[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Alfred\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":130},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,76,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100371255","phase-4-bazedoxifene--treatment-for-women-with-schizophrenia-100371255",false,"NCT04113993","Bazedoxifene -Treatment for Women With Schizophrenia","Bazedoxifene - A New Selective Estrogen Receptor Modulator Treatment for Women With Schizophrenia: a Double-blind, Randomized, Placebo Controlled Trial","Inclusion Criteria:\n\n* Physically well.\n* A current DSM-V diagnosis of schizophrenia or related disorder.\n* 18- 65 years\n* Able to give informed consent.\n* PANSS total score between 40 and 90.\n* Documented normal PAP smear and pelvic examination in the preceding two years.\n* Stable psychotropic medication for previous 4 weeks\n* Normal breast screen (for women aged over 40 years)\n* IQ \\> 70 (as determined by the WAIS IV subtests)\n* English language proficiency (in order to provide informed consent and complete cognitive test battery)\n\nExclusion Criteria:\n\n* Patients with known abnormalities in the hypothalamo-pituitary gonadal axis, thyroid dysfunction, central nervous system tumours, active or past history of a venous thromboembolic event.\n* Patients with a history of severe traumatic brain injury or significant neurological or unstable medical illness such as epilepsy and diabetes or known active cardiac, renal or liver disease; presence of illness causing immobilisation.\n* Patients whose psychotic illness is directly related to illicit substance use or who have a history of substance dependence during the last six months (with the exclusion of caffeine and\u002For nicotine dependence).\n* Women aged 40 or over who have not had a normal mammogram in the last 24 months\n* Use of any form of estrogen, progestin or androgen as hormonal therapy in preceding 4 weeks including the pill (excluding IUD or Hormone Implants).\n* Pregnant (HCG will be measured at screening)\n* Breastfeeding\n* Planned changes to psychotropic medication or psychotherapy regimen.","FEMALE","18 Years","65 Years",{"count":20,"type":21},160,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","To study the effect of adjunctive bazedoxifene - a selective estrogen receptor modulator (SERM) in a double blind, placebo-controlled adjunctive study in the treatment of women with schizophrenia. All patients receive standardized antipsychotic medication.",[27,28,29],"Schizophrenia","Schizophreniform Disorders","Schizo Affective Disorder","RECRUITING","2026-06-01",{"date":33,"type":34},"2026-06-03","ACTUAL",{"date":36,"type":34},"2019-10-07",{"date":38,"type":21},"2026-12-31",{"name":40,"class":41},"The Alfred","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100537977","secondary-access---femoral-or-radial-in-transcatheter-aortic-valve-implantation-100537977","NCT06284837","Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?","SAFER-TAVI","Inclusion Criteria:\n\n* Age \\>18 years\n* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve\n* Suitable radial and secondary femoral access\n\nExclusion Criteria:\n\n* Primary arterial access via surgical cut-down\n* Inadequate contralateral femoral artery access and\u002For bilateral radial artery access as determined by the interventional cardiologist\n* Previously failed attempt to access bilateral radial arteries.\n* Patient on hemodialysis","ALL",{"count":52,"type":21},542,[54],"NA","Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.",[57],"Valve Stenoses, Aortic",[59,60,61,62,63,64,65,66],"TAVI","TAVR","transcatheter aortic valve replacement","transcatheter aortic valve implantation","aortic stenosis","vascular access","primary access","secondary access","2026-05-12",{"date":69,"type":34},"2026-05-14",{"date":71,"type":34},"2023-12-04",{"date":73,"type":21},"2026-08",{"name":40,"class":41},3,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":75},"100626025","dilation-optimisation-for-uniform-bioprosthetic-leaflet-expansion-100626025","NCT07430267","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion","Dilation Optimisation for Uniform Bioprosthetic Leaflet Expansion: The ACE-DOUBLE Trial","ACE-DOUBLE","Inclusion Criteria:\n\n* Severe aortic stenosis undergoing trans-femoral TAVI using the SAPIEN 3 Ultra\u002FRESILIA balloon-expandable transcatheter heart valve.\n* Tricuspid or bicuspid aortic valve stenosis\n\nExclusion Criteria:\n\n* Valve-in-valve TAVI for failure of an existing prosthetic surgical or transcatheter valve failure\n* TAVI performed for native valve aortic regurgitation\n* High risk 'hostile' annular anatomy as adjudicated by multidisciplinary Heart Team based on pre-procedure CT anatomy.",{"count":85,"type":21},250,[54],"The goal of this clinical trial is to discover if routine 'double tap' balloon post-dilation improves valve expansion and clinical outcomes in adults undergoing Transcatheter Aortic Valve Implantation (TAVI) with the SAPIEN balloon-expandable TAVI prosthesis.\n\nThe primary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve expansion. The secondary hypothesis is that routine 'double tap' balloon post-dilation improves TAVI valve haemodynamic performance.\n\nParticipants will be randomised to balloon-expandable TAVI either with or without routine 'double tap' balloon post-dilation.",[89,90],"Aortic Stenosis","TAVI(Transcatheter Aortic Valve Implantation)",[59,60,92,93,94],"Double Tap","balloon post-dilation","Balloon-expandable TAVI","NOT_YET_RECRUITING","2026-02-18",{"date":98,"type":34},"2026-02-24",{"date":100,"type":21},"2026-04-01",{"date":102,"type":21},"2029-04-01",{"name":40,"class":41},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":50,"minAge":17,"maxAge":18,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":42},"100216660","phase-2-a-novel-drug-for-borderline-personality-disorder-100216660","NCT02097706","A Novel Drug for Borderline Personality Disorder","A Randomised Double-blind Placebo Controlled Investigation of the Efficacy of a Novel Drug as an Adjunct in Patients With Borderline Personality Disorder","Inclusion criteria\n\nParticipants will be eligible to proceed in the study if they meet all of the following criteria (as determined in the screening session):\n\n1. Men and women aged between 18-65 years of age\n2. A current diagnosis of BPD, or a score ≥ 8 on Diagnostic Interview for Borderline patients, or a score ≥ 15 on Zanarini Rating Scale for Borderline Personality Disorder\n3. Proficient in reading and writing English\n\nExclusion criteria\n\nPotential participants who meet the criteria for any of the following will be excluded from participating in the study:\n\n1. Clinical evidence of acute delirium or severe head injury\n2. Epilepsy or other current seizure disorder, history of seizures or convulsions (not including febrile convulsions), or presence of predisposing factors for epilepsy.\n3. Clinically significant hepatic or renal impairment, haematological, or cardiovascular disease.\n4. Concomitant use of NMDA antagonists (amantadine, ketamine, dextromethorphan), L-dopa, dopamine agonists or anticholinergics.\n5. Lifetime diagnosis of schizophrenia, schizoaffective disorder, substance-induced psychotic disorder or bipolar I disorder (DSM-V).\n6. Risk of suicide such that inpatient admission is required, as determined by PI (psychiatrist) on the basis of clinical assessment and baseline BPDSI-IV and\u002For ZAN-BPD suicide subscale scores.\n7. Taking more than 4 psychotropic medications.\n8. Planned changes to psychotropic medication or psychotherapy regime.\n9. Substance abuse or dependence requiring intervention or rehabilitation in last 3 months.\n10. Pregnant or breastfeeding; if of child-bearing age, not using appropriate contraceptive precaution.",{"count":112,"type":21},150,[114],"PHASE2","Borderline Personality Disorder (BPD) is one of the most prevalent psychiatric disorders with high morbidity and mortality. It affects the lives of millions worldwide and is often highly incapacitating, leading to significant psychosocial dysfunction. Moreover, nearly all patients have experienced suicidal ideation and about 10% actually commit suicide, a rate almost 50 times higher than in the general population. Mostly young women are at greater risk for the disorder and are three times more likely to be diagnosed with BPD than men.\n\nBPD aetiology is complex and could be explained by both biological and environmental factors. Among the environmental factors, sexual or physical abuse, parental divorce, loss or illnesses are identified as the most common ones. These factors can induce dysfunctional behaviours, which might cause emotional dysregulation, high impulsivity and frequent self- injurious behaviour.\n\nHowever, there are no pharmacologic interventions that are known to be specifically effective to treat BPD. Therapeutic options for this devastating disorder is still far from adequate for treating acute illness episodes, relapses, and recurrences and in restoring premorbid functioning. In addition, some patients are unable to tolerate existing therapies for BPD, which leads to either frequent changes in medications or to non-adherence. Therefore there is an urgent need for the development of more rapidly effective treatments for BPD.\n\nA growing body of evidence suggests that glutamatergic neurotransmission, in particular N-methyl-D-aspartate (NMDA) subtype may play a role in the pathophysiology of multiple psychiatric disorders. This has led to various clinical trials with glutamate modulating drugs. The trial drug is an uncompetitive NMDA receptor antagonist approved for Alzheimer's disease is increasingly being studied in a variety of non-dementia psychiatric disorders. Results from these studies have proved that the trial drug was safe and well tolerated and has the potential for use in the treatment of psychiatric disorders.\n\nTo date, there are no published data on the use of trial drug in the treatment for BPD. Therefore, the investigators intend to study the efficacy of this novel drug as an addition to ongoing therapy with atypical antipsychotics in patients with Borderline Personality Disorder. This study will recruit 150 BPD patients. The patients will be randomly allocated to receive either the study medication (20mg\u002F day) or placebo via oral administration for twelve weeks. To observe the efficacy of the trial treatment, all participants will be assessed at various time intervals for different borderline and cognitive symptoms.",[117],"Borderline Personality Disorder",[119,120,121],"Boderline Personality Disorder","Mental Illness","Cognition","2025-08-12",{"date":124,"type":34},"2025-08-15",{"date":126,"type":4},"2015-01",{"date":128,"type":21},"2025-12",{"name":40,"class":41},""]