Search results for "randomized controlled trial"
showing 10 items of 2199 documents
Hexyl aminolevulinate, 5‐aminolevulinic acid nanoemulsion and methyl aminolevulinate in photodynamic therapy of non‐aggressive basal cell carcinomas:…
2020
Background In the photodynamic therapy (PDT) of non‐aggressive basal cell carcinomas (BCCs), 5‐aminolevulinic acid nanoemulsion (BF‐200ALA) has shown non‐inferior efficacy when compared with methyl aminolevulinate (MAL), a widely used photosensitizer. Hexyl aminolevulinate (HAL) is an interesting alternative photosensitizer. To our knowledge, this is the first study using HAL‐PDT in the treatment of BCCs. Objectives To compare the histological clearance, tolerability (pain and post‐treatment reaction), and cosmetic outcome of MAL, BF‐200 ALA, and low‐concentration HAL in the PDT of non‐aggressive BCCs. Methods Ninety‐eight histologically verified non‐aggressive BCCs met the inclusion criter…
Efficacy of Low-Dose Paroxetine for the Treatment of Hot Flushes in Surgical and Physiological Postmenopausal Women: Systematic Review and Meta-Analy…
2019
Background and Objectives: Hot flushes and sleep disturbances are the most common vasomotor symptoms (VMS) reported by postmenopausal women. Hormonal treatment is to date referred to as the gold standard approach but not suitable for all the patients. Alternative treatments are needed in case of a contraindication to menopausal hormone therapy (MHT), adverse side effects, and poor compliance. Paroxetine salt is the only nonhormonal medication approved by the US Food and Drug Administration for the management of VMS. Nonetheless, few trials with low consensus are available about this topic. In this review, we aimed to evaluate the efficacy of low-dose paroxetine therapy in the treatment of v…
Effect of exercise and dietary intervention on serum metabolomics in men with insomnia symptoms: a 6-month randomized-controlled trial
2020
AbstractBackgroundAccumulating evidences have shown that lifestyle interventions such as exercise and diet are associated with improved sleep quality. However, the underlying molecular mechanisms remain unclear. Assessing exercise and diet intervention associated changes in circulating metabolomics profile in people with insomnia symptoms may help to identify molecular biomarkers that may link lifestyle changes to improved sleep outcomes.MethodsThe present study is a part of a 6-month randomized lifestyle intervention on sleep disorder subjects. Seventy-two Finnish men (aged: 51.6 ± 10.1 years; body mass index, BMI: 29.3 ± 3.9 kg/m2) with chronic insomnia symptoms who were assigned into dif…
A106 Gastroesophageal reflux disease in patients with severe obesity and type 2 diabetes one year after sleeve gastrectomy or Roux-en-Y gastric bypas…
2019
Ten-year follow-up on efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine or one dose of monovalen…
2020
Abstract Background We assessed the 10-year efficacy, immunogenicity and safety of two doses of a combined measles-mumps-rubella-varicella vaccine (MMRV) or one dose of a monovalent varicella vaccine (V) in children from Czech Republic, Lithuania, Poland, Romania and Slovakia. Methods This was a phase IIIB follow-up of an observer-blind, randomized, controlled trial (NCT00226499). In phase A, healthy children aged 12–22 months from 10 European countries were randomized in a 3:3:1 ratio to receive two doses of MMRV (MMRV group), one dose of MMR followed by one dose of V (MMR + V group), or two doses of MMR (MMR; control group), 42 days apart. Vaccine efficacy (VE) against varicella (confirme…
Motivational strategies in interventions for intimate partner violence offenders: a systematic review and meta-analysis of randomized controlled tria…
2020
ABSTRACT Previous research suggests that the inclusion of motivational strategies in interventions for intimate partner violence (IPV) offenders could increase their effectiveness. This review evaluated the effectiveness of interventions for IPV offenders that includes motivational strategies to reduce physical and psychological IPV, treatment dropout, official recidivism to IPV offending, and to increase intervention attendance dose. The present systematic review and meta-analysis were conducted using PRISMA guidelines. The following databases were searched from 1983 to 2018 for randomized controlled trials (RCTs) of interventions for IPV offenders that incorporated motivational strategies…
HCC therapies--lessons learned.
2014
The antiangiogenic multikinase inhibitor sorafenib was the first systemic agent to demonstrate a significant improvement in the overall survival of patients with advanced hepatocellular carcinoma (HCC), thereby introducing molecularly-targeted therapy in a therapeutic field of unmet needs. However, survival benefits for patients on sorafenib treatment are modest in clinical practice and advancing the field is far more challenging than initially anticipated. Molecular and clinical heterogeneity diminishes signals of potential activity in unselected populations, and underlying liver cirrhosis seals the fate of many novel targeted agents by causing relevant toxicity and mortality. The failure …
Field-practice study of sorafenib therapy for hepatocellular carcinoma: a prospective multicenter study in Italy
2011
A multicenter randomized controlled trial established sorafenib as a standard of care for patients with advanced hepatocellular carcinoma (HCC). Because the study was prematurely interrupted due to survival benefits in the sorafenib arm, we conducted an observational study to adequately assess risks and benefits of this regimen in field practice. Starting in 2008, all clinically compensated patients with advanced HCC and those with an intermediate HCC who were unfit or failed to respond to ablative therapies were consecutively evaluated in six liver centers in Italy, for tolerability as well as radiologic and survival response to 800-mg/d sorafenib therapy. Treatment was down-dosed or inter…
Outcomes of hepatocellular carcinoma patients treated with sorafenib: a meta-analysis of Phase III trials
2019
Aim: To benchmark overall survival (OS) and time to radiological progression (TTP) of patients enrolled in randomized controlled trials (RCTs) assessing sorafenib in advanced hepatocellular carcinoma using individual participant survival data, and to meta-analyze prognostic factors for OS and TTP. Methods: RCTs were identified through literature search until December 2018. Individual participant survival was reconstructed with an algorithm from published Kaplan–Meier curves. Results: Ten RCTs were included. Median OS was 10.0 months (95% CI: 9.6–10.5), and median TTP was 4.1 months (95% CI: 3.8–4.3). Multivariable analyses showed HCV positivity, absence of macrovascular invasion and extra-…
Systemic therapy for intermediate and advanced hepatocellular carcinoma: Sorafenib and beyond.
2018
The hepatocellular carcinoma (HCC) treatment landscape changed a decade ago, with sorafenib demonstrating survival benefit in the first-line setting and becoming the first systemic therapy to be approved for HCC. More recently, regorafenib and nivolumab have received approval in the second-line setting after sorafenib, with further positive phase 3 studies emerging in the first line (lenvatinib non-inferior to sorafenib) and second line versus placebo (cabozantinib and ramucirumab). A key recommendation in the management of patients receiving sorafenib is to promote close communication between the patient and the physician so that adverse events (AEs) are detected early and severe AEs can b…