Search results for "Randomized controlled trial"
showing 10 items of 2199 documents
Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted vaccine administered according to an alternative dosing schedule compared wit…
2011
BACKGROUND: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine is immunogenic, has a clinically acceptable safety profile, and prevents incident and persistent HPV-16/18 infection and cervical precancerous lesions. This study (NCT00552279) evaluated the vaccine when administered according to an alternative dosing schedule (0-1-12 months) compared with the standard dosing schedule (0-1-6 months). METHODS: The study was of randomized open design and was conducted at multiple centers in Europe. Healthy women aged 15 to 25 years were randomized (1:1) to receive HPV-16/18 vaccine according to the standard schedule at months 0, 1, and 6 (n = 401) or an alternative schedule at months 0, …
Efficacy of Nonpharmacological Treatments on Comorbid Internalizing Symptoms of Adults With Attention-Deficit/Hyperactivity Disorder: A Meta-Analytic…
2019
Background: Attention-deficit/hyperactivity disorder (ADHD) is highly comorbid in adulthood. This meta-analysis was aimed at ascertaining the efficacy of different psychotherapies in improving comorbid internalizing symptoms in adults with ADHD. Method: Twenty randomized controlled trials and 12 uncontrolled pretest–posttest studies were included and combined using the inverse variance method. Risk of bias and heterogeneity assessment and moderator analyses were performed. Results: Cognitive-behavioral therapy (CBT) improved quality of life (QoL), emotional dysregulation (ED), depression, and anxiety symptoms, particularly at follow-up, which was predicted by core symptoms reduction. A sig…
Photobiomodulation therapy reduces postoperative pain after third molar extractions: A randomized clinical trial
2020
Background To assess the efficacy of PBMT on reducing postoperative pain scores in patients submitted to third molar extractions. Material and Methods A randomized controlled trial (ReBEC:RBR-94BCKZ) was designed according to the SPIRIT and followed the CONSORT. Patients were randomly allocated according to control or PBMT groups. PBMT consisted of the application of GaAlAs laser (808nm;50mW) applied in six points (1.23 min;11 J/cm2) after extraction. Pain scores were assessed using the Visual Analogue Scale (VAS) in millimeters evaluated after 6 (T6), 24 (T24), and 48 (T48) hours. The Wilcoxon Mann–Whitney test was used to check for possible associations between VAS scores and treatment gr…
Effect of lingual-based flap design on postoperative pain of impacted mandibular third molar surgery : split-mouth randomized clinical trial
2020
Background The extraction of third molars is one of the most common procedures in oral and maxillofacial surgery clinic. Surgical extraction involves the manipulation of both soft and hard tissues, so the patient usually experiences pain, swelling, and trismus in the immediate post-operative period. Several studies have been conducted using different types of surgical flaps to provide access with the least possible damage of soft tissues. Designing and implementing an optimum flap, which provides easier technique, better visibility, minimal post-operative complications, and best healing, is an aspired goal of every oral surgeon. This study aimed to compare lingual-based four-cornered flap w…
High-flow nasal cannula versus non-invasive ventilation for acute hypercapnic respiratory failure in adults: a systematic review and meta-analysis of…
2022
Abstract Background Non-invasive ventilation (NIV) with bi-level positive pressure ventilation is a first-line intervention for selected patients with acute hypercapnic respiratory failure. Compared to conventional oxygen therapy, NIV may reduce endotracheal intubation, death, and intensive care unit length of stay (LOS), but its use is often limited by patient tolerance and treatment failure. High-flow nasal cannula (HFNC) is a potential alternative treatment in this patient population and may be better tolerated. Research question For patients presenting with acute hypercapnic respiratory failure, is HFNC an effective alternative to NIV in reducing the need for intubation? Methods We sear…
Tumor-Infiltrating Lymphocytes and Response to Neoadjuvant Chemotherapy With or Without Carboplatin in Human Epidermal Growth Factor Receptor 2–Posit…
2015
Purpose Modulation of immunologic interactions in cancer tissue is a promising therapeutic strategy. To investigate the immunogenicity of human epidermal growth factor receptor 2 (HER2) –positive and triple-negative (TN) breast cancers (BCs), we evaluated tumor-infiltrating lymphocytes (TILs) and immunologically relevant genes in the neoadjuvant GeparSixto trial. Patients and Methods GeparSixto investigated the effect of adding carboplatin (Cb) to an anthracycline-plus-taxane combination (PM) on pathologic complete response (pCR). A total of 580 tumors were evaluated before random assignment for stromal TILs and lymphocyte-predominant BC (LPBC). mRNA expression of immune-activating (CXCL9, …
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…