[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"side-effect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:side-effect":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100547068","transfusion-surveillance-in-anaesthesia-100547068",false,"NCT06403163","Transfusion Surveillance in Anaesthesia","Biological Transfusion Efficiency Registry Transfusion Surveillance in Anaesthesia","STAR","Inclusion Criteria:\n\n* all patients who have received an hemostasis product\n\nExclusion Criteria:\n\n* patient who refused to consent to data analysis and study participation","ALL",{"count":19,"type":20},50000,"ESTIMATED","2 Weeks","OBSERVATIONAL","the aim of this register is to collect exhaustively the different data available surrounding a transfusion act in the context of an active haemorrhage. The aim is to allow different modelling and analysis related to emergency transfusion.",[25,26,27,28,29,30,31,32],"Transfusion Reaction","Transfusion Related Complication","Anesthesia","Anesthesia; Shock","Side Effect","Fresh Blood Stool","Blood Coagulation Disorder","Blood Loss",[34,35,36,37,38],"transfusion","monitoring","emergency situation","shock","fresh frozen plasma","RECRUITING","2025-08-25",{"date":42,"type":43},"2025-09-02","ACTUAL",{"date":45,"type":43},"2022-09-01",{"date":47,"type":20},"2030-12-31",{"name":49,"class":50},"Erasme University Hospital","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":51},"100595242","personalised-nocebo-assessment-of-beta-blocker-symptoms-in-heart-failure-100595242","NCT07029906","pErsonalised Nocebo Assessment of Beta-blockEr Symptoms in Heart Failure","ENABLE-HF","Inclusion Criteria:\n\n* Heart failure with index LVEF \\\u003C40%\n* Not currently taking beta-blocker tablets\n* Previously tried one of beta-blocker tablet, and stopped taking it due to symptoms attributed to the beta-blocker\n* Consenting to participate in the study\n\nExclusion Criteria:\n\n* Documented anaphylaxis to beta-blockers\n* Clinical contraindication to Bisoprolol including (but not limited to):\n\n  1. Asthma requiring BTS treatment step 3 or higher\n  2. Marked bradycardia (\\\u003C50 bpm)\n  3. Symptomatic hypotension (systolic BP \\\u003C85mmHg)\n  4. Metabolic acidosis\n  5. Phaeochromocytoma\n  6. 1st degree heart block with PR interval \\>250ms\n  7. 2nd degree or complete heart block\n  8. Sick sinus syndrome\n  9. Acute pulmonary oedema\n* Life expectancy \\\u003C1 year\n* Patient refusal or inability to participate in the study","18 Years",{"count":61,"type":20},150,"INTERVENTIONAL",[64],"NA","Beta-blocker tablets are an effective treatment for heart failure that make people live longer and reduce the need to be admitted to hospital. Many patients who are at high risk of death are prescribed beta-blockers, but later choose to stop taking them because of symptoms that they perceive to be side-effects. Some patients' symptoms may genuinely be side-effects due to the beta-blocker tablets, but, in reality, many of the symptoms which may lead to people stopping beta-blockers are actually experienced at similar rates compared to placebo. The symptoms may be caused by heart failure itself, or the expectation that they will have a side effect when they take a tablet (the nocebo effect). There is a need to be able to identify the majority of patients who aren't actually having side-effects so that they can restart beta-blockers and not miss out on life-prolonging treatment. To answer this question reliably and with high precision requires a personalised approach with an 'N-of-1' study. This study will measure participants' symptoms in three scenarios: taking a beta-blocker tablet (bisoprolol 2.5mg) or a placebo tablet or no study medication in a randomised order.\n\nThe primary aim of this study is to determine, for an individual, whether the adverse effects of beta-blockade in heart failure are genuine. Specifically, the objectives are:\n\n1. To determine the proportion of a patient's symptoms that are due to taking beta-blocker tablets, and the proportion that are due to the expectation that the treatment will cause symptoms (the nocebo effect).\n2. To determine whether, on average, symptoms are worse when taking beta-blocker compared to placebo tablets or no treatment.\n3. To determine whether on average symptom intensity associated with beta-blockade decreases after receiving a report on how much of their symptoms are due to the beta-blocker.\n\nThroughout the protocol participants report daily the intensity of the symptom that previously led to their beta-blocker cessation via a smartphone app. Participants will report weekly their adherence, general heart failure symptoms and quality of life. In this way the investigators will discover, for an individual patient, the proportion of their symptom that is due to the beta-blocker tablet, and whether knowing their personalised results helps them to restart beta-blocker tablets.",[67,68],"Side-Effect","Heart Failure",[70,71,72,73,74,68],"Side-effect","Beta-blocker","Nocebo","Heart Failure Reduced Ejection Fraction","HFrEF","2025-06-17",{"date":77,"type":43},"2025-06-19",{"date":79,"type":43},"2025-04-29",{"date":81,"type":20},"2027-12",{"name":83,"class":50},"Imperial College London",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":62,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100443533","phase-3-proton-versus-photon-therapy-for-esophageal-cancer---a-trimodality-strategy-100443533","NCT05055648","PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy","PROton Versus Photon Therapy for Esophageal Cancer - a Trimodality Strategy (PROTECT) a Multicenter International Randomized Phase III Study of Neoadjuvant Proton Versus Photon Chemoradiotherapy in Locally Advanced Esophageal Cancer","PROTECT","Inclusion Criteria:\n\n* Patients with histologically verified squamous cell carcinoma or adenocarcinoma (including signet cell carcinoma and large cell carcinoma, not further specified) of the esophagus (E) or gastro-esophageal junction (GEJ).\n\n  * FDG PET\u002FCT performed.\n  * Tumor stage according to TNM (8th edition): cT1-4a and\u002For cN+, cM0.\n  * Age ≥18 years.\n  * Performance status WHO ≤2.\n  * Adequate laboratory findings: hematological: hemoglobin \\> 90 g\u002FL, absolute neutrophil count (ANC) ≥ 1,5 x 109\u002FL, platelets ≥ 75 x 109\u002FL hepatic: bilirubin ≤ 1.5 x upper limit of normal (ULN), ALAT ≤ 3 x ULN renal: creatinine ≤ 1.5 x ULN, GFR (may be calculated) \\> 30 ml\u002Fmin\n  * MDT decision on suitability to undergo curatively intended nCXT or nCPT followed by surgery.\n  * Planned transthoracic esophagectomy or gastrectomy being open, minimally invasive of combination of both.\n  * Ability to adhere to procedures for study and follow-up.\n  * Patients with low risk cancers with a life expectancy above 5 years (e.g. low risk prostate cancer) are allowed in the study. Adequately treated diagnoses such as cervix uteri carcinoma in situ, in situ urothelial carcinoma or localized non-melanoma skin cancer are allowed, regardless of time of diagnosis.\n  * Patients of childbearing potential: pregnancy prevention according to the standards of each country. Patients of childbearing potential must present a negative pregnancy test. Patients and their partners must use effective contraception. Patients of childbearing potential included in the study must use oral contraceptives, intrauterine devices, depot injection of progestin subdermal implantation, a hormonal vaginal ring, or transdermal patch during the study treatment and one month after.\n\nExclusion Criteria:\n\nPatients who meet one or more of the following exclusion criteria cannot be included in the study:\n\n* Prior thoracic XT or PT, chemotherapy or surgical resection in the esophageal\u002Fgastric region (previous EMR or ESD is allowed).\n* Tumor \\\u003C 3 cm from oropharyngeal sphincter.\n* Planned transhiatal resection\n* Patients with other previous malignancies are excluded unless a complete remission or complete resection was achieved at least 5 years prior to study entry.\n* Any unstable systemic disease (including clinically significant lung and cardiovascular disease, unstable angina, New York Heart Association (NYHA) grade III-IV congestive heart, severe hepatic, renal or metabolic disease or active inflammatory bowel disease).\n* Symptomatic peripheral neuropathy greater than grade 1 (scored according to CTCAE v5.0).\n* Any other serious or uncontrolled illness, which, in the opinion of the investigator, makes it undesirable for the patient to enter the trial.\n* Unable to understand and digest study patient information or comply with study treatment and safety instructions.\n* Gastro-esophageal stent within the irradiated volume.",{"count":93,"type":20},396,[95],"PHASE3","The PROTECT trial will test the hypothesis that proton (PT) -enabled radiation dose reductions to sensitive, normal tissues will result in lower rates of treatment-related pulmonary complications in esophageal cancer compared to standard photon therapy (XT).",[98,99,29,100],"Esophageal Cancer","Radiotherapy","Proton Therapy","2024-12-12",{"date":103,"type":43},"2024-12-17",{"date":105,"type":43},"2022-05-01",{"date":107,"type":20},"2032-12-01",{"name":109,"class":50},"University of Aarhus",15]