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The aim of this study was to compare clinical and radiologic results among patients with 3 versus 6 weeks of immobilization after arthroscopic rotator cuff (RC) repair in a prospective randomized controlled non-inferiority trial.
Long-term pharyngeal dysphagia is a common complication following head and neck cancer (HNC) therapies. High-level evidence for pharyngoesophageal junction (POJ) dilatation as a treatment in this population is lacking. We aimed to evaluate the safety and efficacy of POJ dilatation in dysphagic HNC survivors. This single-center, single-blind, placebo-controlled trial (St George Hospital, Sydney, Australia) randomly assigned (1:1) HNC survivors with long-term dysphagia (≥12 months postcompleted HNC therapie...
BACKGROUND This study was designed to explore the effect of menopausal hormone therapy (MHT) on bone mineral density (BMD) in Chinese women. MATERIAL AND METHODS This was a prospective, open-label, randomized-controlled clinical trial. We randomly assigned 123 postmenopausal women to 3 groups: group A received 0.625 mg conjugated equine estrogen (CEE) plus 100 mg micronized progesterone (MP), group B received 0.3 mg CEE daily plus 100 mg MP, and group C received 0.625 mg CEE daily plus 10 mg dydrogesterone ...
Dose and schedule optimization of treatment with tyrosine kinase inhibitors is of utmost importance. On the basis of preclinical data, a phase I clinical trial of once weekly or once every 2 weeks administration of high-dose sunitinib in patients with refractory solid malignancies was conducted.
Pre-mRNA Splicing Modulation by Antisense Oligonucleotides.
Pre-mRNA splicing, a dynamic process of intron removal and exon joining, is governed by a combinatorial control exerted by overlapping cis-elements that are unique to each exon and its flanking intronic sequences. Splicing cis-elements are usually 4-to-8-nucleotide-long linear motifs that provide binding sites for specific proteins. Pre-mRNA splicing is also influenced by secondary and higher order RNA structures that affect accessibility of splicing cis-elements. Antisense oligonucleotides (ASOs) that bloc...
Combining a thiopurine with the human anti-tumor necrosis factor- monoclonal antibody adalimumab for Crohn's disease (CD) treatment is controversial with regard to efficacy and safety. By conducting a sub-analysis of a multicenter, randomized, prospective, open-label trial (the DIAMOND study, UMIN registration number 000005146), we studied the risk of discontinuation of thiopurine in combination with adalimumab.
The objective of this study was to compare the effectiveness of Problem Based Learning (PBL) versus PBL associated with the Active Learning Model for Critical Thinking (ALMCT) to improve critical thinking (CT) in nursing students in an educational intervention on Basic Life Support (BLS). A two-arm randomized, single-blinded, parallel clinical trial was carried out with 108 Brazilian undergraduate nursing students who participated in a BLS course. PBL + ALMCT was used in the control group (CG), and PBL wa...
The preparation of a randomized controlled trial (RCT) requires substantial resources and the administrative processes can be burdensome. To facilitate the conduct of RCTs it is important to better understand cost drivers. In January 2014 the enactment of the new Swiss Legislation on Human Research (LHR) considerably changed the regulatory framework in Switzerland. We assess if the new LHR was associated with change in (i) resource use and costs to prepare an RCT, and (ii) approval times with research ethic...
Randomized controlled trial of vitamin D supplementation in older people to optimize bone health.
Vitamin D insufficiency is common in older people and may lead to increased bone resorption, bone loss, and increased falls and fractures. However, clinical trials assessing the effect of vitamin D supplementation on bone mineral density (BMD) have yielded conflicting results.
Obese patients with rheumatoid arthritis (RA) report more joint swelling and tenderness and often have poorer responses to therapy than nonobese patients. The aim of this posthoc analysis of the MUSICA trial was to compare imaging and clinical disease activity measures in obese and nonobese patients with RA.
Inappropriate antibiotic prescribing causes widespread serious health problems. To reduce prescribing of antibiotics in Chinese primary care to children with upper respiratory tract infections (URTIs), we developed an intervention comprising clinical guidelines, monthly prescribing review meetings, doctor-patient communication skills training, and education materials for caregivers. We previously evaluated our intervention using an unblinded cluster-randomised controlled trial (cRCT) in 25 primary care faci...
This study evaluated the feasibility of achieving high response rates in stage II or III breast cancer by tailoring neoadjuvant therapy using clinical and histopathological features and the Oncotype DX Breast Recurrence Score. Genomic determinants of response and resistance were also explored.
We performed prospective randomized comparison of clinical and surgical outcomes of flow diversion versus PVO and bypass in patients with complex anterior circulation aneurysms.
To determine clinical utility of Onclarity human papillomavirus (HPV) assay for atypical squamous cells-undetermined significance (ASC-US) triage, and the value of HPV genotyping within ASC-US.
High blood pressure (BP) is common in acute stroke and associated with poor outcome, but the Efficacy of Nitric Oxide in Stroke (ENOS) trial showed no beneficial effect of antihypertensive treatment in this situation. Antihypertensive agents have accentuated effects in dehydrated patients. We assessed the impact of dehydration on haemodynamics, effects of antihypertensive treatment and prognosis in the ENOS trial.
The early development of Xenopus critically depends on maternal components stored in the egg. Because important events such as axis formation are triggered immediately after fertilization, it is often desirable to perturb gene function before this occurs. Oocytes can be experimentally manipulated in vitro, prior to maturation, and subsequently fertilized or otherwise activated to develop, and then observed for any embryological defects. Available methods for fertilizing cultured oocytes include in vitro fer...
The use of clinical reasoning skills in the setting of uncertainty: Trial femoral head migration.
Clinical skills and medical knowledge enable physicians to overcome the uncertainty of emergent and rare clinical scenarios. Recently, a growing emphasis on evidence-based medicine has flooded medical curricula of universities across the globe with guideline-based material, and while it has given teachers and students new tools to improve medical education, clinical reasoning must be reaffirmed in its capacity to provide physicians with the ability to solve unexpected clinical scenarios. Anatomical educatio...
Inferior alveolar nerve (IAN) damage is a common complication occurring after sagittal split osteotomy (SSO) and results in sensory disorders of the jaw region. In recent years, published experimental and clinical evidence suggests that low-level laser (LLL) radiation is effective in nerve recovery. Therefore, the aim of the present study was to review clinical trial studies investigating the effect of LLL radiation on improving the sensory defects of IAN after SSO. The keywords associated with SSO and LLL ...
Many US academic centers have acquired community practices to expand their clinical care and research footprint. The objective of this assessment was to determine whether the acquisition and integration of community oncology practices by Yale/Smilow Cancer Hospital improved outcomes in quality of care, disease team integration, clinical trial accrual, and patient satisfaction at network practice sites.
OBJECTIVEA short-term lumbar drain (LD) trial is commonly used to assess the response of normal pressure hydrocephalus (NPH) patients to CSF diversion. However, it remains unknown whether the predictors of passing an LD trial match the predictors of improvement after ventriculoperitoneal shunting. The aim of this study was to examine outcomes, complication rates, and associations between predictors and outcomes after an LD trial in patients with NPH.METHODSThe authors retrospectively reviewed the records of...
Choices in vaccine trial design in epidemics of emerging infections.
In a Policy Forum, Marc Lipsitch and colleagues discuss trial design issues in infectious disease outbreaks.
In renal cell carcinoma (RCC), sorafenib was the first targeted agent demonstrating a definitive benefit in a large phase III clinical trial. The objective of this study was to assess the clinical outcomes of 42 consecutive RCC patients with metastases solely to the lung who received sorafenib as a second-line systemic agent.
Only a few overlapping gene pairs are known in the best-analyzed bacterial model organism Escherichia coli. Automatic annotation programs usually annotate only one out of six reading frames at a locus, allowing only small overlaps between protein-coding sequences. However, both RNAseq and RIBOseq show signals corresponding to non-trivially overlapping reading frames in antisense to annotated genes, which may constitute protein-coding genes. The transcription and translation of the novel 264 nt gene asa, whi...
Treatment outcomes in patients with proven/probable vs possible invasive mould disease (IMD; 2008 European Organisation for Research and Treatment of Cancer/Mycoses Study Group [EORTC/MSG] criteria) needed further assessment. The Phase III SECURE trial compared isavuconazole vs voriconazole for treatment of IMD. This post hoc analysis assessed all-cause mortality (ACM) through day 42 (primary endpoint) and day 84, overall and clinical success at end of treatment (EOT), and drug-related treatment-emergent ad...