[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-related-side-effects-and-adverse-reactions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-related-side-effects-and-adverse-reactions":297},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,14,0,[8,57,91,123,155,186,219,254,281,309,336,367,397,421],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100643888","glp-1-receptor-agonists-and-early-proctologic-effects-in-morbid-obesity-100643888",false,"NCT07668765","GLP-1 Receptor Agonists and Early Proctologic Effects in Morbid Obesity","Early Proctologic Effects of GLP-1 Receptor Agonist Therapy in Morbidly Obese Patients: A Prospective Cohort Study With Baseline and 3-Month Proctologic Assessment","GLP-PROCT","Inclusion Criteria:\n\n* Age ≥18 years\n* Morbid obesity (BMI ≥40 kg\u002Fm² or BMI ≥35 kg\u002Fm² with obesity-related comorbidities)\n* Newly prescribed GLP-1 receptor agonist therapy\n* Ability and willingness to provide written informed consent\n* Ability to attend 3-month follow-up visit\n\nExclusion Criteria:\n\n* Inflammatory bowel disease\n* Perianal Crohn's disease\n* History of anorectal malignancy\n* Previous pelvic radiotherapy\n* Anorectal surgery within the previous 3 months\n* Pregnancy\n* Neurogenic bowel dysfunction\n* Inability to comply with follow-up visits\n* Discontinuation of GLP-1 receptor agonist therapy before follow-up assessment\n* Active anorectal infection or abscess","ALL","18 Years",{"count":20,"type":21},100,"ESTIMATED","3 Months","OBSERVATIONAL","Prospective observational cohort study evaluating the early proctologic effects of GLP-1 receptor agonist therapy in morbidly obese patients. Participants will undergo baseline and 3-month anorectal symptom assessment and proctologic examination to evaluate newly developed proctologic diseases and changes in pre-existing symptoms.",[26,27,28,29,30],"Morbid Obesity","Anorectal Diseases","Drug-Related Side Effects and Adverse Reactions","Constipation","Diarrhea",[32,33,34,35,36,37,38,39,40,41,42,43],"GLP-1 receptor agonist","obesity","anorectal symptoms","hemorrhoids","anal fissure","constipation","semaglutide","tirzepatide","proctologic examination","bowel habits","anorectal disease","proctology","NOT_YET_RECRUITING","2026-06-23",{"date":47,"type":48},"2026-06-25","ACTUAL",{"date":50,"type":21},"2026-08",{"date":52,"type":21},"2027-05",{"name":54,"class":55},"Gazi University","OTHER",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":74,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":90},"100606000","phase-2-a-study-to-evaluate-ly3537021-for-the-treatment-of-nausea-and-vomiting-caused-by-chemotherapy-in-adults-with-cancer-100606000","NCT07169851","A Study to Evaluate LY3537021 for the Treatment of Nausea and Vomiting Caused by Chemotherapy in Adults With Cancer","A Phase 2, Double-blind, Placebo-Controlled Study to Evaluate LY3537021 for the Treatment of Chemotherapy-Induced Nausea and Vomiting in Adult Participants With Malignant Disease","Inclusion Criteria:\n\n* Chemotherapy-naive participants, planned to receive AC or cisplatin-based chemotherapy greater than or equal to (≥)70 milligrams per square meter (mg\u002Fm²), on Day 1 of each cycle, with no multiple administrations during the CINV observation period, from Day 2 to Day 5 of each cycle.\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.\n\nExclusion Criteria:\n\n* Have symptomatic or untreated central nervous system (CNS) metastases.\n* Have an established diagnosis of uncontrolled diabetes mellitus.\n* Have a history of, or current evidence of, a clinically significant cardiac condition or QT\u002FQTcF-related conditions.\n* Have another etiology for nausea and vomiting, or receives medications with know or potential antiemetic activity\n* Signs, symptoms or history of thyroid tumors\n* Receives treatment with a gastric inhibitory polypetide (GIP) or glucagon-like peptide-1 (GLP-1) receptor agonist within 4 weeks prior to chemotherapy.\n* Have participated in a clinical study involving study intervention within 30 days of Cycle 1 Day 1 (C1D1). If the previous study intervention has a long half-life, within 3 months or 5 halflives, whichever is longer, of C1D1.\n* Are pregnant, breastfeeding, or intend to become pregnant during the study or within 30 days of the last dose of study intervention.",{"count":65,"type":21},204,"INTERVENTIONAL",[68],"PHASE2","The purpose of this study is to check how well LY35327021 works and how safe it is for controlling nausea and vomiting caused by chemotherapy. Participants who join this study will be in it until all parts are finished, which could take about 2 months.",[71,72,28,73],"Nausea","Vomiting","Neoplasms",[75,76,77,78,79],"Chemotherapy-Induced Nausea and Vomiting (CINV)","Anthracycline and cyclophosphamide (AC)","Glucose-dependent Insulinotropic Peptide (GIP)","Incretins","Cisplatin","RECRUITING","2026-06-19",{"date":45,"type":48},{"date":84,"type":48},"2025-11-28",{"date":86,"type":21},"2027-02",{"name":88,"class":89},"Eli Lilly and Company","INDUSTRY",67,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":100,"conditions":101,"keywords":104,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":56},"100639776","retrospective-kinetic-safety-evaluation-of-an-intravenous-micellar-excipient-platform-100639776","NCT07609069","Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform","Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice","Inclusion Criteria:\n\n* Participant must have received at least one intravenous (IV) investigational exposure of the PICO IV 850-picometer micellar platform (evaluating either a legacy heterogeneous payload or the PIV-850 synthetic-equivalent dual-NCE matrix) between June 1, 2025, and April 15, 2026.\n* The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial.\n* The participant record must have been identified via a 100% consecutive sampling algorithm (15 to 25 patients per site) at the clinical site to eliminate selection bias.\n* Electronic Medical Record (EMR) or clinic infusion logs must contain complete data regarding dosing, administration route (IV Push vs. IV Drip), and post-infusion safety observations.\n\nExclusion Criteria:\n\n* Participants whose exposures were drawn from legacy multi-use vials.\n* Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15, 2026.\n* Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented.\n* Participants whose records were not identified chronologically backward from April 15, 2026.",{"count":99,"type":21},625,"Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform. Researchers will abstract medical records of individuals who previously received this infusion in a clinical setting. The main questions the study aims to answer are: What adverse events (AEs) did participants experience during or after the infusion? Did participants discontinue their infusion regimen early due to adverse events? Researchers will abstract charts from clinical exposures occurring between June 1, 2025, and April 15, 2026. Participants do not undergo any new interventions or clinic visits.",[102,103],"Drug Related Side Effects and Adverse Reactions","Infusion Reactions",[105,106,107,108,109,110,111,112,113],"Sub-nanometer delivery system","Micellar nanotechnology","Real-World Evidence (RWE)","505(b)(2) Regulatory Pathway","Antimicrobial Resistance (AMR)","Biofilm Disruption","Excipient Safety","Polysorbate 80","Immunomodulation","2026-05-26",{"date":116,"type":48},"2026-05-29",{"date":118,"type":21},"2026-05-21",{"date":120,"type":21},"2026-07-30",{"name":122,"class":89},"PICO IV, Inc.",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":66,"phases":133,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":148,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":56},"100635607","nutritional--usual-corticosteroids-randomized-trial-for-immune-related-pneumonia---therapeutic-utilization-evaluation-100635607","NCT07554885","Nutritional + Usual Corticosteroids Randomized Trial for Immune-Related pneumoniA - Therapeutic Utilization Evaluation","A Single-Center, Open-Label, Randomized Controlled Clinical Trial Comparing Nutritional Therapy (Spirulina-Bifidobacterium Capsules, Fish Oil-Grape Seed-Blueberry Soft Capsules, and Ganoderma Spore Oil) Combined With Standard Glucocorticoid Regimen Versus Standard Glucocorticoid Regimen Alone in the Treatment of Immune Checkpoint Inhibitor-Related Pneumonitis","Inclusion Criteria:\n\n1. Voluntary participation with full understanding of the study and signed informed consent form.\n2. Age 18 to 75 years (inclusive) on the day of informed consent signing.\n3. Histologically or cytologically confirmed malignancy.\n4. Received at least one cycle of immune checkpoint inhibitor therapy.\n5. Grade 3-4 immune-related pneumonitis (per CTCAE v5.0 and radiologic grading).\n6. ECOG performance status 0-2, with expected survival of more than 3 months.\n7. Adequate organ function based on laboratory results (without transfusion, apheresis, erythropoietin, or granulocyte colony-stimulating factor support within 14 days before the first dose). Women of childbearing potential must have a negative serum pregnancy test within 7 days before first dose.\n\nExclusion Criteria:\n\n1. Severe cardiac, cerebrovascular, renal, hematologic, or other serious systemic disease, including: NYHA Class III-IV heart failure; acute myocardial infarction or unstable angina within 6 months; severe post-stroke functional impairment (mRS greater than or equal to 3); progressive neurodegenerative disease; Child-Pugh Class B or C liver disease or acute liver failure; CKD stage 4-5 (eGFR less than 30 mL\u002Fmin\u002F1.73 m2) or requiring dialysis; absolute neutrophil count less than 1.5 x 10\\^9\u002FL, platelet count less than 50 x 10\\^9\u002FL, or Grade 3 or higher anemia (Hb less than 8 g\u002FdL).\n2. Severe allergic constitution or contraindications to the study treatment.\n3. Significant psychiatric or psychological disorder, or doubts about the treatment plan.\n4. Investigator judgment that the patient is unsuitable for the trial (e.g., poor follow-up adherence, refusal of supportive care).\n5. Use of anti-tumor traditional Chinese medicine within 14 days before first dose.\n6. History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n7. Severe acute or chronic infection.\n8. Known alcohol or drug abuse history.\n9. Pregnancy or breastfeeding.\n10. Use of antibiotics, probiotic food, or microecological preparations within 2 weeks before enrollment.\n11. Prior treatment-related lung injury: (a) targeted-therapy-related pulmonary toxicity (prior EGFR-TKI, ALK inhibitor, VEGF inhibitor, or antibody-drug conjugate causing interstitial lung disease or pneumonitis that has not fully resolved, with radiologic fibrosis or persistent functional impairment); (b) thoracic radiation-related lung injury (radiation pneumonitis or radiation fibrosis with irreversible CT findings).\n12. Use of another investigational drug within 28 days before first dose that, per investigator judgment, would interfere with evaluation of study treatment.\n13. Gastrointestinal disorder precluding oral administration.","75 Years",{"count":132,"type":21},60,[134],"NA","This is a prospective, single-center, open-label, randomized controlled clinical trial evaluating whether the addition of a nutritional therapy regimen (Spirulina-Bifidobacterium capsules, fish oil-grape seed-blueberry soft capsules, and Ganoderma spore oil) to standard glucocorticoid therapy improves outcomes in patients with Grade 3-4 immune checkpoint inhibitor-related pneumonitis (CIP), compared with standard glucocorticoid therapy alone.\n\nA total of 60 patients with malignancies who develop Grade 3-4 CIP (per CTCAE v5.0) after at least one cycle of immune checkpoint inhibitor therapy will be randomized 1:1 to the experimental or control arm. The primary endpoints are time to pneumonitis downgrading and the proportion of patients achieving downgrading at 3 months.",[137,28,73],"Immune Checkpoint Inhibitor-Related Pneumonitis",[139,140,141,142,143,144,145,146,147],"Immune checkpoint inhibitor","Pneumonitis","Immune-related adverse events","Glucocorticoids","Spirulina","Bifidobacterium","Grape seed proanthocyanidin","Ganoderma spore oil","Antioxidant",{"date":114,"type":48},{"date":150,"type":21},"2026-04",{"date":152,"type":21},"2029-10",{"name":154,"class":55},"Guangzhou Institute of Respiratory Disease",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":4,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":161,"targetDuration":163,"studyType":23,"phases":4,"briefSummary":164,"conditions":165,"keywords":169,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":56},"100640466","impact-of-genetic-variants-on-the-toxicity-of-antibody-drug-conjugates-in-locally-advanced-or-metastatic-breast-cancer-the-role-of-the-ugt1a1-gene-as-a-predictive-biomarker-of-therapeutic-response-100640466","NCT07582887","Impact of Genetic Variants on the Toxicity of Antibody-Drug Conjugates in Locally Advanced or Metastatic Breast Cancer: The Role of the UGT1A1 Gene as a Predictive Biomarker of Therapeutic Response","Inclusion Criteria:\n\n* Patients aged 18 years or older.\n* Patients diagnosed with breast cancer starting or undergoing treatment with Sacituzumab Govitecan, Trastuzumab Deruxtecan, or Datopotamab Deruxtecan.\n* Provision of signed informed consent for the genetic study.\n\nExclusion Criteria:\n\n* Patients who are ultimately not treated with the specified Antibody-Drug Conjugates.\n* Refusal to provide informed consent for genetic analysis.",{"count":162,"type":21},70,"2 Years","The metabolism of anticancer drugs is influenced by genetic variants that affect their bioavailability and toxicity. In the case of antibody-drug conjugates (ADCs), such as sacituzumab-govitecan (SG), trastuzumab-deruxtecan (T-DXd), and datopotamab-deruxtecan (Dato-DXd), the enzyme UDP-glucuronosyltransferase 1A1 (UGT1A1) plays a central role in the glucuronidation and elimination of their cytotoxic components. In particular, the metabolism of SN-38, the active metabolite of irinotecan and SG, is highly influenced by variants in UGT1A1, leading to drug accumulation and the development of severe toxicities. Patients with variants such as UGT1A1\\*28 (rs3064744) and UGT1A1\\*6 (rs4148323) exhibit reduced enzyme activity, increasing the risk of neutropenia and severe diarrhea.\n\nThe relevance of UGT1A1 is not limited to sacituzumab-govitecan; its role in the elimination of camptothecin derivatives suggests it could also impact the toxicity of trastuzumab-deruxtecan and datopotamab-deruxtecan, which contain deruxtecan, a cytotoxic agent 10 times more potent than irinotecan. Despite strong evidence linking the UGT1A1 genotype to irinotecan toxicity, there are currently no established pharmacogenetic recommendations for antidiuretic peptides (ADCs) in metastatic breast cancer.",[166,167,28,168],"Breast Cancer","Metastatic Breast Cancer","Pharmacogenetic Variant",[170,171,172,173,166,174,175,176],"UGT1A1","Genetic Variants","Toxicity","polymorphism","Sacituzumab Govitecan","Trastuzumab Deruxtecan","Datopotamab Deruxtecan","2026-05-06",{"date":179,"type":48},"2026-05-13",{"date":181,"type":48},"2025-07-15",{"date":183,"type":21},"2027-03-31",{"name":185,"class":55},"Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental",{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":194,"conditions":195,"keywords":199,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":56},"100620234","immuno-fit-observational-study-100620234","NCT07354971","IMMUNO-FIT Observational Study","The Immuno-FIT Observational Study: A Phase II Window Observational Study Investigating the Effects of Immunotherapy on Cardiopulmonary Fitness, Quality of Life, and Treatment Outcomes in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Receiving immune checkpoint inhibitors in one of the following settings:\n\n  * Adjuvant: Single-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n  * Metastatic\u002FPalliative: Single-agent or dual-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n* ECOG Performance Status 0-2\n* Able to perform cardiopulmonary exercise testing\n* Able to provide written informed consent\n* Willing and able to comply with study procedures and follow-up schedule\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prior systemic anti-cancer immunotherapy for unresectable or metastatic disease, EXCEPT:\n* Prior adjuvant or neoadjuvant immunotherapy if all treatment-related adverse events have returned to baseline or stabilized\n* Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with at least 6 months since last dose and date of disease recurrence\n* Absolute contraindications to cardiopulmonary exercise testing:\n* Acute myocardial infarction within 6 weeks\n* Unstable angina\n* Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise\n* Active endocarditis\n* Symptomatic severe aortic stenosis\n* Uncontrolled heart failure\n* Acute pulmonary embolism or pulmonary infarction\n* Acute myocarditis or pericarditis\n* Suspected or known dissecting aneurysm\n* Acute systemic infection\n* Inability to perform cardiopulmonary exercise testing (e.g., severe lower limb dysfunction, severe peripheral vascular disease)\n* Inability to provide informed consent\n* Currently enrolled in another interventional clinical trial that would confound study outcomes\n\nADDITIONAL EXCLUSION CRITERIA FOR RESEARCH BIOPSY SUB-STUDY:\n\n* Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies)\n* Suspected bowel obstruction or perforation (for gastrointestinal biopsies)\n* Uncorrectable severe coagulopathy (INR \\>1.5, platelet count \\\u003C50,000\u002FµL)\n* Severe portal hypertension with high-risk varices (for upper endoscopy)\n* Lesion inaccessible for safe biopsy as determined by a performing clinician",{"count":90,"type":21},"This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influence how well patients cope with treatment, yet little is known about how fitness changes during immunotherapy or whether baseline fitness is linked to outcomes.\n\nParticipants will complete fitness testing using cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before starting immunotherapy and again 12 weeks later. Blood samples will also be taken, and long-term outcomes including survival, disease progression, and quality of life will be followed for up to 24 months. All cancer treatment will remain standard of care.\n\nA small number of participants will be invited to take part in an optional research biopsy at week 12 to explore how physical fitness relates to changes in the tumour's immune environment.\n\nThe study will help researchers understand natural changes in fitness during immunotherapy, identify whether baseline fitness is associated with treatment tolerance or outcomes, and generate information needed to design future trials testing exercise-based interventions during immunotherapy.",[73,196,197,198,28],"Immunotherapy","Physical Fitness","Quality of Life",[196,200,197,201,198,202,203,204,205,206,207,208,209],"Immune Checkpoint Inhibitors","Cardiopulmonary Exercise Testing","Immune-Related Adverse Events","Cancer","Exercise Physiology","Tumour Microenvironment","PD-1","PD-L1","CTLA-4","Observational Study","2026-04-22",{"date":212,"type":48},"2026-04-28",{"date":214,"type":48},"2026-03-26",{"date":216,"type":21},"2028-12-31",{"name":218,"class":55},"University Hospital Southampton NHS Foundation Trust",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":226,"minAge":18,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":66,"phases":229,"briefSummary":230,"conditions":231,"keywords":235,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":56},"100633295","telenursing-for-the-early-detection-and-management-of-side-effects-associated-with-cyclin-dependent-kinase-inhibitors-in-breast-cancer-patients-100633295","NCT07524829","Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients","NURSING-Preeffect: Telenursing for the Early Detection and Management of Side Effects Associated With Cyclin-Dependent Kinase Inhibitors in Breast Cancer Patients","Inclusion Criteria:\n\n* Female patients aged ≥18 years\n* Histologically confirmed breast cancer\n* Ongoing treatment with CDK 4\u002F6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib)\n* Ability to understand and provide informed consent\n* Access to a telephone or digital communication device for telenursing follow-up\n\nExclusion Criteria:\n\n* Inability to comply with the study procedures\n* Cognitive impairment or psychiatric conditions interfering with participation\n* Participation in another interventional clinical trial that may affect study outcomes\n* Severe comorbidities limiting life expectancy or follow-up","FEMALE",{"count":228,"type":21},124,[134],"This study is a multicenter randomized controlled trial designed to evaluate the effectiveness of a structured telenursing intervention in patients with breast cancer receiving cyclin-dependent kinase (CDK) inhibitor therapy.\n\nPatients undergoing treatment with CDK inhibitors frequently experience adverse effects that may negatively impact treatment adherence, quality of life, and clinical outcomes. Early detection and timely management of these side effects are essential to optimize therapy and reduce complications, including unplanned hospitalizations and treatment interruptions.\n\nIn this study, participants are randomly assigned to one of two groups: standard care or standard care plus a structured telenursing follow-up program. The intervention consists of scheduled remote contacts (telephone or video consultations) conducted by trained nursing staff at predefined time points during treatment. These contacts aim to monitor symptoms, provide education, reinforce adherence, and facilitate early identification and management of treatment-related toxicities.\n\nThe primary objective of the study is to assess whether the telenursing intervention reduces the incidence and severity of treatment-related adverse events compared to standard care alone. Secondary objectives include evaluating its impact on emergency department visits, hospitalizations, treatment adherence, dose intensity, and patient-reported outcomes.\n\nThe study is currently recruiting participants across multiple centers. Results from this trial may provide evidence to support the integration of structured telenursing programs into routine oncology care, with the potential to improve patient safety, treatment continuity, and overall clinical outcomes.",[166,28,232,233,234],"Chemotherapy Toxicity","Treatment Adherence","Treatment-Related Toxicity",[166,236,237,238,239,240,241,242,233,243],"Telenursing","Telemedicine","Cyclin-Dependent Kinase Inhibitors","CDK4\u002F6 Inhibitors","Treatment Toxicity","Adverse Events","Supportive Care","Oncology Nursing","2026-04-09",{"date":246,"type":48},"2026-04-13",{"date":248,"type":48},"2024-04-09",{"date":250,"type":21},"2028-09",{"name":252,"class":253},"Azienda Sanitaria Locale di Asti","OTHER_GOV",{"id":255,"slug":256,"hasResults":11,"nctId":257,"briefTitle":258,"officialTitle":259,"acronym":260,"eligibilityCriteria":261,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":262,"targetDuration":4,"studyType":66,"phases":264,"briefSummary":265,"conditions":266,"keywords":270,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":275,"completionDateStruct":277,"leadSponsor":279,"locationsCount":56},"100631224","fenox-trial-comparative-effectiveness-of-fexuprazan-co-therapy-in-patients-receiving-non-vitamin-k-antagonist-oral-anticoagulants-100631224","NCT07497893","FENOX Trial (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX Study (Comparative Effectiveness of Fexuprazan Co-therapy in Patients Receiving Non-Vitamin K Antagonist Oral Anticoagulants)","FENOX","Inclusion Criteria:\n\n* Age ≥18 years\n* Documented non-valvular atrial fibrillation\n* Receiving or initiating therapy with a non-vitamin K antagonist oral anticoagulant (NOAC) at guideline-recommended dosing\n* At least one high-risk factor for upper gastrointestinal bleeding, including:\n\n  * Age ≥75 years\n  * Chronic kidney disease (eGFR \\\u003C60 mL\u002Fmin\u002F1.73 m²)\n  * Concomitant antiplatelet therapy\n  * Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids\n  * Prior peptic ulcer disease or upper gastrointestinal bleeding\n  * HAS-BLED score ≥3\n\nExclusion Criteria:\n\n* Active gastrointestinal bleeding at the time of screening\n* Requirement for mandatory long-term proton pump inhibitor (PPI) therapy that cannot be discontinued\n* Severe hepatic dysfunction\n* Life expectancy \\\u003C1 year\n* Known hypersensitivity or contraindication to fexuprazan\n* Participation in another interventional clinical trial that may interfere with study outcomes",{"count":263,"type":21},1000,[134],"Background Non-vitamin K antagonist oral anticoagulants (NOACs) are recommended for stroke prevention in non-valvular atrial fibrillation (AF). Although NOACs substantially reduce intracranial hemorrhage, upper gastrointestinal bleeding (UGIB) remains a frequent and clinically consequential complication. Proton pump inhibitors (PPIs) may reduce UGIB risk; however, concerns regarding long-term safety and pharmacodynamic variability persist. Fexuprazan, a potassium-competitive acid blocker (P-CAB), provides rapid and sustained acid suppression independent of acid activation and CYP2C19 metabolism. No randomized trial has evaluated P-CAB therapy for prevention of UGIB in anticoagulated patients.\n\nMethods FENOX is a multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) superiority trial. Approximately 1,000 high-risk patients with non-valvular AF initiating NOAC therapy will be randomized 1:1 to receive fexuprazan plus NOAC therapy or NOAC therapy alone. High-risk enrichment includes advanced age, renal impairment, concomitant antiplatelet therapy, prior ulcer disease, or elevated HAS-BLED score. The primary endpoint is clinically relevant upper gastrointestinal bleeding (CR-UGIB) at 12 months, defined according to ISTH criteria. All events will be adjudicated by an independent blinded Clinical Events Committee. Primary analyses will follow the intention-to-treat principle using time-to-event methods.\n\nResults The planned sample size provides 80% power to detect a 50% relative risk reduction in CR-UGIB, assuming a 12-month incidence of 10% in the control group. Interim safety monitoring will be conducted under independent oversight.\n\nConclusion FENOX is the first randomized trial designed to evaluate a P-CAB-based gastroprotective strategy for prevention of clinically relevant UGIB in high-risk patients receiving NOAC therapy. By integrating high-risk enrichment, pragmatic design, and blinded endpoint adjudication, the study aims to provide rigorous evidence to inform gastroprotective strategies in anticoagulated populations.",[267,268,269,28],"Atrial Fibrillation (AF)","Upper Gastrointestinal Bleeding (UGIB)","Gastrointestinal Hemorrhage (Clinically Important, Upper)",[271],"Non-vitamin K antagonist oral anticoagulants (NOACs), potassium-competitive acid blocker (P-CAB), Upper gastrointestinal bleeding (UGIB)","2026-03-23",{"date":274,"type":48},"2026-03-27",{"date":276,"type":21},"2026-12-01",{"date":278,"type":21},"2032-11-30",{"name":280,"class":55},"Ewha Womans University Mokdong Hospital",{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":66,"phases":290,"briefSummary":292,"conditions":293,"keywords":298,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":56},"100617495","phase-1-a-real-world-study-of-fecal-transplants-for-cancer-therapy-side-effects-100617495","NCT07319364","A Real-World Study of Fecal Transplants for Cancer Therapy Side Effects","An Observational, Real-World Study Evaluating Fecal Microbiota Transplantation for the Prevention\u002FReduction of Chemotherapy\u002FTargeted Therapy-Induced Gastrointestinal Symptoms in Patients With Gastrointestinal Cancers.","Inclusion Criteria:\n\n1. Age ≥ 18 years, gender not restricted;\n2. Estimated survival time ≥ 3 months;\n3. Confirmed diagnosis of gastrointestinal tumors by pathological examination, including esophageal cancer, gastric cancer, colon cancer, rectal cancer, etc.;\n4. TNM staging of cancer in patients is Stage IV;\n5. Having undergone PD-1 or PD-L1 testing;\n6. Planned to receive the 4th cycle of chemotherapy\u002Ftargeted therapy;\n7. Occurrence of gastrointestinal adverse reactions (including but not limited to diarrhea, constipation, vomiting, nausea, etc.) within 3 cycles of conventional chemotherapy\u002Ftargeted therapy;\n8. Patients are able and willing to sign the informed consent form and complete follow-up;\n9. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n10. Use of oral\u002Fintravenous broad-spectrum antibiotics with caution within 3 days;\n11. Patients are able to swallow capsules without chewing;\n12. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 1-3;\n13. Laboratory test results during the screening period indicate that the subjects have sufficient organ function.\n\nExclusion Criteria:\n\n1. Patients with major organ dysfunction or even failure, including but not limited to cardiac insufficiency or heart failure, renal insufficiency or renal failure, and hepatic insufficiency\u002Fhepatic failure;\n2. Uncontrolled or severe infections;\n3. Known history of psychotropic substance abuse, alcoholism, and drug abuse;\n4. Patients with severe infections complicated with septicemia or sepsis;\n5. Patients with a history of severe allergic reactions or a known allergy to the components of liquid live bacteria enteric-coated capsules;\n6. Patients with active viral infections;\n7. Female subjects with a positive pregnancy test, lactating female subjects, and women of childbearing age who refuse to use contraceptive measures during the entire observation period (15 weeks);\n8. Patients with gastrointestinal perforation and\u002For fistula;\n9. Other conditions deemed unsuitable for enrollment by the investigator.",{"count":289,"type":21},90,[291],"PHASE1","The goal of this clinical trial is to learn if fecal microbiota transplantation can treat in Gastrointestinal cancer patients with chemotherapy \u002F targeted gastrointestinal symptoms. The main question it aims to answer is: To evaluate the effect of fecal microbiota transplantation (FMT) on gastrointestinal tract in patients with gastrointestinal tumors.",[294,295,296,297],"Fecal Microbiota Transplantation (FMT)","Gastrointestinal Neoplasms","Antineoplastic Agents","Drug-related Side Effects and Adverse Reactions",[299,295,296,28],"Fecal Microbiota Transplantation","2025-12-21",{"date":302,"type":48},"2026-01-06",{"date":304,"type":48},"2025-09-01",{"date":306,"type":21},"2026-09-01",{"name":308,"class":55},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":315,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":318,"conditions":319,"keywords":321,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":56},"100454855","compliance-and-tolerance-to-oral-antibiotherapy-in-osteoarticular-infections-otabio-100454855","NCT05202964","Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)","Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections","OTABIO","Inclusion Criteria:\n\n* ≥ 18 years\n* Diagnosis of osteoarticular infection\n* Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date\n* Patient who was informed and did not object to participate in the study\n\nExclusion Criteria:\n\n* Treatment for BJI with oral antibiotic without end of treatment date\n* treatment for BJI with parenteral antibiotic only\n* patient who doesn't have a telephone number or who doesn't want to give it\n* Adults subject to a legal protection measure\n* Pregnant or breastfeeding women",{"count":132,"type":21},"Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.",[28,320],"Treatment Adherence and Compliance",[322,323,324,325,326],"Tolerance","Adherence","Antibiotic","BJI","adverse effect","2025-02-11",{"date":329,"type":48},"2025-02-13",{"date":331,"type":48},"2024-06-13",{"date":333,"type":21},"2026-09",{"name":335,"class":55},"Hospices Civils de Lyon",{"id":337,"slug":338,"hasResults":11,"nctId":339,"briefTitle":340,"officialTitle":341,"acronym":342,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":66,"phases":346,"briefSummary":347,"conditions":348,"keywords":355,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":56},"100512377","sex-psychopharmacology-and-diabetes-100512377","NCT05951660","Sex, Psychopharmacology, and Diabetes","The Effect of Targeted Education on Number, Severity, and Perception of Sexual Side Effects of Patients Suffering From Schizophrenia and Diabetes or Prediabetes.","SECRET","Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis in the schizophrenic spectrum (ICD10 F2x)\n* One of the following:\n\n  1. A diagnosis of diabetes (ICD10 E10x, E11x, E12x, E13x, 14x)\n  2. A current or previous prediabetes defined as an HbA1c between 39-47 mmol\u002Fmol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring\n  3. Obesity defined as a Body-Mass Index (BMI) ≥30 kg\u002Fm2\n* Ongoing treatment with at least one antipsychotic agent\n* A SD that can be rated using Changes in Sexual Function Questionnaire-14 (CSFQ-14)\n\nExclusion Criteria:\n\n* Incapacitated or subject to mental health probation\n* Unable to speak danish",{"count":345,"type":21},256,[134],"The term sexual (SD) dysfunction covers conditions that prevent people from having a satisfactory sex life. SD is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. SD is also associated with diabetes, a common somatic comorbidity in psychiatric patients. SD is associated with both reduced quality-of-life and reduced treatment adherence, yet SD is far too rarely addressed between the patient and the healthcare professional in clinical consultations.\n\nThe purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes\u002Fprediabetes and\u002For their healthcare professionals in causes and management of SD:\n\n* Increases the number of systematic examinations of sexual side effects,\n* Causes changes in the psycho-pharmacological treatment, and\n* Reduces the severity or perception of sexual side effects.\n\nThe study is a multicenter Randomized Controlled Trial (RCT) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. The effect of the educational intervention is compared to a non-educated control group. The study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four Danish regions.\n\nThe study is part of an interdisciplinary project named SECRET. The educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. Parallel to the present RCT, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.",[349,350,351,352,353,28,354],"Schizophrenia","Schizophrenia Spectrum and Other Psychotic Disorders","Diabetes Mellitus","PreDiabetes","Sexual Dysfunction","Education",[356,320,357,358],"Randomized Controlled Trial","Antipsychotic Agents","Patient Education as Topic","2025-02-07",{"date":327,"type":48},{"date":362,"type":48},"2023-08-24",{"date":364,"type":21},"2025-07-31",{"name":366,"class":55},"Zealand University Hospital",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":374,"targetDuration":4,"studyType":66,"phases":376,"briefSummary":378,"conditions":379,"keywords":386,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100547394","phase-3-improvement-of-quality-of-life-through-supportive-treatments-for-hormone-therapy---related-symptoms-in-patients-with-early-breast-cancer-100547394","NCT06407401","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer","Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer; A Pragmatic Randomized Controlled Trial","Inclusion criteria:\n\n* Female (both pre- and postmenopausal) or male patients\n* Age ≥18 years\n* Ongoing adjuvant ET (tamoxifen or OFS plus tamoxifen or OFS plus AI or AI ) for ER positive HER2 negative breast cancer stages I-III\n* Patients must have received at least 3 months and up to 3 years of ET and planned to continue ET during the study conduction\n* Present endocrine therapy related MSK pain (arthralgia and\u002For bone pain and\u002For myalgias), evaluated by the treating clinician as at least grade 2 CTCAE V5.0 for, at least, 4 weeks before enrolment, at the time of the clinic visit:\n\n  * Grade 2: moderate pain; limiting instrumental activities daily living (ADL)\n  * Grade 3: severe pain; limiting activities self-care ADL\n* Previous chemotherapy is allowed if completed at least 3 months before enrolment\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2\n* Adequate organ function\n* Completed baseline assessment of patient-reported questionnaires (EORTC QLQ-C30 and EORTC QLQ breast module)\n* Before patient registration, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations\n* Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test within 7 days prior to the first dose of study treatment.\n\nNote: women of childbearing potential are defined as premenopausal females capable of becoming pregnant (i.e., females who have had any evidence of menses in the past 12 months, except for those who had prior hysterectomy). However, women who have been amenorrhoeic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, antioestrogens, low body weight, ovarian suppression, or other reasons.\n\n* Patients of childbearing \u002F reproductive potential must agree to use at least one acceptable effective contraceptive measure until treatment discontinuation.\n* Female subjects who are breast feeding should discontinue nursing prior to the first dose of study treatment and until 1 month after the last study treatment.\n\nExclusion criteria:\n\n* Current history of moderate\u002Fsevere depression and\u002For anxiety, both defined as grade≥2 CTCAE V5.0\n* History of suicide-related events\n* Current use of diuretics, antidepressants and\u002For phytoestrogens\n* Current use of prescribed or natural medicines with known interactions with furosemide and\u002For duloxetine\n* Contraindications to duloxetine:\n\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Uncontrolled hypertension\n  * Hepatic impairment Child Pugh Class B or C\n* Contraindications to furosemide:\n\n  * Symptomatic hypotension, hypovolemia, or dehydration\n  * Severe renal impairment (creatinine clearance \\< 30 mL\u002Fmin)\n  * Severe hypokalaemia and\u002For severe hyponatremia\n  * Addison's disease\n  * Porphyria\n* Uncontrolled intercurrent illness, including psychiatric conditions, chronic alcoholism, and drug addiction, that would, in the judgment of the investigator, limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent.\n* Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, understanding and completion of questionnaires and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the trial.\n* Participation in another interventional study with drugs.",{"count":375,"type":21},399,[377],"PHASE3","This study is a pragmatic international, multicenter, randomized, open label 3- arm trial of standard care vs. two pharmacological interventions: duloxetine or furosemide in patients with stage I-III ER+\u002FHER2- early breast cancer with joint, muscle and\u002For bone pain caused by the endocrine therapy.\n\nThe purpose of the BC-QOL trial is to find out whether treatment with duloxetine or furosemide, given while patients are on treatment with endocrine therapy, is active in improving quality of life (QoL), specifically by improving joint, muscle and\u002For bone pain caused by the endocrine therapy (based on EORTC QLQ-BR42 skeletal scale).",[380,381,382,383,384,28,385],"ER+ Breast Cancer","HER2-negative Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Musculoskeletal Pain",[198],"2024-11-04",{"date":389,"type":48},"2024-11-05",{"date":391,"type":21},"2024-12",{"date":393,"type":21},"2028-11-30",{"name":395,"class":396},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":407,"conditions":408,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":56},"100548924","routinely-collected-clinical-data-and-evaluation-of-antimicrobial-target-attainment-100548924","NCT06427317","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment","Routinely Collected Clinical Data and Evaluation of Antimicrobial Target Attainment and the Potential Role of Therapeutic Drug Monitoring in UK Infection Management","DATATDM","Inclusion Criteria:\n\n18 years of age or above.\n\n* Under follow-up for management of infection at Imperial College NHS Trust\n* Received a beta-lactam antibiotic within the last 48 hours (or are planned to start imminently).\n* Provides informed written consent see below, or lacks capacity to provide consent because of one of the following conditions (and declaration provided by personal consultee):\n* Delirium which may be caused or exacerbated by having an infection.\n* Suspected\u002Fconfirmed central nervous system infection.\n* Critical illness requiring sedation and\u002For intubation and ventilation which is caused by or exacerbated by having an infection.\n\nExclusion Criteria:\n\n* Less than 18 years of age\n\n  * Severe anaemia (Hb \\\u003C 70g\u002Fl)\n  * Platelets \\\u003C 50x10\\^9\u002Fl, INR \\>1.5 or other known blood clotting impairment\n  * Patient with terminal diagnosis receiving palliative care input who may experience distress if approached for this study.\n  * Enrolled in a clinical trial which stipulates exclusion from other studies including observational studies.\n  * Patients with restricted liberty, prisoners or under legal protection.",{"count":406,"type":21},323,"The primary aim of the study is to determine the proportion of individuals receiving beta-lactam antibiotics at Imperial College Healthcare NHS Trust in whom drug concentration targets are achieved.",[409,410,411,28],"Infections, Bacterial","Pharmacokinetics","Drug Monitoring","2024-05-21",{"date":414,"type":48},"2024-05-23",{"date":416,"type":48},"2024-03-19",{"date":418,"type":21},"2027-03-19",{"name":420,"class":55},"Imperial College London",{"id":422,"slug":423,"hasResults":11,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":4,"eligibilityCriteria":427,"healthyVolunteers":11,"sex":17,"minAge":428,"maxAge":4,"enrollmentInfo":429,"targetDuration":431,"studyType":23,"phases":4,"briefSummary":432,"conditions":433,"keywords":437,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":4},"100458299","individual-risk-profiles-for-adverse-drug-reactions-in-geriatric-patients-100458299","NCT05247814","Individual Risk Profiles for Adverse Drug Reactions in Geriatric Patients","Individual Patient Risk Profiles for Adverse Drug Reactions: Establishing a Consecutive Research Cohort in an Interdisciplinary Polypharmacy Consultation Service of a Geriatric University Outpatient Department","Inclusion Criteria:\n\n* 70 years or older\n* Current drug therapy with three or more drugs\n* Being a patient in the interdisciplinary polypharmacy consultation service of the geriatric university outpatient clinic\n* Sufficient mobility (minimum: Wheelchair mobility)\n* Written informed consent of the patient or the legal representative\n\nExclusion Criteria:\n\n* No sufficient communication possible\n* Patients classified as terminally ill by the medical staff\n* Patients, that are incapable to give their informed consent and who do not have a legal representative","70 Years",{"count":430,"type":21},2000,"6 Months","This project will generate a prospective cohort of geriatric patients with polypharmacy which will be characterized for vulnerability profiles of adverse drug reactions.",[434,435,436,28],"Polypharmacy","Pharmacogenetics","Pharmacogenomic Testing",[438,439,440,441,442,443,444,445,446,447,448,449],"Geriatric Assessment","Medication Adherence","Aged","Aged, 80 and over","Medication therapy management","Pharmacists","Geriatricians","Clinical Pharmacology","Medication reconciliation","Hospital pharmacy services","Hospital outpatient clinics","nterdisciplinary Health Team","2022-06-17",{"date":452,"type":48},"2022-06-23",{"date":454,"type":21},"2022-07",{"date":456,"type":21},"2032-02",{"name":458,"class":55},"RWTH Aachen University"]