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NCT ID: NCT05557019 Recruiting - Clinical trials for STEMI - ST Elevation Myocardial Infarction

Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study

Start date: September 2022
Phase: N/A
Study type: Interventional

The present study is planned to evaluate the safety and feasibility of the Booster Balloon catheter when applied to STEMI patients. The Booster Balloon is a spiral balloon intended to be positioned in the coronary sinus, enabling continuous venous draining while reducing flow and increasing the pressure inside the venous capillaries, and redistributing blood and oxygen to the border zone of the ischemic myocardium. This pilot, first-in-human study is designed to evaluate (in addition to safety and feasibility) the treatment modality in the setting of acute STEMI, as adjunctive therapy after restoring blood blow through the infract-related artery.

NCT ID: NCT05556096 Recruiting - Clinical trials for Generalized Myasthenia Gravis

Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).

NCT ID: NCT05554445 Recruiting - Crohn Disease Clinical Trials

Observational Investigation of the CDED in a Real World IBD Clinic

Start date: February 21, 2022
Phase:
Study type: Observational

A prospective observational study, which will follow a cohort of adult CD patients who are prescribed the Crohn disease exclusion diet (CDED) during their routine clinical dietary therapy. The diet is composed of three phases, at the end of the first two phases we will evaluate whether the patient achieved remission and at the end of phase three the maintenance of remission. We intend to study achievement and remission rate in association to the diet adaptations made by dieticians at phase 1 and 2, together with patient's choice off food at the third phase under real world clinical setting and patient lifestyle characteristics.

NCT ID: NCT05552976 Recruiting - Clinical trials for Relapsed or Refractory Multiple Myeloma

A Study to Evaluate Mezigdomide in Combination With Carfilzomib and Dexamethasone (MeziKD) Versus Carfilzomib and Dexamethasone (Kd) in Participants With Relapsed or Refractory Multiple Myeloma (SUCCESSOR-2)

SUCCESSOR-2
Start date: January 10, 2023
Phase: Phase 3
Study type: Interventional

The purpose of the study is to compare Mezigdomide (CC-92480/BMS-986348) with carfilzomib and dexamethasone (MeziKD) against carfilzomib and dexamethasone (Kd) in the treatment of RRMM: SUCCESSOR-2.

NCT ID: NCT05552768 Recruiting - Clinical trials for Dental Implant Placement

Supracrestal Tissue Attachment Dimensions & Peri-implant Health

Start date: June 20, 2022
Phase: N/A
Study type: Interventional

Decision making in regards to the 3D implant positioning in partially edentulous sites is a complex process particularly when there are adjacent teeth present. Presently, the prevailing paradigm of implant placement guidelines is bone-driven. It calls to seat the implant neck in a crestal position. Clinical studies have demonstrated that implants placed in sites with thin soft tissues are suffering more crestal bone loss than sites with thick gingiva. Consequently, it has been proposed either to place these implants in a subcrestal position or to thicken locally the soft tissues. A recommendation of how much subcrestally the implants should be inserted in these sites is still lacking but clinicians empirically implement a deeper insertion of 1.5-2 mm under the crest. There is some indication that subcrestal placement may lead to bone remodeling above the implant neck and limited bone loss beyond the neck, but clinical trials of bone level implants have not been performed to answer this definitively. Evolving data on the dimensions of the supracrestal tissue attachment zone (aka biological width, BW) around implants suggest that a distance of 4 mm is reserved to accommodate for junctional epithelial and connective tissue attachment zones as well as a healthy peri-implant sulcus. The objective of this study will be to determine if implants placed according to the soft tissue-driving implant placement paradigm, i.e. 4 mm below the tissue margin and associated with a deeper mucosal tunnel will have less bone loss but a more compromised peri-implant health as compared to implants placed at the bone crest level following the bone-driven implant placement paradigm with more bone loss but a shallower mucosal tunnel.It is hypothesized that using the CONNECT as a dedicated immediate tissue-level abutment system which enables avoiding alteration of the peri-implant gingival seal, both groups, the one with a deeper mucosal tunnel and the one with a shallower one, will perform identical in terms of peri-implant health and tissue maintenance outcomes. This would then justify the safe placement of implants in a biologically appropriate manner using biological width-driven placement guidelines. To test this hypothesis, two groups of 30 patients each will be treated according to either the bone-driven or the soft tissue-driven concepts: Control group following the bone level-driven placement guidelines (BL Group): Implants will be placed at the bone level, they will receive a 1.5-2 mm long CONNECT abutment. Test group following the biological width-driven placement guidelines (BW Group): Implants will be placed 4 mm below the mucosal margin using a 3 mm long CONNECT abutment: this means that the implant will be placed sub-crestally in agreement with the corresponding guideline, i.e. at deepest 1 mm subcrestally.

NCT ID: NCT05552222 Recruiting - Multiple Myeloma Clinical Trials

A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma

MajesTEC-7
Start date: October 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).

NCT ID: NCT05551741 Recruiting - Alzheimer's Disease Clinical Trials

A First in Human Study of IBC-Ab002 in Persons With Early Alzheimer's Disease (AD)

Start date: February 23, 2023
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled first-in-human, Phase 1, safety, tolerability, pharmacokinetic (PK) and preliminary exploratory activity study of escalating multiple intravenous (IV) doses of IBC-Ab002 in persons with early Alzheimer's disease. The study will have both Single- and Multiple-Ascending Dose components.

NCT ID: NCT05549414 Recruiting - Brain Cancer Clinical Trials

Pivotal Study of Proton Radiotherapy Treatments Using Fixed Beam Chair-Based Delivery System

PPTS
Start date: March 30, 2023
Phase: N/A
Study type: Interventional

This study with Chair-Based, Gantry-less Proton System (CBGS) (aka P-CURE Proton Beam Therapy System or Fixed Beam Chair-based Delivery System) is composed of 3 arms, as following: ARM1: Patients with locally recurrent, previously irradiated thoracic cancer indicated for re- irradiation. ARM2: Patients with recurrent Head and Neck, Brain and Spinal Cord tumors, indicated for re- irradiation. ARM3: Patients with unresectable pancreatic cancer. The primary objectives of the study for all arms are: 1. to describe the efficacy (local control after 3 month) and acute toxicity for patients treated with a fully-integrated CBGS and (2) to compare treatment plans between the fully-integrated CBGS and Photon therapy defined for each patient, based upon OAR sparing for comparable target coverage.

NCT ID: NCT05542277 Recruiting - Bleeding Clinical Trials

A Pre-market, Multi-center, International, Double-blind, Randomized, Two-arms, Controlled, Prospective Clinical Investigation Assessing the Safety and Performance of a Medical Device (ClearPlasmaâ„¢) for the Treatment of Patients Undergoing Coronary Artery Bypass or Valve Replacement

Start date: November 8, 2022
Phase: N/A
Study type: Interventional

Bleeding is a significant complication in cardiac surgery, with 10-15% of open cardiac surgery patients experiencing major intra- or post-operative bleeding. To address this unmet need, PLAS-FREE LTD has developed ClearPlasmaâ„¢, a single-use, extracorporeal plasma filtration device which extracts plasminogen from plasma to reduce fibrinolysis. The resulting plasminogen-depleted plasma (PDP) is expected to reduce risk of fibrinolysis and bleeding in patients undergoing plasma transfusions.

NCT ID: NCT05537922 Recruiting - Clinical trials for Non Small Cell Lung Cancer

I3LUNG: Integrative Science, Intelligent Data Platform for Individualized LUNG Cancer Care With Immunotherapy

Start date: October 1, 2022
Phase:
Study type: Observational

I3LUNG is an international project aiming to develop a medical device to predict immunotherapy efficacy for NSCLC patients using the integration of multisource data (real word and multi-omics data). This objective will be reached through a retrospective - setting up a transnational platform of available data from 2000 patients - and a prospective - multi-omics prospective data collection in 200 NSCLS patients - study phase. The retrospective cohort will be used to perform a preliminary knowledge extraction phase and to build a retrospective predictive model for IO (R-Model), that will be used in the prospective study phase to create a first version of the PDSS tool, an AI-based tool to provide an easy and ready-to-use access to predictive models, increasing care appropriateness, reducing the negative impacts of prolonged and toxic treatments on wellbeing and healthcare costs. The prospective part of the project includes the collection and the analysis of multi-OMICs data from a multicentric prospective cohort of about 200 patients. This cohort will be used to validate the results obtained from the retrospective model through the creation of a new model (P-Model), which will be used to create the final PDSS tool.