Gauyas, Ecuador
Effectiveness of the Suicidal Crisis Intervention (SCI)
Research has extensively shown that a previous suicide attempt or a history of suicide attempts are important predictors of suicide death. It is therefore important to provide people with appropriate care after a suicide attempt to limit this risk. Although this risk factor (previous attempts) is known, the number of interventions developed for this risk group is limited. Based on these findings, a short-term treatment trajectory was developed for people after a suicide attempt or a suicidal crisis in Flanders, called the Suicidal Crisis Intervention (SCI). This was inspired by the ASSIP treatment trajectory and the safety plan was also given a significant place within the treatment. In addition, the importance of relatives and social support is emphasized by involving relatives in this treatment. Throughout this treatment, further (treatment) goals are drawn up, in order to generate hope for improvement and to facilitate continuity of care. More information about the concrete content of SCI will follow later in this protocol. A pilot study is currently being conducted to assess the feasibility of this treatment, as well as the experience of patients, relatives and care providers. Based on this, the SCI will be further updated for this effectiveness study. There are currently no specific evidence-based short-term treatment methods in Flanders for people after a suicidal crisis or suicide attempt. The primary research question is therefore: 'Is the Suicidal Crisis Intervention (SCI) in Flanders an effective short-term treatment method for people after a suicidal crisis or suicide attempt?'. The main objective of this project is to be able to offer a new, specific short-term treatment method that has been scientifically proven to reduce suicidality. In addition, we want to investigate the influence of SCI on other important aspects of suicidality (secondary goal) such as hopelessness, defeat, entrapment, and interpersonal needs.
Phase
N/ASpan
130 weeksSponsor
University Hospital, GhentRonse
Recruiting
Healthy Volunteers
Belgian Central Sleep Apnea REgistry
Central sleep apnea (CSA) is characterized by intermittent cessation or decrease of airflow and effort of breathing during sleep. The diagnostic criteria for CSA varies according to the type of CSA (e.g. CSA due to cardiac failure, due to a medication, ...). CSA is defined as: (1) an apnea/hypopnea index ≥ 15 per hour of sleep and (2) the number of central apneas and/or hypopneas is > 50% of the total number of apneas and hypopneas. Presence of CSA is associated with excessive daytime sleepiness and poor sleep quality. Furthermore, in patients with heart failure, presence of CSA was found to be related to mortality. As yet, however, there is insufficient knowledge on the clinical features, pathophysiological background and consecutive algorithms for treatment. Currently, it is not fully clear whether CSA or the treatment of CSA is related to disease progress. The aim of this trial is to evaluate the current treatment choices for CSA in Belgium and compliance with and effects of these treatments.
Phase
N/ASpan
522 weeksSponsor
Universitaire Ziekenhuizen KU LeuvenRonse
Recruiting
Ronse
Recruiting
Observational Real-life Study of Cabozantinib in Monotherapy or in Combination With Nivolumab in Advanced Renal Cell Carcinoma (RCC)
Phase
N/ASpan
330 weeksSponsor
IpsenRonse
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
AstraZenecaRonse
Recruiting
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single arm, non-randomized.
Phase
3Span
306 weeksSponsor
Eli Lilly and CompanyRonse
Recruiting
Treatment With Bempedoic Acid and/or Its Fixed-dose Combination With Ezetimibe in Primary Hypercholesterolemia or Mixed Dyslipidemia
This non-interventional study will be conducted to characterize the risks and benefits of bempedoic acid and/or its fixed-dose combination with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia or mixed dyslipidaemia and to gain insight into the effectiveness (managing plasma levels of low-density lipoprotein cholesterol) as well as safety (clinical events associated with the treatment modalities). Real world evidence will be collected in 5000 participants, treated by specialized as well as non-specialized physicians in hospitals and office based centers.
Phase
N/ASpan
242 weeksSponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo CompanyRonse
Recruiting