bioihbjkbjnl/mcl2 huggingface dataset:
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
Condition: Cognitive Disorders; Delirium; Acute Kidney Injury
MeSH terms: Delirium; Acute Kidney Injury; Renal Insufficiency; Postoperative Cognitive Complications; Cognitive Dysfunction; Cognition Disorders
Intervention: Ketamine; Propofol
Intervention description: Ketamine used for induction; Propofol for induction
Intervention MeSH terms: Ketamine; Propofol
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 75 Years
Healthy volunteers: No

Summary:

      Ketamine is a commonly used anesthetic medication which is used for induction of anesthesia
      as well as as an analgesic. It has been shown to have anti-inflammatory properties which may
      decrease post-operative complications following cardiac surgery with cardiopulmonary bypass
      that are thought to associated with inflammation. Some studies have shown that ketamine does
      decrease these complications when compared with anesthetics that are not commonly used in our
      cardiac anesthesiology practice. Propofol is another commonly used anesthetic medication
      which is used for induction of anesthesia. Ketamine has not been compared with propofol for
      potential to reduce post-operative complications associated with the inflammatory process.
      This study aims to see if ketamine will reduce the incidence of cognitive dysfunction,
      delirium, and renal dysfunction in comparison with propofol. In addition, the hemodynamic
      impact of ketamine compared propofol will be investigated.
    

Eligibility criteria:

        Scheduled to undergo cardiac surgery.

        Inclusion criteria:

          -  age greater than or equal to 75 years presenting for cardiac surgery at the Mayo
             Clinic in Rochester, Minnesota;

          -  schedule to undergo complex cardiac surgery. Complex cardiac surgery will be defined
             as surgery involving more than one heart valve, redo-sternotomy procedures, or
             combined valvular and CABG procedures.

        Exclusion criteria will include:

          -  left or right ventricular assist device implantation or explantation,

          -  procedures not requiring cardiopulmonary bypass,

          -  active infection or sepsis, severe hepatic disease or ascites,

          -  pre-operative renal dysfunction including a baseline creatinine equal to or greater
             than 1.5 mg/dL or requiring dialysis,

          -  immunosuppressive medication use (including steroid use),

          -  immunodeficiency syndrome,

          -  known neurologic or psychiatric disorder, or

          -  use of drugs for psychosis.
A Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of APP13007 to Treat Inflammation and Pain After Cataract Surgery
Condition: Ocular Inflammation and Pain After Cataract Surgery
MeSH terms: Cataract; Capsule Opacification; Inflammation
Intervention: APP13007, 0.05%; APP13007, 0.1%; APP13007 Placebo, 0.05%; APP13007 Placebo, 0.1%
Intervention description: APP13007 eye drop, 0.05%; APP13007 eye drop, 0.1%; APP13007 placebo eyedrop, 0.05%; APP13007 placebo eyedrop, 0.1%
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 165.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      This is a Phase 2a, 2-part study (designated Parts A and B) that will evaluate APP13007 dose
      strength and dosing frequency in a randomized double-masked fashion for comparison to the
      respective matching vehicle placebo. Part A will be conducted first to evaluate 0.05%
      APP13007 and matching vehicle placebo in an approximate 1:1 ratio in approximately 42
      subjects who experience postoperative inflammation on the first day following routine,
      uncomplicated, cataract surgery and who meet all eligibility criteria. Based on the results
      of Part A, Part B of the study may be open for enrollment to evaluate 0.05% and/or 0.1%
      APP13007 at various dosing frequency in approximately 84 subjects, also in an approximate 1:1
      ratio, active vs. placebo. In each Part, subjects will return periodically for study
      assessments during the treatment period and then for a follow-up visit approximately 1 week
      after stopping the study drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Expected to undergo unilateral uncomplicated cataract extraction via
             phacoemulsification and posterior chamber intraocular lens implantation in one eye.

          -  In Investigator's opinion, have Early Treatment Diabetic Retinopathy Study estimated
             potential of 0.7 (20/100) or better in study eye.

          -  Have > 10 and ≤ 30 cells in anterior chamber.

          -  Have an intraocular pressure ≤ 30 mmHg.

        Exclusion Criteria:

          -  Have an anterior chamber cell count > 0 or any evidence of intraocular inflammation.

          -  Have a score > 0 on Ocular Pain Assessment in either eye.
Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Intervention: nesiritide; milrinone; placebo
Intervention description: Nesiritide bolus 2 mcg/kg on CPB, then infusion of 0.015 mcg/kg/min. infusion dose may be adjusted; Milrinone 50 mcg/kg bolus on CPB, the infusion of 0.5 mcg/kg/min. Infusion rate may be adjusted; Placebo bolus on CPB, then placebo infusion
Intervention MeSH terms: Milrinone; Natriuretic Peptide, Brain
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 106.0
Sex: All
Healthy volunteers: No
Keywords: Fontan Operation; Cardiopulmonary Bypass; Heart Defects, Congenital; Milrinone; Natriuretic peptide, brain

Summary:

      The staged surgical pathway to treat children with single ventricle heart defects culminates
      with the Fontan operation. In this procedure, systemic venous return is rerouted directly to
      the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.
      Although mortality following the Fontan operation is now uncommon, early postoperative
      morbidity including prolonged postoperative chest tube drainage and hospitalization remains
      significant. The efficacy of empiric inotropic, vasodilator and neurohumoral-inhibitory
      therapies in the perioperative period is unknown and practice varies widely between centers.

      The investigators will propose a single-center, randomized, double-blind, phase II clinical
      trial in children undergoing Fontan surgery. The investigators plan to compare the effects of
      perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical
      course and neurohumoral profile. The investigators hypothesize that, when compared to the
      milrinone and placebo groups, the nesiritide group will have more days alive and out of the
      hospital within the first 30 days after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients undergoing an elective, primary Fontan operation at Children's Hospital
             Boston.

        Exclusion Criteria:

          -  Revision surgery for failing Fontan circulation.

          -  Preoperative serum creatinine > 1.5 mg/dL or chronic dialysis.

          -  The attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a
             compelling indication to initiate either nesiritide or milrinone outside of the
             confines of the study.
Safety and Tolerability of Intravenous Dose of MEDI-546 in Japanese Subjects With Systemic Lupus Erythematosus.
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Intervention: MEDI-546; MEDI-546; MEDI-546
Intervention description: Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks; Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Japan; Phase2; Safety; Tolerability; Systemic Lupus Erythematosus; SLE, MEDI-546

Summary:

      The purpose of this study is to assess safety, tolerability, pharmacokinetics and
      pharmacodynamics of MEDI-546 in Japanese SLE patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Fulfils at least 4 of the 11 American College of Rheumatology (ACR) classification
             criteria for SLE.

          -  Weight greater than or equal to 40.0 kg.

          -  Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing
             treatment or observation for ≥ 24 weeks prior to screening.

          -  Currently receiving stable dose of oral prednisone and/or
             antimalarials/immunosuppressives.

          -  Active moderate to severe SLE disease based on SLE disease activity score.

        Exclusion Criteria:

          -  Active severe or unstable neuropsychiatric SLE.

          -  Active severe SLE-driven renal disease or unstable renal disease.

          -  Clinically significant active infection including ongoing and chronic infections.

          -  Known history of a primary immunodeficiency or an underlying condition such as human
             immunodeficiency virus infection or splenectomy that predisposes the subject to
             infection.

          -  Confirmed positive tests for hepatitis B or positive test for hepatitis C.
Cilostazol for HFpEF
Condition: Heart Failure With Preserved Ejection Fraction
MeSH terms: Heart Failure
Intervention: Cilostazol 100Mg Tab; Placebo
Intervention description: Cilostazol Twice a Day; Placebo
Intervention MeSH terms: Cilostazol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: n-of-1 design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Determine if cilostazol improves symptoms and NTproBNP levels (heart failure blood marker) in
      heart failure with preserved ejection fraction (HFpEF) - a prevalent syndrome without
      targeted evidence-based treatment.

      This will be assessed in a prospective 1-month single blinded study with 2 cross-overs n-of-1
      study design with placebo and cilostazol
    

Eligibility criteria:

        Inclusion Criteria:

          -  >18 yrs

          -  LVEF ≥ 50% (on last assessment, <2 years)

          -  Diagnosis of HFpEF or Shortness of breath with NYHA Class ≥ 2 and one of the
             following:

               1. pulmonary edema on chest imaging or documented on exam or on loop diuretics

               2. NTproBNP >400 ng/ml in the last 24 months

               3. HFpEF>50% hospitalization in the last 3 years

               4. Qualitative echo: > mild diastolic dysfunction on echo report and > mild left
                  ventricular hypertrophy and left atrial dilation or quantitative echo: left
                  ventricular hypertrophy [men ≥115 g/m², women ≥95 g/m² or relative wall thickness
                  >0.42 or any LV wall thickness >1.2cm and has LA dilation (>28ml/m2)

        Exclusion Criteria:

          -  <18yo

          -  resting heart rate >100/min

          -  patients with LVEF <50%

          -  advanced end-stage heart failure,

          -  symptomatic COPD on home O2,

          -  uncontrolled severe HTN (SBP >160/100 mmHg)

          -  patients with life expectancy <6 months,

          -  end-stage liver cirrhosis,

          -  more than moderate valve disease,

          -  infiltrative myocardial disease

          -  constrictive pericarditis or myocarditis,

          -  patients unable to participate in follow up,

          -  pregnant patients or patients without reliable contraceptive agent for the duration of
             study participation),

          -  left ventricular outflow tract obstruction,

          -  bleeding dyscrasias, blood dyscrasias,

          -  Patients on oral ketoconazole, itraconazole, fluconazole, miconazole, fluvoxamine,
             fluoxetine, nefazodone, sertraline, erythromycin, clarithromycin or azithromycin
Open-Label Study to Evaluate Safety and Efficacy of CCX168 in Subjects With IGA Nephropathy on Stable RAAS Blockade
Condition: Immunoglobulin A Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, IGA
Intervention: CCX168
Intervention description: CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary safety objective of this study is to evaluate the safety and tolerability of
      CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose
      of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based
      on an improvement in proteinuria.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of Immunoglobulin A nephropathy

          -  estimated glomerular filtration rate >60 mL/min/1.73 m2

          -  Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine)

        Key Exclusion Criteria:

          -  Severe renal disease

          -  Pregnant or nursing

          -  Proteinuria >8g/g creatinine or >8g/day

          -  Systemic manifestations of Henoch-Schonlein purpura within 2 years prior

          -  Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease

          -  Biopsy reported severe crescentic Immunoglobulin A nephropathy

          -  History of treatment with glucocorticoids, cyclophosphamide, azathioprine,
             mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior

          -  History of clinically significant cardiac conditions

          -  History of cancer within 5 years prior

          -  Any infection requiring antibiotic treatment that has not cleared prior to study start
Efficacy, Safety and Pharmacokinetics of Sugammadex (Org 25969; MK-8616) at 3 Different Time Points After 0.6 mg/kg Esmeron® in Male Participants (P05940; MK-8616-020).
Condition: Neuromuscular Blockade
Intervention: Placebo; Sugammadex; Esmeron®
Intervention description: 0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).; Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.; Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
Intervention MeSH terms: Bromides; Rocuronium
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 99.0
Sex: Male
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No

Summary:

      This study investigates the efficacy, safety, and pharmacokinetics of sugammadex (Org 25969;
      MK-8616) when administered for the reversal of neuromuscular blockade in male participants
      receiving surgery, classified as American Society of Anesthesiologists (ASA) class 1
      (otherwise normal, healthy participant) to class 2 (participant with mild systemic disease).
      The primary objective of this study is to explore the dose-response relation of sugammadex
      given as a reversal agent at 3, 5, or 15 minutes following administration of 0.6 mg/kg
      Esmeron®.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants of ASA class 1 to 2.

          -  Participants scheduled for surgical procedures with an anticipated duration of
             anesthesia of at least 75 minutes, without further need for muscle relaxation other
             than for intubation.

        Exclusion Criteria:

          -  Participants in whom a difficult intubation because of anatomical malformations is
             expected.

          -  Participants known or suspected to have neuromuscular disorders and/or significant
             hepatic or renal dysfunction.

          -  Participants known or suspected to have a (family) history of malignant hyperthermia.

          -  Participants known or suspected to have an allergy to narcotics, muscle relaxants or
             other medication used during general anesthesia.

          -  Participants receiving medication known to interfere with neuromuscular blocking
             agents such as anticonvulsants, aminoglycosides, and Mg^2+.

          -  Participants who have already participated in this trial.

          -  Participants who have participated in another clinical trial, not pre-approved by NV
             Organon, within 30 days of entering into this trial.
A Study to Evaluate ABT-494 (Upadacitinib) in Adults With Moderate to Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Upadacitinib; Placebo
Intervention description: Tablet for oral use; Tablet
Intervention MeSH terms: Upadacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ABT-494; Atopic Dermatitis

Summary:

      The objective of this study was to evaluate the safety and efficacy of multiple doses of
      upadacitinib monotherapy versus placebo in the treatment of adults with moderate to severe
      atopic dermatitis (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Atopic dermatitis with a diagnosis confirmed by a dermatologist (according to the
             Hanifin and Rajka criteria) and onset of symptoms at least 1 year prior to Baseline.

          -  Moderate to severe atopic dermatitis defined by an Eczema Area and Severity Index
             (EASI) ≥ 16, body surface area (BSA) ≥ 10% and an Investigators Global Assessment
             (IGA) score ≥ 3 at the Baseline visit.

          -  Documented history (within 1 year prior to the screening visit) of inadequate response
             to treatment with topical corticosteroids (TCS), or topical calcineurin inhibitors
             (TCI), or for whom topical treatments are otherwise medically inadvisable (e.g.,
             because of important side effects or safety risks).

          -  Twice daily use of an additive-free, bland emollient for at least 7 days prior to
             Baseline.

        Exclusion Criteria:

          -  Prior exposure to any systemic or topical Janus kinase (JAK) inhibitor (including but
             not limited to tofacitinib, baricitinib, ruxolitinib, and filgotinib).

          -  Treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI),
             prescription moisturizers or moisturizers containing additives such as ceramide,
             hyaluronic acid, urea, or filaggrin within 10 days prior to the Baseline visit.

          -  Prior exposure to dupilumab or exposure to systemic therapies for AD including
             corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4
             (PDE4)-inhibitors and mycophenolate mofetil within 4 weeks prior to Baseline.

          -  Prior exposure to any investigational systemic treatment within 30 days or 5
             half-lives (whichever is longer) of the Baseline visit or is currently enrolled in
             another clinical study.
P2 Multi-center Study of SB204 Gel in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: SB204 2%; SB204 4%; Vehicle Gel
Intervention description: Applied topically twice daily; Applied topically daily; Applied topically twice and once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 213.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: acne

Summary:

      This is a randomized, multi-center, double-blinded study in subjects with moderate to severe
      acne vulgaris. Subjects eligible to enroll will be treated once or twice daily with 2
      concentrations of a topical drug in development or a vehicle. Subjects will be treated for up
      to 12 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Moderate to severe acne

          -  25-70 non-inflammatory lesions at Baseline

          -  20-40 inflammatory lesions at Baseline

        Exclusion Criteria:

          -  Subjects with known allergy to any component of the test material or vehicle

          -  Women who are pregnant or nursing
Contezolid Acefosamil Versus Linezolid for the Treatment of Acute Bacterial Skin and Skin Structure Infection
Condition: Skin Diseases, Bacterial; Gram-Positive Bacterial Infections
MeSH terms: Infections; Communicable Diseases; Bacterial Infections; Skin Diseases, Bacterial; Gram-Positive Bacterial Infections; Skin Diseases
Intervention: contezolid acefosamil; linezolid 600 mg
Intervention description: IV and oral contezolid acefosamil given twice a day for 10 to 14 days; IV and oral linezolid given twice a day for 10 to 14 days
Intervention MeSH terms: Linezolid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ABSSSI; Acute bacterial skin and skin structure infection

Summary:

      The purpose of this study is to determine whether contezolid acefosamil is as safe and
      effective as linezolid in the treatment of adult patients with acute bacterial skin and skin
      structure infections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with systemic signs of infection diagnosed with acute bacterial skin and skin
             structure infection (ABSSSI)

          -  Diagnosed with cellulitis/erysipelas, major cutaneous abscess, or wound infections

        Exclusion Criteria:

          -  Uncomplicated skin infections

          -  Severe sepsis or septic shock

          -  ABSSSI solely due to Gram-negative pathogens

          -  Prior systemic antibiotics within 96 hours of randomization