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#35045580   2022/01/19 To Up

Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.

There is an imminent need for faster-acting and more effective antidepressants beyond the monoaminergic hypothesis.
Hitoshi Sakurai, Kengo Yonezawa, Hideaki Tani, Masaru Mimura, Michael Bauer, Hiroyuki Uchida

1280 related Products with: Novel Antidepressants in the Pipeline (Phase II and III): A Systematic Review of the US Clinical Trials Registry.

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#35045579   2022/01/19 To Up

Stroke and Thromboembolism in Patients with Heart Failure and Sinus Rhythm: A Matter of Risk Stratification?

Patients with heart failure (HF) in sinus rhythm (SR) experience an increased incidence of thromboembolic events including stroke. Among patients with HF, high-quality evidence supports the use of oral anticoagulation when atrial fibrillation (AF) is present, but the benefit of anticoagulation in SR in absence of other known indications for anticoagulation is unclear. In four randomized controlled trials (RCTs), warfarin did not improve a composite of clinical outcomes compared with aspirin or placebo in patients with HF with reduced ejection fraction (HFrEF) and SR. A recent RCT assessed the efficacy of the direct oral anticoagulant rivaroxaban versus placebo in patients with HFrEF (including mildly reduced ejection fraction), SR and coronary artery disease. While rivaroxaban had a neutral effect on the primary composite outcome of MI, stroke, or all-cause mortality, exploratory analyses revealed a significant reduction in strokes. It is thus possible that a subgroup of patients with HFrEF who are at high risk of stroke may benefit from anticoagulation. The challenge is to adequately identify this subgroup and to balance the potential benefit of anticoagulation with the risk of major bleeding. There is also an unmet need for evidence around anticoagulation in HF with preserved ejection fraction (HFpEF) and SR. This review explores the current evidence around anticoagulation in patients with HF and SR, identifies challenges regarding outcome definitions and patient selection, and offers suggestions for future research.
Angelica Rivas, Mandy N Lauw, Renate Bonin-Schnabel, Mark Crowther, Harriette Van Spall

2295 related Products with: Stroke and Thromboembolism in Patients with Heart Failure and Sinus Rhythm: A Matter of Risk Stratification?

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#35045574   2022/01/19 To Up

Safety-related outcomes of novel mRNA COVID-19 vaccines in pregnancy.

To describe the safety profile and demographic data for a cohort of pregnant individuals who received an mRNA COVID-19 vaccine.
Angela Nakahara, Joseph Biggio, Ardem Elmayan, Frank B Williams

1859 related Products with: Safety-related outcomes of novel mRNA COVID-19 vaccines in pregnancy.

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#35045572   2022/01/19 To Up

Adherence to definitions of labor arrest influence on primary cesarean delivery rate.

The cesarean delivery rate in the United States is 31.9%. One of the leading indications for primary cesarean delivery is labor arrest. A modern understanding of the labor curve supports more time prior to the diagnosis of labor arrest. We conducted this study to examine the impact of adherence to modern criteria for labor arrest and failed induction on rates of primary cesarean delivery and to identify predictors of meeting these criteria.
Jessica Greenberg, Sarah N Cross, Cheryl Raab, Christian M Pettker, Jessica L Illuzzi

1980 related Products with: Adherence to definitions of labor arrest influence on primary cesarean delivery rate.

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#35045571   2022/01/19 To Up

The association of twin chorionicity with maternal outcomes.

Objective Our objective was to investigate the association between maternal outcomes and twin chorionicity in a large, contemporary obstetric population. Study Design Retrospective cohort study conducted at a single, large tertiary care center. Prenatal and inpatient records for all individuals with twin gestations were reviewed from 2000 to 2016. Patients with monoamniotic twins, higher-order multiples reduced to twins, multiple sets of twins in the study period, or undetermined chorionicity were excluded. Patients with monochorionic twins were compared to those with dichorionic twins. The co-primary outcomes were gestational diabetes mellitus and hypertensive disorders of pregnancy. Secondary outcomes included cesarean delivery, preterm delivery, postpartum hemorrhage, and other maternal outcomes. Bivariable and multivariable analyses were performed to assess associations of chorionicity with maternal outcomes. Results Of the 2979 patients eligible for inclusion, 2627 (88.2%) had dichorionic twin gestations and 352 (11.8%) had monochorionic twin gestations. Patients with monochorionic twins were less likely to self-identify as non-Hispanic white and to have conceived via assisted reproductive technology, but were more likely to be publicly insured, multiparous, and have prenatal care with a maternal fetal medicine provider. Neither gestational diabetes mellitus (6.8% monochorionic vs 6.2% dichorionic, P = .74; adjusted odds ratio 1.06, 95% confidence interval 0.60-1.86) nor hypertensive disorders of pregnancy (21.9% monochorionic s 26.3% dichorionic, P = 0.09; adjusted odds ratio 0.99, 95% confidence interval, 0.71-1.38) differed by chorionicity. Of the secondary maternal outcomes, patients with monochorionic twins experienced a lower frequency of cesarean delivery (46.0% vs 61.8%, P < .001), which persisted after multivariable analyses (adjusted odds ratio 0.60, 95% confidence interval 0.46-0.80). There were no differences in preterm delivery, preterm premature rupture of membranes, hemorrhage, hysterectomy, or intrahepatic cholestasis of pregnancy. Conclusion The odds of gestational diabetes mellitus and hypertensive disorders of pregnancy do not appear to differ by twin chorionicity.
Rachael Cowherd, Danielle T Cipres, Liqi Chen, Olivia H Barry, Samantha L Estevez, Lynn M Yee

2250 related Products with: The association of twin chorionicity with maternal outcomes.

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#35045569   2022/01/19 To Up

Validation of the Khorana score for predicting venous thromboembolism in 40 218 cancer patients initiating chemotherapy.

The Khorana score is recommended for guiding primary venous thromboembolism prophylaxis in cancer patients, but its clinical utility overall and across cancer types remains debatable. Also, some previous validation studies have ignored competing risk of death, hereby potentially overestimating venous thromboembolism risk. We identified ambulatory cancer patients initiating chemotherapy without other indications for anticoagulation using Danish health registries and estimated six-month cumulative incidence of venous thromboembolism stratified by Khorana levels. Analyses were conducted with and without considering death as competing risk using the Kaplan-Meier method versus the cumulative incidence function. Analyses were performed overall and stratified by cancer types. Of 40,218 patients, 35.4% were categorized by Khorana as low risk (score 0), 53.6% as intermediate risk (score 1-2) and 10.9% as high risk (score ≥3). Considering competing risk of death, the corresponding six-month risks of venous thromboembolism were 1.5% (95% CI 1.3-1-7), 2.8% (95% CI 2.6-3.1), and 4.1% (95% CI 3.5-4.7), respectively. Among patients recommended anticoagulation by guidelines (Khorana score ≥2), six-month risk was 3.6% (95% CI 3.3-3.9). Kaplan-Meier analysis overestimated incidence up to 23% compared with competing risk analyses. Using the guideline-recommended threshold of ≥2, the Khorana score did not risk stratify patients with hepatobiliary or pancreatic cancer, lung cancer, and gynecologic cancer. In conclusion, the Khorana score was able to stratify ambulatory cancer patients according to risk of venous thromboembolism, but not for all cancer types. Absolute risks varied by methodology but were lower than in key randomized trials. Thus, although certain limitations with outcome identification using administrative registries apply, the absolute benefit of implementing routine primary thromboprophylaxis in an unselected cancer population may be smaller than seen in randomized trials.
Thure Overvad, Anne Ording, Peter B Nielsen, Flemming Skjøth, Ida E Albertsen, Simon Noble, Anders Krog Vistisen, Inger Lise Gade, Marianne Tang Severinsen, Gregory Piazza, Torben B Larsen

2617 related Products with: Validation of the Khorana score for predicting venous thromboembolism in 40 218 cancer patients initiating chemotherapy.



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#35045567   2022/01/19 To Up

A randomised trial of alendronate as prophylaxis against loss in bone mineral density following lymphoma treatment.

Lymphoma patients often receive high glucocorticoid doses as part of standard therapy. Observational studies have shown substantial risk of glucocorticoid-induced osteoporosis (GIO) with associated fractures. The aim of the SIESTA trial was to determine if oral alendronate (ALN) is a safe and effective prophylaxis against GIO in lymphoma. SIESTA was a single-center, randomized, double-blinded, phase 2 study of lymphoma patients planned for glucocorticoid-containing chemotherapy. After randomization, patients received weekly ALN 70mg or placebo for a total of 52 weeks. Bone mineral density (BMD) was assessed at baseline, after completion of chemotherapy (EOT, 4-6 month), and at end of study (EOS, 12 month). Vertebral fracture and biomarkers were assessed at baseline and EOS. Patients with baseline BMD assessment and at least one follow-up BMD assessment were analyzed for efficacy. Primary endpoint was change in lumbar spine T-score from baseline to EOS. Of the 59 patients enrolled, 23/30 in the ALN arm and 24/29 in the placebo arm were analyzed for efficacy. Mean change in T-score from baseline to 12 month at lumbar spine was +0.15 for ALN and -0.12 for placebo (P=0.023). The difference in ∆T_EOS between the ALN and placebo groups was larger among females (ALN 0.28; placebo -0.28) (P=0,01). Biomarker analyses confirmed reduced bone resorption in ALN treated patients. In conclusion, ALN is a safe and effective primary prophylaxis against loss in BMD following glucocorticoid-containing chemotherapy. Despite reduced BMD loss in the ALN arm, the treatment did not influence fracture risk in this small cohort of patients. This trial is registered at www.clinicaltrials.gov as 2015-005688-18.
Paw Jensen, Lasse Hjort Hjort Jakobsen, Martin Bøgsted, Joachim Baech, Simon Lykkeboe, Marianne Tang Severinsen, Peter Vestergaard, Tarec Christoffer El Galaly

2865 related Products with: A randomised trial of alendronate as prophylaxis against loss in bone mineral density following lymphoma treatment.

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#35045566   2022/01/14 To Up

Effectiveness of COVID-19 booster vaccines against covid-19 related symptoms, hospitalisation and death in England.

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Nick Andrews, Julia Stowe, Freja Kirsebom, Samuel Toffa, Ruchira Sachdeva, Charlotte Gower, Mary Ramsay, Jamie Lopez Bernal

2168 related Products with: Effectiveness of COVID-19 booster vaccines against covid-19 related symptoms, hospitalisation and death in England.

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#35045564   2022/01/17 To Up

Randomized control trial on the efficacy of Limosilactobacillus reuteri ATCC PTA 4659 in reducing inflammatory markers in acute uncomplicated diverticulitis.

Recent guidelines suggest treating acute uncomplicated diverticulitis (AUD) without antibiotics. We tested the efficacy of Limosilactobacillus reuteri ATCC PTA 4659 in AUD. Primary outcome was the reduction of abdominal pain and inflammatory markers [C-reactive protein (C-RP) and calprotectin]. Secondary outcome was the reduction of hours of hospitalization.
Veronica Ojetti, Angela Saviano, Mattia Brigida, Carmine Petruzziello, Martina Caronna, Gunawardena Gayani, Francesco Franceschi

1896 related Products with: Randomized control trial on the efficacy of Limosilactobacillus reuteri ATCC PTA 4659 in reducing inflammatory markers in acute uncomplicated diverticulitis.

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#35045559   2022/01/18 To Up

Efficacy and safety of high dose cholecalciferol in patients with inflammatory bowel disease receiving infliximab.

Vitamin D deficiency is prevalent in patients with inflammatory bowel disease (IBD). The goal of this study was to assess the efficacy and safety of high-dose, interval cholecalciferol administration in patients with IBD receiving infliximab.
Rebecca J Gordon, Reeder Wells, Camille Johansen, Shanshan Liu, Suzanne E Dahlberg, Scott B Snapper, Paul A Rufo

2011 related Products with: Efficacy and safety of high dose cholecalciferol in patients with inflammatory bowel disease receiving infliximab.

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