Clinical trials: Safety of Intervention
Atrial Fibrillation
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.
- Trial name
- CAPstopsLSPAF (NCT01103661)
- Testing
- Numeris®-AF Guided Coagulation System with VisiTrax®
- Where
- 4 sites in United States
- Volunteers
- 7 people
- Sponsor
- nContact Surgical Inc.
Hypertension
The Real-Life Efficacy and Safety of Telmisartan in Patients With Arterial Hypertension
The main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.
- Trial name
- METABOLIC (NCT00471003)
- Testing
- Pritor (Telmisartan , BAY68-9291)
- Where
- 4 sites in Croatia, Poland and 2 more
- Volunteers
- 5,448 people
- Sponsor
- Bayer
Cow's Milk Protein Allergy (CMPA)
TeriFort 1+ Study: Efficacy and Safety of an Extensively Hydrolyzed Formula in the Management of Cow's Milk Protein Allergy in Young Children: A Prospective, Single-Arm Interventional Study (TeriFort 1+)
This study aims to evaluate the clinical effect, as reported by physicians, of an extensively hydrolyzed formula in young children aged 1~3 years with diagnosed with or highly suspected CMPA in a real-world clinical practice…
- Trial name
- NCT07855796
- Testing
- Diagnosed with or highly suspected CMPA: Extensively Hydrolyzed Formula intervention
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Shanghai Teyi Yinuo Health Technology Co., Ltd.
Respiratory Disease
HDDO-1801 Intervention Trial
A randomized, open-label, single-dose, 3-period, 6-sequence, 3-way crossover study
- Trial name
- NCT04097951
- Testing
- Combinations
- Where
- South Korea
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Hyundai Pharmaceutical Co., LTD.
Alzheimer Disease
A Safety and Tolerability Evaluation of Two 10-Week Dose Regimens of Orally-Administered PF-04494700 in Alzheimer's Patients
A 10-week safety and tolerability study of a potential treatment for mild to moderate Alzheimer's disease.
- Trial name
- NCT00141661
- Testing
- PF-04494700 - Low Dose Arm, PF-04494700 - High Dose Arm
- Where
- 12 sites in United States
- Volunteers
- 67 people
- Sponsor
- Pfizer
Healthy Participants
A Trial Investigating Lu AF82422 in Healthy Chinese and Caucasian Adults
The main goals of this trial are to learn more about a) the safety and tolerability of Lu AF82422 (any new or worsening medical issues the participants have with treatment), b) the immunogenicity of Lu AF82422 (the potential for…
- Trial name
- NCT06258720
- Testing
- Lu AF82422
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- H. Lundbeck A/S
Brain Tumor Adult, Epilepsy
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring
The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes.
- Trial name
- WIN (NCT03731455)
- Testing
- WISE Cortical Strip
- Where
- 5 sites in Germany, Italy and 1 more
- Volunteers
- 32 people
- Sponsor
- Wise S.r.l.
Facial Wrinkles (Nasolabial Folds)
A Study to Determine Safety & Efficacy of Autologous Human Platelet Lysate (HPL) in Facial Wrinkles(Nasolabial Folds)
This is a multicentre, open label, pilot study to evaluate safety and efficacy of Autologous Human Platelet Lysate (HPL) in subjects with Facial Wrinkles (Nasolabial Folds). The study is being conducted at 2 centers in India.
- Trial name
- NCT01644461
- Testing
- Autologous Human Platelet Lysate
- Where
- India
- Volunteers
- 20 people
- Sponsor
- Kasiak Research Pvt. Ltd.
Atrial Flutter
Evaluation of the Safety, Feasibility and Usability of the EPD D700 System in Atrial Flutter Ablation Procedures
Demonstrate the safety, feasibility and usability of the EPD D700 system, for the first time in humans, in subjects undergoing ablation for the treatment of atrial flutter.
- Trial name
- NCT02768051
- Testing
- AF Ablation
- Sponsor
- EPD Solutions, A Philips Company
Depressive Disorder, Treatment-Resistant
A Study of Esketamine Nasal Spray in Korean Participants With Treatment-resistant Depression
The purpose of this study is to evaluate how well esketamine nasal spray works in improving depressive symptoms in participants with treatment resistant depression (TRD).
- Trial name
- NCT07053345
- Testing
- Esketamine 56 mg, Esketamine 84 mg
- Where
- 6 sites in South Korea
- Volunteers
- 47 people
- Sponsor
- Janssen Korea, Ltd., Korea
CSF Leak
The Paediatric EVICEL® Neuro Study
The purpose of this study is to evaluate the safety and efficacy of EVICEL® when used for suture-line sealing in dura-mater closure in elective or urgent paediatric cranial neurosurgery to provide intraoperative watertight…
- Trial name
- NCT02309645
- Testing
- EVICEL® Fibrin Sealant, Sutures Only
- Where
- 7 sites in United Kingdom
- Volunteers
- 40 people
- Sponsor
- Ethicon, Inc.
Patent Ductus Arteriosus
Post Marketing Clinical Follow Up Study to Evaluate Efficacy and Safety of the Occlutech PDA Occluder in Patients With Patent Ductus Arteriosus Defects
This retrospective and prospective, multicenter, international post marketing follow up study evaluates the safety and efficacy of the Occlutech® PDA Occluder, delivered using the Occlutech Occlusions Pusher (OOP), in subjects…
- Trial name
- NCT05264753
- Testing
- Occlutech® PDA Occluder
- Where
- 15 sites in Canada, France and 7 more
- Volunteers
- 255 people
- Sponsor
- Occlutech International AB
Menorrhagia, Dysmenorrhea
Prospective, Non-interventional, Multi-center Safety Study of Mirena for Heavy Menstrual Bleeding and Dysmenorrhea
The primary objective in this study is collecting post-marketing information on the safety. Thus, it includes information under the routine clinical practice on adverse events (AEs) and adverse drug reactions (ADRs) including…
- Trial name
- J-MIRAI (NCT02475356)
- Testing
- Levonorgestrel IUS (Mirena, BAY86-5028)
- Where
- Japan
- Volunteers
- 601 people
- Sponsor
- Bayer
Anesthesia
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
- Trial name
- NCT01844830
- Testing
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- St. Renatus, LLC
Lennox-Gastaut Syndrome
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome
This Phase 3 trial will enroll participants diagnosed with Lennox-Gastaut Syndrome (LGS) who are still experiencing at least 4 motor seizures involving the trunk or extremities per week, despite ongoing treatment with up to 3…
- Trial name
- NCT02318537
- Testing
- Cannabidiol Oral Solution
- Sponsor
- INSYS Therapeutics Inc
Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.
This is a Phase 3 extension, global, multicenter study to assess the long-term safety and tolerability of tolebrutinib in adult participants (aged ≥18 years) with RMS, PPMS, or NRSPMS who were previously enrolled in the Phase 2b…
- Conditions
- Relapsing Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Progressive Relapsing Multiple Sclerosis
- Trial name
- NCT06372145
- Testing
- Tolebrutinib, Teriflunomide
- Where
- 352 sites in United States, Argentina and 45 more
- Volunteers
- 2,500 people
- Sponsor
- Sanofi
Arthritis, Psoriatic
Study to Evaluate the Real-World Effectiveness, Safety and Tolerability of Treatment With Apremilast in Psoriatic Arthritis Patients Followed in Canadian Routine Care (APPRAISE)
This will be a Canadian observational study utilizing a prospective cohort design. Patients with active psoriatic arthritis (PsA) for whom the treating physician has decided, prior to and independently of enrollment in the study…
- Trial name
- APPRAISE (NCT03608657)
- Testing
- Apremilast
- Where
- 19 sites in Canada
- Volunteers
- 102 people
- Sponsor
- Amgen
Pulmonary Arterial Hypertension
Pilot Study Evaluating the Safety and Performance of the GeNO NITROsyl Delivery System for Inhaled Nitric Oxide
This is an open label phase 2 pilot study designed to evaluate the safety, tolerability and device performance of the GeNO nitrosyl delivery system during right heart catheterization (RHC) in participants with pulmonary arterial…
- Trial name
- PILOT (NCT01092559)
- Testing
- Nitric Oxide generated by the GeNO nitrosyl delivery system
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Geno LLC
CT-guided Minimally Invasive Procedures e.g., Biopsies
Evaluation of the Safety, Effectiveness & Usability of the XACT Robotic System for Image Guided Percutaneous Procedures
This is a prospective, single-arm study is to evaluate the safety, effectiveness and usability of the XACT device. Subjects undergoing CT-guided, minimally invasive percutaneous procedures in the interventional radiology suite…
- Trial name
- NCT03008603
- Testing
- XACT Robotic System
- Where
- 2 sites in United States, Israel
- Volunteers
- 60 people
- Sponsor
- Xact Robotics Ltd.
Pain, Postoperative, Orthopedic Procedures
A Randomized, Open-Label, Single-Dose, Small Study to Evaluate the Safety and Effectiveness of Hydromorphone in Patients With Short Term, Moderate to Severe Postoperative Pain
The purpose of this small study was to investigate the safety and effectiveness of OROS hydromorphone HCI for the treatment of short-term, moderate to severe postoperative pain following total knee replacement surgery.
- Conditions
- Pain, Postoperative, Orthopedic Procedures, Analgesia
- Trial name
- NCT00411307
- Testing
- OROS hydromorphone HCI
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Alza Corporation, DE, USA