title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Comparison of baseline characteristics between group A and Group B patients. | GROUP B | (Mean±SD); P>0.05 indicates non-significance.In the Standard therapy group (Group A), two patients were lost to follow-up due to non-response to phone calls. In the Standard therapy group + PeaNoc XL group (Group B), one patient was lost to follow-up due to migration. Thus, 34 patients’ data were analyzed in Group A an... | PMC10521040 | |
Effect of standard therapy and PeaNoc XL add-on to standard therapy. | PMC10521040 | |||
Effect of Standard and PeaNoc XL add-on therapy on WOMAC questionnaire. | BLOOD | The values are presented as mean±SD, and the level of significance is indicated as follows: P<0.01* (significant), P<0.05** (significant), and P<0.001*** (highly significant).Patient demographics were recorded for both groups after receiving informed consent. In the baseline assessment, no significant differences (P>0.... | PMC10521040 | |
Effect of standard and PeaNoc XL on biochemical parameters. | Values are presented as mean±SD. Statistical significance levels are indicated as follows: P<0.01* (significant), P<0.05** (significant), P<0.001*** (highly significant), and P>0.05 indicating non-significance. | PMC10521040 | ||
Efficacy of PeaNoc XL tablets on inflammatory cytokines | TNF-α, pain | INFLAMMATION | The values are presented as mean±SD. Significance levels are denoted as follows: P<0.01* (significant), P<0.05** (significant), and P<0.001*** (highly significant).The levels of inflammatory cytokines, including TNF-α, IL-6, IL-1β, and CRP, were assessed using the ELISA technique. The addition of PeaNoc XL to standard ... | PMC10521040 |
Safety and efficacy of PeaNoc XL tablets on arthritis index (WOMAC) | physical stiffness, pain | INFLAMMATION, ADVERSE DRUG REACTIONS | WOMAC questionnaire has three main areas such as pain score, joint stiffness, and physical stiffness. The addition of PeaNoc XL as an adjunct therapy demonstrated significant reductions in pain (P<0.001), joint stiffness (P<0.01), and physical stiffness (P<0.001) compared to baseline among patients with joint pain and ... | PMC10521040 |
Discussion | cognition, mood, and sleep, neurodegenerative, pain | TMJ, DISEASE, DISORDERS, COMMON COLD, CHRONIC PAIN, ALLERGIC REACTIONS | PEA is a bioactive lipid mediator resembling endocannabinoids that falls within the NAE fatty acid amide family. It is ubiquitously present in various tissues, including the brain. PEA is thought to be synthesized in response to cellular injury as a pro-homeostatic protective mechanism and its production is enhanced in... | PMC10521040 |
Key findings | TNF-α, inflammation, physical stiffness, arthritis, pain, joint stiffness | INFLAMMATION, ARTHRITIS | The findings of the present randomized, open-label interventional trial showed that PeaNoc XL tablets help in the reduction of pain, joint stiffness, and physical stiffness (WOMAC questionnaire).Inflammatory levels of TNF-α, IL1-β, IL-6, and CRP levels in patients with joint pain and inflammation were significantly red... | PMC10521040 |
Conclusions | inflammation, physical stiffness, arthritis, pain, joint stiffness | INFLAMMATION, ARTHRITIS | This randomized study showed that adding PeaNoc XL Tablet to standard therapy effectively reduced pain, joint stiffness, and physical stiffness in arthritis patients. It also resulted in significant reductions in inflammatory markers. PeaNoc XL Tablet demonstrates potential as a safe and effective option for managing j... | PMC10521040 |
Author contributions | All authors, including K. N. Nandakumar, Dr. E. Caston, Dr. R. C. Satish Kumar, Dr. T.M. Vijayakumar, S. V. Vishagan, Pankaj Negi, and A. Sukkur, made equal contributions to this report. They had full access to all the data in the study and took responsibility for ensuring the integrity and accuracy of the data analysi... | PMC10521040 | ||
Acknowledgements | Medical writing support for the manuscript was provided by DocMode Health Technologies Ltd., Mumbai. The researchers express their gratitude to the staff members of Pharmacy Practice & IIISM, Pharm D students, volunteers, nurses, and doctors who have made valuable contributions to this research. | PMC10521040 | ||
Data availability | PMC10521040 | |||
Underlying data | Figshare: master sheet peanoc xl 2.xlsx,
| PMC10521040 | ||
Reporting guidelines | inflammation, arthritis, pain | INFLAMMATION, ARTHRITIS | Figshare: CONSORT checklist for “A randomized interventional clinical trial assessing the safety and effectiveness of PeaNoc XL tablets in managing joint pain and inflammation in arthritis patients”,
Data are available under the terms of the
| PMC10521040 |
References | Pain, physical stiffness, arthritis, chronic pain, pain, backpain, joint stiffness | CHRONIC PAIN, ARTHRITIS |
This paper is done very accurately and very useful for clinical practice. Pain relief is very important, this paper reflects the proper usage of peanoc-xl and the potency of the medication. The generated data will be useful for future doctors to use the medicine in treating different chronic painful conditions.Is the ... | PMC10521040 |
Background | Numerous observational studies show associations between family meal frequency and markers of child cardiovascular health including healthful diet quality and lower weight status. Some studies also show the “quality” of family meals, including dietary quality of the food served and the interpersonal atmosphere during m... | PMC10112996 | ||
Methods/design | The | PMC10112996 | ||
Discussion | This study will be the first to our knowledge to use multiple innovative methods simultaneously including ecological momentary intervention, video feedback, and home visiting with CHWs within the novel intervention context of family meals to evaluate which combination of intervention components are most effective in im... | PMC10112996 | ||
Trial registration | This trial is registered in clinicaltrials.gov (Trial ID: NCT02669797). Date recorded 5/02/22. | PMC10112996 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-15504-2. | PMC10112996 | ||
Keywords | PMC10112996 | |||
Background | CVH, CVD | CVD, CHILDHOOD OBESITY, CARDIOVASCULAR DISEASE | Cardiovascular disease (CVD) is a highly prevalent public health problem [First, over two decades of observational cross-sectional and longitudinal research shows that family meal quantity (i.e., frequency) is associated with child health including higher diet quality, lower prevalence of unhealthy weight control behav... | PMC10112996 |
Theoretical framework | Family Systems Theory (FST) [ | PMC10112996 | ||
Methods | The current study protocol was written following the guidelines of the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT) checklist (Additional file The SPIRIT diagram | PMC10112996 | ||
Study design | The The Family Matters Intervention Flowchart | PMC10112996 | ||
Study recruitment | Children ( | PMC10112996 | ||
Inclusion criteria | CVD |
Children ages 5–10, their primary caregiver (e.g., parent, grandparent, aunt) and at least one sibling.Children at high risk for CVD, defined as BMI ≥ 75th percentile [Children from African American/Black, Asian, Hispanic, Native American, or White households who speak Spanish or English.Children who consume ≤ 3 famil... | PMC10112996 | |
Exclusion criteria |
Children with medically necessary dietary restrictions (e.g., feeding tubes) or who are developmentally unable to participate (e.g., non-verbal).Non-custodial parent who lives with the child < 50% of the time.Children participating in a weight management study. | PMC10112996 | ||
Study arms and randomization | stress reduction | Families are randomized into one of three intervention Arms: (1) EMI; (2) EMI + Virtual HV with a CHW + Video Feedback; and (3) EMI + Hybrid HV with a CHW + Video Feedback. All Arms receive 16 weeks (4 months) of EMI stress reduction and family meal tip messages via smartphones. Arms 2 and 3 additionally receive eight ... | PMC10112996 | |
Procedures and data collection | PMC10112996 | |||
Measures | This study has three primary child outcomes: BMI%ile [ | PMC10112996 | ||
Blinding and investigator allocation concealment | BLIND | As with most behavioral interventions, it is not possible to double blind this RCT. However, this study incorporates measurement staff and investigator blinding as much as possible to minimize bias. For example, the intervention is administered by CHWs who are not involved with measurement team responsibilities or meet... | PMC10112996 | |
Measurement team training and supervision | SESSION, INTERACTION | Measurement team members are trained, engage in role-plays, conduct mock visits, and are closely supervised by the measurement team director according to best practice [Training, certification, recertification, and ongoing supervision for measurement team members and intervention community health workersConducted 2–3 t... | PMC10112996 | |
Retention plan | To minimize attrition in all study Arms, the following retention strategies are used, based on our successful prior studies with > 95% retention rate and best practice [ | PMC10112996 | ||
Ethical considerations | The University of Minnesota’s Institutional Review Board (IRB) Human Subjects Committee approved all protocols used in the study. Prior to enrollment into the study, participants are provided with detailed information about the study by our research team via consent and assent forms including study aims and detailed pr... | PMC10112996 | ||
Regulatory oversight/monitoring | ADVERSE EVENTS, RECRUITMENT | All study modifications will be communicated with and regulated by the IRB. Even though the study is expected to pose minimal risk, the Data Safety Monitoring Board (DSMB), in collaboration with the study investigators will closely monitor recruitment, process evaluation, and retention activities. The DSMB will meet ye... | PMC10112996 | |
Intervention | The | PMC10112996 | ||
Study arm #1: EMI | Parents randomized to study Arm 1 receive EMI text messages twice a day for 16 weeks via their smartphone. A study smartphone is provided for use if needed. | PMC10112996 | ||
EMI | Our prior research showed parental stress early in the day was associated with more controlling food parenting practices and serving more unhealthful foods (e.g., fast food) at dinner the same night [ | PMC10112996 | ||
Study arm #2: EMI + Virtual Home Visiting (HV) with CHW + Video feedback | stress reduction | Parents randomized to study Arm 2 receive all elements of study Arm 1, in addition to home visiting by a CHW. Visits by CHWs are virtual via zoom and occur every-other-week (8 total) simultaneously with the 16 weeks of EMI. In between CHW home visits, families complete “Try-it-Yourself” activities (8 total) to reinforc... | PMC10112996 | |
Video feedback | Every other week, starting during home visit three, families video-record and upload one family meal via their smartphone (6 total meals). CHWs watch videos in between home visits to identify specific clips to show family members at the next visit that highlight both strengths and growth areas regarding interpersonal i... | PMC10112996 | ||
“Try-it-Yourself” activities | stress reduction | Families are given food-related (e.g., recipes, meal planning strategies) and interpersonal (e.g., food prep with kids, family meal communication game, stress reduction) activities to try out in between visits to increase their self-efficacy in preparing family meals on their own and reinforce messages they are taught ... | PMC10112996 | |
Study arm #3: EMI + Hybrid HV with CHW + Video feedback | Parents randomized to study Arm 3 receive all elements of study Arm 2, but they are delivered hybrid. Specifically, CHWs meet in-person with families every other HV and then virtually via zoom on the other weeks. Families also engage in two cooking demonstration activities with the CHW during in-person HVs to reinforce... | PMC10112996 | ||
Maintenance phase | After completing four months of the intervention, all study Arms transition to a two-month maintenance phase, based on best practice [ | PMC10112996 | ||
Community Health Workers (CHWs) training and supervision | Interventionists are racially/ethnically diverse CHWs, with half being Spanish speaking. CHWs are trained/certified in MI [ | PMC10112996 | ||
Statistical analysis plan | PMC10112996 | |||
Overview | This study is powered for three pairs of tests [ | PMC10112996 | ||
Sample size and power computations | Study design features were accounted for in powering the study that required increases in sample size to minimize an inflated experiment-wise error rate (EER) due to three pairwise tests between each treatment arm for three primary outcomes (i.e., BMI%ile, neck circumference, and the Healthy Eating Index (HEI)). Accoun... | PMC10112996 | ||
Aim 1 (Primary Outcomes): examine intervention effects on markers of child CVH including BMI%ile, diet quality, neck circumference | Treatment condition mean differences on the three primary outcomes will be examined at the post-intervention primary endpoint (6 months after baseline). Sample size determination allows for primary outcome standardized effect size assessment of all three outcomes of at least 0.38, which is a small-to-moderate minimum d... | PMC10112996 | ||
Aim 2 (Secondary Outcomes): examine intervention effects on family, parental, and sibling factors | Family meal quantity and quality, food parenting practices and stress, and sibling BMI %ile outcomes are powered at similar levels as in Aim 1 with the ability to detect standardized effect sizes as small as 0.38. | PMC10112996 | ||
Sub-group exploratory analyses | Analyses exploring whether interaction effects depend on participant sex, race/ethnicity, and seasonality will also be conducted. These post-hoc analyses will examine whether the intervention has synergistic effects in specific populations or during different seasonal contexts. Post-hoc analyses will be conducted to ex... | PMC10112996 | ||
Other exploratory hypotheses | A model incorporating an interaction effect of treatment arm crossed with the change in family meal quality and quantity between observation periods will be used to evaluate if increases (or decreases) in the quality and quantity of family meals correspond with synergistically favorable (or unfavorable) child outcomes.... | PMC10112996 | ||
Discussion | The | PMC10112996 | ||
Acknowledgements | The success of the | PMC10112996 | ||
Authors’ contributions | JB is the principal investigator of this trial. JB conceptualized the paper and wrote all drafts. ACT and KN assisted with writing the procedures and data collection plan and critically reviewed the paper. MA assisted with the intervention design and writing the process evaluation plan and critically reviewed the paper... | PMC10112996 | ||
Authors’ information | JB is a Professor and Vice Chair for Research in the Department of Family Medicine and Community Health at the University of Minnesota; the Principal Investigator of the Family Matters study; the Director of the Healthy Eating and Activity across the Lifespan (HEAL) Center; and Director of the Center for Women’s Health... | PMC10112996 | ||
Funding | BLOOD, HEART, LUNG | Research is supported by grant number R61/33 HL151978 from the National Heart, Lung, and Blood Institute (PI: Jerica Berge). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung and Blood Institute or the National Institutes of Health. | PMC10112996 | |
Availability of data and materials | The datasets generated from the study will be available from the corresponding author upon reasonable request. | PMC10112996 | ||
Declarations | PMC10112996 | |||
Ethics approval and consent to participate | The study was conducted according to the guidelines of the Declaration of Helsinki and was approved by the Institutional Review Board Human Subjects Committee at the University of Minnesota (IRB ID: STUDY00014632). All participants provide their written informed consent or assent before participating in the study. For ... | PMC10112996 | ||
Consent for publication | Not applicable. | PMC10112996 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10112996 | ||
References | PMC10112996 | |||
Background | femoral head necrosis | The use of degradable magnesium screws to fix the bone flap implanted in the treatment of femoral head necrosis has achieved preliminary good therapeutic results. However, there is no conclusive evidence in the study to demonstrate whether biodegradable magnesium screws promote angiogenesis and no comparison has been m... | PMC10363316 | |
Objective | ONFH | OSTEONECROSIS OF THE FEMORAL HEAD | To investigate the clinical efficacy and safety of biodegradable magnesium screws in pedicled vascularized iliac bone graft transfer (PVIBGT) for osteonecrosis of the femoral head (ONFH). | PMC10363316 |
Materials and methods | ONFH | GROUP B | A total of thirty-six patients (37 hips) with ONFH were recruited from March 2020 to July 2022. The study used a single-blind method, and patients who underwent PVIBGT were randomized into three groups: 12 patients (12 hips) were fixed with biodegradable magnesium screws (Group A), 12 patients (13 hips) were fixed with... | PMC10363316 |
Results | DISEASE | There was no statistically significant difference among these three groups in terms of types, gender, age, course of disease, surgical side, operation time, the length of stay ( | PMC10363316 | |
Conclusions | PVIBGT has a positive effect, especially with regard to improving blood supply of the femoral head. The fixation of biodegradable magnesium screws is reliable and safe in PVIBGT, and promote angiogenesis. | PMC10363316 | ||
Keywords | PMC10363316 | |||
Introduction | ONFH | OSTEONECROSIS OF THE FEMORAL HEAD, JOINT DISEASE | Osteonecrosis of the femoral head (ONFH) is a joint disease with high morbidity and the disability rate that affects young adults [The pedicled vascularized iliac bone graft transfer with the ascending branch of the lateral femoral artery (PVIBGT) is an important method in hip preserving [We set up a trail group (Group... | PMC10363316 |
Materials and methods | PMC10363316 | |||
Flowchart of study protocol | See Fig. Flowchart of the study | PMC10363316 | ||
Patient selection criteria | PMC10363316 | |||
Inclusion criteria | Patients must meet all of the following conditions.Age range: 18–55 years old (including 18 and 55 years old).Patients were in ARCO (Association Research Circulation Osseous) II and III.Patients understood the objective of the clinical trial, signed the informed consent form voluntarily, and agreed to complete the enti... | PMC10363316 | ||
Exclusion criteria | renal, adrenal dysfunction, and nervous system diseases, diabetes, coagulation dysfunction, malignant diseases, allergies, cardiovascular and cerebrovascular diseases | ALLERGIES, CHRONIC KIDNEY FAILURE, DISEASES, OSTEOPOROSIS, MALIGNANT DISEASE | Patients were excluded if they met one of the following conditions.Accompanied by an acute or serious infection;Patients had hypermagnesemia;Patients used glucocorticoids in the past three months;Patients with serious cardiovascular and cerebrovascular diseases, diabetes, coagulation dysfunction, mental and nervous sys... | PMC10363316 |
Ethical approval status | This prospective, randomized controlled study was registered in Chinese Clinical Trial Registry and approved by the Medical Ethics Committee of the Affiliated Hospital of Nanjing University of Chinese Medicine (2020NL-118-02). Written informed consents were obtained from all participants. | PMC10363316 | ||
Surgical methods | Debrided sclerosing, necrotic, necrosis | CAVITY, GROUP B, NECROTIC, NECROSIS | Operations were performed by the same surgeon (JRS) who has been engaged in hip preservation for more than three decades. After general anesthesia, the patients were placed in the supine position, and the affected hip elevated 30°. The operation position was selected on the connecting line between the anterior superior... | PMC10363316 |
Postoperative treatment and follow-up | PMC10363316 | |||
Postoperative treatment | BEND | Patients were instructed to bend and extend ankle joint, exercise quadriceps femoris, and do gastrocnemius isometric exercises after the operation. Patient began partial weight-bearing walk with the aid of walker 3 months after the operation, and conducted weight-bearing walk without walker 6 months after the operation... | PMC10363316 | |
Post-operative follow-up | PMC10363316 | |||
Harris scores | hip joints | The postoperative functional recovery was evaluated through Harris score. The excellent and good rate is the proportion of Harris score above 80 points. 90–100 points are excellent, 80–89 points are good, 70–79 points are medium, and below 69 points are poor.Functional parameters were assessed separately by one orthope... | PMC10363316 | |
Radiological evaluations | femoral head necrosis, ONFH, oedema, necrotic | COLLAPSE, OEDEMA, NECROTIC |
X-ray: X-ray(orthopantomogram and frog-mogram) was taken on 1, 3, 6 months after surgery to assess the preoperative morphological location of necrotic areas, postoperative morphology, progression of ONFH and the amount of gas production of the magnesium screws.CT: The femoral head was evaluated by CT coronal measureme... | PMC10363316 |
Adverse post-operative complications | infection, fracture, non-healing | INFECTION, SUBCUTANEOUS EMPHYSEMA | We conducted post-operative follow-up to detect infection and non-healing of the incision. We evaluated serum magnesium ion level according to liver and kidney function, detect the deep veins of both lower limbs by ultrasound, detect subcutaneous emphysema and fracture of the magnesium screw by X-ray and CT. | PMC10363316 |
Efficacy evaluation indicators | femoral head collapse rate | (1) success rate of surgery; (2) radiological evaluation of the location of bone graft at 3 and 6 months after surgery; (3) Harris score of the patient before and 6 months after surgery; (4) femoral head collapse rate at 6 months after surgery; (5) observation of bone ingrowth by CT at 6 months after surgery; (6) obser... | PMC10363316 | |
Statistical methods | SPSS 26.0 software was used for statistic analysis. The χ2 test or Fisher's exact probability method was used for comparison among three groups. One-way ANOVA was used for the comparison among groups, and independent samples | PMC10363316 | ||
Results | PMC10363316 | |||
General information | liver function abnormalities, idiopathic ONFH, femoral head necrosis, traumatic ONFH, pain, ONFH, alcoholic ONFH | GROUP B | A total of 36 patients met the selection criteria for inclusion in the study from March 2021 to July 2022. Three patients (3 hips) had mild liver function abnormalities during the course of the study. We reported this phenomenon to ethics committee, and they deemed it to have no serious impact on the trial. The 36 pati... | PMC10363316 |
Comparison of the operation time and hospital stay of patients in the three groups | All three groups of patients had successful surgery. The average operating time per side of the hip was 178.18, 179.42 and 183.18 min in Group A, B and C, respectively, and the patients' hospital stay was 18.18, 18.12 and 18.09 d, respectively, with no statistically significant difference among three groups ( | PMC10363316 | ||
Harris score | GROUP B | Group A had a mean Harris score of 64.26 preoperatively and 80.03 at 6 months postoperatively. Group B had a mean Harris score of 66.40 preoperatively and 77.34 at 6 months postoperatively. Group C had a mean Harris score of 67.29 preoperatively and 76.03 at 6 months postoperatively. All three groups showed a statistic... | PMC10363316 | |
Radiological results and evaluation | PMC10363316 | |||
Typical patients in three groups | left idiopathic ONFH, ONFH | GROUP B |
Group A: The patient has left-sided hormonal ONFH. The patient’s hip was fixed with a biodegradable magnesium screw (4.0 mm diameter, 30 mm long) in the PVIBGT. More details are shown in Figs. Pre-operative (Pre-operative (Group B: The patient has bilateral hormonal ONFH.The patient underwent bilateral PVIBGTs with tw... | PMC10363316 |
Evaluation blood supply via DCE-MRI | left idiopathic ONFH, ONFH, abnormal hyperperfusion, necrotic | NECROTIC |
Group A: Patient Yan X, male, 29 years old, with left-sided hormonal ONFH. The patient’s hip was fixed with a biodegradable magnesium screw. More details are shown in Figs. IAUGC and Ktrans synthetic pseudo-colour images. At 6 months postoperatively, there was a significant reduction in abnormal hyperperfusion in the ... | PMC10363316 |
Degradation rate and air production of biodegradable magnesium bone internal fixation screws |
The degradation rate of biodegradable magnesium screws was approximately 10.32% at 3 months and 13.72% at 6 months postoperatively in Group A (Fig. The area of the intermuscular air space of the biodegradable magnesium screw was 0 cmPost-operative (Typical patients in Group A were followed up at 14 days ( | PMC10363316 | ||
Analysis of serum biochemical indexes | The levels of serum potassium, sodium, calcium, phosphorus and magnesium ion were in normal range, and other indexes of kidney function were normal in Group A. More details are shown in Fig. Average serum potassium, sodium, calcium, phosphorus and magnesium ion levels in Group A patients preoperatively, 2-days postoper... | PMC10363316 | ||
Adverse reactions | fractures, non-healing | ADVERSE EVENTS, HIP INFECTION, DEEP VEIN THROMBOSIS | While two patients in Group A had poor healing of the surgical incision, other patients in Group A did not have any hip infection, non-healing incision, deep vein thrombosis in the lower limbs, or other adverse events. Group A had good biocompatibility and no fractures of the magnesium screws. Two patients with poorly ... | PMC10363316 |
Discussion | PMC10363316 | |||
Advantages of PVIBGT in hip preservation | ONFH | There are 8.12 million ONFH patients in China [ | PMC10363316 | |
Advantages of biodegradable magnesium screw-fixed bone flaps | PMC10363316 | |||
Biodegradable magnesium screw promotes osteogenesis and angiogenesis | GROUP B | MgDel Giorno et al [In the present study, we found that the improvement of Harris score was more significant in Group A than Group B and C. This indicates that the application of biodegradable magnesium screw to fix the iliac bone graft could promote the healing of the bone and facilitate recovery. | PMC10363316 | |
Biodegradable magnesium fixation is more reliable | Han et al [Mild displacement of the bone graft occurred in two patients in Group C during follow-up. In the biodegradable magnesium screw group, there was no displacement of the grafted bone. These results suggest that the use of biodegradable magnesium screws for fixation of the iliac graft is an effective method to a... | PMC10363316 |
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