RESUMO

BACKGROUND: Haemorrhage is a leading cause of maternal mortality. The prophylactic use of tranexamic acid during vaginal delivery or caesarean section has the potential to reduce blood loss and postpartum anaemia. OBJECTIVE: To determine the effectiveness and safety of tranexamic acid in reducing blood loss during and within twenty-four hours after a caesarean section. METHODS: This was a randomised controlled study of two hundred and eighty-four (284) pregnant women booked for caesarean section at the University of Nigeria Teaching Hospital (UNTH), Ituku Ozalla, Enugu, Nigeria. The women were randomised into two groups: the intervention group (n = 142) that received intraoperative tranexamic acid with routine post-delivery oxytocin injection and the control group (n =142) that received placebo with routine post-delivery oxytocin. Blood loss was assessed both intra and post-operatively using a standard technique. RESULTS: The mean intraoperative blood loss was significantly lower in the intervention group compared to the control group (435.9±34 vs. 918±258.7, P=0.036). Similarly, the postoperative blood loss within twenty-four hours of surgery was significantly less in the intervention compared to the control group (232.71±67.4 vs. 717±317.6, P=0.031). The incidences of postoperative anaemia and blood transfusion intra or postoperatively were also significantly less in the intervention group compared to the control group (33.2% vs. 48.6; RR = 0.623; 95% CI = 0.46-0.84; p = 0.002, and 6.3% vs 24.6%: RR = 0.257; 95%CI = 0.13-0.52; P= < 0.001, respectively). There were no differences in the incidences of maternal and neonatal complications. CONCLUSION: The use of prophylactic parenteral tranexamic acid significantly reduces blood loss during and after caesarean section. It is therefore recommended in our obstetric practice as it has the potential to reduce the incidence of postpartum anaemia.

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CONTEXTE: L'hémorragie est l'une des principales causes de mortalité maternelle. L'utilisation prophylactique de l'acide tranexamique lors d'un accouchement par voie basse ou d'une césarienne a le potentiel de réduire la perte de sang et l'anémie post-partum. OBJECTIF: Déterminer l'efficacité et la sécurité de l'acide tranexamique dans la réduction de la perte de sang pendant et dans les vingt-quatre heures suivant une césarienne. MÉTHODES: Cette étude contrôlée randomisée a inclus deux cent quatre-vingt-quatre (284) femmes enceintes prévues pour une césarienne à l'Hôpital Universitaire du Nigeria (UNTH), Ituku Ozalla, Enugu, Nigéria. Les femmes ont été randomisées en deux groupes : le groupe d'intervention (n = 142) qui a reçu de l'acide tranexamique en peropératoire avec une injection d'oxytocine post-accouchement de routine et le groupe témoin (n = 142) qui a reçu un placebo avec l'oxytocine de routine post-accouchement. La perte de sang a été évaluée pendant l'opération et après l'opération à l'aide d'une technique standard. RÉSULTATS: La perte de sang moyenne peropératoire était significativement plus faible dans le groupe d'intervention par rapport au groupe témoin (435,9±34 vs. 918±258,7, P=0,036). De même, la perte de sang postopératoire dans les vingt-quatre heures suivant l'opération était significativement plus faible dans le groupe d'intervention par rapport au groupe témoin (232,71±67,4 vs. 717±317,6, P=0,031). Les incidences d'anémie postopératoire et de transfusion sanguine pendant ou après l'opération étaient également significativement plus faibles dans le groupe d'intervention par rapport au groupe témoin (33,2% vs. 48,6%; RR = 0,623; IC 95% = 0,46-0,84; p = 0,002, et 6,3% vs. 24,6%: RR = 0,257; IC 95% = 0,13-0,52; P= < 0,001, respectivement). Il n'y avait pas de différences dans les incidences de complications maternelles et néonatales. CONCLUSION: L'utilisation prophylactique d'acide tranexamique parentéral réduit significativement la perte de sang pendant et après une césarienne. Il est donc recommandé dans notre pratique obstétricale, car il a le potentiel de réduire l'incidence de l'anémie post-partum. MOTS-CLÉS: Acide tranexamique, Perte de sang intrapartum, Hémorragie post-partum, Anémie.

Assuntos

Antifibrinolíticos , Perda Sanguínea Cirúrgica , Cesárea , Hemorragia Pós-Parto , Ácido Tranexâmico , Humanos , Ácido Tranexâmico/administração & dosagem , Feminino , Cesárea/efeitos adversos , Cesárea/métodos , Gravidez , Antifibrinolíticos/administração & dosagem , Adulto , Método Duplo-Cego , Nigéria , Hemorragia Pós-Parto/prevenção & controle , Perda Sanguínea Cirúrgica/prevenção & controle , Ocitocina/administração & dosagem , Adulto Jovem , Hemorragia Pós-Operatória/prevenção & controle , Hemorragia Pós-Operatória/epidemiologia , Resultado do Tratamento

RESUMO

BACKGROUND: The tauopathy inhibitor, davunetide shows sex-dependent efficacy in women suffering from progressive supranuclear palsy. Extending these findings to prodromal Alzheimer's disease, we submitted a double-blind, placebo-controlled, 12 weeks/16 weeks follow-up, davunetide clinical trial results in amnestic mild cognitive impairment (ClinicalTrials.gov ID NCT00422981), to a sex-dependent analysis. METHODS: One hundred forty-four individuals, separated into eight groups (1:2 placebo-and 2 doses, 5 mg davunetide/daily or 15 mg davunetide/twice-daily, with matching placebo intranasal volumes), were evaluated. RESULTS: Significant dose-dependent cognitive increases were observed in men compared to women with a test of delayed (12 ss) visual matching to the sample. In a test of semantic working memory and attention (digit span), women showed a significant low-dose placebo effect, ensuing in a high dose significant davunetide improvement, over the matched placebo. Correlating anxiety with cognition showed sex-opposing results, with women depicting significant anxiety correlations with delayed matching to sample. DISCUSSION: In conclusion, sex-specific prodromal Alzheimer's drug development is encouraged, with davunetide playing a lead initiative role.

Assuntos

Doença de Alzheimer , Disfunção Cognitiva , Sintomas Prodrômicos , Humanos , Doença de Alzheimer/tratamento farmacológico , Feminino , Masculino , Método Duplo-Cego , Idoso , Disfunção Cognitiva/tratamento farmacológico , Disfunção Cognitiva/etiologia , Disfunção Cognitiva/fisiopatologia , Fatores Sexuais , Pessoa de Meia-Idade , Relação Dose-Resposta a Droga , Memória de Curto Prazo/efeitos dos fármacos

RESUMO

Effective antihypertensive therapy is essential for achieving optimal blood pressure (BP) control and reducing cardiovascular events. This double-blind, multicenter, randomized trial aimed to compare the antihypertensive efficacy and safety of a combination of amlodipine (AML) and candesartan cilexetil (CC) versus AML monotherapy in patients with essential hypertension (HTN). After a 4-week run-in period with AML 5 mg, patients whose HTN remained uncontrolled (diastolic BP [DBP]) ≥ 90 mmHg and < 120 mmHg) were randomized to receive either AML + CC or AML alone for 8 weeks. Efficacy was assessed by measuring changes in DBP and systolic BP (SBP). The primary safety measure was the incidence of adverse events (AEs). A total of 174 participants were included in the efficacy analysis. After 8 weeks, DBP decreased by -9.92 ± 0.86 mmHg in the AML + CC arm and - 2.08 ± 0.86 mmHg in the AML arm (p < 0.0001). SBP decreased by -14.27 ± 1.39 mmHg in the AML + CC arm versus - 2.77 ± 1.39 mmHg in the AML arm (p < 0.0001). AEs occurred in 11.24% of the AML + CC group and 5.62% of the AML group (p = 0.1773). AML + CC combination therapy demonstrated superior efficacy with good tolerance, making it a promising option for patients with inadequately controlled hypertension on amlodipine alone.

Assuntos

Anlodipino , Anti-Hipertensivos , Benzimidazóis , Compostos de Bifenilo , Pressão Sanguínea , Quimioterapia Combinada , Hipertensão , Tetrazóis , Humanos , Anlodipino/administração & dosagem , Anlodipino/efeitos adversos , Anlodipino/uso terapêutico , Benzimidazóis/administração & dosagem , Benzimidazóis/efeitos adversos , Benzimidazóis/uso terapêutico , Feminino , Masculino , Pessoa de Meia-Idade , Anti-Hipertensivos/administração & dosagem , Anti-Hipertensivos/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Compostos de Bifenilo/uso terapêutico , Compostos de Bifenilo/administração & dosagem , Compostos de Bifenilo/efeitos adversos , Tetrazóis/administração & dosagem , Tetrazóis/efeitos adversos , Tetrazóis/uso terapêutico , Hipertensão/tratamento farmacológico , Método Duplo-Cego , Pressão Sanguínea/efeitos dos fármacos , Idoso , Resultado do Tratamento , Hipertensão Essencial/tratamento farmacológico , Adulto

RESUMO

BACKGROUND: Glucagon-like peptide-1 receptor agonists are a viable option for the prevention of Alzheimer's disease (AD) but the mechanisms of this potential disease modifying action are unclear. We investigated the effects of once-weekly exenatide (EQW) on AD associated proteomic clusters. METHODS: The Exenatide Study of Cardiovascular Event Lowering study compared the cardiovascular effects of EQW 2 mg with placebo in 13,752 people with type 2 diabetes mellitus. 4,979 proteins were measured (Somascan V0.4) on baseline and 1-year plasma samples of 3,973 participants. C-reactive protein (CRP), ficolin-2 (FCN2), plasminogen activator inhibitor 1 (PAI-1), soluble vascular cell adhesion protein 1 (sVCAM1) and 4 protein clusters were tested in multivariable mixed models. RESULTS: EQW affected FCN2 (Cohen's d -0.019), PAI-1 (Cohen's d -0.033), sVCAM-1 (Cohen's d 0.035) and a cytokine-cytokine cluster (Cohen's d 0.037) significantly compared with placebo. These effects were sustained in individuals over the age of 65 but not in those under 65. CONCLUSIONS: EQW treatment was associated with significant change in inflammatory proteins associated with AD. TRIAL REGISTRATION: EXSCEL is registered on ClinicalTrials.gov: NCT01144338 on 10th of June 2010.

Assuntos

Doença de Alzheimer , Diabetes Mellitus Tipo 2 , Exenatida , Receptor do Peptídeo Semelhante ao Glucagon 1 , Humanos , Doença de Alzheimer/tratamento farmacológico , Doença de Alzheimer/sangue , Masculino , Feminino , Idoso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/sangue , Receptor do Peptídeo Semelhante ao Glucagon 1/agonistas , Exenatida/uso terapêutico , Pessoa de Meia-Idade , Hipoglicemiantes/uso terapêutico , Método Duplo-Cego , Inibidor 1 de Ativador de Plasminogênio/sangue , Proteína C-Reativa/análise , Proteína C-Reativa/metabolismo , Inflamação/tratamento farmacológico

RESUMO

OBJECTIVES: The objective of this study was to evaluate the effectiveness of the combined use of empagliflozin (EMPA) and topiramate (TPM) versus a placebo in overweight/obese individuals without diabetes on a calorie-restricted diet. METHODS: In this study, 44 non-diabetic and overweight/obese subjects who were on a calorie restricted diet were randomly assigned into 2 groups: (1) Participants received a 10 mg EMPA tablet daily plus TPM tablet (at the 1st week 25 mg once a day and from the second week 25 mg twice a day); (2) Participants received an empagliflozin placebo (daily) plus a topiramate placebo (as mentioned for topiramate tablet in group 1), for 12 weeks. At baseline and weeks 4, 8, 12, weight, height, body mass index (BMI), waist circumference (WC), and body composition were evaluated. Before and after the intervention, blood pressure, C reactive protein, and glucose and lipid profile parameters were measured. RESULTS: The EMPA/TPM group, compared to placebo, had a greater percent change of weight at week 12 (- 8.92 ± 1.80 vs. - 4.93 ± 1.17). The intervention group had a greater percent change of fat mass and fat percent at week 12 (P < 0.05). However, there was no difference in the percent of change in fat-free percent between the two groups at week 12 (P = 0.577). Within-group analysis found a significant reduction in SBP, DBP, FBS, insulin, HOMA-IR, TC, LDL, HDL, TG, and CRP in both groups (P < 0.05). At week 12, no statistically significant difference was observed between the two groups in any of mentioned variables (P > 0.05). CONCLUSION: In non-diabetic overweight/obese individuals, the combination of EMPA/TPM and calorie restriction led to a notable decrease in body weight and was generally well-tolerated. Further research is required to evaluate the potential advantages of utilizing this combination for sustained weight management in the long run. LEVEL I: Randomized clinical trial.

Assuntos

Compostos Benzidrílicos , Restrição Calórica , Glucosídeos , Obesidade , Sobrepeso , Topiramato , Humanos , Compostos Benzidrílicos/uso terapêutico , Glucosídeos/uso terapêutico , Masculino , Feminino , Adulto , Obesidade/tratamento farmacológico , Obesidade/dietoterapia , Obesidade/complicações , Sobrepeso/tratamento farmacológico , Sobrepeso/dietoterapia , Topiramato/uso terapêutico , Pessoa de Meia-Idade , Índice de Massa Corporal , Glicemia/metabolismo , Glicemia/efeitos dos fármacos , Quimioterapia Combinada , Método Duplo-Cego , Fármacos Antiobesidade/uso terapêutico , Composição Corporal/efeitos dos fármacos , Circunferência da Cintura/efeitos dos fármacos , Pressão Sanguínea/efeitos dos fármacos , Resultado do Tratamento , Redução de Peso/efeitos dos fármacos , Inibidores do Transportador 2 de Sódio-Glicose/uso terapêutico

RESUMO

BACKGROUND: Multiple system atrophy (MSA) is recognized as an atypical Parkinsonian syndrome, distinguished by a more rapid progression than that observed in Parkinson's disease. Unfortunately, the prognosis for MSA remains poor, with a notable absence of globally recognized effective treatments. Although preliminary studies suggest that transcranial magnetic stimulation (TMS) could potentially alleviate clinical symptoms in MSA patients, there is a significant gap in the literature regarding the optimal stimulation parameters. Furthermore, the field lacks consensus due to the paucity of robust, large-scale, multicenter trials. METHODS: This investigation is a multi-center, randomized, double-blind, sham-controlled trial. We aim to enroll 96 individuals diagnosed with MSA, categorized into Parkinsonian type (MSA-P) and cerebellar type (MSA-C) according to their predominant clinical features. Participants will be randomly allocated in a 1:1 ratio to either the TMS or sham stimulation group. Utilizing advanced navigation techniques, we will ensure precise targeting for the intervention, applying theta burst stimulation (TBS). To assess the efficacy of TBS on both motor and non-motor functions, a comprehensive evaluation will be conducted using internationally recognized clinical scales and gait analysis. To objectively assess changes in brain connectivity, functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) will be employed as sensitive indicators before and after the intervention. DISCUSSION: The primary aim of this study is to ascertain whether TBS can alleviate both motor and non-motor symptoms in patients with MSA. Additionally, a critical component of our research involves elucidating the underlying mechanisms through which TBS exerts its potential therapeutic effects. ETHICS AND DISSEMINATION: All study protocols have been reviewed and approved by the First Affiliated Medical Ethics Committee of the Air Force Military Medical University (KY20232118-F-1). TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2300072658. Registered on 20 June 2023.

Assuntos

Atrofia de Múltiplos Sistemas , Estimulação Magnética Transcraniana , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Duplo-Cego , Eletroencefalografia , Imageamento por Ressonância Magnética , Estudos Multicêntricos como Assunto , Atrofia de Múltiplos Sistemas/terapia , Atrofia de Múltiplos Sistemas/fisiopatologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Estimulação Magnética Transcraniana/métodos , Resultado do Tratamento

RESUMO

BACKGROUND: Global prevalence and incidence of dementia continue to rise at a rapid rate. There is a need for new Alzheimer's disease (AD) treatments globally. Aducanumab is a human monoclonal antibody that selectively targets aggregated soluble amyloid beta oligomers and insoluble amyloid beta fibrils. In June 2021, aducanumab was approved by the US Food and Drug Administration for the treatment of AD under the accelerated approval pathway. OBJECTIVES: We evaluated the efficacy, safety, biomarker and pharmacokinetics (PK) of aducanumab in Japanese subgroups in EMERGE and ENGAGE studies. DESIGN: EMERGE and ENGAGE were two randomized, double-blind, placebo-controlled, global, phase 3 studies of aducanumab in patients with early AD (mild cognitive impairment due to AD or mild AD dementia). SETTING: These studies involved 348 sites in 20 countries. PARTICIPANTS: Participants enrolled in Japan included 121 (7.4% of total 1638 in EMERGE) and 100 (6.1% of total 1647 in ENGAGE) patients (aged 50-85 years with confirmed amyloid pathology) who met clinical criteria for mild cognitive impairment due to AD or mild AD dementia. INTERVENTION: Participants were randomly assigned 1:1:1 to receive aducanumab low dose (3 or 6 mg/kg target dose), high dose (6 or 10 mg/kg target dose) or placebo via IV infusion once every 4 weeks over 76 weeks. MEASUREMENTS: The primary outcome measure was change from baseline to Week 78 on the Clinical Dementia Rating Sum of Boxes (CDR-SB), an integrated scale that assesses both function and cognition. Other measures included safety assessments; secondary and tertiary clinical outcomes that assessed cognition, function, and behavior; biomarker endpoints (amyloid PET and plasma p-tau181); serum PK profiles and immunogenicity. RESULTS: Results from the Japanese subgroup analyses were generally consistent with those of the overall study population across endpoints, while a lower mean body weight (kg) and a smaller proportion of ApoE ε4 carriers were observed in the Japanese subgroup population. A treatment effect was observed in favor of aducanumab on the primary and secondary efficacy endpoints at Week 78 in EMERGE, but not ENGAGE. The incidence and type of adverse events in the Japanese subgroups were generally comparable to those observed in the overall study population; amyloid related imaging abnormalities (ARIA) were common treatment-related adverse events that appeared to be related to the aducanumab dose. ARIA incidence was generally lower in the Japanese subgroup compared with the overall population. Consistent with the overall data set, a robust dose-dependent decrease in amyloid beta levels as assessed with amyloid-PET and plasma p-tau181 was observed. Serum PK profiles and immunogenicity of aducanumab in Japanese population were consistent with the non-Japanese population. CONCLUSION: Efficacy, safety, biomarker, and PK profiles of aducanumab were consistent between the Japanese subgroup and the overall population. A positive treatment effect of aducanumab on efficacy endpoints was observed in EMERGE, but not in ENGAGE.

Assuntos

Doença de Alzheimer , Anticorpos Monoclonais Humanizados , Humanos , Doença de Alzheimer/tratamento farmacológico , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais Humanizados/farmacocinética , Idoso , Masculino , Feminino , Método Duplo-Cego , Japão , Idoso de 80 Anos ou mais , Pessoa de Meia-Idade , Disfunção Cognitiva/tratamento farmacológico , Biomarcadores/sangue , Peptídeos beta-Amiloides/metabolismo , População do Leste Asiático

RESUMO

Introduction: This double-blind, placebo-controlled, randomized (1:1) clinical trial was conducted at the West China Hospital, Sichuan University, from March to September 2017. Methods: Eligible participants included adults aged 18 years and older, living in the community, diagnosed with type 2 Diabetes Mellitus according to ADA guidelines, capable of self-managing their diabetes, and able to visit the study site for follow-up. The intervention group received 25 ml of a probiotic beverage containing with over 10^8 CFU/mL of Lactobacillus, administered four times daily. An equal volume of inactivated Lactobacillus was administered to the control group and the control group was administered the same volume of inactivated Lactobacillus. This study aimed to evaluate the effectiveness of probiotics on glycemic control and other diabetes-related outcomes in patients with type 2 diabetes patients. The primary outcomes were changes in HbA1c and FBG levels post-intervention. Investigators, participants, and study site personnel were blinded to the treatment allocation until the conclusion of the study. This double-blind, randomized, placebo-controlled clinical trial was registered in the Chinese Clinical Trial Registry (ChiCTR-POR-17010850). Results: Of the 490 participants screened, 213 were randomized to either the probiotics group (n = 103) or the placebo group (n = 110). After 16 weeks of follow-up, the probiotic group showed reductions in HbA1c [-0.44 (-0.66 to -0.22)] and FBG [-0.97 (-1.49 to 0.46)] post-intervention, similar to the placebo group with reductions in HbA1c [-0.33 (-0.52 to -0.15)] and FBG [-0.90 (-1.32 to -0.47)], but these changes were not statistically significant in PP and ITT analyses (P>0.05). Adverse events were similarly distributed among groups, indicating comparable safety profiles. Discussion: Overall, 16-week probiotic supplementation showed no beneficial effects on glycemic control, lipid profiles, or weight. Clinical Trial Registration: https://www.chictr.org.cn/showproj.html?proj=18421, identifier ChiCTR-POR-17010850.

Assuntos

Glicemia , Diabetes Mellitus Tipo 2 , Controle Glicêmico , Lipídeos , Probióticos , Humanos , Probióticos/uso terapêutico , Probióticos/administração & dosagem , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/terapia , Masculino , Método Duplo-Cego , Feminino , Pessoa de Meia-Idade , Controle Glicêmico/métodos , Glicemia/metabolismo , Lipídeos/sangue , Idoso , Adulto , Hemoglobinas Glicadas/análise , Hemoglobinas Glicadas/metabolismo , Resultado do Tratamento

RESUMO

PURPOSE: The effects of coffee ingestion on skeletal muscle microvascular function are not well understood. This study aimed to investigate the acute effects of coffee intake with varying levels of caffeine on skeletal muscle microvascular reactivity at rest and oxygen extraction during maximal incremental exercise in physically active individuals. METHODS: Twenty healthy young male participants were administered coffee with low caffeine (3 mg/kg body weight; LC), high caffeine (6 mg/kg body weight; HC), and placebo (decaf) in different sessions. Skeletal muscle reactivity indexes, including tissue saturation index 10s slope (TSI10) and TSI half time recovery (TSI ½) following 5-minute ischemia were measured at rest and were measured at baseline and post-coffee consumption using near-infrared spectroscopy (NIRS). Post-coffee intake, NIRS was also used to measure microvascular oxygen extraction during exercise via maximal incremental exercise. Peak oxygen consumption and peak power output (Wpeak) were simultaneously evaluated. RESULTS: Post-coffee consumption, TSI10 was significantly higher in the LC condition compared to placebo (p = 0.001) and significantly higher in the HC condition compared to placebo (p < 0.001). However, no difference was detected between LC and HC conditions (p = 0.527). HC condition also showed significant less TSI ½ compared to placebo (p = 0.005). However, no difference was detected for microvascular oxygen extraction during exercise, despite the greater Wpeak found for HC condition (p < 0.001) compared to placebo. CONCLUSION: Coffee ingestion with high caffeine level (6 mg/kg body weight) significantly enhanced skeletal muscle reactivity at rest. However, the improvement of exercise performance with coffee intake is not accompanied by alterations in muscle oxygen extraction.

Assuntos

Cafeína , Café , Estudos Cross-Over , Exercício Físico , Músculo Esquelético , Consumo de Oxigênio , Descanso , Humanos , Masculino , Músculo Esquelético/irrigação sanguínea , Músculo Esquelético/metabolismo , Cafeína/administração & dosagem , Cafeína/farmacologia , Exercício Físico/fisiologia , Adulto Jovem , Descanso/fisiologia , Espectroscopia de Luz Próxima ao Infravermelho , Adulto , Microcirculação/efeitos dos fármacos , Método Duplo-Cego , Oxigênio/sangue

RESUMO

BACKGROUND: This study aimed to examine the effect of a commercially available multi-ingredient powder (AG1Ⓡ) on the gut microbiome and assess the impact of AG1Ⓡ on GI tolerability and other clinical safety markers in healthy men and women. METHODS: Using a double-blind, randomized, two-arm, placebo-controlled, parallel design, we examined a 4-week daily supplementation regimen of AG1Ⓡ vs. placebo (PL). Fifteen men and 15 women provided stool samples for microbiome analysis, questionnaires for digestive quality of life (DQLQ), and completed visual analog scales (VAS) and Bristol stool charts to assess stool consistency and bowel frequency before and after the 4-week intervention. Participant's blood work (CBC, CMP, and lipid panel) was also assessed before and after the 4-week intervention. Alpha diversity was determined by Shannon and Chao1 index scores and evaluated by a two-way ANOVA, beta diversity in taxonomic abundances and functional pathways was visualized using partial least squares-discriminant analyses and statistically evaluated by PERMANOVA. To identify key biomarkers, specific feature differences in taxonomic relative abundance and normalized functional pathway counts were analyzed by linear discriminant analysis (LDA) effect size (LEfSe). Questionnaires, clinical safety markers, and hemodynamics were evaluated by mixed factorial ANOVAs with repeated measures. This study was registered on clinicaltrials.gov (NCT06181214). RESULTS: AG1Ⓡ supplementation enriched two probiotic taxa (Lactobacillus acidophilus and Bifidobacterium bifidum) that likely stem from the probiotics species that exist in the product, as well as L. lactis CH_LC01 and Acetatifactor sp900066565 ASM1486575v1 while reducing Clostridium sp000435835. Regarding community function, AG1Ⓡ showed an enrichment of two functional pathways while diminishing none. Alternatively, the PL enriched six, but diminished five functional pathways. Neither treatment negatively impacted the digestive quality of life via DQLQ, bowel frequency via VAS, or stool consistency via VAS and Bristol. However, there may have been a greater improvement in the DQLQ score (+62.5%, p = 0.058, d = 0.73) after four weeks of AG1Ⓡ supplementation compared to a reduction (-50%) in PL. Furthermore, AG1Ⓡ did not significantly alter clinical safety markers following supplementation providing evidence for its safety profile. CONCLUSIONS: AG1Ⓡ can be consumed safely by healthy adults over four weeks with a potential beneficial impact in their digestive symptom quality of life.

Assuntos

Suplementos Nutricionais , Fezes , Microbioma Gastrointestinal , Probióticos , Qualidade de Vida , Humanos , Método Duplo-Cego , Microbioma Gastrointestinal/efeitos dos fármacos , Masculino , Feminino , Adulto , Fezes/microbiologia , Probióticos/administração & dosagem , Adulto Jovem , Pessoa de Meia-Idade

RESUMO

AIMS: To identify baseline characteristics that best correlate to treatment interval for naive neovascular age-related macular degeneration patients treated with faricimab in the first year (Y1) of the TENAYA and LUCERNE phase 3 trials, and to further understand how these characteristics may impact treatment intervals. METHODS: This post-hoc analysis of Y1 data from the TENAYA and LUCERNE trials evaluated ocular baseline characteristics associated with Y1 treatment intervals. Patients were categorised into three subgroups based on their Y1 treatment interval: Q16W, Q12W or Q8W. Baseline characteristics (central subfield thickness (CST), best-corrected visual acuity, presence of subretinal fluid in centre 1 mm, presence of retinal fluid in centre 1 mm, macular neovascularisation (MNV) location and MNV type) were inputted into an R package 'rpart' to create a classification tree model. A data-driven tree model based on CST was fitted, producing CST subgroups of low, middle and high ranges. Within each CST subgroup, the model identified the most impactful variables and associated thresholds. RESULTS: After fitting the data to produce data-driven CST ranges, the model chose MNV location, followed by MNV lesion type as the most impactful baseline characteristics with these factors having a p value <0.05 in a multivariate analysis. CONCLUSIONS: Among the selected ocular baseline characteristics from TENAYA and LUCERNE trial, CST, MNV type and MNV location were seen as the most relevant variables to enable extension of treatment intervals during Y1. While this analysis provides insights for treatment intervals during the first year, further analysis incorporating Y2 data from the TENAYA and LUCERNE studies will be needed to assess factors influencing treatment intervals over a longer period.

Assuntos

Inibidores da Angiogênese , Injeções Intravítreas , Acuidade Visual , Degeneração Macular Exsudativa , Humanos , Masculino , Feminino , Inibidores da Angiogênese/uso terapêutico , Inibidores da Angiogênese/administração & dosagem , Degeneração Macular Exsudativa/tratamento farmacológico , Idoso , Tomografia de Coerência Óptica , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Método Duplo-Cego , Idoso de 80 Anos ou mais , Resultado do Tratamento , Fatores de Tempo

RESUMO

OBJECTIVE: To determine the efficacy of genicular artery embolisation (GAE) compared with sham GAE for pain reduction in patients with symptomatic mild-to-moderate knee osteoarthritis (KOA). DESIGN: Double-blind randomised sham-controlled clinical trial conducted from June 2019 to December 2021. The follow-up period was 4 months. SETTING: Single-centre study conducted at a university medical centre in Rotterdam, Netherlands. PARTICIPANTS: 58 adults with symptomatic mild-to-moderate KOA not improving with conservative treatment. INTERVENTIONS: Participants were randomised to receive either GAE treatment or a sham GAE treatment. MAIN OUTCOME MEASURES: The primary outcome was reduction of pain measured with the Knee Injury and Osteoarthritis Outcome Score pain subscale (0-100, with 0 representing the worst pain outcome and 100 the best) after 4 months. Outcomes were assessed at baseline and 1 and 4 months. RESULTS: From June 2019 to December 2021, 58 patients were included. 29 patients were randomised to the GAE group and 29 to the sham group. All participants completed the study. The mean pain reduction after 4 months was 21.4 (95% CI 13.9 to 28.8) for the GAE group and 18.4 points (95% CI 11.6 to 25.1) for the sham group. The between-group difference for the mean pain reduction was 3.0 (95% CI -7.1 to 13.0) with an estimated Cohen's d effect size of d = 0.15 (95% CI -0.37 to 0.66). Group allocation was not a significant contributor to pain reduction (p = 0.31). No serious adverse events (AEs) occurred. 23 mild AEs occurred in the GAE group and 5 in the sham group. CONCLUSION: We did not establish a clinical effect of GAE in patients with mild-to-moderate KOA as GAE produced a similar effect on pain reduction as a sham GAE procedure. TRIAL REGISTRATION NUMBER: NCT03884049.

Assuntos

Embolização Terapêutica , Osteoartrite do Joelho , Humanos , Osteoartrite do Joelho/terapia , Feminino , Masculino , Embolização Terapêutica/métodos , Pessoa de Meia-Idade , Método Duplo-Cego , Idoso , Medição da Dor , Resultado do Tratamento , Países Baixos

RESUMO

BACKGROUND: Aging leads to a decline in muscle mass and strength, contributing to frailty and decreased quality of life. Sirolimus (rapamycin) , an mTOR inhibitor, has shown potential in preclinical studies to extend lifespan and improve health span. This study evaluates the safety and efficacy of once-weekly sirolimus (rapamycin) administration on muscle strength and endurance in older adults engaged in a 13-week exercise program. METHODS: This randomized, double-blind, placebo-controlled trial will enroll 40 participants aged 65-85. Participants will be randomly assigned to receive either sirolimus (rapamycin) 6 mg/week or placebo for 13 weeks, in conjunction with an at-home exercise program. The primary outcome measure is the change in muscle strength and endurance, assessed by the 30-Second Chair-Stand Test. Secondary outcome measures include adverse events, changes in muscle strength and endurance as measured by the 6-min walk test, handgrip strength, and participant-reported outcomes using the SF-36 survey. Assessments will be conducted at baseline, mid-intervention (week 6), and post-intervention (week 13). Blood samples will be collected for hematology and biochemistry analyses, including full blood count, urea and electrolytes, liver function tests, HbA1c, lipids, serum IGF-1, and hs-CRP. DNA methylation will be analyzed using TruDiagnostic™ to explore changes in biological age. DISCUSSION: This study aims to provide insights into the potential benefits of intermittent sirolimus (rapamycin) administration on muscle performance in older adults. By alternating periods of mTOR inhibition through rapamycin and activation via exercise, this study will explore a novel approach to enhancing muscle strength and endurance in the aging population. The results could have significant implications for developing interventions to improve physical function and overall health outcomes in older adults. Safety and tolerability will also be closely monitored to ensure the feasibility of this regimen for wider application. TRIAL REGISTRATION: Australia New Zealand Clinical Trials Registry, ACTRN12624000790549. Registered on 26 June 2024 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12624000790549 .

Assuntos

Força Muscular , Sirolimo , Humanos , Método Duplo-Cego , Sirolimo/administração & dosagem , Sirolimo/efeitos adversos , Idoso , Força Muscular/efeitos dos fármacos , Idoso de 80 Anos ou mais , Masculino , Feminino , Resistência Física/efeitos dos fármacos , Ensaios Clínicos Controlados Aleatórios como Assunto , Esquema de Medicação , Resultado do Tratamento , Inibidores de MTOR/administração & dosagem , Inibidores de MTOR/efeitos adversos , Músculo Esquelético/efeitos dos fármacos , Terapia por Exercício/métodos , Qualidade de Vida , Fatores de Tempo

RESUMO

BACKGROUND: To study the effects of different interventions on automatic gait processing in contrast with voluntary gait processing in healthy subjects. METHODS: A double-blind randomised controlled trial was designed (120 able-body persons between 18 and 65 years old entered and completed the study), with pre-intervention and post-intervention assessments using the 6-Minute Walk Test (6MWT). The participants were randomly distributed into four groups. Prior to intervention, all participants performed voluntary gait on the ground (VoG) in a calibrated circuit following the 6MWT. The presence of automatic gait (AG) was explored post-intervention without a voluntary demand in the same circuit following the 6MWT. Each group received a different intervention for 30 min: Vojta stimulation, MOTOMED® at no less than 60 revolutions/minute, treadmill walking at 3 km/h, and resting in a chair (control). The main assessment, conducted by a blinded rater, was the difference in distance covered (in meters) during the 6MWT between pre- and post-intervention. Surface electromyography (sEMG) average root mean square (RMS) signals in the right tibialis anterior, right soleus, right rectus femoris, and right biceps femoris were also considered outcome measures. RESULTS: The Vojta group was the only one that initiated AG after the intervention (476.4 m ± 57.1 in VoG versus 9.0 m ± 8.9 in AG, p < 0.001) with comparable kinematics and EMG parameters during voluntary gait, except for ankle dorsal flexion. Within the Vojta group, high variability in kinematics, sEMG activity, and distance covered was observed. CONCLUSIONS: AG isolation is approachable through Vojta at only one session measurable with the 6MWT without any voluntary gait demand. No automatic gait effects were observed post-intervention in the other groups. TRIAL REGISTRATION: NCT04689841 (ClinicalTrials.gov).

Assuntos

Eletromiografia , Marcha , Humanos , Método Duplo-Cego , Adulto , Masculino , Feminino , Marcha/fisiologia , Pessoa de Meia-Idade , Adulto Jovem , Adolescente , Músculo Esquelético/fisiologia , Teste de Caminhada , Idoso , Voluntários Saudáveis

RESUMO

BACKGROUND: Extracorporeal shockwave therapy (ESWT) has been proven beneficial for post-stroke spasticity (PSS) of ankle plantar flexor muscles. This study aims to investigate the dose-response effectiveness of focused-ESWT and the duration of its effect on the treatment of ankle PSS in stroke patients. METHODS: In this double-blinded randomized controlled trial, stroke patients diagnosed with PSS in the ankle plantar flexor muscles were randomly assigned to two groups. The experimental group received double-dose ESWT (4000 pulses per session) targeting spastic calf muscles, while the control group received half the dose (2000 pulses per session). Both groups underwent four sessions over two weeks. The outcomes, including modified Ashworth Scale (MAS), modified Tardieu Scale (MTS), passive range of motion (PROM) of the ankle, Timed Up and Go (TUG) Test, Barthel index and strain elastography were evaluated at baseline, 1st, 4th, 12th, and 24th week after ESWT. RESULTS: Within-group analysis revealed significant improvements in MAS, PROM, TUG Test, and Barthel index for the double-dose ESWT group and improvements in Barthel index for the control group. Between-group analysis revealed greater improvements in TUG Test, Barthel Index and strain elastography for the double-dose ESWT group. Generalized estimating equations analysis indicated that the double-dose ESWT group achieved superior outcomes in the TUG Test, Barthel Index, and strain elastography across various time points and groups. CONCLUSIONS: Double-dose ESWT showed better functional improvement and elastography compared to the control group. ESWT demonstrated dose-response effectiveness for PSS of ankle-equinus. TRIAL REGISTRATION: NCT05878223.

Assuntos

Tratamento por Ondas de Choque Extracorpóreas , Espasticidade Muscular , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Espasticidade Muscular/etiologia , Espasticidade Muscular/reabilitação , Espasticidade Muscular/terapia , Masculino , Tratamento por Ondas de Choque Extracorpóreas/métodos , Feminino , Pessoa de Meia-Idade , Método Duplo-Cego , Acidente Vascular Cerebral/complicações , Reabilitação do Acidente Vascular Cerebral/métodos , Tornozelo , Resultado do Tratamento , Adulto , Idoso , Amplitude de Movimento Articular , Articulação do Tornozelo

RESUMO

Phosphodiesterase 4 (PDE4) inhibitor is associated with a broad-spectrum anti-inflammatory mechanism. However, securing clinically efficacious doses with sufficient safety margins remains challenging due to class specific adverse events that are often unavoidable in the clinic. ART-648 is an orally available PDE4 inhibitor being developed for the treatment of inflammatory diseases. According to the estimated clinical doses based on an in vitro whole-blood assay, a phase I study was designed. The purpose of this phase I study was to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) following single and multiple administration of ART-648 in healthy subjects. PD was assessed by suppression of lipopolysaccharide-induced TNFα release in ex vivo whole-blood assay. In the single rising dose study, ART-648 was safe and well tolerated with a dose-proportional increase in exposures up to 4 mg. Single doses of ART-648 demonstrated dose-dependent PD response, indicating target engagement at 2-8 mg doses. In the multiple rising dose study, doses up to 4 mg BID after careful titration were well tolerated, while doses up to 6 mg BID were tolerated not in all but the majority of subjects. In conclusion, ART-648 exhibits a favorable PK profile with robust target engagement at clinically safe and tolerated doses identified in healthy subjects.

Assuntos

Relação Dose-Resposta a Droga , Voluntários Saudáveis , Inibidores da Fosfodiesterase 4 , Humanos , Inibidores da Fosfodiesterase 4/farmacocinética , Inibidores da Fosfodiesterase 4/administração & dosagem , Inibidores da Fosfodiesterase 4/efeitos adversos , Masculino , Adulto , Feminino , Pessoa de Meia-Idade , Adulto Jovem , Método Duplo-Cego , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Lipopolissacarídeos/administração & dosagem , Administração Oral , Sulfonamidas , para-Aminobenzoatos

RESUMO

Helicobacter pylori (H. pylori) is a major cause of peptic ulcer disease (PUD), which needs effective eradication of the organism to heal ulcers and prevent a recurrence. In recent years, increasing resistance of H. pylori to clarithromycin and amoxicillin have decreased peptic ulcer cure rate following treatment with standard triple therapy worldwide. The addition of probiotics with standard triple therapy has shown excellent efficacy in H. pylori eradication and has appeared to be an alternative treatment strategy. This study aimed to assess the efficacy of standard triple therapy plus probiotics for H. pylori eradication and ulcer healing compared to standard triple therapy alone. This double-blind, randomized placebo-controlled clinical trial included 158 with endoscopically proven H. pylori-positive PUD who were randomly allocated equally into two groups; Group A was treated with standard triple therapy plus probiotics, and Group B was treated with standard triple therapy plus placebo for 14 days. The outcome was evaluated at the end of treatment (14th day) (symptoms plus adverse events) and after 60 days of treatment completion (H. pylori eradication and ulcer healing). One hundred forty four (144) study subjects (73 in Group A and 71 in Group B) completed the study. Significantly higher H. pylori eradication rate (82.2%vs. 67.6%, p=0.043) and ulcer healing rate (92.3% vs. 60.0%, p=0.049) were observed in the standard triple therapy plus probiotic group than the standard triple therapy plus placebo group. Early relief of epigastric pain was also seen among patients getting probiotics than the placebo in addition to standard triple therapy (42.3% vs. 15.1%, p<0.001).The addition of probiotics significantly improves the H. pylori eradication rate and ulcer healing rate among the patients getting standard triple therapy. Further large-scale, multi-center studies are needed to recommend routine use of probiotics with standard triple therapy for H. pylori eradication.

Assuntos

Amoxicilina , Antibacterianos , Quimioterapia Combinada , Infecções por Helicobacter , Helicobacter pylori , Úlcera Péptica , Probióticos , Humanos , Probióticos/uso terapêutico , Probióticos/administração & dosagem , Úlcera Péptica/microbiologia , Úlcera Péptica/tratamento farmacológico , Úlcera Péptica/terapia , Infecções por Helicobacter/tratamento farmacológico , Infecções por Helicobacter/terapia , Masculino , Feminino , Método Duplo-Cego , Pessoa de Meia-Idade , Adulto , Antibacterianos/uso terapêutico , Antibacterianos/administração & dosagem , Amoxicilina/uso terapêutico , Amoxicilina/administração & dosagem , Claritromicina/uso terapêutico , Claritromicina/administração & dosagem , Resultado do Tratamento

RESUMO

AIMS: Patients with epistaxis typically visit the emergency department for initial treatment. According to recent studies, tranexamic acid (TXA) is effective in the treatment of epistaxis. This study compared the therapeutic superiority of saline to that of 500 and 1000 mg doses of topical TXA for the treatment of anterior epistaxis. Materials and methods: This phase 4 clinical trial was a randomized, controlled, and double-blind trial. A total of 152 patients were divided into three groups. Group 1 was treated with 1000 mg TXA, Group 2 with 500 mg TXA, and Group 3 with saline. Results: Based on multinomial logistic regression analysis, the bleeding frequency at the 5th minute was 2.9 times and rebleeding status was 4.3 times less in Group 1 (1000 mg TXA) than in Group 3 (saline). There were no differences between the three groups in terms of side effects or salvage therapy. Conclusion: In addition to its superiority in treatment, 1000 mg of TXA is recommended because of the decreased rate of recurrent bleeding and low incidence of side effects.

Assuntos

Administração Tópica , Antifibrinolíticos , Epistaxe , Ácido Tranexâmico , Ácido Tranexâmico/administração & dosagem , Ácido Tranexâmico/uso terapêutico , Humanos , Epistaxe/tratamento farmacológico , Método Duplo-Cego , Masculino , Feminino , Pessoa de Meia-Idade , Antifibrinolíticos/administração & dosagem , Antifibrinolíticos/uso terapêutico , Adulto , Idoso , Resultado do Tratamento , Relação Dose-Resposta a Droga

RESUMO

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a chronic condition characterized by insulin resistance and impaired insulin production, leading to elevated blood glucose levels. Curcumin, a polyphenolic compound from Curcuma longa, has shown potential in improving insulin sensitivity and reducing blood glucose levels, which may help mitigate type 2 diabetes progression. OBJECTIVE: To assess the efficacy of improving type 2 diabetes (T2DM). STUDY DESIGN: This randomized, double-blind, placebo-controlled trial included subjects (n = 272) with criteria for type 2 diabetes. METHODS: All subjects were randomly assigned to receive curcumin (1500 mg/day) or placebo with blind labels for 12 months. To assess the improvement of T2DM after curcumin treatments body weight and body mass index, fasting plasma glucose, glycosylated hemoglobin A1c, ß-cell function (homeostasis model assessment [HOMA-ß]), insulin resistance (HOMA-IR), insulin, adiponectin, and leptin were monitored at the baseline and at 3-, 6-, 9-, and 12-month visits during the course of intervention. RESULTS: After 12 months of treatment, the curcumin-treated group showed a significant decrease in fasting blood glucose (115.49 vs.130.71; P < 0.05), HbA1c (6.12 vs. 6.47; P < 0.05). In addition, the curcumin-treated group showed a better overall function of ß-cells, with higher HOMA-ß (136.20 vs. 105.19; P < 0.01) The curcumin-treated group showed a lower level of HOMA-IR (4.86 vs. 6.04; P < 0.001) and higher adiponectin (14.51 vs. 10.36; P < 0.001) when compared to the placebo group. The curcumin-treated group also showed a lower level of leptin (9.42 vs. 20.66; P < 0.001). Additionally, body mass index was lowered (25.9 4 vs.29.34), with a P value of 0.001. CONCLUSIONS: A 12-month curcumin intervention in type 2 diabetes patients shows a significant glucose-lowering effect. Curcumin treatment appeared to improve the overall function of ß-cells and reduce both insulin resistance and body weight, with very minor adverse effects. Curcumin intervention in obese patients with type 2 diabetes may be beneficial. TRIAL REGISTRATION: Thai clinical trials regentrify no.20140303003.

Assuntos

Glicemia , Índice de Massa Corporal , Curcumina , Diabetes Mellitus Tipo 2 , Hemoglobinas Glicadas , Resistência à Insulina , Células Secretoras de Insulina , Insulina , Obesidade , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/complicações , Curcumina/farmacologia , Curcumina/administração & dosagem , Masculino , Feminino , Método Duplo-Cego , Pessoa de Meia-Idade , Células Secretoras de Insulina/efeitos dos fármacos , Células Secretoras de Insulina/metabolismo , Glicemia/efeitos dos fármacos , Glicemia/metabolismo , Obesidade/tratamento farmacológico , Obesidade/complicações , Insulina/sangue , Adiponectina/sangue , Extratos Vegetais/farmacologia , Extratos Vegetais/administração & dosagem , Leptina/sangue , Adulto , Curcuma , Peso Corporal/efeitos dos fármacos

RESUMO

Importance: Neurologic post-COVID-19 condition (PCC), or long COVID, symptoms of fatigue and cognitive dysfunction continue to affect millions of people who have been infected with SARS-CoV-2. There currently are no effective evidence-based therapies available for treating neurologic PCC. Objective: To assess the effects of lithium aspartate therapy on PCC fatigue and cognitive dysfunction. Design, Setting, and Participants: A randomized, double-blind, placebo-controlled trial (RCT) enrolling participants in a neurology clinic from November 28, 2022, to June 29, 2023, with 3 weeks of follow-up, was conducted. Subsequently, an open-label lithium dose-finding study with 6 weeks of follow-up was performed among the same participants enrolled in the RCT. Eligible individuals needed to report new, bothersome fatigue or cognitive dysfunction persisting for more than 4 weeks after a self-reported positive test for COVID-19, Fatigue Severity Scale-7 (FSS-7) or Brain Fog Severity Scale (BFSS) score of 28 or greater, Beck Depression Inventory-II score less than 24, and no history of a condition known to cause fatigue or cognitive dysfunction. All participants in the RCT were eligible for the dose-finding study, except for those who responded to the placebo. Intention-to-treat analysis was used. Intervention: Lithium aspartate, 10 to 15 mg/d, or identically appearing placebo for 3 weeks followed by open-label lithium aspartate, 10 to 15 mg/d, for 2 weeks. In the subsequent dose-finding study, open-label lithium aspartate dosages up to 45 mg/d for 6 weeks were given. Main Outcomes and Measures: Change in sum of FSS-7 and BFSS scores. The scores for each measure range from 7 to 49, with higher scores indicating more severe symptoms. Secondary outcomes included changes from baseline in the scores of additional questionnaires. Results: Fifty-two participants were enrolled (30 [58%] males; mean [SD] age, 58.54 [14.34] years) and 26 were randomized to treatment with lithium aspartate (10 females) and 26 to placebo (12 female). Two participants assigned to lithium aspartate were lost to follow-up and none withdrew. No adverse events were attributable to lithium therapy. There were no significant intergroup differences for the primary outcome (-3.6; 95% CI, -16.6 to 9.5; P = .59) or any secondary outcomes. Among 3 patients completing a subsequent dose-finding study, open-label lithium aspartate, 40 to 45 mg/d, was associated with numerically greater reductions in fatigue and cognitive dysfunction scores than 15 mg/d, particularly in 2 patients with serum lithium levels of 0.18 and 0.49 mEq/L compared with 1 patient with a level of 0.10 mEq/L. Conclusions and Relevance: In this RCT, therapy with lithium aspartate, 10 to 15 mg/d, was ineffective for neurologic PCC fatigue and cognitive dysfunction. Another RCT is required to assess the potential benefits of higher lithium dosages for treating neurologic PCC. Trial Registration: ClinicalTrials.gov Identifier: NCT05618587 and NCT06108297.

Assuntos

Ácido Aspártico , COVID-19 , Disfunção Cognitiva , Fadiga , Humanos , Feminino , Masculino , Pessoa de Meia-Idade , Método Duplo-Cego , Fadiga/tratamento farmacológico , Fadiga/etiologia , Disfunção Cognitiva/tratamento farmacológico , Disfunção Cognitiva/etiologia , COVID-19/complicações , Idoso , Adulto , Tratamento Farmacológico da COVID-19 , SARS-CoV-2 , Síndrome de COVID-19 Pós-Aguda , Resultado do Tratamento