[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"United Kingdom\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":748},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,3290,0,25,[9,53,77,105,133,157,191,225,255,284,307,345,370,390,411,438,463,485,510,538,588,621,650,674,698],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100626090","phase-1-a-study-of-air-001-in-adults-with-alpha-1-antitrypsin-deficiency-aatd-100626090",false,"NCT07431112","A Study of AIR-001 in Adults With Alpha-1 Antitrypsin Deficiency (AATD)","Phase 1, Open-Label, Single Ascending Dose and Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered AIR-001 in Adults With AATD Due to PiZZ Genotype","RepAIR1","Inclusion Criteria:\n\n1. Male or female participants \\>18 years and \\\u003C75 years of age at the time of signing informed consent\n2. Total serum AAT levels \\\u003C 11µM (57 mg\u002FdL)\n3. Pi\\*ZZ genotype confirmed by DNA sequencing within the SERPINA1 gene with no known co-occurring SERPINA1 null variants\n4. Spirometry: Forced expiratory volume in 1 second (FEV1) ≥ 40% of predicted\n5. Non-smoker, including vaping, for at least 6 months prior to screening\n6. Body mass index between 18-33.0 kg\u002Fm²\n7. Body weight ≥ 45 kg and ≤110 kg\n8. Willing and able to give written informed consent prior to the initiation of any study procedure by the participant\n9. Negative beta human chorionic gonadotropin (β-hCG) at enrolment for women of childbearing potential (WOCBP) only.\n10. Participants who are either a WOCBP or male participant who is heterosexually active with a WOCBP must consent to use a highly effective method of contraception from screening visit until at least 4 weeks after the last dose of investigational medicinal product (IMP).\n11. Willing and able to comply with the study design schedule, all study procedures, and other requirements\n\nExclusion Criteria:\n\n1. Female participants who are nursing or lactating\n2. Participant has received AAT augmentation therapy within 30 days prior to Screening Visit or plans to receive AAT augmentation therapy at any time during study participation.\n3. Known or suspected allergy or intolerance to AIR-001 or its components\n4. Acute respiratory tract infection or clinically-diagnosed chronic obstructive pulmonary disease (COPD) exacerbation that required antibiotic treatment and\u002For systemic corticosteroids within the 8 weeks prior to dosing.\n5. Positive screening test for COVID-19 and\u002For Influenza.\n6. Lung disease that requires use of continuous oral corticosteroids, continuous supplemental oxygen, day-time ventilatory support, or any participant who is on a lung transplant waiting list.\n7. Liver Fibrosis score \\> 10 kPa defined by screening liver elastography, historical liver biopsy showing ≥ F3 fibrosis (METAVIR or comparable scoring system), or established diagnosis of hepatic cirrhosis.\n8. Any of the following screening laboratory abnormalities:\n\n   1. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \\> 3 x upper limit of normal (ULN)\n   2. Total bilirubin \\> ULN (note: for participants with documented Gilbert's syndrome and direct bilirubin ≤ ULN , exclusion criterion is total bilirubin is \\> 2.5 mg\u002FdL)\n   3. INR \\> ULN (for participants taking stable doses of anticoagulants, the exclusion criterion is INR \\> 3.0)\n   4. Platelet count ≤ 150 k\u002FμL\n   5. Estimated glomerular filtration rate (eGFR) ≤ 60 mL\u002Fmin\u002F1.73m² by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation\n   6. Urine Albumin-to-Creatinine Ratio \\> 300 mg\u002Fg\n   7. Urine Protein-to-Creatinine Ratio \\> 500 mg\u002Fg\n9. Prolonged QT interval on electrocardiogram (ECG), defined as QTcF ≥ 450ms (men) or ≥ 470ms (women)\n10. ECG findings at screening that render measurements of QT interval imprecise.\n11. History of congestive heart failure, serious cardiac arrythmias requiring anti-arrhythmic medications or unexplained black-outs or fainting episodes with a suspected cardiac origin\n12. Positive screening test or known chronic infection with Hepatitis B, Hepatitis C, or HIV.\n13. Known history of coagulopathy or bleeding diathesis\n14. History or intolerance to subcutaneous (SC) injection including relevant dermatological conditions affecting standard injection sites\n15. History or presence of any medical condition, behavioral or psychiatric disorder, or planned surgical procedure or surgical history that may interfere with participation in the study or interpretation of study results, and\u002For put the participant at significant risk (in the opinion of the investigator) if he\u002Fshe participates in the study.\n16. History of any lung-volume reduction procedure in the 6 months prior to screening.\n17. Laboratory value(s) outside the laboratory reference range that is (are) considered to be clinically significant and may affect the safety, efficacy, PK, or PD assessments or interpretation by the Investigator, at screening\n18. History of alcohol or drug abuse within the past three months\n19. Current or previous participation in any other clinical study where the participant has received a dose of an IMP within 3 months or 5 half-lives of the IMP, whichever is longest, prior to Screening Visit\n20. Any previous gene replacement or DNA-editing therapy\n21. Any previous use of an RNA-based therapeutic (except for AIR-001 or RNA-based vaccines) within the 6 months prior to the Screening Visit or at any time if stopped due to drug-related adverse event.\n22. Use of any new prescription, vaccine, herbal remedy, over-the-counter medication, or supplement, or changes in chronic therapies within the 28 days prior to dosing unless approved by study Medical Monitor.","ALL","18 Years","74 Years",{"count":22,"type":23},54,"ESTIMATED","INTERVENTIONAL",[26],"PHASE1","This is a Phase 1, open-label, single ascending dose (SAD) and multiple dose (MD) study of AIR-001 in participants with alpha-1 antitrypsin deficiency (AATD) due to PiZZ genotype.",[29],"Alpha 1 Antitrypsin Deficiency",[31,32,33,34,35,36,37,38,39,29],"Lung Diseases","Liver Diseases","Respiratory Tract Diseases","Genetic Disease","Inborn Congenital, Hereditary, Neonatal Diseases and Abnormalities","Subcutaneous Emphysema","Emphysema","Pathologic Processes","Pathological Conditions, Signs and Symptoms","RECRUITING","2026-08-24",{"date":43,"type":44},"2026-08-25","ACTUAL",{"date":46,"type":44},"2026-03-17",{"date":48,"type":23},"2029-01",{"name":50,"class":51},"AIRNA Corporation","INDUSTRY",8,{"id":54,"slug":55,"hasResults":12,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":24,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":76},"100617698","phase-3-pridopidine-phase-3-study-to-evaluate-efficacy-and-safety-in-als-100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.","80 Years",{"count":63,"type":23},500,[65],"PHASE3","The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[68],"Amyotrophic Lateral Sclerosis",{"date":43,"type":44},{"date":71,"type":44},"2026-02-01",{"date":73,"type":23},"2029-03",{"name":75,"class":51},"Prilenia",56,{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":24,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":104},"100613779","the-use-of-cannabidiol-suppositories-for-sexual-pain-100613779","NCT07271030","The Use of Cannabidiol Suppositories for Sexual Pain","The Use of Cannabidiol Suppositories for Sexual Pain: A Randomised Controlled Study","Inclusion Criteria:\n\n* Has previously used cannabidiol in any capacity and has not experienced any allergic reaction\n* Is experiencing sexual pain\n* There will be an absence of co occurring difficulties\n* Has attempted sexual intercourse in the last month\n* Age 18 years or older\n* Read and write English\n* Patient Health Questionnaire 9 screening score range between 0-9 mild\n* General Anxiety Disorder 7 screening score range between 0-9 mild\n* There are no restrictions on sex, gender, sexuality, or disability\n\nExclusion Criteria:\n\nHas experienced an allergic reaction to cannabidiol in any capacity\n\n* Has not attempted sexual intercourse in the last month\n* Has co occurring difficulties\n* Aged below 18 years old\n* Are not experiencing sexual pain\n* Patient Health Questionnaire 9 screening score range between moderate to severe - 10-27\n* General Anxiety Disorder 7 screening score range between 10- 21.",true,"100 Years",{"count":87,"type":23},50,[89],"NA","Research aim: To determine how cannabidiol suppositories might reduce sexual pain during intimacy. Outcomes are also hoped to increase sexual functioning, well-being, and quality of life.\n\nResearch intention: If cannabidiol suppository intervention reduces sexual pain and increases general well-being, then this research would be repeated on a larger scale, targeting psychosexual services.\n\nA brief overview of the intervention:\n\nQuantitatively, randomisation of cannabidiol suppositories will be into dose-specific groups. The intervention will be delivered over a period of one month, with follow-up scheduled at 12 weeks. Qualitatively, participants were asked approximately eight open-ended feedback questions throughout the study.",[92,93,94,95],"Well-Being, Psychological","Quality of Life","Sexual Behavior","Sexual Pain Disorder",{"date":43,"type":44},{"date":98,"type":44},"2026-01-16",{"date":100,"type":23},"2027-12",{"name":102,"class":103},"London Metropolitan University","OTHER",1,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":24,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100610191","phase-1-an-open-label-study-of-azd0120-in-adults-with-multiple-sclerosis-100610191","NCT07224373","An Open-label Study of AZD0120 in Adults With Multiple Sclerosis","A Phase 1b, Open-label, Multi-center, Randomized Study Evaluating the Safety and Tolerability of AZD0120, an Autologous CD19\u002FBCMA Targeting Chimeric Antigen Receptor T-cells, in Adults With Refractory Relapsing or Progressive Multiple Sclerosis","ZENITH","Participants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Age ≥ 18-years-old to ≤ 60-years-old at the time of consent\n\n   Type of Participant and Disease Characteristics\n2. Written informed consent in accordance with federal, local, and institutional guidelines\n3. Adequate physiological function and reserve at screening\n\n   RMS Cohort Specific Inclusion Criteria\n4. Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin et al 2014.\n5. Participants should have an EDSS of ≤ 6.5 at screening.\n6. Evidence of active disease (clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high efficacy disease-modifying therapy for ≥ 6 months.\n\n   PMS Cohort Specific Inclusion Criteria\n7. Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014.\n8. Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.\n9. Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.\n\nExclusion Criteria\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Any prior CAR-T or CAR-NK cell exposure.\n2. Underwent splenectomy within 12 months prior to signing the ICF.\n3. Received a solid organ transplant at any time or on an active transplant waiting list.\n4. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.\n5. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:\n6. Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics.\n7. Participant has significant psychiatric condition (active or history of).\n8. History of other immune-mediated disease that required continued systemic immunosuppression\u002Fsystemic disease-modifying agents.\n9. Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening\n10. History of malignancy or ongoing treatment for prior malignancy.\n11. Inborn error of immunity and\u002For primary immunodeficiency.\n12. Seropositive for HIV or HTLV (including any history of HIV or HTLV).\n13. Active viral (any etiology, HBV, HCV) hepatitis are excluded.\n14. Major surgery within 4 weeks prior to apheresis or lymphodepletion or has surgery planned during the study or within 4 weeks after study treatment administration.\n15. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer.\n16. Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.\n17. Any contraindications to LP.\n18. Participants not willing, able, or are unsafe to take MRI scans as per protocol.","60 Years",{"count":115,"type":23},24,[26],"This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA\u002FCD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.",[119],"Multiple Sclerosis",[121,119,122,123,124],"AZD0120","MS","RMS","PMS",{"date":43,"type":44},{"date":127,"type":44},"2025-12-09",{"date":129,"type":23},"2028-12-12",{"name":131,"class":51},"AstraZeneca",19,{"id":134,"slug":135,"hasResults":12,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":12,"sex":18,"minAge":141,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":24,"phases":145,"briefSummary":146,"conditions":147,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":156},"100610019","phase-3-a-study-of-baricitinib-ly3009104-for-the-delay-of-stage-3-type-1-diabetes-in-at-risk-children-and-adults-100610019","NCT07222137","A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults","A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Baricitinib to Delay Stage 3 Type 1 Diabetes in At-risk Participants Aged ≥1 to \u003C36 Years","BARICADE-DELAY","Inclusion Criteria:\n\n* Have a history of at least one documented occasion of at least two diabetes-related autoantibodies, AND one occasion of at least two diabetes-related autoantibodies obtained at screening or prescreening\n* Have Stage 1b or Stage 2 type 1 diabetes\n* Have a body weight of ≥8 kilograms (kg) (18 pounds) at screening\n\nExclusion Criteria:\n\n* Have any other type of diabetes\n* Have uncontrolled high blood pressure\n* Have had a heart attack, heart disease, stroke, or heart failure\n* Have a history or high risk of venous thromboembolism, lymphoproliferative disease or malignancy\n* Have a current or recent clinically serious infection","1 Year","35 Years",{"count":144,"type":23},150,[65],"The purpose of this study is to find out if baricitinib can delay the onset of clinical type 1 diabetes (T1D) in people who are at high risk to develop T1D. Participation in the study will last up to approximately 5 years.",[148],"Diabetes Mellitus, Type 1",{"date":43,"type":44},{"date":151,"type":44},"2026-01-12",{"date":153,"type":23},"2031-07",{"name":155,"class":51},"Eli Lilly and Company",113,{"id":158,"slug":159,"hasResults":12,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":24,"phases":165,"briefSummary":167,"conditions":168,"keywords":170,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":190},"100600637","phase-2-study-of-izalontamab-brengitecan-bms-986507-versus-platinum-pemetrexed-for-egfr-mutated-non-small-cell-lung-cancer-after-failure-of-egfr-tki-therapy-izabright-lung01-100600637","NCT07100080","Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)","IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2\u002F3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy","Inclusion Criteria:\n\n* Non-squamous NSCLC, not amenable to treatment in curative intent.\n* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).\n* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.\n* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).\n\nExclusion criteria:\n\n* Inadequate organ function and\u002For bone marrow reserve.\n* Leptomeningeal metastases or spinal cord compression.\n* Poorly controlled systemic medical conditions.\n* Other protocol-defined inclusion\u002Fexclusion criteria apply.",{"count":63,"type":23},[166,65],"PHASE2","A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy",[169],"Non-Small Cell Lung Cancer",[171,172,173,174,175,176,177,178,179,180,181,182],"Epidermal Growth Factor Receptor","Tyrosine Kinase Inhibitors","Osimertinib","Standard of Care","Lung Neoplasms","Antineoplastic Agents","Izalontamab brengitecan","Iza-bren","BL-B01D1","Carboplatin","Cisplatin","Pemetrexed",{"date":43,"type":44},{"date":185,"type":44},"2025-11-05",{"date":187,"type":23},"2030-11-15",{"name":189,"class":51},"Bristol-Myers Squibb",186,{"id":192,"slug":193,"hasResults":12,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":197,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":199,"targetDuration":201,"studyType":202,"phases":4,"briefSummary":203,"conditions":204,"keywords":212,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":217,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"100599511","audit-of-targeted-sentinel-node-biopsy-tsnb-in-patients-with-limited-nodal-disease-undergoing-primary-surgery-100599511","NCT07085442","Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART","Inclusion Criteria:\n\n* cT1-2N1M0 breast cancer\\*\n* FNA or core biopsy confirmed axillary nodal metastases\n* ≤2 abnormal nodes on imaging\n* Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)\n* 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n* If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed‡.\n\n  * patients with T3 tumours on post-operative histology will remain eligible. For multifocal\u002Fmulticentric tumours, the T stage is based on the size of the largest invasive tumour focus rather than the combined size of all tumours.\n\n    * If \\\u003C3 lymph nodes are identified on histology, patient will remain in the NodeSMART registry. The decision regarding any further axillary treatment will be made by the treating MDT and recorded in the registry.\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy\n* Previous ipsilateral axillary lymph node dissection\n* cT3-4 breast cancer\n* ≥3 abnormal nodes on imaging",{"count":200,"type":23},300,"5 Years","OBSERVATIONAL","Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.\n\nThe AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.\n\nTargeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \\[ClinicalTrials.govNCT04109079\\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.\n\nCurrent ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.\n\nThe UK-ANZ POSNOC trial randomised 1,900 patients with \\\u003C3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \\\u003C3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.\n\nNotably, patients with biopsy-confirmed metastases and \\\u003C3 macrometastases on SNB\u002FTAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.\n\nNodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term \"Targeted Axillary Dissection\" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).",[205,206,207,208,209,210,211],"Breast Cancer","Axillary Lymph Nodes Dissection","Axillary Metastases","Sentinel Lymph Node Biopsy (SLNB)","Node Positive Breast Cancer","Axilla; Breast","Axillary Ultrasound",[213,214,197,205,215,206,216],"Targeted Axillary Dissection","Targeted Sentinel Node Biopsy","Sentinel Node Biopsy","Axillary Node Clearance",{"date":43,"type":44},{"date":219,"type":44},"2025-01-17",{"date":221,"type":23},"2032-12",{"name":223,"class":103},"University Hospitals of Derby and Burton NHS Foundation Trust",12,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":230,"acronym":231,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":233,"targetDuration":4,"studyType":24,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":248,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},"100597842","a-study-to-compare-the-combination-of-navlimetostat-bms-986504-with-pembrolizumab-and-chemotherapy-versus-placebo-plus-pembrolizumab-and-chemotherapy-in-first-line-metastatic-non-small-cell-lung-cancer-participants-with-homozygous-mtap-deletion-100597842","NCT07063745","A Study to Compare the Combination of Navlimetostat (BMS-986504) With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","A Randomized Phase 2\u002F3 Study of Navlimetostat (BMS-986504) in Combination With Pembrolizumab and Chemotherapy Versus Placebo Plus Pembrolizumab and Chemotherapy in First-line Metastatic Non-small Cell Lung Cancer Participants With Homozygous MTAP Deletion","MountainTAP-29","Inclusion Criteria\n\n* Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.\n* Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.\n* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Participants must have at least 1 measurable lesion as per RECIST v1.1.\n\nExclusion Criteria\n\n* Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.\n* Participants must not have symptomatic brain metastases or spinal cord compression.\n* Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).\n\nNote: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.\n\n* Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.",{"count":234,"type":23},590,[166,65],"The purpose of this study is to compare the clinical benefit of the combination of Navlimetostat (BMS-986504) (a selective MTA-cooperative inhibitor of PRMT5) plus pembrolizumab and chemotherapy versus placebo plus pembrolizumab and chemotherapy in first-line metastatic non-small cell lung cancer participants with homozygous MTAP deletion",[238],"Metastatic Non-small Cell Lung Cancer With MTAP Deletion",[240,241,242,243,244,245,246,247],"PRMT5","Lung cancer","NSCLC","MTAP","CDKN2A","MRTX1719","First-line","Navlimetostat",{"date":43,"type":44},{"date":250,"type":44},"2026-01-02",{"date":252,"type":23},"2031-08-12",{"name":189,"class":51},320,{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":262,"enrollmentInfo":263,"targetDuration":4,"studyType":24,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":276,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":283},"100594352","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100594352","NCT07018323","A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease","A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease","Inclusion Criteria:\n\n* Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.\n* Male or female participants aged ≥ 18 years.\n* Participants with diagnosis of GD who are hyperthyroid despite ATD treatment.\n* Other, more specific inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy.\n* Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk.\n* Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and\u002For are planning corrective surgery\u002Firradiation or medical therapy for TED during study participation.\n* Additional exclusion criteria are defined in the protocol.","75 Years",{"count":264,"type":23},210,[166],"This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.",[268],"Graves' Disease",[270,271,272,273,274,275],"IMVT-1402","Graves' disease","Thyroid-Stimulating Hormone Receptor","Immunoglobulin G","Antithyroid drug","Imeroprubart",{"date":43,"type":44},{"date":278,"type":44},"2025-06-19",{"date":280,"type":23},"2027-05",{"name":282,"class":51},"Immunovant Sciences GmbH",163,{"id":285,"slug":286,"hasResults":12,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":24,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":299,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":104},"100592936","the-effect-of-ipd-on-lateral-bone-augmentation-100592936","NCT06999915","The Effect of IPD on Lateral Bone Augmentation","Influence of Individual Phenotypical Dimension (IPD) on Hard Tissue Stability Following Lateral Bone Augmentation: a Two-centre Clinical Study","Inclusion Criteria:\n\n* Adult (\\>18 years old) patients\n* Good medical and psychological health\n* Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment\n* Need of a tooth\u002Fteeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis\n* A relatively symmetrical maxillary arch\n* A nearly intact contra-lateral alveolar ridge\n* At least one neighbouring natural tooth present with healthy periodontal conditions\n* After implant placement, presence of a buccal bone dehiscence\u002F fenestration or buccal bone plate thickness of ≤ 1.5 mm requiring GBR (Monje et al., 2022; Jensen et al.,2023, Group 1 ITI Consensus Report).\n* At least 4 weeks of post-extraction socket healing and no ridge preservation prior to implant placement.\n* No acute infection at the site; adequate availability of bone apical and palatal to obtain implant primary stability\n* A functional occlusion with a minimum of 4 occlusal units (i.e., pairs of occluding posterior teeth)\n* Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered.\n\nExclusion Criteria:\n\n* Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).\n* Self-reported HIV or other severe immunosuppression.\n* Self-reported alcoholism or chronic drug abuse.\n* Heavy smokers ( \\> 10 cigarettes\u002Fday)\n* Patients reporting use of vape\u002Fe-cigarettes\n* Self-reported pregnancy or lactation\n* Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.\n* Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation\u002Fcount.\n* Untreated caries lesions in neighbouring teeth and untreated\u002Funcontrolled periodontal disease; If patients require periodontal treatment (non-surgical and\u002For surgical), this will be arranged outside the study protocol and completed prior to enrolment;\n* Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement.\n* Patients requiring maxillary sinus lift surgery before implant placement or presenting bone dimensions (at any time point of the study) that do not allow implant placement or there is no clinical indication to perform study procedures (i.e. bone augmentation, implant placement).\n* Patients not willing to receive animal-derived biomaterials for GBR.\n* Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.",{"count":292,"type":23},28,[89],"Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.\n\nThere will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.",[296,297,298],"Guided Bone Regeneration","Bone Resorption","Diagnostic Imaging","NOT_YET_RECRUITING",{"date":43,"type":44},{"date":302,"type":23},"2026-08",{"date":304,"type":23},"2028-02-01",{"name":306,"class":103},"Queen Mary University of London",{"id":308,"slug":309,"hasResults":12,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":12,"sex":315,"minAge":19,"maxAge":85,"enrollmentInfo":316,"targetDuration":4,"studyType":24,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":337,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":344},"100581820","phase-3-study-comparing-aaa817arpi-versus-standard-of-care-in-adult-participants-with-psma-positive-mcrpc-100581820","NCT06855277","Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC","A Phase III, Open-label, Multi-center, Randomized Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive Metastatic Castration Resistant Prostate Cancer","AcTFirst","Key Inclusion Criteria:\n\n* Signed informed consent must be obtained prior to participation in the study.\n* Participants must be adults ≥ 18 years of age.\n* Participants must have an ECOG performance status of 0 to 2.\n* Participants must have histological, and\u002For cytological confirmation of adenocarcinoma of the prostate. Participants with mixed histology (neuroendocrine) are not eligible.\n* Participants who have received taxane-based chemotherapy in mHSPC setting are eligible if they are deemed appropriate for chemotherapy, ARPI change or AAA617 as the next line of therapy in the opinion of the Investigator. Note: Participants who have received taxane-based chemotherapy for mCRPC are excluded.\n* Participants must not have received taxane-based chemotherapy in mCRPC setting (allowed in mHSPC setting).\n* Participants must have PSMA-PET positive disease using a PSMA imaging agent that is approved as per protocol.\n* Participant must have been diagnosed with mCRPC with documented progressive disease while on treatment with ARPI in mHSPC or earlier setting as their last treatment (and did not progress on more than one ARPI).\n\n  * Participants with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer, as per local testing, may be enrolled if they had prior exposure to PARPi.\n\nKey Exclusion Criteria:\n\n* Previous anti-cancer treatment with any approved or investigational radiopharmaceuticals (for example, \\[177Lu\\]Lu-PSMA, \\[177Lu\\]-DOTA, or Radium- 223.)\n* Previous treatment with any external beam radiotherapy including hemi-body radiation within 6 weeks of randomization (within 2 weeks for radiotherapy of localized metastases).\n\n  * Any prior PARP inhibitor or other systemic anticancer therapy administered for metastatic castration-resistant prostate cancer (mCRPC). Any other approved or investigational systemic therapy (including chemotherapy, immunotherapy, biologics, or monoclonal antibodies) is prohibited within 28 days or 5 half-lives (whichever is shorter) before randomization.\n\nNote: Prior ARPI administered in the mHSPC setting or earlier may continue until C1D1.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","MALE",{"count":317,"type":23},940,[65],"The purpose of this study is to determine whether \\[225Ac\\]Ac-PSMA-617 (AAA817), given for up to 6 cycles at a dose of 10 Megabecquerel (MBq) +\u002F- 10%, plus androgen receptor pathway inhibitor (ARPI), improves the radiographic progression free survival (rPFS) compared to investigator's choice of standard of care (SOC) (ARPI change or taxane-based chemotherapy or \\[177Lu\\]Lu-PSMA-617 (AAA617)) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC) treated with another ARPI as last treatment and who have not been exposed to a taxane-containing chemotherapy in the mCRPC setting nor have received any prior PSMA-targeting radioligand therapy.",[321],"Prostate Cancer",[323,324,325,326,327,328,329,330,331,332,333,334,313,335,336],"Positive Metastatic Castration Resistant Prostate Cancer","PSMA","PSMA-positive","AAA817","[225AC] AC-PSMA-617","Radioligand Therapy","RLT","Androgen receptor pathway inhibitor","ARPI","Taxane","Metastatic castration resistant prostate cancer","mCRPC","[177Lu]Lu- PSMA-617","AAA617",{"date":43,"type":44},{"date":339,"type":44},"2025-07-01",{"date":341,"type":23},"2032-11-04",{"name":343,"class":51},"Novartis Pharmaceuticals",93,{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":355,"briefSummary":356,"conditions":357,"keywords":359,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":362,"startDateStruct":363,"completionDateStruct":365,"leadSponsor":367,"locationsCount":369},"100579143","phase-2-a-study-to-evaluate-the-adverse-events-and-efficacy-of-intravenous-iv-of-telisotuzumab-adizutecan-in-combination-with-iv-oxaliplatin-fluorouracil-folinic-acidleucovorin-bevacizumab-panitumumab-in-adult-participants-with-metastatic-colorectal-cancer-100579143","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":354,"type":23},390,[166],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[358],"Metastatic Colorectal Cancer",[358,360,361],"AndroMETa-CRC-533","Telisotuzumab Adizutecan",{"date":43,"type":44},{"date":364,"type":44},"2025-04-24",{"date":366,"type":23},"2028-04",{"name":368,"class":51},"AbbVie",65,{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":262,"enrollmentInfo":374,"targetDuration":4,"studyType":24,"phases":376,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":383,"startDateStruct":384,"completionDateStruct":386,"leadSponsor":388,"locationsCount":389},"100572003","phase-2-a-study-to-assess-the-efficacy-safety-and-tolerability-of-imvt-1402-as-treatment-for-adult-participants-with-graves-disease-100572003","NCT06727604",{"count":375,"type":23},240,[166],"This is a study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.\n\nThe primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine \\[T3\\] or free triiodothyronine \\[FT3\\]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.",[268],[270,380,381,382,275],"Anti Thyroid Drug","Hyperthyroidism","Autoimmune thyroid disease",{"date":43,"type":44},{"date":385,"type":44},"2024-12-17",{"date":387,"type":23},"2028-06",{"name":282,"class":51},134,{"id":391,"slug":392,"hasResults":12,"nctId":393,"briefTitle":394,"officialTitle":395,"acronym":4,"eligibilityCriteria":396,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":397,"targetDuration":4,"studyType":24,"phases":399,"briefSummary":400,"conditions":401,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":403,"startDateStruct":404,"completionDateStruct":406,"leadSponsor":408,"locationsCount":410},"100563701","phase-1-a-study-to-evaluate-safety-pharmacokinetics-and-activity-of-gdc-7035-as-a-single-agent-and-in-combination-in-patients-with-advanced-solid-tumors-100563701","NCT06619587","A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors","A Phase I\u002FII Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation","Inclusion Criteria:\n\n* Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation\n* Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm\n\nExclusion criteria:\n\n* Malabsorption or other condition that would interfere with enteral absorption\n* Active brain metastases\n* Clinically significant cardiovascular dysfunction or liver disease",{"count":398,"type":23},410,[26],"This is a first-in-human Phase I\u002FII, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.",[402],"Solid Tumor",{"date":43,"type":44},{"date":405,"type":44},"2024-11-14",{"date":407,"type":23},"2028-05-31",{"name":409,"class":51},"Genentech, Inc.",42,{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":18,"minAge":419,"maxAge":420,"enrollmentInfo":421,"targetDuration":4,"studyType":24,"phases":423,"briefSummary":424,"conditions":425,"keywords":428,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":430,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":437},"100557714","phase-3-a-study-investigating-subcutaneously-administered-pozelimab-in-combination-with-cemdisiran-or-cemdisiran-alone-in-adult-participants-with-geographic-atrophy-100557714","NCT06541704","A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy","A Multicenter, Randomized, Double-Masked, Placebo-Controlled Phase 3 Study of the Efficacy, Safety, and Tolerability of Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","SIENNA","Key Inclusion Criteria:\n\n1. Study eye with diagnosis of GA of the macula secondary to AMD as described in the protocol\n2. Total GA area in the study eye measuring between ≥2.5 mm\\^2 and ≤17.5 mm\\^2 as described in the protocol\n3. BCVA of 55 letters or better using ETDRS charts (20\u002F80 Snellen equivalent) in the study eye as described in the protocol\n4. Sufficiently clear ocular media, adequate pupillary dilation and fixation to permit quality fundus imaging in the study eye as described in the protocol\n5. Willing and able to comply with clinic visits and study-related procedures, including completion of the full series of meningococcal vaccinations and pneumococcal vaccination required per protocol\n\nKey Exclusion Criteria:\n\n1. GA in either eye due to causes other than AMD, such as Stargardt disease, cone rod dystrophy or toxic maculopathies like hydroxychloroquine maculopathy\n2. History or current evidence of Macular Neovascularization (MNV) and\u002For exudation or Peripapillary Choroidal Neovascularization (PPCNV) in either eye as described in the protocol\n3. Prior or current Intravitreal (IVT) treatment of any kind for any indication in study eye or fellow eye, except approved or investigational IVT complement inhibitor therapy or anti-VEGF therapy, as long as last dose was ≥6 months prior to randomization\n4. Prior intraocular surgery except cataract extraction or minimally invasive glaucoma surgery in study eye as long as date of these procedures was ≥3 months prior to randomization\n5. Comorbid progressive ocular condition (eg, diabetic retinopathy, macular edema, uncontrolled glaucoma, full thickness macular hole) in study eye that could affect central vision and confound study\n6. Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination of the study eye (e.g., advanced cataract or corneal abnormalities) as described in the protocol\n\n   Systemic Exclusion criteria\n7. History or current use of systemic complement inhibitor therapy within 6 months prior to randomization as described in the protocol\n8. History of solid organ or bone marrow transplantation\n9. Use of chronic (\\>14 days) systemic corticosteroids (oral or parenteral, ≥20 mg oral prednisone or equivalent) within the previous 30 days prior to the first screening visit as described in the protocol\n10. Current or prior use of systemic immunosuppressive therapy other than corticosteroids within 12 months prior to randomization or the likelihood of treatment with any such agent during the study inclusive of the screening period as described in the protocol\n11. Not meeting meningococcal or pneumococcal vaccination requirements as described in the protocol\n12. Carrier of Neisseria meningitidis based on culture collected during screening\n13. Has a hemoglobin A1C ≥ 8.0% during screening as described in the protocol\n\nNOTE: Other protocol-defined Inclusion\u002F Exclusion Criteria apply","50 Years","85 Years",{"count":422,"type":23},975,[65],"This study is researching experimental (study) drugs called pozelimab and cemdisiran. The study is focused on participants who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). Geographic atrophy is a medical term that refers to later-stage cases of AMD which is an eye condition affecting central vision (what one sees straight ahead).\n\nThe purpose of this study is to evaluate the progression rate of Geographic Atrophy in eyes of patients treated with cemdisiran alone or in combination with pozelimab compared to those treated with placebo.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug(s)\n* How much study drug(s) are in the blood at different times\n* Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)",[426,427],"Age-related Macular Degeneration (AMD)","Geographic Atrophy (GA)",[429],"GA secondary to AMD",{"date":43,"type":44},{"date":432,"type":44},"2024-10-30",{"date":434,"type":23},"2033-04-09",{"name":436,"class":51},"Regeneron Pharmaceuticals",224,{"id":439,"slug":440,"hasResults":12,"nctId":441,"briefTitle":442,"officialTitle":443,"acronym":4,"eligibilityCriteria":444,"healthyVolunteers":12,"sex":18,"minAge":445,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":24,"phases":447,"briefSummary":448,"conditions":449,"keywords":451,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":456,"startDateStruct":457,"completionDateStruct":459,"leadSponsor":460,"locationsCount":462},"100544252","phase-3-a-study-of-pitolisant-in-patients-with-prader-willi-syndrome-100544252","NCT06366464","A Study of Pitolisant in Patients With Prader-Willi Syndrome","A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome","Inclusion Criteria:\n\n* Genetically confirmed diagnosis of PWS\n* Excessive daytime sleepiness\n* Has a consistent parent\u002Fcaregiver (preferably the same person throughout the study) who is willing and able to complete the required study assessments.\n* In the opinion of the Investigator, the patient\u002Fparent(s)\u002Fcaregiver(s)\u002Flegal guardian(s) are capable of understanding and complying with the requirements of the protocol and administration of oral study drug.\n\nExclusion Criteria:\n\n* Has a diagnosis of sleep apnea (OSA, CSA) that is not adequately controlled\n* Has a diagnosis of hypersomnia due to another sleep\u002Fmedical disorder\n* Participation in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or 5 half-lives (whichever is longer) of the investigational medication prior to Screening","6 Years",{"count":389,"type":23},[65],"This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, global clinical study to assess the efficacy and safety of pitolisant in patients living with Prader-Willi syndrome.\n\nThe primary objective of this study is to evaluate the efficacy of pitolisant in treating excessive daytime sleepiness (EDS) in patients ≥6 years of age with Prader-Willi syndrome.\n\nSecondary objectives include assessing the impact of pitolisant on:\n\nIrritable and disruptive behaviors Hyperphagia Other behavioral problems including social withdrawal, stereotypic behavior, hyperactivity\u002Fnoncompliance, and inappropriate speech",[450],"Prader-Willi Syndrome",[452,453,454,455],"pitolisant","excessive daytime sleepiness","irritable and disruptive behaviors","Prader-Willi syndrome",{"date":43,"type":44},{"date":458,"type":44},"2024-05-28",{"date":366,"type":23},{"name":461,"class":51},"Harmony Biosciences Management, Inc.",57,{"id":464,"slug":465,"hasResults":12,"nctId":466,"briefTitle":467,"officialTitle":467,"acronym":468,"eligibilityCriteria":469,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":470,"targetDuration":4,"studyType":24,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":477,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":484},"100520674","bradycardia-pacemaker-with-av-interval-modulation-for-blood-pressure-treatment-100520674","NCT06059638","BradycArdia paCemaKer With AV Interval Modulation for Blood prEssure treAtmenT","BACKBEAT","Inclusion Criteria:\n\n1. Patient has or is indicated for a dual-chamber pacemaker. Visit 1 can be performed within 30 days prior to a planned implant of a Medtronic Astra\u002FAzure dual-chamber pacemaker system or at any time thereafter\n2. On a stable antihypertension treatment regimen with at least 1 class of antihypertensive drug\n3. Office SBP ≥135 mmHg and \\\u003C180 mmHg\n4. Average 24-Hour aSBP ≥130 mmHg and \\\u003C170 mmHg\n\nExclusion Criteria:\n\n1. LVEF \\\u003C50%\n2. NYHA Class III-IV\n3. History of cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months\n4. Myocardial infarction (MI) within 3 months\n5. Prior percutaneous or surgical coronary, carotid, or endovascular intervention within 3 months\n6. Permanent atrial fibrillation\n7. Mitral valve regurgitation greater than or equal to grade 3\n8. Aortic stenosis with a valve area less than 1.5 cm2\n9. Has an active or prior device-based anti-hypertensive treatment (e.g., renal denervation procedure, baroreflex activation therapy)\n10. Has an existing active cardiac device or neurostimulator other than the recent Astra\u002FAzure pacemaker implant",{"count":63,"type":23},[89],"A prospective, multinational, randomized, double-blind, clinical trial evaluating the safety and effectiveness of a novel atrioventricular interval modulation (AVIM) algorithm downloaded into a dual-chamber Medtronic Astra\u002FAzure pacemaker.",[474,475,476],"Hypertension","Hypertension, Systolic","Hypertension, Essential",{"date":43,"type":44},{"date":479,"type":44},"2023-12-27",{"date":481,"type":23},"2029-08",{"name":483,"class":51},"Orchestra BioMed, Inc",130,{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":491,"eligibilityCriteria":492,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":493,"targetDuration":4,"studyType":202,"phases":4,"briefSummary":495,"conditions":496,"keywords":499,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":115},"100492944","coroflex-isar-neo-pmcf-study-100492944","NCT05698732","Coroflex® ISAR NEO PMCF Study","Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study","rEPIC07","Inclusion Criteria:\n\nCoroflex® ISAR NEO is intended to be used for\n\n* Patients must be at least 18 years of age AND\n* The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his\u002F her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment AND\n* Patients with Novo lesion length 2-4 mm AND\n* Informed consent signed\n\nExclusion Criteria:\n\n* Patients with express refusal by the patient to participate in the study.\n* Patients pregnant women and lactating women.\n* Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).\n* Patients in whom anti-platelet and\u002For anti-coagulation therapy is contraindicated\n* Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation\n* Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent\n* Patients with known sensitivity to contrast agents who cannot be premedicated.\n* Patients with contraindications or hypersensitivity to sirolimus\n* Patients with a life expectancy of less than 2 years\n* Patients included in other clinical trials",{"count":494,"type":23},3000,"International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.",[497,498],"Coronary Artery Disease (CAD)","Ischemic Heart Disease",[500,501,502],"MDR (Medical Device Regulations)","PMCF (Post-Market Clinical Follow-up)","Drug Eluting Stent",{"date":43,"type":44},{"date":505,"type":44},"2023-08-04",{"date":507,"type":23},"2027-02-01",{"name":509,"class":103},"Fundación EPIC",{"id":511,"slug":512,"hasResults":12,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":517,"targetDuration":4,"studyType":24,"phases":519,"briefSummary":520,"conditions":521,"keywords":524,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100409600","phase-2-phase-2-trial-of-adagrasib-monotherapy-and-in-combination-with-pembrolizumab-and-a-phase-3-trial-of-adagrasib-in-combination-in-patients-with-a-kras-g12c-mutation-krystal-7-100409600","NCT04613596","Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7","A Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation","Inclusion Criteria:\n\n* Phase 2: Histologically confirmed diagnosis of unresectable or metastatic NSCLC with KRAS G12C mutation and any PD-L1 TPS\n* Phase 3: Histologically confirmed diagnosis of unresectable or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS\\>=50%\n* Phase 3: Presence of measurable disease per RECIST1.1\n* Phase 3: CNS Inclusion - Based on screening brain imaging, patients must have one of the following:\n\n  1. No evidence of brain metastases\n  2. Untreated brain metastases not needing immediate local therapy\n  3. Previously treated brain metastases not needing immediate local therapy\n\nExclusion Criteria:\n\n* Phase 2 and Phase 3: Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).\n* Phase 2: Active brain metastases\n* Phase 3: Patients with known central nervous system (CNS) lesions must not have any of the following:\n\n  1. Any untreated brain lesions \\> 2.0 cm in size\n  2. Any brainstem lesions\n  3. Ongoing use of systemic corticosteroids for control of symptoms of brain lesions at a total daily dose of \\> 10 mg of prednisone (or equivalent) prior to randomization.\n  4. Have poorly controlled (\\> 1\u002Fweek) generalized or complex partial seizures, or manifest neurologic progression due to brain lesions notwithstanding CNS-directed therapy\n* Phase 3: Radiation to the lung \\> 30 Gy within 6 months prior to the first dose of study treatment",{"count":518,"type":23},626,[166,65],"The Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.\n\nThe Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \\>=50% and who are candidates for first line treatment.",[522,523],"Advanced Non-Small Cell Lung Cancer","Metastatic Non-Small Cell Lung Cancer",[525,526,242,523,527,528,529],"KRAS G12C","Non-small cell lung cancer","Adagrasib","Krazati","TPS",{"date":43,"type":44},{"date":532,"type":44},"2020-12-02",{"date":534,"type":23},"2029-10-31",{"name":536,"class":51},"Mirati Therapeutics Inc.",770,{"id":539,"slug":540,"hasResults":12,"nctId":541,"briefTitle":542,"officialTitle":543,"acronym":544,"eligibilityCriteria":545,"healthyVolunteers":84,"sex":18,"minAge":546,"maxAge":4,"enrollmentInfo":547,"targetDuration":4,"studyType":24,"phases":549,"briefSummary":550,"conditions":551,"keywords":574,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":104},"100653380","the-role-of-methanogens-in-the-progression-of-parkinsons-disease-and-related-neurological-conditions-100653380","NCT07786116","The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions","Met-Pro Study: The Role of METhanogens in the PROgression Of Parkinson's Disease and Related Neurological Conditions","Met-Pro","Inclusion Criteria:\n\nPeople with PD:\n\n* 55 years of age or above;\n* MDS criteria for Idiopathic PD;\n* H\\&Y\\\u003C3.\n\nPeople at high risk of developing PD (people with REM Sleep behaviour disorders):\n\n* 55 years of age or above;\n* RBD diagnosis confirmed by polysomnography.\n\nOther conditions affecting cognition (e.g. dementia, mild cognitive impairment):\n\n* 55 years of age or above;\n* Diagnosis of non-PD dementia or MCI, or, MoCA score ≤25\n\nHealthy Controls:\n\n* 55 years of age or above\n* MoCA total score ≥26.\n\nExclusion Criteria:\n\n* Presence of other neurological disorder, chronic inflammatory\u002Fautoimmune disorder, active cancer, active metabolic disease, diabetes type I and II, and active or latent infection;\n* Use of immunosuppressive drugs within the preceding 12 months;\n* Use of oral\u002Fintravenous steroids within the preceding 3 months;\n* Regular use (more than twice per week) of non-steroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen, diclofenac, meloxicam) or over 75mg aspirin;\n* Participation in other interventional studies, within the preceding 3 months;\n* Consumption of laxatives, stool softeners, stool bulking agents, motility agents, iron supplements and probiotics within the preceding 3 months;\n* Current smoker\n* Inability to understand or speak English fluently.\n\nFor participants in Component 2 of the study (Experimental Medicine Study), additional exclusion criteria will be in place, namely, known allergy to any of the probiotic's ingredients: Bulking agent (isomalt), sweetener (xylitol), L. reuteri DSM 17938, strawberry flavouring and flavour enhancer (citric acid).","55 Years",{"count":548,"type":23},215,[89],"Gut problems, such as constipation, can have an important impact on quality of life of people who have them, and have been associated with higher risk of developing neurological diseases such as Parkinson's or Alzheimer's disease.\n\nRecent studies suggest that gut problems may also have implications for the progression of these diseases, as constipation is a risk factor for faster Parkinson's and Alzheimer's progression. However, how constipation and brain diseases are linked is unknown.\n\nPrevious research has suggested that gut changes may lead to inflammation, which could play a role in accelerating the progression of both movement and memory problems in Parkinson's and memory and thinking problems in people with cognitive impairment.\n\nMethane is a gas that is naturally produced by microorganisms in the gut. Levels of methane can be measured using a simple breath test. Higher methane levels in the breath are thought to be more common in people with Parkinson's disease (PwP) when compared to people without Parkinson's (healthy controls) and have been associated with gut symptoms, particularly constipation, as well as worse movement problems in PwP, although they are less understood in conditions that affect memory and thinking (like dementia or mild cognitive impairment).\n\nThe investigators want to better understand the changes in the gut of PwP and people with cognitive impairment (e.g. mild cognitive impairment or dementia). They will compare breath methane levels in PwP, people with cognitive impairment, people with REM Sleep Behaviour Disorder (a sleep condition linked to a higher risk of developing Parkinson's) and healthy participants. Participants will be followed-up over time to assess how methane levels are linked to changes in the blood and the stools, gut function, and clinical symptoms.\n\nThis study has 2 components:\n\nComponent 1: observational study, where the study investigators will follow 200 participants over 2 visits, 18 months apart. The study will recruit 4 groups of people:\n\n50 people with Parkinson's disease, 50 people at high risk of developing Parkinson's disease (people with REM Sleep behaviour disorder), 50 people with other conditions affecting cognition (e.g. dementia, mild cognitive impairment), and 50 healthy controls.\n\nComponent 2: study with 15 people with Parkinson's, who produce high methane levels, to test whether a probiotic (Lactobacillus reuteri) affects how much methane is produced.",[552,553,554,555,556,557,558,559,560,561,562,563,564,565,566,567,568,569,570,571,572,573],"PARKINSON DISEASE (Disorder)","Parkinson","Parkinson Disease","Parkinson s Disease","REM Behavior Disorder","REM Sleep Behavior Disorder","REM Sleep Behavior Disorder (iRBD)","REM Sleep Behaviour Disorder","Constipation","SIBO","Mild Cognitive Impairment","Mild Cognitive Impairment (MCI)","Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease","Dementia","Dementia (Diagnosis)","Dementia Alzheimers","Dementia MCI (Mild Cognitive Impairment)","Alzheimer s Disease","Alzheimer Dementia","Alzheimer Dementia (AD)","Alzheimer Disease","Alzheimer Disease (AD)",[575,576,577,556,557,578,579],"parkinson","PARKINSON DISEASE","RBD","Ghrelin","intestinal methanogen overgrowth","2026-08-21",{"date":43,"type":44},{"date":583,"type":44},"2025-11-01",{"date":585,"type":23},"2028-03",{"name":587,"class":103},"University of Cambridge",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":84,"sex":18,"minAge":142,"maxAge":596,"enrollmentInfo":597,"targetDuration":4,"studyType":24,"phases":598,"briefSummary":599,"conditions":600,"keywords":606,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":614,"startDateStruct":615,"completionDateStruct":617,"leadSponsor":619,"locationsCount":104},"100652602","satiety-microbiome-appetite-regulation-and-tracking-energy-across-targeted-snacks-acute-postprandial-study-100652602","NCT07776418","Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study","The ZOE SMART EATS (Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks) Acute Postprandial Study: Investigating the Acute Effects of a High-fibre Plant-based Snack Bar on Subjective Postprandial Hunger, Energy Intake and Eating Behaviour in Healthy UK Adults.","SMARTEATS-PP","Inclusion Criteria:\n\n* Willing and able to follow the study protocol\n* Willing and able to provide informed consent\n* Regular consumption of snacks (≥2 per day)\n* Fibre intake \\\u003C20 g\u002Fd\n* Living in the UK\n\nExclusion Criteria:\n\n* Have BMI of less than 18.5 kg\u002Fm² or more than 40 kg\u002Fm²\n* Have an allergy or intolerance to ingredients in the intervention or control snack bars (including inulin) or cannot eat the food products safely and comfortably for any reason\n* Have a personal medical history of inflammatory bowel disease, coeliac disease, Crohn's disease, irritable bowel syndrome, chronic constipation, or chronic diarrhoea\n* Have started a new supplement in the past month, or are unwilling to maintain current supplement use throughout the study\n* Previously purchased any ZOE products (including Daily30, ZOE gut health bar or ZOE app membership).\n* Have taken any medication or product that may modify the measured study outcomes, in the past 3 months (including but not limited to: fibre supplements, antibiotics, non-topical steroids or other immunosuppressive medicines, probiotics or prebiotics, metformin, GLP-1 receptor agonists, lipid-lowering medications such as fibrates, statins, PCSK9 inhibitors, non-steroidal anti-inflammatory drugs)\n* Have used opiate pain medication or a proton pump inhibitor for 8 or more consecutive days during the past 3 months\n* Have experienced a heart attack, stroke or major surgery in the last 2 months\n* Have received treatment for cancer in the last 3 months\n* Are currently pregnant, breastfeeding or planning a pregnancy\n* Are diagnosed with an eating disorder, type 1 diabetes mellitus or type 2 diabetes mellitus","65 Years",{"count":22,"type":23},[89],"The goal of this clinical trial is to learn how eating different snack foods affects acute hunger, energy intake and eating behaviour in healthy adults. The study will be conducted remotely over 5 days.\n\nThe main questions it aims to answer are:\n\n1. Does eating a snack bar intervention change how hungry participants feel later in the same day?\n2. Does eating a snack bar intervention change participants' energy intake, nutrient intake and eating behaviour on the same day?\n3. Does eating a snack bar intervention change participants mood, energy levels and alertness later in the same day?\n\nResearchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, energy intake, eating behaviour, and other subjective measures.\n\nParticipants will:\n\n* Eat 2 snack bars for breakfast on 2 separate days, with 2 days in between\n* Not eat anything after 9pm the night before each test day\n* Fill out short online surveys (under 5 minutes) before breakfast and at set times over the next 3 hours\n* Not eat for 3 hours after breakfast\n* Write down everything they eat that day",[601,602,603,604,605],"Healthy Participants","Healthy Adult Subject","Healthy Subjects","Healthy Adult Volunteer","Healthy Adult Participants",[607,608,609,610,611,612,613],"Snacks","Snack foods","Dietary intervention","Hunger","Health","Wellbeing","Nutrition study",{"date":41,"type":44},{"date":616,"type":44},"2026-08-14",{"date":618,"type":23},"2026-10",{"name":620,"class":103},"Zoe Global Limited",{"id":622,"slug":623,"hasResults":12,"nctId":624,"briefTitle":625,"officialTitle":625,"acronym":626,"eligibilityCriteria":627,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":628,"enrollmentInfo":629,"targetDuration":631,"studyType":202,"phases":4,"briefSummary":632,"conditions":633,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":643,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":104},"100652303","multimodal-biomarkers-in-coronary-artery-disease-pathogenesis-the-oxford-acute-myocardial-infarction-study-oxami-study-100652303","NCT07772570","Multimodal Biomarkers in Coronary Artery Disease Pathogenesis: The Oxford Acute Myocardial Infarction Study (OXAMI Study)","OXAMI","Inclusion Criteria:\n\n* Evidence of myocardial injury (e.g. elevation of troponin or other cardiac biomarkers, ECG changes, wall motion abnormalities on cardiac imaging) AND\u002FOR referred for coronary angiography with view to proceed to PCI as indicated in either non-emergency or emergency settings.\n\nExclusion Criteria:\n\n* Patients in whom safety or clinical concerns preclude participation.\n* Anaemia (Hb \\\u003C9).\n* Pregnant or breast feeding females.\n\nAdditional exclusion criteria for patients undergoing MRI\n\n* claustrophobia which limits \u002F prevents participants from remaining in MRI scanner.\n* patients who cannot lie flat on the scan table.\n* patients with metallic implants, pacemakers, implantable defibrillators etc, unless known to be MRI compatible.\n* patients with known allergy to medium of contrast (gadolinium)\n\nAdditional exclusion criteria for patients undergoing coronary CT angiography\n\n* patients with a known allergy to iodinated contrast media\n* eGFR\\\u003C 30 ml\u002Fmin (stage 3-5 renal disease)","90 Years",{"count":630,"type":23},2000,"20 Years","Coronary artery disease is one of the most common causes of illness and death. It develops when fatty deposits, known as plaques, build up in the arteries that supply blood to the heart. These plaques can gradually narrow the arteries and reduce blood flow, causing symptoms such as chest pain (angina). Sometimes a plaque can suddenly break open, causing a blood clot to form and block the artery. This can lead to a heart attack and permanent damage to the heart muscle.\n\nAlthough much has been learned about coronary artery disease, important questions remain about why some plaques suddenly become unstable, how this affects blood flow through the smallest blood vessels of the heart, and why some patients develop more heart muscle damage than others.\n\nThe Oxford Acute Myocardial Infarction (OxAMI) research programme aims to improve our understanding of these processes. The investigators will study both the disease within the coronary arteries (the \"upstream\" problem) and its effects on the heart muscle (the \"downstream\" damage). By examining these together, the investigators hope to understand more clearly how changes in coronary plaques lead to heart injury and how this differs between patients.\n\nParticipants undergoing procedures to investigate or treat coronary artery disease provide an important opportunity to study these processes. During coronary angioplasty (also called percutaneous coronary intervention or PCI), a narrow or blocked artery is opened, usually using a small balloon and a stent. This procedure can disturb the underlying plaque in a similar way to the plaque disruption that occurs during a heart attack. Where appropriate, the investigators may therefore collect blood and material released from the plaque during these procedures. Blood may be collected from different locations in the circulation, allowing the investigators to study substances released by the plaque and heart muscle. Material that would otherwise be discarded during treatment may also be collected for laboratory analysis.\n\nThe investigators will use several established and newer techniques to examine the coronary arteries, the small blood vessels within the heart, and the heart muscle. These may include detailed imaging from inside the coronary arteries using intravascular ultrasound (IVUS) or optical coherence tomography (OCT). The investigators may also measure blood pressure and flow within the coronary arteries to assess how well the small blood vessels supplying the heart are working.\n\nNon-invasive heart scans may include cardiovascular magnetic resonance (CMR\u002FMRI), cardiac computed tomography (CT) and echocardiography (ultrasound). These techniques can provide detailed information about the structure and function of the heart, blood supply to the heart muscle, areas of injury or permanent scarring, and changes that occur following a heart attack. In particular, MRI may help distinguish heart muscle that has been permanently damaged from muscle that is injured but could potentially recover after blood flow is restored. This may be especially important for participants who arrive at hospital several hours after their heart attack began.\n\nOther measurements may include electrocardiograms (ECGs), which record the electrical activity of the heart, and measurements of heart pressure, volume and function. Some participants may also have longer-term ECG monitoring.\n\nBlood and tissue samples may be analysed using a range of laboratory techniques. These studies will investigate inflammation, blood clotting and other biological processes involved in coronary artery disease and heart attacks. Newer laboratory methods may allow us to measure large numbers of proteins and small molecules in the blood. Material collected from plaques may also be examined under a microscope to identify its cells and structural components.\n\nWith additional consent, blood samples may be stored for genetic research. This could help us understand whether differences in people's genes influence their risk of coronary artery disease, their response to a heart attack, or the amount of heart damage that occurs.\n\nBy combining information about coronary plaques, blood flow through the heart's circulation, heart muscle injury, imaging, blood and tissue markers, and genetic factors, the OxAMI study aims to build a detailed picture of coronary artery disease and heart attacks. The programme will establish a carefully characterised group of research participants who may contribute to future OxAMI studies conducted under separate research protocols.\n\nUltimately, this research aims to identify better ways to predict, diagnose and understand coronary artery disease and heart attacks, and to identify new approaches that could improve treatment and outcomes for future patients.",[634,635,636,637,638,639,640,641,642],"Myocardial Injury","Atherosclerosis Cardiovascular Disease","Cardiac Imaging Techniques","Genetics","Thrombus","Trained Immunity","Biomarker Discovery","Coronary Physiology","Intravascular Imaging and Microvascular Obstruction",{"date":41,"type":44},{"date":645,"type":44},"2012-05",{"date":647,"type":23},"2046-12",{"name":649,"class":103},"University of Oxford",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":656,"eligibilityCriteria":657,"healthyVolunteers":12,"sex":18,"minAge":658,"maxAge":262,"enrollmentInfo":659,"targetDuration":4,"studyType":24,"phases":661,"briefSummary":662,"conditions":663,"keywords":665,"overallStatus":299,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":668,"startDateStruct":669,"completionDateStruct":670,"leadSponsor":672,"locationsCount":673},"100651359","phase-2-a-study-of-brenipatide-ly3537031-in-adult-participants-with-moderate-to-severe-chronic-obstructive-pulmonary-disease-copd-100651359","NCT07759245","A Study of Brenipatide (LY3537031) in Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","A Phase 2, Multicenter, Randomized, Double-Blind, 52-week Study to Investigate the Efficacy and Safety of Brenipatide Compared With Placebo for the Treatment of Adult Participants With Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)","RENEW-COPD","Inclusion Criteria:\n\n* Have a physician diagnosis of Chronic Obstructive Pulmonary Disease (COPD), at least 12 months prior to screening who meet the following criteria:\n\n  * Current or former smokers with a smoking history of greater than or equal to (≥) 10 pack-years\n  * Moderate-to-severe COPD (post-Bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV₁)\u002Fforced vital capacity (FVC) less than (\\\u003C) 70 percent (%)\n  * Modified Medical Research Council Dyspnea Scale (mMRC-DS) grade ≥2\n  * Exacerbation history of ≥2 moderate or ≥1 severe exacerbations within the year prior to inclusion.\n  * Background double therapy \\[long-acting β₂-agonists (LABA) + long-acting muscarinic antagonists (LAMA)\\] or triple therapy \\[inhaled corticosteroids (ICS) + LABA + LAMA)\\] for 3 months prior to randomization with a stable dose of medication for ≥1 month prior to screening.\n\nExclusion Criteria:\n\n* Have a known pre-existing, clinically important lung condition other than COPD.\n* Have a current or recent acute, active infection before screening and up to randomization.","40 Years",{"count":660,"type":23},606,[166],"The main purpose of this study is to assess if different dose levels of Brenipatide are safe and work the way they are intended to work in participants with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD), when compared with placebo. The study will last approximately one year.",[664],"Pulmonary Disease, Chronic Obstructive",[37,666,667],"Chronic Bronchitis","Lung Disease",{"date":41,"type":44},{"date":302,"type":23},{"date":671,"type":23},"2028-11",{"name":155,"class":51},128,{"id":675,"slug":676,"hasResults":12,"nctId":677,"briefTitle":678,"officialTitle":679,"acronym":4,"eligibilityCriteria":680,"healthyVolunteers":84,"sex":18,"minAge":19,"maxAge":546,"enrollmentInfo":681,"targetDuration":4,"studyType":24,"phases":683,"briefSummary":684,"conditions":685,"keywords":687,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":692,"startDateStruct":693,"completionDateStruct":695,"leadSponsor":697,"locationsCount":104},"100646831","phase-1-investigating-the-effect-of-itraconazole-on-the-pharmacokinetics-of-azd4144-in-healthy-participants-100646831","NCT07685600","Investigating the Effect of Itraconazole on the Pharmacokinetics of AZD4144 in Healthy Participants","An Open-label, Randomised, Two Arm, Fixed Sequence Study in Healthy Participants to Assess the Pharmacokinetics of AZD4144 When Administered Alone and in Combination With Itraconazole","Inclusion Criteria:\n\n1. Healthy male and\u002For female participants with suitable veins for cannulation or repeated venipuncture.\n2. Body mass index (BMI) between 18.0 and 30.0 kg\u002Fm², inclusive, and body weight of at least 50 kg.\n3. Female participants of childbearing potential must have a negative serum or urine pregnancy test and must agree to use highly effective contraception throughout the study and follow-up period.\n4. Male participants must agree to use adequate contraception and refrain from sperm donation during the study and for the protocol-specified period after the last dose.\n\nExclusion Criteria:\n\n1. Any clinically significant disease or medical condition that may interfere with study participation or interpretation of results.\n2. History or presence of gastrointestinal, hepatic, renal or any other condition known to interfere absorption, distribution, metabolism, or excretion of study drugs.\n3. Any clinically important illness, medical\u002Fsurgical procedure, or trauma.\n4. Active systemic bacterial, viral, or fungal infection.\n5. Clinically significant serious active or chronic infections.\n6. Known history of primary immunodeficiency (congenital or acquired) or an underlying condition that predisposes to infection.\n7. Concomitant immunosuppressive, steroid treatment.\n8. Clinically significant abnormalities in physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory assessments.\n9. Known hypersensitivity or allergy to AZD4144, itraconazole, or any excipients of the study interventions.\n10. Positive screening test for drugs of abuse, alcohol, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus (HIV).",{"count":682,"type":23},32,[26],"The purpose of the study is to assess the pharmacokinetics (PK) of AZD4144 when administered alone and in combination with itraconazole in healthy participants.",[686],"Healthy",[688,689,690,691],"Pharmacokinetics","Cardiorenal diseases","Cryopyrin","Drug-drug interaction",{"date":41,"type":44},{"date":694,"type":44},"2026-07-30",{"date":696,"type":23},"2026-10-29",{"name":131,"class":51},{"id":699,"slug":700,"hasResults":12,"nctId":701,"briefTitle":702,"officialTitle":703,"acronym":704,"eligibilityCriteria":705,"healthyVolunteers":12,"sex":315,"minAge":706,"maxAge":707,"enrollmentInfo":708,"targetDuration":4,"studyType":24,"phases":710,"briefSummary":711,"conditions":712,"keywords":727,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":742,"startDateStruct":743,"completionDateStruct":744,"leadSponsor":746,"locationsCount":224},"100638788","phase-3-a-phase-3-study-to-evaluate-the-safety-and-efficacy-of-aoc-1044-also-referred-to-as-delpacibart-zotadirsen-in-participants-with-dmd-with-gene-mutations-amenable-to-exon-44-skipping-100638788","NCT07587242","A Phase 3 Study to Evaluate the Safety and Efficacy of AOC 1044 (Also Referred to as Delpacibart Zotadirsen) in Participants With DMD With Gene Mutations Amenable to Exon 44 Skipping","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (Delpacibart Zotadirsen) for the Treatment of DMD With Gene Mutations Amenable to Exon 44 Skipping","SAFARI44","Key Inclusion Criteria:\n\n* Ambulatory males with clinical and genetic diagnosis of DMD\n* Acceptable genetic test confirming dystrophin gene mutation amenable to exon 44 skipping\n* 7 to 16 years of age at time of consent\n* TTR and NSAA assessment completed within the protocol specified parameters at Screening\n* On a stable regimen of corticosteroids (including Vamolorone) for at least 6 months prior to Day 1. Steroid regimen must be anticipated to remain stable.\n\nKey Exclusion Criteria:\n\n* Previous treatment cell or gene therapy.\n* Treatment with another oligonucleotide within 6 months of informed consent (not including COVID-19 RNA vaccines).\n* Lab values outside of the protocol specified range at Screening\n* If on any of the following treatments (growth hormone, testosterone or givinostat), participants must be on a stable regimen and must plan to maintain it for the duration of the study. Participants will be excluded if regimen stability prior to informed consent is as follows:\n* Less than 1 month, for growth hormone and\u002For testosterone\n* Less than 6 months for givinostat","7 Years","16 Years",{"count":709,"type":23},70,[65],"A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Intravenous AOC 1044 for the treatment of Duchenne Muscular Dystrophy (DMD) with Gene Mutations Amenable to Exon 44 Skipping",[713,714,715,716,717,718,719,720,721,722,723,724,725,726],"Muscular Dystrophies","Muscular Dystrophies (Duchenne, Becker, Myotonic Dystrophy)","Muscular Disorders, Atrophic","Muscular Disease","Musculoskeletal Diseases","Neuromuscular Diseases (NMD)","Nervous System Diseases","Genetic Diseases","X-Linked","Hereditary","Neonatal Disease","Duchene Muscular Dystrophy","Congenital","DMD",[728,729,730,731,732,733,734,735,704,736,737,738,739,740,741,726],"AOC","AOC 1044","AOC 1044-CS3","AOC 1044-CS1","AOC 1044-CS2","EXPLORE44","EXPLORE44-OLE","SAFARI","SAFARI 44","Avidity","Avidity Biosciences","Exon Skipping Therapy","Avidity Biosciences Inc., A Novartis Company","del-zota",{"date":41,"type":44},{"date":302,"type":23},{"date":745,"type":23},"2030-07",{"name":747,"class":51},"Avidity Biosciences, Inc.",""]