[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Royal Surrey County Hospital NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":123},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,80,103],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100609126","side-effects-of-low-dose-rate-brachytherapy-and-ultra-hypofractionated-radiotherapy-in-low-to-intermediate-risk-prostate-cancer-100609126",false,"NCT07210502","Side Effects of Low Dose Rate Brachytherapy and Ultra-hypofractionated Radiotherapy in Low to Intermediate Risk Prostate Cancer","Comparing the Side Effects of Low Dose Rate Brachytherapy Against Ultra-Hypofractionated Radiotherapy Using Spacer Gel Treatment in Men With Cambridge Prognostic Groups (CPG) 1 to 3 (NCCN Low to Intermediate Risk) Prostate Cancer","LDR BURST","Inclusion Criteria:\n\n* Men aged ≥18 years at randomisation\n* The research subject must have capacity to sign a written informed consent document for the trial\n* WHO performance status 0 - 2\n* Gleason score 3+3 or 3+4\n* PSA ≤ 20 ng\u002Fml (please note if the treating clinician determines androgen deprivation therapy (ADT) is required this is an exclusion criteria). A PSA must be available within 60 days of randomisation.\n* Clinical and\u002For MRI stage T1c -T2c, N0-X, M0-X\n* Histological confirmation of prostate adenocarcinoma within the last 18 months (unless on active surveillance). Patients who were on active surveillance should have an up-to-date MRI within 8 weeks of the decision to treat to confirm organ confined disease.\n\nExclusion Criteria:\n\n* Previous malignancy within the last 2 years (except basal cell carcinoma or squamous cell carcinoma of the skin), or if previous malignancy is expected to significantly compromise 10-year survival.\n* Patients under investigation for synchronous primary at time of randomisation\n* Prior pelvic radiotherapy.\n* Prior treatment with ADT or current need for ADT based on risk features\n\n  * Prostate cancer in greater than 50% of template biopsy cores or a significant maximum core length containing prostate cancer for which the treating clinician deems the patient would benefit from ADT\n* Any prior active treatment for prostate cancer (patients previously on active surveillance are eligible if they meet all other eligibility criteria)\n* Life expectancy \\\u003C 10 years Men with a prostate gland larger than 60 cc, or those with a large median lobe• Hip prostheses or any other implants\u002Fhardware that introduce substantial CT artefacts making it challenging to delineate the target or organs at risk. This is to be assessed on a case-by-case basis with the available staging imaging.\n* Medical conditions likely to make radiotherapy inadvisable e.g. inflammatory bowel disease, significant urinary symptoms.\n* International Prostate Symptom Score (IPSS) \\> 15 points\n* Anticoagulation with warfarin\u002F bleeding tendency making fiducial placement, spacer gel insertion or brachytherapy unsafe in the opinion of the clinician\n* Contraindications for Barrigel insertion such as previous documented allergic reaction to gel, previous rectal surgery or known rectal fistula.\n* Participation in another concurrent treatment protocol for prostate cancer.","MALE","18 Years",{"count":20,"type":21},220,"ESTIMATED","INTERVENTIONAL",[24],"NA","The LDR BURST trial will compare the side effects of two radiotherapy treatments for men with localised prostate cancer. The first treatment is 4D low dose rate brachytherapy where small radioactive seeds are inserted into the prostate gland under ultrasound guidance. A computerised tomography scan is subsequently performed to check seed positioning. Patients usually return home the same day. The seeds emit their radiation over several months before losing their activity.\n\nStereotactic radiotherapy, an alternative treatment, is a form of external radiation using precise high energy x-rays to target the prostate gland. It is delivered in 5 treatment sessions on alternate days; the full treatment course is completed within 2 weeks.\n\nStereotactic radiotherapy has recently been approved by the National Health Service following successful results in international trials demonstrating it is safe and effective to give external radiotherapy in five treatment sessions. Delivering a higher dose in each treatment fraction is known as 'ultra-hypofractionation'. Before the treatment, men will undergo a minor procedure, typically under local anaesthetic, to have metallic markers inserted into the prostate to improve visibility of the prostate gland when planning and delivering the treatment.\n\nThe side effects of both the radiation treatments are similar. Common side effects include bladder issues, such as needing to urinate more often and having a slower urine flow. Patients might also experience more frequent and looser bowel movements, occasionally with a little blood. Symptoms usually improve over time. Additionally, some men might have trouble achieving or maintaining an erection after radiation treatment, this can often be managed with medications.\n\nBoth of the treatments use ionising radiation to destroy the prostate cancer cells which may cause cancer many years or decades after exposure. The chances of this happening are the same whether taking part in this trial or not.\n\nA protective gel, called Barrigel, will be inserted into the space between the prostate gland and the rectum increasing the distance between them. This significantly reduces the dose of radiation to the rectum. The gel can be inserted at the same time as the brachytherapy seed or fiducial marker insertion. The gel is slowly reabsorbed following treatment over the next 3 to 6 months.\n\nThe trial will randomly assign 110 men to each radiation treatment to compare their side effects. There is a 50% chance the patient will be assigned to brachytherapy and 50% chance of stereotactic radiotherapy. Patients will be asked to complete four questionnaires prior to starting treatment and at regular time points following treatment. They will be telephoned every 4 weeks for the first 2 months to check on side effects, followed by a face-to-face appointment at 3 months, and a PSA blood test, and then followed up at regular intervals for 5 years.",[27],"Prostate Adenocarcinoma",[29,30,31],"low dose rate brachytherapy","Stereotactic Body Radiation Therapy","rectal spacer gel","NOT_YET_RECRUITING","2025-09-29",{"date":35,"type":36},"2025-10-07","ACTUAL",{"date":38,"type":21},"2025-12-01",{"date":40,"type":21},"2030-12-01",{"name":42,"class":43},"Royal Surrey County Hospital NHS Foundation Trust","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":18,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":67,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":44},"100565162","mirrors-frozen---comparing-open-vs-robotic-surgery-in-the-management-of-women-with-complex-pelvic-adnexal-masses--8cm-100565162","NCT06638593","MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN - a Pilot Randomised Controlled Trial (RCT) Comparing Open Vs Robotic Surgery in the Management of Women with Complex Pelvic Adnexal Masses ≤ 8cm.","MIRRORS-FROZEN","Inclusion Criteria:\n\n* Complex adnexal Pelvic mass\u002Fes ≤8 cm with no malignant disease outside the adnexae on CT or MRI.\n* Women aged ≥18 \\& ≤100 years old.\n* Patients who had given their signed and written informed consent\n\nExclusion Criteria:\n\n* Adnexal pelvic mass \\> 8 cm.\n* Radiological or histological or cytological evidence of stage III or IV disease.\n* Lack of capacity to understand and give informed consent.\n* Patients not suitable for laparoscopic surgery, such as but not limited to those with severe aortic stenosis.\n* Any patient randomized to either of the study arms and found to have disease which appears greater than stage 1 will be withdrawn from the trial and treated according to the national guidelines","FEMALE","100 Years",{"count":56,"type":21},40,[24],"Adnexal masses are growths that can form in the ovaries or fallopian tubes for different reasons, such as hormonal changes, infection, or cancer. These masses may cause pelvic discomfort, pain, constipation, or no symptoms at all. When adnexal masses are found on scans, they are described in a certain way to indicate if they could represent early-stage cancer, and the word \"complex\" is used to refer to these masses. Surgery is often recommended, where the mass is removed and examined under the microscope during surgery in a process called (frozen section analysis); to determine its true nature.\n\nIt is still difficult to confirm cancer before surgery, and many of these masses turn out to be benign (not cancerous) or borderline (slow-growing tumours). Currently, doctors use open surgery with a cut from at least the belly button to the pubic bone to remove these masses. Patients with a cancer diagnosis will then have more surgical steps including assessment and sampling of various areas inside the abdomen (known as staging surgery) to see how far the cancer has spread.\n\nRecovery after open surgery can be long and painful, with a slow return to normal daily activities. The trial investigators know from practice that robotic surgery has replaced open surgery for most benign adnexal diseases and other types of women's cancers, such as womb cancer. Recovery is quicker, with less pain and blood loss, allowing for a faster return to daily activities.\n\nThis study, MIRRORS-FROZEN (pilot), compares robotic versus the standard open surgery in managing women with complex adnexal masses of eight centimetres or less. The hope is to decrease the need for open surgery in patients with benign or borderline disease and to assess if robotic surgery has similar, worse, or better outcomes for patients with cancer.\n\nMIRRORS-FROZEN is funded by Intuitive Foundation and GRACE Charity. The investigators will establish the feasibility of conducting a large multicentre randomized controlled trial in the future comparing certain cancer outcomes between robotic and open surgery.",[60,61,62,63,64,65,66],"Ovarian Cancer","Ovarian Mass","Ovarian Cysts","Fallopian Tube Neoplasms","Adnexal Carcinoma","Adnexal Cyst","Adnexal Masses",[68,69,70],"Robotic","adnexal masses","Adnexal cysts","RECRUITING","2024-10-10",{"date":74,"type":36},"2024-10-15",{"date":76,"type":36},"2024-09-23",{"date":78,"type":21},"2027-02-01",{"name":42,"class":43},{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":18,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":44},"100563214","characterisation-of-endothelial-cells-in-different-inflammatory-pathologies-100563214","NCT06613256","Characterisation of Endothelial Cells in Different Inflammatory Pathologies","JEDI-2","Inclusion Criteria:\n\nHealthy volunteer\n\n* Adult ≥ 18 years\n* Able and willing to give consent\n\nSurgical patients\n\n* Adult ≥ 18 years\n* Patients admitted to RSFT for planned major surgery\n\nCritically ill patients\n\n* Adult ≥ 18 years\n* Emergency admission to ICU at RSFT\n* Meets the sepsis 3.0 definition\n\nExclusion Criteria:\n\nHealthy volunteer\n\n* Not currently a patient within the hospital\n* Absence of inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes, cardiovascular disease and CKD.\n* Not on immunomodulatory medications, such as corticosteroids\n* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)\n\nSurgical patients\n\n* Patients with restricted liberty, prisoners or under legal protection\n* Anticipated prohibitively difficult venous cannulation\n* Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, sepsis, diabetes with end organ damage, cardiovascular disease and CKD\n* Currently prescribed immunomodulatory medication or immunocompromised\n* Received chemotherapy within 2 weeks of predicted sampling\n* Receiving vasopressor support prior to surgery\n* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)\n\nCritically ill patients\n\n* Patients with restricted liberty, prisoners or under legal protection• Anticipated prohibitively difficult venous cannulation\n* Presenting with inflammatory diseases and disorders including but not limited to arthritis, peripheral artery disease, vasculitis, diabetes with end organ damage, cardiovascular disease and CKD.\n* Currently prescribed immunomodulatory medication or immunocompromised\n* Received chemotherapy within 2 weeks of predicted sampling.\n* History of recent major trauma within the last 2 months (e.g., surgery or injury requiring hospitalisation)",true,"ALL",{"count":90,"type":21},105,"OBSERVATIONAL","The goal of this observational study is to characterise changes in gene expression in endothelial cells in patients with either sepsis or post major abdominal surgery.\n\nThe main question we plan to answer is: 'What molecular pathways are differentially expressed during inflammatory pathologies?'",[94,95],"Sepsis","Vasoplegia",{"date":97,"type":36},"2024-09-25",{"date":99,"type":36},"2024-07-16",{"date":101,"type":21},"2026-11-12",{"name":42,"class":43},{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":87,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":91,"phases":4,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":44},"100245285","laparoscopic-surgery-for-severe-recto-vaginal-endometriosis-100245285","NCT02471443","Laparoscopic Surgery for Severe Recto-vaginal Endometriosis","Laparoscopic Surgery for Severe Recto-vaginal Endometriosis: A Prospective Cohort Study","Inclusion Criteria:\n\n* All women undergoing planned surgery for severe endometriosis with bowel involvement.\n\nExclusion Criteria:\n\n* Patients who declined to complete questionnaires for whatever reason and\u002For have their anonymous data analysed.",{"count":111,"type":21},1000,"To determine the quality of life following the radical excision of recto-vaginal endometriosis.",[114],"Endometriosis Rectovaginal Septum","2019-03-25",{"date":117,"type":36},"2019-03-26",{"date":119,"type":4},"2004-05",{"date":121,"type":21},"2040-01",{"name":42,"class":43},""]