LIVIVO - Search results -

Search results

Result 1 - 10 of total 149

Search options

Article ; Online: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19 : In Responding to a Global Health Crisis, Industry is Discovering New, Efficient Ways of Meeting Objectives.

Wegner, Max

Therapeutic innovation & regulatory science

2020 Volume 55, Issue 2, Page(s) 463–466

Abstract: The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented ... ...

Abstract	The urgency and impact of the ongoing COVID-19 pandemic are changing global drug development and regulatory processes. The need for speed to understand the virus and develop new vaccines, medicines, and therapies for patients has provided unprecedented learning opportunities and revealed how the pharmaceutical industry can improve upon traditional processes. To stay competitive while remaining compliant with agency regulations and guidance, companies need to implement new process/tools that allow for more flexible work models, consider expanding the use of decentralized/hybrid trials, and capitalize on the use of real-world evidence (RWE) and cloud-based data systems. In addition, regulatory agencies should retain the agility exhibited during current reviews of potential new therapies, applying this momentum to other areas of unmet medical need. Further, agencies should consider a globally acceptable application platform. This article, by the Pharmaceuticals' Head of Regulatory Affairs at Bayer AG, examines how impacts of the COVID-19 crisis will continue beyond the pandemic period to the benefit of patients, drug developers, regulators, clinicians, and caregivers.
MeSH term(s)	COVID-19/drug therapy ; COVID-19/epidemiology ; Drug Development/legislation & jurisprudence ; Drug Development/organization & administration ; Drug Industry/legislation & jurisprudence ; Global Health ; Government Agencies ; Humans ; Pandemics ; Teleworking
Language	English
Publishing date	2020-11-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2708397-4
ISSN	2168-4804 ; 2168-4790
ISSN (online)	2168-4804
ISSN	2168-4790
DOI	10.1007/s43441-020-00239-8
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

Book: Festschrift Max Wegner zum sechzigsten Geburtstag

Ahrens, Dieter / Wegner, Max

1962

Author's details	[hrsg. von Dieter Ahrens]
Language	German
Size	168 S, Ill
Publisher	Aschendorff
Publishing place	Münster
Document type	Book
Note	Bibliogr. Max Wegner S. 167 - 168
Database	Former special subject collection: coastal and deep sea fishing

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Details ▾

Article ; Online: Characterization of Biomarkers of Thrombo-Inflammation in Patients with First-Diagnosed Atrial Fibrillation.

Friebel, Julian / Wegner, Max / Blöbaum, Leon / Schencke, Philipp-Alexander / Jakobs, Kai / Puccini, Marianna / Ghanbari, Emily / Lammel, Stella / Thevathasan, Tharusan / Moos, Verena / Witkowski, Marco / Landmesser, Ulf / Rauch-Kröhnert, Ursula

International journal of molecular sciences

2024 Volume 25, Issue 7

Abstract: Patients with first-diagnosed atrial fibrillation (FDAF) exhibit major adverse cardiovascular events (MACEs) during follow-up. Preclinical models have demonstrated that thrombo-inflammation mediates adverse cardiac remodeling and atherothrombotic events. ...

Abstract	Patients with first-diagnosed atrial fibrillation (FDAF) exhibit major adverse cardiovascular events (MACEs) during follow-up. Preclinical models have demonstrated that thrombo-inflammation mediates adverse cardiac remodeling and atherothrombotic events. We have hypothesized that thrombin activity (FIIa) links coagulation with inflammation and cardiac fibrosis/dysfunction. Surrogate markers of the thrombo-inflammatory response in plasma have not been characterized in FDAF. In this prospective longitudinal study, patients presenting with FDAF (
MeSH term(s)	Humans ; Atrial Fibrillation/diagnosis ; Longitudinal Studies ; Prospective Studies ; Receptor, PAR-1 ; Biomarkers ; Fibrosis
Chemical Substances	Receptor, PAR-1 ; Biomarkers
Language	English
Publishing date	2024-04-08
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2019364-6
ISSN	1422-0067 ; 1422-0067 ; 1661-6596
ISSN (online)	1422-0067
ISSN	1422-0067 ; 1661-6596
DOI	10.3390/ijms25074109
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article: Systematic review: Validity, reliability, and diagnostic accuracy of the electrogustometer.

Blijleven, Esther E / Fuchten, Denise / Dullaart, Max J / Stokroos, Robert J / Thomeer, Henricus G X M / Wegner, Inge

Laryngoscope investigative otolaryngology

2023 Volume 8, Issue 4, Page(s) 1068–1079

Abstract: Objective: What are the electrogustometer's (EGM) validity, reliability, and diagnostic accuracy in assessing taste sensation in adults compared to other taste tests?: Data sources: PubMed Medline, Elseviers's Embase, and the six databases of ... ...

Abstract	Objective: What are the electrogustometer's (EGM) validity, reliability, and diagnostic accuracy in assessing taste sensation in adults compared to other taste tests? Data sources: PubMed Medline, Elseviers's Embase, and the six databases of Cochrane Library. Methods: We conducted a systematic search on December 20, 2022, consisting of synonyms for EGM. We considered randomized controlled trials and observational studies with original data for inclusion if they included adults who underwent electrogustometry. Articles were excluded if no analysis regarding validity, reliability, or diagnostic accuracy had been performed or if these analyses could not be performed with the published data. Results: Nineteen articles discussing 18 studies were included for data extraction. The included studies carry a high risk of bias. Overall, the association between a variety of reference taste tests and EGM was moderate or weak with correlation coefficients ranging from -0.51 to 0.40 with one outlier of -0.74 found in one study correlating EGM and taste solutions. Test-retest reliability was good with reported correlation coefficients between 0.78 and 1.0. The sensitivity, specificity, PPV, and NPV of EGM in identifying abnormal taste function varied widely between the four studies on diagnostic accuracy. Conclusion: The included studies in this review lack the required standards regarding study design to draw firm conclusions about the validity, reliability, and diagnostic accuracy of the EGM. Future research is needed to assess these measurement properties. Based on the reported results, we would not recommend using the EGM as a screening test for taste disturbance in clinical practice. Level of evidence: NA.
Language	English
Publishing date	2023-07-12
Publishing country	United States
Document type	Journal Article ; Review
ISSN	2378-8038
ISSN	2378-8038
DOI	10.1002/lio2.1108
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Inter-library loan at ZB MED

Your chosen title can be delivered directly to ZB MED Cologne location if you are registered as a user at ZB MED Cologne.

Article: Predictors for Success and Failure in Transoral Robotic Surgery-A Retrospective Study in the North of the Netherlands.

Toppenberg, Alexandra G L / Nijboer, Thomas S / van der Laan, Wisse G W J / Wedman, Jan / Schwandt, Leonora Q / Plaat, Robert E / Witjes, Max J H / Wegner, Inge / Halmos, Gyorgy B

Cancers

2024 Volume 16, Issue 8

Abstract: Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and ... ...

Abstract	Transoral Robotic Surgery (TORS) is utilized for treating various malignancies, such as early-stage oropharyngeal cancer and lymph node metastasis of an unknown primary tumor (CUP), and also benign conditions, like obstructive sleep apnea (OSA) and chronic lingual tonsillitis. However, the success and failure of TORS have not been analyzed to date. In this retrospective observational multicenter cohort study, we evaluated patients treated with TORS using the da Vinci surgical system. Success criteria were defined as identification of the primary tumor for CUP, >2 mm resection margin for malignant conditions, and improvement on respiratory polygraphy and tonsillitis complaints for benign conditions. A total of 220 interventions in 211 patients were included. We identified predictors of success, such as low comorbidity status ACE-27, positive P16 status, and lower age for CUP, and female gender and OSA severity for benign conditions. For other malignancies, no predictors for success were found. Predictors of failure based on postoperative complications included high comorbidity scores (ASA) and anticoagulant use, and for postoperative pain, younger age and female gender were identified. This study provides valuable insights into the outcomes and predictors of success and failure in TORS procedures across various conditions and may also help in patient selection and counseling.
Language	English
Publishing date	2024-04-11
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers16081458
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Role of innovation in pharmaceutical regulation: A proposal for principles to evaluate EU General Pharmaceutical Legislation from the innovator perspective.

Heikkinen, Inkatuuli / Eskola, Sini / Acha, Virginia / Morrison, Alan / Walker, Chris / Weil, Catherine / Bril, Antoine / Wegner, Max / Metcalfe, Thomas / Chibout, Salah-Dine / Chlebus, Magda

Drug discovery today

2023 Volume 28, Issue 5, Page(s) 103526

Abstract: Because the EU General Pharmaceutical Legislation is under review, the EFPIA Innovation Board developed evaluation principles for the policy proposals and key considerations on how the regulatory framework can support innovation while ensuring only safe, ...

Abstract	Because the EU General Pharmaceutical Legislation is under review, the EFPIA Innovation Board developed evaluation principles for the policy proposals and key considerations on how the regulatory framework can support innovation while ensuring only safe, efficacious and quality medicines are authorized. The evaluation principles are anchored on actions to promote: agile adoption of new methodologies with soft law tools; continued emphasis on regulatory science to inform policies; a cost/benefit assessment of the new regulation to ensure they have an overall positive impact; and mitigation of any negative externalities or unintended effects for any type of innovation or products. The evaluation principles are intended to guide the impact assessment of the pharmaceutical legislation in the EU but the principles can be applied globally.
MeSH term(s)	Cost-Benefit Analysis ; Pharmaceutical Preparations
Chemical Substances	Pharmaceutical Preparations
Language	English
Publishing date	2023-02-14
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1324988-5
ISSN	1878-5832 ; 1359-6446
ISSN (online)	1878-5832
ISSN	1359-6446
DOI	10.1016/j.drudis.2023.103526
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 4725: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article: Intestinal Barrier Dysfunction and Microbial Translocation in Patients with First-Diagnosed Atrial Fibrillation.

Blöbaum, Leon / Witkowski, Marco / Wegner, Max / Lammel, Stella / Schencke, Philipp-Alexander / Jakobs, Kai / Puccini, Marianna / Reißner, Daniela / Steffens, Daniel / Landmesser, Ulf / Rauch, Ursula / Friebel, Julian

Biomedicines

2023 Volume 11, Issue 1

Abstract: Background: According to the leaky gut concept, microbial products (e.g., lipopolysaccharide, LPS) enter the circulation and mediate pro-inflammatory immunological responses. Higher plasma LPS levels have been reported in patients with various ... ...

Abstract	Background: According to the leaky gut concept, microbial products (e.g., lipopolysaccharide, LPS) enter the circulation and mediate pro-inflammatory immunological responses. Higher plasma LPS levels have been reported in patients with various cardiovascular diseases, but not specifically during early atrial fibrillation (AF). Methods: We studied data and blood samples from patients presenting with first-diagnosed AF (FDAF) ( Results: Circulating biomarkers that are suggestive of mucosal inflammation (zonulin, mucosal adhesion molecule MAdCAM-1) and intestinal epithelium damage (intestinal fatty acid binding protein, IFABP) were increased in the plasma of patients with FDAF when compared to patients with chronic cardiovascular diseases but without AF. Surrogate plasma markers of increased intestinal permeability (LPS, CD14, LPS-binding protein, gut-derived LPS-neutralising IgA antibodies, EndoCAbs) were detected during early AF. A reduced ratio of IgG/IgM EndoCAbs titres indicated chronic endotoxaemia. Collagen turnover biomarkers, which corresponded to the LPS values, suggested an association of gut-derived low-grade endotoxaemia with adverse structural remodelling. The LPS concentrations were higher in FDAF patients who experienced a major adverse cardiovascular event. Conclusions: Intestinal barrier dysfunction and microbial translocation accompany FDAF. Improving gut permeability and low-grade endotoxaemia might be a potential therapeutic approach to reducing the disease progression and cardiovascular complications in FDAF.
Language	English
Publishing date	2023-01-10
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2720867-9
ISSN	2227-9059
ISSN	2227-9059
DOI	10.3390/biomedicines11010176
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

Article ; Online: Surgical Versus Interventional Treatment of Major Access Site Complications During Transfemoral TAVI Procedures at a Large Volume Center.

Meertens, Max / Wegner, Moritz / Fischnaler, Carlos / Wienemann, Hendrik / Macherey, Sascha / Lee, Samuel / Kuhn, Elmar / Mauri, Victor / Dorweiler, Bernhard / Baldus, Stephan / Adam, Matti / Ahmad, Wael

Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists

2023 , Page(s) 15266028231204291

Abstract: Purpose: Access-related vascular complications in transfemoral transcatheter aortic valve implantation (TAVI) can be treated endovascularly or surgically. The aim of this study was to evaluate the short- and long-term outcomes of endovascular treatment ... ...

Abstract	Purpose: Access-related vascular complications in transfemoral transcatheter aortic valve implantation (TAVI) can be treated endovascularly or surgically. The aim of this study was to evaluate the short- and long-term outcomes of endovascular treatment compared with surgical repair for access-related vascular complications. Methods: This retrospective study was performed from January 1, 2018, to December 31, 2020. All transfemorally treated TAVI patients in whom a surgical or endovascular treatment for an access site complication was needed were included. The primary outcome was the need for any related vascular re-operation. Results: In total, 1219 transfemoral TAVI procedures were conducted during the study period. 19 patients suffered an access complication requiring endovascular treatment, while 54 patients required surgical repair. No differences were seen with regard to re-operations (endovascular 15.8% vs surgical 14.8%; p=0.919), wound infections (endovascular 0% vs surgical. 11.1%; p=0.129), and wound healing disorders (endovascular 15.8% vs surgical 29.6%; p=0.237). Patients undergoing endovascular treatment were discharged earlier (endovascular 11.2 vs surgical 14.9 days; p=0.028). After surgical repair, patients received significantly more blood transfusions than endovascularly treated patients (endovascular 1.00 vs surgical 3.1 red blood cell concentrate bags; p<0.001). No differences were found regarding the new onset of walking pain, rest pain, and ischemic ulcers during follow-up. Conclusion: In this retrospective cohort, endovascular treatment of access-related vascular complications of transfemoral TAVI procedures was safe and feasible. During the hospital stay, endovascularly treated patients received fewer blood transfusions and were discharged faster than surgically treated patients. No differences regarding clinical outcomes and re-intervention rates were seen during the follow-up. Clinical impact: Given the in this retrospective study demonstrated safety and feasibility of endovascular treatment for major access-related vascular complications, along with the in-hospital benefits and absence of follow-up disadvantages compared to surgical treatment, endovascular treatment should be considered in cases of major access-related vascular complications in transfemoral TAVI patients.
Language	English
Publishing date	2023-10-18
Publishing country	United States
Document type	Journal Article
ZDB-ID	2006618-1
ISSN	1545-1550 ; 1526-6028
ISSN (online)	1545-1550
ISSN	1526-6028
DOI	10.1177/15266028231204291
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Zs.A 4547: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
Jg. 1995 - 2021: Lesesall (2.OG)
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Supplementary Feeding of Moderately Wasted Children in Sierra Leone Reduces Severe Acute Malnutrition and Death When Compared with Nutrition Counseling: A Retrospective Cohort Study.

Rajabi, Tannaz / Schell, Sam K / Agapova, Sophia E / Hassan, Amir / Zalta, Max / Wegner, Donna R / Callaghan-Gillespie, Meghan / Koroma, Aminata / Kamara, Mohamed T / Manary, Mark J / Stephenson, Kevin B

The Journal of nutrition

2023 Volume 152, Issue 4, Page(s) 1149–1158

Abstract: Background: There is uncertainty about whether children with moderate wasting should receive supplementary feeding.: Objectives: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented ... ...

Abstract	Background: There is uncertainty about whether children with moderate wasting should receive supplementary feeding. Objectives: We examined whether supplementary feeding compared with counseling alone in children with moderate wasting prevented progression to severe acute malnutrition (SAM) or death. Methods: This was a retrospective, dual-cohort study in which 1791 children with moderate wasting were drawn from 2 prior randomized controlled trials that took place in the same location in rural Sierra Leone. A total of 1077 children received supplementary feeding, whereas 714 children received counseling alone. Children in both cohorts were followed for ≥24 wk from enrollment. The primary outcome was time to SAM or death using Kaplan-Meier analysis. Secondary outcomes included time to death as well as proportions of children with healthy midupper arm circumference (MUAC), moderate wasting, SAM, or death at 6, 12, and 24 wk from enrollment. Results: Children who received supplementary feeding were less likely to develop SAM or die across the entire follow-up period (HR: 0.53; 95% CI: 0.44, 0.65; P < 0.001). Time to event for death alone also revealed a lower risk for children who received supplementary feeding (HR: 0.52; 95% CI: 0.28, 0.94; P = 0.03). Children who received supplementary feeding were more likely to have a healthy MUAC at 6 wk (RR: 2.0; 95% CI: 1.7, 2.2) and 12 wk (RR: 1.3; 95% CI: 1.2, 1.5), were less likely to develop SAM at 6 (RR: 0.7; 95% CI: 0.6, 0.9), 12 (RR: 0.5; 95% CI: 0.3, 0.8), and 24 wk (RR: 0.2; 95% CI: 0.1, 0.5), and had higher rates of gain in weight and MUAC at 6 and 12 wk. Conclusions: Supplementary feeding of children with moderate wasting reduces risk of SAM and death across 24 wk of follow-up.
MeSH term(s)	Infant ; Humans ; Child ; Retrospective Studies ; Sierra Leone/epidemiology ; Cohort Studies ; Severe Acute Malnutrition ; Cachexia ; Counseling ; Malnutrition/epidemiology ; Malnutrition/prevention & control ; Randomized Controlled Trials as Topic
Language	English
Publishing date	2023-02-18
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S. ; Research Support, Non-U.S. Gov't
ZDB-ID	218373-0
ISSN	1541-6100 ; 0022-3166
ISSN (online)	1541-6100
ISSN	0022-3166
DOI	10.1093/jn/nxab451
Database	MEDical Literature Analysis and Retrieval System OnLINE

In stock of ZB MED Cologne/Königswinter

Uc I Zs.205: Show issues

Location:
Je nach Verfügbarkeit (siehe Angabe bei Bestand)
bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
ab Jg. 2022: Lesesaal (EG)

Order via subito

Details ▾
- See ZB MED holdings
- Order with fees

Article ; Online: Cytotoxic CD8

Friebel, Julian / Witkowski, Marco / Wegner, Max / Blöbaum, Leon / Lammel, Stella / Schencke, Philipp-Alexander / Jakobs, Kai / Puccini, Marianna / Reißner, Daniela / Steffens, Daniel / Moos, Verena / Schutheiss, Heinz-Peter / Landmesser, Ulf / Rauch, Ursula

Cells

2022 Volume 12, Issue 1

Abstract: Background: Atrial myopathy and atrial fibrillation (AF) accompany thrombo-inflammation. This facilitates disease progression and promotes major adverse cardiovascular events (MACEs). Thrombin receptor (protease-activated receptor 1, PAR1) signalling is ...

Abstract	Background: Atrial myopathy and atrial fibrillation (AF) accompany thrombo-inflammation. This facilitates disease progression and promotes major adverse cardiovascular events (MACEs). Thrombin receptor (protease-activated receptor 1, PAR1) signalling is central in mediating thrombo-inflammation. We hypothesised that PAR1 signalling links coagulation and inflammation through cytotoxic CD8 Methods: A total of 210 patients were studied. We included data and blood samples from patients presenting with FDAF ( Results: During early AF, a pro-inflammatory and cytotoxic subset of T lymphocytes (CD8 Conclusions: In patients with FDAF, the TF-factor Xa-factor IIa-axis contributes to thrombo-inflammation via PAR1 in CD8
MeSH term(s)	Humans ; Atrial Fibrillation ; Receptor, PAR-1 ; CD8-Positive T-Lymphocytes ; Inflammation/complications ; Disease Progression
Chemical Substances	Receptor, PAR-1
Language	English
Publishing date	2022-12-29
Publishing country	Switzerland
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2661518-6
ISSN	2073-4409 ; 2073-4409
ISSN (online)	2073-4409
ISSN	2073-4409
DOI	10.3390/cells12010141
Database	MEDical Literature Analysis and Retrieval System OnLINE

Order via subito

To top

More links

Kategorien

Order via subito

More links

Kategorien

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

More links

Kategorien

Order via subito

Inter-library loan at ZB MED

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

In stock of ZB MED Cologne/Königswinter

Order via subito

More links

Kategorien

Order via subito