[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jessa Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":428},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,44,75,105,129,150,169,197,225,257,283,303,335,358,384,406],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100636279","determining-the-extent-of-the-genitourinary-syndrome-of-menopause-burden-in-breast-cancer-survivors-100636279",false,"NCT07563621","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors","Determining the Extent of the Genitourinary Syndrome of Menopause Burden in Breast Cancer Survivors: a Cohort Study","V-light cohort","Inclusion Criteria:\n\n* Women diagnosed with breast cancer stage 0, I, II, and III\n* Prior to CT\u002FET, receiving only one of both (no combination)\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Dutch-speaking (be able to understand the informed consent and study-related questionnaires)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Concomitant CT and ET treatment\n* Structural restorative therapies, such as photobiomodulation therapy (PBM) and fractional CO₂ laser treatment, are not permitted during the study period. During the study period, only symptomatic treatment of GSM (e.g., vaginal lubricants or moisturizers) will be allowed",true,"FEMALE","18 Years",{"count":21,"type":22},264,"ESTIMATED","12 Months","OBSERVATIONAL","Breast cancer survivors (BCS) often face unique challenges during and after treatment, including the onset of menopause-related symptoms. Genitourinary Syndrome of Menopause (GSM) is a common concern in BCS undergoing endocrine therapy (ET). It is a chronic condition caused by estrogen deficiency, leading to vaginal and urinary symptoms such as dryness, irritation, pain during intercourse, recurrent infections, and urinary urgency.\n\nThe prevalence of GSM in BCS varies widely depending on factors such as the type of ET, individual patient characteristics, and the duration of treatment. As such, the prevalence of GSM in BCS can range from 13% to 95.2%. A recent systematic review performed by part of the investigators of this study concludes that GSM is a significant problem for breast cancer patients. However, most studies lack a control group, limiting the results' validity. Therefore, this study aims to determine the extent of the GSM burden in BCS using a prospective, controlled cohort study. This study will compare breast cancer patients receiving endocrine therapy (ET) with those undergoing chemotherapy (CT), as CT may also induce GSM-like symptoms. In addition, a comparison will be made with healthy controls.\n\nFor this study, two groups of participants are included: women with breast cancer and a healthy control group without breast cancer. Within the breast cancer group, a distinction is made between women receiving chemotherapy only and women undergoing hormone therapy only. All participants complete questionnaires. The control group completes these questionnaires once, whereas women with breast cancer are asked to complete the same questionnaires at multiple time points during their treatment and follow-up. This longitudinal approach allows us to assess how potential symptoms evolve over the course of treatment. By comparing responses between both groups, a clearer understanding of which symptoms occur more frequently in women with breast cancer as a consequence of their treatment can be obtained.",[27,28,29,30],"Genitourinary Syndrome of Menopause (GSM)","Breast Cancer","Vulvovaginal Atrophy","Genitourinary Syndrome of Menopause","RECRUITING","2026-04-29",{"date":34,"type":35},"2026-05-04","ACTUAL",{"date":37,"type":35},"2026-03-05",{"date":39,"type":22},"2028-08-31",{"name":41,"class":42},"Jessa Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":43},"100630138","feasibility-and-health-economic-evaluation-of-remote-clinical-monitoring-enabling-same-day-discharge-after-bariatric-surgery-100630138","NCT07483775","Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery","Feasibility and Health-economic Evaluation of Remote Clinical Monitoring Enabling Same-day Discharge After Bariatric Surgery: a Randomized Controlled Pilot Feasibility Trial","REMABS","Inclusion Criteria:\n\n* 18-65 years old\n* Undergoing scheduled ambulatory Roux en Y Gastric Bypass\n* ASA score I or II\n* Competent to provide informed consent\n* Surgery is planned in the morning\n* Fluent in Dutch\n* Owning a smartphone or having a caregiver who can assist\n* Cognitively capable of understanding the study and using the remote wearables\n* An informal caregiver is available following hospital discharge, more specifically during the remainder of the day of surgery (Postoperative day POD 0 and throughout POD 1)\n\nExclusion Criteria:\n\n* Presence of coagulation abnormalities or use of anticoagulant therapy\n* History of major abdominal surgeries, including laparotomy\n* Absence of informed consent or request not to participate in the study","ALL","65 Years",{"count":55,"type":22},40,"INTERVENTIONAL",[58],"NA","The ultimate goal of this research is to optimize care for patients undergoing laparoscopic bariatric surgery while alleviating pressure on hospital resources and staff. Furthermore, the study aims to generate policy-relevant data that can inform policymakers and healthcare providers in developing funding models and care pathways that balance safety, efficiency, and cost-effectiveness. This could support a broader implementation of ambulatory bariatric surgery without compromising quality of care.",[61],"Roux-en Y Gastric Bypass",[63,64,65],"feasibility study","remote monitoring","bariatic surgery","NOT_YET_RECRUITING","2026-04-21",{"date":69,"type":35},"2026-04-24",{"date":71,"type":22},"2026-05-05",{"date":73,"type":22},"2027-12-31",{"name":41,"class":42},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":43},"100635425","patient-reported-outcome-measurements-registration-in-spinal-pathologies-and-neuromodulation-100635425","NCT07552519","Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation","Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation: a Prospective Real-world Data Collection With Pre-determined Follow-up Moments","PROMSPINE","Inclusion Criteria:\n\n1. Clinical diagnosis of spinal disease\n2. Clinical indication to perform treatment of this disease\n3. willing and capable to provide informed consent\n4. Age ≥18 y\n\nExclusion Criteria:\n\nnot able to provide consent",{"count":84,"type":22},5000,"Longitudinal prospective observational data collection with questionnaires and categorical diagnostic and therapeutic registration and follow-up in spinal pathologies and neuromodulation",[87,88,89,90,91,92],"Spinal Pathologies","Pain","Cervical Pain","Lumbar Pain Syndrome","Neurostimulation","Disc Degenerative Disease",[94,95,96],"neuromodulation","pain","spinal pathologies","2026-04-20",{"date":99,"type":35},"2026-04-27",{"date":101,"type":22},"2026-04",{"date":103,"type":22},"2030-06-01",{"name":41,"class":42},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":56,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":43},"100593718","using-digital-health-in-a-postoperative-setting-after-major-surgery-survey-study-100593718","NCT07010081","Using Digital Health in a Postoperative Setting After Major Surgery: Survey Study","Using Digital Health in a Postoperative Setting After Major Surgery: a Prospective Single-center Quantitative Survey Study","Inclusion Criteria:\n\n* Surgical patients\n\n  * \\>18 years old, Undergone major surgery at Jessa Hospital Hasselt\n\nExclusion Criteria:\n\n* Unable to provide informed consent or request to not participate in the study\n* Cognitively incapable of understanding the study\n* No understanding of the Dutch language",{"count":113,"type":22},220,[58],"This study aims to explore patients' use of digital services for self-management of their health following major surgery at Jessa Hospital. Besides this, the study evaluates patients' ability to process and critically assess health information during recovery, their understanding of health concepts and risk factors, and their perception of data security and control over personal health information. Additionally, the study aims to examine patients' motivation to use digital services, their access to and trust in reliable digital health resources, and how well these services meet their individual needs. Furthermore, the study assesses the acceptability, appropriateness, and feasibility of using digital health tools in a post-operative setting, as well as evaluating the digital readiness of patients after surgery.",[117],"Digital Health",[119,120],"Remote monitoring","Major surgery","2025-09-26",{"date":123,"type":35},"2025-10-01",{"date":125,"type":35},"2025-05-26",{"date":127,"type":22},"2027-05-01",{"name":41,"class":42},{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":137,"enrollmentInfo":138,"targetDuration":4,"studyType":56,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":148,"leadSponsor":149,"locationsCount":4},"100583843","remote-clinical-monitoring-after-robotic-distal-pancreatectomy-100583843","NCT06881602","Remote Clinical Monitoring After Robotic Distal Pancreatectomy","Remote Clinical Monitoring After Robotic Distal Pancreatectomy: a Pilot and Feasibility Study","TOTEM","Inclusion Criteria:\n\n* 18-75 years old\n* Competent to provide informed consent\n* Fluent in Dutch\n* Cognitively capable of understanding and engaging with the study\n* Undergoing robotic distal pancreatectomy\n* Owing a smartphone or has a caregiver who can assist\n* Does not live alone\n* Have a valid national identification number\n\nExclusion Criteria:\n\n* Extended left pancreatectomy\n* Spleen-preserving procedure\n* Residing in a nursing home\n* Patients who are deemed unsuitable for the study by the physician based on clinical evaluation\n* Absence of informed consent or request to not participate in the study","75 Years",{"count":139,"type":22},20,[58],"This feasibility trial has three main objectives:\n\n* To investigate the impact of the transmural care pathway TOTeM on the Length of Stay (LOS) for patients undergoing robotic distal pancreatectomy.\n* To investigate the feasibility of the implementation of TOTeM for patients undergoing robotic distal pancreatic surgery, we will measure the recruitment rate by tracking the number of eligible patients who are approached for participation, the percentage who consent to join the study over a specified time period, and the adherence rate which describes how well participants follow the study protocol including the prescribed interventions or follow-up assessments.\n* Assessment of the potential changes in medical costs and outcomes for the purpose of performing a cost-effectiveness analysis from a hospital and patient perspective.",[117],[119,144],"Pancreatectomy",{"date":146,"type":35},"2025-09-29",{"date":123,"type":22},{"date":73,"type":22},{"name":41,"class":42},{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":56,"phases":158,"briefSummary":159,"conditions":160,"keywords":161,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":4},"100593716","using-digital-health-in-a-postoperative-setting-after-major-surgery-semi-structured-interview-study-100593716","NCT07010055","Using Digital Health in a Postoperative Setting After Major Surgery: Semi-structured Interview Study","Using Digital Health in a Postoperative Setting After Major Surgery: a Prospective Single-center Qualitative Semi-structured Interview Study",{"count":157,"type":22},30,[58],"This study aims to evaluate whether patients recognize a need for a remote monitoring care pathway during the post-operative period following major surgery at Jessa Hospital by means of a semi- structured interview. Besides this, the study explores patient perceptions and willingness to participate in digital monitoring care pathways, identifies potential barriers to adoption, and addressing concerns related to safety, data security, and privacy. Additionally, the study aims to assess patient needs regarding parameter collection, technology usage, and the overall functionality of digital monitoring systems, while evaluating the perceived usefulness of such a pathway in post-operative care.",[117],[119,120],"2025-06-06",{"date":164,"type":35},"2025-06-08",{"date":166,"type":22},"2025-06-02",{"date":127,"type":22},{"name":41,"class":42},{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":4,"eligibilityCriteria":175,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":56,"phases":178,"briefSummary":179,"conditions":180,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":43},"100531905","high-versus-low-dose-serratus-anterior-plane-block-after-minimally-invasive-valve-surgery-100531905","NCT06205875","High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery.","High Versus Low Dose Serratus Anterior Plane Block After Minimally Invasive Valve Surgery: a Double-blinded Randomized Controlled Trial.","Inclusion Criteria:\n\n* Scheduled for elective aortic valve surgery or elective mitral valve surgery via right anterolateral thoracotomy\n* Adult patients (minimally 18 years old)\n* Bodyweight \\> 50kg\n* EuroScore ii \\\u003C 3%\n\nExclusion Criteria:\n\n* Refusal to participate\n* Inability to communicate due to language or neurologic barriers\n* Inability to control and self-administer opioids with PCIA or to comprehend the NRS pain score due to confusion or learning difficulties\n* Chronic use of opioids\n* Chronic use of analgesic antidepressants and\u002For antiepileptics\n* Use of prohibited medication which possibly interacts with bupivacaine-epinephrine or opioids (mexiletine, ketoconazole, theophylline, IMAO, Digitalis and cimetidine)\n* History of major trauma or surgery to right chest wall\n* History of chronic pain at right chest wall\n* Allergy to opioids and\u002For local anesthetics\n* Allergy to paracetamol\n* Class 3 obesity (BMI 40 or more)\n* Pregnancy\n* Intraoperative events compromising early postoperative recovery (aortic dissection, systolic anterior motion of the mitral valve, cardiac tamponade, brady-arrhytmias requiring external pacing,...)",{"count":177,"type":22},100,[58],"This study aims to compare the efficacy and quality of pain relief provided by the high-dose serratus anterior plane (SAP) block with the standard SAP block in preventing and treating acute postoperative pain after total endoscopic aortic or mitral valve surgery.",[181,182,183,184],"Analgesia","Surgery","Cardiac Disease","Post Operative Pain",[186,187,188,189],"Aorta\u002Fmitral valve surgery","Serratus anterior plane block","Enhanced recovery after surgery","post operative pain","2025-05-12",{"date":192,"type":35},"2025-05-14",{"date":194,"type":35},"2024-02-21",{"date":73,"type":22},{"name":41,"class":42},{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":203,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":56,"phases":208,"briefSummary":209,"conditions":210,"keywords":212,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":43},"100573429","block-study-better-local-orthopedic-pain-control-after-knee-arthroplasty-100573429","NCT06746168","BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty","Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) With Femoral Triangle Block (TFB) Versus Surgical Local Infiltration Analgesia (LIA) in Unilateral Total Knee Arthroplasty (TKA): A Multicenter Double-blind, Prospective Randomized Controlled Study.","BLOCK","Inclusion Criteria:\n\n* ASA I-III\n* BMI 17-35 kg\u002Fm2\n* Patient is able to give informed consent\n* Patient is scheduled for TKA\n\nExclusion Criteria:\n\n* Refusal of patient\n* Inability to communicate due to language or neurologic barriers\n* Bilateral TKA or unilateral knee arthroplasty\n* Chronic opioid use (including partial opioid agonists) + chronic pain patients:\n* Use of atypical analgesics (gabapentin, pregabalin, …)\n* History of Sudeck atrophy\n* History of \\>3 chronic pain consultations\n* Contraindications for spinal anesthesia\n* Patient refusal\n* Local infection\n* Aberrant coagulation (according to the latest ESRA guidelines)\n* Severe spinal canal stenosis\n* Intracranial hypertension\n* History of neurological injury in the affected limb\n* Contraindications for local anesthetics\n* Allergy for local anesthetics\n* Absolute contraindications for NSAIDs or paracetamol\n* Proven allergy for NSAID's (including ASA syndrome) or paracetamol\n* Severe renal function impairment (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2)\n* Active or recent (\\\u003C6 months) history of gastric ulcera\u002Fperforations\u002Fbleeding\n* Crohn disease or colitis ulcerosa\n* Liver function impairment or severe renal function impairment (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2)\n* Pregnancy or breast-feeding","85 Years",{"count":207,"type":22},210,[58],"The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.",[211],"Knee Arthroplasty, Total",[213,214,215,216],"iPACK","Femoral Triangle Block","Local infiltration analgesia","knee arthoplasty","2025-02-18",{"date":219,"type":35},"2025-02-20",{"date":221,"type":35},"2025-01-09",{"date":223,"type":22},"2027-11-30",{"name":41,"class":42},{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":4,"eligibilityCriteria":231,"healthyVolunteers":17,"sex":52,"minAge":19,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":56,"phases":234,"briefSummary":236,"conditions":237,"keywords":240,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":43},"100571092","phase-4-effects-of-exogenous-ketones-on-acute-changes-and-recovery-of-the-heart-muscle-after-intense-exercise-100571092","NCT06715748","Effects of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle After Intense Exercise.","Prospective Study Investigating the Effects of Intense Endurance Exercise on the Heart Muscle and the Effect of Exogenous Ketones on Acute Changes and Recovery of the Heart Muscle.","Inclusion Criteria:\n\n* healthy recreational male and female cyclists between 18 and 50 years old, who have signed an informed consent form.\n* Participants will be included if they achieve a VO2-max\u002Fkg value above P90, corrected for age and sex, based on the reference value by E. Van der Steeg et al.\n\nExclusion Criteria:\n\n* Cardiovascular, metabolic, or respiratory diseases\n* Participants with cardiovascular risk factors\n* Contraindications for maximum exercise\n* Contraindications for MRI.","50 Years",{"count":157,"type":22},[235],"PHASE4","It is well known that scar tissue on the heart muscle can cause (life-threatening) arrhythmias. However, the exact cause of this scar tissue is not entirely clear. It is possible that prolonged and intense exercise is associated with (limited) inflammation of the heart muscle, carrying the risk of scar tissue development.\n\nThe aim of this project is to evaluate the impact of prolonged and intense exercise on the heart. Participants will be asked to cycle for a total of 3 hours, of which 2 hours will be at an intense pace. Approximately 30 recreational cyclists will be invited to participate in this research project. Specifically, the investigators want to examine whether prolonged and intense exercise is associated with inflammation of the heart muscle and whether it affects heart function recovery. The research project will take place in a laboratory setting, where heart rate, blood pressure, food and fluid intake, and exertion level will be monitored. Before, after and 20-24h after the intense exercise, a lab test and extensive heart imaging will be performed using magnetic resonance imaging (MRI) and cardiac ultrasound. The investigators aim to study the effect of ketone intake (a dietary supplement that may enhance performance or recovery) on recovery. For this, a double blind cross-over design will be setup. Participants will complete the same exercise twice, with a 1-3 week interval, once with a placebo and once with ketones. All the same baseline, post-exercise and recovery investigations will be perfromed.\n\nIn the second part of the study, the investigators will evaluate and compare various rhythm-monitoring devices, both during intense exercise and in daily life. For this, participants will be asked to wear each of four devices for one week in a home setting. These are very small devices that are not externally visible when worn under clothing.\n\nParticipation in this project will involve a various questionnaires and tests.",[238,239],"Exercise-induced Myocardial Damage","Right Ventricular Diastolic Dysfunction",[241,242,243,244,245,246,247,248],"Exercise induced cardiac damage","Exogeneous ketone","Cardiac Recovery","CMR","Cardiac US","Troponine","Lpa","Exercise-CMR","2024-11-28",{"date":251,"type":35},"2024-12-04",{"date":253,"type":35},"2024-10-17",{"date":255,"type":22},"2026-12-22",{"name":41,"class":42},{"id":258,"slug":259,"hasResults":11,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":265,"targetDuration":4,"studyType":56,"phases":267,"briefSummary":268,"conditions":269,"keywords":272,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100451942","photobiomodulation-therapy-in-the-prevention-and-management-of-radiotherapy-induced-vaginal-toxicity-100451942","NCT05165056","Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity","Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Radiotherapy-induced Vaginal Toxicity: a Randomized Controlled Trial","GynLight","Inclusion Criteria:\n\n* Diagnosed with endometrial cancer\n* Scheduled for external beam radiotherapy (EBRT), intracavitary brachytherapy (BT), or a combination\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy\n* Diagnosis of vaginal stenosis before radiotherapy (RT)\n* Previous pelvic tumor or pelvic RT\n* Interruption of RT for more than five sessions\n* Severe psychological disorder or dementia.\n* Inability to speak and understand Dutch\n* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator",{"count":266,"type":22},62,[58],"This study aims to investigate the effectiveness of photobiomodulation therapy (PBMT) in the prevention and management of radiotherapy-induced vaginal toxicity (RIVT). Therefore, we hypothesize that PBMT can reduce the severity of RIVT in gynecological cancer patients, increasing the patient's QoL and sexual functioning.",[270,271],"Radiotherapy Side Effect","Vaginal Abnormality",[273],"Photobiomodulation therapy","2023-09-28",{"date":276,"type":35},"2023-09-29",{"date":278,"type":35},"2022-08-24",{"date":280,"type":22},"2030-01",{"name":41,"class":42},2,{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":56,"phases":293,"briefSummary":294,"conditions":295,"keywords":297,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":298,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":302,"locationsCount":43},"100452882","photobiomodulation-therapy-in-the-prevention-and-management-of-chemotherapy-induced-alopecia-100452882","NCT05177289","Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-Induced Alopecia","Evaluating the Feasibility and Efficacy of Photobiomodulation Therapy in the Prevention and Management of Chemotherapy-induced Alopecia: a Randomized Controlled Trial","HairLight","Inclusion Criteria:\n\n* Diagnosed with gynecological cancer (endometrium, cervix, ovarian or vulva) or breast cancer\n* Receiving chemotherapy ((Carbo)-Taxol)\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy\n* Active infection of the scalp\n* Previous diagnosis of a hair loss condition\n* Interruption of chemotherapy for more than two consecutive cycles\n* Medication to stimulate hair growth (e.g., Minoxidil)\n* Severe psychological disorder or dementia.\n* Inability to speak and understand Dutch\n* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator",{"count":292,"type":22},72,[58],"This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the prevention and management of chemotherapy-induced alopecia (CIA). Therefore, we hypothesize that PBMT can reduce the severity of CIA in gynecological and breast cancer patients, increasing the patient's QoL.",[296],"Chemotherapy-induced Alopecia",[273],{"date":276,"type":35},{"date":300,"type":35},"2022-02-28",{"date":280,"type":22},{"name":41,"class":42},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":56,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":282},"100437653","photobiomodulation-therapy-in-the-management-of-hand-foot-syndrome-and-hand-foot-skin-reaction-100437653","NCT04979078","Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction","Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Hand-foot Syndrome and Hand-foot Skin Reaction: A Single-arm Trial","DermLight","Inclusion Criteria:\n\n* Diagnosed with cancer of different aetiologies\n* Undergoing chemotherapy or targeted therapy (TKIs)\n* Diagnosed with HFS-HFSR grade 1, 2 or 3 (National Cancer Institute - Common Terminology Criteria for Adverse Events, NCI-CTCAE v5)\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Pre-existing skin rash, ulceration or open wound in the treatment area (hand, foot)\n* Known allergy to polyurethane\n* Substance abuse patients or patients with medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results as judged by the investigator\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator",{"count":55,"type":22},[58],"Hand-foot syndrome (HFS) is a side effect of chemotherapy. HFS is characterized by redness, swelling, and pain on the palms of the hands and\u002For soles of the feet, which can progress to blistering. Hand-foot skin reaction (HFSR) refers to symptoms affecting the hands and\u002For feet associated with multikinase inhibitors (TKIs). HFS and HFSR are painful complications that can lead to compromised daily activities, sleep-wake disturbance and impaired mobility, eventually decreasing Quality of Life (QoL).\n\nPhotobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and\u002For near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. The aim of this study is to evaluate the effectiveness of PBMT in the management of HFS and HFSR.",[315,316],"Hand-foot Syndrome","Hand-foot Skin Reaction",[318,319,320,321,322,323,324,325,326],"Dermatology","Oncology","Photobiomodulation","Skin toxicity","Hand-foot syndrome","Hand-foot skin reaction","Hand-foot skin toxicity","Supportive cancer care","Light therapy","2023-06-15",{"date":329,"type":35},"2023-06-18",{"date":331,"type":35},"2022-01-12",{"date":333,"type":22},"2029-08",{"name":41,"class":42},{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":56,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":43},"100497934","photobiomodulation-therapy-in-the-management-of-chemotherapy-induced-peripheral-neuropathy-100497934","NCT05763706","Photobiomodulation Therapy in the Management of Chemotherapy-Induced Peripheral Neuropathy","Evaluating the Efficacy of Photobiomodulation Therapy in the Management of Chemotherapy-induced Peripheral Neuropathy: a Randomized Controlled Trial","NeuroLight 2","Inclusion Criteria:\n\n* Finished one of the following types of chemotherapy: paclitaxel, docetaxel, oxaliplatin, cisplatin, vincristine, thalidomide and\u002For bortezomib.\n* Diagnosed with CIPN\n* Age 18 years or above\n* Have no documented or observable psychiatric or neurological disorders that might interfere with study participation (e.g., dementia or psychosis)\n* Dutch-speaking\n* Signed informed consent\n\nExclusion Criteria:\n\n* Taking stable doses of medication on prescription for peripheral neuropathy. Related medications are: gabapentin, pregabalin (Lyrica), nortriptyline, amitriptyline, duloxetine (Cymbalta), and venlafaxine.\n* Severe or unstable cardio- respiratory or musculoskeletal disease\n* Interruption of more than two consecutive laser treatments\n* Dark brown or black skin pigmentation (described as skin type VI in the Fitzpatrick scale)",{"count":344,"type":22},172,[58],"This study aims to investigate the effectiveness of photobiomodulation therapy (PBM) in the management of chemotherapy-induced peripheral neuropathy (CIPN). Therefore, the hypothesis is that PBM can reduce the severity of CIPN in cancer patients, increasing the patient's quality of life.",[348],"Chemotherapy-induced Peripheral Neuropathy",[273],"2023-03-28",{"date":352,"type":35},"2023-03-30",{"date":354,"type":35},"2023-03-27",{"date":356,"type":22},"2030-03-15",{"name":41,"class":42},{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":56,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":383,"locationsCount":282},"100415500","photobiomodulation-therapy-for-the-management-of-breast-cancer-related-lymphedema-100415500","NCT04690439","Photobiomodulation Therapy for the Management of Breast Cancer-related Lymphedema","Evaluating the Effectiveness of Photobiomodulation Therapy in the Management of Breast Cancer-Related Lymphedema: a Randomized Controlled Trial","LymphLight","Inclusion Criteria:\n\n* Diagnosed with breast cancer\n* Underwent ipsilateral lumpectomy or mastectomy + sentinel lymph node biopsy +\u002F- lymph node dissection\n* Underwent radiotherapy with or without chemotherapy\n* Diagnosed with BCRL (i.e. International Society of Lymphology (ISL) lymphedema stage I or higher)\n* Age ≥ 18 years\n* Able to comply to the study protocol\n* Able to sign written informed consent\n\nExclusion Criteria:\n\n* Metastatic disease\n* Pregnancy\n* History of surgery or trauma to the arm\n* History of arm infection in the past 3 months\n* Use of medications that affect body fluid (e.g., diuretics) in the last 3 months\n* Severe psychological disorder or dementia\n* Any condition that is unstable or could affect the safety of the patient and their compliance in the study as judged by the investigator",{"count":367,"type":22},104,[58],"Up to one out of five patients with breast cancer will develop lymphedema in the upper extremity after cancer treatment. Patients with breast cancer-related lymphedema (BCRL) suffer from pain, heaviness, tightness, and a decreased range of motion. Photobiomodulation therapy (PBMT) is a non-invasive therapy based on the application of visible and\u002For near-infrared light produced by a laser diode or a light-emitting diode. The scientifically proven biologic effects of PBM are improved wound healing, and a reduction in pain, inflammation, and oedema. Therefore, the aim of this study is to evaluate the effectiveness of PBMT on the management of BCRL.",[28,371,372],"Breast Cancer Related Lymphedema","Lymphedema of Upper Arm",[374,375,320],"Lymphedema","Breast cancer","2023-02-27",{"date":378,"type":35},"2023-02-28",{"date":380,"type":35},"2021-02-22",{"date":382,"type":22},"2028-02",{"name":41,"class":42},{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":389,"acronym":4,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":4,"enrollmentInfo":391,"targetDuration":393,"studyType":24,"phases":4,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":43},"100340774","genotype-phenotype-correlation-study-of-presymptomatic-and-symptomatic-dfna9-patients-100340774","NCT03716908","Genotype-phenotype Correlation Study of Presymptomatic and Symptomatic DFNA9 Patients","Evaluation of Hearing and Vestibular Function in Presymptomatic and Symptomatic DFNA9 Patients Carrying the Pro51Ser (P51S) Mutation in the COCH Gene.","Inclusion Criteria:\n\n* subject must be 18 year of older\n* subject is a family member of the family pedigree's proband(s) carrying a P51S COCH mutation\n\nExclusion Criteria:\n\n* subject is younger than 18 years\n* subject is not a family member of the pedigree's proband(s) carrying a P51S\n* subject cannot undergo investigations (medical and\u002For mental reasons)\n* subject is not willing to be enrolled into the study\n* subject suffers other concomitant middle or inner ear disease\n* subject has undergone middle ear or inner ear surgery\n* subject suffers other concomitant vestibular disease than DFNA9\n* subject has undergone vestibular surgery or other non-invasive vestibular treatment (gentamicin intratympanal injections for example)",{"count":392,"type":22},70,"1 Year","DFNA9 (Deafness Autosomal Dominant 9) is an autosomal dominant hereditary hearing loss which is associated with vestibular deterioration. The most recent genotype-phenotype correlation studies have been conducted more than 15 years ago. Meanwhile, emerging and valuable vestibular tests have been added to the vestibular test battery. These tests were not available at the time of the correlation studies. The aim of this study is to carry out a prospective cross-sectional study on symptomatic and presymptomatic affected carriers of the Pro51Ser (P51S) Coagulation Factor C Homology (COCH) mutation in order to correlate vestibular data using the complete vestibular test battery with the known data on hearing and vestibular function in relation to age.",[396,397],"Vestibular Diseases","DFNA9","2021-10-27",{"date":400,"type":35},"2021-10-28",{"date":402,"type":35},"2018-06-01",{"date":404,"type":22},"2026-11-30",{"name":41,"class":42},{"id":407,"slug":408,"hasResults":11,"nctId":409,"briefTitle":410,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":52,"minAge":19,"maxAge":412,"enrollmentInfo":413,"targetDuration":414,"studyType":24,"phases":4,"briefSummary":415,"conditions":416,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":43},"100367949","correlation-of-radiological-lesions-with-vestibular-function-in-patients-with-bilateral-vestibulopathy-100367949","NCT04070937","Correlation of Radiological Lesions With Vestibular Function in Patients With Bilateral Vestibulopathy","Inclusion Criteria:\n\n* must meet the Barany criteria for bilateral vestibulopathy: bilaterally pathological horizontal angu- lar VOR gain \\\u003C0.6, measured by the video-HIT5 or scleral-coil technique and\u002For\n* reduced caloric response6 (sum of bither- mal max. peak SPV on each side \\\u003C6◦\u002Fsec7) and\u002For\n* reduced horizontal angular VOR gain \\\u003C0.1 upon sinusoidal stimulation on a rota- tory chair (0.1 Hz, Vmax = 50◦ \u002Fsec) and a phase lead \\>68 degrees (time constant \\\u003C5 sec).\n* must be 18 or older\n\nExclusion Criteria:\n\n* \\\u003C 18 y\n* does not meet Barany criteria for BV\n* contraindication for CT and MR imaging","90 Years",{"count":55,"type":22},"2 Years","In 2014 radiologic lesions were detected at one or more semicircular canals using CT and MR imaging of temporal bone in subjects carrying the p.P51S mutation in COCH. These lesions are believed to present at more advanced stages of the hearing and vestibular deterioration. Since then, other authors have described similar lesions in advanced non-genetic hearing and vestibular impairment as well.\n\nThe purpose of this study is therefore to assess the radiologic investigation using CT and MR imaging of temporal bone to all subjects presenting with bilateral vestibulopathy, using the Barany criteria, compared to the p.P51S population.",[417,418,397,419],"Hearing Loss, Sensorineural","Bilateral Vestibular Deficiency","Radiology","2021-08-24",{"date":422,"type":35},"2021-08-25",{"date":424,"type":35},"2019-09-01",{"date":426,"type":22},"2026-10-30",{"name":41,"class":42},""]