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157 results on '"Ferdinandus, J"'

1. Impact of individualized treatment on recovery from fatigue and return to work in survivors of advanced-stage Hodgkin’s lymphoma: results from the randomized international GHSG HD18 trial

Author

Ferdinandus, J., Müller, H., Damaschin, C., Jacob, A.S., Meissner, J., Krasniqi, F., Mey, U., Schöndube, D., Thiemer, J., Mathas, S., Zijlstra, J., Greil, R., Feuring-Buske, M., Markova, J., Rüffer, J.U., Kobe, C., Eich, H.-T., Baues, C., Fuchs, M., Borchmann, P., and Behringer, K.

Published
2024
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5. Impact of individualized treatment on recovery from fatigue and return to work in survivors of advanced-stage Hodgkin’s lymphoma: results from the randomized international GHSG HD18 trial

Author

Ferdinandus, J., primary, Müller, H., additional, Damaschin, C., additional, Jacob, A.S., additional, Meissner, J., additional, Krasniqi, F., additional, Mey, U., additional, Schöndube, D., additional, Thiemer, J., additional, Mathas, S., additional, Zijlstra, J., additional, Greil, R., additional, Feuring-Buske, M., additional, Markova, J., additional, Rüffer, J.U., additional, Kobe, C., additional, Eich, H.-T., additional, Baues, C., additional, Fuchs, M., additional, Borchmann, P., additional, and Behringer, K., additional

Published
2023
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10. 1497P Safety and efficacy of [90Y]Y-FAPI-46 radioligand therapy in patients with advanced sarcomas and other cancer entities

Author

Hamacher, R.W., primary, Pabst, K.M., additional, Kessler, L., additional, Costa, P.F., additional, Ferdinandus, J., additional, Weber, M., additional, Lippert, M., additional, Lueckerath, K., additional, Hirmas, N., additional, Kostbade, K., additional, Mavroeidi, I.A., additional, Schuler, M.H.H., additional, Ahrens, M., additional, Rischpler, C., additional, Bauer, S., additional, Herrmann, K., additional, Siveke, J.T., additional, and Fendler, W.P., additional

Published
2022
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11. Advanced-stage Hodgkin lymphoma

Author

Ferdinandus, J., Oertel, M., Eichenauer, D. A., Meissner, J., Engert, A., Borchmann, P., Ferdinandus, J., Oertel, M., Eichenauer, D. A., Meissner, J., Engert, A., and Borchmann, P.

Abstract

Background In recent years, positron emission tomography (PET)-adapted protocols and new agents such as brentuximab vedotin are increasingly used as part of first-line protocols of advanced-stage Hodgkin lymphoma (HL). Objectives This manuscript reviews guideline-based therapy and available trial data in advanced-stage HL. Materials and methods This is a narrative review. Results The German HL guideline recommends interim PET2-guided (PET after 2 cycles) chemotherapy using 4 cycles of eBEACOPP (bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine and prednisone) for PET2-negative patients up to 60 years of age with advanced HL and 6 cycles eBEACOPP for PET2-positive patients. Furthermore, patients with PET-positive residual lymphoma should receive consolidation radiotherapy with 30 Gy. This is based on effective tumor control and short duration of therapy of 3 months in most patients. For elderly patients, treatment with 2 cycles of ABVD (adriamycin, bleomycin, vinblastine and dacarbazine) followed by 4 cycles of AVD and irradiation of PET-positive residuals is recommended. Conclusions Advanced-stage HL is curable in more than 90% of cases. The goal of current scientific efforts is to reduce toxicity while maintaining efficacy by including immune checkpoint inhibitors.

Published
2022

13. PSMA PET disease extent for European Association of Urology biochemical recurrence risk groups: An international multicentre study

Author

Fendler, W., primary, Ferdinandus, J., additional, Farolfi, A., additional, Washington, S., additional, Mohamad, O., additional, Pampaloni, M., additional, Scott, P., additional, Rodnick, M., additional, Viglianti, B., additional, Eiber, M., additional, Herrmann, K., additional, Czernin, J., additional, Armstrong, W., additional, Calais, J., additional, Hope, T., additional, and Piert, M., additional

Published
2022
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19. Ga-68-PSMA-11 PET/CT improves tumor detection and impacts management in patients with hepatocellular carcinoma (HCC)

Author

Hirmas, N, additional, Leyh, C, additional, Sraieb, M, additional, Barbato, F, additional, Schaarschmidt, BM, additional, Umutlu, L, additional, Nader, M, additional, Wedemeyer, H, additional, Ferdinandus, J, additional, Rischpler, C, additional, Herrmann, K, additional, Costa, PF, additional, Lange, CM, additional, Weber, MM, additional, and Fendler, WP, additional

Published
2021
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22. Cardiac fibroblast activation detected by Ga-68 FAPI PET imaging as a potential novel biomarker of cardiac injury/remodeling

Author

Siebermair, J., primary, Köhler, M. I., additional, Kupusovic, J., additional, Nekolla, S. G., additional, Kessler, L., additional, Ferdinandus, J., additional, Guberina, N., additional, Stuschke, M., additional, Grafe, H., additional, Siveke, J. T., additional, Kochhäuser, S., additional, Fendler, W. P., additional, Totzeck, M., additional, Wakili, R., additional, Umutlu, L., additional, Schlosser, T., additional, Rassaf, T., additional, and Rischpler, C., additional

Published
2020
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23. 1896MO Volumetric PET response assessment outperforms conventional criteria in patients receiving high-dose pembrolizumab for malignant mesothelioma

Author

Christoph, D.C.C., primary, Barbato, F., additional, Chodyla, M-K., additional, Fendler, W.P., additional, Kessler, L., additional, Pomykala, K.L., additional, Metzenmacher, M., additional, Krefting, F., additional, Hager, T., additional, Herrmann, K., additional, and Ferdinandus, J., additional

Published
2020
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24. Impact of 68Ga-PSMA-11 PET on the management of biochemically recurrent prostate cancer in a prospective single-arm clinical trial

Author

Ferdinandus, J., primary, Fendler, W.P., additional, Calais, J., additional, Eiber, M., additional, Flavell, R.R., additional, Mishoe, A., additional, Feng, F.Y., additional, Nguyen, H.G., additional, Reiter, R.E., additional, Rettig, M.B., additional, Gartmann, J., additional, Smith, R., additional, Small, E.J., additional, Slavik, R., additional, Carroll, P.R., additional, Herrmann, K., additional, Czernin, J., additional, and Hope, T.A., additional

Published
2020
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26. PSMA-PET identifies PCWG3 target populations with high concordance however superior reproducibility when compared to conventional imaging

Author

Farolfi, A, additional, Gafita, A, additional, Hirmas, N, additional, Weber, M, additional, Barbato, F, additional, Wetter, A, additional, Ferdinandus, J, additional, Mei, R, additional, Pianori, D, additional, Hadaschik, B, additional, Castellucci, P, additional, Fanti, S, additional, Eiber, M, additional, Herrmann, K, additional, and Fendler, WP, additional

Published
2020
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27. Impact of 68 Ga-PSMA-11 PET on the Management of biochemically recurrent Prostate Cancer in a Prospective Single-Arm Clinical Trial

Author

Ferdinandus, J, additional, Fendler, WP, additional, Calais, J, additional, Eiber, M, additional, Flavell, RR, additional, Mishoe, A, additional, Feng, FY, additional, Nguyen, HG, additional, Reiter, RE, additional, Rettig, MB, additional, Gartmann, J, additional, Smith, R, additional, Small, EJ, additional, Slavik, R, additional, Carroll, PR, additional, Herrmann, K, additional, Czernin, J, additional, and Hope, TA, additional

Published
2020
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28. Medical conditions at enrollment do not impact efficacy and safety of the adjuvanted recombinant zoster vaccine : a pooled post-hoc analysis of two parallel randomized trials

Author

Oostvogels, Lidia, Heineman, Thomas C., Johnson, Robert W., Levin, Myron J., McElhaney, Janet E., Van den Steen, Peter, Zahaf, Toufik, Dagnew, Alemnew F., Chlibek, Roman, Diez-Domingo, Javier, Gorfinkel, Iris S., Herve, Caroline, Hwang, Shinn-Jang, Ikematsu, Hideyuki, Kalema, George, Lal, Himal, McNeil, Shelly A., Mrkvan, Tomas, Pauksens, Karlis, Smetana, Jan, Watanabe, Daisuke, Weckx, Lily Yin, Cunningham, Anthony L., Ahonen, Anitta, Athan, Eugene, Berglund, Johan, Choi, Won Suk, de Looze, Ferdinandus J., Desole, Maria Giuseppina, Esen, Meral, Geeraerts, Brecht, Ghesquiere, Wayne, Rombo, Lars, and Volpi, Antonio

Subjects
Vaccine safety, Male, viruses, General Practice, Neuralgia, Postherpetic, Infektionsmedicin, Comorbidity, medicine.disease_cause, law.invention, 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, Immunology and Allergy, Herpes Zoster Vaccine, vaccine safety, 030212 general & internal medicine, Vaccines, Synthetic, Vaccination, virus diseases, vaccine efficacy, Middle Aged, comorbidity, Data Interpretation, Statistical, Recombinant DNA, Zoster vaccine, Female, medicine.drug, medicine.medical_specialty, Infectious Medicine, 030231 tropical medicine, Immunology, Short Report, Herpes Zoster, 03 medical and health sciences, Immunocompromised Host, Adjuvants, Immunologic, Internal medicine, Post-hoc analysis, medicine, Humans, Vaccine Potency, Aged, Pharmacology, business.industry, Varicella zoster virus, Vaccine efficacy, medicine.disease, Allmänmedicin, adjuvanted recombinant zoster vaccine, Chronic Disease, Varicella-zoster virus, underlying chronic disease, business
Abstract

In two pivotal efficacy studies (ZOE-50; ZOE-70), the adjuvanted recombinant zoster vaccine (RZV) demonstrated >90% efficacy against herpes zoster (HZ). Adults aged >= 50 or >= 70 years (ZOE-50 [NCT01165177]; ZOE-70 [NCT01165229]) were randomized to receive 2 doses of RZV or placebo 2 months apart. Vaccine efficacy and safety were evaluated post-hoc in the pooled (ZOE-50/70) population according to the number and type of selected medical conditions present at enrollment. At enrollment, 82.3% of RZV and 82.7% of placebo recipients reported >= 1 of the 15 selected medical conditions. Efficacy against HZ ranged from 84.5% (95% Confidence Interval [CI]: 46.4-97.1) in participants with respiratory disorders to 97.0% (95%CI: 82.3-99.9) in those with coronary heart disease. Moreover, efficacy remained >90% irrespective of the number of selected medical conditions reported by a participant. As indicated by the similarity of the point estimates, this post-hoc analysis suggests that RZV efficacy remains high in all selected medical conditions, as well as with increasing number of medical conditions. No safety concern was identified by the type or number of medical conditions present at enrollment.

Published
2019
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29. Safety profile of the adjuvanted recombinant zoster vaccine : Pooled analysis of two large randomised phase 3 trials

Author

Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, Zahaf, Toufik, Lopez-Fauqued, Marta, Campora, Laura, Delannois, Frederique, El Idrissi, Mohamed, Oostvogels, Lidia, De Looze, Ferdinandus J., Diez-Domingo, Javier, Heineman, Thomas C., Lal, Himal, McElhaney, Janet E., McNeil, Shelly A., Yeo, Wilfred, Tavares-Da-Silva, Fernanda, Ahonen, Anitta, Avelino-Silva, Thiago Junquera, Fernando Barba-Gomez, Jose, Berglund, Johan, Brotons Cuixart, Carlos, Caso, Covadonga, Chlibek, Roman, Choi, Won Suk, Cunningham, Anthony L., Desole, Maria Guiseppina, Eizenberg, Peter, Esen, Meral, Espie, Emmanuelle, Gervais, Pierre, Ghesquiere, Wayne, Godeaux, Olivier, Gorfinkel, Iris, Hui, David Shu Cheong, Hwang, Shinn-Jang, Korhonen, Tiina, Kovac, Martina, Ledent, Edouard, Leung, Edward, Levin, Myron J., Narejos Perez, Silvia, Neto, Jose Luiz, Pauksen, Karlis, Poder, Airi, Rodriguez de la Pinta, Maria Luisa, Rombo, Lars, Schwarz, Tino F., Smetana, Jan, Staniscia, Tommaso, Tinoco, Juan Carlos, Toma, Azhar, Vastiau, Ilse, Vesikari, Timo, Volpi, Antonio, Watanabe, Daisuke, Weckx, Lily Yin, and Zahaf, Toufik

Abstract

Background: The ZOE-50 (NCT01165177) and ZOE-70 (NCT01165229) phase 3 clinical trials showed that the adjuvanted recombinant zoster vaccine (RZV) was >= 90% efficacious in preventing herpes zoster in adults. Here we present a comprehensive overview of the safety data from these studies. Methods: Adults aged >= 50 (ZOE-50) and >= 70 (ZOE-70) years were randomly vaccinated with RZV or placebo. Safety analyses were performed on the pooled total vaccinated cohort, consisting of participants receiving at least one dose of RZV or placebo. Solicited and unsolicited adverse events (AEs) were collected for 7 and 30 days after each vaccination, respectively. Serious AEs (SAEs) were collected from the first vaccination until 12 months post-last dose. Fatal AEs, vaccination-related SAEs, and potential immune-mediated diseases (pIMDs) were collected during the entire study period. Results: Safety was evaluated in 14,645 RZV and 14,660 placebo recipients. More RZV than placebo recipients reported unsolicited AEs (50.5% versus 32.0%); the difference was driven by transient injection site and solicited systemic reactions that were generally seen in the first week post-vaccination. The occurrence of overall SAEs (RZV: 10.1%; Placebo: 10.4%), fatal AEs (RZV: 4.3%; Placebo: 4.6%), and pIMDs (RZV: 1.2%; Placebo: 1.4%) was balanced between groups. The occurrence of possible exacerbations of pIMDs was rare and similar between groups. Overall, except for the expected local and systemic symptoms, the safety results were comparable between the RZV and Placebo groups irrespective of participant age, gender, or race. Conclusions: No safety concerns arose, supporting the favorable benefit-risk profile of RZV.

Published
2019
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30. Natural history of Ross River virus-induced epidemic polyarthritis

Author

Mylonas, Andrea D., Brown, Allison M., Cathew, Tracy L., McGrath, Barry, Purdie, David M., Pandeya, Nirmala, Vecchio, Philip C., Collins, Louisa G., Gardner, Ian D., de Looze, Ferdinandus J., Reymond, Elizabeth J., and Suhrbier, Andreas

Subjects
Arthritis, Infectious -- Patient outcomes, Arthritis, Infectious -- Care and treatment, Arthritis, Infectious -- Diagnosis, Arthritis, Infectious -- Research, Diseases -- Patient outcomes, Diseases -- Care and treatment, Diseases -- Diagnosis, Diseases -- Research, Infectious arthritis, Diseases -- Australia, Health
Abstract

A questionnaire-based study was used to describe the natural history, cost and treatment of the Ross River virus-induced epidemic polyarthritis (RRV disease). Results of the study showed that other diagnosis should be seeked in RRV patients who exhibit persistent symptoms due to the fact that other conditions were attributable to the disease persisting six to 12 months after initial diagnosis.

Published
2002

32. Safety profile of the adjuvanted recombinant zoster vaccine: Pooled analysis of two large randomised phase 3 trials

Author

López-Fauqued, Marta, primary, Campora, Laura, additional, Delannois, Frédérique, additional, El Idrissi, Mohamed, additional, Oostvogels, Lidia, additional, De Looze, Ferdinandus J., additional, Diez-Domingo, Javier, additional, Heineman, Thomas C., additional, Lal, Himal, additional, McElhaney, Janet E., additional, McNeil, Shelly A., additional, Yeo, Wilfred, additional, Tavares-Da-Silva, Fernanda, additional, Ahonen, Anitta, additional, Avelino-Silva, Thiago Junquera, additional, Barba-Gomez, Jose Fernando, additional, Berglund, Johan, additional, Cuixart, Carlos Brotons, additional, Caso, Covadonga, additional, Chlibek, Roman, additional, Choi, Won Suk, additional, Cunningham, Anthony L., additional, Desole, Maria Guiseppina, additional, Eizenberg, Peter, additional, Esen, Meral, additional, Espié, Emmanuelle, additional, Gervais, Pierre, additional, Ghesquiere, Wayne, additional, Godeaux, Olivier, additional, Gorfinkel, Iris, additional, Hui, David Shu Cheong, additional, Hwang, Shinn-Jang, additional, Korhonen, Tiina, additional, Kovac, Martina, additional, Ledent, Edouard, additional, Leung, Edward, additional, Levin, Myron J., additional, Perez, Silvia Narejos, additional, Neto, Jose Luiz, additional, Pauksens, Karlis, additional, Poder, Airi, additional, de la Pinta, Maria Luisa Rodriguez, additional, Rombo, Lars, additional, Schwarz, Tino F., additional, Smetana, Jan, additional, Staniscia, Tommaso, additional, Tinoco, Juan Carlos, additional, Toma, Azhar, additional, Vastiau, Ilse, additional, Vesikari, Timo, additional, Volpi, Antonio, additional, Watanabe, Daisuke, additional, Weckx, Lily Yin, additional, and Zahaf, Toufik, additional

Published
2019
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33. Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes

Author

Roberts, Michael S, Stokes, Julie A, King, Michelle A, Lynne, Teresa A, Purdie, David M, Glasziou, Paul P, Wilson, D Andrew J, McCarthy, Sean T, Brooks, Geoffrey E, de Looze, Ferdinandus J, and Del Mar, Christopher B

Subjects
Aged, 80 and over, Health Services for the Aged, Cost-Benefit Analysis, Confounding Factors, Epidemiologic, Survival Analysis, Drug Utilization, Nursing Homes, Age Distribution, Cross-Sectional Studies, Residence Characteristics, Outcome Assessment, Health Care, Homes for the Aged, Humans, Longitudinal Studies, Aged
Abstract

AIMS: To evaluate whether a year long clinical pharmacy program involving development of professional relationships, nurse education on medication issues, and individualized medication reviews could change drug use, mortality and morbidity in nursing home residents. METHODS: A cluster randomised controlled trial, where an intervention home was matched to three control homes, was used to examine the effect of the clinical pharmacy intervention on resident outcomes. The study involved 905 residents in 13 intervention nursing homes and 2325 residents in 39 control nursing homes in south-east Queensland and north-east New South Wales, Australia. The outcome measures were: continuous drug use data from government prescription subsidy claims, cross-sectional drug use data on prescribed and administered medications, deaths and morbidity indices (hospitalization rates, adverse events and disability indices). RESULTS: This intervention resulted in a reduction in drug use with no change in morbidity indices or survival. Differences in nursing home characteristics, as defined by cluster analysis with SUDAAN, negated intervention-related apparent significant improvements in survival. The use of benzodiazepines, nonsteroidal anti-inflammatory drugs, laxatives, histamine H2-receptor antagonists and antacids was significantly reduced in the intervention group, whereas the use of digoxin and diuretics remained similar to controls. Overall, drug use in the intervention group was reduced by 14.8% relative to the controls, equivalent to an annual prescription saving of A64 dollars per resident (approximately 25 pound sterling). CONCLUSIONS: This intervention improved nursing home resident outcomes related to changes in drug use and drug-related expenditure. The continuing divergence in both drug use and survival at the end of the study suggests that the difference would have been more significant in a larger and longer study, and even more so using additional instruments specific for measuring outcomes related to changes in drug use.

Published
2016
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34. Toxicities at one year follow‐up in patients with advanced stage classical Hodgkin Lymphoma: results from the randomized phase III HD21 trial by the German Hodgkin Study Group.

Author

Ferdinandus, J., Moccia, A. A., Greil, R., Hertzberg, M., Schaub, V., Hüttmann, A., Keil, F., Dierlamm, J., Hänel, M., Novak, U., Meissner, J., Zimmermann, A., Mathas, S., Zijlstra, J. M., Fosså, A., Viardot, A., Hertenstein, B., Martin, S., Giri, P., and Kamper, P.

Subjects
CLINICAL trials, HODGKIN'S disease
Abstract

At FU12, grade 2 or higher PNP was reported for 17 (2.7%) patients following eBEACOPP and for 12 (1.9%) patients following BrECADD; however, no or only grade 1 PNP was reported for most patients in both treatment groups with 97.3% for eBEACOPP and 98.1% for BrECADD. B Introduction: b The HD21 trial compares BrECADD with eBEACOPP for the first-line treatment of advanced stage classical Hodgkin Lymphoma (AS-cHL). FSH levels at FU12 were available for 597 patients and were higher for patients who received eBEACOPP (mean FSH 29.4 and 31.8 after 4 and 6 cycles, respectively) compared to BrECADD (mean FSH 18.3 and 20.5 after 4 and 6 cycles, respectively. [Extracted from the article]

Published
2023
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35. Impact of PET‐2 guided treatment de‐escalation on time‐to‐recovery from cancer‐related fatigue in advanced stage Hodgkin Lymphoma: results from the GHSG HD18 study.

Author

Ferdinandus, J., Müller, H., Damaschin, C., Jacob, A. S., Meissner, J., Krasniqi, F., Mey, U., Schöndube, D., Thiemer, J., Mathas, S., Zijlstra, J. M., Greil, R., Feuring‐Buske, M., Markova, J., Kobe, C., Eich, H. T., Baues, C., Fuchs, M., Behringer, K., and Borchmann, P.

Subjects
HODGKIN'S disease, CANCER fatigue
Abstract

B Introduction: b Persisting cancer related fatigue (CRF) has impact on health related quality of life (HRQoL) and social re-integration of patients with Hodgkin lymphoma (HL). Impact of PET-2 guided treatment de-escalation on time-to-recovery from cancer-related fatigue in advanced stage Hodgkin Lymphoma: results from the GHSG HD18 study The GHSG HD18 trial established treatment PET-2 guided de-escalation of treatment for advanced-stage HL as new standard. [Extracted from the article]

Published
2023
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36. Soluble immune checkpoints HVEM and TIM‐3 are prognostic biomarkers for outcome in classical Hodgkin lymphoma.

Author

Ferdinandus, J., Cirillo, M., Bröckelmann, P. J., von Tresckow, B., Klapper, W., Engert, A., Borchmann, P., and Borchmann, S.

Subjects
IMMUNE checkpoint proteins, HEPATITIS A virus cellular receptors, HODGKIN'S disease, PROGNOSIS
Abstract

While few studies reported elevated PD-L1 serum levels in cHL compared to healthy individuals, the distribution and prognostic significance of soluble immune checkpoints (sCP) in the serum of cHL patients remains unclear. Soluble immune checkpoints HVEM and TIM-3 are prognostic biomarkers for outcome in classical Hodgkin lymphoma B Introduction: b Immune checkpoints expressed in the tumor microenvironment (TME) play a key role in the immune evasion of cancer in general and in classical Hodgkin lymphoma (cHL) in particular. [Extracted from the article]

Published
2023
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37. CORRELATION BETWEEN PROGRESSION‐FREE AND OVERALL SURVIVAL IN PATIENTS WITH CLASSICAL HODGKIN LYMPHOMA: A COMPREHENSIVE ANALYSIS OF INDIVIDUAL PATIENT DATA FROM GHSG TRIALS.

Author

Bröckelmann, P. J., Müller, H., Gillessen, S., Jacob, A., Momotow, J., Damaschin, C., Ferdinandus, J., Yang, X., Fuchs, M., Kobe, C., Eich, H., Engert, A., Borchmann, P., and von Tresckow, B.

Subjects
HODGKIN'S disease, OVERALL survival, PROGRESSION-free survival, TREATMENT effectiveness
Abstract

The statistical analysis at patient level confirmed a high correlation of treatment effects on PFS and OS. B Introduction: b Progression-free survival (PFS) and overall survival (OS) are predominant measures of treatment efficacy in classical Hodgkin lymphoma (HL). Additionally, we correlated risk factor effects with marginal Cox PH models at patient level (WLW) and applied copula models to correlate PFS and OS directly at patient level. [Extracted from the article]

Published
2023
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38. Effect of intensive structured care on individual blood pressure targets in primary care: multicentre randomised controlled trial

Author

Simon, Stewart, Melinda J, Carrington, Carla H, Swemmer, Craig, Anderson, Nicol P, Kurstjens, John, Amerena, Alex, Brown, Louise M, Burrell, Ferdinandus J, de Looze, Mark, Harris, Joseph, Hung, Henry, Krum, Mark, Nelson, Markus, Schlaich, Nigel P, Stocks, Garry L, Jennings, Michele, Zwi, Stewart, Simon, Carrington, Melinda J, Swemmer, Carla H, Anderson, Craig, Kurstjens, Nicol P, Amerena, John, Brown, Alex, Burrell, Louise M, De Looze, Ferdinandus J, Harris, Mark, Hung, Joseph, Krum, Henry, Nelson, Mark, Schlaich, Markus, Stocks, Nigel P, and Jennings, Garry L

Subjects
Male, medicine.medical_specialty, hypertension, Critical Care, outcomes, law.invention, antihypertensive treatment, Randomized controlled trial, prevention, law, Internal medicine, Intensive care, medicine, adults, Humans, Prospective Studies, Adverse effect, people, Framingham Risk Score, Intention-to-treat analysis, Primary Health Care, business.industry, Absolute risk reduction, General Medicine, home, mortality, Blood pressure, Relative risk, Hypertension, Physical therapy, all-cause, Female, business, metaanalysis
Abstract

Objective: To determine the effectiveness of intensive structured care to optimise blood pressure control based on individual absolute risk targets in primary care. Design: Pragmatic multicentre randomised controlled trial. Setting: General practices throughout Australia, except Northern Territory, 2009-11. Participants: Of 2185 patients from 119 general practices who were eligible for drug treatment for hypertension according to national guidelines 416 (19.0%) achieved their individual blood pressure target during a 28 day run-in period of monotherapy. After exclusions, 1562 participants not at target blood pressure (systolic 150 (SD 17) mm Hg, diastolic 88 (SD 11) mm Hg) were randomised (1:2 ratio) to usual care (n=524) or the intervention (n=1038). Intervention: Computer assisted clinical profiling and risk target setting (all participants) with intensified follow-up and stepwise drug titration (initial angiotensin receptor blocker monotherapy or two forms of combination therapy using angiotensin receptor blockers) for those randomised to the intervention. The control group received usual care. Main outcome measures: The primary outcome was individual blood pressure target achieved at 26 weeks. Secondary outcomes were change in mean sitting systolic and diastolic blood pressure, absolute risk for cardiovascular disease within five years based on the Framingham risk score, and proportion and rate of adverse events. Results: On an intention to treat basis, there was an 8.8% absolute difference in individual blood pressure target achieved at 26 weeks in favour of the intervention group compared with usual care group (358/988 (36.2%) v 138/504 (27.4%)): adjusted relative risk 1.28 (95% confidence interval 1.10 to 1.49, P=0.0013). There was also a 9.5% absolute difference in favour of the intervention group for achieving the classic blood pressure target of

Published
2012

42. 1. Testing for proteinuria

Author

Ferdinandus J. Delooze

Subjects
medicine.medical_specialty, Nephrology, business.industry, Urology, medicine, Diagnostic test, General Medicine, Urine, business
Published
2004
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43. Efficacy and safety of beloranib for weight loss in obese adults: a randomized controlled trial

Author

Kim, Dennis, Krishnarajah, J., Lillioja, Stephen, De Looze, Ferdinandus J, Marjason, Joanne K, Proietto, Joseph, Shakib, S, Stuckey, Bronwyn, Vath, J E, Hughes, T, Kim, Dennis, Krishnarajah, J., Lillioja, Stephen, De Looze, Ferdinandus J, Marjason, Joanne K, Proietto, Joseph, Shakib, S, Stuckey, Bronwyn, Vath, J E, and Hughes, T

Abstract

2015 John Wiley & Sons Ltd. Aim: To assess the efficacy, safety and tolerability of beloranib treatment for obesity. Methods: This phase II, double-blind, randomized study investigated the effects of beloranib suspension (0.6, 1.2 and 2.4mg) or placebo, administered subcutaneously, for 12weeks in 147 participants (primarily white women) with obesity. No diet or exercise advice was administered. Results: At week 12, beloranib resulted in dose-dependent progressive weight loss of -5.5±0.5, -6.9±0.6 and -10.9±1.1kg for the 0.6, 1.2 and 2.4mg beloranib doses, respectively, compared with -0.4±0.4kg with placebo (all p<0.0001 vs placebo). Weight loss with beloranib was associated with corresponding reductions in waist circumference and body fat mass, as well as improvements in lipids, high-sensitivity C-reactive protein and blood pressure. Sleep disturbance and gastrointestinal adverse events were more common with beloranib than with placebo; these were generally mild to moderate, transient and dose-related, and led to more early study withdrawals in participants in the group with the highest dose of beloranib. Conclusions: In this 12-week phase II study, beloranib produced clinically and statistically significant weight loss and corresponding improvements in cardiometabolic risk factors. Beloranib appeared safe, and the 0.6 and 1.2mg doses were generally well tolerated. The 2.4mg dose was associated with increased sleep latency and mild to moderate gastrointestinal adverse events over the first month of treatment. These findings represent a novel mechanism for producing clinically meaningful weight loss.

Published
2015

44. More rigorous protocol adherence to intensive structured management improves blood pressure control in primary care

Author

Stewart, Simon, primary, Stocks, Nigel P., additional, Burrell, Louise M., additional, de Looze, Ferdinandus J., additional, Esterman, Adrian, additional, Harris, Mark, additional, Hung, Joseph, additional, Swemmer, Carla H., additional, Kurstjens, Nicol P., additional, Jennings, Garry L., additional, and Carrington, Melinda J., additional

Published
2014
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45. Impact of nurse-mediated management on achieving blood pressure goal levels in primary care: Insights from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study.

Author

Carrington, Melinda J., Jennings, Garry L., Harris, Mark, Nelson, Mark, Schlaich, Markus, Stocks, Nigel P., Burrell, Louise M., Amerena, John, de Looze, Ferdinandus J., Swemmer, Carla H., Kurstjens, Nicol P., and Stewart, Simon

Subjects
BLOOD pressure, CARDIOVASCULAR disease nursing, HYPERTENSION, MEDICAL cooperation, NURSES, NURSING, PRIMARY health care, RESEARCH, STATISTICAL sampling, OCCUPATIONAL roles, RANDOMIZED controlled trials, DESCRIPTIVE statistics
Abstract

Background: Blood pressure targets in individuals treated for hypertension in primary care remain difficult to attain. Aims: To assess the role of practice nurses in facilitating intensive and structured management to achieve ideal BP levels. Methods: We analysed outcome data from the Valsartan Intensified Primary carE Reduction of Blood Pressure Study. Patients were randomly allocated (2:1) to the study intervention or usual care. Within both groups, a practice nurse mediated the management of blood pressure for 439 patients with endpoint blood pressure data (n=1492). Patient management was categorised as: standard usual care (n=348, 23.3%); practice nurse-mediated usual care (n=156, 10.5%); standard intervention (n=705, 47.3%) and practice nurse-mediated intervention (n=283, 19.0%). Blood pressure goal attainment at 26-week follow-up was then compared. Results: Mean age was 59.3±12.0 years and 62% were men. Baseline blood pressure was similar in practice nurse-mediated (usual care or intervention) and standard care management patients (150 ± 16/88 ± 11 vs. 150 ± 17/89 ± 11 mmHg, respectively). Practice nurse-mediated patients had a stricter blood pressure goal of ⩽125/75 mmHg (33.7% vs. 27.3%, p=0.026). Practice nurse-mediated intervention patients achieved the greatest blood pressure falls and the highest level of blood pressure goal attainment (39.2%) compared with standard intervention (35.0%), practice nurse-mediated usual care (32.1%) and standard usual care (25.3%; p<0.001). Practice nurse-mediated intervention patients were almost two-fold more likely to achieve their blood pressure goal compared with standard usual care patients (adjusted odds ratio 1.92, 95% confidence interval 1.32 to 2.78; p=0.001). Conclusion: There is greater potential to achieve blood pressure targets in primary care with practice nurse-mediated hypertension management. [ABSTRACT FROM AUTHOR]

Published
2016
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