bioihbjkbjnl/mcl2 huggingface dataset:
Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: Dexamethasone; Buprenorphine
Intervention MeSH terms: Dexamethasone; Buprenorphine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study looks at addition of medications to the local anesthetic for the nerve blockade.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery

          -  Patients aged 18-75

          -  Patients scheduled for discharge from HSS after foot or ankle surgery

          -  A single-injection popliteal fossa nerve block is judged appropriate

          -  Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate
             is not an exclusion criterion)

        Exclusion Criteria:

          -  < 18 and > 75

          -  Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac
             crest bone graft)

          -  Bilateral surgery

          -  Chronic pain (defined as regular use of opioid analgesics for > 3 months)

          -  Chronic use of steroids (defined as regular use of steroids for > 3 months)

          -  Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25%
             bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)

          -  Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent
             diabetes mellitus, etc.)

          -  Patients who have been diagnosed with altered pain perception or have lack of
             sensation

          -  Inability of the patient to describe postoperative pain (e.g. psychiatric disorder,
             dementia)

          -  Non-English speaking patients (the questionnaire is in English, and translations would
             have to be separately validated)
CP-751,871 Treatment For Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CP-751,871
Intervention description: CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IGF-1R inhibitor; CP-751871; multiple myeloma

Summary:

      This study represents the first-in-human study for CP-751,871. The study aimed to define the
      safety, tolerability, and maximum tolerated dose of CP-751,871 in patients with multiple
      myeloma through a dose escalation design.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Previously treated multiple myeloma with a quantifiable serum (M spike ≥ 1 g/dL)
             and/or urine (≥ 200 mg/24-hr) paraprotein

          -  Adequate bone marrow, renal, liver and cardiac function

          -  Eastern Cooperative Oncology Group [ECOG] performance status less than or equal to 2

        Exclusion Criteria:

          -  Prior allogeneic stem cell transplant (alloSCT)

          -  Myelosuppressive chemotherapy or immunotherapy within 3 weeks prior to treatment with
             CP-751,871

          -  Prior organ allograft

          -  Concurrent use of insulin, oral hypoglycemic medication, growth hormone (GH), or
             growth hormone inhibitors

          -  Female patients who are pregnant or lactating
Safety Study of PLX4032 in Patients With Solid Tumors
Condition: Malignant Melanoma; Colorectal Carcinoma
MeSH terms: Melanoma; Colorectal Neoplasms
Intervention: PLX4032
Intervention description: Oral capsules administered BID
Intervention MeSH terms: Vemurafenib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary objective of this FIH study is to assess the safety and pharmacokinetics of
      PLX4032 in patients with solid tumors. The secondary objective is to assess the
      pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant
      melanoma who have the V600E BRAF oncogenic mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Solid tumors confirmed histologically whose tumors are refractory to standard therapy,
             or for whom standard or curative therapy does not exist

          -  Patients from whom paired melanoma biopsies are planned must have a V600E+ BRAF
             mutation confirmed prior to the administration of PLX4032

          -  Previous chemotherapy, immunotherapy, or radiation therapy must have been completed at
             least 2 weeks prior to starting PLX4032 therapy, and all associated toxicity must be
             resolved prior to administration of PLX4032

          -  Patients in the Extension cohorts (melanoma or adenocarcinoma of the colon or rectum)
             must have both a V600E+ BRAF mutation and measurable disease (by RECIST V 1.0
             criteria) prior to the administration of PLX4032. All patients enrolled must provide
             archival or fresh melanoma tumor biopsy for confirmation of V600E+ BRAF mutation
             status by TaqMan assay

          -  ECOG performance status 0 or 1

          -  Life expectancy ≥ 3 months

          -  Adequate hematologic, hepatic, and renal function

        Exclusion Criteria:

          -  Brain metastases that are progressing or have been documented to be stable for less
             than 3 months, or for which systemic corticosteroids are required

          -  Investigational drug use within 28 days of the first dose of PLX4032

          -  Uncontrolled intercurrent illness

          -  Refractory nausea and vomiting, malabsorption, or significant bowel resection that
             would preclude adequate absorption
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Inhaled Montelukast (MK-0476) in Participants With Mild or Moderate Asthma (MK-0476-380 AM3)(COMPLETED)
Condition: Asthma
MeSH terms: Asthma
Intervention: Montelukast; Placebo
Intervention description: Montelukast dry powder inhaler, 0.1 mg, 0.3 mg, 1 mg, 3 mg or 10 mg; Placebo dry powder inhaler
Intervention MeSH terms: Montelukast
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      A study to evaluate the safety, tolerability and pharmacokinetics of inhaled Montelukast
      (MK-0476) in participants with mild or moderate asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female between the ages of 18 and 65

          -  Must have mild or moderate asthma (Part III only)

          -  Nonsmoker for at least 6 months

        Exclusion Criteria:

          -  History of stroke, chronic seizures or major neurological disorder

          -  You are nursing

          -  Drink more than 3 glasses of alcohol a day

          -  Have allergy to or not able to tolerate lactose

          -  Have a history of drug abuse in the last 5 years

          -  Drink more than 6 beverages containing caffeine a day

          -  Have had surgery, donated blood or participated in another investigational study in
             the last 4 weeks
A Study of LY2409021 Formulations in Healthy Participants
Condition: Healthy
Intervention: LY2409021
Intervention description: Administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to measure how much of the new LY2409021 tablet formulations get
      into the blood stream and how long it takes the body to get rid of them, compared to the
      current LY2409021 capsule formulation. In addition, the safety and tolerability of both the
      new and current formulations will be evaluated. Information about any side effects that may
      occur will also be collected. The study has two parts. Each participant may enroll in one
      part only. The study will last up to 8 weeks for each participant. Screening is required
      prior to the start of the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Overtly healthy males or surgically sterile or postmenopausal females, as determined
             by medical history and physical examination

          -  Have a body mass index (BMI) of 18.0 to 32.0 kilogram per square meter (kg/m^2)

          -  Have clinical laboratory test results within normal reference range for the population
             or investigator site, or results with acceptable deviations that are judged to be not
             clinically significant by the investigator

        Exclusion Criteria:

          -  Have known allergies to LY2409021, related compounds or any components of the
             formulation, or history of significant atopy

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have known or ongoing psychiatric disorders
Safety, Tolerability and Pharmacokinetics of Etelcalcetide in Hemodialysis Patients With Secondary Hyperparathyroidism
Condition: Hyperparathyroidism, Secondary
MeSH terms: Neoplasm Metastasis; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Placebo; Etelcalcetide
Intervention description: Single IV injection.; Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Clinical Trial, Phase 1; Renal Dialysis; Secondary Hyperparathyroidism; Parathyroid hormone

Summary:

      The purpose of this study is to characterize the safety and tolerability of single rising
      doses of etelcalcetide in hemodialysis patients with secondary hyperparathyroidism.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects provides written informed consent.

          -  Intact parathyroid hormone (iPTH) ≥ 400 pg/mL (≥ 300 and < 1200 pg/ml for Cohorts
             1-3).

          -  Serum corrected calcium ≥ 9.0 mg/dL

          -  Receiving hemodialysis three times per week for at least 3 months and had adequate
             hemodialysis with a delivered Kt/V (dialyzer clearance of urea * dialysis time/ volume
             of distribution of urea) ≥ 1.2 or urea reduction ratio (URR)

             ≥ 65%.

          -  Excepting chronic renal failure, subject is judged to be in stable medical condition
             based on medical history, physical examination, and routine laboratory tests

        Exclusion Criteria:

          -  History or symptomatic ventricular dysrhythmias

          -  History of angina pectoris or congestive heart failure

          -  History of myocardial infarction, coronary angioplasty, or coronary artery bypass
             grafting within the past 6 months

          -  History of or treatment for seizure disorder

          -  Recent (3 months) parathyroidectomy
Study of the JAK Inhibitor Ruxolitinib Administered Orally to Patients With Primary Myelofibrosis (PMF), Post-Polycythemia Vera-Myelofibrosis (PPV-MF) or Post-Essential Thrombocythemia-Myelofibrosis (PET-MF)
Condition: Myelofibrosis
MeSH terms: Primary Myelofibrosis; Polycythemia
Intervention: Ruxolitinib
Intervention description: Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase IB, open-label, dose-finding study of the JAK 1 and 2 inhibitor ruxolitinib
      in patients with myelofibrosis (MF). The study consists of two periods: the core study
      period, comprising the dose escalation stage and the safety extension phase up to Week 24,
      then the extension study period beyond Week 24 and up to 3 years, to further characterize the
      safety and efficacy of ruxolitinib in this patient population. The dose escalation phase will
      enroll successive cohorts of patients who receive increasing doses of ruxolitinib until the
      maximum safe starting dose (MSSD) is determined. In the safety expansion phase, additional
      patients will be treated with ruxolitinib at the MSSD defined during dose escalation. The
      primary objective is to establish the MSSD of ruxolitinib in patients with MF and starting
      platelet counts < 100 x 10 ^9/L
    

Eligibility criteria:

        Inclusion Criteria:

          -  Require treatment for MF and classified at least as intermediate risk level 1 defined
             by the International Working Group.

          -  Platelet count < 100x10 ^9/L at screening or at Study Day 1.

        Exclusion Criteria:

          -  Received platelet transfusion within 14 days prior to Screening evaluations.
Study of the Safety of QRH-882260 Heptapeptide
Condition: Healthy Adults
Intervention: QRH-882260
Intervention description: The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 25 Years
Maximum age: 100 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety of orally administered QRH-882260, a
      topically administered Cy5-labeled heptapeptide specific for epithelial growth factor
      receptor (EGFR).
    

Eligibility criteria:

        Inclusion Criteria

          -  Adults age 25 to 100 years

          -  Not pregnant (willing to have pregnancy test if applicable)

          -  No recent illness (infection, URI, virus or flu) within 2 weeks,

          -  Stable health status (i.e. no medication changes within 2 months, no recent surgery,
             etc. per PI)

          -  Willing and able to sign informed consent

          -  Willing and able to drink the peptide and a tap water chaser

          -  Willing and able to get baseline and 24-48 hours post ingestion labs Exclusion
             Criteria

          -  Known allergy to Cy5 or derivatives, such as indocyanine green (ICG)

          -  Subjects on active chemotherapy or radiation therapy

          -  Diabetics on insulin/hypoglycemic (due to fasting requirements)
Safety, Tolerability and Pharmacokinetics of Multiple Rising Doses of BI 113608 in Healthy Male Volunteers
Condition: Healthy
Intervention: BI 113608 PIB bid; Placebo to BI 113608 PIB bid; Placebo to BI 113608 PIB bid; Placebo to BI 113608 PIB qd; Placebo to BI 113608 PIB bid; BI 113608 PIB bid; BI 113608 PIB bid; BI 113608 PIB qd
Intervention description: powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution; powder for oral solution
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics
      of multiple rising doses of BI 113608 in healthy male volunteers
    

Eligibility criteria:

        Inclusion criteria:

        1. healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
A Pharmacokinetic And QT Study Of CP-751,871 In Healthy Subjects
Condition: Healthy Volunteers
Intervention: CP-751,871; CP-751,871; CP-751,871, moxifloxacin, saline
Intervention description: single dose, 1-hr IV infusion; single dose, 1-hr IV infusion; Two doses at 20 mg/kg each on two consecutive days, each administered via 1-hr IV infusion
Intervention MeSH terms: Moxifloxacin; Antibodies, Monoclonal
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pharmacokinetics; Pharmacodynamics; QTc interval prolongation

Summary:

      This study is primarily to evaluate the single dose pharmacokinetics of CP-751,871 and its
      effect on QT interval prolongation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects and/or healthy female subjects of non-childbearing potential
             between the ages of 18 and 55 years, inclusive

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at time of dosing).

          -  12-lead ECG demonstrating QTc >450 msec at screening or other clinically significant
             abnormalities at screening.

          -  History or family history of risk factors for QTc interval prolongation or torsades de
             pointes (eg, organic heart disease, congestive heart failure, hypokalemia,
             hypomagnesemia, congenital long QT syndrome, myocardial ischemia or infarction);
             family history of sudden death.
A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Condition: Healthy
Intervention: PF-04447943; Placebo; Moxifloxacin
Intervention description: Single oral dose of PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution; Single oral dose of moxifloxacin administered as tablet
Intervention MeSH terms: Moxifloxacin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a study designed to ascertain the effect of PF-04447943 on QT interval in healthy
      adult subjects. This is conducted as part of standard drug development.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy female subjects of non childbearing potential and/or healthy male subjects,
             between the ages of 18 and 55 years.

          -  Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg.

        Exclusion Criteria:

          -  Evidence or history of clinically significant hematological, renal, endocrine,
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
             allergic disease (including drug allergies, but excluding untreated, asymptomatic,
             seasonal allergies at the time of dosing).

          -  History of cerebrovascular accident, transient ischemic attack (TIA), or traumatic
             brain injury.

          -  History of seizures or history or physical examination findings (eg localizing signs
             on neurologic examination) suggestive of structural central nervous system (CNS)
             abnormalities which may place patient at increased risk of seizures.

          -  History of orthostatic blood pressure changes or clinically significant orthostatic
             symptoms.

          -  Self reported history or risk factors for QT prolongation or torsades de pointes (eg,
             organic heart disease, congestive heart failure, hypokalemia, hypomagnesaemia,
             congenital long QT syndrome, myocardial ischemia or infarction), congenital deafness,
             family history of sudden death, and family history of long QT syndrome.