title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Referências | Potential conflict of interestNo potential conflict of interest relevant to this article was reported. | PMC10263431 | ||
Abstract | PMC10263431 | |||
Background | ISCHEMIC HEART DISEASE | Exercise plays a positive role in the course of the ischemic heart disease, enhancing functional capacity and preventing ventricular remodeling. | PMC10263431 | |
Objective | ACUTE MYOCARDIAL INFARCTION, CONTRACTION, AMI | To investigate the impact of exercise on left ventricular (LV) contraction mechanics after an uncomplicated acute myocardial infarction (AMI). | PMC10263431 | |
Methods | AMI, CONTRACTION | A total of 53 patients was included, 27 of whom were randomized to a supervised training program (TRAINING group), and 26 to a CONTROL group, who received usual recommendations on physical exercise after AMI. All patients underwent cardiopulmonary stress testing and a speckle tracking echocardiography to measure severa... | PMC10263431 | |
Results | No significant difference were found in the analysis of LV longitudinal, radial and circumferential strain parameters between groups after the training period. After the training program, analysis of torsional mechanics demonstrated a reduction in the LV basal rotation in the TRAINING group in comparison to the CONTROL... | PMC10263431 | ||
Conclusions | torsion | TORSION | Physical activity did not cause a significant improvement in LV longitudinal, radial and circumferential deformation parameters. However, the exercise had a significant impact on the LV torsional mechanics, consisting of a reduction in basal rotation, twist velocity, torsion and torsional velocity which can be interpre... | PMC10263431 |
Introduction | systolic dysfunction | ACUTE MYOCARDIAL INFARCTION, CONTRACTION, AMI, TORSION, SYSTOLIC DYSFUNCTION | The benefits of exercise after acute myocardial infarction (AMI) have been investigated for several years and most publications have demonstrated a better prognosis related to this practice.Benefits have been demonstrated in cases of AMI with greater impairment of LV contraction, causing moderate and severe systolic dy... | PMC10263431 |
Methods | PMC10263431 | |||
Study design and population | CORONARY DISEASE, EVENT, RESPIRATORY COMPENSATION, AMI, HEART | This was a prospective, longitudinal, randomized and controlled study. Patients with uncomplicated AMI admitted to the Acute Coronary Disease Unit of the Heart Institute of the University of Sao Paulo Medical School (InCor/HCFMUSP), who agreed to participate in the study, were randomized to two groups (TRAINING and CON... | PMC10263431 | |
Conventional echocardiogram | BLIND | The echocardiogram was performed by a single experienced operator blind to the allocation group. Commercially available echocardiographic equipment (Vivid E9; GE Medical Systems, Milwaukee, WI, USA) was used, equipped with linear broadband transducers with a frequency of 5-2 MHz. Measurements, and analysis of valve flo... | PMC10263431 | |
STE image acquisition and analysis | For image acquisition for speckle tracking analysis, the machine was adjusted to acquire three cardiac cycles, with frame rate between 40-80 frames/s. Images were obtained in the parasternal short axis (PSAX) view in its three main levels: basal (mitral valve), mid (papillary muscles) and apical. LV apical window was c... | PMC10263431 | ||
– A) example of apical rotation measurement. B) graphical representation of left ventricular torsion. AVC: aortic valve closure. | PMC10263431 | |||
Cardiopulmonary exercise testing | The CPX was performed on an electromagnetic cycle ergometer (Medfit 400L, Medical Fitness Equipment, Maarn, Netherlands), following a ramp protocol, with a speed of 60 revolutions per minute (rpm) and workload increments from 10w to 20w per minute, until achieving physical exhaustion. Participants were connected to a v... | PMC10263431 | ||
Statistical analysis | Continuous data are presented as mean ± standard deviation (SD) or median and interquartile ranges (IQR), according to normality of distribution assessed by the Shapiro-Wilk test. Categorical data were presented as numbers and percentages. To calculate the sample size, the mean value of global longitudinal strain of 15... | PMC10263431 | ||
Pearson’s linear correlation was performed to assess correlations between CPX and echocardiographic variables. | All tests were 2-tailed and a p value <0.05 was considered statistically significant. Statistical analysis was done using the SPSS v.25.0 software for Macintosh (SPSS Inc, Chicago, IL). Inter and intra-observer analyses and Bland-Altman plots are disposed in the | PMC10263431 | ||
Results | PMC10263431 | |||
Clinical characteristics | From 2016 to 2019, a total of 76 patients was enrolled. Of these, 23 were excluded for several reasons, with poor adherence to exercise as the main reason (
| PMC10263431 | ||
– Patient inclusion flowchart. ACS: acute coronary syndrome. | The clinical characteristics of the population are shown in
| PMC10263431 | ||
Cardiopulmonary exercise testing | PMC10263431 | |||
Conventional echocardiogram | Echocardiographic data are shown in | PMC10263431 | ||
Analysis of LV contraction mechanics | PMC10263431 | |||
Apical view | PMC10263431 | |||
Strain and strain rate (SR) | No significant differences in strain or SR in response to exercise was found between the groups at the end of the follow-up (
| PMC10263431 | ||
Transversal axis | PMC10263431 | |||
Circumferential and Radial Strain and SR, and Rotations | Data obtained from the analysis of LV transversal axis are presented in
| PMC10263431 | ||
: Influence of Physical Training after a Myocardial Infarction on Left Ventricular Contraction Mechanics | PMC10263431 | |||
LV twist and torsion | torsion | TORSION | Results of the LV twist and torsion analyses are shown in | PMC10263431 |
Correlation analysis | Pearson’s linear correlation were performed to assess correlation between the VO | PMC10263431 | ||
Discussion | and radial myocardial deformations, myocardial muscle | AMI, CONTRACTION | This present study investigated the hypothesis that cardiovascular rehabilitation by a supervised exercise program would have a positive impact on the LV contraction mechanics in a population after an uncomplicated AMI. There is a lack of knowledge, with few studies investigating the real benefit of exercise on LV remo... | PMC10263431 |
Limitations | First, the relatively small sample size, the short duration of the exercise program, the small number of training sessions for patients in the TRAINING group (twice a week), and the low adherence of some patients to the program may have decreased the power of the study to demonstrate possible intergroup differences. Su... | PMC10263431 | ||
Conclusion | torsion | TORSION | In our study, exercise led to no significant improvement in the LV longitudinal, radial and circumferential myocardial deformation parameters. However, exercise was associated to a reduced basal rotation, twist velocity, torsion and torsional velocity. This outcome may be interpreted as a “LV torsional reserve” in indi... | PMC10263431 |
* Supplemental Materials | For additional information Supplemental Material 1, please For additional information Supplemental Material 2, please For additional information Supplemental Material 3, please For additional information Supplemental Material 4, please For additional information Supplemental Material 5, please For additional informatio... | PMC10263431 | ||
Objective | colorectal neuroendocrine neoplasms, DSS, Cancer | CANCER | Edited by: Valentina Guarnotta, University of Palermo, ItalyReviewed by: Ziyi Zuo, First Affiliated Hospital of Wenzhou Medical University, China; Jinkui Wang, Children’s Hospital of Chongqing Medical University, China†These authors have contributed equally to this workThis article was submitted to Cancer Endocrinology... | PMC9928741 |
Methods | Competing, DSS | REGRESSION | Among all patients diagnosed with CRNENs in the Surveillance, Epidemiology, and End Results (SEER) database from 1975 to 2019, temporal trends in incidence were assessed. Clinical data of 668 patients with stage II-IV CRNENs from 2010 to 2016 were extracted for survival analysis. Patients were randomly divided into a t... | PMC9928741 |
Results | DSS | LIVER METASTASIS, APC, BRAIN METASTASIS | In the period of 1975-2019, the incidence of CRNENs increased steadily with an annual percentage change (APC) of 4.50 (95% confidence interval [CI]: 3.90–5.11, P < 0.05). In total, 668 patients with stage II-IV CRNENs were included in the survival analysis from 2010 and 2016. Independent adverse prognostic factors for ... | PMC9928741 |
Conclusion | DSS, stage II-IV stage CRNENs | LIVER METASTASIS, BRAIN METASTASIS | Over the past 40 years, the incidence of CRNENs presented increased steadily, along with improved survival outcomes. Grade III-IV, higher TNM stage, liver metastasis, brain metastasis, and without receiving surgery were found to be associated with worse OS and DSS. Advanced age was a risk factor for OS but not DSS. Nom... | PMC9928741 |
Introduction | death, heterogeneous tumors, cancer, NENs, Tumors | NEUROENDOCRINE NEOPLASM, CANCER, TUMORS | Neuroendocrine neoplasms (NENs) generally refer to all heterogeneous tumors originating from peptidergic neurons and neuroendocrine cells, which can occur in many organs and tissues of the body. The 2019 World Health Organization (WHO) classification of Tumors of the digestive system updated the digestive system NENs c... | PMC9928741 |
Methods | PMC9928741 | |||
Datasets and patients | PMC9928741 | |||
Datasets and respective aims | Cancer | CANCER | We assessed the time trend of incidence by extracting the annual incidence of CRNENs from 1975 to 2019 from the SEER Research Plus Data 9 registry. Since our study was limited to the 7th AJCC staging, we only extracted data from the SEER database of stage II-IV CRNENs from January 2010 to December 2016 to investigate s... | PMC9928741 |
Inclusion and exclusion criteria | tumor, death | NEUROENDOCRINE CARCINOMA, NOS, DISEASES, LARGE CELL NEUROENDOCRINE CARCINOMA, TUMOR, MIXED ADENONEUROENDOCRINE CARCINOMA, CARCINOID TUMOR, SMALL CELL CARCINOMA, NOS, SECONDARY TUMORS, ONCOLOGY, ATYPICAL CARCINOID TUMOR, ENTEROCHROMAFFIN CELL CARCINOID | All the required data was extracted using SEER Stat software (version 8.4.0, SEER ID: 12834-Nov2021). Patients with CRNENs should meet the following criteria: i) NENs pathological type according to the International Classification of Diseases for Oncology, 3rd edition (ICD-O3, 8013/3: Large cell neuroendocrine carcinom... | PMC9928741 |
Study variables and outcomes | DSS, death, AJCC, Cancer | LUNG METASTASIS, SECONDARY, METASTASIS, CANCER | Clinical variables including age, sex, incidence, race, location, histology, grade, TNM stage which were according to the 7th editions of the American Joint Committee on Cancer (AJCC) TNM staging system, metastasis information (i.e bone, brain, liver, and lung metastasis), treatment (i.e. surgery, chemotherapy, and rad... | PMC9928741 |
Incidence analysis of CRNENs from 1975 to 2019 | The incidence was age-adjusted to the 2000 US Standard Population and was calculated as cases per 1 million people per year from 1975 to 2019. The time trend of CRNENs incidence of different sex and race were also evaluated. The annual percentage changes (APCs) were calculated based on weighted least squares. | PMC9928741 | ||
Nomogram construction and validation | A total of 668 patients with stage II-IV CRNENs from the SEER database were randomly divided into a training cohort (n=468) and a validation cohort (n=200) at a ratio of 7:3. Next, the training cohort was used for prognostic analysis and competing risk analysis, the validation cohort and the independent validation coho... | PMC9928741 | ||
Cox regression analysis and nomogram establishment for OS | REGRESSION | In the prognostic analysis of OS, univariate and multivariate Cox regression analyses were applied, the proportional hazard hypothesis test (PH) was applied to evaluate prognostic factors, and factors with P-values < 0.05 in univariate Cox analysis were added to a multivariate Cox regression model to detect independent... | PMC9928741 | |
Competing risk analysis and nomogram establishment for DSS | REGRESSION | In the competing risk analyses, we used cumulative incidence function (CIF) and Fine-Gray competing risk regression to evaluate the cumulative rate of stage II-IV CRNENs mortality | PMC9928741 | |
Nomogram validation of OS and DSS | DSS | The predicting outcomes of the model nomogram of OS and DSS were evaluated in the respective training, internal, and external validation cohorts by calibrating curves and the decision-curve analysis (DCA). Besides, we evaluated the accuracy of the nomogram model by examining the 1-, 3-, 5- year receiver operating chara... | PMC9928741 | |
Online predictive tools regarding OS and DSS | DSS | Two online tools regarding OS and DSS of patients with CRNENs were built to conveniently calculate patient nomogram scores, determine risk group, and predict survival probability using the “DynNom” and “Shiny” R package, as well as the Shiny website ( | PMC9928741 | |
Statistical analysis | DSS | REGRESSION | Baseline categorical variables were described using frequencies with percentages. The optimal cutoff value of continuous variable age was calculated using the “surv_cutpoint” function of the “survminer” R package. Pearson’s chi-square test was used in the comparison of categorical data, while when frequencies were belo... | PMC9928741 |
Results | PMC9928741 | |||
Incidence and patient baseline characteristics | colorectal neuroendocrine neoplasms, DSS | LUNG METASTASIS | From 1975 to 2019, there had been a steady rise in the incidence of CRNENs (
In this study, there were 668 patients with stage II-IV CRNENs recruited from 2010 to 2016 for prognostic analysis, among which males and females accounted for 53.3% and 46.7%, respectively. 20.7% of patients were ≥75 years old. 73.7% of patie... | PMC9928741 |
Survival and prognostic analysis | DSS, colorectal neuroendocrine neoplasms | After a median follow-up time of 74 months (95%CI: 70-78), the median OS was 42 months (95%CI 32-57) among all 668 patients. After a median follow-up time of 68 months (95%CI: 66-73), the median DSS was 79 months (95%CI 45-not available [NA]) among all patients. In our study of the SEER dataset, the reason why NA conta... | PMC9928741 | |
Cox regression analysis for OS | BRAIN METASTASIS, LIVER METASTASES, BRAIN METASTASES, LUNG METASTASES, REGRESSION, LIVER METASTASIS, BONE METASTASES | In patients with stage II-IV CRNENs, univariate and multivariate Cox regression analyses were used to identify independent prognostic factors of OS. After univariate analysis, variables with a P<0.05 including sex, age, histology, grade, stage, surgery, chemotherapy, radiation, liver metastases, brain metastases, bone ... | PMC9928741 | |
Competing risk analysis for DSS | DSS, death, colorectal neuroendocrine neoplasms, CRNENs-specific death | LIVER METASTASIS, BRAIN METASTASIS | In the univariate competing risk analysis of DSS, factors including age, histology, grade, TNM stage, and treatment (surgery, chemotherapy, and radiation) were found to be associated with the DSS of patients with stage II-IV CRNENs. According to the multivariate analysis results, patients in grade III/IV (HR: 4.79, 95%... | PMC9928741 |
Developing nomograms and risk stratification | DSS, death | In the training cohort, independent prognostic factors were used to construct the nomogram of OS for predicting patients’ risk of living shorter than 1-, 3-, or 5-year (Nomograms to predict OS for patients with CRNENs and risk stratification. Similarly, the nomogram of DSS for predicting CRNENs’ specific death of less ... | PMC9928741 | |
Validation of the nomograms of OS and DSS | DSS | Several validation methods have demonstrated the stability and efficacy of the established nomograms. The calibration plots in the training, internal validation, and external validation cohorts for 1-, 3-, and 5-year OS and DSS were described in Calibration curves of the nomogram of CRNENs for 1, 3, and 5-year OS rates... | PMC9928741 | |
Discussion | death, tumor, CgA, DSS, unresectable primary tumors | TUMOR, RARE DISEASE, NEOPLASMS, TUMOR GROWTH, PATHOGENESIS | The CRNENs are heterogeneous neoplasms characterized by neuroendocrine secretory granules in the cytoplasm of the cells, but its pathogenesis is still unclear. As little information is available on the incidence and survival of CRNENs, it is difficult to assess its prognosis. In this study, we assessed the incidence an... | PMC9928741 |
Conclusion | DSS, stage II-IV stage CRNENs | LIVER METASTASIS, BRAIN METASTASIS | Over the past 40 years, the incidence of CRNENs increased steadily, along with improved survival outcomes. Grade III-IV, higher TNM stage, liver metastasis, brain metastasis, and without receiving surgery were found to be associated with worse OS and DSS. Advanced age was a risk factor for OS but not DSS. Nomograms for... | PMC9928741 |
Data availability statement | The original contributions presented in the study are included in the article/supplementary material. Further inquiries can be directed to the corresponding author. | PMC9928741 | ||
Ethics statement | Cancer | CANCER | The studies involving human participants were reviewed and approved by the ethics committee of the Cancer Hospital of the Chinese Academy of Medical Sciences & Peking Union Medical College. The patients/participants provided their written informed consent to participate in this study. Written informed consent was obtai... | PMC9928741 |
Author contributions | QL contributed to the conception and design of the study. FZ, LH, and ZW analyzed the data and drafted the manuscript. FW and TX checked all data and results. All authors contributed to the article and approved the submitted version. | PMC9928741 | ||
Acknowledgments | The authors wish to thank all patients included in this study and their families, we also would like to thank all doctors who were involved in the treatment of these patients. | PMC9928741 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC9928741 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or ... | PMC9928741 | ||
References | PMC9928741 | |||
Supplementary Information | CORTEX | This study examined whether a 3-month mild-exercise intervention could improve executive function in healthy middle-aged and older adults in a randomized control trial. Ultimately, a total of 81 middle-aged and older adults were randomly assigned to either an exercise group or a control group. The exercise group receiv... | PMC10828372 | |
Keywords | PMC10828372 | |||
Introduction | RECRUITMENT, CORTEX | Given the expected healthcare cost growth due to the rapid increase in population age in developed countries [In addition to a cardiovascular exercise regime, there is also evidence that mild (very light intensity) exercise, which is easily attainable by sedentary people and those with low aerobic fitness without elici... | PMC10828372 | |
Methods | PMC10828372 | |||
Participants | Community-dwelling healthy older adults (Demographic information is found in Table Participant characteristics68.2(67.0–69.4)68.7(67.0–70.3)67.7(65.9–69.6)156.6(154.9–158.3)156.5(153.9–159.1)156.8(154.4–159.1)56.0(53.5–58.5)55.6(52.4–58.9)56.4(52.5–60.3)23.0(22.0–23.9)23.2(21.9–24.6)22.7(21.3–24.1)13.6(13.2–14.1)13.4(1... | PMC10828372 | ||
Cardiovascular fitness-related variables | Maximal oxygen uptake ( | PMC10828372 | ||
Mild-exercise intervention | Participants assigned to the ME group participated in three exercise sessions per week for 12 weeks, supervised by qualified exercise specialists. For safety, participants self-monitored their resting heart rate and blood pressure and reported them, along with any daily subjective symptoms they may have been experienci... | PMC10828372 | ||
Behavioral measurements | The color-word matching Stroop test, as used in event-related designs in previous studies [Participants were instructed to determine whether the color of the upper letters matched the meaning of the lower letters. The lower letters were presented 350 ms after the upper letters to obtain sequential visual attention. Par... | PMC10828372 | ||
fNIRS measurements | CORTEX | Cortical hemodynamic changes in the prefrontal cortex during the CWST were monitored with a multichannel fNIRS optical topography system ETG-7000 (Hitachi Medical Corporation, Japan) using two wavelengths of near-infrared light (785 and 830 nm). The device included two sets of 4 × 4 multichannel probe holders consistin... | PMC10828372 | |
fNIRS data analysis | Optical signals were analyzed based on the modified Beer-Lambert law allowing us to calculate concentration changes of the oxygenated hemoglobin (oxy-Hb) and deoxygenated hemoglobin (deoxy-Hb) in units of millimolar-millimeter (mM・mm) [As the optical properties of neighboring CHs are known to be similar [ | PMC10828372 | ||
Neural efficiency | ’s active cognitive demands | To examine the effects of the intervention on neural efficiency (NE), which relates neurophysiological measures of cortical activity (oxy-Hb changes in ROIs) to an individual’s active cognitive demands (RT for Stroop interference), we calculated NE scores using the following equation [ | PMC10828372 | |
Statistical analyses | Statistical analyses were performed using SPSS Statistical Packages (SPSS 25.0, Chicago, USA). First, baseline characteristics were compared between groups (Con vs ME) with ANOVA for continuous variables and Next, we examined whether the effect of the mild-exercise intervention on NE differed by age as a subgroup analy... | PMC10828372 | ||
Results | PMC10828372 | |||
Characteristics of participants and the mild-exercise intervention | There were no significant differences between Con and ME groups in age, sex, height and weight, aerobic fitness level ( | PMC10828372 | ||
Aerobic fitness levels | Aerobic fitness levels at baseline between Con and ME groups did not significantly differ. There was a significant interaction effect between group (Con/ME) and time (baseline/3 months) on Impact of a 3-month ME intervention on maximal oxygen consumption. Data are mean with 95% CI including individual data. Note. ** | PMC10828372 | ||
Behavioral outcomes | A repeated-measures three-way ANOVA for RT and error rate (ER) with task (neutral/incongruent), group (Con/ME), and time (baseline/3 months) revealed significant main effects of task (Stroop task performance. Comparison between neutral and incongruent tasks for response time (Stroop task performance1300.5(1212.5–1388.5... | PMC10828372 | ||
Neural activation in the prefrontal cortex | There were no significant differences between pre-conditions for the ME and Con groups in SI-related oxy-Hb changes (the oxy-Hb contrast between the incongruent condition and neutral condition of the Stroop task) in any ROIs. The ANOVA for oxy-Hb changes in response to SI revealed that there were no significant interac... | PMC10828372 | ||
Exercise-enhanced neural efficiency in the OA group | OA | The ANOVA for neural efficiency score related to SI demonstrated that there were no significant interactions between group and time factors in all ROIs (Supplementary Fig. There was a significant interaction between group and time in SI-related RT in the OA subgroup (Changes of Stroop performance in the older-age (OA) ... | PMC10828372 | |
Discussion | cognitive decline | CORTEX | Most studies examining the preventive effects of exercise intervention on age-related decline in executive function have focused on cardiovascular exercise protocols such as moderate-intensity exercise. In contrast, we focused on the potential effects of exercise at very light intensity (mild exercise) based on our pre... | PMC10828372 |
Conclusion | cognitive decline | CORTEX | In the present study, we revealed that a long-term mild-exercise intervention improves executive performance in middle-aged and elderly adults. However, there were no significant increases in task-related neural activation or task-related neural efficiency in the prefrontal cortex. Interestingly, it was revealed that a... | PMC10828372 |
Acknowledgements | We thank the human research group members (Ochi Genta, Kurono Hiroma, Kunii Yuki) of the Laboratory of Exercise Biochemistry and Neuroendocrinology for their assistance in operating the exercise intervention program and express our gratitude to all participants of our intervention study. | PMC10828372 | ||
Funding | This work was supported in part by the Japan Society for the Promotion of Science (JSPS) Grants (18H04081 [H.S.], 21H04858 [H.S.], 12J01926 [K.H.]), the Japan Science and Technology Agent Grant JPMJMI19D5 (H.S.), the Inviting Overseas Educational Research Units in University of Tsukuba (2016-2023), the Incheon National... | PMC10828372 | ||
Data Availability | The data that support the findings of this study are available from the corresponding author, HS, upon reasonable request. | PMC10828372 | ||
Declarations | PMC10828372 | |||
Conflict of interest | The authors declare any conflicts of interest related to work in a manuscript. | PMC10828372 | ||
References | PMC10828372 | |||
Methods | In Stage-1, three induction doses of FCZ (1200mg/day, 1600mg/day and 2000mg/day) were tested in sequential cohortsand compared with AMB in a 3:1 ratio. A particular dose was not tested in Stage 2 if there were significant predetermined safety or efficacy concerns. In Stage-2, the 1200mg dose was excluded per protocol b... | PMC9925064 | ||
Findings | One hundred and sixty eight participants were enrolled with 48, 50, and 48 in the AMB, 1600mg and 2000mg cohorts. The Kaplan Meier proportion for mortality (90% CI) at 10 and 24 weeks for AMB was 17% (10, 29) and 24% (15, 37), compared to 20% (12, 32) and 30% (20, 43) for 1600mg, and 33% (23, 46) and 38% (27, 51) for 2... | PMC9925064 | ||
Interpretation | CM | Induction phase weight and renal-adjusted doses of 1600mg and 2000mg/day FCZ for CM were safe and well tolerated except for increased GI side effects in the 2000mg/day dose, and had similar times to achieve CSF sterilization, but took significantly longer than AMB. The WHO recommended 1200mg FCZ was associated with a h... | PMC9925064 | |
Data Availability | Due to confidentiality issues and ethical restrictions, study data are available upon request from | PMC9925064 | ||
Introduction | toxicity, deaths, death, CM | CRYPTOCOCCAL MENINGITIS, SECONDARY | An estimated 220 000 cases and 180 000 deaths occur annually from cryptococcal meningitis (CM), mostly in sub-Saharan Africa [An open label phase I/II dose-escalation (Stage-1) and dose-validation (Stage-2) study was planned to investigate the safety, tolerability, and efficacy of an induction-consolidation strategy of... | PMC9925064 |
Methods | AIDS, toxicity | ADVERSE EVENTS, AIDS, CONSOLIDATION | The study was approved by the USA Food and Drug Administration. In addition, each of the multicentre sites that participated in the study received approval from their local Institutional Review Boards viz: Associacion Civil Impacta–San Miguel Jiron, Lima Peru; Research Institute for Health Sciences, Chiang Mai, Thailan... | PMC9925064 |
Participants | AIDS, meningtis, CM | HIV-1 INFECTION, AIDS, CRYPTOCOCCAL MENINGITIS | Participants 16 years and older with HIV presenting with the first episode of CM, able to take oral medication and provide signed informed consent were recruited. Nasogastric tube, but not intravenous administration of FCZ was permitted. HIV-1 infection was documented by any licensed rapid HIV test or HIV enzyme or che... | PMC9925064 |
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