journal
MENU ▼
Read by QxMD icon Read
search

Trials

journal
https://www.readbyqxmd.com/read/28931440/core-outcomes-in-periodontal-trials-study-protocol-for-core-outcome-set-development
#1
Thomas J Lamont, Jan E Clarkson, David N J Ricketts, Peter A Heasman, Craig R Ramsay
BACKGROUND: There are a large number of clinical outcome measures used to assess the effectiveness of prevention and management strategies of periodontal diseases. This heterogeneity causes difficulties when trying to synthesise data for systematic reviews or clinical guidelines, reducing their impact. Core outcome sets are an agreed, standardised list of outcomes that should be measured and reported in all trials in specific clinical areas. We aim to develop a core outcome set for effectiveness trials investigating the prevention and management of periodontal disease in primary or secondary care...
September 20, 2017: Trials
https://www.readbyqxmd.com/read/28931439/effects-of-whole-body-vibration-exercise-on-neuromuscular-function-for-individuals-with-knee-osteoarthritis-study-protocol-for-a-randomized-controlled-trial
#2
Zhangqi Lai, Xueqiang Wang, Seullee Lee, Xihe Hou, Lin Wang
BACKGROUND: Knee osteoarthritis (KOA) is a leading cause of public disability. Neuromuscular function contributes to the development and/or progression of KOA. Whole body vibration (WBV) exercise improve the neuromuscular function of patients with neurological disorders and even that of older patients with limited exercise options. Therefore, WBV exercise may offer an efficient and alternative treatment for individuals with KOA. However, the effects of WBV training on the neuromuscular function of individuals with KOA remain unclear...
September 20, 2017: Trials
https://www.readbyqxmd.com/read/28931411/topiramate-s-effectiveness-on-weight-reduction-in-overweight-obese-persons-with-schizophrenia-study-protocol-for-a-randomized-controlled-trial
#3
Miyuru Chandradasa, Layani Champika, Silumini de Silva, K A L A Kuruppuarachchi
BACKGROUND: Schizophrenia is a psychiatric disorder with a higher mortality than that of the general population. Most of the deaths are due to cardiovascular causes and are related to metabolic risks. This risk is due not only to antipsychotics but also to inherent factors of the disorder. Studies in the West have shown topiramate to be effective in schizophrenia to reduce weight gain and for symptomatic control. Whether this is effective for South Asians is not known. It is important because South Asians have a higher risk of metabolic syndrome...
September 20, 2017: Trials
https://www.readbyqxmd.com/read/28931404/a-cluster-randomized-trial-to-reduce-major-perinatal-morbidity-among-women-with-one-prior-cesarean-delivery-in-qu%C3%A3-bec-prisma-trial-study-protocol-for-a-randomized-controlled-trial
#4
N Chaillet, E Bujold, B Masse, W A Grobman, P Rozenberg, J C Pasquier, A Shorten, M Johri, F Beaudoin, H Abenhaim, S Demers, W Fraser, M Dugas, S Blouin, E Dubé, R Gauthier
BACKGROUND: Rates of cesarean delivery are continuously increasing in industrialized countries, with repeated cesarean accounting for about a third of all cesareans. Women who have undergone a first cesarean are facing a difficult choice for their next pregnancy, i.e.: (1) to plan for a second cesarean delivery, associated with higher risk of maternal complications than vaginal delivery; or (b) to have a trial of labor (TOL) with the aim to achieve a vaginal birth after cesarean (VBAC) and to accept a significant, but rare, risk of uterine rupture and its related maternal and neonatal complications...
September 20, 2017: Trials
https://www.readbyqxmd.com/read/28927442/a-primary-school-active-break-programme-acti-break-study-protocol-for-a-pilot-cluster-randomised-controlled-trial
#5
Amanda Watson, Anna Timperio, Helen Brown, Kylie D Hesketh
BACKGROUND: Levels of overall physical activity have been shown to decline across childhood. Schools are considered ideal settings to promote physical activity as children spend a large amount of their waking hours at school. Time-efficient physical activity strategies that demonstrate a positive impact on academic-related outcomes are needed to enable physical activity to be prioritised in the school day. The ACTI-BREAK programme requires classroom teachers to integrate active breaks; 5-min bursts of moderate-intensity physical activity into their classroom routine...
September 19, 2017: Trials
https://www.readbyqxmd.com/read/28923118/hypothermia-for-encephalopathy-in-low-and-middle-income-countries-helix-study-protocol-for-a-randomised-controlled-trial
#6
Sudhin Thayyil, Vania Oliveira, Peter J Lally, Ravi Swamy, Paul Bassett, Mani Chandrasekaran, Jayashree Mondkar, Sundaram Mangalabharathi, Naveen Benkappa, Arasar Seeralar, Mohammod Shahidullah, Paolo Montaldo, Jethro Herberg, Swati Manerkar, Kumutha Kumaraswami, Chinnathambi Kamalaratnam, Vinayagam Prakash, Rema Chandramohan, Prathik Bandya, Mohammod Abdul Mannan, Ranmali Rodrigo, Mohandas Nair, Siddarth Ramji, Seetha Shankaran
BACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-income countries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care...
September 18, 2017: Trials
https://www.readbyqxmd.com/read/28915907/effect-of-a-mother-s-recorded-voice-on-emergence-from-general-anesthesia-in-pediatric-patients-study-protocol-for-a-randomized-controlled-trial
#7
Seok Young Song, Sang Gyu Kwak, Eugene Kim
BACKGROUND: Emergence delirium is a behavioral disturbance after general anesthesia in children and may distress both the patients and the primary caregivers, such as parents and medical staff, looking after the patients. Various medical and emotional interventions have been investigated to reduce emergence delirium; however, none are completely effective. This trial intends to assess whether the mother's recorded voice can reduce this adverse post-anesthesia event and facilitate arousal from general anesthesia...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28915904/tiga-cub-manualised-psychoanalytic-child-psychotherapy-versus-treatment-as-usual-for-children-aged-5-11-years-with-treatment-resistant-conduct-disorders-and-their-primary-carers-study-protocol-for-a-randomised-controlled-feasibility-trial
#8
Elizabeth Edginton, Rebecca Walwyn, Kayleigh Burton, Robert Cicero, Liz Graham, Sadie Reed, Sandy Tubeuf, Maureen Twiddy, Alex Wright-Hughes, Lynda Ellis, Dot Evans, Tom Hughes, Nick Midgley, Paul Wallis, David Cottrell
BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28915900/a-randomized-phase-ii-study-to-assess-the-effect-of-adjuvant-immunotherapy-using-%C3%AE-galcer-pulsed-dendritic-cells-in-the-patients-with-completely-resected-stage-ii-iiia-non-small-cell-lung-cancer-study-protocol-for-a-randomized-controlled-trial
#9
Hideo Saka, Chiyoe Kitagawa, Yukito Ichinose, Mitsuhiro Takenoyama, Hidenori Ibata, Tatsuo Kato, Koji Takami, Motohiro Yamashita, Tadashi Maeda, Sadanori Takeo, Hitoshi Ueda, Kan Okabayashi, Seiji Nagashima, Tadayuki Oka, Hidenori Kouso, Seiichi Fukuyama, Kentaro Yoshimoto, Mototsugu Shimokawa, Akiko M Saito, Suminobu Ito
BACKGROUND: As the toxicity associated with the α-GalCer-pulsed dendritic cell (DC) therapy could be considered to be negligible, its addition to postoperative adjuvant chemotherapy would be expected to greatly improve the therapeutic effect, and could result in prolonged survival. The aim of the present study is to compare the therapeutic efficacy of alpha-galactosylceramide-pulsed DC therapy in patients who have undergone a complete resection of stage II-IIIA non-small-cell lung cancer (NSCLC) followed by postoperative adjuvant therapy with cisplatin plus vinorelbine, to that in patients who did not receive additional treatment (surgical resection plus postoperative adjuvant chemotherapy only)...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28915826/acupuncture-lowering-blood-pressure-for-secondary-prevention-of-stroke-a-study-protocol-for-a-multicenter-randomized-controlled-trial
#10
Yu-Zheng Du, Xin-Xin Gao, Cheng-Ting Wang, Hai-Zhen Zheng, Yun Lei, Meng-Han Wu, Xue-Min Shi, Hai-Peng Ban, Wen-Long Gu, Xiang-Gang Meng, Mao-Ti Wei, Chun-Xiao Hu
BACKGROUND: Stroke is the prime cause of morbidity and mortality in the general population, and hypertension will increase the recurrence and mortality of stroke. We report a protocol of a pragmatic randomized controlled trial (RCT) using blood pressure (BP)-lowering acupuncture add-on treatment to treat patients with hypertension and stroke. METHODS: This is a large-scale, multicenter, subject-, assessor- and analyst-blinded, pragmatic RCT. A total of 480 patients with hypertension and ischemic stroke will be randomly assigned to two groups: an experimental group and a control group...
September 15, 2017: Trials
https://www.readbyqxmd.com/read/28903769/specific-barriers-to-the-conduct-of-randomised-clinical-trials-on-medical-devices
#11
REVIEW
Edmund A M Neugebauer, Ana Rath, Sunya-Lee Antoine, Michaela Eikermann, Doerthe Seidel, Carsten Koenen, Esther Jacobs, Dawid Pieper, Martine Laville, Séverine Pitel, Cecilia Martinho, Snezana Djurisic, Jacques Demotes-Mainard, Christine Kubiak, Vittorio Bertele, Janus C Jakobsen, Silvio Garattini, Christian Gluud
BACKGROUND: Medical devices play an important role in the diagnosis, prevention, treatment and care of diseases. However, compared to pharmaceuticals, there is no rigorous formal regulation for demonstration of benefits and exclusion of harms to patients. The medical device industry argues that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices...
September 13, 2017: Trials
https://www.readbyqxmd.com/read/28899412/the-effect-of-information-about-the-benefits-and-harms-of-mammography-on-women-s-decision-making-study-protocol-for-a-randomized-controlled-trial
#12
Misericòrdia Carles, Montserrat Martínez-Alonso, Anna Pons, Maria José Pérez-Lacasta, Lilisbeth Perestelo-Pérez, Maria Sala, Carmen Vidal, Montse Garcia, Ana Toledo-Chávarri, Núria Codern, Maria Feijoo-Cid, Anabel Romero, Roger Pla, Jorge Soler-González, Xavier Castells, Montserrat Rué
BACKGROUND: The decision to participate or not in breast cancer screening is complex due to the trade-off between the expected benefit of breast cancer mortality reduction and the major harm of overdiagnosis. It seems ethically necessary to inform women so that they can actively participate in decision-making and make an informed choice based on their values and preferences. The objective of this study is to assess the effects of receiving information about the benefits and harms of screening on decision-making, in women approaching the age of invitation to mammography screening...
September 12, 2017: Trials
https://www.readbyqxmd.com/read/28893317/perceived-barriers-and-facilitators-to-risk-based-monitoring-in-academic-led-clinical-trials-a-mixed-methods-study
#13
Caroline Hurley, Carol Sinnott, Mike Clarke, Patricia Kearney, Emmy Racine, Joseph Eustace, Frances Shiely
BACKGROUND: In November 2016, the ICH published a requirement for sponsors to develop a systematic, prioritised, risk-based approach to monitoring clinical trials. This approach is more commonly known as risk-based monitoring (RBM). However, recent evidence suggests that a 'gold standard', validated approach to RBM does not exist and it is unclear how sponsors will introduce RBM into their organisations. A first step needed to inform the implementation of RBM is to explore academic trialists' readiness and ability to perform RBM...
September 11, 2017: Trials
https://www.readbyqxmd.com/read/28893306/monitored-supplementation-of-vitamin-d-in-preterm-infants-mosvid-trial-study-protocol-for-a-randomised-controlled-trial
#14
Alicja Kołodziejczyk, Maria K Borszewska-Kornacka, Joanna Seliga-Siwecka
BACKGROUND: The pivotal role of vitamin D (vit D) in skeletal health is well known. Neonatal vit D storage at birth is dependent on maternal levels, and newborns receive 50-70% of their mother's 25-hydroxyvitamin D [25(OH)D]. Deficiency of vit D can lead to prematurity bone disease, with an incidence of up to 55% in infants weighing < 1000 g. The aim of this study is to assess the effectiveness of monitored supplementation of vit D in a population of preterm infants. METHODS/DESIGN: Preterm infants born at 24-32 weeks of gestation will be recruited within the first 7 days of life...
September 11, 2017: Trials
https://www.readbyqxmd.com/read/28893297/evidence-based-practice-within-nutrition-what-are-the-barriers-for-improving-the-evidence-and-how-can-they-be-dealt-with
#15
REVIEW
Martine Laville, Berenice Segrestin, Maud Alligier, Cristina Ruano-Rodríguez, Lluis Serra-Majem, Michael Hiesmayr, Annemie Schols, Carlo La Vecchia, Yves Boirie, Ana Rath, Edmund A M Neugebauer, Silvio Garattini, Vittorio Bertele, Christine Kubiak, Jacques Demotes-Mainard, Janus C Jakobsen, Snezana Djurisic, Christian Gluud
BACKGROUND: Evidence-based clinical research poses special barriers in the field of nutrition. The present review summarises the main barriers to research in the field of nutrition that are not common to all randomised clinical trials or trials on rare diseases and highlights opportunities for improvements. METHODS: Systematic academic literature searches and internal European Clinical Research Infrastructure Network (ECRIN) communications during face-to-face meetings and telephone conferences from 2013 to 2017 within the context of the ECRIN Integrating Activity (ECRIN-IA) project...
September 11, 2017: Trials
https://www.readbyqxmd.com/read/28889798/erratum-to-attention-training-for-infants-at-familial-risk-of-adhd-interstaars-study-protocol-for-a-randomised-controlled-trial
#16
Amy Goodwin, Simona Salomone, Patrick Bolton, Tony Charman, Emily J H Jones, Luke Mason, Andrew Pickles, Emily Robinson, Tim Smith, Edmund J S Sonuga-Barke, Sam Wass, Mark H Johnson
No abstract text is available yet for this article.
September 11, 2017: Trials
https://www.readbyqxmd.com/read/28886747/women-s-views-and-experiences-of-two-alternative-consent-pathways-for-participation-in-a-preterm-intrapartum-trial-a-qualitative-study
#17
Alexandra Sawyer, Celine Chhoa, Susan Ayers, Angela Pushpa-Rajah, Lelia Duley
BACKGROUND: The Cord Pilot Trial compared alternative policies for timing of cord clamping at very preterm birth at eight UK hospitals. In addition to standard written consent, an oral assent pathway was developed for use when birth was imminent. The aim of this study was to explore women's views and experiences of two alternative consent pathways to participate in the Cord Pilot Trial. METHODS: We conducted a qualitative study using semi-structured interviews. A total of 179 participants in the Cord Pilot Trial were sent a postal invitation to take part in interviews...
September 9, 2017: Trials
https://www.readbyqxmd.com/read/28886751/uva-ursi-extract-and-ibuprofen-as-alternative-treatments-of-adult-female-urinary-tract-infection-atafuti-study-protocol-for-a-randomised-controlled-trial
#18
Jeanne Trill, Catherine Simpson, Frances Webley, Mike Radford, Louise Stanton, Tom Maishman, Angeliki Galanopoulou, Andrew Flower, Caroline Eyles, Merlin Willcox, Alastair Hay, Gareth Griffiths, Paul Little, George Lewith, Michael Moore
BACKGROUND: Women with acute uncomplicated urine infection are usually treated with antibiotics. One trial has demonstrated that delayed antibiotic treatment offered without symptom relief results in a modest reduction in antibiotic use. There is some evidence that ibuprofen provides symptom relief and reduces antibiotic use. Uva-ursi, a herbal product, has a traditional use for urinary infection symptom relief. We set out to test: in adult women with suspected UTI who accept the delayed prescription strategy: Do NSAIDs or uva-ursi (a herbal product) provide relief from urinary symptoms and reduce antibiotic use...
September 8, 2017: Trials
https://www.readbyqxmd.com/read/28886745/bayesian-dose-selection-design-for-a-binary-outcome-using-restricted-response-adaptive-randomization
#19
Caitlyn Meinzer, Renee Martin, Jose I Suarez
BACKGROUND: In phase II trials, the most efficacious dose is usually not known. Moreover, given limited resources, it is difficult to robustly identify a dose while also testing for a signal of efficacy that would support a phase III trial. Recent designs have sought to be more efficient by exploring multiple doses through the use of adaptive strategies. However, the added flexibility may potentially increase the risk of making incorrect assumptions and reduce the total amount of information available across the dose range as a function of imbalanced sample size...
September 8, 2017: Trials
https://www.readbyqxmd.com/read/28882167/implementation-and-results-of-an-integrated-data-quality-assurance-protocol-in-a-randomized-controlled-trial-in-uttar-pradesh-india
#20
Jonathon D Gass, Anamika Misra, Mahendra Nath Singh Yadav, Fatima Sana, Chetna Singh, Anup Mankar, Brandon J Neal, Jennifer Fisher-Bowman, Jenny Maisonneuve, Megan Marx Delaney, Krishan Kumar, Vinay Pratap Singh, Narender Sharma, Atul Gawande, Katherine Semrau, Lisa R Hirschhorn
BACKGROUND: There are few published standards or methodological guidelines for integrating Data Quality Assurance (DQA) protocols into large-scale health systems research trials, especially in resource-limited settings. The BetterBirth Trial is a matched-pair, cluster-randomized controlled trial (RCT) of the BetterBirth Program, which seeks to improve quality of facility-based deliveries and reduce 7-day maternal and neonatal mortality and maternal morbidity in Uttar Pradesh, India. In the trial, over 6300 deliveries were observed and over 153,000 mother-baby pairs across 120 study sites were followed to assess health outcomes...
September 7, 2017: Trials
journal
journal
41241
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"