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Clinical trial recruitment

Andrew B Schenkel, Ivy Peltz, Analia Veitz-Keenan
BACKGROUND: Resin-based composite (RBC) is currently accepted as a viable material for the restoration of caries for posterior permanent teeth requiring surgical treatment. Despite the fact that the thermal conductivity of the RBC restorative material closely approximates that of natural tooth structure, postoperative hypersensitivity is sometimes still an issue. Dental cavity liners have historically been used to protect the pulp from the toxic effects of some dental restorative materials and to prevent the pain of thermal conductivity by placing an insulating layer between restorative material and the remaining tooth structure...
October 25, 2016: Cochrane Database of Systematic Reviews
Karen J Mickle, Peter Caputi, Jan M Potter, Julie R Steele
BACKGROUND: Reduced toe flexor strength is an independent predictor of falls in older people. However it is unknown whether strengthening programs can restore toe flexor strength in older individuals. The aim of this study was to investigate whether a progressive resistance training program, focused specifically on the foot muscles, could improve toe flexor strength in community-dwelling older people. METHODS: After baseline testing, 85 men and women (age range 60-90years) were randomized to either a supervised, progressive resistance training (n=43) or a home-based exercise (n=42) group for 12weeks...
October 7, 2016: Clinical Biomechanics
Barbara Farquharson, Marie Johnston, Karen Smith, Brian Williams, Shaun Treweek, Stephan U Dombrowski, Nadine Dougall, Purva Abhyankar
AIMS: To evaluate the efficacy of a behaviour change technique-based intervention and compare two possible modes of delivery (text+visual and text-only) with usual care. BACKGROUND: Patient delay prevents many people from achieving optimal benefit of time-dependent treatments for Acute Coronary Syndrome. Reducing delay would reduce mortality and morbidity, but interventions to change behaviour have had mixed results. Systematic inclusion of behaviour change techniques or a visual mode of delivery might improve the efficacy of interventions...
October 25, 2016: Journal of Advanced Nursing
Oma N Agbai, Parastoo Davari, Jennifer Johnson, April Armstrong, Nasim Fazel
INTRODUCTION: Patient treatment satisfaction and adherence may be affected by the initial understanding of outcomes in the treatment of actinic keratoses with 5-fluorouracil 5% cream (5-FU). Pre-treatment educational videos may optimize this understanding. The objective of this study was to determine whether prospective patient viewing of an educational video delineating treatment effects and expectations improves patient satisfaction and treatment completion rates for the treatment of actinic keratoses with 5-FU...
October 24, 2016: Dermatology and Therapy
Shinji Kuroda, Satoru Kikuchi, Masahiko Nishizaki, Shunsuke Kagawa, Shiro Hinotsu, Toshiyoshi Fujiwara
Although intermittent pneumatic compression (IPC) has become common as perioperative prophylaxis for venous thromboembolism (VTE) consisting of pulmonary thromboembolism (PE) and deep vein thrombosis (DVT), the prophylactic effect against VTE, especially lethal PE, is not yet satisfactory. Therefore, pharmacologic prophylaxis, such as with enoxaparin, is desirable. While the efficacy and safety of enoxaparin have been proven in several clinical trials, concern about bleeding with longterm (at least 7 days) use have potentially decreased its widespread adoption...
October 2016: Acta Medica Okayama
Christopher Coyle, Fay H Cafferty, Samuel Rowley, Mairead MacKenzie, Lindy Berkman, Sudeep Gupta, C S Pramesh, Duncan Gilbert, Howard Kynaston, David Cameron, Richard H Wilson, Alistair Ring, Ruth E Langley
BACKGROUND: There is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy. METHODS: Add-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n=3100), colorectal (n=2600), gastro-oesophageal (n=2100) or prostate cancer (n=2120) are registered into four tumour specific cohorts...
October 21, 2016: Contemporary Clinical Trials
Salah-Eddin Al-Batran, Ralf D Hofheinz, Claudia Pauligk, Hans-Georg Kopp, Georg Martin Haag, Kim Barbara Luley, Johannes Meiler, Nils Homann, Sylvie Lorenzen, Harald Schmalenberg, Stephan Probst, Michael Koenigsmann, Matthias Egger, Nicole Prasnikar, Karel Caca, Jörg Trojan, Uwe M Martens, Andreas Block, Wolfgang Fischbach, Rolf Mahlberg, Michael Clemens, Gerald Illerhaus, Katja Zirlik, Dirk M Behringer, Wolff Schmiegel, Michael Pohl, Michael Heike, Ulrich Ronellenfitsch, Martin Schuler, Wolf O Bechstein, Alfred Königsrainer, Timo Gaiser, Peter Schirmacher, Wael Hozaeel, Alexander Reichart, Thorsten O Goetze, Mark Sievert, Elke Jäger, Stefan Mönig, Andrea Tannapfel
BACKGROUND: Docetaxel-based chemotherapy is effective in metastatic gastric and gastro-oesophageal junction adenocarcinoma, but has not yet been evaluated in the context of resectable patients. Here we report findings from the phase 2 part of the phase 2/3 FLOT4 trial, which compared histopathological regression in patients treated with a docetaxel-based triplet chemotherapy versus an anthracycline-based triplet chemotherapy before surgical resection. METHODS: In this randomised, open-label, phase 2/3 study, eligible participants were recruited from 28 German oncology centres...
October 21, 2016: Lancet Oncology
F Franceschi, S Togni, G Belcaro, M Dugall, R Luzzi, A Ledda, L Pellegrini, R Eggenhoffner, L Giacomelli
OBJECTIVE: Several experimental studies and clinical trials support the potential of Boswellia serrata extracts (BSE) for the treatment of various inflammatory diseases. The aim of this registry study was to assess the safety and the efficacy of a novel lecithin-based delivery form of Boswellia serrata extract (Casperome®) in the supportive management of osteo-muscular pain. PATIENTS AND METHODS: 52 healthy young rugby players with acute knee pain and inflammation were recruited...
October 2016: European Review for Medical and Pharmacological Sciences
David Okai, Sally Askey-Jones, Joel Mack, Anne Martin, Kallol Ray Chaudhuri, Michael Samuel, Anthony S David, Richard G Brown
BACKGROUND: Impulse-control behaviors (ICBs) are increasingly recognized in Parkinson's disease (PD) as drug-related effects of dopaminergic mediation that occur in 15% to 35% of patients with PD. The authors describe the design and evaluation of a new, clinician-rated severity scale for the assessment of syndromal and subsyndromal forms of impulse-control disorders (ICDs), simple (punding) and complex (hobbyism) repetitive behaviors, and compulsive overuse of medication (dopamine dysregulation syndrome)...
September 2016: Movement Disorders Clinical Practice
Michelle L Munro-Kramer, Nicole M Fava, Tanima Banerjee, Cynthia S Darling-Fisher, Michelle Pardee, Antonia M Villarruel, Kristy K Martyn
INTRODUCTION: The purpose of this study was to examine the effect of a youth-centered assessment, the Sexual Risk Event History Calendar (SREHC), compared with the Guidelines for Adolescent Preventive Services (GAPS) assessment, on sexual risk attitudes, intentions, and behaviors. METHODS: The Interaction Model of Client Health Behavior guided this participatory research-based randomized control trial. Youth participants recruited from university and community clinics in the Midwestern United States were randomized to a health care provider visit using either the SREHC or GAPS and completed surveys at baseline, postintervention, and 3, 6, and 12 months...
October 20, 2016: Journal of Pediatric Health Care
Handoo Rhee, John Blazak, Chui Ming Tham, Keng Lim Ng, Benjamin Shepherd, Malcolm Lawson, John Preston, Ian Vela, Paul Thomas, Simon Wood
BACKGROUND: In this study, we prospectively evaluate the diagnostic potential of a gallium-68 (68Ga) prostate-specific membrane antigen (PSMA)-binding ligand and positron emission tomography (PET) in detecting metastatic lesions in patients with renal tumour. The secondary aim was to determine whether the findings would result in the alteration of patient management. RESULTS: Ten patients with renal lesion and potential metastatic disease on conventional imaging were recruited...
December 2016: EJNMMI Research
Katherinne Ferro Moura Franco, Yuri Rafael Dos Santos Franco, Naiane Teixeira Bastos de Oliveira, Gisela Cristiane Miyamoto, Matheus Oliveira Santos, Richard Eloin Liebano, Cristina Maria Nunes Cabral
OBJECTIVE: To determine whether interferential current prior to Pilates exercises is more effective than placebo in patients with chronic non-specific low back pain. DESIGN: Two-arm randomized controlled trial, with blinded assessor, and six months follow-up. SETTING: Clinic of the School of Physical Therapy. PARTICIPANTS: The random sample consisted of 148 patients of both genders, with age between 18 and 80 and chronic non-specific low back pain...
October 19, 2016: Archives of Physical Medicine and Rehabilitation
Sonia Johnson, Luke Sheridan Rains, Steven Marwaha, John Strang, Thomas Craig, Tim Weaver, Paul McCrone, Michael King, David Fowler, Stephen Pilling, Louise Marston, Rumana Z Omar, Meghan Craig, Mark Hinton
BACKGROUND: Around 35-45 % of people in contact with services for a first episode of psychosis are using cannabis. Cannabis use is associated with delays in remission, poorer clinical outcomes, significant increases in the risk of relapse, and lower engagement in work or education. While there is a clear need for effective interventions, so far only very limited benefits have been achieved from psychological interventions. Contingency management (CM) is a behavioural intervention in which specified desired behavioural change is reinforced through financial rewards...
October 22, 2016: Trials
Donna M Urquhart, Anita E Wluka, Malcolm R Sim, Maurits van Tulder, Andrew Forbes, Stephen J Gibson, Carolyn Arnold, Chris Fong, Shane N Anthony, Flavia M Cicuttini
BACKGROUND: Low back pain is a major clinical and public health problem, with limited evidence-based treatments. Low-dose antidepressants are commonly used to treat pain in chronic low back pain. However, their efficacy is unproven. The aim of this pragmatic, double-blind, randomised, placebo-controlled trial is to determine whether low-dose amitriptyline (an antidepressant) is more effective than placebo in reducing pain in individuals with chronic low back pain. METHODS/DESIGN: One hundred and fifty individuals with chronic low back pain will be recruited through hospital and private medical and allied health clinics, advertising in local media and posting of flyers in community locations...
October 22, 2016: Trials
Dennis Toddenroth, Janakan Sivagnanasundaram, Hans-Ulrich Prokosch, Thomas Ganslandt
BACKGROUND: The difficulty of managing patient recruitment and documentation for clinical trials prompts a demand for instruments for closely monitoring these critical but unpredictable processes. Increasingly adopted Electronic Data Capture (EDC) applications provide novel opportunities to reutilize stored information for an efficient management of traceable trial workflows. In related clinical and administrative settings, so-called digital dashboards that continuously visualize time-dependent parameters have recently met a growing acceptance...
October 18, 2016: Journal of Biomedical Informatics
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
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
Wouter van Ballegooijen, Jeroen Ruwaard, Eirini Karyotaki, David D Ebert, Johannes H Smit, Heleen Riper
BACKGROUND: Ecological momentary assessment (EMA) of mental health symptoms may influence the symptoms that it measures, i.e. assessment reactivity. In the field of depression, EMA reactivity has received little attention. We aim to investigate whether EMA of depressive symptoms induces assessment reactivity. Reactivity will be operationalised as an effect of EMA on depressive symptoms measured by a retrospective questionnaire, and, secondly, as a change in response rate and variance of the EMA ratings...
October 21, 2016: BMC Psychiatry
Helen Cullington, Padraig Kitterick, Lisa DeBold, Mark Weal, Nicholas Clarke, Eva Newberry, Lisa Aubert
Purpose: This research note describes a planned project to design, implement, and evaluate remote care for adults using cochlear implants and compare their outcomes with those of individuals following the standard care pathway. Method: Sixty people with cochlear implants will be recruited and randomized to either the remote care group or a control group. The remote care group will use new tools for 6 months: remote and self-monitoring, self-adjustment of device, and a personalized online support tool...
October 1, 2016: American Journal of Audiology
Lyndon G Amorin-Woods, Gregory F Parkin-Smith, Lee Nedkoff, Colleen Fisher
BACKGROUND: This paper reports the quantitative outcomes of a mixed-methods pilot study of the characteristics and demographics of chiropractic practices and patients in Western Australia. METHODS: This was a mixed-methods data transformation model (qualitative to quantitative) pilot study. A non-random sample of chiropractic practices across Western Australia was recruited and data collected anonymously from consecutive new patients using an online platform. Data covered practice and patient demographics and characteristics, alongside quality of life measures...
2016: Chiropractic & Manual Therapies
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