[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vejle Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":277},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,38,66,96,119,147,177,204,228,249],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":26,"lastUpdatePostDateStruct":27,"startDateStruct":30,"completionDateStruct":32,"leadSponsor":34,"locationsCount":37},"100570982","smarter-using-blood-samples-to-improve-fit-based-colorectal-cancer-screening-100570982",false,"NCT06714318","SMARTER: Using Blood Samples to iMprove FIT-bAsed coloRecTal cancEr scReening","Inclusion Criteria:\n\n* Participation in the colorectal cancer screening program.\n\nExclusion Criteria:\n\n* Participants are excluded if a colonoscopy is not completed unless this is due to a colorectal cancer obstruction.","ALL","50 Years","74 Years",{"count":19,"type":20},1000,"ESTIMATED","OBSERVATIONAL","The project aims to investigate whether colorectal cancer screening can be improved using blood tests, thereby reducing the number of unnecessary colonoscopies. The Danish colorectal cancer screening program was implemented in 2014, and currently, all individuals aged 50-74 are invited every two years to participate. Those who test positive for hidden blood in their stool are referred for a colonoscopy. More than a third of the approximately 25,000 colonoscopies performed annually in the screening program can be classified as unnecessary, as they reveal a normal colon. This results in avoidable and unpleasant procedures for individuals and strains healthcare resources.\n\nThe project seeks to reduce the number of these unnecessary colonoscopies by investigating whether blood biomarkers can identify individuals at very low risk of colorectal cancer after a positive stool test for hidden blood. By utilizing blood tests, screening could become more personalized, precise, and resource-efficient for the healthcare system.",[24],"Colorectal Cancer","RECRUITING","2026-06-26",{"date":28,"type":29},"2026-06-29","ACTUAL",{"date":31,"type":29},"2024-12-02",{"date":33,"type":20},"2028-09",{"name":35,"class":36},"Vejle Hospital","OTHER",2,{"id":39,"slug":40,"hasResults":11,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":43,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":37},"100635430","blood-based-risk-evaluation-with-ai-for-targeted-primary-health-care-in-early-lung-cancer-detection-100635430","NCT07552584","Blood Based Risk Evaluation With AI for Targeted Primary Health Care in Early Lung Cancer Detection","BREATHE","Inclusion Criteria:\n\n* Diagnosed with COPD.\n* =\\> 50 years.\n* Former or current smoker.\n* Speaks and understands Danish.\n* Able to give informed consent to participation.\n\nExclusion Criteria:\n\n* Had a CT scan of the thorax within 6 months.\n* Received active treatment for cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* Diagnosed with cancer within one year (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* Presents with symptoms giving suspicion of cancer (except non-melanoma skin cancer and carcinoma in situ cervicis uteri).\n* In a condition not allowing diagnostic workup for or treatment of lung cancer.\n* Does not have Eboks (electronic communication with Danish authorities).",{"count":19,"type":20},"INTERVENTIONAL",[48],"NA","The study is a prospective, non-randomized feasibility study evaluating blood sample and machine learning-based risk stratification for lung cancer in patients with COPD (chronic obstructive pulmonary disease).\n\nPatients with COPD will be recruited in general practice, where they will have a blood sample drawn. All data will be analyzed by the machine learning model, and patients with increased risk of lung cancer will be referred for a low-dose CT scan of the chest.\n\nThe primary objective of the study is to evaluate the feasibility of AI and DNA methylation-based risk stratification for lung cancer in patients with COPD in a primary care setting.\n\nThe secondary objectives are to evaluate the safety of the risk stratification approach, the potential effects on quality of life and wellbeing, to gain insight into the patient and physician perspectives, and to estimate the health economic consequences.",[51],"Lung Cancer (Diagnosis)",[53,54,55,56,57],"Lung cancer","Biomarkers","Machine learning","Risk stratification","COPD","2026-06-02",{"date":60,"type":29},"2026-06-03",{"date":62,"type":29},"2026-05-26",{"date":64,"type":20},"2034-04",{"name":35,"class":36},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":46,"phases":76,"briefSummary":77,"conditions":78,"keywords":84,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},"100608410","holistic-acupuncture-for-patients-with-chemotherapy-induced-nausea-100608410","NCT07201194","Holistic Acupuncture for Patients With Chemotherapy Induced Nausea","HOL-AKU: Holistic Acupuncture for Patients With Chemotherapy Induced Nausea","Inclusion criteria\n\n* ≥ 18 years of age\n* Undergoing chemotherapy and experiencing nausea despite adherence to the prescribed antiemetic regimen\n* Understands and speaks Danish\n* Written and orally informed consent\n* Planned for treatment every 14 days\n* At least two chemotherapy cycles planned at the time of inclusion\n\nExclusion Criteria:\n\n* Brain metastases\n* Performance status \\>2","18 Years",{"count":75,"type":20},90,[48],"The study explores whether acupuncture as a supplement to conventional antiemetic medicine is superior in reducing the level of chemotherapy induced nausea compared to conventional anitemetic medicine alone.\n\nA total of 90 patients experiencing chemotherapy induced nausea will be allocated 1:1 to either acupuncture and antiemetic medicine or antiemetic medicine alone.\n\nThe level of nausea and other cancer related symptoms will be assessed at baseline and 8 and 22 days after enrollment",[79,80,81,82,24,83],"Breast Cancer","Prostate Cancer","Lung Cancer","Gynaecologic Cancer","Pancreatic Cancer Metastatic",[85,86],"acupuncture","chemotherapy induced nauseau","2026-05-27",{"date":89,"type":29},"2026-05-28",{"date":91,"type":29},"2025-11-17",{"date":93,"type":20},"2027-12-31",{"name":35,"class":36},1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":46,"phases":106,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},"100470314","prevention-of-oxaliplatin-induced-nerve-damage-in-the-bodys-extremities-100470314","NCT05404230","Prevention of Oxaliplatin-induced Nerve Damage in the Body's Extremities","Prevention of Oxaliplatin-induced Peripheral Neuropathy - a Randomized Controlled Trial","OxaNeuro","Inclusion Criteria:\n\n* Histopathologically verified adenocarcinoma of the colon or rectum and planned standard adjuvant treatment with capecitabine in combination with oxaliplatin.\n* ECOG performance status 0-2 (measurement of a patient's function in terms of self-care, daily activity and physical ability.\n* Written and orally informed informed consent\n\nExclusion Criteria:\n\n* Inability to speak, read, and understand Danish.\n* Previous treatment with neurotoxic chemotherapy.\n* Neurological (including neuropathy) or psychiatric disorders, diabetes or other significant medical conditions.\n* Alcohol or drug abuse.\n* Sensory disturbances in the feet\n* Spinal stenosis.\n* Vascular disease (Fontaine grade II or more).\n* Known allergy to fish, fish oil or corn oil\n* Fertile patients not willing to use effective methods of contraception during treatment or abstinence.\n* Daily intake of oil supplements and not willing to stop during the trial period.\n* Lack of consent to skin biopsy",{"count":105,"type":20},120,[48],"The purpose of this study is to examine the effect of supplementary polyunsaturated fatty acids on nerve damage in the body's extremitites of patients treated with oxaliplatin containing chemotherapy after surgery for colorectal cancer.",[109,24],"Peripheral Neuropathy","2026-05-18",{"date":112,"type":29},"2026-05-19",{"date":114,"type":29},"2022-07-15",{"date":116,"type":20},"2028-12",{"name":35,"class":36},4,{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":125,"eligibilityCriteria":126,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":127,"targetDuration":4,"studyType":46,"phases":129,"briefSummary":131,"conditions":132,"keywords":135,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":145,"locationsCount":146},"100570967","phase-2-senicapoc-in-patients-with-worsening-fibrotic-interstitial-lung-disease-100570967","NCT06714123","Senicapoc in Patients With Worsening Fibrotic Interstitial Lung Disease","Senicapoc in Patients With Progressive Fibrotic ILD (Interstitial Lung Disease) and IPF (Idiopathic Pulmonary Fibrosis) to Prevent Progression.","FIBROPOC","Inclusion Criteria:\n\n* Progressive fibrotic ILD or Progressive IPF diagnosed according to ATS\u002FERS\u002FJRS\u002FALAT guidelines at the time of diagnosis\n* Age \\> 18 years\n* HRCT historically performed within 24 months\n* FVC \\> 45 %, FEV1\u002FFVC \\> 0,7 or above LLN\n* Annual FVC decline of at least 5% predicted, based on at least three FVC measurements within 6-24 months before enrolment\n* Subject able to give informed consent.\n* The extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan\n* Male subjects of reproductive potential agree to use highly effective contraception\u002Fpreventive exposure measures from the time of first dose of IMP during the study, and until 90 days (male) after the last dose of IMP.\n* Female subjects agree to use highly effective contraceptive during the study, and must show a negative pregnancy test before inclution.\n* Able to walk at least 150 meters during the 6MWT at screening Visit 1;\n* Able to read and complete the EQ-5D, SGRQ-I, K-BILD questionnaire.\n\nExclusion Criteria:\n\n* Sickle cell disease\n* Any clinical condition or other condition or circumstance that, in the opinion of the investigator, may make a subject unsuitable for inclusion or unlikely or unable to complete the study or comply with study procedures and requirements.\n* Known hypersensitivity to any of the IMP ingredients or a history of a significant allergic reaction to any drug as determined by the investigator\n* A current immunosuppressive condition\n* Clinically significant abnormalities detected on ECG of either rhythm or conduction,\n* Moderate to severe hepatic impairment (Child-Pugh B or C); and\u002For abnormal LFT at screening,\n* Clinical laboratory test suggestive of cholestasis with total serum bile acid levels \\> 3xULN.\n* Abnormal renal function, defined as eGFT \\> 30 ml\u002Fkg\n* History of malignancy within the past 5 years\n* Previous participation in a clinical study with IMP for fibrotic disease within the last 6 months.\n* Concurrent participation in another interventional drug, device, or biological investigational research study, or use of an investigational agent within 5 half-lives of the agent\n* Lower respiratory tract infection requiring treatment within 4 weeks prior to screening and\u002For during the screening period.\n* History of lung volume reduction surgery or lung transplant.\n* Diagnosis of severe pulmonary hypertension\n* Unstable cardiovascular, pulmonary (other than IPF), or other disease within 6 months prior to screening or during the screening period\n* Use of any of the following therapies within 4 weeks prior to screening and during the screening period, or planned during the study: warfarin, imatinib, ambrisentan, azathioprine, cyclophosphamide, cyclosporine A, bosentan, methotrexate, sildenafil (except for occasional use), prednisone at steady dose \\> 10 mg\u002Fday or equivalent.\n* Current alcohol or substance abuse in the opinion of the investigator.",{"count":128,"type":20},140,[130],"PHASE2","This study will investigate whether the senicapoc drug can prevent the scarring from worsening in interstitial lung disease.\n\nResearchers will compare Senicapoc to a placebo (a look-alike substance that contains no drug) to see if Senicapoc works to prevent lung function worsening.\n\nParticipants will be asked to take 3 tablets a day for 26 weeks. Within this period, doctors will follow the participants, ask for experience of adverse events, check lung function and organ status, and participants will need to fill out quality-of-life questionnaires. A total of 5 visits are required, at initiation, after4, 13, 26 and 52 weeks. The final visit will occur 52 weeks after initiation and consist of a normal visit in the outpatient clinic where the doctor asks for relevant information regarding the period after end of administration of the study drug.",[133,134],"Pulmonary Fibrosis, Interstitial Lung Disease","Idiopathic Pulmonary Fibrosis",[136,137,138],"pulmonary fibrosis","Senicapoc","interstitial lung disease","2026-05-06",{"date":141,"type":29},"2026-05-07",{"date":143,"type":29},"2025-08-01",{"date":116,"type":20},{"name":35,"class":36},5,{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":46,"phases":156,"briefSummary":157,"conditions":158,"keywords":164,"overallStatus":168,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100498909","phase-2-the-impact-of-a-patient-decision-aid-on-treatment-choices-for-patients-with-an-unexpected-malignant-colorectal-polyp-100498909","NCT05776381","The Impact of a Patient Decision Aid on Treatment Choices for Patients With an Unexpected Malignant Colorectal Polyp","The Impact of an In-consultation Patient Decision Aid on Treatment Choices and Outcomes of Management for Patients With an Unexpected Malignant Colorectal Polyp A Non-randomized Clinical Phase II Study","Inclusion Criteria:\n\n* Histopathologically verified malignant colorectal polyp removed endoscopically and CT-scan (and MRI if the malignant polyp was situated in the rectum) shows N0, M0 disease.\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Inoperable due to comorbidity\n* Known residual tumor left in situ after local resection, \\>N0 or \\>M0",{"count":155,"type":20},110,[130],"Management of unexpected malignant colorectal polyps removed endoscopically can be challenging due to the risk of residual tumor and lymphatic spread. International studies have shown that in patients choosing surgical management instead of watchful waiting, 54-82% of bowel resections are without evidence of residual tumor or lymphatic spread. As surgical management entails risks of complications and watchful waiting management entails risks of residual disease or recurrence, a clinical dilemma arises when choosing a management strategy.\n\nShared decision making (SDM) is a concept that can be used in preference sensitive decision making to facilitate patient involvement, empowerment, and active participation in the decision making process.\n\nThis is a clinical multicenter, non-randomized, interventional phase II study involving Danish surgical departments planned to commence in the first quarter of 2024. The aim of the study is to examine whether shared decision making and using a patient decision aid (PtDA) in consultations affects patients' choice of management compared with historical data. The secondary aim is to investigate Patient Reported Experience Measures (PREMs) and Patient Reported Outcome Measures (PROMs) using questionnaire feedback directly from the patients.",[159,160,161,162,163,24],"Shared Decision Making","Colonic Polyp","Decision Aids","Rectal Polyp","Colorectal Polyp",[165,166,167,159],"non-randomized trial","malignant colorectal polyp","Patient Decision aid","NOT_YET_RECRUITING","2026-04-29",{"date":171,"type":29},"2026-04-30",{"date":173,"type":20},"2028-02-01",{"date":175,"type":20},"2033-02-01",{"name":35,"class":36},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":46,"phases":187,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":95},"100552485","phase-3-reducing-breathlessness-with-dronabinol-in-copd-patients-100552485","NCT06473701","Reducing Breathlessness With Dronabinol in COPD Patients","BONG: Reducing Severe Breathlessness With Dronabinol in the Severe and Very Severe Chronic Obstructive Pulmonary Disease Patient Group - A Randomized, Double-Blind, Placebo-Controlled, Crossover Study","BONG","Inclusion Criteria:\n\n* Refractory dyspnea despite optimal treatment\n* COPD (GOLD 3,4)\n* Breathlessness corresponding to mMRC score ≥ 3\n* Informed written consent\n* Age ≥ 18 years\n* Cognitive relevant, of legal age\n* Understands and speaks Danish\n* For fertile women defined by amenorrhea for less than 12 months: negative HCG before entry into the trial\n* For fertile and sexually active subjects: use of safe contraception during medication intake and 4 weeks after: intrauterine device (IUD) or hormonal contraception (oral contraceptive pill, implant, transdermal patch, vaginal ring or depot injection).\n\nExclusion Criteria:\n\n* Ongoing infection or exacerbation of COPD within the last month (30 days)\n* Regular treatment with THC or CBD within 1 month (30 days)\n* Life expectancy less than 3 months (90 days)\n* Treatment with medicines that, according to the summary of product characteristics, are strong inhibitors or inducers of CYP3A4, CYP2C9 or CYP2C19\n* History of or current evidence of significant medical or psychiatric disorder that is considered by the investigator to put the subject at greater risk of experiencing an adverse event\n* Current or past substance abuse where the investigator finds it too risky for the subject to be included in the study",{"count":186,"type":20},30,[188],"PHASE3","This clinical trial examines whether Dronabinol, which contains the synthetic psychoactive compound tetrahydrocannabinol (THC), can alleviate severe breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (COPD).",[57,191,192],"Breathlessness","Cannabis",[194,195,192,57,191],"Randomized, Controlled, Double-blind, Crossover trial","Cannabis-based medicine","2026-04-16",{"date":198,"type":29},"2026-04-17",{"date":200,"type":29},"2025-02-26",{"date":202,"type":20},"2026-10",{"name":35,"class":36},{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":211,"targetDuration":4,"studyType":46,"phases":213,"briefSummary":214,"conditions":215,"keywords":216,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":95},"100377135","prospective-study-of-extended-robotic-right-hemicolectomy-with-complete-mesocolic-excision-for-cancer-100377135","NCT04190589","Prospective Study of Extended Robotic Right Hemicolectomy With Complete Mesocolic Excision for Cancer","A Single Center Prospective Study Comparing Robot-assisted and Open Operation With Complete Mesocolic Excision (CME) in Extended Right Colectomy for Colon Cancer in the Right Flexure and Transverse Colon","Inclusion Criteria:\n\n* Suspected or verified colonic cancer visualized by colonoscopy and on CT in the anal part of the ascending colon, in the right flexure or in the oral 2\u002F3 of the transverse colon\n* Patient is 18 years or older, legally competent and able to comprehend information and give consent\n* Tumor is UICC stage I-III on preop CT\n* Operation is elective\n\nExclusion Criteria:\n\n* Previous major open intraabdominal surgery\n* Ileus or other acute abdominal condition\n* CT scan with suspicion of T4 tumor\n* RITA score \\> 3 (Preop risk and frailty score)\n* BMI \\> 35 kg\u002Fm2\n* Project surgeon not available",{"count":212,"type":20},40,[48],"A single-center prospective study to elucidate whether extended robot-assisted right colectomy (e-RARC) performs as well as extended open right colectomy (e-ORC) in terms of specimen quality, and in addition, whether less postoperative morbidity and shorter length of stay (LOS) can be attained. Patients with colonic cancer near the right flexure or the oral part of the transverse colon will be compared excluding the most technically demanding and frail patients in both groups. A total of 40 patients undergoing e-RARC in a prospective series will be included and compared with 44 consecutive patients previously treated with e-ORC.",[24],[217,218,219],"Robot","Hemicolectomy","Cancer","2026-01-06",{"date":222,"type":29},"2026-01-07",{"date":224,"type":29},"2020-05-18",{"date":226,"type":20},"2026-12",{"name":35,"class":36},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":234,"eligibilityCriteria":235,"healthyVolunteers":11,"sex":15,"minAge":73,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":46,"phases":238,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":146},"100369819","phase-3-standard-dose-versus-high-dose-of-radiotherapy-in-rectal-preservation-with-chemo-radiotherapy-in-rectal-cancer-patients-100369819","NCT04095299","Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients","Randomized Trial of Standard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy to Patients With Early Low and Mid Rectal Cancer: The Watchful Waiting 3 Trial (WW3)","WW3","Inclusion Criteria:\n\n* Histopathologically verified adenocarcinoma of the rectum\n* MDT conference finds patient a candidate for rectal resection\n* Clinical tumor category cT1-3\n* MRI findings\n\n  * Maximal cross-sectional size of 4.5 cm (axial plane relative to the rectum)\n  * Lowest edge of tumor located at or below the peritoneal reflection on MRI\n* Performance status 0-2\n* Age ≥ 18 years\n* Eligible for radiotherapy and capecitabine according to investigator, including\n\n  * Adequate function of bone marrow (neutrophils ≥ 1.5 x 10\\^9\u002Fl and thrombocytes ≥ 100 x 10\\^9\u002Fl)\n  * Adequate function of liver (ALAT \\\u003C 2.5 x upper limit of normal, bilirubin \\\u003C 2.5 x upper limit of normal)\n  * Adequate kidney function (Serum creatinine \\\u003C 1.5 x upper limit of normal or measured GFR \\> 30 ml\u002Fmin)\n* Fertile women must present a negative pregnancy test and use secure contraceptives during and three months after treatment\n* Written and orally informed consent\n\nExclusion Criteria:\n\n* Previous surgical treatment of the present cancer, including transanal excision of tumor\n* Other malignant disease within the past five years except non-melanoma skin cancer and premalignant lesions such as carcinoma in situ\n* Distant metastases verified by imaging or biopsy, i.e. cM1\n* Previous radiation treatment of the pelvis\n* Pregnant or breastfeeding women.\n* Existing colostomy or ileostomy",{"count":237,"type":20},162,[188],"In recent years, an increasing number of retrospective and prospective observational studies have indicated that a subset of rectal cancer patients may avoid surgery if they can achieve a complete response to chemoradiotherapy. Prospective trials, including the previous Danish Watchful Waiting trials (NCT00952926, NCT02438839) in early rectal cancer have demonstrated high levels of organ preservation with dose-escalation, but it is unclear whether this was primarily due to tumor stage or dose level.\n\nThe aim of the present study is to investigate if a higher dose of radiotherapy is superior compared to a standard dose in patients with early rectal cancer undergoing chemoradiotherapy with curative intent.",[241],"Cancer of Rectum",{"date":243,"type":29},"2026-01-08",{"date":245,"type":29},"2020-01-20",{"date":247,"type":20},"2033-12",{"name":35,"class":36},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":255,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":46,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":25,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":276,"locationsCount":95},"100614609","frame---implementation-of-a-pro-measure-to-inform-patient-centered-survivorship-care-in-oncology-outpatient-visits-100614609","NCT07281820","FRAME - Implementation of a PRO Measure to Inform Patient-Centered Survivorship Care in Oncology Outpatient Visits","FRAME (Focused Recognition, Assessment and Management of Late Effects): A Single-Center Implementation Study Using RE-AIM to Guide Evaluation in the Department of Oncology, Vejle Hospital","FRAME","Inclusion Criteria:\n\n\\- All oncologists conducting outpatient visits at the Department of Oncology, Vejle Hospital during the study period.\n\nExclusion Criteria:\n\n\\- None.\n\nParticipants for interviews:\n\n* A purposive sample of patients, informal caregivers, and clinicians approached ≥6 months after launch\n* written and verbally informed consent.",{"count":186,"type":20},[48],"FRAME is a patient-centered survivorship care model embedded in routine oncology visits. It consists of: (1) a pre-visit patient-reported questionnaire (FRAME-PRO), (2) a clinician-patient dialogue guided by the responses, and (3) a tailored management plan including stepped-care referrals (general practitioner and municipality; oncology department supportive services; specialized late-effects clinics). The implementation is evaluated with the RE-AIM framework supplemented by Proctor implementation outcomes. Data sources include the \"Mit Sygehus\" app, departmental registries, purpose-built questionnaires, fidelity checklists, and qualitative interviews with clinicians, patients, and informal caregivers.",[219,261],"Late Effects",[263,264,265,266,267,268,269],"Patient-reported outcomes","Survivorship","Oncology","Implementation science","RE-AIM","Proctor Outcomes","Stepped-care","2025-12-01",{"date":272,"type":29},"2025-12-15",{"date":274,"type":29},"2025-03-01",{"date":93,"type":20},{"name":35,"class":36},""]