[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zuyderland Medisch Centrum\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":318},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,42,74,101,130,158,190,218,243,272,292],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100437499","comparison-between-direct-oral-anticoagulation-doac-interruption-and-doac-continuation-in-patients-undergoing-elective-invasive-coronary-angiography-or-percutaneous-coronary-intervention-100437499",false,"NCT04977076","Comparison Between Direct Oral Anticoagulation (DOAC) Interruption and DOAC Continuation in Patients Undergoing Elective Invasive Coronary Angiography or Percutaneous Coronary Intervention","SLIM-2","Inclusion Criteria:\n\n* Patients aged \\>18 years using DOAC and undergoing elective ICA or PCI.\n* Provided signed informed consent\n\nExclusion Criteria:\n\nA potential subject who meets any of the following criteria will be excluded from participation in this study:\n\nAny of the following:\n\n* Patients initially presenting with Acute Coronary Syndrome (STEMI, NSTEMI, UA)\n* Patients \\\u003C18 years old\n* Calculated creatinine clearance \\\u003C30 mL\u002Fmin\n* Patients simultaneously participating in another clinical trial\n* History or condition associated with increased bleeding risk, as listed below:\n\n  * Major surgical procedure within 30 days before the procedure\n  * Known inaccessible radial artery during previous procedure\n  * History of GI bleeding in the previous 6 months\n  * History of intracranial, intraocular, spinal, or atraumatic intra-articular bleeding\n  * Chronic bleeding disorder\n  * Known intracranial neoplasm, arteriovenous malformation, or aneurysm\n  * Known anemia with last measured haemoglobin value \\\u003C6 mmol\u002FL \\[9.67 g\u002FdL\\]\n  * Current pregnancy or breast-feeding\n  * Known significant liver disease (e.g., acute clinical hepatitis, chronic active hepatitis, cirrhosis), or Alanine aminotransferase (ALT) \\>3 x the upper limit of normal.\n* Participation in another clinical trial","ALL","18 Years",{"count":19,"type":20},1270,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, multicenter, 1:1 randomized, investigator initiated study. Goal of this study is to examine the safety of uninterrupted periprocedural DOAC use.",[26,27,28],"Atrial Fibrillation","Coronary Artery Disease","Anticoagulants","RECRUITING","2026-05-26",{"date":32,"type":33},"2026-05-29","ACTUAL",{"date":35,"type":33},"2022-09-01",{"date":37,"type":20},"2027-12-31",{"name":39,"class":40},"Zuyderland Medisch Centrum","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":41},"100634444","obese-hfpef-towards-preventing-obesity-related-hfpef-100634444","NCT07539766","OBESE-HFpEF: Towards Preventing Obesity Related HFpEF","OBESE-HFpEF: Prevalence and Mediators of Heart Failure (Preserved Ejection Fraction) in the Dutch Obesity Clinic South - Towards Preventing Obesity Related HFpEF''","OBESE-HFpEF","Inclusion Criteria:\n\n* Age ≥ 35 years\n* Eligible for surgical treatment for obesity, according to the Dutch guideline, i.e. a BMI ≥ 40 kg\u002Fm2 or a BMI ≥ 35 kg\u002Fm2 with one or more comorbidities associated with obesity. (23)\n\nExclusion Criteria:\n\n* Inability to provide informed consent.\n* A BMI \\>60 kg\u002Fm2\n* Inability of undergoing metabolic bariatric surgery safely.\n* Inability to undergo the study measurement\u002Ftests.\n* Not proficient in the Dutch language\n* A medical history of a reduced LVEF at any time, history of severe cardiac valve defects or severe congenital cardiac defects.\n* A medical history of previous metabolic bariatric surgery.",true,"35 Years",{"count":53,"type":20},250,"2 Years","OBSERVATIONAL","Obesity, severe overweight, is a growing problem worldwide and increases the risk of heart failure, especially a type called heart failure with preserved ejection fraction (HFpEF).\n\nIn HFpEF, the heart becomes stiffer. This makes it harder for the heart to fill with blood, which can lead to shortness of breath during physical activity.\n\nIn the Netherlands, 15% of the population has obesity. In South Limburg, this is even higher at 19%. Among people with HFpEF, obesity is much more common: about 50% of these patients have obesity.\n\nLife expectancy in people with HFpEF is poor, and current treatment mainly focuses on reducing symptoms. Early recognition and treatment of risk factors, such as obesity, are therefore very important.\n\nThis study includes about 250 people with obesity. Using a heart ultrasound and tests of blood and fat tissue, we will look for early signs of HFpEF and study the effects of weight loss. The measurements will be repeated after 1 and 2 years.\n\nThe goal of this study is to better understand how obesity contributes to HFpEF and how weight loss affects the heart. This research may help improve future treatments for patients with HFpEF.",[58,59,60],"Heart Failure and Preserved Ejection Fraction","Obesity (Disorder)","Heart Failure",[62,63,64,65],"Obesity","Heart Failure with preserved ejection fraction","Metabolic Bariatric Surgery","Prospective","2026-04-13",{"date":68,"type":33},"2026-04-20",{"date":70,"type":33},"2025-01-01",{"date":72,"type":20},"2029-01-01",{"name":39,"class":40},{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":21,"phases":84,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},"100523193","investigating-a-tailored-diuretic-algorithm-in-acute-heart-failure-patients-100523193","NCT06092437","Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients","TAILOR-AHF: Randomized Trial Investigating a Tailored Diuretic Algorithm in Acute Heart Failure Patients","TAILOR-AHF","Inclusion Criteria:\n\n* Age \\> 18 years;\n* HF (HFrEF, HFmrEF or HFpEF) diagnosed according to the 2021 HF Guidelines of the European Society of Cardiology \\[5\\];\n* Presentation with AHF meaning at least one symptom (dyspnea, orthopnea, or edema) and one sign (rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography) of AHF;\n* An elevated NT-proBNP \\>300pg\u002Fml;\n* Requiring the need for iv diuretics.\n\nExclusion Criteria:\n\n* Terminal renal insufficiency defined as: dialysis patients or eGFR (estimated glomerular filtration rate) \\\u003C 10 mL\u002Fmin\u002F1.73 m2;\n* Patients included in other investigational studies regarding heart failure.\n* Presentation with cardiogenic shock or respiratory insufficiency or another reason requiring admission to the intensive care unit upon admission (IC transfer later in the hospitalization is not an exclusion).",{"count":83,"type":20},556,[23],"Acutely decompensated heart failure (ADHF) is highly prevalent and has a high (financial) burden on the health care system. Treatment often consists of the administration of IV decongestive agents. Adequate dosing is difficult due to varying diuretic resistance and inadequate parameters to evaluate the response. Urine sodium is a promising biomarker to evaluate the diuretic response. It is hypothesized that a tailored, urine sodium guided diuretic algorithm will result in faster and more complete decongestion and therefore lead to better survival (in terms of mortality and heart failure events) while being non-inferior in terms of safety (mainly regression of kidney function).",[87],"Heart Failure Acute",[89,90,91,92],"Decongestion","Heart failure","Natriuresis","Urinary Sodium","2026-04-07",{"date":66,"type":33},{"date":96,"type":33},"2023-02-27",{"date":98,"type":20},"2026-08-27",{"name":39,"class":40},2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":109,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":21,"phases":112,"briefSummary":113,"conditions":114,"keywords":118,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":100},"100430570","vaginal-notes-hysterectomy-versus-vaginal-hysterectomy-100430570","NCT04886791","Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy","Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial","VANH","Inclusion Criteria:\n\n* Written and orally given informed consent\n* 18 years and older\n* Native Dutch speaker or in control of the Dutch language in speaking and writing\n* Indication for hysterectomy for benign indication\n* Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination\n\nExclusion Criteria:\n\n* Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist\n* History of more than 1 caesarean section\n* History of endometriosis\n* History of rectal surgery\n* History of pelvic radiation\n* Suspected rectovaginal endometriosis\n* History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)\n* Virginity\n* Pregnancy\n* Indication for anterior or posterior colporrhaphy during the same surgery\n* Indication of mid urethral slings\n* Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.","FEMALE",{"count":111,"type":20},124,[23],"Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.\n\nObjective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nStudy design: The study concerns a single-blinded, multicentre, randomised controlled trial.\n\nStudy population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.\n\nIntervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.\n\nMain study parameters\u002Fendpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.\n\nThe secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness:\n\nvNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.",[115,116,117],"Hysterectomy","Natural Orifice Transluminal Endoscopic Surgery","Vaginal Hysterectomy",[119,120,107,121,115],"NOTES surgery","vNOTES","Vaginal hysterectomy","2025-08-13",{"date":124,"type":33},"2025-08-14",{"date":126,"type":33},"2021-07-05",{"date":128,"type":20},"2025-12-31",{"name":39,"class":40},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":50,"sex":109,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":144,"conditions":145,"keywords":148,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":100},"100532915","phase-1-effect-of-honey-for-cin-ii-100532915","NCT06219018","Effect of Honey For CIN II","The Effect of Medical Grade Honey (L-Mesitran) for Cervical Intraepithelial Neoplasia-II","HoneyForCINII","Inclusion Criteria:\n\n* Women 18-40 years\n* Primary CIN II confirmed histologically in the biopsy on colposcopic examination\n* Sufficient mastery of the Dutch language\n\nExclusion Criteria:\n\n* Simultaneous abnormality in columnar epithelial cells (AIS).\n* Hr-HPV negative cytology\n* Immunosuppressant use\u002FAutoimmune disease (HIV, CVID)\n* History of cervical carcinoma or previous treatment for CIN (LLETZ or imiquimod)\n* Pregnancy or the intention to become pregnant during the study period\n* Legal incompetence\n* Known allergies to honey","40 Years",{"count":140,"type":20},60,[142,143],"PHASE1","PHASE2","The following hypothesis is tested: Medical grade honey in CIN II causes a higher clearance of the hr-HPV virus and an increase in the normalization of CIN II lesions compared to expectant management.",[146,147],"Cervical Intraepithelial Neoplasia-II","High Risk Human Papillomavirus",[149],"Honey CINII","2025-06-13",{"date":152,"type":33},"2025-06-18",{"date":154,"type":33},"2024-12-30",{"date":156,"type":20},"2027-12-01",{"name":39,"class":40},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":21,"phases":167,"briefSummary":168,"conditions":169,"keywords":173,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":4},"100585011","a-pilot-study-on-app-based-treatment-combining-physical-exercise-graded-activity-and-pain-journaling-for-patients-with-spinal-complaints-100585011","NCT06896812","A Pilot Study on App-based Treatment Combining Physical Exercise, Graded Activity, and Pain Journaling for Patients with Spinal Complaints","SPINAPP","Inclusion Criteria:\n\n* Patients visiting the spine-centre at Zuyderland Medical Centre.\n* Suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment would be advised.\n* Minimum age of 18 years.\n* Psychosocially, mentally, and physically able to fully comply with this study protocol.\n* Informed consent prior to this study.\n\nExclusion Criteria:\n\n* Requiring a specific intervention (e.g., surgery, pain treatment, rehabilitation, bracing)\n* Inadequate command of the Dutch language.\n* Digitally illiterate or otherwise unable to use an application on a mobile phone.\n* Active spinal infection.\n* Immature bone (ongoing growth).\n* Active malignancy.\n* Pregnancy.",{"count":166,"type":20},30,[23],"Background: The prevalence of spinal complaints such as low back pain is rising due to factors like aging, sedentary lifestyle, and obesity. Traditional conservative treatments include physical therapy and lifestyle modifications. The digital revolution in healthcare has introduced app-based interventions as a promising alternative.\n\nRationale: Given the high burden of spinal complaints and the associated economic impact, there is need for effective and efficient treatment modalities. This is especially evident in Western healthcare systems with growing demands and limited resources due to the changing demographic of the population. An app-based approach offers a viable solution by combining evidence-based conservative treatments. Moreover, an app-based treatment could offer personalized treatment, real-time feedback, and enhanced patient engagement at lower costs, presents as a viable solution.\n\nObjective: This pilot study aims to evaluate the efficacy of an app-based treatment method combining physical exercise, graded activity, and pain journaling for patients with spinal complaints who will otherwise receive physical therapy, general lifestyle advice, or an expectant treatment in current practice.\n\nStudy design: Single center prospective study.\n\nStudy population: A total of 30 patients over 18 years old suffering from spinal complaints for which in current practice physical therapy, general lifestyle advice, or an expectant treatment will be advised.\n\nIntervention: An app-based treatment consisting of a combination of physical exercise, graded activity, and pain journaling.\n\nMain study parameters\u002Fendpoints: Primary endpoint: Patients' experience and satisfaction qualitatively, measured using semi-structured face-to-face interviews after three months of treatment.\n\nSecondary endpoints: Quality of Life (Qol) measured with the EuroQol 5 dimensions (EQ-5D-5L) at baseline, one, two and three months after starting the intervention. Change in back- and leg-pain, measured with the Visual Analogue Scale (VAS). Change in disability, measured with the Oswestry Disability Index (ODI). Change in catastrophizing of pain, measured with the Pain Catastrophizing Scale (PCS). Change in lost productivity, measured with patient reported missed working days. Healthcare consumption, measured with number of visits to doctor or paramedic. Change in Body Mass Index, measured using patients' input on length and weight. Adherence of participants measured using frequency of patients' input in the mobile application. Safety measured using the (serious) adverse events ((S)AE).\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: The nature and extent of the burden associated with participation in the app-based treatment program primarily involve adherence to recommended activities and inputting relevant health data. Given that the investigators are integrating existing treatment modalities, such as physical exercise, graded activity, and pain journaling, the risks associated with participation are minimal, as these interventions are already deemed safe and widely practiced. The responsibility for determining each patient's suitability for participation in this study lies with the referring physician. Participants can expect benefits such as improved pain management, enhanced physical function, and better overall well-being.",[170,171,172],"Back Pain","Spinal Disease","Spinal Condition",[174,175,176,177,178,179,180],"conservative","app","spine","ehealth","e-health","back pain","graded activity","NOT_YET_RECRUITING","2025-03-24",{"date":184,"type":33},"2025-03-26",{"date":186,"type":20},"2025-04-01",{"date":188,"type":20},"2025-09-01",{"name":39,"class":40},{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":217},"100579710","spinal-cord-monitoring-in-multiple-sclerosis-100579710","NCT06827834","Spinal Cord Monitoring in Multiple Sclerosis","A Prospective Longitudinal Study of Spinal Cord Lesions in Multiple Sclerosis: MRI Monitoring and Prognostic Factors for Active Disease","MSpine","Inclusion Criteria:\n\n* Patients between 18 and 65 years old\n* Patients diagnosed with relapsing-remitting MS (≤5 years of first clinical event)\n* Treatment-naïve patients starting (currently in the Netherlands approved) DMT\n\nExclusion Criteria:\n\n* Patients who presented first clinical event more than five years ago\n* Patients who have already started DMT\n* Patients who are incapable of giving informed consent\n* Patients who are unable to undergo local MRI scan, due to for instance\n* Physical problems, for instance due to size\u002Fobesity (not fitting in regular MRI scanner), not being able to lie flat for extended periods of time (e.g. due to pain, shortness of breath)\n* Due to claustrophobia\n* Patients who have contraindications for MRI scan, for instance\n* Due to MRI-unsafe or non-compatible implanted material\u002Fdevices, such as pacemakers or ocular metal splinters\n* Patients who are pregnant at inclusion","65 Years",{"count":200,"type":20},155,"Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common cause of non-traumatic neurological disability in young adults. Magnetic resonance imaging (MRI) is the most important paraclinical investigation used in the diagnosis and monitoring of the disease. In the past years, spinal cord MRI has improved significantly and has become an important part of the diagnostic workup for MS. Presently, follow-up imaging of the spinal cord is only performed when spinal cord related symptoms occur. However, there is increasing evidence that asymptomatic spinal cord lesions can occur, independently of brain disease activity. Despite these cord lesions being asymptomatic, they impact disability accrual in the long term. Although this might be an imaging marker for monitoring and treatment, it is not yet applied in the clinical setting.\n\nThe investigators will prospectively collect spinal cord MRI data (in addition to routine brain MRI), and blood-based biomarkers (plus cerebral spinal fluid markers, if available), in recently diagnosed MS patients, to address the following research questions:\n\n* What is the incidence of asymptomatic spinal cord lesions in patients commencing DMT?\n* And in the absence of radiological progression on brain imaging, how frequently do asymptomatic spinal cord lesions occur? In other words, how often is disease activity solely proven by spinal cord MRI and what is the number-needed-to-scan?\n* A secondary objective is to investigate which patients are predisposed to developing new spinal cord lesions during follow-up in the early stages of the disease. For this question, factors such as cerebrospinal fluid (CSF) profiles, B-cell composition in blood, soluble blood markers, and clinical features will be focused on.",[203],"Multiple Sclerosis",[205,206,207,208],"spinal cord","mri","biomarkers","multiple sclerosis","2025-02-10",{"date":211,"type":33},"2025-02-14",{"date":213,"type":33},"2024-08-06",{"date":215,"type":20},"2028-06-01",{"name":39,"class":40},5,{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":198,"enrollmentInfo":226,"targetDuration":4,"studyType":21,"phases":228,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":41},"100514007","graft-maturity-after-blood-flow-restriction-training-in-acl-reconstruction-100514007","NCT05972876","Graft Maturity After Blood Flow Restriction Training in ACL Reconstruction","MRI-based Graft Maturity After Blood Flow Restriction Training in Bone-patellar Tendon-bone Anterior Cruciate Ligament Reconstruction: a Randomized Controlled Study","TimeToMature","Inclusion Criteria:\n\n* Patients (18-64 years) who will undergo primary BPTB reconstruction at Zuyderland Medical Center and rehabilitation at Knie-Heup centrum Plus.\n\nExclusion Criteria:\n\n* venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or not willing\u002Fable to participate.",{"count":227,"type":20},46,[23],"Rationale Graft maturity is correlated with strength and biomechanical properties of the reconstructed ACL. There are concerns that heavy-load resistance training (HLRT) may have detrimental effects on ACL graft maturation. Therefore, low-load blood flow restriction training (LL-BFRT) has been suggested as an alternative to HLRT. As LL-BFRT is an increasingly popular method for the rehabilitation after an ACL reconstruction, it is important to evaluate the value of this treatment.\n\nObjectives The main objective is to evaluate the effect of LL-BFRT on MRI-based graft maturity after ACL reconstruction compared to HLRT. The secondary objectives are the effect of LL-BFRT on donor-site morbidity, range of motion, knee stability, patient reported outcome measurements, muscle strength, safe return to pre-injury level of sport and patient satisfaction. Furthermore, feasibility and safety of rehabilitation will be assessed.\n\nStudy design Randomized controlled trial . Study population Patients who will undergo primary bone-patellar tendon-bone ACL reconstruction and rehabilitation at Knie-Heup centrum Plus will be assessed for eligibility. The exclusion criteria are: venous thromboembolism, sickle cell anemia, severe hypertension, contra-indication for accelerated rehabilitation, contra-indication for MRI scan or patients who are not willing\u002Fable to participate.\n\nIntervention LL-BFRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.\n\nComparison HLRT includes 12 weeks of biweekly strength training and starts two weeks after surgery.\n\nMain study endpoints The main endpoints are MRI-based graft maturity defined as signal-to-noise quotient three and nine months after surgery.",[231,232],"Anterior Cruciate Ligament Reconstruction","Bone-Patellar Tendon-Bone Grafting",[234],"Blood Flow Restriction Therapy","2025-01-30",{"date":237,"type":33},"2025-02-04",{"date":239,"type":33},"2024-04-17",{"date":241,"type":20},"2027-09",{"name":39,"class":40},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":21,"phases":253,"briefSummary":255,"conditions":256,"keywords":259,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":4},"100538167","phase-4-semaglutide-24mg-for-low-responders-after-bariatric-surgery-100538167","NCT06287307","Semaglutide 2.4mg for Low Responders After Bariatric Surgery","SEABAR","Inclusion Criteria:\n\n* BMI before surgery was ≥ 35.0 kg\u002Fm2\n* Patient is treated with group consultation at the NOK\n* Patient has undergone a primary (banded) RYGB or (banded) sleeve gastrectomy (SG)\n* Patient is in the lowest %TWL quartile, 3 months after surgery and will be enrolled in the plus module.\n\nExclusion Criteria:\n\n* Gastropareses or gastro-intestinal complaints after bariatric surgery\n* Type 1 or type 2 diabetes and\u002For diabetic retinopathy\n* Decreased renal function (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Liver failure (all)\n* Congestive heart failure or angina pectoris NYHA class III and IV\n* Malignancy in history\n* Pancreatitis (in history)\n* (expected) Pregnancy \u002F breast-feeding\n* Inflammatory Bowel Disease\n* Thyroid malignancy in history\n* Use of warfarin or other coumarin derivates","75 Years",{"count":252,"type":20},152,[254],"PHASE4","In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and\u002For tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.",[62,257,258],"Obesity, Morbid","Weight Gain",[62,260,261,262,263],"Semaglutide","GLP-1","Bariatric Surgery","Weight Loss","2024-02-22",{"date":266,"type":33},"2024-03-01",{"date":268,"type":20},"2024-05",{"date":270,"type":20},"2026-09",{"name":39,"class":40},{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":109,"minAge":4,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":282,"conditions":283,"keywords":4,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":289,"leadSponsor":291,"locationsCount":41},"100511585","fixation-of-skin-flaps-after-mastectomy-using-running-or-interrupted-sutures-for-combatting-seroma-100511585","NCT05941351","fixAtion of skiN Flaps After Mastectomy Using ruNning or Interrupted suturEs for Combatting Seroma","ANNIE","Inclusion Criteria:\n\n* Female sex.\n* 18 years or older.\n* Indication for mastectomy.\n\nExclusion Criteria:\n\n* Patients undergoing breast conserving therapy\n* Patients undergoing direct breast reconstruction\n* Patients undergoing modified radical mastectomy\n* Unable to comprehend implications and extent of study and sign for informed consent",{"count":280,"type":20},361,[23],"Rationale: Flap fixation significantly reduces the incidence of seroma formation after mastectomy. Therefore, research should focus on finding the most optimal way to secure the skin flaps to the pectoral muscle. Previous studies have compared running sutures, interrupted sutures and tissue glue application to conventional wound closure. A recent systematic review with network meta-analysis indicated running sutures as the most optimal technique, however direct comparisons and high quality articles were lacking.\n\nObjective: This prospective trial aims to directly compare running sutures with interrupted sutures in order to prevent complications in patients undergoing a mastectomy.\n\nStudy design: This trial will combine a retrospective cohort from the previous SARA-trial in Zuyderland MC with a randomised prospective trial. This study design was chosen to acquire a sample size with sufficient power and the ability to conduct this study in an acceptable time frame.\n\nStudy population: A retrospective cohort of patients participating in the SARA trial (RCT) and a prospective cohort of patients undergoing a mastectomy for breast cancer.\n\nIntervention: Group 1: Flap fixation after mastectomy with running sutures. Group 2: Flap fixation after mastectomy with interrupted sutures.\n\nMain study parameters\u002Fendpoints: The primary endpoint is the incidence of complications requiring interventions in both groups, including clinically significant seroma, infections and bleeding complications. Secondarily, the length of the procedure and cosmetic results will be compared.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: When participating, patients will undergo 3 additional outpatient clinic visits. Study visits will be combined with regular visits where possible, including the first postoperative visit after 7-10 days and either the 6 week or 3 month visit.",[284],"Seroma","2023-07-03",{"date":287,"type":33},"2023-07-12",{"date":70,"type":20},{"date":290,"type":20},"2027-03-01",{"name":39,"class":40},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":297,"acronym":298,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":16,"minAge":300,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":21,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":181,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100497478","deprescribing-in-hospitalized-sarcopenic-geriatric-patients-100497478","NCT05757765","(De)Prescribing in Hospitalized Sarcopenic Geriatric Patients","Medication (de)Prescribing in Hospitalized Geriatric Patients With Sarcopenia, Less is More","MEDEGESARC","Inclusion Criteria:\n\n* Aged 70 years and older\n* Being frail according the Groningen Frailty Indicator (GFI score \\>3)\n* Severely sarcopenic according the European Working Group On Sarcopenia-2 criteria (EWGSOP-2) based on handgrip strength (men \\\u003C 27kg and women \\\u003C 16kg), appendicular skeletal muscle mass (men \\\u003C 7,0 kg\u002Fm2 and women \\\u003C 5,5 kg\u002Fm2) and physical function below cut-off values (Short Physical Performance Battery \\\u003C9)\n* The use of 5 or more different medications before hospitalization\n\nExclusion Criteria:\n\n* Being not instructible\n* Having an implantable cardioverter defibrillator (ICD)\n* No informed consent can be optained with the participant or a legal representative","70 Years",{"count":302,"type":20},160,[23],"The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and polypharmacy. The main question it aims to answer is the number and type of medication that can be stopped in this population without being restarted within 6 months.\n\nAfter inclusion a medication review is performed by a team consisting of the researcher, a geriatrician and a hospital pharmacist, according to the protocol within which the patient was randomised. Participants are follow up at appointments after 1, 3 and 6 months. At these appointments, questionnaires are administered about the quality of life and complications related to medication.",[306],"Sarcopenia",[308,309,310],"Polypharmacy","Deprescribing","Geriatric patients","2023-03-06",{"date":313,"type":33},"2023-03-07",{"date":96,"type":20},{"date":316,"type":20},"2027-08",{"name":39,"class":40},""]