bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Pharmacokinetics and Safety of Carfilzomib in Patients With Multiple Myeloma and Renal Disease
Condition: Relapsed Multiple Myeloma; End-stage Renal Disease
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Kidney Diseases; Kidney Failure, Chronic
Intervention: Carfilzomib
Intervention description: Carfilzomib was administered by IV injection.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see how the body and the cancer react to carfilzomib,
      including measuring the amount of the study drug in the blood at certain times following
      dosing. This study is being done in people with normal kidney function and those with
      end-stage renal disease to see if they respond differently to the study drug.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Relapsed multiple myeloma

          2. Evaluable disease (serum protein electrophoresis [SPEP]/urine protein electrophoresis
             [UPEP]/serum free light chain [SFLC] criteria)

          3. Received at least 1 prior treatment regimen or line of therapy for multiple myeloma

          4. End-stage renal disease (ESRD) on hemodialysis or CrCl ≥ 75 mL/min

          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2

          6. Adequate organ and bone marrow function

          7. Active congestive heart failure (New York Heart Association [NYHA] Class III to IV),
             symptomatic ischemia, conduction abnormalities uncontrolled by conventional
             intervention or myocardial infarction within the protocol-specified period prior to
             enrollment

        Key Exclusion Criteria:

          1. Immunoglobulin M (IgM) multiple myeloma

          2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and
             skin changes)

          3. Waldenström Macroglobulinemia

          4. Active congestive heart failure (NYHA Class III-IV) ischemia, conduction abnormalities

          5. Known human immunodeficiency virus (HIV), recent hepatitis B virus (HBV), hepatitis C
             virus (HCV)

          6. Myelodysplastic Syndrome

          7. Contraindication to test article, constituents, or required concomitant medications

          8. Other investigational drugs
Reducing Dyskinesia in Parkinson's Disease With Omega-3 Fatty Acids
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Dyskinesias
Intervention: Docosahexaenoic Acid (DHA); Placebo
Intervention description: Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years; Sugar Pill, taken for 1.5 years
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 33.0
Sex: All
Minimum age: 21 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: Parkinsons disease; supplement; DHA; dyskinesia; abnormal movements

Summary:

      The purpose of this research study is to measure the safety (side effects) of an Omega 3
      Fatty acid called docosahexanoic acid (DHA) and measure the dyskinesia (involuntary
      movements) in Parkinson 's disease (PD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with Parkinsons disease

          -  No levodopa (Sinemet) treatment or prior exposure to levodopa

        Exclusion Criteria:

          -  Prior exposure to levodopa

          -  Unable to stand for 1 minute without aid

          -  Sensory deficits on feet

          -  Significant cognitive impairment

          -  Current use of dopamine receptor blocking medications (depakote, lithium, amiodarone,
             tetrabenazine, metoclopramide, dronabinol)

          -  Current fish oil or lutein supplementation

          -  Allergy to soy
Erenumab (AMG 334) Plus Combined Oral Contraceptive Drug Interaction Study in Healthy Females
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: Erenumab; Ethynil Estradiol/Norgestimate Oral Contraceptive
Intervention description: A single dose of erenumab administered in the abdomen.; Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.
Intervention MeSH terms: Erenumab; Norgestimate; Contraceptive Agents; Contraceptives, Oral; Estradiol
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A pharmacokinetic drug interaction study of erenumab and an oral contraceptive containing
      progestin and estrogen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female ≥18 to ≤45 years old at the time of enrollment

          -  Regular monthly menstrual cycle during the last 12 months

          -  Good general health based on a medical history evaluation and physical examination

          -  No clinically significant abnormalities in laboratory tests at screening

          -  Subject has provided informed consent/assent prior to initiation of any study specific
             activities/procedures

        Exclusion Criteria:

          -  Intolerance to any recent oral contraceptive in the last three (3) years,

          -  Female subjects with a positive serum pregnancy test at screening

          -  Female subjects not willing to inform her sexual partner of her participation in the
             clinical study

          -  Use of any over the counter or prescription medications within the 14 days or 5 half
             lives (whichever is longer)

          -  Nicotine use eg cigarettes or equivalent during 12 months prior to day 1 and through
             the duration of the study
A Study of the Pharmacokinetics of Two Formulations of MK-1006 (MK-1006-010 AM1)(COMPLETED)
Condition: Type 2 Diabetes
Intervention: MK-1006 DFC; MK-1006 FCT
Intervention description: Each dry filled capsule contains 20 mg MK-1006; Each film coated tablet contains 40 mg of MK-1006
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: 65 Years
Healthy volunteers: No

Summary:

      This study will assess the pharmacokinetics of two formulations of MK-1006. The primary
      hypothesis of this study is that the MK-1006 area under the curve (0 to infinity) and maximum
      concentration after administration of a single 80 mg dose of the dry filled capsule (DFC) and
      film coated tablet (FCT) formulations of MK-1006 will be similar.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is a male or a female of non-child bearing potential

          -  has type 2 diabetes (T2D) and is either being treated with diet and exercise alone or
             with a single or combination oral anti-hyperglycemic agent(s)

          -  has been a nonsmoker for at least 6 months

        Exclusion Criteria:

          -  has a history of stroke, chronic seizures, or major neurological disorder

          -  has a history of major endocrine (except T2D), gastrointestinal, cardiovascular,
             blood, liver, immune, kidney, respiratory, or genitourinary abnormalities or diseases

          -  has a history of cancer, except certain skin or cervical cancers or cancer that was
             successfully treated more than 10 years prior to screening

          -  has unstable or rapidly progressing diabetic retinopathy and/or neuropathy

          -  has had an eye infection or other inflammation of the eye in the 2 weeks prior to
             screening

          -  has glaucoma or is blind

          -  has had incisional eye surgery in the last 6 months or laser eye surgery in the last 3
             months (Lasik is permitted)

          -  has a history of type 1 diabetes

          -  has symptomatic coronary artery disease

          -  consumes excessive amounts of alcohol and/or caffeine
A Renal Impairment Study for PF-06651600
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: PF-06651600
Intervention description: PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1 non-randomized, open-label, parallel cohort study of PF-06651600 in
      subjects with severe renal impairment and subjects without renal impairment (Part 1) and in
      subjects with mild and moderate renal impairment (Part 2).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index (BMI) of >/= 17.5 to </= 40.0 kg/m2; and a total body weight > 50 kg
             (110 lb)

        Additional inclusion criteria for subjects with renal impairment:

          -  Meet the following eGFR criteria during the screening period based upon MDRD equation:

          -  Severe renal impairment: eGFR <30 mL/min but not requiring hemodialysis

          -  Moderate renal impairment (Part 2 only): eGFR >/=30 mL/min and <60 mL/min

          -  Mild renal impairment (Part 2 only): eGFR between 60 and 89 mL/min

          -  Any form of renal impairment except acute nephritic syndrome (subjects with history of
             previous nephritic syndrome but in remission can be included)

          -  Stable drug regimen

        Exclusion Criteria:

          -  Females of child-bearing potential must use an accepted, highly effective
             contraceptive method

          -  Renal transplant recipients

          -  Urinary incontinence without catheterization

          -  Subjects with clinically significant infections within the past 6 months prior to
             first dose of study drug, evidence of active or chronic infection requiring oral
             treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or
             disseminated herpes zoster

          -  Subjects with malignancy or with a history of malignancy, with the exception of
             adequately treated or excised non-metastatic basal cell or squamous cell cancer of
             skin or cervical carcinoma in situ

          -  HIV, Hepatitis B, or Hepatitis C infection

        Additional exclusion criteria for subjects with renal impairment:

          -  Subjects requiring hemodialysis and peritoneal dialysis

          -  Screening BP >/=180 mmHg (systolic) or >/=110 mmHg (diastolic)

          -  Screening 12-lead ECG demonstrating QTcF >470 msec
STUDY OF TALAZOPARIB MONOTHERAPY IN CHINESE PARTICIPANTS WITH ADVANCED SOLID TUMORS
Condition: Neoplasms
Intervention: talazoparib
Intervention description: Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days.
Intervention MeSH terms: Talazoparib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A phase1 study to evaluate the PK (single dose and multiple doses) and safety of talazoparib
      1 mg Once Daily in Chinese adult participants with advanced solid tumors. A maximum of
      approximately 15 participants will be enrolled such that approximately 12 evaluable
      participants complete the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of locally advanced or metastatic solid tumor
             that is resistant to standard therapy or for which no standard therapy is available.

          -  ECOG Performance Status 0 or 1.

          -  Adequate Bone Marrow, Renal and Liver Function.

        Exclusion Criteria:

          -  Participants with brain metastases.

          -  Current or anticipated use of P gp inhibitor and/or inducer within 7 days prior to
             study intervention from lead-in to end of Cycle 1; concomitant use of potent P gp
             inhibitor after Cycle 1 until the end of treatment.

          -  Prior treatment with a PARP inhibitor.
Fludeoxyglucose F 18-PET/CT Scans in Patients Receiving Ultra Short-Term Dexamethasone For Lung Nodules
Condition: Pulmonary Nodule
MeSH terms: Multiple Pulmonary Nodules
Intervention: dexamethasone; PET/Computed Tomography (CT); fludeoxyglucose (18F)
Intervention description: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs
Intervention MeSH terms: Dexamethasone; Fluorodeoxyglucose F18
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: pulmonary nodule

Summary:

      RATIONALE: Imaging procedures, such as fludeoxyglucose F 18 (FDG)-PET/CT scan, done before
      and after steroid therapy may help doctors assess a patient's response to treatment and help
      plan the best treatment.

      PURPOSE: This phase I trial is studying fludeoxyglucose F 18 PET scan performed before and
      after ultra short-term dexamethasone therapy to see how well it measures changes in nodules
      in patients with lung nodules.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Presence of ≥ 1 measurable pulmonary nodule (1.0-3.0 cm) suggestive of malignancy or
             chronic inflammatory process on positron emission tomography (PET) scan

          -  No lesions consistent with malignancy or inflammation according to history, PET
             findings, or biopsy

          -  Baseline scan average time between injection and start of scan within 50-70 min

               -  Mean liver standardized uptake value (SUV) of baseline scan normal

               -  No sign of significant partial paravenous tracer administration in the images of
                  baseline scan

          -  No lung nodule(s) suggestive of lymphoma

          -  No lung lesions suggestive of tuberculosis

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  Blood glucose levels ≤ 150 mg/100 mL

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Able to tolerate PET/CT imaging

          -  No history of diabetes

          -  No poorly controlled hypertension

          -  No prior malignancy other than basal cell or squamous cell carcinoma of the skin,
             carcinoma in situ, or other cancer from which the participant has been disease free
             for < 3 years

               -  No active malignancy within the past 5 years

        PRIOR CONCURRENT THERAPY:

          -  More than 5 years since prior chemotherapy or radiotherapy

          -  No concurrent steroids
Drug-drug Interaction of Empagliflozin (BI 10773) and Simvastatin
Condition: Healthy
Intervention: BI 10773; simvastatin; simvastatin; BI 10773
Intervention description: Medium dose oral administration; Medium dose oral administration; Medium dose oral administration; Medium dose oral administration
Intervention MeSH terms: Empagliflozin; Simvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the study is to investigate the drug-drug interaction potential between BI
      10773 and simvastatin.
    

Eligibility criteria:

        Inclusion criteria:

        - healthy male and female subjects

        Exclusion criteria:

        - Any relevant deviation from healthy conditions
Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of H3B-6527 in Participants With Advanced Hepatocellular Carcinoma
Condition: Advanced Hepatocellular Carcinoma; Hepatocellular Carcinoma; Liver Cancer; Liver Neoplasms; Hepatic Cancer; Hepatic Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Neoplasms
Intervention: H3B-6527
Intervention description: H3B-6527 by mouth once or twice daily at specified doses.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 128.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Advanced Hepatocellular Carcinoma; H3B-6527; Fibroblast growth factor receptor 4 (FGFR4); Fibroblast growth factor 19 (FGF19)

Summary:

      The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended
      Phase 2 dose (RP2D) of H3B-6527, and to assess the safety, tolerability and pharmacokinetics
      of H3B-6527.
    

Eligibility criteria:

        Inclusion criteria:

          1. Participants with hepatocellular carcinoma.

          2. Must have had at least one prior standard-of-care therapy, unless contraindicated.

          3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

          4. Must be willing to undergo a biopsy up to 8 weeks before administration of H3B-6527 on
             Cycle 1 Day 1 for part 2 (dose expansion).

          5. Adequate bone marrow and organ function.

        Exclusion criteria:

          1. Uncontrolled significant active infections, except hepatitis B virus (HBV) or
             hepatitis C virus (HCV).

          2. Known human immunodeficiency virus infection.

          3. Presence of gastric or esophageal varices requiring active treatment.

          4. Previous treatment with a selective FGF19-FGFR4 targeted therapy.

          5. Females of childbearing potential, or males who have not had a successful vasectomy,
             who are unable or unwilling to follow adequate contraceptive measures.

          6. Hereditary problems of galactose intolerance, the Lapp lactase deficiency, or
             glucose-galactose malabsorption.
To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects
Condition: Healthy
Intervention: CT-P17; US-licensed Humira; EU-approved Humira
Intervention description: 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS; 40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
Intervention MeSH terms: Adalimumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 312.0
Sex: All
Minimum age: 19 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a Phase 1, Randomized, Double-blind, Three-arm, Parallel group, Single-dose Study to
      Compare the Pharmacokinetics and Safety of CT-P17 and Humira (US licensed Humira and
      EU-approved Humira) in Healthy Subjects
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy subjects

          -  BMI between 18.0 and 29.9 kg/m2, both inclusive, when rounded to the nearest tenth

        Exclusion Criteria:

          -  A medical history and/or condition that is considered significant

          -  Clinically significant allergic reactions, hypersensitivity

          -  History or current infection of hepatitis B virus (except for past resolved
             infection), hepatitis C virus, human immunodeficiency virus, or syphilis

          -  Active or latent Tuberculosis

          -  History of malignancy

          -  Previous monoclonal antibody or fusion protein treatment, or current use of any
             biologic

          -  Planning to be pregnant or father a child or donate sperm within 5 month after
             administration

          -  Undergone treatment with an investigational drug or participated in another clinical
             trial within 90 days or 5 half-lives (whichever is longer)