louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01845779: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Official title: Evaluation of Immune Response Against Human Papillomavirus (HPV)in Patients With Metastatic Cancer of the Anal Canal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metastatic Anal Canal Cancer
Human Papillomavirus
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Complete response is a rare event in metastatic anal cancer in the case of unresectable recurrence after radiochemotherapy.

In the University Hospital Center of Besançon, 8 patients with metastatic anal cancer were treated between 2005 and 2008 by 6 cycles of chemotherapy including taxane: DCF (Docetaxel, Cisplatin and 5-Fluorouracil.

In more than 90% of cases, anal cancers are related to Human Papilloma Virus (HPV) infection, that is the case of this patients for which HPV16 (human papillomavirus type 16) genotype was identified within the tumor samples.

The hypothesis is that an anti-HPV response immune could be generated by chemotherapy with DCF and contributed to the elimination of the tumour cells and to the increase of complete responses. The aim to this study is to analyze immune response against HPV in this patients in complete response.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status ≤ 1
* patient with metastatic anal cancer HPV+
* presence of a measurable target lesion according to radiological criteria (Recist V1.1)
* patient with more than 12 months of complete remission of metastatic anal cancer according to radiological criteria (Recist V1.1)after treatment by DCF regimen (Docetaxel, Cisplatin and 5-Fluorouracil)

Exclusion Criteria:

* pregnancy or lactation
* patient with any medical or psychiatric condition or disease which would make the patient inappropriate for entry into this study.

Primary outcomes:
measure: presence and characterization of anti-HPV immune responses in patients in complete remission
timeFrame: 3 months after sample
Secondary outcomes:
measure: global survival
timeFrame: from date to initiation of chemotherapy until the date of death for any cause assessed up to 100 months
measure: progression free survival
timeFrame: from date to initiation of chemotherapy until the date of first documented progression, assessed up to 60 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Medical Oncology - University Hospital of Besançon
Study officials:
References:
Clinical trial NCT04970979: Exercise Adherence in Home-based Cardiac Rehabilitation
Official title: Influencing Factors of Exercise Adherence in Home-based Cardiac Rehabilitation in Patients With Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Home-based cardiac rehabilitation
Exercise adherence
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 300
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with coronary artery disease

Brief summary: The study will investigate the influencing factors of exercise adherence of home-based cardiac rehabilitation in patients with coronary artery disease.

Detailed description: The study will conduct a quantitative questionnaire survey. Patients with coronary artery disease in home-based cardiac rehabilitation will receive investigation of the influencing factors of exercise adherence.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of coronary artery disease;
* Age ≤75 years old;
* Participated in home-based cardiac rehabilitation ≥12 weeks;
* Volunteer to participate in this study.

Exclusion Criteria:

* Have other serious acute or chronic diseases;
* Have severe audio-visual or speech impairments that may affect understanding and answering questions.

Primary outcomes:
measure: Influencing factors of exercise adherence
timeFrame: The influencing factors of exercise adherence in home-based cardiac rehabilitation will be measured by the Theory of Planned Behavior Questionnaire through study completion, an average of 1 year
measure: Exercise adherence
timeFrame: The exercise adherence will be measured by the Home-based Exercise Training Adherence Questionnaire through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
affiliation: Peking University Third Hospital
name: Wei Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT01275079: Change of Nasalance After Tonsillectomy in Thai Adult
Official title: Change of Nasalance After Tonsillectomy in Thai Adult
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Voice Quality
Tonsillectomy
Keywords: tonsillectomy
nasalance
tonsil volume
Thai
adult
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2011-01-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai adults who were performed tonsillectomy

Brief summary: The purpose of this study is to analyze the change of nasalance after tonsillectomy in Thai adults.


Eligibility criteria: Inclusion Criteria:

* Thai adults age over 18 years who were perform bilateral tonsillectomy
* The pathological are not malignancy

Exclusion Criteria:

* Craniofacial anomalies
* Neurological problems
* History of Peritonsillar abscess
* Performed other operation beside tonsillectomy
* Can't read Thais
* Visual problem that effect reading
* Nasal disease that cause nasal obstruction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of otolaryngology, faculty of medicine, Chulalongkorn university
Study officials:
affiliation: Department of otolaryngology, faculty of medicine, Chulalongkorn university
name: Permpoon Piyaman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928679: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis; Weight Maintenance
Official title: Multi-parametric Imaging of the Knee in Obese Patients With Knee Osteoarthritis Following Liraglutide Treatment, Investigating the Impact on Inflammation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Obesity
Keywords: Magnetic resonance imaging
Dynamic contrast enhanced MRI
Liraglutide 3 mg
Liraglutide
Obesity
Osteoarthritis
Lead sponsor: Parker Research Institute
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a substudy to a randomised trial investigating the effect of liraglutide on body weight and pain in overweight or obese patients with knee osteoarthritis (NCT02905864). In the parent trial, patients will be subjected to an 8-week diet intervention phase including a low-calorie diet and dietetic counseling, after which patients will be randomised to receive either liraglutide 3 mg or liraglutide 3 mg placebo as an add-on to dietetic guidance on re-introducing regular foods and a focus on continued motivation to engage in a healthy lifestyle.

This substudy aims to investigate the impact of, and subsequent change of, joint inflammation, articular cartilage composition, overall knee morphology, and clinical symptoms, in obese patients with knee osteoarthritis following a randomisation to Liraglutide 3 mg or Liraglutide 3 mg placebo treatment between weeks 0-52.


Eligibility criteria: Inclusion Criteria:

* Same as parent trial (NCT02905864)

Further Exclusion Criteria:

* Same as parent trial (NCT02905864)
* Usual exclusion criteria for MRI (i.e. pacemakers etc.)

Primary outcomes:
measure: Change in the degree of inflammation in the knee-joint (DCE-MRI)
timeFrame: Week 0 to 52
Secondary outcomes:
measure: Change in the degree of inflammation in the knee-joint (CE-MRI)
timeFrame: Week 0 to 52
measure: Change in the degree of inflammation in the knee-joint (MRI)
timeFrame: Week 0 to 52
measure: Change in cartilage composition
timeFrame: Week 0 to 52
measure: Change in bone marrow lesions
timeFrame: Week 0 to 52
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: The Parker Institute and Department of Radiology at Bispebjerg and Frederiksberg Hospital
state: Capital Region
Study officials:
References:
Clinical trial NCT00127179: A Study of an Investigational Study Drug for Benign Prostatic Hyperplasia (0906-140)
Official title: MK0906 Phase III Double-Blind Comparative Study - Benign Prostate Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Benign Prostatic Hyperplasia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-08-05
Enrollment: 600
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to determine the efficacy and safety of an investigational drug in patients with benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

* Patients with benign prostatic hyperplasia

Exclusion Criteria:

* Patients who are suspected to be suffering from prostatic cancer

Primary outcomes:
measure: Change from baseline in the International Prostate Symptom Score
Secondary outcomes:
measure: Change from baseline in QOL - index
measure: Change from baseline in maximum urinary flow rate, %
measure: Change from baseline in Prostate volume
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03356379: Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry
Official title: Application de l'oxymétrie Dynamique Pour le Diagnostic Des pièges artériels poplités
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Popliteal Entrapment Syndrome
Keywords: Diagnosis
Peripheral artery disease
sports
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2017-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: transcutaneous oximetry
Primary purpose: DIAGNOSTIC

Brief summary: Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects

Detailed description: Patients suspected of PES and healthy cpontrols after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of elevation on foot in the standing position.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls)

Exclusion Criteria:

* Refuse to participate Exclusion period from another protocole

Primary outcomes:
measure: Presence of a significant DROP decrease
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
Study officials:
affiliation: University Hospital in Angers
name: Pierre ABRAHAM, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642679: Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects
Official title: Evaluation of Opticell Ag (Chitosan Based Dressing) on Split-Thickness Skin Graft (STSG) Donor Sites in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Split-thickness Skin Graft Donor Sites
Keywords: Split-thickness skin graft, donor site, chitosan, dressing
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Medline Industries
First posted: 2015-12-30
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Opticell Ag dressing applied to STSG donor site
Primary purpose: TREATMENT

Brief summary: The purpose of this single center, prospective case series is to evaluate the effective management of split-thickness skin graft donor site wounds using Opticell Ag (Chitosan-based dressing).


Eligibility criteria: Inclusion Criteria:

* Inpatient status at study site
* Subject must be receiving a split-thickness skin graft (STSG)
* Wounds must not exceed 10% total body surface area (TBSA)
* Any donor site
* Ability to comply with necessary wound care/follow up

Exclusion Criteria:

* Subject is pregnant
* Subject has been diagnosed with Diabetes
* Subject is a smoker
* Subject takes steroids
* Subject is sensitive and/or allergic to shellfish and/or silver
* Wounds that exceed 10% total body surface area (TBSA)
* Inability to comply with necessary wound care/follow up

Primary outcomes:
measure: Pain
timeFrame: Assessed up to 14 days of use
measure: Wound Healing Rate (Re-epithelialization)
timeFrame: Assessed up to 1 month postoperatively.
Secondary outcomes:
measure: Wound Healing Quality
timeFrame: Assessed up to 1 month of use
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Indranil Sinha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01199679: Rubber Band Ligation and Mucosectomy for Gastroesophageal Reflux Disease (GERD)
Official title: Evaluation of Distal Esophageal and Cardia Rubber Band Ligation and Mucosectomy in the Treatment of Subjects With Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia
Keywords: Gastroesophageal Reflux Disease
Heartburn
Regurgitation
Dyspepsia
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 10
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: The purpose of this study is to determine the safety and effectiveness of two separate procedures to treat gastroesophageal reflux disease (GERD) also known as heartburn. The two therapies are: 1) a banding procedure alone using the Cook® 6 Shooter™ Saeed Multi-Band Ligator or 2) a banding/shaving procedure called Endoscopic Mucosal Resection (EMR) using the Cook® Duette™ Multi-Band Mucosectomy device.


Eligibility criteria: Inclusion Criteria:

* Subject is 18 years of age or older.
* Typical symptoms of heartburn and/or regurgitation requiring daily PPI therapy.
* Subject agrees to participate and signs consent form.

Exclusion Criteria:

* Patient is pregnant.
* Patient has a hiatal hernia greater than 2cm.
* Presence of persistent daily solid food dysphagia, unplanned weight loss over ten pounds, esophageal bleeding, or vomiting more than once per week).
* Active medical condition that would preclude the subject from finishing this study.
* BMI \> 39.

Primary outcomes:
measure: Reduction of reflux symptoms measured by GERD HRQL
timeFrame: 6 months
Secondary outcomes:
measure: Reduction in total esophageal acid exposure measured by 48 hour pH monitoring
timeFrame: 6 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Hospital
state: Indiana
Study officials:
affiliation: Indiana University Hospital
name: Glen A. Lehman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00810979: Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hyperlipidemia
Lead sponsor: Response Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-12-18
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.

Detailed description: 1. LDL-C after 12 weeks of treatment
2. Safety and tolerability
3. Plasma levels of SLx-4090

Eligibility criteria: Inclusion Criteria:

* LDL-C \> or = 100 mg/dL
* On stable statin therapy for at least 6 weeks

Exclusion Criteria:

* Coronary heart disease or risk factors for CHD

Primary outcomes:
measure: Reduction in LDL-C
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse events
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Jacksonville
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Addison
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Edina
country: United States
state: Minnesota
city: Saint Louis
country: United States
state: Missouri
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Mount Pleasant
country: United States
state: South Carolina
city: Richmond
country: United States
state: Virginia
Study officials:
References:
Clinical trial NCT01141179: The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
Official title: The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-06-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.


Eligibility criteria: Main Inclusion Criteria:

* Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
* BMI ≥18.0 and ≤ 42 kg/m2
* Patients with stable concomitant medical conditions
* Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:

  * ≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
  * ≥ 30 to \< 50 mL/min (Moderate Group: 8 subjects),
  * \< 30 mL/min (Severe Group: 8 subjects).

Main Exclusion Criteria:

* Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
* Clinically significant illness or surgery within 4 weeks prior to dosing
* Clinically significant ECG abnormalities or vital sign abnormalities at screening
* History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
* Clinically significant history or presence of any gastrointestinal pathology
* Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:

  * multivitamins or vitamin D taken on a regular basis
  * topical products without systemic absorption
* Hemoglobin ≤ 90 g/L
* Serum total calcium (adjusted for albumin) level \< 2.25 mmol/L
* Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease

Primary outcomes:
measure: PK parameters
timeFrame: 1 week
Secondary outcomes:
measure: PD parameters
timeFrame: 1 week
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Anapharm
state: Ontario
Study officials:
affiliation: Anapharm
name: Richard Larouche, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806479: Hypertrophic Cardiomyopathy Pilot Study
Official title: Pilot Observational Case-control Study of the Electrical Heterogeneity in Patients With Hypertrophic Cardiomyopathy and High Arrhythmic Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertrophic Cardiomyopathy
Coronary Artery Disease
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2016-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Case - Control study of hypertrophic cardiomyopathy patients at high risk for ventricular arrhythmias in comparison to three Controls groups

Brief summary: This study evaluates mechanisms of arrhythmogenicity in hypertrophic cardiomyopathy, in comparison to patients with well-understood arrhythmogenic substrate (ischemic cardiomyopathy), as well as to individuals free from arrhythmogenic substrate


Eligibility criteria: Inclusion Criteria:

* Diagnosed HCM
* Documented history of sustained ventricular tachyarrhythmia or resuscitated sudden cardiac arrest
* Maximal left ventricular wall thickness of \> 30mm
* Extensive fibrosis on cardiac MRI (\>15% of total myocardial volume)
* \>7.5%/5-year risk of sudden cardiac death as determined by HCM risk-SCD

Exclusion Criteria:

* age \< 18 years
* Pregnancy
* Atrial Fibrillation

Primary outcomes:
measure: Non-invasively reconstructed epicardial activation map
timeFrame: within one day
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References:
citation: Perez-Alday EA, Haq KT, German DM, Hamilton C, Johnson K, Phan F, Rogovoy NM, Yang K, Wirth A, Thomas JA, Dalouk K, Fuss C, Ferencik M, Heitner S, Tereshchenko LG. Mechanisms of Arrhythmogenicity in Hypertrophic Cardiomyopathy: Insight From Non-invasive Electrocardiographic Imaging. Front Physiol. 2020 Apr 24;11:344. doi: 10.3389/fphys.2020.00344. eCollection 2020.