PRECIOUS: PREvention of Complications to Improve OUtcome in elderly patients with acute Stroke-statistical analysis plan of a randomised, open, phase III, clinical trial with blinded outcome assessment.

abstract：:The period toward the end of patients' participation in late stage blinded clinical trials is highly resource intensive for the sponsor. Consider first a Phase 3 trial. If the trial is a success, the sponsor has to implement the next steps, which might be filing for approval of the drug with the US Food and Drug Admin...

journal_title：Trials

authors： Ganju J

更新日期：2016-07-20 00:00:00

abstract：BACKGROUND:Impulsivity and compulsivity are related to emotional and social maladjustment and often underlie psychiatric disorders. Recently, alterations in microbiota composition have been shown to have implications for brain development and social behavior via the microbiota-gut-brain axis. However, the exact mechani...

journal_title：Trials

authors： Arteaga-Henríquez G,Rosales-Ortiz SK,Arias-Vásquez A,Bitter I,Ginsberg Y,Ibañez-Jimenez P,Kilencz T,Lavebratt C,Matura S,Reif A,Rethelyi J,Richarte V,Rommelse N,Siegl A,Ramos-Quiroga JA

更新日期：2020-02-11 00:00:00

abstract：BACKGROUND:Haemorrhage remains a leading cause of morbidity and mortality in trauma patients. Fibrinogen is an essential endogenous component of haemostasis and the plasma level is associated with bleeding, transfusion and outcome. Fibrinogen concentrate is widely used to correct acquired hypofibrinogenaemia, recommend...

journal_title：Trials

authors： Steinmetz J,Sørensen AM,Henriksen HH,Lange T,Larsen CF,Johansson PI,Stensballe J

更新日期：2016-07-19 00:00:00

abstract：BACKGROUND:Assistive technology and telecare (ATT) are relatively new ways of delivering care and support to people with social care needs. It is claimed that ATT reduces the need for community care, prevents unnecessary hospital admission, and delays or prevents admission into residential or nursing care. The current ...

journal_title：Trials

authors： Leroi I,Woolham J,Gathercole R,Howard R,Dunk B,Fox C,O'Brien J,Bateman A,Poland F,Bentham P,Burns A,Davies A,Forsyth K,Gray R,Knapp M,Newman S,McShane R,Ritchie C

更新日期：2013-10-23 00:00:00

abstract：BACKGROUND:Cardiovascular disease (CVD) is a major contributor to the burden of disease and the number one cause of death worldwide. From 1990 until today, more people died from coronary heart disease than from any other cause. CVD is regularly treated with minimally or non-minimally invasive off- or on-pump cardiothor...

journal_title：Trials

authors： Moza A,Benstoem C,Autschbach R,Stoppe C,Goetzenich A

更新日期：2015-12-02 00:00:00

abstract：BACKGROUND:Acute mountain sickness (AMS) is a cluster of symptoms that commonly occur in those ascending to high altitudes. Symptoms can include headaches, nausea, insomnia and fatigue. Exposure to high altitude can also lead to high-altitude cerebral oedema (HACE), which is a potential cause of death whilst mountainee...

journal_title：Trials

authors： Fisher O,Benson RA,Wayte S,Kimani PK,Hutchinson C,Imray CHE

更新日期：2019-10-24 00:00:00

abstract：BACKGROUND:Chest tube insertion is a standard intervention for management of various injuries of the thorax. Quick and accurate execution facilitates efficient therapy without further complications. Here, we propose a new training concept comprised of e-learning elements as well as continuous rating using an objective ...

journal_title：Trials

authors： Friedrich M,Bergdolt C,Haubruck P,Bruckner T,Kowalewski KF,Müller-Stich BP,Tanner MC,Nickel F

更新日期：2017-02-06 00:00:00

abstract：BACKGROUND:Spin in the reporting of randomized controlled trials, where authors report research in a way that potentially misrepresents results and mislead readers, has been demonstrated in the broader medical literature. We investigated spin in wound care trials with (a) no statistically significant result for the pri...

journal_title：Trials

authors： Lockyer S,Hodgson R,Dumville JC,Cullum N

更新日期：2013-11-06 00:00:00

abstract：BACKGROUND:Motivational interviewing (MI) has great potential in changing health-related behaviors. In addition to delivery in face-to-face individual counseling, MI can be delivered through online groups, a method that is particularly appealing to adolescents and may offer several benefits. This randomized controlled ...

journal_title：Trials

authors： Gao X,Lo EC,McGrath C,Ho SM

更新日期：2015-09-18 00:00:00

abstract：BACKGROUND:Children in low and middle-income countries (LMICs) are at risk for problems in their cognitive, social and behavioural development. Factors such as a lack of cognitive stimulation, harsh parenting practices, and severe and persistent aggression in early childhood are central to the genesis of these problems...

journal_title：Trials

authors： Dowdall N,Cooper PJ,Tomlinson M,Skeen S,Gardner F,Murray L

更新日期：2017-03-09 00:00:00

abstract：BACKGROUND:In a sham-controlled double-blind trial, we aim to establish the efficacy and safety of the local application of laser therapy in patients with diabetes, onychomycosis and risk factors for diabetes-related foot complications. Onychomycosis leads to thickened and distorted nails, which in turn lead to increas...

journal_title：Trials

authors： Nijenhuis-Rosien L,Kleefstra N,Wolfhagen MJ,Groenier KH,Bilo HJ,Landman GW

更新日期：2015-03-22 00:00:00

abstract：BACKGROUND:For the last decade continuous efforts have been made to translate regenerative cell therapy protocols in the cardiovascular field from 'bench to bedside'. Successful clinical introduction, supporting safety, and feasibility of this new therapeutic approach, led to the initiation of the German, Phase III, mu...

journal_title：Trials

authors： Donndorf P,Kaminski A,Tiedemann G,Kundt G,Steinhoff G

更新日期：2012-07-02 00:00:00

abstract：BACKGROUND:This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up. These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data. The cha...

journal_title：Trials

authors： Smith C,Ngo TD,Edwards P,Free C

更新日期：2014-11-12 00:00:00

abstract：BACKGROUND:Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers. Internet-based mental health interventions have the potential to be more engaging and accessi...

journal_title：Trials

authors： Abbott JA,Klein B,McLaren S,Austin DW,Molloy M,Meyer D,McLeod B

更新日期：2014-12-23 00:00:00

abstract：BACKGROUND:The increasing prevalence and associated cost of treating chronic obstructive pulmonary disease (COPD) is unsustainable, and focus is needed on self-management and prevention of hospital admissions. Telehealth monitoring of patients' vital signs allows clinicians to prioritise their workload and enables pati...

journal_title：Trials

authors： Bentley CL,Mountain GA,Thompson J,Fitzsimmons DA,Lowrie K,Parker SG,Hawley MS

更新日期：2014-08-06 00:00:00

abstract：BACKGROUND:Spleen qi deficiency (SQD), a syndrome based on traditional Chinese medicine (TCM) theory, is common in patients after radical gastrectomy. SQD manifests with chronic gastrointestinal disorders and systemic symptoms and is challenging to manage. Hou Gu Mi Xi (HGMX) is a dietary TCM formula for SQD. This stud...

journal_title：Trials

authors： Zhou X,Yan DM,Zhu WF,Liu WJ,Nie HY,Xu S,Jiang YP,Zhang KH,Fu Y,Wan YY,Yu XY,Li H,Sun X,Chen XF

更新日期：2019-06-10 00:00:00

abstract：BACKGROUND:Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICB...

journal_title：Trials

authors： Mechler J,Lindqvist K,Carlbring P,Lilliengren P,Falkenström F,Andersson G,Topooco N,Johansson R,Midgley N,Edbrooke-Childs J,J Dahl HS,Sandell R,Thorén A,Ulberg R,Lindert Bergsten K,Philips B

更新日期：2020-06-29 00:00:00

abstract：BACKGROUND:Three decades of research suggests that prevention of iron deficiency anemia (IDA) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children. A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term...

journal_title：Trials

authors： Abdullah K,Thorpe KE,Mamak E,Maguire JL,Birken CS,Fehlings D,Hanley AJ,Macarthur C,Zlotkin SH,Parkin PC

更新日期：2015-04-02 00:00:00

abstract：BACKGROUND:Burnout is an occupational syndrome that leads to mental health problems, job turnover, and patient safety events. Those caring for critically ill patients are especially susceptible due to high patient mortality, long hours, and regular encounters with trauma and ethical issues. Interventions to prevent bur...

journal_title：Trials

authors： Bateman ME,Hammer R,Byrne A,Ravindran N,Chiurco J,Lasky S,Denson R,Brown M,Myers L,Zu Y,Denson JL

更新日期：2020-12-11 00:00:00

abstract：BACKGROUND:Many funding bodies require researchers to actively involve service users in research to improve relevance, accountability and quality. Current guidance to researchers mainly discusses general principles. Formal guidance about how to involve service users operationally in the conduct of trials is lacking. We...

journal_title：Trials

authors： Evans BA,Bedson E,Bell P,Hutchings H,Lowes L,Rea D,Seagrove A,Siebert S,Smith G,Snooks H,Thomas M,Thorne K,Russell I,West Wales Organisation for Rigorous Trials in Health (WWORTH).

更新日期：2013-07-17 00:00:00

abstract：BACKGROUND:Depression is one of the most common reasons for consulting in primary care. Acupuncture is a popular complementary therapy choice for depression but its evidence base is poor with more robust high quality trials being required. More than half of depressed patients experience painful symptoms, with severe pa...

journal_title：Trials

authors： Schroer S,Macpherson H

更新日期：2009-01-09 00:00:00

abstract：BACKGROUND:Non-retention of participants seriously affects the credibility of clinical trial results and significantly reduces the potential of a trial to influence clinical practice. Non-retention can be defined as instances where participants leave the study prematurely. Examples include withdrawal of consent and los...

journal_title：Trials

authors： Gillies K,Bower P,Elliott J,MacLennan G,Newlands RSN,Ogden M,Treweek SP,Wells M,Witham MD,Young B,Francis JJ

更新日期：2018-03-27 00:00:00

abstract：BACKGROUND:After major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complica...

journal_title：Trials

authors： Straatman J,Cuesta MA,Schreurs WH,Dwars BJ,Cense HA,Rijna H,Sonneveld DJ,den Boer FC,de Lange-de Klerk ES,van der Peet DL

更新日期：2015-08-28 00:00:00

abstract：BACKGROUND:The preliminary results of a randomised controlled trial are presented. The aim of the trial is to determine the efficacy, feasibility and acceptability of email-delivered psychological interventions with telephone support, for adults injured in a motor vehicle crash engaged in seeking compensation. The prim...

journal_title：Trials

authors： Guest R,Tran Y,Gopinath B,Cameron ID,Craig A

更新日期：2018-06-27 00:00:00

abstract：BACKGROUND:Linezolid, an oxazolidinone, substantially improves treatment outcomes of multidrug-resistant tuberculosis and extensively drug-resistant tuberculosis. We started a trial to test whether the use of linezolid instead of ethambutol could increase the rate of sputum culture conversion as of 8 weeks of treatment...

journal_title：Trials

authors： Lee JY,Kim DK,Lee JK,Yoon HI,Jeong I,Heo E,Park YS,Lee JH,Park SS,Lee SM,Lee CH,Lee J,Choi SM,Park JS,Joh JS,Cho YJ,Lee YJ,Kim SJ,Hwang YR,Kim H,Ki J,Choi H,Han J,Ahn H,Hahn S,Yim JJ

更新日期：2017-02-13 00:00:00

abstract：BACKGROUND:Subacromial impingement syndrome (SIS) is a painful, and often long lasting, shoulder condition affecting patient function and quality of life. In a recent study, we observed major strength impairments in shoulder external rotation and abduction (~30%) in a population of patients with pronounced and long-las...

journal_title：Trials

authors： Clausen MB,Bandholm T,Rathleff MS,Christensen KB,Zebis MK,Graven-Nielsen T,Hölmich P,Thorborg K

更新日期：2018-03-02 00:00:00

abstract：BACKGROUND:Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can negatively influence trunk muscle strength, balance, and endurance, the military readiness of active-...

journal_title：Trials

authors： Vining R,Minkalis A,Long CR,Corber L,Franklin C,Gudavalli MR,Xia T,Goertz CM

更新日期：2018-12-05 00:00:00

abstract：BACKGROUND:Patients taking opioids are known to develop opioid-induced constipation (OIC), which reduces their quality of life. The aim of this study is to compare magnesium oxide with naldemedine and determine which is more effective in preventing OIC. METHODS:This proof-of-concept, prospective, randomized controlled...

journal_title：Trials

authors： Ozaki A,Kessoku T,Iwaki M,Kobayashi T,Yoshihara T,Kato T,Honda Y,Ogawa Y,Imajo K,Higurashi T,Yoneda M,Taguri M,Yamanaka T,Ishiki H,Kobayashi N,Saito S,Ichikawa Y,Nakajima A

更新日期：2020-06-01 00:00:00

abstract：BACKGROUND:Distal pancreatectomy for benign and malignant tumours is the second most common surgical procedure on the pancreas. Postoperative pancreatic fistulas (POPF) represent the most significant clinical complication, causing prolongation of hospital stay and the need for additional diagnostic and therapeutic proc...

journal_title：Trials

authors： Hassenpflug M,Bruckner T,Knebel P,Diener MK,Büchler MW,Werner J

更新日期：2013-12-14 00:00:00

abstract：BACKGROUND:Post-dural puncture headache (PDPH) is one of the most common complications of neuraxial anaesthesia. It limits patients' general activity and increases the length of hospital stays and the use of care. It is particularly disabling during the postpartum period, when mothers have to take care of their child. ...

journal_title：Trials

authors： Depaulis C,Steer N,Garessus L,Chassard D,Aubrun F

更新日期：2020-01-08 00:00:00