[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Slovenia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":687},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,194,0,25,[9,51,93,123,154,177,201,226,249,279,307,336,365,390,411,436,460,484,507,526,551,576,615,642,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100053737","phase-2-study-of-advanced-therapies-for-the-treatment-of-adult-participants-with-moderately-to-severely-active-crohns-disease-or-ulcerative-colitis-100053737",false,"NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","ALL","18 Years","75 Years",{"count":21,"type":22},2000,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[28,29],"Crohn's Disease","Ulcerative Colitis",[31,32,33,34,35,36,37],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","NOT_YET_RECRUITING","2026-07-07",{"date":41,"type":42},"2026-07-13","ACTUAL",{"date":44,"type":22},"2026-07-24",{"date":46,"type":22},"2031-10",{"name":48,"class":49},"AbbVie","INDUSTRY",30,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":92},"100527808","phase-3-magnetismm-32-a-study-to-learn-about-the-study-medicine-called-elranatamab-in-people-with-multiple-myeloma-mm-that-has-come-back-after-taking-other-treatments-including-prior-treatment-with-an-anti-cd38-antibody-and-lenalidomide-100527808","NCT06152575","MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)","A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED\u002FREFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY","Inclusion Criteria:\n\n* Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.\n* Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.\n* Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g\u002FdL; (b) Urinary M-protein excretion ≥200 mg\u002F24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg\u002FdL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\\\u003C0.26 or \\>1.65).\n* Have clinical laboratory values within the specified range.\n* ECOG (Eastern Cooperative Oncology Group) performance status ≤2.\n* Not pregnant or breastfeeding and willing to use contraception.\n\nExclusion Criteria:\n\n* Smoldering multiple myeloma.\n* Plasma cell leukemia.\n* Amyloidosis.\n* Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.\n* Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.\n* Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.\n* Any active, uncontrolled bacterial, fungal, or viral infection.\n* Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)\n* Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.\n* Unable to receive investigator's choice therapy.\n* Live attenuated vaccine within 4 weeks of the first dose of study intervention.\n* Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.",{"count":59,"type":22},492,[61],"PHASE3","The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer).\n\nThis study is seeking participants who:\n\n* Are 18 years of age or older and have MM.\n* Have received treatments before for MM.\n* Have MM that has returned or not responded to their most recent treatment.\n\nHalf of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM.\n\nElranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study.\n\nThe medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as:\n\n* a shot under the skin at the study clinic\n* through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects.\n\nParticipants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits).\n\nThe study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.",[64],"Multiple Myeloma",[66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81],"Elranatamab","B-Cell Maturation Antigen","BCMA","Bispecific antibody","BCMA-CD3 bispecific antibody","Myeloma","Multiple myeloma","Relapsed multiple myeloma","Refractory multiple myeloma","MagnetisMM","MagnetisMM-32","Pomalidomide","Elotuzumab","Bortezomib","Carfilzomib","PF-06863135","RECRUITING","2026-06-29",{"date":85,"type":42},"2026-07-01",{"date":87,"type":42},"2024-02-08",{"date":89,"type":22},"2027-12-30",{"name":91,"class":49},"Pfizer",271,{"id":94,"slug":95,"hasResults":12,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":4,"eligibilityCriteria":99,"healthyVolunteers":12,"sex":17,"minAge":100,"maxAge":18,"enrollmentInfo":101,"targetDuration":4,"studyType":23,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100610207","phase-3-beeline-a-phase-3-study-in-grin-related-neurodevelopmental-disorder-100610207","NCT07224581","Beeline: A Phase 3 Study in GRIN-related Neurodevelopmental Disorder","A Multinational, Multicenter Study With an Open-Label Phase 1b and a Randomized, Double-Blind, Placebo-Controlled Phase 3 Followed by an Open-Label Extension to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Radiprodil in Participants With GRIN-Related Neurodevelopmental Disorder","Inclusion Criteria:\n\nPart A, Participant:\n\n* Diagnosed with GRIN-NDD with GRIN1, GRIN2A, GRIN2B, or GRIN2D gene variants known to result in GoF of the NMDA receptor\n* Phase 3 Cohort 1 (Qualifying Seizures Cohort) ONLY: Experiencing at least 1 CMS per week and ≥4 CMS (generalized or focal) during screening\n* With history of inadequate response to at least 2 standard antiseizure medications (ASMs)\n* Phase 3 Cohort 2 (Without Qualifying Seizures Auxiliary Cohort) ONLY: With significant neurodevelopmental symptoms and a GRIN-CGI-S score ≥4\n* On a stable dose of standard ASMs for at least 4 weeks prior to screening and should remain on stable doses throughout study participation\n* On stable nonpharmacological treatments such as ketogenic diet and should remain stable throughout study participation\n\nPart B:\n\n\\- Participant has completed Part A and is eligible to continue study participation according to the judgement of the investigator and sponsor.\n\nExclusion Criteria:\n\nPART A, Participant:\n\n* Has clinically relevant medical, neurologic, or psychiatric condition and\u002For behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation or study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.\n* Is receiving \\>4 standard ASMs at screening\n* Has a body weight of less than 5 kg at screening\n\nPart B:\n\n\\- Participant has clinically relevant medical, neurologic, or psychiatric condition and\u002For behavioral disorder (including those related to GRIN-NDD) that would preclude or jeopardize participant's safe participation of study drug administration or the conduct of the study according to the judgement of the investigator or sponsor.","1 Month",{"count":102,"type":22},100,[61],"The Phase 3 portion of Study RAD-GRIN-101 is a multinational, multicenter, randomized, double-blind, placebo-controlled trial followed by an open-label extension to evaluate the efficacy and safety of radiprodil in participants with GRIN-related neurodevelopmental disorder (GRIN-NDD) with a gain-of-function (GoF) genetic variant.\n\nThis study will enroll two cohorts: one cohort of participants with a minimal number of countable motor seizures (with or without behavioral symptoms) (Phase 3 Cohort 1: Qualifying Seizures Cohort); and a second cohort with disease symptoms but no seizures or fewer seizures than required for the Qualifying Seizures Cohort (Phase 3 Cohort 2: Without Qualifying Seizures Auxiliary Cohort).\n\nParticipants in each cohort will be randomized 1:1 to receive active drug (radiprodil) or matching placebo (Part A). Following completion of Part A, all eligible participants (including those previously on placebo) may continue into the open-label extension period (Part B) to receive radiprodil.\n\nThe placebo-controlled portion is expected to be approximately 16 weeks for participants in Phase 3 Cohort 1 and 28 weeks for participants in Phase 3 Cohort 2.\n\nThe study will evaluate the effect of radiprodil on seizures and non-seizure symptoms and assess safety.",[106],"GRIN-related Neurodevelopmental Disorder",[108,109,110,111,112,113],"Beeline","GRIN1","GRIN2A","GRIN2B","GRIN2D","GRIN-NDD","2026-06-26",{"date":83,"type":42},{"date":117,"type":42},"2026-01-05",{"date":119,"type":22},"2028-07",{"name":121,"class":49},"GRIN Therapeutics, Inc.",33,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100568255","elevate-hfpef-clinical-study-100568255","NCT06678841","ELEVATE-HFpEF Clinical Study","Randomized Trial of ELEVATEd Cardiac Pacing Rate for Personalized Treatment of Heart Failure With Preserved Ejection Fraction (ELEVATE-HFpEF)","ELEVATE-HFpEF","Inclusion Criteria:\n\n1. Age ≥ 40 years\n2. Documented EF ≥50% within the preceding 12 months\n3. HFpEF defined as:\n\n   1. Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR\n   2. Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:\n\n      * Interstitial \u002F pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure\n      * Elevated NT-proBNP in the last year defined as \\>400 pg\u002Fm for patients with no AF or paroxysmal AF, or \\>900 pg\u002Fml for patients with ≥persistent AF\n      * Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)\n      * Echo criteria defined by ≥2 of:\n\n        * LV wall thickness ≥ 12 mm\n        * LV mass index (BSA indexed LVH): sex at birth male \\>115 g\u002Fm2, sex at birth female \\>95 g\u002Fm2\n        * Relative wall thickness ≥0.42\n        * E\u002Fe' ≥15 in sinus rhythm (or \\> 11 in the setting of atrial fibrillation) OR septal \\\u003C7 cm\u002Fs or lateral e' \\\u003C10cm\u002Fs\n        * Tricuspid regurgitation (TR) velocity \\>2.8 m\u002Fs\n        * Left atrial (LA) enlargement, defined by LA volume index \\>34 ml\u002Fm2\n4. Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days\n5. Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)\n6. Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).\n\nExclusion Criteria:\n\n1. Improved or recovered EF (i.e., prior LVEF\\\u003C50%)\n2. Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))\n3. Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)\n4. Average heart rate \\\u003C50 bpm or symptomatic bradycardia\n5. Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.\n6. Current acute decompensated HF requiring intravenous diuretics, vasodilators and\u002For inotropic drugs.\n7. Severe obesity defined as BMI \\>45.\n8. Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate \\\u003C50 bpm or evidence of ventricular pauses exceeding 6 seconds\n9. Planned AF ablation\n10. Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)\n11. Hypertrophic cardiomyopathies\n12. Uncontrolled hypertension as defined by BP \\>160\u002F100 mmHg on two measurements ≥15 minutes apart\n13. End Stage Renal Disease (CKD 4 or greater)\n14. More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)\n15. Significant primary pulmonary disease on home oxygen\n16. Known contraindication for a pacemaker implant\n17. Advanced co-morbidity with life expectancy \\\u003C 1 year\n18. Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.\n19. Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).","40 Years",{"count":133,"type":22},700,[135],"NA","ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).",[138],"Heart Failure With Preserved Ejection Fraction (HFpEF)",[140,141,142,143,144],"Heart Failure","Heart Disease","Cardiovascular Disease","Concentric Hypertrophy","Concentric Remodeling","2026-06-25",{"date":83,"type":42},{"date":148,"type":42},"2025-07-09",{"date":150,"type":22},"2029-02",{"name":152,"class":49},"Medtronic Cardiac Rhythm and Heart Failure",46,{"id":155,"slug":156,"hasResults":12,"nctId":157,"briefTitle":158,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100416869","to-evaluate-the-safety-and-clinical-performance-of-the-archimedes-biodegradable-biliary-and-pancreatic-stent-100416869","NCT04708288","To Evaluate the Safety and Clinical Performance of the ARCHIMEDES Biodegradable Biliary and Pancreatic Stent","A PROSPECTIVE, MULTI-CENTER, SINGLE-ARM, POST MARKET OBSERVATIONAL STUDY TO EVALUATE THE SAFETY AND CLINICAL PERFORMANCE OF THE ARCHIMEDES BIODEGRADABLE BILIARY AND PANCREATIC STENT","Registry","Inclusion Criteria:\n\n* Patient eligible for implantation of a pancreatic or billiary stent prior to participate in the study and according to current guidelines\n* Patient has provided a signed and dated informed consent (according to the laws and regualtions of the country in which the observational study is conducted)\n\nExclusion Criteria:\n\n* Age \\\u003C 18 y\n* Inability to understand the purpose of the study or refusal to cooperate\n* Not available for routine follow-up visits\n* Pregnancy\n* Currently participating in a confounding trial before reaching first endpoint.",{"count":163,"type":22},198,"OBSERVATIONAL","Significant experience with biodegradable materials has been reported in the orthopedic literature; in particular; biodegradable stents have been used in the endovascular and urologic epithelium. Stents are typically made from polymeric materials including Polylactic Acid (PLA), Polyglycolide (PGA), Polydioxanone (PDO), Polyethyleneglycol (PEG), Polycaprolactone (PCL), etc., which have been cleared or approved by the FDA and CE-marked as drug carriers, sutures, and bone fixatives. The material is degraded by hydrolysis in, e.g., lactic acid, which is removed from the body by normal metabolic pathways. In the field of gastroenterology, these stents were first introduced in patients with an esophageal stenosis with encouraging results, although esophageal hyperplasia was a frequently encountered complication.\n\nFor biliary applications, biodegradable stents have been evaluated in several in-vitro and animal studies that demonstrated that the stents were safe and well tolerated. These stents provided an adequate radial force and resulted in complete stricture resolution within several months. The stents did not show any signs of biliary hyperplasia or integration in the epithelium. Moreover, they seem to have a self-clearing effect on attached biofilm as the outer layer sloughs during the degradation process similarly to the exfoliation of human skin. Also, the stent could be removed from the bile duct, thus offering the possibility of extraction if necessary at various times after implantation.\n\nIn 2010, Petryl was the first to use a biodegradable stent in the human bile duct. A stent was successfully placed using percutaneous transhepatic cholangiograpy in two patients with a postsurgical intrahepatic biliary stricture. Transient cholangitis was the only complication encountered and during the two years of follow-up, the bile duct remained patent.\n\nLater, Mauri et al. presented in 2013 and 2016 results of a 107 patient study on a polydioxanone biodegradable biliary stent. The results have been published in the Journal of the European Society of Radiology. The authors concluded that percutaneous placement of a biodegradable biliary stent is a feasible and safe strategy to treat benign biliary strictures refractory to standard bilioplasty, with promising results in the mid-term period.\n\nPrior to this study, the ARCHIMEDES device was assessed in the ARCHIMEDES Investigational study which has completed enrolment with 53 patients included, and the results are not yet published. In this study approximately half the stents were deployed in the bile duct (53%) and half in the pancreatic duct. All 53 patients have either completed, exited, or no longer have the study device. No patient remains in the study with a stent in place during the time of the last patient follow-ups. The study concluded without any device-related SAE. Bilirubin was reduced by 25.6%, which exceeded the \\>20% clinical success criterion, quality of life score improved from 3.7 to 7.9, procedural success was rated 1.4 (good to excellent), and technical success was achieved in all 53 patients.\n\nData from the ARCHIMEDES Investigational study was used for CE Mark approval, which was obtained in June 2018.",[167],"Obstructed Biliary and Pancreatic Duct",{"date":169,"type":42},"2026-06-30",{"date":171,"type":42},"2020-10-03",{"date":173,"type":22},"2027-12-31",{"name":175,"class":49},"QualiMed Innovative Medizinprodukte GmbH",11,{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":185,"targetDuration":4,"studyType":23,"phases":187,"briefSummary":188,"conditions":189,"keywords":190,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":200},"100558240","phase-2-study-of-targeted-therapies-for-the-treatment-of-adult-participants-with-moderate-to-severe-crohns-disease-100558240","NCT06548542","Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease","A Phase 2a Multicenter, Randomized, Platform Study of Targeted Therapies for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease","Target CD","Inclusion Criteria:\n\n* Participants' body weight must be \\>= 40 kg at Baseline.\n* Confirmed diagnosis of CD for at least 3 months prior to Baseline. Documentation of biopsy results consistent with the diagnosis of CD as assessed by the Investigator must be available.\n* CDAI \\>= 220 at Baseline.\n* Endoscopic evidence of mucosal inflammation as documented by an SES-CD of \\>= 6 for ileocolonic or colonic disease or SES-CD of \\>= 4 for isolated ileal disease. All eligible scores exclude the presence of narrowing component and are determined by a reader.\n* Participants must demonstrate intolerance or inadequate response to conventional therapies (OUS) and\u002For TaTs. TaTs include biologics and\u002For targeted small molecules.\n\nExclusion Criteria:\n\n* Participant who demonstrated intolerance to p19 inhibitors, including risankizumab.\n* Participant who received any investigational TaT (or TaT that becomes approved during the conduct of the study) within 30 days or 5 half-lives prior to Baseline, whichever is longer. Note: If there is documentation of an undetectable (or below the lower limit of quantification\u002Fquantitation) drug level measured by a commercially available assay for any of the approved biologics above, there is no minimum washout prior to Baseline.\n* Participant who have any of the following: Current diagnosis of UC or indeterminate colitis. Currently known complications of CD such as: Current ostomy or ileoanal pouch; Current short gut or short bowel syndrome; Surgical bowel resection within the past 3 months prior to Baseline.",{"count":186,"type":22},540,[25],"Crohn's disease (CD) is a long-lasting disease that causes severe inflammation (redness, swelling), in the digestive tract, most frequently affecting the bowels. It can cause many different symptoms including belly pain, diarrhea, tiredness, and weight loss. Treatments are available but do not work the same for all patients or may stop working over time. This study will evaluate the effectiveness and adverse events of targeted therapies (TaTs) for adult participants with moderate to severe CD.\n\nThe medicines assessed in this study are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. When participants join the study, they will be randomized into available study treatment groups. Adult participants with CD will be enrolled. Around 540 participants will be enrolled in the study at approximately 300 sites worldwide.\n\nRisankizumab and trosunilimab are given as an injection under the skin or as an infusion into the vein. Lutikizumab is given as an injection under the skin. ABBV-8736 is given as an infusion into the vein.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[28],[28,33,35,191,192],"Lutikizumab","ABBV-8736","2026-06-24",{"date":114,"type":42},{"date":196,"type":42},"2024-09-04",{"date":198,"type":22},"2030-01",{"name":48,"class":49},255,{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":23,"phases":210,"briefSummary":211,"conditions":212,"keywords":214,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":225},"100590162","phase-3-a-study-of-mezagitamab-in-adults-with-kidney-condition-called-iga-nephropathy-100590162","NCT06963827","A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy","A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants With Primary IgA Nephropathy in Combination With Stable Background Therapy","* Inclusion Criteria:\n\nTo be eligible to participate in this trial, participants must meet all the following criteria:\n\n1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g\u002Fg) or urine protein excretion (UPE) ≥1 grams per day (g\u002Fday), calculated from at least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).\n2. eGFR greater than (\\>)30 milliliters per minute per 1.73 meter square (mL\u002Fmin\u002F1.73m\\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).\n3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (except for open-label cohort participants meeting Inclusion Criterion No. 10.a).\n4. The participant is aged ≥ 18 years or the local legal age as applicable.\n5. The participant (and the participant's legally acceptable representative, as applicable per local regulations or determination) has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \\[ICF\\]) and any required privacy authorization before the initiation of any clinical trial procedures.\n6. Diagnosis of primary immunoglobulin A nephropathy (IgAN) supported by a renal biopsy report that is dated more recently than 10 years before the signing of the informed consent for the clinical trial. The redacted report must be made available for review. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.\n7. Participants must be on stable renin-angiotensin-aldosterone system (RAAS) inhibitor therapy with an angiotensin-converting enzyme inhibitor (ACE-I) and\u002For angiotensin receptor blocker (ARB) or endothelin receptor antagonist (ERA) or mineralocorticoid receptor antagonist (MRA) agent for at least 12 weeks before signing the ICF with dosing at the maximally tolerated or labeled dose as determined by the investigator, with the intent to continue stable dosing during the clinical trial. Those intolerant of RAAS inhibitor therapy are potentially eligible after consultation with the medical monitor. Intolerance is defined as a documented side effect causing discontinuation of the therapy.\n8. Resting blood pressure less than or equal to (≤)150 millimeters of mercury (mmHg) systolic and ≤100 mmHg diastolic.\n9. Female participants of childbearing potential who are not pregnant during screening (confirmed by negative serum human chorionic gonadotropin \\[hCG\\]) and on Visit 1 before first dose of trial intervention (confirmed by negative urine pregnancy test).\n10. Any one of the following (only applicable for participants in the open-label cohort):\n\n    1. Participants in Trial TAK-079-1006 who completed the Week 96 visit or the retreatment period with either UPCR \\>0.5 g\u002Fg or UPE \\>0.5 g\u002Fd calculated from a 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\>30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    2. UPCR \\\u003C0.8 g\u002Fg and UPE ≥0.75 and \\\u003C1.0 g\u002Fday, by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR \\> 30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n    3. UPCR ≥ 0.8 g\u002Fg or UPE ≥ 1.0 g\u002Fd by 24-hour urine collection during the screening period (or pre-screening, if applicable) and eGFR ≥25 and ≤30 mL\u002Fmin\u002F1.73m\\^2 at screening based on the CKD-EPI formula.\n\n       * Exclusion Criteria:\n\nA participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN (for example, diabetic nephropathy, lupus nephritis, minimal change disease).\n2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies), and immunoglobulin A (IgA) vasculitis.\n3. Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months before the signing of the ICF).\n4. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria \\>3.5 g\u002Fday and hypoalbuminemia (\\\u003C3.0 grams per deciliter \\[g\u002FdL\\]) with or without peripheral edema.\n5. Renal or other organ transplantation prior to or expected during the clinical trial.\n6. Treatment with oral immunosuppressive agents (including cyclophosphamide, mycophenolate mofetil, cyclosporine, azathioprine, calcineurin inhibitors) or biologic therapy for immunomodulation (including immunomodulatory monoclonal or polyclonal antibodies) within 6 months (both B-cell and non-B-cell directed agents) before signing of the ICF.\n7. If the participant has received anti-CD20 treatment, the participant is excluded if either of the following apply:\n\n   1. The last dose was received within 6 months before the signing of the ICF.\n   2. The last dose was received between 6 and 12 months before the signing of the ICF and the participant has a CD19+ count below the lower limit of normal.\n\n   Note: Participants who have received the last dose of anti-CD20 treatment \\>12 months before the signing of the ICF are not excluded from clinical trial participation based on this criterion and are not required to undergo CD19+ testing.\n8. Within 4 months of the screening visit, use of either a) systemic corticosteroids at an average dose of 40 milligrams (mg) prednisone equivalent or higher for more than 14 days or b) oral budesonide delayed release capsules.\n9. The participant has received a live or live-attenuated vaccine within 4 weeks before signing the ICF or has any live or live-attenuated vaccine planned during the clinical trial.\n10. Participation in any other investigational drug trial (including vaccine trial) with receipt of at least 1 dose of investigational drug, or has been exposed to another investigational agent within 4 weeks or 5 half-lives, whichever is longer, before Visit 1.\n11. The participant has active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n12. The participant has had any of the following types of infections within the specified timeframes where applicable:\n\n    1. Active bacterial, viral, or fungal infection (except for the common cold and onychomycosis), or any other serious infection within 2 weeks of signing the ICF. Any anti-infective course for infection must be completed at least 2 weeks before Visit 1.\n    2. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) infection within 4 weeks of signing the ICF.\n    3. Opportunistic infection or treatment for an opportunistic infection less than or equal to (≤)12 weeks before signing the ICF.\n    4. Active tuberculosis (TB), any history of prior active TB, or any signs or symptoms of active TB infection (including but not limited to chronic fever, chronic productive cough, night sweats, weight loss, or malnutrition) as judged by the investigator.\n    5. For participants in European Union (EU) member states, positive or 2 indeterminant QuantiFERON results, unless there is documentation of prior complete treatment for latent TB, or participant has initiated prophylaxis based on local guidelines and in consultation with a pulmonology or infectious disease specialist prior to the first administration of IMP.\n13. In the opinion of the investigator, the participant is currently experiencing any medical condition that might interfere with participation in the trial (for example, significant ocular, cardiovascular, pulmonary, hematologic, gastrointestinal, endocrinologic, hepatic, renal, neurologic, malignancy, infectious disease, immunodeficiency, or alcohol and drug abuse), that poses an added risk for the participant or could confound the assessment of trial results.\n14. In the opinion of the investigator, the participant has a serious medical or psychiatric illness that could potentially interfere with the completion of treatment.\n15. The participant has a history of major surgery within 3 months before screening (or longer, at the discretion of the investigator); or, either has a planned tonsillectomy or underwent a tonsillectomy within 6 months before screening.\n\n    Note: Major surgery typically requires at least 1 night in the hospital.\n16. History of malignancy (including myelodysplastic syndrome) within 5 years of signing the ICF, except for adequately treated non-melanoma skin cancer, superficial bladder cancer, and curatively treated cervical carcinoma-in-situ.\n17. The participant has a history of a severe allergic or anaphylactic reaction to recombinant proteins or excipients used in the mezagitamab or placebo formulation.\n18. The participant has (1) been diagnosed with or has suspected chronic obstructive pulmonary disease (COPD) or asthma and (2) has a prebronchodilatory forced expiratory volume in 1 second (FEV1) \\\u003C50% of predicted normal at screening.\n19. The participant is capable of breastfeeding but does not agree to forego breastfeeding from first dose of investigational medicinal product (IMP) through 30 days after the last dose of IMP.\n20. The participant is an individual with potential for pregnancy but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n21. The participant is a sexually active, non-sterilized individual who produces sperm but does not agree to use a barrier method (preferably male condom) combined with at least 1 form of highly effective contraception for any partner(s) with potential for pregnancy when engaging in heterosexual sex for the protocol specified duration after the last dose of IMP.\n22. In the investigator's opinion, the participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) is unwilling and\u002For unable to understand and fully comply with clinical trial procedures and requirements (including digital tools and applications).",{"count":209,"type":22},347,[61],"Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo.\n\nParticipants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time.\n\nIn the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab.\n\nDuring the study, participants will visit their study clinic several times.",[213],"Kidney Disease",[215,216],"TAK-079","Drug Therapy","2026-06-23",{"date":193,"type":42},{"date":220,"type":42},"2025-07-15",{"date":222,"type":22},"2030-01-14",{"name":224,"class":49},"Takeda",170,{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":248},"100534422","phase-3-a-follow-up-study-to-test-long-term-treatment-with-nerandomilast-in-people-with-pulmonary-fibrosis-who-took-part-in-a-previous-study-with-nerandomilast-100534422","NCT06238622","A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast","An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis (PPF) (FIBRONEER™-ON)","FIBRONEER™-ON","Inclusion Criteria:\n\n1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control\n\nExclusion Criteria:\n\n1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.\n2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:\n\n   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)\n   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)\n3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \\>14 at Visit 1.\n4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.\n5. Patient will undergo lung transplantation, with an assigned date of surgery.\n6. Patients with a Body Mass index (BMI) \\\u003C18.5 kg\u002Fm² that experienced an additional, unexplained and clinically significant (\\>10%) weight loss during the parent trial\n7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial\n8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.\n\nFurther exclusion criteria apply.",{"count":235,"type":22},1700,[61],"This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550.\n\nThe goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die.\n\nEvery participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study.\n\nParticipants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.",[239,240],"Idiopathic Pulmonary Fibrosis","Progressive Pulmonary Fibrosis",{"date":193,"type":42},{"date":243,"type":42},"2024-05-06",{"date":245,"type":22},"2027-05-05",{"name":247,"class":49},"Boehringer Ingelheim",372,{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":257,"targetDuration":4,"studyType":23,"phases":259,"briefSummary":260,"conditions":261,"keywords":264,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":278},"100641537","experimental-pbt-study-in-fall-prone-subjects-100641537","NCT07654335","Experimental PBT Study in Fall-prone Subjects","Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults","PACE-R","Inclusion Criteria for both arms:\n\n* ability for independent community walking without aids;\n* sufficient cognitive, visual, and communication abilities for study participation.\n\nExclusion Criteria for both arms:\n\n* musculoskeletal impairments;\n* cardiovascular health-related problems;\n* other health conditions that could interfere with the training.\n\nAdditional Inclusion Criteria for post-stroke patients:\n\n* discharge from their regular rehabilitation;\n* at least 6 months after first unilateral cerebral stroke;\n* 18 to 70 years of age;\n* absence of additional neurologic conditions.\n\nAdditional Inclusion Criteria for older adults:\n\n* age 65 to 75 years;\n* no known health-related problems significantly affecting balance and walking.",{"count":258,"type":22},50,[135],"The study will investigate safety, usability, feasibility and preliminary efficacy of perturbation-based training in participants post-stroke and older adults with mild balance deficits. Both group will receive three weks of training. The primary outcome measure will be derived from laboratory-induced falls.",[262,263],"Stroke","Aging",[265,266,267,268],"Accidental Falls","Walking","Fall prevention","Perturbation-based training","2026-06-19",{"date":193,"type":42},{"date":272,"type":22},"2026-09",{"date":274,"type":22},"2028-09",{"name":276,"class":277},"University Rehabilitation Institute, Republic of Slovenia","OTHER",1,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":284,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":17,"minAge":286,"maxAge":4,"enrollmentInfo":287,"targetDuration":289,"studyType":164,"phases":4,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":299,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":306},"100273106","specta-screening-cancer-patients-for-efficient-clinical-trial-access-100273106","NCT02834884","SPECTA: Screening Cancer Patients for Efficient Clinical Trial Access","SPECTA","* Patients with pathologically confirmed selected tumor types (at site or centrally);\n* Mandatory availability of adequate human biological material (HBM);\n* Centrally performed confirmation of HBM adequacy in terms of quality and quantity for SPECTA downstream project requirements;\n* Age ≥ 12 years;\n* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule;\n* Written informed consent according to applicable legal and ethical requirements;","12 Years",{"count":288,"type":22},4975,"5 Years","SPECTA is a quality assured platform for collecting clinicopathologically annotated biological material, imaging data, operative images, environmental assessment, questionnaires as well as patient-reported outcomes from cancer patients to support biospecimen-based translational research and clinical cancer research, including biomarker discovery to improve the understanding of tumor biology and cancer patients care.",[292],"All Tumor Types",[294,295,296,297,298],"rare cancer","biomarker","molecular screening","cancer","biobanking",{"date":193,"type":42},{"date":301,"type":42},"2017-05-03",{"date":46,"type":22},{"name":304,"class":305},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",136,{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":313,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":23,"phases":316,"briefSummary":317,"conditions":318,"keywords":324,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":278},"100415769","effect-of-nano-structured-alumina-coating-on-the-bond-strength-of-zirconia-resin-bonded-fixed-dental-prostheses-100415769","NCT04693949","Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses","Inclusion Criteria:\n\n1\\. Patients with missing central or lateral incisor\n\nExclusion Criteria:\n\n1. inadequate edentulous space for the pontic\n2. signs of bruxism\n3. abutment tooth with active periodontal or periapical disease\n4. inadequate enamel bonding surface of the abutment tooth\n5. inadequate interocclusal space for a retainer wing and a proximal connector\n6. pontic guidance\n7. physical or psychological disease likely to interfere with normal conduct of the study",true,{"count":315,"type":22},80,[135],"The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC).\n\nThe study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention\u002Fsurvival of the zirconia RBFDPs pretreated with APA and NAC.",[319,320,321,322,323],"Missing Incisors","Zirconia Surface Pretreatment","Children","Adults","Debonding",[325,326,327],"Airborne particle abrasion","Nanostructured alumina coating","Resin-bonded fixed dental prostheses","2026-06-18",{"date":217,"type":42},{"date":331,"type":42},"2018-01-03",{"date":333,"type":22},"2030-01-01",{"name":335,"class":277},"University of Ljubljana, Faculty of Medicine",{"id":337,"slug":338,"hasResults":12,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":313,"sex":17,"minAge":344,"maxAge":345,"enrollmentInfo":346,"targetDuration":4,"studyType":23,"phases":347,"briefSummary":348,"conditions":349,"keywords":351,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":278},"100644142","polarized-aerobic-training-and-vascular-adaptations-in-apparently-healthy-individuals-100644142","NCT07665632","Polarized Aerobic Training and Vascular Adaptations in Apparently Healthy Individuals","Adaptations of Vascular and Cardiorespiratory Function to a 6-week Polarized Aerobic Training Model in Apparently Healthy Individuals","ACT-ON-CHRONIC","Inclusion Criteria:\n\n* Men and women aged 30-50 years\n* Apparently healthy individuals without diagnosed cardiovascular, metabolic, or renal disease\n* Sedentary lifestyle verified using the Global Physical Activity Questionnaire (GPAQ) and current physical activity classification criteria\n* Ambulatory blood pressure values within the normotensive range (\\\u003C140 mmHg systolic and \\\u003C90 mmHg diastolic)\n* Body mass index (BMI) \\\u003C30 kg\u002Fm²\n* No regular participation in structured exercise training\n\nExclusion Criteria:\n\n* Ambulatory blood pressure values ≥140 mmHg systolic and\u002For ≥90 mmHg diastolic\n* Moderate or high physical activity level according to the Global Physical Activity Questionnaire (GPAQ)\n* Diagnosed chronic cardiovascular, metabolic, renal, respiratory, or other systemic disease\n* Use of prescribed medication influencing cardiovascular or metabolic function\n* Musculoskeletal injury of the lower extremities within the previous six months\n* Menopause\n* Absence of a regular menstrual cycle\n* Pregnancy\n* Current smoking or tobacco use","30 Years","50 Years",{"count":50,"type":22},[135],"This randomized controlled trial will investigate the effects of a 6-week polarized aerobic training intervention on vascular and cardiorespiratory function in apparently healthy sedentary adults aged 30-50 years. Polarized training is characterized by a high proportion of low-intensity aerobic exercise combined with a smaller volume of high-intensity interval exercise, potentially providing complementary haemodynamic and physiological stimuli that support vascular adaptations and cardiovascular health. Although polarized training has been extensively studied in athletic populations, its effects on vascular function in sedentary adults remain insufficiently understood.\n\nThirty participants will be randomly assigned in a 1:1 ratio to either a supervised polarized aerobic training group or a non-exercising control group. The intervention will consist of a 6-week supervised cycle ergometer training program performed three times per week and prescribed according to individual ventilatory thresholds obtained during cardiopulmonary exercise testing. Training sessions will combine low-to-moderate-intensity continuous exercise and high-intensity interval exercise. Participants allocated to the control group will maintain their habitual sedentary lifestyle throughout the study period.\n\nThe primary outcome will be endothelial function assessed by brachial artery flow-mediated dilation. Secondary outcomes will include arterial stiffness assessed by pulse wave velocity, central haemodynamics, microvascular function, cardiorespiratory fitness, skeletal muscle function, pulmonary function, respiratory muscle strength, and circulating biomarkers related to vascular health. Outcome measures will be assessed at baseline and after completion of the 6-week intervention period. The findings of this study may improve understanding of vascular and systemic adaptations to polarized aerobic training and help inform future exercise-based strategies for cardiovascular risk reduction in apparently healthy sedentary adults.",[350],"Sedentary Lifestyle",[352,353,354,355,356],"Polarized training","Vascular function","Flow-mediated dilation","Pulse wave velocity","Randomized controlled trial","2026-06-17",{"date":193,"type":42},{"date":360,"type":22},"2026-05-25",{"date":362,"type":22},"2027-12-20",{"name":364,"class":277},"University of Ljubljana",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":373,"conditions":374,"keywords":376,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":278},"100644103","prediction-of-pancreatogenic-diabetes-after-partial-resection-of-the-pancreas-100644103","NCT07665710","Prediction of Pancreatogenic Diabetes After Partial Resection of the Pancreas","Inclusion Criteria:\n\n* age ≥ 18 years\n* planned partial resection of the pancreas\n* absence of known diabetes before the procedure\n* absence of known borderline basal glycemia before the procedure\n* absence of impaired glucose tolerance before the procedure\n* signed written informed consent\n\nExclusion Criteria:\n\n* known diabetes mellitus before the procedure\n* known borderline basal glycemia before the procedure\n* impaired glucose tolerance before the procedure\n* inability to provide informed consent\n* withdrawal of consent during the course of the study\n* incomplete key data\n* total resection of the pancreas\n* a subsequent decision for conservative treatment (based on clinical characteristics at the time of the surgical procedure)",{"count":372,"type":22},150,"The primary aim of the study is to identify clinical, laboratory, imaging, and pathohistological risk factors for the development of pancreatogenic diabetes after partial resection of the pancreas (PRP) and, based on these, to build a predictive model that would enable reliable and accurate identification of patients who will develop pancreatogenic diabetes. A review of the literature shows that there is currently no validated tool available in clinical practice for identifying patients at risk of this type of diabetes after PRP. Etiological differences between type 2 diabetes and pancreatogenic diabetes often lead to late diagnosis, limiting opportunities for timely intervention. The development of a comprehensive predictive model would contribute to a better understanding of the pathophysiology of pancreatogenic diabetes, enable the identification of patients at risk, facilitate tailored clinical monitoring, and allow the implementation of targeted preventive or therapeutic measures in the perioperative period.\n\nBased on a review of the literature and clinical observations, the investigators formulated the following hypotheses:\n\nH1: Clinical, laboratory, imaging, and pathohistological variables are independently associated with the development of pancreatogenic diabetes after partial pancreatic resection.\n\nH2: A predictive model that allows reliable and accurate identification of patients who will develop pancreatogenic diabetes can be build based on the identified variables (H1).\n\nH3: A comprehensive predictive model in the perioperative period allows more precise identification of patients who will develop pancreatogenic diabetes, and thus more effective risk stratification compared to the use of individual risk factors (variables).\n\nBased on the reviewed literature and our own clinical observations, this constitutes an original contribution to science. The investigators expect that the research will identify key clinical, laboratory, imaging, and pathohistological factors associated with the development of pancreatogenic diabetes after partial pancreatic resection. The development of a clinically useful predictive model that will allow individual risk assessment for the development of pancreatogenic diabetes in patients after partial pancreatic resection is anticipated. A similar comprehensive model has not yet been described in the accessible literature. The research will contribute to a better understanding of metabolic changes and will enable the identification of patients who will develop pancreatogenic diabetes after partial pancreatic resection. The results of the study could provide a basis for improved perioperative monitoring of these patients in the field of pancreatogenic diabetes.",[375],"Pancreatogenic Diabetes Mellitus",[377,378,379,380,381,382],"Partial Pancreatectomy","Pancreatogenic Diabetes","Prediction Model","Pancreas Volume","C-peptide","HOMA-IR",{"date":193,"type":42},{"date":385,"type":42},"2026-04-01",{"date":387,"type":22},"2029-04-01",{"name":389,"class":277},"University Medical Centre Ljubljana",{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":23,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":409,"locationsCount":410},"100548691","phase-3-a-study-to-test-whether-vicadrostat-in-combination-with-empagliflozin-helps-people-with-heart-failure-100548691","NCT06424288","A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure","EASi-HF Preserved - A Phase III Double-blind, Randomised, Parallel-group Superiority Trial to Evaluate Efficacy and Safety of the Combined Use of Oral Vicadrostat (BI 690517) and Empagliflozin Compared With Placebo and Empagliflozin in Participants With Symptomatic Heart Failure (HF: NYHA II-IV) and Left Ventricular Ejection Fraction (LVEF) ≥40%","Inclusion criteria:\n\n1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years\n2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial\n3. Male or female participants. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Conference on Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the participant information\n4. Chronic Heart failure (HF) diagnosed at least 3 months before Visit 1, and in New York Heart Association (NYHA) class II-IV at Visit 1, with left ventricular ejection fraction (LVEF) ≥40% per local reading. A historical LVEF may be used if it was measured within 12 months prior to Visit 1, or the LVEF may be measured after study consent has been obtained and before randomisation at Visit 2\n5. Presence of structural heart abnormality (confirmed by any imaging modality; i.e. echocardiography at Visit 1, as defined by left ventricular hypertrophy or left atrial enlargement). Historical imaging may be used if performed within 12 months prior to Visit 1, or imaging may be completed after study consent has been obtained and before Visit 2\n6. Elevated N-terminal pro-brain natriuretic peptide (NT-proBNP) at Visit 1, analysed at the central laboratory at Visit 1:\n\n   1. in participants with body mass index (BMI) \\\u003C27 kg\u002Fm²: ≥300 pg\u002FmL for participants without atrial fibrillation (Afib) or atrial flutter (Aflutter) (at Visit 1 electrocardiogram (ECG)) and ≥900 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   2. in participants with BMI ≥27 kg\u002Fm² to \\\u003C35 kg\u002Fm²: ≥220 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥660 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n   3. in participants with BMI ≥35 kg\u002Fm²: ≥125 pg\u002FmL for participants without Afib or Aflutter (at Visit 1 ECG) and ≥375 pg\u002FmL for participants with Afib or Aflutter (at Visit 1 ECG)\n7. At least one of the following:\n\n   * Currently treated with diuretic therapy e.g. loop diuretics or thiazides, and on a stable dose for at least 1 week prior to Visit 1\n   * Documented hospitalisation for HF within 6 months prior to Visit 1\n   * Elevated NT-proBNP at Visit 1, analysed at the central laboratory at Visit 1\n\n     * in participants without Afib or Aflutter (at Visit 1 ECG): ≥900 pg\u002FmL\n     * for participants with Afib or Aflutter (at Visit 1 ECG): ≥1800 pg\u002FmL\n   * Urine albumin-to-creatinine ratio (UACR) ≥30 mg\u002Fg, analysed at the central laboratory at Visit 1\n8. Treated according to best possible standard of care (SOC) (disregarding Sodium-dependent glucose co-transporter 2 inhibitors (SGLT2is) and Mineralocorticoid receptor antagonists (MRAs)) in accordance with applicable HF local\u002Finternational guidelines and judgment of the investigator Further inclusion criteria apply.\n\nExclusion criteria:\n\n1. Treatment with an mineralocorticoid receptor antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone) within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator. Treatment with MRA should not be interrupted with the intention of enrolment into the study\n2. Treatment with amiloride, or other potassium-sparing diuretic within 14 days prior to Visit 1 or requiring such treatment before randomisation or planned during the trial based on the judgment of the investigator\n3. Receiving the following treatments:\n\n   * a direct renin inhibitor (e.g. aliskiren) at Visit 2\n   * more than one angiotensin-converting enzyme inhibitor (ACEI), angiotensin receptor blocker (ARB) or angiotensin receptor-neprilysin inhibitor (ARNI) used simultaneously at Visit 2\n   * In case of acute decompensated HF:\n\n     * i.v. inotrope, i.v. vasodilating drug (e.g. nitrate, nitroprusside), or i.v. natriuretic peptide (e.g. nesiritide, carperitide), or mechanical support (e.g. intra-aortic balloon pump, endotracheal intubation, mechanical ventilation, any ventricular assist device) within 24 hours prior to randomisation (Visit 2)\n     * i.v. diuretic with a dose that has been increased\u002Fintensified within 6 hours prior to randomisation (a stable dose of an i.v. diuretic is not exclusionary)\n   * Systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) at Visit 2\n   * Other aldosterone synthase inhibitors, e.g. baxdrostat at Visit 2 or planned during the trial\n4. Myocardial infarction (MI), transient ischemic attack (TIA), stroke, coronary artery bypass graft (CABG) surgery, heart valve surgery\u002Fintervention or any other major surgery (major according to the investigator's assessment) within 90 days prior to Visit 2, or scheduled for major elective surgery (e.g. hip replacement, coronary artery bypass graft surgery\u002FCABG)\n5. Percutaneous coronary intervention (PCI) ( scheduled or unscheduled) or any angiography using iodinated contrast agents in the 7 days prior to Visit 2\n6. Heart transplant recipient, awaiting heart transplant, or currently implanted left ventricular assist device (LVAD)\n7. Known cardiomyopathy based on infiltrative diseases (e.g. amyloidosis), accumulation diseases (e.g. haemochromatosis, Fabry disease), muscular dystrophies, hypertrophic obstructive cardiomyopathy or genetic hypertrophic cardiomyopathy,known pericardial constriction, or cardiomyopathy with potentially reversible cause such as stress or peripartum cardiomyopathy or cardiomyopathy induced by chemotherapy within the 12 months prior to Visit 1 and until Visit 2\n8. Acute inflammatory heart disease, such as acute myocarditis, within the 90 days preceding prior to Visit 1 and until Visit 2\n9. Known severe valvular heart disease (obstructive or regurgitant), as per investigator's judgment, or valvular heart disease scheduled for surgical or invasive procedures at Visit 1, or anticipated invasive treatment during the study Further exclusion criteria apply.",{"count":398,"type":22},6000,[61],"This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure.\n\nParticipants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are:\n\n* Vicadrostat\u002Fempagliflozin group: participants take vicadrostat\u002Fempagliflozin as tablets once a day.\n* Placebo\u002Fempagliflozin group: participants take placebo\u002Fempagliflozin as tablets once a day.\n\nParticipants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being.\n\nThe study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.",[140],"2026-06-12",{"date":404,"type":42},"2026-06-15",{"date":406,"type":42},"2024-06-17",{"date":408,"type":22},"2028-05-22",{"name":247,"class":49},652,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":419,"targetDuration":4,"studyType":23,"phases":421,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":435},"100586793","phase-3-a-study-to-assess-efficacy-and-safety-of-empasiprubart-versus-ivig-in-adults-with-cidp-100586793","NCT06920004","A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP","A Phase 3, Randomized, Double-Blinded, Double-Dummy Study Evaluating the Efficacy and Safety of Intravenous Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy","emvigorate","Inclusion Criteria:\n\n* Meets criteria for CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Has either typical CIDP or 1 of the following CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis-Sumner syndrome), focal CIDP, or distal CIDP\n* Has responded to IVIg in the past 5 years\n* Receiving treatment with IVIg within a standard optimal maintenance dosing regimen, with a minimum weekly IVIg dose of at least 0.125 g\u002Fkg\n* Has residual disability and active disease\n\nExclusion Criteria:\n\n* Besides the indication under study, known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of CIDP or puts the participant at undue risk, including polyneuropathy of other causes\n* Meets the criteria for possible or sensory CIDP based on EAN\u002FPNS Task Force CIDP guidelines, second revision (2021)\n* Use of other long-acting immunomodulatory treatment",{"count":420,"type":22},218,[61],"The main purpose of this study is to compare empasiprubart and IVIg for treating people with CIDP. This study consists of a Part A where participants will either receive empasiprubart and a placebo resembling IVIg, or IVIg and a placebo resembling empasiprubart for 24 weeks (6 months). Following Part A, participants will enter Part B in which all participants will receive empasiprubart for 96 weeks (24 months).\n\nMore information can be found here: https:\u002F\u002Fclinicaltrials.argenx.com\u002Femvigorate",[424,425,426],"Chronic Inflammatory Demyelinating Polyneuropathy","CIDP","CIDP - Chronic Inflammatory Demyelinating Polyneuropathy","2026-06-11",{"date":402,"type":42},{"date":430,"type":42},"2025-08-22",{"date":432,"type":22},"2030-09",{"name":434,"class":49},"argenx",75,{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":23,"phases":446,"briefSummary":447,"conditions":448,"keywords":449,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":457,"leadSponsor":459,"locationsCount":278},"100565373","perceptions-of-rehatt-mixed-reality-system-100565373","NCT06641336","Perceptions of RehAtt Mixed Reality System","Perceptions of Using RehAtt Mixed Reality System in Stroke Motor Rehabilitation","RehAtt","Inclusion Criteria:\n\n* first ischaemic or hemorrhagic stroke,\n* one-sided hemiparesis,\n* adequate cognitive abilities.\n\nExclusion Criteria:\n\n* severe cognitive impairment,\n* aphasia,\n* known presence of an epileptic seizure in the last year,\n* other orthopaedic and neurological diseases affecting sensory or motor functions,\n* inability to sit independently,\n* severe visual impairment,\n* severe depression.",{"count":445,"type":22},10,[135],"The study aims to explore the patients' perspective on usability and feasibility of the RehAtt™ mixed-reality system during upper limb, gait and balance function rehabilitation.",[262],[450,451,452,453],"rehabilitation","mixed reality","motor rehabilitation","patients' perspective",{"date":404,"type":42},{"date":456,"type":42},"2024-10-11",{"date":458,"type":22},"2026-10",{"name":276,"class":277},{"id":461,"slug":462,"hasResults":12,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":466,"eligibilityCriteria":467,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":468,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":469,"conditions":470,"keywords":473,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":479,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":483,"locationsCount":278},"100565659","usability-of-the-smart-hallway-system-in-clinical-setting-100565659","NCT06645054","Usability of the Smart Hallway System in Clinical Setting","Smart Hallway for Gait Assessment","SmartHallway","Inclusion Criteria:\n\n* ability to walk at least 10 metres without help of a person,\n* no severe cognitive problems (able to answer questionnaires),\n* native Slovenian speakers,\n* wiling to participate (signed informed consent)\n\nExclusion Criteria:\n\n* severe cognitive impairment,\n* not being able to walk with or without a prosthesis or orthosis.",{"count":102,"type":22},"The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.",[471,472],"Amputation","Gait Disorders, Neurologic",[474,475,476,477,478],"Gait analysis","Computerised assessment","Rehabilitation","Lower limb loss","Prosthetics and orthotics",{"date":404,"type":42},{"date":481,"type":42},"2024-03-24",{"date":272,"type":22},{"name":276,"class":277},{"id":485,"slug":486,"hasResults":12,"nctId":487,"briefTitle":488,"officialTitle":489,"acronym":490,"eligibilityCriteria":491,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":23,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":501,"startDateStruct":502,"completionDateStruct":504,"leadSponsor":506,"locationsCount":278},"100522999","effectiveness-of-robot-assisted-upper-limb-exercise-in-cervical-sci-100522999","NCT06089915","Effectiveness of Robot-assisted Upper-limb Exercise in Cervical SCI","Assessing Effectiveness of Robot-assisted Upper-limb Exercise in Persons After Cervical Spinal Cord Injury","RVZU","Inclusion Criteria:\n\n* ability to move unloaded upper limbs\n* at least 18 years of age\n* ability to sit for one hour\n* ability to understand the instructions for robot-assisted exercise\n\nExclusion Criteria:\n\n* inability to sit for one hour\n* presence of hospital-acquired infection that requires isolation\n* bodily impairment other than spinal cord injury\n* inability to understand the instructions for robot-assisted exercise",{"count":50,"type":22},[135],"The aim of the project is to test the effectiveness of robot-assisted upper-limb exercise in persons after cervical spinal cord injury. In a randomised controlled two-arm trial, the effect of adding two types of robot-assisted upper-limb exercise to standard occupational therapy will be tested. Three primary and two secondary outcomes will be assessed using well-established measures.",[496],"Cervical Vertebrae Injury",[498,499,500,450],"spinal cord injury","upper limbs","impairment",{"date":404,"type":42},{"date":503,"type":42},"2023-09-01",{"date":505,"type":22},"2026-12",{"name":276,"class":277},{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":513,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":515,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":520,"startDateStruct":521,"completionDateStruct":523,"leadSponsor":525,"locationsCount":278},"100465135","dysphagia-qol-and-attitudes-towards-peg-in-als-patients-100465135","NCT05336760","Dysphagia, QoL and Attitudes Towards PEG in ALS Patients","Dysphagia, Quality of Life and Attitudes Towards Percutaneous Endoscopic Gastrostomy in Patients With Amyotrophic Lateral Sclerosis","ALSDPEG","Inclusion Criteria for patients:\n\n* 18 years of age or older\n* diagnosis of ALS\n* follow-up at University Medical Centre Ljubljana, Division of Neurophysiology, every 3 months\n* be able to visit the study site for in-person procedures every 3 months\n\nInclusion Criteria for relatives:\n\n* at least 18 years of age\n\nExclusion Criteria for patients:\n\n* co-existing illness or disorder that could influence the swallowing function independently of the ALS diagnosis\n* clinically significant cognitive deterioration or dementia at enrollment, as determined by the ALS study neurologist\n\nExclusion criteria for relatives:\n\n* signs of probable cognitive deterioration or dementia at enrollment",{"count":516,"type":22},60,"In Amyotrophic Lateral Sclerosis, dysphagia has a high incidence. With deterioration of swallowing function, percutaneous endoscopic gastrostomy (PEG) tube is recommended to ensure sufficient and safe oral intake. Dysphagia and PEG placement alter quality of life (QoL). However, QoL and attitudes toward PEG remain largely unexplored. The purpose of this study is to monitor the swallowing function in relationship to QoL and attitudes toward PEG tube insertion and feeding.",[519],"Amyotrophic Lateral Sclerosis",{"date":404,"type":42},{"date":522,"type":42},"2023-01-01",{"date":524,"type":22},"2026-09-30",{"name":276,"class":277},{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":23,"phases":536,"briefSummary":537,"conditions":538,"keywords":541,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":550,"locationsCount":278},"100437390","goal-attainment-scaling-in-upper-limb-spasticity-treatment-100437390","NCT04975646","Goal Attainment Scaling in Upper Limb Spasticity Treatment","Goal Attainment Scaling in Upper Limb Spasticity Treatment With Botulinum Toxin and the Influence of Regular Exercise for Spastic Upper Limb on Quality of Life in Patients After Stroke","GASBTX","Inclusion Criteria:\n\n* patient's or caregiver's approval\n* ischemic or hemorrhagic stroke diagnosed using head CT\u002FMRI\n* at least one upper limb muscle spasticity (MAS ≥ 3)\n* candidate for BTX-A treatment or already given BTX-A in the past\n* patient's or caregiver's capability for goal attainment protocol cooperation (Mini Mental Examination ≥ 24 points)\n\nExclusion Criteria:\n\n* aphasic patients without caregiver's presence\n* other neurological or musculoskeletal diseases that could affect the treatment outcome",{"count":535,"type":22},70,[135],"Patients after stroke with upper limb spasticity treated with botulinum toxin-A (BTX-A) will be included in this two-part study. In the first part, goal attainment scaling and comprehensive assessment of motor functioning will be performed before BTX-A application and after two weeks. In the second part, the patients will be randomised into a test group performing prescribed regular exercise for two weeks and a control group exercising at their own discretion during the same period, whereby the patients' health-related quality of life will be assessed at the beginning and end of the two-week period.",[539,540],"Ischemic Stroke","Hemorrhagic Stroke",[450,542,543,544,545],"spasticity","botulinum toxin A","goal setting","spasticity-related quality of life",{"date":404,"type":42},{"date":548,"type":42},"2021-01-03",{"date":458,"type":22},{"name":276,"class":277},{"id":552,"slug":553,"hasResults":12,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":561,"conditions":562,"keywords":566,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":278},"100368519","urinary-disorders-in-subacute-patients-after-stroke-100368519","NCT04078373","Urinary Disorders in Subacute Patients After Stroke","Assessment and Treatment of Urinary Disorders in Patients in the Subacute Phase After Stroke","UIMK","Inclusion Criteria:\n\n* subacute patients after ischaemic or hemorrhagic stroke;\n* direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.\n\nExclusion Criteria:\n\n* incontinence before stroke;\n* previous brain injury or other brain disease;\n* previous bladder or prostate surgery;\n* inability to ambulate before stroke;\n* terminal disease with expected survival less than three months.",{"count":560,"type":22},250,"This observational study will address urinary disorders in subacute stroke patients. Patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.",[563,564,565],"Stroke, Ischemic","Stroke Hemorrhagic","Urinary Incontinence",[567,568,569,570],"stroke","inpatient rehabilitation","urinary disorders","treatment",{"date":404,"type":42},{"date":573,"type":42},"2019-06-01",{"date":458,"type":22},{"name":276,"class":277},{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":581,"acronym":4,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":583,"minAge":18,"maxAge":4,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":586,"briefSummary":587,"conditions":588,"keywords":591,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":614},"100596352","phase-3-puxitatug-samrotecan-azd8205-monotherapy-vs-chemotherapy-in-b7-h4-selected-endometrial-cancer-bluestar-endometrial01-100596352","NCT07044336","Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4-selected Endometrial Cancer (Bluestar-Endometrial01)","Puxitatug Samrotecan (AZD8205) Monotherapy vs Chemotherapy in B7-H4 Selected Advanced\u002FMetastatic Endometrial Cancer Who Progressed On or After Platinum Based Chemotherapy and Anti-PD-1\u002FAnti-PD-L1 Therapy (Bluestar-Endometrial01)","The main inclusion criteria include but are not limited to the following:\n\n* Histologically confirmed diagnosis of endometrial carcinoma or carcinosarcoma.\n* Recurrent\u002Fmetastatic EC ie, with radiological or objective evidence of recurrence or progression.\n* Has received prior platinum-based chemotherapy and anti-programmed cell death 1 protein (PD-1)\u002Fanti- programmed cell death ligand 1 (PD-L1) therapy, either separately or in combination.\n* A WHO\u002FECOG performance status of 0 or 1 at Screening.\n* Has radiographically measurable disease by RECIST 1.1\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Had uterine sarcomas or uterine neuroendocrine carcinoma.\n* Has had a recurrence of endometrial carcinoma or carcinosarcoma more than \\> 12 months after completing platinum-based therapy administered in the curative-intent setting without any additional platinum-based therapy received in the recurrent setting.\n* Had previously received treatment with any therapy (approved or investigational) that contained a TOP1i including ADCs .\n* Had previously received treatment with Puxi-Sam or another B7-H4 targeting agent.\n* History of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.\n* Active or previously documented autoimmune or inflammatory disorders","FEMALE",{"count":585,"type":22},800,[61],"This is a Phase III, 2-arm, randomized, open label, multicenter, global study assessing the efficacy and safety of puxitatug samrotecan compared to physician's choice of chemotherapy (doxorubicin or paclitaxel) in participants with B7-H4 selected advanced\u002Fmetastatic EC that progressed following platinum based chemotherapy and anti-PD-1\u002Fanti-PD-L1 therapy.",[589,590],"Endometrial Cancer","Malignant Solid Tumour",[592,593,594,595,596,597,598,589,599,600,601,602,603,604],"Bluestar-Endometrial01","AZD8205","Puxitatug Samrotecan","Puxi-Sam","Platinum-based chemotherapy","B7-H4","advanced\u002Fmetastatic","Anti-PD-1","Anti-PD-L1","antibody-drug conjugate","Topoisomerase 1 Inhibitors","uterine neoplasm","female urogenital neoplasm","2026-06-09",{"date":607,"type":42},"2026-06-10",{"date":609,"type":42},"2025-08-01",{"date":611,"type":22},"2029-07-17",{"name":613,"class":49},"AstraZeneca",317,{"id":616,"slug":617,"hasResults":12,"nctId":618,"briefTitle":619,"officialTitle":620,"acronym":4,"eligibilityCriteria":621,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":622,"targetDuration":4,"studyType":23,"phases":624,"briefSummary":625,"conditions":626,"keywords":627,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100595454","phase-2-imeroprubart-in-adult-participants-with-chronic-inflammatory-demyelinating-polyneuropathy-cidp-100595454","NCT07032662","Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 2b, Multi-center, Randomized, Double-blind, Placebo-controlled Study of IMVT-1402 Treatment in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","Inclusion Criteria:\n\n* Have met clinical diagnostic criteria for typical CIDP or one of the following CIDP variants: multifocal CIDP or motor CIDP per the 2021 European Academy of Neurology\u002FPeripheral Nerve Society (EAN\u002FPNS) Guideline on Diagnosis and Treatment of CIDP.\n* Have electrodiagnostic test results supporting the diagnosis of CIDP per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Are currently on, and have been receiving chronic, stable doses of systemic corticosteroids (i.e., daily or every other day oral or pulse regimen), or immunoglobulin therapy (IVIg or SCIg) ± low dose oral corticosteroids for at least 3 months for the treatment of CIDP at the time of the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have current or prior history of IgM paraproteinemia with or without anti-myelin-associated-glycoprotein antibodies.\n* Have distal, sensory, or focal CIDP, or have a diagnosis of autoimmune nodopathy per the EAN\u002FPNS guideline on diagnosis and treatment of CIDP.\n* Have polyneuropathy of causes other than CIDP including but not limited to:\n\n  * Multifocal motor neuropathy\n  * Hereditary demyelinating neuropathy\n  * Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes (i.e., POEMS)\n  * Lumbosacral radiculoplexus neuropathy\n  * Systemic illnesses including vitamin deficiency syndromes and paraneoplastic neuropathies\n  * Drug- or toxin-induced\n* Have diabetes mellitus (DM) and meets any of the following criteria:\n\n  * Does not have both typical CIDP and strong evidence of demyelination on nerve conduction study.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM preceding the diagnosis of CIDP.\n  * In the opinion of the Investigator, there is evidence of poorly controlled DM at screening.\n* Have a history of myelopathy or evidence of central demyelination. Additional exclusion criteria are defined in the protocol.",{"count":623,"type":22},162,[25],"This is a Phase 2b study to evaluate the efficacy and safety of Imeroprubart in adults with CIDP.",[424],[424,628,629,630,425,631],"IMVT-1402","Monoclonal antibody","Human immunoglobulin G1 (IgG1)","Imeroprubart","2026-06-05",{"date":634,"type":42},"2026-06-08",{"date":636,"type":42},"2025-03-18",{"date":638,"type":22},"2030-05",{"name":640,"class":49},"Immunovant Sciences GmbH",135,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":647,"acronym":4,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":164,"phases":4,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":655,"startDateStruct":656,"completionDateStruct":658,"leadSponsor":660,"locationsCount":662},"100568407","a-real-world-study-to-gain-clinical-insights-into-faricimab-fareal-study-100568407","NCT06680817","A Real-World Study to Gain Clinical Insights Into Faricimab (FaReal Study)","Real-World, Long-Term Data Collection to Gain Clinical Insights Into Faricimab (FaReal Study)","Inclusion Criteria:\n\n* Patients receiving faricimab according to the local faricimab product label and who have initiated treatment with faricimab at time of the ICF signature date or no more than 3 months prior to the ICF signature date, in diabetic macular edema (DME) or neovascular age-related macular degeneration (nAMD) in at least one eye\n* Patients have received at least one faricimab treatment (the first dose) in the study eye\n* Patients should have available data for visual acuity (VA) and Central Subfield Thickness (CST) for the Baseline level (i.e. examinations to be performed at the index date or within 4 months prior to it)\n\nExclusion Criteria:\n\n* Patient participation in any investigational ophthalmology clinical trial that includes receipt of any ophthalmological investigational drug or procedure within the last 28 days prior to the ICF signature date\n* Concomitant participation in any interventional clinical study\n* Active ocular inflammation and\u002For suspected\u002Factive ocular infection in either eye\n* Patients treated with faricimab who have and are currently participating in patient support programs (PSP) that are Market Research and Patient Support Programs (MAP) including Post Trial Access Programs (PTAP) and Compassionate Use Programs (CUP)\n* Patients with non-ocular sight threatening disease which have an effect on the primary endpoint (e.g., apoplexia)\n* Hypersensitivity to the active substance or any of the excipients of Vabysmo (as per label)",{"count":650,"type":22},850,"The FaReal study aims to evaluate the effectiveness, safety, clinical insights and treatment patterns in patients treated with faricimab, in neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in at least one eye, in real-world routine clinical practice over a 2-year patient follow-up period. Additionally, the FaReal study also aims to describe and evaluate health economic aspects of previous anti-VEGF treatments and current treatment with faricimab.",[653,654],"Neovascular Age-related Macular Degeneration","Diabetic Macular Edema",{"date":605,"type":42},{"date":657,"type":42},"2025-02-05",{"date":659,"type":22},"2028-06-30",{"name":661,"class":49},"Hoffmann-La Roche",59,{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":583,"minAge":18,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":23,"phases":674,"briefSummary":675,"conditions":676,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":678,"lastUpdatePostDateStruct":679,"startDateStruct":680,"completionDateStruct":682,"leadSponsor":684,"locationsCount":686},"100550636","phase-3-a-study-of-nipocalimab-in-reducing-the-risk-of-fetal-and-neonatal-alloimmune-thrombocytopenia-fnait-100550636","NCT06449651","A Study of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT)","Double-blind, Randomized, Placebo-controlled Study Evaluating the Safety and Efficacy of Nipocalimab in Reducing the Risk of Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) in At-risk Pregnancies","FREESIA-1","Inclusion Criteria:\n\n* Pregnant and an estimated gestational age (GA; based on ultrasound dating) from Week 13 to 18 at randomization\n* Has a history of greater than or equal to (\\>=) 1 prior pregnancy with fetal and neonatal alloimmune thrombocytopenia (FNAIT) (including neonatal platelet count less than (\\\u003C) 150×10\\^9\u002FLiter) with none of them affected by fetal\u002Fneonatal intracranial hemorrhage (ICH) or severe hemorrhage based on medical records\n* Current pregnancy with presence of maternal anti- human platelet antigen (HPA)-1a alloantibody and positive fetal HPA-1a genotype as confirmed by cell-free fetal deoxyribonucleic acid (DNA) in maternal blood\n* Health status considered stable by the investigator based on physical examination, medical history, vital signs, 12-lead Electrocardiogram (ECG), and clinical laboratory tests performed at screening\n* For maternal participant and neonate\u002Finfant, willing to forego participation in another clinical study of an investigational therapy until the last follow-up visit\n\nExclusion Criteria:\n\n* Currently pregnant with multiple gestations (twins or more)\n* History of severe preeclampsia in a previous pregnancy\n* History of myocardial infarction, unstable ischemic heart disease, or stroke\n* Known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients (refer to the Investigator Brochure (IB))\n* Has any confirmed or suspected clinical immunodeficiency syndrome or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant","45 Years",{"count":673,"type":22},39,[61],"The purpose of this study is to evaluate the effectiveness of nipocalimab compared with placebo in reducing the risk of severe fetal and neonatal alloimmune thrombocytopenia (FNAIT).",[677],"Thrombocytopenia, Neonatal Alloimmune","2026-06-04",{"date":632,"type":42},{"date":681,"type":42},"2024-11-11",{"date":683,"type":22},"2029-12-05",{"name":685,"class":49},"Janssen Research & Development, LLC",21,""]