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1. Safety and efficacy of tamoxifen in boys with Duchenne muscular dystrophy (TAMDMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Ridout, Deborah, Muntoni, Francesco, Manzur, Adnan., Quinlivan, Rosaline, Baranello, Giovanni, Main, Marion, Abbott, Lianne, Burnett, Nicola, Rohwer, Anne-Marie, Milev, Evelin, Wolfe, Adrian, O'Reilly, Emer, Straub, Volker, Guglieri, Michela, Bettolo, Chiara, Muni-Lofra, Robert, James, Meredith, Sodhi, Jassi, Willis, Tracey, Wright, Elizabeth, Rylance, Claire, Birchall, Nicola, Childs, Anne-Marie, Pysden, Karen, Martos-Lozano, Cristina, Pallant, Lindsey, Wadsworth, Steph, Spinty, Stefan, Madhu, Rajesh, Karuvattil, Rajesh, Gregson, Sarah, Clark, Stuart, Wraige, Elizabeth, Jungbluth, Heinz, Gowda, Vasantha, Vanegas, Maria, Sheehan, Ennie, Wolfe, Amy, Schofield, Alex, Hughes, Imelda, McCullagh, Gary, Whitehouse, Emily, Varma, Uma., Warner, Sinead, Reading, Emily, Benson, Lucy., Moustoukas, Jenny, Strachan, Kate, Emery, Nicholas, Ong, Min, Atherton, Mark, Durso, Sarah, White, Kay, Hinde, Neil, Skone, Kate, Sanchez Marco, Silvia, Saxena, Anurag, Gibbon, Frances, TeWaterNaude, Johann, Davis, Hayley, Thompson, Laura, Majumdar, Anirban, Murugan, Archana, Lynch, Mollie, Milton, Emily, Guarino, Iolanda, Tomlinson, Richard, Jarvis, Heather, Berry, Jane, Wills, Lucy, Frimpong-Ansah, Claire, Watson, Jackie, Robertson, Gemma, Cobb, Gavin, Burslem, Julie, Horrocks, Iain, Wong, Jarod, Brunklaus, Andreas, DiMarco, Marina, Brown, Sarah, Mckenzie, Susanne, Torne, Krupa, Mohamed, Rana, Velmurugan, Vel, Prasad, Manish, Sedehizadeh, Saam, Williamson, Sarah, Fenty, Paula, Degoede, Christian, Parkes, Amy, Illingworth, Marjorie, Bhangu, Neeraj, Geary, Michelle, Palmer, Jenni, Shill, Catherine, White, Cathy, Greenfield, Kathryn, Tomos, Heledd, Gates, Sarah, Tirupathi, Sandya, Shah, Ayaz, O'Donoghue, Dara, McVeigh, Janine, McFetridge, Jaci, Nic Fhirleinn, Grainne, Hussain, Nahin, Baskaran, Dhinesh, Lambat, Zubeida, Ambegaonkar, Gautam, Krishnakumar, Deepa, Taylor, Jacqui, Moores, Jo, Stephen, Elma, Tewnion, Jane, Ramdas, Sithara, Sa, Mario, Servais, Laurent, Lilien, Charlotte, Ramjattan, Hayley, Taylor, Francesca, English, Hayley, Parasuraman, Deepak, Rabb, Rosanna, McMurchie, Heather, Henzi, Bettina C, Schmidt, Simone, Nagy, Sara, Rubino-Nacht, Daniela, Schaedelin, Sabine, Putananickal, Niveditha, Stimpson, Georgia, Amthor, Helge, Deconinck, Nicolas, de Groot, Imelda, Houwen-van Opstal, Saskia, Laugel, Vincent, Lopez Lobato, Mercedes, Madruga Garrido, Marcos, Nascimento Osorio, Andrés, Schara-Schmidt, Ulrike, von Moers, Arpad, Lawrence, Fiona, Hafner, Patricia, Dorchies, Olivier M, and Fischer, Dirk

Published
2023
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2. Treatment of Nocturnal Enuresis using miniaturised advanced mechatronics with Artificial Intelligence

Author

Kuru, Kaya, Ansell, Darren, Hughes, Dave, Watkinson, Benjamin Jon, Gaudenzi, Fabrizio, Jones, Martin, Lunardi, David, Caswell, Noreen, Montiel, Adela Rabella, Leather, Peter, Irvingr, Daniel, Bennett, Kina, McKenzie, Corrin, Sugden, Paula, Davies, Carl, DeGoede, Christian, Kuru, Kaya, Ansell, Darren, Hughes, Dave, Watkinson, Benjamin Jon, Gaudenzi, Fabrizio, Jones, Martin, Lunardi, David, Caswell, Noreen, Montiel, Adela Rabella, Leather, Peter, Irvingr, Daniel, Bennett, Kina, McKenzie, Corrin, Sugden, Paula, Davies, Carl, and DeGoede, Christian

Abstract

Objective: Our study was designed to develop a customisable, wearable medical — so-called — MyPAD device that generates pre-void alarms using miniaturised mechatronics with Artificial Intelligence (AI). Methods and procedures: The developed features include: multiple bespoke ultrasound (US) probes for sensing, a bespoke electronic device housing custom US electronics for signal processing, a bedside alarm box for processing the echoed pulses and generating alarms, and a phantom to mimic the human body. The validation of the system is conducted on the tissue-mimicking phantom and volunteers using Bidirectional Long Short-Term Memory Recurrent Neural Networks (Bi-LSTM-RNN) and Reinforcement Learning (RL). Results: A Se value of 99% and a Sp value of 99.5% with an overall accuracy rate of 99.3% are observed. Conclusion: The obtained results demonstrate successful empirical evidence for the viability of the device, both in monitoring bladder expansion to determine voiding need and in reinforcing the continuous learning and customisation of the device for bladder control through consecutive uses.

Published
2024

3. Smart Wearable Device for Nocturnal Enuresis

Author

Kuru, Kaya, Watkinson, Benjamin Jon, Ansell, Darren, Hughes, Dave, Jones, Martin, Caswell, Noreen, Leather, Peter, Bennett, Kina, Sugden, Paula, Davies, Carl, DeGoede, Christian, Kuru, Kaya, Watkinson, Benjamin Jon, Ansell, Darren, Hughes, Dave, Jones, Martin, Caswell, Noreen, Leather, Peter, Bennett, Kina, Sugden, Paula, Davies, Carl, and DeGoede, Christian

Abstract

This research was designed to evaluate if it is viable to awaken children with urinary incontinence at the pre-void phase using a smart wearable device and enable them to control incontinence with fine-tuned individual parameters determined by the device intelligently. To address this research question, a miniaturised wearable smart device was built in this multidisciplinary research to monitor the non-linear behaviours of the bladder during its expansion with urine intake. The device, with its customisable abilities, sets an individual alarm point to awaken the child with incontinence before voiding. Safety parameters, aesthetics and ergonomic use of the device were investigated through hospital trials with children and the device was improved based on the obtained feedback from these trials.Clinical Relevance: The device will help children learn how to control their incontinence over time.

Published
2024

4. Treatment of Nocturnal Enuresis Using Miniaturised Smart Mechatronics With Artificial Intelligence

Author

Kuru, Kaya, primary, Ansell, Darren, additional, Hughes, Dave, additional, Watkinson, Benjamin Jon, additional, Gaudenzi, Fabrizio, additional, Jones, Martin, additional, Lunardi, David, additional, Caswell, Noreen, additional, Montiel, Adela Rabella, additional, Leather, Peter, additional, Irving, Daniel, additional, Bennett, Kina, additional, McKenzie, Corrin, additional, Sugden, Paula, additional, Davies, Carl, additional, and Degoede, Christian, additional

Published
2024
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5. Safety and efficacy of tamoxifen in boys with Duchenne muscular dystrophy (TAMDMD): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial

Author

Henzi, Bettina C, primary, Schmidt, Simone, additional, Nagy, Sara, additional, Rubino-Nacht, Daniela, additional, Schaedelin, Sabine, additional, Putananickal, Niveditha, additional, Stimpson, Georgia, additional, Amthor, Helge, additional, Childs, Anne-Marie, additional, Deconinck, Nicolas, additional, de Groot, Imelda, additional, Horrocks, Iain, additional, Houwen-van Opstal, Saskia, additional, Laugel, Vincent, additional, Lopez Lobato, Mercedes, additional, Madruga Garrido, Marcos, additional, Nascimento Osorio, Andrés, additional, Schara-Schmidt, Ulrike, additional, Spinty, Stefan, additional, von Moers, Arpad, additional, Lawrence, Fiona, additional, Hafner, Patricia, additional, Dorchies, Olivier M, additional, Fischer, Dirk, additional, Ridout, Deborah, additional, Muntoni, Francesco, additional, Manzur, Adnan., additional, Quinlivan, Rosaline, additional, Baranello, Giovanni, additional, Main, Marion, additional, Abbott, Lianne, additional, Burnett, Nicola, additional, Rohwer, Anne-Marie, additional, Milev, Evelin, additional, Wolfe, Adrian, additional, .O'Reilly, Emer, additional, Straub, Volker, additional, Guglieri, Michela, additional, Bettolo, Chiara, additional, Muni-Lofra, Robert, additional, James, Meredith, additional, Sodhi, Jassi, additional, Willis, Tracey, additional, Wright, Elizabeth, additional, Rylance, Claire, additional, Birchall, Nicola, additional, Pysden, Karen, additional, Martos-Lozano, Cristina, additional, Pallant, Lindsey, additional, Wadsworth, Steph, additional, Madhu, Rajesh, additional, Karuvattil, Rajesh, additional, Gregson, Sarah, additional, Clark, Stuart, additional, Wraige, Elizabeth, additional, Jungbluth, Heinz, additional, Gowda, Vasantha, additional, Vanegas, Maria, additional, Sheehan, Ennie, additional, Wolfe, Amy, additional, Schofield, Alex, additional, Hughes, Imelda, additional, McCullagh, Gary, additional, Whitehouse, Emily, additional, Varma, Uma., additional, Warner, Sinead, additional, Reading, Emily, additional, Benson, Lucy., additional, Moustoukas, Jenny, additional, Strachan, Kate, additional, Emery, Nicholas, additional, Ong, Min, additional, Atherton, Mark, additional, Durso, Sarah, additional, White, Kay, additional, Hinde, Neil, additional, Skone, Kate, additional, Sanchez Marco, Silvia, additional, Saxena, Anurag, additional, Gibbon, Frances, additional, TeWaterNaude, Johann, additional, Davis, Hayley, additional, Thompson, Laura, additional, Majumdar, Anirban, additional, Murugan, Archana, additional, Lynch, Mollie, additional, Milton, Emily, additional, Guarino, Iolanda, additional, Tomlinson, Richard, additional, Jarvis, Heather, additional, Berry, Jane, additional, Wills, Lucy, additional, Frimpong-Ansah, Claire, additional, Watson, Jackie, additional, Robertson, Gemma, additional, Cobb, Gavin, additional, Burslem, Julie, additional, Wong, Jarod, additional, Brunklaus, Andreas, additional, DiMarco, Marina, additional, Brown, Sarah, additional, Mckenzie, Susanne, additional, Torne, Krupa, additional, Mohamed, Rana, additional, Velmurugan, Vel, additional, Prasad, Manish, additional, Sedehizadeh, Saam, additional, Williamson, Sarah, additional, Fenty, Paula, additional, Degoede, Christian, additional, Parkes, Amy, additional, Illingworth, Marjorie, additional, Bhangu, Neeraj, additional, Geary, Michelle, additional, Palmer, Jenni, additional, Shill, Catherine, additional, White, Cathy, additional, Greenfield, Kathryn, additional, Tomos, Heledd, additional, Gates, Sarah, additional, Tirupathi, Sandya, additional, Shah, Ayaz, additional, O'Donoghue, Dara, additional, McVeigh, Janine, additional, .McFetridge, Jaci, additional, Nic Fhirleinn, Grainne, additional, Hussain, Nahin, additional, Baskaran, Dhinesh, additional, Lambat, Zubeida, additional, Ambegaonkar, Gautam, additional, Krishnakumar, Deepa, additional, Taylor, Jacqui, additional, Moores, Jo, additional, Stephen, Elma, additional, Tewnion, Jane, additional, Ramdas, Sithara, additional, Sa, Mario, additional, Servais, Laurent, additional, Lilien, Charlotte, additional, Ramjattan, Hayley, additional, Taylor, Francesca, additional, English, Hayley, additional, Parasuraman, Deepak, additional, Rabb, Rosanna, additional, and McMurchie, Heather, additional

Published
2023
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6. MyPAD: An Intelligent Wearable Medical Device to Treat Incontinence

Author

Kuru, Kaya, Watkinson, Benjamin Jon, Ansell, Darren, Hughes, Dave, Jones, Martin, Caswell, Noreen, Leather, Peter, Bennett, Kina, Sugden, Paula, Davies, Carl, DeGoede, Christian, Kuru, Kaya, Watkinson, Benjamin Jon, Ansell, Darren, Hughes, Dave, Jones, Martin, Caswell, Noreen, Leather, Peter, Bennett, Kina, Sugden, Paula, Davies, Carl, and DeGoede, Christian

Abstract

A smart, wearable, medical device -- the so-called ``MyPAD'' which monitors the fullness of the bladder, triggering an alarm indicating the need to void, in order to prevent badwetting -- i.e., treating Nocturnal Enuresis (NE) at the pre-void stage, was developed in this research. Patient and public engagement was an integral part of each development phase, particularly with respect to human factors, in collaboration with physicians, radiologists, psychologists, nurses, engineers and designers. Feedback was obtained from real-world trials and further improvements were incorporated into the device. Clinical Relevance: MyPAD will treat the NE efficiently against wetness-based post-void alarms and will enable children to gain control of incontinence over time.

Published
2023

7. Treatment of Nocturnal Enuresis using miniaturised advanced mechatronics with Artificial Intelligence

Author

Kuru, Kaya, Ansell, Darren, Hughes, Dave, Watkinson, Benjamin Jon, Gaudenzi, Fabrizio, Jones, Martin, Lunardi, David, Caswell, Noreen, Montiel, Adela Rabella, Leather, Peter, Irvingr, Daniel, Bennett, Kina, McKenzie, Corrin, Sugden, Paula, Davies, Carl, DeGoede, Christian, Kuru, Kaya, Ansell, Darren, Hughes, Dave, Watkinson, Benjamin Jon, Gaudenzi, Fabrizio, Jones, Martin, Lunardi, David, Caswell, Noreen, Montiel, Adela Rabella, Leather, Peter, Irvingr, Daniel, Bennett, Kina, McKenzie, Corrin, Sugden, Paula, Davies, Carl, and DeGoede, Christian

Abstract

Objective: Our study was designed to develop a customisable, wearable medical — so-called — MyPAD device that generates pre-void alarms using miniaturised mechatronics with Artificial Intelligence (AI). Methods and procedures: The developed features include: multiple bespoke ultrasound (US) probes for sensing, a bespoke electronic device housing custom US electronics for signal processing, a bedside alarm box for processing the echoed pulses and generating alarms, and a phantom to mimic the human body. The validation of the system is conducted on the tissue-mimicking phantom and volunteers using Bidirectional Long Short-Term Memory Recurrent Neural Networks (Bi-LSTM-RNN) and Reinforcement Learning (RL). Results: A Se value of 99% and a Sp value of 99.5% with an overall accuracy rate of 99.3% are observed. Conclusion: The obtained results demonstrate successful empirical evidence for the viability of the device, both in monitoring bladder expansion to determine voiding need and in reinforcing the continuous learning and customisation of the device for bladder control through consecutive uses.

Published
2023

8. Treatment of Nocturnal Enuresis Using Miniaturised Smart Mechatronics With Artificial Intelligence.

Author

Kuru K, Ansell D, Hughes D, Watkinson BJ, Gaudenzi F, Jones M, Lunardi D, Caswell N, Montiel AR, Leather P, Irving D, Bennett K, McKenzie C, Sugden P, Davies C, and Degoede C

Subjects
Child, Humans, Artificial Intelligence, Urinary Bladder, Urination, Neural Networks, Computer, Nocturnal Enuresis therapy
Abstract

Our study was designed to develop a customisable, wearable, and comfortable medical device - the text so-called "MyPAD" that monitors the fullness of the bladder, triggering an alarm indicating the need to void, in order to prevent badwetting - i.e., treating Nocturnal Enuresis (NE) at the text pre-void stage using miniaturised mechatronics with Artificial Intelligence (AI). The developed features include: multiple bespoke ultrasound (US) probes for sensing, a bespoke electronic device housing custom US electronics for signal processing, a bedside alarm box for processing the echoed pulses and generating alarms, and a phantom to mimic the human body. The validation of the system is conducted on the text tissue-mimicking phantom and volunteers using Bidirectional Long Short-Term Memory Recurrent Neural Networks (Bi-LSTM-RNN) and Reinforcement Learning (RL). A Se value of 99% and a Sp value of 99.5% with an overall accuracy rate of 99.3% are observed. The obtained results demonstrate successful empirical evidence for the viability of the device, both in monitoring bladder expansion to determine voiding need and in reinforcing the continuous learning and customisation of the device for bladder control through consecutive uses. Clinical impact: MyPAD will treat the NE better and efficiently against other techniques currently used (e.g., post-void alarms) and will i) replace those techniques quickly considering sufferers' condition while being treated by other approaches, and ii) enable children to gain control of incontinence over time and consistently have dry nights. Category: Early/Pre-Clinical Research., (© 2023 The Authors.)

Published
2023
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9. Systematic identification of disease-causing promoter and untranslated region variants in 8,040 undiagnosed individuals with rare disease.

Author

Martin-Geary AC, Blakes AJM, Dawes R, Findlay SD, Lord J, Walker S, Talbot-Martin J, Wieder N, D'Souza EN, Fernandes M, Hilton S, Lahiri N, Campbell C, Jenkinson S, DeGoede CGEL, Anderson ER, Burge CB, Sanders SJ, Ellingford J, Baralle D, Banka S, and Whiffin N

Abstract

Background: Both promoters and untranslated regions (UTRs) have critical regulatory roles, yet variants in these regions are largely excluded from clinical genetic testing due to difficulty in interpreting pathogenicity. The extent to which these regions may harbour diagnoses for individuals with rare disease is currently unknown., Methods: We present a framework for the identification and annotation of potentially deleterious proximal promoter and UTR variants in known dominant disease genes. We use this framework to annotate de novo variants (DNVs) in 8,040 undiagnosed individuals in the Genomics England 100,000 genomes project, which were subject to strict region-based filtering, clinical review, and validation studies where possible. In addition, we performed region and variant annotation-based burden testing in 7,862 unrelated probands against matched unaffected controls., Results: We prioritised eleven DNVs and identified an additional variant overlapping one of the eleven. Ten of these twelve variants (82%) are in genes that are a strong match to the individual's phenotype and six had not previously been identified. Through burden testing, we did not observe a significant enrichment of potentially deleterious promoter and/or UTR variants in individuals with rare disease collectively across any of our region or variant annotations., Conclusions: Overall, we demonstrate the value of screening promoters and UTRs to uncover additional diagnoses for previously undiagnosed individuals with rare disease and provide a framework for doing so without dramatically increasing interpretation burden.

Published
2023
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