Academic Journals Database
Disseminating quality controlled scientific knowledge

Trials

ISSN: 1745--6215
Publisher: BioMed Central


ADD TO MY LIST
 
Inhaled nitric oxide for the adjunctive therapy of severe malaria: Protocol for a randomized controlled trial

Author(s): Hawkes Michael | Opoka Robert | Namasopo Sophie | Miller Christopher | Thorpe Kevin | Lavery James | Conroy Andrea | Liles W Conrad | John Chandy | Kain Kevin
Volume: 12
Issue: 1
Year: 2011
Panax ginseng C.A Meyer root extract for moderate Chronic Obstructive Pulmonary Disease (COPD): study protocol for a randomised controlled trial

Author(s): Xue Charlie | Shergis Johannah | Zhang Anthony | Worsnop Christopher | Fong Harry | Story David | Da Costa Cliff | Thien Francis
Volume: 12
Issue: 1
Year: 2011
The serious mental illness health improvement profile [HIP]: study protocol for a cluster randomised controlled trial

Author(s): White Jacquie | Gray Richard | Swift Louise | Barton Garry | Jones Martin
Volume: 12
Issue: 1
Year: 2011
Effect of spinal manipulation on sensorimotor functions in back pain patients: study protocol for a randomised controlled trial

Author(s): Wilder David | Vining Robert | Pohlman Katherine | Meeker William | Xia Ting | DeVocht James | Gudavalli R Maruti | Long Cynthia | Owens Edward | Goertz Christine
Volume: 12
Issue: 1
Year: 2011
Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial

Author(s): Goodyer Ian | Tsancheva Sonya | Byford Sarah | Dubicka Bernadka | Hill Jonathan | Kelvin Raphael | Reynolds Shirley | Roberts Christopher | Senior Robert | Suckling John | Wilkinson Paul | Target Mary | Fonagy Peter
Volume: 12
Issue: 1
Year: 2011
Comprehensive early intervention for patients with first-episode psychosis in Japan (J-CAP): study protocol for a randomised controlled trial

Author(s): Koike Shinsuke | Nishida Atsushi | Yamasaki Syudo | Ichihashi Kayo | Maegawa Sanae | Natsubori Tatsunobu | Harima Hirohiko | Kasai Kiyoto | Fujita Izumi | Harada Masanori | Okazaki Yuji
Volume: 12
Issue: 1
Year: 2011
Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial

Author(s): Moholdt Trine | Salvesen Kjell | Ingul Charlotte | Vik Torstein | Oken Emily | Mørkved Siv
Volume: 12
Issue: 1
Year: 2011
Bath Breakfast Project (BBP) - Examining the role of extended daily fasting in human energy balance and associated health outcomes: Study protocol for a randomised controlled trial [ISRCTN31521726]

Author(s): Betts James | Thompson Dylan | Richardson Judith | Chowdhury Enhad | Jeans Matthew | Holman Geoffrey | Tsintzas Kostas
Volume: 12
Issue: 1
Year: 2011
LigaSure Impact™ versus conventional dissection technique in pylorus-preserving pancreatoduodenectomy in clinical suspicion of cancerous tumours on the head of the pancreas: study protocol for a randomised controlled trial

Author(s): Gehrig Tobias | Knebel Phillip | Scheel Verena | Hinz Ulf | Seiler Christoph | Müller-Stich Beat | Büchler Markus | Gutt Carsten
Volume: 12
Issue: 1
Year: 2011
Mineral trioxyde aggregate versus calcium hydroxide in apexification of non vital immature teeth: Study protocol for a randomized controlled trial

Author(s): Beslot-Neveu Aurélie | Bonte Eric | Baune Bruno | Serreau Raphaël | Aissat Fawzia | Quinquis Laurent | Grabar Sophie | Lasfargues Jean-Jacques
Volume: 12
Issue: 1
Year: 2011
PRegnancy Outcomes after a Maternity Intervention for Stressful EmotionS (PROMISES): study protocol for a randomised controlled trial

Author(s): Meijer Judith | Bockting Claudi | Beijers Chantal | Verbeek Tjitte | Stant A | Ormel Johan | Stolk Ronald | de Jonge Peter | van Pampus Mariëlle | Burger Huibert
Volume: 12
Issue: 1
Year: 2011
Individually integrated traditional chinese medicine approach in the management of knee osteoarthritis: study protocol for a randomized controlled trial

Author(s): Yuelong Cao | Hongsheng Zhan | Jian Pang | Feiyue Li | Shaojian Xu | Jinghua Gao | Zhanwang Xu | Gang Li | Ting Liu | Chaoqing Guo | Yinyu Shi
Volume: 12
Issue: 1
Year: 2011
Paramedic Initiated Lisinopril For Acute Stroke Treatment (PIL-FAST): study protocol for a pilot randomised controlled trial

Author(s): Shaw Lisa | Price Christopher | McLure Sally | Howel Denise | McColl Elaine | Ford Gary
Volume: 12
Issue: 1
Year: 2011
Primary care practice-based care management for chronically ill patients (PraCMan): study protocol for a cluster randomized controlled trial [ISRCTN56104508]

Author(s): Freund Tobias | Peters-Klimm Frank | Rochon Justine | Mahler Cornelia | Gensichen Jochen | Erler Antje | Beyer Martin | Baldauf Annika | Gerlach Ferdinand | Szecsenyi Joachim
Volume: 12
Issue: 1
Year: 2011
Immediate vs. delayed insertion of intrauterine contraception after second trimester abortion: study protocol for a randomized controlled trial

Author(s): Norman Wendy | Kaczorowski Janusz | Soon Judith | Brant Rollin | Bryan Stirling | Trouton Konia | Dicus Lyda
Volume: 12
Issue: 1
Year: 2011
Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial

Author(s): Kim Jong-In | Kim Tae-Hun | Lee Myeong | Kang Jung | Kim Kun | Choi Jun-Yong | Kang Kyung-Won | Kim Ae-Ran | Shin Mi-Suk | Jung So-Young | Choi Sun-mi
Volume: 12
Issue: 1
Year: 2011
Intracluster correlation coefficients and coefficients of variation for perinatal outcomes from five cluster-randomised controlled trials in low and middle-income countries: results and methodological implications

Author(s): Pagel Christina | Prost Audrey | Lewycka Sonia | Das Sushmita | Colbourn Tim | Mahapatra Rajendra | Azad Kishwar | Costello Anthony | Osrin David
Volume: 12
Issue: 1
Year: 2011
Effectiveness, relapse prevention and mechanisms of change of cognitive therapy vs. interpersonal therapy for depression: Study protocol for a randomised controlled trial

Author(s): Lemmens Lotte | Arntz Arnoud | Peeters Frenk | Hollon Steven | Roefs Anne | Huibers Marcus
Volume: 12
Issue: 1
Year: 2011
A post-trial survey to assess the impact of dissemination of results and unmasking on participants in a 13-year randomised controlled trial on age-related cataract

Author(s): Williams Sally | Ferrigno Luigina | Maraini Giovanni | Rosmini Francesco | Sperduto Robert
Volume: 12
Issue: 1
Year: 2011
Social validity of randomised controlled trials in health services research and intellectual disabilities: a qualitative exploration of stakeholder views

Author(s): Robotham Dan | King Michael | Canagasabey Anton | Inchley-Mort Sophie | Hassiotis Angela
Volume: 12
Issue: 1
Year: 2011
Prevention of: self harm in British South Asian women: study protocol of an exploratory RCT of culturally adapted manual assisted Problem Solving Training (C- MAP)

Author(s): Husain Nusrat | Chaudhry Nasim | Durairaj Steevart | Chaudhry Imran | Khan Sarah | Husain Meher | Nagaraj Diwaker | Naeem Farooq | Waheed Waquas
Volume: 12
Issue: 1
Year: 2011
Prednisolone and acupuncture in Bell's palsy: study protocol for a randomized, controlled trial

Author(s): Xia Feng | Han Junliang | Liu Xuedong | Wang Jingcun | Jiang Zhao | Wang Kangjun | Wu Songdi | Zhao Gang
Volume: 12
Issue: 1
Year: 2011
Community interventions to reduce child mortality in Dhanusha, Nepal: study protocol for a cluster randomized controlled trial

Author(s): Shrestha Bhim | Bhandari Bishnu | Manandhar Dharma | Osrin David | Costello Anthony | Saville Naomi
Volume: 12
Issue: 1
Year: 2011
Analysis and design of randomised clinical trials involving competing risks endpoints

Author(s): Tai Bee-Choo | Wee Joseph | Machin David
Volume: 12
Issue: 1
Year: 2011
Pilot randomized trial of therapeutic hypothermia with serial cranial ultrasound and 18-22 month follow-up for neonatal encephalopathy in a low resource hospital setting in uganda: study protocol

Author(s): Robertson Nicola | Hagmann Cornelia | Acolet Dominique | Allen Elizabeth | Nyombi Natasha | Elbourne Diana | Costello Anthony | Jacobs Ian | Nakakeeto Margaret | Cowan Frances
Volume: 12
Issue: 1
Year: 2011
Reporting of complex interventions in clinical trials: development of a taxonomy to classify and describe fall-prevention interventions

Author(s): Lamb Sarah | Becker Clemens | Gillespie Lesley | Smith Jessica | Finnegan Susanne | Potter Rachel | Pfeiffer Klaus
Volume: 12
Issue: 1
Year: 2011
The UK clinical research network - has it been a success for dermatology clinical trials?

Author(s): Thomas Kim | Koller Karin | Foster Katharine | Perdue Jo | Charlesworth Lisa | Chalmers Joanne
Volume: 12
Issue: 1
Year: 2011
Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication

Author(s): Lewis Roger | Connor Jason | Teerlink John | Murphy James | Cooper Leslie | Hiatt William | Brass Eric
Volume: 12
Issue: 1
Year: 2011
Comparison of early-, late-, and non-participants in a school-based asthma management program for urban high school students

Author(s): Joseph Christine | Saltzgaber Jacquelyn | Havstad Suzanne | Johnson Christine | Johnson Dayna | Peterson Edward | Alexander Gwen | Couper Mick | Ownby Dennis
Volume: 12
Issue: 1
Year: 2011
Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial

Author(s): Beadle Roger | Williams Lynne | Abozguia Khaild | Patel Kiran | Leon Francisco | Yousef Zaheer | Wagenmakers Anton | Frenneaux Michael
Volume: 12
Issue: 1
Year: 2011
Transfer of manualized Short Term Psychodynamic Psychotherapy (STPP) for social phobia into clinical practice: study protocol for a cluster-randomised controlled trial

Author(s): Wiltink Jörg | Ruckes Christian | Haselbacher Antje | Canterino Marco | Leichsenring Falk | Joraschky Peter | Leweke Frank | Pöhlmann Karin | Beutel Manfred
Volume: 12
Issue: 1
Year: 2011
Improving delirium care in the intensive care unit: The design of a pragmatic study

Author(s): Campbell Noll | Khan Babar | Farber Mark | Campbell Tiffany | Perkins Anthony | Hui Siu | Abernathy Greg | Buckley John | Sing Regg | Tricker Jason | Zawahiri Mohammad | Boustani Malaz
Volume: 12
Issue: 1
Year: 2011
To assess whether indoor residual spraying can provide additional protection against clinical malaria over current best practice of long-lasting insecticidal mosquito nets in The Gambia: study protocol for a two-armed cluster-randomised trial

Author(s): Pinder Margaret | Jawara Musa | Jarju Lamin | Kandeh Ballah | Jeffries David | Lluberas Manuel | Mueller Jenny | Parker David | Bojang Kalifa | Conway David | Lindsay Steve
Volume: 12
Issue: 1
Year: 2011
The Home-Based Older People's Exercise (HOPE) trial: study protocol for a randomised controlled trial

Author(s): Clegg Andrew | Barber Sally | Young John | Forster Anne | Iliffe Steve
Volume: 12
Issue: 1
Year: 2011
The effectiveness of early lens extraction with intraocular lens implantation for the treatment of primary angle-closure glaucoma (EAGLE): study protocol for a randomized controlled trial

Author(s): Azuara-Blanco Augusto | Burr Jennifer | Cochran Claire | Ramsay Craig | Vale Luke | Foster Paul | Friedman David | Quayyum Zahidul | Lai Jimmy | Nolan Winnie | Aung Tin | Chew Paul | McPherson Gladys | McDonald Alison | Norrie John
Volume: 12
Issue: 1
Year: 2011
Community mobilisation and health management committee strengthening to increase birth attendance by trained health workers in rural Makwanpur, Nepal: study protocol for a cluster randomised controlled trial

Author(s): Morrison Joanna | Tumbahangphe Kirti | Budhathoki Bharat | Neupane Rishi | Sen Aman | Dahal Kunta | Thapa Rita | Manandhar Reema | Manandhar Dharma | Costello Anthony | Osrin David
Volume: 12
Issue: 1
Year: 2011
Strategic use of new generation antidepressants for depression: SUN(^_^)D study protocol

Author(s): Furukawa Toshi | Akechi Tatsuo | Shimodera Shinji | Yamada Mitsuhiko | Miki Kazuhira | Watanabe Norio | Inagaki Masatoshi | Yonemoto Naohiro
Volume: 12
Issue: 1
Year: 2011
Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial

Author(s): Davis Jeremy | Pandalai Prakash | Ripley R Taylor | Langan Russell | Steinberg Seth | Walker Melissa | Toomey Mary | Levy Elliot | Avital Itzhak
Volume: 12
Issue: 1
Year: 2011
Evaluation of a Medical and Mental Health Unit compared with standard care for older people whose emergency admission to an acute general hospital is complicated by concurrent 'confusion': a controlled clinical trial. Acronym: TEAM: Trial of an Elderly Acute care Medical and mental health unit

Author(s): Harwood Rowan | Goldberg Sarah | Whittamore Kathy | Russell Catherine | Gladman John | Jones Rob | Porock Davina | Lewis Sarah | Bradshaw Lucy | Elliot Rachel
Volume: 12
Issue: 1
Year: 2011
Culturally-Tailored Smoking Cessation for American Indians: Study protocol for a randomized controlled trial

Author(s): Choi Won | Faseru Babalola | Beebe Laura | Greiner Allen | Yeh Hung-Wen | Shireman Theresa | Talawyma Myrietta | Cully Lance | Kaur Baljit | Daley Christine
Volume: 12
Issue: 1
Year: 2011
Clinical Trials: Minimising source data queries to streamline endpoint adjudication in a large multi-national trial

Author(s): Tolmie Elizabeth | Dinnett Eleanor | Ronald Elizabeth | Gaw Allan
Volume: 12
Issue: 1
Year: 2011
Study Protocol: Phase III single-blinded fast-track pragmatic randomised controlled trial of a complex intervention for breathlessness in advanced disease

Author(s): Farquhar Morag | Prevost A Toby | McCrone Paul | Higginson Irene | Gray Jennifer | Brafman-Kennedy Barbara | Booth Sara
Volume: 12
Issue: 1
Year: 2011
Does clinical equipoise apply to cluster randomized trials in health research?

Author(s): Binik Ariella | Weijer Charles | McRae Andrew | Grimshaw Jeremy | Boruch Robert | Brehaut Jamie | Donner Allan | Eccles Martin | Saginur Raphael | Taljaard Monica | Zwarenstein Merrick
Volume: 12
Issue: 1
Year: 2011
Peer mentorship to promote effective pain management in adolescents: study protocol for a randomised controlled trial

Author(s): Allen Laura | Tsao Jennie | Hayes Loran | Zeltzer Lonnie
Volume: 12
Issue: 1
Year: 2011
Study protocol: ICONS: Identifying continence options after stroke: A randomised trial

Author(s): Thomas Lois | Watkins Caroline | French Beverley | Sutton Christopher | Forshaw Denise | Cheater Francine | Roe Brenda | Leathley Michael | Burton Christopher | McColl Elaine | Booth Jo
Volume: 12
Issue: 1
Year: 2011
Design paper: A phase II study of Bevacizumab and Erlotinib in patients with non-Squamous non-small cell lung cancer that is refractory or relapsed after 1-2 previous Treatment (BEST)

Author(s): Tanaka Shiro | Sakamori Yuichi | Niimi Miyuki | Hazama Megumi | Kim Young | Yanagihara Kazuhiro
Volume: 12
Issue: 1
Year: 2011
Study protocol for the recreational stimulation for elders as a vehicle to resolve delirium superimposed on dementia (Reserve For DSD) trial

Author(s): Kolanowski Ann | Fick Donna | Litaker Mark | Clare Linda | Leslie Doug | Boustani Malaz
Volume: 12
Issue: 1
Year: 2011
Beta Agonist Lung Injury TrIal-2 (BALTI-2) trial protocol: A randomised, double-blind, placebo-controlled of intravenous infusion of salbutamol in the acute respiratory distress syndrome

Author(s): Perkins Gavin | Gates Simon | Lamb Sarah | McCabe Chris | Young Duncan | Gao Fang
Volume: 12
Issue: 1
Year: 2011
The effect of family-based multidisciplinary cognitive behavioral treatment in children with obesity: study protocol for a randomized controlled trial

Author(s): Vos Rimke | Wit Jan | Pijl Hanno | Kruyff Carolien | Houdijk Euphemia
Volume: 12
Issue: 1
Year: 2011
The Reversal Intervention for Metabolic Syndrome (TRIMS) study: rationale, design, and baseline data

Author(s): Dunkley Alison | Davies Melanie | Stone Margaret | Taub Nicholas | Troughton Jacqui | Yates Thomas | Khunti Kamlesh
Volume: 12
Issue: 1
Year: 2011
Through the looking glass: understanding non-inferiority

Author(s): Schumi Jennifer | Wittes Janet
Volume: 12
Issue: 1
Year: 2011
A cluster-randomized, placebo-controlled, maternal vitamin a or beta-carotene supplementation trial in bangladesh: design and methods

Author(s): Labrique Alain | Christian Parul | Klemm Rolf | Rashid Mahbubur | Shamim Abu | Massie Allan | Schulze Kerry | Hackman Andre | West Keith
Volume: 12
Issue: 1
Year: 2011
Ethical issues posed by cluster randomized trials in health research

Author(s): Weijer Charles | Grimshaw Jeremy | Taljaard Monica | Binik Ariella | Boruch Robert | Brehaut Jamie | Donner Allan | Eccles Martin | Gallo Antonio | McRae Andrew | Saginur Raphael | Zwarenstein Merrick
Volume: 12
Issue: 1
Year: 2011
Surgical Trial in Lobar Intracerebral Haemorrhage (STICH II) Protocol

Author(s): Mendelow A David | Gregson Barbara | Mitchell Patrick | Murray Gordon | Rowan Elise | Gholkar Anil
Volume: 12
Issue: 1
Year: 2011
Depression care management for late-life depression in China primary care: Protocol for a randomized controlled trial

Author(s): Chen Shulin | Conwell Yeates | Xu Baihua | Chiu Helen | Tu Xin | Ma Yan
Volume: 12
Issue: 1
Year: 2011
Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

Author(s): Hemmes Sabrine | Severgnini Paolo | Jaber Samir | Canet Jaume | Wrigge Hermann | Hiesmayr Michael | Tschernko Edda | Hollmann Markus | Binnekade Jan | Hedenstierna Göran | Putensen Christian | de Abreu Marcelo | Pelosi Paolo | Schultz Marcus
Volume: 12
Issue: 1
Year: 2011
Challenges of maintaining research protocol fidelity in a clinical care setting: A qualitative study of the experiences and views of patients and staff participating in a randomized controlled trial

Author(s): Lawton Julia | Jenkins Nicholas | Darbyshire Julie | Holman Rury | Farmer Andrew | Hallowell Nina
Volume: 12
Issue: 1
Year: 2011
The International Stroke Trial database

Author(s): Sandercock Peter | Niewada Maciej | Członkowska Anna
Volume: 12
Issue: 1
Year: 2011
Te Ira Tangata: A Zelen randomised controlled trial of a treatment package including problem solving therapy compared to treatment as usual in Maori who present to hospital after self harm

Author(s): Hatcher Simon | Coupe Nicole | Durie Mason | Elder Hinemoa | Tapsell Rees | Wikiriwhi Karen | Parag Varsha
Volume: 12
Issue: 1
Year: 2011
The methodology for developing a prospective meta-analysis in the family planning community

Author(s): Turok David | Espey Eve | Edelman Alison | Lotke Pamela | Lathrop Eva | Teal Stephanie | Jacobson Janet | Simonsen Sara | Schulz Kenneth
Volume: 12
Issue: 1
Year: 2011
Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial

Author(s): Hassiotis Angela | Serfaty Marc | Azam Kiran | Strydom Andre | Martin Sue | Parkes Charles | Blizard Robert | King Michael
Volume: 12
Issue: 1
Year: 2011
Cluster randomised trial in the General Practice Research Database: 1. Electronic decision support to reduce antibiotic prescribing in primary care (eCRT study)

Author(s): Gulliford Martin | van Staa Tjeerd | McDermott Lisa | Dregan Alex | McCann Gerard | Ashworth Mark | Charlton Judith | Grieve Andrew | Little Paul | Moore Michael | Yardley Lucy
Volume: 12
Issue: 1
Year: 2011
A Depression Recognition and Treatment package for families living with Stroke (DepReT-Stroke): study protocol for a randomised controlled trial

Author(s): Gray Richard | Myint Phyo | Elender Frances | Barton Garry | Pfeil Michael | Price Gill | Wyatt Niki | Ravenhill Garth | Thomas Ester | Jagger Jenny | Hursey Amelia | Waterfield Kelly | Hardy Sheila
Volume: 12
Issue: 1
Year: 2011
A pseudo-randomised clinical trial of in situ gels of fluconazole for the treatment of oropharngeal candidiasis

Author(s): Nairy Harish | Charyulu Narayana | Shetty Veena | Prabhakara Prabhu
Volume: 12
Issue: 1
Year: 2011
Low omega-6 vs. low omega-6 plus high omega-3 dietary intervention for Chronic Daily Headache: Protocol for a randomized clinical trial

Author(s): Ramsden Christopher | Mann J Douglas | Faurot Keturah | Lynch Chanee | Imam Syed | MacIntosh Beth | Hibbeln Joseph | Loewke James | Smith Sunyata | Coble Rebecca | Suchindran Chirayath | Gaylord Susan
Volume: 12
Issue: 1
Year: 2011
Limited accessibility to designs and results of Japanese large-scale clinical trials for cardiovascular diseases

Author(s): Sawata Hiroshi | Ueshima Kenji | Tsutani Kiichiro
Volume: 12
Issue: 1
Year: 2011
Resources for authors of reports of randomized trials: harnessing the wisdom of authors, editors, and readers

Author(s): Moher David | Hopewell Sally | Schulz Kenneth | Altman Douglas
Volume: 12
Issue: 1
Year: 2011
Randomized placebo-controlled trial on azithromycin to reduce the morbidity of bronchiolitis in Indigenous Australian infants: rationale and protocol

Author(s): Chang Anne | Grimwood Keith | White Andrew | Maclennan Carolyn | Sloots Theo | Sive Alan | McCallum Gabrielle | Mackay Ian | Morris Peter
Volume: 12
Issue: 1
Year: 2011
Who is the research subject in cluster randomized trials in health research?

Author(s): McRae Andrew | Weijer Charles | Binik Ariella | White Angela | Grimshaw Jeremy | Boruch Robert | Brehaut Jamie | Donner Allan | Eccles Martin | Saginur Raphael | Zwarenstein Merrick | Taljaard Monica
Volume: 12
Issue: 1
Year: 2011
Community mobilisation with women's groups facilitated by Accredited Social Health Activists (ASHAs) to improve maternal and newborn health in underserved areas of Jharkhand and Orissa: study protocol for a cluster-randomised controlled trial

Author(s): Tripathy Prasanta | Nair Nirmala | Mahapatra Rajendra | Rath Shibanand | Gope Raj | Rath Suchitra | Bajpai Aparna | Singh Vijay | Nath Vikash | Ali Sarfraz | Kundu Alok | Choudhury Dibarkar | Ghosh Sanjib | Sarbani Swati | Sinha Rajesh | Pagel Christina | Costello Anthony | Houweling Tanja | Prost Audrey
Volume: 12
Issue: 1
Year: 2011
Rationale and design of the plate or pin (pop) study for dislocated midshaft clavicular fractures: study protocol for a randomised controlled trial

Author(s): Wijdicks Frans | Houwert R Marijn | Dijkgraaf Marcel | De Lange Diederik | Meylaerts Sven | Verhofstad Michiel | Verleisdonk Egbert
Volume: 12
Issue: 1
Year: 2011
The Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial: study protocol for a randomized controlled trial

Author(s): Lawlor Debbie | Jago Russell | Noble Sian | Chittleborough Catherine | Campbell Rona | Mytton Julie | Howe Laura | Peters Tim | Kipping Ruth
Volume: 12
Issue: 1
Year: 2011
SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial

Author(s): Lensvelt Mare | Holewijn Suzanne | Fritschy Wilbert | Wikkeling Otmar | van Walraven Laurens | Wallis de Vries Bas | Zeebregts Clark | Reijnen Michel
Volume: 12
Issue: 1
Year: 2011
Reporting of factorial trials of complex interventions in community settings: a systematic review

Author(s): Montgomery Alan | Astin Margaret | Peters Tim
Volume: 12
Issue: 1
Year: 2011
Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial

Author(s): Omollo Raymond | Alexander Neal | Edwards Tansy | Khalil Eltahir | Younis Brima | Abuzaid Abuzaid | Wasunna Monique | Njoroge Njenga | Kinoti Dedan | Kirigi George | Dorlo Thomas | Ellis Sally | Balasegaram Manica | Musa Ahmed
Volume: 12
Issue: 1
Year: 2011
TREC-SAVE: a randomised trial comparing mechanical restraints with use of seclusion for aggressive or violent seriously mentally ill people: study protocol for a randomised controlled trial

Author(s): Huf Gisele | Coutinho Evandro | Ferreira Marco | Ferreira Silvana | Mello Flavia | Adams Clive
Volume: 12
Issue: 1
Year: 2011
Early postoperative cognitive dysfunction and postoperative delirium after anaesthesia with various hypnotics: study protocol for a randomised controlled trial - The PINOCCHIO trial

Author(s): Bilotta Federico | Doronzio Andrea | Stazi Elisabetta | Titi Luca | Zeppa Ivan | Cianchi Antonella | Rosa Giovanni | Paoloni Francesca | Bergese Sergio | Asouhidou Irene | Ioannou Polimnia | Abramowicz Apolonia | Spinelli Allison | Delphin Ellise | Ayrian Eugenia | Zelman Vladimir | Lumb Philip
Volume: 12
Issue: 1
Year: 2011
Developing and evaluating the implementation of a complex intervention: using mixed methods to inform the design of a randomised controlled trial of an oral healthcare intervention after stroke

Author(s): Brady Marian | Stott David | Norrie John | Chalmers Campbell | St George Bridget | Sweeney Petrina | Langhorne Peter
Volume: 12
Issue: 1
Year: 2011
Stepped care treatment for depression and anxiety in primary care. a randomized controlled trial

Author(s): Seekles Wike | van Straten Annemieke | Beekman Aartjan | van Marwijk Harm | Cuijpers Pim
Volume: 12
Issue: 1
Year: 2011
INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

Author(s): Murdoch Megan | McColl Elaine | Howel Denise | Deverill Mark | Buckley Brian | Lucas Malcolm | Chapple Christopher | Tincello Douglas | Armstrong Natalie | Brennand Cath | Shen Jing | Vale Luke | Hilton Paul
Volume: 12
Issue: 1
Year: 2011
Effectiveness of technology-assisted case management in low income adults with type 2 diabetes (TACM-DM): study protocol for a randomized controlled trial

Author(s): Egede Leonard | Strom Joni | Fernandes Jyotika | Knapp Rebecca | Rojugbokan Adebola
Volume: 12
Issue: 1
Year: 2011
Which dressing do donor site wounds need?: study protocol for a randomized controlled trial

Author(s): Eskes Anne | Brölmann Fleur | Gerbens Louise | Ubbink Dirk | Vermeulen Hester
Volume: 12
Issue: 1
Year: 2011
Oxygen persufflation as adjunct in liver preservation (OPAL): Study protocol for a randomized controlled trial

Author(s): Minor Thomas | Pütter Carolin | Gallinat Anja | Ose Claudia | Kaiser Gernot | Scherag Andre | Treckmann Jürgen | Paul Andreas
Volume: 12
Issue: 1
Year: 2011
The chronic care for age-related macular degeneration study (CHARMED): Study protocol for a randomized controlled trial

Author(s): Frei Anja | Woitzek Katja | Wang Mathyas | Held Ulrike | Rosemann Thomas
Volume: 12
Issue: 1
Year: 2011
Alzheimer's disease - input of vitamin D with mEmantine assay (AD-IDEA trial): study protocol for a randomized controlled trial

Author(s): Annweiler Cédric | Fantino Bruno | Parot-Schinkel Elsa | Thiery Samuel | Gautier Jennifer | Beauchet Olivier
Volume: 12
Issue: 1
Year: 2011
Investigating a TELEmedicine solution to improve MEDication adherence in chronic Heart Failure (TELEMED-HF): study protocol for a randomized controlled trial

Author(s): Kessing Dionne | Denollet Johan | Widdershoven Jos | Kupper Nina
Volume: 12
Issue: 1
Year: 2011
Effectiveness of heat-sensitive moxibustion in the treatment of lumbar disc herniation: study protocol for a randomized controlled trial

Author(s): Chen Mingren | Chen Rixin | Xiong Jun | Yi Fan | Chi Zhenhai | Zhang Bo
Volume: 12
Issue: 1
Year: 2011
Combined STN/SNr-DBS for the treatment of refractory gait disturbances in Parkinson's disease: study protocol for a randomized controlled trial

Author(s): Weiss Daniel | Wächter Tobias | Meisner Christoph | Fritz Melanie | Gharabaghi Alireza | Plewnia Christian | Breit Sorin | Krüger Rejko
Volume: 12
Issue: 1
Year: 2011
Multi-professional clinical medication reviews in care homes for the elderly: study protocol for a randomised controlled trial with cost effectiveness analysis

Author(s): Desborough James | Houghton Julie | Wood John | Wright David | Holland Richard | Sach Tracey | Ashwell Sue | Shaw Val
Volume: 12
Issue: 1
Year: 2011
Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

Author(s): Krzych Lukasz | Lees Belinda | Nugara Fiona | Banya Winston | Bochenek Andrzej | Cook Jo | Taggart David | Flather Marcus
Volume: 12
Issue: 1
Year: 2011
A randomised evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial

Author(s): Mitchell Natasha | Hewitt Catherine | Adamson Joy | Parrott Steve | Torgerson David | Ekers David | Holmes John | Lester Helen | McMillan Dean | Richards David | Spilsbury Karen | Godfrey Christine | Gilbody Simon
Volume: 12
Issue: 1
Year: 2011
Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians)

Author(s): Douglas Anne | Bhopal Raj | Bhopal Ruby | Forbes John | Gill Jason | Lawton Julia | McKnight John | Murray Gordon | Sattar Naveed | Sharma Anu | Tuomilehto Jaakko | Wallia Sunita | Wild Sarah | Sheikh Aziz
Volume: 12
Issue: 1
Year: 2011
Reduction of surgical site infection using a novel intervention (ROSSINI): study protocol for a randomised controlled trial

Author(s): Pinkney Thomas | Bartlett David | Hawkins William | Mak Tony | Youssef Haney | Futaba Kaori | Harrison Gareth | Gheorghe Adrian | Bradbury Jennifer | Calvert Melanie | Dowswell George | Magill Laura | Redman Val | Wilson Sue | Leaper David | Morton Dion
Volume: 12
Issue: 1
Year: 2011
The effect of C1-esterase inhibitor on systemic inflammation in trauma patients with a femur fracture - The CAESAR study: study protocol for a randomized controlled trial

Author(s): Heeres Marjolein | Visser Tjaakje | van Wessem Karlijn | Koenderman Anky | Strengers Paul | Koenderman Leo | Leenen Luke
Volume: 12
Issue: 1
Year: 2011
Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial

Author(s): Ko Seok-Jae | Ryu Bongha | Kim Jinsung | Hong Beom-Gi | Yeo Inkwon | Lee Beom-Joon | Lee Jin-Moo | Park Jae-Woo
Volume: 12
Issue: 1
Year: 2011
DIABRISK - SL Prevention of cardio-metabolic disease with life style modification in young urban Sri Lankan's - study protocol for a randomized controlled trial

Author(s): Wijesuriya Mahen | Gulliford Martin | Vasantharajah Laksha | Viberti Giancarlo | Gnudi Luigi | Karalliedde Janaka
Volume: 12
Issue: 1
Year: 2011
The effect of participatory women's groups on birth outcomes in Bangladesh: does coverage matter? Study protocol for a randomized controlled trial

Author(s): Houweling Tanja | Azad Kishwar | Younes Layla | Kuddus Abdul | Shaha Sanjit | Haq Bedowra | Nahar Tasmin | Beard James | Fottrell Edward | Prost Audrey | Costello Anthony
Volume: 12
Issue: 1
Year: 2011
Meropenem vs standard of care for treatment of late onset sepsis in children of less than 90 days of age: study protocol for a randomised controlled trial

Author(s): Lutsar Irja | Trafojer Ursula | Heath Paul | Metsvaht Tuuli | Standing Joseph | Esposito Susanna | de Cabre Vincent | Oeser Clarissa | Aboulker Jean-Pierre
Volume: 12
Issue: 1
Year: 2011
Failure to report protocol violations in clinical trials: a threat to internal validity?

Author(s): Sweetman Elizabeth | Doig Gordon
Volume: 12
Issue: 1
Year: 2011
Stimulant Reduction Intervention using Dosed Exercise (STRIDE) - CTN 0037: Study protocol for a randomized controlled trial

Author(s): Trivedi Madhukar | Greer Tracy | Grannemann Bruce | Church Timothy | Somoza Eugene | Blair Steven | Szapocznik Jose | Stoutenberg Mark | Rethorst Chad | Warden Diane | Ring Kolette | Walker Robrina | Morris David | Kosinski Andrzej | Kyle Tiffany | Marcus Bess | Crowell Becca | Oden Neal | Nunes Edward
Volume: 12
Issue: 1
Year: 2011
Transfusion of red cells in hematopoietic stem cell transplantation (TRIST): study protocol for a randomized controlled trial

Author(s): Tay Jason | Tinmouth Alan | Fergusson Dean | Allan David
Volume: 12
Issue: 1
Year: 2011
Acute medical unit comprehensive geriatric assessment intervention study (AMIGOS)

Author(s): Edmans Judi | Conroy Simon | Harwood Rowan | Lewis Sarah | Elliott Rachel | Logan Philippa | Bradshaw Lucy | Franklin Matthew | Gladman John
Volume: 12
Issue: 1
Year: 2011
When is informed consent required in cluster randomized trials in health research?

Author(s): McRae Andrew | Weijer Charles | Binik Ariella | Grimshaw Jeremy | Boruch Robert | Brehaut Jamie | Donner Allan | Eccles Martin | Saginur Raphael | White Angela | Taljaard Monica
Volume: 12
Issue: 1
Year: 2011
Effect of selenium supplementation on CD4 T-cell recovery, viral suppression, morbidity and quality of life of HIV-infected patients in Rwanda: study protocol for a randomized controlled trial

Author(s): Kamwesiga Julius | Mutabazi Vincent | Kayumba Josephine | Tayari Jean-Claude | Smyth Richard | Fay Heather | Umurerwa Alice | Baziruwiha Marcel | Ntizimira Christian | Murebwayire Antoinette | Haguma Jean | Nyiransabimana Julienne | Habarurema Donatille | Mukarukundo Veneranda | Nzabandora Jean | Nzamwita Pascal | Mukazayire Ernestine | Mills Edward | Seely Dugald | McCready Douglas | Warren Don
Volume: 12
Issue: 1
Year: 2011
Cardiac magnetic resonance imaging parameters as surrogate endpoints in clinical trials of acute myocardial infarction

Author(s): Desch Steffen | Eitel Ingo | de Waha Suzanne | Fuernau Georg | Lurz Philipp | Gutberlet Matthias | Schuler Gerhard | Thiele Holger
Volume: 12
Issue: 1
Year: 2011
EARLYDRAIN- outcome after early lumbar CSF-drainage in aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

Author(s): Bardutzky Jürgen | Witsch Jens | Jüttler Eric | Schwab Stefan | Vajkoczy Peter | Wolf Stefan
Volume: 12
Issue: 1
Year: 2011
Peer support for family carers of people with dementia, alone or in combination with group reminiscence in a factorial design: study protocol for a randomised controlled trial

Author(s): Charlesworth Georgina | Burnell Karen | Beecham Jennifer | Hoare Zoë | Hoe Juanita | Wenborn Jennifer | Knapp Martin | Russell Ian | Woods Bob | Orrell Martin
Volume: 12
Issue: 1
Year: 2011
Illness management and recovery (IMR) in Danish community mental health centres

Author(s): Dalum Helle | Korsbek Lisa | Mikkelsen John | Thomsen Karin | Kistrup Kristen | Olander Mette | Hansen Jane | Nordentoft Merete | Eplov Lene
Volume: 12
Issue: 1
Year: 2011
Simultaneous use of traditional Chinese medicine (Si-Ni-Tang) to treat septic shock patients: study protocol for a randomized controlled trial

Author(s): Chen Huang-Chi | Chen Wen-Chi | Lin Kai-Huang | Chen Yung-Hsiang | Lo Lun-Chien | Lee Tsung-Chieh | Hsia Te-Chun | Wang Chu-Hsien | Wu Shin-Hwar | Hsu Hsin-Whae | Chang Yu-Jun | Huang Yu-Chuen | Ku Tien-Hsiung | Horng Ming-Hwarng
Volume: 12
Issue: 1
Year: 2011
Promoting smoking cessation in Pakistani and Bangladeshi men in the UK: pilot cluster randomised controlled trial of trained community outreach workers

Author(s): Begh Rachna | Aveyard Paul | Upton Penney | Bhopal Raj | White Martin | Amos Amanda | Prescott Robin | Bedi Raman | Barton Pelham | Fletcher Monica | Gill Paramjit | Zaidi Qaim | Sheikh Aziz
Volume: 12
Issue: 1
Year: 2011
Randomized, double-blind, placebo-controled clinical trial of sublingual immunotherapy in natural rubber latex allergic patients

Author(s): Gastaminza Gabriel | Algorta Jaime | Uriel Olga | Audicana Maria | Fernandez Eduardo | Sanz Maria | Muñoz Daniel
Volume: 12
Issue: 1
Year: 2011
Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial

Author(s): Thornell Anders | Angenete Eva | Gonzales Elisabeth | Heath Jane | Jess Per | Läckberg Zoltan | Ovesen Henrik | Rosenberg Jacob | Skullman Stefan | Haglind Eva
Volume: 12
Issue: 1
Year: 2011
Psycho-education with problem solving (PEPS) therapy for adults with personality disorder: A pragmatic multi-site community-based randomised clinical trial

Author(s): McMurran Mary | Crawford Mike | Reilly Joseph | McCrone Paul | Moran Paul | Williams Hywel | Adams Clive | Duggan Conor | Delport Juan | Whitham Diane | Day Florence
Volume: 12
Issue: 1
Year: 2011
Pre-referral rectal artesunate in severe malaria: flawed trial

Author(s): Hirji Karim | Premji Zulfiqarali
Volume: 12
Issue: 1
Year: 2011
A Single-Blind randomized controlled trial to evaluate the effect of extended counseling on uptake of pre-antiretroviral care in eastern uganda

Author(s): Muhamadi Lubega | Tumwesigye Nazarius | Kadobera Daniel | Marrone Gaetano | Wabwire-Mangen Fred | Pariyo George | Peterson Stefan | Ekström Anna
Volume: 12
Issue: 1
Year: 2011
The B-VITAGE trial: A randomized trial of homocysteine lowering treatment of depression in later life

Author(s): Ford Andrew | Flicker Leon | McCaul Kieran | van Bockxmeer Frank | Hegarty Sarah | Hirani Varsha | Fenner Stephen | Almeida Osvaldo
Volume: 12
Issue: 1
Year: 2011
Classic yin and yang tonic formula for osteopenia: study protocol for a randomized controlled trial

Author(s): Yang Feng | Tang De-Zhi | Cui Xue-Jun | Holz Jonathan | Bian Qin | Shi Qi | Wang Yong-Jun
Volume: 12
Issue: 1
Year: 2011
Between-centre differences and treatment effects in randomized controlled trials: A case study in traumatic brain injury

Author(s): Lingsma Hester | Roozenbeek Bob | Perel Pablo | Roberts Ian | Maas Andrew | Steyerberg Ewout
Volume: 12
Issue: 1
Year: 2011
Approaches to interim analysis of cancer randomised clinical trials with time to event endpoints: A survey from the Italian National Monitoring Centre for Clinical Trials

Author(s): Floriani Irene | Rotmensz Nicole | Albertazzi Elena | Torri Valter | De Rosa Marisa | Tomino Carlo | de Braud Fillipo
Volume: 9
Issue: 1
Year: 2008
Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

Author(s): Iwanowski Piotr | Budaj Andrzej | Członkowska Anna | Wąsek Wojciech | Kozłowska-Boszko Beata | Olędzka Urszula | Masełbas Wojciech
Volume: 9
Issue: 1
Year: 2008
A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

Author(s): Laurence Caroline | Gialamas Angela | Yelland Lisa | Bubner Tanya | Ryan Philip | Willson Kristyn | Glastonbury Briony | Gill Janice | Shephard Mark | Beilby Justin
Volume: 9
Issue: 1
Year: 2008
Non-invasive cardiac assessment in high risk patients (The GROUND study): rationale, objectives and design of a multi-center randomized controlled clinical trial

Author(s): de Vos Alexander | Rutten Annemarieke | van de Zaag-Loonen Hester | Bots Michiel | Dikkers Riksta | Buiskool Robert | Mali Willem | Lubbers Daniel | Mosterd Arend | Prokop Mathias | Rensing Benno | Cramer Maarten | van Es H Wouter | Moll Frans | van de Pavoordt Eric | Doevendans Pieter | Velthuis Birgitta | Mackaay Albert | Zijlstra Felix | Oudkerk Matthijs
Volume: 9
Issue: 1
Year: 2008
Bright light in elderly subjects with nonseasonal major depressive disorder: a double blind randomised clinical trial using early morning bright blue light comparing dim red light treatment

Author(s): Lieverse Ritsaert | Nielen Marjan | Veltman Dick | Uitdehaag Bernard | van Someren Eus | Smit Jan | Hoogendijk Witte
Volume: 9
Issue: 1
Year: 2008
Multicenter double blind trial of autologous bone marrow mononuclear cell transplantation through intracoronary injection post acute myocardium infarction – MiHeart/AMI study

Author(s): Dohmann Hans | Silva Suzana | Sousa André | Braga Alcione | Branco Rodrigo | Haddad Andréa | Oliveira Mônica | Moreira Rodrigo | Tuche Fabio | Peixoto Cíntia | Tura Bernardo | Borojevic Radovan | Ribeiro Jorge | Nicolau José | Nóbrega Antonio | Carvalho Antonio
Volume: 9
Issue: 1
Year: 2008
Design paper: The CapOpus trial: A randomized, parallel-group, observer-blinded clinical trial of specialized addiction treatment versus treatment as usual for young patients with cannabis abuse and psychosis

Author(s): Hjorthøj Carsten | Fohlmann Allan | Larsen Anne-Mette | Madsen Mette | Vesterager Lone | Gluud Christian | Arendt Mikkel | Nordentoft Merete
Volume: 9
Issue: 1
Year: 2008
The third international stroke trial (IST-3) of thrombolysis for acute ischaemic stroke

Author(s): Sandercock Peter | Lindley Richard | Wardlaw Joanna | Dennis Martin | Lewis Steff | Venables Graham | Kobayashi Adam | Czlonkowska Anna | Berge Eivind | Slot Karsten | Murray Veronica | Peeters Andre | Hankey Graeme | Matz Karl | Brainin Michael | Ricci Stefano | Celani Maria | Righetti Enrico | Cantisani Teresa | Gubitz Gord | Phillips Steve | Arauz Antonio | Prasad Kameshwar | Correia Manuel | Lyrer Phillippe
Volume: 9
Issue: 1
Year: 2008
Inefficacy of different strategies to improve guideline awareness – 5-year follow-up of the hypertension evaluation project (HEP)

Author(s): Hagemeister Jens | Schneider Christian | Diedrichs Holger | Mebus Diana | Pfaff Holger | Wassmer Gernot | Höpp Hans
Volume: 9
Issue: 1
Year: 2008
Effectiveness of the Austrian disease-management-programme for type 2 diabetes: study protocol of a cluster-randomized controlled trial

Author(s): Sönnichsen Andreas | Rinnerberger Andreas | Url Maria | Winkler Henrike | Kowatsch Peter | Klima Gert | Fürthauer Bernhard | Weitgasser Raimund
Volume: 9
Issue: 1
Year: 2008
Randomised, crossover clinical trial, in healthy volunteers, to compare the systemic availability of two topical intranasal budesonide formulations

Author(s): Algorta Jaime | Pena Maria | Francisco Silvia | Abajo Zurine | Sanz Emilio
Volume: 9
Issue: 1
Year: 2008
Automated external cardioversion defibrillation monitoring in cardiac arrest: a randomized trial

Author(s): Ali Bakhtiar | Bloom Heather | Veledar Emir | House Dorothy | Norvel Robert | Dudley Samuel | Zafari A Maziar
Volume: 9
Issue: 1
Year: 2008
Effectiveness of computer-tailored Smoking Cessation Advice in Primary Care (ESCAPE): a Randomised Trial

Author(s): Gilbert Hazel | Nazareth Irwin | Sutton Stephen | Morris Richard | Godfrey Christine
Volume: 9
Issue: 1
Year: 2008
GALA: an international multicentre randomised trial comparing general anaesthesia versus local anaesthesia for carotid surgery

Author(s): Gough Michael | Bodenham Andrew | Horrocks Michael | Colam Bridget | Lewis Steff | Rothwell Peter | Banning Adrian | Torgerson David | Gough Moira | Dellagrammaticas Demosthenes | Leigh-Brown Anne | Liapis Christos | Warlow Charles
Volume: 9
Issue: 1
Year: 2008
GENetic and clinical Predictors Of treatment response in Depression: the GenPod randomised trial protocol

Author(s): Thomas Laura | Mulligan Jean | Mason Victoria | Tallon Debbie | Wiles Nicola | Cowen Philip | Nutt David | O'Donovan Michael | Sharp Deborah | Peters Tim | Lewis Glyn
Volume: 9
Issue: 1
Year: 2008
Streamlining tasks and roles to expand treatment and care for HIV: randomised controlled trial protocol

Author(s): Fairall Lara | Bachmann Max | Zwarenstein Merrick | Lombard Carl | Uebel Kerry | van Vuuren Cloete | Steyn Dewald | Boulle Andrew | Bateman Eric
Volume: 9
Issue: 1
Year: 2008
Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors'

Author(s): Hopewell Sally | Altman Douglas | Moher David | Schulz Kenneth
Volume: 9
Issue: 1
Year: 2008
An assessment of the quality of randomised controlled trials conducted in China

Author(s): Zhang Dalu | Yin Peng | Freemantle Nick | Jordan Rachel | Zhong Nanshan | Cheng KK
Volume: 9
Issue: 1
Year: 2008
Investigation of the effect of Interleukin-1 receptor antagonist (IL-1ra) on markers of inflammation in non-ST elevation acute coronary syndromes (The MRC-ILA-HEART Study)

Author(s): Crossman David | Morton Allison | Gunn Julian | Greenwood John | Hall Alistair | Fox Keith | Lucking Andrew | Flather Marcus | Lees Belinda | Foley Claire
Volume: 9
Issue: 1
Year: 2008
Echocardiographic predictors of severe heart failure symptoms in hypertrophic cardiomyopathy patients with sinus rhythm

Author(s): Bayrak Fatih | Kahveci Gokhan | Degertekin Muzaffer | Mutlu Bulent
Volume: 9
Issue: 1
Year: 2008
Community based trial of home blood pressure monitoring with nurse-led telephone support in patients with stroke or transient ischaemic attack recently discharged from hospital

Author(s): Kerry Sally | Markus Hugh | Khong Teck | Doshi Reena | Conroy Rachel | Oakeshott Pippa
Volume: 9
Issue: 1
Year: 2008
Design of the Pacemaker REmote Follow-up Evaluation and Review (PREFER) trial to assess the clinical value of the remote pacemaker interrogation in the management of pacemaker patients

Author(s): Chen Jane | Wilkoff Bruce | Choucair Wassim | Cohen Todd | Crossley George | Johnson W Ben | Mongeon Luc | Serwer Gerald | Sherfesee Lou
Volume: 9
Issue: 1
Year: 2008
Randomised controlled trial of thermostatic mixer valves in reducing bath hot tap water temperature in families with young children in social housing: A protocol

Author(s): Kendrick Denise | Stewart Jane | Coupland Carol | Hayes Michael | Hopkins Nick | McCabe Debbie | Murphy Robert | O'Donnell George | Phillips Ceri | Radford David | Ryan Jackie | Smith Sherie | Groom Lindsay | Towner Elizabeth
Volume: 9
Issue: 1
Year: 2008
From multidimensional neuropsychological outcomes to a cognitive complication rate: The International Subarachnoid Aneurysm Trial

Author(s): Scott Richard | Eccles Fiona | Lloyd Andrew | Carpenter Katherine
Volume: 9
Issue: 1
Year: 2008
TIPIT: A randomised controlled trial of thyroxine in preterm infants under 28 weeks' gestation

Author(s): Ng Sze | Turner Mark | Gamble Carrol | Didi Mohammed | Victor Suresh | Weindling Alan
Volume: 9
Issue: 1
Year: 2008
Protocol for the combined immunosuppression & radiotherapy in thyroid eye disease (CIRTED) trial: A multi-centre, double-masked, factorial randomised controlled trial

Author(s): Rajendram Rathie | Lee Richard | Potts Mike | Rose Geoff | Jain Rajni | Olver Jane | Bremner Fion | Hurel Steven | Cook Anne | Gattamaneni Rao | Tomlinson Marjorie | Plowman Nicholas | Bunce Catey | Hollinghurst Sandra | Kingston Laura | Jackson Sue | Dick Andrew | Rumsey Nichola | Morris Olivia | Dayan Colin | Uddin Jimmy
Volume: 9
Issue: 1
Year: 2008
Efficacy of acupuncture for chronic low back pain: protocol for a randomized controlled trial

Author(s): Cherkin Daniel | Sherman Karen | Hogeboom Charissa | Erro Janet | Barlow William | Deyo Richard | Avins Andrew
Volume: 9
Issue: 1
Year: 2008
Improving the outcomes of primary care attenders with common mental disorders in developing countries: a cluster randomized controlled trial of a collaborative stepped care intervention in Goa, India

Author(s): Patel Vikram | Kirkwood Betty | Pednekar Sulochana | Araya Ricardo | King Michael | Chisholm Daniel | Simon Gregory | Weiss Helen
Volume: 9
Issue: 1
Year: 2008
A study to assess changes in myocardial perfusion after treatment with spinal cord stimulation and percutaneous myocardial laser revascularisation; data from a randomised trial

Author(s): Khan Sadia | McNab Duncan | Sharples Linda | Freeman Carol | Hardy Ian | Stone David | Schofield Peter
Volume: 9
Issue: 1
Year: 2008
What constitutes a "clinical trial"?: A survey of oncology professionals

Author(s): Wright James | Kowaleski Brenda | Sussman Jonathan
Volume: 9
Issue: 1
Year: 2008
A concept for trial institutions focussing on randomised controlled trials in surgery

Author(s): Rahbari Nuh | Diener Markus | Fischer Lars | Wente Moritz | Kienle Peter | Büchler Markus | Seiler Christoph
Volume: 9
Issue: 1
Year: 2008
Cluster-randomised controlled trial of community mobilisation in Mumbai slums to improve care during pregnancy, delivery, postpartum and for the newborn

Author(s): More Neena | Bapat Ujwala | Das Sushmita | Patil Sarita | Porel Maya | Vaidya Leena | Koriya Bhaveshree | Barnett Sarah | Costello Anthony | Fernandez Armida | Osrin David
Volume: 9
Issue: 1
Year: 2008
The ACTIVE (Acute Cholecystitis Trial Invasive Versus Endoscopic) study: Multicenter randomized, double-blind, controlled trial of laparoscopic (LC) versus open (LTC) surgery for acute cholecystitis (AC) in adults

Author(s): Catena Fausto | Ansaloni Luca | Di Saverio Salomone | Gazzotti Filippo | Gagliardi Stefano | Coccolini Federico | D'Alessandro Luigi | Ercolani Giorgio | Talarico Carlo | Bassi Uberto | Leone Leonardo | Calzolari Filippo | Pinna Antonio
Volume: 9
Issue: 1
Year: 2008
Seminars may increase recruitment to randomised controlled trials: lessons learned from WISDOM

Author(s): Paine Bronwen | Stocks Nigel | MacLennan Alastair
Volume: 9
Issue: 1
Year: 2008
Recruitment of young women to a trial of chlamydia screening – as easy as it sounds?

Author(s): Atherton Helen | Banks Debbie | Harbit Ruth | Long Linzie | Chadd Fiona | Hay Phillip | Kerry Sally | Simms Ian | Oakeshott Pippa
Volume: 8
Issue: 1
Year: 2007
Breast MRI in nonpalpable breast lesions: a randomized trial with diagnostic and therapeutic outcome – MONET – study

Author(s): Peters Nicky | Borel Rinkes Inne | Mali Willem | van den Bosch Maurice | Storm Remmert | Plaisier Peter | de Boer Erwin | van Overbeeke Adriaan | Peeters Petra
Volume: 8
Issue: 1
Year: 2007
Figures in clinical trial reports: current practice & scope for improvement

Author(s): Pocock Stuart | Travison Thomas | Wruck Lisa
Volume: 8
Issue: 1
Year: 2007
Multiple treatment comparisons in epilepsy monotherapy trials

Author(s): Tudur Smith Catrin | Marson Anthony | Chadwick David | Williamson1 Paula
Volume: 8
Issue: 1
Year: 2007
VERTOS II: Percutaneous vertebroplasty versus conservative therapy in patients with painful osteoporotic vertebral compression fractures; rationale, objectives and design of a multicenter randomized controlled trial

Author(s): Klazen CAH | Verhaar HJJ | Lampmann LEH | Juttmann JR | Blonk MC | Jansen FH | Tielbeek AV | Schoemaker MC | Buskens E | van der Graaf Y | Janssens X | Fransen H | van Everdingen KJ | Muller AF | Mali WPThM | Lohle PNM
Volume: 8
Issue: 1
Year: 2007
Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for diagnosis of colonic cancer in older symptomatic patients: The SIGGAR study

Author(s): Halligan Steve | Lilford Richard | Wardle Jane | Morton Dion | Rogers Pauline | Wooldrage Katherine | Edwards Rob | Kanani Reshma | Shah Urvi | Atkin Wendy
Volume: 8
Issue: 1
Year: 2007
Do trialists endorse clinical trial registration? Survey of a Pubmed sample

Author(s): Reveiz Ludovic | Krleža-Jerić Karmela | Chan An-Wen | De Aguiar Sylvia
Volume: 8
Issue: 1
Year: 2007
Safety and efficacy of botox injection in alleviating post-operative pain and improving quality of life in lower extremity limb lengthening and deformity correction

Author(s): Hamdy Reggie | Montpetit Kathleen | Ruck-Gibis Joanne | Thorstad Kelly | Raney Ellen | Aiona Michael | Platt Robert | Finley Allen | Mackenzie William | McCarthy James | Narayanan Unni
Volume: 8
Issue: 1
Year: 2007
Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial

Author(s): Schlosser Katja | Veit Johannes | Witte Stefan | Fernández Emilio | Victor Norbert | Knaebel Hans-Peter | Seiler Christoph | Rothmund Matthias
Volume: 8
Issue: 1
Year: 2007
Randomised trial of glutamine and selenium supplemented parenteral nutrition for critically ill patients. Protocol Version 9, 19 February 2007 known as SIGNET (Scottish Intensive care Glutamine or seleNium Evaluative Trial)

Author(s): Andrews Peter | Avenell Alison | Noble David | Campbell Marion | Battison Claire | Croal Bernard | Simpson William | Norrie John | Vale Luke | Cook Jonathon | de Verteuil Robyn | Milne Anne
Volume: 8
Issue: 1
Year: 2007
A cluster randomized trial evaluating electronic prescribing in an ambulatory care setting

Author(s): Zwarenstein Merrick | Dainty Katie | Quan Sherman | Kiss Alex | Adhikari Neill
Volume: 8
Issue: 1
Year: 2007
Double blind, randomized, placebo controlled clinical trial for the treatment of diabetic foot ulcers, using a nitric oxide releasing patch: PATHON

Author(s): Silva Sandra | Rueda Ligia | Márquez Gustavo | López Marcos | Smith Daniel | Calderón Carlos | Castillo Juan | Matute Jaime | Rueda-Clausen Christian | Orduz Arturo | Silva Federico | Kampeerapappun Piyaporn | Bhide Mahesh | López-Jaramillo Patricio
Volume: 8
Issue: 1
Year: 2007
Acute cholecystitis – early laparoskopic surgery versus antibiotic therapy and delayed elective cholecystectomy: ACDC-study

Author(s): Weigand Kilian | Köninger Jörg | Encke Jens | Büchler Markus | Stremmel Wolfgang | Gutt Carsten
Volume: 8
Issue: 1
Year: 2007
Structuring communication relationships for interprofessional teamwork (SCRIPT): a cluster randomized controlled trial

Author(s): Zwarenstein Merrick | Reeves Scott | Russell Ann | Kenaszchuk Chris | Conn Lesley | Miller Karen-Lee | Lingard Lorelei | Thorpe Kevin
Volume: 8
Issue: 1
Year: 2007
Early loading of plalatal implants (ortho-type II) a prospective multicenter randomized controlled clinical trial

Author(s): Jung Britta | Wehrbein Heinrich | Hopfenmüller Werner | Harzer Winfried | Gedrange Tomasz | Diedrich Peter | Kunkel Martin
Volume: 8
Issue: 1
Year: 2007
Aspirin and Simvastatin Combination for Cardiovascular Events Prevention Trial in Diabetes (ACCEPT-D): design of a randomized study of the efficacy of low-dose aspirin in the prevention of cardiovascular events in subjects with diabetes mellitus treated with statins

Author(s): De Berardis Giorgia | Sacco Michele | Evangelista Virgilio | Filippi Alessandro | Giorda Carlo | Tognoni Gianni | Valentini Umberto | Nicolucci Antonio
Volume: 8
Issue: 1
Year: 2007
PROUD: Effects of preoperative long-term immunonutrition in patients listed for liver transplantation

Author(s): Nickkholgh Arash | Schneider Heinz | Encke Jens | Büchler Markus | Schmidt Jan | Schemmer Peter
Volume: 8
Issue: 1
Year: 2007
Is looped nasogastric tube feeding more effective than conventional nasogastric tube feeding for dysphagia in acute stroke?

Author(s): Beavan Jessica | Conroy Simon | Leonardi-Bee Jo | Bowling Tim | Gaynor Catherine | Gladman John | Good Dawn | Gorman Peter | Harwood Rowan | Riley Jan | Sach Tracey | Sunman Wayne
Volume: 8
Issue: 1
Year: 2007
Method for evaluating prediction models that apply the results of randomized trials to individual patients

Author(s): Vickers Andrew | Kattan Michael | Sargent Daniel
Volume: 8
Issue: 1
Year: 2007
Practical methods for incorporating summary time-to-event data into meta-analysis

Author(s): Tierney Jayne | Stewart Lesley | Ghersi Davina | Burdett Sarah | Sydes Matthew
Volume: 8
Issue: 1
Year: 2007
Telecare motivational interviewing for diabetes patient education and support: a randomised controlled trial based in primary care comparing nurse and peer supporter delivery

Author(s): Dale Jeremy | Caramlau Isabela | Docherty Andrea | Sturt Jackie | Hearnshaw Hilary
Volume: 8
Issue: 1
Year: 2007
Silent cerebral infarct after cardiac catheterization as detected by diffusion weighted Magnetic Resonance Imaging: a randomized comparison of radial and femoral arterial approaches

Author(s): Hamon Michèle | Burzotta Francesco | Oppenheim Catherine | Morello Rémy | Viader Fausto | Hamon Martial
Volume: 8
Issue: 1
Year: 2007
Evaluation of two formulations of adjuvanted RTS, S malaria vaccine in children aged 3 to 5 years living in a malaria-endemic region of Mozambique: a Phase I/IIb randomized double-blind bridging trial

Author(s): Macete Eusebio | Sacarlal Jahit | Aponte John | Leach Amanda | Navia Margarita | Milman Jessica | Guinovart Caterina | Mandomando Inacio | López-Púa Yolanda | Lievens Marc | Owusu-Ofori Alex | Dubois Marie-Claude | Cahill Conor | Koutsoukos Marguerite | Sillman Marla | Thompson Ricardo | Dubovsky Filip | Ballou W Ripley | Cohen Joe | Alonso Pedro
Volume: 8
Issue: 1
Year: 2007
Phase II study of two dose schedules of C.E.R.A. (Continuous Erythropoietin Receptor Activator) in anemic patients with advanced non-small cell lung cancer (NSCLC) receiving chemotherapy

Author(s): Hirsh Vera | Glaspy John | Mainwaring Paul | Manegold Christian | Ramlau Rodryg | Eid Joseph
Volume: 8
Issue: 1
Year: 2007
"Me's me and you's you": Exploring patients' perspectives of single patient (n-of-1) trials in the UK

Author(s): Brookes Sara | Biddle Lucy | Paterson Charlotte | Woolhead Gillian | Dieppe Paul
Volume: 8
Issue: 1
Year: 2007
Does it matter if clinicians recruiting for a trial don't understand what the trial is really about? Qualitative study of surgeons' experiences of participation in a pragmatic multi-centre RCT

Author(s): Ziebland Sue | Featherstone Katie | Snowdon Claire | Barker Karen | Frost Helen | Fairbank Jeremy
Volume: 8
Issue: 1
Year: 2007
Feasibility study to inform the design of a UK multi-centre randomised controlled trial of prophylactic antibiotics for the prevention of recurrent cellulitis of the leg

Author(s): Thomas Kim | Cox Neil | Savelyich Boki | Shipley Debbie | Meredith Sarah | Nunn Andrew | Reynolds Nick | Williams Hywel
Volume: 8
Issue: 1
Year: 2007
Financial considerations in the conduct of multi-centre randomised controlled trials: evidence from a qualitative study

Author(s): Snowdon Claire | Elbourne Diana | Garcia Jo | Campbell Marion | Entwistle Vikki | Francis David | Grant Adrian | Knight Rosemary | McDonald Alison | Roberts Ian
Volume: 7
Issue: 1
Year: 2006
Multicenter randomized trial of cell therapy in cardiopathies – MiHeart Study

Author(s): Tura Bernardo | Martino Helena | Gowdak Luis | dos Santos Ricardo | Dohmann Hans | Krieger José | Feitosa Gilson | Vilas-Boas Fábio | Oliveira Sérgio | Silva Suzana | Bozza Augusto | Borojevic Radovan | de Carvalho Antonio
Volume: 8
Issue: 1
Year: 2007
Comparison of the efficacy and safety of rosuvastatin 10 mg and atorvastatin 20 mg in high-risk patients with hypercholesterolemia – Prospective study to evaluate the Use of Low doses of the Statins Atorvastatin and Rosuvastatin (PULSAR)

Author(s): Clearfield Michael | Amerena John | Bassand Jean-Pierre | García Hugo | Miller Sam | Sosef Froukje | Palmer Michael | Bryzinski Brian
Volume: 7
Issue: 1
Year: 2006
Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

Author(s): Seiler CM | Fröhlich BE | Veit JA | Gazyakan E | Wente MN | Wollermann C | Deckert A | Witte S | Victor N | Buchler MW | Knaebel HP
Volume: 7
Issue: 1
Year: 2006
A randomized, double blind, cross-over, placebo-controlled clinical trial to assess the effects of Candesartan on the insulin sensitivity on non diabetic, non hypertense subjects with dysglyce mia and abdominal obesity. "ARAMIA"

Author(s): López-Jaramillo Patricio | Pradilla Lina | Lahera Vicente | Sieger Federico | Rueda-Clausen Christian | Márquez Gustavo
Volume: 7
Issue: 1
Year: 2006
Selecting patients for randomized trials: a systematic approach based on risk group

Author(s): Vickers Andrew | Kramer Barry | Baker Stuart
Volume: 7
Issue: 1
Year: 2006
Factors associated with compliance and non-compliance by physicians in a large-scale randomized clinical trial

Author(s): Oba Koji | Morita Satoshi | Rahman Mahbubur | Sakamoto Junichi
Volume: 7
Issue: 1
Year: 2006
Double blind randomized placebo-controlled trial on the effects of testosterone supplementation in elderly men with moderate to low testosterone levels: design and baseline characteristics [ISRCTN23688581]

Author(s): Nakhai Pour Hamid Reza | Emmelot-Vonk Marielle | Sukel-Helleman Marja | Verhaar Harald | Grobbee Diederick | van der Schouw Yvonne
Volume: 7
Issue: 1
Year: 2006
Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction

Author(s): Hofmeijer Jeannette | Amelink G Johan | Algra Ale | van Gijn Jan | Macleod Malcolm | Kappelle L Jaap | van der Worp H Bart
Volume: 7
Issue: 1
Year: 2006
Double blind, randomized controlled trial, to evaluate the effectiveness of a controlled nitric oxide releasing patch versus meglumine antimoniate in the treatment of cutaneous leishmaniasis [NCT00317629]

Author(s): Silva Sandra | Rueda Ligia | López Marcos | Vélez Iván | Rueda-Clausen Christian | Smith Daniel | Muñoz Gerardo | Mosquera Hernando | Silva Federico | Buitrago Adriana | Díaz Holger | López-Jaramillo Patricio
Volume: 7
Issue: 1
Year: 2006
Comparison of Venae Sectio vs. modified Seldinger Technique for Totally Implantable Access Ports; Portas-trial [ISRCTN:52368201]

Author(s): Knebel P | Fröhlich B | Knaebel H-P | Kienle P | Luntz S | Buchler MW | Seiler CM
Volume: 7
Issue: 1
Year: 2006
Sub-vastus approach versus the medial parapatellar approach in primary total knee: a randomised controlled trial [ISRCTN44544446]

Author(s): Bridgman Stephen | Walley Gayle | MacKenzie Gilbert | Clement Darren | Griffiths David | Maffulli Nicola
Volume: 7
Issue: 1
Year: 2006
Lessons and implications from a mass immunization campaign in squatter settlements of Karachi, Pakistan: an experience from a cluster-randomized double-blinded vaccine trial [NCT00125047]

Author(s): Khan Mohammad | Ochiai Rion | Hamza Hasan | Sahito Shah | Habib Muhammad | Soofi Sajid | Bhutto Naveed | Rasool Shahid | Puri Mahesh | Ali Mohammad | Wasan Shafi | Khan Mohammad | Abu-Elyazeed Remon | Ivanoff Bernard | Galindo Claudia | Pang Tikki | Donner Allan | von Seidlein Lorenz | Acosta Camilo | Clemens John | Nizami Shaikh | Bhutta Zulfiqar
Volume: 7
Issue: 1
Year: 2006
1Design of the Primary Prevention Parameters Evaluation (PREPARE) trial of implantablecardioverter defibrillators to reduce patient morbidity [NCT00279279]

Author(s): Wilkoff Bruce | Stern Richard | Williamson Brian | Wathen Mark | Holloman Keith | Fieberg Ann | Brown Mark
Volume: 7
Issue: 1
Year: 2006
Duodenum preserving pancreatectomy in chronic pancreatitis: Design of a randomized controlled trial comparing two surgical techniques [ISRCTN50638764]

Author(s): Köninger Jörg | Seiler Christoph | Wente Moritz | Reidel Margot | Gazayakan Emre | Mansmann Ulrich | Müller Michael | Friess Helmut | Büchler Markus
Volume: 7
Issue: 1
Year: 2006
A randomized clinical trial of unfractioned heparin for treatment of sepsis (the HETRASE study): design and rationale [NCT00100308]

Author(s): Jaimes Fabián | De La Rosa Gisela | Arango Clara | Fortich Fernando | Morales Carlos | Aguirre Daniel | Patiño Pablo
Volume: 7
Issue: 1
Year: 2006
Increasing participation of cancer patients in randomised controlled trials: a systematic review

Author(s): Mc Daid Catriona | Hodges Zoé | Fayter Debra | Stirk Lisa | Eastwood Alison
Volume: 7
Issue: 1
Year: 2006
Whose data set is it anyway? Sharing raw data from randomized trials

Author(s): Vickers Andrew
Volume: 7
Issue: 1
Year: 2006
The effects of organic nitrates on osteoporosis: a randomized controlled trial [ISRCTN94484747]

Author(s): Jamal Sophie | Hamilton Celeste | Black Dennis | Cummings Steven
Volume: 7
Issue: 1
Year: 2006
What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies

Author(s): McDonald Alison | Knight Rosemary | Campbell Marion | Entwistle Vikki | Grant Adrian | Cook Jonathan | Elbourne Diana | Francis David | Garcia Jo | Roberts Ian | Snowdon Claire
Volume: 7
Issue: 1
Year: 2006
Protocol for the Arterial Revascularisation Trial (ART). A randomised trial to compare survival following bilateral versus single internal mammary grafting in coronary revascularisation [ISRCTN46552265]

Author(s): Taggart David | Lees Belinda | Gray Alastair | Altman Douglas | Flather Marcus | Channon Keith
Volume: 7
Issue: 1
Year: 2006
Multifactorial approach and superior treatment efficacy in renal patients with the aid of nurse practitioners. Design of The MASTERPLAN Study [ISRCTN73187232]

Author(s): van Zuilen Arjan | van der Tweel Ingeborgh | Blankestijn Peter | Bots Michiel | van Buren Marjolijn | ten Dam Marc | Kaasjager Karin | van de Ven Peter | Vervoort Gerald | Vleming Louis-Jean | Ligtenberg Gerry | Wetzels Jack
Volume: 7
Issue: 1
Year: 2006
Multifactorial day hospital intervention to reduce falls in high risk older people in primary care: a multi-centre randomised controlled trial [ISRCTN46584556]

Author(s): Masud Tahir | Coupland Carol | Drummond Avril | Gladman John | Kendrick Denise | Sach Tracey | Harwood Rowan | Kumar Pradeep | Morris Rob | Taylor Rachael | Youde Jane | Conroy Simon
Volume: 7
Issue: 1
Year: 2006
Treatment of atrial fibrillation with a dual defibrillator in heart failure patients (TRADE HF): protocol for a randomized clinical trial

Author(s): Botto Giovanni | Boriani Giuseppe | Favale Stefano | Landolina Maurizio | Molon Giulio | Tondo Claudio | Biffi Mauro | Grandinetti Giuseppe | De Filippo Paolo | Raciti Giovanni | Padeletti Luigi
Volume: 12
Issue: 1
Year: 2011
Efficacy and safety of a multifactor intervention to improve therapeutic adherence in patients with chronic obstructive pulmonary disease (COPD): protocol for the ICEPOC study

Author(s): Barnestein-Fonseca Pilar | Leiva-Fernández José | Vidal-España Francisca | García-Ruiz Antonio | Prados-Torres Daniel | Leiva-Fernández Francisca
Volume: 12
Issue: 1
Year: 2011
School-based intervention to improve the mental health of low-income, secondary school students in Santiago, Chile (YPSA): study protocol for a randomized controlled trial

Author(s): Araya Ricardo | Montgomery Alan | Fritsch Rosemarie | Gunnell David | Stallard Paul | Noble Sian | Martinez Vania | Barroilhet Sergio | Vohringer Paul | Guajardo Viviana | Cova Felix | Gaete Jorge | Gomez Alejandro | Rojas Graciela
Volume: 12
Issue: 1
Year: 2011
A primary-school-based study to reduce prevalence of childhood obesity in Catalunya (Spain) - EDAL-Educació en alimentació: study protocol for a randomised controlled trial

Author(s): Giralt Montse | Albaladejo Rosa | Tarro Lucia | Moriña David | Arija Victoria | Solà Rosa
Volume: 12
Issue: 1
Year: 2011
Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

Author(s): Campbell MK | Entwistle VA | Cuthbertson BH | Skea ZC | Sutherland AG | McDonald AM | Norrie JD | Carlson RV | Bridgman S
Volume: 12
Issue: 1
Year: 2011
Cognitive activity for the treatment of older adults with mild Alzheimer's Disease (AD) - PACE AD: study protocol for a randomised controlled trial

Author(s): Vidovich Mandy | Shaw Josephine | Flicker Leon | Almeida Osvaldo
Volume: 12
Issue: 1
Year: 2011
Effects of acupuncture on patients with fibromyalgia: study protocol of a multicentre randomized controlled trial

Author(s): Vas Jorge | Modesto Manuela | Aguilar Inmaculada | Santos-Rey Koldo | Benítez-Parejo Nicolás | Rivas-Ruiz Francisco
Volume: 12
Issue: 1
Year: 2011
Double-blinded, randomized controlled trial comparing real versus placebo acupuncture to improve tolerance of diagnostic esophagogastroduodenoscopy without sedation: a study protocol

Author(s): Knebel P | Schwan K | Bruckner T | Seiler CM | Plaschke K | Streitberger K | Schaible A | Bopp C
Volume: 12
Issue: 1
Year: 2011
Modified versus standard intention-to-treat reporting: Are there differences in methodological quality, sponsorship, and findings in randomized trials? A cross-sectional study

Author(s): Montedori Alessandro | Bonacini Maria | Casazza Giovanni | Luchetta Maria | Duca Piergiorgio | Cozzolino Francesco | Abraha Iosief
Volume: 12
Issue: 1
Year: 2011
Conservative management versus open reduction and internal fixation for mid-shaft clavicle fractures in adults - The Clavicle Trial: study protocol for a multicentre randomized controlled trial

Author(s): Longo Umile | Banerjee Sughran | Barber Julie | Chambler Andrew | Cobiella Carlos | Corbett Steven | Crowther Mark | Drew Steven | Francis Andrea | Lee Marcus | Garlick Nicholas | Packham Iain | Pearse Yemi | Richards Andrew | Roberts Chris | Tennent Duncan | Tims Emily | Ahrens Philip
Volume: 12
Issue: 1
Year: 2011
A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): study protocol for a randomized double-blind controlled trial

Author(s): Fuchs Flávio | Fuchs Sandra | Moreira Leila | Gus Miguel | Nóbrega Antônio | Poli-de-Figueiredo Carlos | Mion Décio | Bortolotto Luiz | Consolim-Colombo Fernanda | Nobre Fernando | Coelho Eduardo | Vilela-Martin José | Moreno Heitor | Cesarino Evandro | Franco Roberto | Brandão Andréa | de Sousa Marcos | Pinho Ribeiro Antônio | Jardim Paulo | Neto Abrahão | Scala Luiz | Mota Marco | Chaves Hilton | Alves João | Sobral Filho Dario | e Silva Ricardo | Figueiredo Neto José | Irigoyen Maria | Castro Iran | Steffens André | Schlatter Rosane | de Mello Renato | Mosele Francisca | Ghizzoni Flávia | Berwanger Otávio
Volume: 12
Issue: 1
Year: 2011
Impact on mortality and cancer incidence rates of using random invitation from population registers for recruitment to trials

Author(s): Burnell Matthew | Gentry-Maharaj Aleksandra | Ryan Andy | Apostolidou Sophia | Habib Mariam | Kalsi Jatinderpal | Skates Steven | Parmar Mahesh | Seif Mourad | Amso Nazar | Godfrey Keith | Oram David | Herod Jonathan | Williamson Karin | Jenkins Howard | Mould Tim | Woolas Robert | Murdoch John | Dobbs Stephen | Leeson Simon | Cruickshank Derek | Campbell Stuart | Fallowfield Lesley | Jacobs Ian | Menon Usha
Volume: 12
Issue: 1
Year: 2011
Randomized clinical trial comparing percutaneous closure of patent foramen ovale (PFO) using the Amplatzer PFO Occluder with medical treatment in patients with cryptogenic embolism (PC-Trial): rationale and design

Author(s): Khattab Ahmed | Windecker Stephan | Jüni Peter | Hildick-Smith David | Dudek Dariusz | Andersen Henning | Ibrahim Reda | Schuler Gerhard | Walton Antony | Wahl Andreas | Mattle Heinrich | Meier Bernhard
Volume: 12
Issue: 1
Year: 2011
Prevention of hypertension in patients with pre-hypertension: protocol for the PREVER-prevention trial

Author(s): Fuchs Flávio | Fuchs Sandra | Moreira Leila | Gus Miguel | Nóbrega Antônio | Poli-de-Figueiredo Carlos | Mion Décio | Bortoloto Luiz | Consolim-Colombo Fernanda | Nobre Fernando | Coelho Eduardo | Vilela-Martin José | Moreno Heitor | Cesarino Evandro | Franco Roberto | Brandão Andréa | de Sousa Marcos | Ribeiro Antônio | Jardim Paulo | Neto Abrahão | Scala Luiz | Mota Marco | Chaves Hilton | Alves João | Filho Dario | Pereira e Silva Ricardo | Neto José | Irigoyen Maria | Castro Iran | Steffens André | Schlatter Rosane | de Mello Renato | Mosele Francisca | Ghizzoni Flávia | Berwanger Otávio
Volume: 12
Issue: 1
Year: 2011
The mesenchymal stem cells in multiple sclerosis (MSCIMS) trial protocol and baseline cohort characteristics: an open-label pre-test: post-test study with blinded outcome assessments

Author(s): Connick Peter | Kolappan Madhan | Patani Rickie | Scott Michael | Crawley Charles | He Xiao-Ling | Richardson Karen | Barber Kelly | Webber Daniel | Wheeler-Kingshott Claudia | Tozer Daniel | Samson Rebecca | Thomas David | Du Ming-Qing | Luan Shi | Michell Andrew | Altmann Daniel | Thompson Alan | Miller David | Compston Alastair | Chandran Siddharthan
Volume: 12
Issue: 1
Year: 2011
A factorial randomized controlled trial to evaluate the effect of micronutrients supplementation and regular aerobic exercise on maternal endothelium-dependent vasodilatation and oxidative stress of the newborn

Author(s): Ramírez-Vélez Robinson | Romero Miryam | Echeverri Isabella | Ortega José | Mosquera Mildrey | Salazar Blanca | Girón Sandra | Saldarriaga Wilmar | Aguilar de Plata Ana | Mateus Julio
Volume: 12
Issue: 1
Year: 2011
Recruitment of high risk women for HIV prevention trials: baseline HIV prevalence and sexual behavior in the CAPRISA 004 tenofovir gel trial

Author(s): Karim Quarraisha | Kharsany Ayesha | Frohlich Janet | Baxter Cheryl | Yende Nonhlanhla | Mansoor Leila | Mlisana Koleka | Maarschalk Silvia | Arulappan Natasha | Grobler Anneke | Sibeko Sengeziwe | Omar Zaheen | Gengiah Tanuja | Mlotshwa Mukelisiwe | Samsunder Natasha | Abdool Karim Salim
Volume: 12
Issue: 1
Year: 2011
Single-dose liposomal amphotericin B (AmBisome®) for the treatment of Visceral Leishmaniasis in East Africa: study protocol for a randomized controlled trial

Author(s): Edwards Tansy | Omollo Raymond | Khalil Eltahir | Yifru Sisay | Musa Brima | Musa Ahmed | Wasunna Monique | Smith Peter | Royce Catherine | Ellis Sally | Balasegaram Manica | Hailu Asrat
Volume: 12
Issue: 1
Year: 2011
The effectiveness of simple psychological and exercise interventions for high prevalence mental health problems in young people: a factorial randomised controlled trial

Author(s): Parker Alexandra | Hetrick Sarah | Jorm Anthony | Yung Alison | McGorry Patrick | Mackinnon Andrew | Moller Bridget | Purcell Rosemary
Volume: 12
Issue: 1
Year: 2011
Clinical efficacy and prognostic indicators for lower limb pedalling exercise early after stroke: Study protocol for a pilot randomised controlled trial

Author(s): Hancock Nicola | Shepstone Lee | Rowe Philip | Myint Phyo | Pomeroy Valerie
Volume: 12
Issue: 1
Year: 2011
An intervention to promote physical activity and self-management in people with stable chronic heart failure The Home-Heart-Walk study: study protocol for a randomized controlled trial

Author(s): Du Hui | Newton Phillip | Zecchin Robert | Denniss Robert | Salamonson Yenna | Everett Bronwyn | Currow David | Macdonald Peter | Davidson Patricia
Volume: 12
Issue: 1
Year: 2011
Acupuncture for sequelae of Bell's palsy: a randomized controlled trial protocol

Author(s): Kwon Hyo-Jung | Kim Jong-In | Lee Myeong | Choi Jun-Yong | Kang Sungkeel | Chung Jie-Yoon | Kim Young-Jin | Lee Seung-Hoon | Lee Sanghoon | Nam Dongwoo | Kim Yong-Suk | Lee Jae-Dong | Choi Do-Young
Volume: 12
Issue: 1
Year: 2011
Using a business model approach and marketing techniques for recruitment to clinical trials

Author(s): McDonald Alison | Treweek Shaun | Shakur Haleema | Free Caroline | Knight Rosemary | Speed Chris | Campbell Marion
Volume: 12
Issue: 1
Year: 2011
A randomized controlled trial investigation of a non-stimulant in attention deficit hyperactivity disorder (ACTION): Rationale and design

Author(s): Tsang Tracey | Kohn Michael | Hermens Daniel | Clarke Simon | Clark C Richard | Efron Daryl | Cranswick Noel | Lamb Chris | Williams Leanne
Volume: 12
Issue: 1
Year: 2011
Pancreatitis, very early compared with normal start of enteral feeding (PYTHON trial): design and rationale of a randomised controlled multicenter trial

Author(s): Bakker Olaf | van Santvoort Hjalmar | van Brunschot Sandra | Ali Usama | Besselink Marc | Boermeester Marja | Bollen Thomas | Bosscha Koop | Brink Menno | Dejong Cornelis | van Geenen Erwin | van Goor Harry | Heisterkamp Joos | Houdijk Alexander | Jansen Jeroen | Karsten Thom | Manusama Eric | Nieuwenhuijs Vincent | van Ramshorst Bert | Schaapherder Alexander | van der Schelling George | Spanier Marcel | Tan Adriaan | Vecht Juda | Weusten Bas | Witteman Ben | Akkermans Louis | Gooszen Hein
Volume: 12
Issue: 1
Year: 2011
A Canadian Critical Care Trials Group project in collaboration with the international forum for acute care trialists - Collaborative H1N1 Adjuvant Treatment pilot trial (CHAT): study protocol and design of a randomized controlled trial

Author(s): Burns Karen | Chant Clarence | Smith Orla | Cuthbertson Brian | Fowler Robert | Cook Deborah | Kruger Peter | Webb Steve | Alhashemi Jamal | Dominguez-Cherit Guillermo | Zala Carlos | Rubenfeld Gordon | Marshall John
Volume: 12
Issue: 1
Year: 2011
Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011)

Author(s): Paramasivan Sangeetha | Huddart Robert | Hall Emma | Lewis Rebecca | Birtle Alison | Donovan Jenny
Volume: 12
Issue: 1
Year: 2011
Adverse events associated with acupuncture: three multicentre randomized controlled trials of 1968 cases in China

Author(s): Zhao Ling | Zhang Fu-wen | Li Ying | Wu Xi | Zheng Hui | Cheng Lin-hao | Liang Fan-rong
Volume: 12
Issue: 1
Year: 2011
Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial

Author(s): Bartl Christoph | Stengel Dirk | Bruckner Thomas | Rossion Inga | Luntz Steffen | Seiler Christoph | Gebhard Florian
Volume: 12
Issue: 1
Year: 2011
"Flogging dead horses": evaluating when have clinical trials achieved sufficiency and stability? A case study in cardiac rehabilitation

Author(s): Dent Louise | Taylor Rod | Jolly Kate | Raftery James
Volume: 12
Issue: 1
Year: 2011
Standard requirements for GCP-compliant data management in multinational clinical trials

Author(s): Ohmann Christian | Kuchinke Wolfgang | Canham Steve | Lauritsen Jens | Salas Nader | Schade-Brittinger Carmen | Wittenberg Michael | McPherson Gladys | McCourt John | Gueyffier Francois | Lorimer Andrea | Torres Ferràn
Volume: 12
Issue: 1
Year: 2011
Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

Author(s): Kyle Richard | Culbard Bill | Evans Josie | Gray Nicola | Ayansina Dolapo | Hubbard Gill
Volume: 12
Issue: 1
Year: 2011
Use of deferred consent for severely ill children in a multi-centre phase III trial

Author(s): Maitland Kathryn | Molyneux Sassy | Boga Mwamvua | Kiguli Sarah | Lang Trudie
Volume: 12
Issue: 1
Year: 2011
Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia

Author(s): Buyse Marc | Squifflet Pierre | Lucchesi Kathryn | Brune Mats | Castaigne Sylvie | Rowe Jacob
Volume: 12
Issue: 1
Year: 2011
Designs for clinical trials with time-to-event outcomes based on stopping guidelines for lack of benefit

Author(s): Royston Patrick | Barthel Friederike | Parmar Mahesh | Choodari-Oskooei Babak | Isham Valerie
Volume: 12
Issue: 1
Year: 2011
Mums 4 Mums: structured telephone peer-support for women experiencing postnatal depression. Pilot and exploratory RCT of its clinical and cost effectiveness

Author(s): Caramlau Isabela | Barlow Jane | Sembi Sukhdev | McKenzie-McHarg Kirstie | McCabe Chris
Volume: 12
Issue: 1
Year: 2011
Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices

Author(s): Gágyor Ildikó | Bleidorn Jutta | Wegscheider Karl | Hummers-Pradier Eva | Kochen Michael
Volume: 12
Issue: 1
Year: 2011
The effect of five years versus two years of specialised assertive intervention for first episode psychosis - OPUS II: study protocol for a randomized controlled trial

Author(s): Melau Marianne | Jeppesen Pia | Thorup Anne | Bertelsen Mette | Petersen Lone | Gluud Christian | Krarup Gertrud | Nordentoft Merete
Volume: 12
Issue: 1
Year: 2011
A randomised sham controlled trial of vertebroplasty for painful acute osteoporotic vertebral fractures (VERTOS IV)

Author(s): Firanescu Cristina | Lohle Paul | de Vries Jolanda | Klazen Caroline | Juttmann Job | Clark William | van Rooij Willem
Volume: 12
Issue: 1
Year: 2011
A Meta-analysis of the effects of Exercise Training on Left Ventricular Remodeling Following Myocardial Infarction: Start early and go longer for greatest exercise benefits on remodeling

Author(s): Haykowsky Mark | Scott Jessica | Esch Ben | Schopflocher Don | Myers Jonathan | Paterson Ian | Warburton Darren | Jones Lee | Clark Alexander
Volume: 12
Issue: 1
Year: 2011
Physical activity as a treatment for depression: the TREAD randomised trial protocol

Author(s): Baxter Helen | Winder Rachel | Chalder Melanie | Wright Christine | Sherlock Sofie | Haase Anne | Wiles Nicola | Montgomery Alan | Taylor Adrian | Fox Ken | Lawlor Debbie | Peters Tim | Sharp Deborah | Campbell John | Lewis Glyn
Volume: 11
Issue: 1
Year: 2010
Comparison of the collagen haemostat Sangustop® versus a carrier-bound fibrin sealant during liver resection; ESSCALIVER-Study

Author(s): Moench Christian | Bechstein Wolf | Hermanutz Valentin | Hoexter Godehard | Knaebel Hanns-Peter
Volume: 11
Issue: 1
Year: 2010
Interaction between drug and placebo effects: a cross-over balanced placebo design trial

Author(s): Hammami Muhammad | Al-Gaai Eman | Alvi Syed | Hammami Muhammad
Volume: 11
Issue: 1
Year: 2010
Compassionate use of interventions: results of a European Clinical Research Infrastructures Network (ECRIN) survey of ten European countries

Author(s): Whitfield Kate | Huemer Karl-Heinz | Winter Diana | Thirstrup Steffen | Libersa Christian | Barraud Béatrice | Kubiak Christine | Stankovski Lea | Grählert Xina | Dreier Gabriele | Geismann Sebastian | Kuchinke Wolfgang | Strenge-Hesse Anke | Temesvari Zsuza | Blasko Gyorgy | Kardos Gabriella | O'Brien Timothy | Cooney Margaret | Gaynor Siobhan | Schieppati Arrigo | Serrano Mariantonia | de Andres Fernando | Sanz Nuria | Hernández Raquel | Kreis Germán | Asker-Hagelberg Charlotte | Johansson Hanna | Asghar Adeeba | Husson Jean-Marc | Demotes Jacques | Gluud Christian
Volume: 11
Issue: 1
Year: 2010
Acupuncture for dry eye: a multicentre randomised controlled trial with active comparison intervention (artificial tear drop) using a mixed method approach protocol

Author(s): Kim Tae-Hun | Kang Jung | Kim Kun | Kang Kyung-Won | Shin Mi-Suk | Jung So-Young | Kim Ae-Ran | Jung Hee-Jung | Lee Seung-Deok | Choi Jin-Bong | Choi Sun-Mi
Volume: 11
Issue: 1
Year: 2010
Statistical design of personalized medicine interventions: The Clarification of Optimal Anticoagulation through Genetics (COAG) trial

Author(s): French Benjamin | Joo Jungnam | Geller Nancy | Kimmel Stephen | Rosenberg Yves | Anderson Jeffrey | Gage Brian | Johnson Julie | Ellenberg Jonas
Volume: 11
Issue: 1
Year: 2010
The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial

Author(s): Vanhaecht Kris | Sermeus Walter | Peers Jan | Lodewijckx Cathy | Deneckere Svin | Leigheb Fabrizio | Decramer Marc | Panella Massimiliano
Volume: 11
Issue: 1
Year: 2010
Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

Author(s): Brealey Stephen | Andronis Lazaros | Dennis Laura | Atwell Christine | Bryan Stirling | Coulton Simon | Cox Helen | Cross Ben | Fylan Fiona | Garratt Andrew | Gilbert Fiona | Gillan Maureen | Hendry Maggie | Hood Kerenza | Houston Helen | King David | Morton Veronica | Robling Michael | Russell Ian | Wilkinson Clare
Volume: 11
Issue: 1
Year: 2010
Can herpes simplex virus type 2 suppression slow HIV disease progression: a study protocol for the VALacyclovir In Delaying Antiretroviral Treatment Entry (VALIDATE) trial

Author(s): Tan Darrell | Raboud Janet | Kaul Rupert | Grinsztejn Beatriz | Cahn Pedro | Walmsley Sharon
Volume: 11
Issue: 1
Year: 2010
A GP caregiver needs toolkit versus usual care in the management of the needs of caregivers of patients with advanced cancer: a randomized controlled trial

Author(s): Mitchell Geoffrey | Girgis Afaf | Jiwa Moyez | Sibbritt David | Burridge Letitia
Volume: 11
Issue: 1
Year: 2010
The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

Author(s): Cyarto Elizabeth | Cox Kay | Almeida Osvaldo | Flicker Leon | Ames David | Byrne Gerard | Hill Keith | Beer Christopher | LoGiudice Dina | Appadurai Kana | Irish Muireann | Renehan Emma | Lautenschlager Nicola
Volume: 11
Issue: 1
Year: 2010
PRALIMAP: study protocol for a high school-based, factorial cluster randomised interventional trial of three overweight and obesity prevention strategies

Author(s): Briançon Serge | Bonsergent Emilie | Agrinier Nelly | Tessier Sabrina | Legrand Karine | Lecomte Edith | Aptel Evelyne | Hercberg Serge | Collin Jean-François
Volume: 11
Issue: 1
Year: 2010
A study of the perceived risks, benefits and barriers to the use of SDD in adult critical care units (The SuDDICU study)

Author(s): Cuthbertson BH | Francis J | Campbell MK | MacIntyre L | Seppelt I | Grimshaw J
Volume: 11
Issue: 1
Year: 2010
Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial

Author(s): Schull Michael | Banda Hastings | Kathyola Damson | Fairall Lara | Martiniuk Alexandra | Burciul Barry | Zwarenstein Merrick | Sodhi Sumeet | Thompson Sandy | Joshua Martias | Mondiwa Martha | Bateman Eric
Volume: 11
Issue: 1
Year: 2010
The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

Author(s): Park Kyungil | Chung Woo-Young | Seo Jae-Bin | Kim Sang-Hyun | Zo Joo-Hee | Kim Myung-A | Park Young-Bae
Volume: 11
Issue: 1
Year: 2010
A randomised controlled trial to compare opt-in and opt-out parental consent for childhood vaccine safety surveillance using data linkage: study protocol

Author(s): Berry Jesia | Ryan Philip | Braunack-Mayer Annette | Duszynski Katherine | Xafis Vicki | Gold Michael
Volume: 12
Issue: 1
Year: 2011
Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

Author(s): Klingberg Stefan | Wittorf Andreas | Meisner Christoph | Wölwer Wolfgang | Wiedemann Georg | Herrlich Jutta | Bechdolf Andreas | Müller Bernhard | Sartory Gudrun | Wagner Michael | Kircher Tilo | König Hans-Helmut | Engel Corinna | Buchkremer Gerhard
Volume: 11
Issue: 1
Year: 2010
A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization

Author(s): Soliman Elsayed | Mendis Shanthi | Dissanayake Wasantha | Somasundaram Noel | Gunaratne Padma | Jayasingne I Kumudini | Furberg Curt
Volume: 12
Issue: 1
Year: 2011
Why do you need a reservation system?      Affiliate Program