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Conclusion
non-PCOS, PCOS
Follicular homocysteine is a suitable reporter that might be investigated as a tool for oocyte-embryo selection. A diet enriched with methyl donors may be useful in PCOS and supplements may also help. These findings may be also true for non-PCOS women, which warrants investigation.The study was approved by the Acibadem...
PMC10371946
Keywords
PMC10371946
Introduction
endocrine disorder, PCOS, infertility, metabolic derangements
POLYCYSTIC OVARY SYNDROME, OVARIAN HYPERSTIMULATION, DEGENERATION, ENDOCRINE DISORDER
Homocysteine (Hcy) is a non-proteogenic amino acid resulting from (adenosyl)methionine de-methylation in transmethylation reactions. Due to the wide involvement of carbon unit trafficking in animal metabolism, Hcy is massively and continuously produced within cells with one-fifth to one-sixth of the total Hcy pool reno...
PMC10371946
Methods
PMC10371946
Study design, inclusion criteria, and randomization
primary infertility, PCOS
PRIMARY INFERTILITY
This was a prospective, randomized, parallel group, open label, controlled versus no treatment clinical study. The study was approved by the Acibadem University Research Ethics Committee. Clinical trial retrospective registration number ISRCTN55983518.The patients were enrolled between April 2017 and February 2022. The...
PMC10371946
Study procedures
ADVERSE EVENTS
The patients randomized for the treatment arm also received instructions on how to assume the supplement and how to report on adverse events. They assumed one tablet per day of a supplement containing essential or conditionally essential micronutrients in support to the OCM including: betaine 200 mg, l-cystine 200 mg, ...
PMC10371946
Clinical endpoints
Biochemical pregnancy rates were calculated as the rate of patients with positive beta-hCG 7 days post embryo transfer out of the number of patients receiving an embryo transfer. Implantation rates were calculated as the number of gestational sacs observed at vaginal ultrasound 7 weeks after transfer out of the number ...
PMC10371946
Statistical analysis
This was a pilot study and, in the absence of previous data to build a statistical hypothesis, the sample was not statistically sized. The inclusion of 40 patients, 20 per group, was believed to be a clinically significant sample allowing to calculate the sample size for any future larger studies. Assuming a drop-out r...
PMC10371946
Results
ADVERSE EVENTS
Five patients, all from the intervention group, withdrew their consent to the study post randomization so that 43 patients completed the study: 19 in the intervention group and 24 in the control group. None of the patients consuming the supplement reported adverse events.The demographic and baseline characteristics of ...
PMC10371946
Funding
The study was partially funded by Partogen Ilac, Turkey, covering the cost for the external laboratory running Hcy detection in follicular fluids.
PMC10371946
Declarations
PMC10371946
Ethics approval
The study was approved by the Acibadem University Research Ethics Committee (2017–3-42). Clinical trial retrospective registration number ISRCTN55983518.
PMC10371946
Competing interests
AK reports personal fees from Partogen Ilac, outside the submitted work. MD reports personal fees from Parthenogen SAGL, outside the submitted work; in addition, MD is inventor of the pending patents “Dietary supplementation to achieve oxy-redox homeostasis and epigenetic stability” and “Combination of micronutrients t...
PMC10371946
References
PMC10371946
Background
death, injury or disease and failure, infection, fractures, blisters
INFECTION
The main activity of the skin is to create a protective barrier against damage. Loss of the skin due to injury or disease and failure to regenerate the affected area may result in disability, infection, or even death. We conducted a clinical trial to evaluate the therapeutic effect of dressing containing silver in proc...
PMC10148518
Method
blisters, skin blisters, fractures, pain
This is a pioneering randomized trial that compares the effectiveness of two dressings containing silver (Ag coat) and Gaz Vaseline among patients with skin blisters due to bone fractures who were randomly selected from patients referred to the Kashani Medical Training Center. There were two treatment groups containing...
PMC10148518
Result
During this study, there was no significant difference between the mean of age and BMI and frequency of gender in the two study groups (
PMC10148518
Conclusion
decreases pain
In conclusion, Ag coat dressing, not only has a significant effect on wound healing but also, decreases pain, shorter visit time, and its more cost-effective.
PMC10148518
Keywords
PMC10148518
Introduction
tissue disorders, tissue injury, Fracture blisters, fracture, fibrosis, burns, infection, fractures, fracture blisters, blisters, skin damage
INFILTRATION, SCAR, FIBROSIS, PATHOPHYSIOLOGY, INFECTION, COMPLICATIONS
Investigating the intricate healing process of wounds is essential to understand the multifaceted nature of the wound environment and its complexity. Preclinical models, such as those used in mice, rabbits, and pigs, can be used to simulate different types of wounds, including acute and impaired ones. To ensure reprodu...
PMC10148518
Method and material
PMC10148518
Study desgine
skin blisters, fracture, Hemorrhagic, fractures, blisters, Fractures
PAD, SENSITIVITY
This is a clinical trial study conducted according to the guidelines of the Ethical Committee of Isfahan University of Medical Sciences (Ethics code: IR.MUI.MED.REC.1401.025, Iranian Registry of Clinical Trials (IRCT) code: IRCT20221207056744N1). Eligible patients attending the Orthopedic Clinic of Isfahan Research Cen...
PMC10148518
How to use the dressing
The wound or burn site was cleaned with distilled water, betadine, burn ointment, etc. The dressing was removed from the package and moistened with distilled water. The excess water was taken from the dressing and placed directly on the wound so that the side was placed at least one centimeter outside the wound. Then a...
PMC10148518
Evaluation of blisters
blisters, pain
LENS
The blisters are all superficial) All blisters are drained during the operation (and the width was measured by ruler next to the blister (Fig. macroscopic view of the blisters and healing process based on dressing type. (The blisters were dressed by Agi coat once a week and every day with Gaz Vaseline, and were followe...
PMC10148518
Result
fracture
From 2020 to 2021, 40 patients with skin blister due to bone fracture entered to study. Data obtained from 31 patients were analyzed after applying the exclusion criteria. The participants were randomly assigned to two. Ag coat groups with 16 participants and Gaz Vaseline group with 15 participants. Table Determining a...
PMC10148518
Discussion
blisters, infection, inflammation, pain
INFECTION, WOUND INFECTION, INFLAMMATION
In this study, the patients which their blisters dressed with ag coat dressing had significantly less pain during the time and between groups in compaire with gaz vaselin group, which was mesured by VAS score. Also, in ag coat group the wound healing was significantly faster during the time and in the presence of both ...
PMC10148518
Acknowledgements
We would like to thank the colleagues and personnel of the Orthopedic Department and archive staff of Kashani hospital for their valuable technical help and general support.
PMC10148518
Authors’ contributions
Conception and Design: Mehdi Teimouri and Sahar sadat Lalehzar; Data collection: Mehdi Teimouri, Sahar sadat Lalehzar. Data analysis and interpretation: Sahar sadat Lalehzar, Mehdi Teimouri; Writing the original draft: Mehdi Teimouri, Sahar sadat Lalehzar. All authors approved the final version of the manuscript prior ...
PMC10148518
Funding
The project was supported financially by the Isfahan University of Medical Sciences for the design of the study and collection, analysis, and interpretation of data (Research project Number: IR.MUI.MED.REC.1401.025).
PMC10148518
Availability of data and materials
fracture
The datasets generated and/or analyzed during the current study are not publicly available due to the nature of patients with humeral shaft fracture but are available from the corresponding author on reasonable request.
PMC10148518
Declarations
PMC10148518
Ethics approval and consent to participate
This research has been performed in accordance with the Declaration of Helsinki and has been approved by the ethics committee of Isfahan University of Medical Sciences (Ethics code: IR.MUI.MED.REC.1401.025 and Iranian Registry of Clinical Trials (IRCT) code: IRCT20221207056744N1). Written informed consent was obtained ...
PMC10148518
Consent for publication
Not applicable.
PMC10148518
Competing interests
The authors declared there is no conflict of interest.
PMC10148518
References
PMC10148518
Background
PCOS, hirsutism
HIRSUTISM, SECONDARY, POLYCYSTIC OVARY SYNDROME (PCOS), METABOLIC DISORDERS
Considering the high prevalence of polycystic ovary syndrome (PCOS) in women of reproductive age and the metabolic disorders associated with it, this study was conducted to determine the effects of curcumin on metabolic indices and androgen level (primary outcomes), and menstruation characteristics, and hirsutism (seco...
PMC9930238
Methods
PCOS, hirsutism
BLOOD, HIRSUTISM
This triple-blind randomized controlled trial was conducted on women with PCOS who visited the health centers at Eslamshahr County (Tehran Province-Iran) from 2020 to 2022. The participants were allocated into two groups (curcumin and placebo) using block randomization method. The treatment group received two 500 mg ed...
PMC9930238
Results
hirsutism, oligomenorrhea, amenorrhea
OLIGOMENORRHEA, HIRSUTISM
There was no statistically significant difference between the two groups in terms of socio-demographic and the baseline levels of measured outcomes. After 12 weeks of intervention, the mean serum FBS levels in the curcumin group were significantly lower than in the placebo group (mean difference: 6.24; 95%confidence in...
PMC9930238
Conclusion
hirsutism, PCOS, amenorrhea
OLIGOMENORRHEA, HIRSUTISM
Curcumin decreased FBS levels and improved menstruation characteristics (amenorrhea, oligomenorrhea, and menstrual irregularities) in women with PCOS but did not affect other metabolic, hormonal, and hirsutism indices. More studies using a larger sample size are required for a definitive conclusion.
PMC9930238
Trial registration
Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N51 Date of registration: 30/11/2019. URL:
PMC9930238
Keywords
PMC9930238
Background
obesity, PCOS, infertility, intrauterine factors, acne, hirsutism, metabolic syndrome
OBESITY, COMPLICATIONS, METABOLIC SYNDROME, MENSTRUAL DISORDERS, INSULIN RESISTANCE, ACNE, HIRSUTISM, POLYCYSTIC OVARY SYNDROME, PATHOGENESIS, INSULIN RESISTANCE SYNDROME
Polycystic ovary syndrome (PCOS), also known as metabolic syndrome or insulin resistance syndrome [Many of the systems in the body are affected by PCOS which leads to several complications such as menstrual disorders, infertility, hirsutism, acne, obesity and metabolic syndrome [PCOS pathogenesis are still unknown but ...
PMC9930238
Methods
PMC9930238
Study design and setting
This study was a superiority randomized controlled trial with two-parallel arms. The participants, researcher, and analyst in this study were blinded to the intervention received by the participants. This study was conducted in the health centers at Eslamshahr County (Tehran Province-Iran) from 2020 to 2022.
PMC9930238
Eligibility criteria
PCOS, metabolic diseases, CAH, androgenic disorders, diabetes
CAH, METABOLIC DISEASES, CUSHING SYNDROME, THYROID GLAND DISEASES, DIABETES
The study was conducted on women aged 18 to 45 with PCOS and a BMI of 18.5 to 40. The exclusion criteria were as follows: taking vitamins, contraceptives, hormonal drugs, minerals, and omega-3 during the study and 3 months before intervention; having other metabolic diseases such as diabetes and androgenic disorders su...
PMC9930238
Sampling
oligomenorrhea, PCOS, hirsutism
BLOOD, INSULIN RESISTANCE, OLIGOMENORRHEA, HIRSUTISM
Sampling started after the approval of the ethics committee of Tabriz University of Medical Sciences (Ethics code: IR.TBZMED.REC.1398.017) and registering the study in Iranian Registry of Clinical Trials (IRCT) (Code: IRCT20120718010324N51). The researcher attended at the health centers in the Eslamshahr city and searc...
PMC9930238
Random allocation & intervention
The participants were allocated into two groups (curcumin and placebo) using block randomization with a ratio of 1:1. Identical black opaque bottles numbered consecutively (in order of allocation) were used to conceal what was allocated to each participant. The bottles were prepared by a third party that had no role in...
PMC9930238
Data collection tools
bleeding, hirsutism
BLEEDING, EXCESSIVE HAIR GROWTH, HIRSUTISM
Questionnaires for socio-demographic information, a checklist for recording tests, a menstrual cycle characteristics questionnaire, and the Ferriman–Gallwey scale were used to collect the data. The food frequency questionnaire (FFQ) was used to measure the nutritional status of the participants.The menstrual cycle char...
PMC9930238
Sample size
The sample size was determined based on the testosterone levels using G*Power software. Considering the data from the Gholizadeh Shamasbi study [
PMC9930238
Statistical analysis
hirsutism
HIRSUTISM
After gathering the data, SPSS software version 24 was used for data analysis. Descriptive statistics such as mean (standard deviation) were used for quantitative data and number (percentage) was used for qualitative data. Median (percentile 25 to percentile 75) was used for quantitative data that had an abnormal distr...
PMC9930238
Results
Between 2019 and 2022 about 100 people were evaluated in terms of having the necessary criteria. Four did not enter the study for lack of interest, 15 for having a certain diet, and 27 for having used contraceptives recently. In the end, the data from 27 people in the intervention group and 27 people in the control gro...
PMC9930238
Primary outcomes
The mean (SD) serum FBS level before intervention was 93.92 (9.12) in the curcumin group and 91.33 (9.40) in the placebo group so there was no statistically significant difference between the two groups (P = 0.314). After 12 weeks of intervention, the mean (SD) serum FBS level in the curcumin group was 90.38 (10.69) an...
PMC9930238
Discussion
hirsutism, oligomenorrhea, PCOS, amenorrhea
INSULIN RESISTANCE, OLIGOMENORRHEA, HIRSUTISM
According to the study results, administrating curcumin only led to a decrease in FBS levels and did not significantly affect other metabolic indices (triglyceride, cholesterol, LDL-C, HDL-C, insulin, testosterone and SHBG). Regarding the amenorrhea and oligomenorrhea frequency, the numbers in the curcumin group were s...
PMC9930238
Acknowledgements
We sincerely thank all women who participated in this study. Also, we thank Dineh Iran pharmaceutical company for supplying the curcumin and placebo tablets.
PMC9930238
Funding
NG and MM were responsible for drafting the trial protocol, data collection, data analysis and interpretation and writing of the final report. SG, ES and SA were involved in drafting the protocol, data collection and approved the final version of the manuscript.This research is supported by Tabriz University of Medical...
PMC9930238
Declarations
The datasets generated and/or analysed during the current study are not publicly available due to limitations of ethical approval involving the patient data and anonymity but are available from the corresponding author on reasonable request.
PMC9930238
Ethics approval and consent to participate
This study was approved by the Ethics committee of Tabriz University of Medical Sciences with the code of IR.TBZMED.REC.1398.017. All participants were ensured about the matter of confidentiality. Also, informed written consent was obtained from all participants and parent/legally authorized representatives of illitera...
PMC9930238
Consent for publication
Not applicable.
PMC9930238
Competing interests
The authors declare that they have no competing interests.
PMC9930238
References
BLOOD, INSULIN RESISTANCE
Fasting Blood InsulinFasting Blood SugarLow Density Lipoprotein- cholesterolHigh Density Lipoprotein- cholesterolSex Hormone Binding GlobulinIranian Registry of Clinical TrialsPolycystic ovary syndromedehydroepiandrosterone sulfateCongenital Adrenal HyperplasiaFood Frequency QuestionnaireStandard DeviationMean Differen...
PMC9930238
Methods
A total of 21 preoperative CPETs were interpreted by two exercise physiologists using stationary time-based data-averaging intervals of 10, 20, and 30 seconds and rolling average intervals of 3 and 7 breaths. Mean values of CPET variables between different data averaging intervals were compared using repeated measures ...
PMC10019694
Results
Between data-averaging intervals, no statistically significant differences were found in the mean values of CPET variables except for the ventilatory equivalent for carbon dioxide at the ventilatory anaerobic threshold (P = 0.001). No statistically significant differences were found in the proportion of patients classi...
PMC10019694
Conclusion
There appears to be no significant or clinically relevant influence of the evaluated data-averaging intervals on the mean values of CPET outcomes used for preoperative risk assessment. Clinicians may choose a data-averaging interval that is appropriate for optimal interpretation and data visualization of the preoperati...
PMC10019694
Clinical trial registration
Prospectively registered at ClinicalTrials.gov (
PMC10019694
Data Availability
All relevant data are within the paper and its
PMC10019694
Introduction
POSTOPERATIVE COMPLICATIONS
Preoperative aerobic fitness is independently associated with postoperative outcomes following major abdominal surgery [During CPET, a patient exercises against a progressively increasing work rate until volitional exhaustion, while breath-by-breath respiratory gasses are analyzed. The large number of data-points that ...
PMC10019694
Methods
SECONDARY
This observational cross-sectional study was performed at the VieCuri Medical Center, a large teaching hospital in Venlo, the Netherlands. The current study was executed as a secondary analysis of data collected in a study [
PMC10019694
Participants
colorectal cancer
COLORECTAL CANCER
Data from consecutive patients considered for colorectal cancer surgery who were ≥18 years of age, had a score ≤7 metabolic equivalents of task on the veterans-specific activity questionnaire, and therefore performed preoperative CPET as a part of a tele-prehabilitation study [
PMC10019694
Preoperative cardiopulmonary exercise testing
Patients preoperatively performed incremental CPET up to volitional exertion in upright position on an electronically-braked cycle ergometer (Lode Corival, Lode BV, Groningen, the Netherlands). Prior to the test, patients were asked to refrain from vigorous physical activity, caffeine, and tobacco for 24 hours and meal...
PMC10019694
Procedures
comorbidity, tumor
TUMOR
Preoperative CPET patient data was anonymized and patient characteristics other than anthropometric measures were concealed. A medical and clinical exercise physiologist (BB) and a clinical exercise physiologist (RF) determined VOApart from the CPET data, the preoperative patient characteristics age, sex, body mass ind...
PMC10019694
Sample size
A sample size calculation was performed with G*Power [
PMC10019694
Statistical analysis
Continuous data were checked for normality using the Shapiro-Wilks test. To assess the difference between different CPET data-averaging intervals, differences in mean numerical values of VO
PMC10019694
Results
colorectal cancer
COLORECTAL CANCER
A total of 21 CPETs of patients with colorectal cancer (see
PMC10019694
Baseline characteristics of subjects.
Data are presented as mean ± standard deviation (SD) or as number (%).Mean values of the CPET-derived variables ranged from 14.5 mL/kg/min to 14.6 mL/kg/min for VO
PMC10019694
Discussion
colorectal cancer, CRF
COLORECTAL CANCER, CRF, SECONDARY, POSTOPERATIVE COMPLICATIONS
To our knowledge, the current study was the first study that aimed to investigate whether the selection of different CPET data-averaging intervals would translate into differences in mean values of CPET-derived variables in patients with colorectal cancer who performed CPET for preoperative risk assessment. As CPET-der...
PMC10019694
Conclusion
On a group level there appear to be no clinically relevant differences in the mean values of VO
PMC10019694
Supporting information
PMC10019694
Graphical display of the Wasserman plots of patient 21.
(PDF)Click here for additional data file.
PMC10019694
Guideline for systematic interpretation of preoperative cardiopulmonary exercise testing.
(PDF)Click here for additional data file.(XLSX)Click here for additional data file.The authors like to thank Accuramed BVBA (Halen, Belgium) for providing a free unrestricted copy of the Blue Cherry software to support this study.
PMC10019694
Objective
POSTOPERATIVE COMPLICATIONS
Hepatobiliary surgery bares obstacles to informed consent for the patients due to its complexity and related risk of postoperative complications. 3D visualization of the liver has been proven to facilitate comprehension of the spatial relationship between anatomical structures and to assist in clinical decision-making....
PMC9970129
Design, setting
THORACIC
We conducted a prospective, randomized pilot study comparing 3D liver model-enhanced (3D-LiMo) surgical education against regular patient education during preoperative consultation at the department of Visceral, Thoracic and Vascular Surgery, University Hospital Carl Gustav Carus, Dresden, Germany.
PMC9970129
Participants
Of 97 screened patients, undergoing hepatobiliary surgery, 40 patients were enrolled from July 2020 to January 2022.
PMC9970129
Results
The study population (
PMC9970129
Conclusion
MINOR, POSTOPERATIVE COMPLICATIONS
In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education and facilitate patients’ understanding of the surgical procedure as well as awareness of postoperative complications. Therefore, the study protocol is feasible to apply to an adequately powered, multicenter, randomiz...
PMC9970129
Supplementary Information
The online version contains supplementary material available at 10.1007/s00464-023-09915-w.
PMC9970129
Keywords
Open Access funding enabled and organized by Projekt DEAL.Liver surgery is one of the most technically challenging procedures in the field of abdominal surgery due to the complex intrahepatic anatomy of the vasculature and biliary tree with frequent variations. In the last decades, advancements in perioperative patient...
PMC9970129
Material and methods
PMC9970129
Study design
This study was designed as a prospective, non-blinded, randomized controlled, monocentric pilot trial [Flow diagram of the study protocol including time points of scheduled patient visitations, generation of the 3D liver models and data acquisition
PMC9970129
Patient population
cognitive impairment
97 patients, presenting in the outpatient clinic of the Surgery Department in the University Hospital Dresden for liver surgery between July 2020 and January 2022, were screened for inclusion. Inclusion criteria implied age above 18 years, indication for liver resection and preoperative CT imaging. In addition, a 2 wee...
PMC9970129
Study endpoints
postoperative blood transfusions
The primary endpoint of this study was patient satisfaction with surgical education. Secondary endpoints included understanding of the planned surgery, surgery length, conversion to open surgery, postoperative blood transfusions, postoperative morbidity and mortality, need of surgical revision, postoperative interventi...
PMC9970129
Statistics
The Kolmogorov–Smirnov test was used to assess distribution of investigated parameters. Categorical and quantitative variables were analyzed using Fisher’s exact test and unpaired t-test, respectively. Data was expressed as mean±standard deviation. Numeric variables were expressed as median with interquartile range (IQ...
PMC9970129
Ethical aspects and trial registration
The study was conducted according to the Declaration of Helsinki with waivers of informed consent of all patients. Ethical approval by local ethics committee was obtained before analysis (Number: BO-EK-168052020). The current study was registered at the German Clinical Trials Register (Deutsches Register Klinische Stud...
PMC9970129
Results
PMC9970129
Patients’ satisfaction with surgical education and perception of the 3D liver model.
Immediately after surgical and anesthesiological education, patient’s satisfaction was inquired via questionnaire. No significant differences were observed with satisfaction with overall medical care, medical care by surgeons or nurses, surgical preparations in general and anesthesiological preparations (Table Preopera...
PMC9970129
Patient’s apprehension of the underlying disease and planned surgery
We evaluated patient’s understanding of the planned surgical procedure following surgical education. First, patients had to name the surgical procedure in their own words, we saw that most patients referred to unspecific terms (e.g. removal of mass) without clarifying mass count and location or type of resection (52.5%...
PMC9970129
Surgical procedures and postoperative clinical course
intraoperative blood loss
ADVERSE EVENTS, INTRAOPERATIVE BLOOD LOSS, POSTOPERATIVE COMPLICATIONS
The control and 3D-LiMo groups displayed no differences in the length of the operation, intraoperative blood loss and other characteristics of the surgical procedure. Also, none of the patients experienced adverse events during surgery (Table Specification of surgical procedure, postoperative clinical course and postop...
PMC9970129
Follow-up evaluation 4 to 12 weeks after hospital discharge
cancer, death
CANCER, EVENT, RECURRENCE, COMPLICATIONS
No differences in the occasion of complications, recurrence of cancer or death was assessed (Supplementary table 1). First, we assessed that 95% of control population correctly recalled the event of complications in comparison to 67% of patients in the 3D-LiMo group. Second, we evaluated patient’s health awareness and ...
PMC9970129
Discussion
tumors
POSTOPERATIVE COMPLICATIONS, DISEASE, RECRUITMENT, TUMORS, COMPLICATIONS
The present study analyzes whether a personalized 3D-printed liver model manifests an educational benefit to patients, encourages their involvement in the decision-making process and thereby enhances patient’s satisfaction. As surgical procedures of the liver have become more complex and are frequently associated with ...
PMC9970129
Conclusion
MINOR, POSTOPERATIVE COMPLICATIONS
In conclusion, individual 3D-printed liver models increase patient satisfaction with surgical education immediately following patient education. Besides this comforting value, liver models implicate an educational benefit for patients and reinforce patients’ engagement in the decision-making process. Patients of the 3D...
PMC9970129
Author contributions
CR: designed the clinical trial. All authors contributed to the study conception. Material preparation, data collection and analysis were performed by CR, SD, EGB, SG and FO. The first draft of the manuscript was written by EGB and CR and all authors commented on previous versions of the manuscript. All authors read an...
PMC9970129