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1.
BMJ ; 366: l5101, 2019 09 18.
Artigo em Inglês | MEDLINE | ID: mdl-31533934

RESUMO

OBJECTIVE: To determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke. DESIGN: Multicentre, randomised controlled, endpoint blinded trial. SETTING: Seven inpatient rehabilitation sites in Germany (2013-17). PARTICIPANTS: 200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care. INTERVENTION: Participants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment. MAIN OUTCOME MEASURES: The primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values. RESULTS: Compared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (-5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36). CONCLUSIONS: Among moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT01953549.


Assuntos
Terapia por Exercício/métodos , Aptidão Física/fisiologia , Reabilitação do Acidente Vascular Cerebral/métodos , Atividades Cotidianas , Adulto , Idoso , Avaliação da Deficiência , Teste de Esforço , Terapia por Exercício/efeitos adversos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Recuperação de Função Fisiológica , Terapia de Relaxamento , Índice de Gravidade de Doença , Método Simples-Cego , Acidente Vascular Cerebral/fisiopatologia , Reabilitação do Acidente Vascular Cerebral/efeitos adversos , Resultado do Tratamento , Caminhada/fisiologia
2.
Am J Orthod Dentofacial Orthop ; 156(3): 303-311, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31474260

RESUMO

INTRODUCTION: One of the goals of malocclusion treatment is to improve the oral health-related quality of life (OHRQoL) of patients. The aim of this trial was to assess the OHRQoL of children before, during, and after anterior open bite (AOB) correction, compared with nontreated children, in a 2-arm parallel single-blind randomized controlled trial. METHODS: Eighty children with AOB aged 8-10 years were randomly assigned to 2 groups (n = 40 each): a group treated with the use of fixed palatal crib (FPC; TG) and a control group (nontreated; CG). Randomization was performed with the use of BioEstat software. The outcome (OHRQoL) was assessed with the use of the validated Brazilian Portuguese version of the Child Perceptions Questionnaire (CPQ8-10) applied before (baseline, phase 1), 3 months after FPC placement (phase 2), and 1 month after FPC removal (phase 3) in the TG. In the CG, CPQ8-10 was applied at baseline (phase 1), 3 months (phase 2), and 12 months (phase 3). Data were analyzed by means of a blinded statistic with the use of Friedman, Wilcoxon, and Mann-Whitney tests (α = 0.05). RESULTS: All participants finished the RCT, and demographic characteristics were similar between groups. In phase 1, the TG had lower scores for the "social well-being" domain (P = 0.02). In phase 2, the CG had higher scores than the TG for the "emotional well-being" and "social well-being" domains, but the opposite was observed for "oral symptoms" and "functional limitations" (P < 0.001). In phase 3, the TG showed a lower impact on OHRQoL than the CG in all domains and in the overall score (P < 0.001). In the 3 phases, the CG showed progressive increase (mean scores 70.37, 74.70, and 84.22, respectively; P < 0.001) and the TG a decrease (mean scores 70.20, 70.80, and 6.05, respectively; P < 0.001) in overall scores. The increase of scores in the CG was considered to represent a serious harm. CONCLUSIONS: Correction of AOB had a positive impact and failure to correct it had a negative impact on the OHRQoL of children. REGISTRATION: This trial was not registered. PROTOCOL: The protocol was not published before trial commencement.


Assuntos
Mordida Aberta/psicologia , Mordida Aberta/terapia , Saúde Bucal , Qualidade de Vida , Brasil , Criança , Estética Dentária , Feminino , Humanos , Masculino , Má Oclusão/complicações , Ortodontia Corretiva , Método Simples-Cego , Inquéritos e Questionários
3.
Arch Endocrinol Metab ; 63(4): 376-384, 2019 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-31365624

RESUMO

OBJECTIVE: To test the influence of oral fructose and glucose dose-response solutions in blood glucose (BG), glucagon, triglycerides, uricaemia, and malondialdehyde in postprandial states in type 1 diabetes mellitus (T1DM) patients. SUBJECTS AND METHODS: The study had a simple-blind, randomized, two-way crossover design in which T1DM patients were selected to receive fructose and glucose solutions (75g of sugars dissolved in 200 mL of mineral-water) in two separate study days, with 2-7 weeks washout period. In each day, blood samples were drawn after 8h fasting and at 180 min postprandial to obtain glucose, glucagon, triglycerides, uric acid, lactate, and malondialdehyde levels. RESULTS: Sixteen T1DM patients (seven men) were evaluated, with a mean age of 25.19 ± 8.8 years, a mean duration of disease of 14.88 ± 4.73 years, and glycated hemoglobin of 8.13 ± 1.84%. Fructose resulted in lower postprandial BG levels than glucose (4.4 ± 5.5 mmol/L; and 12.9 ± 4.1 mmol/L, respectively; p < 0.01). Uric acid levels increased after fructose (26.1 ± 49.9 µmol/L; p < 0.01) and reduced after glucose (-13.6 ± 9.5 µmol/L; p < 0.01). The malondialdehyde increased after fructose (1.4 ± 1.6 µmol/L; p < 0.01) and did not change after glucose solution (-0.2 ± 1.6 µmol/L; p = 0.40). Other variables did not change. CONCLUSIONS: Fructose and glucose had similar sweetness, flavor and aftertaste characteristics and did not change triglycerides, lactate or glucagon levels. Although fructose resulted in lower postprandial BG than glucose, it increased uric acid and malondialdehyde levels in T1DM patients. Therefore it should be used with caution. ClinicalTrials.gov registration: NCT01713023.


Assuntos
Diabetes Mellitus Tipo 1/metabolismo , Frutose/metabolismo , Glucose/metabolismo , Período Pós-Prandial/efeitos dos fármacos , Edulcorantes/metabolismo , Adolescente , Adulto , Glicemia/análise , Glicemia/efeitos dos fármacos , Estudos Cross-Over , Relação Dose-Resposta a Droga , Tolerância a Medicamentos , Feminino , Frutose/farmacologia , Glucose/farmacologia , Humanos , Masculino , Malondialdeído/sangue , Pessoa de Meia-Idade , Projetos Piloto , Método Simples-Cego , Soluções/farmacologia , Edulcorantes/farmacologia , Paladar/efeitos dos fármacos , Triglicerídeos/sangue , Ácido Úrico/sangue , Adulto Jovem
4.
Medicine (Baltimore) ; 98(32): e16768, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31393397

RESUMO

BACKGROUND: As the number of patients who suffer from non-specific chronic neck pain (CNP) is increasing in the Republic of Korea, conservative treatments for patients with CNP have been spotlighted. Although several studies on thread embedding acupuncture (TEA) treatment have been published for the treatment of such patients, no randomized controlled trial has been reported that investigates the effectiveness and safety of the TEA treatment compared with other conservative treatments for the treatment of patients with CNP. Therefore, the purpose of this trial is to compare the effectiveness and safety of TEA to those of physical therapy (PT) for the treatment of patients with CNP. METHODS/DESIGN: This study is planned as a parallel design, randomized, controlled, assessor-blinded, clinical study. One hundred twenty-eight patients diagnosed with CNP will be randomly assigned to either the TEA group or the PT group in a 1:1 ratio. Participants in the TEA group will receive 4 sessions of TEA treatment, while those in the PT group will receive 8 sessions of PT treatment over 4 weeks. An assessment of effectiveness based on the outcomes of the Neck Pain and Disability Scale (NPDS), cervical spinal angle, Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Patient Global Impression of Change (PGIC), EuroQol-Five Dimension 3 level version (EQ-5D-3L), and Pressure Pain Threshold (PPT) will be conducted at baseline, and at 5, 9, and 13 weeks. The primary outcome is the mean change in the NPDS at 9 weeks. Adverse events (AEs) will be recorded at every visit. DISCUSSION: The results of this study will be expected to provide useful information for the effectiveness and safety of TEA treatment compared to PT treatment for patients with CNP. TRIAL REGISTRATION: Clinical Research Information Service of Republic of Korea (CRIS- KCT0003720), April 5, 2019.


Assuntos
Terapia por Acupuntura/métodos , Cervicalgia/terapia , Modalidades de Fisioterapia , Polidioxanona/química , Projetos de Pesquisa , Terapia por Acupuntura/efeitos adversos , Dor Crônica , Avaliação da Deficiência , Humanos , Saúde Mental , Método Simples-Cego
5.
Medicine (Baltimore) ; 98(35): e16978, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31464945

RESUMO

INTRODUCTION: Inhalation sedation is a proven safe method for reducing children's dental anxiety and has been used worldwide for decades. There is controversy regarding the use of acclimatization or familiarization visits for dental sedation treatment pathways for children. This may increase acceptance to the treatment based on desensitization and acclimatization principles underpinning many behavior management techniques. This study aims to identify whether, an inhalation sedation acclimatization visit is effective in reducing the stress level in anxious children as measured by salivary Alpha Amylase and Cortisol levels. METHODS: The study is a single-center, single blinded, parallel group 2 arm clinical trial. Children in need of inhalation sedation aged 5 to 15 years from September 2019 through March 2020 attending the Postgraduate Pediatric Clinic at the Hamdan Bin Mohammed College of Dental Medicine, in Dubai, will be allocated randomly and equally to either:At the initial visit a salivary sample will be collected at the beginning of the visit and the sedation need score will be recorded using the pediatric indicator of sedation need. Treatment for both groups will commence at the second visit. Salivary samples will be collected 15 minutes before the start of the treatment and 15 minutes after the conclusion of the treatment. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment using Frankl rating behavior scale and physiological anxiety related changes will be recorded using salivary Alpha Amylase and Cortisol levels. Mean changes of physiologic anxiety levels and corresponding 95% confidence intervals will be determined to compare the 2 treatments (sedation with familiarization and sedation without familiarization). DISCUSSION: This is will be the first study to measure the effect of the acclimatization visit of nitrous oxide inhalation sedation on the level of physiological anxiety and the behavior of the pediatric patients during treatment.


Assuntos
Sedação Consciente/métodos , Ansiedade ao Tratamento Odontológico/prevenção & controle , Ansiedade ao Tratamento Odontológico/fisiopatologia , Aceitação pelo Paciente de Cuidados de Saúde , alfa-Amilases Salivares/análise , Adolescente , Criança , Comportamento Infantil , Pré-Escolar , Feminino , Humanos , Hidrocortisona/sangue , Masculino , Projetos de Pesquisa , Método Simples-Cego , Emirados Árabes Unidos
6.
JAMA ; 322(2): 123-133, 2019 07 09.
Artigo em Inglês | MEDLINE | ID: mdl-31287523

RESUMO

Importance: Herpes zoster, a frequent complication following autologous hematopoietic stem cell transplantation (HSCT), is associated with significant morbidity. A nonlive adjuvanted recombinant zoster vaccine has been developed to prevent posttransplantation zoster. Objective: To assess the efficacy and adverse event profile of the recombinant zoster vaccine in immunocompromised autologous HSCT recipients. Design, Setting, and Participants: Phase 3, randomized, observer-blinded study conducted in 167 centers in 28 countries between July 13, 2012, and February 1, 2017, among 1846 patients aged 18 years or older who had undergone recent autologous HSCT. Interventions: Participants were randomized to receive 2 doses of either recombinant zoster vaccine (n = 922) or placebo (n = 924) administered into the deltoid muscle; the first dose was given 50 to 70 days after transplantation and the second dose 1 to 2 months thereafter. Main Outcomes and Measures: The primary end point was occurrence of confirmed herpes zoster cases. Results: Among 1846 autologous HSCT recipients (mean age, 55 years; 688 [37%] women) who received 1 vaccine or placebo dose, 1735 (94%) received a second dose and 1366 (74%) completed the study. During the 21-month median follow-up, at least 1 herpes zoster episode was confirmed in 49 vaccine and 135 placebo recipients (incidence, 30 and 94 per 1000 person-years, respectively), an incidence rate ratio (IRR) of 0.32 (95% CI, 0.22-0.44; P < .001), equivalent to 68.2% vaccine efficacy. Of 8 secondary end points, 3 showed significant reductions in incidence of postherpetic neuralgia (vaccine, n=1; placebo, n=9; IRR, 0.1; 95% CI, 0.00-0.78; P = .02) and of other prespecified herpes zoster-related complications (vaccine, n=3; placebo, n=13; IRR, 0.22; 95% CI, 0.04-0.81; P = .02) and in duration of severe worst herpes zoster-associated pain (vaccine, 892.0 days; placebo, 6275.0 days; hazard ratio, 0.62; 95% CI, 0.42-0.89; P = .01). Five secondary objectives were descriptive. Injection site reactions were recorded in 86% of vaccine and 10% of placebo recipients, of which pain was the most common, occurring in 84% of vaccine recipients (grade 3: 11%). Unsolicited and serious adverse events, potentially immune-mediated diseases, and underlying disease relapses were similar between groups at all time points. Conclusions and Relevance: Among adults who had undergone autologous HSCT, a 2-dose course of recombinant zoster vaccine compared with placebo significantly reduced the incidence of herpes zoster over a median follow-up of 21 months. Trial Registration: ClinicalTrials.gov Identifier: NCT01610414.


Assuntos
Transplante de Células-Tronco Hematopoéticas , Vacina contra Herpes Zoster , Herpes Zoster/prevenção & controle , Hospedeiro Imunocomprometido , Adjuvantes Imunológicos , Adulto , Feminino , Seguimentos , Herpes Zoster/epidemiologia , Vacina contra Herpes Zoster/administração & dosagem , Hospitalização/estatística & dados numéricos , Humanos , Incidência , Injeções Intramusculares , Masculino , Pessoa de Meia-Idade , Neuralgia Pós-Herpética/prevenção & controle , Modelos de Riscos Proporcionais , Método Simples-Cego , Transplante Autólogo , Vacinas Sintéticas/administração & dosagem
7.
Bone Joint J ; 101-B(7): 793-799, 2019 07.
Artigo em Inglês | MEDLINE | ID: mdl-31256660

RESUMO

AIMS: The aim of this randomized trial was to compare the functional outcome of two different surgical approaches to the hip in patients with a femoral neck fracture treated with a hemiarthroplasty. PATIENTS AND METHODS: A total of 150 patients who were treated between February 2014 and July 2017 were included. Patients were allocated to undergo hemiarthroplasty using either an anterolateral or a direct lateral approach, and were followed for 12 months. The mean age of the patients was 81 years (69 to 90), and 109 were women (73%). Functional outcome measures, assessed by a physiotherapist blinded to allocation, and patient-reported outcome measures (PROMs) were collected postoperatively at three and 12 months. RESULTS: A total of 11 patients in the direct lateral group had a positive Trendelenburg test at one year compared with one patient in the anterolateral group (11/55 (20%) vs 1/55 (1.8%), relative risk (RR) 11.1; p = 0.004). Patients with a positive Trendelenburg test reported significantly worse Hip Disability Osteoarthritis Outcome Scores (HOOS) compared with patients with a negative Trendelenburg test. Further outcome measures showed few statistically significant differences between the groups. CONCLUSION: The direct lateral approach in patients with a femoral neck fracture appears to be associated with more positive Trendelenburg tests than the anterolateral approach, indicating a poor clinical outcome. Cite this article: Bone Joint J 2019;101-B:793-799.


Assuntos
Fraturas do Colo Femoral/cirurgia , Indicadores Básicos de Saúde , Hemiartroplastia/métodos , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Masculino , Medidas de Resultados Relatados pelo Paciente , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento
8.
Am J Occup Ther ; 73(4): 7304205040p1-7304205040p9, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31318668

RESUMO

OBJECTIVE: We investigated whether demographic, disease-related, or personal baseline determinants can predict a positive response to energy conservation management (ECM). METHOD: We conducted a secondary analysis of a single-blind, two-parallel-arms randomized controlled trial that included ambulatory adults with severe MS-related fatigue. Therapy responders and nonresponders were categorized by Checklist Individual Strength fatigue change scores between baseline and end of treatment. Logistic regression analyses were used to assess the determinants of response. RESULTS: Sixty-nine participants were included (ECM group, n = 34; control group, n = 35). In the ECM group, fatigue severity, perception of fatigue, illness cognitions about MS, and social support discrepancies were related to the probability of being a responder. CONCLUSION: The results suggest that people with MS-related fatigue who had a less negative perception of fatigue and who perceived fewer disease benefits and a higher discrepancy in social support had the best response to ECM treatment.


Assuntos
Fadiga/fisiopatologia , Esclerose Múltipla , Humanos , Método Simples-Cego
9.
Medicine (Baltimore) ; 98(30): e16139, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31348227

RESUMO

BACKGROUND: Subacromial impingement syndrome (SIS) is a common clinical condition with a multifactorial etiology. Currently, there is a great variety of therapeutic exercise modalities aimed at treating SIS. Based on alterations of the glenohumeral and/or dysfunctional scapular kinematics associated with SIS, we hypothesize that the implementation of a specific exercise program with special focus on the correction of muscle deficits should be more effective than nonspecific exercises performed at home. This article describes the rationale and methods of study aimed at testing the effectiveness of specific exercise programs versus home exercises in patients with SIS. METHOD/DESIGN: Ninety-four patients between the ages of 18 and 50 years referred to the Physical Therapy department of the Clinical Hospital San Borja Arriaran in Chile will be randomized to 2 treatment arms. The intervention group will receive a program of specific exercises with a duration of 12 weeks, taking as a reference the algorithm of clinical decision proposed by a panel of experts. The control group will receive a program of nonspecific exercises to perform at home. Three evaluations will be performed: before the initiation of treatment, and at the 12-week and 1-year follow-up. The primary outcome measure will be the shoulder function by the Constant-Murley questionnaire, and the secondary outcome measures will be the upper extremity function by the Disabilities of the Arm, Shoulder and Hand questionnaire, and pain by the visual analog scale. DISCUSSION: This article reports the design of a randomized clinical trial aimed at assessing the effectiveness of a specific exercise program versus home exercises in patients with SIS. TRIAL REGISTRATION: Brazilian registry of clinical trials UTN number U1111-1204-0268. Registered 27 September 2017.


Assuntos
Terapia por Exercício/métodos , Síndrome de Colisão do Ombro/terapia , Adolescente , Adulto , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição da Dor , Método Simples-Cego , Adulto Jovem
10.
Medicine (Baltimore) ; 98(30): e16587, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31348298

RESUMO

BACKGROUND: Traumatic brain injury (TBI) has become a major cause of morbidity and mortality both in China and abroad. Disorders of consciousness following severe TBI is a common refractory complication, resulting in difficult rehabilitation and poor life quality. However, effective therapeutic approaches remain limited. Although acupuncture has been widely applied in the treatment of neurological disorders in China, its efficacy and safety for consciousness recovery remain to be elucidated. METHODS: Here, we conduct a study design and protocol of a randomized, blinded, controlled study to evaluate the efficacy and safety of electroacupuncture at auricular acupoints "heart" and "brainstem" combined with body acupuncture in the consciousness recovery of patients with TBI. A total of 80 patients with initial Glasgow coma scale score between 3 and 8 points will be recruited in the trial and randomized into intervention (combined application of auricular electroacupuncture and body acupuncture) group or control (conventional treatment) group. Patients in the intervention group will receive electroacupuncture at bilateral auricular acupoints "heart" and "brainstem" (4 points in total) combined with body acupuncture in addition to conventional treatment while patients in the control group will receive conventional treatment alone for 8 weeks. The primary outcomes are changes of Glasgow coma scale score and mismatch negativity of event-related brain potentials at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The secondary outcome measures will be changes of Barthel and FuglMeyer scores at baseline after 4 weeks after the final treatment and 4 weeks after the final treatment. The safety will also be assessed by monitoring the incidence of adverse events and changes in vital signs during the study. DISCUSSION: Results from this trial will significantly support the application of auricular acupuncture and body acupuncture in the consciousness recovery of patients with severe TBI. If found to be effective and safe, auricular acupuncture combined with body acupuncture will be a valuable complementary option for comatose patients with TBI. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1800020245. Registered on 21 December 2018.


Assuntos
Terapia por Acupuntura/métodos , Lesões Encefálicas Traumáticas/complicações , Transtornos da Consciência/etiologia , Transtornos da Consciência/terapia , Pontos de Acupuntura , Adolescente , Adulto , Idoso , Eletroacupuntura/métodos , Feminino , Escala de Coma de Glasgow , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Adulto Jovem
11.
Medicine (Baltimore) ; 98(27): e16275, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31277154

RESUMO

BACKGROUND: Halitosis is the term used to define an unpleasant odor emanating from the mouth. However, no studies have evaluated the causes and treatment of halitosis in the population of older adults with denture. METHODS: A randomized, controlled trial is proposed. The patients will be divided into 2 groups: G1: older adults who wear complete dentures and will be treated with tongue scraper (n = 20); G2 older adults who wear complete dentures and will be treated with PDT (n = 20). If the halitosis persists, the participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be made before and after treatments, with OralChroma. If the halitosis is solved, the participants will return after 1 week for an additional evaluation. Oral Health Impact Profile (OHIP-14) will be administered by a calibrated examiner on the day the patient history is taken (baseline) and 1 week after treatment for halitosis. DISCUSSION: This protocol will determine the effectiveness of photodynamic therapy regarding the reduction of halitosis in older adults with complete denture. TRIAL REGISTRATION: This protocol was registered in ClinicalTrial.gov, under number NCT03960983. It was first posted and last updated in May 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03960983.


Assuntos
Prótese Total/efeitos adversos , Halitose/tratamento farmacológico , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes/uso terapêutico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Idoso , Seguimentos , Humanos , Pessoa de Meia-Idade , Estudos Retrospectivos , Método Simples-Cego , Fatores de Tempo
12.
Medicine (Baltimore) ; 98(27): e16298, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31277165

RESUMO

BACKGROUND: The optimal treatment strategy for stage N2-3A/3B non-small cell lung cancer (NSCLC) remains controversial owing to its heterogeneity. Although multimodal therapy is considered the standard therapeutic approach for stage N2-3A/3B resectable NSCLC patients, the optimal combination strategy still needs to be clarified. PATIENTS AND METHODS: In total, 25 male and female patients aged between 20 and 75 years with stage N2-3A/3B resectable NSCLC will be included. Eligible patients will undergo tri-modality therapy comprising induction chemotherapy (3 cycles of combination therapy with carboplatin and nab-paclitaxel), followed by surgery and postoperative radiotherapy. Recruitment was commenced in April 2017, with a planned last follow-up in March 2024. As of May 2019, 1 subject has been enrolled. The primary endpoint is the treatment completion rate. The secondary endpoints are objective response rate (ORR) of induction chemotherapy, treatment-related adverse event, recurrence-free survival (RFS) time, and overall survival (OS) time. RFS and OS time will be calculated as the time from this study registration to first recurrence and all-cause death, respectively. ETHICS AND DISSEMINATION: The protocol was approved by the institutional review boards of Kyoto Prefectural University of Medicine and all the participating hospitals. Written informed consent was obtained from all patients before registration, in accordance with the Declaration of Helsinki. The study results will be disseminated via publication in peer-reviewed journals. TRIAL REGISTRATION: Trial registration number UMIN000025010 and jRCT1051180028.


Assuntos
Antineoplásicos/uso terapêutico , Carcinoma Pulmonar de Células não Pequenas/terapia , Quimioterapia de Indução/métodos , Neoplasias Pulmonares/terapia , Estadiamento de Neoplasias , Adulto , Idoso , Carcinoma Pulmonar de Células não Pequenas/diagnóstico , Intervalo Livre de Doença , Feminino , Seguimentos , Humanos , Neoplasias Pulmonares/diagnóstico , Masculino , Pessoa de Meia-Idade , Terapia Neoadjuvante , Pneumonectomia , Tomografia Computadorizada com Tomografia por Emissão de Pósitrons , Estudos Prospectivos , Radioterapia Adjuvante , Método Simples-Cego , Resultado do Tratamento , Adulto Jovem
13.
Am J Dent ; 32(3): 107-112, 2019 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-31295390

RESUMO

PURPOSE: The primary aim of this study was to evaluate the gingivitis-reduction efficacy of an experimental manual toothbrush with CrissCross and tapered bristle technology in comparison with a marketed control manual toothbrush with traditional design and non-tapered bristles. In addition, the study compared the two toothbrushes for plaque-reduction efficacy. METHODS: This was a randomized, controlled, parallel group, examiner-blind, single-center, 4-week clinical trial with adult subjects in good general health. All subjects had presence of gingivitis (at least 10 bleeding sites). The subjects were randomly assigned to one of two treatment groups: a manual toothbrush having CrissCross and tapered bristle technology (tapered group: Oral-B CrossAction Ultrathin manual toothbrush); or a traditional flat-trim design and regular non-tapered bristles (control group: Oral-B Indicator Soft 35 manual toothbrush). Subjects were instructed to brush twice-daily for 4 weeks with their assigned brush and a standard sodium fluoride dentifrice. At baseline, Week 2, and Week 4, gingivitis was assessed using the Mazza Modification of the Gingival Bleeding Index (Mazza GI) and pre-brushing whole-mouth plaque was measured using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI). RESULTS: 100 subjects (50 per group) were randomized to treatment and assessed at baseline, and 97 subjects (48 in the tapered group and 49 in the control group) completed the study. At both Weeks 2 and 4, both groups showed a significant (P< 0.005) reduction versus baseline in Mazza GI and number of bleeding sites, and the tapered group showed a significantly (P< 0.001) greater reduction from baseline for both these assessments compared to the control group. By Week 4 the tapered group showed a reduction from baseline of 17.9% in Mazza GI and 38.5% in the number of bleeding sites; the corresponding figures for the control group were 7.5% and 12.6%, respectively. Both groups showed a significant (P< 0.001) reduction versus baseline in TMQHPI by Week 4, with no significant (P=0.06) between-group difference. CLINICAL SIGNIFICANCE: The twice-daily use of a manual toothbrush with CrissCross design and tapered bristles had a statistically significantly greater gingivitis reduction compared to a manual toothbrush of traditional flat-trim design and regular non-tapered bristles, which could be a clinical advantage.


Assuntos
Placa Dentária , Gengivite , Escovação Dentária , Adulto , Placa Dentária/terapia , Gengivite/terapia , Humanos , Índice Periodontal , Método Simples-Cego
14.
Bone Joint J ; 101-B(7_Supple_C): 84-90, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-31256644

RESUMO

AIMS: The aim of this study was to determine whether closed suction drain (CSD) use influences recovery of quadriceps strength and to examine the effects of drain use on secondary outcomes: quadriceps activation, intra-articular effusion, bioelectrical measure of swelling, range of movement (ROM), pain, and wound healing complications. PATIENTS AND METHODS: A total of 29 patients undergoing simultaneous bilateral total knee arthroplasty (TKA) were enrolled in a prospective, randomized blinded study. Patients were randomized to receive a CSD in one limb while the contralateral limb had the use of a subcutaneous drain (SCDRN) without the use of suction ('sham drain'). Isometric quadriceps strength was collected as the primary outcome. Secondary outcomes consisted of quadriceps activation, intra-articular effusion measured via ultrasound, lower limb swelling measured with bioelectrical impendence and limb girth, knee ROM, and pain. Outcomes were assessed preoperatively and postoperatively at day two, two and six weeks, and three months. Differences between limbs were determined using paired Student's t-tests or Wilcoxon's signed-rank tests. RESULTS: No significant differences were identified between limbs prior to surgery for the primary or secondary outcomes. No significant differences in quadriceps strength were seen between CSD and SCDRN limbs at postoperative day two (p = 0.09), two weeks (primary endpoint) (p = 0.7), six weeks (p = 0.3), or three months (p = 0.5). The secondary outcome of knee extension ROM was significantly greater in the CSD limb compared with the SCDRN (p = 0.01) at two weeks following surgery, but this difference was absent at all other intervals. Secondary outcomes of quadriceps activation, intra-articular effusion, lower limb swelling, and pain were not found to differ significantly at any timepoint following surgery. CONCLUSION: The use of CSD during TKA did not influence quadriceps strength, quadriceps activation, intra-articular effusion, lower limb swelling, ROM, or pain. These results have limited drain use by the authors in primary uncomplicated TKA. Cite this article: Bone Joint J 2019;101-B (7 Supple C):84-90.


Assuntos
Artroplastia do Joelho/métodos , Drenagem/métodos , Articulação do Joelho/cirurgia , Complicações Pós-Operatórias/prevenção & controle , Músculo Quadríceps/fisiopatologia , Amplitude de Movimento Articular/fisiologia , Recuperação de Função Fisiológica , Idoso , Feminino , Humanos , Articulação do Joelho/fisiopatologia , Masculino , Pessoa de Meia-Idade , Força Muscular/fisiologia , Estudos Prospectivos , Método Simples-Cego , Resultado do Tratamento
15.
J Urol ; 202(3): 609-610, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31199176
16.
J Urol ; 202(3): 610, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31199177
17.
JAMA ; 321(21): 2092-2100, 2019 06 04.
Artigo em Inglês | MEDLINE | ID: mdl-31162569

RESUMO

Importance: Whether exercise reduces subsequent falls in high-risk older adults who have already experienced a fall is unknown. Objective: To assess the effect of a home-based exercise program as a fall prevention strategy in older adults who were referred to a fall prevention clinic after an index fall. Design, Setting, and Participants: A 12-month, single-blind, randomized clinical trial conducted from April 22, 2009, to June 5, 2018, among adults aged at least 70 years who had a fall within the past 12 months and were recruited from a fall prevention clinic. Interventions: Participants were randomized to receive usual care plus a home-based strength and balance retraining exercise program delivered by a physical therapist (intervention group; n = 173) or usual care, consisting of fall prevention care provided by a geriatrician (usual care group; n = 172). Both were provided for 12 months. Main Outcomes and Measures: The primary outcome was self-reported number of falls over 12 months. Adverse event data were collected in the exercise group only and consisted of falls, injuries, or muscle soreness related to the exercise intervention. Results: Among 345 randomized patients (mean age, 81.6 [SD, 6.1] years; 67% women), 296 (86%) completed the trial. During a mean follow-up of 338 (SD, 81) days, a total of 236 falls occurred among 172 participants in the exercise group vs 366 falls among 172 participants in the usual care group. Estimated incidence rates of falls per person-year were 1.4 (95% CI, 0.1-2.0) vs 2.1 (95% CI, 0.1-3.2), respectively. The absolute difference in fall incidence was 0.74 (95% CI, 0.04-1.78; P = .006) falls per person-year and the incident rate ratio was 0.64 (95% CI, 0.46-0.90; P = .009). No adverse events related to the intervention were reported. Conclusions and Relevance: Among older adults receiving care at a fall prevention clinic after a fall, a home-based strength and balance retraining exercise program significantly reduced the rate of subsequent falls compared with usual care provided by a geriatrician. These findings support the use of this home-based exercise program for secondary fall prevention but require replication in other clinical settings. Trial Registration: ClinicalTrials.gov Identifiers: NCT01029171; NCT00323596.


Assuntos
Acidentes por Quedas/prevenção & controle , Terapia por Exercício , Acidentes por Quedas/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Feminino , Seguimentos , Humanos , Vida Independente , Masculino , Equilíbrio Postural , Treinamento de Resistência , Prevenção Secundária/métodos , Método Simples-Cego
18.
Lancet ; 394(10194): 190-192, 2019 07 20.
Artigo em Inglês | MEDLINE | ID: mdl-31204111
19.
BJOG ; 126(10): 1259-1266, 2019 09.
Artigo em Inglês | MEDLINE | ID: mdl-31207009

RESUMO

OBJECTIVE: To compare the efficacy of intermittent intrauterine balloon dilatation versus standard care in the prevention of adhesion reformation. DESIGN: Single-blind randomised controlled trial. SETTING: Hysteroscopic Centre of a tertiary University Hospital. POPULATION: Two hundred patients with moderate to severe (European Society for Gynaecological Endoscopy Grade ≥II) intrauterine adhesions who underwent hysteroscopic adhesiolysis. METHODS: All participants were randomised to a balloon group or a control group postoperatively. The balloon group received intrauterine balloon dilatation therapy at 2 weeks and 6 weeks after surgery, whereas the control group did not. All patients underwent follow-up hysteroscopy at 4 and 8 weeks postoperatively. MAIN OUTCOME MEASURES: The adhesion reformation rate and the Pictorial Blood Loss Assessment Chart scores were analysed. RESULTS: A total of 191 patients successfully completed the study protocol (94 cases for the balloon group and 97 cases for the control group). According to hysteroscopic evaluation at the 8th week, the overall adhesion reformation rate was significantly lower in patients in the balloon group than patients in the control group (20.2% versus 40.2%, respectively; P < 0.05). There was also a significant increase in menstruation flow, as assessed by the Pictorial Blood Loss Assessment Chart score (30 versus 9, respectively; P < 0.001). CONCLUSIONS: Postoperative intermittent intrauterine balloon dilatation therapy can significantly reduce postoperative adhesion reformation and significantly increase menstruation flow. TWEETABLE ABSTRACT: RCT: Postoperative intermittent intrauterine balloon therapy can prevent adhesion reformation after hysteroscopic adhesiolysis.


Assuntos
Histeroscopia/efeitos adversos , Dispositivos Intrauterinos , Complicações Pós-Operatórias/prevenção & controle , Aderências Teciduais/prevenção & controle , Tamponamento com Balão Uterino/métodos , Doenças Uterinas/patologia , Doenças Uterinas/prevenção & controle , Adulto , China , Feminino , Humanos , Complicações Pós-Operatórias/patologia , Método Simples-Cego , Stents , Aderências Teciduais/patologia , Resultado do Tratamento
20.
Lancet ; 394(10194): 230-239, 2019 07 20.
Artigo em Inglês | MEDLINE | ID: mdl-31204115

RESUMO

BACKGROUND: The optimal technique of percutaneous coronary intervention in patients at high bleeding risk is not known. The hypothesis of the DEBUT trial was that percutaneous coronary intervention with drug-coated balloons is non-inferior to percutaneous coronary intervention with bare-metal stents for this population. METHODS: The DEBUT trial is a randomised, single-blind non-inferiority trial done at five sites in Finland. Patients were eligible if they had an ischaemic de-novo lesion in a coronary artery or bypass graft that could be treated with drug-coated balloons, at least one risk factor for bleeding, and a reference vessel diameter of 2·5-4·0 mm. Those with myocardial infarction with ST-elevation, bifurcation lesions needing a two-stent technique, in-stent restenosis, and flow-limiting dissection or substantial recoil (>30%) of the target lesion after predilation were excluded. After successful predilation of the target lesion, patients were randomly assigned (1:1), by use of a computer-generated random sequence, to percutaneous coronary intervention with a balloon coated with paclitaxel and iopromide or a bare-metal stent. The primary outcome was major adverse cardiac events at 9 months. Non-inferiority was shown if the absolute risk difference was no more than 3%. All prespecified analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01781546. FINDINGS: Between May 22, 2013, and Jan 16, 2017, 220 patients were recruited for the study and 208 patients were assigned to percutaneous coronary intervention with drug-coated balloon (n=102) or bare metal stent (n=106). At 9 months, major adverse cardiac events had occurred in one patient (1%) in the drug-coated balloon group and in 15 patients (14%) in the bare-metal stent group (absolute risk difference -13·2 percentage points [95% CI -6·2 to -21·1], risk ratio 0·07 [95% CI 0·01 to 0·52]; p<0·00001 for non-inferiority and p=0·00034 for superiority). Two definitive stent thrombosis events occurred in the bare metal stent group but no acute vessel closures in the drug-coated balloon group. INTERPRETATIONS: Percutaneous coronary intervention with drug-coated balloon was superior to bare-metal stents in patients at bleeding risk. The drug-coated balloon-only coronary intervention is a novel strategy to treat this difficult patient population. Comparison of this approach to the new generation drug-eluting stents is warranted in the future. FUNDING: B Braun Medical AG, AstraZeneca, and Competitive State Research Funding of the Kuopio University Hospital Catchment Area.


Assuntos
Angioplastia Coronária com Balão/instrumentação , Materiais Revestidos Biocompatíveis , Doença da Artéria Coronariana/terapia , Idoso , Idoso de 80 Anos ou mais , Angioplastia Coronária com Balão/métodos , Doença da Artéria Coronariana/complicações , Doença da Artéria Coronariana/patologia , Reestenose Coronária/prevenção & controle , Feminino , Hemorragia/etiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Paclitaxel/administração & dosagem , Método Simples-Cego , Stents , Moduladores de Tubulina/administração & dosagem
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