bioihbjkbjnl/mcl2 huggingface dataset:
Phase I of OratecanTM in Combination With Capecitabine in Patients With Advanced Solid Malignancies
Condition: Solid Tumor; Advanced Cancer
Intervention: Oratecan and Capecitabine
Intervention description: Oratecan in combination with Capecitabine
Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14
Intervention MeSH terms: Capecitabine; Irinotecan
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: 19 Years
Healthy volunteers: No
Keywords: Advanced solid cancer

Summary:

      The main objective of this study is to determine the maximum tolerated dose (MTD) of Oratecan
      in combination with capecitabine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed advanced solid tumor

          -  Patients who have experienced progressive disease despite of conventional anticancer
             therapy. Patients who cannot expect effective treatment or prolonged survival with
             conventional anticancer therapy

          -  Previous chemotherapy, radiotherapy and surgical operation are allowed if they are
             discontinued for at least 4 weeks prior to D0 and all adverse events are resolved

          -  Aged ≥19

          -  Eastern Cooperative Oncology Group (ECOG) performance score of less than or equal to 2

          -  A life expectancy greater than 12 weeks

          -  Adequate bone marrow, renal and liver function.

          -  Subjects must provide written informed consent prior to performance of study specific
             procedures or assessments, and must be willing to comply with treatment and follow up
             assessments and procedures

        Exclusion Criteria:

          -  Patients with hematopoietic malignancies,uncontrolled infection, CNS metastasis.

          -  Patients who have undergone hematopoietic stem cell transplantation (HSCT) or are
             candidates for planned HSCT

          -  Patients who have GI malabsorption or difficulty taking oral medication

          -  Patients who have psychiatric or congenital disorder Subjects who, in the
             investigator's opinion, cannot be treated per protocol due to functional impairments

          -  Pregnant or breast-feeding patients; Women of childbearing potential without adequate
             contraception (Men must use adequate contraception.)
Phase 1 Oral Solution and Crushed Tablet Relative Bioavailability Study of Apixaban When Administered Through a Nasogastric Tube in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Crush Injuries
Intervention: Apixaban; Boost Plus
Intervention MeSH terms: Apixaban
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the bioavailability of Apixaban oral solution
      administered through an Nasogastric Tube (NGT) in the presence of Boost® Plus and Apixaban
      administered as crushed tablet through a nasogastric tube relative to Apixaban solution
      administered orally in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects as determined by no clinically significant deviation from normal in
             medical history, physical examination, ECGs, and clinical laboratory determinations

        Exclusion Criteria:

          -  Any significant acute or chronic medical illness

          -  Any history or evidence of abnormal bleeding or coagulation disorders, intracranial
             hemorrhage, or abnormal bleeding (including heavy menstrual bleeding that has resulted
             in anemia within the past 1 year) or coagulation disorders in a first degree relative
Treatment of Participants With Advanced and/or Refractory Solid Tumors (MK-5108-001)
Condition: Cancer, Neoplasms, Tumors
Intervention: MK-5108; docetaxel
Intervention description: MK-5108 will be administered orally, every 12 hours (Q12H) during the first 2 days of each cycle. Cycle length will be 14-21 days in Panel 1 and 21 days in Panel 2.; Docetaxel will be administered intravenously (I.V.) at a dose of 60 mg/m^2 Q12H during the first 2 days of each 21-day cycle.
Intervention MeSH terms: Docetaxel
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will investigate the safety, side effects and how well the body tolerates MK-5108
      as well as determine different doses of MK-5108 in participants with advanced and/or
      refractory solid tumors. The corresponding primary hypotheses of this study are that 1)
      administration of oral MK-5108 (twice daily for 2 out of 14-21 days) to participants with
      advanced and/or refractory solid tumors will be safe and tolerable, and that 2) the spectrum
      of side effects observed in these participants after administration of oral MK-5108 alone and
      in combination with docetaxel will be dose-dependent and allow for definition of a maximum
      tolerated dose (MTD).
    

Eligibility criteria:

        Inclusion Criteria:

        - Participant has a histologically-confirmed metastatic or locally advanced solid tumor
        that has failed to respond to standard therapy or progressed with standard therapy

        Exclusion Criteria:

          -  Participant has had chemotherapy, radiotherapy or biological therapy within 4 weeks
             prior to study start or has not recovered from adverse events caused by therapy more
             than 4 weeks earlier

          -  Participant is currently participating or has participated in a study with an
             investigational compound or device within 4 weeks prior to signing informed consent

          -  Participant has received more than 2 courses of chemotherapy for metastatic disease

          -  Participant has had prolonged neutropenia or neutropenia with fever from previous
             chemotherapy treatment

          -  Participant has a primary central nervous system tumor

          -  Participant is a regular or recreational user of any illicit drugs or has a recent
             history within the last year of drug or alcohol abuse

          -  Participant is pregnant, breastfeeding or planning to have children during the study

          -  Participant is Human Immunodeficiency Virus (HIV) positive

          -  Participant has a history of Hepatitis B or C
A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer
Condition: Neoplasms; Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma, Non-Hodgkin
Intervention: PD-0332991
Intervention description: Dose ranging study - evaluating two oral schedule: (1) 3/1 Schedule - PD-0332991 administered days 1-21 of a 28-day schedule, doses ranging from 25 to 150 mg once daily; (2) 2/1 Schedule - PD-0332991 administered days 1-14 of a 21-days schedule, doses ranging from 100 to 225 mg once daily
Intervention MeSH terms: Palbociclib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced cancer

Summary:

      PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a
      new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is
      the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse
             large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis
             which is refractory to or intolerant of established therapy know to provide clinical
             benefit for their condition; tumors must express Rb

          -  Adequate blood cell counts, kidney function and liver function and and ECOG score of
             0, 1, or 2.

          -  Patients may have to have tumor biopsy before and after treatment.

        Exclusion Criteria:

          -  Prior stem cell or bone marrow transplant

          -  Uncontrolled infection, unstable or sever intercurrent medical condition, or current
             drug or alcohol abuse

          -  Active or unstable cardiac disease or history of heart attack within 6 months
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Healthy Male Volunteers
Condition: Hyperparathyroidism, Secondary
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Etelcalcetide; Placebo
Intervention description: Administered as a single intravenous (IV) injection; Administered as a single intravenous (IV) injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 32.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to characterize the safety and tolerability of etelcalcetide in
      healthy young males.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male between 18 and 45 years of age who have provided written informed consent

          -  Subject is judged to be in good health based on medical history, physical examination,
             and routine laboratory tests

        Exclusion Criteria:

          -  History or presence of any significant acute or chronic illness (e.g., cardiovascular,
             pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic,
             dermatologic, or neurologic disease) according to the investigator

          -  History of any ongoing medical condition requiring treatment with prescription
             medication

          -  History of asthma, severe allergies including skin reactions or prior anaphylactic
             type reactions

          -  Clinically significant abnormalities on screening clinical examination or laboratory
             safety tests

          -  History of drug or alcohol abuse
Effect of Vitamin D Supplementation on Endothelial Function in Obese Adolescents
Condition: Obesity; Endothelial Dysfunction; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Intervention: Vitamin D3
Intervention description: Vitamin D 3 at 100,000 IU once a month for 3 months
Intervention MeSH terms: Vitamin D; Cholecalciferol
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 12 Years
Maximum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Obesity; Endothelial dysfunction; Vitamin D deficiency

Summary:

      Vitamin D deficiency has been linked to endothelial dysfunction in adults. Obese adolescents
      have a high prevalence of Vitamin D deficiency as well as evidence of endothelial
      dysfunction. Our hypothesis is that supplementation of Vitamin D deficient adolescents with
      Vitamin D would lead to improvement in endothelial dysfunction.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 12-18 years

          2. BMI >95% for age and gender

          3. 25 (OH) D levels less than 30 ng/ml

        Exclusion Criteria:

          1. 25 (OH) D levels >30 ng/mL

          2. Serum calcium >10.4 mg/dL

          3. Serum phosphorus > 4.7 mg/dl

          4. Pregnancy or nursing

          5. Current cancer

          6. Patients on vitamin D3 supplementation exceeding 400 IU/day

          7. Hypertension defined as Blood Pressure over the 95th percentile for age, gender and
             height

          8. Dietary calcium intake exceeding 1500 mg/day

          9. Hepatic or renal disorders

         10. Type 1 or type 2 diabetes mellitus

         11. Subjects receiving insulin, metformin, or oral hypoglycemic medications

         12. Subjects with malabsorption disorders (celiac disease, cystic fibrosis, inflammatory
             bowel disease)
Pilot Clinical Trial of Computer-based Motivational Intervention - 1
Condition: Substance-Related Disorders
MeSH terms: Substance-Related Disorders
Intervention: Brief computer-delivered intervention
Intervention description: 20-minute interaction with voice-enabled software that could provide reflections, images, text, etc.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Pilot trial of computer-based motivational intervention. Hypothesis: The brief
      computer-delivered intervention would result in higher motivation to change at follow-up.
    

Eligibility criteria:

        Woman in immediate post-partum period

        Inclusion Criteria:

        Self-report of drug use prior to pregnancy

        Exclusion Criteria:

        Frank psychosis or other cognitive impairment; inability to communicate in English;
        fatigue; recent receipt of narcotic pain medication; grieving over medically compromised
        infant
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-06649751 in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: PF-06649751; PF-06649751; PF-06649751; PF-06649751
Intervention description: Oral daily doses titrated up to 5mg QD; Oral daily doses titrated up to 15 mg QD; Oral daily doses titrated up to 15 mg QD (slow titration with option to down titrate); Oral daily doses titrated up to 25 mg QD
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This study will be an open label, dose escalation study to investigate the safety,
      tolerability, pharmacokinetics and pharmacodynamics of repeated daily quaque die (QD) doses
      given over 21 days (Day 3 to Day 23) to sequential cohorts of subjects with Parkinson's
      disease. Each cohort will have 2 study periods. For each cohort, subjects will enter Period 1
      and if they meet criteria, approximately 12 subjects will be enrolled into Period 2 and dosed
      with PF 06649751. Based on results observed in a previous study, Cohorts 1 and 2 will not be
      conducted. Cohorts 3 - 6 will test doses uptitrated to 5 mg, 15 mg and 25 mg QD. Doses may be
      modified based on emerging safety, tolerability and PK data, but the maximum daily dose that
      will be given in any cohort will have PK predictions at steady state that are anticipated to
      be below toxicokinetic limits. An option for down titration to the previous dose level is
      available should the investigator consider that an AE is intolerable. Following down
      titration, a single up titration to the next dose level may be attempted if the subject
      remains symptom free for at least 48 hrs. Safety, tolerability and PK data of Cohort 3 will
      be reviewed prior to initiating the dosing in Cohorts 4 and 5. Available safety, tolerability
      and PK data up to Day 24 of at least 5 subjects from Cohorts 4 will be reviewed prior to
      initiating the dosing in Cohort 6.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of idiopathic Parkinson's Disease with at least 2 out of 3 cardinal
             characteristics (tremor, rigidity, bradykinesia)

          -  Mini-Mental State Examination (MMSE) ≥ 25

          -  Hoehn & Yahr Stage I-III inclusive

          -  Documented history of end of L-Dopa wearing OFF

          -  Cohort 5 only: History of dyskinesia following L-Dopa dosing and Score of at least 2
             on Part IV, item 4.2 (functional impact of dyskinesia) of the MDS-UPDRS

        Exclusion Criteria:

          -  Atypical/secondary parkinsonism

          -  History of surgical intervention for Parkinson's Disease

          -  Dementia/cognitive impairment that can interfere with study assessments
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine
Condition: Advanced Melanoma
MeSH terms: Melanoma
Intervention: Ipilimumab; Carboplatin; Paclitaxel; Dacarbazine
Intervention description: Solution, intravenous, 10mg/kg, every 3 weeks in the induction phase, up to 4 doses in the induction phase, 48 weeks; Solution, intravenous, Area Under the Concentration Time Curve=6, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks; Solution, intravenous, 175 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks; Solution, intravenous, 850 mg/m2, every 3 weeks in the induction phase, up to 8 doses in the induction phase, 48 weeks
Intervention MeSH terms: Paclitaxel; Carboplatin; Ipilimumab; Dacarbazine
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Untreated Advanced Melanoma

Summary:

      The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab
      when combined with Paclitaxel/Carboplatin or Dacarbazine
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic diagnosis of advanced malignant melanoma

          -  Eastern Cooperative Oncology Group (ECOG) performances status 0-1

          -  Measurable/evaluable disease as per modified World Health Organization (mWHO) criteria

        Exclusion Criteria:

          -  Evidence of active brain metastases

          -  Prior treatment with anti-cytotoxic lymphocyte antigen 4 (CTLA-4) or anti-CD137 (type
             of tumor necrosis factor) antibody

          -  Total Bilirubin greater than (>) 1.5 * upper limit of normal (ULN) and aspartate
             aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 * upper limit of normal
             (ULN)

          -  Prior Autoimmune disease

          -  Use of immunosuppressing therapies
Bioequivalence And Food Effect Study Comparing The Commercial Formulation Of Crizotinib To Its Clinical Study Formulations And Commercial Formulation With Or Without Food In Healthy Volunteers
Condition: Healthy
Intervention: crizotinib
Intervention description: Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.
Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.
Treatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.
Treatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC
Intervention MeSH terms: Crizotinib
Phase: Phase 1
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: bioequivalence; food effect; pharmacokinetics; crizotinib

Summary:

      The purpose of this study is to demonstrate bioequivalence of the Commercial Image Capsule
      (CIC) relative to the Immediate Release Tablet (IRT) of crizotinib, bioequivalence of CIC
      relative to Powder in Capsule (PIC) of crizotinib, and lack of an effect of high fat meal on
      the pharmacokinetics (PK) of crizotinib when administered as CIC Formulation in healthy
      volunteers.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female of non-childbearing potential subjects between the ages of
             18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities
             identified by a detailed medical history, full physical examination, including blood
             pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs)

        Exclusion Criteria:

          -  Subjects who are smoking, or with evidence of disease, conditions affecting
             absorption, treatment with other investigational drug within 30 days, history of
             regular alcohol consumption, use of prescription, nonprescription drugs and dietary
             supplement within 7 days, or blood donation of 500 mL within 56 days.
Investigation of Drug-drug Interaction of Dabigatran and Ticagrelor
Condition: Healthy
Intervention: dabigatran etexilate; dabigatran etexilate; ticagrelor; ticagrelor; ticagrelor; dabigatran etexilate
Intervention description: multiple doses of dabigatran; medium dose dabigatran; loading dose of ticagrelor; multiple doses of ticagrelor; loading dose of ticagrelor; single dose of dabigatran
Intervention MeSH terms: Dabigatran; Ticagrelor
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the pharmacokinetic and pharmacodynamic interaction of dabigatran and
      ticagrelor under steady state conditions; to investigate the effect of staggered
      administration of ticagrelor loading dose on dabigatran exposure (in Part II)
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects.

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions.