louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00239876: Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
Official title: A Two-year Extension to a One-year, Multicenter, Open-label, Randomised Study to Evaluate the Safety and Efficacy of FTY720 Combined With Tacrolimus and Steroids Versus Mycophenolate Mofetyl Combined With Tacrolimus and Steroids, in de Novo Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Transplantation, kidney, and organ transplant
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of FTY720 combined with tacrolimus and corticosteroids in patients receiving a kidney transplant


Eligibility criteria: Inclusion Criteria

* Completed the 12 month core study
* Informed consent Exclusion Criteria
* N/A Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: IA, IB, IIA, IIB, III, or humoral rejection diagnosed by biopsy according to Banff 97 criteria within 36 months post transplant
measure: Permanent resumption of dialysis within 36 months post transplant
measure: Surgical removal of graft within 36 months post transplant
measure: Death within 36 months post transplant
measure: Withdrawal of consent, death, or lost to follow up within 36 months post transplant
measure: Serum creatinine, estimated creatinine clearance, assessment of other laboratory abnormalities and vital signs and measurement of urine protein. at Months 18, 24, 30 and 36
measure: Pulmonary FEV1 , FVC, FEV1/FVC, DLCO and FEF 25%-75% at Months 18, 24, 30 and 36
measure: Absolute lymphocyte count at Month 18, 24, 30 and 36.
Secondary outcomes:
measure: Physical examinations at Months 18, 24, 30 and 36
measure: Vital signs at Months 18, 24, 30 and 36
measure: Electrocardiogram at Months 24 and 36
measure: Chest X-ray Months 24 and 36
measure: Safety laboratory tests 18, 24, 30 and 36
measure: Ophthalmic evaluations 18, 24, 30 and 36
measure: AEs and SAEs
measure: FTY720/CsA levels at Months 18, 24, 30 and 36
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT04457427: Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Official title: Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diaphragm Issues
Ventilator-Induced Lung Injury
Tracheostomy
Keywords: Mechanical Ventilators
Ventilators, Pulmonary
Failure to wean
Lung Injury, Ventilator-Induced
Tracheostomy
Diaphragm pacing
Lead sponsor: Synapse Biomedical
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.

Detailed description: 15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.

Eligibility criteria: Inclusion Criteria:

* Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
* Signed written informed consent has been obtained prior to performing any study related procedure(s)
* Subject is at least 18 years of age
* Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)

Exclusion Criteria:

* Diaphragm malformation which makes electrode insertion impossible
* Presence of an implantable cardioverter-defibrillator
* Severe chronic obstructive pulmonary disease (COPD)
* Subject is pregnant or breastfeeding
* Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
* Terminal patients expected to die during their stay in the hospital
* Participation in other clinical studies that could interfere with the results in the ongoing study

Primary outcomes:
measure: Device and procedure safety
timeFrame: Through study completion, an average of 6 years
measure: Monitoring
timeFrame: Through study completion, an average of 6 years
measure: Stimulation
timeFrame: Through study completion, an average of 6 years
Secondary outcomes:
measure: Effects of diaphragm stimulation
timeFrame: Through study completion, an average of 6 years
Other outcomes:
measure: Electrode removal
timeFrame: Through study completion, an average of 6 years
Locations:
city: Istanbul
country: Turkey
facility: Marmara Univeristy
Study officials:
affiliation: Marmara University
name: Tunç Laçin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06010927: Effect of Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol on Recovery Profile in Pediatrics Undergoing Adenotonsillectomy.
Official title: Ketamine/Midazolam Premedication Versus Pre-extubation Ketofol. Effect on Emergence Agitation and Recovery Profile After Pediatric Adenotonsillectomy: A Randomized Comparative Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Emergence Delirium
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 140
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An optimum recovery profile after AT includes a rapid, smooth awakening without emergence agitation (EA), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (PONV), controlled postoperative pain, and patient or parents' satisfaction. Ketamine is a low-cost drug with a wide therapeutic window. Ketamine is a competitive N-methyl-D-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia.

The ketamine/midazolam combination was administered in different ways with controversial results about their effect on the EA and recovery profile.

Ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative EA and PONV.

This study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the EA and the recovery profile.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I or II
* Children scheduled for AT under general anesthesia (GA).

Exclusion Criteria:

* Congenital cardiovascular anomalies
* Behavioral changes
* Delayed physical development
* Children receiving sedatives or anticonvulsants therapy

Primary outcomes:
measure: incidence of Emergence agitation
timeFrame: starting from time of PACU admission after recover from anesthesia till 6 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Abeer Ahmed
state: Cairo
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
References:
Clinical trial NCT02504827: Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis
Official title: Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Keywords: pharmacokinetics
ceftazidime/avibactam
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2015-07-22
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: OTHER

Brief summary: The purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with Cystic Fibrosis.

Detailed description: Cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. The principal pathogen is Pseudomonas aeruginosa which is present in the airways of 70% of adult patients with CF. Of particular concern is the increasing resistance observed to existing agents.

While ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. Ceftazidime/avibactam offers a potential advancement in the management of infections involving P. aeruginosa in CF due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of CF based on positive sweat chloride or know CF mutation
* Age \> 17 years
* Able to spontaneously expectorate sputum

Exclusion Criteria:

* Any clinically significant laboratory abnormality
* Presence of an ongoing acute pulmonary exacerbation
* Pregnancy
* Serious past allergy to a beta-lactam antibiotic

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 8 hours
measure: Peak Sputum Concentration
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Paul Beringer, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bensman TJ, Wang J, Jayne J, Fukushima L, Rao AP, D'Argenio DZ, Beringer PM. Pharmacokinetic-Pharmacodynamic Target Attainment Analyses To Determine Optimal Dosing of Ceftazidime-Avibactam for the Treatment of Acute Pulmonary Exacerbations in Patients with Cystic Fibrosis. Antimicrob Agents Chemother. 2017 Sep 22;61(10):e00988-17. doi: 10.1128/AAC.00988-17. Print 2017 Oct.
Clinical trial NCT03500627: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 After Intravenous Administration in Healthy Volunteers
Official title: A Phase 1 Open-Label Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of OP-101 (Dendrimer N-Acetyl-Cysteine) After Intravenous Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adrenoleukodystrophy (ALD)
Childhood Cerebral Adrenoleukodystrophy (ccALD)
OP-101
Dendrimer
N-Acetyl-Cysteine (NAC)
Lead sponsor: Orpheris, Inc.
Sponsor class: INDUSTRY
First posted: 2018-04-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A clinical study to measure the effect of OP-101 after being administered intravenously in healthy volunteers.


Eligibility criteria: Key Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 32 kg/m\^2.
* Is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG), as judged by the investigator.
* Female subjects may not be pregnant, lactating, or breastfeeding.
* Subjects must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and Check-in.

Key Exclusion Criteria:

* Evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease, or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study.
* History of malignancy (other than successfully treated basal cell or squamous cell skin cancer).
* History or presence of an abnormal ECG that, in the opinion of the Investigator, is clinically significant.
* Has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study.
* Has used medications that affect gastrointestinal motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and H2 blockers; within 30 days prior to Day 1.
* Has used prescription or over-the-counter medication, vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to Day 1.

Primary outcomes:
measure: Number of Participants with Treatment Emergent Adverse Events Graded as Assessed by CTCAE Version 4.0
timeFrame: Screening to Day 15.
Secondary outcomes:
measure: Pharmacokinetic (PK) Profile Analysis
timeFrame: Days 1, 2, 3, 4, 8, and 15.
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Medpace Clinical Pharmacology Unit
state: Ohio
Study officials:
affiliation: Orpheris, Inc.
name: Stephen Huhn, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05948527: Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Official title: Safety and Efficacy of High Flow Nasal Canula in Patients With Mild Hypercapnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypercapnia
Keywords: hypercapnia
high flow nasal canula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in Mansoura University chest department with mild Hypercapnia (Pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (Chronic obstructive pulmonary disease acute exacerbation, pneumonia, Interstitial lung diseases, etc).


Eligibility criteria: Inclusion Criteria:

* patients with mild Hypercapnia

Exclusion Criteria:

* Excluded cases had age less than 18 years or pediatric group .
* patients with their mental state altered, confused, comatose, severe agitation or non cooperative
* Cases with moderate or severe Hypercapnia
* cases in need for immediate invasive mechanical ventilation
* cases with respiratory rate more than 35 breath per minute.
* cases with Respiratory exhaustion , fatigue , excess use of respiratory accessory muscles
* Shock , hemodynamic instability, post arrest cases,
* cases with facial trauma or severe nasal deformity,
* Patients with sleep breathing disorders or upper airway obstruction
* patients with history of home ventilation prior admission

Primary outcomes:
measure: Arterial Blood Gases changes
timeFrame: 48 hours
Secondary outcomes:
measure: Number of participants in need for ventilation
timeFrame: 7 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Dakahlia Governorate
Study officials:
References:
Clinical trial NCT04722627: Study of AT-752 in Healthy Subjects
Official title: A First-in Human, Randomized, Double-blind, Placebo Controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dengue
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-752 in healthy subjects

Detailed description: A First-in Human, Randomized, Double-blind, Placebo controlled Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of AT-752 in Healthy Subjects

Eligibility criteria: Inclusion Criteria:

1. Body mass index (BMI) of 18-29 kg/m2
2. Must agree to use protocol-specified methods of contraception
3. Negative pregnancy test
4. Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Abuse of alcohol or drugs
3. Use of other investigational drugs within 30 days of dosing
4. Other clinically significant medical conditions

Primary outcomes:
measure: Proportions (active vs. Placebo) of subjects experiencing treatment-emergent adverse events
timeFrame: Day 6 for single dose or Day 12 for multiple dose
measure: Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
timeFrame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses
measure: Pharmacokinetics (PK) of AT-752 of single and multiple ascending oral doses
timeFrame: Day 1 for subjects receiving a single fasted dose; Days 1 and 7 for subjects receiving multiple doses ]
measure: Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
timeFrame: Day 1 for subjects receiving a single fed dose]
measure: Effect of food on Pharmacokinetics (PK) of AT-752 of a single oral dose
timeFrame: Day 1 for subjects receiving a single fed dose ]
Secondary outcomes:
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Atea Study Site
state: Victoria
Study officials:
References:
Clinical trial NCT00000227: Alternate-Day Buprenorphine Administration. Phase VIII - 9
Official title: Alternate-Day Buprenorphine Administration. Phase VIII
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: University of Vermont
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 25
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate open buprenorphine dosing with dose choice.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Opioid withdrawal
measure: Opioid agonist effects
measure: Dose choice
Secondary outcomes:
Other outcomes:
Locations:
city: Burlington
country: United States
facility: Treatment Research Center
state: Vermont
Study officials:
affiliation: University of Vermont
name: Warren Bickel, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04281927: A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
Official title: A Wearable With Photoplethysmography and 6-lead Electrocardiography for Atrial Fibrillation Detection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: wearable
electrocardiography
photoplethysmography
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Kaunas University of Technology
First posted: 2020-02-24
Enrollment: 435
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: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants of defined groups will be enrolled in Vilnius University Hospital Santaros Clinics.

Brief summary: A single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (AF) and sinus rhythm (SR).


Eligibility criteria: Inclusion Criteria:

* Participants with current ECG-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions.
* Age is between 18 - 99.

Exclusion Criteria:

* Participants who refuse to sign an informed consent.
* Participants with atrial fibrillation who are currently in a paced rhythm.

Primary outcomes:
measure: Diagnostic accuracy of a wearable system for atrial fibrillation detection
timeFrame: PPG will be assessed in 2 minutes. ECG will be assessed in up to 10 months.
Secondary outcomes:
measure: Diagnostic accuracy of PPG algorithm of the wearable for atrial fibrillation detection
timeFrame: 2 minutes.
measure: Diagnostic accuracy of a 6-lead ECG of the wearable for atrial fibrillation detection
timeFrame: Up to 10 months.
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Audrius Aidietis, Prof. PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02792127: Online Program for Social Anxiety
Official title: Online Cognitive Behavioural Therapy Program for Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: Social Anxiety
Cognitive Behaviour Therapy
Online Program
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-06-07
Enrollment: 101
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.

Detailed description: While there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. This will be attempted in a six-month online program for social anxiety.

The present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. This information will be collected from students at baseline and upon completion of the online program.

Eligibility criteria: Inclusion Criteria:

* Registered UBC student
* Achieve an above-average score on a validated screening tool for social anxiety

Exclusion Criteria:

* Not a registered UBC student
* Clinical diagnosis of a mental illness

Primary outcomes:
measure: Social Anxiety
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Frances Chen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Helgadottir FD, Ross MG, Onslow M, Packman A, O'Brian, S. Online CBT II: A phase I trial of a standalone, online CBT Treatment Program for Social Anxiety in Stuttering. Behaviour Change 26(4): 254-270. 2009.
citation: Helgadottir FD, Menzies RG, Onslow M, Packman A, O'Brian S. Online CBT I: Bridging the gap between Eliza and modern online CBT treatment packages. Behaviour Change 26(4): 245-253, 2009.
citation: McCall HC, Richardson CG, Helgadottir FD, Chen FS. Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial. J Med Internet Res. 2018 Mar 21;20(3):e91. doi: 10.2196/jmir.8630.