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10. INNODIA Master Protocol for the evaluation of investigational medicinal products in children, adolescents and adults with newly diagnosed type 1 diabetes

Author

Dunger, David B., Bruggraber, Sylvaine F. A., Mander, Adrian P., Marcovecchio, M. Loredana, Tree, Timothy, Chmura, Piotr Jaroslaw, Knip, Mikael, Schulte, Anke M., Mathieu, Chantal, Mathieu, C., Gillard, P., Casteels, K., Overbergh, L., Dunger, D., Wallace, C., Evans, M., Thankamony, A., Hendriks, E., Bruggraber, S., Peakman, M., Tree, T., Morgan, N., Richardson, S., Todd, J., Wicker, L., Mander, A., Dayan, C., Alhadj Ali, M., Pieber, T., Eizirik, D., Cnop, M., Brunak, S., Pociot, F., Johannesen, J., Rossing, P., Legido Quigley, C., Mallone, R., Scharfmann, R., Boitard, C., Knip, M., Otonkoski, T., Veijola, R., Lahesmaa, R., Oresic, M., Toppari, J., Danne, T., Ziegler, A. G., Achenbach, P., Rodriguez-Calvo, T., Solimena, M., Bonifacio, E., Speier, S., Holl, R., Dotta, F., Chiarelli, F., Marchetti, P., Bosi, E., Cianfarani, S., Ciampalini, P., de Beaufort, C., Dahl-Jørgensen, K., Skrivarhaug, T., Joner, G., Krogvold, L., Jarosz-Chobot, P., Battelino, T., Thorens, B., Gotthardt, M., Roep, B., Nikolic, T., Zaldumbide, A., Lernmark, A., Lundgren, M., Costecalde, G., Strube, T., Schulte, A., Nitsche, A., von Herrath, M., Wesley, J., Napolitano-Rosen, A., Thomas, M., Schloot, N., Goldfine, A., Waldron-Lynch, F., Kompa, J., Vedala, A., Hartmann, N., Nicolas, G., van Rampelbergh, J., Bovy, N., Dutta, S., Soderberg, J., Ahmed, S., Martin, F., Agiostratidou, G., Koralova, A., Willemsen, R., Smith, A., Anand, B., Puthi, V., Zac-Varghese, S., Datta, V., Dias, R., Sundaram, P., Vaidya, B., Patterson, C., Owen, K., Piel, B., Heller, S., Randell, T., Gazis, T., Bismuth Reismen, E., Carel, J-C, Riveline, J-P, Gautier, J-F, Andreelli, F., Travert, F., Cosson, E., Penfornis, A., Petit, C., Feve, B., Lucidarme, N., Beressi, J-P, Ajzenman, C., Radu, A., Greteau-Hamoumou, S., Bibal, C., Meissner, T., Heidtmann, B., Toni, S., Rami-Merhar, B., Eeckhout, B., Peene, B., Vantongerloo, N., Maes, T., Gommers, L., Marcovecchio, M.L., Vela, J., Latres, E., Children's Hospital, and HUS Children and Adolescents

Subjects
Trials, Adult, Adolescent, SARS-CoV-2, Prevention, Beta-cell function, COVID-19, Medicine (miscellaneous), Beta-cell Function, C-peptide, Master Protocol, Phase 2, Type 1 Diabetes, Type 1 diabetes, Diabetes Mellitus, Type 1, Treatment Outcome, 3121 General medicine, internal medicine and other clinical medicine, Diabetes Mellitus, Type 1/diagnosis, Master protocol, Humans, Pharmacology (medical), Child, Biomarkers
Abstract

Background The INNODIA consortium has established a pan-European infrastructure using validated centres to prospectively evaluate clinical data from individuals with newly diagnosed type 1 diabetes combined with centralised collection of clinical samples to determine rates of decline in beta-cell function and identify novel biomarkers, which could be used for future stratification of phase 2 clinical trials. Methods In this context, we have developed a Master Protocol, based on the “backbone” of the INNODIA natural history study, which we believe could improve the delivery of phase 2 studies exploring the use of single or combinations of Investigational Medicinal Products (IMPs), designed to prevent or reverse declines in beta-cell function in individuals with newly diagnosed type 1 diabetes. Although many IMPs have demonstrated potential efficacy in phase 2 studies, few subsequent phase 3 studies have confirmed these benefits. Currently, phase 2 drug development for this indication is limited by poor evaluation of drug dosage and lack of mechanistic data to understand variable responses to the IMPs. Identification of biomarkers which might permit more robust stratification of participants at baseline has been slow. Discussion The Master Protocol provides (1) standardised assessment of efficacy and safety, (2) comparable collection of mechanistic data, (3) the opportunity to include adaptive designs and the use of shared control groups in the evaluation of combination therapies, and (4) benefits of greater understanding of endpoint variation to ensure more robust sample size calculations and future baseline stratification using existing and novel biomarkers.

Published
2022

13. Post-radioiodine Graves' management: the PRAGMA study

Author

Perros P, Basu A, Boelaert K, Dayan C, Vaidya B, Williams GR, Lazarus JH, Hickey J, Drake WM, Crown A, Orme SM, Johnson A, Ray DW, Leese GP, Jones TH, Abraham P, Grossman A, Rees A, Razvi S, Gibb FW, Moran C, Madathil A, Zarkovic MP, Plummer Z, Jarvis S, Falinska A, Velusamy A, Sanderson V, Pariani N, Atkin SL, Syed AA, Sathyapalan T, Nag S, Gilbert J, Gleeson H, Levy MJ, Johnston C, Sturrock N, Bennett S, Mishra B, Malik I, Karavitaki N

Published
2022
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14. Safety of the use of gold nanoparticles conjugated with proinsulin peptide and administered by hollow microneedles as an immunotherapy in type 1 diabetes

Author

Tatovic, D, primary, McAteer, M A, additional, Barry, J, additional, Barrientos, A, additional, Rodríguez Terradillos, K, additional, Perera, I, additional, Kochba, E, additional, Levin, Y, additional, Dul, M, additional, Coulman, S A, additional, Birchall, J C, additional, von Ruhland, C, additional, Howell, A, additional, Stenson, R, additional, Alhadj Ali, M, additional, Luzio, S D, additional, Dunseath, G, additional, Cheung, W Y, additional, Holland, G, additional, May, K, additional, Ingram, J R, additional, Chowdhury, M M U, additional, Wong, F S, additional, Casas, R, additional, Dayan, C, additional, and Ludvigsson, J, additional

Published
2022
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17. The 2021 European Group on Graves’ orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves’ orbitopathy

Author

Bartalena, L, primary, Kahaly, G J, additional, Baldeschi, L, additional, Dayan, C M, additional, Eckstein, A, additional, Marcocci, C, additional, Marinò, M, additional, Vaidya, B, additional, Wiersinga, W M, additional, _, _, additional, Ayvaz, Goksun, additional, Konuk, Onur, additional, Ciric, Jasmina, additional, Beleslin, Bijliana, additional, Boschi, Antonella, additional, Cristina Burlacu, Maria, additional, Morris, Dan, additional, Le Moli, Rosario, additional, Marino, Antonio, additional, McKee, Justin, additional, Zammit, Nicola, additional, Führer, Dagmar, additional, Pereni, Ioana, additional, Schittkowski, Michael, additional, Raddatz, Dirk, additional, Lee, Vickie, additional, Meeran, Karim, additional, Abeillon, Juliette, additional, Soui Thcong, Thia, additional, Ponto, Katharina, additional, Muller, Ilaria, additional, Currò, Nicola, additional, Hintschich, Christoph, additional, Gärtner, Roland, additional, Pearce, Simon, additional, Clarke, Lucy, additional, Brix, Thomas, additional, Bechtold, Dorte, additional, Rudovfsky, Gottfried, additional, Fichter, Nicole, additional, Du Pasquier, Laurence, additional, Meney, Julia, additional, Menconi, Francesca, additional, Lanzolla, Giulia, additional, Sundar, Gangadhara, additional, Peiling Yung, Samantha, additional, Boboridis, Kostas, additional, Anagnostis, Panagiotis, additional, Pérez Lopez, Marta, additional, Javier Sanchez, Carlos, additional, Laura Tanda, Maria, additional, Donati, Simone, additional, Papp, Andrea, additional, Li, Shuren, additional, Jablonska, Anna, additional, Miskiewicz, Piotr, additional, Juri Mandic, Jelena, additional, and Baretic, Maja, additional

Published
2021
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19. The 2021 European Group on Graves' orbitopathy (EUGOGO) clinical practice guidelines for the medical management of Graves' orbitopathy.

Author

UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'ophtalmologie, UCL - (SLuc) Centre de malformations vasculaires congénitales, Bartalena, L, Kahaly, G J, Baldeschi, L, Dayan, C M, Eckstein, A, Marcocci, C, Marinò, M, Vaidya, B, Wiersinga, W M, EUGOGO †, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'ophtalmologie, UCL - (SLuc) Centre de malformations vasculaires congénitales, Bartalena, L, Kahaly, G J, Baldeschi, L, Dayan, C M, Eckstein, A, Marcocci, C, Marinò, M, Vaidya, B, Wiersinga, W M, and EUGOGO †

Abstract

Graves' orbitopathy (GO) is the main extrathyroidal manifestation of Graves' disease (GD). Choice of treatment should be based on the assessment of clinical activity and severity of GO. Early referral to specialized centers is fundamental for most patients with GO. Risk factors include smoking, thyroid dysfunction, high serum level of thyrotropin receptor antibodies, radioactive iodine (RAI) treatment, and hypercholesterolemia. In mild and active GO, control of risk factors, local treatments, and selenium (selenium-deficient areas) are usually sufficient; if RAI treatment is selected to manage GD, low-dose oral prednisone prophylaxis is needed, especially if risk factors coexist. For both active moderate-to-severe and sight-threatening GO, antithyroid drugs are preferred when managing Graves' hyperthyroidism. In moderate-to-severe and active GO i.v. glucocorticoids are more effective and better tolerated than oral glucocorticoids. Based on current evidence and efficacy/safety profile, costs and reimbursement, drug availability, long-term effectiveness, and patient choice after extensive counseling, a combination of i.v. methylprednisolone and mycophenolate sodium is recommended as first-line treatment. A cumulative dose of 4.5 g of i.v. methylprednisolone in 12 weekly infusions is the optimal regimen. Alternatively, higher cumulative doses not exceeding 8 g can be used as monotherapy in most severe cases and constant/inconstant diplopia. Second-line treatments for moderate-to-severe and active GO include (a) the second course of i.v. methylprednisolone (7.5 g) subsequent to careful ophthalmic and biochemical evaluation, (b) oral prednisone/prednisolone combined with either cyclosporine or azathioprine; (c) orbital radiotherapy combined with oral or i.v. glucocorticoids, (d) teprotumumab; (e) rituximab and (f) tocilizumab. Sight-threatening GO is treated with several high single doses of i.v. methylprednisolone per week and, if unresponsive, with urgent orbital decom

Published
2021

41. Association of Thyroid Function Test Abnormalities and Thyroid Autoimmunity With Preterm Birth A Systematic Review and Meta-analysis

Author

Consortium on Thyroid and Pregnancy—Study Group on Preterm Birth, Korevaar TIM, Derakhshan A, Taylor PN, Meima M, Chen L, Bliddal S, Carty DM, Meems M, Vaidya B, Shields B, Ghafoor F, Popova PV, Mosso L, Oken E, Suvanto E, Hisada A, Yoshinaga J, Brown SJ, Bassols J, Auvinen J, Bramer WM, López-Bermejo A, Dayan C, Boucai L, Vafeiadi M, Grineva EN, Tkachuck AS, Pop VJM, Vrijkotte TG, Guxens M, Chatzi L, Sunyer J, Jiménez-Zabala A, Riaño I, Murcia M, Lu X, Mukhtar S, Delles C, Feldt-Rasmussen U, Nelson SM, Alexander EK, Chaker L, Männistö T, Walsh JP, Pearce EN, Steegers EAP, and Peeters RP

Abstract

IMPORTANCE Maternal hypothyroidism and hyperthyroidism are risk factors for preterm birth. Milder thyroid function test abnormalities and thyroid autoimmunity are more prevalent, but it remains controversial if these are associated with preterm birth. OBJECTIVE To study if maternal thyroid function test abnormalities and thyroid autoimmunity are risk factors for preterm birth. DATA SOURCES AND STUDY SELECTION Studies were identified through a search of the Ovid MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, and Google Scholar databases from inception to March 18, 2018, and by publishing open invitations in relevant journals. Data sets from published and unpublished prospective cohort studies with data on thyroid function tests (thyrotropin [often referred to as thyroid-stimulating hormone or TSH] and free thyroxine [FT4] concentrations) or thyroid peroxidase (TPO) antibody measurements and gestational age at birth were screened for eligibility by 2 independent reviewers. Studies in which participants received treatment based on abnormal thyroid function tests were excluded. DATA EXTRACTION AND SYNTHESIS The primary authors provided individual participant data that were analyzed using mixed-effects models. MAIN OUTCOMES AND MEASURES The primary outcome was preterm birth (

Published
2019

45. Lexicographic optimization‐based clustering search metaheuristic for the multiobjective flexible job shop scheduling problem.

Author

Bissoli, Dayan C., Zufferey, Nicolas, and Amaral, André R. S.

Subjects
PRODUCTION scheduling, METAHEURISTIC algorithms
Abstract

In recent years, the flexible job shop scheduling problem (FJSP) has received a great deal of attention from researchers not only due to its complexity but also due to its wide range of applications in the industry. The FJSP extends the job shop scheduling problem (JSP) by allowing operations to be processed by a set of alternative machines. Many of the studies found in the literature consider the objective of minimizing the largest completion time of the jobs, that is, the makespan. However, in the real context of industries, considering more than one criterion is often relevant. Thus, the present work addresses two additional criteria besides the makespan: minimizing the maximum workload of the machines and minimizing the total workload of the machines. Aiming at real cases, where it is necessary to define priorities among the criteria, a clustering search (CS) algorithm was implemented using a lexicographic classification of the objectives for solving the multiobjective FJSP (MOFJSP). The results of this study show that compared to the state‐of‐the‐art approach, CS is an effective alternative to solve the MOFJSP. [ABSTRACT FROM AUTHOR]

Published
2021
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