bioihbjkbjnl/mcl2 huggingface dataset:
Nicardipine vs Esmolol Craniotomy Emergence
Condition: Brain Tumors
MeSH terms: Brain Neoplasms
Intervention: Nicardipine; Esmolol
Intervention MeSH terms: Nicardipine; Esmolol
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Emergence hypertension is a common occurrence in patients emerging from general anesthesia.
      This elevation of arterial pressure is particularly concerning in patients undergoing
      craniotomy due to increased risk of morbidity and mortality in patients with altered
      intracranial elastance. Thus, identifying better methods to attenuate the hemodynamic changes
      associated with emergence from anesthesia can improve patient safety, especially in the
      neurosurgical patient.

      Study Hypothesis: Nicardipine is more effective than esmolol as a sole agent in maintaining
      blood pressure within goal range in the setting of emergence hypertension after craniotomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult

          -  non-pregnant patients

          -  (age ≥ 18 years)

          -  undergoing general anesthesia for elective supratentorial, infratentorial, or
             transsphenoidal craniotomy

        Exclusion Criteria:

          -  Patients under 18 years of age

          -  non-English speaking, pregnancy

          -  emergent craniotomy (including trauma)

          -  awake craniotomy

          -  active 3 vessel coronary artery disease or left main coronary artery disease

          -  advanced heart block

          -  severe aortic stenosis

          -  chronic renal failure

          -  known or suspected allergy or intolerance to a study drug or its components
To Assess the Safety, Tolerability, and Pharmacokinetics of AZD7624 in Healthy Volunteers and COPD Patients
Condition: COPD; Healthy Subjects
Intervention: AZD7624; Placebo to match
Intervention description: Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer; Multiple doses inhaled placebo via a nebulizer
Intervention MeSH terms: AZD7624
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Phase 1,; Safety,; Tolerability,; Healthy,; COPD patients

Summary:

      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of multiple ascending doses of AZD7624 in healthy subjects and patients with chronic
      obstructive pulmonary disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable
             veins for cannulation or repeated venipuncture.

          -  Provision of signed and dated, written informed consent prior to any study specific
             procedures

          -  Plasma myoglobin and CK not above the upper reference range of the analysing
             laboratory at Day -1

          -  Male and/or female patients with COPD aged above18 years with suitable veins for
             cannulation or repeated venipuncture.

          -  Clinical diagnosis of COPD for more than 1 year at Visit 1, according to the Global
             Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines

        Exclusion Criteria:

          -  Any clinically important illness, medical/surgical procedure or trauma within 4 weeks
             of the first administration of the IP

          -  Receipt of another new chemical entity (defined as a compound which has not been
             approved for marketing) or participation in any other clinical study that included
             drug treatment within at least 3 months of the first administration of the IP in this
             study

          -  Any clinically important abnormalities in clinical chemistry, haematology or
             urinalysis results as judged by the Investigator

          -  Any positive result on screening for serum hepatitis B surface antigen (HBsAg),
             hepatitis C antibody and human immunodeficiency virus (HIV)

          -  History or presence of gastrointestinal, hepatic or renal disease or any other
             condition known to interfere with absorption, distribution, metabolism or excretion of
             drugs
Safety Tolerability and Pharmacokinetic of BI 411034
Condition: Healthy
Intervention: BI 411034; Placebo; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034; BI 411034
Intervention description: Low dose solution for oral administration; Solution for oral administration; Medium dose solution for oral administration; Low dose solution for oral administration; High dose solution for oral administration; High dose solution for oral administration; Medium dose solution for oral administration; High dose solution for oral administration; Medium dose solution for oral administration
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Enrollment: 62.0
Sex: Male
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the current study is to investigate the safety, tolerability and
      pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of
      single rising doses.

      The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19
      (Cytochrome P450) genotyped extensive metabolisers (EM).

      Another objective is to compare the safety and pharmacokinetic profiles between two different
      groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)
    

Eligibility criteria:

        Inclusion criteria:

        1. Healthy male subjects

        Exclusion criteria:

        1. Any relevant deviation from healthy conditions
Bioavailability of a Fixed Dose Combination Tablet With Empagliflozin (BI 10773) and Metformin Compared With the Monocomponents and Effect of Food on Bioavailability
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: C: BI 10773 / metformin tablet; B: BI 10773 tablet and metformin tablet; A: BI 10773 / metformin tablet
Intervention description: BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal; BI 10773 and metformin single tablets, administered together in fasted state; BI 10773 / metformin fixed dose combination tablet in fasted state
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The objective of the current study is to determine the relative bioavailability of a BI 10773
      / metformin fixed dose combination tablet compared to single tablets of BI 10773 and
      metformin when administered together and to assess the effect of food on the bioavailability
      the fixed dose combination tablet
    

Eligibility criteria:

        Inclusion criteria:

          1. Healthy males and females according to the following criteria

          2. Body Mass Index 18.5 to 29.9 kg/m2 (incl.)

        Exclusion criteria:

          1. Any finding of the medical examination (including Blood Pressure, Pulse Rate and
             electrocardiogram) deviating from normal and of clinical relevance

          2. Any evidence of a clinically relevant concomitant disease
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body
Condition: Neoplasm Metastasis
MeSH terms: Neoplasm Metastasis
Intervention: Drug Cocktail; Abemaciclib
Intervention description: Administered orally; Administered orally
Intervention MeSH terms: Midazolam; Dextromethorphan; Caffeine; Warfarin
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is known as a "drug interaction study" and is being done to see how abemaciclib
      may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin,
      dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant
      will complete screening and four study periods in a fixed sequence, with the option to
      continue to receive abemaciclib in a safety extension phase. All participants will complete a
      safety follow-up.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have histological or cytological evidence of a diagnosis of cancer that is advanced
             and/or metastatic

          -  Have adequate organ function

          -  Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale

          -  Have discontinued all previous therapies for cancer (including chemotherapy,
             radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational
             therapy) for at least 21 days for myelosuppressive agents or 14 days for
             nonmyelosuppressive agents prior to receiving study drug and have recovered from the
             acute effects of therapy(treatment related toxicity resolved to baseline), except for
             residual alopecia

        Exclusion Criteria:

          -  Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9,
             CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end
             of Period 2

          -  History or presence of significant bleeding disorders

          -  Have known active uncontrolled or symptomatic CNS metastases

          -  Have a primary liver tumor

          -  Have lymphoma or leukemia
8-Week PK/PD Atorvastatin Study In Children And Adolescents With Heterozygous Familial Hypercholesterolemia
Condition: Pediatric Heterozygous Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Intervention: Atorvastatin; Atorvastatin
Intervention description: 6-10 years Tanner Stage 1 will be administered 5-mg daily dose of an atorvastatin pediatric tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.; 10-17 years Tanner Stage 2 will be administered 10-mg daily dose of atorvastatin tablet formulation. Dose may be doubled if subjects have not attained target LDL (<3.35 mmol/L) after 4-week treatment.
Intervention MeSH terms: Atorvastatin
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: heterozygous familial hypercholesterolemia (HeFH); atorvastatin; pediatric

Summary:

      To evaluate pharmacokinetics, pharmacodynamics, safety and tolerability of atorvastatin in
      children and adolescents with heterozygous familial hypercholesterolemia
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genetically confirmed heterozygous familial hypercholesterolemia (HeFH) with LDL
             greater or equal 4 mmol/L at baseline

        Exclusion Criteria:

          -  Evidence or history of clinically significant diseases, homozygous familial
             hypercholesterolemia (FH)
A Study of LY3050258 in Healthy Participants
Condition: Healthy Volunteers
Intervention: LY3050258; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 63.0
Sex: All
Minimum age: 30 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a multiple dose study of LY3050258 in healthy men and postmenopausal women. This
      study will evaluate the safety and how well the body tolerates LY3050258. It will last
      approximately 14 weeks with a 2 week follow-up appointment after the last treatment with
      study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy males or healthy postmenopausal females, including Japanese participants

          -  Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m^2), inclusive

        Exclusion Criteria:

          -  Abnormal siting blood pressure as determined by the investigator

          -  Abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, places the participant at an unacceptable risk for study participation

          -  Aspartate aminotransferase (AST) or alkaline phosphatase (ALT) greater than 2 times
             the upper limit of normal (ULN)

          -  Skin condition that in the opinion of the investigator makes the participant
             unsuitable for study participation

          -  Current use of statins within the last 3 months prior to dosing

          -  Current use or previous use of anabolic steroids in the preceding 6 months prior to
             dosing

          -  Use of dehydroepiandrosterone, other potential over-the-counter steroidal supplements,
             or other nutritional products intended to have weight-reduction and/or
             performance-enhancing effects within 21 days prior to dosing
Exercise Intervention for Cancer Survivors and Caregivers
Condition: Cancer
Intervention: Survivor-only progressive walking and resistance exercise; Dyadic progressive walking and resistance exercise
Intervention description: Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only; Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to see whether exercise can improve the health and well-being of
      cancer survivors. We also want to know about the health and well being of caregivers.
    

Eligibility criteria:

        Inclusion Criteria for Cancer Survivors:

          -  Have a diagnosis of cancer (any cancer type excluding squamous and basal cell skin
             cancers) and have received surgery, chemotherapy, and/or radiation therapy within the
             last 1-12 months.

          -  Have a functional capacity rating of 70 or greater on the Karnofsky Performance Scale
             or a rating of 1 or 0 on the ECOG scale when assessed by a medical oncologist (or
             physicians designee) following cancer treatments

          -  Have a caregiver willing to participate int he study

          -  Be able to read English

          -  Be 21 years of age or older

          -  Give written informed consent

        Inclusion Criteria for Caregivers:

          -  Be nominated by a cancer survivor

          -  Be able to read English

          -  Be 21 years of age or older

          -  Give written informed consent

        Exclusion Criteria:

          -  have physical limitations (e.g. cardiorespiratory, orthopedic) contraindicating
             participation in a low to moderate intensity home based walking and progressive
             resistance program, as assessed by their medical oncologist, their primary care
             physician, and/or the study medical monitor.

          -  For caregivers, be currently undergoing active treatment for cancer
Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: MMX Mesalamine; MMX Mesalamine; MMX Mesalamine
Intervention description: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.; 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.; 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
Intervention MeSH terms: Mesalamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine
      following administration in children and adolescents with ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Subjects aged 5-17 years, with appropriately obtained informed consent and assent.

          2. Subject has a documented history of ulcerative colitis for at least 3 months.

          3. Subjects who are currently on 5-ASA or product(s) containing or metabolized to
             mesalamine must have been on a stable regimen for at least 4 weeks prior to first dose
             of investigational medicinal product.

          4. Subjects who are not currently on a drug regimen, or on a 5-ASA or product containing
             or metabolized to mesalamine, must have been on a stable regimen for at least 4 weeks
             prior to first dose at least 4 weeks prior first dose of investigational medicinal
             product.

          5. Body weight of 18kg-82kg inclusive.

        Exclusion Criteria:

          1. Current or recurrent disease (eg cardiovascular, renal, liver, malignancy or other
             conditions) that could affect the colon, the action, absorption or disposition of the
             IMP, or clinical or laboratory assessments with the exception of their existing
             ulcerative colitis.

          2. Ulcerative Colitis known to be confined to the rectum (isolated rectal proctitis).

          3. Any history of hepatic impairment or moderate to severe renal impairment.

          4. The use of systemic or rectal steroids within the last 4 weeks, immunomodulators
             within the last 6 weeks, biologics within 6 months, antibiotic use within the last 7
             days prior to the first dose of investigational medicinal product.
Japanese Study of BMS-901608 (Elotuzumab) in Combination With Lenalidomide and Low Dose Dexamethasone
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: BMS-901608 (Elotuzumab) 10 mg; BMS-901608 (Elotuzumab) 20 mg
Intervention description: Injection, Intravenous, 10 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent; Injection, Intravenous, 20 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent
Intervention MeSH terms: Elotuzumab
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the safety and tolerability of Elotuzumab when given
      in combination with Lenalidomide and low-dose Dexamethasone in subjects with relapsed or
      refractory multiple myeloma (MM) in Japan.
    

Eligibility criteria:

        For additional information, please contact the BMS oncology clinical trial information
        service at 855-216-0126 or email MyCancerStudyConnect@emergingmed.com. Please visit
        www.BMSStudyConnect.com for more information on clinical trial participation.

        Inclusion Criteria:

          -  Received between 1 to 4 prior lines of therapy

          -  Measureable disease

          -  Men and women of childbearing potential (WOCBP) must be using two acceptable methods
             of contraception

          -  Men must agree to use a latex condom and a second form of birth control during sexual
             contact with WOCBP and must agree to not donate semen during study drug therapy

          -  Subjects must be willing to refrain from blood donations during study drug therapy

        Exclusion Criteria:

          -  Subjects with non-secretory or oligo-secretory or light-chain only myeloma or
             active/prior plasma cell leukemia or known /suspect POEMS syndrome

          -  Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma
             cell dyscrasia

          -  Unable to take aspirin daily as prophylactic anticoagulation therapy. Prior history of
             inability to tolerate weekly 40 mg dexamethasone

          -  History of renal failure

          -  History of clinical significant thrombosis, such as treatment for thrombosis was
             required
A Study To Examine The Safety, Tolerability And Pharmacokinetics Of PF-02545920 In Psychiatrically Stable Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: PF-02545920; PF-02545920; PF-02545920; Placebo
Intervention description: 15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h; 15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h; 15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h; Placebo Q12h
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Masking: Double (Participant, Investigator)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: PF-02545920; safety; schizophrenia

Summary:

      To evaluate the safety and tolerability of multiple doses of PF 02545920 administered orally
      to psychiatrically stable subjects with schizophrenia receiving background antipsychotic +/-
      other adjunctive medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Psychiatrically stable subjects with schizophrenia.

          -  Evidence of stable schizophrenia symptomatology greater than or equal to 3 months.

          -  Subjects must be on a stable medication treatment regimen greater than or equal to 2
             months, including concomitant psychotropic medications.

        Exclusion Criteria:

          -  History of seizures or of a condition with risk of seizures.

          -  Subjects who have had electroconvulsive therapy within the 6 months prior to
             randomization.

          -  Pregnant or nursing females, and females of child bearing potential.