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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Data analysis | pain | The data were entered into the SPSS program for Windows (v. 22.0) and were described using the measures of descriptive statistics, namely mean, standard deviation, and frequency. Groups were compared respecting participants’ demographic and clinical characteristics using the Chi-square, Fisher’s exact, and Kruskal–Wall... | PMC10214554 | |
Ethical considerations | This study has the approval of the Ethics Committee of Rafsanjan University of Medical Sciences, Rafsanjan, Iran (code: IR.RUMS.REC.1397.174) and was registered in the Iranian Registry of Clinical Trials (code: IRCT20131228015965N18). Permissions for conducting the study were obtained from the authorities of the above-... | PMC10214554 | ||
Discussion | pain | COLD | This study compared the effects of cold compress, TENS, and combined cold compress-TENS on CTR-associated pain among patients with cardiac surgery. Study findings indicated that while there was no significant difference among the groups respecting the pretest mean score of pain intensity, the variations of the mean sco... | PMC10214554 |
Conclusion | pain | COLD | This study concludes that the combination of cold compress and TENS is more effective than both cold compress and TENS in significantly reducing CTR-associated pain among patients with CABG. As independent nursing measures, cold compression and TENS are safe, inexpensive, and easy to use methods for pain management and... | PMC10214554 |
Acknowledgements | This article came from the Master’s thesis of the first author. We would like to thank the Research and Technology Administration of Rafsanjan University of Medical Sciences, Rafsanjan, Iran, for its financial support as well as the authorities of the study setting and all patients who participated in the study. | PMC10214554 | ||
Author contributions | Study design: MK, FH. Data collection and analysis: FH, PM, MK. Manuscript writing: MK, PM, SH, FH, HH. All authors read and approved the final manuscript. | PMC10214554 | ||
Funding | This study was conducted based on a master’s thesis about nursing and supported by Rafsanjan University of Medical Sciences, Rafsanjan, Iran. | PMC10214554 | ||
Availability of data and materials | The data of this study will be provided to the editor of the journal if it is needed. | PMC10214554 | ||
Declarations | PMC10214554 | |||
Ethics approval and consent to participate | This study was conducted according to the World Medical Association's Declaration of Helsinki, in which a written consent was obtained from all patients. In addition, the study protocol was approved by the Ethics Committee of Rafsanjan University of Medical Sciences (IR.RUMS.REC.1397.174). Besides, it was registered at... | PMC10214554 | ||
Consent for publication | All authors declare their full consent for publishing their article in Journal of Cardiothoracic Surgery. | PMC10214554 | ||
Competing interest | The authors declare that there is no conflict of interests regarding the publication of this article. | PMC10214554 | ||
References | PMC10214554 | |||
Background | INFLAMMATION | This post-hoc analysis of the DELIGHT trial assessed effects of the SGLT2 inhibitor dapagliflozin on iron metabolism and markers of inflammation. | PMC10685512 | |
Methods | type 2 diabetes, albuminuria | TYPE 2 DIABETES | Patients with type 2 diabetes and albuminuria were randomized to dapagliflozin, dapagliflozin and saxagliptin, or placebo. We measured hemoglobin, iron markers (serum iron, transferrin saturation, and ferritin), plasma erythropoietin, and inflammatory markers (urinary MCP-1 and urinary/serum IL-6) at baseline and week ... | PMC10685512 |
Results | 360/461 (78.1%) participants had available biosamples. Dapagliflozin and dapagliflozin-saxagliptin, compared to placebo, increased hemoglobin by 5.7 g/L (95%CI 4.0, 7.3; p < 0.001) and 4.4 g/L (2.7, 6.0; p < 0.001) and reduced ferritin by 18.6% (8.7, 27.5; p < 0.001) and 18.4% (8.7, 27.1; p < 0.001), respectively. Dapa... | PMC10685512 | ||
Conclusions | INFLAMMATION | Dapagliflozin increased hemoglobin and reduced ferritin and urinary markers of inflammation, suggesting potentially important effects on iron metabolism and inflammation. | PMC10685512 | |
Trial registration | ClinicalTrials.gov NCT02547935. | PMC10685512 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12933-023-02027-8. | PMC10685512 | ||
Keywords | PMC10685512 | |||
Background | CKD, chronic kidney disease, Anemia, kidney failure, type 2 diabetes | ANEMIA, KIDNEY FAILURE, TYPE 2 DIABETES | Anemia is common in patients with chronic kidney disease (CKD), particularly those with type 2 diabetes [Sodium glucose co-transporter 2 (SGLT2) inhibitors reduce CKD progression and the risk of kidney failure in patients with type 2 diabetes and CKD [In this post-hoc analysis of the DELIGHT trial [ | PMC10685512 |
Methods | PMC10685512 | |||
Patients and study design | non-diabetic kidney disease | MAY, TYPE 1 DIABETES | DELIGHT was a double-blind, placebo-controlled, multicenter trial that enrolled 461 patients from nine countries. The study was conducted from July 2015 to May 2018. Methods and results were previously published [Excluding criteria included a diagnosis of type 1 diabetes and non-diabetic kidney disease. Patients with h... | PMC10685512 |
Biomarker assessment | Urine and blood samples for exploratory biomarker research were obtained at baseline and week 24. Samples were stored at -80 °C until measurement. We measured the following iron and erythropoiesis markers: serum iron, ferritin, transferrin, and plasma EPO. TSAT was calculated with iron and transferrin concentrations [ | PMC10685512 | ||
Statistical analysis | INFLAMMATION | Baseline characteristics were reported in n (%) for categorical variables and in mean (SD) or median (IQR) for continuous variables. Biomarkers were log-transformed in the following analyses. We calculated mean percentage changes (95% CI) in biomarkers from baseline to week 24 by treatment allocation. Estimations were ... | PMC10685512 | |
Discussion | CKD, inflammation, diabetic kidney disease, anemia, Inflammation, heart failure | DIABETIC KIDNEY DISEASE, INFLAMMATION, ANEMIA, IRON DEFICIENCY, INFLAMMATION, EVENTS, HEART FAILURE, TYPE 2 DIABETES | In this post-hoc analysis of the DELIGHT trial, dapagliflozin and a combination of dapagliflozin and saxagliptin increased hemoglobin/hematocrit and reduced ferritin in patients with type 2 diabetes and CKD. Dapagliflozin reduced urinary inflammatory markers, specifically MCP-1/Cr and IL-6/Cr.The effect on iron homeost... | PMC10685512 |
Conclusions | CKD | INFLAMMATION, TYPE 2 DIABETES | In patients with type 2 diabetes and CKD, dapagliflozin increased hemoglobin/hematocrit and reduced ferritin and urinary MCP-1/Cr and IL-6/Cr, suggesting potentially important effects on iron metabolism and inflammation. | PMC10685512 |
Acknowledgements | The authors thank all investigators, trial teams, and patients for their participation in the trial. | PMC10685512 | ||
Authors’ contributions | A.K., B.L.N. and H.J.L.H. wrote the first draft of the report. A.K. and N.J. analyzed the data. C.P. and H.J.L.H. involved in data collection. All authors contributed to the interpretation of the data and revision of the paper. The first author and corresponding author take responsibility for the integrity of the data ... | PMC10685512 | ||
Funding | This study was funded by AstraZeneca. | PMC10685512 | ||
Data Availability | Individual de-identified participant data are not freely available because of the risk of patient re-identification, but interested parties can request access to de-identified participant data or anonymised clinical study reports through submission of a request for access via the AstraZeneca Group of Companies Data Req... | PMC10685512 | ||
Declarations | PMC10685512 | |||
Ethics approval and consent to participate | Local ethics committees approved all study procedures for the DELIGHT trial and subsequent analyses. Consent was obtained from all study participants. | PMC10685512 | ||
Consent for publication | Not applicable. | PMC10685512 | ||
Competing interests | Diabetes | DIABETES | A. Koshino, N. Jongs and T. Wada have no conflicts of interest.B.L. Neuen has received fees for advisory boards, scientific presentations, speaker fees, steering committee roles and travel support from the American Diabetes Association, AstraZeneca, Bayer, Boehringer and Ingelheim, Cambridge Healthcare Research, Jansse... | PMC10685512 |
Abbreviations | Chronic kidney diseaseErythropoietinDipeptidyl | Chronic kidney diseaseErythropoietinDipeptidyl peptidase-4Interleukin-6Monocyte chemoattractant protein-1Sodium glucose co-transporter 2Transferrin saturationUrinary albumin-creatinine ratio | PMC10685512 | |
References | PMC10685512 | |||
Keywords | HIV however | Cash transfers are increasingly used to motivate adherence to HIV care. However, evidence on cash transfers and intimate partner violence (IPV) is mixed and little is known about their safety for women living with HIV. We conducted in-depth interviews with women living with HIV who participated in a randomized trial pr... | PMC10338570 | |
Introduction | Economic interventions including cash transfers have been used to address poor engagement and retention in HIV care and support the UNAIDS 95-95-95 targets [Cash transfers are commonly used as a strategy to combat IPV, hypothesized to reduce poverty-related household stress and improve women’s bargaining power in relat... | PMC10338570 | ||
Methods | PMC10338570 | |||
Study Population and Setting | This qualitative study was conducted with participants from a three-arm randomized trial investigating the effect of cash transfers on viral suppression (Participants in the trial were enrolled from April-December 2018 and randomized in a 1:1:1 ratio to receive six months of cash transfers of 10,000 TZS (~ 4.5 USD) or ... | PMC10338570 | ||
Theoretical Framework | HIV [ | This study was informed by the Theory on Gender and Power and its extension to HIV [ | PMC10338570 | |
Data Collection | A list of all potentially eligible participants and their upcoming HIV clinic appointment dates was generated from baseline trial data. Potential participants attending clinic visits were approached discreetly in the waiting room by female interviewers to present the qualitative study. Upon conducting a final eligibili... | PMC10338570 | ||
Analysis | Interviewers produced field notes in English after each interview. Emergent themes from field notes were reviewed and discussed weekly by the study team; this included dialogue around social and cultural expectations of partnered women in Tanzania, reflection on our individual beliefs about women’s finances and positio... | PMC10338570 | ||
Ethics | Human subjects research approval was obtained from the Institutional Review Boards at the University of California, Berkeley [CPHS 2017-12-10558] and National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol. IX/2677). The study conforms to the principles embodied in the Declaration of Helsinki. | PMC10338570 | ||
Acknowledgements | The authors would like to acknowledge and thank the local research team at Health for a Prosperous Nation and the study participants for their time participating in this research study. | PMC10338570 | ||
Funding | Funding for the parent trial discussed in this study was supported by the National Institute of Mental Health under award number R01MH112432. | PMC10338570 | ||
Data Availability | Data provided upon official request. | PMC10338570 | ||
Code Availability | Not applicable. | PMC10338570 | ||
Declarations | PMC10338570 | |||
Competing Interests | There are no conflicts of interest to declare. | PMC10338570 | ||
Ethics Approvals | Human subjects research approval was obtained from the Institutional Review Boards at the University of California, Berkeley [CPHS 2017-12-10558] and National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol. IX/2677). | PMC10338570 | ||
Consent to Participate | All study participants provided written informed consent during study enrollment. | PMC10338570 | ||
Consent for Publication | Not applicable. | PMC10338570 | ||
References | PMC10338570 | |||
Background | In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms... | PMC10039497 | ||
Methods | LEMS, fatigue, pain | ADVERSE EVENTS, SPINAL CORD | A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower lim... | PMC10039497 |
Results | fatigue, pain | ADVERSE EVENTS | No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87... | PMC10039497 |
Conclusions | The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment. | PMC10039497 | ||
Keywords | PMC10039497 | |||
Background | cord injury | PARTIAL PARALYSIS, STILL | One of the most limiting consequences of spinal cord injury (SCI) is the complete or partial paralysis of the lower limbs. Still, independent from the severity of the spinal injury, the time after lesion, or age at the time of injury, the restoration of walking is given high priority by subjects with SCI [Functional wa... | PMC10039497 |
Methods | A prospective, randomized, comparative study was carried out (Fig. CONSORT flow diagram | PMC10039497 | ||
HANK exoskeleton | stroke, Exo-H2 | STROKE | The HANK exoskeleton (Gogoa Mobility Robots SA, Spain) is an updated version of Exo-H2 exoskeleton, previously described and studied in patients with stroke [HANK exoskeleton; | PMC10039497 |
Participants | injuy, brachial muscle, spasticity, contracture, arthrodesis, lower extremity fracture | RECRUITMENT, ULCERS, SPINAL CORD | This clinical study focused on individuals with incomplete SCI less than 1 year since injuy. The cohort was recruited at the National Hospital for Paraplegics (Toledo, Spain) and the eligibility criteria were: age between 16 and 70 years old; C2-L4 level of injury; severity (American Spinal Cord Injury Association Impa... | PMC10039497 |
Intervention procedures | The IG training protocol consisted of 15 robotic ambulatory gait training sessions, each session lasting 30 min. Three sessions were performed on non-consecutive days each week for 5 consecutive weeks. The total duration of each session was about 1 h, which included 20 min to put on and remove the exoskeleton, 30 min f... | PMC10039497 | ||
Outcome variables | pain | PRESSURE ULCER, SPINAL CORD, PRESSURE ULCER, ADVERSE EVENT, SKIN LESIONS | Safety was closely monitored during the study. It was assessed by registering and analyzing any adverse event, particularly those related to skin lesions, falls and pain. The participants’ skin was inspected before and after each session based on the US National Pressure Ulcer Advisory Panel and European Pressure Ulcer... | PMC10039497 |
Statistical analysis | LEMS | Statistical analyses were performed using the commercial IMB SPSS v22 software package (IBM Corporation, Armonk, NY).The sample size was calculated based on the LEMS score as the main variable, considering a mean difference of 8.2 and a standard deviation of 10 that was obtained from a pilot study [ | PMC10039497 | |
Results | LEMS | RECRUITMENT, SPINAL CORD | The eligibility criteria were met by 23 participants with incomplete SCI within the recruitment period: 12 out of the 23 were randomly allocated to the IG and 11 of the 23 to the CG. We experienced a slow recruitment rate due to different but common reasons [Patients´ baseline characteristicsVariables are expressed as ... | PMC10039497 |
Safety, feasibility, pain and fatigue | muscle pain, skin erythema, fatigue, pain | AIDS, SKIN ERYTHEMA | No participants experienced a fall during the study, yet two IG participants suffered mild skin erythema in the tibia contact zone during the first session that was related to the strap. This issue was resolved by adding padding to the specific zones and the lesions disappeared within one day. In addition, mild neck an... | PMC10039497 |
Effects on LEMS | ηLower extermity motor score, LEMS | The two-way ANOVA showed significant differences for the “time” factor in LEMS (F = 19.9, p < 0.001) but not for the “group” factor (F = 0.16, p = 0.69) and for the “time-group” interaction (F = 0.5, p = 0.4). A post-hoc pairwise comparison with Bonferroni correction showed a significant increase in the LEMS score afte... | PMC10039497 | |
Effects on the functional scales | SPINAL CORD | The functional outcomes at baseline and post-intervention were assessed (Table Functional outcomes following exoskeleton training or convectional training, and comparison among times and interventions WISCI-II(0–20) SCIM-III(0–100) WISCI-II(0–20) SCIM-III(0–100)CG: control group; IG: intervention group; *significant di... | PMC10039497 | |
Discussion | stroke, fatigue, Exo-H2, pain | ADVERSE EVENTS, ADVERSE EFFECTS, STROKE | This article reports the results of a prospective, randomized, comparative clinical study, blinded to the evaluators conducted in a sample of individuals with incomplete SCI less than 1 year since injury to: (1) assess the safety and adherence to the robotic-assisted walking training as provided with of the device HANK... | PMC10039497 |
Study limitations | RECRUITMENT | There were some limitations to the present study. Firstly, we did not set guidance force and step initiation detection specifically for each patient. Adapting robot guidance to the actual walking capacity of the patient, in other words to the patient’s movement as needed (Assist-as-Needed, AAN [The sample size was not ... | PMC10039497 | |
Conclusion | The results of a prospective, randomized, comparative study of walking training with the lower limb robotic ambulatory exoskeleton HANK, are presented. This study provides evidence of its safety and feasibility for gait training in patients with SCI less than 1 year since injury. We found that both the IG and CG subjec... | PMC10039497 | ||
Acknowledgements | We acknowledge Mark Shefton for the revision of the English version. | PMC10039497 | ||
Author contributions | Study conception and design: AJA and AG. Coordination: JLP. Experimental procedure: AM, VL. Data extraction: NC, IS. Statistical analysis of the results: AMG. Writing manuscript: AG, AM, AJA. Review manuscript: all authors. All authors read and approved the final manuscript. | PMC10039497 | ||
Funding | This work was partially supported by the Institute of Health Carlos III (Spain) and co-funded by FEDER (PI15/01437), as well as the Spanish Ministerio de Ciencia, Innovación y Universidades, under the Programa Estatal de Investigación, Desarrollo e Innovación Orientada a los Retos de la Sociedad (Ref.: RTI2018-097290-B... | PMC10039497 | ||
Availability of data and materials | The dataset analyzed during the current study are available from the corresponding author on reasonable request. | PMC10039497 | ||
Declarations | PMC10039497 | |||
Ethics approval and consent to participate | The present study was approved by the local Ethical Committee in Hospital Virgen de la Salud (Ref. No. 39; 07/02/2007). We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers. | PMC10039497 | ||
Consent for publication | Participants give their consent for publication of their image if require. | PMC10039497 | ||
Competing interests | José L. Pons, Angel Gil-Agudo and Antonio J. del-Ama are founding partners of Gogoa Mobility Robots S.A. | PMC10039497 | ||
References | PMC10039497 | |||
Introduction | LUTZ | Edited by: Luca Roncati, University of Modena and Reggio Emilia, ItalyReviewed by: Elizabeth De Gaspari, Adolfo Lutz Institute, Brazil; Srinivasa Reddy Bonam, University of Texas Medical Branch at Galveston, United StatesInterim analysis of phase I and phase II clinical trials of personalized vaccines made from autolog... | PMC10315914 | |
Methods | ADVERSE EVENTS, VIRUS DISEASE | Adult subjects (>18 years old) were given autologous DCs derived from peripheral blood monocytes, which were incubated with the S-protein of SARS-CoV-2. The primary outcome is safety in phase I clinical trials. Meanwhile, optimal antigen dosage is determined in phase II clinical trials. Corona Virus Disease 2019 (COVID... | PMC10315914 | |
Results | A total of 28 subjects in the phase I clinical trial were randomly assigned to nine groups based on antigen and Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) dosage. In the phase II clinical trial, 145 subjects were randomly grouped into three groups based on antigen dosage. During the 1-year follow-up peri... | PMC10315914 | ||
Conclusions | After 1 year of follow-up, this vaccine is proven safe and effective for preventing COVID-19. A phase III clinical trial involving more subjects should be conducted to establish its efficacy and see other possible side effects. | PMC10315914 | ||
Introduction | deaths | ADVERSE EVENT | Since being designated by the WHO as a pandemic in March 2019, SARS-CoV-2 has infected more than 540 million people and was responsible for 6 million deaths in June 2022 (The development of dendritic cell (DC)–based vaccines is an innovative vaccine that can overcome existing problems. DC–based vaccines utilize the abi... | PMC10315914 |
Methods | PMC10315914 | |||
Study oversight and outcomes | MAY | The study was randomized and double-blinded phase 1 and 2 clinical trials. The phase I clinical trial was carried out at Dr. Kariadi Hospital Semarang, Faculty of Medicine, Diponegoro University, from December 2020 to December 2021. The phase II clinical trial was carried out at Gatot Subroto Hospital from April 2021 t... | PMC10315914 | |
Participants, randomization, and blinding | obesity, autoimmune laboratory abnormalities, immunodeficiency diseases, thromboembolic, physical/mental disabilities, Hepatitis C | OBESITY, UNCONTROLLED HYPERTENSION, HIV INFECTION, INVASIVE CANCER, COVID-19 INFECTION, IMMUNODEFICIENCY DISEASE, HEPATITIS B, HEPATITIS C | In phase I, as many as 106 prospective subjects were screened, and 33 subjects met the criteria and received the vaccine. Meanwhile, in phase II, as many as 227 prospective subjects were screened, and 145 subjects met the criteria and received the vaccine. The subjects included in this study were over 18 years old, gen... | PMC10315914 |
Vaccine | The vaccine consists of DCs and lymphocytes obtained from the blood of the peripheral autologous. First, 40 cc of blood was taken and then incubated with GM-CSF and IL-4 for 5 days to differentiate monocytes into DCs. Then, DCs and lymphocytes were incubated with recombinant SARS-CoV-2 S protein for 2 days. S protein i... | PMC10315914 | ||
Procedure | CRF | EVENTS, DIABETES MELLITUS, CRF | Screening of all potential subjects by medical staff was carried out. In the phase I clinical trial, eligible subjects were randomly divided into nine groups based on dose and GM-CSF addition, while in the phase II clinical trial, the subjects were divided into three groups. Then, 40 cc peripheral blood were drawn from... | PMC10315914 |
Safety assessment | meanwhile non-fasting blood glucose | EVENTS, DIABETES MELLITUS | Safety assessments are carried out by evaluating local and systemic reactions experienced by post-vaccination subjects. Subjects were monitored for 30 min post-vaccination to assess the immediate effects of the vaccine. On the 7th and 28th days after vaccination, we conducted a safety laboratory examination consisting ... | PMC10315914 |
Immunogenicity and effective dose assessment | In phase II, the determination of an effective dose is assessed based on the immunogenicity of the vaccine. The doses of the SARS-CoV-2 S protein composition tested were 0.10, 0.33, and 1.00 mcg. The immune response to detect specific memory T cells against SARS-CoV-2 was assessed by performing an ELISPOT examination m... | PMC10315914 | ||
Efficacy assessment | The efficacy assessment was assessed by looking at the immunogenicity of the vaccine through the results of the ELISPOT examination at weeks 2 and 4. In addition, clinical trial subjects were followed for up to 1 year and incidence rates of COVID-19 that occurred were recorded. Efficacy is assessed by the vaccine’s pro... | PMC10315914 | ||
Statistical analysis | EVENTS | In phase, I and phase II, vaccine safety and efficacy analysis for up to 1 year were performed on all vaccinated subjects (intention-to-treat). Vaccine safety is presented descriptively by showing the proportion of unintended events in each dose group. The efficacy of the vaccine for up to 1 year was presented descript... | PMC10315914 | |
Result | PMC10315914 | |||
Subject characteristics | In the phase, I clinical trial, a total of 28 subjects received the vaccine and were grouped into nine groups. A total of 16 subjects (57.14%) were men, and 12 (42.83%) were women. The subjects of the study were in the age range of 18–61 years for men and 23–60 years for women. In the phase II clinical trial, a total o... | PMC10315914 | ||
Safety | ADVERSE EVENT, ALLERGIC REACTIONS | AEs occurring up to 28 days post-vaccination in phase I and phase II clinical trial subjects have been previously reported where there were no acute allergic reactions, SAE, or AE of degree 3 or 4[8]. In phase, I, subjects who experienced AE degrees 1 and 2 to 28 days were 64.5%. Meanwhile, in phase II, which experienc... | PMC10315914 |
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