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NCT ID: NCT05721989 Completed - Clinical trials for Healthy Participants

A Research Study Looking Into Blood Levels of Three Different Formulations of the Study Medicine Ziltivekimab

Start date: February 3, 2023
Phase: Phase 1
Study type: Interventional

A research study to investigate how quickly and to what extent different compositions of the study medicine ziltivekimab are absorbed, transported, and eliminated from the body. Ziltivekimab is not yet approved for market. The study medicine will be injected under the skin (this is called subcutaneous administration). Two different administration methods will be compared: a syringe and a pen-injector. A pen-injector is a device that is developed to make injections more easy and convenient. They are for example used by diabetes patients to inject insulin. It will also be investigated how safe ziltivekimab is and how well it is tolerated when it is used by healthy participants. Ziltivekimab has already been administered to patients with chronic kidney disease or rheumatoid arthritis. The current study will be the first study where ziltivekimab will be given to healthy participants.

NCT ID: NCT05721820 Completed - Aortic Stenosis Clinical Trials

Aortic Cross-clamp and Opening After Transcatheter Aortic Valve Implantation: a Real Issue?

Start date: October 5, 2019
Phase:
Study type: Observational

Since its first clinical introduction by Alan Cribier in 2002, transcatheter aortic valve implantation has become the treatment of choice for severe aortic stenosis in high-risk and elderly patients. In such a population, cardiac surgery after TAVI is seldom performed (<1%), and only in cases of life-threatening complications such as device embolization, heart rupture, aortic dissection, endocarditis, etc. - State-of-the-art Nowadays, patients submitted to TAVI are getting younger, with lower surgical risk and longer life-expectancy, and their number is continuously increasing . As a consequence, the number of patients treated with TAVI who will require subsequent cardiac surgery will also expand, both acutely (due to the above-mentioned complications) and during follow-up (due to late endocarditis, valve degeneration and other non-aortic indications). - Previous informations Despite cardiac surgery after TAVI has been already performed several times across the world without documented issues in regard to aortic cross-clamp and aortotomy, it has been long debated whether the presence of TAVI devices with a tall stent frame in the ascending aorta may theoretically jeopardize the ability of surgeons to clamp and open the aorta. No specific data is yet available in regard to the existence and the incidence of such issue. - Ethical issues Not present. Aim of the study The aim of this study was to assess the anatomical feasibility of surgical aortic cross-clamp and aortotomy after TAVI based on post-TAVI computed tomographies (CT). Study design This study enrolled patients who underwent TAVI in three high-volume centers (San Raffaele University Hospital in Milan - Italy, Rigshospitalet Univeristy Hospital in Copenhagen - Denmark, Semmelweiss University in Budapest - Hungary) between October 2008 and May 2017. 117 CT acquired after TAVI procedures that were cardiac-gated and included the aortic arch into the field of view were retrospectively reviewed. 11 patients of San Raffaele Hospital will be involved. Reasons for post-TAVI acquisition were: participation into a clinical study with a previous Ethical Committee approval (91.4% n = 107); residual aortic regurgitation assessment for Valve-in-Valve evaluation (6.0% n = 7); TAVI complication assessment (ventricular septum defect 1.7% n = 2, left ventricular outflow tract obstruction 0.9% n = 1). Median time of CT acquisition after TAVI was 451 [290-780] days. As per study design, only TAVI devices with a long stent were assessed: CoreValve (Medtronic Inc., MN, USA) n = 82 (size 26 n = 23; size 29 n = 48; size 31 n = 11); CoreValve Evolut R (Medtronic Inc., MN, USA) n = 19 (size 23 n = 1; size 26 n = 7; size 29 n = 10; size 34 n = 1); Portico (Abbott, IL; USA) n = 16 (size 25 n = 9; size 27 n = 4; size 29 n = 3). Acurate Neo device (Boston Scientific, MA, USA, former Symetis) presents three stabilization arches in the ascending aorta which differ this prosthesis from the circular tubular stent of other self-expandable valves. To limit the introduction of possible confounding factors in the analysis, the investigators decided on purpose not to include the Acurate in the present study. Indication for TAVI respects international guidelines (EACTS 2017 Guidelines for Treatment of Valvular Heart Disease). A transthoracic examination is performed before the procedure at hospital admission. The in-hospital pathway pf examination is equal to every other patient treated in the participating centers.

NCT ID: NCT05684718 Completed - Clinical trials for Bacterial Infections

To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100

Start date: February 1, 2023
Phase: Phase 1
Study type: Interventional

Phase I clinical study to evaluate the effect of multiple doses of itraconazole on the pharmacokinetics of BV100 in healthy volunteers.

NCT ID: NCT05678517 Completed - Clinical trials for Age-Related Macular Degeneration

Seven-year Outcomes Following Intensive Anti-VEGF Therapy in Wet AMD

Start date: January 1, 2010
Phase:
Study type: Observational

The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

NCT ID: NCT05667129 Completed - Healthy Clinical Trials

A Phase 1 Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of XEN-101

Start date: December 1, 2022
Phase: Phase 1
Study type: Interventional

The goal of this study is to assess the safety and tolerability of single and multiple ascending doses of XEN-101

NCT ID: NCT05640245 Completed - Clinical trials for Arthritis, Psoriatic

Evaluation of Sonelokimab for the Treatment of Patients With Active Psoriatic Arthritis

Start date: December 13, 2022
Phase: Phase 2
Study type: Interventional

This is a study to demonstrate the clinical efficacy and safety of the nanobody® sonelokimab administered subcutaneously (sc) compared with placebo in the treatment of adult participants with active psoriatic arthritis. The study includes adalimumab treatment as an active reference arm.

NCT ID: NCT05639868 Completed - Cardiac Arrest Clinical Trials

Effectiveness of Video-assisted Cardiopulmonary Resuscitation

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

Sudden cardiac arrest is a major public health problem worldwide and it is one of the leading causes of death in industrialized countries. Emergency Medical Services (EMS) dispatchers play an important role to recognize cardiac arrest and give help to the lay first responder via telephone CPR (T-CPR) which improves survival rates. The current technology allows the live video connection between the scene and the dispatcher which provides the opportunity for video-assisted CPR (V-CPR) via the bystander smartphone. Effectiveness of V-CPR has only been investigated to a limited extent. Comparing effectiveness of V-CPR (effectiveness of chest compression, time parameters eg. time to first chest compression) to T-CPR and non-instructed CPR can be useful to implement V-CPR technology.

NCT ID: NCT05626556 Completed - Frailty Clinical Trials

A Technology-based Intervention to Support Older Adults in Living Independently

SAVE
Start date: October 17, 2022
Phase: N/A
Study type: Interventional

The general objective of this study is to test the usability and efficiency of the SAVE prototype, a technology-based support for enabling older adults to keep their independent and active lives in their homes and maintain their social relationships for as long as possible.

NCT ID: NCT05612737 Completed - Bone Loss, Alveolar Clinical Trials

Evaluation of a Novel Horizontal Ridge Augmentation Technique in Dentistry

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

This case series aimed to assess the efficacy of a novel horizontal ridge augmentation modality using histomorphometry and Raman spectroscopy. Combinations of "sticky bone" and tenting screws without autologous bone were used as augmentative materials.

NCT ID: NCT05571254 Completed - Syncope Clinical Trials

The Management of Transient Loss of Consciousness and Suspected Syncope in European Emergency Departments

SEED
Start date: September 12, 2022
Phase:
Study type: Observational

Prospective multi centre cohort study examining the clinical presentation, diagnostic tests, and management of adult Emergency Department (ED) patients presenting with Transient Loss of Consciousness (TLOC) either undifferentiated or thought to be of syncopal origin.