The 96% pregnancy rate among our cohort of NCAH females was similar to the 95% rate reported for the normal population. Glucocorticoid therapy may shorten the time to conceive in a subgroup of women with NCAH. Glucocorticoid therapy did not affect the rate of first trimester miscarriage. Our 77% live birth rate was similar to the 72% live birth rate in the current healthy US population.
We sought to assess the frequency and predictors of early and late posttransplantation anemia (PTA). In addition, we aimed to assess the outcomes of patients with anemia and to assess the impact of anemia on mortality, graft function, and graft failure.Patients who underwent kidney transplantation in a single center during a 4-year period were included. Predictors associated with the development of anemia at 6 months (early PTA) or 2 years (late PTA) were evaluated in a univariate and multivariate analyses. The effects of anemia and other variables on mortality and graft function were assessed.A total of 266 kidney transplant recipients were included. The prevalence of PTA at 6 months (early PTA) was 51.3% and at 2 years (late PTA) was 36.6%. Female sex was significantly associated with early PTA. Patients with early PTA proceeded to late PTA. Patients with both early and late PTA had a higher mortality rate at 4 years compared to patients without anemia. On multivariable analysis, lower Hb at 2 years posttransplantation (hazard ratio [HR] 0.716, 95% confidence intervals [CI] 0.541–0.948, for every increment of 1 g/dL) was significantly associated with mortality. Patients with late PTA suffered a decline in eGFR compared to patients without anemia (P = .026). Furthermore, a lower Hb at 2 years posttransplantation was also associated with graft failure (HR 0.775, 95% CI 0.619–0.969, for every increment of 1 g/dL).Post-transplantation anemia is significantly associated with late mortality, with a decline in graft function and with an increased incidence of graft failure.
ObjectiveTo assess the effect of linagliptin vs. standard therapy in improving clinical outcomes in patients hospitalized with diabetes and coronavirus disease 2019 (COVID-19).Materials and MethodsWe did an open-label, prospective, multicenter, randomized clinical trial in 3 Israeli hospitals between October 1, 2020, and April 4, 2021. Eligible patients were adults with type 2 diabetes mellitus and a diagnosis of COVID-19. A total of 64 patients, 32 in each group, were randomized to receive linagliptin 5 mg PO daily throughout the hospitalization or standard of care therapy. The primary outcome was time to clinical improvement within 28 days after randomization, defined as a 2-point reduction on an ordinal scale ranging from 0 (discharged without disease) to 8 (death).ResultsThe mean age was 67 ± 14 years, and most patients were male (59.4%). Median time to clinical improvement was 7 days (interquartile range (IQR) 3.5-15) in the linagliptin group compared with 8 days (IQR 3.5–28) in the standard of care group (hazard ratio, 1.22; 95% CI, 0.70–2.15; p = 0.49). In-hospital mortality was 5 (15.6%) and 8 (25.0%) in the linagliptin and standard of care groups, respectively (odds ratio, 0.56; 95% CI, 0.16–1.93). The trial was prematurely terminated due to the control of the COVID-19 outbreak in Israel.ConclusionsIn this randomized clinical trial of hospitalized adult patients with diabetes and COVID-19 who received linagliptin, there was no difference in the time to clinical improvement compared with the standard of care.Clinical Trial RegistrationClinicalTrials.gov, identifier NCT04371978.
Background Although regulatory changes towards correcting the underrepresentation of women in randomized controlled trials (RCTs) occurred (National Institutes of Health 1994), concerns exist about whether an improvement is taking place. In this systematic review and meta-analysis, we aimed to assess the inclusion rates of women in recent RCTs and to explore the potential barriers for the enrollment of women. Methods RCTs published in 2017 examining any type of intervention in adults were searched in PubMed and Cochrane Library. The following predefined medical fields were included: cardiovascular diseases, neoplasms, endocrine system diseases, respiratory tract diseases, bacterial and fungal infections, viral diseases, digestive system diseases, and immune system diseases. Studies were screened independently by two reviewers, and an equal number of studies was randomly selected per calendric month. The primary outcome was the enrollment rate of women, calculated as the number of randomized women patients divided by the total number of randomized patients. Rates were weighted by their inverse variance; statistical significance was tested using general linear models (GLM). Results Out of 398 RCTs assessed for eligibility, 300 RCTs were included. The enrollment rate of women in all the examined fields was lower than 50%, except for immune system diseases [median enrollment rate of 68% (IQR 46 to 81)]. The overall median enrollment rate of women was 41% (IQR 27 to 54). The median enrollment rate of women decreased with older age of the trials’ participants [mean age of trials’ participants ≤ 45 years: 47% (IQR 30–64), 46–55 years: 46% (IQR 33–58), 56–62 years: 38% (IQR 27–50), ≥ 63 years: 33% (IQR 20–46), p < 0.001]. Methodological quality characteristics showed no significant association with the enrollment rates of women. Out of the 300 included RCTs, eleven did not report on the number of included women. There was no significant difference between these studies and the studies included in the analysis. Conclusions Women are being inadequately represented, in the selected medical fields analyzed in our study, in recent RCTs. Older age is a potential barrier for the enrollment of women in clinical trials. Low inclusion rates of elderly women might create a lack of crucial knowledge in the adverse effects and the benefit/risk profile of any given treatment. Factors that might hinder the participation of women should be sought and addressed in the design of the study.
There is a limited literature discussing the long-term outcome of patients admitted to the emergency department with elevated blood pressure. The aim of the present study was to evaluate outcomes of patients with hypertension who attended an emergency department. All patients with hypertension who attended an emergency department without target organ damage were evaluated. A composite end point at 18months, which included all-cause mortality, acute coronary syndrome, cerebrovascular accident, or hospitalization for heart failure, were compared between patients with hypertension and those with normotension. Overall, 410 patients were included in the study. Baseline characteristics were similar between patients with hypertension and those with normotension, except chronic renal failure being more prevalent in patients with hypertension. The composite primary end point occurred similarly in both groups; however, hospitalization for heart failure was significantly more common in patients with hypertension. Elevated blood pressure during an emergency department visit is associated with an increased risk for hospitalization for heart failure during an 18-month follow-up period compared with normotension. | INTRODUCTION
Objective The treatment strategy for nonfunctioning pituitary adenomas (NFPA) includes surgery, radiotherapy, medical treatment, or follow‐up. Prior series of patients with NFPAs followed without intervention include small numbers of patients with macroadenomas. This study investigated the natural history of patients with macroadenomas followed without treatment. Design and patients Retrospective cohort study included patients>18 years, with a diagnosis of NFPA ≥ 10 mm who were naïve to surgery or medical treatment and followed more than 12 months after diagnosis. Patients with chiasmal threat were excluded. Follow‐up terminated if the patient underwent surgery, received cabergoline or was lost to follow‐up. Measurements Data collected included evaluation of tumour characteristics and size by MRI, symptoms including visual disturbances, and hormonal levels. Tumour growth was defined as maximal diameter increase of ≥2 mm. Results The cohort included 49 patients (30 males, mean age 68.0 ± 12.0 years). At diagnosis, the average tumour size was 17.8 ± 5.9 mm. Mean follow‐up time was 4.9 ± 4.9 years. Increase in tumour size occurred in 16 patients (33%), with an average growth of 5.1 ± 4.4 mm. Reduction in tumour size occurred in 10 patients (20%), with a mean decrease of 3.5 ± 1.3 mm. Twenty‐three patients remained with stable tumours. Overall, 33 patients (67%) were observed without any intervention; 3 patients were operated and 13 were treated with cabergoline. None of the parameters including age, gender, baseline tumour size, invasiveness, visual disturbances, or hypopituitarism at diagnosis, predicted tumour growth. Conclusion Observation of NFPAs without surgery or medical therapy is a reasonable approach in selected patients. In our study, no parameter predicted tumour growth.
Introduction: Randomized controlled trials that compared direct oral anticoagulants (DOACs) to vitamin K antagonists (VKA) for the treatment of venous thromboembolism (VTE), demonstrated both efficacy and safety of DOACs. The aim of the current study was to compare DOACs to VKA for the treatment of VTE in the elderly, in a real-life setting. Methods: A retrospective cohort study was performed in Rabin Medical Center encompassing a 7-year period. Hospitalized patients >65 years, with a diagnosis of VTE discharged with DOACs or VKA were included. The primary outcome was a composite of all-cause mortality, major bleeding, recurrent VTEs and hospitalizations throughout the follow-up period of one year. Results: A total of 603 patients were included in the final analysis. The mean age was 79.6 ± 8.5 years. The primary composite outcome occurred in 74.6% and 56.7% of the patients in the VKA group and DOACs group, respectively, hazard ratio 0.59, 95% confidence interval 0.46 to 0.76, in favor of the DOACs group. In a matched cohort analysis, the results were the same as the original analysis. Conclusion: In the elderly population, treatment of VTE with DOACs was associated with a lower rate of the composite outcome. DOACs are safe and effective for elderly patients with VTE.
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