louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00040092: A Study to Test the Effectiveness of Virulizin® Given in Combination With Standard Chemotherapy for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pancreatic Cancer
Keywords: Virulizin
Immunotherapy
Pancreas
Pancreatic Cancer
clinical trial
Lead sponsor: Aptose Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2002-06-20
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Virulizin is an immunotherapy drug preparation that is thought to stimulate the patient's immune system, which in turn may slow the growth of tumors. It is presented in vials as a sterile preparation for IM injection. The purpose of the trial is to investigate if Virulizin in combination with gemcitabine provides better efficacy than gemcitabine alone (with placebo) against pancreatic cancer.Virulizin® efficacy will continue to be assessed if chemotherapy is changed to 5-Fluorouracil.

Detailed description: A Phase III, Double-blind, Multicenter, Randomized Study in Chemonaive Patients with Locally Advanced or Metastatic Pancreatic Cancer to Compare a Combination Therapy of Virulizin® plus Gemcitabine versus Placebo plus Gemcitabine; Optional Secondline Therapy may Include Continuation of Virulizin® or Placebo, Alone or in Combination with 5-Fluorouracil.

Patients who have not received any prior chemotherapy will be randomized to receive Gemcitabine plus Virulizin® versus Gemcitabine plus placebo in a double blind fashion. On disease progression patients may be switched to 5-Fluorouracil and continue to receive Virulizin® or placebo. Patients may continue Virulizin® alone, if clinically indicated when 5-Fluorouracil is discontinued.

Eligibility criteria: * Patients with advanced (unresectable or metastatic) pancreatic adenocarcinoma (TNM stages II, III or IV)
* No previous systemic chemotherapy(unless given as a radiosensitizer).
* ECOG Performance Status 0-2
* Life expectancy equal to or greater than 12 weeks
* Adequate laboratory and organ functions
* Stabilizable pain (stable analgesic intake)
* No radiotherapy during 4 weeks prior to trial entry
* No evidence of ascites, pleural effusion or third space fluid accumulation
* Not currently using, and have not used in 4 weeks prior to entering trial, systemic steroids or hormonal therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ferdinandi ES, Braun DP, Liu C, Zee BC, Ely G. Virulizin(R) - A review of its antineoplastic activity. Expert Opin Investig Drugs. 1999 Oct;8(10):1721-1735. doi: 10.1517/13543784.8.10.1721.
citation: Liu C, Ferdinandi ES, Ely G, Joshi SS. Virulizin-2gamma, a novel immunotherapeutic agent, in treatment of human pancreatic cancer xenografts. Int J Oncol. 2000 May;16(5):1015-20. doi: 10.3892/ijo.16.5.1015.
citation: Warner E, Weinroth J, Chang S, MacDonald M, Strauss B. Phase II trial of Virulizin in patients with pancreatic cancer. Clin Invest Med. 1994 Feb;17(1):37-41.
Clinical trial NCT03816592: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypass
Official title: Opioid Free Anaesthesia in Cardiac Surgery With Cardiopulmonary Bypas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid Free Anaesthesia
Opioid Anaesthesia
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac surgical

Brief summary: Since the 1990s, the concept of anesthesia without morphine (OFA) has been developed. The principle is based on the fact that in a sleeping patient a sympathetic reaction marked by hemodynamic changes does not reflect a painful phenomenon, that a painful phenomenon in a sleeping patient is not memorized, that hormonal stress, sympathetic reaction and inflammatory reaction can be controlled by therapeutic classes other than a morphine agent. This therapeutic management would avoid the side effects associated with the use of morphine. In cardiac surgery, no studies have evaluated the effect of an OFA on morphine consumption and on a post-operative composite endpoint. Lidocaine was only studied in the context of cardioprotection and neuroprotection. Studies found a cardioprotective effect with a decrease in episodes of rhythmic disorders, and neuroprotective with a non-constant improvement in postoperative cognitive functions, but all these studies were performed during opioid anaesthesia (opioid agent use)/ The purpose of our study is to demonstrate that general anesthesia without opioid (OFA) is associated with a decrease in post-operative morphine consumption and an improvement in the patient's post-operative well-being (complications, confusion, vigilance, length of stay).


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* cardiac surgery with cardiopulmonary bypass

Exclusion Criteria:

* patient with chronic analgesia treatment
* patient on antidepressive therapy
* gabapentin use
* preoperative cognitive dysfunction
* patient treated with zyvoxid

Primary outcomes:
measure: Morphine consumption
timeFrame: Day 2
measure: Complications
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
citation: Guinot PG, Spitz A, Berthoud V, Ellouze O, Missaoui A, Constandache T, Grosjean S, Radhouani M, Anciaux JB, Parthiot JP, Merle JP, Nowobilski N, Nguyen M, Bouhemad B. Effect of opioid-free anaesthesia on post-operative period in cardiac surgery: a retrospective matched case-control study. BMC Anesthesiol. 2019 Jul 31;19(1):136. doi: 10.1186/s12871-019-0802-y.
Clinical trial NCT05327192: VVC Sampling Study for Analysis Validation
Official title: Collection of Samples From Women Diagnosed With Vulvovaginal Candidiasis for Validation of Vaginal Microbiome Analysis Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vulvovaginal Candidiasis
Lead sponsor: Gedea Biotech AB
Sponsor class: INDUSTRY
First posted: 2022-04-14
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.

Brief summary: This is a biomarker multi-centre study to validate an extraction method of fungal and bacterial DNA extracted from vaginal swabs from adult women with confirmed VVC.

The study population will consist of post-menarchal, pre-menopausal females, 18 years or older, seeking care for VVC symptoms.

Vaginal samples will be examined under a microscope for yeast forms (hyphae or pseudohyphae) or budding yeast. If the Investigator assesses that the patient has VVC, based on examination and the potassium hydroxide (KOH) test, two vaginal secretion samples will be collected by a vaginal swab. One sample will be cultured to verify the presence of Candida and the other will be used for sequencing analysis of the vaginal microbiome.

Samples from a total of 10 women are planned to be taken.


Eligibility criteria: Inclusion Criteria:

1. Adult women aged 18 years or older
2. Diagnosis of VVC, defined as having a white or creamy vaginal discharge plus the following findings:

   1. At least 2 of the following signs and symptoms of VVC that are characterized as at least moderate: itching, burning, irritation, edema, redness, or excoriation.
   2. Potassium hydroxide (KOH) or saline preparation from the inflamed vaginal mucosa or secretions revealing yeast forms (hyphae or pseudohyphae) or budding yeasts.
3. Having decisional capacity and providing written informed consent
4. Signed informed consent and willing and able to comply with all study requirements

Exclusion Criteria:

None

Primary outcomes:
measure: Correlation between vaginal sample DNA sequencing and VVC confirmed by clinical diagnosis and culture.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
measure: Evaluate resolution of bacterial DNA sequencing using 16S regions.
timeFrame: 1 day
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Slough
country: United Kingdom
facility: Research and Development Department, Berkshire Healthcare NHS Foundation Trust
Study officials:
References:
Clinical trial NCT03469492: Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose
Official title: Investigating the Role of the Polyol Pathway in the Central Nervous System Production of Fructose: an Intervention Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hyperglycaemia (Diabetic)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-03-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether longer-term improvement of glycemic control in poorly controlled diabetes patients with a 12-week intensified insulin treatment regimen will lead to decreased polyol pathway activity.

Detailed description: Polyol pathway activity will decrease in diabetic individuals who undergo intensification of their insulin treatment regimens as reflected by lower baseline brain intracellular fructose levels and higher intracellular glutathione levels. Furthermore, following longer-term improved glycemic control, patients may also have down-regulation of the pathway as reflected by decreased production of intracellular fructose in response to hyperglycemic clamp.

Eligibility criteria: Inclusion Criteria:

* 15 Type 2 DM subjects with HbA1C \> 7.5%
* 15 Type 1 DM subjects with HbA1C \> 7.5%
* Age 18-60
* BMI ≥18 kg/m2
* Weight ≤ 285 pounds

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL, Hgb \< 10 mg/dL, ALT \> 2.5 X ULN,
* untreated thyroid disease,
* uncontrolled hypertension,
* known neurological disorders,
* untreated psychiatric disorders,
* malignancy,
* bleeding disorders,
* current or recent steroid use in last 3 months,
* illicit drug use;
* for women: pregnancy, actively seeking pregnancy, or breastfeeding; inability to enter
* MRI/MRS

Primary outcomes:
measure: Change in HbA1c Levels
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Gluthathione
timeFrame: 0 weeks
measure: Gluthathione
timeFrame: 12 weeks
measure: Plasma Glucose
timeFrame: 0 weeks
measure: Plasma Glucose
timeFrame: 12 weeks
measure: Plasma Fructose
timeFrame: 0 weeks
measure: Plasma Fructose
timeFrame: 12 weeks
measure: Plasma Insulin
timeFrame: 0 weeks
measure: Plasma Insulin
timeFrame: 12 weeks
Other outcomes:
measure: Optional Hyperglycemic Clamp
timeFrame: upon enrollment
Locations:
city: New Haven
country: United States
facility: The Anylan Center
state: Connecticut
Study officials:
affiliation: Section of Endocrinology
name: Janice Hwang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sanchez-Rangel E, Gunawan F, Jiang L, Savoye M, Dai F, Coppoli A, Rothman DL, Mason GF, Hwang JJ. Reversibility of brain glucose kinetics in type 2 diabetes mellitus. Diabetologia. 2022 May;65(5):895-905. doi: 10.1007/s00125-022-05664-y. Epub 2022 Mar 5.
Clinical trial NCT01939392: Rapid Renal Sympathetic Denervation for Resistant Hypertension II
Official title: Rapid Renal Sympathetic Denervation for Resistant Hypertension Using the OneShot Renal Denervation System II
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Resistant Hypertension
Uncontrolled Hypertension
Renal Artery Ablation
Keywords: Resistant hypertension
Uncontrolled hypertension
Renal artery ablation
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2013-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a global, multi-center, prospective, randomized, controlled study of the safety and effectiveness of renal denervation with the OneShot Renal Denervation System in patients with uncontrolled hypertension.


Eligibility criteria: Inclusion Criteria:

* Individual has a systolic blood pressure ≥ 160 mmHg based on an average of three office blood pressure readings.
* Stable drug regimen including three or more anti-hypertensive medications including a diuretic

Exclusion Criteria:

* Renal anatomy unsuitable for treatment
* Presence of hemodynamically significant valvular heart disease for which reduction of blood pressure would be considered hazardous
* Patient has Type I diabetes
* Has scheduled or planned surgery within the next 6 months
* Individual is pregnant nursing or plans to be pregnant

Primary outcomes:
measure: Major adverse event (MAE) rate through 30 days post randomization
timeFrame: 30 days
measure: Change in office systolic blood pressure (SBP) from baseline to 6 months post-randomization
timeFrame: 6 months
Secondary outcomes:
measure: Acute Procedural Safety
timeFrame: 30 days
measure: Chronic procedural safety
timeFrame: 6 months
measure: Reduction in SBP by >10 mmHg at 6 months
timeFrame: 6 months
measure: Changes in office SBP and diastolic blood pressure (DBP) from baseline to follow-up visits
timeFrame: 6, 12, 24, and 36 months
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Hospital San Raffaele
Study officials:
affiliation: Park-Krankenhaus Liepzig
name: Dierk Scheinert, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universita Minano-Bicocca, Ospedale San Gerardo di Monza
name: Guiseppe Mancia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02819492: Side Specific Withdrawal Times for Colonoscopy: Impact on Adenoma Detection in the Proximal and Distal Colon
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Adenoma
Keywords: Adenoma
Colonoscopy
Withdrawal
Proximal
Observation Time
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 500
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients receiving colonoscopy at the study site are eligible for participation.

Brief summary: Adenoma detection in the main goal of screening colonoscopy. In order to detect adenomas it is mandatory to spend a long enough time investigating the colonic mucosa. A minimum observation time of 6 minutes has been proposed as a quality criterion for screening colonoscopy. However, different locations of the colon (proximal, distal) may require specific observation time periods. The colon can be divided into a proximal (right) and distal (left) part. Until now, it is unclear whether observation time has a significant impact on adenoma detection in both parts of the colon. The aim of this study therefore is to conduct a trial in which side-specific observation times and adenoma detection rates are measured in order to investigate this correlation in particular for the right colon.


Eligibility criteria: Inclusion Criteria:

* indication for colonoscopy
* age ≥ 40 years

Exclusion Criteria:

* American Society of Anesthesiologists class IV or higher
* pregnant women
* indication for colonoscopy: inflammatory bowel disease
* indication for colonoscopy: polyposis syndrome
* indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
* contraindication for polyp resection e.g. patients on warfarin

Primary outcomes:
measure: Adenoma detection rate in the proximal colon
timeFrame: up to 2 weeks (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)
Secondary outcomes:
measure: Polyp detection rate
timeFrame: up to one day
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
Study officials:
References:
Clinical trial NCT05061992: A Trial to Improve Quality of Life in People With Cirrhosis
Official title: A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cirrhosis
Keywords: Hepatic Encephalopathy
Liver Disease
Cirrhosis and portal hypertension
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-09-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cirrhosis - must meet one of the following criteria:

  1. liver biopsy, OR
  2. history of cirrhosis complication: ascites, variceal bleeding, hepatic encephalopathy, OR
  3. 2 of the following 4 criteria:

     1. Ultrasound, Computed tomography (CT) or Magnetic resonance imaging (MRI) findings of cirrhosis (cirrhotic appearing liver, splenomegaly, varices, ascites)
     2. Fibroscan liver stiffness score \>13 Kilopascal (kPa)
     3. Laboratory testing: aspartate aminotransferase (AST)/platelet ratio index (APRI) \>2.0
     4. CT, MRI or Esophagogastroduodenoscopy (EGD) showing presence of esophageal varices

        Exclusion Criteria:
* Non-English speaking
* Pregnancy (self-reported)
* Unable or unwilling to provide consent
* History of liver transplant
* Disorientation at the time of enrollment, Dementia, or Treated Memory Disorder
* History of prior lactulose use or HE within 6 months
* Metastatic solid malignancy or blood malignancy
* Hemoglobin A1C \> 12 (within past year)

Primary outcomes:
measure: Short Form-8 Health Survey (SF-8) at 28 Days
timeFrame: 28 days
Secondary outcomes:
measure: Animal Naming Test (ANT)
timeFrame: 28 days
measure: Change in Overall Sleep Quality
timeFrame: Change between baseline (day 0) and 28 days
measure: Regular Daily Activity Impairment
timeFrame: 28 days
measure: Participants Who Fell
timeFrame: 28 days
measure: Daily Bowel Movements
timeFrame: 28 days
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elliot Tapper, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02897492: Rapid and Highly Sensitive Detection of Fluorescently-labeled Troponin in Patients Admitted With Chest Pain
Official title: Rapid and Highly Sensitive Detection of Fluorescently-labeled Troponin in Patients Admitted With Chest Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Enrolled subjects will be patients admitted to Rambam health campus for the investigation of chest pain. Five m"l blood will be collected for troponin assay. No further intervention will be applied for subjects. Blood will be centrifuged and plasma separated for study purposes (detailed in "methods"- section 3.2.1.

Brief summary: Patients with chest pain may have postponed or missed diagnosis of acute coronary events due to relatively late detection of troponin elevation. The study will investigate a new diagnostic method for early detection of even minimal troponin elevation in patients admitted with chest pain.

Detailed description: Patients with chest pain may have postponed or missed diagnosis of acute coronary events due to relatively late detection of troponin elevation. The study will investigate a new diagnostic method for early detection of even minimal troponin elevation in patients admitted with chest pain.

A new diagnostic method will be applicated in the recent studies.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years old or older
2. Admitted to Rambam health campus for the investigation of chest pain

Exclusion Criteria:

1. No exclusion criteria will be applied

Primary outcomes:
measure: Time to detect troponin elevation
timeFrame: sixty to 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05484544: Safety and Efficacy of Hs-cTnT Protocols
Official title: Safety and Efficacy of Hs-cTnT Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Pain
Diagnosis
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 1167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive ED chest pain patients

Brief summary: Chest pain is a common presenting complaint among patients in the emergency department (ED). A large portion of patients with chest pain undergo lengthy assessment in the ED or are admitted to rule out acute oronary syndrome (ACS), often with stress testing, creating a substantial health care burden. The new high-sensitivity cardiac troponin assays allow use of shorter time intervals for repeated blood samples and may improve care for chest pain patients. The aim of this cohort is to evaluate high-sentivity troponin based protocols for ruling out and ruling in ACS in the ED.

Detailed description: This is a prospective observational study conducted at Skåne University Hospital (Lund, Sweden). Patients presenting with non-traumatic chest pain and for whom hs-cTnT testing was ordered at presentation will be enrolled between february 2013 to April 2014 after providing written informed consent. Patients with STEMI during index visit and those with severe communication barriers will not be enrolled. Enrolled patients will have a second blood sample for hs-cTnT analyzed 1 h after the first sample. Patients with hemolysis with a hemoglobin concentration \>0.1 g/dl, H-index \>=100 in either the 0- or

1-h sample will be excluded. Clinical data and 1-h high sensitivity troponin T samples will be collected by research assistants. Further diagnostic testing and treatment will be performed, as in routine care, at the discretion of the responsible physician.

Eligibility criteria: Inclusion Criteria:

* \>=18 years of age
* Presented to the ED with non-traumatic chest pain/discomfort
* Hs-cTnT testing was ordered at presentation

Exclusion Criteria:

* STEMI at presentation
* Severe communication barriers
* Hemolysis with a hemoglobin concentration\>0.1 g/dl, H-index\>=100

Primary outcomes:
measure: 30-day MACE
timeFrame: 30 days
Secondary outcomes:
measure: 30-day MACE without UA
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: Lund University
name: Ulf Ekelund, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mokhtari A, Borna C, Gilje P, Tyden P, Lindahl B, Nilsson HJ, Khoshnood A, Bjork J, Ekelund U. A 1-h Combination Algorithm Allows Fast Rule-Out and Rule-In of Major Adverse Cardiac Events. J Am Coll Cardiol. 2016 Apr 5;67(13):1531-1540. doi: 10.1016/j.jacc.2016.01.059.