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NCT ID: NCT05317416 Recruiting - Multiple Myeloma Clinical Trials

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

MagnetisMM-7
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

NCT ID: NCT05316740 Recruiting - Clinical trials for Bone Marrow Transplant Complications

Vaginal Microbiome and the Development of Vulvovaginal Graft Versus Host Disease

Start date: February 15, 2022
Phase:
Study type: Observational

Allogeneic stem cell transplantation (also termed "bone marrow transplantation") involves transferring stem cells from a healthy person (the donor) to the patient, after high-intensity chemotherapy or radiation, given to destroy any remaining cancer cells in the body. When a transplant is successful, the donor stem cells replace the original cells in the bone marrow. It may provide the only long-term cure of the patient's disease. Of transplant-related complications, graft-versus-host disease (GVHD) is one of the most important complications. GVHD arises from donor immune cells, that identify the recipient's (the patien's) cells as foreign and attack them. Approximately half of women undergoing transplantation will experience GVHD involving the genitalia (i.e., the vulva and vagina), termed vulvovaginal GVHD (VV-GVHD). VV-GVHD may cause irreversible anatomical changes, including complete vaginal obliteration, and not surprisingly, it has a severe impact on patients' quality of life and sexual function. This complication is unpredictable and non-preventable by the usual immunosuppressive treatment given to patients. Frequent gynecological examinations and prolonged follow-up of transplanted women are needed, to allow early diagnosis and prevention of harmful results of VV-GVHD. This follow-up adds inconvenience and anxiety to the patients. The suggested study aims to evaluate a possible association between vaginal microorganisms (the "microbiome") to the progress of VV-GVHD. Finding such association may allow prediction of VV-GVHD progress, a better understanding of the development of VV-GVHD and a potential to develop interventions for the treatment and prevention of VV-GVHD.

NCT ID: NCT05311761 Recruiting - Delirium Clinical Trials

CogMe for the Prevention and Early Detection of Delirium

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

This study is designed as a prospective interventional study to evaluate the CogMe system for early detection and prevention of delirium. The study will collect physiological and cognitive measurements to evaluate the ability of the CogMe system to predict and detect delirium and to aid the development of future delirium prevention methods.

NCT ID: NCT05311163 Recruiting - Clinical trials for Mitral Regurgitation

Change in LVEF Following Transcatheter Mitral Edge-To-Edge Repair

MITRA-EF
Start date: August 1, 2021
Phase:
Study type: Observational [Patient Registry]

Little is known regarding the impact of transcatheter mitral valve edge-to-edge repair (TEER) on the acute changes in left ventricular ejection fraction (LVEF) and the effect of an acute reduction in LVEF, the so-called "afterload mismatch" (AM), on prognosis. We thereby aim to assess changes in LVEF after TEER, identify rate and predictors AM, and estimate its impact on prognosis.

NCT ID: NCT05308680 Completed - COVID-19 Clinical Trials

Myocardial Injury After BNT162b2 mRNA COVID-19 Fourth Dose Vaccination Among Israeli Health Care Workers

Start date: January 6, 2022
Phase:
Study type: Observational

The aim of the study is to prospectively evaluate the incidence of myocardial injury after the administration of the fourth dose BNT162b2 mRNA vaccine (Pfizer-BioNTech) against COVID-19.

NCT ID: NCT05308654 Recruiting - Clinical trials for Relapsed/Refractory Multiple Myeloma

A Study to Assess the Adverse Events and Change in Disease Activity in Adult Participants With Relapsed or Refractory Multiple Myeloma Receiving Oral ABBV-453 Tablets

Start date: May 17, 2022
Phase: Phase 1
Study type: Interventional

Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. The purpose of this study is to assess the safety and toxicity of ABBV-453 in adult participants with relapsed/refractory (R/R) MM. Adverse events and change in disease activity will be assessed. ABBV-453 is an investigational drug being developed for the treatment of R/R MM. Part 1 will be a monotherapy dose escalation phase to determine the best dose of ABBV-453. In Part 2, participants are placed in 1 of 3 groups called treatment arms. Each group receives a different treatment. Approximately 28 to 48 adult participants in Part 1 and 150 to 312 adult participants in Part 2 with R/R MM will be enrolled in the study in approximately 70 sites worldwide. In Part 1 and the Japan Cohort, Participants will receive oral ABBV-453 tablets once daily (QD) in 28-day cycles. In Part 2, Arm 1, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with oral dexamethasone tablets once weekly in 28-day cycles. In Part 2, Arm 2, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks and oral dexamethasone tablets once weekly in, 28-day cycles. In Part 2, Arm 3, participants will receive continuous doses of oral ABBV-453 tablets QD in combination with subcutaneous injections of daratumumab every 1 to 4 weeks, oral lenalidomide capsules QD on Days 1-21, and oral dexamethasone tablets once weekly, in 28-day cycles. There 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, and side effects.

NCT ID: NCT05308186 Completed - Clinical trials for Disorder of Consciousness

Effectiveness of Sensory Stimulation on Attenuating Pain and Stress Among Patients With Disorders of Consciousness

Start date: April 10, 2022
Phase: N/A
Study type: Interventional

The aim of the presented study is to examine the effectiveness of sensory stimulation in reducing pain and stress of patients diagnosed with Disorder of consciousness.

NCT ID: NCT05306418 Recruiting - Clinical trials for Haemophilia A With or Without Inhibitors

A Research Study Looking at Mim8 in Children With Haemophilia A With or Without Inhibitors

Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

This study is looking at how Mim8 works compared to other medicines in children with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeds. Mim8 will be injected with a thin needle into the skin. The study will last for about 54-98 weeks, from screening to follow-up visit, In case the participant experiences bleeds, these can be treated with additional haemostatic medicine as agreed with the study doctor.

NCT ID: NCT05306197 Enrolling by invitation - Clinical trials for Military Combat Performance

Improving Performance of Combat Soldiers by Utilizing Attentional Training Based on Eye Tracking

Start date: March 14, 2022
Phase: N/A
Study type: Interventional

Military service in combat units entails exposure to traumatic events that require mental adjustment. To develop and efficiently apply attentional interventions aimed at enhancing soldiers' combat performance, it is essential to extensively investigate the efficiency of these training programs, which has yet to been done. The prupose of the current study is to examine the efficiency of the new attention eye-tracking based training, in comparison to RT-based training and to a control group, in improving performance of combat soldiers. In addition, the influence of the attention training on aspects of psychological resilience will also be examined in questionnaires.

NCT ID: NCT05305079 Recruiting - Clinical trials for Non-arteritic Ischemic Optic Neuropathy

NA-AION Risk Factors: New Perspectives

NARROW
Start date: August 1, 2021
Phase:
Study type: Observational

The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.