatment for multiple myeloma not within 21 days prior to study treatment
             initiation

          -  Bone marrow transplant not within 3 months prior to study treatment initiation

          -  Required baseline hematology and chemistry parameters.

        Key Exclusion Criteria:

          -  Clinically significant cardiac disease (New York Heart Association Class III or IV)

          -  Abnormal QT interval corrected for heart rate using Fridericia's formula prolonged
             (>450 msec) after electrolytes have been corrected on baseline electrocardiogram

          -  Malabsorption syndrome or uncontrolled gastrointestinal toxicities

          -  Dementia, chronic medical or psychiatric condition, or laboratory abnormality that may
             increase the risk associated with study participation

          -  Clinically significant pleural effusion in the previous 12 months or current ascites

          -  Clinically significant coagulation or platelet function disorder

          -  Intolerance to dasatinib and/or bortezomib

          -  Acute diffuse infiltrative pulmonary disease

          -  Prior or concurrent malignancy, except for adequately treated basal cell or squamous
             cell skin cancer, adequately treated Stage I or II cancer currently in complete
             remission, cervical carcinoma in situ, or any other cancer from which the participant
             has been disease-free for 3 years.
A Bioequivalence Study of 3 Formulations of Ondansetron in Healthy Adults (0869-095)(COMPLETED)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Intervention: Comparator: Treatment A (Zofran, ondansetron); Comparator: Treatment B (Zofran, ondansetron); Comparator: Treatment C (Zofran, ondansetron)
Intervention description: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) Zofran taken by mouth (PO); a single 8 mg tablet of Zofran marketed in the U.K., taken PO; a single 8 mg tablet of Zofran marketed in the United States (U.S.), taken PO
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the bioequivalence of a Merck clinical trial formulation of
      ondansetron compared to a U.S. and non-U.S. marketed formulation of ondansetron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, subject is not pregnant or breast-feeding

          -  Subject is a nonsmoker

          -  Subject is in good general health

        Exclusion Criteria:

          -  Subject has a history of high blood pressure, asthma, or cardiovascular, liver,
             neurologic, or kidney disease

          -  Subject is taking prescription or nonprescription drugs that can not be discontinued
             during the study

          -  Subject is a habitual and heavy consumer of caffeine
A Formulation Screening Study of Dalcetrapib and Atorvastatin in Healthy Volunteers
Condition: Healthy Volunteer
Intervention: atorvastatin; dalcetrapib
Intervention description: single dose of atorvastatin on day 1; single dose of dalcetrapib on day 1
Intervention MeSH terms: Atorvastatin; Dalcetrapib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A single-center, crossover study to evaluate the pharmacokinetics of dalcetrapib and
      atorvastatin from prototype fixed dose combination formulations in healthy volunteers.
      Volunteers will receive a single dose of dalcetrapib with atorvastatin in each of four
      treatment periods.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy volunteers, 18 to 55 years of age, inclusive

        Exclusion Criteria:

          -  Any concomitant disease or ongoing condition that in the investigator's opinion could
             interfere with the study or could pose an unacceptable risk to the patient

          -  Clinically significant abnormal laboratory values
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
Condition: Healthy
Intervention: Colcrys™ (colchicine)
Intervention description: 0.6 mg taken by mouth on day 1
Intervention MeSH terms: Colchicine
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy; bioavailability

Summary:

      The purpose of this study is to evaluate and compare the relative bioavailability of a single
      dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects
      18-30 years of age compared to a group of older, generally healthy subjects 60 years of age
      or older following an overnight fast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy adults 18-30 years of age or generally healthy adults over 60 years of age
             (elderly subjects with minor renal impairment may be allowed to participate at the
             discretion of the investigator), non-smoking and non-pregnant (post-menopausal,
             surgically sterile or using effective contraceptive measures) with a body mass index
             (BMI) of 18-30 kg/m2.

        Exclusion Criteria:

          -  Recent participation (within 30 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)

          -  History of treatment for drug or alcohol addiction within the previous 12 months or
             excessive alcohol consumption during the past 12 months

          -  Significant history of chronic infectious disease, system disorders, organ
             dysfunction, especially cardiovascular disorders (angina, heart failure, irregular
             heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic
             disorder, diabetes or bleeding disorders, gastrointestinal disease or psychiatric
             disorders.

          -  Presence of a medical condition requiring regular treatment with prescription drugs

          -  Subjects who have used any drugs or substances known to inhibit or induce
             drug-metabolizing enzymes within 30 days prior to the first dose and throughout the
             study

          -  Drug allergies or sensitivity to colchicine

          -  Positive test results for drugs of abuse at screening
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Condition: Chemotherapy-Induced Nausea and Vomiting
MeSH terms: Vomiting
Intervention: ondansetron clinical trial formulation; ondansetron marketed formulation
Intervention description: Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.; Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.
Intervention MeSH terms: Ondansetron
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will assess the bioequivalence of a Merck clinical trial formulation of
      ondansetron compared to a non-U.S. marketed formulation of ondansetron.
    

Eligibility criteria:

        Inclusion Criteria:

          -  If female, subject is not pregnant or breast-feeding

          -  Subject has been a nonsmoker for at least 6 months

          -  Subject is in good health

        Exclusion Criteria:

          -  Subject has a history of high blood pressure, asthma, other pulmonary disease,
             Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver,
             neurologic, or kidney disease

          -  Subject is a habitual and heavy consumer of caffeine
A Safety, Tolerability and Preliminary Efficacy Study of LiRIS® 400 mg in Women With Interstitial Cystitis (IC) and Hunner's Lesions
Condition: Chronic Interstitial Cystitis
MeSH terms: Cystitis; Cystitis, Interstitial
Intervention: LiRIS® 400 mg
Intervention description: LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hunner's lesion

Summary:

      The purpose of the study is to evaluate if LiRIS 400 mg is safe and tolerable when
      administered to women with Interstitial Cystitis with Hunner's lesions, and to evaluate any
      change in the bladder or in IC symptoms, following LiRIS administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women age 18 and older

          -  Interstitial Cystitis with history of Hunner's lesions in the bladder

          -  Moderate to severe bladder discomfort

          -  Confirmation of Hunner's lesions in Bladder

          -  Able to report symptom (pain and voiding frequency) in a diary throughout the study

        Exclusion Criteria:

          -  Pregnant women

          -  History or presence of bladder cancer

          -  History or presence of any condition that would make it difficult to evaluate bladder
             symptoms
A Study in Healthy Men to Test Whether Four Capsules of 25 mg Nintedanib Are Taken up in the Body in the Same Way as One 100 mg Capsule
Condition: Healthy
Intervention: nintedanib 25 mg; nintedanib 100 mg
Intervention description: soft gelatin capsule; soft gelatin capsule
Intervention MeSH terms: Nintedanib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: Male
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main objective of this trial is to investigate the relative bioavailability of 100 mg
      nintedanib given as four capsules of 25 mg nintedanib compared with one capsule of 100 mg
      nintedanib.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, as based on a
             complete medical history including a physical examination, vital signs (blood pressure
             (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests

          -  Age of 18 to 55 years (inclusive)

          -  Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)

          -  Signed and dated written informed consent prior to admission to the study, in
             accordance with Good Clinical Practice (GCP) and local legislation

        Exclusion Criteria:

          -  Any finding in the medical examination (including BP, PR or ECG) deviating from normal
             and assessed as clinically relevant by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 45 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease assessed as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Cholecystectomy or other surgery of the gastrointestinal tract that could interfere
             with the pharmacokinetics of the trial medication (except appendectomy or simple
             hernia repair)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  History of relevant orthostatic hypotension, fainting spells, or blackouts Further
             exclusion criteria apply.