Clinical trials: Observation
Malignant Melanoma
An Observational Safety Study in Zelboraf (Vemurafenib)-Treated Patients With BRAF-V600 Mutation-Positive Unresectable or Metastatic Melanoma (ZeSS)
This multi-center, prospective, observational safety study will evaluate the safety and effectiveness of Zelboraf (vemurafenib) in a real world setting.
- Trial name
- NCT01990248
- Where
- 80 sites in Austria, Belgium and 8 more
- Volunteers
- 339 people
- Sponsor
- Hoffmann-La Roche
Right Ventricular Outflow Tract Dysfunction
Observational Study of Venus P-Valve
Real-world evidence, retrospective and prospective, non-randomized, multicenter observational study of VenusP-ValveTM System in treating moderate or greater pulmonary regurgitation with/without pulmonary stenosis in patients with…
- Trial name
- Registry (NCT05835349)
- Testing
- transcatheter pulmonary valve implantation (TPVI)
- Where
- 10 sites in France, Germany and 2 more
- Volunteers
- 200 people
- Sponsor
- Venus MedTech (HangZhou) Inc.
Phenylketonuria, Maternal
A Global, Multicenter Study to Assess Maternal, Fetal and Infant Outcomes of Exposure to Palynziq® (Pegvaliase) During Pregnancy and Breastfeeding
This is a Phase 4 observational study designed to assess the impact of Palynziq ® (pegvaliase) treatment in pregnant women with PKU and on their offspring who were exposed to pegvaliase at any time during pregnancy and…
- Trial name
- PALomino (NCT05579548)
- Testing
- Pegvaliase
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 50 people
- Sponsor
- BioMarin Pharmaceutical
Vascular Closure, Endovascular Procedure
Post-market Clinical Investigation of the Angio-Seal™ VIP VCD (ANGIO-SEAL CLOSE)
The present post-market surveillance study aims to evaluate the safety and effectiveness of the Angio-SealTM VIP VCD in patients undergoing endovascular procedures via femoral access in real-world setting.
- Conditions
- Vascular Closure, Endovascular Procedure, Hemostasis, Peripheral Vascular Disease
- Trial name
- NCT05335525
- Testing
- Closure of the femoral arterial puncture site
- Where
- 4 sites in France, Germany and 1 more
- Volunteers
- 230 people
- Sponsor
- Terumo Europe N.V.
Diabetes, Diabetes Mellitus, Type 2
Observational Study of Safety and Effectiveness of NovoMix® 30 for the Treatment of Diabetes
This study is conducted in Asia, Europe, Japan and North America. The aim of this observational study is to evaluate the safety and effectiveness while using NovoMix® 30 during 26 weeks under normal clinical practice, in the…
- Trial name
- IMPROVE™ (NCT00659282)
- Testing
- biphasic insulin aspart
- Where
- 11 sites in Canada, China and 9 more
- Volunteers
- 57,610 people
- Sponsor
- Novo Nordisk A/S
Rheumatoid Arthritis
Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were…
- Trial name
- NCT01683604
- Testing
- Observational study
- Where
- 7 sites in Australia
- Volunteers
- 37 people
- Sponsor
- Hoffmann-La Roche
Central Precocious Puberty
A Study to Assess the Safety and Efficacy of Enantone (Leuprorelin) in Central Precocious Puberty (CPP) Among Chinese Participants
The purpose of this study is to evaluate the long-term safety and efficacy of Enantone in the treatment of CPP in Chinese participants.
- Trial name
- NCT02993926
- Testing
- Enantone, GnRH agonist
- Where
- 6 sites in China
- Volunteers
- 108 people
- Sponsor
- Takeda
COVID-19
Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents
This study is a multi-center and open design, phase Ⅳ clinical trial of an inactivated SARS-CoV-2 vaccine (CoronaVac) manufactured by Sinovac Research and Development Co., Ltd.The purpose of this study is to evaluate the safety…
- Trial name
- NCT04992208
- Testing
- Experimental Group
- Where
- China
- Volunteers
- 31,041 people, healthy volunteers welcome
- Sponsor
- Sinovac Life Sciences Co., Ltd.
Multiple Sclerosis
A Study Utilising Data From European Union (EU) National Multiple Sclerosis (MS) Registries to Assess the Incidence of Anti-Natalizumab Antibody Among Participants Who Receive Subcutaneous Administration of Natalizumab for Treatment of Relapsing-remitting Multiple Sclerosis (RRMS)
The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab…
- Trial name
- NCT05925049
- Testing
- Natalizumab
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Biogen
Autoimmune Diseases
Trial Assessing Safety and Efficacy of Gammanorm® in Autoimmune Diseases
This observational trial assesses the safety and efficacy of Gammanorm® in autoimmune diseases.
- Trial name
- NCT03656640
- Testing
- Gammanorm
- Where
- 3 sites in France, Martinique
- Volunteers
- 60 people
- Sponsor
- Octapharma
Colitis, Ulcerative
A Study to Assess Clinical Effectiveness and Safety of Vedolizumab Intravenous in Real World Clinical Practice in Ulcerative Colitis (UC) Korean Participants
The purpose of this study is to assess the clinical effectiveness by the clinical response at 6 weeks and the safety of vedolizumab intravenous in UC Korean participants.
- Trial name
- NCT03535649
- Where
- 15 sites in South Korea
- Volunteers
- 105 people
- Sponsor
- Takeda
Aortic Valve Stenosis
Hydra Single-centre Experience - Copenhagen, Denmark
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure.
- Trial name
- NCT06342635
- Testing
- Hydra Transcatheter Aortic Valve (THV) Series
- Where
- Denmark
- Volunteers
- 50 people
- Sponsor
- Sahajanand Medical Technologies Limited
Crohn Disease, Inflammatory Bowel Disease (IBD)
Retrospective Observational Multicenter Study on the Treatment Patterns, Extra-Intestinal Manifestations, Resource Utilisation, and Outcomes of Patients With Inflammatory Bowel Disease in Dutch Hospitals
This multicenter retrospective real-world data study will evaluate the treatment pathways and disease burden of adult patients with Crohn's disease (CD) and ulcerative colitis (UC) treated in 5-10 Dutch hospitals between 2018 and…
- Conditions
- Crohn Disease, Inflammatory Bowel Disease (IBD), Colitis Ulcerative
- Trial name
- NCT07682038
- Testing
- Routine hospital care data (observational)
- Volunteers
- 3,500 people
- Sponsor
- LOGEX
Carcinoma
A Non Interventional Study With Paclitaxel Onkovis (Paclitaxel) Utilized for the Treatment of Cancer
The main purpose of this observational study with Paclitaxel is to determine the number of treatment cycles and the quantity of Paclitaxel onkovis needed therefore under the special circumstance of ambulant chemotherapy.
- Trial name
- NCT01668108
- Where
- 5 sites in Germany
- Volunteers
- 770 people
- Sponsor
- Onkovis GmbH
Breast Cancer, HER2-negative Breast Cancer
Post-Marketing Surveillance Study of Eribulin on the Status and Factors for the Development of Peripheral Neuropathy in Japan.
The primary objective of the study is to clarify factors affecting the incidence of peripheral neuropathy in patients treated with HALAVEN.
- Trial name
- NCT02371174
- Where
- 2 sites in Japan
- Volunteers
- 651 people
- Sponsor
- Eisai Co., Ltd.
Hepatitis B, Chronic
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis B Who Have Failed Antiviral Treatment With Nucleoside (Nucleotide) Analogues
This observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis B who have failed antiviral treatment with nucleoside (nucleotide) analogues.
- Trial name
- NCT01794234
- Where
- 9 sites in Poland
- Volunteers
- 44 people
- Sponsor
- Hoffmann-La Roche
COPD Exacerbation
COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device
The Headstart Test system is an in vitro diagnostic test intended for self-testing for the detection of five biomarkers of infection in the urine of patients diagnosed with chronic obstructive pulmonary disease (COPD).
- Trial name
- COPE-WEL (NCT04296318)
- Where
- United Kingdom
- Volunteers
- 86 people
- Sponsor
- Mologic Ltd
Niemann-Pick Diseases, Acid Sphingomyelinase Deficiency
A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)
US, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care…
- Trial name
- NCT06192576
- Testing
- Olipudase alfa
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
Sleep Disturbance
Sleep Well Observation Study
Insomnia is characterized by the recurring difficulty to fall or remain asleep despite motivation and means to do so. People with insomnia also experience excessive daytime sleepiness and other cognitive impairments while they…
- Trial name
- NCT05748574
- Testing
- Sleep Well Sachet
- Where
- Germany
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- A. Vogel AG
Major Depressive Disorder (MDD), fNIRS
Prediction of REsponse to Depression Interventions (Accelerated rTMS) Using Clinical and TD-fNIRS Measurements
This observational, longitudinal, multi-cohort study aims to evaluate functional brain activity in adults undergoing treatment for Major Depressive Disorder (MDD) at participating clinical sites.
- Trial name
- PREDICT-ACC (NCT07294924)
- Testing
- fNIRS measurement
- Where
- 2 sites in United States
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- Kernel
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