Clinical trials

The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems. The main questions this study aims to answer are: * Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention? * Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)? Researchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention. Participants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old. If assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.

The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.

The goal of this observational study is to learn if we can identify immune biomarkers in first-void urine and vaginal brush samples in Chlamydia trachomatis (CT) positive adult women. Participants will self-collect a first-void urine sample, self-collect a vaginal brush, and a blood sample will be collected by a healthcare worker. Participants will complete a questionnaire.

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion. The primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time. Candidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers: * The University Hospital of Antwerp (UZA). * The University Hospital of Leuven (UZ Leuven). * Ghent University Hospital (UZ Gent). Women are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints. The following laboratory procedures will be applied to reach study objectives * Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples. * Assessment of HPV infectivity: Detection of HPV16 E1\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples. * Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.

This feasibility study investigates whether high-intensity interval training (HIIT) is feasible and acceptable for individuals with long-term shoulder pain where low-grade inflammation is suspected. Many patients do not recover fully with current local treatments, and systemic factors such as inflammation, and metabolic changes, additionally disturbances in the functioning of the nervous system often seem to play a role. HIIT is a time-efficient form of exercise that has been shown to improve inflammation and metabolic values and positively influence the balance of the nervous system. In this feasibility study, the investigators are enrolling 15 individuals with persistent shoulder pain (diagnosed with rotator cuff-related shoulder pain or frozen shoulder) with \>3 months of symptoms, and 15 individuals without shoulder complaints. All participants will undergo measurements of inflammatory levels, glycosylated hemoglobin (HbA1c), blood pressure, body composition, pain sensitivity tests, and complete questionnaires about autonomic complaints and quality of life. Participants with shoulder pain will also perform one personalized HIIT session on a cycle ergometer. The investigators will assess whether participants accept a systemic intervention for their shoulder pain, if they are cooperative, and how they feel about the session; additionally, any side effects will be recorded. The aim is to determine whether HIIT is practically feasible and safe for this group and whether there are indications that systemic factors such as inflammation and nervous system function are associated with persistent shoulder pain. The outcome will determine whether follow-up research with a larger study is worthwhile.

This cross-sectional study aims to determine the test-retest reliability of surface electromyography (sEMG) outcomes in detecting levels of fatigue among healthy adolescents engaged in physical activities. It seeks to evaluate the consistency of sEMG parameters across two test sessions and correlate these measurements with both performance metrics and subjective fatigue assessments. Participants will perform repetitive squatting until volitional exhaustion while their muscular activity is recorded. They will do so on two different test sessions with an interval of one week in between.

The goal of the KiTaLymph trial is to investigate whether the application of kinesio tape is effective in women with persistent (\>6 months) breast and/or truncal oedema after treatment for breast cancer. The main objectives are to assess whether kinesio taping: * reduces pain and symptoms, * decreases swelling, * improves quality of life (QoL). This study will compare a control group receiving standard care, decongestive lymphatic therapy (DLT), to an intervention group receiving DLT in combination with kinesio taping, in order to determine whether the addition of kinesio tape yields superior clinical outcomes. Participants will be randomly allocated to one of the two study arms. Both groups will participate in a 4-week intervention phase, consisting of two treatment sessions per week. This will be followed by a 6-month follow-up period to assess the durability of treatment effects and cost-related outcomes. A total of approximately 128 participants will be recruited. Outcome assessments will be conducted at baseline, immediately post-intervention (1 month), and at 3 and 6 months following the end of the intervention. These assessments will include standardised patient-reported outcome measures evaluating symptoms, quality of life, and pain, namely, the Breast Edema Questionnaire (BrEQ), the EORTC-QLQ-BR23, the EQ-5D-5L, and a visual analogue scale (VAS), as well as objective physical measurements of oedema using the LymphScanner (expressed as percentage water content, PWC). In addition to the primary research objective, several sub-studies will be conducted. These will include: (1) a longitudinal analysis of the effects of standard treatment; (2) an evaluation of the responsiveness and clinical utility of the BrEQ; and (3) a cross-sectional analysis of the compression pressure exerted by various compression bras. All sub-studies are methodologically feasible within the projected sample size of the primary objective and aim to provide supplementary insights into the clinical management of breast and truncal oedema.

A study is undertaken to examine the feasibility of the newly developed transition program in adolescents with type 1 diabetes, asthma and obesity in a multicentric setting. Specific objectives for this study are: (1) examining the impact of the program in terms of patient-reported health outcomes, (2) examining patients' and healthcare providers' experiences related to the program implementation process, and (3) examining the impact of the program in terms of cost-effectiveness.

This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future. Participants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy. * Before start of induction chemotherapy the patient will receive a whole-body FDG PET/LDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES). * For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET/LDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF). * During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information). * Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET/CT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy. * In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).

Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and/or feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.

The scientific goals of the project are: 1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to: * usual care (i.e. superiority of the eHealth self-management support program) and * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program) on pain-related disability (measured with the Pain Disability Index). 2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including: * Other dimensions of pain * Health-related quality of life * Physical functioning, including physical activity levels * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence * Participation in society, including return to work * Healthcare-related costs for the patient and society 3. The tertiary scientific objectives of this study are * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets. * To examine the implementation process, mechanisms of impact and contextual factors.

The objective of this project is to investigate the effectiveness of neglect training in our self-developed VR application "SpatialSense". The investigators aim to reach the following goals: i. Compare conventional neglect therapy for neglect training with SpatialSense to evaluate the impacts on neglect recovery to see whether the VR therapy improves the clinical outcomes, such as balance recovery, perception of verticality, quality of life, independence in daily activities, and cognitive impairment, after rehabilitation training. ii. Analyze and compare the search strategies employed by stroke patients with VSN and those without VSN during the execution of the search task with SpatialSense to summarize typical visual scanning strategies for facilitation, rehabilitation training, and improving the transfer effect in daily activities. The experimental group will receive both conventional OT and PT treatment, but 3 days a week, half an hour of conventional treatment will be replaced by treatment with SpatialSense software. The control group will receive their regular dose-matched conventional OT and PT sessions without interference. The experimental group will receive SpatialSense training 3 times a week for a consecutive 4 weeks (12 sessions in total of 30 minutes).

Scars can be caused by physical trauma, surgical incisions, burn injuries and even acne. Deep cutaneous injuries induce pathological scars. Other factors, such as mechanical loading, bacterial colonization are potential factors thought to underlie human hypertrophic and keloid scar formation or contractures. The effect may include functional impairment and aesthetic disadvantages. Various non-invasive mechanical interventions of physical scar management (e.g. extracorporeal shock wave therapy or ESWT) could have a beneficial influence on wound healing and prevention of hypertrophic scars. ESWT considerably improves the appearance and symptoms of hypertrophic scars. However, the mechanism underlying the observed beneficial effects is not well understood. The objective of the first part of the study is to elucidate the mechanism underlying changes in cellular mechanosensitive pathways that are induced by ESWT. This review will introduce the histopathological effects on ESWT during wound healing and scar development. The main objective of this study is to determine how much mechanical loading on dermal scars will lead to normal scar healing. The optimal duration, the frequency and the intensity of the applied forces in ESWT to generate a beneficiary effect during different phases of wound healing remains unclear. In this study, biopsies from abdomionplasty postsurgical scars will be examined. Thereby it is possible to evaluate the outcomes on a cellular level through assessing the histology of human biopsies under controlled condition. In the second part, the underlying mechanism of ESWT on postsurgical scars will be explored, in different stages of wound healing. Furthermore, the investigators will investigate if changes in physical characteristics (redness, thickness and pliability) in postsurgical scars are associated with changes in reactivity of mechanosensitive pathways. This study will close the gap between the fundamental knowledge on cellular mechanotransduction and the clinical application of mechanotherapy during physical scar management (ESWT).

After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised. Ultrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.

The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.

This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.

The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.

The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.

This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).

The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing.