Search results for "Randomized"
showing 10 items of 2323 documents
Long‐term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42‐month analysis of the phase II randomized, double‐blind…
2019
Background: Basal cell carcinomas (BCCs) exhibit aberrant activation of the hedgehog pathway. Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment]. Objectives: This is the final 42-month analysis of the BOLT study, evaluating the efficacy and safety of sonidegib. Methods: Adults with no prior hedgehog pathway inhibitor therapy were randomized in a 1 : 2 ratio to sonidegib 200 mg or 800 mg once daily. Treatment continued for up to 42 months or until disease progression, unacceptable toxicity, death, study termin…
Effectiveness of High-Frequency Transcranial Magnetic Stimulation and Physical Exercise in Women With Fibromyalgia: A Randomized Controlled Trial
2020
Abstract Objective Fibromyalgia (FM) is characterized by chronic widespread pain and both physical and emotional alterations, which in turn may affect the individual’s quality of life. Thus, interventions aimed at treating such symptoms, without increasing fatigue, are needed. The aim of this study was to explore the effect of high-frequency transcranial magnetic stimulation (HF-TMS) and physical exercise (PE) on pain, impact of FM, physical conditioning, and emotional status in women with FM. Methods Forty-nine women with FM were randomly allocated to: (1) a PE group (PEG, n = 16), who underwent an 8-week (two 60-minute sessions/wk) low-intensity PE program; (2) a TMS group (TMSG, n = 17) …
Access to an online video enhances the consent process, increases knowledge, and decreases anxiety of caregivers with children scheduled for inguinal…
2019
Abstract Background There is limited time within the clinical workflow of most pediatric surgeons to obtain a comprehensive, well informed consent. This study evaluates whether ad-lib access to an online video on the consent dialogue enhances the consent process for inguinal hernia repair (IHR) in children. Methods The study was approved by the state ethics board. A 6-min video of a consent speech on IHR was produced and uploaded to a nonpublic online channel, explaining the condition, procedure, complications, and postoperative expectations. A total of 50 families were randomized to conventional, face-to-face consenting in clinic either with (intervention) or without (control) access to th…
Study protocol: fit for delivery - can a lifestyle intervention in pregnancy result in measurable health benefits for mothers and newborns? A randomi…
2013
Abstract Background The global obesity epidemic has led to increased attention on pregnancy, a period when women are at risk of gaining excessive weight. Excessive gestational weight gain is associated with numerous complications, for both mother and child. Though the problem is widespread, few studies have examined the effect of a lifestyle intervention in pregnancy designed to limit maternal weight gain. The Fit for Delivery study will explore the effectiveness of nutritional counseling coupled with exercise classes compared with standard prenatal care. The aims of the study are to examine the effect of the intervention on maternal weight gain, newborn birth weight, glucose regulation, co…
Peri‐implant marginal bone loss reduction with platform‐switching components: 5‐Year post‐loading results of an equivalence randomized clinical trial
2019
Abstract Aim To compare the clinical performance and marginal bone levels of implants restored with platform‐switching (PS) or platform‐matching (PM) abutments. Materials and Methods Adult patients missing two or more adjacent teeth in the posterior mandible received 2–4 CAMLOG SCREW‐LINE implants and were randomly allocated to the PM or PS group, receiving the corresponding prosthetic components from surgery onwards. Implants were conventionally loaded with single cemented crowns. Patients were followed annually for 5 years. Outcome measures were marginal bone level changes, implant survival, performance of the prosthetic components and clinical parameters plaque index, sulcus bleeding ind…
Cost-effectiveness and cost-utility evaluation of individual vs. group transdiagnostic psychological treatment for emotional disorders in primary car…
2022
Abstract Background Emotional disorders are common, and they have become more prevalent since the COVID-19 pandemic. Due to a high attendance burden at the specialized level, most emotional disorders in Spain are treated in primary care, where they are usually misdiagnosed and treated using psychotropic drugs. This contributes to perpetuate their illness and increase health care costs. Following the IAPT programme and the transdiagnostic approach, the PsicAP project developed a brief group transdiagnostic cognitive-behavioural therapy (tCBT) as a cost-effective alternative. However, it is not suitable for everyone; in some cases, one-on-one sessions may be more effective. The objective of t…
GINA 2019: a fundamental change in asthma management
2019
GINA no longer recommends treating adults/adolescents with asthma with short-acting bronchodilators alone. Instead, they should receive symptom-driven (in mild asthma) or a daily corticosteroid-containing inhaler, to reduce risk of severe exacerbations.http://bit.ly/310LLzE
Consequences of long-term oral corticosteroid therapy and its side-effects in severe asthma in adults: a focused review of the impact data in the lit…
2018
This review provides an overview of the role of long-term treatment of severe asthma with oral corticosteroids (OCS) and its associated side-effects in adults. It is based on a systematic literature search conducted in MEDLINE, Embase and the Cochrane Library to identify relevant studies. After a short overview of severe asthma and its treatment we present studies showing a dose–response relationship in asthmatic patients treated with OCS and then consider by organ systems the undesired effects demonstrated in clinical and epidemiological studies in patients with OCS-dependent asthma. It was found that the risk of developing various OCS-related complications, including infections, diabetes …
The randomized shortened dental arch study (RaSDA): design and protocol
2010
Abstract Background Various treatment options for the prosthetic treatment of jaws where all molars are lost are under discussion. Besides the placement of implants, two main treatment types can be distinguished: replacement of the missing molars with removable dental prostheses and non-replacement of the molars, i.e. preservation of the shortened dental arch. Evidence is lacking regarding the long-term outcome and the clinical performance of these approaches. High treatment costs and the long time required for the treatment impede respective clinical trials. Methods/design This 14-center randomized controlled investigator-initiated trial is ongoing. Last patient out will be in 2010. Patien…
Group treatment for substance use disorder in adults: A systematic review and meta-analysis of randomized-controlled trials
2019
Abstract Background and aims From residential programs to outpatient services, group therapy permeates the clinical field of substance misuse. While several group interventions for substance use disorders (SUDs) have demonstrated effectiveness, the existing evidence on group therapy has not been systematically reviewed. The current meta-analysis aims to provide estimates of the efficacy of group therapy for SUDs in adults using rigorous methods. Methods We included studies comparing group psychotherapy to no treatment control groups, individual psychotherapy, medication, self-help groups, and other active treatments applying no specific psychotherapeutic techniques for patients with substan…