Methods: This is a randomized clinical trial with parallel groups and a blinded evaluator. There are two non-surgical interventions: AE and BE. Patients will be randomly assigned. A hundred twenty eight consecutive adult patients with acute (up to 7 days) displaced DRF of type A2, A3, C1, C2 or C3 by the Arbeitsgemeinschaft für Osteosynthesefragen (AO) classification will be included. The primary outcome will be the maintenance of reduction by evaluation of radiographic parameters and Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH). Secondary outcomes include function measured by Patient Rated Wrist Evaluation (PRWE), pain measured by the Visual Analogue Scale (VAS), objective functional evaluation (goniometry and dynamometry) and rate of complications. Evaluations will be performed at 1, 2, 3, 4, 6, 8, 12 and 24 weeks. For the Student ’ s t-test, a difference of 10 points in DASH score, with 95% confidence interval, a statistical power of 95%, and 20% sampling error. We consider an extra 10% for balancing follow up losses results in 64 patients per group.
Recent guidelines advise to perform ERC with sphinc- terotomy in case of pancreatitis with cholestasis, but acknowledge the moderate quality of evidence for this recommendation [2, 9]. For those patients with pancrea- titis and at high risk for developing complications (that is, predicted to be severe) without cholangitis, data are conflicting. A meta-analysis found no beneficial effect of routine early ERC compared with conservativetreatment . However, the studies have notable shortcomings that preclude reliable recommendations on the use of ERC in patients with predicted severe biliary pancreatitis with- out cholangitis . First, patients included were those with a low pre-likelihood of a biliary etiology, those at low risk for developing complications (that is, predicted to be mild), and those with cholangitis at presentation. Second, patient selection criteria and study endpoints (complications) varied considerably between studies and also included clinically less relevant complications such as pleural effusion or ascites. Third, the trials did not present data separately regarding liver biochemical tests, an omission that precludes performing a subgroup ana- lysis for patients with cholestasis. Fourth, routine “ early ” ERC was performed during a wide time frame (48 to 72 hours after admission), which may be too late to pre- vent complications from severe disease or increase the risk for ERC-related complications. Fifth, the trial proto- cols did not specify precisely when the sphincterotomy
Any participant must be approved eligible for the study by either one of the consultants in the research group or the house physician on call. Patients are primarily recruited by directly contact in the emergency room on the day of primary contact, where they are informed about the study and asked for written consent. The Danish consent form and patient information material is given to the patient, a blank sample can be ordered from the corresponding author. Every patient who is treated in the emergency department during a shift is discussed the following day on a conference, where all radiographs also are reviewed. This additional control ensures that every potential par- ticipant is assed for eligibility and offered enrollment in the study either directly in the emergency room or the day after by telephone. When recruitment is done over the telephone, written consent is obtained before surgery or at the 2 week out-patient visit, if the participant should be randomly assigned to conservativetreatment or if the patient is in the control group. The recruiting health care personnel randomly assigns participants to the interven- tions as described below.
A recent randomised controlledtrial by Arora et al. compared open reduction and internal fixation with a volar locking plate with closed reduction and plaster im- mobilisation. They included patients of 65 years and older who had suffered all types of displaced distalradius frac- tures with inadequate reduction or redisplacement . The operative treatment group showed better wrist func- tion in the early post-operative period. However, at six and twelve months there were no significant differences in wrist function between treatment groups. At all times, grip strength was significantly better in the operative group. These results are consistent with a previous retrospective cohort study among elderly patients conducted by Arora et al. as well . Future studies compare the quality of
To ensure patients’ safety and integrity of clinical data, e.g., correct informed consent procedure and primary endpoint evaluation in adherence to the studyprotocol, continuous clinical monitoring procedures are set in place. Clinical monitors from the Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany, will introduce all sites to study procedures and documenta- tion before beginning of the trial. Onsite monitoring during the study will be done by personal visits accord- ing to the standard operating procedures of the KKS. The monitors review amongst others the entries into case report forms on the basis of source documents. Therefore, each investigator must allow monitors full access to all essential documents, and must provide necessary support to the monitors. In addition to regu- lar site visits, continuous support is guaranteed through email- and phone communication between monitor and trial site.
Following a successful initial application for a British Society of Elbow and Shoulder Surgery primer grant, a period of 1 year for trial preparation, obtaining ethics approval, and Research and Development approval, a 6 month period establishing and piloting of all trial materials and processes was commenced at the Royal Free Hospital in December 2007, the official start date for general recruitment was July 2008. The award of a BUPA foundation grant allowed the appointment of a dedicated researcher in 2010 and the subsequently inclusion on National Institute of Health Research port- folio of clinical trials has allowed expansion of the trial sites. Currently there are 4 sites recruiting, and 4 further sites are planned, 2 of which have approval in place. The further planned recruitment period is 18 months, and completion of follow-up 9 months later. Study comple- tion, which includes submission of the draft trial report to the funders for publication is scheduled for December 2012. The date of registration of the trial is 07/09/2006. The date the first patient was recruited is 18/12/2007. Dissemination of trial findings
Patients randomised to surgical treatment will undergo preoperative evaluation of age, clinical condition (acute in- fection) and co-morbidities. The intervention will take place in the surgical centre of the institution, where four previously-specified surgeons, who are experienced with the surgical technique described by Livani and Belangero , will perform the surgical procedures. After the anaes- thetic procedure, the patient will be kept in the horizontal dorsal decubitus position and two incisions will be made. The 3 to 5 cm proximal incision will access the proximal fragment between the biceps brachii muscle medially and the deltoid muscle laterally. The 3 to 5 cm distal incision will expose the anterior humeral cortex of the distal frag- ment, after dissection of the lateral cutaneous nerve of the forearm, and after the brachialis muscle is split longitudin- ally (Figure 4). In distal-third fractures, the lateral column
All patients presenting a Cooney Score of at least 90 after 24 months and, if clinically obvious, a radiologic displacement not exceeding 5°, will be compared be- tween treatment groups by calculating a one-sided 97.5 % confidence interval of the difference of rates ac- cording to Farrington and Manning . If this interval is located completely above the noninferiority bound of -5 %, noninferiority of the experimental intervention will be claimed. The primary analysis population is the per- protocol population, comprising all randomized patients without major protocol violations and at least one Cooney score radiological displacement measurement after intervention.
All consecutive adult patients who are diagnosed with a displaced complete articular distalradius fracture (AO/ OTA type C) and scheduled for ORIF will be invited to participate in this study if they meet the inclusion and exclusion criteria. Informed consent will be obtained at the outpatient clinic before the operation. Randomisa- tion will be performed by means of a computerised ran- domisation procedure, using Castor®, which is an online secure randomisation service. Allocation concealment will be ensured until patients have been randomised, which takes place after baseline characteristics have been obtained. The sequence of allocation is concealed until trial completion. To avoid imbalances between treatment groups, patients will be randomised in two strata according to age: 18–65 years and ≥ 65 years using a mixed block randomisation with blocks of four, six and eight patients. The order of the block sizes is unknown to the researchers, who therefore remain blinded to the allocation of the next individual through- out the whole study.
Following a prospective study comparing the different types of DRF immobilisation, Wahlstrom argued that elbow immobilisation was necessary to avoid loss of fracture reduction. However, and in contrast with Sar- miento et al., that author noted that a plaster cast in pronation was associated with a lower incidence of loss of fracture reduction in comparison with one in supin- ation or in the midway position [17, 18]. Bunger et al., on the other hand, published the outcomes of a pro- spective randomised trial comparing functional bracing in supination and dorsal plaster immobilisation of DRF; the former treatment involved an above-elbow func- tional brace in supination, while the second a below- elbow plaster splint. They noted a statistically significant difference in fracture reduction between the two tech- niques, and therefore concluded that the functional brace in supination was preferable to any other immobil- isation technique due to both its capacity to maintain fracture reduction and the excellent clinical results achieved . Fernandez et al. also promoted above- elbow casts in an article published in 2005, maintaining that pronation-supination movement of the forearm was to be prevented in Colles fractures .
Children were randomly assigned to receive either a short arm (belowelbow) plaster cast or an individually fitted plaster splint (composed of 12 plaster layers) that attached with a tensor bandage. A plaster splint was chosen instead of a preformed commercially available splint to reflect the reality of available materials at many hospitals. The randomization sequence was computer- generated with a block size of 4. Initially, a Web-based allocation program was used for group allocation. How- ever, because of problems with timely access to the program, sealed opaque envelopes containing the group assignment were used from November 2003 onward. The research assistant accessed either the Web-based allocation program or used the next envelope to deter- mine to which group the patient was assigned. After random assignment, baseline data and study measure- ments were recorded. The intervention was applied by the research assistant or by the ED medical staff (and monitored by the research assistant). The emergency physician who referred the patient to the study made the initial diagnosis of buckle fracture. Research assistants were available 12 to 16 hours/day. Some patients were recruited when a pediatric radiologist was not available to immediately review the patient films (eg, on week- ends and evenings), but all of the radiographs were reviewed by a pediatric radiologist within 24 hours. We decided a priori to withdraw patients from the study who were subsequently determined to have a fracture other than a buckle fracture. Among these patients, those who had been randomly assigned to a cast re- mained in a cast, whereas those who were randomly assigned to a splint had their treatment changed to a cast.
Absolute values of continuous variables will be expressed using standard summary statistics, arithmetic mean, standard deviation, and corresponding 95 % confidence interval. The study is designed to compare recurrence rates of AF or atrial tachycardia episodes at 24 months between two treatment groups as the primary endpoint. The arrhythmia-free survival rate is defined as the per- centage of patients free of atrial arrhythmias. Fisher’s exact test will be used for this categorical data to assess the difference in frequency of arrhythmia recurrence. The odds ratio and its 95 % confidence interval will be estimated as a quantitative measure of risk in the asso- ciation frequency table. Differences in continuous data describing duration of arrhythmia recurrences will be tested using Student’s t test. Kaplan-Meier curves will be plotted to compare event-free survival time between both groups. The log-rank test will be performed to compare arrhythmia-free survival time distributions between the study arms. Influence of mutually independent risk factors will be quantified on the basis of the hazard ratio (HR) and its 95 % confidence interval. Both univariate and multivariate adjusted HRs will be estimated using the Cox proportional hazard models with an adopted forward stepwise algorithm. All variables will be analyzed on the basis of the intention-to-treat protocol. A P value less than 0.05 will be considered as a boundary of statistical signi- ficance of differences in all performed tests. Analyses will be performed using SPSS version 16.0 (SPSS Inc., Chicago, IL, USA).
Background: Staphylococcus aureus bacteremia is associated with significant morbidity and mortality. To treat this infection, the current standard of care includes intravenous anti-staphylococcal beta-lactam antibiotics and obtaining adequate source control. Combination therapy with an aminoglycoside or rifampin, despite early promise, can no longer be routinely recommended due to an absence of proven benefit and risk of harm. Daptomycin is a rapidly acting bactericidal antibiotic that is approved for the treatment of Staphylococcus aureus bacteremia as monotherapy but has not been shown to be superior to the current standard of care. As demonstrated in vitro, the addition of daptomycin to beta-lactam therapy may result in enhanced anti-staphylococcal activity. Our objective is to assess the efficacy and safety of prescribing the combination of daptomycin with cefazolin or cloxacillin for the treatment of methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia in adults. We hypothesize that adjunctive therapy with daptomycin will reduce the duration of bacteremia in this population.
According to the definition of the clinical, etiological, ana- tomical, and pathological classification (CEAP), the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints. Several invasive techniques are commonly used for treatment, including mini phlebectomy, laser ablation, and radiofrequency ablation. However, a wide range of sclerosing agents may serve as minimally invasive alternatives, promoting chemical sclerosis of the vein wall. Reticular veins have a diameter no greater than 3 mm and are straight, bluish, and located in the subcutaneous tissue of the lower limbs . They have the same complex etiology of all types of primary venous insufficiency such as hormo- nal issues, family history, and standing position [2,3]. How- ever, despite its common occurrence, the condition remains poorly understood . Sclerotherapy is the preferred treat- ment for some patients because of its simplicity and repro- ducibility [5,6], and consists of an intraluminal sclerosing agent application to trigger endothelial injury, with subse- quent luminal occlusion of these segments. Many agents, such as hypertonic saline and hypertonic glucose as hyper- osmolar sclerosing agents, as well as ethamolin® and polido- canol as detergent agents [5,7], are known to be effective. Hypertonic osmotic solutions cause dehydration and de- struction of endothelial cells. Hypertonic dextrose (or glu- cose) and sodium tetradecyl sulfate are commonly used due to their low cost and safety [8-10]. Conversely, polidocanol acts as a detergent on vein wall lipids, destroying the cellular cement and causing endothelial maceration; this process ef- fectively occludes the vein [11-14]. Due to its efficacy and manipulability, the use of polidocanol is quite common throughout the world. Usually, it is mixed with a wide variety of diluents, such as distilled water, air, or hypertonic glucose. However, some collateral damage can occur from these mixtures, including necrosis, hyperpigmentation stains, allergic reactions, and systemic disorders. Chest pain, cough, anaphylaxis, scotoma, and gas embolization are un- usual, but serious adverse events have already been reported in other studies due to this agent, although these issues are commonly related to miscalculated dosages [15-17].
After signing the informed consent form, each patient underwent treatment that included closed reduction and a bridging external fixation (Hoffman Compact II, Stryker AB, Malmö, Sweden) under general anesthesia. All pa- tients were operated on by the authors. All patients were given a single dose of 2 g isoxazolyl penicillin before sur- gery as prophylaxis. Two Apex™ screws (APEX Fasteners Inc., Monrovia, CA, USA) were placed from the dorsal side into the radius and two Apex™ screws were placed from the dorso-radial side into the second metacarpal bone. After the external fixation had been mounted, the fracture was reduced under fluoroscopic guidance into an anatomic or near anatomic position after which the frame was locked. K-wires for temporary fixation were not used in any case, mainly because no severely displaced intraarti- cular fractures were included. The patients were then ran- domized in the operating room to one of two treatment groups using a closed envelope technique with strictly sealed, numbered, and not transparent envelopes.
Allocation to prolonged conservativetreatment may possibly result in subjects becoming less active. As the activity level decreases, situations as walking/standing that give rise to symptoms of neurogenic intermittent claudication diminish and possibly result in symptom/ pain relief. Although physical activity, disability and symptom severity are assessed during follow-up exami- nations, typically the reliability and validity of the mea- surement of habitual physical activity by questionnaires is low . A continuous 7-day measurement with triax- ial accelerometers (GENEA ® , Unilever) provides infor- mation about the total amount, the frequency, the intensity, and the duration of physical activity [31-33]. Further, a common geriatric assessment, the Short Phy- sical Performance Battery (SPPB), is used to assess how well older persons perform simple movements that represent the building blocks of daily activities that require good lower extremity function .
The concept of biofield therapies originates from many different cultures over thousands of years . Currently, biofield therapies are used increasingly in modern-day healthcare and have only recently been studied by con- ventional scientific methods to evaluate their actual effects. Biofield therapies are defined as noninvasive, practitioner-mediated practices that stimulate the heal- ing response in patients. Biofield therapies show strong evidence of reducing pain intensity in pain populations and moderate evidence of reducing pain intensity in hospitalized and cancer patient populations . Au- thors of a recent review  reported 18 clinical trials on biofield therapies with a high level of evidence, among which 12 had at least one primary outcome with statistically significant beneficial treatment. More mod- erate evidence in a nonrandomized study showed a decrease in depressed mood  or reduced pain after biofield therapies in populations with cancer . These healing practices involve electromagnetic fields that are delivered either proximally (with the practitioner and the receiver in the same room) or distally. Biofield therapy produces a wide variety of clinically significant effects, including growth enhancement, wound repair, regeneration, and reduction of pain [6–10], but, to our knowledge, nothing has been studied to date in the treatment of warts. Palmar or plantar warts are one of the most common infectious skin diseases caused by the human papillomavirus. Even if warts are benign skin growths that disappear over time without treat- ment, they remain unsightly and contagious and can cause significant discomfort. The main topical treat- ments for cutaneous warts are summarized in a Cochrane review . Salicylic acid and cryotherapy stand out as the most commonly used treatments, but they remain only moderately effective. Resistance of warts to conventional therapies leads some patients to use alternative medicine such as biofield therapies, and most of them report positive results. At this stage, however, there is no clear or convincing scientific evi- dence to prove a positive effect. Despite controversies and current gaps in research studies, biofield therapies are widely used by a significant number of patients. Some believe that this response derives partly from the placebo effect.
A sterile protocol was followed as for any other musculo- skeletal intervention. The subcutaneous tissues overlying the lateral epicondyle were infiltrated tangential to the plane of the lateral epicondyle with 2 mL lidocaine via a 22-gauge hypodermic needle. Then, the bulb containing the injectable (PRP or lidocaine) was connected to the nee- dle, which was inserted parallel to the tendon long axis, from distal to proximal. The tendon was repeatedly fenes- trated (15–25 times) by redirecting the needle in different directions, until softening of the tissue. In addition to pier- cing the tendon, the tip needle was used to abrade the peri- osteum. At the same time, the injectable was delivered in the areas of hypoechogenicity and the surround. A second intervention, involving approximately ten tendon perfora- tions and no abrasions of the periosteum, was performed after 2 weeks. We injected 4.23 ± 1.09 mL (range 1 – 5) of lidocaine and 4.47 ± 1.11 (range 1–5) of PRP in the first intervention and 4.18 ± 1.14 mL (range 1–5) of lidocaine and 4.53 ± 0.88 mL (range 2 – 5) of PRP in the second inter- vention. There were no differences between the injected volumes. After each intervention, patients were instructed to rest for the first 48 h and avoid weight lifting. Patients did not follow any post-procedural exercise programme, but they modified their activities and resumed physical work upon demand.
Conservativetreatment consists of a subacromial steroid infiltration. The first infiltration will be performed imme- diately following inclusion. Using a 21-gauge needle with the covered syringe, the treating orthopedic surgeon injects the patient ’ s subacromial bursa via the anterolat- eral approach applying an aseptic technique . If no relief is obtained with the first subacromial infiltration, a second infiltration will be performed under radiological or ultrasound guidance. The infiltration will be repeated at a maximum of three times. Further treatment consists of analgesic medication with NSAIDs, paracetamol, and/ or tramadol. Patients will be referred to a physiotherapist that uses a standardized protocol developed by the Department of Physical Therapy of Martini Hospital (Table 1). During the first 4 weeks passive movements will be performed to preserve glenohumeral and scapu- lothoracic mobility. After 6 weeks active movements will be performed. Twelve weeks after commencement of treatment physiotherapy will be aimed at strength regen- eration. Mobility will be further optimized. Physical ther- apy is continued until patients reach a full range of motion and an improvement in strength is achieved.
Potential participants will be identified by AVIVA claims adjusters when policy holders contact AVIVA's claim center to report an injury. The adjuster will determine whether the claimant resides or works within the catch- ment areas of our treatment centers and has sustained a physical injury during the motor vehicle collision. If both these criteria are met, she/he will use a standardized script to invite the claimant to learn more about the trial. Claim- ants who are interested will be referred immediately to the University Health Network (UHN) trial coordinator who will arrange an appointment at the nearest study clinic to assess the claimant's eligibility for the trial.