Clinical trials: Performance and Safety
Tuberculosis
A Trial in Subjects Suspected to Have Tuberculosis, Comparing the Diagnostic Performance of C-Tb to QuantiFERON®, in Combination With a Safety Assessment of C-Tb Versus Tuberculin PPD RT23 SSI
Tuberculosis (TB) continues to be one of the most serious bacterial infections worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. The new skin test is named C-Tb.
- Trial name
- NCT01642888
- Testing
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Where
- 9 sites in South Africa
- Volunteers
- 1,190 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Tuberculosis
Comparison of Diagnostic Performance of C-Tb to QuantiFERON®-TB, in Combination With a Safety Assessment of C-Tb vs Tuberculin PPD RT23 SSI
Tuberculosis (TB) continues to be the most important bacterial infection worldwide and therefore new improved diagnostic tests are needed to help doctors in diagnosing TB. We are investigating a new skin test named C-Tb.
- Trial name
- NCT01631266
- Testing
- C-Tb, 2 T.U. Tuberculin PPD RT 23 SSI
- Where
- 13 sites in Spain
- Volunteers
- 979 people, healthy volunteers welcome
- Sponsor
- Statens Serum Institut
Hyperpronated Foot, Reconstruction Surgeries of the Foot
Evaluate the Continued Safety and Performance of the Foot and Ankle Products
The objective of the registry is to evaluate the continued safety and performance of Arthrex foot and ankle products, including the ProStop® implant for hyperpronated foot; Bio-Compression Screw for reconstruction surgeries of…
- Conditions
- Hyperpronated Foot, Reconstruction Surgeries of the Foot, Fixation of Fractures and Fusion (Bunionectomy Osteotomies) of the Foot/Ankle, Fixation of Small Bone Fragments of the Foot/Ankle
- Trial name
- NCT04715139
- Testing
- Products listed in Group/Cohort Description
- Where
- 7 sites in United States, Germany and 1 more
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- Arthrex, Inc.
Safety and Performance
A Retro/Prospective Multi-Centre Data Capture on REDAPT Sleeved Stem
Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.
- Trial name
- NCT05600712
- Testing
- REDAPT Sleeved Stem
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Foundation for Orthopaedic Research and Education
TMJ Disc Disorder, TMJ Pain
MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
The objective of this retrospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the JuggerKnot Mini Soft Anchor (implant and instrumentation) when used for soft tissue…
- Conditions
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw, TMJ Disease
- Trial name
- NCT04033692
- Testing
- JuggerKnot Mini Soft Anchor
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Cognitive Performance, Sleep Quality
The Effect of Caffeinated Chewing Gum on Cognitive Performance in Night-shift Emergency Physicians
This study aimed to examine the impact of caffeinated chewing gum on the cognitive performance of night-shift emergency physicians in a partially sleep-deprived state.
- Trial name
- NCT06693505
- Testing
- caffeinated chewing gum
- Where
- Taiwan
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- China Medical University Hospital
Musical Performance, Neuromodulation
Safety and Acute Effects of tDCS on Musical Performance in Adolescent Instrumentalists
This randomized, sham-controlled proof-of-concept study aims to investigate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) on musical performance in adolescent instrumentalists aged…
- Trial name
- NCT07826923
- Testing
- Active Transcranial Direct Current Stimulation (tDCS)
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro Universitário Augusto Motta
Vocal Performance, Neuromodulation
Safety and Acute Effects of tDCS on Vocal Performance in Adolescent Singers
This randomized, sham-controlled proof-of-concept study aims to investigate the safety, tolerability, and acute effects of transcranial direct current stimulation (tDCS) on vocal performance in adolescent singers aged 12 to 16…
- Trial name
- NCT07861490
- Testing
- Active Transcranial Direct Current Stimulation (tDCS)
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Centro Universitário Augusto Motta
Respiratory Diseases, Pneumonia
Performance and Safety of the Pneumoscope Device in Adults and Children
Respiratory diseases are associated with high morbidity and mortality worldwide. Proper diagnosis and risk assessment of these conditions are essential for optimal management.
- Conditions
- Respiratory Diseases, Pneumonia, Asthma, Cyanotic Heart Disease
- Trial name
- NCT06373939
- Testing
- Digital lung auscultation, Pulse oximetry measurement, Non invasive body temperature measurement
- Where
- Switzerland
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Pediatric Clinical Research Platform
Diaper Rash
Evaluation of the Safety and Performance of LiNiDERM® in the Prevention of Infant Diaper Rash
Result of immaturity of the skin and factors promoting maceration and mechanical interactions, Irritant diaper dermatitis (IDD) can manifest as early as the third week of life.
- Trial name
- NCT03640897
- Testing
- Liniderm, Wipes, Water
- Where
- Poland
- Volunteers
- 133 people, healthy volunteers welcome
- Sponsor
- Laboratoires Gilbert
Overtraining Syndrome
Safety and Prevention of OveRTraining
Athletic training aims to increase and improve physical performance that is achieved through training overload combined with periods of rest and recovery.
- Trial name
- SuPpOrt (NCT03833973)
- Testing
- Overtraining Monitoring
- Where
- Greece
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Thessaly
AI (Artificial Intelligence), Large Language Model
OpenEvidence Safety and Comparative Efficacy of Four LLM's in Clinical Practice
OpenEvidence is an online tool that aggregates and synthesizes data from peer-reviewed medical studies, then producing a response to a user's questions using generative AI.
- Conditions
- AI (Artificial Intelligence), Large Language Model, Generative Artificial Intelligence
- Trial name
- NCT07199231
- Testing
- AI clinical reference tool
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cambridge Health Alliance
Glioma
68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients.
- Trial name
- NCT02520882
- Testing
- 68Ga-NOTA-Aca-BBN, PET/CT
- Where
- China
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Dyslexia
Evaluation of the Performance and Safety of the Atoldys/ Lexilens Glasses Developed to Improve the Reading of Dyslexic Subjects
The aim of this study is to evaluate the efficacy and safety of a new medical device (Atoldys/ Lexilens glasses) on the improvement of reading skills of young dyslexic subjects.
- Trial name
- NCT04586621
- Where
- 3 sites in France
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- ABEYE
Stoma Ileostomy
Post Market Clinical Follow-up Study Evaluating Performance and Safety of the SenSura® Mio Kids Device
This is a post market clinical follow-up study and devices will carry the CE mark once the study is initiated. The investigational device is SenSura® Mio Kids, which is a flat ostomy device.
- Trial name
- NCT03784989
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Bankart Lesion, Acetabular Labrum Tear
S&P of Q-Fix™ All-Suture Anchor System
Post-market clinical follow-up needed to address existing clinical data and gaps on the existing Q-Fix™ device and meet existing MDD/MEDDEV requirements
- Conditions
- Bankart Lesion, Acetabular Labrum Tear, SLAP Lesion, Acromioclavicular Sprain
- Trial name
- NCT03594071
- Testing
- The Q-Fix™ All-Suture Anchor
- Where
- 5 sites in United States
- Volunteers
- 294 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Incontinence, Urge
T-DOC® 5 Fr Pediatric Clinical Investigation
A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
- Trial name
- NCT03429270
- Testing
- TDOC 5Fr
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Laborie Medical Technologies Inc.
Total Knee Arthroplasty
Journey II Bi-Cruciate Stabilized (BCS) Total Knee System Retrospective Study
The objective of this study is to estimate the safety and performance of Journey II BCS TKS.
- Trial name
- NCT03292003
- Testing
- Journey II BCS Total Knee System
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 1,694 people, healthy volunteers welcome
- Sponsor
- Smith & Nephew, Inc.
Behavior
RxConnect User Testing Study
Background Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically…
- Trial name
- NCT05493072
- Testing
- RxConnect
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial College London