title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Ethical approval | Not applicable. | PMC10468939 | ||
Consent to participate | Not applicable. | PMC10468939 | ||
Consent for publication | Not applicable. | PMC10468939 | ||
References | PMC10468939 | |||
1. Introduction | Depressive, ’ mental functioning (reduction, mood disorders, mineral deficiencies, mental deterioration, depressive symptoms | (1) Background: studies have shown that some patients experience mental deterioration after bariatric surgery. (2) Methods: We examined whether the use of probiotics and improved eating habits can improve the mental health of people who suffered from mood disorders after bariatric surgery. We also analyzed patients’ mental states, eating habits and microbiota. (3) Results: Depressive symptoms were observed in 45% of 200 bariatric patients. After 5 weeks, we noted an improvement in patients’ mental functioning (reduction in BDI and HRSD), but it was not related to the probiotic used. The consumption of vegetables and whole grain cereals increased (DQI-I adequacy), the consumption of simple sugars and SFA decreased (moderation DQI-I), and the consumption of monounsaturated fatty acids increased it. In the feces of patients after RYGB, there was a significantly higher abundance of two members of the Muribaculaceae family, namely Veillonella and Roseburia, while those after SG had more Christensenellaceae R-7 group, Subdoligranulum, Oscillibacter, and UCG-005. (4) Conclusions: the noted differences in the composition of the gut microbiota (RYGB vs. SG) may be one of the determinants of the proper functioning of the gut–brain microbiota axis, although there is currently a need for further research into this topic using a larger group of patients and different probiotic doses.The benefits of bariatric surgery include improvements in psychosocial status, social relationships, and quality of life [One of the factors affecting mental state and mood is gut microbiota [The nutritional status of an organism is also important for proper psychological functioning. For post-bariatric surgery patients, an energy-dense diet with large amounts of vegetables and fruits and restricting the consumption of highly processed products, saturated fatty acids (SFA), and simple sugars is recommended. In addition, consuming an adequate amount of protein is crucial, which is estimated to be 60–80 g/day. Dairy products, eggs, fish, lean meat, and the seeds of legumes are recommended as the main sources of protein. Equally important is the consumption of complex carbohydrates that provide fiber, as well as adequate vitamin and mineral intake [Unfortunately, despite these recommendations, protein, vitamin, and mineral deficiencies are diagnosed in many patients after bariatric surgery. The main causes are insufficient consumption of individual food components, the development of food aversion, a lack of recommended nutritional supplementation, decreased secretion of hydrochloric acid in the stomach, bypassing a part of the intestine that allows absorption of nutrients, and gastrointestinal concomitants [To the best of our current knowledge, there are few scientific studies addressing the relationship between dietary changes, intestinal barrier functioning, and worsening mental status in patients after bariatric surgery. The aim of the study was to evaluate the efficacy of a five week probiotic therapy with multistrain probiotic preparation (Sanprobi Barrier) and the introduction of a balanced diet to improve the mental performance of patients ≥6 months after bariatric surgery who suffered from mood disorders. The multi-strain probiotic used in the previous study, showed both a reduction in depressive symptoms [ | PMC10707788 | |
2. Materials and Methods | depression, Depression | POLAND | Two hundred patients who had undergone a Roux-en-Y gastric bypass (RYGB) or a sleeve gastrectomy (SG) at least 6 months before, completed the Beck Depression Inventory (a self-rating scale to screen for depression symptoms). Patients with a score of ≥12 points were eligible for the study [Patients were randomized and double-blinded into two groups, one of which received a probiotic or placebo for a period of 5 weeks:Probiotic: Sanprobi Barrier (manufacturer: Sanprobi sp. z o. o. sp. k., Szczecin, Poland), consisting of Placebo: corn starch, maltodextrins, vegetable protein;Dosage: 4 capsules (2 × 10The product is available commercially on the Polish market and its composition and dosage have been approved by the relevant health authorities.Patients in both groups were educated about the principles of a healthy diet and were given a balanced meal plan tailored to the needs of patients after bariatric surgery [ | PMC10707788 |
2.1. Surgical Techniques | The sleeve gastrectomy was performed using the laparoscopic method. Approximately 80% of the stomach was removed along the greater curvature to form a new sleeve-like stomach, removing the fundus and body of the stomach. The remaining stomach had a capacity of about 150 mL. The Roux-en-Y Gastric Bypass was also performed laparoscopically. In this procedure, the stomach was transected creating a gastric pouch of approximately 20–30 mL, which was then anastomosed with mid-jejunum, creating the alimentary limb. The Roux-limb length was 75–150 cm [ | PMC10707788 | ||
2.2. Anthropometric Examinations | Body composition analysis was performed using a Jawon Medical ioi-353 analyzer (Jawon, Seongnam-si, Republic of Korea). Body height [cm] was measured using a metric stadiometer. Waist circumference [cm] and hip circumference [cm] were measured using a tape measure. | PMC10707788 | ||
2.3. Survey Research—Mental State | ideation, guilt, anxiety, psychomotor retardation, daytime sleepiness, agitation, insomnia, Insomnia, depressive symptoms, depression, Depression | The Beck Depression Inventory (BDI), a self-assessment questionnaire, was used to assess the occurrence and severity of depressive symptoms. The total score ranges from 0 to 63 points, with the higher the score, the higher the severity of depressive symptoms. ≥12 points were considered as the presence of depressive symptoms [The Athenian Insomnia Scale is a scale consisting of 8 items that assess falling asleep, waking up at night and in the morning, total sleep time, sleep quality, well-being, psychophysical fitness, and daytime sleepiness. The total score ranged from 0 to 24 points, with a higher score representing poorer sleep quality. A score of ≥6 points was considered insomnia [The Hamilton Depression Rating Scale (HDRS) was administered by an experienced psychiatrist. A 21-item version was used in the study, including items on guilt, suicidal ideation, circadian rhythm disturbances, agitation, anxiety, somatic symptoms, and psychomotor retardation. Responses are scored on a scale of 0–4 and 0–2. A score of ≥7 points indicates the presence of depression [ | PMC10707788 | |
2.4. Eating Habits Assessment | chronic diseases, malnutrition | POLAND, CHRONIC DISEASES, MALNUTRITION | A food frequency questionnaire (FFQ), consisting of a comprehensive list of foods and beverages with response categories indicating usual frequency of consumption over a period of time (never or almost never, once a month or less often, several times a month, several times a week, every day, several times a day) was used.The consumption log for the last 72 h was evaluated using the Diet 5D program (Food and Nutrition Institute, Warsaw, Poland). Based on the data collected with the above tools, the International Diet Quality Index (DQI-I) was calculated, with a total score ranging from 0 to 100 points. The lower the score, the poorer the quality of the diet used. This indicator consists of four categories:Variety—consumption of each food group (fish, meat, eggs, legumes, vegetables, fruits, cereals) and different sources of protein (fish, meat, eggs, legumes, dairy products) (0–20 points);Adequacy—assessment of consumption of individual food components that need to be supplied to ensure a healthy diet and prevent malnutrition (vegetables, fruits, cereals, fiber, protein, iron, calcium, vitamin C) (0–40 points);Moderation—assessing the consumption of dietary components that may require a reduction in daily intake due to an increased risk of developing chronic diseases (total fat, cholesterol, saturated fatty acids, sodium, low calorie foods) (0–30 points);Overall dietary balance—assessment of the ratio of individual macronutrients and fatty acids (0–10 points) [ | PMC10707788 |
2.5. Laboratory Tests | POLAND | Biological material was collected from patients at two time points—visit 1 and control (after 5 weeks). Venous blood was collected in EDTA tubes (Sarstedt, Bionovo, Legnica, Poland), centrifuged (3500 rpm for 10 min), and then the plasma and morphos fractions were separated in each eppendorf. Stool was collected using a stool sample kit (Kałszyk, Poland). The biological material was stored at −80 °C until laboratory analyses were performed. | PMC10707788 | |
2.6. Markers of the Intestinal Barrier Integrity | Tecan, LBP | Fecal zonulin levels were determined by enzyme-linked immunosorbent assay (ELISA) (Immundiagnostik AG, Bensheim, Germany) according to the manufacturer’s protocol. Absorbance was measured with a spectrophotometer (Sunrise, Tecan, Männedor, Switzerland) at 450 nm.The concentration of LPS and occludin in blood serum was determined using an ELISA assay (EIAAB SCIENCE INC, Wuhan, China), and that of LBP was determined using an ELISA assay (FineTest, Wuhan, China) according to the manufacturer’s protocols. In each case, absorbance was measured using a spectrophotometer (Sunrise, Tecan, Männedor, Switzerland) at 450 nm. | PMC10707788 | |
2.7. Sequencing Analysis of Bacterial 16S RNA Genes | DNA isolation from feces and sequencing of the V3–V4 regions of the 16S rDNA gene were performed using the Illumina MiSeq instrument (Illumina INC, San Diego, CA, USA) at the Institute of Clinical Molecular Biology, of the University of Kiel (Kiel, Germany) according to their own protocol. DNA was isolated using microcentrifuge columns with silica membrane. Extracted DNA was purified using an Agencourt AMPure | PMC10707788 | ||
2.8. Determination of Homocysteine and Vitamin D Levels in Blood Serum | Tecan | The concentration of vitamin D metabolite 25 (OH) was determined by Diagnostyka SA with the automated chemiluminescence immunoassay method (CLIA) using the LIAISON XL device (DiaSorin, Vercelli, Italy). Serum homocysteine concentration was determined by ELISA (Bioassay Technology Laboratory, Shanghai, China) according to the manufacturer’s protocol. Absorbance was measured using a spectrophotometer (Sunrise, Tecan, Männedor, Switzerland) at 450 nm. | PMC10707788 | |
2.9. 16S rRNA Sequence Preprocessing | The sequencing was carried out using Illumina paired-end technology, specifically targeting the V3–V4 region of the 16S rRNA gene. To assess the quality of the raw sequencing data, a thorough initial quality screening was conducted using FastQC (version 0.12.1) and MultiQC (version 1.12) tools. Subsequently, all data preprocessing was executed using the QIIME 2 software [ | PMC10707788 | ||
2.10. Statistical Analysis | Depression, Insomnia, HRSD | TSS | To compare baseline characteristics of patients, we utilized either the Wilcoxon test or Fisher test. To evaluate differences between treatment groups (Placebo versus Probiotic) concerning changes in clinical response variables from baseline to the end of the intervention, including Beck Depression Inventory (BDI), Hamilton Psychiatric Rating Scale for Depression (HRSD), Insomnia scale, and Diet Quality Index—International (DQI-I), we employed a mixed-effect linear model implemented in the lme4 R package (version 1.1–34) [The analysis of gut microbiome data was conducted at baseline, where alpha-diversity measures were compared between groups using a mixed-effect model (as described above), considering the type of surgery. To test for significant differences in the composition of biological communities among groups, we applied Permutational Multivariate Analysis of Variance (PERMANOVA) implemented in the vegan R package (2.6-4) using the Bray–Curtis dissimilarity metric. Principal Coordinate Analysis (PCoA) was used for reducing the dimensionality of beta-diversity and representing it in two-dimensions.In the analysis of genus-level data (with a 10% prevalence filtering), differential abundance analysis (DAA) was performed using five different methods: ALDEx2, ANCOMBC2, WilcoxTSS, WilcoxRarefied, and LEfSe. WilcoxTSS and WilcoxRarefied applied the Wilcoxon test to relative abundance data (TSS, total sum scaling) and rarefied data WilcoxRarefied (with sampling depth = 14,193), respectively. All statistical analyses were carried out using the R software (version 4.2.3, R Core Team (2022)) [ | PMC10707788 |
3. Results | PMC10707788 | |||
3.1. Patients’ Characteristics | The characteristics of patients are presented in | PMC10707788 | ||
3.2. Psychiatric Scales | Depression, Insomnia, HRSD | First, we examined differences between treatments groups (Placebo versus Probiotic) with respect to the average change from baseline to end of intervention in three response variables, i.e., Beck Depression Inventory (BDI), Hamilton Psychiatric Rating Scale for Depression (HRSD), and Insomnia scale, while accounting for the type of bariatric surgery (RYGB versus SG, The lack of significant interaction between the type of surgery, intervention and time ( | PMC10707788 | |
3.3. DQI-I and Its Subscales | psychiatric | In addition to psychiatric outcomes, Diet Quality Index-International (DQI-I) and four subscales, namely variety, adequacy, moderation and overall balance, were also examined. In the next stage, we investigated the effect of body mass change (BMC), in addition to intervention, to see if patients who had experienced a higher loss of body mass between the time of their surgery and the start of the trial had a distinct reaction to the probiotic intervention. BMC in patients receiving placebo and probiotic is shown in The BMC was computed as the difference between the patient’s body mass at the start of the study and the patient’s body mass at the time of surgery; hence, a decrease is indicated by a negative number, while an increase is indicated by a positive value; BMC did not differ between groups, | PMC10707788 | |
3.4. Gut Microbiota | At baseline, alpha diversity did not differ between Placebo and Probiotic groups regardless of the type of bariatric surgery ( | PMC10707788 | ||
4. Discussion | Depressive, ’ mental functioning (reduction, microbiota disorders, depression, LBP, depressive disorders | To the best of our knowledge, the study conducted is the first to address the possibility of reducing the severity of depressive disorders in people after bariatric surgery using diet and probiotic therapy.Depressive symptoms were observed in 45% of 200 patients who underwent bariatric surgery. The presence of depressive disorders was also noted in other studies. Alsubaie et al. [At present, there are lack of data in the literature examining the relationship between changes in the microbiota and the development of depression after bariatric surgery. Finding such marker bacteria in the future could be a very valuable predictor of the development of depression. In a previous paper, we published results that indicate a role for the gut microbiota and inflammatory processes in the development of depressive disorders in patients after bariatric surgery [In our study, after 5 weeks, we noted an improvement in patients’ mental functioning (reduction in BDI and HRSD), but it was not related to the probiotic used (In our study, the most important factor that contributed to the reduction in the severity of depressive disorders may have been the dietary intervention. Consumption of vegetables and whole grain cereals increased (DQI-I adequacy), consumption of simple sugars and SFA decreased (moderation DQI-I), and consumption of monounsaturated fatty acids derived mainly from olive oil increased (overall balance DQI-I). A Western-style diet, characterized by the consumption of highly processed products with a high content of sugars and saturated fatty acids and, at the same time, a low consumption of vegetables, fruits and fiber, favors the development of microbiota disorders [The original composition of the microbiota may be important for the functioning of the intestinal barrier and the effectiveness of its sealing. It seems that RYGB has a greater impact on the gut microbiota than restrictive surgery [In our study, we noted no significant differences in parameters assessing intestinal barrier integrity (LPS, LBP, zonulin, occludin) between the group taking the probiotic and the placebo. However, the study by Clemente-Postigo et al. [Due to significant limitations, this study should be considered a pilot study. Small study groups, short time of intervention, high heterogeneity and difficulties in compliance were the biggest limitations. However, the topic addressed is very interesting and requires further well-designed clinical and mechanistic studies. | PMC10707788 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10707788 | ||
Author Contributions | Conceptualization, N.K. and E.S.; methodology, E.S. and I.Ł.; software, M.K., A.M.-V.K. and A.N.; validation, E.S., I.Ł. and M.W.; formal analysis, M.K.; investigation, N.K., K.K. and B.K.; resources, K.K. and B.K.; data curation, N.K. and E.S.; writing—original draft preparation, N.K., I.Ł., M.F. and E.S.; writing—review and editing, E.S.; visualization, M.K.; supervision, I.Ł. and M.K.; project administration, E.S.; funding acquisition, E.S. All authors have read and agreed to the published version of the manuscript. | PMC10707788 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Bioethics Committee of the Pomeranian Medical University in Szczecin (resolution no. KB-0012/40/17) on 27 February 2017. | PMC10707788 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10707788 | ||
Data Availability Statement | Data are contained within the article and | PMC10707788 | ||
Conflicts of Interest | Authors Mariusz Kaczmarczyk and Igor Łoniewski were employed by the company Sanprobi sp. z o.o. sp. k. The remaining 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. | PMC10707788 | ||
References | SE, Depression, psychiatric, LBP | Study design. PPI—proton pump inhibitors.Predictor effect plots summarizing the role of intervention and surgery type on predicted values of the BDI (Predictor effect plots summarizing the role of intervention and surgery type on predicted values of the DQI-I (Body mass change (BMC) between the time of patient’s surgery and the start of the study.Alpha-diversity, beta-diversity and differential abundance analysis at baseline. Alpha-diversity (Characteristics of patients.sd—standard deviation, WHR—waist-to-hip ratio, FFM—fat-free mass, BMI—body mass index, LBP—lipopolysaccharide binding protein, LPS—lipopolysaccharide, DQI-I—diet quality index international, RYGB—Roux-en-Y gastric bypass, SG—sleeve gastrectomy.Average marginal effects as a difference in predicted outcomes (Before versus After) for all combinations of levels of the categorical predictor (type of surgery and intervention) for psychiatric outcomes.Examined contrasts in all cases—Before versus After (After minus Before), BDI—Beck Depression Inventory, HRSD—Hamilton Psychiatric Rating Scale for Depression, RYGB—Roux-en-Y Gastric Bypass, SG—Sleeve Gastrectomy, Est—estimate of average marginal effect (AME), SE—standard error, Average marginal effects as a difference in predicted outcomes (Before versus After) for all combinations of levels of the categorical predictor (type of surgery and intervention) for DQI-I.RYGB—Roux-en-Y Gastric Bypass, SG—Sleeve Gastrectomy, DQI-I—diet quality index international, Est—estimate of average marginal effect (AME), SE—standard error, | PMC10707788 | |
COMMENT | obesity, diabetes, shock, erectile dysfunction | UROLOGICAL DISEASES, OBESITY, SHOCK, VASCULOGENIC ERECTILE DYSFUNCTION, PATHOPHYSIOLOGY, DIABETES, DYSLIPIDEMIA, HYPERTENSION, ERECTILE DYSFUNCTION |
None declared.First Department of Urology, G. Gennimatas Hospital, Aristotle University of Thessaloniki, Thessaloniki, GreeceInstitute for the Study of Urological Diseases, Thessaloniki, GreeceDimitrios Kalyvianakis
The undeniably numerous advances in the treatment of erectile dysfunction (ED) over the last two decades have not been able to satisfy the desire to search for a treatment modality capable of altering the underlying pathophysiology of the erectile mechanism. The search for a new modality of clinical treatment that is effective with a lasting effect that restores spontaneous erection has brought the focus of recent studies to a promising modality through low-intensity shock wave therapy (LiST), being treated as one of the treatments that has been increasingly proposed.In 2010, when Vardi et al. first reported the use of LiST for ED (Despite the promising scenario, prospective randomized studies are scarce, conflicting with many unresolved questions. Furthermore, several aspects make it difficult to perform qualitative studies, such as the heterogeneity among shock wave generators, the type of shock waves emitted, and treatment protocols (duration of treatment, number of sessions per week, total number of delivered shock wave pulses, and penile application sites).This very interesting article by Kalyvianakis et al., (Seventy men aged 40 to 70 years, in heterosexual relationships, stable for more than 3 months, with clinically diagnosed erectile dysfunction, were randomized to 12 sessions of LiST or sham therapy (35 patients) twice a week. Patients were evaluated 1 and 3 months after the end of treatment. The results of the present study suggest that LiST is effective and safe for moderate vasculogenic erectile dysfunction as more than two-thirds of patients showed significant improvement on the IIEF-EF scale.However, some relevant aspects need to be highlighted. The assessment of vasculogenic ED, one of the inclusion criteria, was defined by clinical criteria that were not clearly described in the present study. The lack of objective data on the presence of vasculogenic erectile dysfunction such as the penile doppler or penile elastography, or even the description of underlying comorbidities, overshadows the underlying clinical condition. Stratifying the results according to comorbidities (hypertension, diabetes, obesity, dyslipidemia, etc), observing groups with more severe comorbidities, independently of the IIEF, could allow us to observe an association between severe pathologies (greater damage to the corpora cavernosa) and negative impact on the effect of LiST (Moreover, regarding the application technique, no figure was described or presented application points (penile shaft, crura), making it difficult to understand the standardization of the method, in addition to no report if the treatment was performed by a single applicator or even if there was some prior training.Corroborating with previous observations, phosphodiesterase type 5 (PDE5) inhibitor or other erectile dysfunction treatments were prohibited during the entire treatment / follow-up period. The strategy to eliminate the bias of an effect of PDE5 inhibitors is interesting, but the question remains: could this class of drugs optimize the local action of shock wave therapy? Future studies using this class of drugs versus placebo would be interesting to rule out this hypothesis.Other limitations of the present study, appropriately mentioned by the authors, are the profile of patients from a single institution, the total n (70) and the profile of patients - exclusively with moderate ED. Furthermore, the short follow-up period (1 and 3 months) precludes conclusions regarding durability and peak of effect.To conclude, we see in this important article one more confirmation of the effect of LiST, highlighting the importance of advancing in this field. It seems that LiST is here to stay, perhaps not as a major turning point in the treatment of ED but as a good adjuvant therapy applicable to a selected group of patients, capable of influencing and modifying outcomes. | PMC9881815 |
REFERENCES | PMC9881815 | |||
Background and aims | PRETERM BIRTH, DISEASE | Preterm birth has been linked with an increased risk of cardiovascular (CV) disease from childhood into adolescence and early adulthood. In this study, we aimed to investigate differences in CV health profiles between former term- and preterm-born infants in a cohort of Tyrolean adolescents. | PMC10367422 | |
Methods | The Early Vascular Aging (EVA)-Tyrol study is a population-based non-randomized controlled trial, which prospectively enrolled 14- to 19-year-old adolescents in North Tyrol, Austria and South Tyrol, Italy between 2015 and 2018. Metrics of CV health (body mass index (BMI), systolic (SBP) and diastolic blood pressure (DBP), smoking, physical activity, dietary patterns, total cholesterol and fasting blood glucose) were assessed and compared between former term- and preterm-born girls and boys. | PMC10367422 | ||
Results | term-born | In total, 1,491 study participants (59.5% female, mean age 16.5 years) were included in the present analysis. SBP and DBP were significantly higher in former preterm-born adolescents (mean gestational age 34.6 ± 2.4 weeks) compared to term-born controls ( | PMC10367422 | |
Conclusions | hypertension | PRETERM BIRTH, HYPERTENSION | Preterm birth is associated with elevated SBP and DBP in adolescence, which was even confirmed for former late preterm-born adolescents in our cohort. Our findings underscore the importance of promoting healthy lifestyles in former term- as well as preterm-born adolescents. In addition, we advise early screening for hypertension and long-term follow-up in the group of preterm-born individuals.
| PMC10367422 |
Keywords | PMC10367422 | |||
Introduction | PRETERM BIRTH, PRETERM BIRTH, HEART | Preterm birth is defined as a live birth that occurs before 37 completed weeks of pregnancy [The aim of the present study was to investigate differences in CV health profiles between former term and preterm infants in a cohort of Tyrolean adolescents. To the best of our knowledge, we are the first to investigate the impact of preterm birth on the seven CV health metrics defined by the American Heart Association (AHA) [ | PMC10367422 | |
Methods | PMC10367422 | |||
Study population and design | PRETERM BIRTH | The present study was conducted as part of the EVA-Tyrol study, a population-based, non-randomized controlled trial at the Department of Pediatrics II at the Medical University of Innsbruck. EVA-Tyrol is aiming to assess the prevalence of CV health profiles and the efficacy of a health promotion intervention on CV risk factors and health behaviors in a cohort of adolescents in the whole federal province of Tyrol (Austria) with a population of about 745,000 inhabitants and in Bruneck, a city in the autonomous province of Bolzano/South Tyrol (Italy) with about 80,000 inhabitants. Local schools and big companies were contacted and pupils and apprentices with a target age between 14 and 19 years were invited to take part in this study. Whole school classes were recruited thus some older students or apprentices, who wanted to participate were also included. 2273 persons did express their interest in participation in the EVA Tyrol study, yet 171 did either not sign the informed consent or signed the informed consent but did not show up on the examination day. For the latter group no study specific measures were performed. All participants provided a written informed consent or if the participants had not attained the age of 18 years, a parent or legal guardian additionally provided written consent.The study was designed with an intervention group, which received a baseline examination and was invited to a follow-up examination after receiving a health intervention, and a control group. For this exploratory data analysis, information from both the baseline and the control group without health intervention was used to achieve a representative cohort of the adolescent population, in the following they are referred to as the EVA-cohort. A detailed description of the study protocol has been previously published [The present study represents a subanalysis of the EVA-Tyrol study and highlights data on the impact of preterm birth on cardiovascular health. | PMC10367422 | |
Perinatal characteristics | health behaviors | All participating adolescents were asked bringing the so-called “mother–child booklet” with them on the day of examination. Within this official medical document health data about pregnancy, birth and regular pediatric examinations during the first 5 years of life are documented in Austria and Italy. We registered infant data on perinatal characteristics, namely gestational age (GA) and birth weight. To account for gender- and GA-specific differences, birth weight z-scores were calculated for every subject using the Fenton 2013 reference dataset [CV health was assessed by the concept of the seven so called CV health metrics defined by the AHA including three health factors (SBP and DBP, total cholesterol and fasting blood glucose) and four health behaviors (non-smoking, BMI, regular physical activity and favorable dietary patterns) [ | PMC10367422 | |
Anthropometry | For anthropometric measurements study participants wore light indoor clothes without shoes. Weight was assessed using calibrated medical precision scales and height was determined using a Harpenden stadiometer (Holtain, Crymych, United Kingdom). BMI was calculated as body weight in kilograms divided by the square of height in meters and converted to percentiles according to reference data by Kromeyer-Hauschild et al. [ | PMC10367422 | ||
Assessment of lifestyle risk factors | Atherosclerosis | ATHEROSCLEROSIS | Behavioral risk factors, such as smoking status and physical activity, were assessed in a standardized medical interview conducted by trained medical staff in attendance of a specialist in pediatrics, compiled and adapted from the questionnaires from the Atherosclerosis Risk-Factors in Male Youngsters, Atherosclerosis Risk-Factors in Female Youngsters, and Bruneck studies [ | PMC10367422 |
Blood sample collection and laboratory measurements | BLOOD | Blood samples were taken early in the morning after an overnight fasting of at least eight hours and were immediately stored in cooling boxes (at approximately 4 °C). After rapid transport to the ISO-certified Central Institute for Medical and Chemistry Laboratory Diagnosis at Medical University of Innsbruck serum glucose was assessed by a hexokinase method (Cobas 8000, Roche Diagnostics, Rotkreuz, Switzerland). Total cholesterol was determined by standard enzymatic colorimetric assays (Cobas 8000, Roche Diagnostics, Rotkreuz, Switzerland). | PMC10367422 | |
Assessment of socio-economic status | The Family Affluence Score (FAS) was used to determine the socio-economic status. Study participants were asked about four status items (including owning a car in the family, having an own bedroom, going on vacations and number of computers in the household) and classified into the categories high, middle and low affluence [ | PMC10367422 | ||
Classification of education | SECONDARY | After nine years of compulsory school attendance, the Austrian education system offers three different educational pathways. In secondary high schools adolescents receive general academic education, secondary vocational schools provide general education as well as occupation-specific knowledge or adolescents may be trained as apprentices within companies. | PMC10367422 | |
Statistical analysis | SD | Statistical analysis was performed using SPSS version 27.0 for Windows (IBM Corporation, Armonk, New York). Data of the study characteristics at baseline and follow-up are shown as mean ± SD or median (interquartile ranges) and categorical variables as count (percentages). Differences in CV health metrics were determined using t-test or Mann–Whitney-U-test (depending on data distribution) and Pearson χ | PMC10367422 | |
Discussion | obesity, fasting blood glucose | OBESITY, PRETERM BIRTH, GESTATIONAL DIABETES, INTRAUTERINE GROWTH RETARDATION, REGRESSION, ELEVATED BLOOD PRESSURE, PREECLAMPSIA | Although preterm birth rates in developed high-income countries have stagnated or declined over the past 1.5 decades [Regarding blood pressure, SBP as well as DBP were significantly higher in former preterm-born adolescents compared to term-born controls after adjustment for sex, age at examination, BMI, smoking status, physical activity, diet, being SGA, fasting blood glucose and total cholesterol in the multivariate logistic regression model. This finding is corroborated by several meta-analyses, which have also demonstrated an increased risk for elevated blood pressure in the preterm population [Although these differences are small and within normal ranges for this age group, there is evidence that elevated blood pressure levels associated with preterm birth worsen with increasing age [In addition to prenatal factors, such as preeclampsia, gestational diabetes, obesity, intrauterine growth retardation, which lead to adverse fetal programming, there is evidence that a number of other causes play a role in the development of elevated blood pressure in former preterm infants during the postnatal course [Regarding all other health metrics, we could not identify any impact of preterm birth in our cohort. Altered lipid profiles [ | PMC10367422 |
Strengths and limitations | term-born | PRETERM BIRTH | One of the main strengths of our study is the large and homogenous study cohort, which includes adolescents from all types of schools and apprentices of the same age from the entire study region. Furthermore, we investigated a broad spectrum of CV health parameters and data was collected prospectively by a small and stable study team within approximately three years.The small number of former preterm-born adolescents compared with term-born individuals is a limitation, which must be mentioned. The rate of former preterm born adolescents in our cohort, however, corresponds to the rate of preterm birth in Austria [ | PMC10367422 |
Implications and conclusion | hypertension, term-born, prematurity | ELEVATED BLOOD PRESSURE, HYPERTENSION, PRETERM BIRTH | The results of our study underscore the impact of prematurity on CV risk. In our cohort, SBP and DBP were significantly higher in former preterm-born than in term-born adolescents. It should be emphasized that elevated blood pressure levels were even found in adolescents born late preterm. Therefore, early screening for hypertension and long-term follow-up in individuals with a history of preterm birth is warranted. The low number of adolescents meeting the criteria for ideal CV health metrics highlights the need for promotion of a healthy lifestyle in both former preterm- and term-born individuals. | PMC10367422 |
Acknowledgements | None to declare | PMC10367422 | ||
Authors’ contributions | CH and J-PN These authors takes responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. CH, J-PN, NG, AS, BB, KS, SJK, RG, EG, MK and UKK. These authors acquired the data, critically revised the manuscript for key intellectual content and approved the final manuscript. MK and UKK are the corresponding authors and contributed equally to the elaboration of the study protocol, they are principal investigators in Tyrol (Austria) and are EVA-Tyrol’s project directors. All authors read and approved the final manuscript. | PMC10367422 | ||
Funding | Acknowledgement of grant support: The EVA-Tyrol study is financially supported by the excellence initiative (Competence Centers for Excellent Technologies—COMET) of the Austrian Research Promotion Agency FFG: “Research Center of Excellence in Vascular Ageing—Tyrol, VASCage” (K project number 843536) and by the excellence initiative VASCage (Centre for Promoting Vascular Health in the Ageing Community, project number 868624) of the Austrian Research Promotion Agency FFG (COMET program), both funded by the Austrian Ministry for Transport, Innovation and Technology, the Austrian Ministry for Digital and Economic Affairs and the federal states Tyrol (via Standortagentur), Salzburg and Vienna (via Vienna Business Agency). | PMC10367422 | ||
Availability of data and materials | The data that support the findings of this study are available from the corresponding author upon reasonable request. | PMC10367422 | ||
Declarations | PMC10367422 | |||
Ethics approval and consent to participate | The study was performed in accordance with the Declaration of Helsinki, ethical approval was approved by the Institutional Review board of the Medical University of Innsbruck, Austria (approval number AN 2015–0005 345/4.13, first registered 29/04/2019). The study is registered at All study participants provided written informed consent. In case they were younger than the age of 18, a written informed consent was signed by the parents or the legal guardian. | PMC10367422 | ||
Consent for publication | Not applicable. | PMC10367422 | ||
Competing interest | The authors declare that there is no conflict of interest. | PMC10367422 | ||
References | PMC10367422 | |||
Methods | PMC10526658 | |||
Patients | nonbreast malignancy, tumor, toxicity, chronically active hepatitis B or C, infection, primary breast cancer, primary breast cancer stage, autoimmune disease, Cancer | TUMOR, INFECTION, PRIMARY TUMOR, AUTOIMMUNE DISEASE, CANCER | This was a prospective, open-label, nonrandomized phase I diagnostic study in patients with untreated primary breast cancer (ClinicalTrials.gov Identifier: NCT05203497). The study protocol was approved by the Scientific Council of Cancer Research Institute and Board of Medical Ethics, Tomsk National Research Medical Center of the Russian Academy of Sciences (protocol №13, 09.11.2021), and all patients signed a written informed consent form.Inclusion criteria were: age of over 18 years; diagnosis of primary breast cancer stage I-II; HER2 status previously determined on material from the primary tumor; volumetrically quantifiable tumor lesions on US, CT or MRI, with at least one lesion > 2.0 cm in greatest diameter; hematological, liver and renal function test results within normal limits; a negative pregnancy test for all patients of childbearing potential; patient capable of undergoing the diagnostic investigations to be performed in the study; and informed consent.Exclusion criteria were concomitant nonbreast malignancy; active current autoimmune disease or history of autoimmune disease; active infection or history of severe infection within the previous 3 months (if clinically relevant at screening); known HIV-positive or chronically active hepatitis B or C; administration of another investigational medicinal product within 30 days of screening; ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's guidelines.The level of expression of HER2 in biopsy samples was determined by immunohistochemistry using Herceptest (DAKO). In the case of a score of 2+, fluorescent Thirty-one patients were enrolled (Table For all patients, biopsy sampling, mammography (Giotto Image), bone scan (Siemens E.Cam 180) using | PMC10526658 |
Imaging Protocol | STERILE, ANTERIOR, BLOOD | Labeling of For labeling, 150 µL sterile phosphate-buffered saline (PBS) was added to a vial with ZHER2:41071. The vial content was mixed and checked visually to ensure that the content was completely dissolved, and no particles or opalescence was observed.The The yield was 97 ± 1%. The injected activity was 451 ± 71 MBq. Monitoring of safety, thorough assessment of vital signs, ECG and physical examination were performed during imaging visits (0-24 h after injection) and 3-7 days after injection.Imaging was performed using a Siemens Symbia Intevo Bold scanner equipped with a high-resolution low-energy collimator. Anterior and posterior planar whole-body imaging (at a scan speed of 12 cm/min, 1024 × 256 pixel matrix) was performed at 2, 4, 6 and 24 h after injection of Blood samples were obtained 5, 10, 15, 20, 30 and 50 min after injection if the patient's condition permitted. Small (500 µL) aliquots were taken, and activity was measured using an automated gamma-spectrometer with a NaI (TI) detector (Wizard 1480, Perkin Elmer, Waltham) to determine the activity in blood during the distribution phase.Dosimetry was evaluated as described in Maximal standard uptake values (SUV | PMC10526658 | |
Statistics | HER2-negative tumors, tumors, tumor | REGRESSION, TUMOR, TUMORS | Values are reported as the mean ± SD. Differences between uptakes in organs at different injected masses of the protein were analyzed using one-way analysis of variance (ANOVA). The nonparametric Mann-Whitney U test was used to determine whether the differences between uptake for HER2-positive and HER2-low or HER2-negative tumors were significant. A 2-sided P value of less than 0.05 was considered significant. Paired t tests were used to analyze differences between uptake in organs at different time points. A linear regression analysis was performed to determine if there was a correlation (the slope was significantly nonzero) between the HER2 expression level determined by IHC/FISH and tumor uptake. The sensitivity and specificity of discrimination between HER2-positive tumors and tumors with low expression or HER2-negative tumors using imaging after injection of 1000 µg | PMC10526658 |
Discussion | cancer, tumor, HER2-positive primary tumors, HER2-negative | CANCER, TUMOR, HEPATIC METASTASES | Recent advances in HER2-targeted therapy have prompted the need for increased understanding of HER2 expression levels, ideally in each tumor lesion in each patient. It is important to consider the availability and ease of use of the method to become broadly useful. Visualization and quantification of the expression of molecular targets for precision treatment of cancer within theranostics is typically associated with the use of PET This study demonstrated that injections of An unexpected finding in this study was a higher hepatic uptake in patients with HER2-positive primary tumors compared with patients with HER2-low or HER2-negative ones when 500 µg was injected (Figure Studies with the The injection of an increased mass of Affibody molecules may raise a reasonable question of whether this could affect the uptake of HER2-targeting drugs. However, anti-HER2 Affibody molecules bind to a HER2 epitope that is different from the epitopes of the most commonly used anti-HER2 monoclonal antibodies, trastuzumab and pertuzumab An important observation was that the hepatic metastases were clearly visualized in patient 15 (Figure This study was designed to explore the impact of protein mass dose for detecting HER2 expression in light of current recommendations for the selection of first-line HER2-targeting therapies | PMC10526658 |
Conclusions | CAN, Cancer | CANCER | Injections of This research was financially supported by the Swedish Cancer Society (CAN 21 1485 Pj) and the Ministry of Science and Higher Education of the Russian Federation (075-15-2019-1925). | PMC10526658 |
Materials and Methods | pulpitis | PULPITIS | Academic Editor: Sivakumar Nuvvula In this randomized clinical trial, 64 patients who had mandibular first and second molars with irreversible pulpitis were randomly divided into two groups ( | PMC10266914 |
Results | pain | The pain score was not significantly different between the two groups at the baseline or any other postoperative time point ( | PMC10266914 | |
Conclusion | pulpitis, pain | PULPITIS | Both KTP and ibuprofen effectively decreased postendodontic pain. Considering the comparable pattern of pain reduction, KTP can be used as an alternative to ibuprofen tablets for effective pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. | PMC10266914 |
1. Introduction | pulpitis, postoperative pain, Pain, fever, tissue injury, edema, arthritis, pain | EDEMA, PULPITIS, ARTHRITIS, MENSTRUAL PAIN | Pain is an unpleasant sensory experience, which is often associated with possible or actual tissue injury [Postoperative administration of analgesics is often imperative to decrease postendodontic pain especially in teeth with irreversible pulpitis [A high level of postoperative pain is a common concern for both patients and dental clinicians, and it can underline patients' trust in treatment. Thus, analgesics, particularly nonsteroidal anti-inflammatory drugs (NSAIDs), are commonly prescribed before and after endodontic treatment [Ibuprofen is among the most commonly prescribed NSAIDs for arthritis, menstrual pain, postoperative pain, edema, and fever. Approximately 80% of ibuprofen is absorbed through the gastrointestinal system when taken orally, and the analgesia onset occurs 30 minutes after use. It is metabolized in the liver and has a half-life of 1.8 to 2 hours. Also, it is mainly excreted in urine and slightly through the bile [Ketoprofen is another NSAID that has a similar structure to ibuprofen since it has a P-phenylpropionic group [Analgesics can be used through oral, injection, inhalation, and transdermal routes. Oral medication intake is associated with possible hepatic primary metabolism, resulting in subsequent elimination of a large part of medication prior to its systemic absorption [Transdermal patch is a relatively novel form of medication delivery. The patch adheres to the skin and releases a certain dose of drug that passes through the skin and underlying tissues to reach the blood vessels [Considering the limited number of studies on the efficacy of analgesic transdermal patches for postendodontic pain control, this study aimed to compare the efficacy of ketoprofen transdermal patch (KTP) and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. | PMC10266914 |
2. Materials and Methods | This study was conducted at the Shahid Beheshti University of Medical Sciences between February 2019 and April 2021. The study was approved by the Ethics Committee of this university (IR.SBMU.DRC.REC.1398.226) and registered in the Iranian Registry of Clinical Trials (IRCT20190716044230N1). | PMC10266914 | ||
2.1. Trial Design | pain | An intention-to-treat randomized clinical trial was designed in which the experimental group received KTP, while the control group received ibuprofen tablets to control postendodontic pain. The results were reported according to the guidelines of the Consolidate standards of Reporting Trials [ | PMC10266914 | |
2.2. Participants, Eligibility Criteria, and Settings | inferior alveolar nerve block, postoperative pain, pulpitis, edema, perforation, radiolucency, postoperative edema, pain, fistula, pulpal necrosis, tooth | EDEMA, PULPITIS | The inclusion criteria were age between 18 and 65 years, ASA class I physical health status [The exclusion criteria were emergency cases, presence of radiolucency on the radiograph, presence of edema and fistula, use of more than 2 anesthetic cartridges for inferior alveolar nerve block or supplemental injections during the endodontic procedure, noticing pulpal necrosis in general or in one canal after initiation of treatment, not being able to complete endodontic treatment of the respective tooth within a 2-hour single session, iatrogenic errors during treatment (such as perforation, accidental overinstrumentation, or extension of root filling material into the periapical region or beyond the working length), postoperative edema and the need for postoperative antibiotic therapy, and noncompliant patients not precisely reporting the postoperative pain scores.The sample consisted of 64 eligible patients with mandibular first or second molars with irreversible pulpitis and moderate to severe pain presenting to the Endodontics Department of School of Dentistry, Shahid Beheshti University of Medical Sciences. | PMC10266914 |
2.3. Interventions | inferior alveolar nerve block, NRS, anxiety, pain | SIDE EFFECTS, CAVITY, COMPLICATIONS | Eligible patients were enrolled after signing informed consent forms. They were briefed about the study protocol and objectives and the advantages and possible side effects of medications.Demographic information of patients was recorded, and their preoperative level of pain and anxiety was quantified using an NRS. Accordingly, they were requested to select a number from 0 to 10 that best described their pain level (0 indicated no pain at all, while 10 indicated most severe pain imaginable). A graded NRS with information below each number was used in this study for easy understanding and high accuracy [All procedures were entirely performed under rubber dam isolation. Patients received 1 cartridge of 2% lidocaine with 80,000 epinephrine (Persocaine, Darupakhsh, Tehran, Iran) for inferior alveolar nerve block. If the patients had pain during access cavity preparation or root canal therapy, they received a PDL supplemental injection of lidocaine. An apex locator (Root ZX, Morito Corporation, Kyoto, Japan) was used for determination of the working length. The working length was determined 1 mm shorter than the radiographic apex and confirmed by a periapical radiograph. In addition, 1 mL of 2.5% sodium hypochlorite was used for root canal irrigation after using each file to the working length. First, the coronal part of the canals was flared with Side effects and complications reported by patients were also recorded. | PMC10266914 |
2.4. Outcomes (Primary and Secondary) | pulpitis, tooth, postoperative pain, pain | PULPITIS, SECONDARY | The main objective of this study was to compare the efficacy of KTP and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. The effects of sensitivity to percussion preoperatively, type of tooth, and gender of patients on postoperative pain were also assessed as the secondary outcome measures. | PMC10266914 |
2.5. Sample Size Calculation | The sample size was calculated to be 28 in each group (a total of 56) according to a previous study by Murthykumar and Varghese [ | PMC10266914 | ||
2.6. Interim Analyses and Stopping Guidelines | No interim analyses were performed, and no stopping guidelines were established. | PMC10266914 | ||
2.7. Randomization | The patients were randomly divided into two groups by stratified permuted block randomization with block size = 4 using sequentially numbered, sealed, opaque envelopes [ | PMC10266914 | ||
2.8. Blinding | A dental assistant randomly assigned the medication envelopes to patients. The dental clinician, researcher, and statistician who analyzed the data were all blinded to the group allocation of patients. Only the dental assistant who randomly assigned the coded envelopes to patients was aware of the contents of the envelopes. To ensure allocation concealment, sequentially numbered sealed opaque envelopes were used [ | PMC10266914 | ||
2.9. Statistical Analysis | pain | REGRESSION | Normal distribution of pain data was evaluated by the Kolmogorov–Smirnov test. The results showed that distribution of pain data was normal at 2, 4, 8, and 12 hours. Thus, comparisons at these time points were performed by the Considering the differences in distribution of data at different time points, the quantitative trend of pain over time was analyzed by generalized estimating equation (GEE). Since the trend of pain reduction over time was not linear, the Spline technique was used to analyze the trend of pain score change over time such that one line was considered from 2 to 10 hours and a second line was considered from 10 to 48 hours post-treatment. The overall form of the linear regression formula was as follows:Mean pain score:Finally, Fisher's exact test was used to compare the two groups regarding complete analgesia (NRS score 0) at different time points. All statistical analyses were carried out using SPSS version 20 at the 0.05 level of significance. | PMC10266914 |
3. Results | The sample consisted of 64 patients including 32 males and 32 females, in two groups with equal gender distribution (16 males and 16 females in each group). The mean age of patients was 34.87 ± 11.16 years in the experimental group and 35.81 ± 11.19 years in the control group. The two groups had no significant difference regarding the mean age ( | PMC10266914 | ||
3.1. Harms | No patients were harmed during the study. | PMC10266914 | ||
3.2. Group Analyses | redness, pulpitis, postoperative pain, gastrointestinal problems, anxiety, itchiness, pain, tooth on postoperative pain | PULPITIS |
Spearman's correlation test showed a significant positive correlation between the anxiety score of patients before treatment with their preoperative (rho = 0.387,
Comparison of patients with pain score 0 between the two groups at each time point by Fisher's exact test revealed no significant difference (Regarding sensitivity to percussion before treatment, 21 patients were evaluated (since the results of the percussion test had been recorded for only 21 patients); out of which, 5 were sensitive and 16 were not sensitive to percussion. The Two out of 32 patients in the ibuprofen tablet group reported gastrointestinal problems in the form of mild pain. Also, one patient in the KTP group experienced slight redness and itchiness when used the first KTP. Since he wanted to continue using the patch, he applied the next patch on another area with no problem.Assessment of the pain score over time showed a nonlinear trend of reduction in pain over time in both groups (Although the mean preoperative pain score was higher in the KTP group, the difference between the two groups was not significant (The interaction effect of time and medication was not significant at any interval in any group (GEE was applied to assess the effect of type of tooth on postoperative pain and showed that although patients with a second molar with irreversible pulpitis had higher postoperative pain than those with a first molar with irreversible pulpitis (GEE was also used to analyze the effect of gender, and it indicated that although females in both groups had a higher pain score than males ( | PMC10266914 |
4. Discussion | pulpitis, postoperative pain, allodynia, pain, gastrointestinal pain, tooth on postoperative pain, tooth, NRS | PULPITIS | This study compared the efficacy of KTP and ibuprofen tablets for pain control after endodontic treatment of mandibular first and second molars with irreversible pulpitis. The severity of preoperative pain and pulpal diagnosis are among the factors that can affect postoperative pain [In the present study, the NRS was used for quantification of pain due to its slightly superior efficacy to the visual analog scale [Evidence shows that preoperative pain and periapical allodynia (sensitivity to percussion) can significantly affect postendodontic pain [Assessment of the effect of gender on the postoperative pain score by GEE in the present study showed that although females in both groups had a higher pain score than males, this difference did not reach statistical significance, which was in line with a previous study [GEE also assessed the effect of type of tooth on postoperative pain, and it showed that although patients with a second molar with irreversible pulpitis had higher postoperative pain than those with a first molar with irreversible pulpitis, this difference was not significant. No previous study is available on this topic to compare our results with.In the present study, 2 patients in the ibuprofen tablet group had mild gastrointestinal pain, which was reported in 12 out of 16 patients in a study by Mangal et al. [In the current study, although the mean preoperative pain score was higher in the KTP group, the difference between the two groups was not significant. In both groups, the reduction in the pain score in both the first (2–10 hours) and second (10–48 hours) intervals was significant. The interaction effect of time and medication was not significant at any interval in any group, which means that the pattern of pain reduction over time was the same in both the groups.As mentioned earlier, several studies have evaluated the effects of NSAIDs in the form of transdermal patch on pain after tooth extraction [Moreover, controversy exists in the literature regarding the efficacy of transdermal patches. Three studies on pain control by oral intake of diclofenac sodium and its transdermal patch following periodontal flap surgery showed that its transdermal patch could have a higher [To the best of the authors' knowledge, this study is the first to assess the efficacy of KTP for postendodontic pain control, which is a major strength of this study. Assessment of the effect of gender on postoperative pain was another strength of this study.This study had some limitations as well. Absence of a placebo group was a limitation of this study. However, it was not ethically possible to have a placebo group. Also, subjective nature of pain is another limitation, which cannot be controlled for. Moreover, the age range of the study population was high, which can affect the pain threshold.Future studies on a larger sample size are required to increase the generalizability of the results. | PMC10266914 |
5. Conclusion | pulpitis, pain | PULPITIS | Both KTP and ibuprofen effectively decreased postendodontic pain. Nonetheless, considering the optimal analgesic efficacy of KTP comparable to that of ibuprofen tablets and lower side effects of KTP, it may be used as an alternative to oral ibuprofen tablets for pain control following endodontic treatment of mandibular first and second molars with irreversible pulpitis. | PMC10266914 |
Acknowledgments | This study was funded by the research committee of Shahid Beheshti University of Medical Sciences. | PMC10266914 | ||
Data Availability | The patients' data used to support the findings of this study are included within the supplementary pdf file, named “data.” | PMC10266914 | ||
Conflicts of Interest | The authors declare that they have no conflicts of interest regarding the publication of this article. | PMC10266914 | ||
Supplementary Materials | postoperative pain, pain | The pain database of patients can be found in the attached pdf file, named 8549655.f1.Click here for additional data file.CONSORT flow diagram of the study.Mean pain score over time by the medication type.Mean pain score over time according to the molar type.Mean pain score over time by gender.Demographic variables in the two groups.
Mean pain score at different time points in the two groups.
Correlation of preoperative pain and postoperative pain separately in each group.
| PMC10266914 | |
Background | Reduced physical activity (PA) is one of the significant health concerns in adults and children alike. Despite the proven benefits of PA, most children, globally, do not meet the weekly criteria of enough PA to maintain health. The proposed systematic review is the review of the factors and will provide information on the factors associated with PA participation in children. | PMC10134558 | ||
Methods | ROB-II | The proposed systematic review will be conducted based on the methodology from the Cochrane Handbook for Systematic Reviews of Interventions. We will include observational studies (cross-sectional, case–control, and cohort studies), randomized controlled trials (RCTs), and non-randomized study designs for information on factors associated with PA participation among children. Studies with participants in the age range of 5–18 years, indulging in physical activity of 60 min per day for a minimum of 3 days a week, will be included. Studies including differently abled children, children under medical treatment, and those taking medications for illnesses such as neurological, cardiac, and mental health conditions will be excluded from the review. We will search MEDLINE (via PubMed and Web of Science), Scopus, EMBASE, CINAHL, Cochrane CENTRAL, and PEDro for English language publications published from the inception till October 2022. For additional studies, we will search websites such as the Australian Association for Adolescent Health International Association for Adolescent Health and a reference list of the included publications. Selection of studies, data extraction, and quality assessment of the included studies will be performed in duplicate. Quality assessment of the included studies will be performed using the Cochrane Risk of Bias tool (ROB-II) for RCTs, New-Castle Ottawa, for observational studies, and ROBINS-I (Risk of Bias for Non-Randomized studies of Interventions) for non-randomized study designs. | PMC10134558 | |
Discussion | The proposed systematic review and meta-analysis will present a summary of the available evidence on factors associated with PA participation in children. The findings of this review will provide new insights into how exercise providers can improve PA participation among children and can also help healthcare workers, clinicians, researchers, and policymakers to plan long-term interventions targeting child health. | PMC10134558 | ||
Systematic review registration | PROSPERO CRD42021270057. | PMC10134558 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13643-023-02226-0. | PMC10134558 | ||
Keywords | PMC10134558 | |||
Background | metabolic and cardiovascular disorders | CHILDHOOD OBESITY, HYPERTENSION, CHRONIC DISEASES | Regular physical activity (PA) is essential for healthy adulthood and reducing the risk of chronic diseases such as hypertension, and metabolic and cardiovascular disorders [The Institute of Medicine (IOM) proposed the use of the social-ecological model (SEM) for childhood obesity interventions [Reduced PA levels among children are a global health issue. Examining the magnitude of the influence of factors affecting PA participation among children will be valuable in setting priorities and designing interventions to increase PA in children and prevent chronic diseases in adulthood. Previous reviews have reported that children globally do not meet recommended levels of PA, but the specific contributing factors have not been identified. Our review will address the gap in the evidence by systematically reviewing published literature to establish the specific factors that influence PA participation in children. Summarizing the factors associated with PA participation in children can inform policymakers, researchers, and healthcare practitioners to formulate appropriate PA strategies and facilitation of PA adherence.
| PMC10134558 |
Objectives | Primary objectiveTo identify the factors (enablers and barriers) associated with PA participation among children.Secondary objectiveTo provide recommendations for increasing the PA participation among children (based on the findings of the primary objective) | PMC10134558 | ||
Methods | This systematic review protocol is based on the Preferred Reporting Items for Systematic Review and Meta-analysis Protocols (PRISMA-P) guideline [ | PMC10134558 | ||
Eligibility criteria for study selection | PMC10134558 | |||
Types of participants | The review will include studies assessing the influence of factors on children’s participation in PA, regardless of gender, ethnicity, and socio-economic status. The age groups for inclusion will be 5–18 years. Studies on differently abled children, children under medical treatment and those taking medications for illnesses such as neurological, cardiac and mental health conditions will be excluded from the review as the factors influencing differently abled and children under medical treatment will vary. | PMC10134558 | ||
Exposure | The exposures in the review will be factors (both facilitators and barriers) influencing PA participation in children. The factors can be categorized as (a) individual factors known to influence one’s propensity for being physically active regularly [ | PMC10134558 | ||
Dependent variable | The dependent variable is the participation of children in PA where PA is defined as any bodily movement increasing resting energy expenditure [ | PMC10134558 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.