Clinical trials: Digital
Device Latency
Substudy 'B' of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study is to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02404532)
- Testing
- MIND1 System
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Healthy
A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing
Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app.
- Trial name
- COOL (NCT03729960)
- Testing
- LENA recorder
- Where
- Singapore
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
Schizophrenia, Mental Disorder
Open-label Study to Assess Usability of the Medical Information Device #1 (MIND1) System in Adults With Schizophrenia On Oral Aripiprazole
The purpose of this study is to determine the usability of the Medical Information Device #1 (MIND1) system in adults with schizophrenia who are treated with oral aripiprazole.
- Conditions
- Schizophrenia, Mental Disorder, Nervous System Diseases
- Trial name
- NCT02219009
- Testing
- MIND1 System
- Where
- 6 sites in United States
- Volunteers
- 67 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Device Latency
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)
The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.
- Trial name
- OSMITTER (NCT02091882)
- Testing
- Combination product of Aripiprazole + IEM + Sensor + MIND1 Application
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Schizophrenia, Schizoaffective Disorder
A Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adults With Schizophrenia, Schizoaffective Disorder, or First Episode Psychosis on an Oral Atypical Antipsychotic
Digital medicine systems (DMS) have been designed to assist individuals with the management of their daily health, wellness, and medication use.
- Conditions
- Schizophrenia, Schizoaffective Disorder, First Episode Psychosis
- Trial name
- NCT03568500
- Testing
- Digital Medicine System, Aripiprazole, Olanzapine
- Where
- 5 sites in United Kingdom
- Volunteers
- 44 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Idiopathic Pulmonary Fibrosis
Patient-reported Monitoring of Symptoms and Spirometry Via the patientMpower Platform in Idiopathic Pulmonary Fibrosis
Pilot-scale, open-label, fixed-order, two-period crossover study in idiopathic pulmonary fibrosis (IPF) over 16 weeks. Patients will use an electronic health journal (patientMpower platform) to record treatment compliance, forced…
- Trial name
- NCT03104322
- Testing
- patientMpower platform, usual care
- Where
- Ireland
- Volunteers
- 7 people
- Sponsor
- patientMpower Ltd.
Breast Cancer
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or…
- Trial name
- NCT00999596
- Where
- 3 sites in United States, Germany
- Volunteers
- 107 people
- Sponsor
- Philips Healthcare
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
Chronic Obstructive Pulmonary Disease
A Randomized Study to Evaluate the Effect of Reminder Notifications and Motivational/Adaptive Messaging on Treatment Adherence
This study was evaluating the effect of reminder notifications and motivational/adaptive messages on treatment adherence behavior in subjects with COPD.
- Trial name
- ADVICE (NCT03379233)
- Testing
- Concept2 inhaler, Concept2 inhaler with patient application
- Where
- 9 sites in Germany, Netherlands
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Attention Deficit Disorder With Hyperactivity
Software Treatment for Actively Reducing Severity of ADHD
The purpose of this study is to evaluate the effects of videogame-like digital therapies on attentional functioning and symptoms in children diagnosed with ADHD.
- Trial name
- STARS-ADHD (NCT02674633)
- Testing
- AKL-T01, AKL-T09
- Where
- 20 sites in United States
- Volunteers
- 348 people
- Sponsor
- Akili Interactive Labs, Inc.
Systemic Sclerosis
Open-Label Study of Oral Treprostinil in Digital Ulcers
This open label extension trial will allow ongoing treatment of subjects who participated in the randomized controlled trials, and will provide long term information about the safety of treprostinil diethanolamine SR in subjects…
- Trial name
- DISTOL-EXT (NCT00848107)
- Testing
- treprostinil diethanolamine
- Where
- 26 sites in United States, Canada and 1 more
- Volunteers
- 115 people
- Sponsor
- United Therapeutics
Cognitive Functioning of Healthy Individuals
Psychometric Properties of IntelliSpace Cognition
This study aims to validate the tests that are on the IntelliSpace Cognition platform and to establish normative data for these tests.
- Trial name
- NCT03801382
- Testing
- IntelliSpace Cognition (ISC), Paper-Pencil Tests
- Where
- United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Philips Clinical & Medical Affairs Global
Schizophrenia, Major Depressive Disorder
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.
- Conditions
- Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
- Trial name
- NCT02722967
- Testing
- Aripiprazole + IEM (Ingestible Event Marker)
- Where
- 4 sites in United States
- Volunteers
- 49 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
Autism Spectrum Disorder
Cognoa Autism Spectrum Disorder (ASD) Digital Therapeutic Engagement and Usability Study
Cognoa will measure usability, engagement with the device, and changes in parent-reported socialization during a 4-week period of intervention at home with the Cognoa ASD therapeutic device.
- Trial name
- NCT04326231
- Testing
- Usability assessment of Cognoa ASD Therapeutic Device
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Cognoa, Inc.
Healthy
Clinical Evaluation of the Carestream PRO 3543 and PRO 3543C Digital Detectors
The purpose of this clinical study is to evaluate the imaging performance of the Carestream PRO 3543 Detector and Carestream PRO 3543C Detector (referred to as the "investigational devices") as compared to the currently marketed…
- Trial name
- NCT02383420
- Testing
- Radiation
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Carestream Health, Inc.
Alcohol Use Disorder (AUD), Substance Use Disorders
The Anchor Study: Digitally Delivered Intervention for Reducing Problematic Substance Use
This study aims to validate W-SUDs as a digitally-delivered substance use disorder program through a fully-powered randomized control trial that will test the comparative efficacy of the mobile-app based substance use disorder…
- Trial name
- NCT04925570
- Testing
- W-SUDs, Digitally-delivered Psychoeducation
- Where
- United States
- Volunteers
- 258 people
- Sponsor
- Woebot Health
Breast Cancer, Tumors, Breast
Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT)
The aim of this recruitment plan (ADAPT-BX) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results…
- Trial name
- ADAPT (NCT02324205)
- Testing
- DBT and FFDM
- Where
- 3 sites in United States, France
- Volunteers
- 196 people
- Sponsor
- GE Healthcare
Refractive Errors
Clinical Validation of DACP Digital Design
The purpose of this study is to evaluate the visual performance of DAILIES® AquaComfort Plus® (DACP) Digital lenses by assessing distance visual acuity (VA) as compared to DACP sphere contact lenses after one week of wear.
- Trial name
- NCT03567005
- Testing
- Nelfilcon A digital contact lenses, Nelfilcon A contact lenses
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Alcon Research
Solitary Pulmonary Nodules
Clinical Evaluation of CARESTREAM Dual Energy and Digital Tomosynthesis
The purpose of this study is to evaluate the imaging performance of Dual Energy and Digital Tomosynthesis (DE-DT) application against the commercially available predicate devices.
- Trial name
- NCT02531646
- Testing
- Radiation
- Volunteers
- 66 people
- Sponsor
- Carestream Health, Inc.
Schizophrenia, Bipolar 1 Disorder
A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder
The primary objective of this pragmatic clinical trial (Main Study) was to assess the difference between all-cause hospitalizations in participants using Abilify MyCite versus virtual matched controls.
- Conditions
- Schizophrenia, Bipolar 1 Disorder, Major Depressive Disorder
- Trial name
- NCT03643159
- Testing
- Abilify MyCite - Digital Medicine System, Aripiprazole or other oral antipsychotics
- Where
- 5 sites in United States
- Volunteers
- 2 people
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.