[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Universiteit Antwerpen\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":594},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,57,84,111,146,172,204,227,259,290,311,336,363,385,410,433,459,487,521,545,566],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100634594","developing-and-testing-a-preventive-primary-care-parenting-intervention-to-strengthen-parent-infant-co-regulation-in-families-experiencing-early-regulatory-difficulties-100634594",false,"NCT07541716","Developing and Testing a Preventive Primary Care Parenting Intervention to Strengthen Parent-Infant Co-Regulation in Families Experiencing Early Regulatory Difficulties","Inclusion Criteria:\n\n* Parent (or primary caregiver) of an infant aged approximately 3 months at enrollment.\n* Aged 18 years or older.\n* One parent has completed the brief screening questionnaire and scored above a predefined cutoff indicating elevated levels of infant regulatory problems and eligibility for the intervention.\n\nExclusion Criteria:\n\n* Insufficient proficiency in Dutch to understand study materials or participate in intervention sessions\n* No access to the internet or a compatible device required to use the mobile application","ALL","18 Years",{"count":18,"type":19},200,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this randomized controlled trial is to evaluate the effectiveness of a structured parenting support program for families with young infants experiencing early regulatory difficulties. Participants are families with infants approximately 3 months of age who score above a predefined threshold on a screening questionnaire assessing early regulatory problems.\n\nThe main questions this study aims to answer are:\n\n* Does participation in the parenting support program reduce parental stress and improve parental self-efficacy from baseline to post-intervention?\n* Does the intervention reduce infant regulatory problems (e.g., excessive crying, feeding difficulties, and sleep problems) at 6-month follow-up (i.e., when the child is approximately 12 months old)?\n\nResearchers will compare families receiving the structured parenting support program to families receiving usual care to evaluate the effects of the intervention.\n\nParticipants will complete questionnaires when the infant is approximately 3-4 months old (baseline), around 6 months of age (post-intervention), and follow-up assessments will be conducted when the child is approximately 9 and 12 months old.\n\nIf assigned to the intervention group, participants will attend one individual session and five group sessions led by trained psycho-educators and receive access to psycho-educational content through a mobile application.",[25,26,27,28],"Infant Regulatory Problems","Regulatory Problems in Infancy","Parental Stress","Parental Self-efficacy",[30,31,32,33,34,35,36,37,38,39,40,41,42,43],"Early infancy","Infant regulatory problems","Parental well-being","Parenting support","Behavioral intervention","Family intervention","Parent-infant relationship","Randomized controlled trial","Psychoeducation","Regulatory problems in infancy","Infant mental health","Parent-infant mental health","Parental stress","Parental self-efficacy","RECRUITING","2026-06-05",{"date":47,"type":48},"2026-06-09","ACTUAL",{"date":50,"type":48},"2026-05-06",{"date":52,"type":19},"2027-07",{"name":54,"class":55},"Universiteit Antwerpen","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":15,"minAge":16,"maxAge":66,"enrollmentInfo":67,"targetDuration":4,"studyType":20,"phases":69,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":56},"100643813","sample-collection-and-instruction-optimization-100643813","NCT07636668","Sample Collection and Instruction Optimization","SCIO: Sample Collection and Instruction Optimization","SCIO","Inclusion Criteria:\n\n* Naïve to first-void urine collection (standard urine cup is allowed)\n* Able to understand the information brochure and what the study is about",true,"65 Years",{"count":68,"type":19},60,[22],"The aim of this study is to improve the instructions for use and to evaluate the usability of a novel first-void urine collection device.",[72,73],"Instructions for Use","Usability",[75,76],"First-void urine","Self-sampling","2026-06-03",{"date":47,"type":48},{"date":80,"type":48},"2026-05-13",{"date":82,"type":19},"2027-01",{"name":54,"class":55},{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":91,"minAge":16,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":56},"100637650","using-urine-to-study-antibodies--functional-cell-mediated-immunity-in-the-context-of-chlamydia-trachomatis-100637650","NCT07596316","Using Urine to Study Antibodies & Functional Cell-Mediated Immunity in the Context of Chlamydia Trachomatis","URSAFE-CT","Inclusion Criteria:\n\n* Female\n* Chlamydia trachomatis NAAT positive vaginal sample or first-void urine sample.\n* Able to understand the information brochure and what the study is about.\n* Willing to give informed consent to use their samples for details described in the study protocol.\n\nExclusion Criteria:\n\n* Pregnancy (self-reported)\n* Being positive for Human Immunodeficiency Virus (HIV)\n* Women that underwent hysterectomy.\n* Menstruation at the time of sample collection.\n* Current use of antibiotics effective against Chlamydia trachomatis (doxycyline or azithromycine) or use of such antimicrobials in the past 14 days before participating in the study.\n* Participating in another clinical trial at the same time of participating in this study.\n* Having a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.","FEMALE",{"count":93,"type":19},73,"OBSERVATIONAL","The goal of this observational study is to learn if we can identify immune biomarkers in first-void urine and vaginal brush samples in Chlamydia trachomatis (CT) positive adult women. Participants will self-collect a first-void urine sample, self-collect a vaginal brush, and a blood sample will be collected by a healthcare worker. Participants will complete a questionnaire.",[97],"Chlamydia Trachomatis Genital Infection",[99,100,101,102],"first-void urine","Colli Pee","Chlamydia","Mucosal immunity","2026-05-12",{"date":105,"type":48},"2026-05-19",{"date":107,"type":48},"2025-12-10",{"date":109,"type":19},"2027-06",{"name":54,"class":55},{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":119,"enrollmentInfo":120,"targetDuration":4,"studyType":20,"phases":122,"briefSummary":125,"conditions":126,"keywords":128,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100538841","phase-2-comparative-study-of-the-effects-of-dry-needling-and-botulinum-toxin-type-a-as-a-treatment-for-lower-limb-post-stroke-spasticity-100538841","NCT06296082","Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity","Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial","STROKEPOC","Inclusion Criteria:\n\n1. aged 18-75 years.\n2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).\n3. first stroke.\n4. 0-12 months evolution.\n5. no previous BTX-A or DN treatment for spasticity.\n6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \\~30°.\n7. independent ambulation with or without aids.\n\nExclusion Criteria:\n\n1. medical conditions interfering with data interpretation.\n2. contraindications for BTX-A or DN treatment.\n3. changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.\n4. pregnant or breastfeeding.","75 Years",{"count":121,"type":19},90,[123,124],"PHASE2","PHASE3","This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.",[127],"Stroke",[129,130,131,132,133,134,135,136],"Stroke [Mesh]","Dry Needling","Muscle Spasticity [Mesh]","Botulinum Toxins [Mesh]","Tonic Stretch Reflex Threshold","Ultrasound imaging","Gait analysis","Quality of Life [Mesh]","2026-04-28",{"date":139,"type":48},"2026-05-04",{"date":141,"type":48},"2024-09-01",{"date":143,"type":19},"2027-03-29",{"name":54,"class":55},3,{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":91,"minAge":16,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":20,"phases":157,"briefSummary":158,"conditions":159,"keywords":161,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":168,"completionDateStruct":169,"leadSponsor":171,"locationsCount":145},"100624279","phase-2-developing-a-first-void-urine-based-infection-model-to-study-hpv-specific-antibody-virion-interaction-before-and-after-hpv-vaccination-100624279","NCT07407569","Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After HPV Vaccination","Developing a First-void Urine-based Infection Model to Study HPV-specific Antibody-virion Interaction Before and After Vaccination With the Gardasil-9 HPV Vaccine - a Non-randomized Open-label Study.","URVIVE","Candidates are eligible for inclusion in the study if they:\n\n* Are females between 18 and 45 years old (including both limits) at the time of signing the informed consent form.\n* Have tested positive for HPV16 DNA (single or co-infection) but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion or within the last twelve months before inclusion.\n* Did not receive prior vaccination with a prophylactic HPV vaccine.\n* Are able to understand the information brochure and what the study is about.\n* Are willing to give informed consent to the study team to access their medical records, including details on their HPV vaccination schedule and cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).\n\nCandidates must be excluded from the study if they:\n\n* Are previously (completely or partially) vaccinated against HPV or have planned administration of another HPV vaccine during the study.\n* Are pregnant at the time of signing informed consent or are planning to become pregnant within the full duration of the study. Participants must use an effective method of contraception throughout the entire study. Acceptable methods include combined hormonal contraception (oral, vaginal ring, transdermal patch), progestogen-only contraception (oral, injectable, implantable), intrauterine device (IUD)\u002Fintrauterine system (IUS), condom, vasectomized male partner, or (periodic) abstinence. Lactating women may be included.\n* Have had full hysterectomy.\n* Have had any anogenital lesion treated in the last twelve months before participating in the study.\n* Have invasive cancer (except basocellular carcinoma) or other immunocompromising conditions as described as high-risk in the latest scientific guidelines from Sciensano.\n* Use immunosuppressive therapy for inflammatory bowel disease, rheumatological disorders, neuromyelitis optica, sarcoidosis, adenocarcinoma in situ, or use of local anogenital corticosteroids.\n* Have used any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planning to use during the study period.\n* Have received immunoglobulin or blood-derived products in the three months prior to the first study vaccination (Month 0), or are expected to require immunoglobulin or blood-derived products from Month 1 until Month 7 of the study.\n* Receive any vaccine not foreseen in the study protocol administered in the period beginning 30 days preceding each dose of the study vaccine and ending one month (minimum 30 days) after each dose of the study vaccine.\n* Have known allergy or history of any reaction or hypersensitivity likely to be exacerbated by any component of the Gardasil 9 vaccine or known history of severe allergic reaction to other vaccines (e.g. anaphylaxis).\n* Are concurrently enrolled in another clinical study of investigational agents.\n* Have acute disease or contraindications for vaccination at the time of enrolment. Acute disease is defined as the presence of moderate or severe illness with or without fever. Enrolment will be deferred until the condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral\u002Faxillary temperature \\>37.5 °C.\n* Have a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.\n* Are, as determined by the investigator, unlikely to adhere to the study procedures, keep appointments, or are planning to relocate from the area prior to completion of the study.","45 Years",{"count":156,"type":19},50,[123],"The current study is an open-label, non-randomized, longitudinal exploratory trial using the licensed Gardasil 9 (9vHPV) vaccine in an off-label context to investigate biological and immunological outcomes in human papillomavirus type 16 (HPV16) positive women. Two doses of the licensed Gardasil 9 vaccine will be administered to approximately 50 women between 18 and 45 years old, who test positive for HPV16 DNA at baseline using a type-specific quantitative PCR assay, but have no presence of apparent anogenital lesions and are thus not referred for treatment or intervention at the time of inclusion.\n\nThe primary objective of this study is to demonstrate that vaccination with a two-dose regimen of the 9vHPV vaccine reduces the viral infectivity of particles in the female genital tract of HPV16-positive women, by using first-void urine samples. The secondary objectives are to follow up HPV type-specific antibody responses in these first-void urine samples after natural infection and vaccination after one or two doses of the 9vHPV vaccine and to compare these with the responses in serum, and to monitor HPV infections in first-void urine over time.\n\nCandidates will be selected for participation based on the result of their HPV DNA test performed on a sample collected during routine screening or symptomatic (opportunistic) testing in one of the following centers:\n\n* The University Hospital of Antwerp (UZA).\n* The University Hospital of Leuven (UZ Leuven).\n* Ghent University Hospital (UZ Gent).\n\nWomen are followed for up to 24 months, in which first-void urine and serum samples will be collected at different timepoints.\n\nThe following laboratory procedures will be applied to reach study objectives\n\n* Assessment of HPV DNA positivity: HPV genotyping in first-void urine samples.\n* Assessment of HPV infectivity: Detection of HPV16 E1\\^E4 spliced mRNA in HaCaT keratinocytes after infection with virions from first-void urine samples.\n* Assessment of HPV immunogenicity: Detection of HPV-specific antibodies in first-void urine and serum samples.",[160],"Human Papilloma Virus Infection Type 16",[162,163,164,76,75],"HPV-specific antibodies","Gardasil 9","Vaccination","2026-03-25",{"date":167,"type":48},"2026-03-27",{"date":165,"type":48},{"date":170,"type":19},"2029-01-01",{"name":54,"class":55},{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":4,"eligibilityCriteria":178,"healthyVolunteers":65,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":20,"phases":181,"briefSummary":182,"conditions":183,"keywords":189,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":201,"leadSponsor":203,"locationsCount":56},"100614097","hiit-for-inflammatory-driven-shoulder-pain-100614097","NCT07275164","HIIT for Inflammatory-driven Shoulder Pain.","Revolutionizing Musculoskeletal Shoulder Pain Management: High-intensity Interval Training as a Systemic Intervention. A Feasibility Study.","Inclusion Criteria:\n\nShoulder pain group\n\n* Shoulder pain \\> 3 months\n* Diagnosis of rotator cuff related shoulder pain or frozen shoulder\n* Understanding Dutch in speaking and writing.\n\nControl group\n\no Understanding Dutch in speaking and writing\n\nExclusion Criteria:\n\nShoulder pain group\n\n* \\\u003C18 years\n* Shoulder surgery or trauma in past year\n* Neurological, cancer, or neuromuscular disease\n* Osteoarthritis, cervical or AC joint pathology\n* Heavy physical exertion \\\u003C48h before testing\n\nControl group\n\n* \\\u003C18 years\n* recent or recurrent neck\u002Fshoulder pain\n* systemic or neurological disease\n* psychiatric disorders\n* pregnancy\u002Fbreastfeeding\n* pain medication \\\u003C48h before test",{"count":180,"type":19},30,[22],"This feasibility study investigates whether high-intensity interval training (HIIT) is feasible and acceptable for individuals with long-term shoulder pain where low-grade inflammation is suspected. Many patients do not recover fully with current local treatments, and systemic factors such as inflammation, and metabolic changes, additionally disturbances in the functioning of the nervous system often seem to play a role. HIIT is a time-efficient form of exercise that has been shown to improve inflammation and metabolic values and positively influence the balance of the nervous system. In this feasibility study, the investigators are enrolling 15 individuals with persistent shoulder pain (diagnosed with rotator cuff-related shoulder pain or frozen shoulder) with \\>3 months of symptoms, and 15 individuals without shoulder complaints. All participants will undergo measurements of inflammatory levels, glycosylated hemoglobin (HbA1c), blood pressure, body composition, pain sensitivity tests, and complete questionnaires about autonomic complaints and quality of life. Participants with shoulder pain will also perform one personalized HIIT session on a cycle ergometer. The investigators will assess whether participants accept a systemic intervention for their shoulder pain, if they are cooperative, and how they feel about the session; additionally, any side effects will be recorded. The aim is to determine whether HIIT is practically feasible and safe for this group and whether there are indications that systemic factors such as inflammation and nervous system function are associated with persistent shoulder pain. The outcome will determine whether follow-up research with a larger study is worthwhile.",[184,185,186,187,188],"Chronic Shoulder Pain","Rotator Cuff Related Shoulder Pain","Frozen Shoulder","Shoulder Adhesive Capsulitis","Shoulder Pain",[190,191,192,193,194,195,196],"low-grade inflammation","chronic shoulder pain","autonomic dysfunction","metabolic syndrome","frozen shoulder","rotator cuff related shoulder pain","high intensity interval training","2026-02-10",{"date":199,"type":48},"2026-02-13",{"date":107,"type":48},{"date":202,"type":19},"2026-10",{"name":54,"class":55},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":65,"sex":15,"minAge":211,"maxAge":212,"enrollmentInfo":213,"targetDuration":4,"studyType":20,"phases":215,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":56},"100605362","test-retest-reliability-of-semg-to-measure-fatigue-in-adolescents-100605362","NCT07161531","Test-retest Reliability of sEMG to Measure Fatigue in Adolescents","Evaluating Test-Retest Reliability of Surface Electromyography (sEMG) in Measuring Fatigue in Adolescents Through Prolonged Activity","Inclusion Criteria:\n\n* engage in regular physical activity, such as sports or dance\n\nExclusion Criteria:\n\n* neuromuscular disorders\n* conditions that affect muscle function","13 Years","19 Years",{"count":214,"type":19},27,[22],"This cross-sectional study aims to determine the test-retest reliability of surface electromyography (sEMG) outcomes in detecting levels of fatigue among healthy adolescents engaged in physical activities. It seeks to evaluate the consistency of sEMG parameters across two test sessions and correlate these measurements with both performance metrics and subjective fatigue assessments.\n\nParticipants will perform repetitive squatting until volitional exhaustion while their muscular activity is recorded. They will do so on two different test sessions with an interval of one week in between.",[218],"Healthy Adolescents","2025-09-03",{"date":221,"type":48},"2025-09-08",{"date":223,"type":48},"2025-03-12",{"date":225,"type":19},"2026-06-30",{"name":54,"class":55},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":91,"minAge":16,"maxAge":4,"enrollmentInfo":235,"targetDuration":4,"studyType":20,"phases":237,"briefSummary":238,"conditions":239,"keywords":244,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":258},"100599129","effectiveness-of-kinesio-taping-in-patients-with-chronic-breast-andor-truncal-oedema-after-treatment-for-breast-cancer-100599129","NCT07080476","Effectiveness of Kinesio Taping in Patients With Chronic Breast and\u002For Truncal Oedema After Treatment for Breast Cancer.","Effectiveness of Kinesio Taping in Patients With Chronic Breast and\u002For Truncal Oedema After Breast Cancer Treatment: A Randomized Controlled Trial","KiTaLymph","Inclusion Criteria:\n\n* Female patients previously treated for breast cancer.\n* Suffering from persistent (\\>6 months) breast and\u002For truncal oedema, established at least six months after completion of radiotherapy.\n* Objective measurements:\n\n  * BrEQ score ≥9.\n  * PWC (LymphScanner) showing at least one of the following:\n\n    * Truncal oedema: ratio ≥ 1.32.\n    * Breast oedema: ratio ≥ 1.28.\n    * Local PWC of 52.90%.\n* Clinical evaluation:\n\n  * At least one positive sign of breast and\u002For truncal oedema such as:\n\n    * Visual swelling compared with the contralateral side.\n    * Visible imprint of the bra on the skin.\n    * Peau d'orange appearance on the breast.\n\nExclusion Criteria:\n\n* Presence of skin infections or wounds of the breast\u002Ftruncal region at the time of inclusion making it impossible to apply kinesio tape.\n* Age under 18 years.\n* Not able to read and understand Dutch language.\n* Having received mastectomy.\n* Metastatic breast cancer.",{"count":236,"type":19},128,[22],"The goal of the KiTaLymph trial is to investigate whether the application of kinesio tape is effective in women with persistent (\\>6 months) breast and\u002For truncal oedema after treatment for breast cancer.\n\nThe main objectives are to assess whether kinesio taping:\n\n* reduces pain and symptoms,\n* decreases swelling,\n* improves quality of life (QoL).\n\nThis study will compare a control group receiving standard care, decongestive lymphatic therapy (DLT), to an intervention group receiving DLT in combination with kinesio taping, in order to determine whether the addition of kinesio tape yields superior clinical outcomes.\n\nParticipants will be randomly allocated to one of the two study arms. Both groups will participate in a 4-week intervention phase, consisting of two treatment sessions per week. This will be followed by a 6-month follow-up period to assess the durability of treatment effects and cost-related outcomes.\n\nA total of approximately 128 participants will be recruited. Outcome assessments will be conducted at baseline, immediately post-intervention (1 month), and at 3 and 6 months following the end of the intervention. These assessments will include standardised patient-reported outcome measures evaluating symptoms, quality of life, and pain, namely, the Breast Edema Questionnaire (BrEQ), the EORTC-QLQ-BR23, the EQ-5D-5L, and a visual analogue scale (VAS), as well as objective physical measurements of oedema using the LymphScanner (expressed as percentage water content, PWC).\n\nIn addition to the primary research objective, several sub-studies will be conducted. These will include: (1) a longitudinal analysis of the effects of standard treatment; (2) an evaluation of the responsiveness and clinical utility of the BrEQ; and (3) a cross-sectional analysis of the compression pressure exerted by various compression bras. All sub-studies are methodologically feasible within the projected sample size of the primary objective and aim to provide supplementary insights into the clinical management of breast and truncal oedema.",[240,241,242,243],"Breast Edema","Breast Cancer Related Lymphoedema","Breast Cancer Related Lymphedema","Truncal Lymphedema",[245,246,247,248,249,250],"RCT","Decongestive Lymphatic Therapy (DLT)","Health-related quality of life (HRQoL)","Breast cancer","Kinesio taping","Breast oedema","2025-08-26",{"date":219,"type":48},{"date":254,"type":48},"2025-08-25",{"date":256,"type":19},"2028-12",{"name":54,"class":55},4,{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":65,"sex":15,"minAge":267,"maxAge":268,"enrollmentInfo":269,"targetDuration":4,"studyType":20,"phases":271,"briefSummary":272,"conditions":273,"keywords":277,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":56},"100604142","the-coccos-study-a-transition-program-for-young-persons-with-chronic-conditions-100604142","NCT07145671","The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions","The COCCOS Study: Implementing and Evaluating a Transition Program for Young Persons With Chronic Conditions","COCCOS","Inclusion criteria:\n\nFor participants in the intervention group (IG):\n\n* 17 years old;\n* diagnosed with type 1 diabetes, asthma and\u002For obesity;\n* who had at least one pediatric outpatient visit, prior to inclusion, in one of both hospitals within the past 12 months;\n* are Dutch speaking;\n* planned to transfer to adult care within the next 12 months.\n\nFor participants in the control group (CG):\n\n* age 17,5 and 18 years old, as the control period has a shorter duration (4 months vs. 12 months)\n* diagnosed with type 1 diabetes, asthma and\u002For obesity;\n* who had at least one pediatric outpatient visit, prior to inclusion, in one of both hospitals within the past 12 months;\n* are Dutch speaking;\n* planned to transfer to adult care within the next 12 months.\n\nExclusion criteria:\n\nApplicable for both CG and IG:\n\n\\- patients with severe mental, cognitive or neurological problems will be excluded","16 Years","21 Years",{"count":270,"type":19},150,[22],"A study is undertaken to examine the feasibility of the newly developed transition program in adolescents with type 1 diabetes, asthma and obesity in a multicentric setting. Specific objectives for this study are: (1) examining the impact of the program in terms of patient-reported health outcomes, (2) examining patients' and healthcare providers' experiences related to the program implementation process, and (3) examining the impact of the program in terms of cost-effectiveness.",[274,275,276],"Type 1 Diabetes Mellitus","Obesity","Asthma",[278,279,280,281],"adolescent","young adult","transitional care","transition program","2025-08-20",{"date":284,"type":48},"2025-08-28",{"date":286,"type":48},"2025-03-13",{"date":288,"type":19},"2026-12",{"name":54,"class":55},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":298,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":258},"100599705","positron-emission-tomography-with-innovative-laboratory-techniques-for-improved-risk-and-disease-assessment-in-newly-diagnosed-multiple-myeloma-patients-100599705","NCT07087964","Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Newly Diagnosed Multiple Myeloma Patients","Positron Emission Tomography With Innovative Laboratory Techniques for Improved Risk and Disease Assessment in Myeloma","IMMPROVED","Inclusion Criteria:\n\n* Transplant-eligible newly diagnosed multiple myeloma based on current IMWG criteria and scheduled for induction chemotherapy followed by ASCT. Remark: patiënts can also be included after ASCT, prior to maintenance therapy, if a baseline FDG-PET CT scan showing FDG avid disease is available.\n* Baseline 18F-FDG PET\u002FWBLDCT scan should be performed before start of treatment (preferably) or within 7 days after start of treatment. Scan must show FDG avid disease (=at least 1 FL ≥ DS3 and\u002For diffuse bone marrow involvement).\n* WHO performance status 0-2 (WHO \\> 2 can be allowed if due to underlying disease and after discussion with the physician).\n* Age ≥ 18 years\n* Life expectancy \\> 12 months, based on clinical judgement.\n\nEligibility criteria for the primary endpoint\n\n* achieving at least a VGPR after induction chemotherapy and ASCT according to the standard IMWG response criteria.\n* received at least one (28-day) cycle of lenalidomide as maintenance therapy after ASCT. No new therapy can be given until clinical relapse.\n\nExclusion Criteria:\n\n* Any physical or physiological condition that may affect adherence to the study protocol, e.g. severe claustrophobia or the inability to lie still for 30 minutes.\n* uncontrolled diabetes\n* History of concomitant presence of any other malignancy, except for:\n\n  * non-melanoma skin cancer\n  * carinoma in situ of the cervix\n  * any other effectively treated malignancy that has been in remission for \\> 5 years or that is highly likely to be cured at the time of enrollment.\n* pregnant or breastfeeding\n* refusal or inability to provide written informed consent",{"count":299,"type":19},120,"This study investigates newly diagnosed multiple myeloma patients following standard of care treatment. The primary endpoint of the study is to determine minimal residual disease (MRD) by combining 2 techniques in order to better predict progression free survival (PFS) of a patient. Secondary endpoint is to gain more insight into diagnostic features to better stratify patients based on risk factors for early relapse. Both endpoints could lead to a more patient specific treatment in the future.\n\nParticipants will be followed throughout their standard of care treatment. This treatment consists of indcution chemotherapy, followed by autologous stem cell transplant (ASCT), followed by lenalidomide maintenance therapy.\n\n* Before start of induction chemotherapy the patient will receive a whole-body FDG PET\u002FLDCT scan and an additional bone marrow aspirate sample will be taken during a routine bone marrow punction. This sample will be used for whole exome sequencing (WES).\n* For those patients who achieve at least a very good partial response (VGPR) after induction chemotherapy and ASCT a repeat whole body FDG PET\u002FLDCT scan will be performed before start of maintenance therapy. This scan will be repeated for a third time after 1 year of maintenance therapy. Besides this, an additional bone marrow aspirate sample will be taken for MRD detection. This will be done before start of maintenance therapy, after 1 year of maintenance therapy and after 2 years of maintenance therapy. MRD detection is done by next generation flow cytometery (NGF).\n* During mantenance therapy patient follow-up will be performed at least every 3 months to determine best response to therapy or possible relapse (based on routine lab information).\n* Those patients who do not achieve VGPR or better will not need to receive a whole body FDG PET\u002FCT scan and MRD detection by flow cytometry, but these patients will undergo the same follow-up during maintenance therapy.\n* In case of relapse, for all patients, an additional bone marrow aspirate sample will be taken for WES (during a routine bone marrow investigation).",[302],"Newly Diagnosed Multiple Myeloma (NDMM)","2025-07-23",{"date":305,"type":48},"2025-07-28",{"date":307,"type":48},"2022-05-16",{"date":309,"type":19},"2028-12-31",{"name":54,"class":55},{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":20,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":335},"100590066","the-effect-of-personalized-exercise-interventions-for-the-prevention-of-chemotherapy-induced-peripheral-neuropathy-100590066","NCT06962579","The Effect of Personalized Exercise Interventions for the Prevention of Chemotherapy-induced Peripheral Neuropathy","CIPN-EX","Inclusion Criteria:\n\n* age above 18 years\n* a primary diagnosis of breast, gynaecological or colon cancer, without distant metastasis\n* been chemotherapy naïve\n* been scheduled for at least 12 weeks of taxane- or platinum-based chemotherapy without other neurotoxic chemotherapy\n\nExclusion Criteria:\n\n* life expectancy of less than six months according to the patient's oncologist or designee\n* advanced stage of disease\n* having a known current neuropathy\n* having cognitive or physical limitations that contraindicate participation in a low- to moderate intensity home-based walking and progressive resistance program (determined by the patient's oncologist)\n* not able to read and understand Dutch\n* not able to provide informed consent\n* not able to participate during the entire study period\n* pregnancy",{"count":319,"type":19},206,[22],"Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating and common side effect of neurotoxic cancer treatment. The most frequent symptoms include sensory disturbances and weakness in the hands and\u002For feet. CIPN can interfere with both daily activities and cancer treatment itself. Although there is proof of concept for physical activity as a preventive measure for CIPN, physical activity is currently not included in the international evidence-based guideline for the prevention of CIPN due to the need of larger sample-sized definitive studies. The aim of this project is, on the one hand, to investigate the preventive effect of an exercise program based on international physical activity guidelines on CIPN symptoms in patients with breast or colorectal cancer undergoing taxane- or platinum-based chemotherapy. On the other hand, the study will also explore how patients and healthcare professionals experience the implementation of physical activity during this phase of therapy. A prospective randomized controlled trial will be conducted, with CIPN symptoms as the primary outcome measure.",[323],"Chemotherapy Induced Peripheral Neuropathy (CIPN)",[325,326],"chemotherapy induced peripheral neuropathy","exercise","2025-07-03",{"date":329,"type":48},"2025-07-09",{"date":331,"type":48},"2025-06-05",{"date":333,"type":19},"2028-11-01",{"name":54,"class":55},2,{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":340,"acronym":341,"eligibilityCriteria":342,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":343,"targetDuration":4,"studyType":20,"phases":345,"briefSummary":346,"conditions":347,"keywords":349,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":362,"locationsCount":335},"100539760","effectiveness-of-an-ehealth-self-management-support-program-for-persistent-pain-after-breast-cancer-treatment-100539760","NCT06308029","Effectiveness of an eHealth Self-management Support Program for Persistent Pain After Breast Cancer Treatment","PECAN","Inclusion criteria\n\n* Patients (men and women) with primary breast cancer and with unilateral or bilateral axillary surgery (Axillary Lymph Node Dissection or Sentinel Node Biopsy);\n* Be non-metastatic and have finished their primary treatment with a curative intent at least 3 months prior to study participation;\n* Adjuvant hormonal therapy and immunotherapy form the exception to the rule are tolerated;\n* Presence of self-reported persistent pain in the last 3 months that interferes with daily activities (yes\u002Fno)\n\nExclusion criteria\n\n* Can not participate during the entire study period;\n* Mentally or physically unable to participate in the study;\n* Previous participation in a pain science education program.\n* No acces to a digital device\n* Do not speak\u002Funderstand Dutch",{"count":344,"type":19},270,[22],"The scientific goals of the project are:\n\n1. The primary scientific objective of the study is to determine the effectiveness of an eHealth self-management support program for persistent pain after breast cancer treatment compared to:\n\n   * usual care (i.e. superiority of the eHealth self-management support program) and\n   * a comprehensive pain rehabilitation program delivered face-to-face in a physical therapy setting (i.e. non-inferiority of the eHealth self-management support program)\n\n   on pain-related disability (measured with the Pain Disability Index).\n2. The secondary scientific objectives of this study entails to examine if the eHealth self-management support program has a relative benefit for other biopsychosocial factors, including:\n\n   * Other dimensions of pain\n   * Health-related quality of life\n   * Physical functioning, including physical activity levels\n   * Psychosocial functioning, including self-efficacy, stress, anxiety, depression, coping style (key secondary outcome) and fear of cancer recurrence\n   * Participation in society, including return to work\n   * Healthcare-related costs for the patient and society\n3. The tertiary scientific objectives of this study are\n\n   * to identify moderators of treatment effect, including behavioural determinants (e.g. self-efficacy, motivation, coping style), in order to identify breast cancer survivors who would benefit the most of the eHealth self-management support program and to allow more stratified and efficient pain management care and more targeted allocation of budgets.\n   * To examine the implementation process, mechanisms of impact and contextual factors.",[348],"Breast Cancer",[350,351,352,353,354],"eHealth","pain","active lifestyle","pain management","physiotherapy","2025-06-20",{"date":357,"type":48},"2025-06-26",{"date":359,"type":48},"2024-05-26",{"date":361,"type":19},"2029-01",{"name":54,"class":55},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":20,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":376,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":382,"leadSponsor":384,"locationsCount":56},"100592902","assessment-and-treat-neglect-patients-with-a-vr-application-100592902","NCT06999473","Assessment and Treat Neglect Patients With a VR Application","Assess and Treat Visuospatial Neglect in Central Neurological Conditions Via an Innovative Virtual Reality Software","Inclusion Criteria:\n\n1. Age 18 years or older\n2. Able to provide informed consent\n3. have had a hemispheric stroke\n\nExclusion Criteria:\n\n1. Have a severe comorbid psychiatric (E.g. psychotic symptoms) disorder\n2. Have a premorbid neurodegenerative disease (E.g. Alzheimer's dementia, vascular dementia)\n3. Have severe written language comprehension deficits\n4. Have a medical implant, such as a cochlear implant or a pacemaker\n5. Have a severe visual impairment that cannot be corrected by wearing glasses while training\n6. Have a history of epileptic seizures The following exclusion criteria do not apply to the Non-VSN stroke group.\n7. Do not show signs of a spatial asymmetry in performance on a battery of screening tasks\n8. Having visual field deficits or lesions in the occipital lobe",{"count":180,"type":19},[22],"The objective of this project is to investigate the effectiveness of neglect training in our self-developed VR application \"SpatialSense\". The investigators aim to reach the following goals:\n\ni. Compare conventional neglect therapy for neglect training with SpatialSense to evaluate the impacts on neglect recovery to see whether the VR therapy improves the clinical outcomes, such as balance recovery, perception of verticality, quality of life, independence in daily activities, and cognitive impairment, after rehabilitation training.\n\nii. Analyze and compare the search strategies employed by stroke patients with VSN and those without VSN during the execution of the search task with SpatialSense to summarize typical visual scanning strategies for facilitation, rehabilitation training, and improving the transfer effect in daily activities.\n\nThe experimental group will receive both conventional OT and PT treatment, but 3 days a week, half an hour of conventional treatment will be replaced by treatment with SpatialSense software. The control group will receive their regular dose-matched conventional OT and PT sessions without interference. The experimental group will receive SpatialSense training 3 times a week for a consecutive 4 weeks (12 sessions in total of 30 minutes).",[374,127,375],"Neglect, Hemispatial","Virtual Reality Therapy","NOT_YET_RECRUITING","2025-05-22",{"date":379,"type":48},"2025-05-31",{"date":381,"type":19},"2025-06-01",{"date":383,"type":19},"2027-07-01",{"name":54,"class":55},{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":391,"eligibilityCriteria":392,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":393,"enrollmentInfo":394,"targetDuration":4,"studyType":20,"phases":395,"briefSummary":396,"conditions":397,"keywords":400,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":258},"100579495","the-effects-of-extracorporeal-shock-wave-therapy-in-postsurgical-scars-especially-after-abdominplasty-and-breast-reduction-100579495","NCT06825039","The Effects of Extracorporeal Shock Wave Therapy in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.","The Effects of Extracorporeal Shock Wave Therapy in Different Stages of Scar Formation in Postsurgical Scars Especially After Abdominplasty and Breast Reduction.","Effect of SWT","Inclusion criteria\n\n* Eligible patients aged between 18 and 80 years\n* Dutch or English speaking\n* Patients who had undergone an abdominoplasty resulting in a dermal scar\n* Informed consent (approved by the ethics committee) will be provided before the surgical intervention Exclusion criteria\n* All type of skin diseases or dermatological problems\n* Previous surgery or ESWT intervention at the current scar site\n* Age under 18 years or above 80 years\n* Inability to provide informed consent\n* Expected problems in therapy compliance or follow up\n* Pregnancy","80 Years",{"count":270,"type":19},[22],"Scars can be caused by physical trauma, surgical incisions, burn injuries and even acne. Deep cutaneous injuries induce pathological scars. Other factors, such as mechanical loading, bacterial colonization are potential factors thought to underlie human hypertrophic and keloid scar formation or contractures. The effect may include functional impairment and aesthetic disadvantages.\n\nVarious non-invasive mechanical interventions of physical scar management (e.g. extracorporeal shock wave therapy or ESWT) could have a beneficial influence on wound healing and prevention of hypertrophic scars. ESWT considerably improves the appearance and symptoms of hypertrophic scars. However, the mechanism underlying the observed beneficial effects is not well understood. The objective of the first part of the study is to elucidate the mechanism underlying changes in cellular mechanosensitive pathways that are induced by ESWT. This review will introduce the histopathological effects on ESWT during wound healing and scar development.\n\nThe main objective of this study is to determine how much mechanical loading on dermal scars will lead to normal scar healing. The optimal duration, the frequency and the intensity of the applied forces in ESWT to generate a beneficiary effect during different phases of wound healing remains unclear.\n\nIn this study, biopsies from abdomionplasty postsurgical scars will be examined. Thereby it is possible to evaluate the outcomes on a cellular level through assessing the histology of human biopsies under controlled condition. In the second part, the underlying mechanism of ESWT on postsurgical scars will be explored, in different stages of wound healing. Furthermore, the investigators will investigate if changes in physical characteristics (redness, thickness and pliability) in postsurgical scars are associated with changes in reactivity of mechanosensitive pathways. This study will close the gap between the fundamental knowledge on cellular mechanotransduction and the clinical application of mechanotherapy during physical scar management (ESWT).",[398,399],"Scar","Shockwave Therapy",[401],"Skin scars, Post surgical, Underlying mechanisms, Shock wave","2025-03-03",{"date":404,"type":48},"2025-03-06",{"date":406,"type":48},"2023-12-20",{"date":408,"type":19},"2027-02",{"name":54,"class":55},{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":416,"eligibilityCriteria":417,"healthyVolunteers":11,"sex":91,"minAge":16,"maxAge":4,"enrollmentInfo":418,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":419,"conditions":420,"keywords":422,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":56},"100529966","reliability-and-validity-of-ultrasound-for-the-assessment-of-soft-tissue-properties-after-breast-cancer-treatment-100529966","NCT06180642","Reliability and Validity of Ultrasound for the Assessment of Soft Tissue Properties After Breast Cancer Treatment","Reliability and Validity of Ultrasound for the Assessment of Structural and Mechanical Properties of Soft Tissues at the Upper Limb Region in Women After Breast Cancer Treatment","SOFT-TI","1. Breast cancer patients without upper limb dysfunctions (n=30) Inclusion Criteria\n\n   * Patients with unilateral primary breast cancer\n   * Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy\n   * At least 3 months after surgery or radiotherapy in order to take into account wound healing\n   * Comprehensive of the Dutch language\n   * QuickDASH score \\\u003C15\u002F100\n\n   Exclusion Criteria:\n   * Bilateral surgery, widespread distance metastases, previous breast surgery\n   * Diagnosis of neurological or rheumatological condition\n   * upper limb dysfunctions caused by other reasons\n2. Breast cancer patients with upper limb dysfunctions (n=30) Inclusion Criteria\n\n   * Patients with unilateral primary breast cancer\n   * Surgery including, either: Mastectomy with axillary lymph node dissection or sentinel lymph node biopsy or breast conserving surgery with axillary lymph node dissection or sentinel lymph node biopsy\n   * At least 3 months after surgery or radiotherapy in order to take into account wound healing\n   * Comprehensive of the Dutch language\n   * QuickDASH score \\>15\u002F100\n\n   Exclusion Criteria:\n   * Bilateral surgery, widespread distance metastases, previous breast surgery\n   * Diagnosis of neurological or rheumatological condition\n   * upper limb dysfunctions caused by other reasons\n3. Healthy volunteers (n=30)\n\nInclusion criteria:\n\n* Healthy women (QuickDASH \\\u003C15) age-matched with a breast cancer patient from the main study\n* Comprehensive of the Dutch language\n\nExclusion criteria:\n\n* upper limb dysfunctions\n* Diagnosis of neurological or rheumatological condition, diabetes",{"count":121,"type":19},"After 1 year, more than 50% experience upper limb (UL) complaints after treatment for breast cancer. These complaints are disabling and cause limitations in daily life and this leads to a decrease in the patient's quality of life. The cause of these UL complaints is complex and multifactorial. Due to breast cancer treatment, the structural (tissue composition and volume) and mechanical (tissue stiffness) properties of the soft tissue may change. These changes can occur in the muscle, skin and surrounding fascia and especially in the soft tissue around the breast and axilla where that treatment is localised.\n\nUltrasound with specific 'add-on' techniques can objectively assess these features and provide a picture of their role in UL function after breast cancer. The first aim in this study is to investigate the reliability and validity of conventional 2D ultrasound for 1) soft tissue composition and 2) soft tissue thickness at the level of the breast and upper limb. The reliability and validity of shear wave elastography, a specific complement to conventional 2D ultrasound, to assess tissue stiffness will also be examined.",[421],"Breast Neoplasms",[423,424],"ultrasound","upper limb dysfunctions","2024-12-06",{"date":427,"type":48},"2024-12-11",{"date":429,"type":48},"2023-05-02",{"date":431,"type":19},"2026-05-02",{"name":54,"class":55},{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":65,"sex":15,"minAge":439,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":20,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":56},"100560252","transfer-of-microorganisms-between-green-areas-and-humans-100560252","NCT06574724","Transfer of Microorganisms Between Green Areas and Humans","Inclusion criteria:\n\nChildren (min. 4 years old) and adult participants (18+) of any gender in generally good health.\n\nNo strict exclusion criteria will be set in advance.","4 Years",{"count":270,"type":19},[22],"The goal of this study is to understand how visiting green areas affects the human microbiome through microbial transfer. Additionally, the project aims to understand which environmental, health and lifestyle factors can influence these microbiome changes. Participants will visit a green area, provide microbiome samples before and after the visit, and complete questionnaires related to environmental, health, lifestyle and demographic factors.",[444],"Microbial Colonization",[446,447,448,449,450],"green areas","nature","microbiome","biodiversity","sequencing","2024-12-03",{"date":453,"type":48},"2024-12-05",{"date":455,"type":48},"2024-08-27",{"date":457,"type":19},"2027-07-07",{"name":54,"class":55},{"id":460,"slug":461,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":66,"enrollmentInfo":467,"targetDuration":4,"studyType":20,"phases":469,"briefSummary":470,"conditions":471,"keywords":474,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":145},"100488760","phase-3-inflammation-based-stratification-for-immune-targeted-augmentation-in-major-depressive-disorder-100488760","NCT05644301","INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive Disorder","INflammation-based Stratification for Immune-Targeted Augmentation in Major Depressive","INSTA-MD","Inclusion Criteria:\n\n* Male or female, 18-65 years inclusive.\n* Able and willing to give informed consent and take oral medication.\n* Physically healthy.\n* Diagnosis of Major Depressive Disorder by DSM-5 criteria, confirmed by the Mini International Neuropsychiatric Interview (MINI).\n* The current episode of depression has failed to remit to the current antidepressant treatment at the adequate dose (as defined in the Maudsley Prescribing guidelines). Relapse while taking an antidepressant is also considered a treatment failure.\n* Tolerant to the current antidepressant and having no planned changes in their current therapy for the duration of the study.\n* Stable on current treatment for a minimum of 4 weeks (6 weeks for fluoxetine) prior to baseline.\n* If female and of childbearing age, willing to use adequate contraceptive precautions and willing to take a pregnancy test at baseline.\n\nExclusion Criteria:\n\n* Primary diagnosis of a bipolar disorder, psychotic spectrum disorder, obsessive-compulsive disorder, eating disorder, post-traumatic stress disorder, or alcohol and\u002For substance use disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (\\\u003C 4 weeks before screening, excl. nicotine and caffeine).\n* Use of immunosuppressant or immunostimulant drugs within 21 days of screening (e.g., glucocorticoid treatment, methotrexate, etc.).\n* History of peptic ulcer disease or gastrointestinal (GI) bleeding.\n* Having an acute infection or inflammatory bowel disorder.\n* Current severe cardiovascular disease, congestive heart failure (NYHA-class II-IV), ischemic or thrombotic events or unstable coronary artery (incl. coronary artery bypass graft (CABG) surgery),\n* Liver impairment (alanine aminotransferase \\> 2x upper limit, serum albumin \\\u003C 25 g\u002Fl or Child-Pugh Score ≥ 10)\n* Renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin).\n* Having received \\>14 days of tetracycline or non-steroidal anti-inflammatory medication within the previous 2 months, or having a history of sensitivity or intolerance to these classes of drugs.\n* Chronic severe hypertension (systolic BP \\> 170 mmHg).\n* Serology positive for hepatitis-B surface antigen, hepatitis-C antibodies or HIV antibodies.\n* Received electroconvulsive therapy \\\u003C 2 months prior to screening.\n* Blood donation in 30 days prior to screening.\n* Pregnancy or breastfeeding.\n* Currently enrolled in an intervention study.",{"count":468,"type":19},240,[124],"This is a randomised, double-blind, placebo-controlled clinical trial in which patients with major depressive disorder will receive augmentation through minocycline (MCO), celecoxib (CXB) or placebo.",[472,473],"Major Depressive Disorder","Inflammation",[475,476,477,473,478],"Immunopsychiatry","Celecoxib","Minocyclin","Randomised Controlled Clinical Trial","2024-10-09",{"date":481,"type":48},"2024-10-15",{"date":483,"type":48},"2023-09-21",{"date":485,"type":19},"2026-09",{"name":54,"class":55},{"id":488,"slug":489,"hasResults":11,"nctId":490,"briefTitle":491,"officialTitle":492,"acronym":493,"eligibilityCriteria":494,"healthyVolunteers":11,"sex":91,"minAge":495,"maxAge":496,"enrollmentInfo":497,"targetDuration":4,"studyType":20,"phases":499,"briefSummary":500,"conditions":501,"keywords":506,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":56},"100562054","developing-a-combined-molecular-screening-and-triage-test-for-cervical-cancer-in-self-samples-100562054","NCT06598176","Developing a Combined Molecular Screening and Triage Test for Cervical Cancer in Self-samples","Developing a Combined Molecular Screening and Triage Test for Cervical Cancer Based on Human Papillomavirus (HPV) Detection, Quantification, Genotyping and DNA Methylation in Self-samples (COMBISCREEN)","COMBISCREEN","Inclusion Criteria:\n\n* Female\n* 25 until 64 years old\n* Diagnosed with cervical cancer (CIN3+, irrespective of stage) OR in need of conization (irrespective of diagnostic or therapeutic purposes)\n* Has not started any form of cancer treatment prior to study enrollment\n* Written informed consent must be obtained from patient\n* Is able to understand the information brochure and what the study is about\n\nExclusion Criteria:\n\n* Women that underwent hysterectomy\n* Pregnant women or 6 weeks post-partum\n* Treatment for cervical (pre)cancer in the last 6 months before participation in the study\n* Participating in another interventional clinical study (where e.g., a medical device, drug, or vaccine is evaluated) at the same time of participating in this study. Participation in another observational or low-interventional clinical study at the same time is allowed.\n* Unable to give informed consent\n* Patient has severe anaemia\n* Patient received blood transfusion two weeks before sample collection\n* Blood sampling would compromise patients' overall health\n* Patients who are positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.\n* Patients who are alcoholic or drug abusers\n* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, or is not in the best interest of the patient to participate, in the opinion of the investigator.","25 Years","64 Years",{"count":498,"type":19},100,[22],"The goal of the COMBISCREEN project is to develop a fully molecular cervical screening and triage approach that is applicable on self-samples, which are an easily accessible and non-invasive source of biomarkers. The project allows a one-step screening and triage modality and thereby identifies women with clinically relevant disease that are in need of treatment.",[502,503,504,505],"Uterine Cervical Neoplasm","Uterine Cervical Dysplasia","Human Papilloma Virus","HPV-Related Cervical Carcinoma",[507,99,508,509,510,511,512],"biomarker","vaginal sample","screening","triage","self-sampling","prevention","2024-09-13",{"date":515,"type":48},"2024-09-19",{"date":517,"type":48},"2024-03-28",{"date":519,"type":19},"2037-02-28",{"name":54,"class":55},{"id":522,"slug":523,"hasResults":11,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":65,"sex":15,"minAge":529,"maxAge":530,"enrollmentInfo":531,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":56},"100560861","normalizing-antibody-detection-in-first-void-urine-100560861","NCT06582654","Normalizing Antibody Detection in First-void Urine","URINORM: Normalizing Antibody Detection in First-void Urine","URINORM","Inclusion Criteria:\n\n* Vaccinated with either the Cervarix, Gardasil or Gardasil9 HPV-vaccine and able to present vaccination booklet or another official document proving this.\n* Able to understand the information brochure and what the study is about.\n* Willing to give informed consent to contact his\u002Fher general practitioner and\u002For gynecologist to access details on their HPV vaccination schedule and, in case a woman within the screening population, cervical cancer screening results (smears, HPV tests, colposcopy, biopsy).\n\nExclusion Criteria:\n\n* Participating in another clinical trial at the same time of participating in this study.\n* Women that underwent hysterectomy or were treated for cervical (pre)cancer lesions within the six months prior to study enrolment.\n* Pregnant women.\n* Being positive for Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C.\n* Having a history or current evidence of any condition or abnormality that might confound the results of the study or is not in the best interest of the individual to participate, in the opinion of the investigator.","9 Years","70 Years",{"count":270,"type":19},"The aim of this study is to develop robust analytical protocols for the monitoring of vaccine induced immunity against the Human Papillomavirus (HPV) in first-void urine samples and to examine fluctuations of urinary HPV-specific antibodies and potential normalization markers in different cohorts.",[534],"Human Papillomavirus Infection",[536,164,76,75],"Antibodies","2024-08-30",{"date":539,"type":48},"2024-09-03",{"date":541,"type":48},"2023-12-07",{"date":543,"type":19},"2026-01-01",{"name":54,"class":55},{"id":546,"slug":547,"hasResults":11,"nctId":548,"briefTitle":549,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":20,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":565,"locationsCount":56},"100529506","the-effect-of-music-on-procedural-distress-during-mobilization-in-intensive-care-unit-patients-a-randomized-controlled-trial-100529506","NCT06174662","The Effect of Music on Procedural Distress During Mobilization in Intensive Care Unit Patients: A Randomized Controlled Trial","MUSICU","Inclusion Criteria:\n\n* They are admitted to the ICU\n* They have a Richmond Agitation-Sedation Scale (RASS) score of +1, 0, or -1\n* They are able to speak Dutch\n\nExclusion Criteria:\n\n* They are younger than 18 years old\n* They have a hearing impairment\n* They are in isolation\n* They have a cranial dressing or intracranial pressure monitoring",{"count":236,"type":19},[22],"This intervention study will investigate the effects of music therapy on procedural distress, the overall experience of pain, anxiety, and stress, during the procedure of sitting up in a chair for patients admitted to the intensive care unit (ICU).",[556,557,558],"Pain","Stress","Anxiety","2024-07-01",{"date":561,"type":48},"2024-07-03",{"date":563,"type":48},"2024-02-02",{"date":379,"type":19},{"name":54,"class":55},{"id":567,"slug":568,"hasResults":11,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":65,"sex":15,"minAge":66,"maxAge":574,"enrollmentInfo":575,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":576,"conditions":577,"keywords":582,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":56},"100542650","gait-and-postural-balance-analysis-during-head-motion-perturbed-standing-and-walking-in-older-adults-100542650","NCT06345625","Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults","Gait and Postural Balance Analysis During Head-motion Perturbed Standing and Walking in Older Adults - a Multisensory Approach by Use of Mixed-reality","BALANCAR","Inclusion Criteria:\n\n* Community dwelling\n* an age of 65 years or above\n\nExclusion Criteria:\n\n* age \\\u003C 65 years\n* medical history encompassing diagnosed vestibulopathy, orthostatic hypotension, peripheral neuropathy, limb amputation, neurological or neuromuscular disorders affecting balance, diagnosed neck disorders affecting sensorimotor control, blindness, deafness\n* a full-time walking aid is indispensable.","100 Years",{"count":498,"type":19},"The main aim of this study is to unravel the biomechanics of postural balance reactions during head-motion perturbed standing and walking in older adults who fall, while integrating the influence of frailty, sensory functioning and cognitive processing.",[578,579,580,581],"Aged","Accidental Fall","Postural Balance","Gait",[583,584,585],"older adults","Sensorimotor integration","visual tracking while walking","2024-05-08",{"date":588,"type":48},"2024-05-09",{"date":590,"type":48},"2024-05-07",{"date":592,"type":19},"2028-01",{"name":54,"class":55},""]