[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Luxembourg\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":593},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,49,84,108,141,172,207,232,259,295,316,343,371,395,420,444,477,511,536,568],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100217003","aurora-aiming-to-understand-the-molecular-aberrations-in-metastatic-breast-cancer-100217003",false,"NCT02102165","AURORA: Aiming to Understand the Molecular Aberrations in Metastatic Breast Cancer.","AURORA","Inclusion Criteria:\n\n1. Female or male ≥ 18 years with diagnosis of locally recurrent\u002Fadvanced BC not amenable to treatment with curative intent or MBC who have not received more than 1 line of systemic therapy (any type) in the metastatic setting.\n\n   Under protocol 4.0, eligible patients will be limited to locally recurrent\u002Fadvanced breast cancer not amenable to treatment with curative intent or MBC with:\n   * histopathology-confirmed TNBC as defined by ER \\\u003C1% and HER2 negative following ASCO-CAP guidelines\n   * ILC (either based on ILC morphology or negative E-cadherin expression confirmed by IHC). Mixed ILC\u002Finvasive ductal carcinoma are not eligible for the ILC cohort.\n   * late relapse BC (any subtype). Late relapse is defined as a patient with a radiologic or histologic confirmation of advanced or MBC relapse \\> 10 years from the primary BC diagnosis.\n2. Written informed consent prior to registration into the program.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n4. Availability of primary tumor tissue for research purposes.\n5. Patient must have a metastatic lesion accessible for biopsy and must agree with the biopsy procedure.\n\n   1. Up until protocol 3.0, up to 100 patients with bone-only metastasis have been included without a metastatic biopsy, if plasma samples have been collected at screening, and if the patient met all other eligibility criteria.\n   2. In protocol 4.0, metastatic tumor biopsies from bone lesions will be accepted provided that the chosen site of biopsy was not previously irradiated.\n   3. Brain tissue is accepted if it is obtained through surgical excision not planned for AURORA, but as part of the routine clinical practice.\n6. The biopsy of the metastatic lesion must be conducted either at the initial diagnosis of the BC relapse before the initiation of 1st line systemic therapy or at the 1st disease progression before initiation of a second line systemic treatment. There is no restriction in the type of therapeutic modality considered as 1st line systemic treatment, which can consist of any type of treatment administered after the diagnosis of the advanced BC relapse till the 1st disease progression thereafter.\n7. Biopsies obtained during routine clinical practice are accepted if both formalin-fixed paraffin-embedded (FFPE) and Frozen Tissue (FT) blocks were collected concurrently from the same metastatic lesion and if collected at the pre-specified timelines for AURORA.\n8. Availability of a whole blood, serum and plasma samples collected at the time of screening.\n9. Patient agrees to provide blood samples at regular intervals, from the screening as well as during the follow-up phase of the program.\n\nExclusion Criteria:\n\n1. The patient has received more than 1 line of systemic therapy (any type) in the metastatic setting.\n2. Patients who have received prior palliative radiotherapy to the only site that is accessible to biopsy.\n3. Presence of severe hematopoietic, renal, and\u002For hepatic dysfunction, including but not restricted to albumin \\\u003C 3 g\u002Fdl.\n4. Known increased risk of hemorrhage during biopsy procedure, as evaluated by the treating physician.\n5. Previous or current malignancies of other histologies within the last 5 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.","ALL","18 Years",{"count":19,"type":20},1000,"ESTIMATED","INTERVENTIONAL",[23],"NA","This program initially aims to recruit 1300 breast cancer patients from a large number of hospitals across Europe. Eligible patients are those who are 18 or older, either female or male, and who have not received more than 1 type of treatment from the time metastases were discovered, metastasi(e)s has just been diagnosed or their disease has come back (disease relapse). Biopsy samples from both the primary and metastatic (or relapsed) tumor will be collected for central analyses, together with blood, serum and plasma samples. Any samples not analyzed immediately will be stored in an independent bio-repository to enable future (not yet defined) research aimed at better understanding metastatic breast cancer.\n\nIn summary, the main objectives of AURORA are to better understand the genetic aberrations in metastatic breast cancer and to discover the mechanisms of response or resistance to therapy, in order to ultimately identify the \"right therapy for each individual patient\". At the same time, patients with genetic aberrations that are being targeted by new drugs in development will be offered the possibility to participate in clinical trials, when approved and available in their countries. Ultimately, the aim of AURORA is to improve the outcomes of all patients diagnosed with metastatic breast cancer.",[26],"Metastatic Breast Cancer",[28,29,30,31,32,33,34,35],"Aurora","breast cancer","metastatic","molecular screening","targeted gene sequencing","molecular aberrations","exploratory","biomarker","RECRUITING","2026-08-04",{"date":39,"type":40},"2026-08-06","ACTUAL",{"date":42,"type":40},"2014-04",{"date":44,"type":20},"2031-03",{"name":46,"class":47},"Jules Bordet Institute","OTHER",52,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":16,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":83},"100399177","ppmi-clinical---establishing-a-deeply-phenotyped-pd-cohort-100399177","NCT04477785","PPMI Clinical - Establishing a Deeply Phenotyped PD Cohort","The Parkinson's Progression Markers Initiative (PPMI) Clinical - Establishing a Deeply Phenotyped PD Cohort","PPMI","7.1 Healthy Controls (HC) Note: Active Healthy controls previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.1.1 Inclusion Criteria (HC)\n\n1. Male or female age 57 years or older at Screening visit.\n2. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n3. Confirmation that participant is eligible based on Screening SPECT imaging.\n4. Able to provide informed consent.\n5. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.1.2 Exclusion Criteria (HC)\n\n1. First degree relative with PD (i.e., biologic parent, sibling, child).\n2. Current or active clinically significant neurological disorder (in the opinion of the Investigator).\n3. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n4. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n5. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.\n6. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n7. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.2 Parkinson's Disease (PD) Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.2.1 Inclusion Criteria (PD)\n\n1. Male or female age 30 years or older at Screening Visit.\n2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.\n3. Not expected to require PD medication within at least 6 months from Baseline.\n4. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n5. Hoehn and Yahr stage I or II at Baseline.\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.2.2 Exclusion Criteria (PD)\n\n1. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n2. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit.\n3. Has taken levodopa or dopamine agonists prior to Baseline visit for more than a total of 90 days.\n4. Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy).\n5. A clinical diagnosis of dementia as determined by the investigator.\n6. Previously obtained MRI scan with evidence of clinically significant neurological disorder (in the opinion of the Investigator).\n7. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n8. Current treatment with anticoagulants (e.g., coumadin, heparin, oral thrombin inhibitors) that might preclude safe completion of the lumbar puncture.\n9. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n10. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n11. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.3 Parkinson's Disease (PD) with LRRK2 or GBA variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.3.1 Inclusion Criteria (PD ¬- LRRK2 or GBA)\n\n1. Male or female age 30 years or older at Screening Visit.\n2. A diagnosis of Parkinson's disease for 2 years or less at Screening Visit.\n3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n4. Hoehn and Yahr stage I or II at Baseline.\n5. Confirmation of causative LRRK2 or GBA (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.3.2 Exclusion Criteria (PD - LRRK2 or GBA)\n\n1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.4 Parkinson's Disease (PD) with SNCA or rare genetic variant Note: Active PD participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\n7.4.1 Inclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))\n\n1. Male or female age 30 years or older at Screening Visit.\n2. Parkinson's disease diagnosis at Screening Visit.\n3. Patients must have at least two of the following: resting tremor, bradykinesia, rigidity (must have either resting tremor or bradykinesia); OR either asymmetric resting tremor or asymmetric bradykinesia.\n4. Hoehn and Yahr stage I, II, or III at Baseline.\n5. Confirmation of causative SNCA or rare genetic variant (such as Parkin or Pink1) (willingness to undergo genetic testing as part of genetic screening and be informed of genetic testing results, or approved documentation of prior genetic testing results).\n6. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n7. Confirmation that participant is eligible based on Screening SPECT imaging.\n8. Able to provide informed consent.\n9. Either is male, or is female and meets additional criteria below, as applicable:\n\n   * Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n7.4.2 Exclusion Criteria (PD - SNCA or rare genetic variant (such as Parkin or Pink1))\n\n1. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Screening visit.\n2. Current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n3. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n4. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n5. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.\n\n7.5 Prodromal Note: Active Prodromal participants previously enrolled in PPMI do not require re-assessment of eligibility criteria listed below for enrollment in PPMI Clinical. Active participants do need to be able to provide informed consent for PPMI Clinical participation (includes use of a designated research proxy).\n\nThe specific predictive eligibility criteria for participants recruited through PPMI Remote to advance to PPMI Clinical will be iteratively optimized based on data collected from these studies.\n\n7.5.1 Inclusion criteria (Prodromal)\n\nFor Screening:\n\n1. Confirmation that participant is eligible based on centrally determined predictive criteria including the University of Pennsylvania Smell Identification Test (UPSIT).\n\n   * For participants in PPMI Remote, referral to the clinical site confirms predictive eligibility.\n   * For participants identified by the clinical site, predictive criteria are based on generalized risk such as first degree biologic relative, known risk of PD including RBD, or known genetic variants associated with PD risk.\n\n   Additionally, confirmation of UPSIT eligibility during the Screening visit prior to SPECT Imaging.\n2. Male or female age 60 years or older (except age 30 years or older for SNCA, or rare genetic variants (such as Parkin or Pink1) participants).\n3. Individuals taking any of the following drugs: alpha methyldopa, methylphenidate, amphetamine derivatives or modafinil, must be willing and medically able to hold the medication for at least 5 half-lives before SPECT imaging.\n4. Able to provide informed consent.\n5. Either is male, or is female and meets additional criteria below, as applicable:\n\n   • Female of childbearing potential who is not pregnant, lactating, or planning pregnancy during the study and has a negative pregnancy test on day of Screening SPECT imaging test prior to injection of DaTscanTM.\n\n   For continuation to Baseline visit and ongoing follow-up:\n6. Confirmation that participant is eligible based on \\*Screening SPECT imaging.\n\n   * Screening SPECT Imaging eligibility:\n\nBased on the results of the SPECT imaging test, Prodromal participants eligible to continue their participation in PPMI Clinical will be asked to return for their PPMI Clinical baseline visit. Neither the participant nor the site investigator will be made aware of the participant's DAT status during the study.\n\n* It is anticipated that approximately 6,000 participants will complete a screening visit to undergo DAT imaging. Approximately 2,000 participants will be eligible to continue their participation in PPMI Clinical (those not eligible to proceed will remain in PPMI Remote, as applicable).\n* All participants with DAT deficit will be eligible to continue their participation in PPMI Clinical. It is estimated that about 75% of eligible participants will have a DAT deficit (defined by a hybrid of visual assessment and quantitative striatal specific binding analysis).\n* Some participants without DAT deficit will also be eligible to continue their participation in PPMI Clinical. These participants will be chosen based on DAT binding that is reduced from age expected but it not outside the normal range and\u002For from individuals with high-risk of PD including RBD, LRRK2, GBA, SNCA, or rare genetic variants (such as Parkin or Pink1) that do not demonstrate DAT deficit. It is estimated that about 25% of eligible participants will not have a DAT deficit.\n* It is anticipated that approximately 30% of the PPMI Clinical prodromal participants with DAT deficit will phenoconvert to motor parkinsonism during a 3 to 5-year follow-up.\n\n7.5.2 Exclusion Criteria (Prodromal)\n\n1. Clinical diagnosis of PD at screening, other parkinsonism, or dementia.\n2. Received any of the following drugs: dopamine receptor blockers (neuroleptics), metoclopramide and reserpine within 6 months of Baseline Visit.\n3. Current treatment with anticoagulants (e.g. coumadin, heparin) that might preclude safe completion of the lumbar puncture.\n4. Condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia.\n5. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.\n6. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n7. Has taken levodopa, dopamine agonists, MAO-B inhibitors or amantadine within 60 days of Baseline visit. except for low-dose treatment of restless leg syndrome (with permission of medical monitor).\n8. Any other reason that, in the opinion of the investigator, would render the participant unsuitable for study enrollment.",true,"30 Years",{"count":60,"type":20},4500,"OBSERVATIONAL","The Parkinson Progression Marker Initiative (PPMI) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls.\n\nThe overall goal of PPMI is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.",[64],"Parkinson Disease",[66,67,68,69,70,71,72,73],"Parkinson","Bio-markers","Neurodegenerative disorder","Imaging","Prodromal","Genetics","At Risk","Loss of Smell","2026-07-24",{"date":76,"type":40},"2026-07-27",{"date":78,"type":40},"2020-07-01",{"date":80,"type":20},"2033-12",{"name":82,"class":47},"Michael J. Fox Foundation for Parkinson's Research",50,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":107},"100373439","study-to-learn-more-about-the-safety-and-effectiveness-of-the-drug-vitrakvi-during-routine-use-in-patients-with-trk-fusion-cancer-which-is-locally-advanced-or-spread-from-the-place-where-it-started-to-other-places-in-the-body-100373439","NCT04142437","Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body","PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib","ON-TRK","Inclusion Criteria:\n\n* Adult and pediatric (from birth to 18-year-old) patients\n* Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above.\n* Life expectancy of at least 3 months based on clinical judgement\n* Decision to treat with larotrectinib made by the treating physician prior to study enrollment\n* Patients can also be enrolled if the initial visit (larotrectinib start date) occurred within 2 months ±3 days prior to informed consent signed date\n* Signed informed consent form\n* For patients under legal age, signed assent by the patient (where applicable) and parental\u002Flegal guardian signed informed consent is required\n\nExclusion Criteria:\n\n* Any contraindications as listed in the local approved product information\n* Pregnancy\n* Participation in an investigational program with interventions outside of routine clinical practice\n* Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition\n* Patients with NTRK gene amplification or NTRK point mutation",{"count":93,"type":20},150,"In this observational study researcher want to learn more about the effectiveness of drug VITRAKVI (generic name: larotrectinib) and how well the drug is tolerated during routine use in patients with TRK fusion cancer which is locally advanced or spread from the place where it started to other places in the body. TRK fusion cancer is a term used to describe a variety of common and rare cancers that are caused by a change to the NTRK (Neurotrophic Tyrosine Kinase) gene called a fusion. During this fusion, an NTRK gene joins together, or fuses, with a different gene. This joining results in the activation of certain proteins (TRK fusion proteins), which can cause cancer cells to multiply and form a tumor. VITRAKVI is an approved drug that blocks the action of the NTRK gene fusion. This study will enroll adult and paediatric patients suffering from a solid tumor with NTRK gene fusion for whom the decision to treat their disease with VITRAKVI has been made by their treating physicians. During the study, patients' medical information such as treatment information with VITRAKVI, other medication or treatments, changes in disease status and other health signs and symptoms will be collected within the normal medical care by the treating doctor. Participants will be observed over a period from 24 to 60 months.",[96],"Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion","2026-07-03",{"date":99,"type":40},"2026-07-07",{"date":101,"type":40},"2020-04-03",{"date":103,"type":20},"2030-03-31",{"name":105,"class":106},"Bayer","INDUSTRY",76,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":116,"targetDuration":4,"studyType":21,"phases":118,"briefSummary":119,"conditions":120,"keywords":123,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100642157","evaluation-of-calcified-coronary-lesion-preparation-with-the-naviscore-scoring-balloon-100642157","NCT07650578","Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU: Minimize Intra Luminal Obstructive Underexpansion: A Prospective, Multi-Center Randomized Trial for the Evaluation of Calcified Coronary Lesion Preparation With the Naviscore Scoring Balloon","MILOU","Inclusion Criteria:\n\n* Patient written consent is given, ≥18 years.\n* A de novo lesion to be treated in a vessel between 2.5 and 4.0 mm.\n* Moderate to heavily calcified lesions detected by coronary angiography on two orthogonal views, and confirmed by IVUS if the lesion can be crossed with the catheter.\n\nExclusion Criteria:\n\n* Patient \\\u003C18 years old.\n* Pregnant female.\n* Contraindication to dual antiplatelet therapy.\n* Thrombocytopenia (under 100 000).\n* Major surgical intervention planned within one year.\n* Significant left main lesion.\n* Chronic total occlusion.\n* Lesion in a graft.\n* In-stent restenosis lesion.\n* Lesion responsible of a ST elevated Myocardial Infarction (STEMI)",{"count":117,"type":20},200,[23],"The purpose of this clinical study is to evaluate the effectiveness and safety of a specialized medical device, the Naviscore scoring balloon, in preparing calcified coronary artery narrowings before the implantation of a drug-eluting stent. During percutaneous coronary interventions, the presence of calcified plaques in the heart arteries represents a major challenge because it can prevent stents from expanding fully. When a stent remains under-expanded, it significantly increases the long-term risk of arterial re-narrowing or blood clot formation. To optimize stent expansion, appropriate preparation of the diseased vessel section before stent insertion is a critical phase.\n\nThis study is a prospective, multi-center randomized trial designed to test the hypothesis that treating calcified coronary lesions with the Naviscore scoring balloon will achieve a better stent expansion and a larger final minimal stent area compared to standard lesion preparation using regular non-compliant balloons. Eligible participants will be randomized in a one-to-one ratio to one of these two lesion preparation strategies. For all included patients, standard drug-eluting stents will be deployed. The study will use intravascular ultrasound imaging to evaluate the final minimum area of the stent directly inside the treated artery at the site of the highest initial calcium burden. Participant health and clinical outcomes will be monitored for up to twelve months following the procedure.",[121,122],"Coronary Arterial Disease (CAD)","Calcific Coronary Arteriosclerosis",[124,125,126,127,128,129],"Percutaneous Coronary Intervention","Lesion Preparation","Scoring Balloon","Intravascular Ultrasound","Stent Expansion","Coronary Artery Calcification","NOT_YET_RECRUITING","2026-06-10",{"date":133,"type":40},"2026-06-16",{"date":135,"type":20},"2026-07",{"date":137,"type":20},"2028-06",{"name":139,"class":47},"University of Mons",14,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":21,"phases":151,"briefSummary":152,"conditions":153,"keywords":157,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":171},"100506446","evaluation-of-the-medical-benefit-of-spa-therapy-on-fibrosis-after-radiotherapy-for-breast-cancer-or-uadt-upper-aerodigestive-tract-cancer-100506446","NCT05874492","Evaluation of the Medical Benefit of Spa Therapy on Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer","Evaluation of the Medical Benefit of a Spa Therapy on the Evolutionary Genius of Late Sequelae Fibrosis After Radiotherapy for Breast Cancer or UADT (Upper Aerodigestive Tract) Cancer in Remission","FIBROTHERME","Inclusion Criteria:\n\n* Age ≥ 18 years\n* In situ or invasive breast cancer or cancer of the upper aerodigestive tract\n* DLQI ≥ 6 (at least moderate effect on patient's life)\n* General status WHO 0-1\n* Radiotherapy completed at least 6 months ago (with no maximum post radiotherapy delay)\n* Unilateral breast radiotherapy for breast cancer patients\n* Skin or soft tissue toxicity (- modules: Skin atrophy, fibrosis of deep connective tissues, fibrosis of superficial soft tissues) CTCAE v4.0 grade ≥ 2\n* No inflammatory or infectious flare at inclusion\n* Female of childbearing potential: negative urine pregnancy test at inclusion\n* Patient informed and signed consent\n* Affiliation to a social security systeme or equivalent\n\nExclusion Criteria:\n\n* Progressive phase of cancer\n* Metastatic disease\n* Patient undergoing specific treatment for breast cancer (except adjuvant hormone therapy and\u002For adjuvant herceptin)\n* Bilateral breast\u002Fparietal radiotherapy\n* Breast prosthesis wearer for breast cancer patients\n* Patient with a tracheostomy for patients with head and neck cancer\n* Obvious skin ulceration in the site of interest\n* Contraindication to spa treatment (acute inflammatory disease, active infections, heart failure with NYHA stage \\> 1, chronic respiratory failure, labile hypertension, bullous disease)\n* Chronic progressive dermatological disease\n* Women who are pregnant or likely to become pregnant within 6 months or who are breastfeeding\n* Persons deprived of liberty or under guardianship",{"count":150,"type":20},110,[23],"FIBROTHERME is a comparative, controlled, randomized, multicenter and simple blinded (investigator) trial.\n\nThe aim of this study is to evaluate the medical benefit in terms of quality of life on the dermatological sequelae of fibrosis 6 months after a dermatologically oriented spa therapy in patients with severe late reactions affecting the skin and\u002For soft tissues at least 6 months after radiotherapy for breast cancer or UADT (Upper Aerodigestive Tract) cancer.",[154,155,156],"Fibrosis","Breast Cancer","Head and Neck Cancer",[158,29,159,160,161],"fibrosis","radiotherapy","spa treatment","head and neck cancer","2026-04-08",{"date":164,"type":40},"2026-04-13",{"date":166,"type":40},"2024-01-29",{"date":168,"type":20},"2027-12",{"name":170,"class":47},"Association Francaise pour la Recherche Thermale",13,{"id":173,"slug":174,"hasResults":11,"nctId":175,"briefTitle":176,"officialTitle":177,"acronym":178,"eligibilityCriteria":179,"healthyVolunteers":11,"sex":16,"minAge":180,"maxAge":181,"enrollmentInfo":182,"targetDuration":4,"studyType":21,"phases":184,"briefSummary":185,"conditions":186,"keywords":190,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":206},"100631405","advancing-diagnosis-and-treatment-of-pediatric-asthma-100631405","NCT07500246","Advancing Diagnosis and Treatment of Pediatric Asthma","Advancing Diagnosis and Treatment of Pediatric Asthma by Deep Immunophenotyping and Evaluation of Two Spacer Devices for Inhaled Corticosteroid Administration","Care4Asthma","Inclusion Criteria:\n\n* Patient aged between 5-16 years, male or female\n* Physician diagnosis of asthma requiring a controller treatment with ICS or ICS\u002FLong-acting beta-agonists (LABA) via MDI\n* Partly controlled or uncontrolled asthma based on GINA criteria and definitions\n* Informed consent signed by legally authorized representatives (LAR) and assent from young patient (only applicable for children ≥ 10 years)\n\nExclusion Criteria:\n\n* Patients with severe asthma exacerbation treated with systemic corticosteroids within the last 2 weeks or patients with active respiratory tract infection\n* Diagnosis of underlying chronic lung disease other than asthma (e.g., BPCO\u002Fcystic fibrosis etc.)\n* Severe asthma based on GINA definitions\n* Severe underlying disorders ((severe congenital heart disease, oncologic patients) (non-exhaustive list, left to the evaluation of the PI))\n* Immune deficiency or under immunosuppressive treatments\n* In receipt of immunotherapy (only for participants in Luxembourg donating samples for biomarker research)\n* Patients with neurological diseases \u002F impaired cognitive disorder\n* Siblings of patients already included in the study","5 Years","16 Years",{"count":183,"type":20},208,[23],"Asthma is one of the most common chronic diseases in children, and treatment success often depends on proper inhaler use and consistent medication adherence. Exposure to allergens and pollutants can also impact treatment response and asthma control. Moreover, there is a growing need for non-invasive biomarkers to support better diagnosis and personalized care. The goal of this clinical trial is to investigate if a new digital inhaler can improve inhalation technique and treatment adherence in children aged 5 to 16 years old, with partly controlled or uncontrolled asthma requiring treatment with inhaled corticosteroids. The main questions it aims to answer are:\n\n* Does the use of a digital inhaler improve adherence to inhaled corticosteroids and asthma control in children?\n* Which biomarkers could support diagnosis and help predict treatment responses in children with asthma?\n* How do environmental factors influence asthma control and treatment outcomes?\n\nResearchers will compare adherence to inhaled corticosteroid therapy between children using a new digital inhaler (Whizz spacer) and those using a standard, non-digital inhaler (AeroChamber Plus® Flow-Vu®) to see if the digital inhaler improves treatment administration and asthma control. They will quantify inflammatory markers in biological samples from asthmatic children and children without respiratory disease, to find biomarkers linked to disease and treatment response.\n\nParticipants will:\n\n* Use the Whizz spacer or the AeroChamber Plus® Flow-Vu® during 12 weeks for corticosteroid inhalation, and complete daily a study diary to follow treatment administration.\n* Complete asthma control and quality of life questionnaires and have an evaluation of asthma control through GINA score at baseline, 6 and 12 weeks.\n* Undergo spirometry tests and FENO measurements at baseline and 12 weeks.\n* Give biological samples at baseline and 12 weeks.\n* Collect children's bedroom dust samples at baseline.\n* Wear a bracelet for 7 days at baseline and 12 weeks to monitor physical activity.",[187,188,189],"Asthma Childhood","Asthma","Inhalation Spacers",[188,191,192,193,194,195],"Child","Immunophenotyping","Environmental exposure","Inhalation spacers","Allergy and asthma","2026-03-24",{"date":198,"type":40},"2026-03-30",{"date":200,"type":40},"2026-01-02",{"date":202,"type":20},"2027-08",{"name":204,"class":205},"Luxembourg Institute of Health","OTHER_GOV",1,{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":215,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":217,"conditions":218,"keywords":220,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":225,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":231},"100606605","the--gal-syndrome---investigating-immune-reactions-to-tick-bites-100606605","NCT07177729","The α-gal Syndrome - Investigating Immune Reactions to Tick Bites","The α-gal Syndrome - Investigating Immune Reactions to Tick Bites Leading to Inflammation and Allergic Sensitization","ImmunoGal","Inclusion criteria:\n\n* Individuals aged ≥ 18 years, Male and Female.\n* Experience of a tick bite: the tick has been removed less than 48 hours ago, or the tick is still attached to the skin and can be removed on site by the study nurse.\n* Tick available for analysis.\n* Informed consent signed.\n\nExclusion criteria:\n\n* Individuals \\\u003C 18 years of age, Male or Female.\n* Individuals with an acute viral\u002Fbacterial inflammation.\n* Individuals with an immune deficiency or under immunosuppressive treatments.\n* Individuals in receipt with immunotherapy with omalizumab.\n* Individuals with neurological diseases \u002F impaired cognitive disorder.",{"count":216,"type":20},100,"Tick bites can transmit pathogens, but they can also induce a food allergy to mammalian meat. The goal of this clinical trial is to follow immune response and antibody build-up in individuals bitten by a tick. Participants are invited to enroll within 48 hours after the tick removal and donate some blood. The tick is also collected and analysed. Researchers will then try to answer the following questions:\n\n* Was the tick infected with parasites?\n* Did the participant make antibodies against tick proteins or tick-borne parasites?\n* Did the participant develop IgE antibodies against the alpha-Gal sugar? The alpha-Gal sugar is present on mammalian meat, and ticks can transmit the alpha-Gal sugar to the host during their blood meal. Humans recognize the alpha-Gal sugar as foreign and some individuals will build IgE antibodies in response. These IgE antibodies against alpha-Gal can lead to a food allergy to red meat, also known as alpha-Gal syndrome.\n\nResearchers will compare a group of participants that develop IgE against the alpha-Gal sugar with participants that will not. They want to find out if there are specific immune features that differentiate the 2 groups.\n\nParticipants will:\n\n* Enroll after a recent tick bite within 48 hours after tick removal: they will be asked to donate some blood and fill out a questionnaire.\n* Visit the clinic 4 to 6 weeks later for a follow-up sample and questionnaire.\n* Visit the clinic 3 months after the tick bite for allergy tests if they have been selected for this 3rd visit.",[219],"Alpha-Gal Syndrome",[221,222,223,224],"Tick-borne diseases","Tick bites","alpha-Gal syndrome","immuno-phenotyping",{"date":198,"type":40},{"date":227,"type":40},"2025-07-01",{"date":229,"type":20},"2027-02",{"name":204,"class":205},2,{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":57,"sex":16,"minAge":239,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":206},"100427639","identification-of-vocal-biomarkers-to-monitor-the-health-of-people-with-a-chronic-disease-100427639","NCT04848623","Identification of Vocal Biomarkers to Monitor the Health of People With a Chronic Disease","CoLive Voice","Inclusion Criteria:\n\n* Adolescents and adults \\> 15 years\n* With or without health conditions\n* From all countries\n\nExclusion Criteria:\n\n* Children \\\u003C 15 years","15 Years",{"count":241,"type":20},50000,"The CoLive Voice research project aims to identify vocal biomarkers of severe conditions and frequent health symptoms. The project is based on digital technologies and statistical algorithms. This is an international anonymous survey where vocal recordings are collected simultaneously with large validated clinical and epidemiological data, in the context of various chronic diseases or frequent health symptoms in the general population.",[244],"Chronic Disease",[246,247,248,249,250,251,252],"vocal biomarker","digital biomarker","digital health","artificial intelligence","telemonitoring","medical devices","precision health digital biomarker",{"date":198,"type":40},{"date":255,"type":40},"2021-06-26",{"date":257,"type":20},"2031-05-01",{"name":204,"class":205},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":279,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":206},"100576220","upper-limb-nerve-cryoneurolysis-is-non-inferior-to-the-usual-care-and-has-therapeutic-add-value-in-dealing-with-shoulder-pain-and-functional-problems-caused-by-spasticity-and-motor-impairment-100576220","NCT06782464","Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment","Ultrasound Guided Cryoneurolysis to Treat Shoulder Pain and Functional Problems Related to Upper Limb Spasticity","spastiCRYO-UL","Inclusion Criteria:\n\n* Be over 18 years old.\n* Have a clinically and functionally stable condition.\n* Present spastic hemiplegia of the upper limb caused by a stroke, traumatic, or hypoxic brain event occurring more than 6 months before the study.\n* The paretic upper limb must present significant spastic plegia at the shoulder adductors and\u002For shoulder internal rotators (≥ 1+ on the Modified Ashworth Scale).\n* Have a Visual Analogue Scale (VAS) pain score \\> 40\u002F100 mm.\n* Have spasticity causing limitations in providing care.\n* Have the cognitive capacity to make informed decisions. A comprehensive explanation of the study will be provided orally and in writing to participants and a trusted relative of their choosing.\n* Maintain any medications on a stable schedule.\n* Accept and have access to an interdisciplinary rehabilitation program and standardized evaluation sessions throughout the study.\n\nExclusion Criteria:\n\n* In the investigator's opinion, the subject will be exposed to unacceptable risk by participation.\n* Previous intervention or condition that altered the target neural anatomy of the upper limb.\n* Any injection (neurolytic, sclerosing, anesthesia, etc.) to the upper limb within the last 4 months.\n* Spasticity invasive treatment such as intrathecal baclofen during the trial.\n* Current enrollment in an investigational drug or device study targeting spasticity management.\n* Pregnancy or lactation.\n* Allergy or intolerance to local anesthesia\u002FBoNT-A.\n* Contraindications to BoNT-A administration, such as:\n\n  * Myasthenia Gravis\n  * Eaton-Lambert syndrome\n  * Possible drug interactions (e.g., aminoglycosides and BoNT-A)\n* Any local skin condition at the treatment site that may adversely affect treatment or outcomes.\n* Chronic medication use (prescription or over-the-counter) that, in the investigator's opinion, would affect study participation or subject safety.\n* Contraindications to cryoneurolysis, including:\n\n  * Diagnosis of cryoglobulinemia\n  * Paroxysmal cold hemoglobinuria\n  * Cold urticaria\n  * Raynaud's disease\n  * Any form of peripheral neuropathy\n  * Open and\u002For infected wounds on the affected limb\n* Diagnosis of concomitant progressive neurological diseases such as Amyotrophic Lateral Sclerosis.\n* Any reason, in the investigator's opinion, that the subject may not be suitable for study participation (e.g., history of noncompliance, drug addiction, or any related upper limb injury).",{"count":83,"type":20},[23],"This trial is part of the spastiCRYO clinical research project. The primary objective of this clinical trial is to test the hypothesis: \"Upper limb nerve cryoneurolysis is non inferior to the usual care and has therapeutic add value in dealing with shoulder pain and functional problems caused by spasticity and motor impairment\".\n\nIt is a non-inferiority study on the referred topic, comparing the therapeutic effect (improvement in function and pain) of cryoneurolysis of selected nerves (lateral pectoral nerve and thoracodorsal nerve) with the usual care: intramuscular botulinum neurotoxin type A (BoNT-A) injection of pectoralis major, teres major and subscapularis muscles. The hypothesis is that cryoneurolysis is not inferior to the usual care in terms of magnitude of the therapeutic effect and might have a therapeutic add-value in terms of duration of that effect.\n\nTwo secondary hypotheses are firstly, that cryoneurolysis is a safe procedure that can be deployed in a rehabilitation hospital setting with minimum requirements to perform mini-invasive procedures and secondly that selecting patients who might benefit from this treatment is straightforward.\n\nTo test these hypotheses, the research team will gather, analyse and compare outcome measures data from the endpoints which are the changes along the trial duration in shoulder pain, upper limb function, involved muscles spasticity, shoulder range of motion (abduction and external rotation) level of impairment, and follow-up of potential adverse effects in two independent and equivalent groups of participants who have shoulder pain and functional limitations caused by spasticity and are in a stable phase of their condition. Participants in one group (cryoneurolysis arm) have one session of selected nerves ultrasound and neurostimulation guided cryoneurolysis and participants in the other group (BoNT-A arm) have one session of ultrasound and neurostimulation guided injection of BoNT-A in the pectoralis major, teres major and subscapularis.\n\nThe participants of the two groups follow an upper limb analogous rehabilitation program for 24 weeks after each intervention. Longitudinal follow-up in the trial will take 24 weeks. In a real-world scenario, within 24 weeks the effect of Bont-A intramuscular injection has already waned, and the procedure should be repeated.\n\nSecondary objectives are to compare changes in upper limb sensory function and electroneuromyographic parameters with the intention to understand the cryoneurolysis mechanism of action and the reversibility of this mini-invasive intervention. Changes in quality-of-life dimension of participants is a secondary endpoint as well.",[271,272,273,274,275,276,277,278],"Hemiplegia","Spasticity","Shoulder Spasticity","Shoulder Stiffness","Stroke","Multiple Sclerosis","Traumatic Brain Injury","Spinal Cord Injury",[280,281,282,283,284,285],"cryoneurolysis","spasticity","pain","stroke","traumatic brain injury","spinal cord injury","2026-03-17",{"date":288,"type":40},"2026-03-19",{"date":290,"type":40},"2024-12-12",{"date":292,"type":20},"2028-12-12",{"name":294,"class":47},"Centre National de Rééducation Fonctionnelle et de Réadaptation",{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":21,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},"100370882","a-brain-metastases-research-platform-to-tackle-the-challenge-of-cns-metastases-in-solid-tumours-100370882","NCT04109131","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours","A Brain Metastases Research Platform to Tackle the Challenge of CNS Metastases in Solid Tumours - BrainStorm Program","BrainStorm","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n3. Female or Male\n4. Eligible for part A: Subjects (from cohorts 1 to 5) with newly diagnosed or up to 24 months from diagnosis of non-CNS metastases. Enrolment of exceptional cases surpassing 24 months from diagnosis will be allowed for up to 20% of subjects enrolled with HER2+ BC (cohort 2) and NSCLC harbouring driver mutations (cohort 3).\n\n   Eligible for part B: Subjects (from cohorts 1 to 7) presenting with a first CNS event and not yet enrolled in the program\n\n   Seven cohorts of subjects are defined in this prospective multicenter study:\n   * Cohort 1: Triple negative breast cancer (TNBC)\n   * Cohort 2: HER 2 positive breast cancer (HER2+ BC)\n   * Cohort 3: Non-small cell lung cancer (NSCLC)\n   * Cohort 4: Small cell lung cancer (SCLC)\n   * Cohort 5: Melanoma\n   * Cohort 6: Other solid tumours (apart from the above mentioned subtypes\n   * Cohort 7: Radiologically or cytologically confirmed leptomeningeal carcinomatosis\n5. Availability of either primary and\u002For non-CNS metastatic archival tumour tissue is mandatory for inclusion.\n6. Willingness to undergo lumbar puncture at diagnosis of CNS metastases unless medical contra-indications\n7. Predicted life expectancy \\> 3 months.\n8. Women of childbearing potential must have a negative urine pregnancy test done within 28 days prior to enrolment\n9. Effective contraception is in place for women of childbearing potential\n10. Completion of all necessary screening procedures within 28 days prior to enrolment.\n11. Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\n    Inclusion criterion applicable to FRANCE only\n12. Affiliated to the French Social Security System\n\nExclusion Criteria:\n\n1. Pregnant and\u002For lactating women.\n2. Previous or current malignancies of other histologies within the last 2 years, with the exception of in situ carcinoma of the cervix, and adequately treated basal cell or squamous cell carcinoma of the skin.\n3. Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n\n   Exclusion criterion applicable to FRANCE only\n4. Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.",{"count":304,"type":20},600,[23],"Despite some encouraging data, systemic treatment of CNS metastases from solid tumors remains experimental.\n\nBetter knowledge on the evolving epidemiology and biology of BM are key elements for the development of new treatment strategies and identification of promising therapeutic targets for new compounds. Further biological findings may help to better understand the heterogeneity between the primary tumor and the CNS metastases and to identify new targets for therapy thus improving patients' outcome.\n\nIn this context, the Oncodistinct network and the Jules Bordet institute propose to build a multidisciplinary Brain Metastases Clinical Research Platform called BrainStorm. The BrainStorm program will focus on patients with newly diagnosed non-CNS metastatic solid tumors with high risk of developing CNS metastases and will allow building a large clinico pathological database for CNS metastases including ctDNA analyzes from CSF samples. Substudies will be proposed at each time-period with the final objective to develop innovative treatment approaches and strategies.",[308],"CNS Metastases",{"date":310,"type":40},"2026-01-06",{"date":78,"type":40},{"date":313,"type":20},"2029-01",{"name":46,"class":47},17,{"id":317,"slug":318,"hasResults":11,"nctId":319,"briefTitle":320,"officialTitle":320,"acronym":321,"eligibilityCriteria":322,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":323,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":324,"conditions":325,"keywords":330,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":206},"100614536","clinnova-ms-a-prospective-cohort-study-of-patients-with-multiple-sclerosis-a-trans-regional-digital-health-effort-unlocking-the-potential-of-artificial-intelligence-and-data-science-in-health-care-100614536","NCT07280871","Clinnova-MS: A Prospective Cohort Study of Patients With Multiple Sclerosis: A Trans-regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care","Clinnova-MS","Inclusion Criteria:\n\n1. Signed informed consent form\n2. ≥ 18 years of age\n3. Willing and able to comply with the protocol for the duration of the study including data and samples collection as well as study visits and examinations.\n4. Diagnosed with MS according to the revised McDonald criteria 2017 or revised McDonald criteria 2024, all clinical forms inclusive (CIS, RRMS, SPMS, PPMS) AND early disease stages (\\\u003C 3 years), OR presenting at hospital for evaluation of a change in therapy (flare) OR transitioning phase to progressive disease as evaluated based on EDSS.\n\nExclusion Criteria:\n\n1. Diagnosis uncertain (no fulfilment of inclusion criteria)\n2. Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits such as mental disability that makes it difficult or impossible to answer questionnaires.\n3. Not fluent in any of the following languages: French, English or German.\n4. Known pregnancy before the inclusion into the study",{"count":216,"type":20},"The Clinnova-Multiple Sclerosis (MS) study is part of the Clinnova program (NCT06526364; NCT06235684 and NCT05733702), which seeks to advance precision medicine and the digitalization of healthcare through high-quality, interoperable health data.\n\nThis program focuses on people with multiple sclerosis (MS) and aims to identify objective surrogate markers derived from clinical, epidemiological, imaging, and omics data that can predict disease activity, such as progression or relapses.\n\nBy combining data science and artificial intelligence, the project seeks to improve patient stratification, support personalized therapeutic decisions, and provide insights into the mechanisms underlying treatment response and disease progression.\n\nAlthough many therapies are available for MS, it remains challenging to determine the most appropriate strategy for each patient and to prevent long-term disability. Current treatments mainly target relapses and inflammation, with limited effects on chronic progression. Clinnova-MS will collect and analyze real-world and research data to better understand variability in disease activity and treatment outcomes, enabling more precise, evidence-based care within the standard of care. This study represents the first step toward the broader Clinnova objective: developing sustainable, personalized, and preventive healthcare for people living with MS.",[326,327,328,329],"Multiple Sclerosis, Relapsing-Remitting","Multiple Sclerosis, Chronic Progressive","Clinically Isolated Syndrome","Primary Progressive Multiple Sclerosis",[331,332,333,334,335],"AI","Machine Learning","MS","phenotyping","personalised medicine","2025-12-31",{"date":310,"type":40},{"date":339,"type":20},"2026-06",{"date":341,"type":20},"2040-06",{"name":204,"class":205},{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":57,"sex":16,"minAge":351,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":21,"phases":354,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":206},"100578811","healthyw860-pilot-100578811","NCT06816147","HealthyW8_60+ Pilot","Empowering Healthy Lifestyle Behavior Through Personalized Intervention Portfolios to Prevent and Control Obesity in the Elderly","HealthyW8","Inclusion Criteria:\n\nIndividuals aged 60 or older:\n\n* both males\u002Ffemales, general free-living population,\n* residing in Luxembourg,\n* having normal weight or being overweight, i.e., with a BMI between 18.5 ; 30 kg\u002Fm², which is considered a risk factor for developing obesity,\n* owning a smartphone.\n\nExclusion Criteria:\n\n* With known manifest chronic diseases that prohibits participation in the study (e.g., cancer, Parkinson's),\n* Persons with cognitive diseases (Alzheimer's) or those who are not able to lead an independent life,\n* Persons following a strict diet (on their own or advised by their physician),\n* Particular population groups, such as prisoners, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question.","60 Years",{"count":353,"type":20},30,[23],"This pilot study will focus on men and women aged ≥60 years for a period of 3 months during which each participant will use the HLRS. The primary purpose is to study whether the HLRS, reflecting a multi-component intervention, is well accepted by the participant, has a decent adherence (i.e., user time of the app). In addition, investigators will study the feasibility of the design, i.e. whether the overall design is well suited to the participants, in order to improve their lifestyle, e.g., dietary habits and PA, among others. Secondary outcomes related to the feasibility approach include dietary habits, PA patterns, and selected plasma and urinary endpoints. This pilot study will be of longitudinal design without a control group. A later trial that is planned for the following year will focus further on biological endpoints and will be randomized. In this present pilot study, investigators aim to assess mainly the user-friendliness of the HLRS, and gather first evidence that the intervention can indeed produce healthier lifestyle patterns.\n\nThe study's primary objective is to determine whether the developed HLRS can be successfully applied to the target population (men and women aged ≥60 years) and whether they use it frequently during the study and are satisfied with the HLRS.\n\nSecondly, investigators will study whether the assessment of endpoints required for the later and separately planned ensuing long-term study can be well assessed within the study and if, despite the limited time of the intervention duration, the intervention will be able to preliminary improve specific markers related to the risk of obesity and associated comorbidities. This will entail anthropometric measures to assess changes in body mass and body fat in addition to the primary and secondary objectives.",[357],"Obesity Prevention",[359,360,361,362],"Obesity","BMI","overweight","life style recommender solution","2025-12-05",{"date":365,"type":40},"2025-12-12",{"date":367,"type":40},"2025-11-19",{"date":369,"type":20},"2026-12-31",{"name":204,"class":205},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":206},"100605013","development-of-voice-biomarkers-of-frequent-covid-19-and-long-covid-related-symptoms-based-on-data-from-users-of-the-long-covid-companion-app-100605013","NCT07156994","Development of Voice Biomarkers of Frequent COVID-19 and Long Covid-related Symptoms Based on Data From Users of the Long COVID Companion App","Unravelling Health and Frequent Symptoms and Voice Characteristics Evolution Over Time of Users of the Long COVID Companion Application to Develop Voice Biomarkers of Frequent Long Covid-related Symptoms","EVO-LC","Inclusion Criteria:\n\n* Adult (≥18 years old)\n* Male or female\n* People with persisting symptoms related to COVID-19 (With Long COVID diagnosis or not)\n* Adequate understanding of one of the study languages (English, French, German)\n* Electronically signed informed consent form\n\nExclusion Criteria:\n\n● No specific exclusion criteria",{"count":380,"type":20},300,"The LIH DDP research team focuses its research topics on vocal biomarkers and Long COVID, among others. Voice is indeed a promising tool to monitor health, as it contains many information on our health and is easy to collect.\n\nThe development of vocal biomarkers of Long COVID-related symptoms could improve the remote monitoring of the health status of people affected by this disease.\n\nThe LIH developed the Long COVID Companion (LCC) app in collaboration with the ApresJ20 Long COVID patient association in France to support patients in their daily lives. LCC app users will be invited to participate in this study to collect voice recordings at the same time as health-related data.\n\nThe objectives of this study are:\n\nPrimary objective: To develop vocal biomarker candidates for the main Long COVID symptoms (fatigue, brain fog, respiratory problems, sleep issues, stress, anxiety,..) in a population of people with Long COVID.\n\nSecondary objectives:\n\n* to assess the intra-individual longitudinal evolution of voice characteristics of people with LC\n* to assess app usability and acceptability in the long-term.",[383],"Long COVID",[383,385,386],"Vocal biomarkers","symptoms","2025-12-01",{"date":389,"type":40},"2025-12-08",{"date":391,"type":20},"2025-12-15",{"date":393,"type":20},"2028-09-30",{"name":204,"class":205},{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":404,"conditions":405,"keywords":407,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":206},"100495630","clinnova-ibd-a-prospective-cohort-of-patients-with-inflammatory-bowel-disease-ibd-100495630","NCT05733702","Clinnova-IBD, a Prospective Cohort of Patients With Inflammatory Bowel Disease (IBD)","A Prospective Cohort Study of Patients With Inflammatory Bowel Disease: A Trans-Regional Digital Health Effort Unlocking the Potential of Artificial Intelligence and Data Science in Health Care","Clinnova-IBD","Inclusion Criteria:\n\n* ≥ 18 years old\n* Participants are willing and able to comply with the protocol including undergoing data and sample collection as well as study visits and examinations.\n* Signed informed consent form\n* Diagnosed with Inflammatory bowel disease, either Crohn's disease or ulcerative colitis, at least 3 months before the enrolment AND occurrence of a significant change in the treatment of the disease (either change of drug dosage OR change of medication within the same treatment class OR change of treatment class OR addition of a drug to a treatment regimen already ongoing). A change of drug dosage or frequency is considered significant if it fulfills the requirements in section 7.1 Note: Patients with ostomy or with short bowel syndrome can be included if they fulfill all the eligibility criteria\n\nExclusion Criteria:\n\n* Any condition that could potentially hamper the compliance with the study protocol, including study procedures and study visits (such as mental disability that makes it difficult or impossible to answer questionnaires)\n* Not fluent in any of the following languages: French, English or German\n* Known pregnancy",{"count":216,"type":20},"This study is part of the Clinnova program. This is a prospective cohort study including patients with IBD recruited at the time of a treatment change.\n\nAt least 800 participants (recruited in France, Germany and Luxembourg) will be enrolled, of which 100 participants are expected to be recruited in Luxembourg with the present study protocol.\n\nThe mission of Clinnova is to support the digitalization of healthcare and precision medicine by creating a data-enabling environment for accessing, sharing and analyzing interoperable, high-quality health data.\n\nThe main hypothesis is that treatment change decided by clinicians is predictable using objective surrogate markers derived from clinical, epidemiological, and omics data. Identifying these objective markers may facilitate future treatment decisions, provide new insights on the molecular causes for differential treatment response, pathogenesis and progression, and potential pointers for improved personalized therapeutic interventions.",[406],"Inflammatory Bowel Diseases",[408,409,410,411],"Artificial Intelligence","Personalized medicine","Treatment change","Phenotyping","2025-09-16",{"date":414,"type":40},"2025-09-22",{"date":416,"type":40},"2024-02-01",{"date":418,"type":20},"2029-11",{"name":204,"class":205},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":426,"eligibilityCriteria":427,"healthyVolunteers":57,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":428,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":430,"conditions":431,"keywords":432,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":443,"locationsCount":231},"100459765","earlier-diagnosis-and-better-treatment-mission-related-to-the-cohort-programme-100459765","NCT05266872","Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme","Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)","LuxPARK","Inclusion Criteria:\n\n* Subjects with neurodegenerative disease or having Parkinson's disease (typical PD or atypical parkinsonism)\n* Subjects of all genders with a full capacity of consent\n* Subjects with a limited consent capacity if the legal guardian\u002Fauthorised representative is in agreement\n* Subjects of at least 18 years of age at the time of inclusion\n\nExclusion Criteria:\n\n* Refusal to sign the informed consent\n* Limited capacity of consent on the part of the donor, if there is no legally determined guardian\u002Fauthorised representative, or the latter is not present or does not agree with the inclusion\n* Active cancer\n* Pregnant women\n* Underage subjects of less than 18 years of age\n* Refusal to comply with mandatory sample collection\n* For invasive procedures, i.e., lumbar puncture and skin biopsy: relevant blood clotting impairment, e.g., anamnestic evidence of frequent or prolonged bleedings.",{"count":429,"type":20},1800,"The Luxembourg Parkinson's Study is an ongoing longitudinal nationwide monocentric observational study. It collects extensive clinical, molecular, genetic, and digital device-based longitudinal data, as well as foreseen post-mortem diagnostic validation (Hipp et al., 2018). The cohort consists of more than 1,600 participants from Luxembourg and the Greater Region, comprising patients with typical PD or atypical parkinsonism - irrespective of disease stage, age, cognitive status, comorbidities, or linguistic background - followed-up annually and age- and sex-matched healthy control subjects followed-up every 4 years. To provide a large, longitudinally followed, and deeply phenotyped set of patients and controls for clinical and fundamental research on PD, the investigators have implemented an open-source digital platform that has been partly harmonized with other international PD cohort studies. This effort is flanked by comprehensive biosampling efforts assuring high quality and sustained availability of body liquids and tissue biopsies (including blood, urine, stool, saliva, hair, skin biopsy and cerebrospinal fluid). All data and samples are stored, curated, and integrated into state-of-the-art data and biobank facilities.",[64],[433,434,435,436],"Parkinson's disease","longitudinal cohort","stratification","risk factors","2025-08-05",{"date":439,"type":40},"2025-08-06",{"date":441,"type":40},"2014-12-19",{"date":336,"type":20},{"name":204,"class":205},{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":450,"eligibilityCriteria":451,"healthyVolunteers":11,"sex":16,"minAge":452,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":21,"phases":456,"briefSummary":458,"conditions":459,"keywords":461,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":476},"100597176","phase-2-prevent-cognitive-decline-in-gba-associated-parkinsons-disease-100597176","NCT07055087","Prevent Cognitive Decline in GBA-associated Parkinson's Disease","A Randomized, Double-blind, Placebo-controlled, 104-week Proof-of-concept Study to Evaluate the Efficacy of Intravenous Prasinezumab in Participants With Parkinson's Disease Carrying a Severe Mutation in the GBA Gene","PreCoDe","Inclusion Criteria:\n\n1. Diagnosis of PD according to MDS-Criteria.\n2. Known heterozygous severe GBA mutation (based on PD-related pathogenicity).\n\n   --\\> In case of slow recruitment after 6 months, inclusion of the GBA risk variant E326K as back-up strategy is possible (based on PD-related pathogenicity). This will be communicated by the sponsor beforehand.\n3. MoCA ≥ 21.\n4. HY in dopaminergic ON ≤3.\n5. 35 to 80 years of age at the time of signing the Informed Consent.\n6. Able and willing to provide written informed consent and to comply with the study protocol according to the International Council for Harmonization (ICH) and local regulations.\n\nExclusion Criteria:\n\nCurrent or Past Medical History:\n\n1. Known pathogenic mutation carriers of the following familial PD genes: PRKN, PINK1, DJ1, LRRK2.\n2. Medical history indicating a Parkinsonian syndrome other than sporadic PD (progressive supranuclear palsy, multiple system atrophy, drug-induced parkinsonism, essential tremor, primary dystonia).\n3. A diagnosis of a significant CNS disease other than PD.\n4. Previous, current or planned (within next 2 years) treatment with Deep Brain Stimulation (DBS) or ablation with high-intensity focused ultrasound or planned treatment with these within the next 2 years.\n5. History of brain MRI scan indicative of clinically significant abnormality of prior hemorrhage or ischemic infarction \\> 1 cm3, \\> 3 lacunar infarctions, vascular encephalopathy with white matter lesions according to Fazekas grade III. Clinical routine brain MRI scan must be available within 2 years before Screening.\n6. Concomitant disease or condition, or treatment thereof that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the participant in this study or interfere with the participant's ability to comply with study procedures or abide by study restrictions, or with the ability to interpret safety data, including:\n\n   1. Autoimmune disease (however, well controlled conditions such as quiescent rheumatoid arthritis \\[RAS\\], controlled type I diabetes, or mild-to-moderate psoriasis not requiring systemic medications may be acceptable after discussion with Sponsor).\n   2. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, non-metastatic prostate cancer, or Stage I uterine cancer.\n   3. Any active infectious disease at Screening.\n   4. Current, or history of, alcohol or drug abuse or other dependence (except nicotine dependence) within one year before Screening. Drug and\u002For alcohol abuse within 12 months prior to screening, in the investigator's judgment (except nicotine dependence, Marijuana use is not allowed \\[this includes all forms of cannabidiol and tetrahydrocannabinol even if given for therapeutic use\\]).\n   5. Any febrile illness within one week prior to first dose administration.\n   6. Any current psychiatric diagnosis according to Diagnostic and Statistical Manual of Mental Disorders fifth edition (DSM-5), International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10) or equivalent, that may interfere with the participant's ability to perform the study and all assessments (e.g., major depression (BDI-II \\>28, mental retardation, schizophrenia, bipolar disorder, etc.).\n\n      Note: Mild depression, depressive mood or mild anxiety arising in the context of PD, are not exclusionary.\n   7. Acute suicidality, as evidenced by a) Question 5 (\"Lifetime\"\u002F\"Since last visit\") on the Columbia- Suicide Severity Rating Scale (C-SSRS), indicating active suicidal ideation with any intent to act, at Screening or baseline (Day 1), or answering \"yes\" for Question 3 (\"In the Past Month\"\u002F\"Since last visit\") on the C-SSRS, indicating active suicidal ideation with any methods (not plan) without intent to act, at Screening or baseline (Day 1)\n7. The following cardiovascular conditions:\n\n   1. Myocardial infarction in the last 12 months prior to baseline.\n   2. Known history or documentation of uncontrolled bradycardia on more than one occasion within three months prior to baseline.\n   3. Resting pulse rate (PR) greater than 110.\n   4. Known history or documentation of uncontrolled hypertension on more than one occasion within three months prior to baseline.\n   5. Clinically significant cardiovascular disease including any of the following: unstable angina, decompensated congestive heart failure, clinically significant arrhythmias.\n8. Clinically significant abnormalities in laboratory test results at the Screening visit, including hepatic and renal panels, complete blood count, and urinalysis, including:\n\n   1. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 2 times the upper limit of normal (ULN).\n   2. Serum creatinine \\> 1.5 times the ULN.\n   3. Hematocrit (Hct) less than 35% for males and less than 32% for females, or absolute neutrophil cell count of \\\u003C 1500\u002FμL (with the exception of a documented history of a chronic benign neutropenia), or platelet cell count of \\\u003C 100,000\u002FμL; international normalized ratio (INR) \\> 1.4\n   4. A clinically significant abnormal thyroid-stimulating hormone (TSH) test.\n   5. A positive urine drug screen for a drug of abuse. For participants treated with selegiline, the amphetamine drug abuse test should be based on the results from a urine assay by liquid chromatography-mass spectrometry which is able to differentiate false positives from true positives for methamphetamine. For participants treated with benzodiazepines: A positive urine drug screen for benzodiazepines is allowed, provided that the prescription has been on a stable dosage for 90 days prior to baseline.\n   6. Positive result for acute or chronic infectious hepatitis B virus (HBV; \\[i.e., hepatitis B surface antigen (HBsAg positive test)\\]), for hepatitis C virus (HCV), or HIV 1 or 2. Successfully treated patients with HCV (undetectable HCV RNA) are eligible for enrollment. Participants who are immune due to HBV natural infection or HBV vaccination are eligible.\n9. Female participants of childbearing potential without highly effective contraceptive methods (that result in a failure rate of \\\u003C 1% per year) during the treatment period and for at least 90 days (or longer if required by local regulations) after the last dose of study drug.\n\n   1. A female participant is considered to be of childbearing potential if she is post-menarchal, has not reached a post-menopausal state (\\> 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (i.e. removal of ovaries, fallopian tubes, and\u002For uterus).\n   2. Examples of highly effective contraceptive methods (with a failure rate of \\\u003C 1% per year) include bilateral tubal ligation, vasectomized partner, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.\n   3. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participant. Periodic abstinence (e.g., calendar, ovulation or post ovulation methods) and withdrawal are not acceptable methods of contraception.\n10. Lactating or pregnant female participants. Female participants of childbearing potential must have a negative serum pregnancy test result during screening prior to initiation of study drug.\n\n    Medications and treatments:\n11. If on treatment with symptomatic therapy: no stable dosage for at least 90 days before Baseline of following drugs\u002Fdrug classes:\n\n    1. dopamine agonists,\n    2. MAO-B inhibitors,\n    3. COMT inhibitors,\n    4. amantadine, and\u002For\n    5. levodopa. Note: pumps for continuous levodopa treatment are acceptable if on stable dosage for at least 90 days before Baseline\n12. Manifest Gaucher's Disease and treatment for Gaucher's Disease:\n\n    1. enzyme replacement therapy (ERT),\n    2. substrate reduction therapy (SRT). Note: A second PD-associated risk variant in the GBA gene, namely E326K and T396M is allowed\n13. Anti-epileptic medication for non-seizure-related treatment which has not remained on a stable dosage for at least 90 days prior to baseline and not planned to remain stable during the study.\n14. Anti-depressant or anxiolytic use that has not remained on a stable dosage for at least 90 days prior to baseline and not planned to remain stable during the study.\n15. Use of any of the following medications within 90 days prior to baseline: typical neuroleptics, metoclopramide, flunarizine, amoxapine, amphetamine derivatives, reserpine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, modafinil, alpha methyldopa, cocaine.\n\n    Note: Amantadine, quetiapine, and clozapine are allowed but should be on a stable dose for at least 90 days prior to baseline.\n16. Prior and concomitant participation in a putative disease-modifying investigational trial with surgical, or stem cell intervention in PD.\n17. Prior and concomitant participation in an investigational clinical trial with symptomatic or disease modifying PD treatment within 90 days (or 5 half-lives of the drug, whichever is longer) before baseline.\n18. Any prior treatment with an investigational PD-related vaccine (including active immunization or passive immunotherapy with monoclonal antibodies).\n19. Prior participation in any prasinezumab study or study with other compounds targeting alpha-synuclein.\n20. Receipt of any non-PD investigational product or device, or participation in a non-PD drug research study within a period of 90 days (or 5 half-lives of the drug, whichever is longer) before baseline.\n21. Receipt of any monoclonal antibody or investigational immunomodulator within 180 days (or 5 half-lives, whichever is longer) before baseline (e.g., monoclonal antibodies, intravenous immunoglobulin \\[IVIG\\], interleukin 2 \\[IL-2\\], interleukin 12 \\[IL-12\\], interferon or immunosuppressive drugs).\n22. Immunomodulating drugs including oral corticosteroids within 90 days prior to baseline.\n23. Allergy to any of the components of prasinezumab such as citrate, trehalose and polysorbate (Tween) 20 or a known hypersensitivity or an IRR to the administration of any other monoclonal antibody.\n\n    Note: Enrollment in a non-interventional study may be allowed if approved in advance by the Sponsor.\n\n    Procedural:\n24. Any contraindications to obtaining a brain MRI (if brain MRI was not already performed within 2 years before of Screening, see exclusion criteria) (e.g., claustrophobia unresponsive to reassurance or low dose of an anxiolytic agent, tooth implants).\n25. Donation of blood over 500 mL within three months prior to Screening.\n26. For participants consenting to provide optional CSF samples by lumbar puncture (LP): LP will only be performed if the participant does not have any contraindication to undergoing an LP including: INR \\> 1.4 or other coagulopathy, platelet cell count of \\\u003C 120,000\u002FμL, infection at the desired LP site, taking anti-coagulant medication within 10 days of baseline (Note: low dose aspirin \\[acetylsalicylic acid and clopidogrel is permitted\\], severe degenerative arthritis of the lumbar spine, suspected non-communicating hydrocephalus or intracranial mass, prior history of spinal mass or trauma is\u002Fare identified. Participants failing to meet these criteria can still participate in the study and all other study assessments (with the exception of LP) as appropriate.\n\n    Regulatory \\& Administrational:\n27. Patients under legal supervision or guardianship.\n28. Participants who are not fluent in the national language.\n29. Residing in a nursing home or assisted care facility.\n30. Participating in any other interventional clinical trial.","35 Years","80 Years",{"count":455,"type":20},120,[457],"PHASE2","This is a proof-of-concept trial to investigate the efficacy of prasinezumab to slow or prevent cognitive decline in people with Parkinson's disease carrying a severe mutation in the GBA (glucocerebrosidase) gene. The duration of the intervention per patient will be 104 weeks with monthly infusions. The investigators plan to enroll 120 participants (60 participants per treatment arm). This study will be conducted across Europe in the following countries: France, Germany, Italy, Luxembourg, Spain, Sweden, UK.",[460],"Parkinson's Disease",[462,463,464,465,466],"Parkinson's disease","Cognitive function","GBA","anti-α-synuclein","monoclonal antibody","2025-07-03",{"date":469,"type":40},"2025-07-08",{"date":471,"type":20},"2025-12",{"date":473,"type":20},"2031-05",{"name":475,"class":47},"University Hospital Tuebingen",8,{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":349,"eligibilityCriteria":483,"healthyVolunteers":57,"sex":16,"minAge":484,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":21,"phases":487,"briefSummary":488,"conditions":489,"keywords":494,"overallStatus":130,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":506,"completionDateStruct":507,"leadSponsor":509,"locationsCount":171},"100593817","empowering-healthy-lifestyle-personalised-intervention-to-prevent-and-control-obesity-the-healthyw8-project-100593817","NCT07011368","Empowering Healthy Lifestyle Personalised Intervention to Prevent and Control Obesity: The HealthyW8 Project","Empowering Healthy Lifestyle Behaviour Through Personalized Intervention Portfolios to Prevent and Control Obesity During Vulnerable Stages of Life: The HealthyW8 Project.","Inclusion Criteria:\n\n* Overweight (BMI between 25-30 kg\u002Fm\\^2)\n* To have a smart phone\n\nExclusion Criteria:\n\n* Individuals with manifest chronic diseases\n* Individuals with cognitive diseases\n* Individuas not able to lead an independent life","7 Years",{"count":486,"type":20},2720,[23],"The goal of the HealthyW8 study (an intervention study) is:\n\nTo assess the usefulness and effects of a digital-based healthy lifestyle recommender system (HRLS) on the prevention of obesity in the following propulations: schoolchildren (5-10 y) and their parents, young adults (18-25 y) and elders (\\>65 y).\n\nThe main questions it aims to answer are:\n\nOutcome 1: To select and validate a tool-assisted 3-mo intervention (mostly digital) by iteratively testing the HLRS on reducing risk of overweight\u002Fobesity among the described age groups.\n\nOutcome 2: To assess the effect of 1-y interventions (mostly digital) with the HLRS described and further iteratively improved previously (outcome 1) on reducing risk of overweight\u002Fobesity at described ages.\n\nResearchers will compare the intervention group before the intervention (baseline) and after it (3-mo intervention trial), or control group (standard care) vs. Intervention group (1-y intervention) to see changes on changes in overweight\u002Fobesity, and related parameters (body composition and biomarkers).\n\nParticipants will follow the HLRS recommendations (meal plans, physical activity and sleep pattern measures and recommendations, assessment of behavioural\u002Fpsychological aspects, and motivational features through digital devices), which will be assessed by means of measurement of body weight, body composition, and biomarkers.",[357,490,491,492,493],"Obesity and Overweight","Obesity and Obesity-related Medical Conditions","Digital Health","Behavioural Science Interventions to Improve Health Equity",[495,496,497,498,499,500,501,502,503],"Healthy lifestyle recommender system","digital empowerment","health literacy","personalised prevention","pre-obesity biomarkers","mHealth","Human Digital Twin","behavior change techniques","physical activity","2025-06-27",{"date":227,"type":40},{"date":227,"type":20},{"date":508,"type":20},"2028-06-30",{"name":510,"class":205},"Fundació d'investigació Sanitària de les Illes Balears",{"id":512,"slug":513,"hasResults":11,"nctId":514,"briefTitle":515,"officialTitle":516,"acronym":4,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":21,"phases":519,"briefSummary":520,"conditions":521,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":526,"lastUpdatePostDateStruct":527,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":535},"100532064","stepcare-extended-follow-up-substudy-100532064","NCT06207942","Stepcare Extended Follow-up Substudy","Extended Follow-up Substudy of the Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation -STEPCARE Trial","All OHCA participants randomized in the STEPCARE trial at the extended follow-up participating sites, who survive and provide consent, with no further inclusion or exclusion criteria.\n\nThe inclusion and exclusion criteria for the STEPCARE trial are:\n\n* Inclusion criteria: out-of-hospital cardiac arrest of non-traumatic origin, minimum of 20 minutes without chest compressions (defined as stable return of spontaneous circulation. ROSC), unconsciousness (defined as not being able to obey verbal commands equal to a FOUR-score motor response of \\\u003C4, or being intubated and sedated because of agitation after sustained ROSC, eligible for intensive care without restrictions or limitation, inclusion within 4 hours (240 minutes) of ROSC (or 220 minutes of stable ROSC).\n* Exclusion criteria: on ECMO prior to randomization, pregnancy, suspected or confirmed intracranial hemorrhage, previously randomized in the STEPCARE trial.\n\nFor caregivers, the eligibility will be that they live with, or have weekly or more frequent contact (in person or over the telephone) with the post OHCA survivor. Only one nominated caregiver per post OHCA survivor will be able to be included in the study. This would typically be the caregiver that would identify as the primary caregiver of the post OHCA survivor if needed, but may also be another close family member.",{"count":304,"type":20},[23],"To provide detailed information on long-term outcomes in relation to potential neuroprotection and improvements in recovery for different targets of sedation, temperature, and pressure management in post out of hospital cardiac arrest survivors at 6 and 12 months. In addition, the impact of caring for a post OHCA survivor will be explored.",[522,523,524,525],"Cardiac Arrest With Successful Resuscitation","Hypoxia, Brain","Cognitive Impairment","Caregiver Burden","2025-04-17",{"date":528,"type":40},"2025-04-23",{"date":530,"type":40},"2023-08-01",{"date":532,"type":20},"2027-07-31",{"name":534,"class":47},"Region Skane",34,{"id":537,"slug":538,"hasResults":11,"nctId":539,"briefTitle":540,"officialTitle":541,"acronym":542,"eligibilityCriteria":543,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":544,"enrollmentInfo":545,"targetDuration":4,"studyType":21,"phases":546,"briefSummary":547,"conditions":548,"keywords":551,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":559,"lastUpdatePostDateStruct":560,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":206},"100556257","periodic-fasting-for-treatment-of-long-covid-in-adults-a-pilot-study-100556257","NCT06522750","Periodic Fasting for Treatment of Long Covid in Adults: a Pilot Study","Pilot Study on the Feasibility of an RCT: Evaluating Periodic Fasting as a Treatment Strategy for Long Covid in Adults","FASTCOV-P","Inclusion Criteria:\n\n* Age 18-64\n* Diagnosis Long Covid Syndrome (post-acute COVID-19 symptoms persisting ≥12 weeks)\n* Normal body Mass Index (18.5 to 25 kg\u002Fm2)\n* Marginal Iron status ( PF\\\u003C 25 ng\u002Fml)\n* Able to communicate in and comprehend English and\u002For German and\u002For French language\n* Present written \u002F signed declaration of consent\n* Ability to understand the patient information and willingness to sign the consent form\n* Consent to specimen collection and specimen use\n\nExclusion Criteria:\n\n* Current underweight condition (body mass index less than 18.5 kg\u002Fm2) or weight loss exceeding 3 kg within the last month or 5 kg within the last three months.\n* Existing \u002F current eating disorder within the past five years (e.g., anorexia, bulimia).\n* Psychiatric condition that limits understanding of the examination protocol (unable to consent)\n* Severe internal disease (e.g. kidney deficiency with creatinine \\> 2mg\u002Fdl), chronic inflammatory illness other than LCS\n* Participation in another intervention study.\n* Existing vegan diet or fasting during the last six months\n* Pregnancy or breastfeeding status.\n* Presence or suspicion of pre-existing ME\u002FCFS or early autonomous dysfunction\n* Diagnosis of chronic inflammatory bowel diseases, celiac disease or colorectal cancer according to the guidelines of the German Society of Gastroenterology\n* Use of anti-psychotic drugs\n* Antibiotic use during the previous 12 months\n* Start of novel drug therapy\n* Contraindication for additional blood draws (e.g. hemoglobin \\\u003C10)","64 Years",{"count":5,"type":20},[23],"Background:\n\nLong COVID, characterized by persistent symptoms following acute COVID-19 infection, has emerged as a significant public health concern. Symptoms range from fatigue, cognitive impairments, to respiratory difficulties, affecting patients\\' quality of life. Dietary interventions, particularly fasting, have historically been used to modulate immune responses and improve health outcomes in various conditions. The Buchinger-Wilhelmi method represents a structured and medically supervised fasting approach. Given the inflammatory nature of long COVID, fasting may offer therapeutic benefits by modulating the immune response, enhancing cellular repair mechanisms, and resetting metabolic processes.\n\nObjectives:\n\nThis clinical trial aims to assess the feasibility of a 7-day ambulatory fasting intervention using the Buchinger-Wilhelmi method on long COVID patients as primary objective. As secondary objectives, the study will investigate the potential beneficial impact of fasting on clinical, biological, and psychological parameters over a period of 4 weeks, offering insights into potential therapeutic avenues for long COVID management.\n\nStudy timeline:\n\nThe research will span a period of 4 weeks\n\nStudy population:\n\nThis study aims to recruit around 20 participants, who will all receive a fasting intervention using the Buchinger-Wilhelmi method.\n\nBiological sample and data collection:\n\nParticipants will undergo various data and sample collection procedures, including blood draws of up to 90 42 ml per visit, collection of peripheral mononuclear cells, stool samples, and completion of questionnaires in a smartphone-based Application (MyCap).\n\nSample analysis:\n\nThe collected samples will be subjected to a range of analyses, including the assessment of serological markers for routine blood chemistry, evaluation of inflammation markers, and examination of stool samples.",[549,550],"Long Covid","Chronic Inflammation",[552,553,554,555,556,557,558],"long covid","fasting","caloric restriction","chronic inflammation","dysbiosis","mitochondrial dysfunction","thrombosis","2025-03-25",{"date":561,"type":40},"2025-03-30",{"date":563,"type":40},"2025-02-19",{"date":565,"type":20},"2025-09-30",{"name":567,"class":47},"University of Luxembourg",{"id":569,"slug":570,"hasResults":11,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":576,"targetDuration":4,"studyType":21,"phases":578,"briefSummary":580,"conditions":581,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":584,"lastUpdatePostDateStruct":585,"startDateStruct":587,"completionDateStruct":589,"leadSponsor":591,"locationsCount":206},"100556987","phase-1-long-term-safety-trial-with-nvdx3-100556987","NCT06532253","Long-term Safety Trial with NVDX3","Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.","X3LTFU","Inclusion Criteria:\n\n1. Patient being implanted with NVDX3.\n2. Previously participated to one of the NVDX3 core clinical trials.\n3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years\n4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.\n\nExclusion Criteria:\n\nNo exclusion criteria are applicable.",{"count":577,"type":20},15,[579,457],"PHASE1","An study evaluating the long-term safety of all patients previously treated with NVDX3.",[582,583],"Distal Radius Fractures","Degenerative Lumbar Spondylolisthesis","2024-09-01",{"date":586,"type":40},"2024-09-05",{"date":588,"type":40},"2024-08-22",{"date":590,"type":20},"2036-03",{"name":592,"class":106},"Novadip Biosciences",""]