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https://www.readbyqxmd.com/read/28088231/efficacy-of-gabapentin-for-prevention-of-postherpetic-neuralgia-study-protocol-for-a-randomized-controlled-clinical-trial
#1
Manuel Rullán, Oana Bulilete, Alfonso Leiva, Aina Soler, Antonia Roca, María José González-Bals, Patricia Lorente, Joan Llobera
BACKGROUND: Postherpetic neuralgia (PHN) is a chronic neuropathic pain that results from alterations of the peripheral nervous system in areas affected by the herpes zoster virus. The symptoms include pain, paresthesia, dysesthesia, hyperalgesia, and allodynia. Despite the availability of pharmacological treatments to control these symptoms, no treatments are available to control the underlying pathophysiology responsible for this disabling condition. METHODS/DESIGN: Patients with herpes zoster who are at least 50 years old and have a pain score of 4 or higher on a visual analogue scale (VAS) will be recruited...
January 14, 2017: Trials
https://www.readbyqxmd.com/read/28088218/spinal-versus-general-anaesthesia-in-surgery-for-inguinodynia-spinasia-trial-study-protocol-for-a-randomised-controlled-trial
#2
Willem A R Zwaans, Léon H P M le Mair, Marc R M Scheltinga, Rudi M H Roumen
BACKGROUND: Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations...
January 14, 2017: Trials
https://www.readbyqxmd.com/read/28086983/mailed-hpv-self-sampling-for-cervical-cancer-screening-among-underserved-minority-women-study-protocol-for-a-randomized-controlled-trial
#3
Erin Kobetz, Julia Seay, Anthony Amofah, Larry Pierre, Jordan Baeker Bispo, Dinah Trevil, Martha Gonzalez, Martine Poitevien, Tulay Koru-Sengul, Olveen Carrasquillo
BACKGROUND: Underserved ethnic minority women experience significant disparities in cervical cancer incidence and mortality, mainly due to lack of cervical cancer screening. Barriers to Pap smear screening include lack of knowledge, lack of health insurance and access, and cultural beliefs regarding disease prevention. In our previous SUCCESS trial, we demonstrated that HPV self-sampling delivered by a community health worker (CHW) is efficacious in circumventing these barriers. This approach increased screening uptake relative to navigation to Pap smear screening...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086943/a-lifestyle-intervention-among-elderly-men-on-active-surveillance-for-non-aggressive-prostate-cancer-a-randomised-feasibility-study-with-whole-grain-rye-and-exercise
#4
Anne Kirstine Eriksen, Rikke Dalgaard Hansen, Michael Borre, Ryan Godsk Larsen, Jeppe Munthe Jensen, Kristian Overgaard, Mette Borre, Cecilie Kyrø, Rikard Landberg, Anja Olsen, Anne Tjønneland
BACKGROUND: The prognosis for men with non-aggressive prostate cancer is good, and several studies have investigated the impact of lifestyle changes including physical activity and diet on the prognosis. Despite positive results in animal studies and a few human interventions with whole-grain rye on markers of prostate cancer progression, the feasibility of trials investigating such dietary changes in combination with physical activity remains largely unstudied. The primary aim was to investigate the feasibility of an intervention with high whole-grain rye intake and vigorous physical activity for 6 months in men diagnosed with prostate cancer...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086934/electroacupuncture-plus-moxibustion-therapy-for-patients-with-major-depressive-disorder-study-protocol-for-a-randomized-controlled-trial
#5
Mikyung Kim, Eun-Ji Choi, Sung-Phil Kim, Jung-Eun Kim, Hyo-Ju Park, Ae-Ran Kim, Bok-Nam Seo, O-Jin Kwon, Jung Hyo Cho, Sun-Yong Chung, Joo-Hee Kim
BACKGROUND: Major depressive disorder (MDD) is one of the most prevalent mental health disorders and has a significant societal economic burden. Antidepressants and cognitive behavioral therapy are two primary interventions for the standardized treatment of MDD. However, their weaknesses, such as a low response rate, a high risk of adverse events from medication, and the high cost of cognitive behavioral therapy, have resulted in a need for complementary and alternative medicine (CAM)...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086906/physical-activity-and-nutrition-behaviour-outcomes-of-a-cluster-randomized-controlled-trial-for-adults-with-metabolic-syndrome-in-vietnam
#6
Van Dinh Tran, Andy H Lee, Jonine Jancey, Anthony P James, Peter Howat, Le Thi Phuong Mai
BACKGROUND: Metabolic syndrome is prevalent among Vietnamese adults, especially those aged 50-65 years. This study evaluated the effectiveness of a 6 month community-based lifestyle intervention to increase physical activity levels and improve dietary behaviours for adults with metabolic syndrome in Vietnam. METHODS: Ten communes, involving participants aged 50-65 years with metabolic syndrome, were recruited from Hanam province in northern Vietnam. The communes were randomly allocated to either the intervention (five communes, n = 214) or the control group (five communes, n = 203)...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086851/efficacy-of-intermittent-theta-burst-stimulation-itbs-and-10-hz-high-frequency-repetitive-transcranial-magnetic-stimulation-rtms-in-treatment-resistant-unipolar-depression-study-protocol-for-a-randomised-controlled-trial
#7
Samuel Bulteau, Veronique Sébille, Guillemette Fayet, Veronique Thomas-Ollivier, Thibault Deschamps, Annabelle Bonnin-Rivalland, Edouard Laforgue, Anne Pichot, Pierre Valrivière, Elisabeth Auffray-Calvier, June Fortin, Yann Péréon, Jean-Marie Vanelle, Anne Sauvaget
BACKGROUND: The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS)...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28086836/an-internet-based-self-help-intervention-for-older-adults-after-marital-bereavement-separation-or-divorce-study-protocol-for-a-randomized-controlled-trial
#8
Jeannette Brodbeck, Thomas Berger, Hans Joerg Znoj
BACKGROUND: Marital bereavement and separation or divorce are among the most stressful critical life events in later life. These events require a dissolution of social and emotional ties, adjustments in daily routine and changes in identity and perspectives for the future. After a normative grief or distress reaction, most individuals cope well with the loss. However, some develop a prolonged grief reaction. Internet-based self-help interventions have proved beneficial for a broad range of disorders, including complicated grief...
January 13, 2017: Trials
https://www.readbyqxmd.com/read/28081712/erratum-to-perfusion-pressure-cerebral-infarct-ppci-trial-the-importance-of-mean-arterial-pressure-during-cardiopulmonary-bypass-to-prevent-cerebral-complications-after-cardiac-surgery-study-protocol-for-a-randomised-controlled-trial
#9
https://www.readbyqxmd.com/read/28077163/the-efficacy-of-varenicline-in-achieving-abstinence-among-waterpipe-tobacco-smokers-study-protocol-for-a-randomized-controlled-trial
#10
Raana Zahid, Omara Dogar, Sonia Mansoor, Amina Khan, Mona Kanaan, Mohammed Jawad, Jasjit S Ahluwalia, Kamran Siddiqi
BACKGROUND: Waterpipe tobacco smoking has increased among youth across the globe including in the US, and it continues as a common and traditional form of smoking tobacco in Pakistan. A range of behavioral and pharmacological therapies are available to support people in quitting cigarette smoking; however, little evidence exists for the efficacy of these therapies in achieving abstinence among waterpipe tobacco smokers. The objective of this study is to assess the efficacy of varenicline when added to behavioral support for waterpipe tobacco smoking cessation, by measuring biochemically validated continuous abstinence in waterpipe tobacco smokers...
January 11, 2017: Trials
https://www.readbyqxmd.com/read/28077162/a-fixed-inhaled-nitrous-oxide-oxygen-mixture-as-an-analgesic-for-adult-cancer-patients-with-breakthrough-pain-study-protocol-for-a-randomized-controlled-trial
#11
Qiang Liu, Yu Wang, Xiang-Jiang Luo, Ning-Ju Wang, Ping Chen, Xin Jin, Guo-Xia Mu, Xiao-Min Chai, Yue-Juan Zhang, Yu-Xiang Li, Jian-Qiang Yu
BACKGROUND: The management of breakthrough pain in cancer patients is always a challenge for medical professions. Occurring in 80% of cancer patients with advanced disease, breakthrough pain significantly decreases both patient's and caregiver's quality of life. The aim of this study is to assess the analgesic efficacy of a fixed inhaled nitrous oxide/oxygen mixture for adult cancer patients with breakthrough pain. METHODS/DESIGN: This is a randomized, placebo-controlled, double-blind study; it will be conducted in the General Hospital of Ningxia Medical University...
January 11, 2017: Trials
https://www.readbyqxmd.com/read/28069072/pansaid-paracetamol-and-nsaid-in-combination-study-protocol-for-a-randomised-trial
#12
Kasper Højgaard Thybo, Daniel Hägi-Pedersen, Jørn Wetterslev, Jørgen Berg Dahl, Henrik Morville Schrøder, Hans Henrik Bülow, Jan Gottfrid Bjørck, Ole Mathiesen
BACKGROUND: Effective postoperative pain management is essential for the rehabilitation of the surgical patient. No 'gold standard' exists after total hip arthroplasty (THA) and combinations of different nonopioid medications are used with virtually no evidence for additional analgesic efficacy compared to monotherapy. The objective of this trial is to investigate the analgesic effects and safety of paracetamol and ibuprofen alone and in combination in different dosages after THA. METHODS: PANSAID is a placebo-controlled, parallel four-group, multicentre trial with centralised computer-generated allocation sequence and allocation concealment and with varying block size and stratification by site...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28069068/the-sygma-programme-of-phase-3-trials-to-evaluate-the-efficacy-and-safety-of-budesonide-formoterol-given-as-needed-in-mild-asthma-study-protocols-for-two-randomised-controlled-trials
#13
Paul M O'Byrne, J Mark FitzGerald, Nanshan Zhong, Eric Bateman, Peter J Barnes, Christina Keen, Gun Almqvist, Kristine Pemberton, Carin Jorup, Stefan Ivanov, Helen K Reddel
BACKGROUND: In many patients with mild asthma, the low frequency of symptoms and the episodic nature of exacerbations make adherence to regular maintenance treatment difficult. This often leads to over-reliance on short-acting β2-agonist (SABA) reliever medication and under-treatment of the underlying inflammation, with poor control of asthma symptoms and increased risk of exacerbations. The use of budesonide/formoterol 'as needed' in response to symptoms may represent an alternative treatment option for patients with mild asthma...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28069051/traditional-chinese-medicine-combination-therapy-for-patients-with-steroid-dependent-ulcerative-colitis-study-protocol-for-a-randomized-controlled-trial
#14
Kai Zheng, Hong Shen, Jia Jia, Yuelin Lu, Lei Zhu, Lu Zhang, Zhaofeng Shen
BACKGROUND: Approximately 20% of patients with ulcerative colitis become steroid dependent. Azathioprine is recommended in steroid-dependent ulcerative colitis, but its side effects limit its use. Chinese herbal medicine has been widely used to treat ulcerative colitis in China. However, its effectiveness in steroid-dependent patients has not been evaluated. This study aims to investigate the efficacy of traditional Chinese medicine combination therapy with 5-aminosalicylic acid in patients with steroid-dependent ulcerative colitis...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28069045/improving-nursing-home-care-through-feedback-on-performance-data-inform-protocol-for-a-cluster-randomized-trial
#15
Matthias Hoben, Peter G Norton, Liane R Ginsburg, Ruth A Anderson, Greta G Cummings, Holly J Lanham, Janet E Squires, Deanne Taylor, Adrian S Wagg, Carole A Estabrooks
BACKGROUND: Audit and feedback is effective in improving the quality of care. However, methods and results of international studies are heterogeneous, and studies have been criticized for a lack of systematic use of theory. In TREC (Translating Research in Elder Care), a longitudinal health services research program, we collect comprehensive data from care providers and residents in Canadian nursing homes to improve quality of care and life of residents, and quality of worklife of caregivers...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28069040/anti-inflammatory-and-immune-regulatory-effects-of-acupuncture-after-craniotomy-study-protocol-for-a-parallel-group-randomized-controlled-trial
#16
Seung-Yeon Cho, Seung-Bo Yang, Hee Sup Shin, Seung Hwan Lee, Jun Seok Koh, Seungwon Kwon, Woo-Sang Jung, Sang-Kwan Moon, Jung-Mi Park, Chang-Nam Ko, Seong-Uk Park
BACKGROUND: Despite recent advances in the medical and surgical fields, complications such as infection, pneumonia, or brain swelling may occur after a craniotomy. In some patients, perioperative antibiotic prophylaxis causes adverse effects such as itching, rash, or digestive conditions. Certain patients still develop infections severe enough to require a repeat operation despite antibiotic prophylaxis. Acupuncture has been used to treat inflammatory conditions, and many basic and clinical studies have provided evidence of its anti-inflammatory and immune regulatory effects...
January 10, 2017: Trials
https://www.readbyqxmd.com/read/28069060/sticks-study-short-stretch-inelastic-compression-bandage-in-knee-swelling-following-total-knee-arthroplasty-a-feasibility-study
#17
T M Brock, A P Sprowson, S Muller, M R Reed
BACKGROUND: Postoperative knee swelling is common and impairs early postoperative function following total knee arthroplasty. It was hypothesised that the use of a short-stretch, inelastic compression bandage would reduce knee swelling and improve pain and early function. The aim of this study was to provide preliminary data and test feasibility with a view to informing a larger, future trial. METHODS: Fifty consecutive patients selected for primary total knee arthroplasty underwent distance randomisation to receive a short-stretch, inelastic compression bandage or a standard wool and crepe bandage for the first 24 h postoperatively...
January 9, 2017: Trials
https://www.readbyqxmd.com/read/28069054/the-effect-of-a-novel-probiotic-on-metabolic-biomarkers-in-adults-with-prediabetes-and-recently-diagnosed-type-2-diabetes-mellitus-study-protocol-for-a-randomized-controlled-trial
#18
Talia Palacios, Luis Vitetta, Samantha Coulson, Claire D Madigan, Gareth S Denyer, Ian D Caterson
BACKGROUND: Shifts in the gastrointestinal microbiome have been shown to contribute to the progression of metabolic diseases including prediabetes and type 2 diabetes mellitus. Research suggests that in-vivo modulation of the gut microbiome by specific probiotic microorganisms may improve insulin sensitivity and blood sugar management, preventing or delaying the development of type 2 diabetes mellitus. However, further research is needed to understand the effect of probiotics as a therapy for the treatment of metabolic diseases...
January 9, 2017: Trials
https://www.readbyqxmd.com/read/28069042/publishing-protocols-for-trials-of-complex-interventions-before-trial-completion-potential-pitfalls-solutions-and-the-need-for-public-debate
#19
LETTER
Anna Purna Basu, Janice Elizabeth Pearse, Tim Rapley
BACKGROUND: Open Science is 'the movement to make scientific research, data and dissemination accessible to all levels of an inquiring society'. In the spirit of the Open Science movement, advance publication of protocols for clinical trials is now being advocated by BioMed Central, BMJ Open and others. Simultaneously, participants are becoming increasingly active in their pursuit and sharing of trial- and health- related information. Whilst access to protocols alongside published trial findings has clear benefits, advance publication of trial protocols is potentially problematic for trials of complex behavioural interventions...
January 9, 2017: Trials
https://www.readbyqxmd.com/read/28061873/prophylactic-melatonin-for-delirium-in-intensive-care-pro-medic-study-protocol-for-a-randomised-controlled-trial
#20
F Eduardo Martinez, Matthew Anstey, Andrew Ford, Brigit Roberts, Miranda Hardie, Robert Palmer, Lynn Choo, David Hillman, Michael Hensley, Erin Kelty, Kevin Murray, Bhajan Singh, Bradley Wibrow
BACKGROUND: Delirium is an acute state of brain dysfunction characterised by fluctuating inattention and cognitive disturbances, usually due to illness. It occurs commonly in the intensive care unit (ICU), and it is associated with greater morbidity and mortality. It is likely that disturbances of sleep and of the day-night cycle play a significant role. Melatonin is a naturally occurring, safe and cheap hormone that can be administered to improve sleep. The main aim of this trial will be to determine whether prophylactic melatonin administered to critically ill adults, when compared with placebo, decreases the rate of delirium...
January 6, 2017: Trials
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