5 results on '"Philipp Maximilian Doldi"'
Search Results
2. IMPORTANCE trial: a provisional study-design of a single-center, phase II, double-blinded, placebo-controlled, randomized, 4-week study to compare the efficacy and safety of intranasal esketamine in chronic opioid refractory pain [version 1; peer review: 2 approved]
- Author
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Mauricio Fernandes, Magdalena Schelotto, Philipp Maximilian Doldi, Giovanna Milani, Abul Andrés Ariza Manzano, Doriam Perera Valdivia, Alexandra Marie Winter Matos, Yasmin Hamdy Abdelrahim, Shaza Ahmed Hamad Bek, Benito K. Benitez, Vanessa Luiza Romanelli Tavares, Abdulrahim M. Basendwah, Luis Henrique Albuquerque Sousa, Naiara Faria Xavier, Tania Zertuche Maldonado, Sarah Toyomi de Oliveira, Melisa Chaker, Michelle Menon Miyake, Elif Uygur Kucukseymen, Kinza Waqar, Ola M.J. Alkhozondar, Ricardo Bernardo da Silva, Guilhermo Droppelmann, Antonio Vaz de Macedo, Rui Nakamura, and Felipe Fregni
- Subjects
Medicine ,Science - Abstract
Background: Cancer is the second leading cause of death globally. Up to 86% of advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription of opioids resulted in 33,000 deaths in the US in 2015. Both reduce patients’ functional status and quality of life. While cancer survival rates are increasing, therapeutic options for chronic opioid refractory pain are still limited. Esketamine is the s-enantiomer of ketamine, with superior analgesic effect and less psychotomimetic side effects. Intranasal esketamine was approved by the FDA for treatment-resistant depression. However, its use in chronic cancer pain has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial to evaluate the efficacy and safety of intranasal esketamine in chronic opioid refractory cancer pain. Methods and analysis: We will recruit 120 subjects with chronic opioid refractory pain, defined as pain lasting more than 3 months despite optimal therapy with high dose opioids (>60 mg morphine equivalent dose/day) and optimal adjuvant therapy. Subjects will be randomized into two groups: intranasal esketamine (56mg) and placebo. Treatment will be administered twice a week for four consecutive weeks. The primary outcome is defined as reduction in the Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS reduction after four weeks, the number of daily morphine rescue doses, functional status and satisfaction, and depression. Conclusion: This study may extend therapeutic options in patients with chronic pain, thus improving their quality of life and reducing opioid use. Trial registration: Clinical Trials.gov, NCT04666623. Registered on 14 December 2020
- Published
- 2021
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3. Indocyanine green clearance predicts outcome in patients undergoing transcatheter valve intervention for severe atrio-ventricular valve regurgitation
- Author
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Philipp Maximilian Doldi, Lukas Stolz, Joscha Buech, Shekhar Saha, Ludwig Weckbach, Jonas Gmeiner, Martin Orban, Daniel Braun, Thomas J Stocker, Michael Nabauer, Christian M Lange, Steffen Massberg, Christian Hagl, and Jörg Hausleiter
- Abstract
OBJECTIVESSevere mitral regurgitation (MR) and tricuspid regurgitation (TR) aggravate haemodynamic stress leading to congestive heart failure with impaired hepatic function, also known as cardiohepatic syndrome (CHS). Current perioperative risk calculators do not sufficiently consider CHS and serum liver function parameters lack sensitivity to diagnose CHS. Indocyanine green and its elimination (measured by the LIMON® test) represent a dynamic and non-invasive test which correlates with the hepatic function. Nevertheless, its utility in the setting of transcatheter valve repair/replacement (TVR) to predict CHS and outcome remains unknown.METHODSWe analysed liver function and outcomes of patients undergoing TVR for MR or TR between August 2020 and May 2021 at the Munich University Hospital.RESULTSOut of a total of 44 patients treated at the University Hospital of Munich, 21 (48%) were treated for severe MR, 20 (46%) for severe TR and 3 (7%) for both diseases. Procedural success defined as MR/TR ≤2+ was 94% among MR patients and 92% among TR patients. While classical serum liver function parameters did not change after TVR, there was a significant improvement in liver function as assessed by the LIMON® test (P ≤ 0.001). Patients with baseline indocyanine green plasma disappearance rate CONCLUSIONSEspecially in the context of the recently stressed importance of a careful patient selection prior to the interdisciplinary treatment of valvular heart disease, the LIMON® test may provide further real-time information on the patients’ cardiohepatic injury and prognosis.
- Published
- 2023
4. Transcatheter Aortic Valve Replacement with the Self-Expandable Core Valve Evolut Prosthesis Using the Cusp-Overlap vs. Tricusp-View
- Author
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Philipp Maximilian Doldi, Lukas Stolz, Felix Escher, Julius Steffen, Jonas Gmeiner, Daniel Roden, Marie Linnemann, Kornelia Löw, Simon Deseive, Thomas J. Stocker, Martin Orban, Hans Theiss, Konstantinos Rizas, Adrian Curta, Sebastian Sadoni, Joscha Buech, Dominik Joskowiak, Sven Peterss, Christian Hagl, Steffen Massberg, Jörg Hausleiter, and Daniel Braun
- Subjects
General Medicine ,TAVR ,aortic stenosis ,TAVI ,permanent pacemaker implantation ,conduction disturbance ,self-expandable valves ,cusp-overlap view ,three-cusp view - Abstract
Despite the rapid increase in experience and technological improvement, the incidence of conduction disturbances in patients undergoing transcatheter aortic valve replacement (TAVR) with the self-expandable CoreValve Evolut valve remains high. Recently, a cusp-overlap view (COP) implantation technique has been proposed for TAVR with self-expandable valves offering an improved visualization during valve expansion compared to the three-cusp view (TCV). This study aims to systematically analyze procedural outcomes of TAVR patients treated with the CoreValve Evolut valve using a COP compared to TCV in a high-volume center. The primary endpoint was technical success according the 2021 VARC-3 criteria. A total of 122 consecutive patients (61 pts. TCV: April 2019 to November 2020; 61 pts. COP: December 2020 to October 2021) that underwent TAVR with the CoreValve Evolut prosthesis were included in this analysis. Although there was no difference in the primary endpoint technical success between TCV and COP patients (93.4% vs. 90.2%, OR 0.65, 95% CI 0.16, 2.4, p = 0.51), we observed a significantly lower risk for permanent pacemaker implantation (PPI) among COP patients (TCV: 27.9% vs. COP: 13.1%, OR 0.39, 95% CI 0.15, 0.97, p = 0.047). Implantation of the CoreValve Evolut prosthesis using the COP might help to reduce the rate of PPI following TAVR.
- Published
- 2022
5. IMPORTANCE trial: a provisional study-design of a single-center, phase II, double-blinded, placebo-controlled, randomized, 4-week study to compare the efficacy and safety of intranasal esketamine in chronic opioid refractory pain
- Author
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Ola M.J. Alkhozondar, Felipe Fregni, Tania Zertuche Maldonado, Alexandra Marie Winter Matos, Michelle Menon Miyake, Melisa Chaker, Kinza Waqar, Luis Henrique Albuquerque Sousa, Philipp Maximilian Doldi, Sarah Toyomi de Oliveira, Elif Uygur Kucukseymen, Antonio Vaz de Macedo, Abul Andrés Ariza Manzano, Giovanna Milani, Shaza Ahmed Hamad Bek, Doriam Perera Valdivia, Yasmin Hamdy Abdelrahim, Rui Nakamura, Naiara Faria Xavier, Abdulrahim M. Basendwah, Ricardo Bernardo da Silva, Vanessa Luiza Romanelli Tavares, Guilhermo Droppelmann, Magdalena Schelotto, Mauricio Fernandes, and Benito K. Benitez
- Subjects
medicine.medical_specialty ,Esketamine ,viruses ,Placebo ,General Biochemistry, Genetics and Molecular Biology ,Study Protocol ,03 medical and health sciences ,0302 clinical medicine ,Double-Blind Method ,Internal medicine ,medicine ,Adjuvant therapy ,Humans ,Ketamine ,030212 general & internal medicine ,Cancer pain ,General Pharmacology, Toxicology and Pharmaceutics ,Pain measurement ,General Immunology and Microbiology ,business.industry ,Chronic pain ,virus diseases ,Articles ,General Medicine ,biochemical phenomena, metabolism, and nutrition ,medicine.disease ,digestive system diseases ,Pain, Intractable ,Analgesics, Opioid ,Treatment Outcome ,Opioid ,Opioid refractory ,Quality of Life ,Morphine ,Chronic Pain ,business ,030217 neurology & neurosurgery ,medicine.drug - Abstract
Background: Cancer is the second leading cause of death globally. Up to 86% of advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription of opioids resulted in 33,000 deaths in the US in 2015. Both reduce patients’ functional status and quality of life. While cancer survival rates are increasing, therapeutic options for chronic opioid refractory pain are still limited. Esketamine is the s-enantiomer of ketamine, with superior analgesic effect and less psychotomimetic side effects. Intranasal esketamine was approved by the FDA for treatment-resistant depression. However, its use in chronic cancer pain has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial to evaluate the efficacy and safety of intranasal esketamine in chronic opioid refractory cancer pain. Methods and analysis: We will recruit 120 subjects with chronic opioid refractory pain, defined as pain lasting more than 3 months despite optimal therapy with high dose opioids (>60 mg morphine equivalent dose/day) and optimal adjuvant therapy. Subjects will be randomized into two groups: intranasal esketamine (56mg) and placebo. Treatment will be administered twice a week for four consecutive weeks. The primary outcome is defined as reduction in the Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS reduction after four weeks, the number of daily morphine rescue doses, functional status and satisfaction, and depression. Conclusion: This study may extend therapeutic options in patients with chronic pain, thus improving their quality of life and reducing opioid use. Trial registration: Clinical Trials.gov, NCT04666623. Registered on 14 December 2020
- Published
- 2021
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