[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Wroclaw Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":475},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,51,82,108,135,167,199,227,254,276,305,333,355,379,404,424,453],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100640896","effects-of-repletion-of-sodium-chloride-on-natriuresis-blood-pressure-and-neurohormonal-activity-in-patients-with-chronic-heart-failure-with-reduced-ejection-fraction-100640896",false,"NCT07614295","Effects of Repletion of Sodium Chloride on Natriuresis, Blood Pressure, and Neurohormonal Activity in Patients With Chronic Heart Failure With Reduced Ejection Fraction","Impact of Sodium Chloride Supplementation for Natriuresis, Blood Pressure and Neurohormonal Activity in Chronic Heart Failure With Reduced Ejection Fraction and Low Serum Sodium Concentration - Double-blinded, Placebo-controlled, Prospective Trial","RESALT-CHF","Inclusion Criteria:\n\n1. Chronic heart failure NYHA I-III.\n2. LVEF ≤40% documented in the echocardiography.\n3. Stable Heart Failure symptoms:\n\n   * Stable symptoms (subjectively declared by the patient) over the past three months.\n   * No increase in peripheral edema or body weight (declared by the patient).\n   * Loop diuretic dose equivalent to 80 mg of furosemide or 20 mg of torasemide daily, with no changes in the past three months.\n4. Age over 18 and under 85 years.\n5. Male or female.\n6. Use of guideline-directed medical therapy (GDMT), with each drug group at maximum tolerated doses but no more than half of the maximum dose.\n7. Systolic blood pressure \\\u003C100 mmHg and\u002For diastolic blood pressure \\\u003C60 mmHg.\n8. Resting heart rate up to 80 bpm.\n9. Serum sodium concentration \\\u003C140 mmol\u002FL, regardless of the cause.\n\nExclusion Criteria:\n\n1. Hospitalization due to heart failure decompensation within the last three months.\n2. Primary hypertrophic or restrictive cardiomyopathy, constrictive pericarditis.\n3. Systemic disease known to be associated with cardiac muscle infiltration.\n4. Significant valvular disease (moderate or severe stenosis of any valve, moderate or severe aortic or pulmonary regurgitation, severe tricuspid or mitral regurgitation).\n5. Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² based on the MDRD formula).\n6. Stroke or transient ischemic attack (TIA) within the last three months.\n7. Cardiac resynchronization therapy (CRT), ICD, ablation, or pacemaker implantation (or planned implantation) within the last three months.\n8. Severe lung disease or \"cor pulmonale\" or other causes of isolated right ventricular failure not associated with left ventricular dysfunction.\n9. Severe lung disease with respiratory failure requiring home oxygen therapy.\n10. Body weight \\\u003C40 kg or ≥150 kg.\n11. Life expectancy \\\u003C12 months according to the investigator's assessment\n12. Pregnancy or breastfeeding.\n13. Ongoing drug or alcohol abuse.\n14. Lactose intolerance.","ALL","18 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"NA","The study is a single-center, prospective, randomized, placebo-controlled, double-blind trial conducted at the Institute of Heart Diseases and the Department of Cardiology of Wroclaw Medical University Hospital. It aims to evaluate the effects of three-month oral sodium chloride supplementation (3 g\u002Fday, equivalent to 1.2 g of sodium) versus placebo (lactose) in patients with chronic heart failure with reduced ejection fraction (HFrEF) and low serum sodium, who have not reached the maximum recommended doses of guideline-directed medical therapy (GDMT).\n\nA total of 30 patients will be enrolled, with 15 randomized to the experimental group receiving sodium chloride and 15 to the control group receiving placebo. Patient selection will involve careful screening, including recent serum sodium measurements, to ensure all inclusion and exclusion criteria are met.\n\nParticipants will attend bi-weekly visits to assess clinical parameters (medical history, EVEREST heart failure symptoms score, blood pressure, body weight), biochemical markers (serum: morphology, urea, creatinine, sodium, chloride, potassium, NT-proBNP, aldosterone, renin; urine: urea, creatinine, sodium, chloride, potassium), and the safety of supplementation (body weight, serum sodium and chloride, exercise tolerance). Visits will also allow attempts to optimize GDMT doses where clinically feasible, based on objective criteria (e.g., systolic blood pressure \\>110 mmHg and\u002For diastolic blood pressure \\>60 mmHg).\n\nCapsules containing sodium chloride or placebo will be prepared according to pharmacy standards to ensure intestinal release and maintain blinding. The Primary Investigator will remain blinded to treatment allocation. Follow-up will include both in-person and telephone visits, monitoring clinical status and safety parameters throughout the study period.\n\nSample size was calculated based on previous studies in this field, to achieve a type I error probability of 0.05 and a power of 0.80. At the end of the three-month supplementation, participants will undergo a comprehensive final assessment. Study data will be analyzed statistically to determine the effects of sodium chloride supplementation on natriuresis, blood pressure, neurohormonal activity, and the potential for optimizing GDMT in HFrEF patients with low serum sodium.",[27],"Chronic Heart Failure With Reduced Ejection Fraction",[29,30,31,32,33,34,35,36,37],"sodium supplementation","sodium chloride","HFrEF","chronic heart failure","neurohormonal activity","aldosterone","renin","blood pressure","natriuresis","NOT_YET_RECRUITING","2026-05-25",{"date":41,"type":42},"2026-05-29","ACTUAL",{"date":44,"type":21},"2026-05",{"date":46,"type":21},"2028-07",{"name":48,"class":49},"Wroclaw Medical University","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":69,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":50},"100640061","phase-4-pre-discharge-influenza-vaccination-in-patients-hospitalized-for-acute-cardiac-conditions-100640061","NCT07617376","Pre-discharge Influenza Vaccination in Patients Hospitalized for Acute Cardiac Conditions","Inclusion Criteria:\n\n* Acute cardiac hospitalization,\n* Planned discharge home within the next 48 hours following completion of in-hospital treatment,\n* No prior influenza vaccination for the current influenza season.\n\nExclusion Criteria:\n\n* History of a severe adverse reaction to influenza vaccination,\n* Allergy to any component of the vaccine to be administered,\n* Discharge to another hospital for continuation of treatment or discharge to a long-term care facility,\n* Antibiotic therapy to be continued after discharge.",{"count":58,"type":21},400,[60],"PHASE4","Patients hospitalized for acute cardiac conditions-including acute myocardial infarction, acute heart failure, pulmonary embolism, arrhythmias, and hypertensive emergencies-represent a heterogeneous population at very high risk of recurrent cardiovascular events. Influenza infection may act as a trigger for adverse cardiovascular events. Given the persistently low influenza vaccination uptake despite evidence-based benefits observed in vulnerable populations, including patients with cardiac conditions, new strategies to improve vaccination coverage are being explored. Recently, increasing attention has been directed toward an approach already used in fields such as neonatology, where vaccinations are administered prior to hospital discharge.\n\nIn this investigator-initiated, single-center, randomized, open-label interventional study, we will evaluate whether influenza vaccination administered within 24 hours before hospital discharge in patients hospitalized for acute cardiac conditions is safe and effective in reducing subsequent infections, cardiovascular events, and mortality during the 6 months following hospitalization.",[63,64,65,66,67,68],"Myocardial Infarction","Decompensated Chronic Heart Failure","Acute Heart Failure (AHF)","Pulmonary Embolism Acute","Hypertension Emergency","Arrhythmias",[70,71,72],"influenza vaccination","acute cardiac emergencies","pre-discharg vaccination","RECRUITING","2026-05-20",{"date":76,"type":42},"2026-06-01",{"date":78,"type":42},"2025-11-12",{"date":80,"type":21},"2027-07-01",{"name":48,"class":49},{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":93,"conditions":94,"keywords":98,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":50},"100632304","bruxism-induced-by-obstructive-sleep-apnoea-100632304","NCT07511946","Bruxism Induced by Obstructive Sleep Apnoea.","Evaluation of the Relationship Between Upper Airway Volume and the Risk of Bruxism Induced by Obstructive Sleep Apnoea.","Inclusion Criteria:\n\n* age equal to\u002Fgreater than 18 years\n* moderate or high risk of sleep apnea according to the STOP-Bang questionnaire\n* presence of bruxism symptoms in the oral cavity according to the current international consensus on bruxism\n* positive history of bruxism during sleep\n\nExclusion Criteria:\n\n* refusal to participate in the study\n* pregnancy\n* breastfeeding\n* presence of severe mental illness\n* alcohol and\u002For drug addiction\n* taking medications that affect the neuromuscular and\u002For respiratory systems\n* severe systemic diseases such as cancer\n* severe neurological and autoimmune diseases\n* multiple missing teeth\n* edentulism in the upper and\u002For lower jaw",true,{"count":91,"type":21},80,"OBSERVATIONAL","The relationship between obstructive sleep apnea (OSA), sleep bruxism, and temporomandibular disorders is becoming clearer, but data on how upper airway volume affects bruxism due to OSA is limited. Recent studies have shown that Cone-Beam Computed Tomography (CBCT) accurately images the upper airway, enabling analysis of its volume and its potential impact on bruxism. CBCT uses low radiation doses, significantly lower than harmful levels, making it a safe method for such assessments. Understanding these relationships can inform clinical practices for managing sleep bruxism, which affects 21% of the global population. The study aims to explore how upper airway volume influences the intensity of sleep bruxism related to OSA.",[95,96,97],"Sleep Apnea Syndrome, Obstructive","Bruxism, Sleep-Related","Upper Respiratory Tract Illness",[99,96],"Sleep Apnea","2026-03-30",{"date":102,"type":42},"2026-04-06",{"date":104,"type":21},"2026-09",{"date":106,"type":21},"2026-11",{"name":48,"class":49},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":92,"phases":4,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":50},"100605050","vascular-complications-in-patients-undergoing-peripheral-revascularization-and-taking-sglt-2-inhibitors-100605050","NCT07157475","Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors","Ocena powikłań Naczyniowych u pacjentów Poddanych Rewaskularyzacji Obwodowej: wpływ inhibitorów SGLT-2 The Assessment of Vascular Complications in Patients Undergoing Peripheral Revascularization: The Impact of SGLT-2 Inhibitors","Inclusion Criteria:\n\n* Peripheral vascular procedure ( Conventional surgical procedure or minimally invasive procedure) due to acute or chronic ischemia\n* Use of SGLT2 inhibitors (applies only to the group exposed to flozins) for at least 3 months prior to the vascular procedure (the indication for initiating the drug is irrelevant: chronic kidney disease \\[CKD\\] \u002F cardiac reasons \u002F diabetes), or immediately after the vascular procedure\n* Ability to determine the patient's outcomes within a minimum of 30 days up to 1 year following the vascular procedure\n\nExclusion Criteria:\n\n* Vascular injury as the reason for the procedure\n* Amputation due to causes other than ischemia (e.g., cancer, neuropathy, trauma without coexisting ischemia)\n* Planned revascularization procedure other than for the lower limbs at the time of hospital discharge (e.g., coronary or carotid arteries)\n* Planned ischemia-related amputation or reoperation of the operated limb at the time of hospital discharge\n* Planned other major surgical procedure with high cardiovascular risk at the time of hospital discharge",{"count":116,"type":21},300,"The study is observational and involves patients (pts) with peripheral arterial occlusive disease (PAD) who have undergone lower limb revascularization procedures. Patients who are at least one year post-procedure will be contacted by phone and asked whether any cardiovascular complications occurred during that period, specifically major adverse cardiovascular events (MACE) or major adverse limb events (MALE), and whether they had been taking sodium-glucose co-transporter 2 inhibitors (SGLT2-i, \"flozins\") during the year following the procedure. The results from the group of pts who, for any reason, received SGLT2-i treatment after the vascular procedure (including those who had initiated treatment before surgery) will be compared to the results from the group of patients who did not receive such treatment, with regard to the occurrence of the aforementioned complications.",[119],"Peripheral Arterial Disease(PAD)",[121,122,123,124,125,126],"flozins","SGLT2i","peripheral arterial disease","revascularisation","MACE","MALE","2026-03-18",{"date":129,"type":42},"2026-03-23",{"date":131,"type":42},"2025-07-01",{"date":133,"type":21},"2026-12-31",{"name":48,"class":49},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":152,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":50},"100624729","evaluation-of-remote-motivational-interviewing-for-disease-management-in-heart-failure-patients-and-their-carers-100624729","NCT07413419","Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers","REMIND HF - Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers","REMIND-HF","Inclusion Criteria:\n\n* Adult patients aged 18 years or older.\n* Diagnosis of heart failure.\n* New York Heart Association (NYHA) functional class II-IV.\n* Poor self-care as assessed at baseline.\n* Receiving care at the participating heart failure clinic.\n* Access to the internet and a device capable of videoconferencing.\n* Ability to understand the study procedures and provide written informed consent.\n* Having an identified primary informal caregiver willing to participate in the study.\n* Informal caregivers aged 18 years or older.\n* Caregivers identified by the patient as the primary person providing unpaid support in daily disease management.\n* Caregivers able to understand the study procedures and provide written informed consent.\n\nExclusion Criteria:\n\n* Severe cognitive impairment that would limit the ability to participate in the intervention or complete study assessments.\n* Acute coronary syndrome or other acute cardiac event within the last 3 months.\n* Residence in a nursing home or long-term care facility.\n* Inability to participate in videoconferencing sessions.\n* Participation in another interventional study that could interfere with the outcomes of this trial.",{"count":144,"type":21},600,[24],"Heart failure (HF) is a chronic and progressive condition that significantly affects patients' quality of life and increases the burden on family caregivers. Many patients struggle with self-care, including medication adherence, diet, and symptom monitoring.\n\nThe REMIND HF (REmote Motivational INterviewing for Disease Management in Heart Failure) study aims to evaluate the effectiveness of remote motivational interviewing (MI) as a behavioral intervention to improve disease management and self-care among heart failure patients and their informal caregivers. The intervention consists of a series of online motivational interviews conducted by trained nurses over a 12-month period, focusing on lifestyle modification, self-monitoring, and patient-caregiver cooperation.\n\nThe study will be conducted at the Wroclaw Medical University and collaborating centers. It will enroll 300 patients with heart failure (The New York Heart Association Functional Classificaion - NYHA class: II-IV) and their primary caregivers. Outcomes will include self-care behaviors, quality of life, psychological well-being, and health service utilization. The results will contribute to developing accessible, patient-centered models of heart failure management based on telehealth and behavioral support.",[148,149,150,151],"Heart Failure (HF)","Self Care","Caregiver","Motivational Interviewing (MI)",[153,154,155,156,157,158],"heart failure","Self-Care","Motivational Interviewing","caregivers","telehealth","nursing","2026-02-11",{"date":161,"type":42},"2026-02-17",{"date":163,"type":21},"2026-02-28",{"date":165,"type":21},"2028-01-30",{"name":48,"class":49},{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":22,"phases":177,"briefSummary":178,"conditions":179,"keywords":181,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":50},"100605239","poland-integrated-medicines-management-pl-imm---study-assessing-the-provision-of-complex-clinical-pharmacy-services-to-hospitalized-patients-100605239","NCT07159932","Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients","Poland Integrated Medicines Management (PL-IMM) - Randomized Controlled Trial Assessing the Provision of Complex Clinical Pharmacy Services to Hospitalized Patients in the Polish Healthcare System","PL-IMM","Inclusion Criteria:\n\nPatients meeting the following inclusion criteria:\n\n• ≥18 years old and an acute admission to the hospital fulfilling at least one of the following criteria:\n\n* taking ≥4 medicines\n* taking high risk medicines listed in the medicines reconciliation standard of Polish Society of Clinical Pharmacy (….)\n* medicine related admission to the hospital within last 12 months\n* chronic kidney or liver disease\n* after solid organ transplantation\n\nExclusion Criteria:\n\n* age below 18 years old\n* pregnancy\n* resident of long-term care facility\n* unable to express informed consent to participate in the research\n* expected survival less than 6 months",{"count":176,"type":21},610,[24],"The aim of the study is to assess whether the involvement of a clinical pharmacist in patient care at every stage of hospitalization, from admission to discharge, will improve the quality of healthcare services provided in clinical and economic terms. As part of the research study, we will randomly assign you to two different groups.\n\nWithin one group, a pharmacist will be involved in the process of caring for you throughout your hospital stay. The pharmacist will participate in medical rounds, verify medications upon admission to the hospital, check current test results and medical orders regarding pharmacotherapy, verify medications upon discharge and provide advice on the use of medications. All activities will be carried out in consultation with other medical staff. The aim is to check whether such a model of patient care increases safety and leads to improved pharmacotherapy for patients, and also has a positive effect on patient satisfaction and compliance with therapeutic recommendations. Additionally, the opinion of the medical staff and the economic aspects of this solution will be assessed. Within the second group, you will receive standard care offered by the hospital. In the case of both groups, after the hospitalization is completed, the pharmacist will contact you after 1, 3, 6 months to verify your health condition - he or she will ask about any hospitalizations, complications, side effects, and additional visits to the doctor.",[180],"Acute Admitted Multimorbid Patients",[182,183,184,185,186,187,188,189,190],"clinical pharmacy","integrated medicines managment","pharmacist interventions","clinical pharmacy services","medicines management","transfer of care","medicines review","medicines reconcilliation","patient education","2025-08-28",{"date":193,"type":42},"2025-09-08",{"date":195,"type":21},"2026-01-01",{"date":197,"type":21},"2027-12-30",{"name":48,"class":49},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":22,"phases":209,"briefSummary":210,"conditions":211,"keywords":216,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":219,"lastUpdatePostDateStruct":220,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":50},"100603840","electroporation-vs-radiofrequency-ablation-guided-by-3d-imaging-in-repeat-procedures-for-atrial-fibrillation-100603840","NCT07141745","Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation","ERA-rePVI","Inclusion Criteria:\n\nDocumented recurrence of AF or atypical atrial flutter after prior PVI Eligibility for re-PVI\n\nExclusion Criteria:\n\nLeft ventricular ejection fraction \\\u003C 30% Left atrial volume index (LAVI) \\> 72 mL\u002Fm² Untreated hyperthyroidism Hypertrophic cardiomyopathy Severe valvular heart disease","85 Years",{"count":208,"type":21},250,[24],"This is a prospective, randomized clinical trial evaluating the efficacy and safety of two techniques for repeat catheter ablation in patients with recurrent atrial fibrillation (AF): thermal energy ablation (radiofrequency) and non-thermal electroporation (pulsed field ablation), both guided by 3D imaging systems.\n\nPatients undergoing repeat AF ablation will be randomly assigned to receive either thermal or electroporation ablation, performed according to standard hospital protocols. No additional invasive procedures are required. Following the ablation, participants will attend follow-up visits at 3, 6, and 12 months, including medical history review, physical examination, 12-lead ECG, and 24-hour Holter monitoring. Unscheduled ECG assessments will also be available if arrhythmia symptoms occur.\n\nAll study-related procedures are non-invasive and align with routine post-ablation care. Risks are limited to those typically associated with standard AF ablation procedures.\n\nThe main benefit of participation is close, structured follow-up by experienced electrophysiologists, allowing for early detection of arrhythmia recurrence and timely medical intervention when necessary.\n\nParticipant confidentiality and data protection will be ensured in accordance with GDPR regulations.",[212,213,214,215],"Atrial Fibrillation (AF)","Ablation Techniques","Radiofrequency Catheter Ablation","Pulsed Field Ablation",[217,215,214,218],"Atrial fibrillation re-ablation","Atrial firbillation reccurence","2025-08-26",{"date":221,"type":42},"2025-08-27",{"date":223,"type":21},"2025-08-30",{"date":225,"type":21},"2028-10-01",{"name":48,"class":49},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":248,"completionDateStruct":250,"leadSponsor":252,"locationsCount":253},"100600622","simple-urine-composition-based-personalized-algorithm-for-effective-congestion-relief-in-decompensated-heart-failure-100600622","NCT07099885","Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure","SAFER-DHF","Inclusion Criteria:\n\n* Adult patients over 18 years of age who provide informed consent\n* Ability to enroll in the study within the first 24 hours of hospitalization\n* Primary reason for hospitalization is acute heart failure with signs of congestion (at least moderate lower extremity edema)\n* NT-proBNP \\> 1500 pg\u002Fml\n* Anticipated need for diuretic therapy for at least 48 hours from the time of study enrollment\n\nExclusion Criteria:\n\n* End-stage kidney disease requiring renal replacement therapy\n* Hemodynamic instability requiring inotropic support\n* Active infection requiring intravenous antibiotic therapy",{"count":235,"type":21},90,[24],"The aim of this study is to evaluate the effectiveness of loop diuretic adaptative algorithm that is based on machine learning, urine output prediction tool, in decongestion of acute heart failure patients.\n\nA total of 90 patients will be enrolled in the study. Of these, 45 will be assigned to the algorithm-based intervention group, while the remaining 45 will serve as the control group. In the control group, all decisions regarding diuretic therapy will be made solely by the attending physician, without the use of the algorithm.\n\nPatients will receive intravenous furosemide, with the initial dose determined by the attending physician. Two hours after administration of the diuretic, a spot urine sample will be collected to measure sodium and creatinine concentrations. Based on these values, the 6-hour urine output will be estimated using the machine learning, urine output prediction tool (http:\u002F\u002Fdiuresis.umw.edu.pl). This estimate will guide the diuretic therapy plan for the first 24 hours of hospitalization. On the second day, the procedure will be repeated using the same methodology.",[65,239],"Congestion, Venous",[241,242,243,244],"decongestion","diuretics","algorithm","acute heart failure","2025-08-06",{"date":247,"type":42},"2025-08-12",{"date":249,"type":42},"2025-08-01",{"date":251,"type":21},"2027-01-31",{"name":48,"class":49},2,{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":258,"acronym":259,"eligibilityCriteria":260,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":261,"targetDuration":263,"studyType":92,"phases":4,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":50},"100601334","registry-of-atrial-arrhythmia-ablation-procedures-using-pulsed-field-ablation-in-poland-100601334","NCT07109141","Registry of Atrial Arrhythmia Ablation Procedures Using Pulsed Field Ablation in Poland","PFA Registry","Inclusion Criteria:\n\n* Informed consent obtained from the participant\n* Subject is undergoing ablation of an atrial arrhythmia using the PFA\n\nExclusion Criteria:\n\n\\-",{"count":262,"type":21},500,"12 Months","The aim of the described project is to establish a multicenter, nationwide registry of atrial arrhythmia ablation procedures using the Pulsed Field Ablation (PFA) method. These procedures have only recently begun to be performed in several centers across Poland. With proper coordination of the registry, this will enable the consolidation of clinical data and the expansion of knowledge regarding the efficacy and safety of these procedures.",[212,266,267,213,215],"Atrial Flutter","Atrial Tachycardia","2025-07-31",{"date":270,"type":42},"2025-08-07",{"date":272,"type":42},"2024-08-01",{"date":274,"type":21},"2030-07-01",{"name":48,"class":49},{"id":277,"slug":278,"hasResults":11,"nctId":279,"briefTitle":280,"officialTitle":281,"acronym":282,"eligibilityCriteria":283,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":284,"enrollmentInfo":285,"targetDuration":4,"studyType":22,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":303,"locationsCount":304},"100497579","phase-4-effect-of-intravenous-ferric-carboxymaltose-onmortality-and-cardiovascular-morbidity-and-quality-of-life-in-iron-deficient-patients-with-recent-myocardial-infarction-100497579","NCT05759078","Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion","Effect of INtravenous FERRic Carboxymaltose Onmortality and Cardiovascular Morbidity, and Quality of Life in Iron Deficient Patients With Recent Myocardial infarCTion SUBTITLE Prevention of Cardiovascular Death, Heart Failure Events and Deterioration in Quality of Life With INtravenous FERRic Carboxymaltose in Iron Deficient Patients With Recent Myocardial Infarction","INFERRCT","Inclusion criteria:\n\n1. Age ≥18 years;\n2. Diagnosis of AMI (STEMI or NSTEMI) up to 4 weeks (28 days) before randomisation\n3. Presence of iron deficiency (ID) defined as transferrin saturation TSAT\\\u003C20% assessed within up to 4 weeks (28 days) before randomisation;\n4. Presence of ≥3 factors (confirmed within up to 4 weeks before randomisation) (note: at least one of a-c must be present):\n\n   1. LVEF ≤50%;\n   2. NT-proBNP ≥400 pg\u002FmL for subjects in sinus rhythm and NT-proBNP ≥800 pg\u002FmL for subjects with atrial fibrillation;\n   3. Clinical features of congestion\u002Fvolume overload (including Killip class II or more) requiring i.v. loop diuretic use;\n   4. Diagnosis of diabetes mellitus (also de novo diagnosis);\n   5. Diagnosis of atrial fibrillation (any time in the past or de-novo diagnosis);\n   6. Multivessel coronary disease (regardless of completeness of revascularisation during an index AMI);\n   7. Not complete revascularisation or\u002Fand no reperfusion (during an index AMI);\n   8. History of AMI (despite an index AMI);\n   9. eGFR \\\u003C60 mL\u002Fmin\u002F1.73m2; 1. Age ≥70 years.\n5. Written informed consent\n\nExclusion criteria:\n\n1. Subject temperature \\>38 ͦ C or any infection requiring antibiotic therapy within 48 hours prior to randomisation;\n2. Severe, symptomatic valve disorder;\n3. Urgent hospitalisation for whatever reasons (percutaneous\u002Fsurgical procedure requiring hospitalisation within 4 weeks prior to randomisation).\n4. Body weight \\\u003C50 kg;\n5. Haemoglobin \\\u003C8 g\u002FdL or \\>15,5 g\u002FdL;\n6. Serum ferritin \\>400 ng\u002FmL;\n7. Active gastroenteral bleeding;\n8. Known hypersensitivity to any of the administered preparations;\n9. Treatment with erythropoiesis stimulating factors, i.v. iron therapy or blood transfusion within 6 months prior to randomisation;\n10. Subject has known active malignancy of any organ system, i.e., clinical evidence of current malignancy or not in stable remission for at least 3 years since completion of last treatment with exception of non-invasive basal cell carcinoma, squamous cell carcinoma of the skin or cervical intra-epithelial neoplasia;\n11. Documented liver diseases;\n12. Participation in a device or drug trial within 3 months prior to randomisation or 5 half-lives, whichever period is longer, prior to the screening visit;\n13. Pregnancy or lactation;\n14. Any situation that may prevent the test from being performed in accordance with the protocol, or the consent of the investigator to be given in writing, including alcohol, drugs or any other substance overuse or addiction.","90 Years",{"count":286,"type":21},1000,[60],"Non-commercial, multicentre, randomised, double-blind, parallel group, placebo-controlled clinical trial. Eligible patients were randomly assigned (1:1) using a secure, central, interactive, web-based response system, to intervention FCM or placebo arm. Time of observation: minimum of 8 months up to a maximum of 36 months.\n\nPrimary Study Objective: Primary:\n\nEvaluation of the effect of i.v. FCM treatment compared with placebo on the risk of death, the risk of heart failure events (HFE\\*) (number of events and time to first event), NTproBNP concentration and the change in quality of life (QoL) assessed using EQ-5D during the follow-up up to 36-months in patients with recent AMI and ID (with an implementation of a win ratio approach in a hierarchical descending order).\n\n\\*HFE: unplanned hospitalization for HF (including unplanned visit at emergency department due to HF), ambulatory significant intensification of diuretic therapy (either starting i.v. loop diuretic or more than doubling oral loop diuretic dose or de novo initiation of oral loop diuretic therapy due to HF signs\u002Fsymptoms).",[290],"Myocardial Infarction, Acute",[292,293,294,295,296],"Myocardial infarction","acute","iron deficiency","Infusion","ferric carboxymaltose","2025-07-25",{"date":299,"type":42},"2025-07-30",{"date":301,"type":42},"2022-09-22",{"date":133,"type":21},{"name":48,"class":49},43,{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":332,"locationsCount":50},"100520210","the-impact-of-expandable-cryoballoon-on-autonomic-control-of-the-heart-100520210","NCT06053606","The Impact of Expandable Cryoballoon on Autonomic Control of the Heart","The Impact of Cryoablation Using Expandable (POLARxFIT) vs. Standard Size (POLARx) Balloon on Autonomic Control of the Heart","Inclusion Criteria:\n\n* primary PVI\n* paroxysmal atrial fibrillation\n* sinus rhythm at the admission\n* participant meets clinical criteria for PVI\n\nExclusion Criteria:\n\n* LA diameter \\\u003C38 mm or \\>50 mm\n* LVEF \\\u003C40%\n* intrinsic sinus node disease\n* advanced atrioventricular block (PR interval \\>300 ms, II or III degree AV block)\n* previous cardioneuroablation procedure\n* pregnancy\n* contraindications to anticoagulation treatment\n* any other clinical contraindications to PVI\n* known atropine intolerance","79 Years",{"count":314,"type":21},100,[24],"Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.",[318],"Paroxysmal Atrial Fibrillation",[320,321,322,323,324,325],"atrial fibrillation","ganglionated plexus","autonomic modulation","cryoablation","cryoballoon","expandable balloon","2025-07-20",{"date":328,"type":42},"2025-07-24",{"date":330,"type":42},"2024-05-10",{"date":133,"type":21},{"name":48,"class":49},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":338,"eligibilityCriteria":339,"healthyVolunteers":89,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":345,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":353,"leadSponsor":354,"locationsCount":50},"100593936","immunological-clinical-evaluation-of-the-etiopathogenesis-of-peri-implantitis-100593936","NCT07012915","Immunological-Clinical Evaluation of the Etiopathogenesis of Peri-Implantitis","PERI-EDU","Inclusion Criteria:\n\n* PD (Pocket Depth) at the implant site exceeds 6mm,\n* Positive BoP (Bleeding on Probing) index\n* Bone loss exceeding 66% on at least one implant surface\n\nExclusion Criteria:\n\n* General and local contraindications for surgical procedures\n* Pregnancy\n* Use of bisphosphonates or other antiresorptive medications in medical history",{"count":314,"type":21},[24],"A total of 100 adult volunteers of both sexes will be enrolled in the project. The study will be conducted within an international consortium formed for the project, comprising the following institutions: Wroclaw Medical University (Poland), Sapienza University of Rome (Italy), University of Barcelona (Spain), University of Bern (Switzerland), and Egas Moniz University (Portugal). Each international partner institution will recruit 20 volunteers as participants in the experiment. Each of the participating institutions will submit an application to their respective local bioethics committee for approval to conduct the medical experiment. Each partner institution will conduct procedures at their respective clinical locations.\n\nEligibility Criteria participants must have undergone previous implant treatment that has resulted in active, advanced peri-implantitis. Exclusion Criteria: General and local contraindications for surgical procedures Pregnancy; Use of bisphosphonates or other antiresorptive medications in medical history Laboratory Analysis Procedures.\n\nDuring the initial visit, patients will undergo a medical interview and a dental examination with regard to: Oral Hygiene Indices; Periodontal disease indices. For the implant site, the following parameters will be evaluated: Pocket Depth Bleeding on Probing Width and height of the attached gingiva Possible implant mobility, assessed using the Mobility Index Following the clinical examination, each participant will be referred for a Cone Beam Computed Tomography (CBCT) scan with measurements including: Bone loss percentage for each of the four implant surfaces, Bone density. Next, a 20ml venous blood sample will be collected from the antecubital vein of each participant and sent to a laboratory for further analysis, including: Hematological Inflammation Indices: Systemic Immune-Inflammation Index, Aggregate Index of Systemic Inflammation, Complete blood count, Lipid profile, APOA., APOBg, Inflammatory markers, albumin, total protein, total ferritin, fibrinogen, Cytokine profile, HOMA2 Parameters, Thyroid profile, Vitamin D level Next, each participant will undergo implant explantation surgery, during which tissue samples will be collected for further analysis. Implant surface will be analyzed using: light microscopy, scanning electron microscopy, corrosion testing.\n\nFollow-Up will be scheduled four weeks later with following evaluation: Clinical assessment of the implantation site. A CBCT scan to assess bone structure in the post-implantation region, with measurements including percentage of bone loss. Moreover, 20ml of venous blood will be collected from the antecubital vein of each participant. The blood sample will be preserved and sent to an analytical laboratory for further testing, including for same as previously mentioned tests.",[344],"Peri-Implantitis",[346,347,348],"Perii-implantitis","Titanium alloys corosion","Titanium implants","2025-07-07",{"date":351,"type":42},"2025-07-10",{"date":131,"type":42},{"date":133,"type":21},{"name":48,"class":49},{"id":356,"slug":357,"hasResults":11,"nctId":358,"briefTitle":359,"officialTitle":360,"acronym":361,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":363,"targetDuration":364,"studyType":92,"phases":4,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":378,"locationsCount":253},"100569657","polish-nationwide-registry-of-diagnostics-treatment-and-outcome-in-patients-with-cardiogenic-shock-100569657","NCT06697093","Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock","Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock CaS-POL","CaS-POL","Inclusion Criteria:\n\n* Cardiogenic shock patients of all etiologies in SCAI stage B, C, D, E.\n* age \\> 18 years old\n* persistent hemodynamic failure defined as systolic blood pressure of \\\u003C90 mmHg for ≥ 30 minutes or the requirement for inotropic or vasopressor agents with evidence of hypoperfusion of the peripheral organs\n\nExclusion Criteria:\n\n* patients without return of spontaneous circulation who were considered to extracorporeal cardiopulmonary resuscitation (ECPR)\n* primary septic, anaphylactic, hypovolemic shock\n* post-operative cardiogenic shock\n* end-stage of heart failure disqualified from mechanical circulatory support and heart transplantation",{"count":262,"type":21},"6 Months","The registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in Poland. Obtained information will help to plan the nationwide initiative for modern cardiogenic shock treatment with established place for mechanical circulatory support.\n\nIt is hypothesized that the treatment and outcome of cardiogenic shock, including mechanical circulatory support, are currently poor in Poland and should be improved. Unfortunately, without status quo data, efficient planning for its improvement cannot be conducted, hence the CaS-POL registry initiative.",[367],"Cardiogenic Shock",[369,370,371],"mechanical circulatory support","myocardial infarction","Cardiogenic shock","2025-03-26",{"date":374,"type":42},"2025-04-02",{"date":376,"type":21},"2025-04-01",{"date":133,"type":21},{"name":48,"class":49},{"id":380,"slug":381,"hasResults":11,"nctId":382,"briefTitle":383,"officialTitle":384,"acronym":385,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":387,"enrollmentInfo":388,"targetDuration":390,"studyType":92,"phases":4,"briefSummary":391,"conditions":392,"keywords":393,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":398,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":50},"100474999","lower-silesia-cardiogenic-shock-initiative-100474999","NCT05465200","Lower Silesia Cardiogenic Shock Initiative","Coordinated Treatment of Cardiogenic Shock Patients in Lower Silesia, Poland","LSCSI","Inclusion Criteria:\n\n1. Fulfilled definition of cardiogenic shock\n2. Age 18 - 60 years\n3. Shock duration below 24 hours\n\nExclusion Criteria:\n\n1. History of cardiac arrest with anoxemic brain injury\n2. Irreversible multiorgan failure\n3. End stage of chronic diseases other than heart failure\n4. Neoplastic disease\n5. Lack of vascular access","60 Years",{"count":389,"type":21},50,"1 Year","LSCSI is a Hub\\&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland. It consists of one \"hub\" which is Wroclaw University Hospital and eleven \"spokes\" which are eleven cardiology departments situated in Lower Silesian Voivodeship. The consortium have unified protocol defining which cardiogenic shock patient and when should be transferred to the \"hub\" for enhanced treatment options including durable mechanical circulatory support or heart transplant. The \"hub\" have 7\u002F24 Shock Team on-site supplied with a protocol how to proceed with \"spoke\" transferred patients including decision making on which mechanical circulatory support implant with subsequent de-escalation or escalation pathway.",[367],[371,394,395,396,397],"ECMO","Heart transplant","Mechanical circulatory support","Impella",{"date":374,"type":42},{"date":400,"type":42},"2022-01-01",{"date":402,"type":21},"2028-01-01",{"name":48,"class":49},{"id":405,"slug":406,"hasResults":11,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":387,"enrollmentInfo":411,"targetDuration":412,"studyType":92,"phases":4,"briefSummary":413,"conditions":414,"keywords":416,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":423,"locationsCount":50},"100449431","wroclaw-out-of-hospital-cardiac-arrest-registry-100449431","NCT05132387","Wroclaw Out-Of-Hospital Cardiac Arrest Registry","WOHCA","Inclusion Criteria:\n\n* Age \\\u003C 60 years\n* witnessed sudden cardiac arrest with immediate CPR\n* supposed cardiac cause of the event\n* ventricular fibrillation (VF) or pulseless ventricular tachycardia (VT) at first medical contact with 3 unsuccessful defibrillations (no ROSC)\n* CPR conducted with Lund University Cardiopulmonary Assist System (LUCAS™)\n* Estimated transfer time from the scene to the Emergency Department \\\u003C 30 minutes.\n* End tidal carbon dioxide (ETCO2) \\> 10 mmHg\n\nExclusion Criteria:\n\n* Total presumed time from 112 call to ECMO implantation longer than 60 minutes\n* Age \\\u003C 18 years old or \\> 60 years old;\n* Non-shockable initial rhythm\n* Unavailability of the automated CPR device\n* Unavailability of the catheterisation laboratory\n* Severe concomitant illness with decreased life expectancy\n* Severe body injury\n* Severe active bleeding\n* Drowning\n* Terminal cancer",{"count":389,"type":21},"1 Month","The purpose of this study is to assess the efficacy of institutionalized care program of patients with out-of-hospital cardiac arrest.",[415],"Out-Of-Hospital Cardiac Arrest",[417],"Cardiac arrest, ECMO, ECMO-CPR",{"date":419,"type":42},"2025-03-30",{"date":421,"type":42},"2021-10-25",{"date":402,"type":21},{"name":48,"class":49},{"id":425,"slug":426,"hasResults":11,"nctId":427,"briefTitle":428,"officialTitle":429,"acronym":430,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":432,"enrollmentInfo":433,"targetDuration":4,"studyType":22,"phases":435,"briefSummary":436,"conditions":437,"keywords":439,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":50},"100575894","phase-4-evaluation-of-the-efficacy-of-allergen-specific-immunotherapy-using-assessment-in-an-allergen-exposure-chamber-a-randomized-placebo-controlled-double-blind-study-100575894","NCT06778213","Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Assessment in an Allergen Exposure chamber-a Randomized Placebo-controlled Double-blind Study","A Randomized Placebo-controlled Double-blind Clinical Study for Evaluation of the Efficacy of Allergen-specific Immunotherapy Using Clinical and Biomarker Assessment in an Allergen Exposure Chamber and During Natural Exposure in Patients With House Dust Mite-triggered Allergic Rhinoconjunctivitis RANSES","RANSES","Inclusion Criteria:\n\nTo be eligible for trial participation, patients must meet all the following inclusion criteria:\n\n1. Written informed consent given from patient according to local requirements before any trial-related activities started (a trial-related activity is any procedure that would not have been performed during the routine management of the patient)\n2. Legally competent male or female outpatient between 18 and ≤ 65 years\n3. IgE-mediated moderate to severe allergic rhinitis or rhinoconjunctivitis with or without allergic asthma caused by HDM allergens documented by\n\n   Positive Skin prick test (SPT) result to D. pteronyssinus allergens:\n\n   D. pteronyssinus test solution (wheal diameter) ≥ 3 mm and Positive histamine-control reaction (wheal diameter) ≥ 3 mm and Negative NaCl-control reaction (wheal diameter) \\\u003C 2 mm Immunoassay result for specific IgE ≥ 0.70 kU\u002FL to D. pteronyssinus\n4. Symptoms of rhinitis or rhinoconjunctivitis e.g., during the months October to February or over the entire year for at least 2 years before enrolment.\n5. Assessment of persistent, moderate-severe rhinitis acc. to ARIA guidelines (Brozek et al.\n\n2017, Bousquet et al. 2001) Symptoms for 4 or more consecutive weeks in the previous years and for at least 4 days per week during those weeks More than one of the symptoms evaluated as \"troublesome\" by the patients and\u002For impairing their daily activities, leisure or sport, school, or work and\u002For involving sleep disturbance 6. Symptoms requiring regular intake of anti-symptomatic medication 7. Previous symptomatic anti-allergic medication for at least 2 seasons prior to enrolment 8. At entry to this trial: No diagnosis of bronchial asthma in medical history or confirmed diagnosis of asthma as being \"well controlled\" according to GINA recommendation (GINA 2022)\n\nExclusion Criteria:\n\nGeneral criteria:\n\n1. Patients are unable to understand and comply with the requirements of the trial, as judged by the investigator\n2. Currently participating in another clinical trial or participating in any other clinical trial within 30 days prior informed consent for this trial\n3. Low adherence to trial procedures expected or inability to understand instructions\u002Ftrial documents\n4. Involvement in the planning and conduct of the trial\n5. Any relationship of dependence with the investigator\n6. Previous randomization to treatment in the present trial\n7. Mentally disabled\n8. Institutionalized due to an official or judicial order For female patients with childbearing potential (i.e., females who are not chemically or surgically sterilized or females who are not post-menopausal)\n9. Positive urine pregnancy test or pregnant\n10. Wish to become pregnant during the course of the trial\n11. Not using highly effective and reliable contraception, as judged by the investigator (reliable and highly effective methods of birth control defined as a failure rate of less than 1% per year \\[CTFG recommendations 2020\\]) during the trial. Sexual abstinence is an allowed method of birth control (sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.) Males are not required to use any contraception during the study.\n12. Wish to breastfeed or breastfeeding\n\n    Immunotherapy criteria:\n13. History of a confirmed anaphylaxis after an AIT injection\n14. Current treatment with any kind of AIT\n15. AIT with HDM allergoids or allergens within the last 5 years\n16. AIT with unknown allergen within the last 5 years Sensitization criteria\n17. Clinically relevant symptoms to perennial and seasonal allergens which interfere with the assessment period of October to January. Exceptions are symptoms to allergens of cat and dog, if the patient has no direct contact to these animals.\n\n    Diseases and health status:\n18. Clinically relevant chronic rhinoconjunctival or respiratory symptoms related to other reasons than allergy\n19. Chronic persistent rhinitis symptoms for 20 years or longer\n20. Forced expiratory volume in 1 second (FEV1) \\\u003C 70 % of predicted normal values according to Quanjer (Quanjer et al. 2012) under adequate asthma treatment according to GINA recommendation (GINA 2022)\n21. Uncontrolled or partly controlled asthma according to GINA recommendation (GINA 2022)\n22. Asthma exacerbation within the last 6 months prior to randomization defined as unscheduled doctors visit, hospitalization, or emergency unit visit requiring the use of systemic corticosteroids or change of controller medication\n23. Severe acute or chronic diseases (e.g., COVID-19, chronic urticaria, mastocytosis, active tuberculosis, diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases (liver, kidneys)\n24. Autoimmune diseases, immune defects including immunosuppression, immune-complexinduced immunopathies (e.g., HIV, post-transplant patients, lupus erythematodes \\[SLE\\], vitiligo, Grave's disease, multiple sclerosis)\n25. Severe psychiatric and psychological disorders including impairment of cooperation (e.g., alcohol or drug abuse)\n26. Recurrent seizures (e.g., febrile convulsion, untreated epilepsy)\n27. Irreversible secondary alterations of the reactive organ (e.g., emphysema, bronchiectasis)\n28. For assessment the normal reference ranges of the central laboratory should be applied. If out of range, laboratory values greater than grade 1 according to the FDA Guidance for Industry (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials) will lead to exclusion of the patient.\n\n    Medications:\n29. Use of β-blockers (locally or systemically) and\u002For angiotensin-converting enzyme (ACE) inhibitors\n30. Contraindication for use of adrenalin (e.g., acute, or chronic symptomatic coronary heart disease, severe hypertension)\n31. Completion or ongoing treatment with anti-IgE-antibodies (e.g., omalizumab) or anti IL4\u002FIL13 antibodies (e.g., dupilumab) or other biological medication interfering with the TH2 pathway\n32. Completed or ongoing long-term treatment with tranquilizer or other psychoactive drugs","65 Years",{"count":434,"type":21},67,[60],"The main objective of the study is to measure and correlate clinical parameters suitable for the assessment of allergen immunotherapy (AIT) with an aluminum hydroxide-adsorbed preparation of house dust mite (Dermatophagoides pteronyssinus\u002F Dermatophagoides farinae) allergens in adults with moderate to severe allergic rhinitis\u002Frhinoconjunctivitis with or without controlled allergic bronchial asthma caused by house dust mite (HDM) allergens. The assessment of clinical responses will be evaluated following an allergen challenge in allergen exposure chamber (AEC) before and during the course of AIT. Patients' response to therapy will be evaluated as well as in the AEC and by patient's personal environment (Diary).",[438],"Allergic Rhinoconjunctivitis",[440,441,442,443,444],"allergen-specific immunotherapy","biomarker assessment","allergen exposure chamber","house dust mite","allergic rhinoconjunctivitis","2025-01-23",{"date":447,"type":42},"2025-01-28",{"date":449,"type":42},"2024-11-02",{"date":451,"type":21},"2026-12-01",{"name":48,"class":49},{"id":454,"slug":455,"hasResults":11,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":50},"100558389","comparison-of-three-types-of-distal-arteriovenous-fistulas-sbavf-rcavf-and-rcavf-with-venous-branch-patch-100558389","NCT06550479","Comparison of Three Types of Distal Arteriovenous Fistulas: SBAVF, RCAVF, and RCAVF With Venous Branch Patch.","Comparison of Tree Types of Distal Arteriovenous Fistulas: Snuffbox Fistula (SBAVF), Radiocephalic Fistula (RCAVF) and RCAVF With Venous Branch Patch.","Inclusion Criteria:\n\n* Aged \\>18 years\n* Chronic kidney disease with estimated glomerular filtration rate (eGFR) \\\u003C20 mL\u002Fmin\u002F1.73 m2\n\nExclusion Criteria:\n\n* Heart failure of New York Heart Association functional class III or IV,\n* Episode of cardio- or cerebrovascular event or receiving intervention therapy within 3 months prior to screening.\n* The patient had the primary anastomosis in the past on ipsilateral extremity",{"count":461,"type":21},180,[24],"This study aims to determine which type of distal arteriovenous fistula (SBAVF, RCAVF, and RCAVF with venous branch patch) is most clinically favorable.\n\nThe recommendations and scientific evidence do not suggest which option should be chosen initially.\n\nThe investigators expect that results will show which type of the anastomosis should be preferred.",[465,466],"Dialysis; Complications","Vascular Access Complication","2024-08-08",{"date":469,"type":42},"2024-08-13",{"date":471,"type":42},"2024-01-01",{"date":473,"type":21},"2030-07-31",{"name":48,"class":49},""]