Clinical trials: Information Systems
Constipation
Study to Gather Information on the Acceptability of a New Flavor System With Increasing Levels of 2, 4, 6 g or Higher of Mannitol for PEG 3350 in Subjects Having Infrequent Bowel Movements.
Study to gather information on the acceptability of a new flavor system with increasing levels of 2, 4, 6 g or higher of the sugar alcohol Mannitol for Polyethylene glycol (PEG) 3350 a drug stimulating bowel movement to pass…
- Trial name
- NCT04534465
- Testing
- Polyethylene glycol (MiraLAX, BAY81-8430), Mannitol
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Bayer
Overactive Bladder
Study to Gather Information About the Actual Use of an Adhesive Patch Placed on the Skin to Deliver Oxytrol Through the Skin Into the Bloodstream.
With this study researchers want to gather information about the consumer use behavior of Oxytrol in a simulated setting in which the medicine is sold directly to a consumer without a prescription from a healthcare professional.
- Trial name
- NCT04534491
- Testing
- Oxybutynin (Oxytrol, BAY839380)
- Where
- United States
- Volunteers
- 855 people
- Sponsor
- Bayer
Hearing Loss
Post-market Study to Capture Information Regarding Performance of Lyric2
Randomized post market study comparing Lyric to Lyric2 capturing information regarding comparative performance and safety.
- Trial name
- NCT01861704
- Testing
- Lyric, Lyric2
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- Phonak AG, Switzerland
Infections, Rotavirus
Reactogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Rotarix™ (Human Rotavirus Vaccine) in Indian Infants
This post marketing surveillance will evaluate reactogenicity and safety data of human rotavirus vaccine when administered to healthy infants according to the Prescribing Information in India.
- Trial name
- NCT00938327
- Testing
- Rotarix™
- Where
- 12 sites in India
- Volunteers
- 332 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Rotavirus, Rotavirus Vaccines
To Evaluate Safety & Reactogenicity of GSK Bio's Human Rotavirus (HRV) Vaccine in Filipino Infants at Least 6 Weeks of Age at First Vaccination
GSK has submitted a registration file for its live attenuated oral human rotavirus (HRV) vaccine in several countries. In view of its registration in the Philippines, the present study will collect data on the safety of the…
- Trial name
- NCT00353366
- Testing
- Rotarix, Data collection
- Where
- 18 sites in Philippines
- Volunteers
- 1,439 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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.
Neoplasms, Rectal
A Post-marketing Surveillance Study to Assess the Safety of Cervarix (GlaxoSmithKline [GSK] Biologicals' Human Papillomavirus [HPV] -16/18 Vaccine), When Administered According to the Approved Prescribing Information (PI) in Korea
The purpose of this post-marketing surveillance (PMS) study is to collect safety information on the use of Cervarix upon the expanded indication to anal cancer to both women and men (at least 600 Korean women and men) within 30…
- Trial name
- NCT03671369
- Testing
- Safety data collection (following routine vaccination) by a continuous surveillance method.
- Where
- 29 sites in South Korea
- Volunteers
- 670 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis B
HEPSERA Post Marketing Surveillance
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of adefovir dipivoxil administered in Korean CHB patients according to the prescribing information
- Trial name
- HEPSERA PMS (NCT01329419)
- Testing
- adefovir dipivoxil
- Volunteers
- 4,393 people
- Sponsor
- GlaxoSmithKline
Analgesia
ULTIVA Post Marketing Surveillance
This study is a post-marketing surveillance to monitor safety and efficacy of remifentanil during various surgeries and identify SAEs, adverse drug reactions, and unexpected AEs not described as precautions or warnings and to…
- Trial name
- NCT01299584
- Testing
- Remifentanil
- Volunteers
- 775 people
- Sponsor
- GlaxoSmithKline
Paroxysmal Atrial Fibrillation
Electrical Coupling Information From The Rhythmia HDx System And DirectSense Technology In Subjects With Paroxysmal Atrial Fibrillation
The objective of the study is to collect data on the use of the Rhythmia HDx mapping system running commercially available Software Version 2.0 or any future commercially available Software Version with DirectSense technology and…
- Trial name
- LOCALIZE (NCT03232645)
- Testing
- Ablation procedure
- Where
- 6 sites in France, Germany and 2 more
- Volunteers
- 62 people
- Sponsor
- Boston Scientific Corporation
Infections, Rotavirus
Evaluation of Reactogenicity and Safety of GSK Biologicals' Rotarix (Human Rotavirus Vaccine) in Infants
This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least…
- Trial name
- NCT00750893
- Testing
- Rotarix or Rotarix liquid formulation
- Where
- South Korea
- Volunteers
- 3,111 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Restless Legs Syndrome
REQUIP RLS Post Marketing Surveillance
post-marketing surveillance to monitor safety and efficacy of ropinirole during using of treatment for RLS
- Trial name
- REQUIP RLS PMS (NCT01327339)
- Testing
- Ropinirole
- Volunteers
- 755 people
- Sponsor
- GlaxoSmithKline
Diabetes Mellitus, Type 2
An Open Label, Multi-centre, Non-interventional Post-marketing Surveillance to Monitor the Safety and/or Efficacy of AVANDAMET Between June 2004 and January 2010
An open label, multi-centre, non-interventional post-marketing surveillance to monitor the safety and/or efficacy of rosiglitazone/metformin administered in Korean Diabetic patients according to the prescribing information
- Trial name
- AVANDAMETPMS (NCT01294553)
- Testing
- Administration of rosiglitazone/metformin
- Volunteers
- 717 people
- Sponsor
- GlaxoSmithKline
Pregnancy
Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns.
- Trial name
- NCT00116272
- Testing
- Etanercept
- Where
- United States
- Volunteers
- 830 people
- Sponsor
- Amgen
Narcolepsy
A Study to Collect Information of People With Narcolepsy in Spain
This study aims to review information of people with a sleep condition called narcolepsy. Narcolepsy is a condition that causes extreme sleepiness during the day including falling asleep suddenly.
- Trial name
- SOMNUS (NCT04667338)
- Where
- Spain
- Volunteers
- 214 people
- Sponsor
- Takeda
Colo-rectal Cancer
Safety,Usability and Compliance of Using C-Scan System for Providing Information on Colonic Polypoid Lesions and Masses
Protocol Title: Evaluation of safety, usability and subject compliance while using Check- Cap's C-Scan System for providing structural information on colonic polypoid lesions and masses Study Design: Prospective, Multi-center…
- Trial name
- C-Scan (NCT03735407)
- Testing
- C-Scan procedure
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Check-Cap Ltd.
Urea Cycle Disorder
Observational Study That Will Collect Information on Patients With Urea Cycle Disorders (UCDs)
THRIVE is an observational study that will collect information on patients with UCDs. THRIVE will follow enrolled participants for up to 10 years.
- Trial name
- THRIVE (NCT01948427)
- Where
- United States
- Volunteers
- 203 people
- Sponsor
- Amgen
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.
Heart Failure
A Study of Ponsegromab in People With Heart Failure
The primary purpose of this clinical trial is to compare the effects of study medicine (Ponsegromab/PF-06946860) with a placebo (an injection that looks like the study medicine but does not contain the active medicine) to find…
- Trial name
- GARDEN TIMI 74 (NCT05492500)
- Testing
- Main cohort (Cohort A): Ponsegromab low dose, Main cohort (Cohort A): Ponsegromab medium dose, Main cohort (Cohort A): ponsegromab high dose
- Where
- 122 sites in United States, Australia and 9 more
- Volunteers
- 455 people
- Sponsor
- Pfizer
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.