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BACKGROUND: Although research on the mechanism and control of pain and inflammation in fish has increased in recent years, the use of analgesic drugs is limited due to the lack of pharmacological information about analgesic drugs. Tolfenamic acid is a non-steroidal anti-inflammatory drug and can be used in fish due to its low side effect profile and superior pharmacokinetic properties. OBJECTIVES: The pharmacokinetics, bioavailability and plasma protein binding of tolfenamic acid were investigated following single intravascular (IV), intramuscular (IM) and oral administration of 2 mg/kg in rainbow trout at 13 ± 0.5°C. METHODS: The experiment was carried out on a total of 234 rainbow trout (Oncorhynchus mykiss). Tolfenamic acid was administered to fish via IV, IM and oral route at a dose of 2 mg/kg. Blood samples were taken at 13 different sampling times until the 72 h after drug administration. The plasma concentrations of tolfenamic acid were quantified using high pressure liquid chromatography-ultraviolet (UV) and pharmacokinetic parameters were assessed using non-compartmental analysis. RESULTS: The elimination half-life (t1/2Êz) of tolfenamic acid for IV, IM and oral routes was 3.47, 6.75 and 9.19 h, respectively. For the IV route, the volume of distribution at a steady state and total body clearance of tolfenamic acid were 0.09 L/kg and 0.03 L/h/kg, respectively. The peak plasma concentration and bioavailability for IM and oral administration were 8.82 and 1.24 µg/mL, and 78.45% and 21.48%, respectively. The mean plasma protein binding ratio of tolfenamic acid in rainbow trout was 99.48% and was not concentration dependent. CONCLUSIONS: While IM route, which exhibits both the high plasma concentration and bioavailability, can be used in rainbow trout, oral route is not recommended due to low plasma concentration and bioavailability. However, there is a need to demonstrate the pharmacodynamic activity of tolfenamic acid in rainbow trout.
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Anti-Inflamatórios não Esteroides , Disponibilidade Biológica , Proteínas Sanguíneas , Oncorhynchus mykiss , ortoaminobenzoatos , Animais , Oncorhynchus mykiss/metabolismo , Oncorhynchus mykiss/sangue , ortoaminobenzoatos/farmacocinética , ortoaminobenzoatos/sangue , Anti-Inflamatórios não Esteroides/farmacocinética , Anti-Inflamatórios não Esteroides/sangue , Administração Oral , Proteínas Sanguíneas/metabolismo , Injeções Intramusculares/veterinária , Ligação Proteica , Injeções Intravenosas/veterinária , Meia-VidaRESUMO
BACKGROUND AND AIM: Autologous haematopoietic stem cell transplantation [AHSCT] is a therapeutic option for refractory Crohn's disease [CD]. However, high adverse event rates related to chemotherapy toxicity and immunosuppression limit its applicability. This study aims to evaluate AHSCT's safety and efficacy using a cyclophosphamide (Cy)-free mobilisation regimen. METHODS: A prospective observational study included 14 refractory CD patients undergoing AHSCT between June 2017 and October 2022. The protocol involved outpatient mobilisation with G-CSF 12-16 µg/kg/daily for 5 days, and optional Plerixafor 240 µg/d (1-2 doses) if the CD34+ cell count target was unmet. Standard conditioning with Cy and anti-thymocyte globulin was administered. Clinical, endoscopic, and radiological assessments were conducted at baseline and during follow-up. RESULTS: All patients achieved successful outpatient mobilisation (7 patients needed Plerixafor) and underwent transplantation. Median follow-up was 106 weeks (IQR 52-348). No mobilisation-related serious adverse events (SAEs) or CD worsening occurred. Clinical and endoscopic remission rates were 71% and 41.7% at 26 weeks, 64% and 25% at 52 weeks, and 71% and 16.7% at the last follow-up. The percentage of patients who restarted CD therapy for clinical relapse and/or endoscopic/radiological activity was 14% at 26 weeks, 57% at 52 weeks, and 86% at the last follow-up. Peripheral blood cell populations and antibody levels post-AHSCT were comparable to Cy-based mobilisation. CONCLUSIONS: Cy-free mobilisation is safe and feasible in refractory CD patients undergoing AHSCT. Although relapse occurs in a significant proportion of patients, clinical and endoscopic responses are achieved upon CD-specific therapy reintroduction.
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Liposarcomas, malignant adipocytic tumors, primarily manifest in the lower extremities and retroperitoneum, with a strikingly low incidence in the head and neck region. Symptomatology typically remains absent until the tumor attains significant size, leading to cosmetic concerns or compression-related complications. This report presents a unique case of well-differentiated retropharyngeal liposarcoma in an 81-year-old male, emphasizing diagnostic challenges, management strategies, and the crucial role of Mouse double minute 2 (MDM2) fluorescence in situ hybridization (FISH) analysis in confirmation. The patient exhibited dysphagia attributed to a retropharyngeal mass, prompting suspicion of malignancy. Diagnostic assessments, including flexible laryngoscopy and percutaneous tru-cut biopsy, highlighted unique features such as atypical nuclear features in adipocytes. MDM2 FISH analysis definitively confirmed the diagnosis by detecting MDM2 gene amplification. The rarity of retropharyngeal liposarcomas complicates diagnosis, often leading to confusion with benign lesions. Surgical excision, the mainstay of treatment, varies based on tumor size and extension. In this case, a left neck dissection via a hockey stick incision successfully resected a 17 cm well-differentiated liposarcoma. Pathologic analysis revealed focal involvement of resection margins, with no complications or vocal cord damage. In conclusion, retropharyngeal liposarcomas pose diagnostic challenges, warranting reliance on MDM2 FISH analysis for accurate confirmation. Early surgical intervention, guided by tumor size and extension, is paramount for optimal outcomes in managing these rare tumors. This case underscores the significance of a detailed surgical approach in achieving successful outcomes for retropharyngeal liposarcomas.
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Rhodococcus equi is responsible for foal pneumonia worldwide, with a significant economic impact on the production and breeding of horses. In Chile, the first case was reported in 2000, and since then, its incidence has been increasing. Distinctive characteristics of R. equi as an intracellular pathogen in macrophages, emergence of virulence plasmids encoding surface lipoprotein antigens, and appearance of antibiotic resistance against macrolides and rifampicin have significantly complicated the treatment of R. equi pneumonia in foals. Therefore, in vitro susceptibility studies of first-line and newer antibiotics against R. equi are the first step to establishing effective treatments and optimizing new therapeutic options. The aim of the present study is to determine the susceptibility profile of fourteen strains of R. equi isolated from foals in Chile to several antibiotics of the macrolide group including azithromycin, amikacin, tildipirosin and gamithromycin as well as others such as rifampicin, doxycycline and ceftiofur. Identification of R. equi in collected isolates from foals in Chile has been performed by CAMP test and PCR based on detecting of the gene encoding the 16 S rRNA. The presence of genes encoding virulence plasmids was also determined using PCR. Results obtained have demonstrated presence of virulent R. equi strains in Chile. In vitro susceptibility pattern to different antibiotics has shown better results for doxycycline and rifampicin similar to previous studies performed. Current macrolides have been evaluated in order to consider alternative treatment options in a context of emerging resistance to classic macrolides and rifampicin, obtaining better results with gamithromycin (MIC range of 0.125 to 128 mg/ml) than with tildipirosin (MIC range of 16 to 128 mg/ml). An adequate diagnosis of bacterial susceptibility based on antibiograms is necessary to treat the Rhodococcus equi infection in foals.
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Rhodococcus equi , Rifampina , Cavalos , Animais , Rifampina/farmacologia , Doxiciclina , Rhodococcus equi/genética , Chile , Macrolídeos , Antibacterianos/farmacologiaRESUMO
The assessment of the mechanical power production is of great importance for researchers and practitioners. The purpose of this review was to compare the differences in ground reaction force (GRF), kinematic, and combined (bar velocity x GRF) methods to assess mechanical power production during weightlifting exercises. A search of electronic databases was conducted to identify all publications up to 31 May 2019. The peak power output (PPO) was selected as the key variable. The exercises included in this review were clean variations, which includes the hang power clean (HPC), power clean (PC) and clean. A total of 26 articles met the inclusion criteria with 53.9% using the GRF, 38.5% combined, and 30.8% the kinematic method. Articles were evaluated and descriptively analysed to enable comparison between methods. The three methods have inherent methodological differences in the data analysis and measurement systems, which suggests that these methods should not be used interchangeably to assess PPO in Watts during weightlifting exercises. In addition, this review provides evidence and rationale for the use of the GRF to assess power production applied to the system mass while the kinematic method may be more appropriate when looking to assess only the power applied to the barbell.
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Músculo Esquelético , Levantamento de Peso , Humanos , Fenômenos Biomecânicos , Exercício Físico , Força MuscularRESUMO
Mastitis is a significant disease in dairy ruminants, causing economic losses to the livestock industry and severe risks to public health. Antibiotic therapy is one of the most crucial practices to treat mastitis, although the susceptibility of caprine mastitis pathogens to current antibiotics has not been tested under standard or modified incubation conditions. This work evaluated the in vitro activity of tildipirosin, gamithromycin, oxytetracycline, and danofloxacin against caprine mastitis pathogens incubated following standard conditions of Clinical and Laboratory Standards Institute (CLSI) and deviation method by 25% supplementation with goat serum. Mycoplasma agalactiae, Escherichia coli, Staphylococcus aureus, Streptococcus spp., and coagulase-negative Staphylococci (CNS) were isolated from dairy goats with mastitis in Spain. Minimum inhibitory concentrations (MICs) were determined using the broth microdilution technique. The lowest MIC90 under standard conditions was obtained with danofloxacin for mastitis-causing pathogens. An exception was M. agalactiae, where danofloxacin and oxytetracycline obtained low values. However, after adding serum, gamithromycin showed the lowest MIC50 for S. aureus, Streptococcus spp., and CNS. The lowest MIC50 was obtained with all the antibiotics tested (< 0.125 µg/ml) against M. agalactiae. Supplementing with serum resulted in a significant variation in tildipirosin and gamithromycin MIC values for CNS, S. aureus, M. agalagtiae, and E. coli. In brief, the MIC for antibiotics used against mastitis should be determined under conditions closely resembling intramammary infections to obtain representative susceptibility patterns against mastitis pathogens. Caprine mastitis pathogens were broadly susceptible to danofloxacin under standard conditions. The potency of macrolides against caprine mastitis pathogens increases when serum is present in culture media.
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Mastite Bovina , Oxitetraciclina , Animais , Antibacterianos/farmacologia , Bovinos , Escherichia coli , Feminino , Fluoroquinolonas , Cabras , Humanos , Macrolídeos , Mastite Bovina/tratamento farmacológico , Oxitetraciclina/farmacologia , Oxitetraciclina/uso terapêutico , Staphylococcus , Staphylococcus aureus , Streptococcus , Tilosina/análogos & derivados , Tilosina/farmacologia , Tilosina/uso terapêuticoRESUMO
Tildipirosin is a novel semisynthetic macrolide antibiotic exclusively used in veterinary practice to treat respiratory infections. There are no pharmacokinetic or safety information available regarding the use of tildipirosin after intramuscular administration in horses. Thus, the objective of this work was to determine the disposition kinetics of tildipirosin after intravenous (IV) and intramuscular (IM) administration in horses and its potential muscle damage and cardiotoxicity. Six mature, Spanish-breed horses were used in a crossover study with a washout period of 30 days. Tildipirosin (18%) was administered at single doses by IV (2 mg/kg) and IM (4 mg/kg) routes. Tildipirosin plasma concentrations were determined by HPLC assay with ultraviolet detection. Muscle damage and inflammation were assessed by creatine kinase (CK) and haptoglobin (Hp), respectively. Creatine kinase myocardial band (CK-MB) and troponin (Tn) were used to evaluate cardiotoxicity. Tildipirosin in horses reached peak concentrations (Cmax = 1.13 µg/mL) at 0.60 h (tmax) after IM administration with an absolute bioavailability of 109.2%. Steady-state volume of distribution and clearance were 3.31 ± 0.57 L/kg and 0.22 ± 0.02 L/h/kg, respectively. Tildipirosin did not cause cardiotoxicity since CK-MB and Tn basal levels were not significantly different from those obtained after several days post-administration. Mild local reactions were observed after IM administration. This local inflammation was associated with mild myolysis (CK 239-837 UI/L), which was detectable for 48 h. In brief, tildipirosin could help to treat respiratory infections in horses because it showed extensive distribution, high bioavailability and did not provoke general adverse reactions.
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Doenças dos Cavalos , Inflamação , Infecções Respiratórias , Cavalos , Animais , Estudos Cross-Over , Cardiotoxicidade/tratamento farmacológico , Cardiotoxicidade/etiologia , Cardiotoxicidade/veterinária , Injeções Intravenosas/veterinária , Injeções Intramusculares/veterinária , Área Sob a Curva , Creatina Quinase , Disponibilidade Biológica , Músculos/metabolismo , Infecções Respiratórias/tratamento farmacológico , Infecções Respiratórias/veterinária , Inflamação/tratamento farmacológico , Inflamação/veterinária , Meia-Vida , Doenças dos Cavalos/tratamento farmacológico , Doenças dos Cavalos/etiologiaRESUMO
Tylvalosin (TV) is a macrolide antibiotic that is used for treating respiratory and enteric bacterial infections in swine and in poultry. In the coming years, the use of this drug will probably be widely studied in different species, but before its use in each veterinary species, macrolide analytical determination in various biological fluids is a pre-requisite step for the rational dose calculation of TV based on specific pharmacokinetic information. Its quantification is essential for detecting and avoiding the appearance of residues in animal products intended for human consumption. Therefore, a robust chromatographic method coupled with an ultraviolet detector was fully validated for the quantification of TV in pig plasma. A mixture (78:22) of (A) 0.3% formic acid in water and (B) acetonitrile was used as the mobile phase. TV and enrofloxacin (internal standard) were eluted at 14.1 and 5.9 min, respectively. Calibration curves ranged from 0.1 to 5 µg/mL. The accuracy and precision parameters for the quality controls were always <13.0%. Recovery ranged from 89.66 to 96.92%. The detection and quantification limits were found to be 0.05 µg/mL and 0.1 µg/mL, respectively. This method could be applied to develop pharmacokinetic studies.
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Tildipirosin is a macrolide currently authorized for treating respiratory diseases in cattle and swine. The disposition kinetics of tildipirosin in plasma, milk, and somatic cells were investigated in dairy goats. Tildipirosin was administered at a single dose of 2 mg/kg by intravenous (IV) and 4 mg/kg by intramuscular (IM) and subcutaneous (SC) routes. Concentrations of tildipirosin were determined by an HPLC method with UV detection. Pharmacokinetic parameters were estimated by non-compartmental analysis. Muscle damage, cardiotoxicity, and inflammation were evaluated. After IV administration, the apparent volume of distribution in the steady state was 7.2 L/kg and clearance 0.64 L/h/kg. Plasma and milk half-lives were 6.2 and 58.3 h, respectively, indicating nine times longer persistence of tildipirosin in milk than in plasma. Moreover, if somatic cells are considered, persistence and exposure measured by the area under concentration-time curve (AUC) significantly exceeded those obtained in plasma. Similarly, longer half-lives in whole milk and somatic cells compared to plasma were observed after IM and SC administration. No adverse effects were observed. In brief, tildipirosin should be reserved for cases where other suitable antibiotics have been unsuccessful, discarding milk production of treated animals for at least 45 days or treating goats at the dry-off period.
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OBJECTIVES: The purpose of this study was to determine the effects of short-term lumbopelvic stability training on muscular endurance and stability in elite female cyclists. METHODS: Twenty-four female road cyclists were randomly allocated to a core training group (CTG, n=12) or control group (CG, n=12). In addition to their scheduled training the CTG performed a core training program, that consisted of 6 core exercises performed in a session every other day until a total of 8 training sessions were completed. The CG did not receive the core training program and completed their scheduled training. The lumbopelvic-hip complex was assessed pre- and post-core program included the following exercises: single leg deadlift (SLD), bird-dog (BD), plank test (PT), and side-bridge plank test (SPT). RESULTS: In comparison to CG, CTG significantly improved the time to failure in PT, SPT-Left, and SPT-Right (p<0.05). Further, CTG resulted in a significant decrease in SLD (p<0.05) compared to CG for the three accelerometry measures. CONCLUSION: The present results indicate that following 8 sessions of lumbopelvic stability training muscular endurance and core stability were enhanced.
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Ciclismo , Teste de Esforço , Terapia por Exercício , Estabilidade Central , Terapia por Exercício/métodos , Feminino , HumanosRESUMO
BACKGROUND: The single leg squat (SLS) test is a clinical functional test commonly used to evaluate clinically aberrant movement patterns of the knee. The SLS could be an interesting option to analyze ankle control in the frontal plane during dynamic load analysis. However, to date, there are no studies that have analyzed the associations between the increased subtalar joint pronation by navicular drop (ND) test and ankle control with single leg squat (SLSankle) using a three-point scale. The purpose of this study was to evaluate the reliability of a clinical observation method to assess and determine the relationship between navicular drop (ND) and ankle control on the SLSankle score. METHODS: A total of fifty-five healthy, physically active (31 females and 24 males) volunteers participated in this study. The degree of subtalar pronation was assessed through the ND test, and the ankle control was defined as the ankle displacement in the frontal plane during the SLS. RESULTS: We found good intra-rater and inter-rater agreement during SLSankle, with Kappa values from 0.731 to 0.750. The relationship between the SLSankle and ND was significant ; the Spearman's rank correlation coefficient was 0.504 (p < 0.05). CONCLUSIONS: The SLSankle score supplied the clinical practice with a reliable and valid alternative for quantifying foot mobility in comparison to the ND test.
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Tornozelo , Perna (Membro) , Masculino , Feminino , Humanos , Reprodutibilidade dos Testes , Extremidade Inferior , Articulação do TornozeloRESUMO
Delafloxacin is a novel fluoroquinolone antibiotic that was approved by the European Medicine Agency to treat bacterial infections of the skin and underlying tissues, and community-acquired pneumonia. Despite being in the market since 2019 in the European Union, there is no published liquid chromatography-fluorescence method for delafloxacin quantification in biological samples. A novel, rapid, and sensitive high-performance liquid chromatographic method was developed to determine delafloxacin in human plasma using its native fluorescence. Plasma delafloxacin concentrations were determined by reverse-phase chromatography with fluorescence detection at 405/450 nm of excitation/emission wavelengths. Delafloxacin was separated on a Kromasil C18 column 250 × 4.6 mm id, 5 µm using isocratic elution. The mobile phase was a mixture of 0.05% trifluoroacetic acid/acetonitrile (52/48). Retention times were 5.4 and 11.6 min for delafloxacin and valsartan (internal standard), respectively. Regression calibration curves were linear over the range of 0.1-2.5 µg/mL. The lower limit of detection was 0.05 µg/mL, and the lower limit of quantification was 0.1 µg/mL. Accuracy and precision were always <11%, and the limit of quantification was <16%. Mean recovery was 98.3%. This method can be applied to determine delafloxacin in human plasma and could be useful to perform pharmacokinetic studies.
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Cromatografia de Fase Reversa , Fluoroquinolonas , Cromatografia Líquida de Alta Pressão/métodos , Cromatografia Líquida , Cromatografia de Fase Reversa/métodos , Humanos , Reprodutibilidade dos Testes , Sensibilidade e EspecificidadeRESUMO
Antimicrobial drug resistance is an important problem that challenges veterinary clinicians to provide effective treatments without further spreading resistance to other animals and people. The most commonly used pharmacodynamic parameter to define potency of antimicrobial drugs is minimum inhibitory concentration (MIC). The aim of this study was to evaluate the antibiotic susceptibility of thirty-six strains of Staphylococcus aureus isolated from dairy goats with mastitis and rabbits with chronic staphylococcosis. Four cephalosporins were tested: cephalexin, cephalotin, cefonicid and ceftiofur. MIC tests were performed according to the microdilution broth method. The calculated values of sensitivity in goats and rabbits were 66.67% and 72.22% for cephalexin, 72.22 % and 94.44% for cefonicid, 77.78% and 94.44% for cephalotin and 77.78% and 100% for ceftiofur, respectively. For all antibiotics, MIC90 of S. aureus from rabbits were lower than MIC90 from goats. These data suggest that more antibiotics are used in goat milk production than in rabbit farming. According to MIC values obtained in this study, ceftiofur and cephalotin may be the best option for treating S. aureus infections in lactating goats. For rabbits, ceftiofur showed lowest MIC values, therefore, it could be an alternative to treatment the infections caused by S. aureus in this species.
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Doenças das Cabras , Infecções Estafilocócicas , Animais , Feminino , Coelhos , Staphylococcus aureus , Fazendas , Cefonicida , Cabras , Espanha , Lactação , Cefalosporinas , Monobactamas , Infecções Estafilocócicas/veterinária , Cefalotina , Cefalexina , AntibacterianosRESUMO
ABSTRACT: Soriano, MA, García-Ramos, A, Calderbank, J, Marín, PJ, Sainz de Baranda, P, and Comfort, P. Does sex impact the differences and relationships in the one repetition maximum performance across weightlifting overhead pressing exercises? J Strength Cond 36(7): 1930-1935, 2022-This study aimed to determine the impact of sex on the differences and relationships of the one repetition maximum (1RM) performance between 3 overhead pressing exercises (push press [PP], push jerk [PJ] and split jerk [SJ]). 15 men (body mass [BM]: 82.3 ± 9.9 kg; weightlifting training experience: 2.6 ± 1.6 years) and 15 women (BM: 64.4 ± 7.0 kg; weightlifting training experience: 2.2 ± 1.4 years) participated in this study. A ratio-scaled (1RM·BM-1) was used for the comparison between them. The 1RM of the 3 exercises were evaluated within the same testing session using a combined 1RM assessment method. The interaction effect of exercise and sex did not reach statistical significance (p = 0.671; η2 = 0.001). In contrast, there were significant main effects of exercise (p ≤ 0.01) and sex (p < 0.001) with medium (η2 = 0.096) and large effect sizes (η2 = 0.306), respectively. A similar main effect of exercise was reported for both men (PP [1.0 ± 0.1 kg·kg-1] < PJ [1.1 ± 0.2 kg·kg-1] â¼ SJ [1.2 ± 0.2 kg·kg-1]) and women (PP [0.8 ± 0.1 kg·kg-1] < PJ [0.9 ± 0.2 kg·kg-1] â¼ SJ [0.9 ± 0.2 kg·kg-1]). The 1RM performance of the 3 exercises was significantly correlated for men (r [range] = 0.856-0.963) and women (r [range] = 0.636-0.925). Sex does not affect the differences in the 1RM performance across weightlifting overhead pressing exercises. However, stronger correlations and lower variation in the 1RM performance during the PP, PJ, and SJ are expected for men compared with women.
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Força Muscular , Treinamento Resistido , Exercício Físico , Feminino , Humanos , Masculino , Músculo Esquelético , Treinamento Resistido/métodos , Levantamento de PesoRESUMO
OBJECTIVES: The purpose of the present study is to assess the effects of an intense cycling training session on the stability of the lumbopelvic-hip complex through two dynamic exercise tests - the single-leg-deadlift (SLD) and a variation of the bird-modified dog (BD), via the OCTOcore application. METHODS: Thirty-one elite female road cyclists were self-evaluated with their own smartphones, before and immediately after finishing their training sessions. Right, left and composite were measured for each exercise test. RESULTS: There was a significant time effect on performance for both the SLB and BD tests (p<0.05; η2=0.137), and the SLD and BD tests were increased with respect to the pre-test at 15% and 17%, respectively. CONCLUSION: An intense cycling training session produced significant alterations in lumbopelvic behavior in the elite female cyclists. The OCTOcore application demonstrated that it was a sensitive tool in detecting these changes and it could easily be used by the cyclists themselves.
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Ciclismo , Teste de Esforço , Animais , Cães , FemininoRESUMO
Whole-body vibration (WBV) is an exercise modality or treatment/prophylaxis method in which subjects (humans, animals, or cells) are exposed to mechanical vibrations through a vibrating platform or device. The vibrations are defined by their direction, frequency, magnitude, duration, and the number of daily bouts. Subjects can be exposed while performing exercises, hold postures, sitting, or lying down. Worldwide, WBV has attracted significant attention, and the number of studies is rising. To interpret, compare, and aggregate studies, the correct, complete, and consistent reporting of WBV-specific data (WBV parameters) is critical. Specific reporting guidelines aid in accomplishing this goal. There was a need to expand existing guidelines because of continuous developments in the field of WBV research, including but not limited to new outcome measures regarding brain function and cognition, modified designs of WBV platforms and attachments (e.g., mounting a chair on a platform), and comparisons of animal and cell culture studies with human studies. Based on Delphi studies among experts and using EQUATOR recommendations, we have developed extended reporting guidelines with checklists for human and animal/cell culture research, including information on devices, vibrations, administration, general protocol, and subjects. In addition, we provide explanations and examples of how to report. These new reporting guidelines are specific to WBV variables and do not target research designs in general. Researchers are encouraged to use the new WBV guidelines in addition to general design-specific guidelines.
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BACKGROUND: Chronic lower limb ischemia develops earlier and more frequently in patients with type 2 diabetes mellitus. Diabetes remains the main cause of lower-extremity non-traumatic amputations. Current medical treatment, based on antiplatelet therapy and statins, has demonstrated deficient improvement of the disease. In recent years, research has shown that it is possible to improve tissue perfusion through therapeutic angiogenesis. Both in animal models and humans, it has been shown that cell therapy can induce therapeutic angiogenesis, making mesenchymal stromal cell-based therapy one of the most promising therapeutic alternatives. The aim of this study is to evaluate the feasibility, safety, and efficacy of cell therapy based on mesenchymal stromal cells derived from adipose tissue intramuscular administration to patients with type 2 diabetes mellitus with critical limb ischemia and without possibility of revascularization. METHODS: A multicenter, randomized double-blind, placebo-controlled trial has been designed. Ninety eligible patients will be randomly assigned at a ratio 1:1:1 to one of the following: control group (n = 30), low-cell dose treatment group (n = 30), and high-cell dose treatment group (n = 30). Treatment will be administered in a single-dose way and patients will be followed for 12 months. Primary outcome (safety) will be evaluated by measuring the rate of adverse events within the study period. Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. Tertiary outcome (quality of life) will be evaluated with SF-12 and VascuQol-6 scales. DISCUSSION: Chronic lower limb ischemia has limited therapeutic options and constitutes a public health problem in both developed and underdeveloped countries. Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. TRIAL REGISTRATION: ClinicalTrials.gov NCT04466007 . Registered on January 07, 2020. All items from the World Health Organization Trial Registration Data Set are included within the body of the protocol.
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COVID-19 , Diabetes Mellitus Tipo 2 , Transplante de Células-Tronco Hematopoéticas , Células-Tronco Mesenquimais , Noma , Tecido Adiposo , Animais , Ensaios Clínicos Fase II como Assunto , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/diagnóstico , Diabetes Mellitus Tipo 2/terapia , Método Duplo-Cego , Humanos , Isquemia/diagnóstico , Isquemia/terapia , Estudos Multicêntricos como Assunto , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , SARS-CoV-2 , Resultado do TratamentoRESUMO
Since 1948, the World Health Organization has been publishing the International Statistical Classification of Diseases and Related Health Problems (ICD), a coded system of causes of disease and death with an in-depth revision every 10-15 years. In its latest revision, the ICD-11 uses nomenclature characterizing old age as "initial and final geriatric periods," implying the medicalization of this stage of life, which has created confusion and sparked controversy. This article discusses the new nomenclature proposed, given the current knowledge about old age and the aging process and its most accepted definition. The ICD not only classifies diseases but periods of life and "health-related problems," and old age per se is not a health-related problem for many people at this stage of life. It is therefore essential to change or provide a more nuanced definition of the term "old age" in the ICD-11, so it is not perceived as a symptom, sign, or anomalous clinical outcome, and to introduce nomenclature that more accurately reflects pathological aging. Two terms that are enjoying growing experimental and bibliographic support are "fragility" and "loss of intrinsic capacity," which offer greater precision when defining the condition of a person who is not experiencing healthy aging.
Desde 1948, a Organização Mundial da Saúde publica um sistema codificado de causas de doença e morte sob o nome de Classificação Estatística Internacional de Doenças e Problemas Relacionados à Saúde (CID), com revisões profundas a cada 10-15 anos. Sua última versão, a CID-11, utiliza determinada terminologia para caracterizar a velhice como "períodos geriátricos iniciais e finais", o que implica uma medicalização dessa fase da vida que tem gerado confusão e polêmica. Este artigo discute a nova terminologia proposta à luz dos conhecimentos atuais sobre a velhice e o processo de envelhecimento, e sua definição mais aceita. A CID não classifica apenas as doenças, mas também períodos da vida e "problemas de saúde", sendo que a velhice por si só não representa um problema de saúde para muitos que se encontram nesta fase da vida. A partir dessa perspectiva, é imprescindível alterar ou qualificar o verbete "velhice" da CID-11 para que não seja percebido como sintoma, sinal ou resultado clínico anormal, e em seu lugar introduzir termos que melhor reflitam o estado de envelhecimento patológico. Entre os termos que têm crescente suporte experimental e bibliográfico estão "fragilidade" e "perda de capacidade intrínseca", que proporcionam uma precisão muito maior na definição da condição de quem não goza de um envelhecimento saudável.
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Core stability (CS) deficits can have a significant impact on lower limb function. The aim of this study was to investigate the relationship between two dynamic core exercise assessments and dynamic knee valgus during single-leg squats. In total, 20 physically active female students participated in this study. The OCTOcore smartphone application assesses CS during two dynamic exercise tests, the partial range single-leg deadlift (SLD) test and the bird-dog (BD) test. A two-dimensional assessment of a single-leg squat test was used to quantify participants' hip frontal angle (HFASLS) and knee frontal plane projection angle (FPPASLS). Ankle dorsiflexion was evaluated through the weight-bearing dorsiflexion test. The correlational analyses indicated that the HFASLS was significantly related to the partial range single-leg deadlift test (r = 0.314, p < 0.05) and ankle dorsiflexion (r = 0.322, p < 0.05). The results showed a significant difference (p < 0.05) in the CS test between cases categorised as dynamic knee valgus (>10°) and normal (≤10°). The CS deficit may influence the neuromuscular control of the lumbopelvic-hip complex during single-leg movements. The link between CS and kinematic factors related to knee injuries was only observed when CS was measured in the SLD test but not in the BD test.