OBJECTIVE: To determine the relationships between psilocybin dose, psychedelic experiences, and therapeutic outcome in treatment-resistant depression. METHODS: For treatment-resistant depression, 233 participants received a single dose of 25, 10, or 1 mg of COMP360 psilocybin (a proprietary, pharmaceutical-grade synthesized psilocybin formulation, developed by the sponsor, Compass Pathfinder Ltd.) with psychological support. The resulting psychedelic experience (Five-Dimensional Altered States of Consciousness questionnaire [5D-ASC] and Emotional Breakthrough Inventory [EBI]) were measured. These proximal variables and outcome 3 weeks post-administration (change in Montgomery-Åsberg Depression Rating Scale [MADRS]) were explored using correlation analysis. RESULTS: The mean intensity of psychedelic effects was dose-related, but distributions of scores for different doses overlapped considerably. Depression response correlated with select aspects of the psychedelic experience overall and for individual doses. At the 25 mg dose, 5D-ASC dimensions Oceanic Boundlessness (Pearson correlation coefficient r = -0.508) and Visual Restructuralization (r = -0.516), and EBI (r = -0·637) were the variables with the strongest correlation to the Week 3 change from Baseline in MADRS score. LIMITATIONS: The existence of correlation does not establish causation and exploratory findings require further replication, preferably in larger independent samples. CONCLUSIONS: The intensity of psychedelic experience overlaps widely across doses and mitigates the risk of unblinding to dose. Correlations between psychedelic experience and outcome suggest specificity in psilocybin's mechanism of action. Quality and intensity of psychedelic experience may be a measure of pharmacodynamic effect and reveal an effective dose response phenomenon for single oral doses.

• MeSH
• deprese nereagující na léčbu * farmakoterapie   MeSH
• depresivní porucha unipolární farmakoterapie   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• halucinogeny * aplikace a dávkování   farmakologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• psilocybin * farmakologie   aplikace a dávkování   MeSH
• psychiatrické posuzovací škály MeSH
• výsledek terapie MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• randomizované kontrolované studie MeSH

Herein, a series of new 1,1,2-trimethyl-1H-benzo[e]indole dyes was prepared via Knoevenagel condensation reaction between 1,1,2-trimethyl-1H-benzo[e]indole and benzaldehydes, and characterized using various spectroscopic methods. The obtained compounds showed cytotoxic properties in G361 melanoma cell line upon irradiation with 414 nm blue light at submicromolar doses. The mechanism of action of the most potent compound 15 was further investigated. The treatment induced substantial generation of reactive oxygen species, leading to DNA damage followed by cell death depending on the concentration of the photosensitizer compound and the irradiation intensity.

• MeSH
• barvicí látky farmakologie   chemie   chemická syntéza   MeSH
• fotosenzibilizující látky farmakologie   chemická syntéza   chemie   MeSH
• indoly * chemie   farmakologie   chemická syntéza   MeSH
• lidé MeSH
• molekulární struktura MeSH
• nádorové buněčné linie MeSH
• poškození DNA účinky léků   MeSH
• proliferace buněk účinky léků   MeSH
• protinádorové látky * farmakologie   chemická syntéza   chemie   MeSH
• reaktivní formy kyslíku metabolismus   MeSH
• screeningové testy protinádorových léčiv * MeSH
• světlo MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• vztahy mezi strukturou a aktivitou MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

A series of new indole-pyrazole hybrids 8a-m were synthesized through the palladium-catalyzed ligandless Heck coupling reaction from easily accessible unsubstituted, methoxy- or fluoro-substituted 4-ethenyl-1H-pyrazoles and 5-bromo-3H-indoles. These compounds exerted cytotoxicity to melanoma G361 cells when irradiated with blue light (414 nm) and no cytotoxicity in the dark at concentrations up to 10 μM, prompting us to explore their photodynamic effects. The photodynamic properties of the example compound 8d were further investigated in breast cancer MCF-7 cells. Evaluation revealed comparable anticancer activities of 8d in both breast and melanoma cancer cell lines within the submicromolar range. The treatment induced a massive generation of reactive oxygen species, leading to different types of cell death depending on the compound concentration and the irradiation intensity.

• MeSH
• fotochemoterapie * MeSH
• fotosenzibilizující látky * farmakologie   chemická syntéza   chemie   MeSH
• indoly * farmakologie   chemie   chemická syntéza   MeSH
• lidé MeSH
• MFC-7 buňky MeSH
• molekulární struktura MeSH
• nádorové buněčné linie MeSH
• nádory prsu farmakoterapie   patologie   MeSH
• palladium chemie   farmakologie   MeSH
• protinádorové látky * farmakologie   chemická syntéza   chemie   MeSH
• pyrazoly * farmakologie   chemická syntéza   chemie   MeSH
• reaktivní formy kyslíku * metabolismus   MeSH
• viabilita buněk účinky léků   MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• vztahy mezi strukturou a aktivitou MeSH
• Check Tag
• lidé MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH

• MeSH
• diabetes mellitus terapie   MeSH
• enterální výživa metody   MeSH
• krevní glukóza * analýza   účinky léků   MeSH
• lidé středního věku MeSH
• lidé MeSH
• péče o pacienty v kritickém stavu metody   MeSH
• senioři MeSH
• statistika jako téma MeSH
• syrovátka * aplikace a dávkování   MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé středního věku MeSH
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• ženské pohlaví MeSH
• Publikační typ
• klinická studie MeSH

The distribution of time that people spend in physical activity of various intensities has important health implications. Physical activity (commonly categorised by the intensity into light, moderate and vigorous physical activity), sedentary behaviour and sleep, should not be analysed separately, because they are parts of a time-use composition with a natural constraint of 24 h/day. To find out how are relative reallocations of time between physical activity of various intensities associated with health, herewith we describe compositional scalar-on-function regression and a newly developed compositional functional isotemporal substitution analysis. Physical activity intensity data can be considered as probability density functions, which better reflects the continuous character of their measurement using accelerometers. These probability density functions are characterised by specific properties, such as scale invariance and relative scale, and they are geometrically represented using Bayes spaces with the Hilbert space structure. This makes possible to process them using standard methods of functional data analysis in the L2 space, via centred logratio (clr) transformation. The scalar-on-function regression with clr transformation of the explanatory probability density functions and compositional functional isotemporal substitution analysis were applied to a dataset from a cross-sectional study on adiposity conducted among school-aged children in the Czech Republic. Theoretical reallocations of time to physical activity of higher intensities were found to be associated with larger and more progressive expected decreases in adiposity. We obtained a detailed insight into the dose-response relationship between physical activity intensity and adiposity, which was enabled by using the compositional functional approach.

• MeSH
• adipozita * MeSH
• Bayesova věta MeSH
• časové faktory MeSH
• cvičení * fyziologie   MeSH
• dítě MeSH
• lidé MeSH
• obezita * MeSH
• průřezové studie MeSH
• Check Tag
• dítě MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH

Může se zdát, že vzhledem k progresivnímu zhoršování metabolické poruchy, která je podkladem diabetu 2. typu, budeme při změně léčby diabetu odkázáni jen k navyšování počtu léků nebo jednotlivých dávek. V některých případech ale může platit, že i díky neustále se rozšiřující nabídce nových léčivých přípravků můžeme pacientovi nabídnout nejen jednodušší, ale i účinnější léčbu. Takovým příkladem může být náhrada intenzifikované inzulínové terapie (IIT) použitím přípravku Xultophy. Intenzifikovaný inzulínový režim je totiž náročný nejen ze strany pacienta, ale i ze strany lékaře. Takže i kdyby byla výsledná úroveň kompenzace diabetu při srovnání obou léčebných systémů stejná, bude léčba přípravkem Xultophy vítězit svou jednoduchostí, hmotnostním poklesem a kardiovaskulárním benefitem, který je dán léčbou liraglutidem. Níže uvedená kazuistika použití přípravku Xultophy po převodu z IIT ukazuje situaci, kdy bylo dosaženo nejen cílové úrovně kompenzace, ale současně byla zachována jednoduchost léčby (aplikace 1× denně bez vazby na jídlo) při maximální spokojenosti pacienta.

It may seem that, due to the progressive deterioration of metabolic disorder that underlies type 2 diabetes, we will only be limited to increasing the number of drugs or individual doses when changing the treatment of diabetes. In some cases, however, thanks to the constantly expanding range of new medicinal products, it may be possible to offer the patient not only simpler but also more effective treatment. Such an example can be the replacement of intensive insulin therapy (ITT) with Xultophy. Intensive insulin regimen is quite demanding not only on the part of the patient, but also on the part of the physician. So, even if the resulting levels of diabetes control were the same when comparing the two treatment systems, the Xultophy treatment would win because of its simplicity, weight loss and cardiovascular benefit given by the liraglutide treatment. The following case report of the use of Xultophy after transferring from ITT shows a situation in which not only the target levels of diabetes control were achieved, but at the same time the simplicity of the treatment was maintained (administration once a day without food connection) with maximum patient satisfaction.

• Klíčová slova
• xultophy, inzulin degludek,
• MeSH
• diabetes mellitus 2. typu * farmakoterapie   MeSH
• hypoglykemika terapeutické užití   MeSH
• kombinovaná farmakoterapie metody   MeSH
• lidé MeSH
• liraglutid aplikace a dávkování   terapeutické užití   MeSH
• metformin terapeutické užití   MeSH
• senioři MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• mužské pohlaví MeSH
• senioři MeSH
• Publikační typ
• kazuistiky MeSH

Purpose: The early drop-out in professional youth athletes is a complex and multi factors process and seems to be more common in individual sports with higher physical demands, such as the running disciplines. Also, it has previously been reported that youth female athletes presented a higher drop-out rate compared with males. The present study, therefore, investigated the causes of early-career termination and possible association with wellness and low energy availability in youth female runners. Methods: Data from four female runners (aged from 22 to 24 years) from the Slovakian national team in running disciplines who have ended their careers early were collected. A semi-structured interview was performed to explore multiple factors (advent athletics, training, regeneration, sleep, diet, health, emotions, motivation, communication, environmental pressure, coach, habits, reasons for ending an athletic career and a better relationship with the sport) and the questionnaire about wellness and low energy availability in females (LEAF-Q). Results: The interview shows that the most common factors of early-career termination of a former runner were: an early specialization in the discipline, inadequate training dose-response (e.g., high intensity and insufficient recovery), pathological nutritional behaviour, health problems, psychological factors, and loss of motivation. The factors reported during the interview were associated with negative results of the wellness questionnaire (score 10±1.9) and with LEAF-Q (score 12±2.9). Conclusion: The study highlights the multi factors involved in early career termination. Based on the athletes’ reports, was possible to notice that the early sports specialization in running disciplines affected negatively their health, nutrition and psychological aspects, and could be triggered by higher training loads and insufficient recovery. Caution should be taken by coaches and professionals involved during the sports specialization, in order to minimize the negative impact of training routine on youth athletes and consequently avoid an early drop-out.

Léčba mnohočetného myelomu (MM) se v posledních letech vyvíjí značným tempem. Za hlavní milníky, které vedly k zásadnímu zlepšení prognózy, jsou považovány: posunutí léčby do časnější (bezpříznakové) fáze onemocnění, důraz na dosažení negativity minimální zbytkové choroby a též rozvoj nových léků s biologickým mechanismem účinku. Mezi nové třídy využívané v léčbě MM patří zejména inhibitory proteasomu (bortezomib, karfilzomib, ixazomib), imunomodulační látky (thalidomid, lenalidomid, pomalidomid) a monoklonální protilátky (daratumumab, elotuzumab, isatuximab). Nově diagnostikovaní pacienti vhodní k intenzivní léčbě jsou indikováni k indukční imunochemoterapii následované vysokodávkovaným melfalanem s podporou autologní transplantace krvetvorných buněk a dlouhodobou udržovací terapií lenalidomidem. Léčba doporučovaná pro netransplantabilní nemocné je rovněž dlouhodobá, doporučovanými režimy jsou Dara‑VMP (daratumumab, bortezomib, melfalan, prednison), DRD (daratumumab, lenalidomid, dexametazon) a VRD (bortezomib, lenalidomid, dexametazon). Pro nemocné s relabujícím a refrakterním onemocněním jsou k dispozici nové léčebné kombinace, opírající se o algoritmy odvozené od předchozí léčby a refrakterity k podaným lékům. Mezi zásadní určující faktory patří zejména agresivita relapsu, předešlá léčba a její efekt a celkový stav pacienta. Nejlepší účinek mají v současnosti kombinované režimy s lenalidomidem. Při refrakteritě na lenalidomid či při léčbě vyšší linie je obecným pravidlem volba léku/lékové skupiny, která dosud nebyla v předešlých fázích použita. V pozdních multirefrakterních fázích onemocnění je prognóza nepříznivá a volba léčebného přístupu je výzvou. Velkou naději přináší vývoj nových léků a zejména imunoterapie.

The treatment of multiple myeloma (MM) has evolved significantly in the recent years. The following are considered to be the major milestones which have led to a substantial improvement in prognosis: a shift of treatment to early (asymptomatic) disease stage, an emphasis on achieving negativity of minimal residual disease as well as the development of novel drugs with a biological mechanism of action. The novel drug classes used in the treatment of MM particularly include proteasome inhibitors (bortezomib, carfilzomib, ixazomib), immunomodulatory drugs (thalidomide, lenalidomide, pomalidomide), and monoclonal antibodies (daratumumab, elotuzumab, isatuximab). Newly diagnosed patients eligible for intensive treatment are indicated to receive induction immunochemotherapy followed by high-dose melphalan supported by autologous stem cell transplantation and long-term maintenance therapy with lenalidomide. The treatment recommended in non-transplantable patients is long-term as well; the regimens recommended are Dara-VMP (daratumumab, bortezomib, melphalan, prednisone), DRD (daratumumab, lenalidomide, dexamethasone), and VRD (bortezomib, lenalidomide, dexamethasone). For patients with relapsed and refractory disease, novel treatment combinations are available, based on algorithms derived from the previous treatment and refractoriness to the drugs administered. The key determining factors particularly include relapse aggressiveness, previous treatment and its effect, and the patient's general condition. Combination regimens with lenalidomide currently have the best efficacy. In the case of refractoriness to lenalidomide or higher-line treatment, the general rule is the choice of a drug / drug group which has not been used in previous treatment phases. In late, multirefractory disease stages, the prognosis is unfavourable and the choice of therapeutic approach is challenging. The development of novel drugs and, in particular, immunotherapy brings great promise.

• MeSH
• autologní transplantace MeSH
• cílená molekulární terapie metody   MeSH
• imunoterapie metody   MeSH
• indukční chemoterapie metody   MeSH
• kombinovaná farmakoterapie metody   MeSH
• konsolidační chemoterapie metody   MeSH
• lidé MeSH
• mnohočetný myelom * terapie   MeSH
• monoklonální protilátky terapeutické užití   MeSH
• prognóza MeSH
• protinádorové látky terapeutické užití   MeSH
• recidiva MeSH
• transplantace kostní dřeně metody   MeSH
• udržovací chemoterapie metody   MeSH
• výběr pacientů MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH

Heparin je v klinické praxi široce používán; jeho účinek na sekundární hemostázu je dobře známý, ale jeho účinky na primární hemostázu jsou kontroverzní. Analyzátor funkcí destiček Innovance®-200 ™ (PFA-200) provádí skupinu testů, které hodnotí primární hemostázu plné krve. Často se používá u kriticky nemocných pacientů, ale účinek heparinu na jeho výsledky vyjádřené jako čas srážení („closure time“) je kontroverzní. Účelem této studie bylo popsat, zda různé typy a dávky heparinu mohou ovlivnit výsledky PFA-200. V této studii bylo hodnoceno 30 pacientů, kteří byli rozděleni do 3 skupin podle typu a dávky podávaného heparinu. První skupina zahrnovala 10 pacientů, kteří byli léčeni vysokou dávkou nefrakcionovaného heparinu (3 až 4 mg/kg) před zahájením kardiopulmonálního bypassu během operace srdce. Druhá skupina byla tvořena 10 pacienty z cévní i hrudní chirurgie, kterým byla podávána nízká dávka nefrakcionovaného heparinu (1 mg/kg). Posledních 10 pacientů z jednotky intenzivní péče dostalo profylaktickou dávku nízkomolekulárního heparinu monitorovaného pomocí anti-Xa. Porovnávali jsme čas srážení na zařízení PFA-200 a to testy kolagen/ADP a kolagen/epinefrin před a po podání antikoagulancií. Výsledky ukázaly, že pouze vysoká dávka nefrakcionovaného heparinu prodloužila čas srážení u testu kolagen/ADP. Ostatní skupiny nevykazovaly žádný rozdíl. Myslíme si, že toto zjištění je důležité pro kliniky používající mimotělní systémy k rozlišení patologie primární hemostázy způsobené heparinem od patologie způsobené samotnými mimotělními zařízeními.

Heparin is widely used in clinical practice; its effect on secondary hemostasis is well known, but its effects on primary hemostasis are controversial. The Innovance® Platelet Function Analyzer-200™ (PFA-200) performs a group of tests that evaluate the primary hemostasis of whole blood. It is frequently used in critically ill patients, but the effect of heparin on its results expressed as closure time is controversial. The purpose of this study was to describe whether different types and doses of heparin may influence closure time results on PFA-200 devices. For this study, 30 patients were recruited and divided into three groups based on the type and dose of heparin being administered. The first group included ten patients who were treated with a high dose of unfractionated heparin (concentration from 3 to 4 mg/kg) before commencement of cardiopulmonary bypass during cardiac surgery. The second group consisted of ten patients from both vascular and thoracic surgery who were administered a low dose of unfractionated heparin (concentration 1 mg/kg). The remaining ten patients from intensive care units received a prophylactic dose of low-molecular-weight heparin monitored by anti-Xa. We compared closure times on PFA-200 devices with collagen/ADP and collagen/epinephrine cartridges before and after anticoagulant administration. The results showed that only a high dose of unfractionated heparin prolonged the collagen/ ADP closure time. The other groups failed to show any difference. We consider this finding to be important for clinicians using extracorporeal systems to differentiate primary hemostasis pathology caused by heparin or by extracorporeal devices themselves.

• Klíčová slova
• PFA-200,
• MeSH
• hemostáza * účinky léků   MeSH
• heparin * aplikace a dávkování   terapeutické užití   MeSH
• lidé MeSH
• pilotní projekty MeSH
• prospektivní studie MeSH
• vyšetření funkce trombocytů přístrojové vybavení   MeSH
• vyšetření krevní srážlivosti MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• práce podpořená grantem MeSH

OBJECTIVES: The primary objective of this study is to test the hypothesis that administration of dexamethasone 20 mg is superior to a 6 mg dose in adult patients with moderate or severe ARDS due to confirmed COVID-19. The secondary objective is to investigate the efficacy and safety of dexamethasone 20 mg versus dexamethasone 6 mg. The exploratory objective of this study is to assess long-term consequences on mortality and quality of life at 180 and 360 days. TRIAL DESIGN: REMED is a prospective, phase II, open-label, randomised controlled trial testing superiority of dexamethasone 20 mg vs 6 mg. The trial aims to be pragmatic, i.e. designed to evaluate the effectiveness of the intervention in conditions that are close to real-life routine clinical practice. PARTICIPANTS: The study is multi-centre and will be conducted in the intensive care units (ICUs) of ten university hospitals in the Czech Republic. INCLUSION CRITERIA: Subjects will be eligible for the trial if they meet all of the following criteria: 1. Adult (≥18 years of age) at time of enrolment; 2. Present COVID-19 (infection confirmed by RT-PCR or antigen testing); 3. Intubation/mechanical ventilation or ongoing high-flow nasal cannula (HFNC) oxygen therapy; 4. Moderate or severe ARDS according to Berlin criteria: • Moderate - PaO2/FiO2 100-200 mmHg; • Severe - PaO2/FiO2 < 100 mmHg; 5. Admission to ICU in the last 24 hours. EXCLUSION CRITERIA: Subjects will not be eligible for the trial if they meet any of the following criteria: 1. Known allergy/hypersensitivity to dexamethasone or excipients of the investigational medicinal product (e.g. parabens, benzyl alcohol); 2. Fulfilled criteria for ARDS for ≥14 days at enrolment; 3. Pregnancy or breastfeeding; 4. Unwillingness to comply with contraception measurements from enrolment until at least 1 week after the last dose of dexamethasone (sexual abstinence is considered an adequate contraception method); 5. End-of-life decision or patient is expected to die within next 24 hours; 6. Decision not to intubate or ceilings of care in place; 7. Immunosuppression and/or immunosuppressive drugs in medical history: a) Systemic immunosuppressive drugs or chemotherapy in the past 30 days; b) Systemic corticosteroid use before hospitalization; c) Any dose of dexamethasone during the present hospital stay for COVID-19 for ≥5 days before enrolment; d) Systemic corticosteroids during present hospital stay for conditions other than COVID-19 (e.g. septic shock); 8. Current haematological or generalized solid malignancy; 9. Any contraindication for corticosteroid administration, e.g. • intractable hyperglycaemia; • active gastrointestinal bleeding; • adrenal gland disorders; • presence of superinfection diagnosed with locally established clinical and laboratory criteria without adequate antimicrobial treatment; 10. Cardiac arrest before ICU admission; 11. Participation in another interventional trial in the last 30 days. INTERVENTION AND COMPARATOR: Dexamethasone solution for injection/infusion is the investigational medicinal product as well as the comparator. The trial will assess two doses, 20 mg (investigational) vs 6 mg (comparator). Patients in the intervention group will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. Patients in the control group will receive dexamethasone 6 mg day 1-10. All authorized medicinal products containing dexamethasone in the form of solution for i.v. injection/infusion can be used. MAIN OUTCOMES: Primary endpoint: Number of ventilator-free days (VFDs) at 28 days after randomisation, defined as being alive and free from mechanical ventilation. SECONDARY ENDPOINTS: a) Mortality from any cause at 60 days after randomisation; b) Dynamics of inflammatory marker (C-Reactive Protein, CRP) change from Day 1 to Day 14; c) WHO Clinical Progression Scale at Day 14; d) Adverse events related to corticosteroids (new infections, new thrombotic complications) until Day 28 or hospital discharge; e) Independence at 90 days after randomisation assessed by Barthel Index. The long-term outcomes of this study are to assess long-term consequences on mortality and quality of life at 180 and 360 days through telephone structured interviews using the Barthel Index. RANDOMISATION: Randomisation will be carried out within the electronic case report form (eCRF) by the stratified permuted block randomisation method. Allocation sequences will be prepared by a statistician independent of the study team. Allocation to the treatment arm of an individual patient will not be available to the investigators before completion of the whole randomisation process. The following stratification factors will be applied: • Age <65 and ≥ 65; • Charlson Comorbidity index (CCI) <3 and ≥3; • CRP <150 mg/L and ≥150 mg/L • Trial centre. Patients will be randomised in a 1 : 1 ratio into one of the two treatment arms. Randomisation through the eCRF will be available 24 hours every day. BLINDING (MASKING): This is an open-label trial in which the participants and the study staff will be aware of the allocated intervention. Blinded pre-planned statistical analysis will be performed. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The sample size is calculated to detect the difference of 3 VFDs at 28 days (primary efficacy endpoint) between the two treatment arms with a two-sided type I error of 0.05 and power of 80%. Based on data from a multi-centre randomised controlled trial in COVID-19 ARDS patients in Brazil and a multi-centre observational study from French and Belgian ICUs regarding moderate to severe ARDS related to COVID-19, investigators assumed a standard deviation of VFD at 28 days as 9. Using these assumptions, a total of 142 patients per treatment arm would be needed. After adjustment for a drop-out rate, 150 per treatment arm (300 patients per study) will be enrolled. TRIAL STATUS: This is protocol version 1.1, 15.01.2021. The trial is due to start on 2 February 2021 and recruitment is expected to be completed by December 2021. TRIAL REGISTRATION: The study protocol was registered on EudraCT No.:2020-005887-70, and on December 11, 2020 on ClinicalTrials.gov (Title: Effect of Two Different Doses of Dexamethasone in Patients With ARDS and COVID-19 (REMED)) Identifier: NCT04663555 with a last update posted on February 1, 2021. FULL PROTOCOL: The full protocol (version 1.1) is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the standard formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

• MeSH
• COVID-19 komplikace   terapie   MeSH
• délka pobytu MeSH
• dexamethason aplikace a dávkování   MeSH
• glukokortikoidy aplikace a dávkování   MeSH
• hodnocení ekvivalence jako téma MeSH
• klinické zkoušky, fáze II jako téma MeSH
• lidé MeSH
• multicentrické studie jako téma MeSH
• progrese nemoci MeSH
• randomizované kontrolované studie jako téma MeSH
• SARS-CoV-2 MeSH
• syndrom dechové tísně etiologie   terapie   MeSH
• umělé dýchání * MeSH
• vztah mezi dávkou a účinkem léčiva MeSH
• Check Tag
• lidé MeSH
• Publikační typ
• dopisy MeSH
• protokol klinické studie MeSH