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  1. Content type: Study protocol

    Recent experimental research has suggested that spinal manipulative therapy (SMT) may reduce pain through modulation of the ascending pain signals and/or the central pain-regulating mechanisms. People with per...

    Authors: Anders Galaasen Bakken, Iben Axén, Andreas Eklund and Søren O’Neill

    Citation: Trials 2019 20:590

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  2. Content type: Study protocol

    Actinic keratoses (AK) are common skin lesions that can progress to invasive squamous cell carcinoma of the skin. A variety of lesion- or field-targeted treatment options exist and their efficacy has been demo...

    Authors: Markus V. Heppt, Theresa Steeb, Lutz Schmitz, Claus Garbe, Lars E. French, Ulrike Leiter and Carola Berking

    Citation: Trials 2019 20:589

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  3. Content type: Study protocol

    Neuropathic pain is a common pain condition that has a major negative impact on health-related quality of life. However, despite decades of research, it remains difficult to treat neuropathic pain. Lacosamide ...

    Authors: Malin E. Carmland, Melissa Kreutzfeldt, Jakob V. Holbech, Niels T. Andersen, Troels S. Jensen, Flemming W. Bach, Søren H. Sindrup and Nanna B. Finnerup

    Citation: Trials 2019 20:588

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  4. Content type: Study protocol

    In critically ill patients receiving invasive mechanical ventilation (MV), research supports the use of daily screening to identify patients who are ready to undergo a spontaneous breathing trial (SBT) followe...

    Authors: K. E. A. Burns, Leena Rizvi, Deborah J. Cook, Andrew J. E. Seely, Bram Rochwerg, Francois Lamontagne, John W. Devlin, Peter Dodek, Michael Mayette, Maged Tanios, Audrey Gouskos, Phyllis Kay, Susan Mitchell, Kenneth C. Kiedrowski and Nicholas S. Hill

    Citation: Trials 2019 20:587

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  5. Content type: Study protocol

    Patellofemoral pain (PFP) often affects young women, and the etiology is multifactorial and poorly understood. Conservative intervention has been focused on risk factors or aggravating factors and is composed ...

    Authors: Natália Camin Silva, Matheus de Castro Silva, Morisa Garcia Guimarães, Manoela Beatriz de Oliveira Nascimento and Lilian Ramiro Felicio

    Citation: Trials 2019 20:586

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  6. Content type: Study protocol

    Nutritional support is essential in the care of critically ill children since malnutrition in this population is associated with increased morbidity and mortality. Injury in patients admitted to pediatric inte...

    Authors: Reyes Fernández, Javier Urbano, Ángel Carrillo, Ana Vivanco, María José Solana, Corsino Rey and Jesús López-Herce

    Citation: Trials 2019 20:585

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  7. Content type: Study protocol

    High salt intake is a risk factor for hypertension and cardiovascular disease. Reducing salt intake has been shown to reduce blood pressure. Despite population-level interventions, including product reformulat...

    Authors: Sarah Payne Riches, Carmen Piernas, Paul Aveyard, James P. Sheppard, Mike Rayner and Susan A. Jebb

    Citation: Trials 2019 20:584

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  8. Content type: Study protocol

    A depressão é uma das principais causas de incapacidade crônica em todo o mundo e um importante fator de risco cardiovascular, aumentando o risco relativo de doença arterial coronariana, bem como as taxas de m...

    Authors: Catarina Magalhães Porto, Tatiana de Paula Santana da Silva and Everton Botelho Sougey

    Citation: Trials 2019 20:583

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  9. Content type: Study protocol

    Intraoperative hypotension is associated with increased morbidity and mortality. Current treatment is mostly reactive. The Hypotension Prediction Index (HPI) algorithm is able to predict hypotension minutes be...

    Authors: M. Wijnberge, J. Schenk, L. E. Terwindt, M. P. Mulder, M. W. Hollmann, A. P. Vlaar, D. P. Veelo and B. F. Geerts

    Citation: Trials 2019 20:582

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  10. Content type: Study protocol

    The World Health Organization recommended (in 2010) universal testing for suspected malaria, due to some fundamental changes in malaria trends such as the declining incidence of malaria in high-burden countrie...

    Authors: Ugwu I. Omale, Benedict N. Azuogu, Chihurumnanya Alo, Ugochukwu C. Madubueze, Onyinyechukwu U. Oka, Kingsley C. Okeke, Ifeyinwa M. Okafor, Rowland Utulu, Uduak E. Akpan, Chijioke V. Iloke, Anthonia O. Nnubia, Ifeyinwa I. Eze, Ogechukwu C. Anene, Chukwuka R. Nnabu and Deborah C. Ibemesi

    Citation: Trials 2019 20:581

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  11. Content type: Study protocol

    Recently factors in the relationship between gut microbiota, obesity, diabetes and the metabolic syndrome have been suggested in the development and progression of nonalcoholic steatohepatitis (NASH). In this ...

    Authors: Amanda Souza Silva-Sperb, Helena Abadie Moraes, Bruna Concheski de Moura, Bruna Cherubini Alves, Juliana Paula Bruch-Bertani, Vittoria Zambon Azevedo and Valesca Dall’Alba

    Citation: Trials 2019 20:580

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  12. Content type: Research

    Few community urologists offer cancer patients the opportunity to participate in cancer clinical trials, despite national guidelines that recommend it, depriving an estimated 260,000 urological cancer patients...

    Authors: Shellie Ellis, Mugur Geana, Tomas Griebling, Charles McWilliams, Jessie Gills, Kelly Stratton, Christine Mackay, Ariel Shifter, Andrew Zganjar and Brantley Thrasher

    Citation: Trials 2019 20:578

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  13. Content type: Research

    One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.

    Authors: Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal and David J. T. Campbell

    Citation: Trials 2019 20:577

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  14. Content type: Study protocol

    Colorectal cancer is the fourth most commonly diagnosed cancer in the United States. Approximately 3–10% of the population has an increased risk for colorectal cancer due to family history and warrants more fr...

    Authors: Karen M. Goldstein, Deborah A. Fisher, R. Ryanne Wu, Lori A. Orlando, Cynthia J. Coffman, Janet M. Grubber, Tejinder Rakhra-Burris, Virginia Wang, Maren T. Scheuner, Nina Sperber, Santanu K. Datta, Richard E. Nelson, Elizabeth Strawbridge, Dawn Provenzale, Elizabeth R. Hauser and Corrine I. Voils

    Citation: Trials 2019 20:576

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  15. Content type: Study protocol

    Dizziness is a common complaint, and the symptom often persists, together with additional complaints. A treatment combining Vestibular Rehabilitation (VR) and Cognitive Behaviour Therapy (CBT) is suggested. Ho...

    Authors: Lene Kristiansen, L. H. Magnussen, K. T. Wilhelmsen, S. Mæland, S. H. G. Nordahl, R. Clendaniel, A. Hovland and B. Juul-Kristensen

    Citation: Trials 2019 20:575

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  16. Content type: Study protocol

    Childhood asthma is a common condition. Currently there is no validated objective test which can be used to guide asthma treatment in children. This study tests the hypothesis that the addition of fractional e...

    Authors: S. Turner, S. C. Cotton, C. D. Emele, R. Thomas, S. Fielding, E. A. Gaillard, J. C. de Jongste, H. Morgan, A. R. Neilson, J. Norrie, M. Pijnenburg, D. Price and M. Thomas

    Citation: Trials 2019 20:573

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  17. Content type: Review

    Master protocols, classified as basket trials, umbrella trials, and platform trials, are novel designs that investigate multiple hypotheses through concurrent sub-studies (e.g., multiple treatments or populati...

    Authors: Jay J. H Park, Ellie Siden, Michael J. Zoratti, Louis Dron, Ofir Harari, Joel Singer, Richard T. Lester, Kristian Thorlund and Edward J. Mills

    Citation: Trials 2019 20:572

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  18. Content type: Methodology

    Internal pilots provide useful information which can help to optimise the running of the main trial. Although some recommendations exist in the literature for the design of internal pilots, little is known abo...

    Authors: Anna Rosala-Hallas, Carrol Gamble, Jane Blazeby and Paula R. Williamson

    Citation: Trials 2019 20:571

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  19. Content type: Research

    Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fra...

    Authors: Ada Keding, Helen Handoll, Stephen Brealey, Laura Jefferson, Catherine Hewitt, Belen Corbacho, David Torgerson and Amar Rangan

    Citation: Trials 2019 20:570

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  20. Content type: Study protocol

    Low health-related physical fitness in college students is a risk factor for future development of cardiovascular diseases at later stages in life, but appropriate exercise is one of the main determinant facto...

    Authors: Fang Zhao, Shanshan Sun, Jian Xiong and Guohua Zheng

    Citation: Trials 2019 20:569

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  21. Content type: Study protocol

    Conduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going ado...

    Authors: Rachana Parikh, Daniel Michelson, Kanika Malik, Sachin Shinde, Helen A. Weiss, Adriaan Hoogendoorn, Jeroen Ruwaard, Madhuri Krishna, Rhea Sharma, Bhargav Bhat, Rooplata Sahu, Sonal Mathur, Paulomi Sudhir, Michael King, Pim Cuijpers, Bruce F. Chorpita…

    Citation: Trials 2019 20:568

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  22. Content type: Study protocol

    Currently, there is limited evidence to guide intervention and service delivery coordination for youth who suffer a concussion and subsequently experience persistent post-concussive symptoms (PCS) (Lumba-Brown...

    Authors: Carolyn A. McCarty, Douglas Zatzick, Teah Hoopes, Katelyn Payne, Rebecca Parrish and Frederick P. Rivara

    Citation: Trials 2019 20:567

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  23. Content type: Methodology

    Patient-reported outcome measures (PROMs) are now frequently used in randomised controlled trials (RCTs) as primary endpoints. RCTs are longitudinal, and many have a baseline (PRE) assessment of the outcome an...

    Authors: Stephen J. Walters, Richard M. Jacques, Inês Bonacho dos Anjos Henriques-Cadby, Jane Candlish, Nikki Totton and Mica Teo Shu Xian

    Citation: Trials 2019 20:566

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  24. Content type: Study protocol

    There are limited data reporting the outcome of patients with non-operatively managed medial malleolus fractures compared to those treated surgically in the presence of fibular stabilisation for unstable fract...

    Authors: Thomas H. Carter, William M. Oliver, Catriona Graham, Andrew D. Duckworth and Timothy O. White

    Citation: Trials 2019 20:565

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  25. Content type: Study protocol

    Polycystic ovary syndrome (PCOS) is one of the most common endocrine diseases for women. Acupuncture is widely used for the infertile female because of it is non-invasive and has fewer side effects, but the po...

    Authors: Qiao Wang, Haiping Deng, Ke Cheng, Zouqin Huang, Xiuqi Yin, Yichen Zhou, Yiqin Yang, Weidong Shen, Ling Zhao and Xueyong Shen

    Citation: Trials 2019 20:564

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  26. Content type: Study protocol

    The increasing use of implantable cardiac monitors (ICMs) allows early documentation of asymptomatic cardiac arrhythmias that would previously have gone unnoticed. The addition of remote monitoring to cardiac ...

    Authors: Christian Jons, Peter Sogaard, Steffen Behrens, Jürgen Schrader, Sascha Mrosk and Poul Erik Bloch Thomsen

    Citation: Trials 2019 20:563

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  27. Content type: Study protocol

    Interval training in deep water running (DWR-IT) is a training method to improve cardiovascular fitness, functional health, and quality of life and to help control body weight. Its main advantages are the redu...

    Authors: Bruna Pianna, Bianca Christianini Moreno, Caroline Aquino de Souza, Thais Fernanda Bôscoa, Guilherme Eleutério Alcalde, Silvia Regina Barrile, Camila Gimenes, Bruno Martinelli, Antonio Roberto Zamunér, Bruna Varanda Pessoa-Santos and Eduardo Aguilar Arca

    Citation: Trials 2019 20:562

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  28. Content type: Research

    Critically ill patients lose up to 2% of muscle mass per day. We assessed the feasibility of administering a leucine-enriched essential amino acid (L-EAA) supplement to mechanically ventilated trauma patients ...

    Authors: L. Wandrag, S. J. Brett, G. S. Frost, M. To, E. Alves Loubo, N. C. Jackson, A. M. Umpleby, V. Bountziouka and M. Hickson

    Citation: Trials 2019 20:561

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  29. Content type: Study protocol

    Myocardial damage in patients undergoing cardiac surgery increases both morbidity and mortality. Different protective strategies dealing with either preconditioning or postconditioning or assessing a single as...

    Authors: Pascal Chiari, Michel Durand, Olivier Desebbe, Marc-Olivier Fischer, Diane Lena-Quintard, Jean-Charles Palao, Catherine Mercier, Géraldine Samson, Yvonne Varillon, Matteo Pozzi, Nathan Mewton, Delphine Maucort-Boulch, Michel Ovize and Jean-Luc Fellahi

    Citation: Trials 2019 20:560

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  30. Content type: Study protocol

    Keeping a certain level of physical activity has beneficial effects on the body itself but also, surprisingly, on cognition: specifically, physical high-intensity intermittent aerobic exercise (HIE) can show i...

    Authors: Dalila Burin, Noriki Yamaya, Rie Ogitsu and Ryuta Kawashima

    Citation: Trials 2019 20:559

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  31. Content type: Study protocol

    Within the field of plastic surgery, free tissue transfer is common practice for knee and lower leg defects. Usually, after such free flap reconstruction, patients undergo a dangling protocol in the postoperat...

    Authors: David D. Krijgh, Teun Teunis, Pascal P. A. Schellekens, Marc A. M. Mureau, Antonius J. M. Luijsterburg, Tallechien M. T. Tempelman, Eva S. J. van der Beek, Wiesje Maarse and J. Henk Coert

    Citation: Trials 2019 20:558

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  32. Content type: Correction

    Following publication of the original article [1], it has been brought to our attention that an error was slipped into the article’s title.

    Authors: Marion Henderson, Anja Wittkowski, Emma McIntosh, Alex McConnachie, Katie Buston, Philip Wilson, Rachel Calam, Helen Minnis, Lucy Thompson, John O’Dowd, James Law, Elizabeth McGee and Daniel Wight

    Citation: Trials 2019 20:557

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    The original article was published in Trials 2019 20:499

  33. Content type: Study protocol

    Tobacco smoking is a highly prevalent, addictive behaviour and a key public health priority. However available cessation therapies have low quit and high relapse rates, indicating an urgent need for more effec...

    Authors: Lauren Arancini, Chiara C. Bortolasci, Seetal Dodd, Olivia M. Dean and Michael Berk

    Citation: Trials 2019 20:555

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  34. Content type: Study protocol

    Hypertension is a major risk factor for cardiovascular disease (CVD), yet treatment and control rates for hypertension are very low in low- and middle-income countries (LMICs). Lack of effective referral netwo...

    Authors: Tim Mercer, Benson Njuguna, Gerald S. Bloomfield, Jonathan Dick, Eric Finkelstein, Jemima Kamano, Ann Mwangi, Violet Naanyu, Sonak D. Pastakia, Thomas W. Valente, Rajesh Vedanthan and Constantine Akwanalo

    Citation: Trials 2019 20:554

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  35. Content type: Research

    Adverse events (AEs) in clinical trials may be reported in multiple sources. Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent informati...

    Authors: Evan Mayo-Wilson, Nicole Fusco, Hwanhee Hong, Tianjing Li, Joseph K. Canner and Kay Dickersin

    Citation: Trials 2019 20:553

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  36. Content type: Study protocol

    Mild cognitive impairment (MCI) is an intermediate state between normal aging and Alzheimer’s disease, which is the world’s most common form of dementia. It is important to identify early and easily available ...

    Authors: Jae-Hong Kim, Myoung-Rae Cho, Gwang-Cheon Park and Jeong-Soon Lee

    Citation: Trials 2019 20:551

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  37. Content type: Study protocol

    Cigarette smoking negatively impacts on maternal and fetal health. Smoking cessation is one of the few interventions capable of improving pregnancy outcomes. Despite the risks, the most effective antenatal mod...

    Authors: Brendan P. McDonnell, Patrick Dicker, Sheila Keogan, Luke Clancy and Carmen Regan

    Citation: Trials 2019 20:550

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  38. Content type: Study protocol

    There is a global pandemic of type 2 diabetes mellitus (T2DM), especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher than the world average of 8.8%. Multiple studies have shown that ...

    Authors: Eberta Tan, Joan Khoo, Linsey Utami Gani, Roy Debajyoti Malakar, Tunn Lin Tay, Prasanna Sivanath Tirukonda, Jia Wen Kam, Aung Soe Tin and Tjun Yip Tang

    Citation: Trials 2019 20:549

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  39. Content type: Study protocol

    Diabetes is an important health burden in Indonesia. However, diabetes management and treatment remain poor, with most people with diabetes in Indonesia not achieving the recommended blood glucose levels. Peer...

    Authors: Till Seuring, Marthoenis, Sabrina Rhode, Lisa Rogge, Holger Rau, Stéphane Besançon, Hendra Zufry, Hizir Sofyan and Sebastian Vollmer

    Citation: Trials 2019 20:548

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  40. Content type: Research

    Nicotine replacement therapy (NRT) bought over the counter (OTC) appears to be largely ineffective for smoking cessation, which may be partially explained by poor adherence. We developed and evaluated the NRT2...

    Authors: Aleksandra Herbec, Jamie Brown, Lion Shahab, Robert West and Tobias Raupach

    Citation: Trials 2019 20:547

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  41. Content type: Study protocol

    Lower urinary tract symptoms (LUTS) can relate to urinary storage or voiding. In men, the prevalence and severity of LUTS increases with age, with a significant impact on quality of life. The majority of men p...

    Authors: Jessica Frost, J. Athene Lane, Nikki Cotterill, Mandy Fader, Lucy Hackshaw-McGeagh, Hashim Hashim, Margaret Macaulay, Stephanie J. MacNeill, Sian Noble, Jonathan Rees, Matthew J. Ridd, Luke Robles, Gordon Taylor, Jodi Taylor, Marcus J Drake and Jo Worthington

    Citation: Trials 2019 20:546

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  42. Content type: Study protocol

    There are significant barriers to providing accessible, quality mental health care for young adolescents affected by adversity. In an attempt to overcome this, the World Health Organization (WHO) has developed...

    Authors: Felicity L. Brown, Frederik Steen, Karine Taha, May Aoun, Richard A. Bryant, Mark J. D. Jordans, Aiysha Malik, Mark van Ommeren, Adnan Abualhaija, Ibrahim Said Aqel, Maha Ghatasheh, Rand Habashneh, Marit Sijbrandij, Rabih El Chammay, Sarah Watts and Aemal Akhtar

    Citation: Trials 2019 20:545

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  43. Content type: Study protocol

    Large field irradiation had been standard for early-stage follicular lymphoma (FL) for a long time. Although involved field radiotherapy (IF-RT) was recently favored because of the toxicity of large field irra...

    Authors: Laila König, Martin Dreyling, Jan Dürig, Marianne Engelhard, Karin Hohloch, Andreas Viardot, Mathias Witzens-Harig, Meinhard Kieser, Wolfram Klapper, Christiane Pott and Klaus Herfarth

    Citation: Trials 2019 20:544

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  44. Content type: Study protocol

    The sectorization of health-care systems leads to inefficient treatment, especially for elderly people with cognitive impairment. The transition from hospital care to primary care is insufficiently coordinated...

    Authors: Angela Nikelski, Armin Keller, Fanny Schumacher-Schönert, Terese Dehl, Jessica Laufer, Ulf Sauerbrey, Diana Wucherer, Adina Dreier-Wolfgramm, Bernhard Michalowsky, Ina Zwingmann, Horst Christian Vollmar, Wolfgang Hoffmann, Stefan H. Kreisel and Jochen René Thyrian

    Citation: Trials 2019 20:543

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  45. Content type: Study protocol

    The optimal vitamin D intake for nursing mothers with overweight or obesity has not been defined. Vitamin D concentrations are associated with body composition indices, particularly body fat mass. Few studies ...

    Authors: Zohre Gerveieeha, Fereydoun Siassi, Mostafa Qorbani, Farzaneh Ziaeian and Gity Sotoudeh

    Citation: Trials 2019 20:542

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  46. Content type: Study protocol

    Early childhood is a critical period of development. Caregivers, including providers of early care and education (ECE), have a substantial influence on the health of young children. Family child care homes (FC...

    Authors: Susan B. Sisson, Alicia L. Salvatore, Deana Hildebrand, Tiffany Poe, Cady Merchant, Megan Slawinski, Chelsea L. Kracht, Julie A. Stoner, Naneida Alcala Lazarte, Lu Ann Faulkner Schneider, Jennifer Weber, Felecia Jones and Dianne Ward

    Citation: Trials 2019 20:541

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  47. Content type: Study protocol

    In Hong Kong, one of six couples is affected by subfertility problems. Male infertility contributes to half of the infertility cases. In male infertility, there is no effective treatment for patients with idio...

    Authors: Mingpeng Zhao, Carol Pui Shan Chan, Cosy Wing Ching Cheung, Odai Alqawasmeh, Ronald Chi Chiu Wang, Justin Che Yuen Wu, Zhi Xiu Lin, Tin Chiu Li, Jacqueline Pui Wah Chung, Jennifer Sze Man Mak, Tracy Sze Man Law and David Yiu Leung Chan

    Citation: Trials 2019 20:540

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