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Traditional opioid, such as morphine, sufentanil , is an important drug treatment of postoperative period of acute pain, but their use is often limited because of significant side effects, such as respiratory depression, postoperative nausea and vomiting and sedation. If a drug is effective treatment of postoperative pain and avoid these adverse reactions, it will shorten the postoperative recovery time of patients, increase patients' satisfaction, and reduce hospitalization costs. Basic research shows that traditional opioids mainly bind to μ-opioid receptors and activate G protein signal transduction to exert analgesic effect. In addition, they stimulate the recruitment of β-arrestin, leading to respiratory depression, nausea and vomiting and other side effects. Oliceridine is a newly μ-opioid receptor agonist, which mainly activates the G protein signaling pathway to exert analgesic effect, but has a weak recruitment effect on β-arrestin and thus reduces the incidence of adverse reactions. However, due to its recent introduction to the market, there is still a lack of large-scale clinical studies on the application of Oliceridine in the population. So this topic to discuss the analgesic efficacy and adverse reactions of Oliceridine in patients with acute pain after abdominal surgery. Our study hypothesized that Oliceridine would have comparable analgesic efficacy and a lower incidence of associated side effects than sufentanil.
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Change from Baseline in PGAS as Efficacy of Botox intramuscularly at Week 6, Efficacy of Botox intramuscularly at Week 12, Efficacy of Botox intramuscularly at Week 18, Efficacy of Botox intramuscularly at Week 24, and Efficacy of Botox intramuscularly at Week 30 vs.Efficacy of Botox subdermally at Week 6, Efficacy of Botox subdermally at Week 12, Efficacy of Botox subdermally at Week 18, Efficacy of Botox subdermally at Week 24, and Efficacy of Botox subdermally at Week 30. The Physician Global Assessment Scale or PGAS is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from -4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement.
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PURPOSE:To provide the titled agent containing garlic extract component, effective to proliferate bifidus bacteria and other useful lactobacilli in the intestines of man and animal and useful as a medicine, health food, feed, etc. CONSTITUTION:The objective agent contains a garlic extract component (e.g. oxoamidine) as an active component. The usefulness of bifidus bacteria and other useful lactobacilli for man and animal is gradually getting to become clear. However, major part of the bacteria are anaerobic bacteria living in large intestine to which air is hardly transported from the mouth. Accordingly, the nutrients for the bacteria are also hardly transported to the living part and if any, the nutrients are consumed by a number of harmful bacteria. Accordingly, the part is not a desirable place for the growth of the bifidus bacteria and other useful lactobacilli. The garlic extract component selectively proliferates the useful bacterial while inhibiting the proliferation of the harmful bacteria in the intestines. The agent can be used not only as a medicine or feed but also as an additive of a culture process in the production of lactobacillus.
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BACKGROUND/OBJECTIVES: Phase angle (PhA) serves as a prognostic marker in various clinical scenarios, reflecting oxidative stress and cellular damage. Despite its clinical relevance, its connection with adiposity and cardiovascular risk markers remains underexplored. Hence, our study sought to investigate the relationship between PhA and metabolic, adiposity, and cardiovascular risk parameters among outpatients with cardiology diagnosis.
SUBJECTS/METHODS: Adults aged between 26 and 59 years, under the care of a cardiology unit, were included. Ultrasound imaging was used to assess visceral adipose tissue (VAT). Single-frequency bioelectrical impedance analysis (BIA) [50 kHz] was employed to calculate PhA, from BIA's resistance and reactance measurements. Muscle strength, body mass index, waist circumference, and waist-to-height ratio were also evaluated. Framingham's risk score was calculated to estimate the cardiovascular risk events. Metabolic blood samples' results were obtained from medical records.
RESULTS: One hundred and five participants were included in our study. Low PhA was observed in 29.5% of our sample. Higher PhA values were independently and inversely associated with both higher VAT and cardiovascular risk (adjusted OR: 0.79 [95% CI 0.69;0.91], OR: 0.74 [95% CI 0.60;0.89], respectively). Lower PhA values (≤5.59) were goodly associated with high VAT (AUC: 0.82 p < 0.001). Lower PhA values (≤5.06) were fairly associated with higher cardiovascular risk (AUC: 0.70 p = 0.003).
CONCLUSION: Our study provides evidence that PhA is independently and inversely associated with elevated VAT and cardiovascular risk. These findings underscore the potential of PhA as a valuable complementary marker in assessing cardiometabolic health.
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Crutches are the most prescribed ambulatory assistive device and are used for mobility and maintaining weight-bearing restrictions after injury or surgery. However, standard axillary crutches (SACs) can lead to overuse and other injuries and restrict upper limb movement. Hands-free crutches (HFC) do not restrict upper limb movement but their effect on balance control, with or without commonly prescribed walking boots, is poorly understood. The purpose of this study was to compare the effect of crutch type (SACs vs. HFC) and boot use on whole-body angular momentum (RAM), a measure of balance control. Participant's balance confidence, pain, comfort, and device preference were assessed. Seventeen participants were evaluated while walking without a crutch (NONE), with SACs, and with an HFC, and walked with and without a walking boot in each crutch condition. The gait pattern used with SACs resulted in significantly greater limb angular velocity (p < .05), and an 84% increase in RAM (p < .001) as compared to the HFC. There were no differences between the SAC and HFC for balance confidence, pain, or comfort, however most (71.1%) participants preferred the HFCs. These results suggest that individuals can better control angular momentum with the HFCs and thus may be less susceptible to loss of balance.
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Extremely low birth weight (ELBW) infants have significant transepidermal water loss immediately after birth. This significant fluid loss is related to proportionally large extracellular pool of fluids, the immaturity of the skin barrier, and the relatively large surface area exposed to evaporation. Water depletion in this population is associated with development of significant electrolyte imbalance in the form of hypernatremia, hyperkalemia, hyperglycemia and hyperosmolarity. In order to compensate for these losses, clinicians have to progressively increase fluid intake. Excessive fluid intake in the first days of life is associated with worsening patent ductus artriosus (PDA), necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD) and mortality. Also skin integrity is important to protect against skin infection and secondary sepsis. Based on recent studies and relevant data, the risk of sepsis in ELBW is up to 40% nationwide, but only about 25% at GWUH Water application is a benign treatment that is routinely applied to the skin of premature babies and was shown to decrease skin colonization. The current practice at GWUH is to clean the bodies of premature infants using a piece of damp cloth with warm water. This is performed at birth and consequently every other days. The study group will receive more frequent and standardized applications. The investigators hypothesize that application of sterile water in ELBW infants is associated with decreased fluid requirements in the first week of life. As a secondary outcome, the investigators hypothesize that sterile water application is associated with improved skin integrity, decreased incidence of BPD with no increased incidence of skin or systemic infections.
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The research will be carried out with two groups as intervention and control groups. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 27 for each group and 54 in total. Considering the possible case losses, 20% of the sample was increased. The sample consisted of 64 babies, 32 intervention and 32 control. Mothers of the infants meeting the study inclusion criteria will be informed both in written and verbally. Written consent will be obtained. The infants will be divided into two groups according to stratified block randomization in the computer environment. The infants will be stratified by gender and age. After the randomization, therapeutic touch will be applied to the intervention group. No method will be applied to the control group by the researcher. In obtaining research data, 4 tools will be used: "Mother-infant Information Form", "Infantile Colic Scale", Crying Time Registration Form and Sleep Time Registration Form.
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Distribution: When each drug is administered intravenously, the steady-state volume of distribution is 1.1 to 2.1 L/kg (mean 1.5, ±0.3 SD, n=13) for lidocaine and is 0.7 to 4.4 L/kg (mean 2.6, ±1.3 SD, n=13) for prilocaine. The larger distribution volume for prilocaine produces the lower plasma concentrations of prilocaine observed when equal amounts of prilocaine and lidocaine are administered. At concentrations produced by application of lidocaine and prilocaine cream, lidocaine is approximately 70% bound to plasma proteins, primarily alpha-1-acid glycoprotein. At much higher plasma concentrations (1 to 4 μg/mL of free base) the plasma protein binding of lidocaine is concentration dependent. Prilocaine is 55% bound to plasma proteins. Both lidocaine and prilocaine cross the placental and blood brain barrier, presumably by passive diffusion.
Metabolism: It is not known if lidocaine or prilocaine are metabolized in the skin. Lidocaine is metabolized rapidly by the liver to a number of metabolites including monoethylglycinexylidide (MEGX) and glycinexylidide (GX), both of which have pharmacologic activity similar to, but less potent than that of lidocaine. The metabolite, 2,6-xylidine, has unknown pharmacologic activity. Following intravenous administration, MEGX and GX concentrations in serum range from 11 to 36% and from 5 to 11% of lidocaine concentrations, respectively. Prilocaine is metabolized in both the liver and kidneys by amidases to various metabolites including ortho-toluidine and N-n-propylalanine. It is not metabolized by plasma esterases. The ortho-toluidine metabolite has been shown to be carcinogenic in several animal models (see Carcinogenesis subsection of PRECAUTIONS). In addition, ortho-toluidine can produce methemoglobinemia following systemic doses of prilocaine approximating 8 mg/kg (see ADVERSE REACTIONS). Very young patients, patients with glucose-6-phosphate dehydro- genase deficiencies and patients taking oxidizing drugs such as antimalarials and sulfonamides are more susceptible to methemoglobinemia (seeMethemoglobinemia subsection of WARNINGS).
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666,463. Hemophilus pertussis antigens. SHARP & DOHME, Inc. Nov. 22, 1949 [June 28, 1949], No. 29909/49. Class 81 (i). A pertussis toxin-containing solution is detoxified by exposing it to a solution of an aliphatic alcohol having 2 to 4 carbon atoms in its molecule, the alcoholic concentration being 20 to 80 per cent by volume. According to an example, H. pertussis is grown for 48 hours at 37‹ C. on a casein hydrolysate base medium. The culture is centrifuged and the pertussis cells suspended in distilled water. The suspension is subjected to sonic oscillations and the supernatant liquid is centrifugally separated from the cell debris. The solution is cooled to 2-5‹ C. and anhydrous ethanol having a temperature of -50‹ C. is added until the alcohol concentration is 40 per cent by volume. The mixture is maintained at -10‹ C. for 24 hours. After dilution with distilled water to an alcohol concentration of 4 per cent, potash alum is added. After standing, the resulting precipitate is filtered, washed with distilled water and suspended in an isotonic phosphate buffer solution having a pH of 7.4. According to other examples ethanol is replaced by propyl, isopropyl or butyl alcohol. Specification 643,546 is referred to.
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Methods are provided for preparing just before administration unit doses of therapeutic solutions which contain redox active unstable and/or diffusable metabolites such as ketoacid, a sulfhydryl-containing amino acid, or carbon dioxide. The method involves preparing and storing an aqueous solution of stable components which may or may not contain carbon dioxide. A dry powder comprised of unstable components is also prepared and stored separately. These separate component compositions are packaged in, for example, individual chambers of a common sealed container which is so constructed as to permit the opening, by externally applied manual means or the like, of a passageway between such chambers at the time when usage is contemplated. Thus, a fresh solution in desired full dosage form is preparable just before administration. Improved container structures for practice of this method are also provided.
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Participants randomized to this group will complete three high intensity interval training sessions per week, two of which will be supervised. They will exercise for a total of 30 minutes per session. Each session will begin with a five-minute warm-up and end with a five-minute cool-down.
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The invention provides a method for extracting antioxidant crocodile grease. Compared with the prior art, not only is the problem that the grease is easily oxidized solved, but also a potential safety hazard caused by adding of a synthetic antioxidant to the grease is avoided, and green, healthy and environment-friendly ideas are accorded. IC50 is the concentration of the required antioxidant when the removal rate is 50%, and frequently applied to comparison of the ability for removing DPPH.free radical, and the half maximal inhibitory concentration (IC50) is determined by drawing a curve according to the removal rate of different concentrations of antioxidants. The IC50 is smaller in value, which indicates that the oxidation resistance is stronger and the ability of removing free radical is stronger. The crocodile grease extracted by the traditional method (control group) is detected by adopting the DPPH method and compared with the grease product obtained in the embodiments 1,4 (experimental group) disclosed by the invention in the antioxidant activity; the determination result displays the crocodile grease IC50=24.920mg/mL extracted by the traditional method, a final grease product IC50=14.138mg/mL obtained by the embodiment 1, and the final grease product IC50=14.545mg/mL obtained by the embodiment 4. The antioxidant activity of the final crocodile grease product extracted by the Chinese herbal medicine soup is obviously improved.
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Developmental dysplasia of the hip (DDH) is the most common musculoskeletal disorder in infancy. However there are few reports of long term effects of successfully treated DDH. Incidence of DDH in neonatal period is approximately 1-10/1000 depending on screening protocols used, the age of the infant during screening and which ultrasonographic findings are considered normal and which DDH. The prevalence of hip dysplasia in adult population is grossly 4 % when using Wibergs Centre-Edge (CE) ≤ 20° as definition of dysplasia. It is still unclear, what is the relation between adult acetabular dysplasia and developmental dysplasia in children. Hip dysplasia overall is a major contributing factor in hip osteoarthrosis and total hip replacement in young adults.
The aim of this study is to assess long term effects of developmental dysplasia of the hip to overall health and quality of life later in life. We compare hip radiographs, hip symptoms, clinical examination, head asymmetry, dental examination and intraoral scans of 170 children and young adults treated for DDH in their early childhood with age and sex matched controls.
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BACKGROUND: Overweight and obesity affect more than 18% of children and adolescents in the world. Obesity-related associations with brain morphology might be associated with reduced efficiency of inhibitory control. This association highlights a possible mechanism by which obesity impacts intelligence and academic achievement. Prior work indicates a mediating effect of inhibitory control on the relationship between body mass index (BMI) and intelligence and academic achievement. However, although obesity is associated with impaired math performance, we do not know whether inhibitory control also mediates the relationship between BMI and math performance. This study tests the hypothesis that inhibitory control statistically mediates the relationship between BMI and math performance.
METHODS: 161 children (9 to 13 years old, 80 female) participated in the present study. We evaluated BMI; math performance, in a test composed of 20 arithmetic equations of the type x = (a × b) - c; and inhibitory control through the Flanker test. We carried out Spearman correlation tests, hierarchical multiple linear regression, and tested the confidence of the model where inhibitory control statistically mediates the indirect association between BMI and math performance. Mediation analysis in this cross-sectional study aimed to improve understanding of indirect relationships and offer insights into possible causal connections.
RESULTS: Better math performance and lower BMI were associated with greater accuracy on the inhibitory control test and greater accuracy on the inhibitory control test was associated with better performance on math test. We found an indirect association between higher BMI in children and impairments in math performance, that was mediated by inhibitory control (a: -0.008, p = 0.025; b: 7.10, p = 0.0004; c: 0.05, p = 0.592; c': 0.11, p = 0.238; Indirect Effect: -0.0599, 95% CI: -0.13, -0.005).
CONCLUSIONS: An indirect association between higher body mass indices in children and impairments in math performance was detected, through the impact that BMI has on inhibitory control.
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Isolated cells that are not embryonic stem cells, not embryonic germ cells, and not germ cells are described. These cells are capable of differentiating into at least one cell type of each of at least two of the endodermal, ectodermal and mesodermal embryonic lineages. These cells do not elicit a deleterious immune response. These cells are capable of modulating immune responses. For example, these cells can suppress immune responses in the host caused by allogeneic cells, tissues and organs. Methods of using these cells, by themselves or adjunctively, to treat a subject are described. For example, these cells can be used adjunctively for immunosuppression in transplantation therapy. Methods of obtaining these cells and compositions using them are also described.
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The present invention relates to a Chinese medicinal preparation for treating high blood pressure and high blood fat, which is mainly composed of 10 to 20 of haws, 10 to 20 of milk vetch, 10 to 20 of semen cassiae, 5 to 15 of liquorice and 5 to 15 of broadleaf holly leaf (proportions by weight). The production method of the Chinese medicinal preparation is simple, clear and reliable. The Chinese medicinal materials are pulverized into coarse powder by a conventional method; the coarse powder is dried for achieving the proportions by weight prescribed by a recipe; then, the Chinese medicinal materials are subpackaged in a drinking tea bag and packed for obtaining a tea preparation. The Chinese medicinal preparation does not have the defect of large side effect of a plurality of kinds of western medicine for treating high blood pressure and high blood fat. The Chinese medicinal preparation comprises few Chinese medicine varieties; however, the Chinese medicinal preparation has strong pertinency, and is prepared from pure Chinese medicine. Compared with the existing variety, each variety of the present invention has the characteristics of fast effects, stable functions, convenient carrying and administration, and no toxic side effect after long-term administration. Proved by a test, the variety of the present invention has the functions of reducing blood fat and adjusting blood pressure, and can be used for treating and adjusting high blood fat and high blood pressure.
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### Carcinogenesis
Venlafaxine was given by oral gavage to mice for 18 months at doses up to 120 mg/kg per day, which was 16 times, on a mg/kg basis, and 1.7 times on a mg/m2 basis, the maximum recommended human dose. Venlafaxine was also given to rats by oral gavage for 24 months at doses up to 120 mg/kg per day. In rats receiving the 120 mg/kg dose, plasma levels of venlafaxine were 1 times (male rats) and 6 times (female rats) the plasma levels of patients receiving the maximum recommended human dose. Plasma levels of the O-desmethyl metabolite were lower in rats than in patients receiving the maximum recommended dose. Tumors were not increased by venlafaxine treatment in mice or rats.
### Mutagenicity
Venlafaxine and the major human metabolite, O-desmethylvenlafaxine (ODV), were not mutagenic in the Ames reverse mutation assay in Salmonella bacteria or the CHO/HGPRT mammalian cell forward gene mutation assay. Venlafaxine was also not mutagenic in the in vitro BALB/c-3T3 mouse cell transformation assay, the sister chromatid exchange assay in cultured CHO cells, or the in vivo chromosomal aberration assay in rat bone marrow. ODV was not mutagenic in the in vitro CHO cell chromosomal aberration assay. There was a clastogenic response in the in vivo chromosomal aberration assay in rat bone marrow in male rats receiving 200 times, on a mg/kg basis, or 50 times, on a mg/m2 basis, the maximum human daily dose. The no effect dose was 67 times (mg/kg) or 17 times (mg/m2) the human dose.
### Impairment of Fertility
Reproduction and fertility studies of venlafaxine in rats showed no adverse effects on male or female fertility at oral doses of up to 2 times the maximum recommended human dose of 225 mg/day on a mg/m2 basis.
However, reduced fertility was observed in a study in which male and female rats were treated with O-desmethylvenlafaxine (ODV), the major human metabolite of venlafaxine, prior to and during mating and gestation. This occurred at an ODV exposure (AUC) approximately 2 to 3 times that associated with a human venlafaxine dose of 225 mg/day.
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A retrospective, cohort, single center, chart review was conducted to compare rates of opioid-associated serious adverse events (SAEs) in a patient cohort 6 months before and 6 months after data-based opioid risk review. The primary objective was the composite reduction in opioid-related SAEs including suicide-related events and opioid overdoses. The impact of the reviews was assessed via multivariate logistic regression and a McNemar's test to analyze difference in rates of opioid-associated SAEs. This study demonstrates that data-based opioid risk review can reduce opioid-related SAEs, opioid overdoses, and suicide-related events in the 6 months post-review. The primary outcome was not statistically significant with a p-value of 0.080. In the population that underwent opioid tapers, the hazard ratios (HR) for suicide-related events and opioid-related SAEs were 6.64 (1.09-40.53, p = 0.05) and 10.43 (0.48-226.80, p = 0.02) respectively when compared to non-tapered patients. The HR for suicide-related events and opioid-related SAEs when opioid therapy was discontinued were 9.95 (2.16-45.94, p = 0.009) and 15.64 (1.09-225.19, p = 0.001) respectively when compared to continuation of opioids. This study showed that data-based opioid risk review may reduce incidence of opioid-related SAEs in patients with chronic pain. Additionally, opioid tapers and discontinuations are significant risk factors for suicide-related events and opioid-related SAEs.
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This is a randomized, open-label, parallel group, multicenter study to determine the safety and effectiveness of levofloxacin (488 mg once daily by mouth or 500 mg administered intravenously once daily for 7 - 14 days) compared with ceftriaxone sodium (1 - 2 grams administered into a vein or muscle once daily or in divided doses twice daily for 7 - 14 days) or cefuroxime axetil (500 mg by mouth twice daily for 7 - 14 days) in adults with community-acquired pneumonia. The study consists of 4 visits: one visit for screening and enrollment, and 3 visits for assessment of safety and effectiveness (one visit on Day 2 - 4 \[on-therapy\], one visit \[post-therapy\] 5 - 7 days after the last dose of the study drug, and one visit \[post-study\] 21 - 28 days after the last dose of the study drug). The total duration of patient participation in the study is approximately 6 weeks. Levofloxacin is an antibacterial agent used for the treatment of many types of infections in adults. The purpose of this study is to compare the safety and effectiveness of levofloxacin with other frequently used antibiotics (ceftriaxone sodium or cefuroxime axetil) in the treatment of adults with pneumonia acquired in the community. The primary efficacy assessment is the clinical response 5 - 7 days after the last dose of study drug, (categorized as cured, improved, or failed) based upon changes in signs and symptoms, and changes in x-ray findings, Safety evaluations (incidence of adverse events, physical examination, and laboratory tests) are performed throughout the study. Cost-effectiveness is also assessed for the study drugs. The study hypothesis is that treatment with levofloxacin will be at least as effective as ceftriaxone sodium or cefuroxime axetil in treating patients with pneumonia acquired in the community, and that it will be well tolerated. Levofloxacin 488 mg by mouth once daily or 500 mg intravenously once daily; ceftriaxone sodium (1 - 2 grams administered into a vein or muscle once daily or in divided doses twice daily); or cefuroxime axetil (500 mg by mouth twice daily). Treatment duration is 7 - 14 days.
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Women in Arm B received deferred, or postpartum-initiated, INH treatment. Women received placebo for INH at study entry through Week 12 postpartum, then switched to INH through Week 40 postpartum.
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Approximately 24-48 hours prior to surgical resection or biopsy, patients receive EF5 IV over no more than 2½ hours. Tissue samples are analyzed by immunohistochemistry for EF5 binding. Blood samples are analyzed for genetic markers and cytokines associated with hypoxia and EF5 concentration.
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The invention provides an application of glycine tomentella hayata. root and extract thereof in preparing a medicament for treating rheumatoid arthritis. The glycine tomentella hayata. root is the dried root of glycine tomentella hayata., and can be conventionally decocted or pulverized and tableted to be used for treating rheumatoid arthritis. The application provided by the invention is preferably realized by preparing the extract of the glycine tomentella hayata. root. The extract of the glycine tomentella hayata. root comprises water extract and alcohol extract of the glycine tomentella hayata. root, and proven by research, the extract of the glycine tomentella hayata. root has obvious curative effects on animal models such as an acute inflammation model, a subacute inflammation model, an immunity inflammation model and the like in vivo, and down regulating the levels of proinflammatory cytokines IL-1 beta and TNF-alpha. Therefore, the extract of the glycine tomentella hayata. root can be used for preparing medicaments for treating rheumatoid arthritis.
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PURPOSE: To provide a milk-like food which has a protein component, such as natural whey protein, phosphate component, fats, carbohydrate and mineral materials which are respectively decreased to prescribed ratios and is low in protein and phosphorus and high in calcium content in spite of a high energy content. CONSTITUTION: This diet therapy food for renal failure patients has the decreased protein component and phosphate component and has the fats, carbohydrate and mineral materials. The protein component of this food is intrinsically formed of the natural protein obtd. from the whey. The food from the natural whey protein, the fats, such as vegetable fats, the carbohydrate, such as dextrin, and the mineral materials is composed to resemble cow's milk in terms of sensation and cooking technique and has a total energy content of 50 to 500kcal/100ml, of which 1 to 10% of the total energy content is formed of the protein component. The phosphorus component of the desired food is below 10mg/protein g. The calcium component may be incorporated into this food up to 300mg/100ml.
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Parkinson´s Disease (PD) affects between 4.1 and 4.6 million people in the world. The diagnosis of PD is currently clinical and based on its motor manifestations (bradykinesia, rest tremor, and rigidity). However, non-motor symptoms such as pain, fatigue, and neuropsychiatric manifestations are present in more than 70% of subjects. Pain affects about 85% of patients but is paradoxically under-reported and consequently under-treated in PD patients with a great impact on their quality of life. Levodopa, which is the election treatment in PD, has shown controversial results regarding pain sensitivity and has been shown ineffective for enhancing the endogenous pain modulation system. Furthermore, there is a lack of management protocols and nonpharmacologic treatments for pain in PD. Several syndromes are hypothesized to be involved in PD pain generation. Generally, PD patients suffer from alterations in peripheral transmission, sensitive-discriminative processing, pain perception, and pain interpretation in multiple levels, due to neurodegenerative changes in dopaminergic pathways and non-dopaminergic pain-related structures. Therefore, central mechanisms are proposed to be crucial for the development and establishment of pain in PD patients. Regarding pain processing features, PD patients have reduced pain thresholds, an augmented Temporal Summation (TS) after repetitive nociceptive stimulus, and the impairment of their Conditioned Pain Modulation (CPM) is correlated with greater severity and premature onset of the disease. Cortical excitability reduction is common in patients with pain. Therefore, diverse therapies are being developed to counteract this cortical excitability reduction and obtaining, consequently, effective pain relief. In consonance with these findings, in PD condition, especially in off state, there is also evidence of cortical excitability decrease but, to the best of investigators´ knowledge, there are no studies targeting cortical excitability to treat pain in PD. Thus, the present study proposes mental representation techniques for the treatment of PD-related pain. The mental representation techniques included in the protocol will be Action Observation (AO) and Motor Imagery (MI). The combination of AO and MI has shown to synergically increase cortical excitability, influencing the activation of cortical areas such as M1 and DLPFC. Specifically in PD, AO and MI have also demonstrated to produce corticomotor facilitation. In addition, mental representation training can produce neurophysiological activity similar to actual exercise training, which has shown to decrease the intensity and severity of pain in PD patients. The main aim of this study is to conduct an independent parallel randomized controlled trials based on AO+MI-BCI targeting changes in 1. validated general and specific PD related pain scales and 2. psychophysical measurements of pain modulation mechanisms. The investigators´ main hypothesis is that AO+MI-BCI will be superior to their respective control placebo intervention.
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High pressure to treat aggregated interferons, particularly recombinant human interferon-β, to reduce the aggregate content of interferon material. Highly pure, soluble monomeric recombinant interferon-β is prepared in representative embodiments. Multiple strategies may be used in combination that make nonglycosylated IFN-β more amenable to high pressure treatment. It has been found that refolding yields of high pressure treatment can be significantly improved by use of a combination of strategies, including, or example a pre-treatment of the IFN-β that involves solubilizing and then precipitating the protein. This pre-treatment is particularly effective with respect to recombinant IFN-β inclusion bodies recovered from host cells such as E. coli cells. According to another strategy, refolding under high pressure is much more effective when the refolding reagent incorporating the IFN-β incorporates a zwitterionic surfactant and/or a cholate salt. When a solubilization and precipitation pre-treatment is used, the effectiveness of the high pressure treatment is further enhanced when the refolding reagent incorporating the protein incorporates a disulfide shuffling chemistry such as cysteine/cystine. According to still yet another strategy, high pressure treatment is more effective when using atypically high treatment pressures. When coupled with purification techniques, these strategies singly or in combination provide a low aggregate or substantially aggregate free, biologically active solution. Biologically active solutions comprising nonglycosylated interferon, said interferon comprising less than about 5 weight percent of protein aggregation has been found to exhibit improved PK/PD characteristics.
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After microneedling, we will apply methotrexate topically (25 mg/ml) on half of the scalp at a dose of 0.02ml/cm2 with a maximum of 0.1-0.2 ml (2,5-5 mg) and rub it gently. The patient will take a session every 2 weeks for 12 weeks, on the same patient on the other patch or half of the scalp according to the pattern.
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Apply Catapres‑TTS® (clonidine transdermal system) once every 7 days to a hairless area of intact skin on the upper outer arm or chest. Each new application of Catapres‑TTS® should be on a different skin site from the previous location. If the system loosens during 7‑day wearing, the adhesive cover should be applied directly over the system to ensure good adhesion. There have been rare reports of the need for patch changes prior to 7 days to maintain blood pressure control.
To initiate therapy, Catapres‑TTS® dosage should be titrated according to individual therapeutic requirements, starting with Catapres‑TTS®-1. If after one or two weeks the desired reduction in blood pressure is not achieved, increase the dosage by adding another Catapres‑TTS®-1 or changing to a larger system. An increase in dosage above two Catapres‑TTS®-3 is usually not associated with additional efficacy.
When substituting Catapres‑TTS® for oral clonidine or for other antihypertensive drugs, physicians should be aware that the antihypertensive effect of Catapres‑TTS® may not commence until 2‑3 days after initial application. Therefore, gradual reduction of prior drug dosage is advised. Some or all previous antihypertensive treatment may have to be continued, particularly in patients with more severe forms of hypertension.
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Ninety percent of stroke survivors have clinically significant gait impairments that lead to secondary medical complications, including cardiovascular deconditioning and reduced quality of life (QOL). Several rehabilitative interventions that increase the level of activity and mobility have been shown to be beneficial. Challenges posed by most of these locomotor gait training interventions require recurring visits to a rehabilitation center. The recent development of novel powered exoskeletons offers a potential mechanism for stroke survivors to improve mobility in the home and community. Although the predominant research using these devices have been in persons with spinal cord injury, there are currently two devices are commercially available for use in patients with stroke and additional devices are being developed. The Keeogo powered orthotic exoskeleton is a novel device intended for persons with stroke who can ambulate but have gait impairment. This device consists of a ridged orthotic structure placed over clothing on the legs and batteries to the power motors that assist both knees in gait movement. The system monitors hip movement driven by the user and interprets this movement to apply the appropriate assistance at the knee joint. This unique approach makes learning intuitive, enabling the user only to acclimate to the system rather than learning how to control the device to initiate the desired movement.
This proposal is a randomized controlled pilot study. Fifteen veterans with chronic stroke (\>6months) and who retain some ability to take steps but have impaired gait will be recruited. Ten participants will be randomized into the exoskeleton group and 5 into the control group. Both groups will be asked to complete 36 one-hour sessions of ambulation training. The exoskeleton group will train using the Keeogo powered orthotic exoskeleton and the control group will train without using their own conventional aide.
The primary aim is to determine the efficacy of training with this exoskeleton and its ability to improve transfers to standing and sitting as assessed by the five times sit-to-stand test. A secondary aim will be to assess effects of the device during overground ambulation. Outcome measurements to investigate changes of knee range of motion and loading of the paretic limb. An exploratory outcome of changes in energy expenditure during ambulation with and without the powered exoskeleton. Additional exploratory outcome measures of QOL will be determined.
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The child 1) learns to become more aware of any sensations, or urges that may trigger tics, and 2) learn some other behavior (competing response) to do every time he/she feels the urge to tic. The child's parent is trained to provide prompts and praise for use of the competing response. The parent and family also receive psychoeducation about tics, and learn ways to reduce the impact of environmental stimuli on tic severity. The child learns relaxation techniques to reduce stress and make it easier for him/her to resist his or her tics. Prior to treatment sessions, the parent and child spend about 10 minutes discussing with the therapist any problematic issues he/she is having. At the end of treatment sessions the child is assigned some tasks to practice prior to the next session.
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A 12 week pilot trial will be conducted at two rural food pantries in Montana with 40 low-income adults to measure within-participant changes over time. The study will provide the initial investigation of the extent to which UP3 will improve overall dietary quality as measured by the Healthy Eating Index-2015 (HEI) compared to baseline. Psychosocial factors will be measured to understand changes in knowledge, attitudes, and perceptions about processed foods. Data on biomarkers of health (i.e., weight, systolic blood pressure, HbA1c, fasting lipid panel) will be collected to assess the feasibility of measuring potential short-term health effects of UP3.
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OBJECTIVES: To investigate the factors influencing imipenem/cilastatin (IMI) and meropenem (MEM) concentrations in critically ill adult patients and the role of these concentrations in the clinical outcome.
METHODS: Plasma trough concentrations of IMI and MEM were detected by high-performance liquid chromatography. A target value of 100%-time above MIC was used for the drugs.
RESULTS: A total of 186 patients were included, with 87 receiving IMI and 99 receiving MEM. The percentages of patients reaching the target IMI and MEM concentrations were 44.8% and 38.4%, respectively. The proportions of patients infected with drug-resistant bacteria were 57.5% and 69.7% in the IMI group and MEM group, respectively. In the multivariate analysis, the risk factors for an IMI concentration that did not reach the target were infection with drug-resistant bacteria, and those for MEM were infection with drug-resistant bacteria, estimated glomerular filtration rate, and diabetes mellitus. A total of 47.1% of patients had good outcomes in the IMI cohort, and 38.1% of patients had good outcomes in the MEM cohort. The duration of mechanical ventilation and IMI concentration were associated with ICU stay in patients in the IMI cohort, while MEM concentration and severe pneumonia affected the clinical outcome of patients in the MEM cohort.
CONCLUSION: Infection with drug-resistant bacteria is an important factor influencing whether IMI and MEM concentrations reach the target. Furthermore, IMI and MEM concentrations are associated with the clinical outcome, and elevated doses of IMI and MEM should be given to patients who are infected with drug-resistant bacteria.
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This study translated basic research from several areas of cognitive science to a new intervention procedure designed to reduce HIV risk and increase screening for HIV and other infections. A randomized trial was conducted (N = 343) to test effects on testing for infection (HIV and hepatitis B/C) and condom use frequency in a sample of drug offenders at risk for infection. Many populations of drug offenders are not currently receiving evidence-based prevention for HIV or hepatitis and are in need of effective interventions that can be used in existing drug programs. At three-month follow-up, the results revealed that the condition translating basic research on memory practice and integrative processing significantly increased the odds of infection testing as compared to two alternative conditions. This condition also significantly improved the extent of condom use, compared to a traditional health education condition. The results show promise for increased translation of basic research on memory to behavioral interventions on health and prevention science. Such procedures can be effectively applied in a complex field setting in existing drug diversion programs.
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Reproductive Toxicology: Subcutaneous studies in mice and rats at 45 and 100 mcg/kg (approximately 0.1 and 0.5 times the MRHD in adults on a mg/m2 basis, respectively) revealed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification.
In rabbits, fetal weight reduction and cleft palate were observed at a subcutaneous dose of 4 mcg/kg (approximately 0.04 times the MRHD in adults on a mg/m2 basis). However, no teratogenic effects were reported at oral doses up to 300 mcg/kg (approximately 3 times the MRHD in adults on a mg/m2 basis) of fluticasone propionate. No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see Clinical Pharmacology (12.3)].
Fluticasone propionate crossed the placenta following subcutaneous administration to mice and rats and oral administration to rabbits.
In animals and humans, propellant HFA-134a was found to be rapidly absorbed and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in animals and 5 to 7 minutes in humans. Time to maximum plasma concentration (Tmax) and mean residence time are both extremely short, leading to a transient appearance of HFA-134a in the blood with no evidence of accumulation.
Propellant HFA-134a is devoid of pharmacological activity except at very high doses in animals (i.e., 380 to 1,300 times the maximum human exposure based on comparisons of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation. These events are similar to effects produced by the structurally related CFCs, which have been used extensively in metered-dose inhalers.
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In the branched-chain amino acid (BCAA group), participants will receive oral BCAA for 24 weeks, with a daily dosage of approximately 13.68 g/day. Each sachet of BCAA will contain 6.84 g of BCAA (valine 1.82 g, leucine 3.29 g, isoleucine 1.72 g), total protein 17.08 g, carbohydrates 25.48 g, fat 5.66 g, providing 221.2 kcal of energy. Each sachet weighs 52 g and should be mixed with 150 ml of water. Participants will consume 2 sachets daily, one after breakfast and one after dinner.
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Ovariohysterectomy is a common surgical procedure in pet rabbits and one of its potential complications is postoperative gastrointestinal stasis, possibly exacerbated by prolonged surgery time. The objective of this prospective clinical study was to compare two techniques for surgical haemostasis with respect to procedural duration, postoperative pain, and return of gastrointestinal function, in 22 female rabbits undergoing ovariohysterectomy. Rabbits were assigned to one of two groups: conventional vessel ligation (CVL) and haemostasis with a vessel sealing device (VSD). The outcome variables for comparison between the two groups, recorded at 60-, 120-, 180-, and 360-minutes post anaesthesia, were duration of anaesthesia and surgery, postoperative Rabbit Grimace Scale scores, and measured food intake and faecal output. The vessel sealing device caused no appreciable blood loss. The duration of both surgery and anaesthesia was shorter in group VSD (20 ± 4 and 31 ± 6 minutes, respectively) than in group CVL (43 ± 9 and 54 ± 9 minutes, respectively) (p < 0.001). There were no differences between groups in time elapsed from the end of anaesthesia to both first food intake and first defecation. In both groups, the score of the Rabbit Grimace Scale decreased over time with statistically significant differences between 60 minutes and all the subsequent time points (p < 0.001). Vessel sealing devices may be recommended over conventional haemostasis for rabbit ovariohysterectomy to decrease the duration of surgery and anaesthesia, with potential beneficial effects on sustainability and practice workflow.
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LUNESTA is a CNS depressant and can impair daytime function in some patients at the higher doses (2 mg or 3 mg), even when used as prescribed. Prescribers should monitor for excess depressant effects, but impairment can occur in the absence of symptoms (or even with subjective improvement), and impairment may not be reliably detected by ordinary clinical exam (i.e., less than formal psychomotor testing). While pharmacodynamic tolerance or adaptation to some adverse depressant effects of LUNESTA may develop, patients using 3 mg LUNESTA should be cautioned against driving or engaging in other hazardous activities or activities requiring complete mental alertness the day after use.
Additive effects occur with concomitant use of other CNS depressants (e.g., benzodiazepines, opioids, tricyclic antidepressants, alcohol), including daytime use. Downward dose adjustment of LUNESTA and concomitant CNS depressants should be considered [see Dosage and Administration (2.4)].
The use of LUNESTA with other sedative-hypnotics at bedtime or the middle of the night is not recommended.
The risk of next-day psychomotor impairment is increased if LUNESTA is taken with less than a full night of sleep remaining (7- to 8 hours); if higher than the recommended dose is taken; if coadministered with other CNS depressants; or coadministered with other drugs that increase the blood levels of eszopiclone [see Dosage and Administration (2.3) and Clinical Studies (14.3)].
Because Lunesta can cause drowsiness and a decreased level of consciousness, patients, particularly the elderly, are at higher risk of falls.
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PROBLEM TO BE SOLVED: To obtain a food raw material for preventing obesity and Diabetes mellitus having strong α-glucosidase inhibiting activity, exhibiting suppressing effect of high blood glucose level after eating even when orally ingested in an amount capable of practically ingesting in practical application, capable of safely, inexpensively and readily producing and a food containing the food raw material by including Pelvetia wrightii Okamura. SOLUTION: This food raw material comprises Pelvetia wrightii Okamura. The food raw material is obtained by extracting Pelvetia wrightii Okamura with water or an organic solvent such as an alcohol (e.g. methanol). The above extraction method includes a method for adding preferably 10-70 vol.% methanol aqueous solution in an amount of 3-10 times by weight based on weight of Pelvetia wrightii Okamura to Pelvetia wrightii Okamura, mechanically powdering Pelvetia wrightii Okamura and carrying out centrifugal separation and concentration, etc., of the mixture. The food raw material is useful for health foods.
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This study will be a 2 arm controlled clinical trial (CCT) comparing usual care to usual care plus MBSR. Participants will be residents of a local inpatient treatment facility for adolescents with serious mental health issues. Outcomes the investigators will measure include mental health status as well as mindfulness. The investigators will also conduct qualitative interviews to assess the personal impact of the intervention on the patients and their families. In order to map and measure cognitive changes during MBSR the investigators will conduct brain imaging using functional magnetic resonance imaging (fMRI) and Event-Related Potential (ERP) recordings. Through this study the investigators will determine if MBSR is helpful to our population.
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An insulin preparation having a protracted effect comprises the reaction product of insulin e.g. amorphous and crystalline insulin, and an isothiocyanate of aliphatic, aromatic, isocyclic, or heterocyclic compounds e.g. phenyl, ethyl, alkyl or octyl isothiocyanate. The isothiocyanate may be stirred into an aqueous alkaline solution of the insulin e.g. in a phosphate or borate buffer solution, at room temperature, and the required product separated as a solid precipitate or aqueous layer. Reference is made to the production of insulin isocyanate. The insulin may be prepared by the process of U.S.A. Specification 2,595,278.
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AIM: To elucidate the biological functionality and regulatory mechanisms of GdX in breast cancer (BC).
METHODS: The examination of GdX expression in human BC tissues and cell lines was conducted through immunohistochemical (IHC) and Western blot. Cell proliferation capacity was assessed via the CCK-8 and colony formation assay, while cell migration was determined through the wound healing assay. The expression levels of BCL-XL, Cyclin D1, and C-myc gene were quantified using RT-qPCR and Western blot. In vivo tumor growth was evaluated in nude mice xenografted with MDA-MB-231 cells overexpressing GdX, and a mouse model with GdX-deficient BC was established to observe the impact of GdX on BC formation and metastasis. Dual-luciferase reporter assay and immunofluorescence were employed to confirm the interaction between GdX and STAT3. Western blot was employed to validate the influence of GdX overexpression on the phosphorylation process of STAT3.
RESULTS: GdX exhibited low expression in the cancer tissues of BC patients and cell lines. MDA-MB-231 and MCF-7 cells overexpressing GdX displayed a notable reduction in proliferation and diminished migratory capabilities, accompanied by downregulated mRNA and protein expression of BCL-XL, Cyclin D1, and C-myc. In the xenograft mouse model, heightened GdX expression correlated with a decelerated in vivo tumor growth. Furthermore, in mice deteleing GdX, both the quantity and weight of tumors increased, along with evident pulmonary metastasis. Mechanistically, STAT3 emerged as a downstream target gene of GdX.
CONCLUSIONS: GdX exerts its inhibitory effects on the initiation and progression of BC by negatively modulating the phosphorylation of STAT3.
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There has been virtually no experience with overdosage with ranitidine injection and limited experience with oral doses of ranitidine. Reported acute ingestions of up to 18 g orally have been associated with transient adverse effects similar to those encountered in normal clinical experience (see ADVERSE REACTIONS). In addition, abnormalities of gait and hypotension have been reported.
When overdosage occurs, clinical monitoring and supportive therapy should be employed.
Studies in dogs receiving dosages of ranitidine hydrochloride in excess of 225 mg/kg/day have shown muscular tremors, vomiting, and rapid respiration. Single oral doses of 1,000 mg/kg in mice and rats were not lethal. Intravenous LD50 values in mice and rats were 77 and 83 mg/kg, respectively.
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Part1:Investigators will conduct this study to find the effectiveness of cystoinflation to prevent bladder injury in women with adhesions of previous C-sections. This prospective analytic longitudinal study will be conducted in Lady Willingdon Hospital, a tertiary care teaching hospital affiliated with King Edward Medical University Pakistan, from August 2017 to July 2019, after approval by the institutional review board of King Edward Medical University, Pakistan. The subjects will be randomly allocated to cystoinflation and control groups. The healthy pregnant women with previous operative deliveries admitted for elective C-section will be counselled and conditioned informed consent will be taken to be included in either study group if dense pelvic adhesions will be found during their operation. Adhesiolysis will be performed using bladder retro-fill with 300cc saline in the cystoinflation group, and without retro-fill in control. We will assess primary outcome by observing bladder injury rate, blood loss and operative time. The secondary outcome will be assessed by Urinary tract infection, micturition problems and fistula formation during 3month follow up period. The cystoinflation will be considered effective if the proportion of bladder injury in the study group will be less than 50% of the control group.
Part2\&3:Details of part2\&3 will be provided after publication
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INTRODUCTION: The aim of this study was to evaluate whether a forensic odontologist working remotely could accurately undertake forensic dental identifications using videos produced by non-dental forensic staff operating an intra-oral video camera (IOVC). The study's aims were to assess the accuracy and time taken to perform remote forensic dental identifications in this manner.
MATERIALS AND METHODS: Eight cadavers from the Centre for Anatomy and Human Identification (CAHID), University of Dundee, UK, were examined by a forensic odontologist via a traditional dental examination. Their dental condition was recorded to serve as ante-mortem records for this study. Videos of each dentition were produced using an IOVC operated by a medical student. Post-mortem records were produced for each dentition from the videos by a remote second forensic odontologist who was not present at the traditional dental examination. The ante-mortem and post-mortem records were then compared, and identification was classified as positively established, possible or excluded.
RESULTS: Established identifications were positively made in all eight cases although there were some non-critical inconsistencies between ante-mortem and post-mortem records. Before the second opinion, 85.6% of the teeth per study subject were charted consistently. After the second opinion, the percentage of consistency increased to 97.2%. Each video on average was about 4.13 minutes in duration and the average time taken to interpret and chart the post-mortem dental examination at the first attempt was 11.63 minutes. The time taken to chart from the videos was greater than is typical of a traditional dental examination.
CONCLUSION: This pilot study supports the feasibility of undertaking remote dental identification. This novel "tele-dental virtopsy" approach could be a viable alternative to a traditional post-mortem dental examination, in situations where access to forensic dental services is difficult or limited due to geographical, logistical, safety, and/or political reasons.
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System comprising means 2 for transmitting nutritional information from a food item 1; means for transmitting the nutritional information to a server at a time t1 and for transmitting physiological information of a user following consumption of the food item to the server at a time t2; and means for providing updated physiological information to the user at a time t3 based on the nutritional information and the physiological information. May comprise means for providing updated physiological information to the user based on information provided by the user at a time t4. The means for transmitting nutritional information from a food item may comprise a NFC transmitter, which may be integrated into packaging of the food item. The nutritional information may comprise a food type, ingredients, calorie, macronutrient or micronutrient content of the food item. The means for transmitting the nutritional information to the server and for providing physiological information of the user may comprise a smart phone, smart watch, wearable smart device, smart clothing, smart shoes, or wearable body sensor. Also provided is a smart device configured to receive nutritional information from a food item without user input and transmit the information to a server.
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Itraconazole decreases busulfan clearance by up to 25%. Metronidazole decreases the clearance of busulfan to a greater extent than does itraconazole; metronidazole coadministration has been associated with increased busulfan toxicity. Fluconazole (200 mg) has been used with busulfan.
Decreased clearance of busulfan was observed with concomitant use with deferasirox. The mechanism of this interaction is not fully elucidated. Discontinue iron chelating agents well in advance of administration of busulfan to avoid increased exposure to busulfan.
Because busulfan is eliminated from the body via conjugation with glutathione, use of acetaminophen prior to (less than 72 hours) or concurrent with busulfan may result in reduced busulfan clearance based upon the known property of acetaminophen to decrease glutathione levels in the blood and tissues.
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Cardiac surgery is a recommended therapeutic option as a form of secondary prevention for the treatment of cardiovascular diseases, but may present postoperative alterations such as reduction of pulmonary volumes and flows, impairment in gas exchange and increase in the rate of pulmonary complications. The use of positive pressure may reduce these complications. Objective: To evaluate the efficacy of positive expiratory pressure (PEP) in the blow-bottle device compared to expiratory positive airway pressure (EPAP), both associated with conventional physiotherapy, and conventional physiotherapy in the pulmonary function in postoperative cardiac patients. Methods:This is a randomized clinical trial, with patients in postoperative cardiac surgery. On the first day of postoperative, the patients will be randomized into three groups: 1 group that will receive positive expiratory pressure with blow-bottle device associated with conventional physiotherapy; 2- group that will receive positive expiratory pressure in the airways with valve unidirectional therapy associated with conventional physiotherapy; 3- group that will only receive conventional physiotherapy. The intervention of the positive expiratory pressure with blow-bottle device group will consist of exercise with a blow-bottle device of 10 cm high; the positive expiratory pressure in the airways group, exercise with unidirectional positive expiratory pressure valve (10cmH2O). Both the groups will perform three sets of 10 repetitions per day, by the third day of PO. The third group will receive conventional physiotherapy of intensive care unit. The outcomes evaluated will be: pulmonary function (primary), respiratory muscle strength, pulmonary complications, radiological changes and length of stay (at the Intensive CareUnit - ICU - and hospital). Assessment of pulmonary function, muscle strength and radiological changes will be performed in the preoperative period, prior to the interventions and on the third postoperative day, immediately prior to discharge of cardiac intensive care unit. Pulmonary complications and ICU length of stay will be recorded after discharge from intensive care unit cardiac. The length of hospital stay was recorded after hospital discharge.
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PURPOSE: Intracerebral metastases present a substantial risk of tumor-associated intracerebral hemorrhage (ICH). This study aimed to investigate the risk of hemorrhagic events in brain metastases (BM) from various primary tumor sites and evaluate the safety and outcomes of surgical tumor removal.
METHODS: A retrospective, single-center review of medical records was conducted for patients who underwent BM removal between January 2016 and December 2017. Patients with hemorrhagic BM were compared to those with non-hemorrhagic BM. Data on preoperative predictors, perioperative management, and postoperative outcomes were collected and analyzed.
RESULTS: A total of 229 patients met the inclusion criteria. Melanoma metastases were significantly associated with preoperative hemorrhage, even after adjusting for confounding factors (p = 0.001). Poor clinical status (p = 0.001), larger tumor volume (p = 0.020), and unfavorable prognosis (p = 0.001) independently predicted spontaneous hemorrhage. Importantly, preoperative use of anticoagulant medications was not linked to increased hemorrhagic risk (p = 0.592). Surgical removal of hemorrhagic BM, following cessation of blood-thinning medication, did not significantly affect intraoperative blood loss, surgical duration, or postoperative rebleeding risk (p > 0.096). However, intra-tumoral hemorrhage was associated with reduced overall survival (p = 0.001).
CONCLUSION: This study emphasizes the safety of anticoagulation in patients with BM and highlights the safety of neurosurgical treatment in patients with hemorrhagic BM when blood-thinning medication is temporarily paused. The presence of intra-tumoral hemorrhage negatively impacts survival, highlighting its prognostic significance in BM patients. Further research with larger cohorts is warranted to validate these findings and elucidate underlying mechanisms.
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SWI/SNF chromatin remodeling complexes play a key role in gene transcription as epigenetic regulators and are typically considered to act as tumor suppressors in cancers. Compared to other cancer-related components of the SWI/SNF complex, research on SMARCC2, a component of the initial BAF core, has been relatively limited. This study aimed to elucidate the role of SMARCC2 in breast cancer by employing various in vitro and in vivo methods including cell proliferation assays, mammosphere formation, and xenograft models, complemented by RNA-seq, ATAC-seq, and ChIP analyses. The results showed that SMARCC2 silencing surprisingly led to the suppression of breast tumorigenesis, indicating a pro-tumorigenic function for SMARCC2 in breast cancer, which contrasts with the roles of other SWI/SNF subunits. In addition, SMARCC2 depletion reduces cancer stem cell features of breast cancer cells. Mechanistic study showed that SMARCC2 silencing downregulated the oncogenic Ras-PI3K signaling pathway, likely by directly regulating the chromatin accessibility of the enhancers of the key genes such as PIK3CB. Together, these results expand our understanding of the SWI/SNF complex's role in cancer development and identify SMARCC2 as a promising new target for breast cancer therapies.
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See WARNINGS box above.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to the fetus or newborns have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Reproduction studies of amikacin have been performed in rats and mice and revealed no evidence of impaired fertility or harm to the fetus due to amikacin. There are no well controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Amikacin Sulfate Injection, USP, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Risk of Ototoxicity Due to Mitochondrial DNA Variants
Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m. 1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
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Take INTUNIV orally once daily, either in the morning or evening, at approximately the same time each day. Begin at a dose of 1 mg/day, and adjust in increments of no more than 1 mg/week.
In monotherapy clinical trials, there was dose- and exposure-related clinical improvement as well as risks for several clinically significant adverse reactions (hypotension, bradycardia, sedative events). To balance the exposure-related potential benefits and risks, the recommended target dose range depending on clinical response and tolerability for INTUNIV® is 0.05-0.12 mg/kg/day (total daily dose between 1-7 mg) (See Table 1).
In the adjunctive trial which evaluated INTUNIV® treatment with psychostimulants, the majority of patients reached optimal doses in the 0.05-0.12 mg/kg/day range. Doses above 4 mg/day have not been studied in adjunctive trials.
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TIL from bladder biopsies will be propagated and cultured with interleukin-2 (IL-2) to a target goal of \>30 million cells. These TIL then undergo rapid clonal expansion (REP) by incubation with anti-CD3 monoclonal antibody (mAb), resulting in \>500-fold expansion. After 4-6 weeks culture time intravesical TIL will be administered via intravesical infusion, consisting of up to 3.2e8 cells in 40 mL aliquot. Intravesical therapy will be administered for up to 2 hours. This treatment will occur four times (Day 0, Day 7, Day 14 and Day 21).
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Carefully consider the potential benefits and risks of VICOPROFEN and other treatment options before deciding to use VICOPROFEN. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with VICOPROFEN, the dose and frequency should be adjusted to suit an individual patient's needs.
For the short-term (generally less than 10 days) management of acute pain, the recommended dose of VICOPROFEN is one tablet every 4 to 6 hours, as necessary. Dosage should not exceed 5 tablets in a 24-hour period. It should be kept in mind that tolerance to hydrocodone can develop with continued use and that the incidence of untoward effects is dose related.
The lowest effective dose or the longest dosing interval should be sought for each patient (see WARNINGS), especially in the elderly. After observing the initial response to therapy with VICOPROFEN, the dose and frequency of dosing should be adjusted to suit the individual patient's need, without exceeding the total daily dose recommended.
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Postoperative ileus (POI) is the leading cause of prolonged hospital stay after abdominal surgery and is characterized by a functional paralysis of the digestive tract, leading to symptoms such as constipation, vomiting, and functional obstruction. Current treatments are mainly supportive and inefficacious and yield acute side effects. Although electrical stimulation studies have demonstrated encouraging pacing and entraining of the intestinal slow waves, no devices exist today to enable targeted intestinal reanimation. Here, we developed an ingestible self-propelling device for intestinal reanimation (INSPIRE) capable of restoring peristalsis through luminal electrical stimulation. Optimizing mechanical, material, and electrical design parameters, we validated optimal deployment, intestinal electrical luminal contact, self-propelling capability, safety, and degradation of the device in ex vivo and in vivo swine models. We compared the INSPIRE's effect on motility in models of normal and depressed motility and chemically induced ileus. Intestinal contraction improved by 44% in anesthetized animals and up to 140% in chemically induced ileus cases. In addition, passage time decreased from, on average, 8.6 days in controls to 2.5 days with the INSPIRE device, demonstrating significant improvement in motility. Luminal electrical stimulation of the intestine via the INSPIRE efficaciously restored peristaltic activity. This noninvasive option offers a promising solution for the treatment of ileus and other motility disorders.
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As with other agents administered either intravenously or intramuscularly, careful supervision of dose and rate of injection should be observed. Rate of injection should not exceed 3 mL per minute-i.e., one 10 mL vial in approximately three minutes. Since Methocarbamol Injection is hypertonic, vascular extravasation must be avoided. A recumbent position will reduce the likelihood of side reactions.
Blood aspirated into the syringe does not mix with the hypertonic solution. This phenomenon occurs with many other intravenous preparations. The blood may be injected with the methocarbamol, or the injection may be stopped when the plunger reaches the blood, whichever the physician prefers.
The total dosage should not exceed 30 mL (three vials) a day for more than three consecutive days except in the treatment of tetanus.
Caution should be observed in using the injectable form in patients with suspected or known seizure disorders.
Information for Patients
Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery. Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
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In adult patients with primary (thyroidal) hypothyroidism, serum TSH levels (using a sensitive assay) alone may be used to monitor therapy. The frequency of TSH monitoring during levothyroxine dose titration depends on the clinical situation but it is generally recommended at 6-8 week intervals until normalization. For patients who have recently initiated levothyroxine therapy and whose serum TSH has normalized or in patients who have had their dosage of levothyroxine changed, the serum TSH concentration should be measured after 8-12 weeks. When the optimum replacement dose has been attained, clinical (physical examination) and biochemical monitoring may be performed every 6-12 months, depending on the clinical situation, and whenever there is a change in the patient's status. It is recommended that a physical examination and a serum TSH measurement be performed at least annually in patients receiving Levothyroxine Sodium Tablets, USP. (see WARNINGS, PRECAUTIONS and DOSAGE AND ADMINISTRATION).
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Osteosarcoma (OS) is the most common primary malignant tumour of the bone with high mortality. Here, we comprehensively analysed the hypoxia signalling in OS and further constructed novel hypoxia-related gene signatures for OS prediction and prognosis. This study employed Gene Set Enrichment Analysis (GSEA), Weighted correlation network analysis (WGCNA) and Least absolute shrinkage and selection operator (LASSO) analyses to identify Stanniocalcin 2 (STC2) and Transmembrane Protein 45A (TMEM45A) as the diagnostic biomarkers, which further assessed by Receiver Operating Characteristic (ROC), decision curve analysis (DCA), and calibration curves in training and test dataset. Univariate and multivariate Cox regression analyses were used to construct the prognostic model. STC2 and metastasis were devised to forge the OS risk model. The nomogram, risk score, Kaplan Meier plot, ROC, DCA, and calibration curves results certified the excellent performance of the prognostic model. The expression level of STC2 and TMEM45A was validated in external datasets and cell lines. In immune cell infiltration analysis, cancer-associated fibroblasts (CAFs) were significantly higher in the low-risk group. And the immune infiltration of CAFs was negatively associated with the expression of STC2 (P < 0.05). Pan-cancer analysis revealed that the expression level of STC2 was significantly higher in Esophageal carcinoma (ESCA), Head and Neck squamous cell carcinoma (HNSC), Kidney renal clear cell carcinoma (KIRC), Lung squamous cell carcinoma (LUSC), and Stomach adenocarcinoma (STAD). Additionally, the higher expression of STC2 was associated with the poor outcome in those cancers. In summary, this study identified STC2 and TMEM45A as novel markers for the diagnosis and prognosis of osteosarcoma, and STC2 was shown to correlate with immune infiltration of CAFs negatively.
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The recommended starting dose for SAD is 150 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 300 mg once daily in the morning. Doses above 300 mg of bupropion hydrochloride extended-release were not assessed in the SAD trials.
For the prevention of seasonal MDD episodes associated with SAD, initiate Wellbutrin XL in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue Wellbutrin XL in early spring. For patients treated with 300 mg per day, decrease the dose to 150 mg once daily before discontinuing Wellbutrin XL. Individualize the timing of initiation, and duration of treatment should be individualized, based on the patient’s historical pattern of seasonal MDD episodes.
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Oxytocin has long been thought to play a substantial role in social behaviors, such as social attachment and parenting behavior. However, how oxytocin neurons respond to social and non-social stimuli is largely unknown, especially in high temporal resolution. Here, we recorded the in vivo real-time responses of oxytocin neurons in the paraventricular nucleus of the hypothalamus (PVN) in freely behaving mice. Our results revealed that oxytocin neurons were activated more significantly by stressors than social stimuli. The activation of oxytocin neurons was precisely correlated with struggling behavior during stress. Furthermore, we found that oxytocin mediated stress-induced social memory impairment. Our results reveal an important role of PVN oxytocin neurons in stress-induced social amnesia.
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Cassava common mosaic virus (CsCMV, genus Potexvirus) is a prevalent virus associated with cassava mosaic disease, so it is essential to elucidate the underlying molecular mechanisms of the coevolutionary arms race between viral pathogenesis and the cassava (Manihot esculenta Crantz) defense response. However, the molecular mechanism underlying CsCMV infection is largely unclear. Here, we revealed that coat protein (CP) acts as a major pathogenicity determinant of CsCMV via a mutant infectious clone. Moreover, we identified the target proteins of CP-related to abscisic acid insensitive3 (ABI3)/viviparous1 (VP1) (MeRAV1) and MeRAV2 transcription factors, which positively regulated disease resistance against CsCMV via transcriptional activation of melatonin biosynthetic genes (tryptophan decarboxylase 2 (MeTDC2), tryptamine 5-hydroxylase (MeT5H), N-aceylserotonin O-methyltransferase 1 (MeASMT1)) and MeCatalase6 (MeCAT6) and MeCAT7. Notably, the interaction between CP, MeRAV1, and MeRAV2 interfered with the protein phosphorylation of MeRAV1 and MeRAV2 individually at Ser45 and Ser44 by the protein kinase, thereby weakening the transcriptional activation activity of MeRAV1 and MeRAV2 on melatonin biosynthetic genes, MeCAT6 and MeCAT7 dependent on the protein phosphorylation of MeRAV1 and MeRAV2. Taken together, the identification of the CP-MeRAV1 and CP-MeRAV2 interaction module not only illustrates a molecular mechanism by which CsCMV orchestrates the host defense system to benefit its infection and development but also provides a gene network with potential value for the genetic improvement of cassava disease resistance.
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<P>PROBLEM TO BE SOLVED: To provide an additive for imparting pseudo-spa water quality to daily life water such as city water, ground water or the like which is used as bath water. <P>SOLUTION: The additive for bath comprises an alkaline inorganic component and a polycarboxylic acid salt similar to those in a natural spa. As the alkaline inorganic component, any carbonate salt such as sodium hydrogen carbonate, sodium carbonate, sodium sesquicarbonate, potassium hydrogen carbonate, potassium carbonate and potassium sesquicarbonate are used as a simple substance or a mixture thereof, wherein the compounding ratio thereof is adjusted so that the pH value of the resultant mixture as a hot bath falls within the range of 9-11. In addition to the alkaline inorganic component above, a sodium or potassium salt of an organic polycarboxylic acid bearing at least two carboxy groups in one molecule is used in an amount within 0.00005-2% by weight in a water bath finally used. Thus, hot bath effects on bathing are enhanced and a spa-like feeling is attained. <P>COPYRIGHT: (C)2009,JPO&INPIT
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PURPOSE: Chronic, high-altitude hypoxic exposure increases the risk of high-altitude pulmonary hypertension (PH). Emerging evidence shows maternal exercise may improve offspring resistance to disease throughout life. The purpose of this study is to determine if maternal exercise mitigates chronic hypoxic-induced changes in the offspring indicative of high-altitude PH development.
METHODS: Female adult C57BL/6J mice were randomly allocated to nonexercise or exercise conditions. Exercise consisted of voluntary running wheel exercise for 4 wk during the perinatal period. Three days after birth, the pups remained at low altitude (normoxia) or were exposed to hypobaric hypoxia of 450 mm Hg to simulate ~4500 m of altitude exposure until 8 wk of age. The study consisted of four groups: hypoxia + nonexercise pregnancy, hypoxia + exercise, or the respective normoxia conditions (normoxia + nonexercise or normoxia + exercise). Offspring body size, motor function, right ventricular systolic pressure (RVSP), and cardiopulmonary morphology were assessed after 8 wk in normoxia or hypoxia.
RESULTS: Both hypoxic groups had smaller body sizes, reduced motor function, increased hematocrit, RVSP, muscularization in medium-sized pulmonary arteries, as well as right ventricular hypertrophy and contractility compared with the normoxic groups ( P < 0.05).
CONCLUSIONS: Chronic hypoxia simulating 4500 m attenuated growth, lowered motor function, and elicited PH development. Voluntary maternal exercise did not significantly decrease RVSP in the offspring, which aligned with a lack of effect to attenuate abnormal body size and cardiopulmonary development due to chronic hypoxia. These findings are preliminary in nature, and more powered studies through larger group sizes are required to generalize the results to the population.
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Prepn. of porous silica gel powder of low density comprises: (a) adding an acid soln. to a basic aq. silicate soln. to cause neutralisation; (b) forming a hydrosol from the above reaction mixt.; (c) gelling the hydrosol to give a hydrogel and then destroying this to give a silica gel slurry; (d) sepg., washing, drying and decomposing the hydrogel slurry. In step (a) mixing the solns. is carried out by spraying, in order to achieve partial neutralisation of the reaction mixt. at pH 11.6 or more, and then further adding acid soln. to give a reaction mixt. of pH 10.8-11.4.
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OBJECTIVE: Deep brain stimulation (DBS) is an effective treatment for medically refractory movement disorders and other neurological conditions. To comprehensively characterize the prevalence, locations, timing of detection, clinical effects, and risk factors of DBS-related intracranial hemorrhage (ICH), the authors performed a systematic review of the published literature.
METHODS: PubMed, EMBASE, and Web of Science were searched using 2 concepts: cerebral hemorrhage and brain stimulation, with filters for English, human studies, and publication dates 1980-2023. The inclusion criteria were the use of DBS intervention for any human neurological condition, with documentation of hemorrhagic complications by location and clinical effect. Studies with non-DBS interventions, no documentation of hemorrhage outcome, patient cohorts of ≤ 10, and pediatric patients were excluded. The risk of bias was assessed using Centre for Evidence-Based Medicine Levels of Evidence. The authors performed proportional meta-analysis for ICH prevalence.
RESULTS: A total of 63 studies, with 13,056 patients, met the inclusion criteria. The prevalence of ICH was 2.9% (fixed-effects model, 95% CI 2.62%-3.2%) per patient and 1.6% (random-effects model, 95% CI 1.34%-1.87%) per DBS lead, with 49.6% being symptomatic. The ICH rates did not change with time. ICH most commonly occurred around the DBS lead, with 16% at the entry point, 31% along the track, and 7% at the target. Microelectrode recording (MER) during DBS was associated with increased ICH rate compared to DBS without MER (3.5 ± 2.2 vs 2.1 ± 1.4; p[T ≤ t] 1-tail = 0.038). Other reported ICH risk factors include intraoperative systolic blood pressure > 140 mm Hg, sulcal DBS trajectories, and multiple microelectrode insertions. Sixty percent of ICH was detected at 24 hours postoperatively and 27% intraoperatively. The all-cause mortality rate of DBS was 0.4%, with ICH accounting for 22% of deaths. Single-surgeon DBS experience showed a weak inverse correlation (r = -0.27, p = 0.2189) between the rate of ICH per lead and the number of leads implanted per year.
CONCLUSIONS: This study provides level III evidence that MER during DBS is a risk factor for ICH. Other risk factors include intraoperative systolic blood pressure > 140 mm Hg, sulcal trajectories, and multiple microelectrode insertions. Avoidance of these risk factors may decrease the rate of ICH.
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INTRODUCTION: Chronic non-specific low back pain (CNLBP) is among the most common musculoskeletal system conditions reported worldwide; however, few studies are available from low- and middle-income countries (LMICs). Self-management is a set of tasks performed by the patient aiming at managing their symptoms and interference in activities, mood and relationships due to pain. A physiotherapy-guided self-management programme (SMP) following a biopsychosocial approach has been reported as effective and affordable in the management of CNLBP in high-income countries. The objective of this systematic review is to determine the overall effectiveness of SMPs for adults with CNLBP in LMICs.
METHODS AND ANALYSIS: In this systematic review, the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Protocol (PRISMA-P) guidelines will be followed. A three-step search strategy will be used to search the electronic databases (PubMed, MEDLINE, SPORTDiscus, Scopus and CINAHL, Academic Search Complete and PEDro) for randomised controlled trials assessing the effectiveness of physiotherapy-guided self-management for CNLBP among adult participants in LMICs. The processes of screening search results for eligible studies, extracting data from included studies and appraising will be done independently by at least two review authors. Random effects meta-analysis will be used to synthesise results and heterogeneity will be assessed using the I2 test statistic and χ2 test.
ETHICS AND DISSEMINATION: Ethics clearance was obtained for the broader PhD study on the development of a physiotherapy-guided SMP for adult people with CNLBP in Limpopo Province, South Africa. The results of the manuscript for this protocol will be published in peer-reviewed journals and also presented at conferences, symposia, and congresses.
PROSPERO REGISTRATION NUMBER: CRD42023399572.
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High dose radiation exposures are rare. However, medical management of such incidents is crucial due to mortality and tissue injury risks. Rapid radiation biodosimetry of high dose accidental exposures is highly challenging, considering that they usually involve non uniform fields leading to partial body exposures. The gold standard, dicentric assay and other conventional methods have limited application in such scenarios. As an alternative, we propose Premature Chromosome Condensation combined with Fluorescent In-situ Hybridization (G0-PCC-FISH) as a promising tool for partial body exposure biodosimetry. In the present study, partial body exposures were simulated ex-vivo by mixing of uniformly exposed blood with unexposed blood in varying proportions. After G0-PCC-FISH, Dolphin's approach with background correction was used to provide partial body exposure dose estimates and these were compared with those obtained from conventional dicentric assay and G0-PCC-Fragment assay (conventional G0-PCC). Dispersion analysis of aberrations from partial body exposures was carried out and compared with that of whole-body exposures. The latter was inferred from a multi-donor, wide dose range calibration curve, a-priori established for whole-body exposures. With the dispersion analysis, novel multi-parametric methodology for discerning the partial body exposure from whole body exposure and accurate dose estimation has been formulated and elucidated with the help of an example. Dose and proportion dependent reduction in sensitivity and dose estimation accuracy was observed for Dicentric assay, but not in the two PCC methods. G0-PCC-FISH was found to be most accurate for the dose estimation. G0-PCC-FISH has potential to overcome the shortcomings of current available methods and can provide rapid, accurate dose estimation of partial body and high dose accidental exposures. Biological dose estimation can be useful to predict progression of disease manifestation and can help in pre-planning of appropriate & timely medical intervention.
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We are currently screening women (approximately 535) from whom we expect 400 HIV-negative high-risk, non-pregnant NIDU women will be enrolled to participate in a two-arm randomized trial of an enhanced HIV risk reduction intervention plus an enhanced vaccine education intervention compared to controls. At screening, women complete an assessment, receive HIV and HBV pre-test counseling, and are tested for HIV antibody, markers of hepatitis B virus (HBV) infection and pregnancy. At the enrollment visit (2 weeks later), eligible and willing participants are randomized to receive either the enhanced HIV risk reduction intervention plus the enhanced vaccine education intervention or control conditions. Enrolled women provide urine for pregnancy testing. Enrolled women found to be susceptible to HBV are offered hepatitis B (HB) vaccine at the enrollment visit. Follow-up visits coincide with the HB vaccine schedule (1 and 6 months post enrollment) for all women, regardless of whether or not they received HB vaccine. Pregnancy testing is conducted at these follow-up visits. Participants provide sera for HIV antibody testing at the 6- and 12-months visits. A final visit will occur at 12 months post enrollment to assess longer term effects on risk behaviors and knowledge and understanding of vaccine concepts. All standardized interviews are conducted using Audio Computer Assisted Self-Interview (ACASI) technology.
The enhanced HIV risk reduction intervention is a series of three, interactive, individually-delivered, counseling sessions. The enhanced sessions also include tailored male and female condom demonstrations to build skills, and each session concludes with a client-initiated sexual risk reduction goal. The follow-up sessions (at 1 and 6 months) resume by reviewing goal attainment, exploring the reasons and beliefs associated with progress toward that goal. The control group receives the client-centered HIV counseling based on the Centers for Disease Control and Prevention (CDC) Project RESPECT model. Both the control and enhanced risk reduction counseling are delivered at the baseline (time 0) and at follow up visits (1 month and 6 months).
The enhanced vaccine education component will test the two-session model informed consent process outlined by Coletti et al but enhanced with simplified illustrated educational material delivered through flipcharts, video and individual counseling at baseline and 1 week later. The control condition is based on the Coletti two-session informed consent process.
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Variants of coagulation factor VIII (FVIII) and expression cassettes encoding the FVIII variants thereof are described. A variant FVIII includes a glycoepitope of the FVIII protein including an N2118Q mutation. The N2118Q mutation can be combined with other mutations including a BDD-FVIII, N6, V3, RH, furin-cleavage site deletion, X10, K12, and/or F309S mutation to form additional FVIII variants. The FVIII variants with the N2118Q mutation and expression cassettes thereof can result in reduced immunogenicity of the resulting protein. When combined with other FVIII mutations, higher gene expression, increased secretion, increased stability, and higher FVIII functional activity can be achieved by the expressed FVIII variants. The variant FVIII and expression cassettes described here can be useful in protein replacement therapy and/or gene therapy for the treatment of hemophilia A.
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Telmisartan
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ARBs, including telmisartan, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. The antihypertensive effect of ARBs may be attenuated by NSAIDs. Therefore, monitor renal function and blood pressure periodically in patients receiving telmisartan and hydrochlorothiazide tablets and NSAIDs.
Hydrochlorothiazide
Administration of a non-steroidal anti-inflammatory agent, including a selective COX-2 inhibitor, can reduce the diuretic, natriuretic, and antihypertensive effects of diuretics. Therefore, when telmisartan and hydrochlorothiazide tablets and non- steroidal anti-inflammatory agents including selective COX-2 inhibitors are used concomitantly, observe closely to determine if the desired effect of the diuretic is obtained.
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Participants attend 4 sessions (1.5 hours each) consisting of education and skills training to address cancer-related concerns. Sessions occur via videoconference.
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The use of sumatriptan and naproxen sodium tablets is contraindicated in patients with ischemic or vasospastic coronary artery disease (CAD) and in the setting of coronary artery bypass graft (CABG) surgery due to increased risk of serious cardiovascular events with sumatriptan and NSAIDS [see Contraindications (4)].
Cardiovascular Events with Sumatriptan
There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of sumatriptan. Some of these reactions occurred in patients without known CAD. Sumatriptan and naproxen sodium tablets may cause coronary artery vasospasm (Prinzmetal’s angina), even in patients without a history of CAD.
Cardiovascular Thrombotic Events with Nonsteroidal Anti-inflammatory Drugs
Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.
To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as naproxen, increases the risk of serious gastrointestinal (GI) events [see Warnings and Precautions (5.2)].
Status Post Coronary Artery Bypass Graft (CABG) Surgery
Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see Contraindications (4)].
Post-MI Patients
Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Perform a cardiovascular evaluation in patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) prior to receiving sumatriptan and naproxen sodium tablets. If there is evidence of CAD or coronary artery vasospasm, sumatriptan and naproxen sodium tablets are contraindicated. For patients with multiple cardiovascular risk factors who have a negative cardiovascular evaluation, consider administering the first dose of sumatriptan and naproxen sodium tablets in a medically supervised setting and performing an electrocardiogram (ECG) immediately following administration of sumatriptan and naproxen sodium tablets. For such patients, consider periodic cardiovascular evaluation in intermittent long-term users of sumatriptan and naproxen sodium tablets.
Physicians and patients should remain alert for the development of cardiovascular events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the signs and/or symptoms of serious cardiovascular events and the steps to take if they occur.
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Acupuncture is used as an adjuvant therapy for Alzheimer's disease (AD), but available evidence for efficacy is weak. Growing studies suggest that resident gut microbiota contributes to the development and progression of AD. Acupuncture is reported to treat gastrointestinal and neurodegenerative disorders via the gut-brain axis. The aim is to determine if adjunctive acupuncture acts as an AD treatment rather than a placebo, and identify if benefits are linked to shifts of the gut microbiota.
This is a randomized, participant-masked, sham-controlled trial. One hundred and sixty participants with mild AD will be randomly assigned (1:1) to either active acupuncture or non-penetrating sham acupuncture (3 times weekly for 14 weeks) added to donepezil treatment (5 mg per day for 28 weeks). The primary efficacy outcome is the change from baseline to week 28 in the Alzheimer's disease Assessment Scale (ADAS-cog12). Secondary efficacy outcomes include other assessments of the Mini-Mental State Examination (MMSE), the Alzheimer's disease Cooperative Study-Activities of Daily Living (ADCS-ADL), Neuropsychiatric Inventory (NPI) and gut microbiota.
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The therapeutic effects of alpha lipoic acid (LA) and/or caffeine-loaded chitosan nanoparticles (CCNPs) on obesity-induced memory impairment were evaluated in the present study. Rats were divided into control rats, obese rats induced by high fat diet (HFD) and obese rats treated with LA and/or CCNPs. Obesity was confirmed by measuring the body mass index (BMI). Memory and cognitive functions were evaluated by novel object recognition test (NORT). The levels of serotonin (5-HT), dopamine (DA), norepinephrine (NE), lipid peroxidation (MDA), nitric oxide (NO), reduced glutathione (GSH), interleukin-1β (IL-1β), tumor necrosis factor-α (TNF-α), leptin (LEP) and ghrelin (GHR) and the activities of monoamine oxidase (MAO), acetylcholinesterase (AchE) and Na+,K+,ATPase were determined in the cortex and hippocampus. The cerebral histopathological alterations were examined in obese rats. Obese rats showed impaired memory and exhibited significant neurochemical changes, including decreased levels of 5-HT, DA, GSH, GHR, and Na+,K+-ATPase activity, as well as an increase in AchE, MAO, MDA, NO, IL-1β, TNF-α, and LEP. LA and/or CCNPs treatment reduced BMI and improved memory. LA or CCNPs alleviated the cortical and hippocampal neurochemical changes and histopathological changes induced by obesity. Furthermore, LA and CCNPs exhibited antioxidant and anti-inflammatory properties, which likely contributed to their effects. However, no synergistic effect was observed between LA and CCNPs. These findings suggest that LA or CCNPs may be a potential therapy against obesity and its adverse effects on memory, mediated by their ability to restore monoamine levels and exhibit antioxidant and anti-inflammatory properties.
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Osteogenesis Imperfecta (OI) is a rare disorder that causes bones to break easily. People with OI may have broken bones with little or no trauma, dentinogenesis imperfecta (DI), and, in adult years, hearing loss. It is seen in both genders and all races. OI can range from very severe to very mild. Individuals with the most severe type of OI may die at birth. People with severe OI who survive may have bowed arms and legs, very short stature and be unable to walk. People with the mildest form of OI may only break bones occasionally and have normal height and lifespan. Breaks can occur in any bone, but are most common in the arms and legs. People with OI also often have problems with the spine. The spine problems include compression fractures and scoliosis (a curvature of the spine). DI is characterized by grey or brown teeth that may chip and wear down and break easily. In addition to weak teeth, the teeth in the upper jaw may not match up with the teeth in the lower jaw.
Before the genetic cause of OI was known, OI was classified into four types. Each type was based upon the symptoms and severity of OI. In most people with OI, the cause is a change in one of the genes that makes a protein called type 1 collagen. In the past decade, it was discovered that in about 5% of people with OI it is in another gene. Some doctors now classify OI both on how severe it is as well as which gene is causing OI. When people classify OI this way, there are more than 10 types of OI. The current laboratory testing to determine OI subtype involves the collection of blood and/or skin cells.
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Read this Medication Guide carefully before you start taking ribavirin tablets and read the Medication Guide each time you get more ribavirin tablets. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about ribavirin tablets?
1\. Ribavirin tablets may cause birth defects or death of an unborn child. Therefore, if you are pregnant or your partner is pregnant or plans to become pregnant, do not take ribavirin tablets. Female patients and female partners of male patients being treated with ribavirin tablets must not becomepregnant during treatment and for 6 months after treatment has stopped.
During this time you must have pregnancy tests that show you are not pregnant. You must also use 2 effective forms of birth control during therapy and for 6 months after stopping therapy. Male patients should use a condom with spermicide as one of the two forms.
If pregnancy occurs, report the pregnancy to your healthcare provider right away. (See " What should I avoid while taking ribavirin tablets? ")
If you or a female sexual partner becomes pregnant, you should tell your healthcare provider. There is a Ribavirin Pregnancy Registry that collects information about pregnancy outcomes of female patients and female partners of male patients exposed to ribavirin. You or your healthcare provider are encouraged to contact the Registry at 1-800-593-2214.
2\. Ribavirin tablets can cause a dangerous drop in your red blood cell count.
Ribavirin tablets can cause anemia, which is a decrease in the number of red blood cells. This can be dangerous, especially if you have heart or breathing problems. This may cause a worsening of heart (cardiovascular) or circulatory problems. Some patients may get chest pain and rarely, a heart attack. Patients with a history of heart disease have the highest chance of this. Tell your healthcare provider, before taking ribavirin tablets if you have or have ever had any heart or breathing problems. Your healthcare provider should check your red blood cell count before you start treatment with ribavirin tablets and often during the first 4 weeks of treatment. Your red blood cell count may be done more often if you have any heart or breathing problems.
3\. Do not take ribavirin tablets alone to treat hepatitis C virus infection.
Ribavirin tablet does not treat hepatitis C virus infections by itself. Ribavirin tablets should be used in combination with peginterferon alfa-2a to treat continuing (chronic) hepatitis C virus infections. You should read the Medication Guide for peginterferon alfa-2a because it has additional important information about treatment that is not covered in this Medication Guide. Your healthcare provider or pharmacist should give you a copy of the peginterferon alfa-2a Medication Guide.
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PROBLEM TO BE SOLVED: To obtain the subject composition having excellent insecticidal/ acaricidal effectiveness by making the composition include phenoxyphenyl pyridyloxypropyl ether and difluorophenylethoxy-tertiary-butylphenyloxazoline as active ingredients. SOLUTION: This composition comprises (A) 4-phenoxyphenyl 2-(pyridyloxy) propyl ether and (B) 2-(2,6-difluorophenyl)-4-(2-ethoxy-4-tertiary-butylphenyl)-2- oxazoline as active ingredients. In the composition, the total contents of the component A and the component B is 0.01-90 wt.% and the amount of the component B is preferably 0.01-30 pts.wt. based on 1 pt.wt. of the component A. In the case of applying the composition as a controller for insect pests of agriculture and forestry, the amount of application is preferably 1-1,000 g of the total of the active ingredients based on 10 ares.
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This is a Phase 1 study to investigate TBio-4101. TBio-4101 is an autologous tumor infiltrating lymphocyte (TIL) therapy that utilizes tumor specific antigens to select, sort, and expand patient-specific tumor-reactive T-cells to be reinfused into the patient. The adoptive cell therapy is further enhanced through the use of non-myeloablative chemotherapy prior to TIL infusion, followed by the TIL plus IL-2 infusion. Low-dose radiation therapy is administered prior to and after TIL plus IL-2 infusion. Pembrolizumab is provided after the resolution of IL-2 toxicities. The trial is open to solid tumors of varying tumor mutational burdens.
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Didanosine Delayed-Release Capsules are available as:
200 mg: Two-piece hard gelatin capsule with green opaque cap and white opaque body filled with white pellets. Imprinted in black ink barr over 200 mg on one piece and 588 on the other piece.
250 mg: Two-piece hard gelatin capsule with blue opaque cap and white opaque body filled with white pellets. Imprinted in black ink barr over 250 mg on one piece and 589 on the other piece.
400 mg: Two-piece hard gelatin capsule with red opaque cap and white opaque body filled with white pellets. Imprinted in black ink barr over 400 mg on one piece and 590 on the other piece.
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Protein SUMOylation, a post-translational modification, intricately regulates diverse biological processes including gene expression, cell cycle progression, signaling pathway transduction, DNA damage response, and RNA metabolism. This modification contributes to the acquisition of tumorigenicity and the maintenance of cancer hallmarks. In malignancies, protein SUMOylation is triggered by various cellular stresses, promoting tumor initiation and progression. This augmentation is orchestrated through its specific regulatory mechanisms and characteristic biological functions. This review focuses on elucidating the fundamental regulatory mechanisms and pathological functions of the SUMO pathway in tumor pathogenesis and malignant evolution, with particular emphasis on the tumorigenic potential of SUMOylation. Furthermore, we underscore the potential therapeutic benefits of targeting the SUMO pathway, paving the way for innovative anti-tumor strategies by perturbing this dynamic and reversible modifying process.
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In addition to standard of care participants received cinacalcet at a starting dose (based on dry body weight) of 0.20 mg/kg administered once a day by mouth. Dose adjustments and withholding were based on ionized calcium levels, plasma iPTH, and corrected calcium levels.
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CAVA 2 is a single arm study testing a diagnostic device to diagnose different inner-ear conditions appraised by calculating values for sensitivity and specificity. Head and eye movements recorded by the CAVA device will enable the computer algorithms (to be developed) to differentiate between the three target conditions.
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<P>PROBLEM TO BE SOLVED: To provide a water-in-oil type emulsified cosmetic that has a high internal water phase ratio to allow good serviceability and exhibits good emulsion stability though it is a water-in-oil type solid emulsified cosmetic exhibiting good makeup sustainability and having a refreshing feeling to the skin. <P>SOLUTION: The water-in-oil type emulsified cosmetic contains the following components (A), (B), (C) and (D), and satisfies the requirements (1) and (2) below. Components: (A) one or two or more selected from among glycerin monooleate, glycerine monoisostearate and polyoxyethylene glyceryl monostearate; (B) an aqueous component; (C) an oily component; and (D) a powder. Requirements: (1) The internal water phase ratio which is obtained by dividing the sum of the mass of the component (A) and the component (B), the aqueous component, by the sum of the mass of the component (A), the component (B), the aqueous component, and the component (C), the oily component, is at least 50%. (2) For the component (A), the purity of glycerine monooleate is at least 90 mass% based on the total amount of glycerin monooleate, glycerine dioleate and glycerine trioleate; the purity of glycerine monoisostearate is at least 90 mass% based on the total amount of glycerine monoisostearate, glycerine diisostearate and glycerine triisostearate; and the purity of polyoxyethylene glyceryl monostearate is at least 90 mass% based on the total amount of polyoxyethylene glyceryl monostearate, polyoxyethylene glyceryl distearate and polyoxyethylene glyceryl tristearate. <P>COPYRIGHT: (C)2010,JPO&INPIT
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The present invention relates to a Chinese medicine preparation which has the effect of invigorating stomach, promoting digestion, keeping fit and benefiting qi. The invention is characterized in that the Chinese medicine preparation is prepared by the following crude drugs as raw materials by weight: 20-80 parts of ginseng, 70-130 parts of bighead atractylodes rhizome (bran stir-fried), 70-130 parts of picrorhiza rhizome, 1-60 parts of liquorice, 50-110 parts of quisqualis fruit (decladded), 40-100 parts of whitethorn, 40-100 parts of medicated leaven (stir-fried), 1-50 parts of coptis, 40-100 parts of wheat germ (stir-fried), 30-90 parts of poria cocos wolf and 20-80 parts of Chinese aloe. The ginseng, bighead atractylodes rhizome, picrorhiza rhizome, Chinese aloe and coptis are crushed to fine powder and are sieved for standby. The medicated leaven is percolated with 25146005230f ethanol, and then the ethanol is recycled. The quisqualis fruit and liquorice beverage are boiled twice. The boiled water liquid is combined and filtered. The whitethorn, the wheat germ and poria cocos wolf are immersed twice in moderate temperature. The moderate temperature immersion liquids are combined and filtered. The percolated liquid, the boiled liquid and moderate temperature immersion liquid are mixed and condensed to paste. The condensed paste is added with powders of ginseng, etc. and supplementary material and is mixed to uniform. Various common oral preparation can be prepared. The Chinese medicine preparation provided by the invention has the advantages of remarkable curative effect, stomach invigorating, digestion promoting, fit keeping and qi benefiting. The Chinese medicine preparation is used for treating indigestion of child, food and milking taking stoppage and weak somatoplasm.
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1530846 Anti-cancer agent from Staphylococcus epidermidis TOBISHI PHARMACEUTICAL CO Ltd 13 Sept 1977 [13 Sept 1976] 38218/77 Heading A5B An anti-cancer agent active against liquid and solid cancers (e.g. leukemia, sarcoma) is obtained by cultivating a new strain of Staphylococcus epidermidis designated as strain STF (Bikoken Deposit No. 3706, ATCC 31310). The strain is cultivated in culture medium containing assimilable sources of nitrogen, carbon and inorganic salts, preferably under aerobic conditions, and the active agent is present in the cell - free culture medium. It may be isolated by concentrating the medium (e.g. by evaporation under reduced pressure), separating resulting solid matter, redissolving this matter in water and fractionating the solution (e.g. on adsorptive gel, by ion-exchange chromatography or by use of a molecular sieve membrane), to give anti-cancer fractions (a) of molecular weight 1000-5000, and (b) of molecular weight 5000-10,000. The material is stable at 100C for 15 minutes and is negative in Ninhydrin, Ehrlich and Sakaguchi reactions. The solutions may be evaporated to give the agent in solid form. It may be administered as a purified cell-free culture fluid or as various oral, parenteral or suppository pharmaceutical forms with a suitable carrier.
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In a randomized crossover design, participants will consume a single bulletproof coffee or a single black coffee separated by \~7 days. Each visit commences in the morning after an overnight fast of 10-12 hours, with no exercise the day prior, no coffee consumption the morning of testing, and completion of a food log for dietary duplication prior to visit 2. A fasting blood draw is obtained and cognitive function tests administered, along with questionnaires to assess gastrointestinal distress, arousal, and hunger/fullness before coffee consumption. Following this, one of the coffee beverages is consumed (randomized to each visit). Cognitive testing and questionnaires are completed at 60 minutes after finishing the coffee, another blood draw at 90 minutes, and then cognitive testing, questionnaires and a final blood draw 180 minutes after consuming the coffee. This procedure is repeated during their second experimental visit, in which they consume the remaining coffee based on their randomization.
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BACKGROUND: Many children consume a poor quality diet with only a third of children aged 6-9 years eating vegetables daily. A high quality diet is important for good health in childhood; however, the prevalence of children living with obesity has doubled from 10% to 23% during primary school in the UK. Cooking lessons have the potential to improve diet quality and reduce obesity prevalence in childhood, both of which are associated with improved cardiometabolic outcomes in adulthood. The aim of this systematic review is to investigate the impact of school-based cooking classes on cooking skills, food literacy and vegetable intake of children aged 4-12 years.
METHODS: We conducted a systematic review of OVID Medline, OVID Embase, EBSCO CINHAL and EBSCO ERIC for comparative studies that evaluated outcomes of children receiving cooking classes compared to a control group. Interventions included contained food preparation or a cooking activities and took place on school premises. Risk of bias was assessed using ROB2 and Robins-I. Outcomes were pooled in a meta-analysis using a random-effects model using standardised mean differences or reviewed using narrative synthesis. Certainty of evidence was assessed using GRADE.
RESULTS: We included 21 studies, (6 randomised). Meta-analysis showed a small positive effect on cooking self-efficacy of 0.39 units (95% CI 0.05 to 0.54), and a small positive effect on vegetable intake of 0.25 units (95% CI 0.05 to 0.45). Programmes with more than 6 h of cooking showed the greatest effects.
CONCLUSIONS: Children's cooking programmes result in small improvements in cooking efficacy and vegetable intake, particularly those with more than 6 h of classes. It is recommended that future interventions use consistent measurement for children's food literacy and cooking confidence.
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BACKGROUND: To investigate the clinical effects and safety of the hybrid debranching technique for patients with acute Stanford type A aortic dissection (AD).
METHODS: One hundred nine patients with acute Stanford type a AD were selected and divided into observation group and control group according to the different surgical methods. Fifty-five patients in the observation group were treated with hybrid debranching, and 54 patients in the control group were treated with Sun's operation. The operation duration, clamp time, cardiopulmonary bypass duration, volume of blood transfusion, ventilator application duration, duration of stay in the intensive care unit, aortic rupture, second thoracotomy due to hemorrhage, gastrointestinal hemorrhage, stroke, paraplegia, renal failure, and all-cause mortality were recorded. Postoperative follow-up was conducted. The number of cases that underwent follow-up and the number of cases with complete thrombosis of the false aneurysm cavity detected by computed tomography angiography (CTA) was recorded.
RESULTS: The surgical success rate was 100% in both groups, and there were no cases with unplanned secondary surgery. Compared with the control group, only the difference in the volume of blood transfusion was not significantly significant between the two groups (P = 0.052), while the rest of the observation indicators were significantly lower in the observation group than in the control group (P < 0.001 for all). The proportion of cases with complete thrombosis of the false aneurysm cavity was significantly higher in the observation group than in the control group at 3 and 6 months after surgery (P < 0.05).
CONCLUSION: In patients with acute Stanford type A AD involving the arch, the hybrid debranching technique was safe and effective. It was recommended for patients with advanced age and a high risk of intolerance to deep hypothermic circulatory arrest.
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To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There is no research in the literature that has compared the rates and behavior of miscarriage during the time of the COVID-19 pandemic to before the time of the pandemic. As described in the literature, there is an established connection between COVID-19 and stress, anxiety, and depression. There is also an established connection between stress, anxiety, and depression and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19 pandemic on miscarriages.
In this study, The investigators will analyze the number of early missed abortions and number of termination of pregnancies in the first trimester before and during the COVID-19 pandemic. The investigators will also analyze the time interval between diagnosis of missed abortion and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The investigators will be comparing the reasons for termination of pregnancy during this time, as well as analyzing age, religion, and demographic variables during the COVID-19 pandemic compared to years prior.
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A printer blank for a computer system printer is disclosed. The blank has a contiguous pressure adhesive backed label section and may also have a larger plain paper section separated from the label section by a perforation line. The label section is comprised of a plurality of adhesive backed labels and a backing sheet, including a main label portion and at least one smaller auxiliary label. A preferred blank comprises a plurality of auxiliary labels. In use, at least one, but preferably not all, of the auxiliary labels on such a preferred blank are simultaneously removed from the backing sheet with the main label portion. Any auxiliary label(s) simultaneously removed with the main label but not printed upon are readily separated from the main label.
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Subjects Healthy able-bodied control volunteers, individuals with acute and chronic spinal cord injury, and individuals who have undergone a period of bed rest.
ASIA and SSR Assessment. The severity of injury to the motor and sensory spinal pathways will be documented in accordance to the American Spinal Injury Association (ASIA). The sympathetic skin response (SSR) will be examined in order to determine the completeness of injury to the DSSP. SSRs will be recorded in subjects in supine position, with the room temperature between 21-25oC. Subjects will rest supine for at least 30 min before the beginning of the examination. The procedure will take approximately 20-30 min. Self-adhesive electrodes will be applied to the hands and feet of the patient. SSRs will be recorded bilaterally and simultaneously from both hands and feet over 5 s and sampled at a band pass of 3Hz to 3 kHz. The median nerve will be stimulated (0.2ms duration, 10-20mA intensity) and 5-10 SSRs samples will be recorded. The latency and amplitude of SSRs will be measured and compared in each case.
"Sit up test". We will use a sit-up test to evaluate blood pressure control and orthostatic tolerance. Before the test the subject will lie down on a tilt table, in a temperature controlled environment for a period of 10 min. Then the subject will be passively seated to 90° and will keep this position without moving for 20 minutes. The test will be aborted if subjects become lightheaded or symptomatic. All individuals with SCI will be assessed for the continuity of the DSSP. Continuous non-invasive BP (Finometer, FMS, Arnhem, The Netherlands) and ECG (lead II, 3 electrodes on the thorax), monitoring will be performed pre-test, during and post-test. In all subjects the following measurements are planned: recordings of BP and ECG during 10 min in supine and 20 min in sitting position. Two blood samples will be collected prior to the sit-up test after 30 min of rest in supine position and 3-5 min after sit-up test. Serum level catecholamines will be examined. Butterfly catheters will be inserted at least 30 min prior to the sit-up test. This will allow the collection of blood without additional stress to the participant and activation of catecholamines release by venopuncture. Two blood samples will be drawn to determine the serum levels of NE and E from the antecubital vein of each individual before and immediately after the orthostatic challenge.
Circadian rhythm and 24hr Holter monitoring of ECG. We will obtain continuous HR recordings and following analysis will determine the beat-to-beat HRV during the 24 hr period. The subject will wear a portable unit connected with electrodes on the chest-wall. During the day the subject can do normal daily activities. We will analyze at least 3 measurement points (10 min interval) during the day and night periods in each individual. HRV analysis will occur off-line: briefly, we will use an autoregressive model for the frequency domain variables of HRV: low-frequency power (LF, 0.04-0.15 Hz), and high-frequency power (HF, 0.15-0.4 Hz). LF power is believed to represent sympathetic tone while HF power represents parasympathetic tone.
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Participants with myelodysplastic syndromes (MDS) will receive JNJ-64619178 at a dose less than or equal to the RP2D selected in Part 1 for 24 weeks, or longer if there is evidence of clinical benefit. The dose level of JNJ-64619178 may be adjusted based on observed toxicities.
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Carcinogenicity, mutagenicity, and impairment of fertility studies were not conducted with TWYNEO.
Benzoyl peroxide
The role of benzoyl peroxide as a tumor promoter has been well established in several animal species; however the significance of this finding in humans is unknown.
No significant increase in tumor formation was observed in rats treated topically with 15 to 25% benzoyl peroxide carbopol gel (5 to 8 times the concentration of benzoyl peroxide in TWYNEO) for two years. Similar results were obtained in mice topically treated with 25% benzoyl peroxide carbopol gel for 56 weeks followed by intermittent treatment with 15% benzoyl peroxide gel for the rest of the two-year study period, and in mice treated topically with 5% benzoyl peroxide carbopol gel for two years.
Bacterial mutagenicity assays (Ames test) conducted with benzoyl peroxide have provided mixed results. Mutagenic potential was observed in a few studies but not in a majority of investigations. Benzoyl peroxide has been found to cause DNA strand breaks in a variety of mammalian cell types and to cause sister chromatid exchanges in Chinese hamster ovary cells.
Fertility studies were not conducted with benzoyl peroxide.
Tretinoin
In a 91-week dermal study, CD-1 mice were administered 0.017% and 0.035% formulations of tretinoin, cutaneous squamous cell carcinomas and papillomas in the treatment area were observed in some female mice. A dose-related incidence of liver tumors in male mice was observed at those same doses. The maximum systemic doses associated with the administered 0.017% and 0.035% formulations are 0.5 and 1.0 mg/kg/day, respectively. These doses are 1.3 and 2.7 times the MRHD based on BSA comparison and assuming 100% absorption. The biological significance of these findings is not clear because they occurred at doses that exceeded the dermal maximally tolerated dose (MTD) of tretinoin and because they were within the background natural occurrence rate for these tumors in this strain of mice. There was no evidence of carcinogenic potential when 0.025 mg/kg/day of tretinoin was administered topically to mice (0.07 times the MRHD based on BSA comparison and assuming 100% absorption). The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test and an in vivo rat micronucleus assay, both of which were negative.
In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count and motility were seen at 0.5 mg/kg/day (approximately 2.7 times the MRHD based on BSA comparison and assuming 100% absorption), and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with 0.25 mg/kg/day and above (1.3 times MRHD based on BSA comparison and assuming 100% absorption) were observed.
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The survey instrument will be a validated structured survey questionnaire. The content validity of the structured questionnaire will be reported in terms of validity index (CVI), using ratings of item relevance by content experts.1 The content validation of identified items will be executed by the online Delphi method. Initially first round of Delphi survey of contentment validation will be carried out to achieve a consensus of 80% agreement among the identified panel of 10 experts in the field of neonatology will be consulted during the content validation in each round. If not achieved in first round, second round of Delphi survey of contentment validation will be carried out to achieve a consensus of 80% agreement among the identified panel of 10 experts. As more than 10 experts were deemed to be unnecessary, we will not include more than panel of 10 experts in each Delphi survey. The survey instrument will be created on an online survey platform (Survey Monkey). It was evaluated for both face and content validity by the investigators and approved by the experts. The survey will be pilot tested on a group of neonatologists and pediatricians before distribution. The survey will be administered electronically via email along with instructions and a hyperlink to the survey. The participants will be notified of the voluntary nature of participation, confidentiality and non-compensation for participation. Lists of email addresses of neonatologists and neonatal practitioners were assembled by liaising with the Neonatology Chapter of Indian Academy of Pediatrics (IAP Neochap). The invitation will be sent to the 800 neonatologists and pediatricians nationwide in India. To encourage response rates, an additional survey reminder will be emailed 1 week later.Each question will be validated and reported in term of I-CVI. The overall validation of proposed scale with item pool will be reported with S-CVI after the end of each Delphi method of scale validation. S-CVI will be computed by both approaches, universal agreement calculation method (S-CVI/UA) and averaging calculation method (S-CVI/Ave).Lynn recommended that minimum I-CVI of 0.78, in case of 6 to 10 experts and overall the scale should an SCVI/Ave of 0.90 or higher for considered to have excellent content validity.
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Patients receive neratinib maleate PO QD on days 1-14 of cycle 0 in the absence of disease progression or unacceptable toxicity. Patients then receive neratinib maleate PO QD on days 1-28 and palbociclib PO QD on days 1-21 of each subsequent cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA during screening and on study, and CT or MRI and collection of blood samples throughout the trial. Patients may also undergo tumor biopsy during screening and on study.
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Patients receive onvansertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
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PROBLEM TO BE SOLVED: To obtain the subject new peptide consisting of an osteogenetic polypeptide chain including a specific amino acid sequence, with a dimeric osteogenetic protein including this polypeptide chain capable of inducing endochondral osteogenesis in mammals and useful for e.g. repairing bone and chartilaginous tissue. SOLUTION: This new polypeptide is such one as to constitute an osteogenetic polypeptide including an amino acid sequence described by the amino acid residues 303-399 of the formula. A dimeric osteogenetic protein including this polypeptide has a site capable of inducing endochondral osteogenesis, when the dimeric osteogenetic protein including this polypeptide is embedded in mammals in association with matrix; and therefore, this new polypeptide is useful for e.g. repairing bone and cartilagious tissue. This new polypeptide is obtained by screening a human genome and cDNA library through a probe designed from the sequence data of a bovine-derived osteogenetic peptide, integrating a vector with a gene encoding the resultant human osteogenetic polypeptide and expressing in host cells of various morphology including procaryotic cells and eucaryotic cells.
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Efficacy studies of moxifloxacin hydrochloride could not be conducted in humans with pneumonic plague for ethical and feasibility reasons. Therefore, approval of this indication was based on an efficacy study conducted in animals and supportive pharmacokinetic data in adult humans and animals.
A randomized, blinded, placebo-controlled study was conducted in an African Green Monkey (AGM) animal model of pneumonic plague. Twenty AGM (10 males and 10 females) were exposed to an inhaled mean (± SD) dose of 100 ± 50 LD50 (range 92 to 127 LD50) of Yersinia pestis (CO92 strain) aerosol. The minimal inhibitory concentration (MIC) of moxifloxacin for the Y. pestis strain used in this study was 0.06 mcg/mL. Development of sustained fever for at least 4 hours duration was used as the trigger for the initiation of 10 days of treatment with either a humanized regimen of moxifloxacin or placebo. All study animals were febrile and bacteremic with Y. pestis prior to the initiation of study treatment. Ten of 10 (100%) of the animals receiving the placebo succumbed to disease between 83 to 139 h (mean 115 ± 19 hours) post treatment. Ten of 10 (100%) moxifloxacin-treated animals survived for the 30-day period after completion of the study treatment. Compared to the placebo group, mortality in the moxifloxacin group was significantly lower (difference in survival: 100% with a two-sided 95% exact confidence interval [66.3%, 100%], p-value<0.0001).
The mean plasma concentrations of moxifloxacin associated with a statistically significant improvement in survival over placebo in an AGM model of pneumonic plague are reached or exceeded in human adults receiving the recommended oral and intravenous dosage regimens. The mean (± SD) peak plasma concentration (Cmax) and total plasma exposure defined as the area under the plasma concentration-time curve (AUC) in human adults receiving 400 mg intravenously were 3.9 ± 0.9 mcg/mL and 39.3 ± 8.6 mcg•h/mL, respectively [see Clinical Pharmacology (12.3)]. The mean (± SD) peak plasma concentration and AUC0-24 in AGM following one-day administration of a humanized dosing regimen simulating the human AUC0-24 at a 400 mg dose were 4.4 ± 1.5 mcg/mL and 22 ± 8.0 mcg·h/mL, respectively.
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Each participant randomized to a standard-assessment were evaluated with the resource available at the institution including a physical examination,12 lead-ECG, radiographic, laboratory testing as clinically required. All study participants underwent a comprehensive transthoracic echocardiogram for anatomical assessments of the severity of rheumatic and structural heart disease prior to percutaneous valvuloplasty or a surgical valve replacement.
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Hospital-acquired pneumonia (HAP) is a leading cause of morbidity and mortality, commonly caused by Pseudomonas aeruginosa. Meropenem is a commonly used therapeutic agent, although emergent resistance occurs during treatment. We used a rabbit HAP infection model to assess the bacterial kill and resistance pharmacodynamics of meropenem. Meropenem 5 mg/kg administered subcutaneously (s.c.) q8h (±amikacin 3.33-5 mg/kg q8h administered intravenously[i.v.]) or meropenem 30 mg/kg s.c. q8h regimens were assessed in a rabbit lung infection model infected with P. aeruginosa, with bacterial quantification and phenotypic/genotypic characterization of emergent resistant isolates. The pharmacokinetic/pharmacodynamic output was fitted to a mathematical model, and human-like regimens were simulated to predict outcomes in a clinical context. Increasing meropenem monotherapy demonstrated a dose-response effect to bacterial kill and an inverted U relationship with emergent resistance. The addition of amikacin to meropenem suppressed the emergence of resistance. A network of porin loss, efflux upregulation, and increased expression of AmpC was identified as the mechanism of this emergent resistance. A bridging simulation using human pharmacokinetics identified meropenem 2 g i.v. q8h as the licensed clinical regimen most likely to suppress resistance. We demonstrate an innovative experimental platform to phenotypically and genotypically characterize bacterial emergent resistance pharmacodynamics in HAP. For meropenem, we have demonstrated the risk of resistance emergence during therapy and identified two mitigating strategies: (i) regimen intensification and (ii) use of combination therapy. This platform will allow pre-clinical assessment of emergent resistance risk during treatment of HAP for other antimicrobials, to allow construction of clinical regimens that mitigate this risk.IMPORTANCEThe emergence of antimicrobial resistance (AMR) during antimicrobial treatment for hospital-acquired pneumonia (HAP) is a well-documented problem (particularly in pneumonia caused by Pseudomonas aeruginosa) that contributes to the wider global antimicrobial resistance crisis. During drug development, regimens are typically determined by their sufficiency to achieve bactericidal effect. Prevention of the emergence of resistance pharmacodynamics is usually not characterized or used to determine the regimen. The innovative experimental platform described here allows characterization of the emergence of AMR during the treatment of HAP and the development of strategies to mitigate this. We have demonstrated this specifically for meropenem-a broad-spectrum antibiotic commonly used to treat HAP. We have characterized the antimicrobial resistance pharmacodynamics of meropenem when used to treat HAP, caused by initially meropenem-susceptible P. aeruginosa, phenotypically and genotypically. We have also shown that intensifying the regimen and using combination therapy are both strategies that can both treat HAP and suppress the emergence of resistance.
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Clinical trial designed as a comparative, randomized, non-blind intervention study involving elderly patients with cancer and palliative care in outpatient follow-up at the University Hospital of the Ribeirão Preto Medical School - University of São Paulo. Patients were randomized into 3 blocks of 15 subjects in the control (CG), 55% cocoa intervention (GI1) and white chocolate (GI2) intervention groups. The volunteers were evaluated before and after 4 weeks (28 days) for clinical and laboratory nutritional parameters, quality of life analysis and presence and grading of symptoms. The nutritional status of the patients was evaluated using the Mini Nutritional Assessment (MNA) and the current and usual food intake through the 24-hour recall survey (IR24h) and the food frequency questionnaire (FFQ), respectively. The body mass index (BMI), arm circumference and calf circumference of the volunteers were obtained and the body composition was evaluated by the deuterium oxide method. The inflammatory profile was analyzed by serum interleukin 6 levels and the antioxidant capacity was evaluated by the quantification of reduced glutathione (GSH) and ascorbic acid. Serum lipid peroxidation was measured by determining malonaldehyde levels and the presence and quantification of damage to genetic material by 8-hydroxy-2'-deoxyguanosine levels. To analyze quality of life, the European Organization for Cancer Research and Treatment (EORTC) - Quality of Life Questionnaire (QLQ) - C30 was administered and the Edmonton Symptom Assessment System (ESAS) scale was used to assess the frequency and intensity of symptoms. Data were analyzed by SAS Statistical Software (version 9.3; SAS Institute, Inc. Cary, NC) and R Core Team (2016). Initially, a descriptive analysis of the data was performed. Chi-square test was used to evaluate categorical variables. For the comparison between the groups at each moment and between the moments in each group was used linear regression model with mixed effects. The significance level established was \<0.05.
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Like group I, each participant will be trained on a conventional treadmill for (50 minutes) as follows: warming up by walking on the treadmill belt with a comfortable walking speed suitable for each participant for 5 minutes. The speed should be determined Then participants continue training on the treadmill for 20 minutes; no VR will be used or applied. Participants should get a 5-min break and then resume training on the treadmill again for 25 minutes.
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