title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
|---|---|---|---|---|
Trial Pathway and Randomization | Once eligible patients were identified, managing physicians discussed the trial with them, and written informed consent was obtained ( | PMC10098968 | ||
Randomized Clinical Trial Algorithm | serous, infection, opacity, inadequate lung re-expansion | INFECTION, OPACITY, CAVITY | IPFT indicates intrapleural fibrinolytic therapy.Effectiveness of drainage and/or lung re-expansion was determined on protocol image 1, defined as imaging (chest radiography or chest computed tomography) the day following chest tube placement. Patients with complete pleural fluid drainage and adequate lung re-expansion... | PMC10098968 |
Objectives and Outcomes | SECONDARY, RECRUITMENT, COMPLICATIONS | The primary objective was to determine the feasibility of the proposed study algorithm comparing IPFT and surgical intervention as measured by percentage of enrollment to completion of the study algorithm and percentage of multidisciplinary participation in adherence to the algorithm. There were multiple secondary obje... | PMC10098968 | |
Definitions | pleural infection, fever, infection, Comorbidity, leukocytosis, Infection | RENAL, ALEUKOCYTOSIS, PLEURAL INFECTION, INFECTION, INFECTION | Comorbidities were classified according to the Charlson Comorbidity Index.Treatment failure was defined by evidence of ongoing infection, including fever and/or leukocytosis and a persistent pleural collection still present at least 48 hours following the initial intervention. Crossover treatment, independent of treatm... | PMC10098968 |
Statistical Analysis | As this was a pilot study testing feasibility, we aimed to enroll a total of 30 patients, with the goal of randomizing 20 patients (10 in each group) and consideration for patients not randomized falling into the observation group. Groups were compared using an intention-to-treat analysis.Continuous data were reported ... | PMC10098968 | ||
Results | PMC10098968 | |||
Algorithm Feasibility | A total of 26 patients were enrolled, with 10 in each treatment group and 6 in the observation group. There was 100% enrollment of patients in each treatment group to study completion. Although there were no health care professional protocol deviations in consented patients, 2 thoracic surgeons voiced a preference for ... | PMC10098968 | ||
Patient Identification and Accrual | Seventy-four patients with a CPI were assessed for eligibility over the study period, and 48 (65%) were excluded ( | PMC10098968 | ||
Flow Diagram of Trial Profile | PLEURAL INFECTION | CPI indicates complicated pleural infection; IPFT, intrapleural fibrinolytic therapy. | PMC10098968 | |
Clinical Outcomes of Randomized Patients | Overall, the 20 randomized patients had a median age of 57 (IQR, 46-65) years; 15 (75%) were men and 5 (25%) were women ( | PMC10098968 | ||
Summary Statistics of Baseline Measures Overall and Stratified by Treatment Group | hemothorax, opacification, chest pain, Infection | RENAL, PLEURAL INFECTION, HEMOTHORAX, INFECTION | Abbreviations: CPI, complicated pleural infection; IPFT, intrapleural fibrinolytic therapy; RAPID, Renal, Age, Purulence, Infection Source, and Dietary Factors.Unless otherwise indicated, data are expressed as No. (%) of patients. Percentages have been rounded and may not total 100.Calculated as weight in kilograms div... | PMC10098968 |
Clinical and Outcome Details Overall and Stratified by Treatment Group | death, organ dysfunction | MINOR, COMPLICATION | Abbreviations: ICU, intensive care unit; IPFT, intrapleural fibrinolytic therapy.Unless otherwise indicated, data are expressed as No. (%) of patients. Percentages have been rounded and may not total 100.Grade I indicates any complication without need for pharmacological treatment or other intervention; grade II, any c... | PMC10098968 |
Major Postprocedure Complication Details, Stratified by Treatment Group | organ dysfunction | Abbreviation: IPFT, intrapleural fibrinolytic therapy.Grade IIIa indicates intervention does not require general anesthesia; grade IVa, single organ dysfunction.The median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups ( | PMC10098968 | |
Observation Patients | pleural infection, fever, empyema, deaths, leukocytosis | PLEURAL EFFUSION, ALEUKOCYTOSIS, PLEURAL INFECTION, DENTAL ABSCESS, COMPLICATION, PARAPNEUMONIC EFFUSION, EMPYEMA, ACUTE HYPOXIC RESPIRATORY FAILURE | There were 6 patients in the observation group. Their median RAPID score was 3 (IQR, 2-4), and 4 (67%) had a complicated pleural infection vs 2 (33%) who had an empyema. During observation, 2 patients (33%) were given additional treatment for radiographic persistent pleural fluid collections; neither had a fever or leu... | PMC10098968 |
Discussion | In this pilot randomized clinical trial, we identified the study algorithm comparing IPFT with surgical management of a CPI to be feasible with 100% patient enrollment to study completion and excellent multidisciplinary protocol adherence following randomization. Patient identification and accrual was adequate, with al... | PMC10098968 | ||
Limitations | hemothorax | HEMOTHORAX, MINOR, COMPLICATION, COMPLICATIONS | This study has some limitations. We identified chest tube duration as a clinically useful primary outcome that is both easy to quantify and standardize; therefore, we intend to use chest tube duration as the primary outcome in the future multicenter trial. Due to the small sample size and skewed mean values in this pil... | PMC10098968 |
Conclusions | pleural infections | PLEURAL INFECTION | In this pilot randomized clinical trial, we identified an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication to be feasible with 100% enrollment to completion, with excellent multidisciplinary participation and adherence. These findings show that the studied algo... | PMC10098968 |
1. Introduction | T2DM | TYPE 2 DIABETES MELLITUS | Aronia melanocarpa berries are rich in antioxidants and possess a high antioxidant capacity. Aronia berries have shown potential in type 2 diabetes mellitus (T2DM) treatment, and previous studies indicate improvements in glycemia after supplementation. Unfortunately, the effectiveness of aronia berries is limited by th... | PMC10574687 |
2. Materials and Methods | PMC10574687 | |||
2.1. Study Design | RECRUITMENT | The trial was a triple-blinded, triple-crossover study with intervention periods of eight weeks duration. Between each intervention period, there was a wash-out period lasting at least three weeks. Each participant received fermented aronia extract (FAE), aronia extract (AE), or placebo in a random order. The dietary s... | PMC10574687 | |
2.2. Participants | substance abuse, T2DM, fasting blood glucose ≤, diabetes | RENAL DISEASES, DIABETES | Inclusion criteria were diagnosis of T2DM, age of 30 to 80 years, fasting blood glucose ≤ 12 mmol/L, and HbA1c > 6.1% and <10% (>43 and <86 mmol/mol) if participants were in medical diabetes treatment OR HbA1c > 6.5% and <10% (>48 and <86 mmol/mol) if participants were treated with lifestyle only. Any treatment modalit... | PMC10574687 |
2.3. Test Products | DECAY | The test products are made on leftover aronia pulp from juice production and kindly provided by the company Elkærholm (Egtved, Denmark). To reduce variations in the test products’ antioxidant potential due to differences in cultivation conditions, all test products were based on berries harvested at the same time and l... | PMC10574687 | |
2.4. Compliance | Each daily dose of test product (2 bars) was individually packed in plastic bags. In order to assess compliance, the participants handed in empty plastic bags after each 8-week intervention period, which were then counted by blinded personnel. | PMC10574687 | ||
2.5. Oral Glucose Tolerance Test | BLOOD | The last supplement was consumed the evening before the OGTT allowing for an eight-hour fast prior to the OGTT. At the OGTT, the participants consumed 75 g of glucose dissolved in 150 mL of water within 5 min. Blood was sampled from a peripheral venous catheter placed at the antecubital fossa at time points −10, 0, 30,... | PMC10574687 | |
2.6. Anthropometric Measurements | Body weight measurements were determined using a calibrated SECA scale. For each participant, the same scale was used at all visits. Waist circumference was determined using a measuring tape. The same investigator undertook all measurements. | PMC10574687 | ||
2.7. Blood Analyses | BLOOD | Blood was collected from participants after an eight-hour fast. HbA1c was measured in whole blood immediately after collection. Baseline values were also measured immediately. Remaining samples were centrifuged at 4 °C and 3989 RPM for 10 min after which plasma was stored at −80 °C until analysis. | PMC10574687 | |
2.7.1. Baseline Measurements, HbA1c and Lipids | Baseline measurements and HbA1c concentrations were measured by Department of Clinical Biochemistry at Aarhus University Hospital, Denmark (DS/EN ISO 15189:2013 approved). | PMC10574687 | ||
2.7.2. Glucose (Complete Cases) | For participants that completed the trial, glucose was quantified on Cobas c111-system using a commercially available enzymatic colorimetric kit (#11491253 216, Roche Diagnostics, Basel, Sitzerland) that employs a glucose oxidase–peroxidase method. Intra-assay and inter-assay coefficients of variability (CV) were betwe... | PMC10574687 | ||
2.7.3. Fructosamine and Glucose (Incomplete Cases) | The Indiko analyzer was used with commercially available kits to determine blood concentrations of fructosamine (#FR4030, Randox Laboratories Ltd., Malling, Denmark) for all participants and glucose (#981779, ThermoFisher Scientific, Roskilde, Denmark) for the non-completers. | PMC10574687 | ||
2.7.4. Insulin, Glucagon, GIP, and GLP-1 | Commercially available ELISA kits were used to determine the concentrations of insulin (#10-1113-01, MERCODIA), glucagon (#10-1271-01, MERCODIA), GIP (#10-1258-01, MERCODIA) and GLP-1 (#10-1278-01, MERCODIA). The concentration of glucagon was below the lower limit of detection in 11 samples. These values were dispersed... | PMC10574687 | ||
2.8. Power Calculation | T2DM | The power calculation was performed for our primary endpoint, which was a 240 min incremental area under the curve (iAUC) for glucose during an OGTT. In a previous study investigating the effect of stevioside in T2DM, we identified a minimally relevant difference for a 240 min iAUC for a test meal of 18% (iAUC 638 ± 55... | PMC10574687 | |
2.9. Statistics and Calculations | INSULIN RESISTANCE, INSULIN SENSITIVITY | For baseline data, normality was assessed visually by histograms and by Shapiro–Wilk test using RStudio (version 2023.06.1). Normally distributed data are presented as mean ± standard deviation (SD) and non-normally distributed data are presented as median (interquartile range (IQR)). Total area under the curve (AUC) a... | PMC10574687 | |
3. Results | PMC10574687 | |||
3.1. Baseline Characteristics | Forty-four persons were screened for the trial, of which thirty-six were randomized. The remaining eight did not fulfill the inclusion criteria. A total of 23 participants completed the trial, of which 15 were men and 8 were women. A CONSORT flow diagram, including reasons for exclusion and reasons for discontinuation ... | PMC10574687 | ||
3.2. Compliance | Based on the number of empty plastic bags the participants handed in, EMM for compliance was 99% ± 1%, 97% ± 1%, and 95% ± 1% for intervention with FAE, AE, and placebo, respectively. The 3% difference in compliance between FAE and placebo was statistically significant at | PMC10574687 | ||
3.3. Anthropometric Measurements | In regard to anthropometric measurements, as outlined in | PMC10574687 | ||
3.4. Blood Analyses | HbA1c and fructosamine measurements were applied to evaluate the effect of the interventions on blood glucose over the preceding period of approximately 3 months and 2 weeks, respectively [ | PMC10574687 | ||
4. Discussion | fasting blood glucose, mean fasting blood glucose, taste and sensory, T2DM, glucometabolic | DISEASE, MINOR, INSULIN SENSITIVITY | In this study, we investigated the effect of an 8-week supplementation regimen with two different formulations of aronia extract, i.e., fermented and non-fermented formulations, and compared with placebo on glucometabolic parameters in subjects with T2DM. We hypothesized that both aronia extracts would improve glucose ... | PMC10574687 |
5. Conclusions | T2DM | INSULIN SENSITIVITY | In conclusion, our study demonstrated that supplementation with either fermented or non-fermented aronia extract did not affect waist circumference, insulin sensitivity, or fasting levels of glucose, insulin, or glucagon in subjects with T2DM. To our knowledge, this study is the first examination of dietary supplementa... | PMC10574687 |
Author Contributions | Conceptualization, C.B.C., P.B.J., K.H. and S.G.; validation, C.B.C., P.B.J., K.H. and S.G.; formal analysis, C.B.C.; investigation, C.B.C.; data curation, C.B.C.; writing—original draft preparation, C.B.C.; writing—review and editing, P.B.J., K.H. and S.G.; supervision, P.B.J., K.H. and S.G.; project administration, C... | PMC10574687 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of The Central Denmark Region Committees on Health Research Ethics (Journal no. 1-10-72-102-19, 12 August 2019). | PMC10574687 | ||
Informed Consent Statement | Informed consent was obtained from all subjects involved in the study. | PMC10574687 | ||
Data Availability Statement | Data supporting reported results can obtained by contacting the corresponding author. | PMC10574687 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10574687 | ||
References | INSULIN RESISTANCE | CONSORT flow diagram outlining inclusions, exclusions, and reasons for discontinuation.Nutritional composition of test products containing aronia extract or placebo. Values are for one daily dose (2 bars). For macronutrients, we also provide energy in percentage in square brackets, which are calculated by assigning 4 k... | PMC10574687 | |
1. Introduction | embolus, death, Strokes, stroke, hemorrhagic, physical disability, psychiatric, musculoskeletal pathologies, disability, strokes | STROKES, STROKE, PHYSICAL DISABILITY, ISCHEMIC STROKE, CEREBROVASCULAR ACCIDENT, CEREBRAL INFARCTION, STROKES | A stroke is a neurological condition with a high impact in terms of physical disability in the adult population, requiring specific and effective rehabilitative approaches. Virtual reality (VR), a technological approach in constant evolution, has great applicability in many fields of rehabilitation, including strokes. ... | PMC10049060 |
2. Materials and Methods | RECRUITMENT | A description of the methods followed for the recruitment of participants, the design of the interventions, the process of data collection and the overview of the statistical analyses are provided in the current section. | PMC10049060 | |
2.1. Participants | stroke, hemorrhagic, neurodegenerative diseases, Alzheimer’s and, Parkinson’s | STROKE, NEURODEGENERATIVE DISEASES | The current study corresponds to a pilot randomized clinical trial involving 26 patients from the outpatient clinical setting “Casaverde” in Murcia (Spain).The inclusion criteria were patients receiving neurological physical therapy treatments, patients having suffered a stroke (hemorrhagic or ischemic) in the last 6 m... | PMC10049060 |
2.2. Intervention | dizziness, headache | This study lasted 6 weeks. Both groups received a 1-h neurological physiotherapy session 5 times a week, but the EG additionally received 3 sessions of VR per week. This pattern of 3 VR sessions per week was previously described and used by Cho et al. [The neurological physiotherapy sessions consisted of upper and lowe... | PMC10049060 | |
2.3. Data Collection | shoulder extensors, elbow extensors, shoulder abduction, knee extensors, elbow flexion, wrist extensors, knee flexors, hip extensors, Spasticity | All researchers involved in data collection were trained in and practiced the standardized data collection and measurement procedures.Initially, sociodemographic data (gender and age) were collected.Measurements of the different clinical variables were taken at baseline (pre-treatment or baseline) and at the end of tre... | PMC10049060 | |
2.4. Statistical Analyses | Means between sex and age groups were analyzed and significant differences were sought between the groups. Data were assessed for normality through the Shapiro–Wilk test due to the small sample size (In relation to the required sample size, a calculation using the G* Power software (ver. 3.1.9.7; Heinrich-Heine-Univers... | PMC10049060 | ||
3. Results | ±, stroke, spasticity | STROKE | This study involved 24 stroke patients. The CG had seven males and five females, with a mean age of 59.58 ± 15.97 years (Median: 65 years; age range: 18 to 75 years of age). The EG encompassed nine males and three females, with a mean age of 51.91 ± 18.58 (Median: 58 years; age range: 18 to 71 years of age). No statist... | PMC10049060 |
4. Discussion | stroke, reduction of motor deficit, spasticity | STROKE | According to the results obtained, the use of neurological physiotherapy in combination with VR and video games is more effective for the treatment of patients following a stroke than neurological physiotherapy alone. This 6-week pilot randomized clinical trialhas shown significant improvements in the Motricity Index, ... | PMC10049060 |
5. Conclusions and Future Work | stroke, post-stroke-related disability, spasticity | STROKE | The use of VR alongside a traditional physiotherapy approach in the treatment of patients following a stroke provided significant improvements in terms of balance, gait, trunk control and functional level of gait, while no significant differences were found in strength or spasticity. The results stemming from our study... | PMC10049060 |
6. Patents | The game and the Blexer environment led to several registrations of intellectual property for software with the following entry numbers: Blexer-med web platform 16/2019/1687; Middleware Chiro 16/2019/1576; and Phiby’s Adventures 16/2019/871.The Blexer environment was loaned by the Universidad Politécnica de Madrid to t... | PMC10049060 | ||
Author Contributions | Conceptualization, Á.M.-C. and F.-J.P.-V.; methodology, Á.M.-C. and M.G.-S.; software, M.E.; validation, F.-J.P.-V., Á.M.-C., M.E. and M.G.-S.; formal analysis, M.G.-S.; investigation, Á.M.-C. and F.-J.P.-V.; data curation, F.-J.P.-V.; writing—original draft preparation, F.-J.P.-V. and Á.M.-C.; writing—review and editi... | PMC10049060 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of the University of Murcia: protocol code: JVP-2022-01 (25.03.2022) and registered in the U.S. National Library of Medicine Clinical Trials.Gov with the identifier: NCT05278403. | PMC10049060 | ||
Informed Consent Statement | Informed consent was obtained from all subjects (or their legal representatives) involved in the study. | PMC10049060 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. The data are not publicly available due to privacy issues. | PMC10049060 | ||
Conflicts of Interest | The authors declare no conflict of interest. All authors have read and approved the paper and it has not been published previously nor is it being considered by any other peer-reviewed journal. | PMC10049060 | ||
References | Flowchart of the study.VR equipment used. 1. Kinect 360 2. Computer with the software. 3. VR glasses (oculus Quest 2) 4. Router.Patient during a VR session.Two different screens of Phiby’s Adventure.Patient playing “Chop the Wood”, “Row the Boat” and “Climb the Tree”, respectively.Results of Clinical Variables (Mean ± ... | PMC10049060 | ||
Objective | pulmonary hypertension | BRONCHOPULMONARY DYSPLASIA, PULMONARY HYPERTENSION | Information is needed to guide the design of randomized controlled trials (RCTs) evaluating L-citrulline therapy for premature infants with pulmonary hypertension associated with bronchopulmonary dysplasia (BPD-PH). Based on our single-dose pharmacokinetic study, we evaluated the ability of a multi-dose enteral L-citru... | PMC10844094 |
Study Design | Plasma L-citrulline concentrations were measured in six premature infants receiving 60 mg/kg L-citrulline every 6 h for 72 h before the first and last L-citrulline doses. L-citrulline concentrations were compared to concentration-time profiles from our previous study. | PMC10844094 | ||
Results | ADVERSE EVENTS | Target trough plasma L-citrulline concentrations were achieved in 2/6 subjects. No serious adverse events occurred. | PMC10844094 | |
Conclusions | Multi-dose L-citrulline was well tolerated. These results will assist in the design of phase II RCTs evaluating L-citrulline dosage strategies to achieve target plasma L-citrulline concentrations in infants at risk for BPD-PH. Clinical trials.gov ID: NCT03542812 | PMC10844094 | ||
Subject terms | PMC10844094 | |||
Introduction | BRONCHOPULMONARY DYSPLASIA (BPD), CHRONIC LUNG DISEASE OF PREMATURITY, PULMONARY HYPERTENSION, PREMATURE, PULMONARY HYPERTENSION | Premature infants with chronic lung disease of prematurity, bronchopulmonary dysplasia (BPD), are at risk of developing pulmonary hypertension (PH) [Research efforts are needed to develop and evaluate therapies to improve outcomes for infants with BPD-PH. In 2022, the Pediatric Pulmonary Hypertension Network (PPHNet) n... | PMC10844094 | |
Materials/subjects and methods | PMC10844094 | |||
Patient population | death, congenital heart disease, fever, diarrhea, liver failure, ventricular septal defect, fetal anomalies, vomiting or, patent ductus arteriosus, BPD, atrial septal defect | LIVER FAILURE, PREMATURE, NECROTIZING ENTEROCOLITIS, ANEUPLOIDY | This study was the multiple-dose steady state arm of a phase I study NCT03542812 (PK of L-citrulline in infants at substantial risk of developing PH associated with BPD). The single-dose PK arm of the study has been previously published [We enrolled participants from two Newborn Intensive Care Units (NICUs) in Salt Lak... | PMC10844094 |
Patient monitoring | diarrhea, vomiting, hypotension, sepsis, gastro-intestinal disturbances | NECROTIZING ENTEROCOLITIS, ADVERSE EVENT, GASTROINTESTINAL BLEEDING, ADVERSE EVENT, SEPSIS | Vital signs (heart rate, respiratory rate, temperature, blood pressure, and oxygen saturation) and respiratory support (FiOL-citrulline administration carries a theoretical risk of systemic hypotension. An adverse drop in blood pressure was defined as a decrease in mean arterial blood pressure of more than 25% of basel... | PMC10844094 |
Drug dosing and sample collection | STERILE | Each patient received 12 doses of 60 mg/kg enteral L-citrulline. The L-citrulline was donated by Askeplion Pharmaceuticals, Baltimore, MD, and was provided in a powder form that was solubilized in sterile water to achieve 50 mg/ml concentration. Each participant received 1.2 ml/kg (60 mg/kg) of the solubilized L-citrul... | PMC10844094 | |
Sample processing and analyses | All blood samples were centrifuged at 1500 g for 5 min at 4 °C. The plasma was separated and stored at −80 °C for later determination of concentrations of the amino acids, L-citrulline (μmol/L) and L-arginine (μmol/L). All amino acid analyses were performed by ARUP Laboratories (Salt Lake City, UT) via Liquid Chromatog... | PMC10844094 | ||
Pharmacokinetic analysis | Dosing regimen (using median dose) for the current study was used to obtain simulated concentration-time data and corresponding profiles of L-citrulline using R (version 4.1.0) via package “linpk”. Parameter values for clearance, volume of distribution and absorption rate constant were obtained from a previous study an... | PMC10844094 | ||
Statistical analyses | Wilcoxon’s signed rank test was used to compare plasma concentrations of L-citrulline and arginine obtained at baseline to plasma concentrations obtained prior to the 12 | PMC10844094 | ||
Results | PMC10844094 | |||
Subject characteristics | sepsis, congenital anomalies, liver disease | SEPSIS, NECROTIZING ENTEROCOLITIS, LIVER DISEASE | A total of 91 infants born ≤ 28 weeks were screened for eligibility. 62 were ineligible for the following reasons: multiple gestations (n = 27), feeding problems or necrotizing enterocolitis (n = 14), lack of consent form in parent’s language (n = 4), respiratory support below eligibility criteria (n = 4), congenital a... | PMC10844094 |
Plasma amino acid and urine NOx data | Basal plasma concentrations were obtained between 30 min to 5 ½ hours prior to administering the first dose of L-citrulline, and a second plasma concentration was obtained between 18–27 min prior to the last, 12 | PMC10844094 | ||
Observed/predicted plasma L-citrulline concentration (μmol/L) time profiles. | Solid black lines represent predicted plasma L-citrulline concentrations. Dotted black lines represent 50 μmol/L and 80 μmol/L concentrations and reflect the target trough plasma concentrations. Black dots are the observed L-citrulline concentrations (μmol/L) collected at study time points (i.e. at baseline and trough ... | PMC10844094 | ||
Individual subject mean BP measurements. | The mean BP measurements (mm Hg) of individual subjects recorded at baseline (dose 0) and with each of the 12 doses of L-citrulline administration. | PMC10844094 | ||
Acknowledgements | We thank Asklepion Pharmaceuticals for the generous gift of the oral L-citrulline used in this study. We also thank the Newborn Clinical Research Nurse Coordinators at the University of Utah and Intermountain Medical Center for their help in enrolling patients and performing the study. | PMC10844094 | ||
Author contributions | CDF, JLA, and CMS contributed to the conception and design of the study. Data collection was performed by CDF. Formal data analysis was performed by CDF, AKB, CA, and CMS. CDF wrote the first draft of the abstract. All authors reviewed and edited drafts of the manuscript and approved the final manuscript. | PMC10844094 | ||
Funding | BLOOD, HEART, LUNG | This work was supported by National Heart, Lung, and Blood Institute Grant R34-HL-142995 (CDF). | PMC10844094 | |
Data availability | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. | PMC10844094 | ||
Competing interests | BRONCHOPULMONARY DYSPLASIA | CDF and JLA are inventors on a patent at Vanderbilt University Medical Center that has been licensed to Asklepion Pharmaceuticals for the “Therapeutic treatment of bronchopulmonary dysplasia.” | PMC10844094 | |
Ethics approval | All procedures performed in this study involving human participants were in accordance with the 1964 Helsinki Declaration and its later amendments. The study design was approved by the institutional review boards of The University of Utah and Intermountain Healthcare. All participants or legal guardians of participants... | PMC10844094 | ||
References | PMC10844094 | |||
Objective | sarcopenia, femoral fracture | SARCOPENIA | Academic Editor: Xiaolong Chen To study the clinical efficacy of nutritional intervention combined with muscle exercise on sarcopenia patients with femoral fracture. | PMC9937758 |
Methods | fracture, pain, sarcopenia, femoral fracture | SARCOPENIA | From January 2019 to January 2021, a total of 100 sarcopenia patients with femoral fracture were included in this study and were divided into a control group (routine postoperative care) and a research group (nutritional intervention and muscle exercise), 50 cases in each group. Primary clinical outcomes included sarc... | PMC9937758 |
Results | sarcopenia | SARCOPENIA | Before the intervention, there was no significant difference in the indicators of sarcopenia and the indicators of functional independence assessed by ADL between the two groups ( | PMC9937758 |
Conclusion | fracture, sarcopenia, sarcopenic femoral fractures | SARCOPENIA | Nutritional intervention combined with muscle exercise can help improve sarcopenia symptoms and promote fracture recovery in patients with sarcopenic femoral fractures. | PMC9937758 |
1. Introduction | loss of skeletal muscle mass, muscle strength loss, swelling, muscle reduction, fracture, pain, fractures, Femoral fracture, Sarcopenia, muscle loss, osteoporosis, femoral fracture | LOSS OF SKELETAL MUSCLE MASS, SYNDROME, SARCOPENIA, DISEASES, OSTEOPOROSIS | Sarcopenia is a syndrome of persistent loss of skeletal muscle mass, strength, and function and characterized by a marked age-dependent onset. Previous studies have found that skeletal muscle begins to age from about 40 years, with an average annual decrease in quantity and quality of about 8%, and muscle loss doubles ... | PMC9937758 |
2. Material and Methods | PMC9937758 | |||
2.1. Patients and Ethics Statement | impaired cognitive function, death, sarcopenia, malignant disease, cardiopulmonary insufficiency, renal insufficiency, neuropsychiatric disorders, sarcopenic femoral fractures, femoral fracture | SARCOPENIA, INFECTIOUS DISEASE, RENAL INSUFFICIENCY, DISEASES, MALIGNANT DISEASE | A total of 100 patients with sarcopenic femoral fractures were included in this study from January 2019 to January 2021 (age from 57 to 74 years old, 53 males and 47 females). The following are the inclusion criteria: (1) femoral fracture and received artificial joint replacement; (2) combined with sarcopenia; (3) aged... | PMC9937758 |
2.2. Intervention Protocol | Patients in the control group were received routine care such as primary care and symptomatic care. Patients in the research group received nutritional interventions and muscle exercises in addition to routine care. Nutritional intervention and muscle exercise duration is from 10 days postoperatively to 3 months plus 1... | PMC9937758 | ||
2.3. Data Collection and Follow-Up | diabetes | HYPERTENSION, CARDIOPULMONARY DISEASE, DIABETES | Baseline data were collected for all patients recruited in this study, including gender, age, education, comorbidities (hypertension, diabetes, and cardiopulmonary disease), drinking, and smoking. All patients received a 4-month follow-up after surgery, including telephone follow-up every 2 weeks and unscheduled hospit... | PMC9937758 |
2.4. Primary Clinical Outcome | Primary clinical outcomes included sarcopenia-related indicators and functional independence assessed by activities of daily living scale (ADL) [ | PMC9937758 | ||
2.5. Secondary Clinical Outcome | fracture, pain | Secondary clinical outcomes included the time of fracture healing and hospital stay, pain as assessed by visual analogue scale (VAS) at different times, and patient satisfaction with care. In detail, we used VAS to assess pain before intervention, 1 week, 2 weeks, 1 month, and 3 months after intervention. The VAS scori... | PMC9937758 | |
2.6. Statistical Analysis | Data in the present study were analyzed by SPSS 20.0 software (SPSS Inc., Chicago, USA). Qualitative data are presented as counts (%), and | PMC9937758 | ||
3. Results | PMC9937758 | |||
3.1. Baseline Data | 167 patients were enrolled in the beginning, and 67 were excluded, and no patient lose to follow-up. 100 eligible patients were randomly divided into two groups, control group and research group. There were no significant differences between the two groups in baseline data ( | PMC9937758 |
Subsets and Splits
No community queries yet
The top public SQL queries from the community will appear here once available.