Ijssel, Netherlands
Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain
Phase
N/ASpan
109 weeksSponsor
Studie- & Opleidingscentrum Neurochirurgie Virga JesseSint-Truiden
Recruiting
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
The purpose of this study is to investigate the efficacy, safety, and tolerability of baxdrostat in combination with dapagliflozin, compared with placebo and dapagliflozin, in reducing the risk of the composite of > 50% decline in eGFR, kidney failure, or CV death, in individuals with CKD and HTN. This study consists of a 4-week dapagliflozin Run-in Period for participants untreated with SGLT2i at screening, and a double-blinded period where participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin. Site visits will take place at 2-, 4-, 8-, 16-, 34, and 52-weeks following randomisation. Thereafter visits will occur approximately every 4 months. The study closure procedures will be initiated when the predetermined number of primary endpoint events is predicted to have occurred ie, the PACD. All randomised participants including any participants who have prematurely discontinued study intervention will be scheduled for a SCV within a few weeks of the PACD. This period can be extended by the Sponsor. In case of premature discontinuation of blinded study intervention, participants will continue in the study and receive dapagliflozin 10 mg, unless the participant meets dapagliflozin specific discontinuation criteria. If study intervention is temporarily or permanently discontinued, the participant should remain in the study, and it is important that the scheduled study visits (including the PTDV for participants with permanent discontinuation of study intervention) and data collection continue according to the study protocol until the SCV.
Phase
3Span
268 weeksSponsor
AstraZenecaSint-Truiden
Recruiting
Implementation of a Multidimensional Quality Model
Phase
N/ASpan
180 weeksSponsor
KU LeuvenSint-Truiden
Recruiting
Healthy Volunteers
HCV Reinfection After DAA Therapy in PWID in Belgium
This protocol is an adapted version of the protocol 'Hepatitis C reinfection after successful directly acting antiviral treatment: A North-Atlantic multicenter interventional study'. The investigators will plan this study so that the data are similar to this protocol and results can be compared within this alliance of hepatologists with special interest in care for substance users. Study schedule: Data collection will be performed according to the study schedule shown in Table 1. Following assessment for SVR12, participants will be followed for 2 years at 6 months' intervals at the discretion of each study site.
Phase
N/ASpan
139 weeksSponsor
Hasselt UniversitySint-Truiden
Recruiting
Active and Healthy Ageing for All: a Multi-component Healthy Lifestyle Program
1. co-creation : all participants will be questioned and included in the co-creation session 2. implementation : the developed multicomponent healthy lifestyle program will be enrolled and implemented in 6 locations (community services for older adults in Flanders and Brussels) 3. evaluation : the program will be evaluated (effects and process)
Phase
N/ASpan
266 weeksSponsor
KU LeuvenSint-Truiden
Recruiting
Healthy Volunteers
LimPrOn: Limburg Pre-eclampsia Investigation
Phase
N/ASpan
766 weeksSponsor
Hasselt UniversitySint-Truiden
Recruiting
Healthy Volunteers