bioihbjkbjnl/mcl2 huggingface dataset:
Phase I Study of MK-0683 in Combination With Bortezomib in Participants With Multiple Myeloma (MK-0683-098)
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Vorinostat; Bortezomib
Intervention description: Vorinostat (MK-0683) three or four 100 mg capsules taken by mouth with food.; Bortezomib (1.0 or 1.3 mg/m^2) intravenous infusion.
Intervention MeSH terms: Bortezomib; Vorinostat
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary purpose of this clinical study is to determine the recommended clinical doses of
      vorinostat (MK-0683) and bortezomib administered in combination to participants with relapsed
      and/or refractory multiple myeloma (MM). It was hypothesized that administration of
      vorinostat in combination with bortezomib is sufficiently safe and tolerated well enough to
      permit further study in participants with relapsed and/or refractory MM. Study results are
      based on data collected up to the data cut-off date of 20-March-2011.
    

Eligibility criteria:

        Inclusion Criteria:

          -  is ≥20 years of age.

          -  has an established diagnosis of MM based on the myeloma diagnostic criteria

          -  has received at least 1 but not more than 3 prior anti-myeloma regimens and has
             progressive disease after the most recent treatment regimen

          -  has adequate organ function

        Exclusion Criteria:

          -  has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone
             marrow transplantation during the study

          -  has known hypersensitivity to any components of vorinostat or bortezomib

          -  has active hepatitis B or C, plasma cell leukemia, or is human immunodeficiency virus
             (HIV) positive

          -  has had prior treatment with vorinostat or histone deacetylase (HDAC) inhibitors
High Dose Vitamin C in Cardiac Surgery Patients
Condition: Disorder of Vitamin C; Atrial Fibrillation; Complications Due to Coronary Artery Bypass Graft; Heart Valve Disease
MeSH terms: Atrial Fibrillation; Heart Valve Diseases
Intervention: Ascorbic Acid; Placebo
Intervention description: Comparing safety and efficacy of IV Vitamin C in CABG patients; Placebo intervention
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Vitamin C; Coronary Artery Bypass Grafting; Atrial Fibrillation; Cardiac Valve Repair

Summary:

      Coronary artery bypass grafting (CABG) is the most common procedure performed by cardiac
      surgeons. Post-operative atrial fibrillation (AF) is the most common adverse event following
      CABG, experienced in 20-50% of patients; the highest incidence of AF occurs by the third
      post-operative day. Reduction of AF by various drugs is moderately effective, but involves
      either rate control with beta blockers or rate conversion with amiodarone after the
      myocardial damage processes initiating AF have already occurred. Decreasing the incidence of
      post-operative AF, and hence the morbidity and mortality of high-risk CABG patients, could be
      more fruitfully approached by targeting the upstream combined processes of inflammation and
      coagulation activation induced by the surgical insult and associated ischemia-reperfusion
      (I/R). We propose that cell damage induced by oxidative stress and I/R injury could be
      prevented and/or inhibited by antioxidant supplementation. Specifically the investigators
      hypothesize that high-dose intravenous (IV) vitamin C supplementation will ameliorate ROS and
      therefore damp down upstream inflammatory processes, leading to a reduction of downstream
      adverse events with demonstrable links to inflammation processes, such as AF.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Scheduled for elective non-emergent valve repair or replacement, or multi-vessel CABG
             surgery

          -  No known coagulopathy prior to surgery

        Exclusion Criteria:

          -  Emergency cardiac surgery

          -  Ejection fraction < 35%

          -  Presence of autoimmune disease or currently receiving immunosuppressant therapy

          -  History of renal calculi

          -  Renal dysfunction (pre-operative creatinine clearance < 40 mL/min, or serum creatinine
             greater than 1.8 mg/dl)

          -  Known bleeding diathesis

          -  Active infection, cancer or tumor

          -  Prior history of atrial fibrillation

          -  Single CABG procedure (one involved coronary vessel)

          -  Prisoner

          -  Pregnant
Evaluation of Safety and Tolerability of Single Rising Doses of BI 473494 in Healthy Subjects
Condition: Healthy
Intervention: BI 473494; Placebo
Intervention description: Solution for injection; Solution for injection
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 16.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this trial is to investigate the safety and tolerability of single
      rising doses of BI 473494 in healthy male subjects.

      The secondary objective is the exploration of PK including dose proportionality, and PD of BI
      473494 after single dosing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male subjects according to the assessment of the investigator, based on a
             complete medical history including a physical examination, vital signs (Blood Pressure
             [BP], Pulse Rate [PR]), 12-lead Electrocardiogram [ECG], and clinical laboratory tests

          -  Age of 18 to 45 years (incl.)

          -  Body Mass Index [BMI] of 20.0 to 29.9 kg/m2 (incl.)

          -  Signed and dated written informed consent prior to admission to the study in
             accordance with Good Clinical Practice [GCP] and local legislation

        Exclusion Criteria:

          -  Any finding in the medical examination (including Blood Pressure [BP], Pulse Rate [PR]
             or Electrocardiogram [ECG]) is deviating from normal and judged as clinically relevant
             by the investigator

          -  Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg,
             diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the
             range of 50 to 90 bpm

          -  Any laboratory value outside the reference range that the investigator considers to be
             of clinical relevance

          -  Any evidence of a concomitant disease judged as clinically relevant by the
             investigator

          -  Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic,
             immunological or hormonal disorders

          -  Use of drugs within 30 days prior to administration of trial medication if that might
             reasonably influence the results of the trial (incl. QT/QTc interval prolongation)

          -  Diseases of the central nervous system (including but not limited to any kind of
             seizures or stroke), and other relevant neurological or psychiatric disorders

          -  Further exclusion criteria apply
Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment
Condition: Hepatitis C Virus
MeSH terms: Hepatitis C
Intervention: Velpatasvir
Intervention description: Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
Intervention MeSH terms: Velpatasvir
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 79 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of
      velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched
      healthy participants as a control group.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  General good health with stable chronic kidney disease in Severe Renal Impairment
             Group

          -  Screening labs within defined thresholds

          -  Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90
             mL/min for Normal Renal Function group

        Key Exclusion Criteria:

          -  Females who are pregnant or nursing, or males who have a pregnant partner

          -  Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV

          -  History of clinically significant illness (including psychiatric or cardiac) or any
             other medical disorder that may interfere with participant treatment and/or adherence
             to the protocol

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Ketamine for Relapse Prevention in Recurrent Depressive Disorder
Condition: Depression; Relapse; Recurrent Depressive Disorder; Major Depressive Disorder
MeSH terms: Recurrence; Depression; Depressive Disorder; Depressive Disorder, Major
Intervention: Ketamine; Midazolam
Intervention description: A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.; A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
Intervention MeSH terms: Midazolam; Ketamine
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A randomised, double-blind, placebo-controlled study designed to assess feasibility of recruitment, randomisation and retention.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking took place by sealed envelope random allocation and double blinding of participants and raters was assessed throughout. The anaesthesiologist administering infusions was aware of the allocation.
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ketamine; glutamate; relapse prevention

Summary:

      Randomised, controlled, parallel-group, pilot clinical trial of ketamine vs. midazolam for
      depression relapse prevention in persons at high risk. The main purpose of the pilot study is
      to assess trial processes to help inform a future definitive trial.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥18 years old

          -  Hamilton Rating Scale for Depression, 24-item (HRSD-24) score of ≥21

          -  Voluntary admission for treatment of acute depressive episode

          -  Meet DSM-IV criteria for recurrent depressive disorder (RDD): ≥2 previous depressive
             episodes with at least 2-months(consecutive) subthreshold or no symptoms in between
             PLUS(to enrich the sample for those at high risk for relapse) must also have
             experienced ≥3 major depressive episodes(including index episode) within the previous
             2 years

        For the randomised pilot trial, RDD patients must have:

          -  received antidepressant treatment for the acute depressive episode(pharmacological,
             psychotherapeutic or multidisciplinary)

          -  ≥60% decrease from baseline HRSD-24 score and score ≤16

          -  Standardised Mini-Mental State Examination (sMMSE) score of ≥24

          -  able to provide informed consent

        Exclusion Criteria:

          -  Current involuntary admission

          -  Medical condition rendering unfit for ketamine/midazolam

          -  Active suicidal intention

          -  Dementia

          -  History of Axis 1 diagnosis other than RDD

          -  Electroconvulsive therapy (ECT) for treatment of current depressive episode

          -  Alcohol/substance abuse in previous six months

          -  Pregnancy or inability to confirm use of adequate contraception during the trial
A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Condition: Moderate Hepatic Impairment; Normal Hepatic Function
MeSH terms: Liver Diseases
Intervention: Rivipansel
Intervention description: A single dose of IV Rivipansel over 20 minutes
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Hepatic Impairment; Rivipansel

Summary:

      The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK
      and safety.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female subjects of non-childbearing potential or male subjects

               -  Body Mass Index (BMI) of 17.5 to 40.0 kg/m2

               -  Normal Hepatic function for the healthy subjects

               -  Stable Hepatic Impairment for the subjects with moderate hepatic impairment

        Exclusion Criteria:

          -  Treatment with an investigational drug within 30 days of the dose of study medication

          -  Pregnant females, breastfeeding female subjects and male subjects with partners
             currently pregnant

          -  Use of herbal supplements in the 28 days prior to the dose of study medication

          -  Blood donation (excluding plasma donation) of approximately 1 pint or more within 56
             days prior to study medication

          -  A positive urine drug screen for illicit drugs
Double-Blinded, Placebo-Controlled Phase 1b Study for Safety, PK, Efficacy, PD of RO7049665 in Participants With Ulcerative Colitis (UC)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: RO7049665; Placebo
Intervention description: Multiple ascending doses of RO7049665 will be administered SC.; Matching placebo will be administered SC.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The principal aim of this study is to evaluate the safety and tolerability of RO7049665 in
      participants with active ulcerative colitis (UC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with UC for at least 12 weeks prior to screening

          -  Screening colonoscopy for colorectal cancer conducted within the prior two years if a
             history of pancolitis with disease duration ≥ 8 years or history of left-sided colitis
             and disease duration ≥12 years

          -  Evidence of disease activity at time of screening

          -  Insufficient clinical response to standard of care (SOC) therapy or intolerance to SOC

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease or indeterminate colitis

          -  History of infection with hepatitis B, human immunodeficiency virus (HIV), active
             hepatitis C virus (HCV) infection, or other chronic infection

          -  Active infections requiring systemic therapy with antibiotic, antiviral or antifungal
             or febrile illness within 7 days before Day -1

          -  History of primary or acquired immunodeficiency

          -  Abnormal hematologic values

          -  Abnormal hepatic enzyme or hepatic function values
Safety and Pharmacokinetics of Intravenous and Oral Posaconazole in Immunocompromised Children (MK-5592-097)
Condition: Neutropenia
MeSH terms: Neutropenia
Intervention: Posaconazole IV solution; Posaconazole powder for oral suspension
Intervention description: Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10.; Posaconazole once daily by PFS for a minimum of 10 days
Intervention MeSH terms: Posaconazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      This study aims to evaluate the pharmacokinetics of posaconazole (POS) administered
      intravenously (IV) or orally to immunocompromised pediatric participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have documented or anticipated neutropenia expected to last for at least 7 days,
             following treatment in at least one of the following clinical situations: acute
             leukemia, myelodysplasia, severe aplastic anemia, recipients of Autologous
             Hematopoietic Stem Cell Transplant (HSCT), high risk neuroblastoma, advanced stage
             non-Hodgkin's lymphoma, hemophagocytic lymphohistiocytosis

          -  Have a central line in place prior to IV study therapy

          -  Participants of reproductive potential agree to remain abstinent, or use a medically
             accepted method of birth control

        Exclusion Criteria:

          -  Has a proven or probable invasive fungal infection

          -  Has received any formulation of POS within prior 10 days

          -  Is receiving any prohibited drugs

          -  Has laboratory results that are outside of normal limits at screening, as follows: a)
             Moderate or severe liver dysfunction, as defined as: Aspartate Aminotransferase (AST)
             > 5 times the upper limit of normal (ULN), OR Alanine Aminotransferase (ALT) > 5 times
             the ULN, OR Serum total bilirubin >2.5 times the ULN, OR AST or ALT > 3 times ULN with
             total bilirubin > 2 times ULN; b) Calculated creatinine clearance <30 mL/min.

          -  Has QTc (QT interval corrected for rate) prolongation defined as: a) Symptomatic QTc
             prolongation >450 msec (males) or >470 msec (females) OR b) Any QTc prolongation of
             >500 msec

          -  Is pregnant, intends to become pregnant during study, or is breastfeeding

          -  Has a history of anaphylaxis attributed to the azole class of antifungal agents

          -  Is not expected to receive a minimum of 10 days of POS IV solution

          -  Has participated in any Phase 1 Investigational New Drug (IND) study within prior 30
             days or expects to do so within the following 60 days

          -  Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling or
             child) who is investigational site or sponsor staff directly involved with this trial
Pharmacokinetics of Entospletinib in Adults With Normal and Impaired Liver Function
Condition: Oncology
MeSH terms: Neoplasms
Intervention: Entospletinib
Intervention description: Entospletinib 100 mg tablet administered orally
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The primary objective of this study is to evaluate the pharmacokinetics of entospletinib
      (ENTO) and/or its metabolites (if applicable) in participants with impaired hepatic function
      (stratified by smoking status, as appropriate) relative to matched, healthy controls.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Calculated body mass index from 18 to 40 kg/m^2

          -  Not pregnant

          -  Normal electrocardiogram

          -  Participants with impaired liver function must be sufficiently healthy based upon
             medical history and physical examination, vital signs, and screening laboratory
             evaluations.

        Key Exclusion Criteria:

          -  Participation in another clinical study (current or within last 30 days)

          -  HIV, hepatitis B virus, or active hepatitis C virus infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 1 Study in Subjects With Relapsed or Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: AMG 224
Intervention description: Administered as an IV infusion.
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multiple Myeloma; Relapsed Multiple Myeloma; Refractory Multiple Myeloma

Summary:

      This is a first in human phase 1 multicenter open label study in subjects with relapsed or
      refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        - Pathologically documented,multiple myeloma relapsed or refractory progressive disease
        after at least 3 lines of therapy for multiple myeloma.

        Prior therapeutic treatment or regimens must include proteasome inhibitors (e.g.
        bortezomib) and immunomodulatory drugs (e.g. lenalidomide).

          -  Willing and able to undergo bone marrow aspirate per protocol (with or without bone
             marrow biopsy per institutional guidelines).

          -  Measurable disease per the International Myeloma Working Group (IMWG) response
             criteria

          -  Hematological function, as follows, without transfusion support:

          -  Absolute neutrophil count ≥ 1.0 X 10^9/L,

          -  Platelet count ≥ 75 X 10^9/L (in patients with < 50% of bone marrow nucleated cells
             were plasma cells) or ≥ 50 X 10^9/L (in patients with ≥ 50% of bone marrow nucleated
             cells were plasma cells) without transfusion or growth factor support

          -  Hemoglobin > 8 g/dL (> 80 g/L)

          -  Adequate renal and hepatic function

          -  Left ventricular ejection fraction (LVEF) > 50%

        Exclusion Criteria:

          -  Currently receiving treatment in another investigational device or drug study, or less
             than 28 days since ending treatment on another investigational device or drug study

          -  Autologous stem cell transplant less than 90 days prior to study day 1

          -  Multiple myeloma with IgM subtype

          -  POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin
             changes) syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or
             Amyloidosis

          -  Glucocorticoid therapy (prednisone > 30 mg/day or equivalent) within 7 days prior to
             study day

          -  Myocardial infarction within 6 months of study day 1, symptomatic congestive heart
             failure (New York Heart Association > class II)

          -  A baseline ECG QTcF > 470 msec

          -  Anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy, or
             investigational agent) within 28 days prior to study day 1