[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Jewish General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":260},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,41,66,91,119,148,180,211,237],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100615402","phase-1-fmt-in-triple-negative-breast-cancer-guided-by-ctdna-100615402",false,"NCT07292142","FMT in Triple Negative Breast Cancer Guided by ctDNA","FRIDA","Inclusion Criteria:\n\nPHASE 1\n\n* Patients must be 18 years old or older.\n* Patients must have a confirmed diagnosis of TNBC (defined as estrogen receptor expression 0-10%, progesterone receptor expression 0-10%, and HER-2\u002Fneu negative (immunohistochemistry 0, 1+, or 2+ and fluorescent in-situ hybridization negative for HER-2 gene amplification) and are about to start neoadjuvant chemotherapy.\n* Patients with ECOG performance of 0-2.\n* Patients who are willing to provide serial stool and blood samples.\n* Patients must be able to provide written informed consent\n* Patients with available primary tumor biopsy tissue for molecular analysis\n\nPHASE 2\n\n* Patients must be 18 years old or older.\n* Patients must have a confirmed diagnosis of TNBC (defined as estrogen receptor expression 0-10%, progesterone receptor expression 0-10%, and HER-2\u002Fneu negative (immunohistochemistry 0, 1+, or 2+ and fluorescent in-situ hybridization negative for HER-2 gene amplification) and are about to start neoadjuvant chemotherapy-immunotherapy.\n* Patients with ECOG performance of 0-2.\n* Patients must be able to provide written informed consent and understand the infectious risks associated with FMT administration.\n* Ability to ingest capsules.\n* Patients receiving systemic steroids at physiologic doses are permitted to enroll assuming steroid dose is not above the acceptable threshold (\\>10 mg prednisone daily or equivalent).\n\nExclusion Criteria:\n\nPHASE 1\n\n* Clinical or radiological evidence of metastatic disease.\n* Known infection with HIV or hepatitis.\n* Pregnant woman.\n\nPHASE 2\n\n* Previous anti-PD-1 treatment.\n* Patient with a secondary malignancy.\n* Pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.\n* Current exposure to high-dose oral or intravenous corticosteroids (\\>10 mg of prednisone daily or equivalent). Patients who require intermittent use of bronchodilators or local steroid injections are not excluded from the study.\n* Absolute neutrophil count \\\u003C1.0 within 48 hours of planned FMT administration\n* Has a diagnosis of immunodeficiency (for example, HIV or transplantation) or any other form of immunosuppressive therapy before trial treatment.\n* Ongoing use of antibiotics or previous use of antibiotics one week before the FMT procedure.\n* Probiotic supplements and food products labeled as containing probiotics must be discontinued a minimum of 24 hours before FMT administration and are not permitted during the course of neoadjuvant immunotherapy treatment.\n* Presence of a chronic intestinal disease (for example, celiac, malabsorption, and colonic tumor).\n* Presence of absolute contraindications to FMT administration, including toxic megacolon, severe dietary allergies (for example, shellfish, nuts, or seafood), and inflammatory bowel disease.\n* Expected to require any other form of systemic or localized anti-neoplastic therapy other than those proposed by the study while on study.\n* Has an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo, type I diabetes, or resolved childhood asthma\u002Fatopy are exceptions to this rule.\n* A history of recent (\\\u003C30 days) (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Has serious concomitant illnesses, such as uncontrolled cardiovascular disease (congestive heart failure, uncontrolled hypertension, active evidence of cardiac ischemia, myocardial infarction, and severe cardiac arrhythmia), autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, and inflammatory bowel disorders. This includes HIV or AIDS-related illness or active hepatitis B or C virus.\n* Has an active infection requiring systemic therapy.\n* Patient has received a live vaccine within 4 weeks before the first dose of treatment. Note that seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however, intranasal influenza vaccines (for example, FluMist) are live attenuated vaccines and are not allowed.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","ALL","18 Years",{"count":19,"type":20},125,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Triple-negative breast cancer (TNBC) is an aggressive form of breast cancer, usually treated with chemotherapy and an immune checkpoint blockade (ICB) in the pre-operative or neoadjuvant phase. However, about 35% of tumors do not respond fully to this therapy, and patient prognosis is poor. Recent exciting data from our group and others suggest that the alteration of the gut microbiome via fecal microbiota transplantation (FMT) markedly affects the response to ICB in melanoma1-3. The investigators propose to test the safety and feasibility of altering the gut microbiome in the context of neoadjuvant therapy (NAT) for TNBC. This pilot study will assess the safety of FMT given with neoadjuvant chemo-immunotherapy and will determine the feasibility of conducting a future randomized clinical trial to test whether FMT improves the effectiveness of neoadjuvant chemotherapy and ICB in patients with TNBC.\n\nThis study will be divided into two phases. In Phase I (observational phase), the investigators propose to test the feasibility of collecting stool and plasma samples in TNBC patients treated with neoadjuvant therapy (NAT) without FMT treatment. In Phase II (interventional phase), patients will undergo the sample collection procedures as in Phase I, but in addition, the investigators will assess the safety and feasibility of FMT treatment in combination with NAT.",[27],"Breast Cancer","NOT_YET_RECRUITING","2025-12-05",{"date":31,"type":32},"2025-12-18","ACTUAL",{"date":34,"type":20},"2026-02",{"date":36,"type":20},"2031-12",{"name":38,"class":39},"Jewish General Hospital","OTHER",3,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":40},"100429591","triple-negative-breast-cancer-markers-in-liquid-biopsies-using-artificial-intelligence-100429591","NCT04874064","TRIple Negative Breast Cancer Markers In Liquid Biopsies Using Artificial Intelligence","Triple Negative Breast Cancer Markers in Liquid Biopsies Using Artificial Intelligence (TRICIA Study)","TRICIA","Inclusion Criteria:\n\n* Triple negative (ER negative, PR negative and Her2 negative as defined by local standards). ER \\\u003C10% is acceptable.\n* Patients who have completed a minimum of 8 weeks of neoadjuvant chemotherapy.\n* A cohort of TNBC patients who are awaiting surgery that have clinical or radiological evidence of residual tumor prior to surgery. This evaluation will be made at the discretion of the treating physician.\n\nOR A second cohort of TNBC patients will be recruited after surgery, in which pathological evaluation has demonstrated the presence of residual tumor post-surgery.\n\n* Patients who can come to the clinic for standard of care follow-up within 6 weeks post-surgery and in the next 6 months after surgery.\n* Patients who are willing to provide serial blood samples.\n* Participants must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other requirements of the study.\n\nExclusion Criteria:\n\n* Clinical or radiological evidence of metastatic disease.\n* Patient with a recurrence of breast cancer.\n* Patients who have not had neoadjuvant chemotherapy or less than 8 weeks of neoadjuvant chemotherapy.\n* Patient who received radiotherapy treatment prior to surgery.\n* Patients who are not capable of signing or understanding the informed consent form.\n* Known infection with HIV or hepatitis.",{"count":50,"type":20},130,"OBSERVATIONAL","Triple negative breast cancer (TNBC) is the most aggressive of breast cancers and it is usually treated with chemotherapy even before surgery. In many cases, the chemotherapy completely \"melts\" the tumor and these patients do well. When the tumor is not eliminated by the chemotherapy, the patient receive more chemotherapy after surgery to decrease the chances of it coming back. Yet many of these patients don't need that extra chemotherapy and will do well in any case. One of the most exciting recent developments in cancer is the use of \"liquid biopsies\". It turns out that the tumor's DNA, RNA and proteins can be detected in small vesicles found in the patient's blood. Thanks to advances in Artificial Intelligence, there is now informatics tools to integrate many types of molecular information. Our industrial partner, MIMs, will apply novel informatics tools to generate a test using all the molecular information obtained from blood vesicles and tissue that will be able to find out early if tumor has spread outside of the breast, and how much tumor is left after surgery. The goal is hope to develop a multi-dimensional test for TNBC patients that can be used to decide how much treatment they need and if treatment given after surgery is working.",[27],[27,55,56],"Liquid Biopsy","Artificial Intelligence","RECRUITING","2025-11-21",{"date":60,"type":32},"2025-11-28",{"date":62,"type":32},"2019-12-05",{"date":64,"type":20},"2027-12",{"name":38,"class":39},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100494533","functional-pulmonary-capillary-surface-area-in-bpa-for-cteph-100494533","NCT05719415","Functional Pulmonary Capillary Surface Area in BPA for CTEPH","Assessment of Recovery of Functional Capillary Surface Area in Patients Undergoing a Balloon Pulmonary Angioplasty for Chronic Thromboembolic Pulmonary Hypertension","Inclusion Criteria:\n\n* All patients eligible for balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension\n\nExclusion Criteria:\n\n* Treatment with angiotensin-converting enzyme inhibitors or angiotensin receptor blockers,\n* Presence of patent foramen ovale","75 Years",{"count":75,"type":20},40,[77],"NA","Chronic thromboembolic pulmonary hypertension \\[CTEPH\\] is caused by pulmonary emboli that have enlarged in pulmonary arteries and have become organized into the vessel wall. Many patients with CTEPH are treated with balloon pulmonary angioplasty \\[BPA\\] which mechanically opens the narrow pulmonary arteries. It is unclear how much downstream functional pulmonary capillary surface area \\[FCSA\\] is recovered during BPA. The investigators plan to measure FCSAIn CTEPH patients, before and after a session of BPA.",[80,81],"Hypertension, Pulmonary","Pulmonary Thromboembolisms","2025-09-22",{"date":84,"type":32},"2025-09-23",{"date":86,"type":32},"2023-03-23",{"date":88,"type":20},"2028-01-30",{"name":38,"class":39},1,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":98,"minAge":4,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":101,"conditions":102,"keywords":107,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":90},"100570029","the-impact-of-fasting-duration-on-quality-of-recovery-after-cesarean-section-100570029","NCT06701929","The Impact of Fasting Duration on Quality of Recovery After Cesarean Section","How Fasting Duration Before Cesarean Section Affects the Quality of Recovery Score (ObsQoR-11)","Inclusion Criteria:\n\n* Presenting for elective c-section under spinal anesthesia\n\nExclusion Criteria:\n\n* Unable to communicate in French or English\n* Urgent c-section\n* Planned general anesthesia","FEMALE",{"count":100,"type":20},100,"This study will evaluate the effect of fasting duration and elective c-section start time on the overall quality of recovery. Patients will be seen 24 hours after surgery to answer 11 questions on their overall recovery after surgery. Several factors will be tracked to determine their effect on recovery, with the primary variable of interesting",[103,104,105,106],"Quality Improvement","Quality of Recovery From Anaesthesia","Cesarean Section","Fasting ( 6H for Solid ; 2H for Clear Fluid )",[108,109,110],"Quality of Recovery","cesarean section","fasting duration","2025-08-27",{"date":113,"type":32},"2025-09-04",{"date":115,"type":32},"2025-03-18",{"date":117,"type":20},"2026-06-01",{"name":38,"class":39},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":90},"100453721","phase-4-preoperative-maltodextrins-effect-on-cardiac-function-in-cardiac-surgery-100453721","NCT05188222","Preoperative Maltodextrin's Effect on Cardiac Function in Cardiac Surgery","The Effect of Preoperative Maltodextrin on Cardiac Function in Cardiac Surgery Patients with Reduced Left Ventricular Ejection Fraction: a Randomized, Controlled, Double-blind, Clinical Trial","Inclusion Criteria:\n\n* 18 years of age or older\n* Presenting for coronary artery bypass grafting surgery\n* Preoperative left ventricular ejection fraction \\\u003C 50%\n* First case of the day (7:30am start time)\n\nExclusion Criteria:\n\n* Dysphagia, gastroparesis\n* Cannot tolerate oral intake\n* Celiac disease\n* Type 1 diabetes",{"count":127,"type":20},70,[129],"PHASE4","A randomized, controlled, double-blinded clinical trial evaluating the effect of the administration of a Maltodextrin solution on cardiac function in patients presenting for coronary artery bypass grafting surgery with a reduced left ventricular ejection fraction.",[132,108,133],"Left Ventricular Dysfunction","Right Ventricular Dysfunction",[135,136,137,138,139],"Cardiac surgery","Insulin","Maltodextrin","Enhanced Recovery After Surgery","Quality of Recovery After Surgery","2025-02-21",{"date":142,"type":32},"2025-02-24",{"date":144,"type":20},"2025-12-01",{"date":146,"type":20},"2027-03-01",{"name":38,"class":39},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":98,"minAge":17,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":166,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":172,"lastUpdatePostDateStruct":173,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":40},"100414047","targeted-axillary-dissection-tad-in-early-stage-node-positive-breast-cancer-100414047","NCT04671511","Targeted Axillary Dissection (TAD) in Early-stage Node Positive Breast Cancer","Sentinel Node Biopsy and Targeted Axillary Dissection in Node-Positive Breast Cancer Patients With Clinically Negative Axilla","TADEN","Inclusion Criteria:\n\n* Participants must be ≥ 18 years old.\n* Participants with a clinical T1 or T2 invasive ductal or lobular breast carcinoma, regardless of estrogen\u002Fprogesterone\u002Fhuman epidermal growth factor receptor 2 (HER2) receptor status.\n* Participants with clinical (on palpation) N0 and up to two suspicious lymph nodes on axillary ultrasound.\n* Participant with biopsy-proven positive axillary disease made by core needle biopsy or fine-needle aspiration.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status less than 2.\n* Participants must understand, accept, and have signed the approved consent form.\n\nExclusion Criteria:\n\n* Participant with previous ipsilateral axillary surgery, including sentinel lymph node biopsy.\n* Participants with distant metastases.\n* Participants that have had previous radiotherapy to the axillary nodes.\n* Participants who received neoadjuvant therapy.\n* If the injection of blue dye is planned, patients with hypersensitivity or allergy to isosulfan blue, patent blue, methylene blue or radiocolloid dye.\n* Participants who are unable to provide informed consent.",{"count":157,"type":20},98,[77],"RATIONALE: It is now standard for most breast cancer patients with 1-2 positive sentinel nodes to avoid completion node dissection when eligibility criteria from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial are met. The National Comprehensive Cancer Network (NCCN) recently proposed to extend this indication to patients that present with biopsy proven node positive disease if only 1 or 2 suspicious nodes are found on imaging, these positive nodes are not palpable clinically, and the other eligibility criteria from the Z0011 study are otherwise met. However, this recommendation is based on an expert consensus and no study has yet confirmed the optimal method to stage the axilla in this patient population.\n\nPURPOSE: Evaluate the technical success rate and accuracy of sentinel node biopsy (SNB) and the potential benefits of clipping and removing the biopsy proven node using radioactive seed localisation (RSL) (SNB+RSL = Targeted Axillary Dissection (TAD)) in patients with biopsy proven positive nodes, limited nodal disease in imaging and clinically negative axillary examination.",[161,162,163,164,165],"Breast Cancer Female","Early-stage Breast Cancer","Lymph Node Metastases","Axillary Metastases","Sentinel Lymph Node",[167,168,169,170,171],"breast cancer","targeted axillary dissection","sentinel lymph node biopsy","clinically negative axilla","metastatic axillary lymph nodes","2025-02-18",{"date":174,"type":32},"2025-02-20",{"date":176,"type":32},"2021-03-30",{"date":178,"type":20},"2026-07",{"name":38,"class":39},{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":98,"minAge":17,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":21,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100441390","early-ileostomy-closure-for-rectal-cancer-patients-in-north-america-100441390","NCT05027737","Early Ileostomy Closure for Rectal Cancer Patients in North America","Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)","Inclusion Criteria:\n\n* Adult (≥18 years-old) patients\n* Underwent restorative proctectomy by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with creation of a diverting loop ileostomy for the treatment of rectal cancer\n* Negative anastomotic \"leak test\" via CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9.\n\nExclusion Criteria:\n\n* Peri-operative immunosuppression (within 6 weeks of surgery date);\n* Age-adjusted Charlson Comorbidity Index \\>6;\n* Other major surgery during the index operation;\n* Any major complications (Clavien Dindo Grade III or greater) following restorative proctectomy;\n* Inability to speak or comprehend English or French and inability to give informed consent.","90 Years",{"count":189,"type":20},118,[77],"Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop ileostomy (DLI). The feedback from leaders in Europe further supports the need for a large scale randomized-controlled trial (RCT) on this subject in North America. Should the results of such a study be favourable, we believe it could support a change in practice that would be beneficial to patients and the health care system alike. Furthermore, our work will help identify which patients and practices are suitable for EIC.\n\nThe goal of our project is to determine whether EIC in rectal cancer patients undergoing RP with a DLI is safe, feasible and beneficial in a North American population. Specifically, our primary objective is to compare the severity of complications between patients undergoing EIC versus traditional (late) closure. Our secondary objectives include assessing the difference in quality of life (QoL), early and late bowel function, and cost of care between these two groups.",[193,194],"Ileostomy - Stoma","Rectal Cancer",[196,197,198,199,200,201],"Early ileostomy closure","Comprehensive complication index","Bowel function","Quality of life","Recovery","Cost","2022-08-22",{"date":204,"type":32},"2022-08-23",{"date":206,"type":32},"2022-02-22",{"date":208,"type":20},"2026-09-01",{"name":38,"class":39},4,{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":220,"studyType":51,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":4},"100431114","the-opera-study-evaluating-qol-after-rectal-cancer-surgery-100431114","NCT04893876","The OPERa Study: Evaluating QoL After Rectal Cancer Surgery","The OPERa Study: A Multicenter Observational Prospective Cohort Study to Evaluate Determinants of Long-Term Quality of Life Following Restorative Proctectomy for Rectal Cancer Treatment","Inclusion Criteria:\n\n* Patients \\>18 years with histopathologically confirmed adenocarcinoma of the rectum, defined as tumor ≤15cm from the anal verge who are planned for RP ± neoadjuvant treatment or WW (CRT alone without surgery).\n\nExclusion Criteria:\n\n* Metastatic disease at diagnosis;\n* Planned for abdominoperineal resection (APR), low Hartmann's or pelvic exenteration (PE);\n* Cannot be contacted by telephone;\n* Unable to read and comprehend English or French;\n* Unable to give clear and informed consent.",{"count":219,"type":20},1200,"3 Years","Advances in rectal cancer management have significantly reduced morbidity and mortality. The most commonly performed operation for rectal cancer is restorative proctectomy (RP), leaving up to 70% with long-term bowel dysfunction called Low Anterior Resection Syndrome (LARS). LARS manifests as stool frequency, incontinence and difficult defecation. LARS, along with other functional impairments such as sexual and urinary dysfunction (SUD), can impact quality of life (QoL) and cause emotional distress. High-quality longitudinal data on these sequalae are lacking, leading to variable estimates of their prevalence, risk factors and prognosis. Most studies are European, cross-sectional, lack pre-treatment evaluation and long-term follow-up, and use inconsistent assessment measures. Thus, a North American study that evaluates patients longitudinally from diagnosis will provide quality data to fill this knowledge gap.\n\nThe main aim of the proposed study is to contribute evidence regarding the impact of LARS, SUD, emotional\u002Ffinancial distress, and patient activation on long-term post-treatment QoL in North American rectal cancer after RP.\n\nThis multicenter North American, observational, prospective cohort study relies on validated patient reported outcome measures (PROMs) at diagnosis, during and post-treatment. Patients from 20 sites will be recruited over 2 years and followed for 3 years. The primary endpoint is QoL as measured by the European Organization for Research \\& Treatment of Cancer QoL questionnaire. We anticipate accrual of 1200 patients. Factors associated with QoL will be explored. Impact of patient activation in relation to functional outcomes on QoL over time will be explored using a difference-in-differences approach. The study involves a multidisciplinary team who will provide expertise in research methodology, nursing, oncology and surgery.\n\nThe main contributions of this study are 1) provision of reference baseline North American values for important rectal cancer PROMs for clinical and research use, 2) an understanding of the evolution of functional outcomes and QoL post-treatment to counsel patients peri-operatively and throughout survivorship, and 3) to provide the basis for future tailored programs to support rectal cancer survivors.",[194,223,224,225,226,227,228],"Quality of Life","Bowel Dysfunction","Sexual Dysfunction","Urinary Dysfunction","Emotional Distress","Surgery","2022-08-17",{"date":231,"type":32},"2022-08-18",{"date":233,"type":20},"2023-01-01",{"date":235,"type":20},"2029-09-30",{"name":38,"class":39},{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":244,"minAge":17,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100403136","middle-lobe-only-laser-vaporization-or-total-prostate-vaporization-of-the-prostate-prospective-cohort-study-100403136","NCT04529369","Middle Lobe Only Laser Vaporization or Total Prostate Vaporization of the Prostate, Prospective Cohort Study","Efficacy and Long-term Durability of Middle Lobe Only (MLO) Versus Complete Trans-Urethral Vaporization of the Prostate (PVP), Prospective Cohort Study.","Inclusion Criteria:\n\n* Adult males (18-year-old and more)\n* Suffering bothersome LUTS or urinary retention secondary to BPH\n* Cystoscopic examination documenting the predominant middle lobe prostatic adenoma that is considered to be the primary cause of BOO.\n\nExclusion Criteria:\n\n* Patients neurogenic lower urinary tract dysfunction (Neurogenic Bladder)\n* Not competent to give consent and\u002For inability to provide answers to the questionnaire\n* Patient who refuse to participate in the study\n* Patients without a median lobe\n* Patients who have a large prostate (more than 120 g on trans-abdominal ultrasound prostate sizing).\n* Patients who have renal impairment secondary to BPH\n* Patients with proven or suspicion of prostate cancer based on clinical examination and\u002For PSA level\n* Patients with refractory hematuria secondary to BPH\n* Patients with urethral strictures\n* Patients with bladder cancer\n* Patients with history of pelvic radiotherapy","MALE","100 Years",{"count":247,"type":20},280,[77],"The investigator aims to prospectively investigate the efficacy and durability of the middle lobe only versus traditional complete photoselective greenlight vaporization of the prostate in patients with prominent middle lobe. The investigator will select patients based on pre-op cystoscopy if patients have a prominent middle lobe to participate in this study. Researches will start to vaporize only the middle lobe then, at the end of this step, The investigator will look at the verumontanum into the prostatic fossa and determine if the patient is having adequate opened prostatic fossa or not. Patients with unsatisfactory opened fossa will have a complete PVP of lateral lobes, while patients with a satisfactory channel will not receive a complete PVP. Primary objectives of the study are to look into pre and post-operative uroflowmetry and post-void residual, International prostate symptoms scores, need of catheterization, and need for secondary interventions over five then ten years. Secondary objectives are to look into erectile and ejaculatory status using the Male Sexual Health Questionnaire (MSHQ) and MSHQ-EjD Short Form for Assessing EjD. Researchers will follow the patients at three months, six months, one year then yearly for five years then an extension to up to 10 years.",[251],"Benign Prostatic Hyperplasia","2020-08-25",{"date":254,"type":32},"2020-08-27",{"date":256,"type":20},"2020-10",{"date":258,"type":20},"2030-10",{"name":38,"class":39},""]