[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Medical University of Gdansk\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":702},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,30,0,25,[9,48,78,108,142,177,202,236,266,285,307,343,364,392,423,458,488,519,554,577,593,613,632,657,675],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100643988","active-surveillance-vs-adjuvant-chemoradiotherapy-for-locally-resected-intermediate-risk-t1-rectal-cancer-100643988",false,"NCT07669298","Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer","Active Surveillance vs Adjuvant Chemoradiotherapy for Locally Resected Intermediate-Risk T1 Rectal Cancer: Multicentre Randomised Controlled Trial","T-REX","Inclusion Criteria:\n\n1. Pathologically confirmed rectal cancer located extraperitoneally.\n2. Complete tumour resection (R0) by means of ESD or IMD (endoscopic or TAMIS).\n3. Pathological report indicative of:\n\n   \\- pT1 with at least 1 of the following features: poor histological differentiation (grade 3), vascular invasion, lymphatic invasion, high tumour budding (grade 2-3), sm2 or sm3 invasion.\n4. Endoscopic images or video of the tumour before local excision.\n5. Maximum cancer diameter ≤ 30 mm based on the pathological assessment.\n6. cN0 stage based on pelvic MRI; lymph nodes smaller than 10 mm will be considered as benign, independent of morphologic features. Staging must be performed within 6 weeks before randomisation.\n\n   \\- If enlarged lymph nodes are present on MRI performed after ESD\u002FIMD (raising the possibility of reactive inflammatory change), fine needle aspiration (FNA) will be undertaken, and patients with negative FNA cytology will remain eligible.\n7. Adequate distant staging (thoracic and abdominal CT) without signs of distant metastasis (cM0).\n8. Have undergone a high-quality full colonoscopy:\n\n   * Boston Bowel Preparation Scale score equal or greater than 2 in all colonic segments.\n   * Documented caecal intubation.\n   * All polyps ≥20 mm in diameter other than the index lesion must be completely removed and assessed pathologically.\n9. Expected survival time of more than 12 months from randomisation.\n10. At least 18 years old at the time of informed consent.\n11. Eastern Cooperative Oncology Group performance status (ECOG PS) 0, 1 or 2.\n12. Adequate hematologic function, based upon meeting the following laboratory criteria within 7 days before randomisation:\n\n    * Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL.\n    * Haemoglobin (Hb) ≥ 8.0 g\u002FdL (red blood cell transfusions are allowed to reach the target level).\n    * Platelet count ≥ 75 × 10\\^9\u002FL.\n13. Adequate liver function, based upon meeting the following criteria within 7 days before randomisation:\n\n    * Serum albumin ≥ 3.0 g\u002FdL.\n    * Total bilirubin (in serum) ≤ 2.0 mg\u002FdL.\n    * Aspartate aminotransferase (AST) ≤ 3 × the upper limit of normal (ULN).\n    * Alanine aminotransferase (ALT) ≤ 3× ULN.\n    * Alkaline phosphatase (ALP) ≤ 3 × ULN.\n14. Adequate coagulation defined by International Normalized Ratio (INR) ≤ 2.0 within 7 days before randomisation.\n15. Adequate renal function, based upon meeting the following laboratory criteria within 7 days before randomisation:\n\n    * Serum creatinine clearance ≥ 50 mL\u002Fmin calculated using the Cockcroft-Gault formula.\n    * Absence of significant proteinuria. If the subject is found to have dipstick test indicative of proteinuria equal or larger than 2+, or lab urinalysis for protein is greater than or equal to 1 g\u002FL, the subject must demonstrate urine protein \\\u003C 1 g\u002F24 h to be eligible.\n16. Recovery from prior treatment-related toxicities to \\\u003C Grade 2 severity per CTCAE v6.0, unless the adverse events are clinically nonsignificant and\u002For stable on supportive therapy.\n17. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (e.g., barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study treatment. This does not apply to postmenopausal women (amenorrhoeic for at least 12 consecutive months), women aged above 55, or surgically sterilized patients (men and women).\n18. Female participants of childbearing potential must not be lactating or pregnant, with a negative beta-human chorionic gonadotropin (beta-hCG) test (blood or urine) at screening and before the first dose of the study treatment.\n\n    Females of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, ovarian suppression, low body weight, or other reasons.\n19. Written informed consent to participate in the study provided before randomisation.\n20. Capability of understanding and complying with the protocol requirements.\n21. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.\n22. Eligibility for thoracic, abdominal and pelvic CT and MRI.\n\nExclusion Criteria:\n\n1. Suspicion of distant metastases on computed tomography of the abdomen or thorax or lymph node involvement (lymph nodes \\>9mm in short axis); In case of isolated enlarged nodes biopsy will be required before exclusion.\n2. Mesorectal tumour involvement on pelvic MRI.\n3. Synchronous colorectal cancer in screening colonoscopy.\n4. Known genetic cancer syndrome, including, but not limited to adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome.\n5. Known inflammatory bowel disease.\n6. Previously identified allergy or hypersensitivity to 5-FU or capecitabine.\n7. Known or suspected dihydropyridine dehydrogenase (DPD) deficiency.\n8. Prior receipt of pelvic radiation.\n9. Other contraindications to pelvic irradiation.\n10. Serious illness other than cancer that would preclude safe participation in the study\n11. Uncontrolled and significant condition, including, but not limited to, the following conditions:\n\n    * Heart failure NYHA II or above.\n    * Major cardiac arrhythmia.\n    * Myocardial infarction within 6 months before randomisation.\n    * Unstable angina pectoris.\n    * Stroke (including transient ischemic attack, TIA) within 6 months before randomisation.\n    * Thromboembolism within 3 months before randomisation.\n    * History of hypertensive crisis.\n12. Gastrointestinal disorders associated with a high risk of perforation or fistula formation.\n13. Gastrointestinal bleeding event within 28 days of randomisation.\n14. Major surgery performed within 4 weeks prior to randomisation or scheduled for surgery during the study period. Complete healing from major surgery must have occurred 1 month before randomisation. Complete healing from minor surgery must have occurred at least 7 days before randomisation.\n15. Serious non-healing wound or bone fracture.\n16. Malabsorption syndrome.\n17. Pregnancy or lactation.\n18. Mismatch repair deficiency (dMMR) or microsatellite instability-high (MSI-H).","ALL","18 Years",{"count":21,"type":22},480,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to learn if close follow-up alone (active surveillance) works as well as radiation combined with chemotherapy (chemoradiotherapy) after removing early rectal cancer in adults. The main questions it aims to answer are:\n\n1. Does active surveillance cause fewer serious adverse events than chemoradiotherapy within 3 years? Serious adverse events include a permanent or temporary ostomy (a surgical opening in the belly to pass stool), major bowel problems, or severe treatment-related complications.\n2. Is active surveillance as safe as chemoradiotherapy in preventing cancer from coming back or spreading within 3 years?\n\nResearchers will compare active surveillance to chemoradiotherapy to see if surveillance causes fewer serious adverse events while keeping cancer outcomes comparable.\n\nTo join this study, participants must be adults who had an early-stage rectal cancer (T1) removed by an endoscopic procedure, and whose removed tumor showed certain features that raise the risk of cancer cells remaining nearby.\n\nParticipants will be randomly placed in one of two groups:\n\n1. Active surveillance group: Participants will have regular checkups, blood tests, flexible camera exams of the bowel (rectoscopy), scans of the pelvis and abdomen, and colonoscopy on a set schedule for 5 years. If cancer comes back, doctors will propose further treatment options.\n2. Chemoradiotherapy group: Participants will receive radiation to the pelvis along with a chemotherapy pill (capecitabine) or an intravenous (IV) chemotherapy drug (5-FU) for about 5 weeks. After treatment, they will have regular checkups and scans for 5 years.",[28],"Rectal Cancer",[30,31,32,33,34],"early rectal cancer","local excision","active surveillance","adjuvant chemoradiotherapy","organ preservation","RECRUITING","2026-06-20",{"date":38,"type":39},"2026-06-25","ACTUAL",{"date":41,"type":39},"2026-06-14",{"date":43,"type":22},"2037-06",{"name":45,"class":46},"Medical University of Gdansk","OTHER",3,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100415858","phase-4-dual-antithrombotic-therapy-with-dabigatran-and-ticagrelor-in-patients-with-acs-and-non-valvular-af-undergoing-pci-100415858","NCT04695106","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With ACS and Non-valvular AF Undergoing PCI","Dual Antithrombotic Therapy With Dabigatran and Ticagrelor in Patients With Acute Coronary Syndrome and Non-valvular Atrial Fibrillation Undergoing Percutaneous Coronary Intervention (ADONIS-PCI)","ADONIS-PCI","Inclusion Criteria:\n\n* Male and female patients aged ≥18 years'\n* Patients with new-onset or pre-existing non-valvular AF that have been receiving oral anticoagulant treatment with dabigatran for at least 48 hours or were treatment naïve prior to PCI. AF may be paroxysmal, persistent or permanent, but must not be secondary to a reversible disorder such as MI, pulmonary embolism, recent surgery, pericarditis or thyrotoxicosis unless long-term treatment with an OAC is anticipated.\n* Patients presenting with ACS that had undergone a successful PCI with drug-eluting stent (DES) implantation or plain old balloon angioplasty within the previous 120 hours. ACS may be ST-elevation myocardial infarction (STEMI), non-STEMI (NSTEMI), or unstable angina (UA). Successful treatment with PCI is defined as achievement of \\\u003C30% residual diameter stenosis of the target lesion assessed by visual inspection or quantitative coronary angiography and no in-hospital major adverse cardiac events (AMI or repeat coronary revascularisation of the target lesion). For ACS patients with ST-segment elevation, persistent ST-segment elevation of at least 0.1 mV in at least two contiguous leads or a new left bundle-branch block should be present. For ACS patients without ST-segment elevation, at least two of the following three criteria should be met: (i) ST-segment changes on electrocardiography, indicating ischemia; (ii) a positive test of a biomarker, indicating myocardial necrosis; or (iii) one of several risk factors (age ≥60 years; previous myocardial infarction or coronary artery bypass grafting; coronary artery disease with stenosis of ≥50% in at least two vessels; previous ischemic stroke, transient ischemic attack, carotid stenosis of at least 50%, or cerebral revascularization; diabetes mellitus; peripheral arterial disease; chronic renal dysfunction, defined as a creatinine clearance of \\\u003C60 ml per minute per 1.73 m2 of body surface area).\n* The patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and\u002For regulations.\n\nExclusion Criteria:\n\n* Mechanical or biological heart valve prosthesis;\n* PCI with bare-metal stent insertion;\n* Unsuccessful PCI (\\>30% residual stenosis of the target lesion);\n* Cardiogenic shock during current hospitalization;\n* Adverse bleeding or ischaemic event during current hospitalization;\n* Anaemia (haemoglobin \\\u003C10 g\u002FdL) or thrombocytopenia (platelet count \\\u003C100 x109\u002FL) at screening,\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin (estimated CrCl calculated by Cockcroft-Gault equation) at screening;\n* Active liver disease at screening defined as persistently elevated alanine aminotransferase (ALT) or aspartate transaminase (AST) \\>3-fold upper limit of normal (ULN)\n* Use of fibrinolytic agents within 24 hours of screening;\n* Gastrointestinal bleeding within 1 month prior to screening unless, in the opinion of the Investigator, the cause has been permanently eliminated (e.g., by surgery);\n* Major bleeding episode (reduction in the hemoglobin level of at least 2 g\u002FdL, transfusion of at least two units of blood, or symptomatic bleeding in a critical area or organ), including life-threatening bleeding episode (symptomatic intracranial bleeding, bleeding with a decrease in the hemoglobin level of at least 5 g\u002FdL or bleeding requiring transfusion of at least 4 units of blood or inotropic agents or necessitating surgery) within 1 month prior to screening;\n* Stroke within 1 month prior to screening;\n* Major surgery within 1 month prior to screening;\n* Malignancy or radiation therapy within 6 months prior to screening unless, in the opinion of the Investigator, the estimated life expectancy is greater than 36 months;\n* History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding unless the causative factor has been permanently eliminated or repaired;\n* Hemorrhagic disorder or bleeding diathesis (e.g. von Willebrand disease, hemophilia A or B or other hereditary bleeding disorder, history of spontaneous intra-articular bleeding, history of prolonged bleeding after surgery\u002Fintervention);\n* Past an organ transplant or patient on the waiting list for organ transplant;\n* Need for continued treatment with systemic ketoconazole, itraconazole, posaconazole, cyclosporine, tacrolimus, dronedarone, rifampicin, phenytoin, carbamazepine, St. John's Wort or any cytotoxic\u002Fmyelosuppressive therapy.\n* Need for continued treatment with non-steroidal anti-inflammatory drugs (NSAIDs);\n* Pre-menopausal women (last menstruation ≤1 year prior to screening) who: sre pregnant or breastfeeding or are not surgically sterile or are of childbearing potential and not practicing two acceptable methods of birth control, or do not plan to continue practicing an acceptable method of birth control throughout the trial. Acceptable methods of birth control are oral or parenteral (patch, injection, implant) hormonal contraception, which has been used continuously for at least one month prior to the first dose of study medication, intrauterine device or intrauterine system, double-barrier method of contraception (condom and occlusive cap or condom and spermicidal agent), male sterilization and complete sexual abstinence (if acceptable by local authorities). Periodic abstinence is not an acceptable method of contraception.\n* Known allergy to dabigatran, ticagrelor, clopidogrel, aspirin, or to the excipients used for the tables of the drugs;\n* Contraindications, in the Investigator's opinion to dabigatran, ticagrelor, clopidogrel, or aspirin;\n* Participation in another trial with an investigational drug or device within the past 30 days preceding the screening visit (patients participating in an observational study only will not be excluded);\n* Patients who are not willing or able to comply with the protocol requirements or considered unreliable by the Investigator concerning the requirements for follow-up during the study and\u002For compliance with study drug administration, who have a life expectancy less than the expected duration of the trial due to concomitant disease, or who have any condition which in the opinion of the Investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).",{"count":57,"type":22},1194,[59],"PHASE4","More than 25% of patients referred for diagnostic coronary angiography and percutaneous coronary intervention (PCI) due to acute coronary syndrome (ACS) suffer from non-valvular atrial fibrillation (AF). In this particular setting, balancing between the prevention of thrombosis and the risk of bleeding remains challenging. Oral anticoagulation (OAC) prevents stroke and systemic embolism, but has not been shown to prevent stent thrombosis (ST). Dual antiplatelet therapy (DAPT) reduces the incidence of recurrent ischemic events and ST, but is less effective in reducing the incidence of cardioembolic stroke associated with AF. A common guideline-supported practice is to combine three drugs (OAC, aspirin and clopidogrel) in a triple therapy, which is associated with high annual risk (up to 25%) of major bleeding. Thus, new therapeutic strategies are urgently needed to maintain the efficacy while improving the safety of treatment in patients with AF and ACS undergoing PCI.\n\nThis is a prospective, randomized, open-label, blinded-endpoint, non-inferiority trial. 1194 patients with non-valvular AF that had undergone successful PCI due to an ACS within the previous 120 hours will be randomized in 1:1 ratio to receive one of the two treatments: dual therapy with dabigatran (150 mg twice daily or 110 mg twice daily) and ticagrelor (90 mg twice daily for 1 month, followed by 60 mg twice daily up to 12 months), or standard therapy according to current guidelines triple therapy with dabigatran (150 mg b.i.d. or 110 mg b.i.d.) plus clopidogrel (75 mg o.d.) plus aspirin (75 mg o.d.) followed by double therapy depending on the bleeding and ischaemic risk. Study treatment will be continued for 12 months. The primary study end-point is the first major or clinically relevant non-major bleeding event (per ISTH), in a time-to-event analysis. The main secondary end-point is a composite efficacy end-point of thromboembolic events (myocardial infarction, stroke, or systemic embolism), death, or unplanned revascularization (PCI or coronary artery bypass grafting) at 12 months.\n\nWe expect that dual antithrombotic therapy including reduced dose ticagrelor and dabigatran is at least non-inferior regarding bleeding risk and ischaemic protection, compared to the standard triple therapy in patients with AF and after ACS, treated with PCI.",[62,63,64,65],"Atrial Fibrillation","Antithrombotic Therapy","Acute Coronary Syndrome","Percutaneous Coronary Interventions",[62,64,67,68,69],"Dabigatran","Ticagrelor","Antithrombotic therapy",{"date":71,"type":39},"2026-06-16",{"date":73,"type":39},"2021-10-25",{"date":75,"type":22},"2026-08-31",{"name":45,"class":46},1,{"id":79,"slug":80,"hasResults":12,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":23,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100637761","nurse-led-educational-intervention-for-caregivers-of-icu-patients-nurses-for-family---n4f-100637761","NCT07603219","Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F)","Feasibility And Acceptability of a Nurse-Led Educational Intervention for Caregivers of ICU Patients (Nurses For Family - N4F): Pilot Study","N4F","Inclusion Criteria:\n\nPatients:\n\n* Age \\>18 years\n* ICU stay \\> 24h\n\nCaregivers:\n\n* Age \\>18 years\n* consent to participate in the study\n* meeting the definition of a caregiver\n* able to complete questionnaires\n\nExclusion Criteria:\n\nPatients:\n\n* Age \\\u003C 18 years\n* Discharged\u002FDeceased form ICU \\\u003C 24h\n\nCaregivers:\n\n* Age \\\u003C 18 years\n* without cognitive impairment\n* no consent to participate in the study\n* No able to complete questionnaires",true,{"count":88,"type":22},20,[25],"Admission of a loved one to the intensive care unit (ICU) is a highly stressful experience for family members and caregivers. Many caregivers report increased levels of anxiety, stress, and depressive symptoms, often due to uncertainty about the patient's condition and difficulties in understanding medical information. Improving communication and providing clear, structured information may help reduce this psychological burden.\n\nThis study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of a nurse-led educational intervention called \"Nurses for Family\" (N4F), designed to support caregivers of ICU patients.\n\nThe study will include adult caregivers (aged 18 years or older) of patients admitted to the ICU for more than 24 hours. Participants must provide informed consent and be able to complete questionnaires independently. A total of 20 participants will be enrolled and allocated to one of two groups: an intervention group (receiving nurse-led educational support) or a control group (receiving standard care).\n\nData will be collected at two time points during the ICU stay. At baseline (24-48 hours after ICU admission), participants will complete the Hospital Anxiety and Depression Scale (HADS), which measures symptoms of anxiety and depression. At follow-up (7 days later), participants will complete the HADS again, along with the Family Satisfaction in the ICU (FSICU-24) questionnaire. Feasibility will be assessed based on recruitment and retention rates, adherence to the study protocol, and completeness of data collection. Acceptability will be evaluated through interviews conducted with participants from the control group.\n\nThis pilot study is expected to determine whether the N4F intervention is feasible and acceptable in a clinical setting and to provide preliminary evidence regarding its potential to reduce psychological distress and improve satisfaction among caregivers of ICU patients.",[92,93],"Caregiver","ICU Patients",[95,96,97,98],"ICU","caregiver","Family-Centered Care","Nurse-Led Interventions","NOT_YET_RECRUITING","2026-05-19",{"date":102,"type":39},"2026-05-22",{"date":104,"type":22},"2026-09",{"date":106,"type":22},"2027-09",{"name":45,"class":46},{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":12,"sex":18,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":121,"conditions":122,"keywords":126,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":139,"leadSponsor":141,"locationsCount":77},"100633022","individualized-rehabilitation-for-osgood-schlatter-or-sever-pain-in-youth-athletes-100633022","NCT07521280","Individualized Rehabilitation for Osgood-Schlatter or Sever Pain in Youth Athletes","Feasibility, Clinical Response, and Exploratory Predictors of an Individualized Load-Based Rehabilitation Pathway in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Prospective Single-Arm Interventional Study","LEAP-REHAB","Inclusion Criteria:\n\n* Aged 10 to 17 years\n* Participates in organized sport and has at least 12 months of sport participation or training history\n* Has current lower-extremity apophyseal pain consistent with Osgood-Schlatter-related knee pain and\u002For Sever-related heel pain, or has previous Osgood-Schlatter-related or Sever-related symptoms with a residual or low-irritability presentation relevant to rehabilitation\n* Meets criteria for at least one pre-specified rehabilitation entry pathway:\n\npost-trial rehabilitation entry after completion of the separate photobiomodulation trial, or direct-entry rehabilitation with active apophyseal symptoms, or direct-entry rehabilitation with previous Osgood-Schlatter-related or Sever-related symptoms and a low-irritability or residual presentation\n\nFor participants entering with active symptoms:\n\n* pain is located at the tibial tubercle region and\u002For the calcaneal apophyseal\u002Fheel region\n* pain is aggravated by activity, loading, or sport participation\n* pain is reproducible on clinical examination or the clinical history is consistent with the target condition\n\nParticipant and parent\u002Fcaregiver are willing to take part in the rehabilitation program, including in-person visits, home exercises, symptom\u002Factivity monitoring, and follow-up assessments.\n\nA parent or legal guardian provides written informed consent, and the participant provides assent when applicable.\n\nExclusion Criteria:\n\n* Current pain episode started after an acute traumatic injury that better explains the symptoms\n* Clinical presentation suggests a condition other than the target rehabilitation condition, including a major alternative knee or heel diagnosis requiring different management\n* Lower-limb surgery that would substantially affect rehabilitation planning, safety, or interpretation of outcomes\n* Known serious musculoskeletal, neurological, rheumatological, inflammatory, autoimmune, metabolic, or other systemic disease that may affect safe participation or interpretation of outcomes\n* Any medical or developmental condition that would prevent safe participation in exercise-based rehabilitation\n* Current symptoms requiring urgent medical assessment or management outside the rehabilitation pathway\n* Inability to understand study instructions or complete study procedures with parent\u002Fcaregiver support\n* Parent\u002Fcaregiver or participant does not agree to participate or withdraws consent\u002Fassent","10 Years","17 Years",{"count":119,"type":22},45,[25],"The goal of this clinical trial is to learn if a 12-week individualized rehabilitation program is feasible and helpful for children and adolescents with lower-extremity apophyseal pain, including Osgood-Schlatter-related knee pain and Sever-related heel pain. It will also learn about how well participants follow the program, whether the program can be delivered as planned, and whether pain, function, and sports participation improve during rehabilitation.\n\nThe main questions it aims to answer are:\n\n1. Can this rehabilitation program be delivered with good attendance, good home-exercise adherence, and complete follow-up data?\n2. Do pain, function, and sports participation improve during the rehabilitation period?\n3. Which baseline clinical, functional, ultrasound, maturity, or biomarker features may help explain who responds better to rehabilitation?\n\nAll participants will receive the same overall rehabilitation framework. The program includes education, pain and load monitoring, an activity-ladder approach, symptom-guided exercise progression, motor-control training, basic strength exercises, and gradual return to running, jumping, landing, and sport-specific activities. Exercises are individualized according to symptoms, current activity level, movement quality, treatment tolerance, and clinical judgement.\n\nParticipants will:\n\n1. Attend baseline and follow-up physiotherapy assessments.\n2. Receive an individualized rehabilitation plan with education, pain and load monitoring, and home exercises.\n3. Complete home exercises and keep a short symptom and activity log.\n4. Attend in-person physiotherapy review visits during the rehabilitation period.\n5. Answer questionnaires about pain, function, perceived change, and sports participation during follow-up.",[123,124,125],"Osgood-Schlatter Disease","Sever's Disease","Apophyseal Pain",[123,124,127,128,129,130,125,131,132,133,134],"Knee Pain","Heel Pain","Return to Sport","Load Management","Youth Athletes","Exercise Therapy","Physical Therapy","Rehabilitation","2026-05-16",{"date":137,"type":39},"2026-05-20",{"date":137,"type":22},{"date":140,"type":22},"2029-04-05",{"name":45,"class":46},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":12,"sex":150,"minAge":151,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":23,"phases":154,"briefSummary":155,"conditions":156,"keywords":160,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":77},"100638672","tens-as-an-adjunct-to-local-anaesthesia-during-transperineal-prostate-biopsy-a-randomized-sham-controlled-trial-100638672","NCT07578324","TENS as an Adjunct to Local Anaesthesia During Transperineal Prostate Biopsy: A Randomized Sham-Controlled Trial","Transcutaneous Electrical Nerve Stimulation as an Adjunct to Local Anaesthesia During Transperineal MRI-Ultrasound Fusion-Guided Prostate Biopsy: A Randomized Triple-Blind Sham-Controlled Trial","TENS 2","Inclusion Criteria:\n\n* Male patients aged 40 years or older\n* Indication for prostate biopsy: elevated serum PSA (as per institutional protocol and EAU guidelines) or abnormal digital rectal examination (DRE)\n* Suspicious lesion on multiparametric MRI classified as PI-RADS score 3 or higher (version 2.1)\n* Scheduled for transperineal MRI-ultrasound fusion-guided prostate biopsy under local anaesthesia\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Prior treatment for prostate cancer (surgical, radiotherapy, hormonal or focal therapy)\n* Contraindications to TENS: cutaneous damage or dermatologic conditions at electrode application sites; cardiac pacemaker or implantable cardioverter-defibrillator (ICD); uncontrolled cardiac arrhythmia or congestive heart failure; history of epilepsy or seizure disorder; metallic implants near the stimulation site; malignancy at or near the stimulation site\n* Contraindications to transperineal biopsy: active urinary tract infection; bleeding disorder or ongoing anticoagulation not amendable to bridging; anatomical abnormalities preventing safe prostatic access\n* Known allergy or intolerance to local anaesthetic agents or biopsy-related materials\n* Severe comorbidities or unstable medical condition compromising procedural safety\n* Inability to complete questionnaires\n* Participation in another interventional clinical trial within 30 days prior to enrolment","MALE","40 Years",{"count":153,"type":22},140,[25],"Transperineal prostate biopsy is a safe and effective method of diagnosing prostate cancer. When performed under local anaesthesia in an outpatient setting, it can cause significant pain, particularly during the periprostatic nerve block - the injection of local anaesthetic around the prostate. Better pain management during this procedure may improve patient comfort and encourage wider use of the transperineal approach.\n\nTranscutaneous electrical nerve stimulation (TENS) is a non-invasive, low-cost method of pain relief that works by delivering mild electrical impulses through the skin. A preceding pilot study at our centre (n=84) found that TENS used alongside local anaesthesia was associated with significantly lower pain scores during periprostatic nerve block and biopsy sampling, with no device-related complications.\n\nThis study aims to confirm these findings in a larger, formally powered, triple-blind, randomized controlled trial. Participants will be randomly assigned to receive either active TENS or sham TENS (electrodes applied but no electrical current delivered) in addition to standard local anaesthesia. Neither the participant, the operating urologist, nor the nurse recording pain scores will know which group the participant is in.\n\nPain intensity will be assessed at four stages of the procedure using a 0-10 numeric rating scale. Participants will be followed up at 30 days after the biopsy.",[157,158,159],"Prostate Cancer (Diagnosis)","Prostate Biopsy","Pain, Procedural",[161,162,163,164,165,166,167,168],"Transcutaneous Electrical Nerve Stimulation","TENS","Transperineal Prostate Biopsy","Local Anaesthesia","Periprostatic Nerve Block","Pain Management","MRI-Ultrasound Fusion Biopsy","Randomized Controlled Trial","2026-05-05",{"date":171,"type":39},"2026-05-11",{"date":173,"type":22},"2026-06",{"date":175,"type":22},"2027-02",{"name":45,"class":46},{"id":178,"slug":179,"hasResults":12,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":12,"sex":18,"minAge":116,"maxAge":117,"enrollmentInfo":184,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":77},"100627275","low-level-laser-therapy-for-osgood-schlatter-or-sever-pain-in-youth-athletes-100627275","NCT07446517","Low-Level Laser Therapy for Osgood-Schlatter or Sever Pain in Youth Athletes","Effect of Low-Level Laser Photobiomodulation on Pain, Function, Ultrasound Findings, and Biochemical Markers in Youth Athletes With Osgood-Schlatter Disease or Sever Disease: A Randomized, Double-Blind, Sham-Controlled Trial","Inclusion Criteria:\n\n* Aged 10 to 17 years\n* Participates in organized sport with at least 12 months of training history\n* Has knee pain at the tibial tubercle (Osgood-Schlatter-type pain) and\u002For heel pain at the back of the heel (Sever-type pain)\n* Pain is worse with activity and reproduced by pressing on the painful area\n* Pain intensity is 3 out of 10 or higher on the Numeric Pain Rating Scale (NPRS) during the clinical visit and in the last week (0 = no pain, 10 = worst pain imaginable)\n* Symptoms have been present for at least 2 weeks\n* For heel pain consistent with Sever disease, the heel squeeze test is positive\n* Ultrasound shows findings consistent with an apophyseal injury at the painful site\n* Has no signs of acute illness or infection on the assessment day and during the previous 14 days (for example, fever or \"flu-like\" symptoms)\n* A parent\u002Fguardian provides written informed consent\n* The participant provides assent (agreement) to take part\n\nExclusion Criteria:\n\n* Current pain episode started after an acute injury (for example, fall, collision, ankle sprain, or similar trauma)\n* Prior surgery on the lower limb\n* Known diagnosis of patellofemoral pain syndrome (pain around\u002Fbehind the kneecap)\n* Known patellar instability (recurrent kneecap dislocations or giving way)\n* Known complex regional pain syndrome\n* History of lower-limb fracture\n* Ultrasound shows clinically important abnormalities in the assessed area that are not consistent with the target condition (for example, calcifications or other significant findings)\n* Known chronic or systemic disease that may affect the musculoskeletal system (for example, inflammatory joint disease or other clinically significant chronic conditions)\n* Received any of the following in the last 3 months: steroid injection, hydrodilatation, or laser therapy\n* Used non-steroidal anti-inflammatory drugs (NSAIDs) (for example, ibuprofen, naproxen) within the last 14 days, or currently uses them\n* Clinically important abnormal blood test results (complete blood count) that may affect safety or data validity\n* Parent\u002Fguardian or participant does not agree to participate, or withdraws consent\u002Fassent",{"count":5,"type":22},[25],"The goal of this clinical trial is to learn if low-level laser therapy (also called photobiomodulation) works to treat knee or heel pain in physically active children and adolescents with Osgood-Schlatter disease or Sever disease. It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\n1. Does low-level laser therapy lower pain more than a sham (placebo) laser treatment?\n2. Does low-level laser therapy improve daily and sport-related function more than a sham laser treatment?\n3. What medical problems, if any, do participants have during the study?\n\nResearchers will compare active low-level laser therapy to a sham (placebo) laser treatment. The sham treatment looks and feels the same but does not deliver therapeutic light. This comparison will show whether the laser therapy works better than placebo.\n\nParticipants will:\n\n* Complete screening and a baseline visit\n* Be randomly assigned to active laser therapy or sham laser therapy\n* Receive a series of treatment sessions over \\[2 weeks\\]\n* Answer short questionnaires about pain and function at baseline and follow-up visits\n* Have ultrasound imaging and\u002For provide blood or urine samples for research measurements\n\nBoth participants and the study team who assess outcomes will not know which treatment group each participant is in until the study ends.",[123,124],[189,190,123,191,192,128,193],"Low-Level Laser Therapy","Photobiomodulation","Apophysitis","Traction Apophysitis","Tibial Tubercle Pain","2026-03-14",{"date":196,"type":39},"2026-03-17",{"date":198,"type":39},"2026-03-01",{"date":200,"type":22},"2029-02-01",{"name":45,"class":46},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":86,"sex":18,"minAge":19,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100629876","vegan-diet-and-immune-inflammatory-outcomes-in-asthma-and-healthy-adults-100629876","NCT07480369","Vegan Diet and Immune-Inflammatory Outcomes in Asthma and Healthy Adults","The Effect of a Vegan Diet on Inflammatory and Immune Biomarkers in Adult Patients With Asthma and in Healthy Individuals: A Randomized Controlled Trial","VEGASTHMA","Inclusion Criteria:\n\nFor all groups:\n\n* Aged 18-30 years\n* Willing to adhere to assigned dietary plan (vegan or omnivorous) for 12 weeks\n* Non-smoker for at least 5 years\n* Body mass index (BMI) between 18.5 and 24.9 kg\u002Fm2\n\nFor the asthma group:\n\n* Clinical diagnosis of mild or moderate asthma (GINA criteria), made at least 12 months before enrollment\n* Stable asthma status (no exacerbations or changes in therapy within the past 3 months)\n* No change in pharmacotherapy during the study period\n\nExclusion Criteria:\n\n* Use of systemic corticosteroids (oral or intravenous) within the past 3 months\n* Ongoing biological therapy for asthma (e.g., anti-IgE, anti-IL-5, anti-IL-4R)\n* Severe asthma as per GINA criteria\n* Recent asthma exacerbation requiring hospitalization or steroid burst (\\\u003C3 months)\n* Presence of other chronic autoimmune or inflammatory diseases\n* Pregnancy or lactation\n* Active infection or acute illness at the time of recruitment\n* Adherence to specialized exclusion diets (e.g., ketogenic, low-FODMAP)\n* History of eating disorders\n* Inability or unwillingness to participate in follow-up visits or comply with the protocol","50 Years",{"count":212,"type":22},280,[25],"This randomized controlled study evaluates the effects of a balanced vegan diet compared with a balanced omnivorous diet on inflammatory and immune response markers and clinical asthma parameters in healthy adults and individuals with mild to moderate asthma, aged 18 to 50. Participants will follow assigned dietary plans for 12 weeks with dietitian support delivered via digital tools.",[216,217,218],"Asthma","Dietary Intervention","Vegan Diet",[220,221,222,223,224,225,226,227,228],"asthma","asthma control","inflammation","inflammatory markers","immune response","vegan diet","plant-based diet","randomized control trial","dietary intervention",{"date":230,"type":39},"2026-03-18",{"date":232,"type":22},"2026-03",{"date":234,"type":22},"2029-09-30",{"name":45,"class":46},{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":23,"phases":245,"briefSummary":246,"conditions":247,"keywords":252,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100627511","pericapsular-nerve-group-block-versus-intrathecal-morphine-for-analgesia-after-total-hip-arthroplasty-100627511","NCT07449585","Pericapsular Nerve Group Block Versus Intrathecal Morphine for Analgesia After Total Hip Arthroplasty","Comparison of the Efficacy of the Pericapsular Nerve Group (PENG) Block Versus Intrathecal Morphine for Postoperative Analgesia Following Total Hip Arthroplasty","Inclusion Criteria:\n\n* Informed, written consent for study participation.\n* Qualification for elective primary total hip arthroplasty via a posterolateral approach.\n* Age above 18 years.\n* ASA Physical Status I-III.\n* Absence of contraindications to spinal anesthesia.\n* Absence of contraindications to performing a Pericapsular Nerve Group (PENG) block.\n* Absence of contraindications to the administration of the pharmacological agents utilized in the study.\n\nExclusion Criteria:\n\n* Absence of informed consent.\n* Age below 18 years.\n* Psychoactive substance abuse or dependence.\n* Chronic opioid therapy.\n* Contraindications to spinal anesthesia.\n* Contraindications to the Pericapsular Nerve Group (PENG) block.\n* Contraindications to the administration of study medications.\n* Body Mass Index (BMI) above 30 kg\u002Fm\\^2.\n* Pregnancy.\n* History of chronic pain management.",{"count":244,"type":22},180,[25],"The Pericapsular Nerve Group (PENG) block is an effective method for postoperative pain management in patients undergoing primary total hip arthroplasty (THA) via a posterolateral approach. The application of this technique reduces postoperative opioid requirements, thereby limiting the risk of adverse effects associated with systemic opioid administration. Effective pain control and a reduced incidence of side effects may translate into higher patient satisfaction and a decreased length of hospital stay (LOS). The PENG block serves as an effective component of multimodal analgesia and may provide an alternative to intrathecal morphine in patients undergoing primary total hip arthroplasty via a posterolateral approach, where the primary anesthetic technique is spinal anesthesia with hyperbaric bupivacaine.\n\nObjectives\n\n1. To evaluate the efficacy of the PENG block in postoperative pain control and compare its effectiveness with intrathecal morphine administration.\n2. To assess the impact of the PENG block on postoperative opioid consumption in comparison to analgesia achieved via intrathecal morphine.\n3. To analyze the incidence of selected adverse effects associated with systemic opioid administration in patients receiving a PENG block versus those in the intrathecal morphine group.\n4. To evaluate patient satisfaction levels regarding postoperative pain management across the different analgesic modalities.\n5. To analyze the correlation between the type of analgesia employed and the duration of hospitalization.",[248,249,250,251],"Perioperative Analgesia","Hip Replacement, Total","Postoperative Pain","Hip Disease",[253,254,255,256,250,257,258,259],"Pericapsular Nerve Group Block","Intrathecal Morphine","Spinal Anesthesia","Total Hip Arthroplasty","Postoperative Analgesia","Opioid Consumption","Patient-Controlled Analgesia",{"date":261,"type":39},"2026-03-04",{"date":198,"type":22},{"date":264,"type":22},"2028-12-31",{"name":45,"class":46},{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":86,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":274,"phases":4,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":283,"leadSponsor":284,"locationsCount":77},"100623482","assessment-of-the-repeatability-of-sublingual-microcirculation-function-measurements-in-healthy-volunteers-and-critically-ill-patients-100623482","NCT07397208","Assessment of the Repeatability of Sublingual Microcirculation Function Measurements in Healthy Volunteers and Critically Ill Patients","Group 1: Healthy Volunteers\n\nInclusion Criteria:\n\n* ASA Physical Status I-II\n* Age 18-40 years\n\nExclusion Criteria:\n\n* Chronic diseases\n* Chronic medication use\n* Pregnancy\n* Use of stimulants (caffeine, nicotine, alcohol) within 12 hours prior to the study\n* Lack of consent to participate\n\nGroup 2: Patients Hospitalized in the ICU\n\nInclusion Criteria:\n\n* Age \\> 18 years\n* Hospitalization in the Intensive Care Unit (ICU)\n* Requirement for vasoactive drugs (minimum norepinephrine equivalent dose \\>0.1μg\u002Fkg \u002F min )\n* Mechanical ventilation via an endotracheal tube\n\nExclusion Criteria:\n\n* Head and craniofacial trauma\n* Pregnancy\n* Intensive fluid therapy (\\>200ml\u002Fh)\n* Changes in vasoactive drug dosages within 30 minutes prior to study inclusion\n* Hypothermia (body temperature \\\u003C35.5 oC)\n* Fever (body temperature \\>38.5oC)",{"count":273,"type":22},200,"OBSERVATIONAL","The assessment of microcirculatory function plays a pivotal role in perioperative medicine and intensive care. One promising method for evaluating microcirculatory function is the microscopic analysis of the oral mucosal microvasculature. However, this method is not currently fully validated.\n\nThe aim of this study is to assess the repeatability of sublingual microcirculation measurements using the CytoCam-IDF device (Braedius Medical).",[277,278],"Critical Illness","Healthy","2026-02-07",{"date":281,"type":39},"2026-02-10",{"date":279,"type":22},{"date":200,"type":22},{"name":45,"class":46},{"id":286,"slug":287,"hasResults":12,"nctId":288,"briefTitle":289,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":306,"locationsCount":4},"100623462","the-effectiveness-of-two-physiotherapy-protocols-in-the-treatment-of-patellofemoral-pain-syndrome-100623462","NCT07396948","The Effectiveness of Two Physiotherapy Protocols in the Treatment of Patellofemoral Pain Syndrome","Inclusion Criteria: anterior knee pain (unilateral or bilateral) lasting at least one month -\n\nExclusion Criteria: previous knee injuries or surgeries, systemic diseases, patellar dislocation or subluxation, patellar maltracking, ligamentous laxity, patellar tendon pathologies, spinal pain, other abnormalities such as leg length discrepancy \\>2 cm, patients treated pharmacologically, with physiotherapy, or acupuncture in the knee area within the past 30 days\n\n\\-","55 Years",{"count":293,"type":22},46,[25],"Patellofemoral pain syndrome (PFPS) is one of the most common causes of anterior knee pain in young and active individuals. PFPS is characterized by anterior knee pain. The treatment of choice is conservative management. However, there is still lack of widely accepted physiotherapeutic strategies aimed at alleviating patellofemoral pain. The outcomes of conservative treatment remain unsatisfactory. Therefore, the aim of this study was to compare the effectiveness of two physiotherapy protocols based on manual therapy and muscle training in the treatment of patellofemoral pain",[297],"Patellofemoral Disorder",[299],"patellofemoral pain syndrome","2026-02-02",{"date":302,"type":39},"2026-02-09",{"date":304,"type":22},"2026-01-22",{"date":232,"type":22},{"name":45,"class":46},{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":314,"targetDuration":316,"studyType":274,"phases":4,"briefSummary":317,"conditions":318,"keywords":324,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":77},"100619498","genecard---the-use-of-genetic-epigenetic-metabolomic-proteomic-and-microbiotic-markers-image-and-voice-biomarker-analyses-and-pre--and-intraoperative-clinical-data---to-predict-early-complications-after-cardiac-surgery-100619498","NCT07345403","GENECARD - the Use of Genetic, Epigenetic, Metabolomic, Proteomic and Microbiotic Markers, Image and Voice Biomarker Analyses, and Pre- and Intraoperative Clinical Data - to Predict Early Complications After Cardiac Surgery.","GENECARD","Inclusion Criteria:\n\n* Adults (≥18 years old)\n* Undergoing elective cardiac surgery\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Age below 18 years\n* Lack of informed consent\n* Prior or planned solid organ transplantation\n* Prior or planned bone marrow transplantation",{"count":315,"type":22},3000,"30 Days","The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients.\n\nThe main questions it aims to answer are:\n\nWhich biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores?\n\nResearchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers.\n\nParticipants will:\n\nProvide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing.\n\nUndergo standard preoperative and intraoperative imaging and clinical assessments.\n\nAllow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium.\n\nThis study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.",[319,320,321,322,323],"Postoperative Delirium (POD)","Postoperative Bleeding","Acute Kidney Injury","Atrial Fibrillation (AF)","Vasoplegia",[325,326,62,321,327,323,328,329,330,331,332,333,334],"Cardiac Surgery","Postoperative Complications","Postoperative Delirium","Biomarkers","Multi-omics","Risk Prediction","Epigenetics","genetics","microbiota","metabolomics","2026-01-08",{"date":337,"type":39},"2026-01-15",{"date":339,"type":22},"2026-01-01",{"date":341,"type":22},"2029-12-31",{"name":45,"class":46},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":347,"acronym":4,"eligibilityCriteria":348,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":349,"targetDuration":4,"studyType":23,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":4},"100614306","phase-4-the-effect-of-reversal-of-remimazolam-sedation-with-flumazenil-on-cognitive-function-in-patients-undergoing-hip-arthroplasty-under-spinal-anesthesia-100614306","NCT07277881","The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia","Inclusion Criteria:\n\n* Patient qualified for elective, primary, unilateral, total hip replacement.\n* Patient assessed on the ASA I-III scale.\n* MoCA score obtained during screening ≥ 23 points (to exclude patients with significant pre-existing cognitive impairment).\n* Ability to understand information about the study and express informed, written consent to participate.\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to benzodiazepines, flumazenil, local anesthetics\n* Contraindications to spinal anesthesia or patient refusal of this anesthesia technique.\n* Severe liver dysfunction.\n* History of epilepsy or seizures\n* Chronic (daily use for \\> 2 weeks in the last 3 months) use of benzodiazepines or non-benzodiazepine hypnotics (so-called \"Z\" drugs: zolpidem, zopiclone, zaleplon).\n* Alcohol abuse defined as regular consumption of more than: in men: 40 g of pure ethanol at a time; in women: 20 g of pure ethanol at a time, or a history of psychoactive substance dependence.\n* Planned revision hip arthroplasty or bilateral surgery.\n* Significant neurological or psychiatric diseases that may affect the assessment of cognitive function.\n* The need for sedative premedication.",{"count":350,"type":22},150,[59],"This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are:\n\n* Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo?\n* Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium.\n\nParticipants will:\n\n* Undergo a planned total hip replacement surgery under spinal anesthesia.\n* Receive sedation with remimazolam during the operation.\n* At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo.\n* Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery.\n* Complete a questionnaire about their quality of recovery (QoR-15).",[327,354,355,356],"Sedation","Remimazolam","Hip Arthroplasty, Total",{"date":358,"type":39},"2026-01-06",{"date":360,"type":22},"2026-01",{"date":362,"type":22},"2028-10",{"name":45,"class":46},{"id":365,"slug":366,"hasResults":12,"nctId":367,"briefTitle":368,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":12,"sex":371,"minAge":19,"maxAge":4,"enrollmentInfo":372,"targetDuration":4,"studyType":23,"phases":374,"briefSummary":375,"conditions":376,"keywords":379,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":389,"leadSponsor":391,"locationsCount":77},"100617810","a-midwife-led-psychoeducational-intervention-to-reduce-pregnancy-related-anxiety-in-low-risk-pregnant-women-100617810","NCT07323459","A Midwife-Led Psychoeducational Intervention to Reduce Pregnancy-Related Anxiety in Low-Risk Pregnant Women","Effectiveness of an Individual Midwife-Led Psychoeducational Intervention in Reducing Pregnancy-Related Anxiety in Pregnant Women","Inclusion Criteria:\n\n* Pregnant women in the second or third trimester of pregnancy\n* Elevated level of pregnancy-related anxiety (PrA)\n* Low obstetric risk pregnant women (no significant medical contraindications to vaginal delivery)\n* Consent to participate in individual psychoeducational sessions\n* Ability to communicate in Polish at a level sufficient to understand the materials and participate in the sessions\n\nExclusion Criteria:\n\n* Pregnant women with severe mental disorders requiring urgent psychiatric intervention\n* Women with serious obstetric complications in the current pregnancy requiring intensive medical monitoring (e.g., severe hypertension, imminent preterm delivery requiring hospitalization)\n* Patients already undergoing intensive psychotherapy or pharmacotherapy for anxiety\n* Lack of consent to participate or inability to attend sessions (e.g., due to logistical reasons)\n* Pregnant women whose pregnancy-related anxiety is not the primary concern, with other dominant anxiety disorders (e.g., GAD unrelated to pregnancy) or other priority health needs","FEMALE",{"count":373,"type":22},80,[25],"The goal of this clinical trial is to evaluate whether an individualized psychoeducational intervention led by an experienced midwife can reduce pregnancy-related anxiety (PrA) in pregnant women during the second and third trimesters. The main questions it aims to answer are:\n\n* Can individualized midwife-led psychoeducation significantly reduce pregnancy-related anxiety levels as measured by the PRAQ-R2 questionnaire?\n* Does this intervention improve women's sense of control, competence, and readiness for childbirth?\n* Can the intervention reduce preferences for cesarean section without medical indication among low-risk pregnant women?\n\nParticipants will:\n\n* Attend 4-6 individual sessions (approximately 60 minutes each) with a midwife, scheduled every 1-2 weeks\n* Complete the Pregnancy-Related Anxiety Questionnaire (PRAQ-R2) at the beginning and end of the intervention to measure anxiety levels\n* Receive evidence-based education about the physiological process of childbirth, pain management methods (both pharmacological and non-pharmacological), and medical procedures\n* Learn and practice stress-reduction techniques including breathing exercises, relaxation methods, and mindfulness\n* Develop an individualized birth plan and practice communication skills for effective interaction with medical personnel\n* Work on cognitive strategies to address negative thoughts and build positive affirmations about childbirth",[377,378],"Pregnancy-Related Anxiety (PrA)","Fear of Childbirth",[380,381,382,383,384],"prenatal care","pregnancy-related anxiety","maternal mental health","anxiety","pregnancy","2025-12-31",{"date":387,"type":39},"2026-01-07",{"date":339,"type":22},{"date":390,"type":22},"2028-02-28",{"name":45,"class":46},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":400,"enrollmentInfo":401,"targetDuration":402,"studyType":274,"phases":4,"briefSummary":403,"conditions":404,"keywords":411,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":77},"100617151","psychiatric-status-and-symptom-severity-in-graft-versus-host-disease-gvhd-100617151","NCT07314892","Psychiatric Status and Symptom Severity in Graft-versus-Host Disease (GvHD).","Prospective Assessment of the Impact of Psychiatric Status on Clinical Symptom Severity in Patients With Graft-versus-Host Disease (GvHD).","Psych-GvHD","Inclusion Criteria:\n\n* Adult patients with a clinically established diagnosis of graft-versus-host disease (GvHD) receiving specialist follow-up care at the Bone Marrow Transplantation Outpatient Clinic, University Clinical Center (UCK), Gdańsk.\n\nExclusion Criteria:\n\n* Severe psychiatric disorders precluding adequate cooperation, terminal-stage multiorgan failure, or refusal to provide informed consent for study participation.","75 Years",{"count":273,"type":22},"1 Year","This prospective observational study evaluates the association between psychiatric status, GvHD-related symptom severity, and health-related quality of life in patients with graft-versus-host disease. Standardized and validated assessment tools, including the Lee Symptom Scale, will be used to collect psychiatric, clinical, and demographic data.",[405,406,407,408,409,410],"GVHD, Chronic","GVHD - Graft-Versus-Host Disease","GVHD","Quality of Life","Depression Disorders","Cognitive Impairments",[412,413,414,415],"GvHD","depression","quality of life","Cognitive impairment","2025-12-18",{"date":418,"type":39},"2026-01-02",{"date":420,"type":39},"2025-04-08",{"date":362,"type":22},{"name":45,"class":46},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":23,"phases":433,"briefSummary":434,"conditions":435,"keywords":443,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":77},"100613720","reduced-dose-apixaban-and-rivaroxaban-versus-low-molecular-weight-heparin-in-patients-with-hematologic-malignancies-100613720","NCT07270263","Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies","Efficacy and Safety of Reduced-Dose Apixaban and Rivaroxaban Versus Low-Molecular-Weight Heparin in Patients With Hematologic Malignancies: A Prospective Randomized Study","HEM-DOAC","Inclusion Criteria:\n\n* Active hematologic malignancy at the time of initiation of systemic therapy, including multiple myeloma, myeloproliferative neoplasm, lymphoma or other hematologic cancer with a Khorana score ≥ 2 points (intermediate or high risk of venous thromboembolism, VTE)\n* Use of anticoagulant agents for primary thromboprophylaxis, including direct oral anticoagulants (DOACs) at reduced doses (apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily) or low-molecular-weight heparin (LMWH) (enoxaparin 40 mg subcutaneously once daily).\n\nExclusion Criteria:\n\n* Major bleeding within the last month (including gastrointestinal or intracranial bleeding).\n* Active major bleeding.\n* Hemoglobin concentration \\\u003C 8 g\u002FdL.\n* Thrombocytopenia with platelet count \\\u003C30 × 10⁹\u002FL.\n* ECOG performance status of 3 or 4.\n* Expected survival \\\u003C6 months.\n* History of mechanical heart valve or severe mitral stenosis.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 25 mL\u002Fmin.\n* Hepatic impairment (ALT ≥ 3× upper limit of normal or bilirubin ≥ 2× upper limit of normal).\n* Acute coronary syndrome or ischemic stroke within the last 6 months.\n* Anticipated significant drug-drug interactions between DOACs and anticancer agents.\n* Known antiphospholipid syndrome (APS).",{"count":432,"type":22},100,[25],"This study investigates the efficacy and safety of direct oral anticoagulants (DOACs) in comparison with standard low-molecular-weight heparin (LMWH) for the prevention of venous thromboembolism in patients with hematological malignancies. Eligible participants will be randomized to receive reduced-dose apixaban, reduced-dose rivaroxaban, or standard-dose LMWH. The primary objective is to evaluate the incidence of venous thromboembolism during a 6-month follow-up period. Secondary objectives include assessment of bleeding complications, overall survival, and treatment adherence. The results of this study may provide evidence for safer and more convenient thromboprophylaxis strategies in patients with blood cancers.",[436,437,438,439,440,441,442],"Lymphoma","Leukemia","Multiple Myeloma (MM), Lymphoma, Large B-Cell, Diffuse (DLBCL), Lymphoma","Venous Thromboembolic Disease","VTE (Venous Thromboembolism)","PE - Pulmonary Embolism","Hematologic Malignacies",[444,445,446,447,448,449,450],"Apixaban","Rivaroxaban","Low-Molecular-Weight Heparin","Venous Thromboembolism","Cancer-Associated Thrombosis","Hematologic Malignancies","Direct Oral Anticoagulants",{"date":452,"type":39},"2025-12-26",{"date":454,"type":39},"2024-11-22",{"date":456,"type":22},"2026-12-31",{"name":45,"class":46},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":151,"maxAge":400,"enrollmentInfo":466,"targetDuration":4,"studyType":274,"phases":4,"briefSummary":468,"conditions":469,"keywords":472,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":480,"lastUpdatePostDateStruct":481,"startDateStruct":483,"completionDateStruct":485,"leadSponsor":487,"locationsCount":77},"100573020","overnight-dexamethasone-in-primary-aldosteronism-screening-100573020","NCT06740838","Overnight Dexamethasone in Primary Aldosteronism Screening","Overnight Dexamethasone in Primary Aldosteronism Screening in Patients on Interfering Therapy (the ODEPRASC Study)","ODEPRASC","Inclusion Criteria:\n\n* suspected or diagnosed HT,\n* age between 40 and 75,\n* available aldosterone and renin result at the time of one-day clinic stay,\n* scheduled 1-mg-DXM test (indicated for possible mild autonomous cortisol secretion, MACS),\n* presence of an adrenal lesion with radiologic features of adrenocortical adenoma\u002Fhyperplasia.\n\nExclusion Criteria:\n\n* baseline (pre-DXM) hyperreninemia (renin exceeding the upper limit of normal at the study site, i.e. 46.1 mIU\u002Fl, assay manufacturer: Diasorin),\n* baseline (pre-DXM) Ald\\\u003C3 ng\u002Fdl,\n* overt clinical and\u002For biochemical features of adrenal hormone deficiency or excess other than MACS (8 a.m. cortisolemia in the 50-140 nmol\u002Fl range in the 1-mg DXM test),\n* therapy with glucocorticoids, non-steroidal anti-inflammatory drugs, hormonal replacement therapy, hormonal contraceptive therapy, and\u002For licorice intake,\n* established or suspected secondary HT other than due to PA,\n* comorbidities including: poorly controlled and\u002For other than type 2 diabetes mellitus (T2DM), present and past alcohol abuse, obesity grade 3 (i.e. body mass index of at least 40 kg\u002Fm2), severe CV disease disqualifying a patient from chronic medication modification, active malignancy, decompensated autoimmune disease as well as an autoimmune disease associated with cardiovascular and\u002For renal complications, estimated glomerular filtration rate (eGFR) below 45 ml\u002Fmin\u002F1.73m2, poor physical condition, lack and withdrawal of consent for participation.",{"count":467,"type":22},240,"The goal of this observational study is to learn whether screening for primary aldosteronism can be improved among patients on chronic blood pressure-lowering medications by ordering intake of 1 mg of dexamethasone prior to hormonal examinations.\n\nPrimary aldosteronism is a condition, in which an adrenal gland steroid aldosterone is released in excessive amounts; it commonly causes hypertension but requires specific therapy different from usually prescribed in other forms of hypertension.\n\nDexamethasone is a synthetic steroid used for both therapeutic and diagnostic purposes. A single 1 mg dexamethasone dose taken at 11 p.m. in order to measure hormone concentrations the following morning (so called overnight 1-mg dexamethasone test) is a commonly applied test in the work-up of adrenal disorders.\n\nThe main question the project aims to answer is:\n\nCan screening for primary aldosteronism be improved among patients receiving blood pressure-lowering medications with overnight 1-mg dexamethasone intake?\n\nParticipants will undergo changes in their chronic medication to be able to definitely rule out or confirm primary aldosteronism in blood hormonal examinations. These modifications and modifications are not part of the research project.\n\nFor this project participants will be asked to\n\n* undergo the 1-mg dexamethasone test one to three times in order to compare hormonal concentrations before and after it,\n* collect urine for 24 hours to determine aldosterone in the urine sample after medications interfering in aldosterone release are temporarily withdrawn.",[470,471],"Primary Aldosteronism","Hypertension",[473,474,475,476,477,478,479],"primary aldosteronism","screening","renin","aldosterone","hypertension","corticotropin","dexamethasone","2025-09-27",{"date":482,"type":39},"2025-10-02",{"date":484,"type":39},"2024-10-22",{"date":486,"type":22},"2026-10-31",{"name":45,"class":46},{"id":489,"slug":490,"hasResults":12,"nctId":491,"briefTitle":492,"officialTitle":493,"acronym":494,"eligibilityCriteria":495,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":496,"targetDuration":498,"studyType":274,"phases":4,"briefSummary":499,"conditions":500,"keywords":505,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":518,"locationsCount":77},"100603801","microplastic-analysis-in-pediatric-inflammatory-bowel-disease-100603801","NCT07141238","Microplastic Analysis in Pediatric Inflammatory Bowel Disease","Analysis of Microplastics in Pediatric Inflammatory Bowel Disease Using Raman Spectroscopy: A Multi-Matrix Study","MAP-IBD","Inclusion Criteria:\n\n* Age \\\u003C18 years\n* Undergoing clinically indicated gastrointestinal endoscopy\n* For IBD group: confirmed diagnosis of Crohn's disease or ulcerative colitis\n* For control group: no current or past diagnosis of IBD\n\nExclusion Criteria:\n\n* Age 18 years or older\n* Lack of informed consent from legal guardian\n* Lack of written assent from the participant if age ≥13 years",{"count":497,"type":22},40,"1 Day","The goal of this observational study is to measure and compare the presence of microplastics in children with inflammatory bowel disease (IBD) and children without IBD. The main questions it aims to answer are:\n\nAre microplastics detectable in different biological samples from children? Are there differences in microplastic burden between children with and without IBD?\n\nResearchers will collect biological samples including: intestinal tissue (from routine endoscopy), stool, urine, blood.\n\nRaman spectroscopy will be used to detect and characterize microplastics in each sample type. Participants will not receive any medication or intervention as part of this study. All samples will be collected during standard clinical procedures.",[501,502,503,504],"Crohn Disease","Pediatric Inflammatory Bowel Diseases","Ulcerative Colitis (UC)","Inflammatory Bowel Disease (IBD)",[506,507,508,509,510,511],"Microplastics","Pediatric Inflammatory Bowel Disease","Raman Spectroscopy","Environmental exposure","Ulcerative Colitis","Crohn's Disease","2025-09-24",{"date":514,"type":39},"2025-09-30",{"date":516,"type":39},"2025-06-15",{"date":173,"type":22},{"name":45,"class":46},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":528,"briefSummary":529,"conditions":530,"keywords":537,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":553},"100586637","study-of-treatment-with-intensified-omeprazole-treatment-to-prevent-high-output-stoma-1-100586637","NCT06917963","Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1","Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1: a Randomized, Non-blinded, Controlled Trial","STOP-HOS-1","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Scheduled for elective or emergency surgery requiring end or loop ileostomy formation\n* Able and willing to provide written informed consent\n* No contraindications to omeprazole use\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Known hypersensitivity or allergy to proton pump inhibitors (including omeprazole)\n* Conditions preventing accurate measurement of daily ileostomy output",{"count":373,"type":22},[25],"The goal of this clinical trial is to evaluate if intensified omeprazole therapy can reduce high-output stoma (HOS) in adults undergoing ileostomy formation surgery. The main objectives of the study are:\n\n* To assess if intensified omeprazole treatment significantly reduces mean daily ileostomy output (ml\u002F24h) during the first three postoperative days compared to standard omeprazole treatment.\n* To evaluate the proportion of patients meeting the criteria for high-output stoma (HOS ≥1400 ml\u002Fday) on consecutive postoperative days.\n* To measure the time required for stabilization of ileostomy output (\\\u003C1400 ml\u002Fday maintained for three consecutive days).\n* To determine the incidence of dehydration-related complications, specifically electrolyte disturbances (hyponatremia, hypokalemia).\n* To compare the length of initial hospital stay, frequency of rehospitalizations within 30 days post-discharge, and total length of hospital stay (including rehospitalizations).\n\nResearchers will compare 10 days intensified omeprazole treatment (loading dose of 80 mg IV followed by 40 mg IV twice daily) with standard treatment (40 mg IV once daily) to determine the effectiveness of intensified dosing in reducing ileostomy output and improving postoperative outcomes.\n\nParticipants will:\n\n* Receive either standard or intensified intravenous omeprazole during their hospitalization and after discharge for 10 days combined.\n* Undergo daily measurements of ileostomy output.\n* Have routine laboratory assessments of electrolyte levels.\n* Participate in follow-up assessments up to 30 days post-discharge, conducted either through outpatient visits or telephone consultations.",[531,532,533,534,535,536],"Stoma - Ileostomy","High Output Stoma","Colon Cancer","IBD (Inflammatory Bowel Disease)","Ileus","Omeprazole",[538,539,540,541,542,543,544],"stoma","ileostomy","high output stoma","omeprazole","ipp","colon cancer","ibd","2025-07-28",{"date":547,"type":39},"2025-07-31",{"date":549,"type":39},"2025-04-10",{"date":551,"type":22},"2027-07",{"name":45,"class":46},2,{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":560,"eligibilityCriteria":561,"healthyVolunteers":86,"sex":150,"minAge":19,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":23,"phases":565,"briefSummary":566,"conditions":567,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":576,"locationsCount":77},"100592358","application-shoulder-manipulation-in-volleyball-players-100592358","NCT06992388","Application Shoulder Manipulation in Volleyball Players","The Influence of Shoulder Manipulation on Muscle Strength and Stiffness and Motor Functionality of Volleyball Players During Training","Manual Therapy","Inclusion Criteria:\n\n* healthy individuals who are over 18 years old,\n* a player from the AZS volleyball league,\n* a player who regularly competes in the league,\n* expressing informed consent to participate in the study and undertaking to comply with the track regulations and wear a helmet.\n\nExclusion Criteria:\n\n* lack of volunteer consent,\n* previous surgeries of the upper, lower limb and spine,\n* other upper limb injuries in the last 6 months,\n* pain limiting participation in the study.","30 Years",{"count":564,"type":22},12,[25],"Currently, it is difficult to find studies in the literature assessing the influence of manual therapy on kinetic and kinematic factors for the upper limbs of volleyball players, which in the long run may translate into a reduction in injuries by improving strength and balance in athletes, when planning training or therapy.",[560,568,569],"Manipulation","Muscles","2025-05-24",{"date":572,"type":39},"2025-05-28",{"date":574,"type":22},"2025-05-19",{"date":514,"type":22},{"name":45,"class":46},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":560,"eligibilityCriteria":583,"healthyVolunteers":86,"sex":150,"minAge":19,"maxAge":562,"enrollmentInfo":584,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":566,"conditions":586,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":589,"startDateStruct":590,"completionDateStruct":591,"leadSponsor":592,"locationsCount":77},"100592357","shoulder-manipulation-in-volleyball-players-100592357","NCT06992375","Shoulder Manipulation in Volleyball Players","Assessment of the Impact of Shoulder Manipulation on Muscle Strength and Stiffness and Motor Functionality of Volleyball Players During Training","Inclusion Criteria:\n\n* healthy individuals who are over 18 years old,\n* a player from the AZS volleyball league,\n* a player who regularly competes in the league,\n* expressing informed consent to participate in the study and undertaking to comply with the track regulations and wear a helmet.\n\nExclusion Criteria:\n\n* lack of volunteer consent,\n* previous surgeries of the upper, lower limb and spine,\n* other upper limb injuries in the last 6 months,\n* pain limiting participation in the study,",{"count":564,"type":22},[25],[560,568,587,569,588],"Muscle Strength","Musculoskeletal System",{"date":572,"type":39},{"date":574,"type":22},{"date":514,"type":22},{"name":45,"class":46},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":560,"eligibilityCriteria":599,"healthyVolunteers":86,"sex":150,"minAge":19,"maxAge":151,"enrollmentInfo":600,"targetDuration":4,"studyType":23,"phases":602,"briefSummary":603,"conditions":604,"keywords":4,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":605,"lastUpdatePostDateStruct":606,"startDateStruct":608,"completionDateStruct":610,"leadSponsor":612,"locationsCount":77},"100585340","hip-manipulation-in-basketball-players-100585340","NCT06901089","Hip Manipulation in Basketball Players","Assessment of the Impact of Hip Manipulation on Muscle Strength and Stiffness as Well as Motor Functionality of Basketball Players During Training","Inclusion Criteria:\n\n* healthy persons aged 18,\n* first league competitor,\n* competitor who regularly competes in the league,\n* expressing informed consent to participate in the study and undertakes to comply with track regulations and wear a helmet.\n\nExclusion Criteria:\n\n* lack of volunteer consent,\n* previous surgeries of the upper, lower limb and spine,\n* other lower limb injuries in the last 6 months,\n* pain limiting participation in the study,\n* neurological diseases,\n* connective tissue diseases.",{"count":601,"type":22},15,[25],"Currently, it is difficult to find studies in the literature assessing the impact of manual therapy on preventing lower limb injuries in basketball players, which may later translate into improved strength and balance in athletes, when planning training or therapy programming, e.g. in patients after ankle sprains.",[560,568,569,588],"2025-05-07",{"date":607,"type":39},"2025-05-09",{"date":609,"type":22},"2025-05-10",{"date":611,"type":22},"2025-06-30",{"name":45,"class":46},{"id":614,"slug":615,"hasResults":12,"nctId":616,"briefTitle":617,"officialTitle":617,"acronym":4,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":620,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":77},"100574464","assessment-of-pulmonary-function-in-relation-to-the-anesthetic-used-in-patients-undergoing-bariatric-surgery-100574464","NCT06759623","Assessment of Pulmonary Function in Relation to the Anesthetic Used in Patients Undergoing Bariatric Surgery","Inclusion Criteria:\n\n* Obese patients qualified for bariatric surgery.\n\nExclusion Criteria:\n\n* Patients who have absolute contraindications to spirometry testing, i.e:\n\n  * with aneurysms of the aorta or cerebral arteries threatening to rupture, after recent vascular surgery\n  * with increased intracranial pressure, after recent intracranial bleeding or head surgery within the cranial cavity\n  * after acute conditions within 6 months prior to surgery such as stroke, myocardial infarction, unstable angina, pneumothorax\n  * with uncontrolled hypertension\n  * after recent eye surgery or a history of retinal detachment\n  * with hemoptysis of unknown etiology. And patients unable to perform spirometry testing",{"count":432,"type":22},[25],"It is known that more or less pronounced impairment of pulmonary function occurs after anesthesia. It has been demonstrated in the postoperative period in both patients undergoing general and regional anesthesia, in patients after intra-abdominal and superficial procedures, in overweight and normal-weight patients. It has also been shown that when general anesthesia is performed with the inhalation anesthetic sevoflurane, there is a slightly smaller reduction in lung function parameters than when only intravenous anesthetics are used.\n\nThe purpose of this study is to evaluate lung function before induction and after awakening from general anesthesia depending on the inhalational anesthetic used in obese patients undergoing bariatric surgery",[623],"Obesity and Obesity-related Medical Conditions","2024-12-28",{"date":626,"type":39},"2025-01-06",{"date":628,"type":22},"2025-01-08",{"date":630,"type":22},"2026-04-01",{"name":45,"class":46},{"id":633,"slug":634,"hasResults":12,"nctId":635,"briefTitle":636,"officialTitle":637,"acronym":4,"eligibilityCriteria":638,"healthyVolunteers":86,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":641,"briefSummary":642,"conditions":643,"keywords":644,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":649,"lastUpdatePostDateStruct":650,"startDateStruct":652,"completionDateStruct":654,"leadSponsor":656,"locationsCount":4},"100573501","application-of-manual-therapy-to-archers-100573501","NCT06747104","Application of Manual Therapy to Archers","Assessment of Upper Limb Muscle Activity and the Effect of Manual Therapy on Fatigue, Stiffness and Muscle Activity During Training","Inclusion Criteria:\n\n* Actively training as an archer at least twice a week for six months;\n* In good health, with no recent injury or illness;\n* Over 18 years of age;\n* Engagement in all phases of the study.\n\nExclusion Criteria:\n\n* Any injury or illness present at the time of the study;\n* Recent history (within six months) of upper extremity injury (shoulder, elbow, or wrist), joint pain, lower extremity joint hypermobility, or neurological\u002Fconnective tissue disease.\n* No training participation\n* No consent for study",{"count":640,"type":22},50,[25],"The aim of this study is to: (i) characterize the effect of repeated archery shots on the EMG parameters of certain selected upper limb muscles; and (ii) evaluate how manipulation of the initial two-second tension phase, in particular involving muscle stretching, affects these EMG parameters after repeated shots.",[278],[645,646,647,648],"archery","muscle fatigue","recovery","manipulation","2024-12-18",{"date":651,"type":39},"2024-12-24",{"date":653,"type":22},"2024-12-10",{"date":655,"type":22},"2024-12-31",{"name":45,"class":46},{"id":658,"slug":659,"hasResults":12,"nctId":660,"briefTitle":661,"officialTitle":661,"acronym":4,"eligibilityCriteria":662,"healthyVolunteers":86,"sex":18,"minAge":19,"maxAge":151,"enrollmentInfo":663,"targetDuration":4,"studyType":23,"phases":664,"briefSummary":665,"conditions":666,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":668,"lastUpdatePostDateStruct":669,"startDateStruct":671,"completionDateStruct":673,"leadSponsor":674,"locationsCount":77},"100567098","correlation-of-pain-intensity-measurements-in-healthy-volunteers-exposed-to-unpleasant-stimuli-100567098","NCT06663761","Correlation of Pain Intensity Measurements in Healthy Volunteers Exposed to Unpleasant Stimuli","Inclusion Criteria:\n\n* American Society of Anesthesiology (ASA) general condition assessment 1 or 2\n* age 18 - 40 yrs\n\nExclusion Criteria:\n\n* any arrhythmia,\n* taking medications from the groups of beta-blockers, gabapentinoids, benzodiazepines, painkillers within the last 12 hours,\n* chronic pain conditions,\n* pregnancy,\n* trypanophobia (fear of needles)",{"count":432,"type":22},[25],"Pain is an unpleasant sensory and emotional phenomenon that can be caused by tissue damage or potentially harmful stimuli. Pain is by definition a subjective phenomenon, and everyone experiences it differently, which creates problems in its assessment and treatment. There are many ways to measure pain, both through patient self-report (scales) and objective physiological indicators. However, there is no single, universal tool for measuring pain intensity that is simultaneously reliable, valid, and easy to use. Moreover, there are reports showing that not only the intensity of the unpleasant experience but also the nature of the stimulus can cause different levels of changes in the used indicators and scales. In this project, we will compare two devices used for pain monitoring based on physiological parameters: PainMonitor (Med-Storm, Oslo, Norway) and ANI Monitor (MetroDoloris, Loos, France). PainMonitor is a device that records skin conductance (SC) as an indicator of pain intensity. SC reflects the level of autonomic nervous system arousal. The device automatically analyzes these parameters and provides a numerical indicator of pain intensity\u002Fanesthesia level. The ANI Monitor is a device based on the analysis of parasympathetic nervous system activity through heart rate variability analysis. Based on this, the device also assesses the degree of pain intensity and presents it in numerical form. The aim of the project is to investigate the correlation between PainMonitor and ANI as tools for measuring pain intensity in situations where healthy volunteers are exposed to various unpleasant stimuli.\n\nThe study will involve approximately 100 healthy adult participants who will be exposed to three types of standardized stimuli: thermal (hot and cold), mechanical (pressure from a blood pressure cuff, pressure on a skin fold), chemical (spicy taste), and visual. Simultaneously, they will be monitored by PainMonitor, ANI, ECG, and peripheral perfusion index (using pulse oximetry). This data will then be compared and subjected to statistical analysis to determine if there is a relationship between the nature of the stimuli used and the objective and subjective indicators of pain intensity.\n\nStimuli (the order of stimuli 1-4 will be electronically randomized), with a break time between stimuli of 5-10 minutes:\n\n1. NON-INVASIVE BLOOD PRESSURE MEASUREMENT: Non-invasive blood pressure measurement (NIBP) (single automatic blood pressure measurement using a Phillips IntelliVue Monitor).\n2. HEAT: A metal cube with a temperature of 45 degrees Celsius will be used for heat stimulation. The cube will be applied for 60 seconds to the inner side of the forearm of the participant's dominant hand. The appropriate temperature of the cube will be maintained by keeping it in a water bath.\n3. ALGOMETER: For mechanical stimulation, the researcher will apply pressure to the skin fold between the second and third fingers of the dominant hand using an algometer. The pressure will gradually increase from 0 to 250-300 kilo Pascal (kPa) and be maintained for 60 seconds.\n4. VISUAL STIMULUS: For visual stimulation, a video will be shown on a display in front of the participant, depicting a model having a short intravenous cannula inserted. Participants will be asked to imagine that the hand on the screen is their own.\n5. COLD: \"Cold pressor test\" - The participant's forearm will be immersed in water at a temperature of 2 degrees Celsius for 60 seconds or until discomfort causes the participant to withdraw their hand.\n6. SPICY TASTE: 0.5 ml of spicy sauce with a specified amount of Scoville units will be applied to the participant's tongue using a syringe.",[667],"Pain","2024-10-25",{"date":670,"type":39},"2024-10-29",{"date":672,"type":39},"2024-07-22",{"date":198,"type":22},{"name":45,"class":46},{"id":676,"slug":677,"hasResults":12,"nctId":678,"briefTitle":679,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":681,"targetDuration":4,"studyType":274,"phases":4,"briefSummary":683,"conditions":684,"keywords":686,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":695,"lastUpdatePostDateStruct":696,"startDateStruct":698,"completionDateStruct":700,"leadSponsor":701,"locationsCount":77},"100559992","vitamin-d-in-dialysis-patients---diagnostic-and-therapeutic-management-100559992","NCT06571344","Vitamin D in Dialysis Patients - Diagnostic and Therapeutic Management","Inclusion Criteria:\n\n* CKD stage 5,dialysed patients with vitamin D deficiency or insufficiency (level of 25(OH)D \\\u003C 30 ng\u002FmL)\n\nExclusion Criteria:\n\n* dialysis time of less than 3 months\n* inadequately controled secondary hyperparathyroidism (iPTH\\>800pg\u002FmL)\n* treatment with calcimimetics\n* treatment with active forms of vitamin D3,\n* parathyroidectomy\n* bilateral nephrectomy\n* treatment with corticosteroids\n* lack of consent to take part in the study.",{"count":682,"type":22},160,"The goal of this observational study is to learn about the effects of cholecalciferol administration, according to guidelines for the general population, on laboratory parameters of Chronic Kidney Disease-Mineral and Bone Disorder in dialysis patients, depending of the attained levels of vitamin D (25OH)D).\n\nThe main question it aims to answer is:\n\nHow does cholecalciferol affect calcium and phosphate metabolism parameters depending on the achieved levels of 25(OH)D?\n\nParticipants taking cholecalciferol as part of their regular medical care for CKD-MBD will have the laboratory result parameters observed for up to 4 years.",[685],"Vitamin D Deficiency Due to Chronic Kidney Disease",[687,688,689,690,691,692,693,694],"vitamin D","cholecalciferol","25-hydroxycholecalciferol","parathyroid hormone","FGF23","GDF15","chronic kidney disease-mineral and bone disorder","dialysis","2024-08-23",{"date":697,"type":39},"2024-08-26",{"date":699,"type":39},"2022-11-01",{"date":456,"type":22},{"name":45,"class":46},""]