Clinical trials: Information Systems
- Condition Information Systems
- Funder type Industry (pharma, biotech, devices)
- Accepts healthy volunteers yes
Polypoid Lesions
Evaluation of Check-Cap C-Scan System in Providing Structural Information and Detection of Polypoid Lesions
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to FIT.
- Trial name
- NCT02990715
- Testing
- C-Scan System
- Where
- 3 sites in Israel
- Volunteers
- 66 people, healthy volunteers welcome
- Sponsor
- Check-Cap Ltd.
Infections, Papillomavirus
Cervarix Long-term Safety Surveillance
This study aims to assess whether the use of Cervarix® is associated with a modified risk of central demyelination, type 1 diabetes (DT1), Cutaneous Lupus, inflammatory arthritis, idiopathic thrombocytopenic purpura (ITP), Lupus…
- Trial name
- PGRx (NCT01498627)
- Testing
- Cervarix, Data collection
- Volunteers
- 2,945 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acellular Pertussis, Diphtheria
Post-marketing Surveillance to Assess the Safety of Infanrix-IPV Vaccine Among Infants and Children in Korea
The purpose of this study is to collect safety information following routine vaccination with Infanrix-IPV among infants and children in Korea.
- Conditions
- Acellular Pertussis, Diphtheria, Tetanus, Poliomyelitis
- Trial name
- NCT01568060
- Testing
- Infanrix-IPV data collection
- Where
- South Korea
- Volunteers
- 645 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.
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.
High Risk (Above Average) Subjects, Non Compliant Patients for Colo Rectal Cancer [CRC] Screening
Evaluation of C-Scan System in Providing Structural Information and Detection of Polypoid Lesions in High Risk Subjects
The purpose of this study is to establish the efficacy of Check-Cap's C-Scan System in providing structural information on colonic polypoid lesions and masses, as an adjacent tool to Feacal Immunochemical Test [FIT] in high risk…
- Conditions
- High Risk (Above Average) Subjects, Non Compliant Patients for Colo Rectal Cancer [CRC] Screening, Counterindicated Patients for Colonoscopy
- Trial name
- NCT03356002
- Testing
- C-Scan System
- Where
- 7 sites in Israel
- Volunteers
- 142 people, healthy volunteers welcome
- Sponsor
- Check-Cap Ltd.
Risk for Colorectal Cancer
Evaluation C-Scan System in Providing Structural Information and Polypoid Lesions in the Colon of Healthy Subjects
Up to 300 subjects will participate in this study. Subjects to be enrolled in this study are typically healthy and at average or high risk for CRC.
- Trial name
- CRC (NCT04038736)
- Testing
- C-Scan System
- Where
- 4 sites in Israel
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Check-Cap Ltd.
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.
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
Epilepsy
Trobalt™ Products Risk Survey
As part of a European post-marketing commitment, GSK will conduct a survey of physicians' and patients' understanding of the significant risks associated with Trobalt™ (retigabine), as described in the Patient Information Leaflet…
- Trial name
- NCT01721213
- Testing
- Trobalt™
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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
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
Colitis, Ulcerative, Crohn's Disease
OTIS Vedolizumab Pregnancy Exposure Registry
The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to…
- Trial name
- NCT02678052
- Testing
- Vedolizumab, Other Biological Agent
- Where
- United States
- Volunteers
- 303 people, healthy volunteers welcome
- Sponsor
- Takeda