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1.
Clin Oral Investig ; 28(1): 55, 2023 Dec 29.
Artigo em Inglês | MEDLINE | ID: mdl-38157063

RESUMO

OBJECTIVES: Skull morphology and growth patterns are essential for orthodontic treatment, impacting clinical decision making. We aimed to determine the association of different cephalometric skeletal configurations on midface parameters as measured in 3D CT datasets. MATERIALS AND METHODS: After sample size calculation, a total of 240 fully dentulous patients between 20 and 79 years of age (mean age: 42 ± 15), who had received a CT of the skull within the scope of trauma diagnosis or intracranial bleeding, were retrospectively selected. On the basis of cephalometric analysis, using MPR reconstructions, patients were subdivided into three different vertical skull configurations (brachyfacial, mesofacial, dolichofacial) and the respective skeletal Class I, II, and III relationships. Anatomic parameters were measured using a three-dimensional post-processing console: the thickness of the maxillary and palatine bones as well as the alveolar crest, maxillary body and sutural length, width and height of the hard palate, maxillary facial wall thickness, and masseter muscle thickness and length. RESULTS: Individuals with brachyfacial configurations had a significantly increased palatal and alveolar ridge thicknesses compared to those with dolichofacial- or mesofacial configurations. Brachyfacial configurations presented a significantly increased length and thickness of the masseter muscle (4.599 cm; 1.526 cm) than mesofacial (4.431 cm; 1.466 cm) and dolichofacial configurations (4.405 cm; 1.397 cm) (p < 0.001). Individuals with a skeletal Class III had a significantly shorter palatal length (5.313 cm) than those with Class I (5.406 cm) and Class II (5.404 cm) (p < 0.01). Sutural length was also significantly shorter in Class III (p < 0.05). CONCLUSIONS: Skeletal configurations have an impact on parameters of the bony skull. Also, measurable adaptations of the muscular phenotype could result. CLINICAL RELEVANCE: The association between viscerocranial morphology and midface anatomy might be beneficial for tailoring orthodontic appliances to individual anatomy and planning cortically anchored orthodontic appliances.


Assuntos
Face , Maxila , Adulto , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Face/anatomia & histologia , Cefalometria/métodos , Maxila/diagnóstico por imagem , Maxila/anatomia & histologia , Palato Duro
2.
Int J Mol Sci ; 24(9)2023 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-37175682

RESUMO

Prothrombotic hereditary risk factors for cerebral vein thrombosis (CVT) are of clinical interest to better understand the underlying pathophysiology and stratify patients for the risk of recurrence. This study explores prothrombotic risk factors in CVT patients. An initial screening in patients of the outpatient clinic of the Department of Transfusion Medicine and Hemostaseology of the University Hospital Erlangen, Germany, revealed 183 patients with a history of CVT. An initial screening identified a number of common prothrombic risk factors, including Factor V Leiden (rs6025) and Prothrombin G20210A (rs1799963). All patients without relevant findings (58 individuals) were invited to participate in a subsequent genetic analysis of 55 relevant genes using next-generation sequencing (NGS). Three intron variants (ADAMTS13: rs28446901, FN1: rs56380797, rs35343655) were identified to occur with a significantly higher frequency in the CVT patient cohort compared to the general European population. Furthermore, the combined prevalence of at least two of four potentially prothrombic variants (FGA (rs6050), F13A1 (rs5985), ITGB3 (rs5918), and PROCR (rs867186)) was significantly higher in the CVT subjects. The possible impact of the identified variants on CVT is discussed.


Assuntos
Veias Cerebrais , Trombose Intracraniana , Trombofilia , Trombose , Humanos , Fatores de Risco , Mutação , Trombose Intracraniana/genética , Sequenciamento de Nucleotídeos em Larga Escala , Trombofilia/genética , Protrombina
3.
Brain Sci ; 13(3)2023 Mar 14.
Artigo em Inglês | MEDLINE | ID: mdl-36979302

RESUMO

Despite available, advanced pharmacological and behavioral therapies, refractory chronic facial pain of different origins still poses a therapeutic challenge. In circumstances where there is insufficient responsiveness to pharmacological/behavioral therapies, deep brain stimulation should be considered as a potential effective treatment option. We performed an individual participant data (IPD) meta-analysis including searches on PubMed, Embase, and the Cochrane Library (2000-2022). The primary endpoint was the change in pain intensity (visual analogue scale; VAS) at a defined time-point of ≤3 months post-DBS. In addition, correlation and regression analyses were performed to identify predictive markers (age, duration of pain, frequency, amplitude, intensity, contact configuration, and the DBS target). A total of seven trials consisting of 54 screened patients met the inclusion criteria. DBS significantly reduced the pain levels after 3 months without being related to a specific DBS target, age, contact configuration, stimulation intensity, frequency, amplitude, or chronic pain duration. Adverse events were an infection or lead fracture (19%), stimulation-induced side effects (7%), and three deaths (unrelated to DBS-from cancer progression or a second stroke). Although comparable long-term data are lacking, the current published data indicate that DBS (thalamic and PVG/PAG) effectively suppresses facial pain in the short-term. However, the low-quality evidence, reporting bias, and placebo effects must be considered in future randomized-controlled DBS trials for facial pain.

4.
J Pers Med ; 12(5)2022 Apr 28.
Artigo em Inglês | MEDLINE | ID: mdl-35629124

RESUMO

Background: Deep inferior epigastric perforator and muscle sparing transverse rectus abdominis muscle flaps are commonly used flaps for autologous breast reconstruction. CT-angiography allows to analyse the perforator course preoperatively. Our aim was to compare the different aspects of perforator anatomy in the most detailed study. Methods: CT-angiographies of 300 female patients with autologous breast reconstruction of 10 years were analysed regarding the anatomy of the deep inferior epigastric artery and every perforator. Results: Overall, 2260 perforators were included. We identified correlations regarding the DIEA branching point and number of perforators and their intramuscular course. The largest perforator emerged more often from the medial branch of the DIEA than the smaller perforators (70% (416/595) vs. 54% (878/1634), p < 0.001) and more often had a direct connection to the SIEV (large 67% (401/595) vs. small 39% (634/1634), p < 0.01). Medial row perforators were larger than the laterals (lateral 1.44 mm ± 0.43 (n = 941) vs. medial 1.58 mm ± 0.52 (n = 1304) (p < 0.001)). The larger and more medial the perforator, the more likely it was connected to the SIEV: perforators with direct connection to the SIEV had a diameter of 1.65 mm ± 0.53 (n = 1050), perforators with indirect connection had a diameter of 1.43 ± 0.43 (n = 1028), perforators without connection had a diameter of 1.31 mm ± 0.37 (n = 169) (p < 0.001). Medial perforators were more often directly connected to the SIEV than lateral perforators (medial 56% (723/1302) vs. lateral 35% (327/941), p < 0.001). A lateral perforator more often had a short intramuscular course than medial perforators (69% (554/800) vs. 45% (474/1055), p < 0.001), which was also more often observed in the case of a small perforator and a caudal exit of the rectus sheath. Conclusion: The largest perforator emerges more often from the medial branch of the DIEA and frequently has a direct connection to the SIEV, making medial row perforators ideal for DIEP flap transplantation.

5.
BMC Oral Health ; 22(1): 148, 2022 04 27.
Artigo em Inglês | MEDLINE | ID: mdl-35477563

RESUMO

BACKGROUND: Orthodontic treatment with fixed appliances is often necessary to correct malocclusions in adolescence or adulthood. However, oral hygiene is complicated by appliances, and prior studies indicate that they may trigger oral inflammation and dysbiosis of the oral microbiota, especially during the first 3 months after insertion, and, thus, may present a risk for inflammatory oral diseases. In recent periodontal therapeutic studies, probiotics have been applied to improve clinical parameters and reduce local inflammation. However, limited knowledge exists concerning the effects of probiotics in orthodontics. Therefore, the aim of our study is to evaluate the impact of probiotics during orthodontic treatment. METHODS: This study is a monocentric, randomized, double blind, controlled clinical study to investigate the effectiveness of daily adjuvant use of Limosilactobacillus reuteri (Prodentis®-lozenges, DSM 17938, ATCC PTA 5289) versus control lozenges during the first three months of orthodontic treatment with fixed appliances. Following power analysis, a total of 34 adolescent patients (age 12-17) and 34 adult patients (18 years and older) undergoing orthodontic treatment at the University Hospital Erlangen will be assigned into 2 parallel groups using a randomization plan for each age group. The primary outcome measure is the change of the gingival index after 4 weeks. Secondary outcomes include the probing pocket depth, the modified plaque index, the composition of the oral microbiota, the local cytokine expression and-only for adults-serum cytokine levels and the frequencies of cells of the innate and adaptive immune system in peripheral blood. DISCUSSION: Preventive strategies in everyday orthodontic practice include oral hygiene instructions and regular dental cleaning. Innovative methods, like adjuvant use of oral probiotics, are missing. The aim of this study is to analyse, whether probiotics can improve clinical parameters, reduce inflammation and prevent dysbiosis of the oral microbiota during orthodontic treatment. If successful, this study will provide the basis for a new strategy of prophylaxis of oral dysbiosis-related diseases during treatment with fixed appliances. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov in two parts under the number NCT04598633 (Adolescents, registration date 10/22/2020), and NCT04606186 (Adults, registration date 10/28/2020).


Assuntos
Microbiota , Probióticos , Adolescente , Adulto , Criança , Citocinas , Disbiose , Humanos , Imunidade , Inflamação , Periodonto , Probióticos/uso terapêutico , Estudos Prospectivos , Ensaios Clínicos Controlados Aleatórios como Assunto
6.
J Plast Reconstr Aesthet Surg ; 75(2): 536-543, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34756655

RESUMO

BACKGROUND: Cinematic Rendering (CR) is a recently introduced post-processing three-dimensional (3D) visualization imaging tool. The aim of this study was to assess its clinical value in the preoperative planning of deep inferior epigastric artery perforator (DIEP) or muscle-sparing transverse rectus abdominis myocutaneous (MS-TRAM) flaps, and to compare it with maximum intensity projection (MIP) images. The study presents the first application of CR for perforator mapping prior to autologous breast reconstruction. METHODS: Two senior surgeons independently analyzed CR and MIP images based on computed tomography angiography (CTA) datasets of 20 patients in terms of vascular pedicle characteristics, the possibility to harvest a DIEP or MS-TRAM flap, and the side of the flap harvest. We calculated inter- and intra-observer agreement in order to examine the accordance of both image techniques. RESULTS: We observed a good inter- and intra-observer agreement concerning the type of flap and the side of the flap harvest. However, the agreement on the pedicle characteristics varies depending on the considered variable. Both investigators identified a significantly higher number of perforators with MIP compared with CR (observer 1, p<0.0001 and observer 2, p<0.0385). CONCLUSION: The current study serves as an explorative study, showing first experiences with CR in abdominal-based autologous breast reconstruction. In addition to MIP images, CR might improve the surgeon's understanding of the individual's anatomy. Future studies are required to compare CR with other 3D visualization tools and its possible effects on operative parameters.


Assuntos
Mamoplastia , Retalho Miocutâneo , Retalho Perfurante , Angiografia , Artérias Epigástricas/transplante , Humanos , Mamoplastia/métodos , Retalho Miocutâneo/transplante , Retalho Perfurante/irrigação sanguínea , Reto do Abdome/irrigação sanguínea , Estudos Retrospectivos
7.
BMC Psychiatry ; 21(1): 191, 2021 04 13.
Artigo em Inglês | MEDLINE | ID: mdl-33849487

RESUMO

BACKGROUND: Severe agitation and its relation to single dimensions of quality of life are not well understood. The aim of this study was to gain more knowledge about severe agitation and to examine the relationships between the severity of agitation and single dimensions of quality of life among residents with dementia living in German nursing homes. METHODS: This exploratory secondary analysis included data from 1947 residents of 66 German nursing homes from the DemenzMonitor study. The construct of agitation was defined as a composite score of the items agitation/aggression, irritability/lability and disinhibition from the Neuropsychiatric Inventory Questionnaire (NPI-Q); the resident was classified as severely agitated if at least one of these symptoms was rated as 'severe'. The single dimensions of quality of life were measured with the short version of the QUALIDEM instrument. To avoid selection bias, two controls with mild or no agitation were selected for each resident with severe agitation using propensity score matching. Mixed linear regression models were then generated to determine the differences in the dimensions of quality of life for the severity of agitation and the defining items. RESULTS: For four out of five dimensions of quality of life of the short version of QUALIDEM, residents with severe agitation had significantly lower values than residents without severe agitation. Converted to scale size, the greatest difference between both groups was found in the dimension social isolation with 23.0% (-2.07 (95% CI: -2.57, -1.57)). Further differences were found in the dimensions restless tense behaviour with 16.9% (-1.52 (95% CI: -2.04, -1.00)), positive affect with 14.0% (-1.68 (95% CI: -2.28, -1.09)) and social relations with 12.4% (-1.12 (95% CI: -1.54, -0.71)). CONCLUSIONS: Severe agitation is a relevant phenomenon among nursing home residents with dementia and is associated with lower values of quality of life in the dimensions social isolation, restless tense behaviour, positive affect and social relations from the QUALIDEM instrument. Therefore, more attention should be paid to severe agitation in nursing practice and research. Moreover, care strategies used to reduce severe agitation should be considered in terms of their impact on the dimensions of quality of life.


Assuntos
Demência , Qualidade de Vida , Agressão , Análise de Dados , Demência/complicações , Humanos , Casas de Saúde , Agitação Psicomotora
8.
BMC Health Serv Res ; 20(1): 788, 2020 Aug 25.
Artigo em Inglês | MEDLINE | ID: mdl-32838773

RESUMO

BACKGROUND: Caring for people with dementia at home requires considerable time, organization and commitment. Therefore, informal caregivers of people with dementia are often overburdened. This study examined the effects of the telephone-based Talking Time intervention, which is an approach used to strengthen the psychological health-related quality of life (HRQoL) and social support of informal caregivers of people with dementia living at home. METHODS: This study was a Medical Research Council framework phase two randomized controlled trial. The intervention consisted of a preliminary talk, information booklet, six structured telephone-based support group meetings and a structured written self-evaluation of each support group meeting. The control participants performed their usual individual self-organized care. After completing the data collection, the control group received the Talking Time intervention for fidelity reasons. The primary outcome was the self-rated psychological HRQoL of the informal caregivers, which was measured with the mental component summary of the General Health Survey Questionnaire Short Form 12 (SF-12). RESULTS: Thirty-eight informal caregivers and their relatives were included and allocated to the intervention or control groups (n = 19 each). After 3 months, the Talking Time intervention group demonstrated an increase in the self-rated psychological HRQoL scores, whereas the scores decreased in the control group. However, the standardized effect size of 1.65 (95% Confidence Interval, - 0.44 - 3.75) was not significant. Additionally, the secondary outcomes demonstrated no significant results. The differences between the groups in most outcomes were in the expected direction. No adverse effects were identified due to the intervention. CONCLUSIONS: The Talking Time intervention is feasible and shows nonsignificant promising results with regard to the self-rated psychological HRQoL. After further adjustment, the intervention needs to be evaluated in a full trial. TRIAL REGISTRATION: Clinical Trials: NCT02806583 , June 9, 2016 (retrospectively registered).


Assuntos
Fardo do Cuidador/prevenção & controle , Cuidadores/psicologia , Apoio Social , Telefone , Idoso , Cuidadores/estatística & dados numéricos , Demência/terapia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Qualidade de Vida/psicologia
9.
BMC Health Serv Res ; 20(1): 646, 2020 Jul 11.
Artigo em Inglês | MEDLINE | ID: mdl-32652983

RESUMO

BACKGROUND: Organizational health care research focuses on describing structures and processes in organizations and investigating their impact on the quality of health care. In the setting of residential long-term care, this effort includes the examination and description of structural differences among the organizations (e.g., nursing homes). The objective of the analysis is to develop an empirical typology of living units in nursing homes that differ in their structural characteristics. METHODS: Data from the DemenzMonitor Study were used. The DemenzMonitor is an observational study carried out in a convenience sample of 103 living units in 51 nursing homes spread over 11 German federal states. Characteristics of living units were measured by 19 variables related to staffing, work organization, building characteristics and meal preparation. Multiple correspondence analysis (MCA) and agglomerative hierarchical cluster analysis (AHC) are suitable to create a typology of living units. Both methods are multivariate and explorative. We present a comparison with a previous typology (created by a nonexplorative and nonmultivariate process) of the living units derived from the same data set. RESULTS: The MCA revealed differences among the living units, which are defined in particular by the size of the living unit (number of beds), the additional qualifications of the head nurse, the living concept and the presence of additional financing through a separate benefit agreement. We identified three types of living units; these clusters occur significantly with a certain combination of characteristics. In terms of content, the three clusters can be defined as: "house community", "dementia special care units" and "usual care". CONCLUSION: A typology is useful to gain a deeper understanding of the differences in the care structures of residential long-term care organizations. In addition, the study provides a practical recommendation on how to apply the results, enabling living units to be assigned to a certain type. The typology can be used as a reference for definitions.


Assuntos
Casas de Saúde/organização & administração , Análise de Dados , Alemanha , Pesquisa sobre Serviços de Saúde , Humanos , Análise Multivariada
10.
BMJ Open ; 10(1): e030268, 2020 01 07.
Artigo em Inglês | MEDLINE | ID: mdl-31915158

RESUMO

INTRODUCTION: Regardless of the healthcare setting, person-centred care and its implementation in caring for older people are a central issue for those who are responsible as professional caregivers and for those in need of care within the care process. Both aspects encompass the possibility of recognising personal preferences. To provide person-centred care, professional caregivers need to know about the individual preferences of the persons being cared for. Therefore, the PELI (an acronym for 'Preferences for Everyday Living Inventory') instrument was developed at the Polisher Research Institute (USA) for the systematic recording of individual preferences of older people in need of care. There is currently no comparable instrument available in the German language. METHODS: As part of the proposed project PELI-D, all versions of the original PELI instrument (nursing home version) were (1) culture-sensitively translated into German and will be (2) examined in a pilot study for their reliability, feasibility and practicability. For the project PELI-D, we worked together with our practice partners in Germany (Diaconia and Caritas in North Rhine-Westphalia) and collaborated with our partners in the USA who developed the PELI instrument. This study protocol focuses on the pilot study, which will be conducted by the German Center for Neurodegenerative Diseases (DZNE) (site Witten). ETHICS AND DISSEMINATION: This study was approved by the internal quality control committee of the DZNE (ID number: WI029 PELI-D) and by the ethics committee of the German Society of Nursing Science Duisburg branch office (ID number: 18-010). All personal information will be deidentified with a specific identification code and stored in a secured location apart from the rest of the study data. Only qualified and study-related staff will be allowed access to the data. The results of the study will be distributed nationally and internationally through peer-reviewed journals, conferences and journals for nursing care practice.


Assuntos
Atividades Cotidianas/psicologia , Competência Cultural , Preferência do Paciente , Assistência Centrada no Paciente/métodos , Inquéritos e Questionários , Idoso , Estudos de Viabilidade , Alemanha , Pesquisa sobre Serviços de Saúde , Serviços de Saúde para Idosos , Humanos , Casas de Saúde , Projetos Piloto , Traduções
11.
J Alzheimers Dis ; 66(4): 1463-1470, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30412491

RESUMO

BACKGROUND: The phenomena of severe agitation is not well understood and often not adequately treated. OBJECTIVE: This article determines the prevalence and associated factors of severe agitation in nursing home residents with dementia. METHODS: Secondary data analysis within an observational study in German nursing homes with n = 1,967 participants. We assessed severity of agitation with the Neuropsychiatric Inventory Questionnaire (NPI-Q) and defined the construct of agitation as a composite score of the NPI-Q items agitation/aggression, disinhibition, and irritability/lability; the dependent variable of severe agitation was considered as being present in residents who scored 'severe' in at least one of these symptoms. A binary logistic regression model was calculated to estimate associations. RESULTS: The prevalence of severe agitation was 6.3% (n = 124). The strongest associations were found for elation/euphoria (OR 7.6, CI 3.1-18.5), delusions (OR 7.3, CI 4.0-13.2), apathy/indifference (OR 2.8, CI 1.7-4.7), anxiety (OR 2.2, CI 1.2-3.8), nighttime behaviors (OR 2.4, CI 1.4-4.2), motor disturbances (OR 2.4, CI 1.4-4.1), and male sex (OR 2.4. CI 1.3-4.2). CONCLUSION: Severe agitation in nursing home residents with dementia is a relevant clinical issue as approximately 70% of residents have a dementia. Residents with elation/euphoria and delusions may have a stronger risk of showing severe agitation. We consider delusions as a possible cause of agitation and therefore a prelude to agitation. Although it might be possible that elation/euphoria follows from agitation, we hypothesize that the residents first experience elation/ euphoria and exhibit agitation afterwards.


Assuntos
Agressão , Demência/epidemiologia , Instituição de Longa Permanência para Idosos , Humor Irritável , Agitação Psicomotora/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Casas de Saúde , Prevalência
12.
JACC Cardiovasc Interv ; 11(10): 934-941, 2018 05 28.
Artigo em Inglês | MEDLINE | ID: mdl-29730375

RESUMO

OBJECTIVES: The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months. BACKGROUND: Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study. METHODS: The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments. RESULTS: The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p < 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group. CONCLUSIONS: Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Constrição Patológica , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recidiva , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
13.
J Endovasc Ther ; 24(4): 459-467, 2017 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28558502

RESUMO

PURPOSE: To evaluate the performance of the Ranger paclitaxel-coated balloon vs uncoated balloon angioplasty for femoropopliteal lesions. METHODS: Between January 2014 and October 2015, the prospective, randomized RANGER SFA study ( ClinicalTrials.gov identifier NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2-4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68±8 years; 53 men) were enrolled in the Ranger drug-coated balloon (DCB) arm and 34 patients (mean age 67±9 years; 23 men) were assigned to the control group. Six-month analysis included angiographic late lumen loss and safety and clinical outcomes assessments. RESULTS: Baseline characteristics of the DCB and control groups were similar, as were lesion lengths (68±46 vs 60±48 mm; p=0.731), severity of calcification (p=0.236), and the prevalence of occlusions (34% vs 34%; p>0.999). At 6 months, late lumen loss was significantly less for the DCB group vs controls (-0.16±0.99 vs 0.76±1.4; p=0.002). The DCB group had significantly greater freedom from binary restenosis (92% vs 64%; p=0.005) and primary patency rates (87% vs 60%; p=0.014). Target lesion revascularization rates were 5.6% in the DCB group and 12% in the control group (p=0.475). No target limb amputations or device-related deaths occurred in either group. CONCLUSION: Six-month results suggest that Ranger DCB treatment effectively inhibited restenosis in symptomatic femoropopliteal disease, resulting in improved vessel patency and a low revascularization rate in the short term compared with uncoated balloon angioplasty.


Assuntos
Angioplastia com Balão/instrumentação , Fármacos Cardiovasculares/administração & dosagem , Materiais Revestidos Biocompatíveis , Artéria Femoral , Paclitaxel/administração & dosagem , Doença Arterial Periférica/terapia , Artéria Poplítea , Dispositivos de Acesso Vascular , Idoso , Angioplastia com Balão/efeitos adversos , Fármacos Cardiovasculares/efeitos adversos , Desenho de Equipamento , Europa (Continente) , Feminino , Artéria Femoral/diagnóstico por imagem , Artéria Femoral/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Paclitaxel/efeitos adversos , Doença Arterial Periférica/diagnóstico por imagem , Doença Arterial Periférica/fisiopatologia , Artéria Poplítea/diagnóstico por imagem , Artéria Poplítea/fisiopatologia , Estudos Prospectivos , Recidiva , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular
14.
Biomed Res Int ; 2015: 569052, 2015.
Artigo em Inglês | MEDLINE | ID: mdl-26568958

RESUMO

PURPOSE: Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study "RESET Real Life" was commissioned by ANM GmbH. Herein we present the results of this study. METHODS: In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder). RESULTS: Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy. CONCLUSION: The field study "RESET Real Life" provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.


Assuntos
Estimulação Acústica/métodos , Zumbido/diagnóstico , Zumbido/terapia , Doença Crônica , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
15.
Chronobiol Int ; 28(10): 949-57, 2011 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-22080740

RESUMO

Suicide rate follows a seasonal pattern that is related to rising air temperature and global radiation. These findings are reproducible within different climatic regions. Numerous studies have attempted to explain this peak in relation to weather. However, many of these studies did not use meteorological data representative of the site of the suicide or attempted suicide, resulting in limitations of the findings. Previous studies also suffered from limitations in the methods of data analysis. The current study examined the relationship between weather, i.e., solar radiation, air temperature, and the rate of suicides and suicidality in the area of Mittelfranken, Germany, using regional meteorological data. Statistical risk estimation revealed associations between higher global radiation and air temperatures on the day of and day before suicide acts. The results could be of interest for general suicide prevention strategies. Future studies should examine additional possible factors of influence and concentrate on a strict standardized study design. The aim is to obtain reproducible data of the seasonal influences on suicide behavior, allowing for the comparison of data from different meteorological regions and patient subgroups.


Assuntos
Ideação Suicida , Suicídio/estatística & dados numéricos , Meio Ambiente , Alemanha/epidemiologia , Humanos , Estações do Ano , Luz Solar , Temperatura
16.
Compr Psychiatry ; 50(6): 573-7, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19840597

RESUMO

OBJECTIVE: The hypothesis of a lunar influence on human abnormal behavior is still widespread, although research has led to conflicting findings. Therefore, a population-based study to assess the influence of lunar phases on violent crimes was conducted. METHODS: The study included all serious crimes of battery (aggravated assaults) committed in Middle Franconia (Bavaria, Germany) between 1999 and 2005 (n = 23 142). Data were analyzed regarding lunar phase, sex, and place of crime scene (outdoor vs indoor). RESULTS: No significant associations between full, absent, and the moon's interphases and serious crimes of battery could be detected. Furthermore, a Fourier analysis was conducted that failed to produce an association between violence and the moon's phases. DISCUSSION: Several possible explanations for the presented results are discussed including biological and social mechanisms. CONCLUSIONS: The present study fails to find a significant association between lunar phases and crimes of battery.


Assuntos
Lua , Violência/psicologia , Adulto , Distribuição de Qui-Quadrado , Feminino , Análise de Fourier , Alemanha , Humanos , Masculino , Estações do Ano , Violência/estatística & dados numéricos
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