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PLoS ONE ◽  
2021 ◽  
Vol 16 (3) ◽  
pp. e0248423
Author(s):  
Jennifer E. Balkus ◽  
Moni Neradilek ◽  
Lee Fairlie ◽  
Bonus Makanani ◽  
Nyaradzo Mgodi ◽  
...  

A systematic chart review was performed to estimate the frequency of pregnancy outcomes, pregnancy complications and neonatal outcomes at facilities in Blantyre, Malawi; Johannesburg, South Africa; Kampala, Uganda; and Chitungwiza and Harare, Zimbabwe to provide comparisons with estimates from an ongoing clinical trial evaluating the safety of two biomedical HIV prevention interventions in pregnancy. A multi-site, cross-sectional chart review was conducted at Maternal Obstetric Units and hospitals where women participating in the ongoing clinical trial would be expected to deliver. All individuals delivering at the designated facilities or admitted for postpartum care within seven days of a delivery elsewhere (home, health clinic, etc.) were included in the review. Data were abstracted for pregnancy outcomes, pregnancy complications, maternal and neonatal death, and congenital anomalies. Data from 10,138 records were abstracted across all four sites (Blantyre n = 2,384; Johannesburg n = 1,888; Kampala n = 3,708; Chitungwiza and Harare n = 2,158), which included 10,426 pregnancy outcomes. The prevalence of preterm birth was 13% (range across sites: 10.4–20.7) and 4.1% of deliveries resulted in stillbirth (range: 3.1–5.5). The most commonly noted pregnancy complication was gestational hypertension, reported among 4.4% of pregnancies. Among pregnancies resulting in a live birth, 15.5% were low birthweight (range: 13.8–17.4) and 2.0% resulted in neonatal death (range:1.2–3.2). Suspected congenital anomalies were noted in 1.2% of pregnancies. This study provides systematically collected data on background rates of pregnancy outcomes, pregnancy complications and neonatal outcomes that can be used as a reference in support of ongoing HIV prevention studies. In addition, estimates from this study provide important background data for future studies of investigational products evaluated in pregnancy in these urban settings.


2021 ◽  
Author(s):  
Gianfranco Lapietra ◽  
Francesca Fazio ◽  
Maria Teresa Petrucci

CD38 is a transmembrane glycoprotein expressed on the surface of different cell lines with several functions (receptor, adhesion molecule, ectoenzyme). Based on its high expression in multiple myeloma cells, CD38 is one of the main molecules used in the target therapy age. Daratumumab is the first fully human monoclonal antibody tested in clinical trials, showing efficacy in relapsed/refractory multiple myeloma patients, especially in combination with immunomodulants and/or proteasome inhibitors. The synergic effect concerns multiple myeloma cells as well as the microenvironment (NK cells, macrophage, regulatory B/T cells and CD8+ effector cells). Therefore, the anti-multiple myeloma activity of Daratumumab greatly depends on the immune system: this is the reason why several ongoing clinical trial are testing its efficacy in the naïve patients, with a more effective immune system.


2021 ◽  
Vol 7 ◽  
pp. 233372142110460
Author(s):  
Tracey L. Yap ◽  
Jenny Alderden ◽  
Susan M. Kennerly ◽  
Susan D. Horn ◽  
Meredeth Rowe ◽  
...  

Background: Nursing home (NH) residents are at high-risk for pressure injuries (PrIs), and those living with Alzheimer's Disease and Related Dementias (ADRD) are at even greater risk. Understanding how nursing staff approach repositioning remains critical. Methods: As part of an ongoing clinical trial, this mixed-method prospective, exploratory, descriptive study examined repositioning efforts for PrI prevention. An investigator-developed checklist guided researcher observations, and focus groups revealed staff perspective on resident behaviors and corresponding repositioning approaches. Focus group transcripts were analyzed using the constant comparative coding method. Results: Repositioning observations were conducted for 88 residents. Resident behaviors and nursing approaches were similar between the ADRD ( n = 62, 70%) and non-ADRD ( n = 26, 30%) groups. Thirty-six staff participated in one of six focus group sessions. A conceptual model was developed to depict the repositioning process. Staff revealed care is guided by clinical frameworks and guidelines, along with resident preferences and behaviors. Conclusions: Protocol-driven, standardized PrI prevention care may limit the capacity to honor repositioning preferences. Insights from the focus groups highlight the importance of being cognizant of competing factors that may interfere with successful repositioning. Approaches by staff may be protocol-driven or an integrated method of care.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Maxine Bennett ◽  
Adrian P. Mander

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