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NCT ID: NCT03566082 Active, not recruiting - Clinical trials for Degenerative Joint Disease of Hip

Post-Approval Study of the R3 Biolox Delta Ceramic Acetabular System - Europe

R3 EU PAS
Start date: February 10, 2017
Phase:
Study type: Observational

The purpose of this prospective, multicenter, single arm study is to confirm the long-term safety and effectiveness of the R3 delta Ceramic Acetabular System PMA (P150030) by evaluating long-term (10 years after surgery) follow-up results.

NCT ID: NCT03564509 Recruiting - Clinical trials for Controlled Ovarian Stimulation

A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.

RAINBOW
Start date: May 14, 2018
Phase: Phase 2
Study type: Interventional

The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol. Furthermore, the study intends: - To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol. - To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol. - To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.

NCT ID: NCT03564418 Recruiting - Low Back Pain Clinical Trials

Ultrasound-Guided Thermocoagulation of Medial Nerve Branch in Lumbar Facet Joints Pain.

Start date: January 2, 2018
Phase: N/A
Study type: Interventional

We propose here to evaluate the precision of lumbar thermocoagulation performed under a transverse ultrasound approach by performing a fluoroscopic control once the needle in the desired position. The effectiveness of the technique will be assessed by measuring different pain and disability scores at six weeks post-thermocoagulation: the Visual analogue pain Scale score (VAS) and the Oswestry disability score (ODI) will be collected, compared to that of the conventional fluoroscopic technique.

NCT ID: NCT03563014 Not yet recruiting - Clinical trials for Prostatic Neoplasms, Castration-Resistant

A Local Retrospective Observational Study to Evaluate the Treatment Patterns of mCRPC Patients in Belgium Treated With Radium-223

BELFIGO
Start date: July 1, 2018
Phase:
Study type: Observational

The aim of this non interventional study is to describe the proportion of Belgian mCRPC patients which were treated with 1 to 4 and 5 to 6 Radium-223 injections and the patient characteristics which are potentially associated with this proportion.

NCT ID: NCT03561636 Active, not recruiting - Health Literacy Clinical Trials

Health Literacy in the General Population in Belgium

Start date: June 1, 2017
Phase:
Study type: Observational

The aims of the study are: - To measure health literacy (HL) levels in a sample composed of members of a health mutual (Solidaris), and its potential associations with several determinants (health, health services consumption, health behaviours...) - To identify potential groups at risk of a lower HL - To identify the determinants of HL level

NCT ID: NCT03560440 Completed - Clinical trials for Gram-Positive Bacterial Infections

Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

Start date: June 2014
Phase:
Study type: Observational

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.

NCT ID: NCT03559621 Not yet recruiting - Clinical trials for Type 2 Diabetes Mellitus

Melinda Pilot Study

MELINDA
Start date: May 6, 2019
Phase: N/A
Study type: Interventional

Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.

NCT ID: NCT03558711 Completed - Prostate Cancer Clinical Trials

PSMA-PET/CT for Prostate Cancer

NGP1
Start date: January 4, 2018
Phase: Phase 1
Study type: Interventional

Prostate cancer is the most frequently occurring male cancer in Belgium. Patients who have been treated for prostate cancer, i.e. by surgery and/or radiotherapy, in a substantial degree suffer from a tumor recurrence, often diagnosed by an increase in serum tumor marker PSA (prostate specific antigen) within the first few years. In these patients with evidence of a tumor recurrence after primary treatment, it is important to most exactly define the location(s) of tumor, to guide appropriate therapy by surgery, radiotherapy and/or hormonotherapy. In so-called oligo-metastatic disease targeted therapy may still be curative and prevent the disease from spreading to distant locations. Therefore it is of paramount importance to have an accurate tool of medical imaging to localize all possible locations to be treated. With some patients, the PSA-value is so low, that conventional nuclear medicine bone scanning or radiological CT or MRI cannot determine where the metastases are. Therefore, [18F]-Choline PET-CT was introduced to improve diagnostic imaging performance. However, in 30 to 40 percent of patients choline-PET does not localize tumor either, especially in small tumors and/or very low PSA values. The PSMA PET is already routinely used in many European centres, and has shown a superior accuracy in these patients as compared to conventional imaging techniques. This has been a very consistent finding in scientifically reported patient studies. Most of these investigations have been performed with PSMA labeled with Gallium-68. The investigators in Ghent, as others, have labeled PSMA with Fluor-18. This tracer provides many advantages, including a higher production yield enabling more patients to be scanned. Also from a perspective of radioprotection and financial costs, Fluor-18 is a better choice. Moreover, several recent studies, comparing Fluor with Gallium modalities seem to suggest equivalent or better diagnostic results, possibly because of a lower aspecific background activity.

NCT ID: NCT03557840 Not yet recruiting - Infection Clinical Trials

Plasma Protein Binding and PK/PD of Total and Unbound Temocillin Non-ICU Patients

TEMODELTA
Start date: July 15, 2018
Phase: N/A
Study type: Interventional

Multidrug resistance towards Gram-negative pathogens makes essential the re-examination of older compounds. Temocillin is a penicillin originally marketed in the 1980s but then largely abandoned. It, however, shows a marked ß-lactamase stability (including most classical and extended-spectrum TEM, SHV, CTX-M enzymes and AmpC ß-lactamase). Temocillin is approved for the treatment of bacterial infections of the chest, the lungs, the kidney, the bladder, as well as bacterial infections of the bloodstream and wound infections. Temocillin efficacy depends primarily from the time interval during which the unbound plasma concentration remains above the minimal inhibitory concentration (MIC) of the antibiotic against the target organism(s). Unfortunately, no comprehensive pharmacokinetic data are available in non-critically-ill patients. The primary objective of the study is characterize the pharmacokinetics of total and unbound temocillin in non-ICU patients, and, on this basis, to propose optimized dosage regimens in this population. The secondary objectives are (i) to look for possible correlations between the plasma protein profile and the unbound temocillin concentrations; (ii) to investigate the impact of the level and nature of circulating plasma proteins on the unbound temocillin concentration. The study will be non-randomized, uncontrolled, prospective, open label, interventional, and monocentric. It will include a population pharmacokinetic-pharmacodynamic analysis of the data obtained. The study will enroll patients ≥ 18 years in need of a treatment with temocillin for (i) complicated urinary tract infection and pyelonephritis (associated or not with bacteremia), or (ii) lower respiratory tract infection, or (iii) abdominal infection, and requiring ≥ 4 days of hospitalization. Blood samples will be obtained at day 0 (control) and after 2 and 4 days of drug treatment (full pharmacokinetic evaluation over 8 to 12 h post-administration). Total and unbound temocillin concentrations in plasma will be quantified by a validated analytical method. A population pharmacokinetic/pharmacodynamics model of plasma total and unbound concentrations of temocillin will be obtained by Bayesian algorithms using Pmetrics software, driven by the predicted plasma total and unbound concentration. The model will be used to assess the probability of target attainment of temocillin.

NCT ID: NCT03557671 Not yet recruiting - Cow Milk Allergy Clinical Trials

Evaluation of the Hypoallergenicity of a New Formula Based on Hydrolyzed Rice Proteins

Start date: June 2018
Phase: N/A
Study type: Interventional

The aim of this study is to show the hypoallergenicity of a new thickened rice based formula (TRHF) through a double blind placebo controlled food challenge (DBPCFC), as recommended by the American Academy of Pediatrics, in subjects with IgE-mediated CMA and in subjects with non-IgE-mediated CMA.