Sittard

Researchers are investigating treatment options for Crohn's disease (CD), a chronic condition with varied symptoms, relapse rates, and responses to therapy. This study compares the long-term effectiveness and safety of periodic adalimumab as an initial treatment against the standard step-up care that begins with corticosteroids. The goal is to prevent overtreatment in low-risk patients while improving outcomes and reducing side effects for those newly diagnosed with CD. Participants will receive either episodic subcutaneous adalimumab treatment for six months or the conventional step-up care starting with corticosteroids and progressing to other treatments if needed. The study monitors the impact of these approaches in newly diagnosed CD patients or those experiencing a flare, aiming to evaluate how well each treatment controls inflammation and maintains remission. Throughout the study, participants will be closely followed to assess treatment efficacy by measuring the number of yearly quarters of corticosteroid-free remission at week 96. They will use tools like myIBDcoach and have regular assessments including ileo-colonoscopy and small bowel imaging. Safety, disease control, and side effects will be monitored to understand the benefits and risks of these treatment strategies over time.

Researchers are evaluating the effectiveness of a specialized version of multisystemic therapy (MST), called MST-ID, for adolescents aged 10 to 19 with severe behavioural problems from families where the adolescent and/or parent(s) have an intellectual disability (ID). The study compares MST-ID to standard MST to see if MST-ID better reduces rule-breaking behaviour and improves outcomes such as living at home, school or work participation, and reduced parenting stress. Both quantitative and qualitative methods are used to explore treatment effects and family experiences. The treatments are intensive, home-based programs involving 3 to 5 visits per week over three to five months. MST-ID is tailored for families with ID by using simplified language, visual supports, more structured sessions, and extra practice time to help generalize skills learned. Families were referred to either MST-ID or standard MST through usual channels rather than random assignment. The qualitative part involves interviews or other methods with about 10 adolescents and/or parents to learn about their experiences with MST-ID. Participants complete questionnaires at five time points: before treatment starts (T0), at treatment end (T1), and follow-ups at 6 (T2), 12 (T3), and 18 months (T4) after treatment start. Both adolescents and parents provide information on rule-breaking behaviour and other outcomes. Routine Outcome Monitoring questionnaires are also collected as part of standard care. The study assesses behavioural changes, parenting stress, and family social support, with safety monitored throughout the follow-up period.

Researchers are investigating the treatment of multiple myeloma using a combination of medicines called daratumumab-lenalidomide-dexamethasone (Dara-Rd). This standard treatment in the Netherlands often suppresses the disease for a long time and continues until it stops being effective. The study aims to find out if stopping treatment temporarily, compared to continuing it without breaks, can improve quality of life by reducing side effects and allowing recovery from toxicity, without reducing survival time. The study involves patients who have completed 12 cycles of Dara-Rd treatment and have responded with at least a partial response without biochemical progression. These patients will be randomly assigned to either continue Dara-Rd treatment continuously or take a treatment-free interval. The medications involved include daratumumab injections, lenalidomide capsules, and dexamethasone. Reduced dosing of lenalidomide is allowed but not below 5 mg, and prior dexamethasone dose changes are permitted. The trial is a nationwide, open-label, randomized Phase III study. Participants will be followed for up to approximately 57 months to compare event-free survival and up to 69 months to compare progression-free survival after randomization. Researchers will monitor disease status, side effects, and overall health during this time. Patients must provide informed consent and will undergo regular assessments to evaluate the impact of continuous versus interrupted therapy on their disease and quality of life.

Researchers are studying adults aged 18 to 64 who are undergoing primary bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction to compare two types of strength training during rehabilitation. The study evaluates how low-load blood flow restriction training (LL-BFRT) affects graft maturity seen on MRI scans compared to traditional heavy-load resistance training (HLRT). This randomized controlled trial also looks at secondary outcomes such as donor-site issues, range of motion, knee stability, patient-reported outcomes, muscle strength, safe return to pre-injury sports level, patient satisfaction, as well as the feasibility and safety of the rehabilitation methods. Participants will begin either LL-BFRT or HLRT two weeks after surgery, each involving 12 weeks of strength training conducted twice weekly. LL-BFRT uses an automatic personalized tourniquet system to restrict blood flow during exercises, while HLRT involves resistance training without blood flow restriction. Both interventions aim to support recovery after ACL reconstruction. Throughout the study, participants will undergo MRI scans to assess graft maturity at three and nine months after surgery, which is the primary outcome. Researchers will also monitor other functional and patient-reported measures to understand the overall effects of the treatments. The study takes place at Zuyderland Medical Center and Knie-Heup centrum Plus, ensuring careful follow-up and evaluation during the recovery period.

Researchers are evaluating the Integrated Oncological Decision-making Model (IODM) to improve how cancer treatment plans are tailored to individual patients. This study aims to assess whether the IODM, which incorporates a patient's health status and personal goals alongside standard clinical guidelines, leads to more personalized treatment decisions. The research uses a stepped-wedge cluster randomized trial design across eight oncological care paths in four medical centers in the Netherlands, involving 400 adult patients. The intervention involves incorporating three key elements into treatment planning: current oncological treatment options with their pros and cons, the patient's overall health including physical, psychosocial, and emotional functioning, and the patient's goals and preferences for both treatment and daily life. Professionals work with patients to integrate these components using optimal tools and strategies. Care paths will transition in steps from standard guideline-based practices to the IODM intervention. Participants will be involved throughout the treatment decision process. Researchers will measure how often the final treatment decisions differ from standard recommendations and whether such differences represent more personalized care. Assessments include shared decision-making outcomes and evaluation of how well the IODM components are implemented. The study includes a 12-month follow-up within a total 2-year observation period to monitor these outcomes.

Researchers are investigating the effectiveness of adding liothyronine (LT3) to levothyroxine (LT4) treatment in patients with autoimmune hypothyroidism who continue to experience significant tiredness despite normalized thyroid hormone levels on LT4 alone. This phase 3 trial addresses the issue that LT4 monotherapy may not achieve the natural balance of thyroid hormones, as some patients still feel tired. The study also explores genetic factors that might influence treatment response. The study begins with a run-in period where all participants switch to a standardized LT4 preparation to stabilize thyroid hormone levels. During this 4-8 month period, doses are adjusted to maintain normal TSH levels, and patients with unstable TSH or heart abnormalities are excluded. Those with persistent tiredness and stable hormone levels then enter a 1-year double-blind randomized trial, receiving either LT4 combined with LT3 or LT4 with placebo. Regular visits occur at baseline and weeks 8, 16, 26, 39, and 52, including dose adjustments and comprehensive assessments. Participants complete questionnaires about tiredness, quality of life, and medical resource use at every visit. Additional blood tests for genetics and thyroid metabolites occur at baseline and 52 weeks, along with monitoring of bone, cardiovascular, metabolic, and brain health through scans, ECGs, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and treatment effects closely monitored throughout the study.

Cachexia is a complex syndrome causing significant loss of body weight, muscle, and fat, which can worsen the quality of life and survival of cancer patients. Accurate diagnosis of cachexia is challenging because it often relies on patient-reported weight loss, which may be biased. Researchers are investigating the use of objective, home-based measurements of body weight and physical activity to improve cachexia diagnosis. This exploratory pilot study focuses on patients 18 years and older undergoing curative-intent chemotherapy or surgery for various cancers, including upper gastrointestinal, hepatobiliary, pancreatic, colorectal, and ovarian cancers. Participants will undergo thorough pre-treatment assessments including physical tests and measurements of body composition using CT scans. They will be given a weight scale and a wrist-worn accelerometer to measure daily body weight and physical activity continuously at home. For chemotherapy patients, monitoring begins before treatment, continues through chemotherapy, and ends 2-3 weeks after completion. Surgery patients will pause monitoring during hospital stay and resume after discharge until 2-3 weeks post-discharge. Body composition will be measured before and after treatment. Participants will have regular evaluations including laboratory tests, adverse event monitoring during and after treatment, and tumor response assessments. Researchers will compare self-reported weight changes with objective data and relate these to treatment side effects, survival, and disease recurrence over up to five years. Safety and postoperative complications are carefully recorded. This study aims to enhance understanding of weight and activity changes in cancer patients to support better treatment decisions and care.

Researchers are evaluating the best rehabilitation approach for patients with displaced intra-articular calcaneal fractures (DIACFs), a rare type of heel bone fracture often requiring surgery. This study compares two rehabilitation protocols: Permissive Weight Bearing (PWB) and Restricted Weight Bearing (RWB), to see which leads to better functional outcomes, quality of life, fewer complications, and cost-effectiveness. The trial focuses on adults aged 18 to 67 who have had surgical treatment for specific types of DIACFs. Participants are randomly assigned to either the PWB or RWB group. The PWB group begins weight bearing about two weeks after surgery once the wound has healed, increasing weight bearing as tolerated based on pain and comfort, guided by milestones like walking with crutches or canes. The RWB group follows a stricter protocol with 8 to 12 weeks of minimal weight bearing, gradually increasing weight bearing by 25% weekly after 8 weeks following current guidelines. Therapists and physicians record the patients' progress and advice throughout treatment. During the study, patients will be monitored at 2, 6, 12 weeks, and 6 months after surgery using functional outcome questionnaires (AOFAS score) and other assessments. Researchers will measure recovery progress, quality of life, differences seen in X-rays, complications, and treatment costs. Follow-up visits align with standard trauma care, and radiation exposure matches usual care, making the study burden minimal and safe for participants.

Researchers are evaluating treatments for patients with hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer that has a PIK3CA mutation. This Phase 3 study compares the effectiveness and safety of RLY-2608 combined with fulvestrant versus capivasertib combined with fulvestrant. The study focuses on patients whose cancer returned or worsened after treatment with a CDK4/6 inhibitor. Participants will receive either RLY-2608 taken orally twice daily every day in 28-day cycles or capivasertib taken orally twice daily on days 1 through 4 each week within a 28-day cycle. All participants will also receive fulvestrant by intramuscular injection on day 1 and day 15 of the first cycle, then on day 1 of each following 28-day cycle. Treatment continues until disease progression or other criteria are met. During the study, researchers will monitor participants regularly to assess progression-free survival, which is the time from starting treatment until cancer progression or death. Assessments include radiographic imaging based on RECIST v1.1 criteria and safety evaluations. The study duration may extend up to approximately 77 months, allowing for long-term monitoring of treatment effects and safety.

Researchers are investigating whether dexrazoxane can prevent anthracycline-induced cardiac dysfunction (AICD) in adult patients with diffuse large B-cell lymphoma (DLBCL) receiving first-line treatment. Patients treated for DLBCL have a higher risk of developing heart damage and heart failure due to anthracycline chemotherapy, with a reported cumulative incidence of 5-10% within five years and even higher rates in elderly patients. The study aims to identify those at highest risk of AICD while ensuring that dexrazoxane does not reduce the effectiveness of cancer treatment. This phase III national trial will enroll 324 patients across 25 Dutch hospitals who are planned to receive six cycles of R-CHOP chemotherapy, including doxorubicin. Participants will be randomly assigned to receive either intravenous dexrazoxane before each doxorubicin infusion or no cardioprotective treatment. Dexrazoxane will be given at a 10:1 ratio to doxorubicin and infused 30 minutes prior to the chemotherapy. Additional drugs given as part of R-CHOP include rituximab, cyclophosphamide, vincristine, and prednisolone. Some patients with double hit lymphoma may also receive lenalidomide. Supportive treatment with pegfilgrastim will be provided if needed. Participants will have their heart function assessed by echocardiography before starting chemotherapy and at 4 and 12 months after randomization. The main outcome is the incidence of AICD, defined by a significant decline in heart pumping ability. Researchers will also measure complete metabolic remission to confirm that dexrazoxane does not interfere with cancer treatment. The study includes detailed monitoring of patient and treatment factors to better predict AICD risk. Total participation lasts at least 12 months post-treatment initiation.