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1. Clinical effectiveness of vaginal pessary self-management vs clinic-based care for pelvic organ prolapse (TOPSY): a randomised controlled superiority trial

Author

Hagen, Suzanne, Kearney, Rohna, Goodman, Kirsteen, Best, Catherine, Elders, Andrew, Melone, Lynn, Dwyer, Lucy, Dembinsky, Melanie, Graham, Margaret, Agur, Wael, Breeman, Suzanne, Culverhouse, Jane, Forrest, Angela, Forrest, Mark, Guerrero, Karen, Hemming, Christine, Khunda, Aethele, Manoukian, Sarkis, Mason, Helen, McClurg, Doreen, Norrie, John, Thakar, Ranee, and Bugge, Carol

Published
2023
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2. Reducing asthma attacks in children using exhaled nitric oxide (RAACENO) as a biomarker to inform treatment strategy: a multicentre, parallel, randomised, controlled, phase 3 trial

Author

Turner, Steve, Cotton, Seonaidh, Wood, Jessica, Bell, Victoria, Raja, Edwin-Amalraj, Scott, Neil W, Morgan, Heather, Lawrie, Louisa, Emele, David, Kennedy, Charlotte, Scotland, Graham, Fielding, Shona, MacLennan, Graeme, Norrie, John, Forrest, Mark, Gaillard, Erol A, de Jongste, Johan, Pijnenburg, Marielle, Thomas, Mike, and Price, David

Published
2022
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3. Correction to: Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Author

Clarkson, Jan E., Ramsay, Craig R., Mannocci, Francesco, Jarad, Fadi, Albadri, Sondos, Ricketts, David, Tait, Carol, Banerjee, Avijit, Deery, Chris, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Hamilton, Alice R., Banister, Katie, Bell, Rosanne, Brown, Lori, Conway, David I., Donaldson, Pina, Duncan, Anne, Dunn, Katharine, Fee, Patrick, Forrest, Mark, Glenny, Anne-Marie, Gouick, Jill, Gupta, Ekta, Jacobsen, Elisabet, Kettle, Jennifer, MacLennan, Graeme, Macpherson, Lorna, McGuff, Tina, Mitchell, Fiona, van der Pol, Marjon, Moazzez, Rebecca, Roberston, Douglas, Wojewodka, Gabriella, Young, Linda, and Lamont, Thomas

Published
2022
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4. Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Author

Hamilton, Alice, Clarkson, Jan E., Ramsay, Craig R., Mannocci, Francesco, Jarad, Fadi, Albadri, Sondos, Ricketts, David, Tait, Carol, Banerjee, Avijit, Deery, Chris, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Hamilton, Alice R., Banister, Katie, Bell, Rosanne, Brown, Lori, Conway, David I., Donaldson, Pina, Duncan, Anne, Dunn, Katharine, Fee, Patrick, Forrest, Mark, Glenny, Anne-Marie, Gouick, Jill, Gupta, Ekta, Jacobsen, Elisabet, Kettle, Jennifer, MacLennan, Graeme, Macpherson, Lorna, McGuff, Tina, Mitchell, Fiona, van der Pol, Marjon, Moazzez, Rebecca, Roberston, Douglas, Wojewodka, Gabriella, Young, Linda, and Lamont, Thomas

Published
2022
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5. The UK resuscitative endovascular balloon occlusion of the aorta in trauma patients with life-threatening torso haemorrhage: the (UK-REBOA) multicentre RCT.

Author

Jansen, Jan O, Hudson, Jemma, Kennedy, Charlotte, Cochran, Claire, MacLennan, Graeme, Gillies, Katie, Lendrum, Robbie, Sadek, Samy, Boyers, Dwayne, Ferry, Gillian, Lawrie, Louisa, Nath, Mintu, Cotton, Seonaidh, Wileman, Samantha, Forrest, Mark, Brohi, Karim, Harris, Tim, Lecky, Fiona, Moran, Chris, and Morrison, Jonathan J

Published
2024
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7. Clinical and cost‐effectiveness of pessary self‐management versus clinic-based care for pelvic organ prolapse in women: the TOPSY RCT with process evaluation.

Author

Bugge, Carol, Hagen, Suzanne, Elders, Andrew, Mason, Helen, Goodman, Kirsteen, Dembinsky, Melanie, Melone, Lynn, Best, Catherine, Manoukian, Sarkis, Dwyer, Lucy, Khunda, Aethele, Graham, Margaret, Agur, Wael, Breeman, Suzanne, Culverhouse, Jane, Forrest, Angela, Forrest, Mark, Guerrero, Karen, Hemming, Christine, and McClurg, Doreen

Published
2024
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8. Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

Author

Ahmed, Irfan, primary, Hudson, Jemma, additional, Innes, Karen, additional, Hernández, Rodolfo, additional, Gillies, Katie, additional, Bruce, Rebecca, additional, Bell, Victoria, additional, Avenell, Alison, additional, Blazeby, Jane, additional, Brazzelli, Miriam, additional, Cotton, Seonaidh, additional, Croal, Bernard, additional, Forrest, Mark, additional, MacLennan, Graeme, additional, Murchie, Peter, additional, Wileman, Samantha, additional, and Ramsay, Craig, additional

Published
2023
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9. Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care

Author

Clarkson, Jan E., Ramsay, Craig R., Ricketts, David, Banerjee, Avijit, Deery, Chris, Lamont, Thomas, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Banister, Katie, Conway, David, Dawett, Bhupinder, Baker, Sarah, Sherriff, Andrea, Young, Linda, van der Pol, Marjon, MacLennan, Graeme, Floate, Ruth, Braid, Hazel, Fee, Patrick, Forrest, Mark, Gouick, Jill, Mitchell, Fiona, Gupta, Ekta, Dakri, Riz, Kettle, Jennifer, McGuff, Tina, and Dunn, Katharine

Published
2021
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10. Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial

Author

Hagen, Suzanne, Kearney, Rohna, Goodman, Kirsteen, Melone, Lynn, Elders, Andrew, Manoukian, Sarkis, Agur, Wael, Best, Catherine, Breeman, Suzanne, Dembinsky, Melanie, Dwyer, Lucy, Forrest, Mark, Graham, Margaret, Guerrero, Karen, Hemming, Christine, Khunda, Aethele, Mason, Helen, McClurg, Doreen, Norrie, John, Karachalia-Sandri, Anastasia, Thakar, Ranee, and Bugge, Carol

Published
2020
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14. Emergency Department Resuscitative Endovascular Balloon Occlusion of the Aorta in Trauma Patients With Exsanguinating Hemorrhage: The UK-REBOA Randomized Clinical Trial.

Author

Jansen, Jan O., Hudson, Jemma, Cochran, Claire, MacLennan, Graeme, Lendrum, Robbie, Sadek, Sam, Gillies, Katie, Cotton, Seonaidh, Kennedy, Charlotte, Boyers, Dwayne, Ferry, Gillian, Lawrie, Louisa, Nath, Mintu, Wileman, Samantha, Forrest, Mark, Brohi, Karim, Harris, Tim, Lecky, Fiona, Moran, Chris, and Morrison, Jonathan J.

Subjects
BALLOON occlusion, HOSPITAL emergency services, CLINICAL trials
Abstract

Key Points: Question: Does the addition of resuscitative endovascular balloon occlusion of the aorta (REBOA) to standard care reduce mortality in trauma patients with exsanguinating hemorrhage? Findings: In this bayesian randomized clinical trial that included 89 patients at 90 days, all-cause mortality was 54% in the REBOA and standard care group vs 42% in the standard care alone group (odds ratio, 1.58; posterior probability of increased odds of death with REBOA, 86.9%). Meaning: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase mortality compared with standard care alone. Importance: Bleeding is the most common cause of preventable death after trauma. Objective: To determine the effectiveness of resuscitative endovascular balloon occlusion of the aorta (REBOA) when used in the emergency department along with standard care vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. Design, Setting, and Participants: Pragmatic, bayesian, randomized clinical trial conducted at 16 major trauma centers in the UK. Patients aged 16 years or older with exsanguinating hemorrhage were enrolled between October 2017 and March 2022 and followed up for 90 days. Intervention: Patients were randomly assigned (1:1 allocation) to a strategy that included REBOA and standard care (n = 46) or standard care alone (n = 44). Main Outcomes and Measures: The primary outcome was all-cause mortality at 90 days. Ten secondary outcomes included mortality at 6 months, while in the hospital, and within 24 hours, 6 hours, or 3 hours; the need for definitive hemorrhage control procedures; time to commencement of definitive hemorrhage control procedures; complications; length of stay; blood product use; and cause of death. Results: Of the 90 patients (median age, 41 years [IQR, 31-59 years]; 62 [69%] were male; and the median Injury Severity Score was 41 [IQR, 29-50]) randomized, 89 were included in the primary outcome analysis because 1 patient in the standard care alone group declined to provide consent for continued participation and data collection 4 days after enrollment. At 90 days, 25 of 46 patients (54%) had experienced all-cause mortality in the REBOA and standard care group vs 18 of 43 patients (42%) in the standard care alone group (odds ratio [OR], 1.58 [95% credible interval, 0.72-3.52]; posterior probability of an OR >1 [indicating increased odds of death with REBOA], 86.9%). Among the 10 secondary outcomes, the ORs for mortality and the posterior probabilities of an OR greater than 1 for 6-month, in-hospital, and 24-, 6-, or 3-hour mortality were all increased in the REBOA and standard care group, and the ORs were increased with earlier mortality end points. There were more deaths due to bleeding in the REBOA and standard care group (8 of 25 patients [32%]) than in standard care alone group (3 of 18 patients [17%]), and most occurred within 24 hours. Conclusions and Relevance: In trauma patients with exsanguinating hemorrhage, a strategy of REBOA and standard care in the emergency department does not reduce, and may increase, mortality compared with standard care alone. Trial Registration: isrctn.org Identifier: ISRCTN16184981 This randomized clinical trial compares the effectiveness of resuscitative endovascular balloon occlusion of the aorta and standard care in the emergency department vs standard care alone on mortality in trauma patients with exsanguinating hemorrhage. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Laparoscopic Cholecystectomy Versus Observation/Conservative Management for Preventing Recurrent Symptoms and Complications in Adults with Uncomplicated Symptomatic Gallstones (C-GALL): A Pragmatic, Multicentre Randomised Controlled Trial

Author

Ahmed, Irfan, primary, Hudson, Jemma, additional, Innes, Karen, additional, Hernandez, Rodolfo, additional, Gillies, Katie, additional, Bruce, Rebecca, additional, Bell, Victoria, additional, Avenell, Alison, additional, Blazeby, Jane, additional, Brazzelli, Miriam, additional, Cotton, Seonaidh, additional, Croal, Bernard, additional, Forrest, Mark, additional, MacLennan, Graeme, additional, Murchie, P, additional, Wileman, Samantha, additional, and Ramsay, Craig, additional

Published
2023
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18. Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Author

Constable, Lynda, Cotterill, Nikki, Cooper, David, Glazener, Cathryn, Drake, Marcus J., Forrest, Mark, Harding, Chris, Kilonzo, Mary, MacLennan, Graeme, McCormack, Kirsty, McDonald, Alison, Mundy, Anthony, Norrie, John, Pickard, Robert, Ramsay, Craig, Smith, Rebecca, Wileman, Samantha, Abrams, Paul, and (Chief Investigator) for the MASTER Study Group

Published
2018
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19. Reducing asthma attacks in children using exhaled nitric oxide (RAACENO) as a biomarker to inform treatment strategy:a multicentre, parallel, randomised, controlled, phase 3 trial

Author

Turner, Steve, Cotton, Seonaidh, Wood, Jessica, Bell, Victoria, Raja, Edwin Amalraj, Scott, Neil W., Morgan, Heather, Lawrie, Louisa, Emele, David, Kennedy, Charlotte, Scotland, Graham, Fielding, Shona, MacLennan, Graeme, Norrie, John, Forrest, Mark, Gaillard, Erol A., de Jongste, Johan, Pijnenburg, Marielle, Thomas, Mike, Price, David, Turner, Steve, Cotton, Seonaidh, Wood, Jessica, Bell, Victoria, Raja, Edwin Amalraj, Scott, Neil W., Morgan, Heather, Lawrie, Louisa, Emele, David, Kennedy, Charlotte, Scotland, Graham, Fielding, Shona, MacLennan, Graeme, Norrie, John, Forrest, Mark, Gaillard, Erol A., de Jongste, Johan, Pijnenburg, Marielle, Thomas, Mike, and Price, David

Abstract

Background: The benefit of fractional exhaled nitric oxide (FeNO) in guiding asthma treatment is uncertain. We evaluated the efficacy of adding FeNO to symptom-guided treatment in children with asthma versus only symptom-guided treatment. Methods: RAACENO was a multicentre, parallel, randomised, controlled, phase 3 trial done in 35 secondary care centres and 17 primary care recruitment sites (only seven primary care sites managed to recruit patients) in the UK. Patients with a confirmed asthma diagnosis, aged 6–15 years, prescribed inhaled corticosteroids, and who received a course of oral corticosteroids for at least one asthma exacerbation during the 12 months before recruitment were included. Participants were randomly assigned to either FeNO plus symptom-guided treatment (intervention) or symptom-guided treatment alone (standard care) using a 24 h in-house, web-based randomisation system. Participants and the clinical and research teams were not masked to the group allocation. A web-based algorithm gave treatment recommendations based on the Asthma Control Test (ACT) or Childhood ACT (CACT) score; current asthma treatment; adherence to study treatment in the past 3 months; and use of FeNO (in the intervention group). Follow-up occurred at 3-month intervals for 12 months. The primary outcome was any asthma exacerbation treated with oral corticosteroids in the 12 months after randomisation, assessed in the intention-to-treat population. This study is registered with the International Standard Randomised Controlled Trial Registry, ISRCTN67875351. Findings: Between June 22, 2017, and Aug 8, 2019, 535 children were assessed for eligibility, 20 were ineligible and six were excluded post-randomisation. 509 children were recruited and at baseline, the mean age of participants was 10·1 years (SD 2·6), and 308 (60·5%) were male. The median FeNO was 21 ppb (IQR 10–48), mean predicted FEV1 was 89·6% (SD 18·0), and median daily dose of inhaled corticosteroids w

Published
2022

20. Treatment guided by fractional exhaled nitric oxide in addition to standard care in 6- to 15-year-olds with asthma: the RAACENO RCT

Author

Turner, Steve, primary, Cotton, Seonaidh, additional, Wood, Jessica, additional, Bell, Victoria, additional, Raja, Edwin-Amalraj, additional, Scott, Neil W, additional, Morgan, Heather, additional, Lawrie, Louisa, additional, Emele, David, additional, Kennedy, Charlotte, additional, Scotland, Graham, additional, Fielding, Shona, additional, MacLennan, Graeme, additional, Norrie, John, additional, Forrest, Mark, additional, Gaillard, Erol, additional, de Jongeste, Johan, additional, Pijnenburg, Marielle, additional, Thomas, Mike, additional, and Price, David, additional

Published
2022
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21. Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Author

Clarkson, Jan E., primary, Ramsay, Craig R., additional, Mannocci, Francesco, additional, Jarad, Fadi, additional, Albadri, Sondos, additional, Ricketts, David, additional, Tait, Carol, additional, Banerjee, Avijit, additional, Deery, Chris, additional, Boyers, Dwayne, additional, Marshman, Zoe, additional, Goulao, Beatriz, additional, Hamilton, Alice R., additional, Banister, Katie, additional, Bell, Rosanne, additional, Brown, Lori, additional, Conway, David I., additional, Donaldson, Pina, additional, Duncan, Anne, additional, Dunn, Katharine, additional, Fee, Patrick, additional, Forrest, Mark, additional, Glenny, Anne-Marie, additional, Gouick, Jill, additional, Gupta, Ekta, additional, Jacobsen, Elisabet, additional, Kettle, Jennifer, additional, MacLennan, Graeme, additional, Macpherson, Lorna, additional, McGuff, Tina, additional, Mitchell, Fiona, additional, van der Pol, Marjon, additional, Moazzez, Rebecca, additional, Roberston, Douglas, additional, Wojewodka, Gabriella, additional, Young, Linda, additional, and Lamont, Thomas, additional

Published
2022
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22. Additional file 2 of Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Author

Hamilton, Alice, Clarkson, Jan E., Ramsay, Craig R., Mannocci, Francesco, Jarad, Fadi, Albadri, Sondos, Ricketts, David, Tait, Carol, Banerjee, Avijit, Deery, Chris, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Hamilton, Alice R., Banister, Katie, Bell, Rosanne, Brown, Lori, Conway, David I., Donaldson, Pina, Duncan, Anne, Dunn, Katharine, Fee, Patrick, Forrest, Mark, Glenny, Anne-Marie, Gouick, Jill, Gupta, Ekta, Jacobsen, Elisabet, Kettle, Jennifer, MacLennan, Graeme, Macpherson, Lorna, McGuff, Tina, Mitchell, Fiona, van der Pol, Marjon, Moazzez, Rebecca, Roberston, Douglas, Wojewodka, Gabriella, Young, Linda, and Lamont, Thomas

Subjects
humanities
Abstract

Additional file 2. Participant consent form.

Published
2022
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23. Additional file 1 of Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (PIP): a feasibility study

Author

Hamilton, Alice, Clarkson, Jan E., Ramsay, Craig R., Mannocci, Francesco, Jarad, Fadi, Albadri, Sondos, Ricketts, David, Tait, Carol, Banerjee, Avijit, Deery, Chris, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Hamilton, Alice R., Banister, Katie, Bell, Rosanne, Brown, Lori, Conway, David I., Donaldson, Pina, Duncan, Anne, Dunn, Katharine, Fee, Patrick, Forrest, Mark, Glenny, Anne-Marie, Gouick, Jill, Gupta, Ekta, Jacobsen, Elisabet, Kettle, Jennifer, MacLennan, Graeme, Macpherson, Lorna, McGuff, Tina, Mitchell, Fiona, van der Pol, Marjon, Moazzez, Rebecca, Roberston, Douglas, Wojewodka, Gabriella, Young, Linda, and Lamont, Thomas

Subjects
technology, industry, and agriculture, cardiovascular system, lipids (amino acids, peptides, and proteins), cardiovascular diseases
Abstract

Additional file 1. Participant information leaflet (PIL).

Published
2022
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27. Pulpotomy for the Management of Irreversible Pulpitis in Mature Teeth (Pip): A Feasibility Study

Author

Clarkson, Jan E, primary, Ramsay, Craig R, additional, Mannocci, Francesco, additional, Jarad, Fadi, additional, Albadri, Sondos, additional, Ricketts, David, additional, Tait, Carol, additional, Banerjee, Avijit, additional, Deery, Chris, additional, Boyers, Dwayne, additional, Marshman, Zoe, additional, Goulao, Beatriz, additional, Banister, Katie, additional, Bell, Rosanne, additional, Brown, Lori, additional, Conway, David, additional, Donaldson, Pina, additional, Duncan, Anne, additional, Dunn, Katharine, additional, Fee, Patrick, additional, Forrest, Mark, additional, Glenny, Anne-Marie, additional, Gouick, Jill, additional, Gupta, Ekta, additional, Hamilton, Alice R, additional, Jacobsen, Elisabet, additional, Kettle, Jennifer, additional, MacLennan, Graeme, additional, Macpherson, Lorna, additional, McGuff, Tina, additional, Mitchell, Fiona, additional, Pol, Marjon Van der, additional, Moazzez, Rebecca, additional, Roberston, Douglas, additional, Wojewodka, Gabriella, additional, Young, Linda, additional, and Lamont, Thomas, additional

Published
2021
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28. The development and characterisation of novel ternary-phase dental composites for improved toughness

Author

Forrest., Mark

Subjects
ComputingMilieux_COMPUTERSANDEDUCATION, ComputerApplications_COMPUTERSINOTHERSYSTEMS, Uncategorized
Abstract

This thesis was scanned from the print manuscript for digital preservation and is copyright the author. Researchers can access this thesis by asking their local university, institution or public library to make a request on their behalf. Monash staff and postgraduate students can use the link in the References field.

Published
2021
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29. Additional file 1 of Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care

Author

Clarkson, Jan E., Ramsay, Craig R., Ricketts, David, Banerjee, Avijit, Deery, Chris, Lamont, Thomas, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Banister, Katie, Conway, David, Dawett, Bhupinder, Baker, Sarah, Sherriff, Andrea, Young, Linda, van der Pol, Marjon, MacLennan, Graeme, Floate, Ruth, Braid, Hazel, Fee, Patrick, Forrest, Mark, Gouick, Jill, Mitchell, Fiona, Gupta, Ekta, Dakri, Riz, Kettle, Jennifer, McGuff, Tina, and Dunn, Katharine

Subjects
technology, industry, and agriculture, cardiovascular system, lipids (amino acids, peptides, and proteins), cardiovascular diseases
Abstract

Additional file 1. Patient information leaflet.

Published
2021
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30. Additional file 2 of Selective Caries Removal in Permanent Teeth (SCRiPT) for the treatment of deep carious lesions: a randomised controlled clinical trial in primary care

Author

Clarkson, Jan E., Ramsay, Craig R., Ricketts, David, Banerjee, Avijit, Deery, Chris, Lamont, Thomas, Boyers, Dwayne, Marshman, Zoe, Goulao, Beatriz, Banister, Katie, Conway, David, Dawett, Bhupinder, Baker, Sarah, Sherriff, Andrea, Young, Linda, van der Pol, Marjon, MacLennan, Graeme, Floate, Ruth, Braid, Hazel, Fee, Patrick, Forrest, Mark, Gouick, Jill, Mitchell, Fiona, Gupta, Ekta, Dakri, Riz, Kettle, Jennifer, McGuff, Tina, and Dunn, Katharine

Subjects
humanities
Abstract

Additional file 2. Consent forms.

Published
2021
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33. Provision of the progestogen-only pill by community pharmacies as bridging contraception for women receiving emergency contraception: the Bridge-it RCT

Author

Cameron, Sharon T, primary, Glasier, Anna, additional, McDaid, Lisa, additional, Radley, Andrew, additional, Patterson, Susan, additional, Baraitser, Paula, additional, Stephenson, Judith, additional, Gilson, Richard, additional, Battison, Claire, additional, Cowle, Kathleen, additional, Vadiveloo, Thenmalar, additional, Johnstone, Anne, additional, Morelli, Alessandra, additional, Goulao, Beatriz, additional, Forrest, Mark, additional, McDonald, Alison, additional, and Norrie, John, additional

Published
2021
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34. Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial.:Protocol for the TOPSY randomised controlled trial

Author

Hagen, Suzanne, Kearney, Rohna, Goodman, Kirsteen, Melone, Lynn, Elders, Andrew, Manoukian, Sarkis, Agur, Wael, Best, Catherine, Breeman, Suzanne, Dembinsky, Melanie, Dwyer, Lucy, Forrest, Mark, Graham, Margaret, Guerrero, Karen, Hemming, Christine, Khunda, Aethele, Mason, Helen, McClurg, Doreen, Norrie, John, Karachalia-Sandri, Anastasia, Thakar, Ranee, and Bugge, Carol

Subjects
Quality of life, Randomised controlled trial (RCT), Pessary, Prolapse, Self-management, Economic evaluation
Abstract

Background: Pelvic organ prolapse (or prolapse) is a common condition in women where the pelvic organs (bladder, bowel or womb) descend into the vagina and cause distressing symptoms that adversely affect quality of life. Many women will use a vaginal pessary to treat their prolapse symptoms. Clinic-based care usually consists of having a pessary fitted in a primary or secondary care setting, and returning approximately every 6 months for healthcare professional review and pessary change. However, it is possible that women could remove, clean and re-insert their pessary themselves; this is called self-management. This trial aims to assess if self-management of a vaginal pessary is associated with better quality of life for women with prolapse when compared to clinic-based care. Methods: This is a multicentre randomised controlled trial in at least 17 UK centres. The intervention group will receive pessary self-management teaching, a self-management information leaflet, a follow-up phone call and access to a local telephone number for clinical support. The control group will receive the clinic-based pessary care which is standard at their centre. Demographic and medical history data will be collected from both groups at baseline. The primary outcome is condition-specific quality of life at 18 months' post-randomisation. Several secondary outcomes will also be assessed using participant-completed questionnaires. Questionnaires will be administered at baseline, 6, 12 and 18 months' post-randomisation. An economic evaluation will be carried out alongside the trial to evaluate cost-effectiveness. A process evaluation will run parallel to the trial, the protocol for which is reported in a companion paper. Discussion: The results of the trial will provide robust evidence of the effectiveness of pessary self-management compared to clinic-based care in terms of improving women's quality of life, and of its cost-effectiveness. Trial registration: ISRCTN Registry ISRCTN62510577. Registered on June 10, 2017.

Published
2020

35. Reducing Asthma Attacks in Children Using Exhaled Nitric Oxide as a Biomarker to Inform Treatment Strategy – A Randomised Trial

Author

Turner, Steve William, primary, Cotton, Seonaidh, additional, Wood, Jessica, additional, Bell, Victoria, additional, Raja, Edwin, additional, Scott, Neil, additional, Morgan, Heather, additional, Lawrie, Louisa, additional, Emele, David, additional, Kennedy, Charlotte, additional, Scotland, Graham, additional, Fielding, Shona, additional, MacLennan, Graeme, additional, Norrie, John, additional, Forrest, Mark, additional, Gaillard, Erol, additional, de Jongste, Johan, additional, Pijnenburg, Marielle, additional, Thomas, Michael, additional, and Price, David, additional

Published
2021
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36. Additional file 1 of Clinical and cost-effectiveness of vaginal pessary self-management compared to clinic-based care for pelvic organ prolapse: protocol for the TOPSY randomised controlled trial

Author

Hagen, Suzanne, Rohna Kearney, Kirsteen Goodman, Melone, Lynn, Elders, Andrew, Manoukian, Sarkis, Agur, Wael, Best, Catherine, Breeman, Suzanne, Dembinsky, Melanie, Dwyer, Lucy, Forrest, Mark, Graham, Margaret, Guerrero, Karen, Hemming, Christine, Aethele Khunda, Mason, Helen, McClurg, Doreen, Norrie, John, Karachalia-Sandri, Anastasia, Ranee Thakar, and Bugge, Carol

Abstract

Additional file 1. SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents.

Published
2020
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37. Pragmatic cluster randomised cohort cross-over trial to determine the effectiveness of bridging from emergency to regular contraception: the Bridge-It study protocol

Author

Cameron, Sharon Tracey, Baraitser, Paula, Glasier, Anna, McDaid, Lisa, Norrie, John, Radley, Andrew, Stephenson, Judith, Trussell, James, Battison, Claire, Cameron, Sarah, Cowle, Kathelen, Forrest, Mark, Gilson, Richard, Goulao, Beatriz, Johnstone, Anne, McDonald, Alison, Morelli, Alessandra, Patterson, Susan, Sally, Deirdre, and Stewart, Nicola

Subjects
education
Abstract

Introduction: Oral emergency contraception (EC) can prevent unintended pregnancy but it is important to start a regular method of contraception. Women in the UK usually access EC from a pharmacy but then need a subsequent appointment with a general practitioner or a sexual and reproductive health (SRH) service to access regular contraception. Unintended pregnancies can occur during this time.\ud \ud Methods and analysis: Bridge-It is a pragmatic cluster randomised cohort cross-over trial designed to determine whether pharmacist provision of a bridging supply of a progestogen-only pill (POP) plus rapid access to a local SRH clinic, results in increased uptake of effective contraception and prevents more unintended pregnancies than provision of EC alone. Bridge-It involves 31 pharmacies in three UK regions (London, Lothian and Tayside) aiming to recruit 626–737 women. Pharmacies will give EC (levonorgestrel) according to normal practice and recruit women to both intervention and the control phases of the study. In the intervention phase, pharmacists will provide the POP (desogestrel) and offer rapid access to an SRH clinic. In the control phase, pharmacists will advise women to attend a contraceptive provider for contraception (standard care).\ud \ud Women will be asked 4 months later about contraceptive use. Data linkage to abortion registries will provide abortion rates over 12 months. The sample size is calculated on the primary outcome of effective contraception use at 4 months (yes/no) with 90% power and a 5% level of significance. Abortion rates will be an exploratory secondary analysis. Process evaluation includes interviews with pharmacists, SRH clinicians and women. Cost-effectiveness analysis will use a healthcare system perspective and be expressed as incremental cost-effectiveness ratio.\ud \ud Ethics and dissemination: Ethical approval was received from South East Scotland REC June 2017. Results will be published in peer-reviewed journals and conference presentations.\ud \ud Trial registration number: ISRCTN70616901.

Published
2019

39. Open urethroplasty versus endoscopic urethrotomy for recurrent urethral stricture in men: the OPEN RCT

Author

Pickard, Robert, primary, Goulao, Beatriz, additional, Carnell, Sonya, additional, Shen, Jing, additional, MacLennan, Graeme, additional, Norrie, John, additional, Breckons, Matt, additional, Vale, Luke, additional, Whybrow, Paul, additional, Rapley, Tim, additional, Forbes, Rebecca, additional, Currer, Stephanie, additional, Forrest, Mark, additional, Wilkinson, Jennifer, additional, McColl, Elaine, additional, Andrich, Daniela, additional, Barclay, Stewart, additional, Cook, Jonathan, additional, Mundy, Anthony, additional, N’Dow, James, additional, Payne, Stephen, additional, and Watkin, Nick, additional

Published
2020
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40. Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial

Author

Cameron, Sharon T, primary, Glasier, Anna, additional, McDaid, Lisa, additional, Radley, Andrew, additional, Baraitser, Paula, additional, Stephenson, Judith, additional, Gilson, Richard, additional, Battison, Claire, additional, Cowle, Kathleen, additional, Forrest, Mark, additional, Goulao, Beatriz, additional, Johnstone, Anne, additional, Morelli, Alessandra, additional, Patterson, Susan, additional, McDonald, Alison, additional, Vadiveloo, Thenmalar, additional, and Norrie, John, additional

Published
2020
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41. Surgical Treatment for Recurrent Bulbar Urethral Stricture: A Randomised Open-label Superiority Trial of Open Urethroplasty Versus Endoscopic Urethrotomy (the OPEN Trial)

Author

Goulao, Beatriz, primary, Carnell, Sonya, additional, Shen, Jing, additional, MacLennan, Graeme, additional, Norrie, John, additional, Cook, Jonathan, additional, McColl, Elaine, additional, Breckons, Matt, additional, Vale, Luke, additional, Whybrow, Paul, additional, Rapley, Tim, additional, Forbes, Rebecca, additional, Currer, Stephanie, additional, Forrest, Mark, additional, Wilkinson, Jennifer, additional, Andrich, Daniela, additional, Barclay, Stewart, additional, Mundy, Anthony, additional, N’Dow, James, additional, Payne, Stephen, additional, Watkin, Nick, additional, and Pickard, Robert, additional

Published
2020
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43. Exposed bone in the palate

Author

Siegel, Michael A., Migliorati, Cesar A., Velez, Inez, and Forrest, Mark

Subjects
Diphosphonates -- Usage, Bones -- Necrosis, Bones -- Diagnosis, Bones -- Causes of, Bones -- Care and treatment, Health
Abstract

A woman was diagnosed to have bisphosphonate-associated osteonecrosis (BON) or the appearance of necrotic bone anywhere in the oral cavity of a patient treated with biphosphonate who has never received radiation thereapy to the head and neck area. The care and treatment for the disease is supplied.

Published
2007

44. Additional file 1: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Consent form. (DOCX 167Â kb)

Published
2018
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45. Additional file 2: of Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Author

Constable, Lynda, Cotterill, Nikki, Cooper, David, Glazener, Cathryn, Drake, Marcus, Forrest, Mark, Harding, Chris, Kilonzo, Mary, MacLennan, Graeme, McCormack, Kirsty, McDonald, Alison, Mundy, Anthony, Norrie, John, Pickard, Robert, Ramsay, Craig, Smith, Rebecca, Wileman, Samantha, and Abrams, Paul

Abstract

SPIRIT 2013 Checklist: recommended items to address in a clinical trial protocol and related documents. (PDF 57 kb)

Published
2018
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46. Additional file 2: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Authorship publication. (DOCX 12Â kb)

Published
2018
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47. Additional file 3: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

Authorship policy. (DOCX 15Â kb)

Published
2018
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48. Additional file 1: of Male synthetic sling versus artificial urinary sphincter trial for men with urodynamic stress incontinence after prostate surgery (MASTER): study protocol for a randomised controlled trial

Author

Constable, Lynda, Cotterill, Nikki, Cooper, David, Glazener, Cathryn, Drake, Marcus, Forrest, Mark, Harding, Chris, Kilonzo, Mary, MacLennan, Graeme, McCormack, Kirsty, McDonald, Alison, Mundy, Anthony, Norrie, John, Pickard, Robert, Ramsay, Craig, Smith, Rebecca, Wileman, Samantha, and Abrams, Paul

Subjects
body regions, nervous system, digestive, oral, and skin physiology, fungi, digestive system
Abstract

Male synthetic sling versus artificial urinary sphincter trial. (PDF 540 kb)

Published
2018
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49. Additional file 4: of HEALTH: laparoscopic supracervical hysterectomy versus second-generation endometrial ablation for the treatment of heavy menstrual bleeding: study protocol for a randomised controlled trial

Author

Cooper, Kevin, McCormack, Kirsty, Breeman, Suzanne, Wood, Jessica, Scott, Neil, Clark, Justin, Hawe, Jed, Hawthorn, Robert, Phillips, Kevin, Hyde, Angela, McDonald, Alison, Forrest, Mark, Wileman, Samantha, Scotland, Graham, Norrie, John, and Siladitya Bhattacharya

Abstract

A completed SPIRIT checklist. (PDF 114Â kb)

Published
2018
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50. The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial

Author

Beard, David J, primary, Davies, Loretta J, additional, Cook, Jonathan A, additional, MacLennan, Graeme, additional, Price, Andrew, additional, Kent, Seamus, additional, Hudson, Jemma, additional, Carr, Andrew, additional, Leal, Jose, additional, Campbell, Helen, additional, Fitzpatrick, Ray, additional, Arden, Nigel, additional, Murray, David, additional, Campbell, Marion K, additional, Barker, Karen, additional, Murray, Gordon, additional, Simpson, Hamish, additional, Dodwell, Donna, additional, Donell, Simon, additional, Waite, Jonathan, additional, Beard, David, additional, Cooper, Cushla, additional, Davies, Loretta, additional, Doll, Helen, additional, Cook, Jonathan, additional, Campbell, Marion, additional, Fernie, Gordon, additional, McDonald, Alison, additional, Duncan, Anne, additional, Castillo, Mayret, additional, Fusco, Francesco, additional, Greshon, Akiko, additional, Holland, Kay, additional, Li, Jiyang, additional, Rabaiotti, Elena, additional, Regan, Sandra, additional, Stalker, Victoria, additional, Forrest, Mark, additional, McPherson, Gladys, additional, Boachie, Charles, additional, Collins, Diana, additional, Cruden, Janice, additional, Halpin, Sophie, additional, Smith, Beverley, additional, Torgerson, David, additional, Maher, Chris, additional, Brownson, Peter, additional, Mullins, Mark Mullins, additional, Blazeby, Jane, additional, Jenkins, Ruth, additional, Lewis, Mark, additional, Mintowt-Czyz, Witek, additional, Beverland, Beverland, additional, Bryce, Leeann, additional, Catney, Julie, additional, Dobie, Ian, additional, Doran, Emer, additional, O'Brien, Seamus, additional, Ali, Fazal, additional, Cripps, Heather, additional, Whileman, Amanda, additional, Williams, Phil, additional, Toms, Julie, additional, Brown, Ellen, additional, Horner, Gillian, additional, Jennings, Andrew, additional, Rose, Glynis, additional, Bamford, Frances, additional, Goddard, Wendy, additional, Marynissen, Hans, additional, Peel, Haleh, additional, Richards, Lyndsey, additional, Bell, Amanda, additional, Deo, Sunny, additional, Grayland, Sarah, additional, Hollinghurst, David, additional, Pegler, Suzannah, additional, Satish, Venkat, additional, Woodruffe, Claire, additional, London, Nick, additional, Duffy, David, additional, Bennett, Caroline, additional, Featherstone, James, additional, Cook, Joss, additional, Dearnley, Kim, additional, Muthukumar, Nagarajan, additional, Onuoha, Laura, additional, Wilson, Sarah, additional, Banher, Sandhu, additional, Emeakaroha, Eunice, additional, Horohan, Jamie, additional, Jain, Sunil, additional, Thompson, Susan, additional, Buckley, Sarah, additional, Ng, Aaron, additional, Shetty, Ajit, additional, Simeson, Karen, additional, Flynn, Julian, additional, Newsom, Meryl, additional, Padilla-Harris, Cheryl, additional, Pearce, Oliver, additional, Bidwell, James, additional, Innes, Alison, additional, Culley, Winifred, additional, Ledingham, Bill, additional, Stephen, Janis, additional, Bray, Rachel, additional, Davies, Hywel, additional, Delgado, Debbie, additional, Eldridge, Jonathan, additional, Morrison, Leigh, additional, Murray, James, additional, Porteous, Andrew, additional, Robinson, James, additional, Dawson, Matt, additional, Dharmarajan, Raj, additional, Elson, David, additional, Hage, Will, additional, Kelsall, Nicci, additional, Orr, Mike, additional, Grosvenor, Jackie, additional, Maheswaran, SS, additional, McCue, Claire, additional, Venkatesh, Hemanth, additional, Wild, Michelle, additional, Wilson, Deborah, additional, Dodd, Chris, additional, Jackson, William, additional, Lovegrove, Pam, additional, Piper, Jennifer, additional, Bradbury, Neil, additional, Clark, Lucy, additional, Duncan, Stefanie, additional, Simpson, Genevieve, additional, Trezies, Allister, additional, Desai, Vikram, additional, Heeley, Cheryl, additional, Guy, Kramer, additional, Jackson, Rosalyn, additional, Hall, Alan, additional, Higgins, Gordon, additional, Hockings, Michael, additional, Isaac, David, additional, Mercer, Pauline, additional, Barber, Lindsey, additional, Cochrane, Helen, additional, Curtis, Janette, additional, Grindey, Julie, additional, Johnson, David, additional, Turner, Phil, additional, Houlihan-Burne, David, additional, Hill, Briony, additional, Langstaff, Ron, additional, Nasseri, Mariam, additional, Bowditch, Mark, additional, Martin, Chris, additional, Pryke, Steven, additional, Purewal, Bally, additional, Servant, Chris, additional, Suresh, Sheeba, additional, Tricker, Claire, additional, Ashford, Robert, additional, Attwal, Manjit, additional, Bunga, Jeanette, additional, Chatterji, Urjit, additional, Cockburn, Susan, additional, Esler, Colin, additional, Godsiff, Steven, additional, Green, Tim, additional, Haines, Christina, additional, Tandon, Subash, additional, Carpio, Racquel, additional, Griffiths, Sarah, additional, Grocott, Natalie, additional, dos Remedios, Ian, additional, Barrett, David, additional, Chapman-Sheath, Phil, additional, Grabau, Caroline, additional, Moghul, Jane, additional, Tice, William, additional, Trevithick, Catherine, additional, Deshmukh, Rajiv, additional, Howes, Mandy, additional, Netherton, Kimberley, additional, Raj, Dipak, additional, Travis, Nikki, additional, Maqsood, Mohammad, additional, Norton, Rebecca, additional, Rashid, Farzana, additional, Raynor, Alison, additional, Rowsell, Mark, additional, and Warner, Karen, additional

Published
2019
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