bioihbjkbjnl/mcl2 huggingface dataset:
Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors
Condition: Advanced Cancer
MeSH terms: Neoplasms
Intervention: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin
Intervention description: Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).
Intervention MeSH terms: Pemetrexed; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced solid tumors including MPM and NSCLC

Summary:

      The purpose of this investigational study is to determine the safety and tolerability of oral
      suberoylanilide hydroxamic acid when administered in combination with standard doses of
      pemetrexed and cisplatin for the treatment of advanced solid tumors.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which
             pemetrexed and cisplatin is acceptable treatment and have received no more than 2
             prior systemic therapies

          -  Has at least 1 measurable lesion

          -  Has adequate blood, liver, and kidney functions

          -  Has not received any chemotherapy for at least 4 weeks prior to entry in this study

          -  Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

        Exclusion Criteria:

          -  Patient has been treated with other investigational agents with a similar anti-tumor
             mechanism

          -  Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6
             months and from Cohorts C and D have received pemetrexed within the past 6 months

          -  Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from
             Cohorts C and D have Grade 3 or higher neuropathy

          -  Patient has active infection or had received IV (intravenous) antibiotic, antiviral,
             or antifungal medications within 2 weeks of the start of study drugs

          -  Patient has HIV, hepatitis B or hepatitis C infection

          -  Patient is pregnant or breast feeding

          -  Patient has allergy to any component of the study drugs

          -  Patient has history of GI (gastrointestinal) surgery or conditions
Vorinostat (MK-0683) Phase I Study in Cutaneous T-Cell Lymphoma (CTCL) Patients (MK-0683-089 EXT1)
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous
Intervention: vorinostat
Intervention description: Parts I & II: Vorinostat (400 mg) Oral, daily (QD). Treatment period is 28 days per cycle.
Intervention MeSH terms: Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      Part I evaluates the safety, tolerability and pharmacokinetics (PK) of vorinostat in Japanese
      patients with relapsed or refractory CTCL. Part II evaluates the safety of vorinostat in
      Japanese pts. with relapsed or refractory CTCL. Relapsed or refractory CTCL patients will be
      newly enrolled in Part II.
    

Eligibility criteria:

        Inclusion Criteria (Parts I & II):

          -  Patients With CTCL Who Have Progressive, Persistent Or Recurrent Disease Subsequent To
             At Least One Prior Therapy

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status Must Be 0-2

          -  Patients Have Adequate Bone Marrow, Liver Function And Renal Function

        Exclusion Criteria (Parts I & II):

          -  Patients Had Prior Therapy Within 3 Weeks Before Registration, Or Have Not Recovered
             From Toxicities Of Prior Therapy

          -  Patients Have Uncontrolled Intercurrent Illness

          -  Pregnant Or Women Have A Will To Be Pregnant And Lactating Woman
A Hepatic Impairment Study for PF-04965842.
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Intervention: PF-04965842
Intervention description: PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
Intervention MeSH terms: Abrocitinib
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Parallel Assignment
Intervention model description: Recruitment for subjects with moderate and mild hepatic impairment (Cohorts 1 and 2) will initiate first and these subjects will be enrolled in parallel.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 non randomized, open label, single dose, parallel cohort study to
      investigate the effect of hepatic impairment on the PK, safety and tolerability of PF
      04965842.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of 17.5 to 40 kg/m2; and a total body weight >50 kg (110
             pounds).

          -  Subjects who are willing and able to comply with all scheduled visits, treatment plan,
             laboratory tests, and other study procedures.

        Additional Inclusion Criteria for subjects with hepatic impairment:

          -  Satisfy the criteria for Class A or Class B of the Child Pugh classification (mild:
             Child Pugh Scores 5 to 6 points, and moderate: Child Pugh Scores 7 to 9 points),
             within 14 days of investigational product administration.

          -  A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to
             any acute ongoing hepatocellular process) documented by medical history, physical
             examination, liver biopsy, hepatic ultrasound, computerized tomography scan, or
             magnetic resonance imaging (MRI).

        Exclusion Criteria:

          -  Subjects with clinically significant infections within the past 3 months (for example,
             those requiring hospitalization, or as judged by the Investigator), evidence of any
             infection (including influenza) within the past 7 days, history of disseminated herpes
             simplex infection or recurrent (>1 episode) or disseminated herpes zoster.

          -  Subjects with a malignancy or with a history of malignancy, with the exception of
             adequately treated or excised non metastatic basal cell or squamous cell cancer of the
             skin or cervical carcinoma in situ.

        Additional exclusion criteria for subjects with hepatic impairment:

          -  Hepatic carcinoma or hepatorenal syndrome or limited predicted life expectancy
             (defined as less than 1 year).

          -  Subjects who have previously had a transplanted kidney, liver, or heart.

          -  At Screening, persistent severe, uncontrolled hypertension.
Study to Evaluate the Effect of Eleclazine on QT, Safety, and Tolerability in Participants With Long QT2 Syndrome
Condition: LQT2 Syndrome
MeSH terms: Long QT Syndrome; Syndrome
Intervention: Eleclazine; Placebo
Intervention description: Tablets administered orally in a single dose; Placebo to match tablets administered orally in a single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Congenital Long QT Syndrome; LQTS; Sudden Cardiac Death

Summary:

      The primary objective of the study is to evaluate the effect of oral eleclazine (formerly
      GS-6615) on corrected QT (QTc) interval in participants with long QT2 syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants with an established diagnosis of LQT2 (by genotype testing)

          -  Mean (of triplicate) QTc interval ≥ 480 msec for at least four out of seven time
             points, determined by standard 12-lead electrocardiogram (ECG), at screening

        Key Exclusion Criteria:

          -  Known mutations associated with long QT syndrome type 1 or long QT syndrome type 3

          -  Known or suspected history of seizures or epilepsy

          -  History of heart failure defined as New York Heart Association (NYHA) Class IV and/or
             known left ventricular ejection fraction (EF) ≤ 45%

          -  Body mass index (BMI) ≥ 36 kg/m^2 at screening

          -  Severe renal impairment at screening (defined as an estimated glomerular filtration
             rate (eGFR) < 30 mL/min/1.73m^2, using the 4 variable modification of diet in renal
             disease (MDRD) equation), as determined by the study center

          -  Abnormal liver function tests at screening, defined as alanine aminotransferase (ALT)
             or aspartate aminotransferase (AST) > 2 x upper limit of normal (ULN), or total
             bilirubin > 1.5 x ULN

          -  An aborted cardiac arrest (ACA), implantable cardioverter-defibrillator (ICD)
             implantation, syncopal episode, or appropriate ICD therapy within 3 months prior to
             screening

          -  Any other condition or circumstance that in the opinion of the investigator would
             preclude compliance with the study protocol.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study of Romosozumab (AMG 785) Administered to Healthy Participants and Patients With Stage 4 Renal Impairment or Stage 5 Renal Impairment Requiring Hemodialysis
Condition: Osteoporosis
MeSH terms: Osteoporosis; Renal Insufficiency
Intervention: Romosozumab
Intervention description: Administered as three 70 mg/mL prefilled syringe injections
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Osteoporosis, Bone, Renal, Insufficiency, Kidney, Hemodialysis, Impairment

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and immunogenicity profile
      of romosozumab after a single 210 mg subcutaneous dose in healthy participants and patients
      with stage 4 renal impairment (RI) or stage 5 RI requiring hemodialysis.
    

Eligibility criteria:

        INCLUSION CRITERIA - ALL SUBJECTS :

          -  Males or females ≥ 50 years of age

          -  Body weight ≥ 45 and ≤ 110 kg

          -  Willing to adhere to calcium and vitamin D supplementation requirements

          -  Females must be of non-reproductive potential

        INCLUSION CRITERIA - SUBJECTS WITH RENAL IMPAIRMENT (GROUPS 1 AND 2):

          -  Group 1 - Stage 4 RI (estimated glomerular filtration rate (eGFR) 15-29 mL/min/1.73
             m²)

          -  Group 2 - End stage renal disease requiring hemodialysis

        INCLUSION CRITERIA - HEALTHY SUBJECTS (GROUP 3):

        • Renal function defined as an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73
        m²

        EXCLUSION CRITERIA - ALL SUBJECTS:

          -  History of metabolic or bone disease (except for metabolic bone disease in renal
             impairment (RI) subjects)

          -  History of osteoporosis, vertebral fracture, or fragility fracture of the wrist,
             humerus, hip, or pelvis after age 50

          -  Recent bone fracture

          -  Vitamin D insufficiency

          -  Hypocalcemia or hypercalcemia

          -  Hypomagnesemia

          -  Hypophosphatemia

          -  Untreated hyper- or hypothyroidism

          -  Females with a positive pregnancy test

          -  Males with pregnant partners

          -  Females who are lactating/breastfeeding or plan to breastfeed on study and for 3
             months after receiving the dose of study drug

          -  History of spinal stenosis

          -  History of facial nerve paralysis

          -  Positive for human immunodeficiency virus (HIV) antibodies

          -  Positive for hepatitis B surface antigen or detectable hepatitis C

          -  Malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma,
             cervical, or breast ductal carcinoma in situ) within 5 years before screening

          -  History of solid organ or bone marrow transplants EXCLUSION CRITERIA - HEALTHY
             SUBJECTS (GROUP 3)

          -  Current hyper- or hypoparathyroidism
A Clinical Trial to Assess the Safety of a Measles Vaccine (Dry Powder) Administered by Two Different Devices
Condition: Prophylaxis for the Measles Infection
MeSH terms: Measles
Intervention: PMV via Puffhaler® device; PMV via SoloventTM device; Licensed Subcutaneous Measles Vaccine
Intervention description: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.; The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.; This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase I, open-label, randomized study in healthy adults. Eligible subjects will be
      given single dose of either Dry Powdered Measles Vaccine (PMV) by Puffhaler® device, Dry PMV
      by SoloventTM device or licensed measles vaccine by subcutaneous route (SMV). Subjects will
      be followed for 180 days for safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male adults of age of 18-45 years.

          -  Measles immune, as determined by IgG antibody levels.

          -  Healthy as supported by medical history, physical examination and laboratory
             evaluation on preset parameters.

          -  Signed informed consent for participation in trial and for HIV screening.

        Exclusion Criteria:

          -  Medical history of immunodeficiency/suppression or subject with history of close
             contact with immunocompromised/ immunosuppressed person.

          -  Chronic administration of immunosuppressants or other immune modifying agents

          -  Acute febrile illness or suspected measles illness or acute infectious disease

          -  Acute or chronic, clinically significant pulmonary, endocrine, autoimmune,
             psychiatric, cardiovascular, neurological, hepatic or renal functional abnormality
             which in the opinion of the investigator, might interfere with the study objectives

          -  History of seizure disorders

          -  Major congenital defects

          -  Thrombocytopenia or known bleeding disorders 8. History of a previous severe allergic
             reaction

          -  Positive serology for HIV antibody, HCV antibody or Hepatitis B surface antigen

          -  Known hypersensitivity to any component of the study vaccine
Bioequivalence of Nomegestrol Acetate (NOMAC) and Estradiol (E2) in Commercial Versus Phase 3 Pivotal Clinical Batches of NOMAC-E2 Tablets (P06328)
Condition: Healthy Postmenopausal Females
Intervention: Commercial NOMAC-E2; Phase 3 NOMAC-E2 "Batch A"; Phase 3 NOMAC-E2 "Batch B"
Intervention description: 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods; 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch A") orally in the morning on Day 1 for all periods; 1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program ("Batch B") orally in the morning on Day 1 for all periods
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 158.0
Sex: Female
Minimum age: 45 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      For the contraceptive application a film-coated tablet has been developed which combines
      nomegestrol acetate (NOMAC) with estradiol (E2). This was an open-label, randomized,
      single-dose, four-way, replicate, cross-over study design conducted in 2 parallel parts at
      two sites, one site per study part. The primary objective of Part 1 was to assess the
      bioequivalence of NOMAC and E2 of the drug product manufactured using the commercial process
      ("commercial batch") versus the Phase 3 drug product ("Batch A"). The primary objective of
      Part 2 was to assess bioequivalence of NOMAC and E2 of the drug product manufactured using
      the commercial process ("commercial batch") versus the Phase 3 drug product ("Batch B").
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Healthy postmenopausal females between the ages of 45 and 70 years, inclusive, having
             a Body Mass Index (BMI) between 18 and 32, inclusive;

          -  Free of any clinically significant disease that would interfere with the study
             evaluations.

        Key Exclusion Criteria:

          -  Any surgical or medical condition which might significantly alter the absorption,
             distribution, metabolism or excretion of any drug;

          -  History of any infectious disease that affected the subject's ability to participate
             in the trial;

          -  History of alcohol or drug abuse in the past 2 years;

          -  Previously received NOMAC-E2;

          -  Current participation in another clinical study or had participated in a clinical
             study (eg, laboratory or clinical evaluation) within 30 days of baseline;

          -  Smoked more than 10 cigarettes or equivalent tobacco use per day;

          -  History of malignancy;

          -  Contraindications for the use of contraceptive steroids;

          -  Recent history of medication use of certain medications specified in the protocol.
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BI 10773 in Type II Diabetes Patients With Different Degrees of Renal Impairment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: BI 10773; BI 10773; BI 10773; BI 10773; BI 10773
Intervention description: oral administration; oral administration; oral administration; oral administration; oral administration
Intervention MeSH terms: Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      Assessment of the effect of normal and impaired kidney function on the pharmacokinetics,
      pharmacodynamics and safety of BI 10773
    

Eligibility criteria:

        Inclusion criteria:

          1. Male and female subjects with type 2 diabetes

          2. Renally impaired male or female subjects

          3. Age 18 - 75 years

          4. BMI 18 - 34 kg/m2, at least 45 kg for females (Body Mass Index)

          5. Signed and dated written informed consent

        Exclusion criteria:

          1. Significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders as judged by the investigator.

          2. Relevant gastrointestinal tract surgery

          3. Diseases of the central nervous system (such as epilepsy, seizures) or psychiatric
             disorders or relevant neurological disorders

          4. History of relevant orthostatic hypotension, fainting spells or blackouts; systolic
             blood pressure < 100 or > 160 mm Hg, diastolic blood pressure < 60 or > 100 mm Hg,
             pulse rate < 50 or > 100 1/min

          5. Chronic or relevant acute infections

          6. History of allergy/hypersensitivity (including drug allergies) that are deemed
             relevant to the trial as judged by the investigator

          7. Use within 10 days prior to administration or during the trial of drugs which might
             reasonably influence the results of the trial based on the knowledge at the time of
             protocol preparation. Co medication known to inhibit or induce P-glycoprotein or CYP3A
             is not allowed. Inhibitors of P-glycoprotein or CYP3A (cytochrom P3A) are e.g.

               -  protease inhibitors, (e.g. ritonavir, lopinavir nelfinavir)

               -  azole antimycotics, (itraconazole, ketoconazole, miconazole)

               -  macrolid antibiotics, (clarithromycin, erythromycin)

               -  amiodarone, cimetidine, diltiazem, fluvoxamine, mibefradil, nefazodone,
                  verapamil, tacrolimus, quinidine, reserpine, cyclosporine A Inducers of P-gp or
                  CYP3A are e.g. carbamazepine, phenobarbital, phenytoin, rifabutin, ri-fampin, St.
                  John's wort, troglitazone. In dubious cases, a case by case decision will be made
                  after consultation with the sponsor.