[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"G.Gennimatas General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":148},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,62,95,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100643352","oxiblumecoq10-ralivia-therapy-for-benign-prostatic-hyperplasia-100643352",false,"NCT07638865","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia:","Oxiblume:CoQ10 (Ralivia) Therapy for Benign Prostatic Hyperplasia: a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.","Inclusion Criteria:\n\n1. Participant must be between 50 and 80 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. International Prostate Symptom Score (IPSS) ≥8 and ≤30\n4. Prostate volume ≥30gram and ≤80gram\n5. Peak urinary flow rate (Qmax) ≥5 ml\u002Fsec and ≤15ml\u002Fsec\n6. Post void residual volume ≤150ml\n\nExclusion Criteria:\n\n1. Current or recurrent urinary tract infection (UTI), prostatitis, gross hematuria (blood in urine without a known cause), or a history of urinary retention.\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition (except from BPH) associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery\n7. Participant with penile or urinary sphincter implants.\n8. Diagnosed neurological conditions known to affect bladder function (e.g., multiple sclerosis, Parkinson's disease, or neurogenic bladder).\n9. Significant medical conditions (e.g., unstable cardiac arrhythmias, uncontrolled diabetes, severe renal impairment) that pose an unreasonable risk to the patient or might interfere with study results.\n10. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n11. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.","MALE","50 Years","80 Years",{"count":20,"type":21},100,"ESTIMATED","INTERVENTIONAL",[24],"NA","Objectives of the study\n\nThe aim of the study is to investigate and compare the treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy vs placebo for BPH patients\n\nStudy center\n\nThe study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications).\n\nPatients visits will be carried out in the BPH Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece.\n\nLaboratory tests of all patients will be performed at the same microbiology laboratory.\n\nStudy population A total of 100 patients (50 in Group A and 50 in Group B) with BPH diagnosis will participate in this study.\n\nStudy design Double-blind placebo-controlled randomized clinical trial\n\nZero hypothesis (H0) and alternative hypothesis (H1):\n\n(H0): Group A demonstrates similar efficacy compared to Group B for the treatment of BPH patients.\n\n(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment of BPH patients.\n\nStudy endpoints Primary endpoint: The difference between the Group A and Group B in the change of IPSS score from baseline to 12 weeks after treatment initiation.\n\nSecondary endpoints:\n\n* Adverse events rate in all patients during study period.\n* The difference between the Group A and Group B in the change of the IPSS score from baseline to 6 weeks after treatment initiation.\n* The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation\n\n  1. Qmax value\n  2. Prostate volume\n  3. Post void residual\n  4. IIEF-ED score\n  5. Psa value\n  6. TNFa, IL 6 values\n\nTreatment Visits :\n\nPatients accordingly to which group they will be randomized will receive:\n\n* Active treatment (Ralivia) Group : 1 pill of Ralivia per os\u002Fday for a 3-month period\n* Placebo Group : 1 placebo pill per os\u002Fday for a 3-month period\n\nAdverse events will be reported.\n\nFU Visit 1: 6 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nPSA TNFa, IL 1β, IL 6, IL 10 will be measured through blood test.\n\nFU Visit 2: 12 weeks after treatment initiation IPSS, IIEF-ED questionnaires will be answered. Prostate and Urinary Bladder ultrasound will be conducted pre- and post-void. Uroflowmetry will be conducted. Adverse events will be reported.\n\nDRE will be performed . PSA TNFa, IL 6 will be measured through blood test.",[27,28,29],"Benign Prostate Enlargement","Benign Prostate Hypertrophy(BPH)","Benign Prostate Obstruction (BPO)","RECRUITING","2026-06-04",{"date":33,"type":34},"2026-06-10","ACTUAL",{"date":36,"type":21},"2026-06-08",{"date":38,"type":21},"2026-12",{"name":40,"class":41},"G.Gennimatas General Hospital","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":50,"maxAge":17,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":60,"leadSponsor":61,"locationsCount":42},"100637276","oxiblumecoq10-ralivia-therapy-for-chronic-prostatitischronic-pelvic-pain-syndrome-cpcpps-100637276","NCT07629505","Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS)","Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS): a Double-blind Placebo-controlled Randomized Clinical Trial Assessing Treatment Efficacy and Safety.","Inclusion Criteria:\n\n1. Participant must be between 18 and 50 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. Participant has had a clinical diagnosis of CP\u002FCPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.\n\nExclusion Criteria:\n\n1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU\u002Fml in mid-stream urine (VB2).\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery or treatment.\n7. Participant with penile or urinary sphincter implants.\n8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.","18 Years",{"count":20,"type":21},[24],"Chronic Prostatitis\u002FChronic Pelvic Pain Syndrome (CP\u002FCPPS) has a huge socioeconomic impact.Presently, a ''scientific dead-end'' regarding effective treatment of CP\u002FCPPS is reported. Promising results of clinical studies, regardless their limitations, upon efficacy of phytotherapy for CP\u002FCPPS patients have been published .Phytotherapy is cost effective and avoids the systemic side effects of other treatments being a therapy with the possibility of repeating the treatment protocol at any time. Certain important issues, regarding the efficacy and safety of phytotherapy, remain to be answered thus investing scientifically and economically to the concept of phytotherapy for CP\u002FCPPS, definitively seems to be a move to the right direction.\n\nIn this concept we will conduct a double-blind placebo-controlled randomized clinical trial assessing treatment efficacy and safety of Oxiblume:CoQ10 (Ralivia) therapy for CP\u002FCPPS\n\nThe study will be coordinated by the research office of 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece. The research office will also support the project (logistics, quality control, management, data acquisition, publications).\n\nPatients visits will be carried out in the CP\u002FCPPS Research Unit of the 1st Urology Department, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Greece.\n\nLaboratory tests of all patients will be performed at the same microbiology laboratory.\n\nStudy population A total of 100 patients (50 in Group A and 50 in Group B) with CP\u002FCPPS diagnosis will participate in this study.\n\nInclusion and exclusion criteria\n\nInclusion criteria:\n\n1. Participant must be between 18 and 50 years old.\n2. Participant has signed and dated the appropriate Informed Consent document.\n3. Participant has had a clinical diagnosis of CP\u002FCPPS defined as symptoms of discomfort or pain in the perineal or pelvic region for at least a three (3) month period within the last six (6) months.\n\nExclusion criteria:\n\n1. Participant has evidence of facultative Gram negative or enterococcus with a value of ≥ 1000 CFU\u002Fml in mid-stream urine (VB2).\n2. Participant has a history of prostate, bladder or urethral cancer.\n3. Participant has undergone pelvic radiation or systemic chemotherapy.\n4. Participant has undergone intravesical chemotherapy.\n5. Participant has unilateral orchialgia without pelvic symptoms, active urethral stricture or bladder stones, or any other urological condition associated with LUTS, any neurological disease or disorder affecting the bladder.\n6. Participant has undergone prostate surgery or treatment.\n7. Participant with penile or urinary sphincter implants.\n8. Participant has been diagnosed with cancer during the last 5 years or had any surgery in the pelvis.\n9. Participant has a neurological impairment or psychiatric disorder preventing his understanding of consent and his ability to comply with the protocol.\n\nStudy design Double-blind placebo-controlled randomized clinical trial\n\nZero hypothesis (H0) and alternative hypothesis (H1):\n\n(H0): Group A demonstrates similar efficacy compared to Group B for the treatment CP\u002FCPPS patients.\n\n(H1): Group A demonstrates greater or decreased efficacy compared to Group B for the treatment CP\u002FCPPS patients.\n\nStudy endpoints Primary endpoint: The difference between the Group A and Group B in the change of the pain domain of NIH-CPSI score from baseline to 12 weeks after treatment initiation.\n\nSecondary endpoints:\n\n* Adverse events rate in all patients during study period.\n* The difference between the Group A and Group B in the change of the pain domain of NIH-CPSI score from baseline to 6 weeks after treatment start.\n* The difference between the Group A and Group B in the change of the following parameters from baseline to 6 and 12 weeks after treatment initiation\n\n  1. Total NIH-CPSI score (Q1-9)\n  2. Urinary symptoms (Q 5-6) and quality of life domains (Q 7-9) of the NIH-CPSI score\n  3. IIEF-ED score\n  4. IPSS\n  5. UPPOINTS phenotype- number of positive domains\n  6. Psa value\n  7. TNFa, IL 6 values\n\nPatients accordingly to which group they will be randomized will receive:\n\n* Active treatment (Ralivia) Group : 1 pill of Ralivia per os\u002Fday for a 3-month period\n* Placebo Group : 1 placebo pill per os\u002Fday for a 3-month period\n\nAdverse events will be reported.\n\nFU Visit 1: 6 weeks after treatment initiation NIH-CPSI, IPSS, IIEF-ED questionnaires will be answered. Adverse events will be reported. Clinical symptoms assessed, in order to determine UPOINT status.\n\nPSA TNFa, IL 1β, IL 6, IL 10 blood test.\n\nFU Visit 2: 12 weeks after treatment initiation NIH-CPSI, IPSS, IIEF-ED questionnaires will be answered. Adverse events will be reported. Clinical symptoms assessed, in order to determine UPOINT status.\n\nDRE will be performed . PSA TNFa, IL 6 blood test",[55],"Chronic Pelvic Pain Syndrome (CPPS)","2026-06-01",{"date":58,"type":34},"2026-06-05",{"date":36,"type":21},{"date":38,"type":21},{"name":40,"class":41},{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":69,"minAge":50,"maxAge":70,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":42},"100636688","evaluation-of-the-stress-response-in-anesthesia-use-inhalation-anesthetic-desflurane-versus-tiva-for-bariatric-surgery-100636688","NCT07568938","Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery","Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA TCI ELEVELD Model for Bariatric Surgery","Inclusion Criteria:\n\n* Signed Informed Consent\n* ASA II-III\n* Morbid obesity confirmed diagnosis and approval for surgical treatment\n* Laparoscopic sleeve gastrectomy (LSG) or Gastric By pass (R-Y By pass \u002FSASI\u002FSADI AND one anastomosis by pass )\n* Preop respiratrory assessment conducted\n* Adequate organ and bone marrow function\n\nExclusion Criteria:\n\n* Patients declining or withdrawing consent\n* Patients unsuitabe with regards to compliance to treatment, according to the researcher's assessment\n* Bradycardia, AV block, , postural hypotension\n* QTcF\\>470msec\n* Known allergy or hypersensitiity to any of the medications administered\n* Stop-BANG score \\>6\n* Intraoperative administration of more than 8mg of prednisolone or equivalent\n* Patients who have received corticosteroids for durations \\>3 weeks at any point in their lifetime\n* Participation in other clinical trial for experimental product administered post operatively\n* Diagnosis of depression","ALL","65 Years",{"count":72,"type":21},70,[24],"The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer :\n\n-Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane?\n\nParticipants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.",[76,77,78,79],"Opioid Use","Bariatric Surgery Candidate","TCI Eleveld","Obesity",[81,82,83,84,85,86],"Morbid Obesity","Opioid Free Anesthesia","Nociception Level","Analgesia","Bariatric Surgery","Eleveld Model TCI","2026-05-01",{"date":89,"type":34},"2026-05-06",{"date":91,"type":34},"2024-01-10",{"date":93,"type":21},"2027-05-30",{"name":40,"class":41},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":69,"minAge":50,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":22,"phases":103,"briefSummary":104,"conditions":105,"keywords":107,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":42},"100497096","evaluation-of-the-stress-response-in-bariatric-surgery-with-and-without-the-use-of-opioids-100497096","NCT05752799","Evaluation of the Stress Response in Bariatric Surgery With and Without the Use of Opioids","Inclusion Criteria:\n\n* Age \\>18y and \\\u003C75y\n* morbid obesity confirmed diagnosis\n* American Society of Anesthesiologists (ASA) II-III\n* elective laparoscopic sleeve gastrectomy surgery\n* signed informed consent\n\nExclusion Criteria:\n\n* bradycardia, bundle branch block, hypotension, postural hypotension\n* obstructive sleep apnoea\n* history of depression\n* chronic corticosteroid use or intraoperative administration of more than 8mg of prednisolone or equivalent\n* refusal to participate","75 Years",{"count":72,"type":21},[24],"The goal of this clinical trial is to compare Opioid Free and Opioid Based Anaesthesia in patients undergoing sleeve gastrectomy. The main questions it aims to answer are:\n\n* Will the total dose of intraoperative opioid be reduced?\n* Will there be difference in pain scores between groups? Participants will be managed with the Nociceptive Level Index algorithm to guide intraoperative analgesia.\n\nThe Opioid Free Anaesthesia Group will be administered the Multimix infusion (Magnesium sulfate, dexmedetomidine, ketamine). The Opioid Based Anaesthesia Group will receive fentanyl as a bolus dose and remifentanil infusion.\n\nRescue fentanyl bolused will be injected as appropriate according to nociceptive level (NOL) values.",[106,77],"Opioid Use, Unspecified",[108,109,110,111,112],"morbid obesity","opioid free anaesthesia","nociception level","analgesia","bariatric surgery","2026-04-25",{"date":115,"type":34},"2026-04-28",{"date":117,"type":34},"2023-01-01",{"date":119,"type":21},"2027-06-01",{"name":40,"class":41},{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":128,"sex":69,"minAge":4,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":132,"conditions":133,"keywords":136,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":42},"100586621","the-impact-of-immersive-virtual-reality-training-in-thyroid-surgery-100586621","NCT06917755","The Impact of Immersive Virtual Reality Training in Thyroid Surgery","The Impact of Immersive Virtual Reality Training in Thyroid Surgery: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* Residents of the 2nd Surgical Department of Aristotle University of Thessaloniki\n* Residents who have completed their 1st year of training programm.\n\nExclusion Criteria:\n\n* Disagreement of participants' randomisation\n* Prolonged surgical time of completion\n* Participant's experience beyond the included limits\n* Participants who are completely incapable of using VR devices or have specific helath restrictions of using these\n* Patients with complex thyroid disease such as recurrent disease, concominant primary hyperparathyroidism, lymph node disease or metastasis, Graves disease and intrathoracic goiter",true,{"count":130,"type":21},12,[24],"Up to this date, there have been no reports on virtual reality (VR) training in thyroid surgery. The purpose of this study is to determine the impact of VR training in residents' education.\n\nInvestigators intend to include general surgery residents in the trial, subgrouped in a VR training group and another one with traditional learning, utilizing a technical textbook as a control. For the purpose of this study, a commercial available VR mask will be given for training in the VR group. Randomization will be used to secure balance in the distribution of residents according to their experience. The task which will be examined include surgical steps from neck incision up to the placement of the C-IONM electrode and will be evaluated by a blinded FEBS certified endocrine surgeon in the operating theatre.\n\nTraining superiority will be assessed by the outcome measures of Objective Structured Assessment of Technical Skills (OSATS) score, need for the main surgeon to intervene (NTI), verbal answers and time to task completion. Participants will complete questionnaires regarding satisfaction of the whole educational process.",[134,135],"Virtual Reality Simulation","Thyroid Surgery",[137,135,138,139],"Endocrine Surgery","Virtual Reality","Training","2025-04-09",{"date":142,"type":34},"2025-04-10",{"date":144,"type":34},"2025-02-20",{"date":146,"type":21},"2025-05-30",{"name":40,"class":41},""]