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NCT ID: NCT05789615 Recruiting - Clinical trials for Hematopoietic Stem Cell Transplantation

Letermovir Prophylaxis for CMV Infection in Haplo-HSCT Recipients: Single-center Data in China

Start date: April 15, 2023
Phase:
Study type: Observational

In the 30 years fighting against CMV infection, the mortality rate of HSCT patients was significantly reduced. Now we should turn to how to better improve the prognosis of HSCT patients and prevent CMV infection. The emergence of letermovir gave this vision a shot in the arm11-13. Letermovir is the only drug with an indication approved for the prevention of CMV infection in HSCT patients, with a novel mechanism of action characterized by inhibition of the CMV DNA terminase complex. The efficacy and safety of letermovir were well demonstrated in key phase III studies, where letermovir prophylaxis significantly reduced CMV infection and all-cause mortality after HSCT without increased myelosuppression and increased nephrotoxicity (vs. placebo)13. A real-world study of letermovir prophylaxis showed a significant reduction in CMV infection rates (47.0% vs 10.7%), and a significant reduction in antiviral use after 180 days. After more than100 days of continuous use, in addition to a significant reduction in clinically significant CMV infections and patients' overall survival increased, significant efficacy was consistently maintained in patients with grade 2 or greater GVHD14-17. A systematic review and meta-analysis of real-world studies on primary prevention in letermovir was showed in EBMT 2022. A total of 48 real-world observational studies were included, and the results showed that the use of CMV primary prevention was effective in reducing the overall risk of CMV performance (including CMV reactivation, cs-CMV infection and CMV disease), all-cause mortality and non-relapse mortality at day 200 in adult HSCT recipients. At 100 days follow-up, CMV reactivation decreased by 87%, meanwhile clinically significant CMV infection by 91%, CMV disease decreased by 69%, CMV-related hospitalization decreased by 94%, and GVHD decreased by 48%18. Letermovir has achieved excellent therapeutic benefits globally but is still in its infancy in China. Letermovir obtained an implied license for a clinical trial in June 2020, and in November 2020, Letermovir submitted and accepted four new drug marketing applications in China, including injection and tablet formulations. On December 31, 2021, the China National Medical Products Administration (NMPA) approved letermovir for cytomegalovirus (CMV) seropositive adult recipients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) [R+] prevention of cytomegalovirus infection and cytomegalovirus disease. The commercial launch of letermovir is estimated to be in August 2022. Since the seropositive rate of CMV in the Chinese population is over 90%, it is not enough to judge whether CMV prevention is necessary depending on serology. In the past few years, with the increased number of only children in China, haploidentical stem cell transplantation (haplo-SCT) has been showing a steady expanding trend in China. Most hospitals' pretreatment methods use the Beijing protocol (including ATG) rather than post-transplant cyclophosphamide method to prevent GVHD, which also greatly increases the risk of CMV. To our knowledge, there is little published data focused on the efficacy of CMV prophylaxis for patients undergoing the haplo-SCT in China. A "real-life" evaluation of the new drug in terms of efficacy, emergence of resistance, tolerance related to CMV infection, is useful to propose recommendations on management strategies. Therefore, we would like to conduct a prospective observation study of CMV surveillance in haplo-SCT patients receiving letermovir prophylaxis in China, to evaluate the potential real-life effect of letermovir on efficacy, drug resistance emergence, tolerability, and CMV infection-related morbidity and mortality. This work contributes to recommendations regarding CMV management strategies, especially for patients at highest risk, i.e., CMV R+ haploidentical transplant recipients.

NCT ID: NCT05792462 Recruiting - Clinical trials for NMO Spectrum Disorder

Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders

Start date: April 15, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1/JAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clincial trials may be needed to observe its efficacy and safety.

NCT ID: NCT05799430 Recruiting - Polypharmacy Clinical Trials

Medication Review in Chronic Complex or Polymedicated Patients After Hospital Discharge.

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The goal of this prospective multicentre clustered randomized controlled trial is to evaluate the effect on new hospitalization episodes of a multidisciplinary medication review in primary care patients with polypharmacy or chronic complex conditions after hospital discharge. The multidisciplinary team will be integrated by a family physician (FP), a primary care nurse (PCN) and a primary care pharmacist (PCP). Patient will be adults aged 65 years and older. Polypharmacy refers to the use of 10 or more drugs based on information in electronic prescription software. Research questions are: In elderly patients with polypharmacy, which is the effect of an interdisciplinary medication review after hospital discharge in comparison with standard care, in terms of: - new hospitalization episodes? - number of drugs prescribed? - prescribed drugs adequacy?

NCT ID: NCT05805176 Recruiting - ADHD Clinical Trials

An Adjunct Study to Assess Guided ADHD Therapy for Managing the Extent and Severity of Symptoms

A-GAMES
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The objective of this study is to assess the safety and effectiveness of an at-home, game-based digital therapy for treating adult patients with Attention-Deficit/Hyperactivity Disorder (ADHD).

NCT ID: NCT05805306 Recruiting - HIV Infections Clinical Trials

Entre Herman@s: Promoting Health Among Latino MSM

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

This is a randomized controlled trial with an attention placebo control group. The goal of this study is to decrease HIV incidence in Latino men who have sex with men by engaging their siblings in PrEP-use promotion. In the intervention arm, siblings will be trained to engage their gay brother in PrEP conversations. In the control arm, siblings will be trained to engage their gay brother in conversations about vaccines to prevent COVID, Hepatitis A/B, or MPOX.

NCT ID: NCT05808439 Recruiting - Clinical trials for On Abdominal Aortic Aneurysms

Endovascular Repair of AAA

Start date: April 15, 2023
Phase:
Study type: Observational

We study differen t endovascular techniques as an alternative to surgical reconstruction to repair AAAS regarding ; success rates, 30-day mortality, endoleak events secondary intervention rates

NCT ID: NCT05819450 Recruiting - Ultrasound Clinical Trials

Sonography-Guided Volumetric Rejuvenation on Dorsal Hands

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled study is to guide volumetric rejuvenation on dorsal hands with the maximal aesthetic appearance. The main questions it aims to answer are: - Which fatty layer(s) is/are the most suitable for filler injection? - Is it feasible to make precise filler injections with sonography guidance? Participants will receive sonography-guided injection on the one hand and another with blinded injection.

NCT ID: NCT05822310 Recruiting - Chronic Hip Pain Clinical Trials

Comparison of Femoral and Obturatory Nerve Joint Branches Conventional Radiofrequency Thermocoagulation ,Intraarticular Steroid Injection and Pericapsular Nerve Group (PENG) Block in Chronic Hip Pain

Start date: April 15, 2023
Phase: N/A
Study type: Interventional

In this study ,the investigators aimed to show the decrease in pain levels and the effect on quality of life of patients who underwent chronic hip painRFT , intraartıcular steroid injection and Peng block.

NCT ID: NCT05827289 Recruiting - Melanoma Clinical Trials

'Cancer Patients Better Life Experience'

CAPABLE
Start date: April 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to compare health-related quality of life, specifically fatigue, in melanoma patients treated with immunotherapy who use or do not use a patient-centered mobile coaching and monitoring system (CAPABLE). It is expected that by using the CAPABLE eHealth tool, patients' fatigue worsens less significantly (10 points) in the first 3 months follow-up than observed in usual care.

NCT ID: NCT05832723 Recruiting - Myopia Clinical Trials

A Real-world Study of 650nm Low-intensity Single-wavelength Red Light for Children and Adolescents

Start date: April 15, 2023
Phase:
Study type: Observational

To evaluate the efficacy and safety of 650nm low-level red-light irradiation for myopia control and prevention in children under less restrictive conditions than randomized controlled trials. Participants included children(aged 7 to 18 years, spherical equivalent error of 0.5D or below) who are already myopic at recruitment, and those who are of Emmetropia or low hyperopia.