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1.
Medicina (Kaunas) ; 57(5)2021 May 13.
Artículo en Inglés | MEDLINE | ID: mdl-34067980

RESUMEN

Background and Objectives: The purpose of this study was to investigate the effects of microcurrent stimulation on pain, shoulder function, and grip strength in patients with rotator cuff repair. Materials and Methods: This randomized single-blind controlled trial was conducted on inpatients of the rehabilitation department, and included 28 patients who underwent rotator cuff repair. Participants were randomly assigned to the experimental group (n = 14), treated with microcurrent stimulation, and the control group (n = 14), treated with false microcurrent stimulation. The microcurrent stimulation administered to the experimental group underwent general physical therapy and microcurrent stimulation three times a week for 4 weeks. Results: Changes in pain, range of motion in shoulder, simple shoulder test, and grip strength were assessed before and after the intervention. Both groups showed a significant decrease in pain and shoulder function (t = 27.412, 22.079, 19.079, and 18.561; p < 0.001), and grip strength showed a significant increase (t = -8.251 and -9.946; p < 0.001). The experimental group that underwent microcurrent stimulation exhibited a significant effect on pain, shoulder function, and grip strength compared with the control group that underwent false microcurrent stimulation (t = -2.17, -2.22, and 2.213; p = 0.039, 0.035, and 0.036). Conclusions: This study confirmed that microcurrent stimulation is effective for the treatment of rotator cuff repair patients.


Asunto(s)
Lesiones del Manguito de los Rotadores , Hombro , Fuerza de la Mano , Humanos , Rango del Movimiento Articular , Manguito de los Rotadores , Lesiones del Manguito de los Rotadores/cirugía , Hombro/cirugía , Dolor de Hombro/terapia , Método Simple Ciego , Resultado del Tratamiento
2.
J Pak Med Assoc ; 71(4): 1058-1062, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-34125743

RESUMEN

OBJECTIVE: To determine the effects of static exercise programme compared to Swiss ball training for core muscles of the lower back and pelvic region in patients with low back pain after child delivery. Methods: The prospective single-blind randomised controlled trial was conducted at Rehabilitation department of Pakistan Railway General Hospital Rawalpindi from March to December 2018, and comprised patients with low back pain after delivery who were randomised into 2 equal groups. The subjects in Group A received static core exercises, while those in Group B got Swiss ball training. Outcome was measured using numeric pain rating scale, Oswestry disability index, goniometry and core stability assessment scale. Data was analysed using SPSS 21. RESULTS: Of the 30 patients, 15(50%) were in Group A with mean age of 28.38±4.8 years, and 15(50%) were in Group B with a mean age of 29.57±3.3 years. Intra-group difference was significant (p<0.05), while inter-group difference was non-significant (p>0.05). CONCLUSIONS: Both exercise protocols used in the study were equally effective in the rehabilitation of postpartum low back pain.


Asunto(s)
Dolor de la Región Lumbar , Adulto , Niño , Terapia por Ejercicio , Femenino , Humanos , Dolor de la Región Lumbar/terapia , Músculos , Pakistán , Pelvis , Estudios Prospectivos , Método Simple Ciego , Suiza , Resultado del Tratamiento , Adulto Joven
3.
Trials ; 22(1): 400, 2021 Jun 14.
Artículo en Inglés | MEDLINE | ID: mdl-34127032

RESUMEN

BACKGROUND: Stroke is a leading cause of disability, injury, and death in elderly people and represents a major public health problem with substantial medical and economic consequences. The incidence of stroke rapidly increases with age, doubling for each decade after age 55 years. Gait impairment is one of the most important problems after stroke, and improving walking function is often a key component of any rehabilitation program. To achieve this goal, a robotic gait trainer seems to be promising. In fact, some studies underline the efficacy of robotic gait training based on end-effector technology, for different diseases, in particular in stroke patients. In this randomized controlled trial, we verify the efficacy of the robotic treatment in terms of improving the gait and reducing the risk of falling and its long-term effects. METHODS: In this single-blind randomized controlled trial, we will include 152 elderly subacute stroke patients divided in two groups to receive a traditional rehabilitation program or a robotic rehabilitation using G-EO system, an end-effector device for the gait rehabilitation, in addition to the traditional therapy. Twenty treatment sessions will be conducted, divided into 3 training sessions per week, for 7 weeks. The control group will perform traditional therapy sessions lasting 50 min. The technological intervention group, using the G-EO system, will carry out 30 min of traditional therapy and 20 min of treatment with a robotic system. The primary outcome of the study is the evaluation of the falling risk. Secondary outcomes are the assessment of the gait improvements and the fear of falling. Further evaluations, such as length and asymmetry of the step, walking and functional status, and acceptance of the technology, will be carried. DISCUSSION: The final goal of the present study is to propose a new approach and an innovative therapeutic plan in the post-stroke rehabilitation, focused on the use of a robotic device, in order to obtain the beneficial effects of this treatment. TRIAL REGISTRATION: ClinicalTrials.gov NCT04087083 . Registered on September 12, 2019.


Asunto(s)
Rehabilitación de Accidente Cerebrovascular , Accidente Cerebrovascular , Accidentes por Caídas , Anciano , Terapia por Ejercicio , Miedo , Marcha , Humanos , Persona de Mediana Edad , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/terapia , Resultado del Tratamiento
4.
BMJ Open ; 11(6): e046390, 2021 06 02.
Artículo en Inglés | MEDLINE | ID: mdl-34083338

RESUMEN

INTRODUCTION: Auditory verbal hallucinations (AVHs) are associated with distress and reduced functioning. Research suggests that distress is associated with the voice hearer's responding to AVH in a passive and subordinate manner. A novel approach focuses on relating to AVH and teaches assertive responses to AVH using experiential role-plays. A small pilot study found a large effect of this approach on AVH distress but an independent multicentre study is required to ascertain effectiveness across different settings. We aim to estimate the expected effect for a subsequent trial to demonstrate that adding a module of Relating Therapy (RT) to treatment as usual (TAU) is superior to TAU alone in reducing AVH distress. We also test the feasibility of patient recruitment, therapist training, and therapy monitoring in different psychological and psychiatric outpatient facilities in Germany. METHODS AND ANALYSIS: We will recruit 75 patients diagnosed with a schizophrenia spectrum disorder and persistent distressing AVH across four sites. Patients will be randomised to receive either 16 sessions of RT plus TAU or TAU alone within a 5-month period. Randomisation will be stratified by sites. Single-blind assessments will take place at baseline, at 5 months (T1) and at 9 months (T2). The primary outcome is the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scale at T2 adjusted for the baseline value. Secondary outcomes are change in depressive symptoms, quality of life, time spent in structured activities as well as negative relating to voices and to other people. ETHICS AND DISSEMINATION: The trial has received ethical approval from the German Psychological Society Ethics Committee. The trial results will be disseminated through conference presentations, peer-reviewed publications and social media. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT04578314).


Asunto(s)
Alucinaciones , Calidad de Vida , Estudios de Factibilidad , Alemania , Alucinaciones/tratamiento farmacológico , Humanos , Proyectos Piloto , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego
5.
Niger J Clin Pract ; 24(6): 860-865, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34121734

RESUMEN

Background: Episiotomy is a deliberate surgical incision of the perineum with the aim of increasing the vulval outlet to facilitate childbirth. However, it could be associated with some complications, such as pain, hemorrhage, and wound infection. It is a surgical procedure that requires adherence to basic surgical principles of providing adequate analgesia. Aim: To determine the efficacy of magnesium sulphate (MgSO4) as an adjunct to local anesthetics for analgesia during episiotomy repair among women that had vaginal delivery at Usmanu Danfodiyo University Teaching Hospital Sokoto, Sokoto, Nigeria. Subject and Methods: This was a single-blind randomized clinical trial. Pregnant women who had episiotomy during the study period were randomized into two groups. Those in Group A had xylocaine administered alone, whereas those in Group B had xylocaine + MgSO4 administered for repair of episiotomy. Pain was assessed by numeric rating scale at commencement of the repair, at 2 and 6 h after the repair. Patient's level of satisfaction, request for additional analgesia, and side effects were also assessed. Results: The pain score in the xylocaine + MgSO4 group was lower throughout the period of assessment. There was no significant difference in the pain scores between the two groups at 0 and 6 h. However, there was significant difference in the mean pain scores between the two groups at 2 h (P < 0.001). There was no significant difference in the level of satisfaction, request for additional analgesia, and side effects between the two groups. Conclusion: Both xylocaine alone and xylocaine with MgSO4 provide adequate perineal pain relief during episiotomy repair. MgSO4 improves the analgesic effect of xylocaine at 2 h after episiotomy repair without any significant side effect.


Asunto(s)
Anestésicos Locales , Episiotomía , Episiotomía/efectos adversos , Femenino , Humanos , Sulfato de Magnesio , Nigeria , Perineo , Embarazo , Método Simple Ciego
6.
Medicina (Kaunas) ; 57(6)2021 May 24.
Artículo en Inglés | MEDLINE | ID: mdl-34073654

RESUMEN

Non-celiac gluten sensitivity (NCGS) is a clinical entity characterized by the absence of celiac disease and wheat allergy in patients that trigger reproducible symptomatic responses to gluten-containing foods consumption. Due to the lack of sensitive and reproducible biomarkers for NCGS diagnosis, placebo-controlled gluten challenges must be carried out for its diagnosis. The gluten challenges can be either double- or single-blind, for research or clinical practice purposes, respectively. For improving our understanding about the magnitude and relevance of NCGS in different populations, epidemiological studies based on self-report have been carried out. However, the gluten challenge-based prevalence of NCGS remains to be estimated. Since NCGS was recently recognized as a clinical entity, more studies are needed to delve into NCGS pathogenesis, for instance, the molecular interactions between the suspected cereal grain components that trigger NCGS, such as fermentable oligo-, di-, monosaccharides, and polyols (FODMAPs) and amylase and trypsin inhibitors, and the immune system remains to be elucidated. Although still under debate, NCGS patients can be susceptible to only one or more than one of the NCGS triggers. The treatment of NCGS involves the dietary restriction of the suspected triggers of the disease, but there is controversial data about the effectiveness of different dietary interventions such as the gluten-free diet and low-FODMAP diet. Certainly, our understanding of NCGS is improving quickly due to the constant availability of new scientific information on this topic. Thus, the aim of the present narrative review is to present an up-to-date overview on NCGS from epidemiology to current therapy.


Asunto(s)
Enfermedad Celíaca , Hipersensibilidad a los Alimentos , Hipersensibilidad al Trigo , Enfermedad Celíaca/diagnóstico , Enfermedad Celíaca/epidemiología , Dieta Sin Gluten , Hipersensibilidad a los Alimentos/diagnóstico , Hipersensibilidad a los Alimentos/epidemiología , Glútenes/efectos adversos , Humanos , Método Simple Ciego
7.
J Pak Med Assoc ; 71(5): 1319-1325, 2021 May.
Artículo en Inglés | MEDLINE | ID: mdl-34091607

RESUMEN

OBJECTIVE: To determine the effects of an exercise programme for core muscle strengthening in patients with low back pain after caesarean section. Methods: The single-blind randomised controlled trail was conducted from August 2018 to January 2019 at the Helping Hand for Relief and Development Comprehensive Rehabilitation Centre, Chakwal, Pakistan, and comprised post-caesarean section women aged 25-40 years with low back pain. Patients were randomised into supervised group I and unsupervised group II using the sealed envelope method. Group I received supervised core stability exercise programme, while group II received unsupervised, home-based core stability exercise programme. Baseline and post-intervention values were compared for numeric pain rating scale, Oswestry disability index, inclinometer and core stability assessment. Data was analysed using SPSS 21. RESULTS: Of the 30 subjects, there were 15(50%) in each of the two groups. There was no significant difference at baseline between the groups (p>0.05). Post-intervention results showed significant intra-group and inter-group differences (p<0.05) with respect to all parameters. No improvement was observed for right and left side bending (p>0.05). CONCLUSIONS: Supervised core stability exercise programme was more effective in reducing pain and disability, and improved core muscle activation than unsupervised, home-based core exercise programme.


Asunto(s)
Dolor de la Región Lumbar , Cesárea , Terapia por Ejercicio , Femenino , Humanos , Dolor de la Región Lumbar/terapia , Músculos , Pakistán , Embarazo , Método Simple Ciego
8.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi ; 35(5): 573-578, 2021 May 15.
Artículo en Chino | MEDLINE | ID: mdl-33998210

RESUMEN

Objective: To compare the effectiveness of calcium phosphate cement (CPC) loaded with recombinant human bone morphogenetic protein 2 (rhBMP-2) combined with CPC loaded with antibiotic versus CPC loaded with antibiotic alone in one stage for chronic osteomyelitis with bone defect. Methods: A single-blind prospective randomized controlled clinical trial was conducted. Between April 2018 and April 2019, 80 patients of chronic osteomyelitis with bone defect in accordance with the random number table were randomly divided into two groups, 40 in the trial group (CPC loaded with rhBMP-2 combined with CPC loaded with antibiotic) and 40 in the control group (CPC loaded with antibiotic). There was no significant difference in gender, age, disease duration, lesion, and preoperative white blood cells (WBC) count, platelet count, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP) between the two groups ( P>0.05). All patients were implanted the corresponding CPC and external fixator after lesion clearance in the two groups. The postoperative WBC count, platelet count, ESR, CRP, hospital stay, cure rate of osteomyelitis, repaired bone defect volume, the time of external fixator removal, and the time of full weight-bearing of the affected limb were compared between the two groups. Results: All patients were followed up 12-24 months, with an average of 18.4 months. There was no significant difference in WBC count, platelet count, ESR, and CRP between the two groups at 4 weeks after operation ( P>0.05). There were significant differences in WBC count, platelet count, and CRP in the two groups between 1 week before operation and 4 weeks after operation ( P<0.05). And the ESR showed no significant difference between pre- and post-operation in the two groups ( P>0.05). In the trial group, the anaphylactic exudate occurred in 1 patient with tibial osteomyelitis and the incision healed after oral administration of loratadine. The incisions of other patients healed by first intention in the two groups. One case of distal tibial osteomyelitis recurred in each group, and 1 case of humeral osteomyelitis recurred in the control group. The cure rates of osteomyelitis were 97.5% (39/40) in the trial group and 95% (38/40) in the control group, showing no significant difference between the two groups ( χ 2 =0.000, P=1.000). There was no significant difference in the repaired bone defect volume and hospital stay between the two groups ( P>0.05). X-ray film and CT showed that the bone defects were repaired in the two groups. The time of external fixator removal and the time of full weight-bearing of the affected limb were significantly shorter in the trial group than in the control group ( P<0.05). Conclusion: Application of CPC loaded with rhBMP-2 and antibiotic in one stage is effective for the chronic osteomyelitis with bone defect, which can accelerate the bone regeneration in situ to repair bone defect, reduce the trauma, shorten the course of treatment, and obtain good function of the affected limb.


Asunto(s)
Proteína Morfogenética Ósea 2 , Osteomielitis , Antibacterianos/uso terapéutico , Cementos para Huesos , Fosfatos de Calcio , Humanos , Osteomielitis/tratamiento farmacológico , Estudios Prospectivos , Método Simple Ciego
9.
BMC Musculoskelet Disord ; 22(1): 425, 2021 May 07.
Artículo en Inglés | MEDLINE | ID: mdl-33962594

RESUMEN

BACKGROUND: We aimed to determine the efficacy and safety of multiple doses of intravenous tranexamic acid (IV-TXA) on perioperative blood loss in patients with rheumatoid arthritis (RA) who had undergone primary unilateral total knee arthroplasty (TKA). METHODS: For this single-center, single-blind randomized controlled clinical trial, 10 male and 87 female participants with RA, aged 50-75 years, who underwent unilateral primary TKA were recruited. The patients received one dose of 1 g IV-TXA 10 min before skin incision, followed by articular injection of 1.5 g tranexamic acid after cavity suture during the surgery. The patients were randomly assigned (1:1) into two groups and received an additional single dose of IV-TXA (1 g) for 3 h (group A) or three doses of IV-TXA (1 g) for 3, 6, and 12 h (group B) postoperatively. Primary outcomes were total blood loss (TBL), hidden blood loss (HBL), and maximum hemoglobin (Hb) level decrease. Secondary outcomes were transfusion rate and D-dimer levels. All parameters were measured postoperatively during inpatient hospital stay. RESULTS: The mean TBL, HBL, and maximum Hb level decrease in group B (506.1 ± 227.0 mL, 471.6 ± 224.0 mL, and 17.5 ± 7.7 g/L, respectively) were significantly lower than those in group A (608.8 ± 244.8 mL, P = 0.035; 574.0 ± 242.3 mL, P = 0.033; and 23.42 ± 9.2 g/L, P = 0.001, respectively). No episode of transfusion occurred. The D-dimer level was lower in group B than in group A on postoperative day 1 (P <  0.001), and the incidence of thromboembolic events was similar between the groups (P > 0.05). CONCLUSION: In patients with RA, three doses of postoperative IV-TXA further facilitated HBL and Hb level decrease without increasing the incidence of adverse events in a short period after TKA. TRIAL REGISTRATION: The trial was registered in the Chinese Clinical Trial Registry ( ChiCTR1900025013 ).


Asunto(s)
Antifibrinolíticos , Artritis Reumatoide , Artroplastia de Reemplazo de Rodilla , Ácido Tranexámico , Administración Intravenosa , Anciano , Antifibrinolíticos/efectos adversos , Artritis Reumatoide/diagnóstico , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/cirugía , Artroplastia de Reemplazo de Rodilla/efectos adversos , Pérdida de Sangre Quirúrgica/prevención & control , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Método Simple Ciego , Ácido Tranexámico/efectos adversos
11.
BMJ Open ; 11(5): e041242, 2021 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-34006536

RESUMEN

INTRODUCTION: Exercise, support and advice are considered core components of management for most musculoskeletal conditions and are typically provided by physiotherapists through regular face-to-face treatments. However, exercise can be provided remotely as part of a home exercise programme, while support and advice can be provided over the telephone. There is initial evidence from trials and systematic reviews to suggest that remotely provided physiotherapy can be used to manage a variety of musculoskeletal conditions safely and effectively. METHODS AND ANALYSIS: The aim of this single-blind randomised controlled non-inferiority trial is to determine whether a supported home exercise programme is as good as or better than face-to-face physiotherapy for the treatment of musculoskeletal conditions. Two hundred and ten participants will be recruited from five public hospitals in Sydney, Australia. Participants will be randomised to either the supported home exercise group or the face-to-face physiotherapy group. Participants allocated to the supported home exercise group will initially receive one face-to-face session with the trial physiotherapist and will then be managed remotely for the next 6 weeks. Participants allocated to the face-to-face physiotherapy group will receive a course of physiotherapy as typically provided in Sydney government hospitals. The primary outcome is function measured by the Patient Specific Functional Scale at 6 weeks. There will be nine secondary outcomes measured at 6 and 26 weeks. Separate analyses will be conducted on each outcome, and all analyses will be conducted on an intention-to-treat basis. A health economic evaluation will be conducted from a health funder plus patient perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained on the 17 March 2017 from the Northern Sydney Local Health District HREC, trial number HREC/16HAWKE/431-RESP/16/287. The results of this study will be submitted for publication to peer-reviewed journals and be presented at national and international conferences. Recruitment commenced in March 2019, and it is anticipated that the trial will be completed by December 2021. This trial will investigate two different models of physiotherapy care for people with musculoskeletal conditions. TRIAL REGISTRATION NUMBER: CPMP/ICH-135/95. PROTOCOL VERSION: The most recent version of the protocol is V.1.2 dated November 2019.


Asunto(s)
Terapia por Ejercicio , Fisioterapeutas , Australia , Humanos , Estudios Multicéntricos como Asunto , Modalidades de Fisioterapia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Resultado del Tratamiento
12.
BMC Public Health ; 21(1): 946, 2021 05 19.
Artículo en Inglés | MEDLINE | ID: mdl-34006237

RESUMEN

INTRODUCTION: After testing the interventions for improving the prevalence of contraceptive use, very few studies have measured the long-term effects thereafter the end of the implementation. This study aimed to measure Yam Daabo interventions' effects on contraceptive use in Burkina Faso at twelve months after completion of the intervention. METHODS: Yam Daabo was a two-group, multi-intervention, single-blind, cluster randomized controlled trial. Interventions comprised refresher training for the provider, a counseling tool, supportive supervision, availability of contraceptive services 7 days a week, client appointment cards, and invitation letters for partners. We used generalized linear mixed-effects models (log Poisson) to compare the modern contraceptive prevalence at 12 months post-intervention in the two groups. We collected data between September and November 2018. We conducted an intention-to-treat analysis and adjusted the prevalence ratios on cluster effects and unbalanced baseline characteristics. RESULTS: Twelve months after the completion of the Yam Daabo trial, we interviewed 87.4% (485 out of 555 women with available data at 12 months, that is, 247/276 in the intervention group (89.5%) and 238/279 in the control group (85.3%). No difference was observed in the use of hormonal contraceptive methods between the intervention and control groups (adjusted prevalence ratio = 1.21; 95% confidence interval [CI] = [0.91-1.61], p = 0.191). By contrast, women in the intervention group were more likely to use long-acting reversible contraceptives (LARC) than those in the control group (adjusted prevalence ratio = 1.35; 95% CI = [1.08-1.69], p = 0.008). CONCLUSION: Twelve months after completion of the intervention, we found no significant difference in hormonal contraceptive use between women in the intervention and their control group counterparts. However, women in the intervention group were significantly more likely to use long-acting reversible contraceptives than those in the control group. TRIAL REGISTRATION: The trial registration number at the Pan African Clinical Trials Registry is PACTR201609001784334 . The date of the first registration is 27/09/2016.


Asunto(s)
Dioscorea , Servicios de Planificación Familiar , Burkina Faso , Anticoncepción , Femenino , Humanos , Periodo Posparto , Embarazo , Método Simple Ciego
13.
N Engl J Med ; 384(20): 1910-1920, 2021 05 20.
Artículo en Inglés | MEDLINE | ID: mdl-34010530

RESUMEN

BACKGROUND: The effectiveness of endovascular therapy in patients with stroke caused by basilar-artery occlusion has not been well studied. METHODS: We randomly assigned patients within 6 hours after the estimated time of onset of a stroke due to basilar-artery occlusion, in a 1:1 ratio, to receive endovascular therapy or standard medical care. The primary outcome was a favorable functional outcome, defined as a score of 0 to 3 on the modified Rankin scale (range, 0 to 6, with 0 indicating no disability, 3 indicating moderate disability, and 6 indicating death) at 90 days. The primary safety outcomes were symptomatic intracranial hemorrhage within 3 days after the initiation of treatment and mortality at 90 days. RESULTS: A total of 300 patients were enrolled (154 in the endovascular therapy group and 146 in the medical care group). Intravenous thrombolysis was used in 78.6% of the patients in the endovascular group and in 79.5% of those in the medical group. Endovascular treatment was initiated at a median of 4.4 hours after stroke onset. A favorable functional outcome occurred in 68 of 154 patients (44.2%) in the endovascular group and 55 of 146 patients (37.7%) in the medical care group (risk ratio, 1.18; 95% confidence interval [CI], 0.92 to 1.50). Symptomatic intracranial hemorrhage occurred in 4.5% of the patients after endovascular therapy and in 0.7% of those after medical therapy (risk ratio, 6.9; 95% CI, 0.9 to 53.0); mortality at 90 days was 38.3% and 43.2%, respectively (risk ratio, 0.87; 95% CI, 0.68 to 1.12). CONCLUSIONS: Among patients with stroke from basilar-artery occlusion, endovascular therapy and medical therapy did not differ significantly with respect to a favorable functional outcome, but, as reflected by the wide confidence interval for the primary outcome, the results of this trial may not exclude a substantial benefit of endovascular therapy. Larger trials are needed to determine the efficacy and safety of endovascular therapy for basilar-artery occlusion. (Funded by the Dutch Heart Foundation and others; BASICS ClinicalTrials.gov number, NCT01717755; Netherlands Trial Register number, NL2500.).


Asunto(s)
Procedimientos Endovasculares , Fibrinolíticos/uso terapéutico , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Insuficiencia Vertebrobasilar/complicaciones , Anciano , Arteriopatías Oclusivas/complicaciones , Arteria Basilar/diagnóstico por imagen , Intervalos de Confianza , Femenino , Humanos , Análisis de Intención de Tratar , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Método Simple Ciego , Accidente Cerebrovascular/tratamiento farmacológico , Accidente Cerebrovascular/etiología , Accidente Cerebrovascular/mortalidad , Terapia Trombolítica , Tiempo de Tratamiento , Resultado del Tratamiento
14.
Lancet Public Health ; 6(6): e416-e427, 2021 06.
Artículo en Inglés | MEDLINE | ID: mdl-33991482

RESUMEN

BACKGROUND: The effectiveness of the COVID-19 vaccination programme depends on mass participation: the greater the number of people vaccinated, the less risk to the population. Concise, persuasive messaging is crucial, particularly given substantial levels of vaccine hesitancy in the UK. Our aim was to test which types of written information about COVID-19 vaccination, in addition to a statement of efficacy and safety, might increase vaccine acceptance. METHODS: For this single-blind, parallel-group, randomised controlled trial, we aimed to recruit 15 000 adults in the UK, who were quota sampled to be representative. Participants were randomly assigned equally across ten information conditions stratified by level of vaccine acceptance (willing, doubtful, or strongly hesitant). The control information condition comprised the safety and effectiveness statement taken from the UK National Health Service website; the remaining conditions addressed collective benefit, personal benefit, seriousness of the pandemic, and safety concerns. After online provision of vaccination information, participants completed the Oxford COVID-19 Vaccine Hesitancy Scale (outcome measure; score range 7-35) and the Oxford Vaccine Confidence and Complacency Scale (mediation measure). The primary outcome was willingness to be vaccinated. Participants were analysed in the groups they were allocated. p values were adjusted for multiple comparisons. The study was registered with ISRCTN, ISRCTN37254291. FINDINGS: From Jan 19 to Feb 5, 2021, 15 014 adults were recruited. Vaccine hesitancy had reduced from 26·9% the previous year to 16·9%, so recruitment was extended to Feb 18 to recruit 3841 additional vaccine-hesitant adults. 12 463 (66·1%) participants were classified as willing, 2932 (15·6%) as doubtful, and 3460 (18·4%) as strongly hesitant (ie, report that they will avoid being vaccinated for as long as possible or will never get vaccinated). Information conditions did not alter COVID-19 vaccine hesitancy in those willing or doubtful (adjusted p values >0·70). In those strongly hesitant, COVID-19 vaccine hesitancy was reduced, in comparison to the control condition, by personal benefit information (mean difference -1·49, 95% CI -2·16 to -0·82; adjusted p=0·0015), directly addressing safety concerns about speed of development (-0·91, -1·58 to -0·23; adjusted p=0·0261), and a combination of all information (-0·86, -1·53 to -0·18; adjusted p=0·0313). In those strongly hesitant, provision of personal benefit information reduced hesitancy to a greater extent than provision of information on the collective benefit of not personally getting ill (-0·97, 95% CI -1·64 to -0·30; adjusted p=0·0165) or the collective benefit of not transmitting the virus (-1·01, -1·68 to -0·35; adjusted p=0·0150). Ethnicity and gender were found to moderate information condition outcomes. INTERPRETATION: In the approximately 10% of the population who are strongly hesitant about COVID-19 vaccines, provision of information on personal benefit reduces hesitancy to a greater extent than information on collective benefits. Where perception of risk from vaccines is most salient, decision making becomes centred on the personal. As such, messaging that stresses the counterbalancing personal benefits is likely to prove most effective. The messaging from this study could be used in public health communications. Going forwards, the study highlights the need for future health campaigns to engage with the public on the terrain that is most salient to them. FUNDING: National Institute for Health Research (NIHR) Oxford Biomedical Research Centre and NIHR Oxford Health Biomedical Research Centre.


Asunto(s)
Vacunas contra la COVID-19/administración & dosificación , Comunicación en Salud/métodos , Comunicación Persuasiva , Vacunación/psicología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Método Simple Ciego , Reino Unido , Adulto Joven
15.
BMJ Open ; 11(3): e046664, 2021 03 08.
Artículo en Inglés | MEDLINE | ID: mdl-34006037

RESUMEN

INTRODUCTION: The massive scale-up of long-lasting insecticidal nets (LLINs) has led to major reductions in malaria burden in many sub-Saharan African countries. This progress is threatened by widespread insecticide resistance among malaria vectors. This cluster-randomised controlled trial (c-RCT) compares three of the most promising dual active ingredients LLINs (dual-AI LLINs), which incorporate mixtures of insecticides or insecticide synergists to standard LLINs in an area of pyrethroid insecticide resistance. METHODS: A four-arm, single-blinded, c-RCT will evaluate the effectiveness of three types of dual-AI LLINs (1) Royal Guard, combining two insecticides, pyriproxyfen and the pyrethroid alpha-cypermethrin; (2) Interceptor G2, combining chlorfenapyr and alpha-cypermethrin; (3) Olyset Plus, an LLIN combining a synergist, piperonyl butoxide and the pyrethroid permethrin, compared with; (4) Interceptor LN, a standard LLIN containing the pyrethroid alpha-cypermethrin as the sole AI. The primary outcomes are malaria infection prevalence in children aged 6 months-14 years and entomological inoculation rate (EIR), as a standard measure of malaria transmission at 24 months postintervention and cost-effectiveness. ETHICS AND DISSEMINATION: Ethical approval was received from the institutional review boards of the Tanzanian National Institute for Medical Research, Kilimanjaro Christian Medical University College, London School of Hygiene and Tropical Medicine, and University of Ottawa. Study findings will be actively disseminated via reports and presentations to stakeholders, local community leaders, and relevant national and international policy makers as well as through conferences, and peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT03554616.


Asunto(s)
Culicidae , Mosquiteros Tratados con Insecticida , Malaria , Piretrinas , Animales , Niño , Humanos , Resistencia a los Insecticidas , Londres , Malaria/prevención & control , Mosquitos Vectores , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Tanzanía
16.
Front Public Health ; 9: 594953, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33968872

RESUMEN

Prospective Memory (PM) is a cognitive function affected by aging. PM is the memory of future intentions and is significantly involved in everyday life, especially among older adults. Nevertheless, there are a few studies focused on PM training among healthy older adults and these studies did not report the optimal duration of training regarding improving PM performance among older adults. The present study aimed to determine the effective duration for training PM performance among healthy older adults. The current study was a randomized, controlled, single-blind, within-participants crossover trial including a training program with a duration of 12 h. The sample of 25 older adults aged 55 to 74 years recruited from the active members of the University of the Third Age (U3A), Kuala Lumpur/Selangor, their family members, and friends. The study design ensured some participants would receive the training after baseline while others would wait for 6 weeks after the baseline before receiving the training. All participants were evaluated five times: at baseline, 6, 12, 16, and at 24 weeks post-baseline. Moreover, the training program ensured all participants were assessed after each training session. The minimum number of hours to achieve training effects for this multi-component training program was eight. Results supported the efficacy of the training program in improving PM performance among healthy older adults. Also, the optimal duration for the multicomponent training program on PM performance among healthy older adults was obtained. This trial is registered at isrctn.com (#ISRCTN57600070).


Asunto(s)
Memoria Episódica , Anciano , Envejecimiento , Cognición , Humanos , Aprendizaje , Persona de Mediana Edad , Método Simple Ciego
17.
BMC Infect Dis ; 21(1): 411, 2021 May 04.
Artículo en Inglés | MEDLINE | ID: mdl-33947344

RESUMEN

BACKGROUND AND OBJECTIVES: An effective treatment option is not yet available for SARS-CoV2, which causes the COVID-19 pandemic and whose effects are felt more and more every day. Ivermectin is among the drugs whose effectiveness in treatment has been investigated. In this study; it was aimed to investigate the presence of gene mutations that alter ivermectin metabolism and cause toxic effects in patients with severe COVID-19 pneumonia, and to evaluate the effectiveness and safety of ivermectin use in the treatment of patients without mutation. MATERIALS AND METHODS: Patients with severe COVID19 pneumonia were included in the study, which was planned as a prospective, randomized, controlled, single-blind phase 3 study. Two groups, the study group and the control group, took part in the study. Ivermectin 200 mcg/kg/day for 5 days in the form of a solution prepared for enteral use added to the reference treatment protocol -hydroxychloroquine + favipiravir + azithromycin- of patients included in the study group. Patients in the control group were given only reference treatment with 3 other drugs without ivermectin. The presence of mutations was investigated by performing sequence analysis in the mdr1/abcab1 gene with the Sanger method in patients included in the study group according to randomization. Patients with mutations were excluded from the study and ivermectin treatment was not continued. Patients were followed for 5 days after treatment. At the end of the treatment and follow-up period, clinical response and changes in laboratory parameters were evaluated. RESULTS: A total of 66 patients, 36 in the study group and 30 in the control group were included in the study. Mutations affecting ivermectin metabolism was detected in genetic tests of six (16.7%) patients in the study group and they were excluded from the study. At the end of the 5-day follow-up period, the rate of clinical improvement was 73.3% (22/30) in the study group and was 53.3% (16/30) in the control group (p = 0.10). At the end of the study, mortality developed in 6 patients (20%) in the study group and in 9 (30%) patients in the control group (p = 0.37). At the end of the follow-up period, the average peripheral capillary oxygen saturation (SpO2) values of the study and control groups were found to be 93.5 and 93.0%, respectively. Partial pressure of oxygen (PaO2)/FiO2 ratios were determined as 236.3 ± 85.7 and 220.8 ± 127.3 in the study and control groups, respectively. While the blood lymphocyte count was higher in the study group compared to the control group (1698 ± 1438 and 1256 ± 710, respectively) at the end of the follow-up period (p = 0.24); reduction in serum C-reactive protein (CRP), ferritin and D-dimer levels was more pronounced in the study group (p = 0.02, p = 0.005 and p = 0.03, respectively). CONCLUSIONS: According to the findings obtained, ivermectin can provide an increase in clinical recovery, improvement in prognostic laboratory parameters and a decrease in mortality rates even when used in patients with severe COVID-19. Consequently, ivermectin should be considered as an alternative drug that can be used in the treatment of COVID-19 disease or as an additional option to existing protocols.


Asunto(s)
Antivirales/uso terapéutico , COVID-19/tratamiento farmacológico , Ivermectina/uso terapéutico , Neumonía Viral/tratamiento farmacológico , Subfamilia B de Transportador de Casetes de Unión a ATP/genética , Anciano , Amidas/uso terapéutico , Antivirales/farmacocinética , Azitromicina/uso terapéutico , COVID-19/sangre , COVID-19/mortalidad , Citocromo P-450 CYP3A/genética , Quimioterapia Combinada , Femenino , Humanos , Hidroxicloroquina/uso terapéutico , Ivermectina/farmacocinética , Masculino , Persona de Mediana Edad , Neumonía Viral/sangre , Neumonía Viral/virología , Estudios Prospectivos , Pirazinas/uso terapéutico , Método Simple Ciego , Resultado del Tratamiento
18.
BMJ Open ; 11(5): e046782, 2021 05 26.
Artículo en Inglés | MEDLINE | ID: mdl-34039576

RESUMEN

INTRODUCTION: Pacing-induced cardiomyopathy occasionally occurs in patients undergoing pacemaker implantation. Although compared with right ventricular (RV) apical pacing, RV septal pacing can attenuate left ventricular dyssynchrony; the success rate of lead placement on the RV septum using the stylet system is low. Additionally, no randomised controlled trial has addressed the issue regarding the accuracy of RV lead placement on the RV septum using the stylet and delivery catheter systems. This study hypothesises that a newly available delivery catheter system can improve the accuracy of RV lead placement on the RV septum. METHODS AND ANALYSIS: In a multicentre, prospective, randomised, single-blind, controlled trial, 70 patients with pacemaker indication owing to atrioventricular block will be randomised to either the delivery catheter or stylet group before the pacemaker implantation procedure. The position of the RV lead tip will be assessed using ECG-gated cardiac CT in all patients within 4 weeks after pacemaker implantation. Lead tip positions are classified into three groups: (1) RV septum, (2) anterior/posterior edge of the RV septal wall and (3) RV free wall. The primary endpoint will be the success rate of RV lead tip placement on the RV septum, which will be evaluated using cardiac CT. ETHICS AND DISSEMINATION: This study will be conducted according to the stipulations of the Helsinki Declaration and the institutional review board of Hamamatsu University School of Medicine. The results of the study will be disseminated at several research conferences and will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: jRCTs042200014; Pre-results.


Asunto(s)
Tabique Interventricular , Catéteres , Ventrículos Cardíacos/diagnóstico por imagen , Humanos , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego , Tomografía Computarizada por Rayos X , Tabique Interventricular/diagnóstico por imagen
19.
BMC Oral Health ; 21(1): 225, 2021 04 30.
Artículo en Inglés | MEDLINE | ID: mdl-33941170

RESUMEN

BACKGROUND: To evaluate the success of plaque reduction after external toothbrushing by instructed laypeople versus dental professionals using either a manual or powered toothbrush. Longitudinal, randomized, parallel-group intervention study in periodontitis patients with reduced oral hygiene quality undergoing anti-infective therapy. Patients were randomly and equally assigned to one of four groups: laypeople using a manual or powered toothbrush or dental professionals using a manual or powered toothbrush. Plaque reduction (Quigley-Hein-Index (QHI), Marginal Plaque Index (MPI)), gingivitis (papilla bleeding index), and cleaning time (seconds) were investigated. RESULTS: Thirty-nine patients participated in the study. Neither the choice of toothbrush (p = 0.399) nor the use of a dental professional (p = 0.790) had a significant influence on plaque levels achieved. However, multivariate modeling indicated statistically significant differences in the external cleaning time between brushing groups, with longer time required by laypeople (p = 0.002) and longer use of the powered toothbrush (p = 0.024). CONCLUSION: When the ability to carry out personal oral hygiene is reduced, external brushing by dental professionals or instructed laypeople who meet previously defined criteria such as sufficient personal oral hygiene at home could help to fill the emerging dental care gap. A combination of oral hygiene approaches adapted to the individual needs of the patients in need of external help is necessary for optimum oral hygiene. TRIAL REGISTRATION: German Clinical Trials register ( https://www.germanctr.de ; number DRKS00018779; date of registration 04/11/2019).


Asunto(s)
Gingivitis , Cepillado Dental , Índice de Placa Dental , Diseño de Equipo , Gingivitis/prevención & control , Humanos , Higiene Bucal , Índice Periodontal , Método Simple Ciego
20.
BMJ Open ; 11(5): e043156, 2021 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-34006542

RESUMEN

INTRODUCTION: Dyspnoea is common in patients with interstitial lung disease (ILD) and often refractory to conventional treatment. Little is known about the efficacy of systemic morphine for dyspnoea in patients with ILD. The aim of this study is to estimate the efficacy of a single subcutaneous morphine injection for dyspnoea in patients with ILD. METHODS AND ANALYSIS: We will conduct a multicentre, prospective, randomised, placebo-controlled, single-blinded phase II study of a single subcutaneous morphine injection for dyspnoea in patients with ILD. In patients with ILD who have dyspnoea at rest refractory to conventional treatment will be eligible for participation in this study. The morphine dose will be 2 mg. The primary endpoint is changes in dyspnoea intensity from baseline to 60 min after treatment as measured using an 11-point Numerical Rating Scale and compared between the morphine and placebo groups. ETHICS AND DISSEMINATION: Ethical approval has been obtained by the Osaka City University Certified Review Board. The results of this study will be submitted for publication in an international peer-reviewed journal and the findings will be presented at international scientific conferences. TRIAL REGISTRATION NUMBER: jRCTs051190030; pre-results.


Asunto(s)
Enfermedades Pulmonares Intersticiales , Morfina , Ensayos Clínicos Fase II como Asunto , Método Doble Ciego , Disnea/tratamiento farmacológico , Disnea/etiología , Humanos , Enfermedades Pulmonares Intersticiales/complicaciones , Enfermedades Pulmonares Intersticiales/tratamiento farmacológico , Estudios Multicéntricos como Asunto , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Método Simple Ciego
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