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1.
BMC Infect Dis ; 20(1): 830, 2020 Nov 11.
Artículo en Inglés | MEDLINE | ID: mdl-33176700

RESUMEN

BACKGROUND: HIV self-testing (HIVST) can be performed using directly assisted and unassisted approaches in facilities or communities to reach different populations. The aim of this study was to compare the practicability and effectiveness of the two delivery approaches for HIVST, unassisted HIVST (UH) and directly assisted HIVST (DAH), in the field setting of Kisangani, the Democratic Republic of the Congo (DRC). METHODS: A randomized (1:1), non-blinded, non-inferiority trial using a blood-based and facility-based HIVST method was carried out in four facilities in Kisangani, the DRC, targeting populations at high risk for HIV infection. The primary outcome was the difference in the practicability of the HIV self-test between the two arms. Practicability was defined as successfully performing the test and correctly interpreting the result. Requests for assistance, positivity rate, linkage to care, and willingness to buy an HIV self-test kit constituted the secondary outcomes for HIVST effectiveness. The adjusted risk ratios (aRRs) were calculated using Poisson regression. RESULTS: The rate of successfully performing the test was same (93.2%) in the UH and DAH arms. The rate of correctly interpreting the results was 86.9% in the UH arm versus 93.2% in the DAH arm, for a difference of - 6.3%. After the follow-up 72 h later, participants in the UH arm had a significantly lower chance of correctly interpreting the test results than those in the DAH arm (aRR: 0.60; P = 0.019). Although the positivity rate was 3.4% among the participants in the DAH arm and 1.7% among those in the UH arm, no significant differences were found between the two arms in the positivity rate, requests for assistance, and linkage to care. Willingness to buy an HIV self-test was higher in the UH arm than in the DAH arm (92.3% versus 74.1%; aRR: 4.20; P < 0.001). CONCLUSION: The results of this study indicate that UH is as practicable and effective as DAH among individuals at high risk for HIV infection in Kisangani, the DRC. However, additional support tools need to be assessed to improve the interpretation of the self-test results when using the UH approach. TRIAL REGISTRATION: PACTR201904546865585. Registered 03 April 2019 - Retrospectively registered, https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=6032.


Asunto(s)
Seropositividad para VIH/diagnóstico , Seropositividad para VIH/epidemiología , VIH/inmunología , Tamizaje Masivo/métodos , Pruebas Serológicas/métodos , Adolescente , Adulto , República Democrática del Congo/epidemiología , Estudios de Factibilidad , Femenino , Estudios de Seguimiento , Seropositividad para VIH/virología , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Adulto Joven
2.
J Immunol Res ; 2020: 9465398, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33134398

RESUMEN

This new decade has started with a global pandemic of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), precipitating a worldwide health crisis and economic downturn. Scientists and clinicians have been racing against time to find therapies for COVID-19. Repurposing approved drugs, developing vaccines and employing passive immunization are three major therapeutic approaches to fighting COVID-19. Chicken immunoglobulin Y (IgY) has the potential to be used as neutralizing antibody against respiratory infections, and its advantages include high avidity, low risk of adverse immune responses, and easy local delivery by intranasal administration. In this study, we raised antibody against the spike (S) protein of SARS-CoV-2 in chickens and extracted IgY (called IgY-S) from egg yolk. IgY-S exhibited high immunoreactivity against SARS-CoV-2 S, and by epitope mapping, we found five linear epitopes of IgY-S in SARS-CoV-2 S, two of which are cross-reactive with SARS-CoV S. Notably, epitope SIIAYTMSL, one of the identified epitopes, partially overlaps the S1/S2 cleavage region in SARS-CoV-2 S and is located on the surface of S trimer in 3D structure, close to the S1/S2 cleavage site. Thus, antibody binding at this location could physically block the access of proteolytic enzymes to S1/S2 cleavage site and thereby impede S1/S2 proteolytic cleavage, which is crucial to subsequent virus-cell membrane fusion and viral cell entry. Therefore, the feasibility of using IgY-S or epitope SIIAYTMS-specific IgY as neutralizing antibody for preventing or treating SARS-CoV-2 infection is worth exploring.


Asunto(s)
Betacoronavirus/inmunología , Infecciones por Coronavirus/terapia , Mapeo Epitopo , Inmunoglobulinas/aislamiento & purificación , Neumonía Viral/terapia , Administración Intranasal , Animales , Anticuerpos Neutralizantes/administración & dosificación , Anticuerpos Neutralizantes/inmunología , Anticuerpos Neutralizantes/aislamiento & purificación , Anticuerpos Antivirales/administración & dosificación , Anticuerpos Antivirales/inmunología , Anticuerpos Antivirales/aislamiento & purificación , Pollos , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/inmunología , Infecciones por Coronavirus/virología , Reacciones Cruzadas , Estudios de Factibilidad , Humanos , Inmunización Pasiva/métodos , Inmunoglobulinas/administración & dosificación , Inmunoglobulinas/inmunología , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/inmunología , Neumonía Viral/virología , Glicoproteína de la Espiga del Coronavirus/inmunología
3.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 1290-1293, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33018224

RESUMEN

Intracranial hemorrhage (ICH) is a life-threatening condition, the outcome of which is associated with stroke, trauma, aneurysm, vascular malformations, high blood pressure, illicit drugs and blood clotting disorders. In this study, we presented the feasibility of the automatic identification and classification of ICH using a head CT image based on deep learning technique. The subtypes of ICH for the classification was intraparenchymal, intraventricular, subarachnoid, subdural and epidural. We first performed windowing to provide three different images: brain window, bone window and subdural window, and trained 4,516,842 head CT images using CNN-LSTM model. We used the Xception model for the deep CNN, and 64 nodes and 32 timesteps for LSTM. For the performance evaluation, we tested 727,392 head CT images, and found the resultant weighted multi-label logarithmic loss was 0.07528. We believe that our proposed method enhances the accuracy of ICH identification and classification and can assist radiologists in the interpretation of head CT images, particularly for brain-related quantitative analysis.


Asunto(s)
Hemorragias Intracraneales , Accidente Cerebrovascular , Encéfalo , Estudios de Factibilidad , Humanos , Hemorragias Intracraneales/diagnóstico por imagen , Tomografía Computarizada por Rayos X
4.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 2532-2535, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33018522

RESUMEN

Experiments with animal models of epilepsy have consistently shown that focal cooling of epilepsy-induced brain region reversibly suppresses or terminates epileptic discharge activity. Recently, we formulated a physiologically plausible temperature dependence in a neural mass model that can reproduce the effect of focal cooling on epileptic discharge activity. This can be used to implement a temperature control in an implantable cooling device for thermal neuromodulation of the epileptogenic zone in patients with partial epilepsy when seizure activity is detected. However, there have been no experiments that looked into the effect of focal cooling in animal models of epilepsy with secondary generalization in which the seizure activity spreads from the pathologic region to other regions of the brain. Using the temperature-dependent neural mass model and a physiological coupling model, we show that focal cooling stops the propagation of low-frequency discharge activity; on the other hand, it increases the amount of coupling required to propagate high-frequency discharge activity. Moreover, discharge activities that are propagated with cooling are lower in both magnitude and frequency compared to those propagated without cooling. These results suggest the feasibility of focal cooling as an effective alternative therapeutic treatment for medically intractable partial epilepsy even with secondary generalization.Clinical Relevance- The computational study establishes focal cooling of the brain region with partial epilepsy not only suppresses epileptic discharges but can also prevent its generalization to other brain regions.


Asunto(s)
Epilepsia Refractaria , Epilepsias Parciales , Animales , Encéfalo , Frío , Epilepsias Parciales/terapia , Estudios de Factibilidad , Humanos
5.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 2841-2844, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33018598

RESUMEN

Multi-session robot-assisted stroke rehabilitation program requires patients to perform repetitive tasks. It is challenging for the patient to maintain concentration during training sessions. A novel intervention strategy using Electroencephalography (EEG) signals is proposed to maintain concentration during training by enhancing the engagement of stroke patients using robot-assisted multi-session rehabilitation. The approach is illustrated by applying it to one stroke patient undergoing 12 training sessions of hand motor training on the AMADEO rehabilitation device. AMADEO offers four modes of training programs of increased intensity comprising passive training, passive training with biofeedback, assistive training as well as active 2D training games. The EEG signals are measured over eight electrode sites: FC4, C4, CP4, FC3, C3, CP3, Cz, and CPz during each training day to extract movement-related cortical potential (MRCP) signals. Moreover, functional hand recovery parameters are determined using the AMADEO assessment tool. The patient's level of engagement is determined by the negative amplitude of the MRCP signal. The rehabilitation program is switched to a more intense training mode when a consistent decrease is observed in the negative amplitude of MRCP signals from the monitored electrodes. Using this approach, the rehabilitation program becomes patient-specific and adaptive. In addition, it is shown that each training mode exhibits a different recovery level of the affected hand and maximum recovery is achieved when MRCP signals indicate that the patient is actively participating in the training.


Asunto(s)
Robótica , Rehabilitación de Accidente Cerebrovascular , Electroencefalografía , Estudios de Factibilidad , Mano , Humanos
6.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 3755-3758, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33018818

RESUMEN

Despite recent advancements in the field of pattern recognition-based myoelectric control, the collection of a high quality training set remains a challenge limiting its adoption. This paper proposes a framework for a possible solution by augmenting short training protocols with subject-specific synthetic electromyography (EMG) data generated using a deep generative network, known as SinGAN. The aim of this work is to produce high quality synthetic data that could improve classification accuracy when combined with a limited training protocol. SinGAN was used to generate 1000 synthetic windows of EMG data from a single window of six different motions, and results were evaluated qualitatively, quantitatively, and in a classification task. Qualitative assessment of synthetic data was conducted via visual inspection of principal component analysis projections of real and synthetic feature space. Quantitative assessment of synthetic data revealed 11 of 32 synthetic features had similar location and scale to real features (using univariate two-sample Lepage tests); whereas multivariate distributions were found to be statistically different (p <0.05). Finally, the addition of these synthetic data to a brief training set of real data significantly improved classification accuracy in a cross-validation testing scheme by 5.4% (p <0.001).


Asunto(s)
Electromiografía , Detección de Señal Psicológica , Estudios de Factibilidad , Movimiento (Física) , Análisis de Componente Principal
7.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 4008-4011, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33018878

RESUMEN

Research on biosignal (ExG) analysis is usually performed with expensive systems requiring connection with external computers for data processing. Consumer-grade low-cost wearable systems for bio-potential monitoring and embedded processing have been presented recently, but are not considered suitable for medical-grade analyses. This work presents a detailed quantitative comparative analysis of a recently presented fully-wearable low-power and low-cost platform (BioWolf) for ExG acquisition and embedded processing with two researchgrade acquisition systems, namely, ANTNeuro (EEG) and the Noraxon DTS (EMG). Our preliminary results demonstrate that BioWolf offers competitive performance in terms of electrical properties and classification accuracy. This paper also highlights distinctive features of BioWolf, such as real-time embedded processing, improved wearability, and energy-efficiency, which allows devising new types of experiments and usage scenarios for medical-grade biosignal processing in research and future clinical studies.


Asunto(s)
Técnicas Biosensibles , Dispositivos Electrónicos Vestibles , Estudios de Factibilidad
8.
Zhonghua Xin Xue Guan Bing Za Zhi ; 48(10): 848-852, 2020 Oct 24.
Artículo en Chino | MEDLINE | ID: mdl-33076622

RESUMEN

Objective: To investigate the efficacy and safety of left bundle branch area pacing (LBBaP) with the new simplified approach (nine-partition method). Methods: A total of 118 patients with clinical indications and received pacemaker implantation from December 1, 2018 to December 31, 2019 in Beijing Anzhen Hospital were enrolled. LBBaP was performed with the nine-partition method (in the right anterior oblique 30° position, the ventriculogram was divided into nine partitions and the initial implant sites were located in the lower base 1/3 partitions). In X-ray image, the 3830 lead is located in the left bundle branch area, the unipolar pacing QRS wave is in the form of right bundle branch block, and the peak time from stimulation to left ventricular activation<90 ms is defined as successful operation. The clinical characters, such as the methods of venipuncture, electrode parameters, operation duration, fluoroscopy duration, the peak time from stimulation to left ventricular, pacemaker types, surgical success rate, complications, and immediate postoperative ECG parameters were collected. The patients were followed up after the operation, and the electrode parameters and postoperative complications were recorded. Results: This study is a retrospective study. There were 62 (52.5%) male patients in this cohort, the average age was (65.9±13.4) years old,and there were 49(41.5%) sick sinus syndrome, 6(5.1%) abnormal sinus node and atrioventricular node simultaneously, 63(53.4%) atrioventricular block, 26(22.0%) atrial fibrillation, 20(16.9%) cardiomyopathy; the baseline duration of QRS was (109.21±39.03) ms. Successful LBBaP was achieved in 109 patients with"nine-partition method"and the success rate was 92.4%; 104 patients (95.5%) were axillary vein puncture, 5 (4.6%) were subclavian vein puncture; the operation duration was (80.3±23.0) min, the fluoroscopy duration was (12.29±5.13) min; the QRS duration after LBBaP was (116.36±18.11) ms. The threshold of the left bundle branch (LBB) lead was (0.92±0.63) V, the R wave amplitude was (10.60±5.04) mV and the impedance was (798.71±194.90) Ω. In 1 V pacing, the peak time from stimulation to left ventricular activation was (67.91±12.15) ms, and in 5 V pacing was (67.52±12.45) ms; 1 case (0.9%) with a single-chamber pacemaker implanted, 106 cases (97.3%) with dual-chamber pacemaker and 2 cases (1.8%) with three-chamber pacemakers. There were no hematomas, pneumothorax, hemothorax, electrode dislocation, infection, and capsular hemorrhage and other serious surgery-related complications during the operation. A total of 97 patients (89.0%) were followed up for (6.21±2.90) months. The electrode parameters of all patients were stable and no complications observed. Conclusions: The LBBaP with nine-partition method is a simple, safe and effective physiological pacing approach. However, its long-term effect still needs to be further verified.


Asunto(s)
Bloqueo Atrioventricular , Estimulación Cardíaca Artificial , Anciano , Bloqueo de Rama/terapia , Estudios de Factibilidad , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
9.
Zhonghua Xin Xue Guan Bing Za Zhi ; 48(10): 842-847, 2020 Oct 24.
Artículo en Chino | MEDLINE | ID: mdl-33076621

RESUMEN

Objective: We aimed to explore the feasibility and perioperative safety of performing catheter ablation and left atrial appendage closure (LAAC) in a single (one-stop) session in patients with atrial fibrillation (AF). Methods: This study is an observational study. Consecutive AF patients who underwent the combined procedure of catheter ablation and LAAC with Watchman device of Xinhua Hospital in Shanghai between March 2017 and May 2019 were prospectively enrolled. Baseline, intra-and peri-procedural parameters were evaluated. Results: A total of 358 AF patients (189 males, (69.0±8.0) years) underwent the one-stop procedure. The CHA2DS2-VASc score was 3.2±1.5 and HAS-BLED score was 2.4±1.1, respectively in this patient cohort. Pulmonary vein isolation was achieved in all patients, while additional linear ablation was applied in 180 (50.3%) patients, yielding immediate success rate of 99.7%. Successful Watchman implantation was achieved in all patients. The perioperative serious adverse event occurred in 14 cases (3.9%). including 6 pericardial effusions (1.7%), 1 stroke (0.3%) and 5 vascular complications (1.4%), yielding procedure-related complication rate of 3.4%. In addition, 2 (0.6%) new-onset heart failures occurred postoperatively. There was no major bleeding or death during the perioperative period. Conclusions: Combined catheter ablation and LAAC can be successfully and safely performed in AF patients with high stroke risk. Follow-up data are needed to evaluate the outcome of this one-stop procedure.


Asunto(s)
Apéndice Atrial , Ablación por Catéter , Anciano , Apéndice Atrial/cirugía , China , Estudios de Factibilidad , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
10.
Nat Commun ; 11(1): 4935, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-33004797

RESUMEN

Gramicidin A (1) is a peptide antibiotic that disrupts the transmembrane ion concentration gradient by forming an ion channel in a lipid bilayer. Although long used clinically, it is limited to topical application because of its strong hemolytic activity and mammalian cytotoxicity, likely arising from the common ion transport mechanism. Here we report an integrated high-throughput strategy for discovering analogues of 1 with altered biological activity profiles. The 4096 analogue structures are designed to maintain the charge-neutral, hydrophobic, and channel forming properties of 1. Synthesis of the analogues, tandem mass spectrometry sequencing, and 3 microscale screenings enable us to identify 10 representative analogues. Re-synthesis and detailed functional evaluations find that all 10 analogues share a similar ion channel function, but have different cytotoxic, hemolytic, and antibacterial activities. Our large-scale structure-activity relationship studies reveal the feasibility of developing analogues of 1 that selectively induce toxicity toward target organisms.


Asunto(s)
Antibacterianos/farmacología , Descubrimiento de Drogas/métodos , Gramicidina/análogos & derivados , Ensayos Analíticos de Alto Rendimiento/métodos , Animales , Antibacterianos/química , Línea Celular Tumoral , Química Farmacéutica , Eritrocitos , Estudios de Factibilidad , Bacterias Grampositivas/efectos de los fármacos , Gramicidina/química , Gramicidina/farmacología , Hemólisis/efectos de los fármacos , Concentración 50 Inhibidora , Ratones , Pruebas de Sensibilidad Microbiana , Estructura Molecular , Conejos , Relación Estructura-Actividad , Espectrometría de Masas en Tándem
12.
Nat Commun ; 11(1): 5036, 2020 10 07.
Artículo en Inglés | MEDLINE | ID: mdl-33028818

RESUMEN

Alkyl carboxylic acids as well as primary amines are ubiquitous in all facets of biological science, pharmaceutical science, chemical science and materials science. By chemical conversion to redox-active esters (RAE) and Katritzky's N-alkylpyridinium salts, respectively, alkyl carboxylic acids and primary amines serve as ideal starting materials to forge new connections. In this work, a Mn-mediated reductive decarboxylative/deaminative functionalization of activated aliphatic acids and primary amines is disclosed. A series of C-X (X = S, Se, Te, H, P) and C-C bonds are efficiently constructed under simple and mild reaction conditions. The protocol is applicable to the late-stage modification of some structurally complex natural products or drugs. Preliminary mechanistic studies suggest the involvement of radicals in the reaction pathway.


Asunto(s)
Aminas/química , Técnicas de Química Sintética/métodos , Ácidos Grasos/química , Manganeso/química , Catálisis , Estudios de Factibilidad , Oxidación-Reducción
13.
Nat Commun ; 11(1): 5041, 2020 10 07.
Artículo en Inglés | MEDLINE | ID: mdl-33028827

RESUMEN

Following introduction of CRISPR-Cas9 components into a cell, genome editing occurs unabated until degradation of its component nucleic acids and proteins by cellular processes. This uncontrolled reaction can lead to unintended consequences including off-target editing and chromosomal translocations. To address this, we develop a method for light-induced degradation of sgRNA termed CRISPRoff. Here we show that light-induced inactivation of ribonucleoprotein attenuates genome editing within cells and allows for titratable levels of editing efficiency and spatial patterning via selective illumination.


Asunto(s)
Sistemas CRISPR-Cas/genética , Edición Génica/métodos , Luz , Estabilidad del ARN/efectos de la radiación , ARN Guia/metabolismo , Sistemas CRISPR-Cas/efectos de la radiación , Línea Celular Tumoral , Roturas del ADN de Doble Cadena , Estudios de Factibilidad , Células HEK293 , Humanos , ARN Guia/efectos de la radiación , Ribonucleoproteínas/metabolismo , Translocación Genética
14.
Artículo en Inglés | MEDLINE | ID: mdl-33017935

RESUMEN

Temporal enhanced ultrasound (TeUS) is a tissue characterization approach based on analysis of a temporal series of US data. Previously we demonstrated that intrinsic or external micro-motions of scatterers in the tissue contribute towards the tissue classification properties of TeUS. This property is beneficial to detect early stage cancer, for example, where changes in nuclei configuration (scatteres) dominate tissue properties. In this study, we propose an analytical derivation and experiments to acquire TeUS through manipulation of US imaging parameters, which may be simpler to translate to clinical applications. The feasibility of the proposed method is demonstrated on tissue-mimicking phantoms. Using an autoencoder classifier, we are able to classify phantoms of varying elasticities and scattering sizes.


Asunto(s)
Ultrasonografía , Elasticidad , Estudios de Factibilidad , Fantasmas de Imagen
15.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 4624-4627, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33019024

RESUMEN

The Sports Concussion Assessment Tool (SCAT) is a pen and paper-based evaluation tool for use by healthcare professionals in the acute evaluation of suspected concussion. Here we present a feasibility study towards instrumented SCAT (iSCAT). Traditionally, a healthcare professional subjectively counts errors according to SCAT marking criteria matrix. It is hypothesized that an instrumented version of the test will be more accurate while providing additional digital-based parameters to better inform player management. The feasibility study focuses on the SCAT physical functioning tasks only: double leg stance, single-leg stance, tandem stance and tandem gait. Amateur university rugby players underwent iSCAT testing and data were recorded with 8 inertial units attached at different anatomical locations. Video data were gathered simultaneously as reference. An iSCAT algorithm was used to detect errors and quantify additional concussion-based time and frequency domain parameters to assess participant stability during balance and gait tasks. Future work aims to instrument other SCAT features such as hand-eye coordination while deploying methods within a large concussion project.


Asunto(s)
Traumatismos en Atletas , Conmoción Encefálica , Fútbol Americano , Atletas , Traumatismos en Atletas/diagnóstico , Conmoción Encefálica/diagnóstico , Estudios de Factibilidad , Humanos
16.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 4632-4635, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33019026

RESUMEN

Various measurement systems can be used to obtain dynamic circumferences of the human upper body, but each of these systems has disadvantages. In this feasibility study we introduce a non-invasive and wearable thoracic belt to measure dynamic changes of circumferences of thorax or abdomen. To evaluate this approach, five subjects undertook various breaths of disparate tidal volumes, which were measured by the belt and simultaneously by a motion capture system which provided a reference metric.The results of the belt concurred with the reference system. A coefficient of determination (adjusted R2) of 0.99 and a mean squared error of less than 0.87 mm2 showed that the belt is capable of measuring changes accurately and a couple of respiratory parameters, such as the respiratory rate, can be obtained.Clinical Relevance-The introduced system links surface motions of the upper body with the underlying respiratory mechanics. Thus it provides some respiratory parameters without the disadvantages of a facemask or a mouthpiece. The system could allow the analysis of breathing status in some clinical applications and could be used for low-cost monitoring in homecare or to analyse respiratory parameters during sports.


Asunto(s)
Respiración , Tórax , Estudios de Factibilidad , Humanos , Proyectos Piloto , Volumen de Ventilación Pulmonar
17.
Annu Int Conf IEEE Eng Med Biol Soc ; 2020: 4652-4655, 2020 07.
Artículo en Inglés | MEDLINE | ID: mdl-33019031

RESUMEN

With rapid advancement in wearable biosensor technology, systems capable of real time, continuous and ambulatory monitoring of vital signs are increasingly emerging and their use can potentially help improve patient outcome. Monitoring continuous body temperature offers insights into its trend, allows early detection of fever and is critical in several diseases and clinical conditions including septicemia, infectious disease and others. There is a complex interaction between physiological and ambient parameters including heart rate, respiratory rate, muscle rigors and shivers, diaphoresis, local humidity, clothing, body, skin and ambient temperatures among others. This article presents feasibility analysis of a wireless biosensor patch device called as VitalPatch in capturing this physio-ambient-thermodynamic interaction to determine core body temperature, and details comparative performance assessments using oral thermometer and ingestible pill as reference devices. Based on a study on a cohort of 30 subjects with reference oral temperature, the proposed method showed a bias of 0.1 ± 0.37 °C, mean absolute error (MAE) of 0.29 ± 0.25 °C. Another cohort of 22 subjects with continuous core body temperature pill as reference showed a bias of 0.16 ± 0.38 °C and MAE of 0.42 ± 0.22 °C.Clinical Relevance- Non-invasive, continuous and real time body temperature monitoring can lead to earlier fever detection and provides remote patient monitoring that can result in improved patient and clinical outcome.


Asunto(s)
Temperatura Corporal , Dispositivos Electrónicos Vestibles , Estudios de Factibilidad , Humanos , Monitoreo Ambulatorio , Frecuencia Respiratoria
18.
Trials ; 21(1): 846, 2020 Oct 13.
Artículo en Inglés | MEDLINE | ID: mdl-33050924

RESUMEN

OBJECTIVES: To assess the efficacy of several repurposed drugs to prevent hospitalisation or death in patients aged 65 or more with recent symptomatic SARS-CoV-2 infection (COVID-19) and no criteria for hospitalisation. TRIAL DESIGN: Phase III, multi-arm (5) and multi-stage (MAMS), randomized, open-label controlled superiority trial. Participants will be randomly allocated 1:1:1:1:1 to the following strategies: Arm 1: Control arm Arms 2 to 5: Experimental treatment arms Planned interim analyses will be conducted at regular intervals. Their results will be reviewed by an Independent Data and Safety Monitoring Board. Experimental arms may be terminated for futility, efficacy or toxicity before the end of the trial. New experimental arms may be added if new evidence suggests that other treatments should be tested. A feasibility and acceptability substudy as well as an immunological substudy will be conducted alongside the trial. PARTICIPANTS: Inclusion criteria are: 65-year-old or more; Positive test for SARS-CoV-2 on a nasopharyngeal swab; Symptoms onset within 3 days before diagnosis; No hospitalisation criteria; Signed informed consent; Health insurance. Exclusion criteria are: Inability to make an informed decision to participate (e.g.: dementia, guardianship); Rockwood Clinical Frailty Scale ≥7; Long QT syndrome; QTc interval > 500 ms; Heart rate <50/min; Kalaemia >5.5 mmol/L or <3.5 mmol/L; Ongoing treatment with piperaquine, halofantrine, dasatinib, nilotinib, hydroxyzine, domperidone, citalopram, escitalopram, potent inhibitors or inducers of cytochrome P450 CYP3A4 isoenzyme, repaglinide, azathioprine, 6-mercaptopurine, theophylline, pyrazinamide, warfarin; Known hypersensitivity to any of the trial drugs or to chloroquine and other 4-aminoquinolines, amodiaquine, mefloquine, glafenine, floctafenine, antrafenine, ARB; Hepatic porphyria; Liver failure (Child-Pugh stage ≥B); Stage 4 or 5 chronic kidney disease (GFR <30 mL/min/1.73 m²); Dialysis; Hypersentivity to lactose; Lactase deficiency; Abnormalities in galactose metabolism; Malabsorption syndrome; Glucose-6-phosphate dehydrogenase deficiency; Symptomatic hyperuricemia; Ileus; Colitis; Enterocolitis; Chronic hepatitis B virus disease. The trial is being conducted in France in the Bordeaux, Corse, Dijon, Nancy, Paris and Toulouse areas as well as in the Grand Duchy of Luxembourg. Participants are recruited either at home, nursing homes, general practices, primary care centres or hospital outpatient consultations. INTERVENTION AND COMPARATOR: The four experimental treatments planned in protocol version 1.2 (April 8th, 2020) are: (1) Hydroxychloroquine 200 mg, 2 tablets BID on day 0, 2 tablets QD from day 1 to 9; (2) Imatinib 400 mg, 1 tablet QD from day 0 to 9; (3) Favipiravir 200 mg, 12 tablets BID on day 0, 6 tablets BID from day 1 to 9; (4) Telmisartan 20 mg, 1 tablet QD from day 0 to 9. The comparator is a complex of vitamins and trace elements (AZINC Forme et Vitalité®), 1 capsule BID for 10 days, for which there is no reason to believe that they are active on the virus. In protocol version 1.2 (April 8th, 2020): People in the control arm will receive a combination of vitamins and trace elements; people in the experimental arms will receive hydroxychloroquine, or favipiravir, or imatinib, or telmisartan. MAIN OUTCOME: The primary outcome is the proportion of participants with an incidence of hospitalisation and/or death between inclusion and day 14 in each arm. RANDOMISATION: Participants are randomized in a 1:1:1:1:1 ratio to each arm using a web-based randomisation tool. Participants not treated with an ARB or ACEI prior to enrolment are randomized to receive the comparator or one of the four experimental drugs. Participants already treated with an ARB or ACEI are randomized to receive the comparator or one of the experimental drugs except telmisartan (i.e.: hydroxychloroquine, imatinib, or favipiravir). Randomisation is stratified on ACEI or ARBs treatment at inclusion and on the type of residence (personal home vs. nursing home). BLINDING (MASKING): This is an open-label trial. Participants, caregivers, investigators and statisticians are not blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 1057 participants will be enrolled if all arms are maintained until the final analysis and no additional arm is added. Three successive futility interim analyses are planned, when the number of participants reaches 30, 60 and 102 in the control arm. Two efficacy analyses (interim n°3 and final) will be performed successively. TRIAL STATUS: This describes the Version 1.2 (April 8th, 2020) of the COVERAGE protocol that was approved by the French regulatory authority and ethics committee. The trial was opened for enrolment on April 15th, 2020 in the Nouvelle Aquitaine region (South-West France). Given the current decline of the COVID-19 pandemic in France and its unforeseeable dynamic in the coming months, new trial sites in 5 other French regions and in Luxembourg are currently being opened. A revised version of the protocol was submitted to the regulatory authority and ethics committee on June 15th, 2020. It contains the following amendments: (i) Inclusion criteria: age ≥65 replaced by age ≥60; time since first symptoms <3 days replaced by time since first symptoms <5 days; (ii) Withdrawal of the hydroxychloroquine arm (due to external data); (iii) increase in the number of trial sites. TRIAL REGISTRATION: The trial was registered on Clinical Trials.gov on April 22nd, 2020 (Identifier: NCT04356495): and on EudraCT on April 10th, 2020 (Identifier: 2020-001435-27). FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Asunto(s)
Betacoronavirus/genética , Infecciones por Coronavirus/tratamiento farmacológico , Pacientes Ambulatorios/estadística & datos numéricos , Neumonía Viral/tratamiento farmacológico , Terapias en Investigación/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Amidas/uso terapéutico , Antihipertensivos/uso terapéutico , Antimaláricos/uso terapéutico , Antivirales/uso terapéutico , Infecciones por Coronavirus/epidemiología , Infecciones por Coronavirus/virología , Tolerancia a Medicamentos , Estudios de Factibilidad , Francia/epidemiología , Hospitalización/tendencias , Humanos , Hidroxicloroquina/uso terapéutico , Mesilato de Imatinib/uso terapéutico , Luxemburgo/epidemiología , Pandemias , Neumonía Viral/epidemiología , Neumonía Viral/virología , Inhibidores de Proteínas Quinasas/uso terapéutico , Pirazinas/uso terapéutico , Conducta de Reducción del Riesgo , Telmisartán/uso terapéutico , Resultado del Tratamiento
19.
Sarcoidosis Vasc Diffuse Lung Dis ; 37(2): 192-202, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33093783

RESUMEN

Idiopathic pulmonary fibrosis (IPF) is characterized by progressive loss of pulmonary function and exercise capacity, leading to loss of quality of life and often social isolation. A new walking aid, the walk-bike, showed an improvement in exercise performance in COPD patients. Aims of this pilot study were to evaluate feasibility of a homebased walk-bike intervention study in IPF patients and to explore the effect of the walk-bike on quality of life (QoL) and exercise capacity. Twenty-three patients with IPF were included in a randomized multicenter crossover study with 8 weeks of standard care and 8 weeks of walk-bike use at home. Ten patients completed both study phases. Study barriers included reluctance to participate and external factors (e.g. weather and road conditions) that hampered adherence. Patients' satisfaction and experience with the walk-bike varied greatly. After training with the walk-bike, health-related QoL (St. George's Respiratory and King's Brief Interstitial Lung Disease questionnaires) demonstrated a tendency towards improvement, exercise capacity did not. A clinically important difference was found between 6-minute walk test with the walk-bike and the standard test; median (range) respectively 602 m (358-684) and 486 m (382-510). Conclusions: Due to practical barriers a larger study with the walk-bike in patients with IPF seems not feasible. Individual patients may benefit from the use of a walk-bike as it improved action radius and showed a tendency towards improvement in QoL. No effect on exercise capacity was observed. (Sarcoidosis Vasc Diffuse Lung Dis 2020; 37 (2): 192-202).


Asunto(s)
Deambulación Dependiente , Terapia por Ejercicio/instrumentación , Tolerancia al Ejercicio , Fibrosis Pulmonar Idiopática/terapia , Limitación de la Movilidad , Calidad de Vida , Caminata , Anciano , Anciano de 80 o más Años , Estudios Cruzados , Diseño de Equipo , Estudios de Factibilidad , Femenino , Humanos , Fibrosis Pulmonar Idiopática/diagnóstico , Fibrosis Pulmonar Idiopática/fisiopatología , Fibrosis Pulmonar Idiopática/psicología , Masculino , Persona de Mediana Edad , Países Bajos , Satisfacción del Paciente , Proyectos Piloto , Recuperación de la Función , Factores de Tiempo , Resultado del Tratamiento
20.
Anim Sci J ; 91(1): e13476, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33078458

RESUMEN

We investigated the feasibility of piglet production by non-surgical embryo transfer (Ns-ET) of vitrified porcine blastocysts and expanded blastocysts transported to commercial farms and warmed on site (V/T/W embryos). Ns-ET was performed by depositing 11-20 vitrified and warmed embryos at a proximal site within the uterus via a catheter. In Experiment 1, the effect of donor-recipient estrous cycle asynchrony on the efficiency of Ns-ET of vitrified and ordinary warmed embryos was investigated at the experimental facility. With a 1-day delay recipients relative to that of donor, the farrowing rate was 50.0% and the survival rate to term was 21.1%. In Experiment 2, Ns-ET using recipients with a 1-day delay and vitrified embryos after one-step warming and dilution was evaluated at the experimental facility. Although the resulting farrowing rate was 42.9%, the survival rate was 6.4%. In Experiment 3, Ns-ET was conducted using V/T/W embryos at four commercial farms, where piglets derived from them were produced. When artificial insemination was conducted prior to Ns-ET, the farrowing and survival rates obtained using V/T/W embryos were 75.0%, and 21.3%, respectively. These results show that Ns-ET of V/T/W embryos using this protocol would be feasible for piglet production at farms.


Asunto(s)
Blastocisto , Cruzamiento/métodos , Criopreservación/métodos , Criopreservación/veterinaria , Técnicas de Cultivo de Embriones/métodos , Técnicas de Cultivo de Embriones/veterinaria , Transferencia de Embrión/métodos , Transferencia de Embrión/veterinaria , Inseminación Artificial/métodos , Inseminación Artificial/veterinaria , Animales , Ciclo Estral , Granjas , Estudios de Factibilidad , Femenino , Porcinos
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