louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03608826: Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Official title: Relationship Between LINQ™ Subcutaneous Impedance and Right-sided Hemodynamic Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2018-08-01
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the ReLINQuish study is to characterize the relationship between subcutaneous impedance and hemodynamic measurements in patients with heart failure. Additionally, the relationship between changes in subcutaneous impedance and other physiologic parameters during acute decompensated HF events will be characterized.


Eligibility criteria: Inclusion Criteria:

* Patients meeting at least 1 of 3 criteria will be included in the study:

  * Patients with symptomatic systolic or diastolic heart failure who in the clinician's judgment have a high likelihood of undergoing serial right heart catheterizations to aid in clinical management of their heart failure
  * Patients with dyspnea on exertion in whom exercise hemodynamics is indicated to diagnose diastolic dysfunction
  * Patients who have or will be implanted with a pulmonary artery pressure monitor
* Patient is 18 years of age or older
* Patient (or patient's legally authorized representative) is willing and able to provide written informed consent
* Patient is willing and able to comply with the protocol, including follow-up visits and Carelink transmissions.

Exclusion Criteria:

* Patient has an existing Medtronic implantable cardiac device
* Patient has a left ventricular assist device (LVAD)
* Patient is pregnant (all females of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
* Patient is enrolled in another study that could confound the results of this study, without documented pre-approval from a Medtronic study manager

Primary outcomes:
measure: Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Pulmonary Artery Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
timeFrame: 18 months
measure: Comparison of Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) With Right Atrial Pressure (Units of mmHg) From a Swan-Ganz Catheter During Right Heart Catheterization Procedures in Patients With Heart Failure.
timeFrame: 18 months
Secondary outcomes:
measure: Characterization of the Changes in Reveal LINQ™ Subcutaneous Impedance (Units of Ohms) Prior to Any Acute Decompensated Heart Failure Events.
timeFrame: 18 months
measure: Characterization of the Changes in Reveal LINQ™ Activity (Units of Hours Per Day) Prior to Any Acute Decompensated Heart Failure Events.
timeFrame: 18 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT05144126: Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
Official title: Safety, Radiological and Patient Reported Outcomes of i-FACTOR+ Matrix Bone Graft Device - A Canadian, Multicenter, Post-Market Clinical Investigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Degenerative Disc Disease
Lead sponsor: CeraPedics, Inc
Sponsor class: INDUSTRY
Collaborators: name: Talosix
name: Medical Metrics Diagnostics, Inc
First posted: 2021-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study intends tracking the usage patterns of a Bonegraft device within spine surgery in a multicenter setting in Canada.

Detailed description: The study wil track the usage patterns of a bone graft by identifying and classifying spine surgery procedures by access and segment type within the spins and furthet, record and analyse safety and performance measures associated with each classification. This is a post-market surveillance study

Eligibility criteria: Inclusion Criteria:

* Adult patient subjects not responding to conservative management of neck / arm or back/leg pain and requiring spinal fusion between levels C1 - T2 or L1 - S1
* Informed Consent

Exclusion Criteria:

* Hypersensitivity to i-FACTOR Bone Graft Devices
* Adult Spinal deformity, Spinal Cord Injury
* Infection
* Compromised renal function

Primary outcomes:
measure: index segment revision
timeFrame: 12-months post-operative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St Michael's Hosptal Toronto
name: Christopher Witiw, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00696826: A Study of MK0431 in Patients WIth Hepatic Insufficiency (0431-017)(COMPLETED)
Official title: An Open-Label, Single Dose Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of MK0431
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Liver Insufficiency
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 20
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: A study to compare the plasma concentrations of MK0431 at different times in patients with hepatic insufficiency vs healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* If female, non pregnant, BMI less than 40 kg/m2
* Patient has chronic, stable hepatic insufficiency

Exclusion Criteria:

* Patient unwilling to refrain from alcohol and grapefruit juice prior to and shortly after study drug administration
* Patient has diabetes, had a heart attack or stroke, or uncontrolled congestive heart failure during the past 6 months
* Patient has a history of drug or alcohol abuse
* Patient smokes \> 10 cigarettes per day
* Patient consumes more that 6 cups of caffeinated beverages per day
* Patient has had surgery, donated blood or participated in another clinical trial within the past 4 weeks

Primary outcomes:
measure: the plasma and urine pharmacokinetic parameters of MK0431
timeFrame: measured at predose, 0.5, 1,1.5, 2, 3, 4, 5, 6, 8, 10, 12, 15, 18, 24, 32, 48, 72 and 96 hours post dose
Secondary outcomes:
measure: Side effects, physical exam, lab safety data, urging drug screen, ECG and vital signs
timeFrame: throughout study and at 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Migoya EM, Stevens CH, Bergman AJ, Luo WL, Lasseter KC, Dilzer SC, Davies MJ, Wagner JA, Herman GA. Effect of moderate hepatic insufficiency on the pharmacokinetics of sitagliptin. Can J Clin Pharmacol. 2009 Winter;16(1):e165-70. Epub 2009 Feb 16.
Clinical trial NCT04421326: Multimodal Investigation of Intracranial Clot Environment
Official title: Multimodal Investigation of Intracranial Clot Environment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Ichemic Stroke
Brain Ischemia
Keywords: Stroke
Blood Brain Barrier
Ischemia
Thrombus
Interventional Neuroradiology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Genomic Institute of Montpellier
First posted: 2020-06-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing Mechanical Thrombectomy for large vessel occclusion with acute ischemic stroke

Brief summary: Analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

Detailed description: It has been shown that immune cells accumulate around the clot at the acute phase of stroke. Leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.

Eligibility criteria: Inclusion criteria:

1. Over 18 years of age,
2. Non-dependent for activities of daily living prior to the onset of the MI (Modified Rankin Score \>2)
3. Having an occlusion of a large arterial trunk proven by imaging (angio-MRI or angio-scanner).

Exclusion criteria:

1. Patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study.
2. Major patients under guardianship or curatorship or patients deprived of liberty

Primary outcomes:
measure: Metalloproteinase 9 quantification
timeFrame: 60 months
measure: Metalloproteinase 2 quantification
timeFrame: 60 months
Secondary outcomes:
measure: Cytokines levels
timeFrame: 60 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: Montpellier University Hospital
name: Vincent COSTALAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00789126: Single and Multiple Dose Escalation Study of VX-509 in Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Single-Dose Escalation Study and Multiple-Dose Escalation Study of VX-509 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2008-11-11
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED

Brief summary: Study to evaluate the safety and tolerability of single ascending doses and multiple ascending doses of VX-509 administered to healthy male and female subjects

Detailed description: Part A of the study will evaluate the safety and tolerability, PK, and PD of single ascending doses of VX-509.

Part B will evaluate the safety and tolerability, PK, and PD of multiple ascending doses of VX-509 administered for 14 days.

A total of 72 subjects will be enrolled: 36 subjects in Part A and 36 subjects in Part B.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking male or healthy, non-smoking, non-pregnant female
* Able to comply with study procedures
* Male subjects must agree to use 2 highly effective methods of contraception
* Female subjects must be of documented non-child-bearing potential or must agree to use 2 highly effective methods of contraception
* No clinically significant abnormal results for physical examination or clinically significant out of range laboratory results

Exclusion Criteria:

* History of any significant illness
* Illness within 5 days before Day 1
* Regular treatment with any medications
* Any type of tobacco or nicotine use
* History of drug or alcohol abuse or addiction within 2 years before Screening visit
* Positive tuberculin skin test at Screening
* Female subjects who are lactating or planning to become pregnant during the study period or within 90 days of last dose of study drug

Primary outcomes:
measure: Safety and Tolerability as measured by adverse events (AEs) and clinically relevant changes in laboratory values, vital signs, electrocardiograms (ECGs), and physical examination variables
timeFrame: Specified timepoints in the protocol
Secondary outcomes:
measure: Pharmacokinetics (PK) parameters (Cmax, AUC, t1/2, tmax)
timeFrame: Specified timepoints in the protocol
measure: Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
timeFrame: Specified timepoints in the protocol
Other outcomes:
Locations:
city: Lenexa
country: United States
state: Kansas
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: George Spencer-Green, MD, MS
role: STUDY_DIRECTOR
References:
Clinical trial NCT04079426: Tetracycline to Limit the Innate Immune Response in Acute Respiratory Distress Syndrome
Official title: Innate Immunity in Acute Respiratory Distress Syndrome: A Translational Approach to Limit Inflammasome-dependent Lung Inflammation by Tetracycline
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adult Respiratory Distress Syndrome
Pneumonia
Sepsis
Keywords: inflammasome
Caspase
NLRP3
Antibiotics
Tetracycline
Lead sponsor: University of Bonn
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants admitted to the Intensive Care Unit of the University Hospital of Bonn with an initial diagnosis of ARDS

Brief summary: The acute respiratory distress syndrome (ARDS) is a severe form of respiratory failure with a mortality rate of approximately 40%. Despite advances in its supportive treatment such as lung protective ventilation or restrictive fluid management, no effective pharmacotherapy exists to treat ARDS. Emerging preclinical data indicates that excessive activation of the inflammasome-Caspase 1 pathway plays a key role in the development of ARDS. Tetracycline has anti-inflammatory properties via inhibiting inflammasome-caspase-1 activation. Since not much is known about the activation of the inflammasome in clinical ARDS, the purpose of this study is i) to investigate the the inflammasome-caspase-1 activation in clinical ARDS and ii) inhibit the innate immune response of alveolar leucocytes obtained by tetracycline from patients with ARDS


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Informed consent of the patient
* Diagnosis of ARDS for \< 48 h

Exclusion Criteria:

* Age \< 18 years
* Missing informed consent
* Immune therapy
* Autoimmune disease

Primary outcomes:
measure: Cytokine Levels in Serum and bronchoalveolar fluid
timeFrame: 1 week
measure: Activation Status of immune cells from blood and bronchoalveolar fluid
timeFrame: 1 week
measure: Alarmins in Serum and bronchoalveolar fluid
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University Hospital Bonn
Study officials:
References:
citation: Peukert K, Fox M, Schulz S, Feuerborn C, Frede S, Putensen C, Wrigge H, Kummerer BM, David S, Seeliger B, Welte T, Latz E, Klinman D, Wilhelm C, Steinhagen F, Bode C. Inhibition of Caspase-1 with Tetracycline Ameliorates Acute Lung Injury. Am J Respir Crit Care Med. 2021 Jul 1;204(1):53-63. doi: 10.1164/rccm.202005-1916OC.
Clinical trial NCT02189226: Usefulness of Probe-based Confocal Laser Endo-microscopy in Delineation of Margin of Early Gastric Cancer for Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Early Gastric Cancer
Keywords: probe-based confocal laser endomicroscopy (pCLE), early gastric cancer (EGC), endoscopic submucosal dissection (ESD), margin
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-07-14
Enrollment: 101
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the usefulness of pCLE (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (CE) for delineating the margin of early gastric cancer (EGC) with endoscopic submucosal dissection (ESD).


Eligibility criteria: Inclusion Criteria:

* Consecutive patients diagnosed as EGC and treated by ESD with following criteria:1) Differentiated mucosal cancer without ulcer 2) Differentiated mucosal cancer with ulcer, ≤ 3 cm 3) Differentiated minute (\<500 μm) submucosal invasive cancer, ≤ 3 cm 4) Undifferentiated mucosal cancer without ulcer, ≤ 2 cm
* Consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of EGC and treated by ESD

Exclusion Criteria:

* Coagulopathy : International normalized ratio \[INR\] \> 1.5 or platelet count \<50,000 cell/cubic millimeter)
* Impaired renal function : Cr \> 1.2 mg/dL
* Pregnancy or breast-feeding
* Age \< 20 years
* Allergy to fluorescein dye
* Inability to provide informed consent

Primary outcomes:
measure: Complete resection rate
timeFrame: One week after ESD
Secondary outcomes:
measure: Horizontal cut end-positive
timeFrame: Within the first 30 days after ESD
measure: vertical cut end-positive
timeFrame: Within the first 30 days after ESD
measure: procedure time
timeFrame: 1 day
measure: adverse event
timeFrame: Within the first 30 days after ESD
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT04256226: Clinical Outcome of Female Non-gastric Gastrointestinal Stromal Tumor
Official title: Far Eastern Memorial Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Stromal Tumor
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 26
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: non-gastric gastrointestinal tumor in women

Brief summary: To elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.

Detailed description: Gastrointestinal stromal tumor (GIST) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. They took up about 3% of gastrointestinal malignancies. Although rarely, the clinical presentation of non-gastric GIST might mimick ovarian cancer, and would be managed by gynecologists. Therefore, retrospective review of female non-gastric GIST cases will be performed to investigate the clinical outcome of non-gastric GIST. The result of this study might be used as an important reference for gynecologists.

Eligibility criteria: Inclusion Criteria:

* \> 20 years of women.
* non-gastric gastrointestinal stromal tumor

Exclusion Criteria:

* Those without pathological report or surgical record.

Primary outcomes:
measure: Overall survival
timeFrame: 20 years
Secondary outcomes:
measure: Recurrence-free survival
timeFrame: 20 years
Other outcomes:
Locations:
city: Banqiao
country: Taiwan
facility: Department of Obstetrics and Gynecology, Far-Eastern Memorial Hospital
state: New Taipei
Study officials:
References:
Clinical trial NCT04334226: The Impact of Preoperative Urostomy Education on Patients and Families
Official title: The Impact of Preoperative Urostomy Education on Patients and Families
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Urostomy
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center and participated in Stoma Botcamp and their caregivers

Brief summary: This is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("Stoma Bootcamp") on patients and their family/informal caregivers

Detailed description: This study will utilize a qualitative descriptive methodology with a thematic analysis approach. Individual interviews will be held with bladder cancer and caregiver dyads who participated in the Stoma Bootcamp study. Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective. Semi-structured interview guides will be developed using Engel Biopsychosocial Model (BPS),5 one guide geared towards patients and the second toward caregivers.

Eligibility criteria: Inclusion Criteria:

* Adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the University of Kansas Medical Center since 2016, AND
* Participated in the Stoma Bootcamp preoperative educational intervention, AND
* Identified an informal/family caregiver who participated in Stoma Bootcamp with them.
* Patient-caregiver dyads must both consent to participation

Exclusion Criteria:

-

Primary outcomes:
measure: Impact of Stoma Bootcamp preoperative educational program on patients and caregivers
timeFrame: Interviews are expected to last 10-20 minutes and analysis expected to last approximately one year
Secondary outcomes:
Other outcomes:
Locations:
city: Westwood
country: United States
facility: University of Kansas Cancer Center
state: Kansas
Study officials:
References:
Clinical trial NCT03146026: The Effects of a Combined Exercise Training Program on Vascular Health and Metabolic Profile in Obese Adolescent Girls.
Official title: The Effects of a 12- Week Combined Exercise Training Program on Arterial Stiffness, Endothelial Function, Inflammatory Markers and Metabolic Profile in Obese Adolescent Girls: A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Adolescent
Lead sponsor: Pusan National University
Sponsor class: OTHER
Collaborators: name: University of Nebraska
First posted: 2017-05-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to examine the impact of 12 weeks of combined exercise training (CET) on arterial stiffness, endothelial function, inflammatory markers, insulin resistance, and body composition in obese adolescent girls. Thirty obese adolescent girls participated in this study. The girls were randomly divided into CET group (n=15) and control group (n=15). The CET group performed concurrent resistance training followed by aerobic training at 40-70% of the heart rate reserves (HRR) 3 days/week for 12 weeks. Plasma nitric oxide, endothelin-1, C-reactive protein, arterial stiffness, homeostasis model assessment of insulin resistance (HOMA-IR), glucose, insulin, and the adiponectin/leptin ratio were measured before and after the 12-weeks study.


Eligibility criteria: Inclusion Criteria:

* Obese with hyperinsulinemia
* Abdominal obesity
* Sedentary (no regular exercise training or physical activity)
* No weight loss diet during last 6 months.

Exclusion Criteria:

* Hypertension
* Pregnancy
* Chronic disease

Primary outcomes:
measure: Arterial stiffness
timeFrame: 12 weeks
measure: Endothelin-1
timeFrame: 12 weeks
measure: Insulin resistance
timeFrame: 12 weeks
measure: Plasma leptin
timeFrame: 12 weeks
measure: Plasma adiponectin
timeFrame: 12 weeks
measure: Body weight
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: Body fat
timeFrame: 12 weeks
measure: Maximal heart rate
timeFrame: 12 weeks
measure: Nitric oxide
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Wong A, Sanchez-Gonzalez MA, Son WM, Kwak YS, Park SY. The Effects of a 12-Week Combined Exercise Training Program on Arterial Stiffness, Vasoactive Substances, Inflammatory Markers, Metabolic Profile, and Body Composition in Obese Adolescent Girls. Pediatr Exerc Sci. 2018 Nov 1;30(4):480-486. doi: 10.1123/pes.2017-0198. Epub 2018 Sep 7.