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Randomized clinical trial

Ming-Jie Kuang, Chao Han, Jian-Xiong Ma, Fei Li, Jie Zhao, Lin Fu, Xin-Long Ma
PURPOSE: Autologous platelet gel, developed from fresh autologous blood, is a breakthrough in the promotion and acceleration of soft tissue and bone repair. The application of autologous platelet gel has been reported to improve haemostasis and promote function recovery. We screened the randomized controlled trials and controlled clinical trials of high quality to investigate whether autologous platelet gel makes a better performance for postoperative bleeding and functional recovery in patients after total knee arthroplasty...
October 19, 2016: International Journal of Surgery
M C M Conde, L A Chisini, R Sarkis-Onofre, H S Schuch, J E Nör, F F Demarco
The aim of this Scoping Study was to evaluate the survival rate and nature of tissue formed inside root canals of human Necrotic Immature Permanent Teeth (NIPT) under root canal revascularization (RCR). The search was performed in SciVerse Scopus(®) , PubMed/Medline, Web of Science(®) , BIREME and in grey literature up to November 2015. The keywords were selected using MeSH terms and DECs. Two independent reviewers scrutinized the records obtained considering specific inclusion criteria. The included studies were evaluated in accordance with a modified Arksey and O' Malley's framework...
October 22, 2016: International Endodontic Journal
Benjamin Kearns, Abdullah Pandor, Matt Stevenson, Jean Hamilton, Duncan Chambers, Mark Clowes, John Graham, M Satish Kumar
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the company that manufactures cabazitaxel (Jevtana(®), Sanofi, UK) to submit evidence for the clinical and cost effectiveness of cabazitaxel for treatment of patients with metastatic hormone-relapsed prostate cancer (mHRPC) previously treated with a docetaxel-containing regimen. The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
October 22, 2016: PharmacoEconomics
Fausto Petrelli, Sandro Barni, Giacomo Bregni, Filippo de Braud, Serena Di Cosimo
BACKGROUND: The interest in platinum salts in breast cancer (BC) therapy has been recently renewed as inhibition of DNA damage response may enhance the effects of DNA-damaging agents in BC tumors with high genomic instability. The present systematic review and meta-analysis of randomized trials were performed to assess the efficacy and safety of therapy with platinum salts in patients with locally advanced or metastatic (hereinafter advanced) BC. METHODS: We searched PubMed, EMBASE, SCOPUS, Web of Science, the Cochrane Library, and CINAHL for phase II/III clinical trials that assessed efficacy of platinum-based therapy in patients with advanced BC...
October 21, 2016: Breast Cancer Research and Treatment
Cecilia Nilsson, Jette Led Sorensen, Lars Konge, Mikkel Westen, Morten Stadeager, Bent Ottesen, Flemming Bjerrum
BACKGROUND: Inexperienced operating assistants are often tasked with the important role of handling camera navigation during laparoscopic surgery. Incorrect handling can lead to poor visualization, increased operating time, and frustration for the operating surgeon-all of which can compromise patient safety. The objectives of this trial were to examine how to train laparoscopic camera navigation and to explore the transfer of skills to the operating room. MATERIALS AND METHODS: A randomized, single-center superiority trial with three groups: The first group practiced simulation-based camera navigation tasks (camera group), the second group practiced performing a simulation-based cholecystectomy (procedure group), and the third group received no training (control group)...
October 21, 2016: Surgical Endoscopy
Amirabbas Azizi, Robab Aboutorabi, Zahra Mazloum-Khorasani, Monavar Afzal-Aghaea, Hamed Tabesh, Mahmood Tara
BACKGROUND: There are 4 main types of chronic or noncommunicable diseases. Of these, diabetes is one of the major therapeutic concerns globally. Moreover, Iran is among the countries with the highest incidence of diabetic patients. Furthermore, library-based studies by researchers have shown that thus far no study has been carried out to evaluate the relationship between Web-based diabetic personal health records (DPHR) and self-care indicators in Iran. OBJECTIVE: The objective of this study is to examine the effect of Web-based DPHR on self-care status of diabetic patients in an intervention group as compared with a control group...
October 21, 2016: JMIR Medical Informatics
Kazuo Saito, Hitoshi Kihara
STUDY DESIGN: A randomized clinical trial, with patients treated either by new 2-step orthosis or by the figure-eight-type orthosis with the distal interphalangeal (DIP) joint extended. PURPOSE OF THE STUDY: To report on our new orthosis and to evaluate the treatment efficacy of using a 2-step orthosis for the treatment of a mallet finger of tendinous origin compared with a conventional orthosis. METHODS: Forty-four patients were randomized into the 2-step or conventional orthosis groups...
October 18, 2016: Journal of Hand Therapy: Official Journal of the American Society of Hand Therapists
Eric L Scholten, Roy Semaan, Peter Illei, Christopher Mallow, Sixto Arias, David Feller-Kopman, Karen Oakjones-Burgess, Bernice Frimpong, Ricardo Ortiz, Hans Lee, Lonny Yarmus
BACKGROUND: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) of thoracic structures is a commonly performed tissue sampling technique. The usage of an inner-stylet in the EBUS needle has never been rigorously evaluated, and may be unnecessary. METHODS: In a prospective randomized single blinded controlled clinical trial, patients with a clinical indication for EBUS-TBNA underwent lymph node sampling using both with-stylet and without-stylet techniques...
October 18, 2016: Chest
Kristy Bultema, Sara Fowler, Melissa Drum, Al Reader, John Nusstein, Mike Beck
INTRODUCTION: In the treatment of patients with symptomatic irreversible pulpitis, endodontic debridement is a predictable method to relieve pain. However, there are clinical situations in which emergency care cannot be provided immediately. An unexplored treatment option in these cases may be the use of a long-acting anesthetic to reduce pain in untreated irreversible pulpitis. Some medical studies have shown potential for infiltrations of liposomal bupivacaine (Exparel; Pacira Pharmaceuticals, San Diego, CA) to prolong pain relief and reduce opioid use postoperatively...
October 18, 2016: Journal of Endodontics
Paul H Lee, Andy C Y Tse
BACKGROUND: There are limited data on the quality of reporting of information essential for replication of the calculation as well as the accuracy of the sample size calculation. We examine the current quality of reporting of the sample size calculation in randomized controlled trials (RCTs) published in PubMed and to examine the variation in reporting across study design, study characteristics, and journal impact factor. We also reviewed the targeted sample size reported in trial registries...
October 18, 2016: European Journal of Internal Medicine
S Gueli Alletti, M Petrillo, G Vizzielli, C Bottoni, F Nardelli, B Costantini, L Quagliozzi, V Gallotta, G Scambia, A Fagotti
OBJECTIVE: To further investigate the role of MIS comparing patients submitted to MI-IDS with a balanced population treated by standard laparotomy. METHODS: The investigational arm (Cases) includes 30 AEOC patients treated with MI-IDS. The Control arm included a consecutive series of 65 AEOC patients submitted to laparotomic IDS. Inclusion criteria were: age>18years, histologically proven EOC, clinical complete/partial response after NACT, and ECOG PS <2. Preoperative clinical data, perioperative and oncological outcomes were analyzed...
October 18, 2016: Gynecologic Oncology
Zainab Khan, Jordan Milko, Munir Iqbal, Moness Masri, David R P Almeida
OBJECTIVE: To investigate the power of unpaired t tests in prospective, randomized controlled trials when these tests failed to detect a statistically significant difference and to determine the frequency of type II errors. DESIGN: Systematic review and meta-analysis. METHODS: We examined all prospective, randomized controlled trials published between 2010 and 2012 in 4 major ophthalmology journals (Archives of Ophthalmology, British Journal of Ophthalmology, Ophthalmology, and American Journal of Ophthalmology)...
October 2016: Canadian Journal of Ophthalmology. Journal Canadien D'ophtalmologie
Sarah A Moore, Ruth Da Silva, Madelaine Balaam, Lianne Brkic, Dan Jackson, Dan Jamieson, Thomas Ploetz, Helen Rodgers, Lisa Shaw, Frederike van Wijck, Christopher Price
BACKGROUND: Loss of upper limb function affects up to 85 % of acute stroke patients. Recovery of upper limb function requires regular intensive practise of specific upper limb tasks. To enhance intensity of practice interventions are being developed to encourage patients to undertake self-directed exercise practice. Most interventions do not translate well into everyday activities and stroke patients continue to find it difficult remembering integration of upper limb movements into daily activities...
October 21, 2016: Trials
Maximilian Bures, Patrick Zardo, Florian Länger, Ruoyu Zhang
BACKGROUND: Albumin-glutaraldehyde glue has gained widespread acceptance for treatment of alveolar air leaks (AAL) in thoracic surgery. As liquid run-off during application is detrimental to its sealing efficacy, we developed a modified technique and assessed it in vitro. METHODS: Caudal lobes of freshly excised swine lungs (n = 20) were intubated and ventilated. A standardized focal superficial parenchymal defect (40 × 25 mm) was created on the inflated lung...
October 21, 2016: Journal of Cardiothoracic Surgery
Ying Zhang, Jin Sun, Yun-Jiao Zhang, Qian-Yun Chai, Kang Zhang, Hong-Li Ma, Xiao-Ke Wu, Jian-Ping Liu
BACKGROUND: Although Traditional Chinese Medicine (TCM) has been widely used in clinical settings, a major challenge that remains in TCM is to evaluate its efficacy scientifically. This randomized controlled trial aims to evaluate the efficacy and safety of berberine in the treatment of patients with polycystic ovary syndrome. In order to improve the transparency and research quality of this clinical trial, we prepared this statistical analysis plan (SAP). METHODS: The trial design, primary and secondary outcomes, and safety outcomes were declared to reduce selection biases in data analysis and result reporting...
October 21, 2016: Trials
Mahnaz Ashoorkhani, Ali Bozorgi, Reza Majdzadeh, Hamed Hosseini, Ali Yoonessi, Ali Ramezankhani, Hassan Eftekhar
BACKGROUND: Hypertension is one of the most important and well-known risk factors for cardiovascular diseases. Unfortunately, in spite of effective treatments, adherence to the regular use of drugs and other nondrug treatments, such as lifestyle improvement, is often poor. This study evaluates the effectiveness of an educational, supportive intervention - in the form of a Blood Pressure Management Application (BPMAP) - on self-management in patients with primary hypertension on controlling the determinant factors of hypertension, and on adherence to treatment...
October 21, 2016: Trials
Hanna F Skjåkødegård, Yngvild S Danielsen, Mette Morken, Sara-Rebekka F Linde, Rachel P Kolko, Katherine N Balantekin, Denise E Wilfley, Pétur B Júlíusson
BACKGROUND: The purpose of the FABO-study is to evaluate the effect of family-based behavioral social facilitation treatment (FBSFT), designed to target children's family and social support networks to enhance weight loss outcomes, compared to the standard treatment (treatment as usual, TAU) given to children and adolescents with obesity in a routine clinical practice. METHODS: Randomized controlled trial (RCT), in which families (n = 120) are recruited from the children and adolescents (ages 6-18 years) referred to the Obesity Outpatient Clinic (OOC), Haukeland University Hospital, Norway...
October 21, 2016: BMC Public Health
Charles Kaboré, Valéry Ridde, Séni Kouanda, Ludovic Queuille, Paul-André Somé, Isabelle Agier, Alexandre Dumont
BACKGROUND: Since 2006, Burkina Faso has subsidized the cost of caesarean sections to increase their accessibility. Caesareans are performed by obstetricians, general practitioners, and nurses trained in emergency surgery. While the national caesarean rate is still too low (only 2 % in 2010), 12 to 24 % of caesareans performed in hospital are, in fact, not medically indicated. The objective of this study is to evaluate the effectiveness and analyze the implementation of a multi-faceted intervention to lower the rate of non-medically indicated caesareans in Burkina Faso...
October 21, 2016: BMC Pregnancy and Childbirth
David Faraoni, Simon Thomas Schaefer
Randomized controlled trials (RCTs) are considered the gold standard for clinical research, thus having a high impact on clinical guidelines and our daily patients' care. However, various treatment strategies which we consider "evidence based" have never been subject to a prospective RCT, as we would rate it unethical to withheld an established treatment to individuals in an placebo controlled trial.In a recent BMC Anesthesiology publication, Trentino et al. analyzed the usefulness of observational studies in assessing benefit and risk of different transfusion strategies...
October 21, 2016: BMC Anesthesiology
Matthew D Hale, Matthew Nankivell, Gordon G Hutchins, Sally P Stenning, Ruth E Langley, Wolfram Mueller, Nicholas P West, Alexander I Wright, Darren Treanor, Lindsay C Hewitt, William H Allum, David Cunningham, Jeremy D Hayden, Heike I Grabsch
BACKGROUND: Neoadjuvant chemotherapy followed by surgery is the standard of care for UK patients with locally advanced resectable oesophageal carcinoma (OeC). However, not all patients benefit from multimodal treatment and there is a clinical need for biomarkers which can identify chemotherapy responders. This study investigated whether the proportion of tumour cells per tumour area (PoT) measured in the pre-treatment biopsy predicts chemotherapy benefit for OeC patients. PATIENTS AND METHODS: PoT was quantified using digitized haematoxylin/eosin stained pre-treatment biopsy slides from 281 OeC patients from the UK MRC OE02 trial (141 treated by surgery alone (S); 140 treated by 5-fluorouracil/cisplatin followed by surgery (CS))...
October 18, 2016: Oncotarget
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