Search results for "Primary outcome"

Can a Prebiotic Formulation Reduce Frailty Levels in Older People?

2019

Objective: The purpose of this study was to examine whether a prebiotic formulation reduces frailty index (FI) levels in older people. Design: We conducted secondary analysis of a placebo-controlled, randomized, double-blind design study. Setting/Participants: The study included non-demented people over the age of 65 who were living in nursing homes and were able to walk. Fifty participants completed the study (75.3±7.3 years, 70% females). Intervention: Participants were randomly assigned to either a group who received daily Darmocare Pre® (inulin and fructooligosaccharides) for 13 weeks or a placebo group (maltodextrin). Measurement: The primary outcome in this secondary analysis was chan…

Women in LOVe: Lacto-Ovo-Vegetarian Diet Rich in Omega-3 Improves Vasomotor Symptoms in Postmenopausal Women. An Exploratory Randomized Controlled Tr…

2019

Objective:In the postmenopausal period, most women suffer vasomotor symptoms (VMS). It is well-known that VMS can worsen the quality of life. Diet seems to play a relevant role in the development of VMS, but the effect of diet on VMS is mainly limited to observational studies, and analyses of nutritional supplements. The aim of this study was thus to determine the efficacy of a lactoovo- vegetarian (LOVe) diet rich in omega-3 fatty acids vs. a lacto-ovo-vegetarian diet rich in EVO (extra-virgin olive oil) in reducing VMS frequency in postmenopausal women.Methods:A two-arms (lacto-ovo-vegetarian diet with EVO vs. lacto-ovo-vegetarian diet rich in omega-3) randomized-controlled trial with a f…

2019

PIK3CA-related overgrowth spectrum (PROS) encompasses a range of debilitating conditions defined by asymmetric overgrowth caused by mosaic activating PIK3CA variants. PIK3CA encodes the p110α catalytic subunit of phosphatidylinositol-3-kinase (PI3K), a critical transducer of growth factor signaling. As mTOR mediates the growth-promoting actions of PI3K, we hypothesized that the mTOR inhibitor sirolimus would slow pathological overgrowth. Thirty-nine participants with PROS and progressive overgrowth were enrolled into open-label studies across three centers, and results were pooled. For the primary outcome, tissue volumes at affected and unaffected sites were measured by dual energy X-ray ab…

An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1-year follow-up efficacy data.

2019

This is the pre-peer reviewed version of the following article: An adaptive virtual reality system for the treatment of adjustment disorder and complicated grief: 1‐year follow‐up efficacy data, which has been published in final form at https://doi.org/10.1002/cpp.2342. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions. Adjustment disorder (AD) and complicated grief (CG) are serious mental conditions that have a high prevalence and are associated with significant impairments in social and work functioning. Recently, these categories have been better specified in the new ICD‐11 proposal. Empirical research on …

Effectiveness of cognitive-behavioral group therapy for patients with hypochondriasis (health anxiety)

2014

Cognitive behavioral therapy (CBT) has been shown to be highly effective in the treatment of health anxiety. However, little is known about the effectiveness of group CBT in the treatment of health anxiety. The current study is the largest study that has investigated the effectiveness of combined individual and group CBT for patients with the diagnosis of hypochondriasis (N=80). Therapy outcomes were evaluated by several questionnaires. Patients showed a large improvement on these primary outcome measures both post-treatment (Cohen's d=0.82-1.08) and at a 12-month follow-up (Cohen's d=1.09-1.41). Measures of general psychopathology and somatic symptoms showed significant improvements, with …

The effective group size for teaching cardiopulmonary resuscitation skills – A randomized controlled simulation trial

2021

Abstract Aim of the study The ideal group size for effective teaching of cardiopulmonary resuscitation is currently under debate. The upper limit is reached when instructors are unable to correct participants’ errors during skills practice. This simulation study aimed to define this limit during cardiopulmonary resuscitation teaching. Methods Medical students acting as simulated Basic Life Support course participants were instructed to make three different pre-defined Basic Life Support quality errors (e.g., chest compression too fast) in 7 min. Basic Life Support instructors were randomized to groups of 3–10 participants. Instructors were asked to observe the Basic Life Support skills and …

Ulipristal acetate versus leuprolide acetate for uterine fibroids

2012

A b s t r ac t Background The efficacy and side-effect profile of ulipristal acetate as compared with those of leuprolide acetate for the treatment of symptomatic uterine fibroids before surgery are unclear. Methods In this double-blind noninferiority trial, we randomly assigned 307 patients with symptomatic fibroids and excessive uterine bleeding to receive 3 months of daily therapy with oral ulipristal acetate (at a dose of either 5 mg or 10 mg) or once-monthly intramuscular injections of leuprolide acetate (at a dose of 3.75 mg). The primary outcome was the proportion of patients with controlled bleeding at week 13, with a prespecified noninferiority margin of −20%. Results Uterine bleed…

Five-year results following treatment of intrabony defects with enamel matrix proteins and guided tissue regeneration

2004

Treatment with enamel matrix proteins (EMD) or guided tissue regeneration (GTR) has been shown to enhance periodontal regeneration. However, until now there are limited data on the long-term results following these treatment modalities.The aim of the present clinical study was to present the 5-year results following treatment of intrabony defects with EMD, GTR, combination of EMD and GTR, and open flap debridement (OFD).Forty-two patients, each of whom displayed one intrabony defect of a probing depth of at least 6 mm, were randomly treated with one of the four treatment modalities. The following parameters were evaluated prior to surgery, at 1 year and at 5 years after: plaque index, gingi…

Customised products for orbital wall reconstruction: a systematic review

2021

Abstract The purpose of this systematic review was to critically analyze the recent literature to present the state of the art in customized reconstruction of orbital fractures. Three electronic databases and manual search approaches were used to identify relevant articles. Only studies with a controlled clinical study design were included. Primary outcome was defined as the status of recovery (complete/partial functional and esthetic disturbances). The benefit of intra-surgical navigation should be described. Secondary outcome was defined as the time of surgery, post-surgical events and hospitalization. A total of eight studies out of 552 records identified met the inclusion criteria. Post…

A Prospective Noninterventional Study to Evaluate Survival and Success of Reduced Diameter Implants Made From Titanium-Zirconium Alloy

2015

Narrow diameter implants may be at increased risk of overload due to occlusal forces; therefore, implants with higher fatigue strength may be beneficial. The aim of this observational study was to evaluate survival and success of narrow diameter (Ø 3.3 mm) TiZr alloy (Roxolid, Institut Straumann AG, Basel, Switzerland) implants for 2 years in daily dental practice. This was a prospective, non-interventional, multicenter study; no specific patient inclusion or exclusion criteria were applied. Each patient received at least one TiZr implant; the treatment plan, including implant loading and final restoration, was at the investigator's discretion. The primary outcome was implant survival and s…