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Competing interests | The authors declare no competing interests. | PMC10495372 | ||
References | PMC10495372 | |||
Background | rotatory, caries | CARIES | Chemomechanical techniques for caries removal have been introduced to overcome the shortcomings of the conventional rotatory instruments. This study aimed to clinically evaluate the effectiveness of the chemomechanical method of caries removal (Carie-Care™) over mechanical caries removal through the Atraumatic Restorative Technique in pediatric patients. | PMC10657635 |
Methods | carious primary molars, caries, pain | CARIES | A randomized controlled clinical trial was conducted. Fifty children fulfilling inclusion criteria were recruited from the outpatient clinic of Pediatric and Dental Public health department, Faculty of Dentistry, Alexandria University. Fifty open carious primary molars were randomly assigned into 2 equal groups according to the method of caries removal. In Group I (test group), caries was removed using the Carie-Care™ system and in Group II (control group), by using mechanical caries removal through the atraumatic restorative technique. Resin modified glass ionomer was used for teeth restoration, the two techniques were compared in each child according to time taken for caries removal, efficacy of caries removal, pain assessment, and child behavior. | PMC10657635 |
Results | caries | CARIES | The mean time taken for caries removal in the Carie-Care™ treatment group was (575.6 ± 114.8) seconds which was statistically significant higher as compared with the ART treatment group (346.1 ± 97.4) seconds ( | PMC10657635 |
Conclusions | carious tissue | Removal of carious tissue in primary teeth using Chemomechanical Carie-Care™ gel proved to be more time consuming than ART, but on the other hand it was more efficient, comfortable, and accepted by the pediatric patients. | PMC10657635 | |
Keywords | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). | PMC10657635 | ||
Background | dentine caries, caries, pain, teeth with hand, carious dentine | DENTAL CARIES, DISEASE, CARIES, DECAY, DENTAL CARIES, HEAT | Dental caries is the most common childhood disease worldwide. Despite reliable scientific advancements and the fact that caries is preventable, the disease continues to be one of the major public health issues [According to estimates, dental caries affects about 60–90% of school-age children. This percentage fluctuates significantly depending on the population, where the incidence of dental caries being much higher in developing countries like the Middle East than in developed [When dental caries is removed using traditional rotary devices, the pulp is frequently subjected to pressure and heat effects that usually cause pain. In addition, drilling could sometimes involve the removal of sound tooth tissue close to the affected caries area [The Mechanical caries removal by ART is restoring teeth with hand instruments for decay removal and fluoride releasing adhesive materials (resin modified glass ionomer) for filling. It is the most documented alternative to traditional drilling for dentine caries removal. There are several advantages for the ART method when used in children, such as the elimination of noise and vibration of the handpiece, water coolant and high velocity suction [The CMCR technique has attracted the attention of dental researchers due to its concept of sparing unaffected tooth structure while assuring the removal of the denatured collagen stage of carious dentine [The CMCR agents are either sodium hypochlorite based such as Carisolv or Papain based such as Papacarie [Few studies were conducted to study the effectiveness of Carie-Care™ as a CMCR agent. Kumar et al. in 2016 [Moreover, Sontakke et al. in 2019 [Papacarie and the earlier CMCR agents, do not contain essential oils which have been included in Carie-Care™ and serves as an anti-inflammatory agent. In addition to softening infected dentin, Carie-Care™ has anti-inflammatory and mild anesthetic effects. Therefore complete patient co-operation is not required [Clinical studies on the Carie-Care™ in primary teeth are scarce in the literature [The tested null hypothesis stated that there was no significant difference between CMCR method and mechanical caries removal by ART in terms of the time taken for caries removal, efficacy of caries removal, pain assessment, and child behavior. | PMC10657635 |
Methods | PMC10657635 | |||
Cytotoxicity assay | CYTOTOXICITY | Before the clinical application of the Carie-Care™ gel, its cytotoxicity was assessed in human gingival fibroblasts isolated from patients who underwent clinical crown lengthening, and signed informed consent was obtained from all participants. At a cell density of 7 × 103/well, gingival fibroblasts from passages to 4–6 were seeded onto a 96-well plate and incubated for 24 h in 5% CO | PMC10657635 | |
Study design | caries | CARIES | This study was a randomized controlled clinical trial in which two methods of caries removal were compared following the consort guidelines [ | PMC10657635 |
Sample size estimation | caries | CARIES | The sample size was based on a 95% confidence level to detect differences in caries removal time between the mechanical and chemo-mechanical removal methods. Pascareli-Carlos et al. [ | PMC10657635 |
Patient recruitment | carious lesions, dentine, caries | CARIES, CARIES | Two hundred and fifty children were assessed for eligibility at the outpatient clinics of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Alexandria University, from March 2022 to November 2022.Two hundred children with radiographic findings of pulp furcation, periapical pathosis and proximal caries evidenced on bitewing radiographs were excluded from the study, and 50 children of both genders aged 5–8 years who met the inclusion criteria were enrolled in the study. Children selected for this study were those with open carious lesions with dentine involvement, but did not reach the pulp (scores five or six, according to the International Caries Detection and Assessment System [ICDAS] [Informed consent from the parents and/or legal guardians, as well as the children’s acceptance of participating in the study, were obtained. Patients and their parents were informed that the procedure would be videotaped to document their level of comfort. | PMC10657635 |
Randomization technique, grouping, and allocation concealment | carious primary molars, caries | CARIES | Fifty children were randomly assigned to two groups according to the caries removal method. Each group comprised 25 carious primary molars; Group I(test group), caries removal by Carie-Care™ chemo-mechanical agent, and Group II(control group), caries removal by the ART method. Randomization was done by the permuted block randomization technique, and the allocation sequence was generated using random allocation software where participants were allotted in blocks of 4. The allocation sequence was then sealed in opaque envelopes by a trial-independent individual who was responsible for keeping the envelopes and unfolding them only at the time of treatment. Blinding of the operator and participants could not be performed because of the difference between the two techniques, but the statistician was blinded to the type of treatment [ | PMC10657635 |
Examiner reliability | caries | CARIES | The main researcher, a pediatric dentist, was trained and calibrated to record caries removal efficacy by Munshi et al. [ | PMC10657635 |
Assessment procedures | caries, pain | WRIGHT, EYE, CARIES | The following was measured for each patient:The time taken for the two techniques was measured from the start of the caries removal procedure until the caries excavation endpoint by using a stopwatch and was recorded in seconds. Efficacy of caries removal: Complete caries excavation was verified by the tip of a blunt explorer (Nordent Manufacturing Inc. USA), which moved smoothly across the dentinal wall and did not give a tug-back sensation [ Numerical scoring criteria for caries removal statusChild pain perception to the respective procedure during caries removal was assessed using the Sound, Eye, and Motor (SEM) scale according to Wright et al. [Child behavior was evaluated immediately upon completing the procedure according to the behavior categories of Frankl et al. [ | PMC10657635 |
Statistical analysis | REGRESSION | IBM SPSS software package version 20.0. (IBM Corp., Armonk, NY,) was used for the data analysis. Qualitative data are represented as numbers and percentages, and the Chi-square test was used to compare the two study groups. Quantitative continuous data were tested for normality using the Shapiro-Wilk test and expressed as range (minimum and maximum), mean, standard deviation, and median. When quantitative variables were not normally distributed, the Mann-Whitney test was applied to identify intergroup differences. The results were judged at a 5% level of significance [Statistical analysis showed that the half-maximal inhibitory concentration (IC50) of the Carie-Care™ gel was analyzed by a non-linear regression test using GraphPad Prism 8.0.1. | PMC10657635 | |
Discussion | carious lesions, Pain, carious primary molars, caries, pain, hand excavation | DECAY, CAVITY, CARIES | The present randomized controlled clinical study aimed to evaluate the efficiency of Carie-Care™ as a chemo-mechanical caries removal agent and compare it with that of ART. To the best of authors’ knowledge, the present study is the first in Egypt and the Easternmediteranean/North African region to evaluate the effectiveness of Carie-Care™ CMCR agent versus ART in pediatric patients in terms of time taken and efficacy for caries removal, together with child pain perception and behavior. To fulfill the aims of this study, fifty children of both genders aged 5–8 years who fulfilled the inclusion criteria were selected from the outpatient clinic. Fifty open carious primary molars were randomly assigned to two equal groups according to the caries removal method. In this study the split mouth technique was not used because of the difficulty to find carious lesions symmetrically distributed in the mouth of children. Based on the findings of the current study, the null hypothesis was rejected. A significant difference was detected between the two procedures in terms of the time required, efficacy of caries removal, pain assessment, and child behavior.The results of the present study revealed that the mean time taken to completely remove caries in the Carie-Care™ treatment group was significantly longer than that in the ART treatment group. This finding could be due to the repeated application of the gel to completely remove caries [There is continuous debate over the most effective strategy for treating caries in primary teeth, especially for multisurface lesions. In the present study, although Carie-Care™ was time consuming, it was significantly more efficient in caries removal than ART. This finding is in agreement with Kumar et al. [On the other hand, Banerjee et al. [Pain assessment in the present study showed significant comfort during the use of Carie-Care™ compared with the ART technique in caries removal. The CMCR gel is effective only on the denuded fibers in demineralized dentine, thus preventing painful removal and damage to healthy dentine. Moreover, the gel itself has a heat-insulating function as it covers the cavity during the procedure, and thus reduces pulpal stimulation. In addition, during ART caries removal, the unpleasant feeling of scraping the decay with hand excavation makes the procedure more stressful than the chemomechanical caries removal method [In agreement with the results of the present study, Soni et al. [Child behavior was evaluated in the current study immediately upon completion of the procedure, showing that children in the Carie-Care™ group were significantly more cooperative and enjoyed the procedure than those in the ART group. The absence of pain in the CMCR treatment group was the cause of the child cooperative behavior. In agreement with the results of Kumar et al. [The results of the current study showed no significant difference between boys and girls regarding assessment parameters (time taken for caries removal, efficacy of caries removal, and child behavior) during the procedure. On the contrary other studies found that dental procedures were affected by the child gender where boys were less dentally anxious than girls which goes with the nature of boys who prefer to seem strong. [Studying the influence of previous dental visit experience on assessment parameters, children in the Carie-Care™ treatment group who did not experience a previous dental visit had a significantly better behavior rating score and efficacy of caries removal score than those who had a previous dental visit, which could be related to a history of dental pain from invasive procedures performed in previous dental visits. This is consistent with previous studies [Within the limitations of the present study and based on the results, the Carie-Care™ CMCR agent can be recommended as an alternative to ART in pediatric patients, considering its effectiveness in caries removal, patient comfort, and relatively low price, which could be of great benefit, especially for low-income developing countries in Africa. However, future large-scale multicenter trials are recommended to verify the findings of the present study. | PMC10657635 |
Conclusions | carious | The use of Chemo-mechanical Carie-Care™ gel to remove carious tissue in primary teeth proved to be more time consuming than ART, but on the other hand it was more efficient, comfortable and accepted by the pediatric patients. Authors believe that this study will make useful contributions to the literature and clinicians. | PMC10657635 | |
Acknowledgements | The authors gratefully thank the Center of Excellence for Research in Regenerative Medicine and Applications (“CERRMA”), Faculty of Medicine, Alexandria University, Egypt (STDF- Funded), for the facilitation provided by the Stem Cell Laboratory for the isolation and propagation of human gingival fibroblasts. | PMC10657635 | ||
Authors' contributions | CYTOTOXICITY | A.G., N.B. and D.T. conceptualized the study. A.G. collected data. M.E. conducted the cytotoxicity assay and interpreted the results. A.G. analyzed the data and wrote the manuscript draft. N.B. and D.T. reviewed and edited the manuscript. The final manuscript was approved by all the authors. | PMC10657635 | |
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). This study was not supported by any funding sources. | PMC10657635 | ||
Availability of data and materials | Patients’ records at the Pediatric Dentistry Department, Faculty of Dentistry, Alexandria University, contain the datasets created and analyzed for the current study and were used under license for this study. The public accessibility of such data is subject to restrictions. However, data from the corresponding author are available upon reasonable request and with permission from the Pediatric Dentistry Department, Faculty of Dentistry, University of Alexandria. | PMC10657635 | ||
Declarations | PMC10657635 | |||
Ethics approval and consent to participate | Before beginning the study, ethical approval was obtained from the Research Ethics Committee of the Faculty of Dentistry, Alexandria University, Egypt (#IRB NO:0312 − 10/2021) and registered at the National Institutes of Health (No. NCT05538559) on (14/09/2022). Informed consent from the parents and/or legal guardians and the children’s consent to participate in the study were obtained. This study was conducted and reported according to the CONSORT guidelines and in accordance with the Declaration of Helsinki. | PMC10657635 | ||
Consent for publication | Consent for publication was obtained from the ethical committee of the Faculty of Dentistry, Alexandria University, in accordance with legal regulations. Written informed consent was obtained from each parent or legal guardian. | PMC10657635 | ||
Competing interests | The authors declare no competing interests. | PMC10657635 | ||
References | PMC10657635 | |||
Methods | We screened a total of 637 cord blood samples from a double blinded randomized clinical trial on Sulfadoxine-Pyrimethamine (SP) and Dihydroartemisinin-Piperaquine (DP) IPTp in a Ugandan birth cohort; study conducted from Busia, Eastern Uganda. Luminex assay was used to measure the cord levels of IgG sub-types (IgG1, IgG2, IgG3 and IgG4) against 15 different | PMC9946240 | ||
Results | Mothers on SP expressed higher levels of cord IgG4 against erythrocyte binding antigens (EBA140, EBA175 and EBA181) ( | PMC9946240 | ||
Conclusion | MALARIA | Malaria prophylaxis in pregnant mothers using either DP or SP does not affect expression of antibodies against | PMC9946240 | |
Data Availability | All relevant data are within the paper and its | PMC9946240 | ||
Introduction | malaria, malaria infections | MALARIA, REGRESSION, DISEASES | Pregnancy greatly changes the physiology of a woman and increases vulnerability to diseases such as malaria by lowering the immune system [Mothers from malaria endemic areas pass on immune IgG to their children [A study in Papua New Guinea randomized mothers into two groups of Sulfadoxine- Pyrimethamine-Azithromycin and SP-chloroquine as malaria prophylaxes and found no difference in cord antibody levels (total IgG) between the two groups [In this study, we determined if use of either DP or SP prophylaxis has any effects on cord levels of IgG. We further examined if placental malaria has any effect on expression of IgG in cord blood. Using cox regression, we modelled if cord blood levels of total IgG against Rh4.2, PfSEA, Etramp5Ag1, AMA1, EBA175 and GLURP181 adjusted for maternal wealth category index, gestational malaria prevalence, gravidity and birth weight have any effects on the risk of malaria infections in the first birth year. | PMC9946240 |
Materials and methods | PMC9946240 | |||
Study participants | BLOOD | Blood samples for the Neonates were collected from Masafu General Hospital (the main Referral health facility within Busia District). Pregnant mothers in the first trimester were enrolled from across 40 (forty) villages located within 30 Kms radius away from Masafu Hospital. Participants were drawn from the Sub-counties of Buteba, Busitema, Masaba, Lunyo, Bulumbi Masafu and Lumino. Demographic information and clinical data of study participants were captured(Mother and baby pair) ( | PMC9946240 | |
Participants and data collection | malaria | MALARIA | The samples for this study were obtained from a previous study done among pregnant mothers. Cord blood samples were screened to assess the levels of malaria specific antibodies. Details of participants’ demographics, socio-economic status and clinical information is contained in a published study. The current study obtained samples archived from the primary study, demographic and clinical details of participants can be found in a previous study [ | PMC9946240 |
Sample collection for this study | BLOOD | Collection of the cord blood by the primary study took place at the time of delivery. Blood collection was done by a midwife, medical officer or obstetrician who conducted delivery or cesarian section. The blood was then centrifuged to obtain serum, archived at appropriate temperature until analysis. Archival was done and random-access numbers generated by the computer to help in tracking the samples in the biobank. | PMC9946240 | |
Laboratory procedures | PMC9946240 | |||
Preparation of buffer A | Buffer A was prepared following a method previously reported in a study by | PMC9946240 | ||
Preparation of buffer B | A method by [ | PMC9946240 | ||
Dilution of cord plasma and expression of | 693μls of buffer B was transferred into deep well plates using multi-channel pipette. 7μl plasma was then dispensed to the same well. The procedure was repeated for all plasma samples and mixed by shaking. The final sample dilution used was 1 in 100. Diluted samples were then incubated in buffer B over night at 4°C to allow | PMC9946240 | ||
Summary of the | A total of 16 recombinant | PMC9946240 | ||
Dilution of | A standard protocol was used to make the dilution [ | PMC9946240 | ||
MagPix multiplex bead array assay | malaria | MALARIA, SECONDARY | IgG sub-types 1–4 against 15 Using a multichannel pipette, 50μl of prepared plasma at a dilution of 1in1000 in buffer B and pooled hyper immune control (27 adults from malaria endemic areas) was added to the beads; two wells had PBS added in them as blanks. The plates were then put on a shaker at 600 rpm for 90 minutes after covering the plates with aluminum foils at room temperature. After incubation, the plates were placed on a magnetic separator for 2 minutes, supernatant poured off by a rapid inversion with a sharp shake followed by a gentle blot on a paper towel. The plates were then washed three times using 200ul wash buffer. 50μl of a secondary antibody specific for an IgG sub-type (IgG1, IgG2, IgG3 and IgG4) with concentration of 1in1000 for IgG1,IgG2 and IgG4 while secondary antibody against IgG3 was diluted at 1in 2000 in dilution buffer and added to each well containing bound primary antibody-antigen complex, blank wells, positive control wells and negative control wells. Incubation was done for 60 minutes in a shaker. The plate was put on a magnetic separator for 2 minutes, supernatant poured off and washed three times using wash buffer to remove unbound antibodies.Using a multichannel pipette, 50μl of 1in 200 R-Phycoerythrin-conjugate AffinPure F (ab’) goat anti-human IgG ( | PMC9946240 |
Luminex assay and quality assurance | malaria | MALARIA, POSITIVE | Luminex assay was done following modified manufacturer’s guidelines. Positive control plasma samples were obtained from 27 adults’ resident in malaria areas with known episodes of malaria and thought to be hyper immune. Negative controls samples were serum samples obtained from whole blood of 6 Caucasians from the United Kingdom with no known history of exposure to | PMC9946240 |
Data analysis | REGRESSION | All Net fluorescence Index (Net MFI) were log transformed prior to analysis. Part of the net MFI was also normalized to minimize effects of extreme values on mean. Graphical representation using box plot was used to compare mean levels of cord IgG sub types against Only IgG specific to one antigen at a time was used in building the Cox regression model while adjusting for non-IgG covariates at each time. The Cox regression model was built using back ward elimination method. For each IgG, the levels were grouped into percentiles, that is 25 | PMC9946240 | |
Ethical clearance | SBS | The primary study was approved by the Research and Ethics Committee, School of Biomedical Sciences, Makerere University College of Health Sciences; Uganda National Council for Science and Technology (SBS 114; | PMC9946240 | |
Results | PMC9946240 | |||
Characteristics of study participants | malaria | MALARIA | Over half, 51.8% of mothers screened positive for malaria at enrollment. Most, 51.3% of the children were female. Some, 8.2% of the newborn children had a low birth weight. The majority, 72%, of the pregnant mothers had | PMC9946240 |
Summary of key characteristics of study participants. | PMC9946240 | |||
Effects of IPT arm on cord levels of IgG sub-types | tetanus, t.t | TETANUS | Significant differences in the mean of the two groups for IgG1 was only noted with tetanus toxoid (t.t) ( | PMC9946240 |
Effects of mother’s IPT arm on cord levels of IgG sub-types. | (A) comparison for IgG1; DP versus SP; (B) comparison of the two groups for IgG2; (C) effects of IPT use on IgG3 cord level; (D) comparison of the effects of the two groups of prophylaxis on IgG4 (all Y axes are in log MFI). | PMC9946240 | ||
Association of placental malaria and malaria specific IgG antibodies | malaria | MALARIA | Placental malaria did not affect cord levels of different IgG sub-classes. This was done by comparing mean cord levels of mothers who were positive for placental malaria with the negative groups. The differences in cord levels of the various IgG sub-classes were evenly distributed among the two groups. For example, For IgG1 ( | PMC9946240 |
Effects of placental malaria on IgG sub-class cord expression. | malaria | MALARIA | (A) effects of placental malaria on IgG1 cord expression against | PMC9946240 |
Comparison of the risk of malaria for whole percentile versus 75 | The adjusted Hazard ratios for the 75 | PMC9946240 | ||
Hazard ratios of non-categorized percentile compared to 75 | PMC9946240 | |||
25 | Percentile plots of log transformed cord serum total IgG levels against Rh4.2, PfSEA, AMA1, GLURP, Etramp5Ag1 and EBA175 was done in excel. Values of 75 | PMC9946240 | ||
Percentile plot of cord blood total IgG levels against | PMC9946240 | |||
Risk of malaria among individual with different levels of expression of total IgG against selected | Increased levels (75 | PMC9946240 | ||
Cox regression model of effects of increased levels of expression of total IgG against Rh4.2 adjusted for selected non-IgG covariates on risk of malaria infections in the first birth year. | malaria, malaria infections | REGRESSION, MALARIA | A. B. Cox regression model of effects of increased levels of expression of total IgG against PfSEA adjusted for selected non-IgG covariates on risk of malaria infections in the first birth year. C. Cox regression model of effects of increased levels of expression of total IgG against Etramp5Ag1 adjusted for non-IgG covariates on risk of malaria infections in the first birth year. D. Cox regression model of effects of increased levels of expression of total IgG against AMA, adjusted for maternal wealth category index on risk of malaria infections in the first birth year. E. Cox regression models of effects of increased levels of expression of total IgG against EBA175, adjusted for non-IgG covariates on risk of malaria infections in the first birth year. F. Cox regression model of effects of increased levels of expression of total IgG against GLURP181 adjusted for non-IgG covariates on risk of malaria infections in the first birth year.KeyWealthcat = categorization of mothers’ economic statusMatprev = categorization of gestational malaria prevalencelogMFIGLURP181cat = 75logMFIEBA175cat = 75logMFIAMA1cat = 75MFIEtramp5cat = 75Birthwgtcat = categorization of neonate’s birth weight in gramsGravidcat = categorization of gravidity status of the motherlogMFISEAcat = 75logMFIRh4 = 75 | PMC9946240 |
Discussion | malaria, infections, tetanus, malaria infection, bacterial infections | BACTERIAL INFECTIONS, MALARIA, INFECTIONS, REGRESSION, TETANUS | We found no significant differences in cord IgG sub-type levels in children whose mothers were on SP versus those on DP for most antigens. Significant differences were only noted for tetanus toxoid in IgG1 levels against all the erythrocyte binding antigens (EBA140, EBA175, EBA181) and IgG4 against merozoite surface proteins (MSPCH150, MSP2Dd2). In all cases where significant differences were observed, mean cord levels for SP group are higher than the DP group. While most of the previous studies haven’t directly compared effects of DP and SP on cord expression of IgG subtypes against We found no association between placental malaria and the cord levels of IgG sub-class levels in malaria holoendemic area of Busia, Eastern Uganda. Even where differences exist, it was never skewed to either mothers who were negative for placental malaria or those positive but varied from one antigen to another. Studies done in other parts of Africa had different findings; some found strong association between placental malaria and reduced transfer/expression of maternal IgG from placental to cord blood. One study of interest concluded there was no significant difference in the expressed levels of antibodies against signature The multivariate cox regression analysis showed children with increased levels of cord blood total IgG against PfSEA, Rh 4.2, AMA1, EBA175, Etramp5Ag1and GLURP antigens have increased risk of malaria infection in the first birth year. The Schizont Egress 1 antigen facilitates merozoites egress; the protein has also been associated with kinetochore function during schizont development [This study found that children born to poor mothers had highest risk of malaria infections during the first birth year. Mothers with inadequate income cannot afford quality food and nutrition supplement required for a baby’s growth, cannot promptly diagnose and treat infections such as malaria, parasitic and bacterial infections and others that can affect a baby’s health [ | PMC9946240 |
Limitation of the study | parasitemia, breast milk | SECONDARY, PARASITEMIA | Most children were breast feeding, so we could not account for IgG taken through breast milk. The roles of other cofounding such as IgGA in breast milk, lactoferritin in breast milk, and fetal Hemoglobin in clearing parasitemia were not adjusted for during this study. We had a challenge with deciding on the appropriate concentration of secondary antibody to be used in the Luminex assay because the original dilution factor in both the protocol and manufacturer’s instruction were not yielding very good results. | PMC9946240 |
Conclusion | MALARIA | Malaria prophylaxis in pregnant mothers using either DP or SP does not affect expression of antibodies against | PMC9946240 | |
Supporting information | malaria | MALARIA, MALARIA | (PDF)Click here for additional data file.(PDF)Click here for additional data file.(DO)Click here for additional data file.(DTA)Click here for additional data file.(DTA)Click here for additional data file.(DTA)Click here for additional data file.(DTA)Click here for additional data file.First, I want to thank Dr. Isaac Sewanyana for the great mentorship he offered to me during my master’s degree study regarding malaria immunology, Dr Moses Ocan, thank you for teaching me the very basics of concept writing, literature review and scientific writing in general. We sincerely appreciate Makerere University Malaria Research training program under the leadership of Prof. R. Kamya and your entire team (Dr. Joaniter Nankabirwa and Dr.Emmanuel Arinaitwe) for sponsoring this study. The team in a special way wants to thank Associate Professor Prasana Jaganathan and August Nicholas Zehner of Stanford University (USA) for providing coupled beads and offering and intensive hands-on technical training and expertise for the Ugandan team. Madam Rhoda Namubiru, thank you for providing finances in time always. Great votes of thanks go to the Ugandan Ministry of Health under the leadership of the Hon. Minister Dr. Jane Ruth Aceng for providing part of tuition during the earlier years of my MSc degree program. Mapronano African Centre of Excellence under the leadership of Prof. Kirabira and Brian Mujuni also offered a much-needed financial boost in the middle of the project, we honestly thank you. Central Public Health Laboratories under the leadership of Dr.Suzan Nabadda and Global Health Laboratories under the leadership of Mr, Waswa thank you for offering your Laboratories to conduct this study and run our Luminex assays.The team also acknowledges the contribution of the entire Makerere University Master of Science-Immunology and Microbiology class of 2017, the entire staffs of the department under the great leadership of Dr.David Patrick Kateete, Dr Obondo James Sand and Dr.Bwanga Freddie who was the course coordinator. Finally, let me acknowledge my wife (stella), kids (Daisy, Arthur, and Pauline), my mother (Margaret) and father (Allan) | PMC9946240 |
1. Introduction | muscle mass, tumor, death, breast cancer, cancer, myalgias, carcinoma, tumors, arthralgias, fractures, osteoporosis-related, a malignant tumor, Cancer | TUMOR, BREAST CANCER, CANCER, DISEASE, BREAST CANCER, CARCINOMA, TUMORS, CANCER | This study examines both the effect of a twice-weekly combined exercise—1 h session of strength and 1 h session of impact-aerobic—on body composition and dietary habits after one year of treatment with aromatase inhibitors (AI) in breast cancer survivors. Overall, forty-three postmenopausal women with a BMI ≤ 35 kg/mBreast cancer (BC) is defined as a malignant tumor that affects different breast cells [The disease can be classified according to the stage of the tumor and its localization, as well as according to the molecular subtype, determined by the analysis of the gene expression of HER2, and by quantitative hormone receptor (HR) [Breast cancer is the most common tumor and is the first cause of death related to cancer among women [The treatment depends on the woman’s hormonal status, kind, and stage of tumor, resulting in surgery therapy, mastectomy, radiation, chemotherapy, or if carcinoma is estrogen receptor–positive, patients may also receive endocrine therapy [Early invasive stages (I, IIa, IIb) and locally advanced stages (IIIa, IIIb, IIIc) have three treatment phases: preoperative phase, surgery, and postoperative phase. The preoperative phase uses systemic endocrine or immunotherapies when tumors express estrogen, progesterone, or ERBB2 receptors. Preoperative chemotherapy may also be used and is the only option when tumors have none of those three receptors, and the postoperative phase includes radiation, immunotherapy, chemotherapy and/or endocrine therapy. When endocrine therapy is needed, only tamoxifen should be used in premenopausal women [Treatment with AI reduces cancer recurrence and improves overall survival in women in the early stages of the disease. However, this treatment is associated with musculoskeletal symptoms such as arthralgias, myalgias, osteoporosis-related bone fractures and unfavorable changes in body composition—a reduction of bone mineral density and muscle mass, and an increase in fat tissue and body weight [Given the efficacy of AIs and the large proportion of women diagnosed with breast cancer using this treatment, it is important to have available interventions to improve those AI side effects as well as the quality of life and all-cause mortality. Therefore, all women should be advised to adopt a healthier lifestyle that promotes overall health. In this context, although the evidence regarding the benefits of non-pharmacological measures specific to breast cancer survivors is limited. Recently, the American Cancer Society [Therefore, taking into account the need for more information, both on the most suitable exercise for patients treated with Ais and on their nutritional status and dietary habits, the aim of this study was two-fold. First, to analyze the effect of a low-frequency and twice-weekly training program combining one session of impact aerobic exercise and one session of resistance exercise on body composition—body weight, body fat tissue and muscle mass—of postmenopausal women with breast cancer after one year of treatment with AI; and second, to examine the lifestyle habits—nutritional and physical activity habits—within this population after one year of treatment with AI. | PMC10049091 |
2. Materials and Methods | PMC10049091 | |||
2.1. Participants | drug addiction, alcoholism, hormone-dependent breast cancer, liver or kidney dysfunction, asthma, COPD | HEART DISEASE, DIABETES MELLITUS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, COPD, JOINT DISORDERS, ASTHMA, ONCOLOGY, HYPOTHYROIDISM, HIGH BLOOD PRESSURE, OSTEOPOROSIS | This was a single-blind study that was undertaken for 5 years, from January 2012 to September 2017. A group of 43 postmenopausal women, aged 55–70 years, with a BMI of 19–35 kg/m², who had surgery for hormone-dependent breast cancer and treatment with chemotherapy and/or radiotherapy, and were about to begin treatment with AI, were included voluntarily in the study. The participants were referred by the Service of Oncology of a hospital in Spain. Performing physical exercise regularly and the presence of osteoporosis, diabetes mellitus, hypothyroidism, liver or kidney dysfunction, high blood pressure, heart disease, asthma, chronic obstructive pulmonary disease (COPD), joint disorders, alcoholism, or any other drug addiction, were considered as exclusion criteria, resulting in a sample of 43 women. The randomization procedure used prevented investigators from influencing group allocation. All researcher staff remained blinded until the end of the study, except for the sports trainers. The volunteers only were informed about their group assignment after the randomization process was completed. The volunteers were randomized using numbered and sealed envelopes that contained a paper with an intervention or control group. One-to-one, and sequentially, participants chose freely the envelope they wanted, resulting in being assigned to a Control Group (CG, 22 patients) or Intervention Group (IG, 21 patients), in which, each volunteer was followed for one year. Participant flow through the study is presented in | PMC10049091 |
2.2. Procedure | ONCOLOGY | The CG and IG followed the usual medical supervision by the Service of Oncology and similar pharmacological treatment with AI and calcium (1000 mg/d) and vitamin D (20 µg/d) supplementation. During the time of the study, the IG followed a supervised training with two sessions per week: one session of odd-impact training (multidirectional impact aerobic exercise) and one of strength training. Both groups maintained their regular lifestyle and filled out a diary in which the volunteers recorded their physical activity, the appearance of symptoms, and the medication taken for the year of study. Further, anthropometric measures and tests of lifestyle, diet and nutritional status were carried out at the beginning of the study, before starting treatment with AI, and also at 6 and 12 months of the treatment. | PMC10049091 | |
2.3. Training Program | musculoskeletal soreness, injuries | COMPLICATIONS | The training was divided into five training cycles in which the load was progressively increased: one cycle of 3 weeks of familiarization and four cycles of 9–14 weeks of duration. Each training session lasted between 60 and 90 min. There were two weeks of a break during the study, at weeks 31–32. The odd-impact training consisted of an aerobic choreography with multidirectional jumps. To increase the workload, the jump distance was increased from one-line jumps to 60 cm side squares jumps. The number of jumps per session varied from 96 during the familiarization period to 756 jumps at the end of the program. For strength training, different resistance machines were used (Technogym, Gambettola, Italy) for different exercises. The training workload began under 40% of 1-RM during the familiarization cycle and progressively was increased to 40–70% of 1-RM in the next four cycles. Each session consisted of 3 sets of 4–12 repetitions for 5 exercises. Two training routines were alternated. Each one had 3 common exercises—leg press, chest press and hip extension—and 4 exercises that were alternately performed according to the routines: Routine 1, which consisted of knee extension and pulldown; and Routine 2, which consisted of knee-flexion and shoulder press. Every 4–8 weeks, the 1-RM test was made to recalculate weights. All the sessions included warm-up, main part, and cool-down. During cool-down, stabilizing work of the abdominal-pelvic area and general stretching of worked-out muscles were made. All participants were required 90% to adhere to the training program. All the sessions were individually supervised by trained leaders. Besides transient musculoskeletal soreness, no major complications or injuries were reported. | PMC10049091 |
2.4. Body Composition and Nutritional Status | muscle mass | The study of body composition involved body weight, muscle mass and fat tissue through anthropometric measurement of body weight, height, waist and arm circumferences, and triceps skinfold (TSF). From these data, we calculated the Body Mass Index (BMI, kg/m | PMC10049091 | |
2.5. Level of Physical Activity | The total level of physical activity was estimated in terms of metabolic equivalents (METs). We collected information about physical activity through a 17-item leisure time physical activity questionnaire, which provided valid and reproducible self-reported data [ | PMC10049091 | ||
2.6. Dietary Habits | The study of dietary habits was conducted by a trained nutritionist. It included the study of nutrient intake through non-consecutive 3-day food records [ | PMC10049091 | ||
2.7. Statistical Analyses | STATA statistical software package version 12.1 was used for the statistical analysis (StataCorp. (2011). Stata Statistical Software: Release 12 College Station, TX: StataCorp LP). On the one hand, two-sided analysis and a level of 5% using the | PMC10049091 | ||
3. Results | At baseline, no significant differences were found between volunteers in the CG and IG. The only exception was the level of physical activity, which was significantly higher in the CG ( | PMC10049091 | ||
3.1. Body Composition and Nutritional Status | At the end of the study, the IG showed a decrease in weight, subcutaneous fat measured by the triceps skinfold (TSF), and waist circumference, associated with a decrease in abdominal fat, both subcutaneous (SAT) and visceral (VAT). Furthermore, the decrease of two points in PG-SGA is interpreted as an improvement in the nutritional status.In contrast, among the volunteers in the CG, there were no significant changes in the nutritional status or body composition, although a tendency towards an increase in total fat was observed ( | PMC10049091 | ||
3.2. Physical Activity Level | At baseline, the participants in the CG presented a higher level of physical activity than those in the IG. However, after one year of follow-up, we observed a clear tendency to a decrease in the total physical activity level of the CG (−11.8 METs/h/week; | PMC10049091 | ||
3.3. Dietary Habits | According to SENC guidelines [After one year of follow-up, no changes in caloric intake and macronutrient intake were observed in any of the two groups of the study ( | PMC10049091 | ||
4. Discussion | PMC10049091 | |||
4.1. Body Composition and Nutritional Status | muscle mass, death, cardiovascular disease, breast cancer, fat loss, Thomas, VAT loss, weight loss | CARDIOVASCULAR DISEASE, BREAST CANCER | The main finding of this study was that a twice-weekly training program combining one session of impact-aerobic exercise and one of resistance training in women treated with breast cancer with AI led to significant weight and fat weight loss, total fat loss, and decreased waist circumference, associated with a significant SAT and VAT loss. In contrast, the CG did not show any variation in body composition. When overweight, VAT and SAT volumes are positively related to cardiovascular risk, and it is known that cardiovascular disease is an important cause of death in patients with breast cancer [However, our training program did not provide enough stimulus to achieve significant improvements in muscle mass. A study by Thomas et al. [These results suggest that although exercise programs equivalent to 10–15 METs/h/week may result in significant fat loss, it would be necessary to perform at least two strength-training sessions per week to achieve significant improvements in muscle mass in postmenopausal breast cancer survivors treated with AI. | PMC10049091 |
4.2. Lifestyle: Physical Activity Level and Dietary Habits | cardiometabolic diseases, cancer, breast cancer death | CANCER, ADVERSE EFFECT | The 2018 American Physical Activity Guide showed that regular recreational physical activity is associated with a decrease in the risk of breast cancer death and mortality from any other cause [Dietary habits can also play a relevant role in body composition and the risk of cardiometabolic diseases [In our study, although in both groups the consumption of most food groups was in line with the SENC recommendations about a healthy diet, the percentage of volunteers with high adherence to MedDiet decreased from 20.8% to 18.6% during the year of the study, and this was reflected in the frequency of consumption by food groups. In general, the consumption of red and processed meats, fast food, pastries, and soft drinks was higher than the recommendations, and this intake has been linked to an adverse effect on body weight control, cardiovascular risk, and cancer risk, due to their higher caloric intake and their content of saturated fat and cholesterol [Concerning the intake of macro and micronutrients, it was barely modified in the whole sample of volunteers during the year of the study, but it is also worth noting that the dietary intake of Calcium, Zinc, Folic acid and vitamins D, A and E did not cover the recommendations for this age group in the Spanish population [In summary, according to the literature, lifestyle interventions that include an increased level of physical activity and nutritional counselling appear to be useful to improve therapeutic efficacy, limiting drug-induced side effects, including those related to AI [ | PMC10049091 |
4.3. Limitations of the Study | The main study limitation was the magnitude of the trial, which limited the ability to draw strong conclusions. Other limitations were the differences in physical activity between the groups before enrollment, but it was a description of the real physical activity of volunteers, not related to the practice of any programmed physical activity; and the use of food records to study dietary habits. However, dietary records are considered a reference method in validation studies. | PMC10049091 | ||
5. Conclusions | weight loss diet or dietary advice, breast cancer | BREAST CANCER | This study shows that a twice-weekly training program combining one session of impact-aerobic exercise and one session of resistance exercise improved the body composition in postmenopausal women treated for breast cancer with AIs. After one year, without a concomitant weight loss diet or dietary advice, women in the exercise group showed a decrease in total fat, SAT, VAT, and waist circumference. This low-frequency combined exercise program may be more acceptable, effective, and practical in optimizing aspects of physical fitness than programs that involve a higher frequency. It is suggested that the choice of this low-frequency regimen will be made when the ability of the individual to withstand a vigorous program or the willingness to devote a high weekly training frequency is a constraint. In addition, the dietary habits of our volunteers were characterized by dietary habits compatible with moderate adherence to the Mediterranean diet pattern, but with a low dietary intake of Ca, Zn, Folic Ac, Vit D, A and E, which suggests the need for nutritional counselling. All these issues should be considered when planning future advice programs for breast cancer survivors. | PMC10049091 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10049091 | ||
Author Contributions | Conceptualization, N.P.S., F.I., J.I.-S. and M.G.-U.; data curation, N.P.S. and M.G.-U.; formal analysis, S.M.-S.; funding acquisition, M.G.-U. and J.I.-S.; investigation, N.P.S., F.I., J.I.-S. and M.G.-U.; methodology, N.P.S., F.I., J.I.-S. and M.G.-U.; project administration and supervision, J.I.-S.; resources, N.P.S., F.I., J.I.-S. and M.G.-U.; validation, N.P.S., F.I., J.I.-S. and M.G.-U.; visualization, M.G.-U. and S.M.-S.; writing—original draft preparation, S.M.-S., M.G.-U. and J.I.-S.; writing—review and editing, J.I.-S. and M.G.-U. All authors have read and agreed to the published version of the manuscript. | PMC10049091 | ||
Institutional Review Board Statement | This study was conducted according to the guidelines of the Declaration of Helsinki and all procedures involving research study participants were approved by the Clinical Research Ethics Committee of Navarra (CEIC, No. 71/11). | PMC10049091 | ||
Informed Consent Statement | Written informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patients to publish this paper. | PMC10049091 | ||
Data Availability Statement | The data presented in this study are available in | PMC10049091 | ||
Conflicts of Interest | The authors declare no conflict of interest. The sponsors had no role in the design, execution, interpretation, or writing of the study. | PMC10049091 | ||
References | Flow chart. The flow of participants throughout the study protocol. Notes: IC—intervention group; CG—control group; n—number of participants.Changes in the body composition and nutritional status after twelve months of study. * Significant difference (Pre-intervention (Baseline characteristics and body composition of the Control Group (CG) and Intervention Group (IG) of the study.Notes: Data are presented as means and standard deviation (SD) or number (Changes in body composition, nutritional status, and physical activity in the Control Group (CG) and Intervention Group (IG) after one year of the study.Notes: Data are presented as means of the difference from baseline, together with the standard deviation (SD). † Within-group, mean difference in parameter, between the beginning and end of the study. ‡ the comparison of differences in the parameters at the end of the study between CG and IG and the p-value. * Significant difference (Changes from the baseline in the Control Group (CG) and Intervention Group (IG) in food consumption patterns and adequacy of food frequency to the recommendations proposed by the Spanish Society of Community Nutrition (SENC).Notes: Data are presented as the mean frequency of consumption by food groups: cereals—services/day; vegetables—services/day; fruit fresh—services/day; pulses—services/week; nuts—services/week; dairy—services/day; fish—services/week; poultry—services/week; red meat—services/week; eggs—services/week; fast food, pastries, soft drinks—services/week; alcoholic drinks—services/day. First, the table shows the recommendations proposed by the Spanish Society of Community Nutrition (SENC) on the frequency of consumption by food groups—SENC. Second, for each group—CG and IG—the intake of the volunteers expressed as the Mean and deviation standard (SD), and the values of the comparison ( | PMC10049091 | ||
Background | EMERGENCY | As unplanned Emergency Department (ED) return visits (URVs) are associated with adverse health outcomes in older adults, many EDs have initiated post-discharge interventions to reduce URVs. Unfortunately, most interventions fail to reduce URVs, including telephone follow-up after ED discharge, investigated in a recent trial. To understand why these interventions were not effective, we analyzed patient and ED visit characteristics and reasons for URVs within 30 days for patients aged ≥ 70 years. | PMC10193595 | |
Methods | Data was used from a randomized controlled trial, investigating whether telephone follow-up after ED discharge reduced URVs compared to a satisfaction survey call. Only observational data from control group patients were used. Patient and index ED visit characteristics were compared between patients with and without URVs. Two independent researchers determined the reasons for URVs and categorized them into: patient-related, illness-related, new complaints and other reasons. Associations were examined between the number of URVs per patient and the categories of reasons for URVs. | PMC10193595 | ||
Results | dyspnea | Of the 1659 patients, 222 (13.4%) had at least one URV within 30 days. Male sex, ED visit in the 30 days before the index ED visit, triage category “urgent”, longer length of ED stay, urinary tract problems, and dyspnea were associated with URVs. Of the 222 patients with an URV, 31 (14%) returned for patient-related reasons, 95 (43%) for illness-related reasons, 76 (34%) for a new complaint and 20 (9%) for other reasons. URVs of patients who returned ≥ 3 times were mostly illness-related (72%). | PMC10193595 | |
Conclusion | As the majority of patients had an URV for illness-related reasons or new complaints, these data fuel the discussion as to whether URVs can or should be prevented. | PMC10193595 | ||
Trial registration | For this cohort study, we used data from a randomized controlled trial (RCT). This trial was pre-registered in the Netherlands Trial Register with number NTR6815 on the 7 | PMC10193595 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12877-023-04021-x. | PMC10193595 | ||
Keywords | PMC10193595 | |||
Introduction | EMERGENCY | With demographic change, there is an increase in Emergency Department (ED) presentations by patients aged 70 years and older worldwide [Many post-ED discharge intervention programs are focused on older patients at high risk for hospital return. However, prediction tools that have been developed to identify patients at risk have poor predictive accuracy, contain different predictors, and are often not suitable for clinical use [Several of these predicting factors could be addressed through specific interventions, such as patient education and community follow-up by a geriatric nurse. However, systematic reviews evaluating the effects of post-discharge interventions initiated in the ED have found that many were not effective in reducing ED re-attendances [In order to understand why these interventions are not effective in reducing URVs, more insight is needed into the reasons why older patients return to the ED. Therefore, we investigated the frequencies, associated patient and ED visit characteristics and reasons for URVs within 30 days after the index ED visit among patients aged ≥ 70 years. In addition, we examined whether specific categories of reasons for URVs were associated with the number of URVs per patient. | PMC10193595 | |
Methods | PMC10193595 | |||
Study design and setting | For this study, we used data from a pragmatic randomized controlled trial (RCT). The research question of this RCT was whether a telephone follow-up call reduces unplanned hospitalizations and URVs within 30 days of ED discharge, compared to a satisfaction survey call. The trial was conducted in the EDs of Haaglanden Medical Center (HMC), a non-academic teaching hospital in the Netherlands, from February 1, 2018 to July 1, 2019. In this RCT, 3175 patients were allocated to either the intervention ( | PMC10193595 | ||
Patients | For this study, only observational data from control group patients were used to exclude a possible effect of the intervention telephone follow-up call. Patients aged ≥ 70 years who were discharged from one of the EDs of HMC to an unassisted living environment were eligible for inclusion. Exclusion criteria were: admission to the hospital, discharge to a nursing home, another care facility or assisted living environment, and planned follow-up appointment at an outpatient clinic or at the ED within 24 h [ | PMC10193595 |
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