WATCHFUL Investigators*
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BACKGROUND: Physical activity is pivotal in managing heart failure with reduced ejection fraction, and walking integrated into daily life is an especially suitable form of physical activity. This study aimed to determine whether a 6-month lifestyle walking intervention combining self-monitoring and regular telephone counseling improves functional capacity assessed by the 6-minute walk test (6MWT) in patients with stable heart failure with reduced ejection fraction compared with usual care. METHODS: The WATCHFUL trial (Pedometer-Based Walking Intervention in Patients With Chronic Heart Failure With Reduced Ejection Fraction) was a 6-month multicenter, parallel-group randomized controlled trial recruiting patients with heart failure with reduced ejection fraction from 6 cardiovascular centers in the Czech Republic. Eligible participants were ≥18 years of age, had left ventricular ejection fraction <40%, and had New York Heart Association class II or III symptoms on guidelines-recommended medication. Individuals exceeding 450 meters on the baseline 6MWT were excluded. Patients in the intervention group were equipped with a Garmin vívofit activity tracker and received monthly telephone counseling from research nurses who encouraged them to use behavior change techniques such as self-monitoring, goal-setting, and action planning to increase their daily step count. The patients in the control group continued usual care. The primary outcome was the between-group difference in the distance walked during the 6MWT at 6 months. Secondary outcomes included daily step count and minutes of moderate to vigorous physical activity as measured by the hip-worn Actigraph wGT3X-BT accelerometer, NT-proBNP (N-terminal pro-B-type natriuretic peptide) and high-sensitivity C-reactive protein biomarkers, ejection fraction, anthropometric measures, depression score, self-efficacy, quality of life, and survival risk score. The primary analysis was conducted by intention to treat. RESULTS: Of 218 screened patients, 202 were randomized (mean age, 65 years; 22.8% female; 90.6% New York Heart Association class II; median left ventricular ejection fraction, 32.5%; median 6MWT, 385 meters; average 5071 steps/day; average 10.9 minutes of moderate to vigorous physical activity per day). At 6 months, no between-group differences were detected in the 6MWT (mean 7.4 meters [95% CI, -8.0 to 22.7]; P=0.345, n=186). The intervention group increased their average daily step count by 1420 (95% CI, 749 to 2091) and daily minutes of moderate to vigorous physical activity by 8.2 (95% CI, 3.0 to 13.3) over the control group. No between-group differences were detected for any other secondary outcomes. CONCLUSIONS: Whereas the lifestyle intervention in patients with heart failure with reduced ejection fraction improved daily steps by about 25%, it failed to demonstrate a corresponding improvement in functional capacity. Further research is needed to understand the lack of association between increased physical activity and functional outcomes. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03041610.
- MeSH
- chůze MeSH
- dysfunkce levé srdeční komory * MeSH
- funkce levé komory srdeční MeSH
- kvalita života MeSH
- lidé MeSH
- senioři MeSH
- srdeční selhání * terapie farmakoterapie MeSH
- tepový objem MeSH
- životní styl MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
OBJECTIVE: Despite advancing technology, national TB surveillance systems are still inadequate in terms of patient detection around the world. It was aimed to investigate suspicious cases detected by active surveillance method in pathology laboratories and to evaluate the effectiveness of this method in terms of finding new TB cases. METHODS: This is a descriptive cross-sectional study. It was administrated in Samsun, Turkey, between January 2012-December 2017. Within the scope of active surveillance, pathology laboratories were regularly visited and reported cases with granulomatous inflammation were assessed. The obtained patient list was compared with the records of the Electronic Tuberculosis Management System (ETMS). Patients who were not included in these records were invited to the dispensary and evaluated for TB. They were also referred to the relevant hospitals for diagnosis if necessary. Frequency values and descriptive statistics were calculated using SPSS method. RESULTS: It was found that 35.6% of 703 patients with the diagnosis of granulomatous inflammation were previously diagnosed, treated or currently undergoing treatment in the ETMS registry. As a result of the assessment of remaining 453 cases, 46 patients (10.1%) were newly diagnosed with TB. Newly diagnosed TB patients were reported, and their treatment started. CONCLUSION: As a result, active surveillance method conducted in pathology laboratories are used to detect unknown or late reported TB cases and allows to start treatment without further delay.
- MeSH
- lidé MeSH
- pozorné vyčkávání * MeSH
- průřezové studie MeSH
- tuberkulóza * farmakoterapie epidemiologie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Geografické názvy
- Turecko MeSH
INTRODUCTION: Conservative active surveillance has been proposed for low-risk papillary thyroid microcarcinoma (PTMC), defined as ≤1.0 cm and lacking clinical aggressive features, but controversy exists with accepting it as not all such PTMCs are uniformly destined for benign prognosis. This study investigated whether BRAF V600E status could further risk stratify PTMC, particularly low-risk PTMC, and can thus help with more accurate case selection for conservative management. METHODS: This international multicenter study included 743 patients treated with total thyroidectomy for PTMC (584 women and 159 men), with a median age of 49 years (interquartile range [IQR], 39-59 years) and a median follow-up time of 53 months (IQR, 25-93 months). RESULTS: On overall analyses of all PTMCs, tumour recurrences were 6.4% (32/502) versus 10.8% (26/241) in BRAF mutation-negative versus BRAF mutation-positive patients (P = 0.041), with a hazard ratio (HR) of 2.44 (95% CI (confidence interval), 1.15-5.20) after multivariate adjustment for confounding clinical factors. On the analyses of low-risk PTMC, recurrences were 1.3% (5/383) versus 4.3% (6/139) in BRAF mutation-negative versus BRAF mutation-positive patients, with an HR of 6.65 (95% CI, 1.80-24.65) after adjustment for confounding clinical factors. BRAF mutation was associated with a significant decline in the Kaplan-Meier recurrence-free survival curve in low-risk PTMC. CONCLUSIONS: BRAF V600E differentiates the recurrence risk of PTMC, particularly low-risk PTMC. Given the robust negative predictive value, conservative active surveillance of BRAF mutation-negative low-risk PTMC is reasonable whereas the increased recurrence risk and other well-known adverse effects of BRAF V600E make the feasibility of long-term conservative surveillance uncertain for BRAF mutation-positive PTMC.
- MeSH
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory štítné žlázy genetika MeSH
- papilární karcinom genetika MeSH
- pozorné vyčkávání metody MeSH
- prognóza MeSH
- protoonkogenní proteiny B-raf genetika MeSH
- rozhodování MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- Research Support, N.I.H., Extramural MeSH
BACKGROUND: Daratumumab, an anti-CD38 monoclonal antibody, has been approved for the treatment of multiple myeloma. Data are needed regarding the use of daratumumab for high-risk smoldering multiple myeloma, a precursor disease of active multiple myeloma for which no treatments have been approved. METHODS: In this phase 3 trial, we randomly assigned patients with high-risk smoldering multiple myeloma to receive either subcutaneous daratumumab monotherapy or active monitoring. Treatment was continued for 39 cycles, for 36 months, or until confirmation of disease progression, whichever occurred first. The primary end point was progression-free survival; progression to active multiple myeloma was assessed by an independent review committee in accordance with International Myeloma Working Group diagnostic criteria. RESULTS: Among the 390 enrolled patients, 194 were assigned to the daratumumab group and 196 to the active-monitoring group. With a median follow-up of 65.2 months, the risk of disease progression or death was 51% lower with daratumumab than with active monitoring (hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.67; P<0.001). Progression-free survival at 5 years was 63.1% with daratumumab and 40.8% with active monitoring. A total of 15 patients (7.7%) in the daratumumab group and 26 patients (13.3%) in the active-monitoring group died (hazard ratio, 0.52; 95% CI, 0.27 to 0.98). Overall survival at 5 years was 93.0% with daratumumab and 86.9% with active monitoring. The most common grade 3 or 4 adverse event was hypertension, which occurred in 5.7% and 4.6% of the patients in the daratumumab group and the active-monitoring group, respectively. Adverse events led to treatment discontinuation in 5.7% of the patients in the daratumumab group, and no new safety concerns were identified. CONCLUSIONS: Among patients with high-risk smoldering multiple myeloma, subcutaneous daratumumab monotherapy was associated with a significantly lower risk of progression to active multiple myeloma or death and with higher overall survival than active monitoring. No unexpected safety concerns were identified. (Funded by Janssen Research and Development; AQUILA ClinicalTrials.gov number, NCT03301220.).
- MeSH
- doba přežití bez progrese choroby MeSH
- dospělí MeSH
- doutnající mnohočetný myelom * diagnóza mortalita terapie MeSH
- injekce subkutánní MeSH
- Kaplanův-Meierův odhad MeSH
- lidé středního věku MeSH
- lidé MeSH
- mnohočetný myelom * diagnóza epidemiologie prevence a kontrola MeSH
- monoklonální protilátky * aplikace a dávkování škodlivé účinky MeSH
- pozorné vyčkávání * statistika a číselné údaje MeSH
- progrese nemoci MeSH
- protinádorové látky * aplikace a dávkování škodlivé účinky MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: Coronavirus disease (COVID-19) vaccine-related side effects have a determinant role in the public decision regarding vaccination. Therefore, this study has been designed to actively monitor the safety and effectiveness of COVID-19 vaccines globally. METHODS: A multi-country, three-phase study including a cross-sectional survey to test for the short-term side effects of COVID-19 vaccines among target population groups. In the second phase, we will monitor the booster doses' side effects, while in the third phase, the long-term safety and effectiveness will be investigated. A validated, self-administered questionnaire will be used to collect data from the target population; Results: The study protocol has been registered at ClinicalTrials.gov, with the identifier NCT04834869. CONCLUSIONS: CoVaST is the first independent study aiming to monitor the side effects of COVID-19 vaccines following booster doses, and the long-term safety and effectiveness of said vaccines.
Počet nově diagnostikovaných cystických nádorů pankreatu se stále zvyšuje. Souvisí to především s rozvojem nových diagnostických metod. Mezi hlavní představitele patří: serózní cystadenom, mucinózní cystická neoplazie, intraduktální papilární mucinózní neoplazie a solidní pseudopapilární tumor. Vzhledem k malignímu potenciálu těchto lézí je velmi důležitá správná indikace chirurgické léčby. Tato práce popisuje naše zkušenosti s diagnostikou a léčbou cystických nádorů pankreatu, diagnostikovaných ve Všeobecné fakultní nemocnici v Praze v období leden roku 2008 až prosinec roku 2012. U všech pacientů bylo provedeno vyšetření počítačové tomografie a endoskopické ultrasonografie, spojené s odběrem aspirační biopsie tenkou jehlou. Celkem bylo diagnostikováno 37 případů s cystickými tumory pankreatu. Z toho bylo: 19 pacientů se serózním cystadenomem, 5 s mucinózní cystickou neoplazií, 5 s mucinózním cystadenokarcinomem, 5 s intraduktální papilární mucinózní neoplazií a 3 se solidním pseudopapilárním tumorem. Ve 14 případech byli pacienti indikováni k chirurgickému řešení. U 1 pacienta byly zjištěny známky maligní transformace. Stanovení optimální strategie diagnostického a terapeutického postupu u pacientů s cystickými nádory pankreatu vyžaduje jejich diagnostiku, léčbu a další sledování v centrech s vysokými zkušenostmi, dostatečným odborným a přístrojovým vybavením.
Number of newly diagnosed cystic pancreatic tumors is permanently increasing. This fact is primarily related to the development of new diagnostic methods. The main representative ones are: serous cystadenoma, mucinous cystic neoplasm, intraductal papillary mucinous neoplasm and solid pseudopapillar tumor. Because of the malignant potential of these lesions, proper indication of surgical treatment is extremely important. The article highlights and describes our experience in diagnostics and therapy of cystic pancreatic tumors diagnosed in the General Teaching Hospital Prague in the period: 1/2008–12/2012. All patients were investigated by computerised tomography and endoscopic ultrasound with fine – needle aspiration biopsy. Thirty seven patients in total were diagnosed with cystic pancreatic tumors: 19 with serous cystadenoma, 5 with mucinous cystic neoplasm, 5 with mucinous cystadenocarcinoma, 5 with intraductal papillary mucinous neoplasm and 3 with solid pseudopapillar tumor. In 14 cases patients were indicated for surgery, in 1 case signs of malignant transformation were found. Determination of the optimal strategy for diagnostic and therapeutic procedures in patients with cystic pancreatic tumors requires the diagnosis, treatment and follow‑up observation in adequately equiped specialized centers.
- Klíčová slova
- aspirační biopsie tenkou jehlou, endoskopická ultrasonografie, solidní pseudopapilární tumor, intraduktální papilární mucinózní neoplazie,
- MeSH
- chirurgie trávicího traktu * metody statistika a číselné údaje MeSH
- endosonografie MeSH
- lidé MeSH
- mucinózní cystadenom diagnóza epidemiologie chirurgie MeSH
- nádory cystické, mucinózní a serózní diagnóza MeSH
- nádory slinivky břišní * diagnóza epidemiologie chirurgie MeSH
- pankreatická cysta * diagnóza epidemiologie MeSH
- pozorné vyčkávání statistika a číselné údaje MeSH
- serózní cystadenom diagnóza epidemiologie chirurgie MeSH
- tenkojehlová biopsie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- práce podpořená grantem MeSH
Background Many patients with severe aortic stenosis are referred late with advanced symptoms or inappropriately denied intervention. The objective was to investigate whether a structured communication to referring physicians (facilitated data relay) might improve the rate and timeliness of intervention. Methods and Results A prospective registry of consecutive patients with severe aortic stenosis at 23 centers in 9 European countries with transcatheter as well as surgical aortic valve replacement being available was performed. The study included a 3-month documentation of the status quo (phase A), a 6-month intervention phase (implementing facilitated data relay), and a 3-month documentation of a legacy effect (phase-B). Two thousand one hundred seventy-one patients with severe aortic stenoses were enrolled (phase A: 759; intervention: 905; phase-B: 507). Mean age was 77.9±10.0 years, and 80% were symptomatic, including 52% with severe symptoms. During phase A, intervention was planned in 464/696 (67%), 138 (20%) were assigned to watchful waiting, 8 (1%) to balloon aortic valvuloplasty, 60 (9%) were listed as not for active treatment, and in 26 (4%), no decision was made. Three hundred sixty-three of 464 (78%) patients received the planned intervention within 3 months. Timeliness of the intervention improved as shown by the higher number of aortic valve replacements performed within 3 months (59% versus 51%, P=0.002) and a significant decrease in the time to intervention (36±38 versus 30±33 days, P=0.002). Conclusions A simple, low-cost, facilitated data relay improves timeliness of treatment for patients diagnosed with severe aortic stenosis, resulting in a shorter time to transcatheter aortic valve replacement. This effect was mainly driven by a significant improvement in timeliness of intervention in transcatheter aortic valve replacement but not surgical aortic valve replacement. Clinical Trial Registration URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02241447.
- MeSH
- aortální stenóza diagnostické zobrazování ošetřování terapie MeSH
- balónková valvuloplastika * škodlivé účinky MeSH
- čas zasáhnout při rozvinutí nemoci * MeSH
- časové faktory MeSH
- chirurgická náhrada chlopně * škodlivé účinky MeSH
- echokardiografie MeSH
- klinické rozhodování MeSH
- konziliární vyšetření a konzultace * MeSH
- lidé MeSH
- pozorné vyčkávání * MeSH
- prospektivní studie MeSH
- průřezové studie MeSH
- registrace MeSH
- role ošetřovatelky * MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- transkatetrální implantace aortální chlopně * škodlivé účinky MeSH
- určení vhodnosti pacienta MeSH
- výběr pacientů MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- srovnávací studie MeSH
- Geografické názvy
- Evropa MeSH
BACKGROUND: Infantile fibrosarcoma (IFS) is a very rare disease occurring in young infants characterised by a high local aggressiveness but overall with a favourable survival. To try to reduce the total burden of therapy, the European pediatric Soft tissue sarcoma Study Group has developed conservative therapeutic recommendations according to initial resectability. MATERIAL AND METHODS: Between 2005 and 2012, children with localised IFS were prospectively registered. Initial surgery was suggested only if possible without mutilation. Patients with initial complete (IRS-group I/R0) or microscopic incomplete (group II/R1) resection had no further therapy. Patients with initial inoperable tumour (group III/R2) received first-line vincristine-actinomycin-D chemotherapy (VA). Delayed conservative surgery was planned after tumour reduction. Aggressive local therapy (mutilating surgery or external radiotherapy) was discouraged. RESULTS: A total of 50 infants (median age 1.4 months), were included in the study. ETV6-NTRK3 transcript was present in 87.2% of patients where investigation was performed. According to initial surgery, 11 patients were classified as group I, 8 as group II and 31 as group III. VA chemotherapy was first delivered to 25 children with IRS-III/R2 and one with IRS-II/R1 disease. Response rate to VA was 68.0%. Mutilating surgery was only performed in three cases. After a median follow-up of 4.7 years (range 1.9-9.0), 3-year event-free survival and overall survival were respectively 84.0% (95% confidence interval [CI] 70.5-91.7) and 94.0% (95% CI 82.5-98.0). CONCLUSIONS: Conservative therapy is possible in IFS as only three children required mutilating surgery, and alkylating or anthracycline based chemotherapy was avoided in 71.0% of patients needing chemotherapy. VA regimen should be first line therapy in order to reduce long term effects.
- MeSH
- adjuvantní chemoterapie metody MeSH
- daktinomycin aplikace a dávkování MeSH
- fibrosarkom farmakoterapie patologie chirurgie MeSH
- kojenec MeSH
- kombinovaná terapie metody MeSH
- lidé MeSH
- lymfatické metastázy MeSH
- nádory měkkých tkání farmakoterapie patologie chirurgie MeSH
- následné studie MeSH
- osobní újma zaviněná nemocí MeSH
- pozorné vyčkávání MeSH
- přežití bez známek nemoci MeSH
- prospektivní studie MeSH
- protinádorové látky terapeutické užití MeSH
- reoperace MeSH
- staging nádorů MeSH
- studie proveditelnosti MeSH
- vinkristin aplikace a dávkování MeSH
- výsledek terapie MeSH
- Check Tag
- kojenec MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
BACKGROUND: Local tumor ablation (LTA) and non-interventional management (NIM) emerged as alternative management options for T1a renal cell carcinoma (RCC). We investigated trends and cancer-specific mortality (CSM) after LTA and NIM, compared to partial nephrectomy (PN). METHODS: Within the Surveillance, Epidemiology, and End Results database (2004-2015), T1a RCC patients treated with PN, LTA or NIM were identified. Estimated annual proportion change methodology (EAPC), 1:1 ratio propensity score (PS) matching, cumulative incidence plots and multivariable competing risks regression models (CRR) were used to compare LTA vs. PN and NIM vs. PN. Subgroup analyses focused on patients <65 and ≥65 years. RESULTS: Overall 4524 patients underwent LTA vs. 1654 NIM vs. 25,435 PN. Annuals rates increased for NIM (EAPC: +3.3%, P<0.001), but not for either LTA or PN. After PS-matching in multivariable CCR, LTA (HR 1.9, P<0.001) and NIM (HR 3.0, P<0.001) showed worse 5-year CSM, relative to PN. In subgroup analyses, LTA showed no CSM disadvantage relative to PN in younger patients (HR 2.0, P=0.07). In older patients 1.64-fold CSM increase was recorded. Conversely, NIM younger (HR 3.1, P=0.001) and older (HR 3.1, P<0.001) patients exhibited higher CSM relative to PN. CONCLUSIONS: In T1a RCC patients, NIM rates showed a modest but significant increase, while LTA and PN rates remained stable. In survival analyses, LTA exhibited higher CSM rates only for elderly patients. Conversely, NIM exhibited higher CSM rates in both younger and older patients.
- MeSH
- analýza přežití MeSH
- incidence MeSH
- karcinom z renálních buněk chirurgie MeSH
- lidé středního věku MeSH
- lidé MeSH
- nádory ledvin mortalita chirurgie MeSH
- nefrektomie metody MeSH
- pozorné vyčkávání * MeSH
- program SEER MeSH
- regresní analýza MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- socioekonomické faktory MeSH
- tendenční skóre MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři nad 80 let MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
... vyznačena -- 10 Cti 2027 -- Národní lékařská knihovna -- Název: Beta-watch -- NLK -- ABA008 -- Autor ... ... -- Rok/vyd -- Contents -- 1107000868400253 -- Přir Č T017122 -- Sign DT 12576 -- Beta-watch -- The journal ... ... ‘Beta-watch’ is published three times a year and distributed to microbiologists, general practitioners ... ... The editorial board of ‘Beta-watch’ has complete independence in the selection of topics and contributors ... ... Any comments on articles included in this issue should be addressed to: -- The Editor, ‘Beta-watch’, ...
19 stran : ilustrace, tabulky ; 30 cm
- MeSH
- antibiotická rezistence MeSH
- mikrobiální testy citlivosti MeSH
- náchylnost k nemoci MeSH
- Streptococcus pneumoniae MeSH
- Publikační typ
- sborníky MeSH
- Konspekt
- Mikrobiologie
- NLK Obory
- bakteriologie
- farmacie a farmakologie
- NLK Publikační typ
- brožury