[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical University of Silesia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":556},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,39,71,100,132,163,191,222,247,281,309,344,371,405,431,453,472,496,523],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100637416","dietary-intervention-and-physical-activity-in-patients-with-heart-failure-and-reduced-ejection-fraction-100637416",false,"NCT07595809","Dietary Intervention and Physical Activity in Patients With Heart Failure and Reduced Ejection Fraction","Inclusion Criteria:\n\nWritten informed consent obtained prior to participation Age \\>30 years Diagnosis of chronic heart failure, NYHA functional class I-III Left ventricular ejection fraction \\\u003C40%\n\nExclusion Criteria:\n\nNYHA functional class IV heart failure Potentially reversible cause of heart failure Estimated glomerular filtration rate \\\u003C30 mL\u002Fmin Severe anemia (hemoglobin \\\u003C9 g\u002FdL) Uncontrolled thyroid disease Severe hepatic dysfunction History of hyperkalemia or hyperkalemia at baseline Epilepsy Presence of joint endoprostheses Gastrointestinal disorders limiting adherence to the DASH diet Physical limitations precluding participation in structured exercis","ALL","30 Years",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","Heart failure with reduced ejection fraction (HFrEF) is frequently associated with abnormalities in body composition, including reduced skeletal muscle mass and sarcopenia, which are independent predictors of reduced exercise tolerance, impaired quality of life, and increased mortality. Despite advances in pharmacological therapy, evidence-based non-pharmacological strategies aimed at preventing muscle mass loss remain limited.\n\nThis randomized controlled trial aims to evaluate the effects of dietary intervention based on the DASH diet with high-protein elements, resistance exercise training, and their combination on skeletal muscle mass, functional capacity, echocardiographic parameters, biochemical markers, and quality of life in patients with HFrEF.",[25],"Heart Failure With Reduced Ejection Fraction","RECRUITING","2026-05-13",{"date":29,"type":30},"2026-05-19","ACTUAL",{"date":32,"type":30},"2023-05-08",{"date":34,"type":19},"2027-04",{"name":36,"class":37},"Medical University of Silesia","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":20,"phases":50,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":38},"100614392","photobiomodulation-photodynamic-therapy-and-clobetasol-in-the-treatment-of-oral-lichen-planus-100614392","NCT07278999","Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of Oral Lichen Planus.","Effectiveness of Photobiomodulation, Photodynamic Therapy, and Clobetasol in the Treatment of the Erosive Form of Oral Lichen Planus - a Randomized Clinical Trial.","Inclusion Criteria:\n\n* Be between 20 and 70 years old.\n* Have histologically confirmed erosive or ulcerative oral lichen planus based on a biopsy.\n* Have no active aerobic bacterial infection or oral fungal infection.\n* Have had no treatment for OLP within the past 3 months.\n* Provide written informed consent.\n\nExclusion Criteria:\n\n* Systemic diseases or conditions such as uncontrolled diabetes (random glucose ≥200 mg\u002Fdl), cardiovascular failure, or a pacemaker.\n* Autoimmune\u002Fconnective tissue diseases such as lupus with positive ANA testing.\n* Current or past cancer, graft-versus-host disease, or hematologic disorders (anemia, leukemia, lymphoma, bleeding disorders, hemophilia, von Willebrand disease).\n* Enzymatic or metabolic disorders such as G6PD deficiency (favism) or porphyria.\n* Viral hepatitis A, B, or C.\n* Recent vaccinations (within the past 6 months).\n* Use of medications known to trigger lichenoid reactions, including:\n* Antihypertensives (beta-blockers, diuretics, ACE inhibitors, centrally acting agents).\n* Oral antidiabetics (sulfonylureas).\n* Metal-containing compounds (lithium, gold, arsenic, mercury).\n* NSAIDs (e.g., ibuprofen).\n* Antibiotics\u002Fchemotherapeutics (tetracyclines, sulfonamides).\n* Pregnancy or breastfeeding (including up to 6 months post-lactation).\n* Photosensitivity to UV light.\n* Smoking more than 5 cigarettes per day.\n* Lesions located adjacent to amalgam fillings or metal prosthetic restorations.\n* Any degree of dysplasia on histopathology.\n* Treatment for OLP within the last 3 months.\n* Active oral fungal or bacterial infection at screening.\n* Lack of consent to participate.","20 Years","70 Years",{"count":49,"type":19},60,[22],"This study aims to compare three treatment approaches for the erosive form of oral lichen planus, a chronic inflammatory condition that often causes pain, impaired oral function, and frequent relapses. Sixty adults with a confirmed diagnosis will be randomly assigned to photobiomodulation, Photodynamic Therapy, or topical clobetasol, which serves as the current standard of care. The project investigates how effectively each method promotes healing of erosive lesions, reduces pain, improves oral functions such as chewing and swallowing, and prevents recurrence after treatment. Before enrollment, participants will undergo microbiological testing, tissue autofluorescence assessment, and histopathological confirmation. Treatment will follow strict protocols tailored to each therapy type, with PBM applied twice weekly, PDT administered once weekly for six consecutive weeks using toluidine blue as a photosensitizer activated by a 635 nm diode laser, and clobetasol used twice daily for thirty days. Clinical outcomes will be measured using lesion size, standardized scoring systems, and patient-reported scales for pain and swelling. Follow up at one week, one month, and three months will document healing progress and relapse rates. Safety monitoring includes evaluation for infections and adverse reactions. The expected outcome is to determine which therapy provides the most effective, safe, and durable improvement. The study may offer evidence supporting laser based methods as alternatives that avoid the risks associated with long term steroid use.",[53,54,55],"Oral Lichen Planus","Erosive Lichen Planus","Mucosal Lesions",[57,58,59,60,61,62],"Oral lichen planus","lichen planus","laser","Photobiomodulation therapy","steroids","PDT","2026-04-24",{"date":65,"type":30},"2026-04-30",{"date":67,"type":30},"2025-12-01",{"date":69,"type":19},"2026-11",{"name":36,"class":37},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":79,"targetDuration":81,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":4},"100634455","alternative-peripheral-tavi-accesses-100634455","NCT07539909","Alternative Peripheral TAVI Accesses","The APTA (Alternative Peripheral TAVI Accesses) Registry.","APTA","Inclusion Criteria:\n\n* Males or females qualified by the \"heart team\" for TAVI procedure, without the possibility of using femoral access.\n* Possibility of TAVI procedure with peripheral access after multi-slice computed tomography analysis.\n\nExclusion Criteria:\n\n* No significant aortic stenosis\n* Cancer with a short expected survival period\n* No qualifications for TAVI",{"count":80,"type":19},600,"6 Months","OBSERVATIONAL","The APTA (Alternative Peripheral TAVI Accesses) registry is an observational multi-center, retrospective and prospective study, including high and medium - risk patients with aortic stenosis (AS) contraindicates for trans-femoral TAVI, treated with TAVI thought to peripheral accesses. Upper Silesian Medical Center, Katowice and the other hospitals will be involved in the study.",[85],"Aortic Stenosis",[87,88,89,90],"trancarotid-TAVI","transaxillary-TAVI","aortic stenosis","alternative accesses","NOT_YET_RECRUITING","2026-04-18",{"date":94,"type":30},"2026-04-23",{"date":96,"type":19},"2026-04-15",{"date":98,"type":19},"2026-07-01",{"name":36,"class":37},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":20,"phases":111,"briefSummary":112,"conditions":113,"keywords":119,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100633062","remote-ecg-monitoring-post-tavi-100633062","NCT07521800","Remote ECG Monitoring Post TAVI","Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.","DRAGON-TAVI","Inclusion Criteria:\n\n* Patient age over 18 years old\n* Severe aortic stenosis\n* Moderate or high cardiovascular risk based on current ESC Guidelines \"Heart Team\" qualification for TAVI\n* Written informed consent of the patient for participation in the study\n\nExclusion Criteria:\n\n* History of atrial fibrillation or atrial flutter\n* Previously known conduction disturbances\\*\\*\n* Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI\n* Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification\n* Haemorrhagic stroke within 1 year before TAVI qualification\n* Chronic immunosuppressive therapy\n* Comorbidities (e.g. drug addiction, alcohol abuse, emotional\u002Fmental disorders) which do not allow safe participation in the study","18 Years",{"count":110,"type":19},250,[22],"The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.",[114,115,116,117,118],"TAVI(Transcatheter Aortic Valve Implantation)","Remote Monitoring","Arrythmia","Atrial Fibrillation (AF)","Atrioventricular Block",[120,121,122],"TAVI","ECG","Monitoring","2026-04-07",{"date":125,"type":30},"2026-04-13",{"date":127,"type":30},"2023-12-01",{"date":129,"type":19},"2028-02-01",{"name":36,"class":37},4,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":20,"phases":143,"briefSummary":145,"conditions":146,"keywords":149,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},"100532428","phase-4-single-stage-pulmonary-vein-isolation-combined-with-percutaneous-left-atrial-appendage-occluder-implantation-in-patients-with-recent-onset-ischemic-stroke-and-atrial-fibrillation-100532428","NCT06212674","Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation","Single-stage Pulmonary Vein Isolation Combined With Percutaneous Left Atrial Appendage Occluder Implantation in Patients With Recent Onset Ischemic Stroke and Atrial Fibrillation (PILOS-AF)","PILOS-AF","Inclusion Criteria:\n\n1. Ischemic stroke within 2-12 weeks after randomization with or without reperfusion therapy, confirmed by imaging studies (CT or MRI) that led to mild to moderate psychomotor dysfunction (mRS 0-3; NIHSS \\\u003C16 points) and was treated with early neurological rehabilitation or was exempt from neurological rehabilitation on account of excellent psychomotor function. An obligatory criterion is persistence of symptoms for \\>24 h.\n2. Diagnosis of paroxysmal or persistent atrial fibrillation on the basis of 12-lead ECG recording, ECG Holter monitoring, event-recorder or loop recorder at any time, but before the screening visit.\n3. CHA2DS2-VA risk score ≥2 points\n4. Left atrial anatomy (atrial septum, pulmonary vein orifices and left atrial appendage) suitable for intervention (PVI + LAAO or LAAO)\n5. ≥ 4 weeks of adequate anticoagulant treatment in the preceding period\n6. no anatomical or functional contraindications and patient consent for transesophageal echocardiography (TEE)\n\nBased on the aforementioned inclusion criteria, patients who can be classified into 3. groups will be enrolled in the study:\n\n1. patients with atrial fibrillation who have been adequately treated with anticoagulation (VKA\u002FNOAC) and have had an ischemic stroke\n2. patients without prior history of atrial fibrillation and without anticoagulation who have an ischemic stroke and the atrial fibrillation is clinically overt (de novo)\n3. patients without a prior history of atrial fibrillation, with an initial diagnosis of so-called cryptogenic stroke, in whom further initial ECG monitoring allowed for the detection of clinically silent atrial fibrillation\n\nExclusion Criteria:\n\n* current participation in another clinical trial\n* lack of informed written consent to participate in the study\n* age \\\u003C18 or \\>80 years\n* indication for chronic anticoagulant treatment independent of AF:\n\n  1. history of mechanical valve implantation\n  2. history of mitral biological valve implantation within 3 months prior to randomization\n  3. history of deep vein thrombosis or pulmonary embolism within preceding 6 months or indication for chronic anticoagulation\n  4. genetically or immunologically confirmed thrombophilia\n* contraindications to NOAC treatment:\n\n  1. eGFR ≤15 ml\u002Fmin\u002F1.73 m2\n  2. mechanical valve prosthesis\n  3. moderate or severe mitral valve stenosis of rheumatic etiology\n  4. life-threatening bleeding during NOAC therapy\n* Ischemic stroke of etiology other than AF, including cryptogenic stroke without evidence of AF etiology\n* valvular AF: presence of moderate to severe aortic stenosis of rheumatic etiology\n* permanent AF\n* persistent long-standing AF (\\>1 year)\n* presence of a thrombus in the left atrial appendage on TEE examination\n* significant psychomotor dysfunction defined as a modified Rankin Scale (mRS) score of 4-6 or NIHSS score ≥16\n* major bleeding as defined by ISTH within 14 days prior to randomization or intracranial bleeding ever\n* active hyperthyroidism\n* history of myocardial infarction with or without intervention within 90 days prior to randomization\n* history of PVI or LAAO implantation\n* history of surgical closure of left atrial appendage\n* history of percutaneous or surgical ASD\u002FPFO closure\n* acute or chronic pericarditis\n* cardiac tamponade\n* lack of vascular access for PVI and LAAO implantation\n* chronic heart failure in NYHA functional class IV\n* left ventricular ejection fraction (LVEF) \\\u003C30%\n* chronic kidney disease stage IV-V (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2)\n* Child-Pugh class B or C chronic liver failure\n* severe valvular heart defect\n* body mass index (BMI, body mass index) ≥40 kg\u002Fm2\n* woman in her childbearing years planning a pregnancy\n* pregnancy or lactation period\n* documented life expectancy \\\u003C 4 years\n* active cancer \\\u003C 5 years after remission\n* active infection, defined as CRP \\>30 mg\u002FdL with symptoms of respiratory, urinary or gastrointestinal tract infection","75 Years",{"count":142,"type":19},240,[144],"PHASE4","The project is a multicenter, open-label, randomized medical experiment, which was designed to evaluate the efficacy and safety of single-stage pulmonary vein isolation (PVI) and implantation of left atrial appendage occluder (LAAO) in comparison with either isolated LAAO implantation or chronic therapy with non-vitamin K antagonists anticoagulants (NOAC) in patients with recent-onset ischemic stroke and atrial fibrillation (AF). Based on former randomized controlled trials, percutaneous implantation of LAAO was shown to be non-inferior to vitamin K antagonists (VKA), but according to guidelines the use of LAAO is recommended only in patients with absolute contraindication to chronic anticoagulation therapy. PVI constitutes an acknowledged rhythm control management strategy in patients with paroxysmal and persistent AF, which leads to symptomatic relief in about 60% of treated patients, however, its beneficial effect on long-term outcome was demonstrated only in patients with heart failure with reduced ejection fraction. The feasibility and compatibility of both interventions performed as a combined single-stage procedure are warranted by common vascular access via transseptal puncture, which may lead to reduction of procedural cost and shortened overall duration of both interventions. Taking into consideration the preliminary registry data, the combined single-stage PVI and LAAO implantation are thought to be a safe procedure in patients with a high risk of recurrent ischemic stroke and cardiovascular death.\n\nThe study will comprise 240 patients who were diagnosed with ischemic stroke within preceding 2-12 weeks, with confirmed paroxysmal or persistent AF and low-to-moderate psychomotor dysfunction in the course of cerebral incident, who completed early neurological rehabilitation and are characterized by high risk of ischemic stroke recurrence (CHA2DS2-VA score ≥2 pts) and who received adequate oral anticoagulation therapy (NOAC\u002FVKA) for ≥4 weeks. After exclusion of thrombus and potential anatomical contraindications to the procedure on transesophageal echocardiography, patients will be randomized in 1:1:1 ratio to study group A treated with combined single-stage PVI + LAAO implantation during 3-day hospitalization or to group B treated with LAAO implantation or control group subject to chronic therapy with NOAC.\n\nPatients in Group A and B will be treated with NOAC until 3 months after procedure. At 3-month visit patients in Group A and B will undergo transesophageal echocardiography so as to confirm procedural success and allow for termination of chronic anticoagulation therapy. If device-related thrombus is excluded and not peri-device leak \\>=5 mm is present, the patients will be switched from NOAC to aspirin 1x75 mg daily until the end of the trial.\n\nThe duration of active enrollment phase will be 12 months. Subsequent follow-up phase will include scheduled outpatient visits (at 3, 12, 48 months) and phone call interview (at 6, 18, 24, 36 months) in order to evaluate the occurrence of clinical and safety endpoints, medical symptoms and signs, quality of life reflected by structured questionnaire, the presence of AF on 24, 7-day or 30-day ECG monitoring (at 12 and 48 months).\n\nFollow-up visits will also include blood laboratory tests analysis, including biomarkers of heart failure and left atrial wall stress, as well as transthoracic echocardiography with tissue Doppler imaging and strain imaging.\n\nCo-primary composite endpoint will comprise cardiovascular death, ischemic stroke, transient ischemic attack, systemic arterial embolism and major non-procedural bleeding, including intracranial bleeding (non-inferiority).\n\nThe current project was based on the preliminary results of nonrandomized studies, which delivered evidence for feasibility of combined single-stage PVI and percutaneous left atrial appendage closure and laid ground for future randomized controlled trials. It is expected that the proposed intervention will be non-inferior in terms of composite cerebrovascular events and superior in terms of major nonprocedural bleeding in comparison to chronic NOAC therapy.",[147,148],"Ischemic Stroke","Atrial Fibrillation",[150,151,152,138,153,154,155],"Pulmonary vein isolation","Occluder implantation","PILOS","LAA ocludder implantation","ischemic stroke","atrial fibrillation",{"date":125,"type":30},{"date":158,"type":30},"2025-10-31",{"date":160,"type":19},"2030-10-31",{"name":36,"class":37},2,{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":4,"eligibilityCriteria":169,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":140,"enrollmentInfo":170,"targetDuration":4,"studyType":20,"phases":172,"briefSummary":173,"conditions":174,"keywords":179,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":4},"100626345","phase-4-comparison-of-the-efficacy-and-safety-of-intravenous-buprenorphine-administered-via-pca-system-versus-oxycodone-in-the-management-of-postoperative-pain-after-video-assisted-thoracoscopic-surgery-100626345","NCT07434427","Comparison of the Efficacy and Safety of Intravenous Buprenorphine Administered Via PCA System Versus Oxycodone in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery","Comparison of the Efficacy and Safety of Intravenous Buprenorphine Administered Via PCA System Versus Oxycodone in the Management of Postoperative Pain After Video-Assisted Thoracoscopic Surgery - A Prospective, Randomized Clinical Trial","Inclusion Criteria:\n\n* qualification for elective thoracic surgery performed using the VATS technique, physical status ASA I-III, anticipated use of PCA in the postoperative period, patient's consent to participate in the study.\n\nExclusion Criteria:\n\n* inability to provide informed consent,\n* hypersensitivity to opioids or study medications,\n* chronic opioid therapy,\n* previously diagnosed chronic pain,\n* chronic use of analgesic medications,\n* disorders of consciousness preventing appropriate use of the PCA pump,\n* severe renal or hepatic insufficiency,\n* pregnancy or breastfeeding,\n* clinically relevant drug interactions (rifampicin, carbamazepine, CYP3A4 inhibitors).",{"count":171,"type":19},200,[144],"The goal of this clinical trial is to learn whether intravenous buprenorphine administered via a patient-controlled analgesia (PCA) system provides effective and safer postoperative pain control than intravenous oxycodone PCA in adults undergoing video-assisted thoracoscopic surgery (VATS). It will also evaluate the overall tolerability of buprenorphine in the early postoperative period and explore longer-term pain outcomes. The main questions it aims to answer are:\n\nDoes buprenorphine PCA provide pain control that meets predefined targets during the first 48 hours after VATS (both at rest and during respiratory rehabilitation\u002Fmobilization), compared with oxycodone PCA? Does buprenorphine PCA reduce clinically relevant respiratory safety events (e.g., apnea or oxygen desaturation requiring intervention) and excessive sedation, compared with oxycodone PCA? What opioid-related adverse effects (e.g., nausea\u002Fvomiting, pruritus, constipation, hypotension) occur with buprenorphine PCA versus oxycodone PCA? Does buprenorphine PCA affect time to first patient-initiated analgesic demand and total opioid consumption within 48 hours? Does the choice of PCA opioid influence quality of recovery and the incidence of persistent postoperative pain at follow-up?\n\nResearchers will compare buprenorphine PCA to oxycodone PCA (both as part of standardized multimodal analgesia and perioperative care, including serratus anterior plane block) to determine whether buprenorphine provides non-inferior analgesia with a superior safety profile.\n\nParticipants will:\n\nBe randomly assigned (double-blind) to receive buprenorphine PCA or oxycodone PCA for 48 hours after surgery, alongside standard multimodal analgesia Receive standardized general anesthesia for VATS with one-lung ventilation and an ultrasound-guided serratus anterior plane block at the end of surgery Have pain scores (NRS) recorded at multiple time points over 48 hours, at rest and during rehabilitation, and complete recovery questionnaires (QoR-15) early after surgery Be monitored regularly for vital signs, sedation level (RASS), respiratory events, and other adverse effects, with total opioid use recorded Provide satisfaction ratings at discharge and be followed after discharge to assess persistent postoperative pain\u002Fhyperalgesia at 1, 3, and 6 months",[175,176,177,178],"Acute Postoperative Pain","Chronic Postoperative Pain","Toracosurgery","Video-assisted Thoracis Surgery (VATS)",[180,181,182],"pain","acute postoperative pain","chronic postoperative pain","2026-02-20",{"date":185,"type":30},"2026-02-25",{"date":187,"type":19},"2026-02",{"date":189,"type":19},"2027-11",{"name":36,"class":37},{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":20,"phases":202,"briefSummary":203,"conditions":204,"keywords":209,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":38},"100614681","evaluation-of-the-efficacy-of-subgingival-application-of-lovastatin-gel-as-an-adjunct-to-non-surgical-treatment-of-periodontitis-in-generally-healthy-smokers-and-non-smokers-patients-in-central-europe-100614681","NCT07282756","Evaluation Of The Efficacy Of Subgingival Application Of Lovastatin Gel As An Adjunct To Non-Surgical Treatment Of Periodontitis In Generally Healthy Smokers And Non-Smokers Patients in Central Europe.","Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.","RCT","Inclusion Criteria:\n\n* generally healthy patients\n* diagnosed periodontal disease (at least one pair of non-adjacent sites with PD≥5 mm or CAL ≥4 mm and vertical bone loss ≥ 3 mm)\n* no history of periodontal disease treatment\n* no history of antibiotic use in the past 6 months\n* an eligible tooth must be alive, with no history of endodontic treatment\n* non-smoking (group I) or active smokers (group 2)\n\nExclusion Criteria:\n\n* Statin allergy\n* receiving systemic statin therapy,\n* alcoholics\n* immunocompromised patients\n* pregnant or breastfeeding women.","59 Years",{"count":201,"type":19},44,[22],"The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing).\n\nThe study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant:\n\n* a gel containing the medication will be applied under the gum of one tooth\n* a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth.\n\nBefore applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working.\n\nThe study will last six months.\n\nExpected results:\n\n* all participants will experience an improvement in the condition of their gums after treatment\n* the effect of treatment will be better in non-smokers than in smokers\n* the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.",[205,206,207,208],"Periodontal Diseases","Periodontitis","Periodontal Disease","Smokers",[210,211,212,213,214],"periodontitis","statins","lovastatin","smoking","periodontal disease","2026-02-18",{"date":183,"type":30},{"date":218,"type":30},"2025-07-11",{"date":220,"type":19},"2026-12",{"name":36,"class":37},{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":4,"eligibilityCriteria":228,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":140,"enrollmentInfo":229,"targetDuration":4,"studyType":20,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100583568","phase-4-comparing-the-safety-and-effectiveness-of-different-doses-of-morphine-administered-in-spinal-anethesia-for-pain-relief-after-hip-replacement-surgery-100583568","NCT06878014","Comparing the Safety and Effectiveness of Different Doses of Morphine Administered in Spinal Anethesia for Pain Relief After Hip Replacement Surgery","Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.","Inclusion Criteria:\n\n* Informed consent to participate in trial\n* Qualification for total hip replacement surgery\n* ASA physical status I-III\n* BMI 19-30\n* Lack of contraindications for drugs and interventions used in trial\n\nExclusion Criteria:\n\n* Incapability to provide informed consent\n* Contraindications for spinal anesthesia\n* Preoperative chronic pain\n* Chronic use of analgesics\n* Obesity (BMI\\>30)\n* Allergies and other contraindications for drugs used in trial\n* Mental or physical incapability to operate PCA syringe pump",{"count":230,"type":19},120,[144],"Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression.\n\nTo limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks.\n\nThe aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.",[234,235,236,237],"Analgesics, Opioid","Anesthesia, Spinal","Total Hip Replacement","Adverse Anesthesia Outcome","2026-02-11",{"date":240,"type":30},"2026-02-12",{"date":242,"type":30},"2025-03-04",{"date":244,"type":19},"2026-06-28",{"name":36,"class":37},3,{"id":248,"slug":249,"hasResults":11,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":11,"sex":255,"minAge":108,"maxAge":256,"enrollmentInfo":257,"targetDuration":259,"studyType":82,"phases":4,"briefSummary":260,"conditions":261,"keywords":266,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":131},"100603498","popq-associated-with-total-laparoscopic-hysterectomy-100603498","NCT07137299","POPQ Associated With Total Laparoscopic Hysterectomy","POPQ Associated With Total Laparoscopic Hysterectomy - Multicenter Prospective Observational Study - POP-LAP STUDY","POP-LAP","Inclusion Criteria:\n\n* persons who underwent total or subtotal hysterectomy for benign conditions regardless of the type of surgery\n* agree to participate and to follow-up\n\nExclusion Criteria:\n\n* having uterus\n* health state - ECOG \\>2\n* pelvic organ prolapse prior to the surgery\n* surgery due to malignant conditions (ovarian, cervical or endometrial cancer)","FEMALE","85 Years",{"count":258,"type":19},2000,"10 Years","The goal of this observational study is to evaluate the impact of different hysterectomy (removal of the uterus) techniques on the risk of pelvic organ prolapse (situation when one or more of your pelvic organs like your bladder, uterus, or rectum have dropped down or slipped out of their normal position, sometimes even bulging into the vagina) and urinary incontinence (leaking urine unexpectedly) in women aged 18-85 who underwent hysterectomy or supracervical hysterectomy (removing of the uterus without its cervix) for benign (not cancer) conditions.\n\nThe main question is: to check how different surgical technique (laparoscopic, with opening the abdomen, vaginal and robotic) increase the risk of pelvic organ prolapse or urinary incontinence There is no randomization or control group; comparisons will be made between surgery types based on clinical and questionnaire data.\n\nParticipants will:\n\n* Receive an invitation to participate if they underwent hysterectomy between 2021-2025.\n* Fill out validated quality of life questionnaires (P-QOL, POPDI-6, PFIQ-7) every two years.\n* Attend follow-up clinical pelvic exams every two years to assess vaginal cuff healing, pelvic organ prolapses (POP-Q system), and urinary symptoms.\n\nThis prospective, non-commercial, multicenter study plans to enroll 2,000 women and will run from July 1, 2025, to July 1, 2036",[262,263,264,265],"Uterine Fibroids (UF)","Abnormal Uterine Bleeding Unrelated to Menstrual Cycle","Endometrial Hyperplasia","Pelvic Organ Prolapse (POP)",[267,268,269,270,271,272],"Hysterectomy","Vaginal hysterectomy","Laparotomy","Laparoscopy","Robotic surgery","pelvic organ prolapse","2025-08-15",{"date":275,"type":30},"2025-08-22",{"date":277,"type":19},"2025-10-01",{"date":279,"type":19},"2037-07-01",{"name":36,"class":37},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":255,"minAge":108,"maxAge":256,"enrollmentInfo":288,"targetDuration":290,"studyType":82,"phases":4,"briefSummary":291,"conditions":292,"keywords":294,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100602209","minimally-invasive-surgery-versus-open-radical-hysterectomy-in-presumably-early-stage-cervical-cancer-a-retrospective-multicenter-non-inferiority-study-comparing-overall-and-progression-free-survival-100602209","NCT07120529","Minimally Invasive Surgery Versus Open Radical Hysterectomy in Presumably Early Stage Cervical Cancer: a Retrospective Multicenter Non-inferiority Study Comparing Overall and Progression-free Survival.","MOOSE","Inclusion Criteria:\n\nWomen undergoing radical hysterectomy type B or C according to the Querleu-Morrow classification for early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3 between November 2018 and August 2025 Not using manipulator during surgery Vaginal cuff protective maneuver during surgery Conization before surgery (optional) SNB as a first stage of treatment (optional)\n\nExclusion Criteria:\n\nWomen undergoing surgery for advanced stage cervical cancer (FIGO \\>IIA1) or FIGO IB3 Metastasis detected in sentinel node biopsy (confirmed in ultrastaging) ECOG\\>2 Not willing to participate in the study Not willing to undergo CT-scans or gynecological examinations",{"count":289,"type":19},300,"5 Years","The goal of this retrospective observational study with prospective follow-up is to compare the safety and treatment outcomes of radical laparoscopic hysterectomy (removal of the uterus with cervix) versus abdominal (open) hysterectomy performed after the publication of the LACC trial in women with early-stage cervical cancer.\n\nEligible participants will include adult, legally competent women diagnosed with early-stage cervical cancer (FIGO stages IB1-IIA1, excluding FIGO IB3) with negative sentinel lymph node biopsy (SNB) confirmed by ultrastaging.\n\nThe main questions it aims to answer are:\n\nIs there a difference in overall survival (OS) and progression-free survival (PFS) between laparoscopic and abdominal radical hysterectomy? Are postoperative complication rates and recurrence patterns comparable between the two surgical approaches?\n\nResearchers will compare outcomes in patients undergoing radical laparoscopic hysterectomy versus abdominal hysterectomy to assess differences in survival, complications, and recurrence.\n\nParticipants will:\n\nHave undergone radical hysterectomy (type B or C per Querleu-Morrow classification), preceded optionally by conization, with the use of uterine manipulators and absence of vaginal cuff protection explicitly excluded; Have had SNB as part of surgical staging; Be followed every 6 months for 5 years; Undergo clinical gynecologic examination and transvaginal and\u002For transabdominal ultrasound during follow-up; Undergo additional imaging (CT and\u002For pelvic MRI) in case of symptoms suggestive of recurrence.\n\nAll participants will follow standard post-treatment surveillance. No additional interventions beyond routine follow-up will be performed. Data on OS, PFS, complications (within 30 and 60 days postoperatively, classified by Clavien-Dindo), duration of surgery, recurrence site, and demographic characteristics will be collected.",[293,267],"Cervical Cancer",[295,296,297,298,299],"cervical cancer","radical laparoscopic hysterectomy","radical abdominal hysterectomy","protective maneuver","LACC study","2025-08-12",{"date":302,"type":30},"2025-08-13",{"date":304,"type":19},"2025-09-15",{"date":306,"type":19},"2030-12-01",{"name":36,"class":37},5,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":20,"phases":318,"briefSummary":319,"conditions":320,"keywords":329,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":38},"100594316","stereotactic-radiosurgery-as-second-line-therapy-for-ventricular-tachycardia-100594316","NCT07017855","Stereotactic Radiosurgery as Second-line Therapy for Ventricular Tachycardia","STAR-4VT","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of enrollment.\n2. Presence of structural heart disease (SHD) of either ischemic or non-ischemic etiology.\n3. Implanted ICD or CRT-D device for primary or secondary prevention of sudden cardiac death (SCD).\n4. History of at least one endocardial CA procedure targeting a substrate of monomorphic sVT.\n5. Recurrence of at least one clinically significant and symptomatic episode of monomorphic sVT.\n6. Optimal pharmacological treatment of underlying SHD, including maximally tolerated doses of guideline-recommended heart failure therapies and appropriate antiarrhythmic management.\n7. Provision of written informed consent prior to study participation.\n\nExclusion Criteria:\n\n1. Reversible cause of sVT recurrence, particularly acute coronary syndrome (ACS), acute myocarditis, or lead-related infective endocarditis (LDIE).\n2. Myocardial infarction (MI) or cardiac surgery within the last 40 days.\n3. Idiopathic sVT unrelated to SHD or sVT associated with genetically determined channelopathies.\n4. Ongoing or persistently recurrent hemodynamically unstable sVT until clinical stabilization is achieved.\n5. Acute decompensation of heart failure, classified as New York Heart Association (NYHA) Class IV, until clinical stabilization is achieved.\n6. Worsening angina, classified as Canadian Cardiovascular Society (CCS) Class III or IV until coronary diagnostic evaluation and clinical stabilization are completed.\n7. A mobile thrombus within the left ventricle (LV).\n8. Presence of a left ventricular assist device (LVAD).\n9. Presence of comorbidities or known risk factors for CA complications that, in the judgment of the electrophysiologist, constitute a contraindication to the procedure for safety reasons.\n10. Active, uncontrolled malignancy and\u002For chemotherapy or immunotherapy administered or planned within 1 month of the scheduled ablation procedure.\n11. Features of an active systemic, pulmonary, or pericardial inflammatory process requiring systemic treatment (disease-modifying therapies, corticosteroids, immunosuppressants) within the past 6 months.\n12. Presence of comorbidities or known risk factors for radiotherapy complications that, in the judgment of the radiation oncologist, constitute a contraindication to STAR for safety reasons.\n13. Pregnancy or breastfeeding.\n14. Systemic disease that limits the probability of survival to less than 1 year\n15. Other comorbidities, addictions, or social indications that, in the investigator's opinion, would preclude practical cooperation or otherwise disqualify the patient from participation in the clinical study.\n16. Refusal to participate or lack of written informed consent for study participation.",{"count":317,"type":19},150,[22],"The aim of the study is to compare the efficacy and safety of treating recurrent sustained Ventricular Tachycardia (sVT) after prior Catheter Ablation (CA) in patients with Implanted Cardioverter-Defibrillator (ICD) between re-do of conventional endocardial CA and Stereotactic Arrhythmia Radioablation (STAR).",[321,322,323,324,325,326,327,328],"Ventricular Tachycardia, Monomorphic","Ventricular Tachycardia, Sustained","Ventricular Tachycardia (VT)","Ventricular Tachycardia (V-Tach)","Stereotactic Body Radiation Therapy (SBRT)","Stereotactic Techniques","Stereotactic Radiation","Cardioverter-Defibrillators, Implantable",[330,331,332,333,334,335],"Ventricular Tachycardia","VT","Stereotactic Arrhythmia Radioablation","STAR","Implanted Cardioverter-Defibrillator","ICD","2025-06-04",{"date":338,"type":30},"2025-06-12",{"date":340,"type":19},"2025-07-01",{"date":342,"type":19},"2028-11-01",{"name":36,"class":37},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":20,"phases":354,"briefSummary":355,"conditions":356,"keywords":358,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":38},"100513531","physiologic-cardiac-pacing-to-prevent-left-ventricular-dysfunction-post-tavi-100513531","NCT05966675","Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post TAVI","Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation","PACE-4-TAVI","Inclusion Criteria:\n\n1. transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation\n2. Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines\n3. Written informed consent\n4. Age of at least 18 years\n\nExclusion Criteria:\n\n1. Permanent pacemaker implantation before TAVI procedure\n2. The occurrence of conduction disturbances more than 30 days after TAVI procedure\n3. No written informed consent\n4. Inability to obtain informed consent from participant\n5. Predicted inability to obtain cooperation from patient during observation period",{"count":353,"type":19},500,[22],"The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).",[357],"Atrioventricular Block, Second and Third Degree",[359,360,361,118,362,363],"Pacemaker","Transcatheter Aortic Valve Replacement","Conduction System Pacing (CSP)","Congestive Heart Failure","Bradycardia",{"date":365,"type":30},"2025-06-08",{"date":367,"type":30},"2024-02-27",{"date":369,"type":19},"2028-06",{"name":36,"class":37},{"id":372,"slug":373,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":20,"phases":380,"briefSummary":381,"conditions":382,"keywords":390,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":397,"lastUpdatePostDateStruct":398,"startDateStruct":400,"completionDateStruct":402,"leadSponsor":404,"locationsCount":38},"100593985","oritavancin-for-cied-infections-with-mdr-gram-positive-cocci-100593985","NCT07013552","Oritavancin for CIED Infections With MDR Gram-positive Cocci","Oritavancin as a Therapeutic Regimen for Cardiac Implantable Electronic Devices Infections With Multidrug-resistant Gram-positive Cocci","ORI-4-CIEDi","Inclusion Criteria:\n\n1. Completed 18 years of age\n2. Presence of signs and symptoms of superficial ABSSSI or PI in the form of a) redness\u002Fwarmth\u002Fswelling\u002Fpain or b) separation of the edges of the surgical incision with signs of inflammation or the need for repeated surgical debridement of the wound or c) the presence of decubitus of the skin and subcutaneous tissue in area of the generator or skin abscess\u002Ferosion of the device pocket, with purulent discharge from the wound or discharge giving a positive microbial culture\n3. Probable\u002F definite diagnosis of right-sided LRIE according to modified Dukes criteria (optional criterion)\n4. Suspected\u002Fconfirmed infection with drug-resistant Gram-positive cocci, i.e., Staphylococcus spp. (Stahphylococcus aureus or coagulase-negative staphylococci), Streptococcus spp. or Enterococcus spp. sensitive to oritavancin\n5. Suspected\u002Fconfirmed infection with Gram-positive cocci, i.e., Staphylococcus spp., Streptococcus spp., Enterococcus spp., sensitive to vancomycin or oritavancin and beta-lactam antibiotics in patients with a history of type I anaphylaxis to penicillin.\n\nExclusion Criteria:\n\n1. Suspected\u002Fconfirmed infection with Gram-positive or Gram-negative bacilli or anaerobic bacteria\n2. Suspected\u002Fconfirmed community-acquired infection or infection with Gram-positive cocci sensitive to betalactam antibiotics, including penicillin, ampicillin, or methicillin, based on empirical data or cultures (does not apply to patients with a history of type I anaphylaxis to penicillin)\n3. Confirmed resistance of Gram-positive cocci, which are the etiological factor of the infection, to vancomycin and oritavancin.\n4. History of hypersensitivity to oritavancin or another lipoglycopeptide antibiotic (applies to the experimental group only)\n5. History of hypersensitivity to vancomycin or another glycopeptide antibiotics (applies to the control group only)\n6. No possibility of temporarily interrupting\u002Finitiating alternative therapy to intravenous infusion of unfractionated heparin\n7. Pregnancy or breastfeeding\n8. Lack of informed written consent of the patient to participate in the study",{"count":18,"type":19},[22],"The study aimed to conduct a randomized, non-inferiority controlled trial to compare the short- and medium-term efficacy and safety of two antibiotic dosage regimens in cardiac implantable electronic devices (CIED) infections with multidrug-resistant Gram-positive cocci: 1) single-dose therapy with a long-half-life antibiotic (oritavancin) vs. standard 7-14 days of therapy with a short-half-life antibiotic (vancomycin) for CIED surgical incision site or pocket infection; and 2) fractionated therapy with a long-half-life antibiotic (oritavancin) at seven-day intervals compared to standard therapy with a short-half-life antibiotic (vancomycin) fractionated in 2-3 daily doses in cases of lead-related infectious endocarditis.",[383,384,385,386,387,388,389],"Cardiac Implantable Electronic Device Infections","Infective Endocarditis","Multidrug-resistant Bacteria Screening","Gram Positive Bacterial Infection","Antibiotic Resistant Strain","Antibiotic Therapy","Healthcare Associated Infections",[391,392,393,394,395,396],"Cardiac implantable electronic device","Gram-positive cocci","Health-care associated infections","Lead-related infective endocarditis","Multidrug-resistant bacteria","Pocket infection","2025-06-02",{"date":399,"type":30},"2025-06-10",{"date":401,"type":19},"2025-06",{"date":403,"type":19},"2026-10",{"name":36,"class":37},{"id":406,"slug":407,"hasResults":11,"nctId":408,"briefTitle":409,"officialTitle":410,"acronym":4,"eligibilityCriteria":411,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":412,"targetDuration":4,"studyType":20,"phases":414,"briefSummary":415,"conditions":416,"keywords":418,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":425,"startDateStruct":427,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100590637","respiratory-stabilization-in-chronic-acidosis-before-bronchofiberoscopy--non-invasive-ventilation-effectivenes-100590637","NCT06970002","Respiratory Stabilization in Chronic Acidosis Before Bronchofiberoscopy & Non-Invasive Ventilation Effectivenes","Assessment of the Importance of Respiratory Stabilization in Patients With Chronic Respiratory Acidosis Before a Diagnostic Bronchofiberoscopy, as Well as the Effectiveness of Different Types of Non-invasive Ventilation During the Procedure","Inclusion Criteria:\n\n1. Patient ≥ 18 years of age with indications for diagnostic bronchoscopy:\n\n   ◦ Diagnostic test: suspected lung cancer, suspected sarcoidosis, mediastinal lymphadenopathy,\n2. Patient who signed a written informed consent to participate in the study,\n3. pCO2 \\> 45 mmHg and\u002For HCO3- \\> 27 mmol\u002Fl but pH ≥ 7.35 in a blood gas test performed immediately before qualification for bronchoscopy.\n\nExclusion Criteria:\n\n1. Lack of written informed consent of the subject to participate in the research project,\n2. Coronary artery disease CCS III\u002FIV,\n3. Hemodynamic failure, use of pressor amines, myocardial infarction in the last 2 weeks without PCI treatment, unstable angina pectoris, severe arrhythmias - especially ventricular,\n4. Pneumothorax not secured with drainage,\n5. Platelet count \\\u003C20,000\u002Fµl, if platelets are not transfused immediately before\u002Fduring the procedure,\n6. INR \\> 1.5xULN or APTT \\>36 s.1.5xULN, in the case of diagnostic FOB \\[16\\],\n7. Anemia: hemoglobin (Hb) level \\\u003C6 g\u002Fdl or 6-10 g\u002Fdl if the physician prescribes a blood transfu-sion,\n8. Patients who were intubated before randomization.",{"count":413,"type":19},210,[22],"Bronchofiberoscopy (FOB) is a minimally invasive and safe procedure performed for diagnostic and therapeutic purposes. FOB frequently impairs respiratory function, which may lead to possible exacerbation of respiratory failure.\n\nCurrently, the most frequent respiratory support is passive oxygen therapy, but non-invasive ventilation (NIV) and high flow nasal cannula (HFNC) are increasingly attempted, however the optimal setting and indications for NIV and HFNC in patients undergoing FOB with respiratory acidosis, haven't been determined yet.\n\nMethods:\n\nThe study protocol describes a prospective, multicenter, two- armed randomized controlled trial (RCT).\n\nThe investigators aim to study two patients groups, based on FOB indications and the type of respiratory acidosis:\n\n1\\) Diagnostic FOB; patients with chronic respiratory acidosis (pH ≥7.35; pCO2 \\> 45mmHg and\u002For HCO3- \\>27 mmol\u002Fl);\n\n1. randomized to: passive oxygen, NIV, HFNC;\n2. total number of participants: 210\n\nRandomization:\n\ntwo-step randomization (1st randomization :a or b; 2nd randomization: i- iii method of respiratory support):\n\na. Stabilization of respiratory parameters before FOB (pH 7.35-7.45; pCO2 35-45 mmHg; HCO3- \\>27 mmol\u002Fl) i. NIV ii. HFNC iii. Passive oxygen therapy b. FOB right away (pH 7.35-7.45; pCO2 \\>45 mmHg; HCO3- \\> 27 mmol\u002Fl) i. NIV ii. HFNC\n\nBefore FOB, both groups will undergo arterial blood gas analysis (ABG). During FOB there will be a continuous monitoring of vital signs as in: SpO2, FiO2, TcCO2, ECG, and Heart Rate. After FOB, the investigators are going to perform another ABG, mark endpoints, and complications, if any arise.\n\nResults:\n\nBased on the selected endpoints, or any complication related to FOB the investigators hope to determine which of the respiratory methods: passive oxygen, NIV, HFNC or IMV provides the best support, leading to a lower number of complications and overall a better tolerance of FOB by the patient. Additionally, our aim is to find the optimal settings for NIV and HFNC in both studied groups.\n\nConclusions:\n\nThe results of this study are going to assess the need and the role of the optimal respiratory support method among patients with respiratory acidosis, leading to a shorter time from admission to diagnosis, better tolerance during the procedure, quicker recovery after procedure.",[417],"Chronic Respiratory Acidosis",[419,420,421,422,423,417],"Bronchofiberoscopy (FOB)","High Flow Nasal Cannula (HNFC)","Non-Invasive Ventilation (NIV)","Passive Oxygen Therapy","Lung Disease Diagnosis","2025-05-05",{"date":426,"type":30},"2025-05-14",{"date":277,"type":19},{"date":429,"type":19},"2028-10-31",{"name":36,"class":37},{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":20,"phases":440,"briefSummary":441,"conditions":442,"keywords":445,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":424,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":451,"leadSponsor":452,"locationsCount":4},"100590640","to-assess-the-types-of-mechanical-ventilation-in-enabling-therapeutic-bronchofiberoscopy-in-patients-with-decompensated-respiratory-acidosis-complete-respiratory-failure-100590640","NCT06970041","To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure).","To Assess the Types of Mechanical Ventilation in Enabling Therapeutic Bronchofiberoscopy in Patients With Decompensated Respiratory Acidosis (Complete Respiratory Failure)","Inclusion Criteria:\n\n1. Patients ≥ 18 years of age with indications for bronchoscopy:\n\n   Therapeutic examination: pneumonia in people with impaired cough reflex, culture and toilet of the bronchial tree, respiratory tract hemorrhages treated with a bronchofiberoscope and aspiration of a foreign body, bronchial unblocking in advanced neoplastic disease.\n2. Patient who signed a written informed consent to participate in the study,\n3. pCO2 \\> 45 mmHg and pH \\\u003C 7.35 in a blood gas analysis performed directly during qualification for FOB.\n\nExclusion Criteria:\n\n1. Lack of written, informed consent of the subject to participate in the research project,\n2. Unstable coronary artery disease chronic coronary syndrome (CCS) III\u002FIV, circulatory failure New York Heart Association (NYHA) III\u002FIV (does not apply to tests for vital indications, e.g. aspiration of a foreign body),\n3. Hemodynamic insufficiency, constant use of pressor amines, myocardial infarction in the last 2 weeks without percutaneous coronary intervention (PCI) treatment, unstable angina pectoris, severe arrhythmias- especially ventricular,\n4. Chronic primary pulmonary hypertension, assessed during right heart catheterization WHO III\u002FIV,\n5. Pneumothorax not secured with drainage,\n6. Platelet count \\\u003C20,000\u002Fµl, if platelets are not transfused immediately before or during the procedure,\n7. International normalized ratio (INR)\\> 2 or activated partial thromboplastin time (APTT) \\> 36 s, in the case of therapeutic FOB \\[16\\],\n\nd. Anemia: hemoglobin (Hb) level \\\u003C6 g\u002Fdl or 6-10 g\u002Fdl if the physician prescribes a blood transfusion, h. Patients who were intubated before randomization.",{"count":439,"type":19},315,[22],"Background:\n\nBronchofiberoscopy (FOB) is a minimally invasive and safe procedure performed for diagnostic and therapeutic purposes. FOB frequently impairs respiratory function, which may lead to possible exacerbation of respiratory failure.\n\nCurrently, the most frequent respiratory support is passive oxygen therapy, but non-invasive ventilation (NIV) and high flow nasal cannula (HFNC) are increasingly attempted, however the optimal setting and indications for NIV and HFNC in patients undergoing FOB with respiratory acidosis, haven't been determined yet.\n\nMethods:\n\nThe study protocol describes a prospective, multicenter, three-armed randomized controlled trial (RCT).\n\nThe investigators aim to study patients undergoing a therapeutic bronchofiberoscopy with decompensated type 2 respiratory failure: (pH \\\u003C7.35 and pCO2 \\>45 mmHg);\n\n1. randomized to: passive oxygen, NIV, HFNC, invasive mechanical ventilation (IMV);\n2. total number of participants: 315. Before FOB, the patient group will undergo arterial blood gas analysis (ABG). During FOB there will be a continuous monitoring of vital signs as in: SpO2, FiO2, TcCO2, ECG, and Heart Rate. After FOB, the investigators are going to perform another ABG, mark endpoints, and complications, if any arise.\n\nResults:\n\nBased on the selected endpoints, or any complication related to FOB the investigators hope to determine which of the respiratory methods: passive oxygen, NIV, HFNC or IMV provides the best support, leading to a lower number of complications and overall a better tolerance of FOB by the patient. Additionally, our aim is to find the optimal settings for NIV and HFNC in the studied group.\n\nConclusions:\n\nThe results of this study are going to assess the need and the role of the optimal respiratory support method among patients with exacerbation of respiratory acidosis, leading to a shorter time from admission to full recovery, better tolerance during the procedure, quicker recovery after procedure.",[443,444],"Respiratory Failure With Hypercapnia","Therapeutic Bronchofiberoscopy",[419,420,421,422,446,447,448],"Type 2 respiratory failure","Exacerbation of Chronic Respiratory Acidosis","Invasive Mechanical Ventilation (IMV)",{"date":426,"type":30},{"date":277,"type":19},{"date":429,"type":19},{"name":36,"class":37},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":457,"acronym":4,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":20,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":38},"100582140","prevention-of-clostridium-difficile-infections-using-lactobacillus-plantarum-299v-strain-in-nephrology-and-transplantation-department-100582140","NCT06859437","Prevention of Clostridium Difficile Infections Using Lactobacillus Plantarum 299v Strain in Nephrology and Transplantation Department","Inclusion Criteria:\n\n* over 18 years old\n* organ transplantation or receiving immunosuppressive drugs for any other reasons\n* antibiotics therapy\n\nExclusion Criteria:\n\n* no consent to participate in the study",{"count":289,"type":19},[22],"The aim of this study was to analyze whether the use of the LP299v strain reduces the risk of Clostridium difficile infection (CDI) among patients receiving antibiotics and hospitalized in the nephrology and transplantation ward.\n\nAdutt patients from risk group (receiving immunosuppressive drugs and treated with antibiotics) were enrolled into study.\n\nPatients who meet the above criteria for inclusion in the study will be assigned to one of two groups. Patients in group I (study) will receive a probiotic containing the Lactobacillus plantarum 299v strain of bacteria as part of the prophylaxis of Clostridioides difficile infection. The daily dose is 1 capsule containing approximately 10x109 colony-forming units of live bacteria taken orally with a meal. Patients in group II (control) will receive a placebo. The duration of probiotic or placebo use will be 3 months. Assignment to groups I and II will be random. The number of patients in each group will be 150.\n\nParticipants will be divided into two groups. First group will receive one capsule of Lactobacillus plantarum 299v (LP299v) orally per a day. Second group will receive placebo. The observation period will last 3 months. The evaluation will consist of an interview, physical examination and laboratory tests.",[463],"Clostridioides Difficile Infection","2025-02-27",{"date":466,"type":30},"2025-03-05",{"date":468,"type":30},"2024-10-01",{"date":470,"type":19},"2027-10-31",{"name":36,"class":37},{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":480,"conditions":481,"keywords":484,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":495,"locationsCount":162},"100522480","cardiovascular-disease-in-patients-with-chronic-kidney-disease-polish-kidney--heart-project-100522480","NCT06083168","Cardiovascular Disease in Patients With Chronic Kidney Disease: Polish Kidney- Heart Project","Inclusion Criteria:\n\n* CKD defined as estimated glomerular filtration rate (eGFR) \\\u003C 60ml\u002Fmin\u002F1.73 m2 and\u002For urine albumin creatinine ratio ( UACR) \\> 30 mg\u002Fg lasting at least 3 months\n* CKD regardless of eGFR\u002Falbuminuria when documented otherwise (by means of imaging, renal biopsy result, genetic background, etc)\n\nExclusion Criteria:\n\n* Death during hospital stay\n* Terminal stage of cancer\n* Lack of an informed consent",{"count":479,"type":19},6000,"This is an observational longitudinal study which will collect routine demographic, laboratory and clinical parameters of patients with chronic kidney disease (CKD) in the Silesian and Warmia and Mazury Regions (Poland) aimed at predicting incident cardiovascular disease and cardiovascular and renal events using machine learning and artificial intelligence approaches. There will be a subgroup analysis of patients with diabetes and CKD.",[482,483],"Chronic Kidney Disease","Cardiovascular Diseases",[485,486,487,488],"chronic kidney disease","cardiovascular disease","artificial inteligence","predictors","2024-04-30",{"date":491,"type":30},"2024-05-02",{"date":127,"type":30},{"date":494,"type":19},"2036-01-31",{"name":36,"class":37},{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":502,"eligibilityCriteria":503,"healthyVolunteers":11,"sex":15,"minAge":108,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":20,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":518,"completionDateStruct":520,"leadSponsor":522,"locationsCount":4},"100518171","phase-4-biologics-and-sublingual-immunotherapy-100518171","NCT06027073","Biologics and Sublingual Immunotherapy","Adding Biological Therapy to Asthmatic Patients on Allergen Immunotherapy to House Dust Mites","BSIPL","Inclusion Criteria:• \\>18 years old\n\n* A total IgE between 30-700 IU\u002FmL\n* Moderate asthma with perennial symptoms confirmed as HDM-driven asthma based on medical history and positive nasal provocation tests, partially controlled asthma;\n* FEV1 \\>70% at baseline;\n* Positive skin prick test results for D. pteronyssinus, D. farinae\n\nExclusion Criteria:\n\n* Sensitisation to other allergens with clinical signs not related to HDM\n* Uncontrolled asthma,\n* Other serious diseases or chronic unstable diseases\n* Allergen immunotherapy during the past 5 years\n* Contraindicating allergen immunotherapy and omalizumab treatment.","65 Years",{"count":317,"type":19},[144],"Most current studies involve using a biological drug to increase the safety of allergen immunotherapy (AIT) especially in the treatment of food allergies, to avoid the risk of anaphylaxis. However, adding Xolair® to AIT may improve the therapy's effectiveness. There are still few observations on this topic, especially in patients with house dust mite (HDM)-driven asthma.",[509],"Asthma, Allergic",[511,512,513,514],"IgE","asthma","omalizumab","immunotherapy","2023-08-30",{"date":517,"type":30},"2023-09-07",{"date":519,"type":19},"2024-05-01",{"date":521,"type":19},"2028-03-01",{"name":36,"class":37},{"id":524,"slug":525,"hasResults":11,"nctId":526,"briefTitle":527,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":15,"minAge":504,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":532,"conditions":533,"keywords":539,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":548,"lastUpdatePostDateStruct":549,"startDateStruct":551,"completionDateStruct":553,"leadSponsor":555,"locationsCount":38},"100301846","frailty-syndrome-in-daily-practice-of-interventional-cardiology-ward-100301846","NCT03209414","Frailty Syndrome in Daily Practice of Interventional Cardiology Ward","FRAPICA","Inclusion Criteria:\n\n* aged ≥ 65\n* symptomatic coronary artery disease A) stable B) unstable C) NSTEMI D) STEMI\n* written, informed consent\n\nExclusion Criteria:\n\n* lack of consent",{"count":531,"type":19},1000,"The impact of frailty on immediate and long term outcomes of invasive treatment of coronary artery disease is not fully characterized. The assessment of frailty may help physicians in the selection of best treatment option and in the timing and modality of the follow-up. The FRAilty syndrome in daily Practice of Interventional CArdiology ward (FRAPICA) study is designed with the aim to validate the use of the Fried frailty scale and instrumental activities of daily living scale (IADL) as prognostic tools in patients admitted to hospital for symptomatic coronary artery disease, either stable, unstable, or acute coronary syndrome (ACS).\n\nThe FRAPICA study is a single center prospective study enrolling patients aged ≥65 years. The aims are (1) to describe Fried frailty scale and IADL scale distribution before hospital discharge and (2) to investigate the prognostic role of Fried frailty and IADL scores. The outcomes are: (1) results of invasive treatment, (2) its complications (periinterventional MI, contrast-induced nephropathy, blood loss), (3) three-year all-cause mortality, cardiovascular mortality, stroke, myocardial infarction, reintervention, heart failure, hospital readmission for any cause, and a composite of the above mentioned. Ancillary analyses will be focused on different clinical presentations, different tools to assess frailty and risk stratification.\n\nThe FRAPICA program will fill critical gaps in the understanding of the relation between frailty, cardiovascular disease, interventional procedures and outcome. It will enable more personalized risk assessment and identification of new targets for interventions.",[534,535,536,537,538],"Frail Elderly Syndrome","Coronary Heart Disease","Acute Coronary Syndrome","Coronary Artery Bypass Grafting","Percutaneous Transluminal Coronary Angioplasty",[540,541,542,543,544,545,546,547],"Frailty syndrome","Coronary heart disease","Coronary revascularization","Major adverse cardiovascular events","Arterial stiffness","Applanation tonometry","Lean body mass","ST2 biomarker","2023-04-10",{"date":550,"type":30},"2023-04-12",{"date":552,"type":30},"2017-05-17",{"date":554,"type":19},"2027-12-31",{"name":36,"class":37},""]