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1 | TITLE: Rapid molecular determination of methicillin resistance in staphylococcal bacteraemia improves early targeted antibiotic prescribing: a randomized clinical trial.ABSTRACT: Empiric therapy of methicillin-susceptible Staphylococcus aureus (MSSA) infections with vancomycin is associated with poorer outcome than targeted therapy with β-lactams. Our objective was to evaluate whether rapid determination of methicillin resistance shortens the time from Gram stain to targeted antimicrobial therapy in staphylococcal bacteraemia, thereby reducing vancomycin overuse. This was a single-centre open parallel RCT. Gram-positive cocci in clusters in positive blood culture underwent real-time PCR for rapid species and methicillin resistance determination parallel to conventional microbiology. Patients were randomized 1:1 so that clinicians would be informed of PCR results (intervention group) or not (control group). Eighty-nine patients (intervention 48, control 41) were analysed. MRSA was identified in seven patients, MSSA in 46, and CoNS in 36. PCR results were highly concordant (87/89) with standard microbiology. Median time (hours) from Gram stain to transmission of methicillin-susceptibility was 3.9 (2.8-4.3) vs. 25.4 (24.4-26-7) in intervention vs. control groups (p <0.001). Median time (hours) from Gram stain to targeted treatment was similar for 'all staphylococci' [6 (3.8-10) vs. 8 (1-36) p 0.13] but shorter in the intervention group when considering S. aureus only [5 (3-7) vs. 25.5 (3.8-54) p <0.001]. When standard susceptibility testing was complete, 41/48 (85.4%) patients in the intervention group were already receiving targeted therapy compared with 23/41 (56.1%) in the control group (p 0.004). There was no significant effect on clinical outcomes. Rapid determination of methicillin resistance in staphylococcal bacteraemia is accurate and reduces significantly the time to targeted antibiotic therapy in the subgroup of S. aureus, thereby avoiding unnecessary exposure to vancomycin. |
1 | TITLE: Comparison of single-layer continues or two-layer interrupted pancreatojejunal suture in Frey procedure for treatment of chronic pancreatitis: a prospective randomized study.ABSTRACT: Many patients with chronic pancreatitis are elected for surgery when endoscopic interventions are ineffective. Duodenum preserving pancreatic head resection introduced by Charles F. Frey is the most common procedure used for surgical treatment of chronic pancreatitis. However, technical aspects of this procedure have not been studied extensively. Goal Our prospective randomized study is aimed to compare usage of single-layer continuous (I group) and two-layer interrupted sutures (II group) in constructing pancreatojejunostomy after Frey procedure.In a period between 2009 and 2016, a total of 103 patients, diagnosed with chronic pancreatitis and determined medical indications for surgical treatment were included into the study and randomized into group I (52 patients) and group II (51 patients). Preoperative, intraoperative patient characteristics and postoperative results were compared between both groups.Mean duration of surgery was statistically shorter in group I - 210 min, while in group II - 240 min (p = 0.004). Pancreatojejunoanastomosis construction time was shorter in group I - 19 (±6) min versus 51 (±18) min in group II, p <0,001. No statistically relevant differences were observed in postoperative morbidity: group I - 51.9% and group II - 45,1% (p = 0.177) and mortality: group I - 3.8% and group II - 2% (p = 0.636).Frey procedure using single-layer continuous pancreatojejunostomy is safe, fast and less complex method in surgical treatment of chronic pancreatitis. |
1 | TITLE: Clinical Study of Standard- vs Reduced-Dose Tacrolimus Combined With Generic Mycophenolate Mofetil in De Novo Kidney Transplantation: A Prospective Randomized Trial.ABSTRACT: The lowering of calcineurin inhibitor exposure is possibly considered as the proper strategy to prevent calcineurin inhibitor-induced nephrotoxicity in kidney transplant. This clinical study was designed to compare the efficacy and tolerability of reduced-dose tacrolimus with standard-dose mycophenolate mofetil (MMF) vs standard-dose tacrolimus with reduced-dose MMF.A prospective, multicenter, open-label, randomized, and parallel-group clinical trial was conducted at 4 transplant centers in Korea. A total sample size was 108, and eligible patients were randomly assigned in a 1:1 ratio to either reduced-dose tacrolimus with standard-dose MMF (the study group) or standard-dose tacrolimus with reduced-dose MMF (the control group) for 6 months in de novo kidney transplant recipients. Graft function, the incidence of efficacy failure, and adverse events were compared.The mean estimated glomerular filtration rate at 6 months post-transplantation was 69.83 ± 16.68 mL/min/1.73 m in the study group and 69.92 ± 17.55 mL/min/1.73 m in the control group (P > .05). The overall incidence of biopsy-proven acute rejection was 3.64% (n = 2) in the study group, compared to 3.77% (n = 2) in the control group (P > .05). There was no graft loss, death, or loss of follow-up in either group.In conclusion, the results suggest that tacrolimus minimization with standard-dose MMF provides adequate immunosuppression with proper renal function and similar rate of incidence of acute rejection compared with the regimen including standard-dose tacrolimus with reduced-dose MMF. |
1 | TITLE: Clinical Outcome in Cerebral Vasospasm Patients Treated with and without Intra-Arterial Nimodipine Infusion.ABSTRACT: Cerebral vasospasm (CV) after aneurysmal subarachnoid hemorrhage (aSAH) is still a problem. Hypertension, hypervolemia, and hemodilution (triple-H) therapy and oral nimodipine only a modest effect on patients. Intra-arterial treatment, including nimodipine, has been studied, but only as retrospective and single-arm prospective studies. We compared the outcomes between CV patients who received an adjunct intra-arterial nimodipine infusion (IANI) and those who received the standard medical treatment alone in a prospective randomized controlled trial.In this study, patients between the age of 18 and 80 years, who underwent angiography within 14 days after aneurysm obliteration, were recruited and randomized to receive adjunct IANI or not, if they were identified with angiographic vasospasm. All the angiographic and neurologic data were recorded and analyzed during their admission, at the discharge date, and during the 6-month follow-up period.From June 2016 to December 2018, we enrolled 68 patients who were randomized into two groups, 36 in the intervention group and 32 in the control group. The patients' characteristics, aneurysm data, and modalities of treatment were similar between the two groups. Within 24 hours after IANI, Glasgow Coma Scale (GCS) score and motor strength revealed a significant improvement of 33.33 and 38.89%, respectively, in the intervention group versus 12.5 and 9.38%, respectively, in the control group. At discharge, the intervention group still had significant motor improvement (58.33 vs. 21.88%; = 0.002).IANI could be considered an effective treatment for CV without significant complications. This is the first RCT demonstrating statistically significant motor strength improvement within 24 hours and at discharge. |
1 | TITLE: The supportive effect of supplementation with α-keto acids on physical training in type 2 diabetes mellitus.ABSTRACT: The maintenance of physical activity is crucial for the prevention and management of type 2 diabetes (T2D), and exercise induced changes including production of metabolites like ammonia can result in fatigue and exercise intolerance. Nutritional supplements may serve as an effective measure in supporting patients undergoing physical training by acting on their metabolism. This study investigates the effects of supplementation with α-keto acids (KAS) on exercise tolerance and glucose control in T2D patients. In a double-blind, placebo-controlled, randomized study 28 T2D patients underwent 6 weeks training on a cycle ergometer while they were supplemented with either a placebo or KAS (0.2 g kg(-1) body weight each day). The weekly training volume, power output at maximum and lactic threshold, leg muscle torque, the plasma concentration and 8 h urinary discharge of glucose, ammonia and urea were determined before and after the training as well as after one week of recovery. With KAS the patients did significantly more voluntary exercise (213 vs. 62 min, P < 0.01), reached a higher VO2max (27.3 vs. 24.8 ml min(-1) kg(-1)), higher power output (224 vs. 193 watts, P < 0.05) and greater endurance capacity (108 vs. 96 watts at lactic threshold, P < 0.05). Although the patients without KAS improved their glucose control after the training (P < 0.05), this effect could not be maintained after recovery as it was in the KAS group, where there was a prolonged benefit in glucose control. KAS also affected the ammonia and urea metabolism. KAS delivered supportive effects on the physical training along with a prolonged benefit in glucose control in T2D patients. |
1 | TITLE: Hypnosis Versus Placebo During Atrial Flutter Ablation: The PAINLESS Study: A Randomized Controlled Trial.ABSTRACT: The aim of this study was to assess the superiority of hypnosis versus placebo on pain perception and morphine consumption during typical atrial flutter (AFL) ablation.AFL ablation commonly requires intravenous opioid for analgesia, which can be associated with adverse outcomes. Hypnosis is an alternative technique with rising interest, but robust data in electrophysiological procedures are lacking.This single center, randomized controlled trial compared hypnosis and placebo during AFl ablation. In addition to the randomized intervention, all patients were treated according to the institution's standard of care analgesia protocol (administration of 1 mg of intravenous morphine in case of self-reported pain ≥5 on an 11-point numeric rating scale or on demand). The primary endpoint was perceived pain quantified by patients using a visual analog scale.Between October 2017 and September 2019, 113 patients (mean age 70 ± 12 years, 21% women) were randomized to hypnosis (n = 56) or placebo (n = 57). Mean pain score was 4.0 ± 2.2 in the hypnosis group versus 5.5 ± 1.8 in the placebo group (p < 0.001). Pain perception, assessed every 5 min during the whole procedure, was consistently lower in the hypnosis group. Patients' sedation scores were also better in the hypnosis group than in the placebo group (8.3 ± 2.2 vs. 5.4 ± 2.5; p < 0.001). Finally, morphine requirements were significantly lower in the hypnosis group (1.3 ± 1.3 mg) compared with the placebo group (3.6 ± 1.8 mg; p < 0.001).In this first randomized trial, hypnosis during AFL ablation was superior to placebo for alleviating pain and reducing morphine consumption. |
0 | TITLE: The Clinical Risk Factors of Adenovirus Pneumonia in Children Based on the Logistic Regression Model: Correlation with Lactate Dehydrogenase.ABSTRACT: Children with bacterial pneumonia (41 cases) and adenovirus pneumonia (179 cases) hospitalized in Tianjin Children's Hospital from January to October 2020 were selected. The differences in baseline and clinical characteristics between children with two pneumonias, respectively, were compared via the chi-square test and Wilcox test. The Least Absolute Shrinkage and Selection Operator (LASSO) model was applied to screen the pneumonia type-related characteristics. Patients were randomly divided into the training set ( = 154) and test set ( = 66). The logistic model was constructed using the screened characteristics in the training set to predict whether the cases are bacterial pneumonia or adenovirus pneumonia. Finally, the model was validated by receiver operating characteristic (ROC) curve and area under curve (AUC) in the test set.The age ( < 0.001), hospital stay ( < 0.001), tonsil condition ( < 0.001), interleukin-6 (IL-6; =0.033), and lactate dehydrogenase (LDH; < 0.001) between children with bacterial pneumonia and adenovirus pneumonia were significantly different. Sex, tonsil condition, age, hospital stay, r-glutamyltransferase (r-GT), and LDH levels were the factors associated with the types of pneumonia. Compared with bacterial pneumonia, children with adenovirus pneumonia were younger (OR = 0.207, 95% CI: 0.041-0.475), with longer hospital stay (OR = 7.974, 95% CI: 2.626-74.354) and higher LDH expression level (OR = 1.025, 95% CI: 1.006-1.060). 92.4% types of pneumonia were correctly predicted, and the AUC value of the model was 0.981.The LDH level was the associated factor to predict the types of pneumonia. Adenovirus pneumonia was associated with earlier age and longer hospital stay than bacterial pneumonia. The established model can well predict the types of pneumonia in children and provide clinical basis for guiding the individualized treatment of children. |
1 | TITLE: FDA Approval Summary: Ivosidenib for the Treatment of Patients with Advanced Unresectable or Metastatic, Chemotherapy Refractory Cholangiocarcinoma with an IDH1 Mutation.ABSTRACT: On August 25, 2021, the FDA approved ivosidenib for the treatment of adult patients with unresectable locally advanced or metastatic hepatocellular isocitrate dehydrogenase 1 (IDH1) mutated cholangiocarcinoma (CCA) as detected by an FDA-approved test with disease progression after 1 to 2 prior lines of systemic therapy for advanced disease. The approval was based on data from Study AG120-C-005 (ClarIDHy), a double-blind placebo-controlled trial that randomly allocated (2:1) patients to receive either ivosidenib or placebo. Independently assessed progression-free survival (PFS) was the primary endpoint. With a median follow-up of 6.9 months, the HR for PFS was 0.37 [95% confidence interval (CI), 0.25-0.54; P < 0.0001). Overall survival (OS) was the key secondary endpoint. At the final analysis of OS, with 70.5% of patients in the placebo arm receiving ivosidenib post disease progression, a non-statistically significant improvement in the ivosidenib arm with an HR = 0.79 (95% CI, 0.56-1.12) and median OS of 10.3 months (95% CI, 7.8-12.4) and 7.5 months (95% CI, 4.8-11.1) in the ivosidenib and placebo arms, respectively, were reported. Adverse reactions occurring in >20% of patients receiving ivosidenib were fatigue/asthenia, nausea, diarrhea, abdominal pain, ascites, vomiting, cough, and decreased appetite. Adverse reactions occurring in >20% of patients receiving placebo were fatigue/asthenia, nausea, abdominal pain, and vomiting. This is the first approval for the subset of patients with CCA harboring an IDH1 mutation. |
1 | TITLE: Rates of formal diagnosis in people screened positive for dementia in primary care: results of the DelpHi-Trial.ABSTRACT: Primary data about rates of formal diagnosis of dementia in the German primary care sector are widely lacking.Main objectives are to analyze the rate of syndrome diagnosis in primary care patients who screened positive for dementia, the distribution of differential diagnoses, and factors associated with undiagnosed dementia.DelpHi-MV (Dementia: life- and person-centered help in Mecklenburg-Western Pomerania) is an ongoing general practitioner (GP)-based, randomized, controlled intervention trial. A total of 4,064 patients (≥70 years, living at home) recruited from 108 participating GP practices were screened for dementia (DemTect < 9). Of 692 eligible patients (17%), a total of 406 subjects (59%) provided informed consent. Present analyses are based on the data of 243 patients with complete baseline assessment on January 1, 2014 (preliminary data). Formal diagnoses were retrieved from the medical records of the treating GPs. A conditional fixed effect regression analysis was performed to analyze factors associated with undiagnosed dementia.A total of 40% of patients who screened positive for dementia had been formally diagnosed with dementia. Unspecified dementia was diagnosed in 53%, vascular dementia in 24%, and Alzheimer's disease in 19% of these patients. Undiagnosed dementia was significantly associated with a higher mean score in the Mini-Mental State Examination (odds ratio, 1.11; p < 0.01, 95% confidence interval 1.04-1.18).The diagnosis rate of dementia in German primary care (40%) is well within the range of the international data (20-50%). The results emphasize the need for action to enhance recognition and differential diagnosis of dementia. |
0 | TITLE: The 5352 A allele of the pro-inflammatory caspase-1 gene predicts late-acquired stent malapposition in STEMI patients treated with sirolimus stents.ABSTRACT: Late-acquired stent malapposition (LASM) is a common finding after sirolimus-eluting stent (SES) implantation and may be the cause for late stent thrombosis. Inflammation may play a pivotal role in LASM just as it plays in stent restenosis. We have therefore investigated seven polymorphisms involved in inflammatory processes, related in previous reports to restenosis, on the risk of LASM in SES patients. Patients with ST-elevation myocardial infarction who underwent SES implantation and had intravascular ultrasonography (IVUS) data available for both immediate post-intervention and 9-month follow-up were included in the present study. In total, 104 patients from the MISSION! Intervention Study were genotyped for the caspase-1 5352 G/A, eotaxin 1382 A/G, CD14 260 A/G, colony stimulating factor 2 1943 C/T, IL10 -1117 C/T, IL10 4251 C/T, and the tumor necrosis factor alpha 1211 C/T polymorphisms. LASM occurred in 26/104 (25%) of patients. We found a significantly higher risk for LASM in patients carrying the caspase-1 (CASP1) 5352 A allele (RR = 2.32; 95% CI 1.22-4.42). In addition, mean neointimal growth was significantly lower in patients carrying this LASM risk allele (1.6 vs. 4.1%, p = 0.014). The other six polymorphisms related to inflammation were not significantly related to the risk of LASM. In conclusion, carriers of the 5352 A allele in the caspase-1 gene are at increased risk of developing LASM after SES implantation. If this is confirmed in larger studies, then screening for this polymorphism in patients undergoing percutaneous coronary interventions could eventually help cardiologists to better select between commercially available stents. |
1 | TITLE: Addition of atropine to submaximal exercise stress testing in patients evaluated for suspected ischaemia with SPECT imaging: a randomized, placebo-controlled trial.ABSTRACT: To evaluate the effects of the addition of atropine to exercise testing in patients who failed to achieve their target heart rate (HR) during stress myocardial perfusion imaging with single-photon emission computed tomography (SPECT).The study was a prospective, randomized, placebo-controlled design. Patients with suspected or known coronary artery disease who failed to achieve a target HR (≥85% of maximal predicted HR) during exercise SPECT imaging were randomized to receive intravenous atropine (n=100) or placebo (n=101).The two groups of patients did not differ with respect to demographic or clinical characteristics. A higher proportion of patients in the atropine group achieved the target HR compared to the placebo group (60% versus 3%, p<0.0001). SPECT imaging was abnormal in a higher proportion of patients in the atropine group as compared to the placebo group (57% versus 42%, p<0.05). Stress-induced myocardial ischaemia was present in more patients in the atropine group as compared to placebo (47% versus 29%, p<0.01). In both groups of patients, no major side effects occurred.The addition of atropine at the end of exercise testing is more effective than placebo in raising HR to adequate levels, without additional risks of complications. The use of atropine in patients who initially failed to achieve their maximal predicted HR is associated with a higher probability of achieving a diagnostic myocardial perfusion study. |
1 | TITLE: Clinical benefits of methylprednisolone in off-pump coronary artery bypass surgery.ABSTRACT: It has not been established whether off-pump coronary artery bypass grafting (OPCABG) is less invasive than conventional CABG. In our experience, OPCABG has several advantages such as shorter operative duration, decreased requirement of blood transfusion and myocardial protection compared with conventional CABG. However, frequency of postoperative paroxysmal atrial fibrillation (PAF) is similar between these techniques and early postoperative C-reactive protein (CRP) levels have been shown to be significantly higher in OPCABG. We hypothesized that preoperative steroid administration, routinely used only in conventional CABG, may alleviate high postoperative PAF and CRP levels. Therefore, a prospective, double-blind, clinical trial was conducted in OPCABG patients to investigate the clinical effects of preoperative steroid administration.Thirty OPCABG patients were randomly divided into 2 groups: control (Group C: n = 15) and methylprednisolone (Group M: n = 15) groups. Group M patients were intravenously administered 1000 mg methylprednisolone during anesthesia induction.Hospital death and infectious complication such as mediastinitis were not observed in either group. Postoperative PAF occurred in 47 % (7/15) of patients in group C but in only 1 patient in group M (7 %, P = 0.013). Early postoperative CRP levels were significantly lower in group M than in group C (peak values on postoperative day 2: group M 15 ± 6 mg/dL vs. group C 23 ± 4 mg/dL; P = 0.0002).Preoperative steroid administration in OPCABG patients significantly suppresses CRP elevation and prevents postoperative PAF without increasing in-hospital mortality or infectious complications. |
1 | TITLE: Does cow's milk protein elimination diet have a role on induction and maintenance of remission in children with ulcerative colitis?ABSTRACT: Aims of this study were to evaluate the efficacy of a cow's milk protein (CMP) elimination diet on induction and maintenance of remission and to define association with atopy in children with ulcerative colitis (UC).Twenty-nine consecutive patients (mean age: 11.2 years; range: 4.6-17 years; F/M: 15/14) with newly diagnosed UC were randomized either to receive a CMP elimination diet (n = 14) or to continue a free diet (n = 15) associated with concomitant steroid induction and mesalazine maintenance treatment. Children were prospectively evaluated at four time points: within 1 month, 6 months and 1 year after diagnosis or at the time of relapse.Twenty-five of the 29 enrolled patients responded to the UC induction therapy with a complete remission (86.2%), 13 belonging to CMP elimination diet group and 12 to free diet group (p = 0.59). Overall, our data showed that 7 of 13 (53.8%) patients treated with CMP elimination diet and 8 of 15 (53.3%) patients on free diet and UC therapy relapsed within 1 year of follow-up (p = 1).In conclusion, data of this paediatric, randomized trial suggest that CMP elimination has no role in the management of UC in non-sensitized children. |
1 | TITLE: Simvastatin for secondary prevention of all-cause mortality and major coronary events in patients with mild chronic renal insufficiency.ABSTRACT: A potentially modifiable risk factor for cardiovascular disease in patients with mild chronic renal insufficiency is dyslipidemia. Few studies examined the effects of statins on all-cause mortality and major coronary events in patients with renal dysfunction.We performed a post hoc analysis from the Randomized Trial of Cholesterol Lowering in 4,444 Patients with Coronary Heart Disease: The Scandinavian Simvastatin Survival Study. Of 4,444 participants, 2,314 (52.1%) had mild chronic renal insufficiency defined as an estimated glomerular filtration rate less than 75 mL/min/1.73 m(2) (<1.25 mL/s), measured using the Modification of Diet in Renal Disease equation. The primary end point was all-cause mortality.During the follow-up period, simvastatin use was associated with decreased all-cause mortality (adjusted hazard ratio [HR], 0.69; confidence interval [CI], 0.54 to 0.89) in the 2,314 participants with mild chronic renal insufficiency. Rates of major coronary events (adjusted HR, 0.67; CI, 0.56 to 0.79) and coronary revascularization (adjusted HR, 0.62; CI, 0.49 to 0.77) also were significantly lower in the simvastatin group. No significant decreases in stroke incidence were observed in the simvastatin group (adjusted HR, 0.88; CI, 0.55 to 1.39). The side-effect profile was similar between the 2 treatment groups.Simvastatin therapy appears to be effective and safe for the secondary prevention of all-cause mortality and major coronary events in patients with mild chronic renal dysfunction. |
1 | TITLE: Randomized controlled trial to assess the role of raised anal pressures in the pathogenesis of symptomatic early hemorrhoids.ABSTRACT: Increased maximum resting anal pressures (MRAP) have been found in patients with large prolapsed hemorrhoids undergoing hemorrhoidectomy, but their pathogenic role is controversial especially in view of the sphincteric damage that occurs with open and stapled procedures. This prospective randomized clinical trial was conducted to compare anal pressure changes in early symptomatic hemorrhoidal disease before and after successful treatment with band ligation or injection sclerotherapy, and to compare these pressures with those in normal asymptomatic controls.32 patients with symptomatic grade II hemorrhoids were randomized to treatment with either band ligation or injection sclerotherapy. Anal manometry was done before treatment and 8 weeks after completion of treatment, and compared with 20 normal age-matched controls.The pretreatment values in both study groups were similar to each other (69.38 cm H(2)O, 95% CI 58.67-80.08, vs. 67.75 cm H(2)O, 95% CI 56.86-78.64; p = 0.790), but were significantly higher (p = 0.0001 in both groups) than in the controls (45.25 cm H(2)O, 95% CI 38.36-52.14). After successful completion of treatment, there was a highly significant drop in the MRAP in both study groups (p = 0.0001 in group A, and p = 0.001 in group B) reaching normal values.Our study shows that even in early-stage hemorrhoids, the anal pressures are significantly raised, but after successful treatment with band ligation or injection sclerotherapy, these pressures return to normal, showing that they do not play a pathogenic role but are secondary to the congested hemorrhoidal cushions. |
1 | TITLE: Effects of aerobic exercise on the circadian rhythm of heart rate and blood pressure.ABSTRACT: Although the effects of aerobic exercise on resting heart rate, heart rate variability, and blood pressure have been investigated, there are scant data on the effects of aerobic exercise on the circadian rhythm of such cardiovascular parameters. In this study, we investigated the effects of aerobic exercise on the 24 h rhythm of heart rate and ambulatory blood pressure in the morning, when cardiovascular events are more common. Thirty-five healthy young subjects were randomized to control and aerobic exercise groups. Subjects in the latter group participated in their respective exercise program for two months, while those in the former group did not exercise. Twenty-four-hour electrocardiogram and ambulatory blood pressure monitoring data were obtained at baseline and at the end of the exercise intervention. The control group showed no changes, while the aerobic exercise group showed a significant decrease in heart rate (73.7 +/- 6.6 bpm to 69.5 +/- 5.1 bpm, p < 0.005) and sympathetic activity such as LF/HF ratio (2.0 +/- 0.7 to 1.8 +/- 0.6, p < 0.05) throughout the 24 h period, particularly in the daytime. The decrease in the heart rate was most prominent in the morning. However, heart rate and LF/HF ratio showed no statistical changes during the night. No significant changes were observed in blood pressure. These findings suggest aerobic exercise exerts beneficial effects on the circadian rhythm of heart rate, especially in the morning. |
1 | TITLE: Long-term safety and efficacy of perinatal probiotic intervention: Evidence from a follow-up study of four randomized, double-blind, placebo-controlled trials.ABSTRACT: Societies worldwide are faced with a progressive increase in immune-mediated health problems such as allergic, autoimmune, and inflammatory diseases, as well as obesity. Perinatal administration of specific probiotic bacteria is an attractive approach in reducing the risk of these conditions, but long-term efficacy and safety data are lacking. The aim here was to evaluate the clinical benefit and long-term safety of specific probiotics administered during the perinatal period.The probiotic strains used were Lactobacillus rhamnosus GG, Bifidobacterium lactis Bb-12, Lactobacillus paracasei ST11, and Bifidobacterium longum BL999. The children involved have subsequently undergone prospective long-term follow-up. In addition to physical examination, data were collected by structured questionnaires on non-communicable diseases and continued probiotic use, and growth data from welfare clinics and school nurses.Altogether 303 mother-infant pairs were included in the analysis. Seventy-six of 163 (47%) children receiving perinatal probiotics had developed allergic disease compared with 79 of 140 (56%) receiving placebo (OR 0.67, 95% confidence intervals [CI] 0.43-1.06, p = 0.09). Fifty-nine of 133 (44%) children receiving L. rhamnosus GG perinatally had developed allergic disease, OR 0.62, 95% CI 0.38-0.99, p = 0.047, as compared to placebo. We found no differences in growth or non-communicable disease prevalence between children receiving perinatally probiotics or placebo.Perinatal probiotic administration is safe in long-term follow-up. Children receiving L. rhamnosus GG perinatally tended to have decreased allergy prevalence. |
1 | TITLE: Electronic Immunization Alerts and Spillover Effects on Other Preventive Care.ABSTRACT: The impact of electronic health record (EHR) immunization clinical alert systems on the delivery of other preventive services remains unknown. We assessed for spillover effects of an EHR immunization alert on delivery of 6 other preventive services, in children 18 to 30 months of age needing immunizations. We conducted a secondary data analysis, with additional primary data collection, of a randomized, historically controlled trial to improve immunization rates with EHR alerts, in an urban, primary care clinic. No significant differences were found in screening for anemia, lead, development, nutrition, and injury prevention counseling in children prompting EHR immunization alerts (n = 129), compared with controls (n = 135). Significant increases in oral health screening in patients prompting EHR alerts (odds ratio = 4.8, 95% CI = 1.8-13.0) were likely due to practice changes over time. An EHR clinical alert system targeting immunizations did not have a spillover effect on the delivery of other preventive services. |
1 | TITLE: Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.ABSTRACT: Radical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD.Patients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction.Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046).This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms. |
1 | TITLE: Coming out under fire: The role of minority stress and emotion regulation in sexual orientation disclosure.ABSTRACT: Minority stress is hypothesized to interfere with sexual orientation disclosure and sexual minority wellbeing. In this study, we investigated whether minority stress is causally linked to reduced disclosure in sexual minorities, and whether emotion regulation, a potentially adaptive form of stigma coping, can intervene to promote disclosure even following exposure to minority stress. Sexual minority adults in the US (N = 168) were recruited online and randomized to a 2 x 2 between-subjects experimental design, where they: 1) received either emotion regulation instructions that asked them to either distance themselves from an emotionally evocative film clip or immerse themselves in the clip, and then 2) viewed either an affirming or a minority stress film clip. Following the film clip, participants completed a written reflection task in which they reflected on the film clip they viewed, which allowed research assistants to subsequently code for participants' spontaneous disclosures of sexual orientation. Participants who viewed the minority stress clip were significantly less likely to spontaneously disclose their sexual orientation in the written task compared to those who viewed the affirming film clip, OR = 3.21, 95% CI [1.14, 9.05], p = .03. Although the emotion regulation manipulation was successful, there was no effect on sexual orientation disclosure. To our knowledge, this is the first study to demonstrate a causal link between minority stress and disclosure in sexual minorities, and thus highlights an important mechanism underlying minority stress's effects on sexual minority wellbeing. Results demonstrate the importance of interventions that affirm marginalized identities and promote safe sexual orientation disclosure. Future research is needed to determine the circumstances under which effective emotion regulation can buffer against the negative emotional effects of minority stress to promote healthy approach behaviors like disclosure in safe contexts. |
1 | TITLE: Bromelain and cardiovascular risk factors in diabetes: An exploratory randomized, placebo controlled, double blind clinical trial.ABSTRACT: To assess whether the dietary supplement (bromelain) has the potential to reduce plasma fibrinogen and other cardiovascular disease (CVD) risk factors in patients with diabetes.This randomized placebo controlled, double blind, parallel design, efficacy study was carried out in China and investigated the effect of 12 weeks of bromelain (1,050 mg/day) on plasma fibrinogen. This randomized controlled trial (RCT) recruited 68 Chinese diabetic patients [32 males and 36 females; Han origin, mean age of 61.26 years (standard deviation (SD), 12.62 years)] with at least one CVD risk factor. Patients were randomized into either bromelain or placebo group. While bromelain group received bromelain capsule, the placebo group received placebo capsule which consisted inert ingredient and has no treatment effect. Subjects were required to take 1,050 mg (3×350 mg) of either bromelain or starch-filled placebo capsules, two to be taken (2×350 mg) after breakfast and another (350 mg) after dinner, daily for 12 weeks. Plasma fibrinogen, CVD risk factors and anthropometric indicators were determined at baseline and at 12 weeks.The change in the fibrinogen level in the bromelain group at the end of the study showed a mean reduction of 0.13 g/L (standard deviation (SD) 0.86g/L) compared with the mean reduction of 0.36 g/L (SD 0.96 g/L) for the placebo group. However, there was no significant difference in the mean change in fibrinogen between the placebo and bromelain groups (mean difference=0.23g/L (SD 0.22 g/L), =0.291). Similarly, the difference in mean change in other CVD risk factors (blood lipids, blood pressure), blood glucose, C-reactive protein and anthropometric measures between the bromelain and placebo groups was also not statistically significant. Statistical differences in fibrinogen between bromelain and placebo groups before the trial despite randomization may have influenced the results of this study.This RCT failed to show a beneficial effect in reducing fibrinogen or influencing other selected CVD risk factors but suggests other avenues for subsequent research on bromelain. |
1 | TITLE: Clinical and metabolic response to flaxseed oil omega-3 fatty acids supplementation in patients with diabetic foot ulcer: A randomized, double-blind, placebo-controlled trial.ABSTRACT: Data on the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with diabetic foot ulcer (DFU) are scarce.This study was conducted to evaluate the effects of flaxseed oil omega-3 fatty acids supplementation on wound healing and metabolic status in subjects with DFU.The current randomized, double-blind, placebo-controlled trial was conducted among 60 subjects (aged 40-85years old) with grade 3 DFU. Subjects were randomly allocated into two groups (30 subjects each group) to receive either 1000mg omega-3 fatty acids from flaxseed oil supplements or placebo twice a day for 12weeks.After the 12-week intervention, compared with the placebo, omega-3 fatty acids supplementation resulted in significant decreases in ulcer length (-2.0±2.3 vs. -1.0±1.1cm, P=0.03), width (-1.8±1.7 vs. -1.0±1.0cm, P=0.02) and depth (-0.8±0.6 vs. -0.5±0.5cm, P=0.01). Additionally, significant reductions in serum insulin concentrations (-4.4±5.5 vs. +1.4±8.3 μIU/mL, P=0.002), homeostasis model of assessment-estimated insulin resistance (-2.1±3.0 vs. +1.0±5.0, P=0.005) and HbA1c (-0.9±1.5 vs. -0.1±0.4%, P=0.01), and a significant rise in the quantitative insulin sensitivity check index (+0.01±0.01 vs. -0.005±0.02, P=0.002) were seen following supplementation with omega-3 fatty acids compared with the placebo. In addition, omega-3 fatty acids supplementation significantly decreased serum high sensitivity C-reactive protein (hs-CRP) (-25.5±31.5 vs. -8.2±18.9μg/mL, P=0.01), and significantly increased plasma total antioxidant capacity (TAC) (+83.5±111.7 vs. -73.4±195.5mmol/L, P<0.001) and glutathione (GSH) concentrations (+60.7±140.2 vs. -15.5±129.7μmol/L, P=0.03) compared with the placebo.Overall, omega-3 fatty acids supplementation for 12weeks among subjects with DFU had beneficial effects on parameters of ulcer size, markers of insulin metabolism, serum hs-CRP, plasma TAC and GSH levels. In addition, flaxseed oil omega-3 fatty acids may have played an indirect role in wound healing due to its effects on improved metabolic profiles. |
1 | TITLE: Effect of ultrasound-guided selective sensory nerve blockade of the knee on pain management compared with periarticular injection for patients undergoing total knee arthroplasty: A prospective randomized controlled trial.ABSTRACT: Ultrasound-guided selective sensory nerve blockade (SSNB) of the knee, including an adductor canal block (ACB), anterior femoral cutaneous nerve block, and infiltration between the popliteal artery and posterior capsule of the knee may provide effective motor-sparing knee analgesia for total knee arthroplasty (TKA). We hypothesized that the SSNB would manage pain better on ambulation 24 hours postoperatively compared to periarticular infiltration (PAI), when combined with postoperative continuous ACB.Seventy-two patients undergoing elective TKA under spinal anesthesia were randomly assigned to either SSNB (SSNB group) or intraoperative PAI (PAI group). All patients received postoperative multimodal analgesia, including continuous ACB. The primary outcome was pain on ambulation 24 hours postoperatively. Secondary outcomes included rest and dynamic numerical rating scale pain score, intravenous morphine requirement, functional performance measures, adverse events, satisfaction, and length of stay.There was no difference in pain score during movement between the groups (mean difference -0.48 [-1.38 to 0.42], p = 0.3) and other immediate overall pain scores 24 hours postoperatively. Patients in the SSNB group had significantly lower intravenous morphine requirement than the PAI group for 48 hours postoperatively (0 [0, 0] vs. 0 [0, 2]; p = 0.008). There was no intergroup difference in the performance-based measures, satisfaction, and length of stay.The SSNB did not provide superior postoperative analgesia, or improvement in immediate functional performance. However, it may result in lower opioid consumption postoperatively when compared with the intraoperative PAI. |
1 | TITLE: A randomized controlled clinical trial on the impact of CCR5 blockade with maraviroc in early infection on T-cell dynamics.ABSTRACT: Initiation of antiretroviral therapy (ART) in early HIV infection demonstrates clinical benefits including enhanced CD4 T-lymphocyte recovery and minimization of the latent HIV reservoir. Whether ART intensification with CCR5 blockade provides additional benefits is unknown.This randomized controlled trial evaluated the impact of maraviroc (MVC) intensification in persons starting ART in acute and early HIV (AEH, within 3 months of estimated date of infection).Twenty persons in AEH in San Diego underwent double-blind randomization to receive either standard of care (SOC) ART or SOC + MVC to evaluate the hypothesis that early CCR5 blockage with a CCR5-containing ART regimen may provide immunologic and clinical benefit. The primary outcome of this study was the difference from baseline to week 48 in the proportion of CCR5 CD4 memory T cells. Blood was drawn at baseline and weeks 12, 24, and 48 to evaluate CCR5 CD4 and CD8 T-cell dynamics using multicolor flow cytometry.MVC intensification (n = 10) did not significantly alter CCR5 T-cell dynamics at week 48 of study compared to SOC (n = 9) in this fully recruited study (mean 1.12 vs 0.63, t = 0.36, df = 16, P = 0.727). Exploratory analyses of additional T-cell subsets suggest that MVC intensification in AEH trended to early greater increases in naïve and activated and proliferating CD4 T cells (P = 0.11, 0.19), and greater decreases in senescent memory CD4 T cells (P = 0.06), but these differences did not remain by week 48. CD8 T-cell evaluations did demonstrate trends to differences at week 48 with slower increases in naïve cells and slower decreases in activated memory cells (P = 0.16, 0.09). There were no reported harms or significantly different adverse events.We did observe a few trends, but did not find compelling evidence that MVC intensification during AEH significantly impacts CD4 and CD8 T-cell dynamics. Diagnosing and starting persons in AEH on ART may be of greater clinical importance than the regimen initiated. |
1 | TITLE: The Prophylactic Use of Remifentanil for Delayed Extubation After Elective Intracranial Operations: a Prospective, Randomized, Double-Blinded Trial.ABSTRACT: Endotracheal extubation is a painful and stressful procedure. The authors hypothesized that the prophylactic use of remifentanil would attenuate the pain intensity and stress responses resulting from extubation in neurosurgical patients.In this prospective, randomized, double-blinded, controlled trial, 160 patients with planned delay extubation after elective intracranial operation were randomized 1:1 to receive either remifentanil or normal saline (control) before their extubation. The dose regime of remifentanil was a bolus of 0.5 μg/kg over 1 minute, followed by a continuous infusion of 0.05 μg/kg/min for 20 minutes. The primary outcome was the incidence of severe pain during the periextubation period. Secondary outcomes included changes in the pain intensity and vital signs, failing to pass an extubation evaluation after the study drug infusion, severe adverse events, postextubation complications, and clinical outcomes.Two patients in the remifentanil group did not pass the extubation evaluation. The incidence of severe pain during the periextubation period was significantly lower in the remifentanil group compared with the control group (25.0% vs. 41.3%, P=0.029). Compared with the control group, the visual analog scale in the remifentanil group was significantly lower after the bolus of remifentanil (12±18 vs. 25±27, P=0.001) and immediately after extubation (19±25 vs. 34±30, P=0.001). There were no significant differences in the vital signs immediately after extubation between the 2 groups (P>0.05).The prophylactic use of remifentanil decreases the incidence of severe pain. Our preliminary findings merit a larger trial to clarify the effect of the prophylactic use of remifentanil on clinical outcomes and adverse events. |
1 | TITLE: Spontaneous versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: A randomized trial.ABSTRACT: Spontaneous ventilation video-assisted thoracic surgery (SV-VATS) is reported to have superior or equal efficacy on postoperative recovery to mechanical ventilation VATS (MV-VATS). However, perioperative safety of the SV-VATS blebectomy is not entirely demonstrated.We performed a noninferiority, randomized controlled trial (No. NCT03016858) for primary spontaneous pneumothorax patients aged 16 to 50 years undergoing a SV-VATS and the MV-VATS procedure. The trial was conducted at 10 centers in China from April 2017 to January 2019. The primary outcome was the comparison of intra- and postoperative complications between SV-VATS and MV-VATS procedures. Secondary outcomes included total analgesia dose, change of vital sign during surgery, procedural duration, recovery time, postoperative visual analog pain scores, and hospitalization length.In this study, 335 patients were included. There was no significant difference between the SV-VATS group and the MV-VATS group in the intra- and postoperative complication rates (17.90% vs 22.09%; relative risk, 0.81; 95% confidence interval, 0.52-1.26; P = .346). The SV-VATS group was associated with significantly decreased total dose of intraoperative opioid agents; that is, sufentanil (11.37 μg vs 20.92 μg; P < .001) and remifentanil (269.78 μg vs 404.96 μg; P < .001). The SV-VATS procedure was also associated with shorter extubation time (12.28 minutes vs 17.30 minutes; P < .001), postanesthesia care unit recovery time (25.43 minutes vs 30.67 minutes; P = .02) and food intake time (346.07 minute vs 404.02 minutes; P = .002). Moreover, the SV-VATS procedure deceased the anesthesia cost compared with the MV-VATS ($297.81 vs $399.81; P < .001).SV-VATS was shown to be noninferior to MV-VATS in term of complication rate and in selected patients undergoing blebectomy for primary spontaneous pneumothorax. |
1 | TITLE: Is a Steroid Injection in Both Compartments More Effective than an Injection in the Extensor Pollicis Brevis Subcompartment Alone in Patients with de Quervain Disease? A Randomized, Controlled Trial.ABSTRACT: Ultrasonography (US)-guided steroid injections can improve the accuracy of injection in patients with de Quervain disease, especially in those with an intracompartmental septum. Although the main lesion of de Quervain disease in patients with a septum is a stenosing tenosynovitis of the extensor pollicis brevis (EPB), no report we know of has compared injection into the EPB subcompartment with an injection into both the abductor pollicis longus (APL) and EPB subcompartments. In this randomized trial, we compared the results of US-guided steroid injections targeting both subcompartments and the EPB subcompartment alone in patients with de Quervain disease.(1) Do patients who receive a steroid injection in the EPB subcompartment alone have lower pain scores at 6 weeks and at 3 months after US-guided injection compared with patients who receive an injection in both subcompartments? (2) Do patients who receive a steroid injection in the EPB subcompartment alone experience fewer steroid injection-related complications than patients who receive an injection in both subcompartments?A randomized controlled study was performed at a single center between August 2018 and March 2021. Patients with a diagnosis of de Quervain disease and with a complete intracompartmental septum between the APL and the EPB tendons were included. In total, 112 patients had a diagnosis of de Quervain disease during the study period. Definite, complete subcompartmentalization was seen in 50 patients. Patients were randomly assigned to US-guided injections targeting both subcompartments (n = 25) or the EPB subcompartment alone (n = 25). There were no between-group differences in age, gender, affected wrist, or disease duration, and all patients had US evidence of tendinosis of the EPB, with or without tendinosis of the APL. Although 33% of patients (16 of 48) showed tendinosis of the APL, no patient showed tendinosis of the APL alone. In all patients, a dorsal-to-palmar side injection of 0.5 mL of 2% lidocaine and 0.5 mL of triamcinolone acetonide (40 mg/mL) was administered by two experienced hand surgeons. In the both-subcompartments group, US-guided injections were performed in each of the APL and EPB subcompartments. In the EPB subcompartment group, US-guided injections were administered in the EPB subcompartment only. All patients underwent the same protocol after the procedure. Four percent (n = 2, 1 in each group) of patients were excluded after randomization because their pain level was not registered. Pre- and postinjection clinical outcome assessments were completed by orthopaedic surgery residents not involved in patient management. Patients were regularly examined at baseline, 6 weeks, and 3 months to evaluate the intensity of pain. We assessed pain by the VAS score, where 0 indicated no pain and 100 the most pain. At baseline, the VAS score was 67 ± 14 in the both-subcompartment group and 67 ± 16 in the EPB subcompartment group (mean difference 0.17 [95% CI -8.45 to 8.82]; p = 0.97). Complications related to the steroid injection, including numbness, tendon rupture, and skin hypopigmentation, were also recorded at final follow-up examinations. To determine statistical power, the VAS score for pain at 6 weeks after the injection was used as the primary outcome variable. The minimum clinically important difference for the VAS score was deemed to be 20 mm, and we estimated an SD of 23. A sample size calculation indicated that a sample of 21 patients per group would provide 80% power to detect an effect of this size between the groups at the p = 0.05 level using a t-test.There were no differences in the VAS scores between the both-subcompartment group and the EPB group at 6 weeks (10 ± 6 versus 10 ± 7, mean difference -0.08 [95% CI -4.08 to 3.91]; p = 0.97). The same was true at 12 weeks (12 ± 13 versus 11 ± 15, mean difference 0.38 [95% CI -7.74 to 8.49]; p = 0.09). No adverse events related to treatment (such as tendon rupture, infections, and numbness) occurred in either group. However, skin hypopigmentation occurred at the final follow-up examination in both groups. The proportion of patients experiencing skin hypopigmentation in the EPB subcompartment group was lower than in the both-subcompartment group (33% [8 of 24] versus 67% [16 of 24]; odds ratio 0.25 [95% CI 0.08 to 0.83]; p = 0.02).Our data suggest that a US-guided steroid injection targeting the EPB subcompartment alone is as effective in terms of pain reduction as targeting both subcompartments in patients with de Quervain disease who have complete septation. Furthermore, an injection targeting the EPB subcompartment alone can reduce the dose of steroids used, perhaps thereby decreasing complications related to steroid injections. We recommend using only single-compartment injections in this context, even among patients with an intracompartmental septum.Level I, therapeutic study. |
1 | TITLE: Triggering with 1,500 IU of human chorionic gonadotropin plus follicle-stimulating hormone compared to a standard human chorionic gonadotropin trigger dose for oocyte competence in in vitro fertilization cycles: a randomized, double-blinded, controlled noninferiority trial.ABSTRACT: To assess if triggering with 1,500 IU of human chorionic gonadotropin (hCG) with 450 IU of follicle-stimulating hormone (FSH) induces noninferior oocyte competence to a standard dose of hCG trigger used in in vitro fertilization (IVF). The alternative trigger will be considered noninferior if it is at least 80% effective in promoting oocyte competence.Randomized, double-blinded, controlled noninferiority trial.Academic infertility practice.Women aged 18-41 undergoing IVF with antral follicle count ≥8, body mass index ≤30 kg/m, and no history of ≥2 IVF cycles canceled for poor response were enrolled. Participants with a serum estradiol >5,000 pg/mL on the day of trigger were excluded because of high risk of ovarian hyperstimulation syndrome.Participants were randomized to receive an alternative trigger of 1,500 IU of hCG plus 450 IU of FSH or a standard trigger dose of hCG (5,000 or 10,000 IU) for final oocyte maturation.The primary outcome was total competent proportion, defined as the probability of 2 pronuclei from an oocyte retrieved. The alternative trigger will be considered noninferior to the standard trigger if a 1-sided 95% confidence interval (CI) of the relative risk (RR) is not <0.8. Secondary outcomes included oocyte recovery and maturity, intracytoplasmic sperm injection fertilization, embryo quality, pregnancy rates, as well as serum and follicular hormones. Secondary outcomes were compared using a 2-sided superiority test. Outcomes were analyzed by intention-to-treat and per-protocol.A total of 105 women undergoing IVF were randomized from May 2015 to June 2018. The probability of the primary outcome was 0.59 with the alternative trigger and 0.65 with the standard trigger, with a RR of 0.91 and a 1-sided 95% CI of 0.83. Noninferiority of the alternative trigger was demonstrated. Live birthrate from all fresh transfers in the alternative trigger group vs. standard trigger was 46.9 vs. 46.4% (RR, 1.01; 95% CI, 0.62-1.62), respectively. Live birthrate per randomized participant was 48.1% in the alternative trigger group vs. 62.7% with the standard trigger (RR, 0.73; 95% CI, 0.48-1.11). No participants had a failed retrieval.Triggering with 1,500 IU of hCG plus 450 IU of FSH promoted noninferior oocyte competence compared to a standard hCG trigger dose.NCT02310919. |
1 | TITLE: Vitamin D Supplementation on Carotid Remodeling and Stiffness in Obese Adolescents.ABSTRACT: Obesity is associated with vitamin D (VD) deficiency and arterial stiffness. This randomized control trial assessed the effects of VD supplementation during a weight-loss program on carotid intima-media thickness (IMT) and carotid compliance in obese adolescents. Participants were randomly assigned to receive either a 12-week lifestyle program with VD supplementation ( = 13), a lifestyle program without VD supplementation ( = 13) or a control group composed of normal-weight adolescents ( = 18). Serum total and free 25-hydroxyvitamin D (25(OH)D), IMT and carotid compliance were measured before and after the trial. Insufficiency in 25(OH)D concentration was found in 73% of obese participants compared to 22% among controls. Obese adolescents had lower free 25(OH)D and displayed higher IMT but lower carotid compliance than controls. Free 25(OH)D and IMT were negatively correlated in adolescents displaying VD insufficiency at baseline. After three months, total and free 25(OH)D increased in both groups. The changes of IMT and carotid compliance were similar between groups. The changes in IMT were correlated with the changes in total 25(OH)D in obese adolescents with VD insufficiency at baseline ( = -0.59, = 0.03). While the lifestyle program with VD supplementation did not affect carotid compliance, IMT reduction was improved in obese adolescents. |
1 | TITLE: Effects of capnometry monitoring during recovery in the post-anaesthesia care unit: a randomized controlled trial in adults (CAPNOSSPI).ABSTRACT: Continuous capnography should be used on patients admitted to post-anaesthesia care units (PACUs) with endotracheal tubes, but this monitoring is not always performed. Optimized ventilation in the PACU could be part of the global standards of practice to maintain the benefits of perioperative ventilation. The main objective was to study the rate of patients with alveolar hypoventilation before tracheal extubation or Laryngeal Mask Airway (LMA) removal upon the measurement of continuous capnography.In this prospective, parallel-group, randomized controlled study, we enrolled adult patients admitted to the PACU after general anaesthesia with an endotracheal tube or LMA in place. Patients were randomly assigned to two groups: in the Capno + group, nurses managed the patients with access to the capnometer and end-tidal carbon dioxide pressure (PETCO) measurements; in the Capno- group, nurses monitored the patients without seeing PETCO measurements. The primary outcome was the percentage of patients with PETCO measurements above 45 mm Hg during the minute before extubation. Secondary endpoints included the delay in recovering spontaneous breathing, rate of hypoxemia, delay before extubation, and length of stay in the PACU.Forty-eight patients were randomized into the two groups. The percentage of patients with PETCO > 45 mm Hg the minute before extubation was significantly decreased in the Capno + group (83.3% versus 54,1% in the Capno- and Capno + groups respectively, p = 0.029). There were no significant differences concerning secondary endpoints.The use of PETCO monitoring improves patient safety by decreasing the incidence of CO retention during recovery from general anaesthesia. This study suggests that this monitoring should be integrated in the PACU. The risk of hypoxemia can also be prevented through the early recognition of apnoea.clinicaltrial.gov. identifier: NCT03370081. |
1 | TITLE: A randomized, double-blind, placebo-controlled pilot study of the comparative effects of dienogest and the combined oral contraceptive pill in women with endometriosis.ABSTRACT: To compare the effects of dienogest and a combined oral contraceptive pill (COCP) after laparoscopic surgery on pain and quality of life in women with severe endometriosis.A randomized double-blind pilot study was conducted from March 2018 to March 2020 in women with severe endometriosis confirmed by laparoscopic surgery. A total of 108 patients who had undergone laparoscopic surgery received dienogest, COCP, or placebo daily for 6 months. Primary and secondary outcomes were compared between the three groups.Treatment with dienogest or COCP was associated with improved self-reported pain after 6 months of treatment, as evidenced by significantly lower scores for pelvic pain and dyspareunia compared with placebo (P < 0.05). Significant differences in overall quality of life score were observed over 6 months in the dienogest, COCP, and placebo groups (mean difference 22.00, 23.45, and 6.45 points, respectively; P < 0.001). Post-hoc analysis revealed a significant difference in overall quality of life score between the placebo group and the dienogest (P < 0.001) and COCP groups (P = 0.004).Postoperative administration of dienogest or COCP reduced endometriosis-associated pain and improved quality of life in women with severe endometriosis.https://en.irct.ir/trial/43070. |
1 | TITLE: Effect of dehydroepiandrosterone administration before in vitro fertilization on the live birth rate in poor ovarian responders according to the Bologna criteria: A randomised controlled trial.ABSTRACT: To evaluate the effect of dehydroepiandrosterone (DHEA) pre-treatment before in vitro fertilization and embryo transfer (IVF-ET) on the live birth rate in infertile women with poor ovarian response (POR) defined according to the Bologna criteria.A randomized, double-blind, placebo-controlled trial.Nine reproductive medical centers in China.A total of 821 participants with POR defined according to the Bologna criteria were enrolled in the study between April 2016 and December 2018.Eligible participants were randomly assigned to receive either DHEA (n = 410) or placebo (n = 411) treatments for 4-12 weeks prior to IVF-ET, in a 1:1 ratio.Live birth rate after the first embryo transfer.Thirty-six (8.8%) of 410 women in the DHEA group and 37 (9.0%) of 411 women in the placebo group had a live birth, with no significant difference observed between groups (relative risk, 0.98, 95% CI, 0.63-1.51; p = 0.911). There were no significant differences in the number of retrieved oocytes, and the rates of clinical pregnancy, pregnancy loss, and cumulative live births between the two groups.DHEA administration prior to IVF-ET had no beneficial effect on the live birth rate relative to placebo in women with POR defined according to the Bologna criteria.No benefit was found in poor ovarian responders who received DHEA administration prior to IVF. |
0 | TITLE: Danger appraisal and pathogen-avoidance mechanisms in stigma towards severe mental illness: the mediating role of affective responses.ABSTRACT: Stereotypes of dangerousness are common predictors of stigmatising attitudes towards Severe Mental Illness (SMI). However less is known about pathogen avoidance mechanisms underlying stigma towards SMI, specially in samples of non-industrialised societies of Latin America and the Caribbean. The primary aim of this study was to examine pathogen-disgust sensitivity and danger appraisal mechanisms in responses of stigma towards SMI.Cross-sectional design with convenience sampling. Using an online survey, volunteers at the Universidad del Norte in Colombia (N = 271) provided their sociodemographic data and completed the Three-Domain Disgust Scale (TDDS). Participants were randomised to different descriptions of someone with SMI that varied in terms of aggressiveness (with and without danger) and causes of the SMI. Then, following the attribution questionnaire (AQ-27), respondents reported affective and discriminatory responses to the person in the description.Increased disgust sensitivity to pathogen stimuli resulted in stronger reports of anger (β = .14; p = .03), and fear (β = 0.27; p < 0.001). The relationship between disgust sensitivity and discriminatory responses was indirectly mediated by fear towards SMI (Bootstrapped CI =-.04,-.009). Dangerousness attributions in the description of SMI predicted stronger feelings of anger (β = .23; p = 0.001) and fear (β = .40; p < .001), as well increased support for coercion-segregation of SMI (β = .34; p = 0.04), but less intentions to help (β = -.26; p = 0.003). The relationship between dangerousness and support for coercion was mediated by fear (Bootstrapped CI = .72, 1.37) and anger (Bootstrapped CI = .06, .44), whereas pity (Bootstrapped CI = .03, .38) and fear (Bootstrapped CI = -1.39, -.69) mediated responses of support for coercion-segregation of SMI. Attributions about causes and personal responsibility were not significantly linked to stigma towards SMI (p > 0.05).Findings suggested that pathogen avoidance and danger appraisal systems interplay in the generation of discriminatory behaviour towards SMI. Anti-stigma programs and policy makers would benefit from introducing strategies that challenge stereotypes of dangerousness and unpredictability by promoting positive contact with people with SMI. |
1 | TITLE: Outcome after percutaneous coronary intervention with contemporary stents in patients with concomitant peripheral arterial disease: A patient-level pooled analysis of four randomized trials.ABSTRACT: A considerable number of patients who undergo percutaneous coronary intervention (PCI) also have peripheral arterial disease (PAD) - a signal of more advanced atherosclerosis. After bare metal and early-generation drug-eluting coronary stent implantation, PAD patients showed inferior outcome. As stents and medical treatment were further improved, we aimed to assess the impact of PAD on outcome of PCI with contemporary new-generation stents.We analyzed 3-year pooled patient-level data from 4 large-scale randomized new-generation stent trials to compare all-comer patients with and without (core lab-verified) history of symptomatic PAD, defined as obstructive lesions in peripheral locations including lower and upper extremities, carotid, vertebral, mesenteric and renal arteries. Main endpoint was target vessel failure: cardiac death, target vessel-related myocardial infarction, or clinically indicated target vessel revascularization.Of all 9204 patients, 695 (7.6%) had a history of symptomatic PAD. They were older and had more often diabetes, renal failure, hypertension, hypercholesterolemia, and prior stroke. PAD was an independent risk factor for target vessel failure (adjusted-HR:1.42, 95%-CI:1.12-1.73, p = 0.001). Target vessel revascularization (adjusted-HR:1.37, 95%-CI:1.04-1.80, p = 0.026), death (adjusted-HR:1.52, 95%-CI:1.17-1.99, p = 0.002), and major adverse cardiovascular event risks (adjusted-HR:1.36, 95%-CI:1.13-1.64, p = 0.001) were also substantially higher.A history of symptomatic PAD still allows to simply identify patients with increased risk of unfavorable clinical outcome after PCI, including a higher risk of repeated coronary revascularization, despite using contemporary stents. In clinical practice, this knowledge about higher event risks of PAD patients is helpful both during Heart Team discussions and when informing patients about the procedural risk. |
1 | TITLE: Effects of eicosapentaenoic acid on serum levels of selenoprotein P and organ-specific insulin sensitivity in humans with dyslipidemia and type 2 diabetes.ABSTRACT: Selenoprotein P (SeP, encoded by SELENOP in humans) is a hepatokine that causes insulin resistance in the liver and skeletal muscle. It was found that polyunsaturated fatty acid eicosapentaenoic acid (EPA) downregulates Selenop expression by inactivating SREBP-1c. The present study aimed to examine the effect of EPA for 12 weeks on circulating SeP levels and insulin sensitivity in humans with type 2 diabetes.A total of 20 participants with dyslipidemia and type 2 diabetes were randomly assigned to an EPA (900 mg, twice daily) group and a control group. The primary endpoint was a change in serum SeP levels. Organ-specific insulin sensitivity in the liver (HGP and %HGP), skeletal muscle (Rd), and adipose tissue (FFA and %FFA) were assessed using a hyperinsulinemic-euglycemic clamp study with stable isotope-labeled glucose infusion.Serum SeP levels were not changed in either group at the end of the study. In the EPA group, the changes in SeP levels were positively correlated with the change in serum EPA levels (r = 0.709, P = 0.022). Treatment with EPA significantly enhanced %FFA but not %HGP and Rd. The change in serum EPA levels was significantly positively correlated with the change in %HGP, and negatively correlated with changes in Rd.The change in serum EPA levels was positively correlated with serum SeP levels, hepatic insulin sensitivity, and negatively with skeletal muscle insulin sensitivity in humans with type 2 diabetes. The EPA-induced enhancement of hepatic insulin sensitivity might be associated with a mechanism independent of serum SeP levels. |
0 | TITLE: Coronary revascularization strategy and outcomes according to blood pressure (from the International Verapamil SR-Trandolapril Study [INVEST]).ABSTRACT: The optimal blood pressure (BP) to prevent major adverse outcomes (death, myocardial infarction, and stroke) for patients with hypertension and coronary artery disease who have undergone previous revascularization is unknown but might be influenced by the type of revascularization procedure. We analyzed data from the INternational VErapamil SR-Trandolapril STudy, focusing on the relation between BP and the outcomes of 6,166 previously revascularized patients, using the 16,410 nonrevascularized patients as a reference group. The previous revascularization strategy consisted of coronary artery bypass grafting (CABG, 45.2%), percutaneous coronary intervention (PCI, 42.1%), or both (CABG+PCI, 12.8%). Patients who had undergone both CABG+PCI and CABG-only had a greater adverse outcome risk (adjusted hazard ratio 1.27% and 1.20%, 95% confidence interval 1.06 to 1.53 and 1.07 to 1.35, respectively). The risk was similar for PCI-only patients (adjusted hazard ratio 1.04, 95% confidence interval 0.92 to 1.19). The relations between the adjusted hazard ratio and on-treatment BP appeared J-shaped for each revascularization strategy, accentuated for PCI and diastolic BP (DBP), but excepting CABG only and DBP for which the relation was linear and positive. In conclusion, major adverse outcomes were more frequent in patients with coronary artery disease who had undergone previous CABG, with or without PCI, compared to those with previous PCI only. This likely reflected more severe vascular disease. The relation to systolic BP was J-shaped for each strategy. Among those patients with previous CABG only, the linear relation with DBP suggested that more complete revascularization might attenuate hypoperfusion at a low DBP. The management of BP might, therefore, require modification of targets according to the revascularization strategy to improve outcomes. |
1 | TITLE: Equilibrium radionuclide angiography for evaluating the effect of facilitated percutaneous coronary intervention on ventricular synchrony in patients with acute myocardial infarction.ABSTRACT: It is unclear whether facilitated percutaneous coronary intervention (PCI) via a transradial approach therapy is preferable to primary PCI, with improved ventricular synchrony performance (VS), in Chinese patients.The 152 patients with their first anterior acute myocardial infarction (AMI) were randomized to a primary PCI group or facilitated PCI group. In the 1(st) week and 6(th) month after AMI onset, the parameters of VS were measured by equilibrium radionuclide angiography with ventricular phase analysis. The rate of TIMI grade-3 flow in the infarct-related artery pre-PCI in the facilitated PCI group was higher than that in the primary PCI group (30.56% vs. 8.45%, P=0.001). At the 6(th) month post-AMI, the parameters of time to peak ejection rate, phase shift and peak phase standard deviation were lower than in the primary PCI group (P<0.05, respectively). The incidence of recurrent ischemia and new or worsening congestive heart failure post-AMI in the facilitated PCI group was significantly lower than that in the primary PCI group (2.78% vs. 9.86%, P=0.043; 2.78% vs. 12.68%, P=0.028).Facilitated PCI via a transradial approach might significantly inhibit left ventricular remodeling and improve left ventricular function because of the complete, persistent patency of the infarct-related artery with few complications of vessel access and bleeding. |
1 | TITLE: Pre-operative education and counselling are associated with reduced anxiety symptoms following carotid endarterectomy: a randomized and open-label study.ABSTRACT: Post-operative anxiety is common and may have significant impact on the post-operative recovery of the patients. Theatre nurse visits before surgery has been shown to reduce patient's anxiety levels following general surgery.To investigate the effect of pre-operative visits and counselling by intensive care unit (ICU) nurses on patient's anxiety levels following carotid endarterectomy.This is an open-label and randomized clinical trial. Patients undergoing carotid endarterectomy were divided into study (n=60) and control group (n=60). For the study group, in addition to routine pre-operational counselling by the surgeons, ICU nurses visited the patients and provided a structured counselling the day before surgery. For the control group, only routine pre-operative counselling was provided. Anxiety levels were assessed by Zung self-rating anxiety scale (SAS) the day before surgery and on the day after being discharged from ICU to the ward.The two groups were comparable in age, sex, surgical methods, and duration of ICU stays. Following the surgery, the mean SAS score in the control group increased from 50.5±5.4 to 58.5±7.3 (p=0.03), whereas the mean SAS score in the study group reduced from 51.5±4.3 to 45.1±6.5 (p=0.02). The proportion of patients with anxiety symptoms in the control group was higher than in the study group following the surgery (58.3% vs. 33.3%, p=0.001).Pre-operative visits and counselling by ICU nurses could reduce patient's anxiety levels following carotid endarterectomy. |
1 | TITLE: Pre-emptive 600 mg oral gabapentin reduces morphine requirements and postoperative pain following non-obstetric lower abdominal surgery.ABSTRACT: Postoperative pain following lower abdominal surgery is one of the most common complications reported by patients. Gabapentin given two hours before surgery as pre-emptive analgesia has been reported to reduce postoperative pain and decrease postoperative analgesia requirements. The aim of this study was to determine the effectiveness of 600 mg oral gabapentin as a pre-emptive analgesia to reduce postoperative pain and morphine requirements following nonobstetric lower abdominal surgery.A double-blind randomized clinical trial was conducted with 72 subjects acquired by consecutive sampling from November 2019 to February 2020 at Tangerang District Hospital. Eligible subjects were randomized to two groups: placebo or 600 mg oral gabapentin two hours before skin incision. The total morphine requirements, visual analogue scale (VAS) score, first-time analgesic demand, and side effects were assessed during the first 24 hours postoperatively.The first 24-hour postoperative total morphine was higher in the placebo group (5.33 ± 1.97 mg vs. 2.47 ± 1.90 mg; P < 0.001). The pain scale at rest and movement during recovery, two hours postoperatively, and 24 hours postoperatively were significantly different between the two groups (P < 0.05). The Mann-Whitney test showed a significant difference in the first-time morphine required as rescue analgesia between the gabapentin group (161.5 [25-990] minutes) and placebo group (67.5 [10-371] minutes; P < 0.001). No significant difference was found in adverse events between the groups.Following nonobstetric lower abdominal surgery, 600 mg oral gabapentin as a pre-emptive analgesia attenuates postoperative pain and reduces morphine requirements. |
0 | TITLE: Association of external cephalic version before term with late preterm birth.ABSTRACT: While evidence suggests that beginning an external cephalic version (ECV) before term (34 to 36 weeks) compared with after term may be associated with an increase in late preterm birth (34 to 36 weeks), it remains unknown what might account for this risk. The objective of the present study is to further investigate the association between ECV before term and late preterm birth.Secondary analysis of data collected from the international, multicenter Early ECV trials. We evaluated the relation between ECV exposure and late preterm birth (34 to 36 weeks), as well as whether additional risk factors for preterm birth (such as maternal age, height, body mass index, parity, placental location, and perinatal mortality rate) moderated this relation. Generalized linear mixed methods were used to account for center effect and adjust for covariates.Among 1765 women with breech pregnancies and without a prior preterm birth, 749 (42.4%) received at least one ECV before term. Exposure to an ECV before term was not associated significantly independently with odds of preterm birth. However, placenta location moderated the association between early ECV exposure and late preterm birth. The odds of preterm birth in women who were exposed to an ECV before term and who also had an anterior placenta were doubled (OR 2.05; 95% CI 1.12-3.71; p = 0.02).In a large cohort of women without known risks for preterm birth, those with an anterior placenta who undergo an ECV before term constitute a subgroup at particular risk for late preterm birth. |
1 | TITLE: Herpes Simplex Virus Type 2 Acquisition Among HIV-1-Infected Adults Treated With Tenofovir Disoproxyl Fumarate as Part of Combination Antiretroviral Therapy: Results From the ACTG A5175 PEARLS Study.ABSTRACT: Tenofovir disoproxyl fumarate (TDF) disoproxyl fumarate (TDF) has in vitro activity against herpes simplex virus type 2 (HSV-2) and reduced HSV-2 acquisition as preexposure prophylaxis. Whether TDF-containing antiretroviral therapy (ART) reduces HSV-2 acquisition is unknown.Secondary analysis of AIDS Clinical Trials Group A5175, a randomized, open-label study of 3 ART regimens among 1571 participants.HSV-2 serostatus was assessed at baseline, at study exit, and before a change in ART regimen.Of 365 HSV-2-seronegative persons, 68 acquired HSV-2, with 24 receiving TDF-containing ART and 44 receiving ART without TDF (HSV-2 seroconversion incidence, 6.42 and 6.63 cases/100 person-years, respectively; hazard ratio, 0.89; 95% confidence interval, .55-1.44).HSV-2 acquisition was not reduced in HIV-infected, HSV-2-uninfected persons during TDF-containing ART. |
1 | TITLE: Effect of an exercise intervention on global cognition after transient ischemic attack or minor stroke: the MoveIT randomized controlled trial.ABSTRACT: Patients with a transient ischemic attack (TIA) or ischemic stroke are at increased risk of developing cognitive impairment in the subacute phase. At present, the effects of exercise on cognitive functioning following a TIA or stroke are not fully known. The purpose of this trial was to investigate the effect of exercise on global cognition.The MoveIT trial is a single-centre, observer-blinded, randomized controlled trial involving a 1-year exercise intervention consisting of a 12-week group exercise program, combined with three counselling visits to the physiotherapists over a 9-month period. The control group received standard care. The primary outcome was global cognitive functioning, assessed at one year, using the Montreal Cognitive Assessment (MoCA). Secondary outcomes included cardiorespiratory fitness, the cardiovascular profile, and attainment of secondary prevention targets, anxiety, depression and fatigue at one and two years.The experimental group consisted of 60 patients, while the control group consisted of 59 patients. The mean age was 64.3 years and 41% were female. No between-group differences were found on global cognitive functioning (MD, 0.7 out of 30, 95% CI, - 0.2 to 1.6) or on secondary outcome measures at 12 months. The only significant between-group difference was found for fatigue, in favour of the experimental group at 12 months (MD, 0.6 out of 63, 95% CI, 0.1 to 1.1).No benefit of this exercise intervention was found regarding global cognition. Future studies need to focus on optimizing rehabilitation strategies for this vulnerable group of patients.http://www.trialregister.nl . Unique identifier: NL3721 . Date first registration: 06-03-2013. |
1 | TITLE: Inverse relationship between body mass index and risk of venous thromboembolism among medically ill hospitalized patients: Observations from the APEX trial.ABSTRACT: Obesity is associated with cardiovascular complications such as diabetes and hypertension. However, obesity and high body mass index (BMI) can also be linked to improved clinical outcomes in certain patient populations. This counterintuitive observation is called the "obesity paradox." The effect of BMI on the risk of developing venous thromboembolism (VTE) in acutely ill medical patients remains unclear. In the Acute Medically Ill VTE Prevention with Extended Duration Betrixaban (APEX) trial, acutely ill hospitalized medical patients were randomized to receive either extended-duration betrixaban or shorter-duration enoxaparin and followed for 77 days. A total of 7372 patients with evaluable VTE endpoints had BMI measured at baseline. The association between BMI and VTE risk was assessed after adjusting for potential confounders. The multivariable adjusted ORs of VTE risk associated with BMI levels referencing the median BMI value (15, 18.5, 28.3 [reference], 35, 40, 45) were: 2.82 (95% CI, 1.32-6.04, [change from 28.3 to 15]), 1.85 (95% CI, 1.14-2.99, [change from 28.3 to 18.5]), 1.30 (95% CI, 1.04-1.63, [change from 28.3 to 35]), 1.13 (95% CI, 0.84-1.52, [change from 28.3 to 40]), and 0.91 (95% CI, 0.57-1.47, [change from 28.3 to 45]), respectively (p = 0.022). In conclusion, acutely ill hospitalized patients with lower BMI had a higher VTE risk through 77 days, which appears to be a manifestation of the BMI paradox. |
1 | TITLE: The effectiveness of emotional freedom techniques (EFT) on depression of postmenopausal women: a randomized controlled trial.ABSTRACT: Postmenopausal women are at greater risk of depression. Depression may negatively affect the quality of life of women. An emotional freedom technique (EFT) is an evidence-based therapy combining cognitive and exposure components with acupressure. This study aimed to evaluate the effect of EFT on depression in postmenopausal women.This was a randomized controlled trial in which 88 women with mild to moderate depression recruited from a menopausal clinic in Ahvaz, Iran, and randomly assigned into two groups of EFT (n=44) and control for sham therapy (n=44). Women in the EFT group received two sessions of training and asked to continue EFT for 8 weeks, one time per day. The Beck Depression Inventory (BDI2) completed by women before and after the intervention. The control group received training on sham acupressure points similar to the intervention group. Data collected using a demographic and BDI2. Women requested to complete the BDI2 before and after the intervention. The independent t-test, chi-square, and ANCOVA were used to analyze data.The mean depression score in the intervention group reduced from 20.93 ± 4.6 to 10.96 ± 4.38 in comparison to the control group that reduced from 19.18 ± 2.79 to 17.01 ± 6.05 after intervention (p=0.001). After the 8 week intervention, the frequency of moderate depression decreased from 56.8 to 9.35% in the intervention and from 50 to 29.5% in the control group. In total, 63.4 and 34.15% in the intervention and control groups were free of depression respectively after the intervention (p<0.001).The results of this study showed that using EFT for 8 weeks could significantly reduce the mean score of depression in postmenopausal women. Using this method in public health centers for postmenopausal women is recommended. |
1 | TITLE: Early Discontinuation of Cow's Milk Protein Ingestion Is Associated with the Development of Cow's Milk Allergy.ABSTRACT: Although early supplementation with cow's milk formula (CMF) reportedly increases the risk of cow's milk allergy (CMA) in breast-fed infants, little is known about the association between the timing of CMF discontinuation and subsequent CMA development.To elucidate the relationship between the timing of CMF discontinuation and CMA development in infants who received CMF in the early days of life.Using data from a randomized controlled trial of a birth cohort from 4 Japanese hospitals, we performed a subgroup analysis of participants who ingested CMF in the first 3 days of life. We compared the proportions of participants who developed CMA at age 6 months in those who discontinued CMF ingestion before age 1 month ("DISC <1-month group"), during age 1 to 2 months ("DISC 1-2-month group"), and during age 3 to 5 months ("DISC 3-5-month group") with those who continued CMF ingestion until age 6 months ("continuous group"). The risk ratios (RRs) and 95% CIs for CMA development were calculated.CMA incidence was significantly higher in the DISC <1-month group (n = 7 of 17, 41.2%; RR, 65.7; 95% CI, 14.7-292.5; P < .001), DISC 1-2-month group (n = 3 of 26, 11.5%; RR, 18.4; 95% CI, 3.2-105.3; P = .003), and DISC 3-5-month group (n = 7 of 69, 10.1%; RR, 16.2; 95% CI, 3.4-76.2; P < .001) than in the continuous group (n = 2 of 319, 0.6%).Early CMF discontinuation, particularly in the first month of life, was associated with CMA development in infants who received CMF in the first 3 days of life. |
1 | TITLE: LAW Trial - The Impact of Local Anesthetics Infiltration in Surgical Wound for Gastrointestinal Procedures (LAW): A Double-Blind, Randomized Controlled Trial.ABSTRACT: Prior studies have suggested that infiltration of local anesthetics reduce the rate of surgical site infections (SSIs). Opioid usage has become an epidemic. Some analgesic modalities, such as epidural analgesia and transversus abdominis plane block are associated with shorter length of stay and lower opioid use. The aim of our study was to assess the relationship between local infiltration of bupivacaine with rates of SSI and pain control.We conducted a prospective, double-blinded randomized controlled trial in patients who underwent open major gastrointestinal procedures from July 2016 to June 2017. Patients were divided into two groups based on administration of 0.5% bupivacaine ( = 30) (group 1) or placebo ( = 30) (control group). Outcomes evaluated were SSI, postoperative opioid requirements and pain scores.Patients in the bupivacaine group required a lower dose of epidural analgesia during the first 24 h (5.3 mcg/kg/h vs. 6.4 mcg/kg/h; = 0.05). Opioid requirement was shorter in the bupivacaine group (3.5 ± 2.3 days vs. 5.7 ± 2.9 days; = 0.01). No difference was found between groups in terms of SSI rates (0% vs. 6.7%, = 0.49).There is no clear association between bupivacaine infiltration and reduction of SSI rate according to our study. Wound bupivacaine infiltration is associated with a lower dose of epidural infusion and opioid requirements. |
0 | TITLE: Radiomics signature for predicting postoperative disease-free survival of patients with gastric cancer: development and validation of a predictive nomogram.ABSTRACT: PURPOSE Radiomics can be used to determine the prognosis of gastric cancer (GC). The objective of this study was to predict the disease-free survival (DFS) after GC surgery based on computed tomography-enhanced images combined with clinical features. METHODS Clinical, imaging, and pathological data of patients who underwent gastric adenocarcinoma resection from June 2015 to May 2019 were retrospectively analyzed. The primary outcome was DFS. Radiomics features were selected using Least Absolute Shrinkage and Selection Operator algorithm and converted into the Rad-score. A nomogram was constructed based on the Radscore and other clinical factors. The Rad-score and nomogram were validated in the training and validation groups. RESULTS Totally, 179 patients were randomly divided into the training (n=124) and validation (n=55) groups. In the training group, validation group, and overall population, the Rad-score could be divided into categories indicating low, moderate, and high risk of recurrence, metastasis, or death; all risk categories showed a significant difference between the training, validation, and overall population groups (all P < .001). Positive lymph nodes (hazard ratio (HR)=3.07, 95% CI: 1.52-6.23, P=.002), cancer antigen-125 (HR=3.24, 95% CI: 1.54-6.80, P=.002), and the Radscore (HR=0.73, 95% CI: 0.61-0.87, P < .001) were independently associated with DFS. These 3 variables were used to construct a nomogram. In the training group, the areas under the curve at 3 years were 0.758 and 0.776 for the Rad-score and the nomogram, respectively, while they were both 1.000 in the validation group. The net benefit rate was analyzed using a decision curve in the training and validation groups, and the nomogram was superior to the single Rad-score. CONCLUSION Rad-score is an independent factor for DFS after gastrectomy for GC. The nomogram established in this study could be an effective tool for the clinical prediction of DFS after gastrectomy. |
1 | TITLE: Effectiveness of self-efficacy-enhancing interventions on rehabilitation following total hip replacement: a randomized controlled trial with six-month follow-up.ABSTRACT: As the world's population ages, hip replacement, a routine treatment for arthritis, has become more common. However, after surgery, rehabilitation has some limited effectiveness with postoperative complications and persistent impairments. This study aimed to explore the effect of a self-efficacy-enhancing intervention program following hip replacement on patients' rehabilitation outcomes (self-efficacy, functional exercise compliance, hip function, activity and social participation, anxiety and depression, and quality of life).A prospective randomized controlled trial with a repeated-measures, two-group design was conducted in a grade A general hospital in Guangdong Province, China. A total of 150 participants with a unilateral total hip replacement were recruited via convenience sampling. Participants were randomly assigned to either the self-efficacy enhancing intervention group (n = 76) or the control group (n = 74). The intervention encompassed a face-to-face education before discharge and four telephone-based follow-ups in six months after surgery. Researchers collected baseline data on one to three days after surgery, and outcomes data were collected one, three, and six months after surgery.Average age (deviation) in intervention and control group were 58 (10.32) and 59 (10.82), respectively. After six months, intervention group scored 86.83 ± 5.89 in rehabilitation self-efficacy, significantly higher than control group (72.16 ± 6.52, t = -10.820, p < 0.001) and their hip function has turned to "excellent" (90.52 ± 4.03), while that of the latter was limited to a "middle" level (78.47 ± 7.57). Statistically significant differences were found in secondary outcomes (p < 0.001). The advantage of intervention in improving quality of life was seen in the long term rather than in the early postoperative period.The self-efficacy-enhancing intervention performed by nurses induced better exercise compliance and physical, psychological, and social functions after hip replacement compared with routine care. We recommend such interventions to be combined with routine care soon after hip replacement. Further research should focus on the social participation of patients with hip replacement. Trial registration Retrospectively registered at Chinese Clinical Trial Registry (31/01/2020, No. ChiCTR2000029422, http://www.chictr.org.cn/index.aspx ). |
0 | TITLE: Antidiabetic Treatment in Patients at High Risk for a Subsequent Keratinocyte Carcinoma.ABSTRACT: Metformin and sulfonylureas are the most commonly prescribed drugs used for the treatment of type II diabetes. Type II diabetes has been linked to the development of keratinocyte carcinoma (KC), consisting of basal cell carcinoma (BCC) and squamous cell carcinoma (SCC). Previously we have demonstrated lower risk for a subsequent KC in metformin users. In this study, we aim to investigate the association between sulfonylureas use and the development of KC in patients with KC history. We performed a retrospective cohort study of the Veterans Affairs Keratinocyte Carcinoma Chemoprevention Trial, which was a randomized double-blind vehicle-control cream originally investigating the effect of 5-fluorouracil on KC development. 932 patients with a history of KC were enrolled (98% male, 99% white, median age of 70 years) and followed for a median duration of 2.8 years. 153 patients were on metformin and 94 on sulfonylureas. We performed a survival analysis with cox regression and controlled for body mass index and known predictors: number of prior BCCs and age (for BCC) and for number of prior SCCs (invasive and in situ), number of actinic keratoses at baseline (for SCC). Sulfonylurea-users com-pared to non-users had a HR of 0.67 (CI: 0.40–1.56; P=0.49) and 0.94 (CI: 0.63–1.40; P= 0.77), for SCC and BCC, respectively. Diabetic patients at high risk for KC might benefit from the use of metformin versus sulfonylureas. J Drugs Dermatol. 2022;21(5):502-505. doi:10.36849/JDD.6087. |
1 | TITLE: Effıcacy of cıtalopram on stroke recurrence: A randomızed clınıcal trıal.ABSTRACT: Post-stroke depression is one of the main causes of cerebrovascular and cardiovascular diseases. The aim of the present study was to investigate the efficacy of citalopram on stroke recurrence. A 52-week, randomized, double-blind, studyinvolved 440 ischemic stroke patients with depression. Patients with depression who met depression criteria of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV and V) and Hamilton Depression Rating Scale ≥ 8 (HAM-DRS) were dichotomized into patients receiving citalopram (225 patients), titrated according to clinical response, and patients with placebo (215 patients) for 52 weeks. The primary outcome measure was stroke recurrence and the secondary outcome measures were cardiovascular events and mortality. Stroke recurrence (66% vs 34%; P = 0.001) and cardiovascular events (76% vs. 24%; P = o.oo1) were significantly higher in the placebo group compared to those treated with citalopram. Multivariable analysis showed that hypertension, atrial fibrillation, and large-artery disease were significantly associated with stroke recurrence. Executive processing disorder was more associated with stroke recurrence than other neuropsychological disorders (OR, 1.74; CI95%, 1.04-2.89; P = 0.035). Survival analysis showed that treatment for depression interacted with time to reduce stroke recurrence by nearly half (39% vs. 61%; P = 0.05). The current study supports the importance of depression treatment in protecting the patients from recurrent strokes. This result warrants further studies to demonstrate the efficacy of depression treatment on stroke recurrence. |
0 | TITLE: Human epicardial adipose tissue expresses a pathogenic profile of adipocytokines in patients with cardiovascular disease.ABSTRACT: Inflammation contributes to cardiovascular disease and is exacerbated with increased adiposity, particularly omental adiposity; however, the role of epicardial fat is poorly understood.For these studies the expression of inflammatory markers was assessed in epicardial fat biopsies from coronary artery bypass grafting (CABG) patients using quantitative RT-PCR. Further, the effects of chronic medications, including statins, as well as peri-operative glucose, insulin and potassium infusion, on gene expression were also assessed. Circulating resistin, CRP, adiponectin and leptin levels were determined to assess inflammation.The expression of adiponectin, resistin and other adipocytokine mRNAs were comparable to that in omental fat. Epicardial CD45 expression was significantly higher than control depots (p < 0.01) indicating significant infiltration of macrophages. Statin treated patients showed significantly lower epicardial expression of IL-6 mRNA, in comparison with the control abdominal depots (p < 0.001). The serum profile of CABG patients showed significantly higher levels of both CRP (control: 1.28 +/- 1.57 microg/mL vs CABG: 9.11 +/- 15.7 microg/mL; p < 0.001) and resistin (control: 10.53 +/- 0.81 ng/mL vs CABG: 16.8 +/- 1.69 ng/mL; p < 0.01) and significantly lower levels of adiponectin (control: 29.1 +/- 14.8 microg/mL vs CABG: 11.9 +/- 6.0 microg/mL; p < 0.05) when compared to BMI matched controls.Epicardial and omental fat exhibit a broadly comparable pathogenic mRNA profile, this may arise in part from macrophage infiltration into the epicardial fat. This study highlights that chronic inflammation occurs locally as well as systemically potentially contributing further to the pathogenesis of coronary artery disease. |
1 | TITLE: Obstetric risk factors for urinary incontinence and preventative pelvic floor exercises: cohort study and nested randomized controlled trial.ABSTRACT: We conducted a cohort study assessing risk factors for developing urinary incontinence following childbirth, and a pilot randomized controlled trial of a physiotherapist-led intervention to reduce incidence of incontinence. A total of 723 women were recruited to the cohort study, of which 234 entered the nested trial and were randomized to intensive training in pelvic floor exercises or standard information. At 6 months post-partum, 45% of women reported some incontinence problems. A pre-existing incontinence problem was the best predictor of future incontinence (odds ratio 4.49, 95% confidence interval (CI) 3.09-6.53). Chronic constipation (1.86, 1.03-3.34) and episiotomy in at least one delivery (1.96, 1.25-3.07) were also independent risk factors, while an epidural or spinal (0.62, 0.42-0.92) was protective. The intervention as designed did not help in preventing future incontinence (relative risk 1.28, 95% CI 0.98-1.67), but this may be due to the failure to persuade the women to return for the classes. Any intervention aimed at promoting postnatal pelvic floor exercises should be limited to women who have already been experiencing incontinence problems. |
0 | TITLE: Evidence for distinct effects of GH and IGF-I in the metabolic syndrome.ABSTRACT: The metabolic syndrome is a cluster of cardiovascular risk factors which include central obesity, dyslipidaemia, glucose intolerance and hypertension. These risk factors are common in patients with growth hormone (GH) deficiency, suggesting a role for the somatotropic axis in the development of metabolic syndrome.We used factor analysis to investigate the relationships linking serum levels of GH and insulin-like growth factor I (IGF-I) to metabolic syndrome variables (high-density lipoprotein cholesterol, triglycerides, fasting glucose, blood pressure and waist circumference). We studied 359 men and 388 women from the Data from an Epidemiological Study on the Insulin Resistance syndrome (DESIR). Their age range was 30-64 years.Three independent latent factors explained 61% of the total variance in women and four factors explained 73% in men. In both men and women, IGF-I showed a strong positive correlation with the lipid factor and a negative correlation with the obesity/glucose factor. In women, GH showed a strong negative correlation with the obesity/glucose factor but not the lipid factor. In men, GH was unrelated to the lipid and obesity/glucose factors. The blood pressure factor was not related to GH or IGF-I. In contrast with IGF-I, GH was significantly lower in women with metabolic syndrome (1575 +/- 449 pg/ml) than in the other women (2121 +/- 520 pg/ml, P = 0.002). No significant difference was observed in men for GH or IGF-I.Our results support a link between the somatotropic axis and several features of the metabolic syndrome, and suggest distinct effects of GH and IGF-I on these parameters. |
1 | TITLE: A five-day gradual reduction regimen of chlormadinone reduces premenstrual anxiety and depression: a pilot study.ABSTRACT: Anxiety and depression commonly occur in premenstrual dysphoric disorder (PMDD). The PMDD symptomatology disappears once the menstrual cycle reinitiates, resembling a withdrawal syndrome.The present study is a pilot, controlled, double-blind study exploring the effectiveness of a premenstrual 5-day gradual reduction regimen of chlormadinone acetate on PMDD. Volunteers received an initial dose of 10 mg (five 2-mg tablets) on the 24(th) day of the menstrual cycle and one-fifth of the dose less (one tablet) each day until a dose of 2 mg (one 2-mg tablet) was reached on the 28(th) day of the menstrual cycle. The control group received placebo with a similar regimen.The 5-day gradual reduction regimen of chlormadinone significantly improved (F(3.76) = 3.29, p <0.02) the daily symptoms report (DSR) scores by the third month of treatment. The resulting relative risk was 4.09 (confidence interval: 1.15-14.57, p <0.005, 95% CI). Compared to placebo, chlormadinone clinically and statistically reduced the severity of depression, anxiety, food cravings, mood swings and cramps. A statistical reduction of symptoms such as poor coordination, irritability, feeling out of control, hopelessness, decreased interest and headache was detected but was not clinically relevant. No changes occurred in concentration difficulties, tiredness, insomnia, swelling, breast tenderness and aches. As side effects, 30% of the volunteers showed changes in the length of the menstrual cycle, and 15% experienced dyspepsia.A 5-day gradual reduction regimen of chlormadinone improves some of the discomforting ailments associated with PMDD, namely, depression and anxiety. |
0 | TITLE: Vitamin B6 status improves in overweight/obese women following a hypocaloric diet rich in breakfast cereals, and may help in maintaining fat-free mass.ABSTRACT: To analyze the changes in vitamin B6 status in women following slightly hypocaloric diets based on the relative increase consumption of foods whose intakes are below those recommended, and to study how these changes influence the proportion of fat-free mass.Intervention study of two slightly hypocaloric diets: diet V (increased consumption of vegetables), or diet C (increased consumption of cereals, especially breakfast cereals).A total of 49 women with a body mass index (BMI) of 25-35 kg/m2.Dietetic, anthropometric and biochemical data were collected at the start of the study and at 2 and 6 weeks.Both the C and V subjects showed a reduction in their energy intake, body weight, BMI and fat mass. Pyridoxine intake increased in both groups and plasma pyridoxal phosphate (PLP) levels increased only with diet C. An association was found between the increase in plasma PLP at 6 weeks and the increase in pyridoxine intake (r=0.451; P<0.01). Multiple regression analysis showed a positive association between the increase in PLP at the end of the study and the increases in the pyridoxine intake, B6 density or B6/protein ratio. At the end of the study, and only in those women whose PLP levels were increased, the higher the increase in PLP level, the higher the increase in fat-free mass percentage (r=0.4426, P<0.05).Interventions aimed at weight control should also try to maintain or improve nutritional status. A diet rich in cereals (especially fortified breakfast cereals) appears to be useful in improving vitamin B6 status. Such an improvement could help maintain fat-free mass during periods of weight loss. |
1 | TITLE: Dietary arginine supplementation speeds pulmonary VO2 kinetics during cycle exercise.ABSTRACT: To test the hypothesis that L-arginine (the substrate for nitric oxide synthase [NOS]) administration slows the VO2 kinetics at the onset of moderate-intensity exercise in humans.Seven physically active males were randomly assigned to receive either placebo (lactose) or L-arginine hydrochloride capsules (7.2 g x d(-1)) for 14 d in a double-blind crossover design, with a 7-d washout period between the two conditions. On day 11 and day 14 of each condition, the subjects completed two consecutive 6-min bouts of cycle exercise at 80% of the ventilatory threshold with a 12-min rest interval. VO2 was measured on a breath-by-breath basis, and VO2 kinetics were determined with a single exponential model from the averaged data derived from four repetitions. Capillary and venous blood samples were taken to determine plasma [La] and serum [arginine], respectively.There were no differences in circulating lactate either before or during exercise. However, serum [arginine] was higher (P < 0.05) in the arginine condition at rest (119.0 +/- 12.6 vs 103.6 +/- 15.7 micromol x L(-1) in the control condition) and after exercise (113.3 +/- 26.0 vs 103.8 +/- 12.6 micromol x L(-1) in the control condition). With regard to the pulmonary VO2 kinetics, no significant difference was observed in the time at which the phase II response emerged or in the phase II amplitude between the two conditions. However, contrary to our hypothesis, the time constant was significantly reduced after arginine administration (i.e., 13.9 +/- 3.1 vs 15.8 +/- 2.6 s in the control condition, P < or = 0.014).Exogenous L-arginine administration speeds the phase II pulmonary VO2 response by 12% at the onset of moderate-intensity exercise in humans. |
0 | TITLE: Estimating the 10-year risk of cardiovascular disease and its economic consequences, by the level of adherence to the Mediterranean diet: the ATTICA study.ABSTRACT: In this study this traditional diet was assessed in relation to coronary heart disease risk and its economic consequences, in a cross-sectional study with economic analysis. From May 2001 to December 2002 we randomly enrolled 1,514 adult men and 1,528 women, without any clinical evidence of cardiovascular disease. Adherence to the Mediterranean diet was ascertained through a food-frequency questionnaire and a special diet score that incorporated the inherent characteristics of this dietary pattern. The 10-year absolute risk for coronary heart disease was derived from the Framingham equations. Persons with a 10-year risk greater than 10% were considered as potential hospitalized patients. The health care cost of hospitalization due to an event was estimated in 690euro per patient. Of the participants who were "closer" to the Mediterranean diet (i.e., above the median diet score) and of those "away" from this dietary pattern, 4.2% and 39.8%, respectively, had a 10-year coronary risk greater than 10% (P < .001). Moreover, participants "closer" to the Mediterranean diet had a 43% (odds ratio = 0.57, 95% confidence interval 0.38 to 0.86) lower likelihood of having a 10-year coronary risk greater than 10%, after adjusting for potential confounders. Total health care cost was estimated to be 336.720euro in those who were "away" and 35.880euro in those who were closer to this diet pattern. Life-years lost due to disability was 6.8 in those who were "away" and 0.9 in those "close" to this pattern. The incremental cost-effectiveness ratio was 50.989euro (i.e., the additive health care cost due to an unhealthy diet for each year lost). The implementation of the Mediterranean dietary pattern may lead to an improvement in life expectancy, a net gain to health, and a reduction in total lifetime costs. |
0 | TITLE: Loneliness and health care consumption among older people.ABSTRACT: Few studies have investigated loneliness in relation to health care consumption among frail older people. The aim of this study was to examine loneliness, health-related quality of life (HRQoL), and health complaints in relation to health care consumption of in- and outpatient care among frail older people living at home. The study, with a cross-sectional design, comprised a sample of 153 respondents aged from 65 years (mean age 81.5 years) or older, who lived at home and were frail. Data was collected utilising structured interviews in the respondent's home assessing demographic data, loneliness, HRQoL and health complaints. Patient administrative registers were used to collect data on health care consumption. Loneliness was the dependent variable in the majority of the analyses and dichotomised. For group comparisons Student's t-test, Mann-Whitney U-test and Chi-square test were used. The results showed that 60% of the respondents had experienced loneliness during the previous year, at least occasionally. The study identified that lonely respondents had a lower HRQoL (p = 0.022), with a higher total number of reported health complaints (p = 0.001), and used more outpatient services including more acute visits at the emergency department, compared to not lonely respondents (p = 0.026). Multiple linear regression analysis showed that a depressed mood was independently associated to total use of outpatient care (B = 7.4, p < 0.001). Therefore, it might not be loneliness, per se, that is the reason for seeking health care. However, reasons for using health care services are difficult to determine due to the complex situation for the frail older person. To avoid emergency department visits and to benefit the well-being of the frail older person, interventions targeting the complex health situation, including loneliness, are suggested. |
1 | TITLE: Village-randomized clinical trial of home distribution of zinc for treatment of childhood diarrhea in rural Western kenya.ABSTRACT: Zinc treatment shortens diarrhea episodes and can prevent future episodes. In rural Africa, most children with diarrhea are not brought to health facilities. In a village-randomized trial in rural Kenya, we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities.We randomized 16 Kenyan villages (1,903 eligible children) to receive a 10-day course of zinc and two oral rehydration solution (ORS) sachets every two months at home and 17 villages (2,241 eligible children) to receive ORS at home, but zinc at the health-facility only. Children's caretakers were educated in zinc/ORS use by village workers, both unblinded to intervention arm. We evaluated whether incidence of diarrhea and acute lower respiratory illness (ALRI) reported at biweekly home visits and presenting to clinic were lower in zinc villages, using poisson regression adjusting for baseline disease rates, distance to clinic, and children's age.There were no differences between village groups in diarrhea incidence either reported at the home or presenting to clinic. In zinc villages (1,440 children analyzed), 61.2% of diarrheal episodes were treated with zinc, compared to 5.4% in comparison villages (1,584 children analyzed, p<0.0001). There were no differences in ORS use between zinc (59.6%) and comparison villages (58.8%). Among children with fever or cough without diarrhea, zinc use was low (<0.5%). There was a lower incidence of reported ALRI in zinc villages (adjusted RR 0.68, 95% CI 0.46-0.99), but not presenting at clinic.In this study, home zinc use to treat diarrhea did not decrease disease rates in the community. However, with proper training, availability of zinc at home could lead to more episodes of pediatric diarrhea being treated with zinc in parts of rural Africa where healthcare utilization is low.ClinicalTrials.gov NCT00530829. |
1 | TITLE: Use of oesophageal flap valvuloplasty and wrapping suturing technique in preventing postoperative complications after oesophagectomy for oesophageal cancer.ABSTRACT: Esophagogastrostomy for oesophageal cancer is the standard surgical treatment. However, traditional techniques have been associated with high frequency of anastomotic complications. The purpose of this study is to clarify the superiority of the oesophageal flap valvuloplasty and wrapping suturing technique in preventing postoperative complications after oesophagectomy for oesophageal cancer.A prospective, randomised study was performed on 394 patients treated for esophageal cancer between January 2006 and December 2010. The trial registry number is ChiCTR-TRC-13003817 in the Chinese Clinical Trial Registry.Anastomotic leaks occurred in four patients in group A (2.1%) and in twelve patients in group B (6.2%) with statistically significant (P = 0.038). During the evaluation of benign stricture seven patients were excluded for hospital mortality. Thirty three patients in group A (6.9%) and 25 patients in group B (13.2%) occurred anastomotic stricture respectively (P = 0.044). Furthermore, reflux oesophagitis and Barrett's epithelium were found in 105 patients (55.3%) of group B, and 54 (28.7%) patients in group A (P < 0.001).The oesophageal flap valvuloplasty and wrapping suturing technique decreased anastomotic leakage incidence and stricture rate thereby decreasing the morbidity and mortality. This procedure also prevented the occurrence of gastroesophageal reflux after esophagectomy. |
1 | TITLE: A cluster randomized controlled trial to reduce childhood diarrhea using hollow fiber water filter and/or hygiene-sanitation educational interventions.ABSTRACT: Safe domestic potable water supplies are urgently needed to reduce childhood diarrheal disease. In periurban neighborhoods in Cochabamba, Bolivia, we conducted a cluster randomized controlled trial to evaluate the efficacy of a household-level hollow fiber filter and/or behavior change communication (BCC) on water, sanitation, and hygiene (WASH) to reduce the diarrheal disease in children less than 5 years of age. In total, 952 households were followed for a period of 12 weeks post-distribution of the study interventions. Households using Sawyer PointONE filters had significantly less diarrheal disease compared with the control arm during the intervention period, which was shown by diarrheal prevalence ratios of 0.21 (95% confidence interval [95% CI] = 0.15-0.30) for the filter arm and 0.27 (95% CI = 0.22-0.34) for the filter and WASH BCC arm. A non-significant reduction in diarrhea prevalence was reported in the WASH BCC study arm households (0.71, 95% CI = 0.59-0.86). |
1 | TITLE: Twenty-four hour ambulatory blood pressure for the management of antihypertensive treatment: a randomized controlled trial.ABSTRACT: The aim of this study was to assess whether the use of 24-h blood pressure (BP) measurement in the management of antihypertensive therapy improves BP in patients with sustained hypertension. Patients with sustained hypertension (office BP > or =140/90 mm Hg, and 24-h systolic BP > or =130/80 mm Hg) were randomly assigned to a strategy using 24-h BP to manage antihypertensive treatment (target <130/80 mm Hg) or to a standard strategy using office BP (target <140/90 mm Hg). The primary end point was change in 24-h systolic BP at 1 year of follow-up. We included 136 patients in the primary analysis. After 1 year of follow-up, the change in 24-h systolic BP was significantly greater in the ambulatory BP group compared with the office BP group (mean difference (95% confidence interval) -3.6 (-7.0, -0.3), P=0.03). Intention-to-treat analysis revealed essentially unchanged results. The mean number of antihypertensive drugs per participant at 1 year of follow-up was 1.76+/-1.1 and 1.95+/-0.9 in the ambulatory and office BP group, respectively (P=0.049). The benefit of ambulatory BP monitoring was mainly seen in patients with previously known hypertension (mean difference -7.2 (-11.6, -2.8), P=0.002), but not in those with newly detected hypertension (mean difference 0.2 (-4.9, 5.4), P=0.93). In conclusion, using 24-h BP for the management of antihypertensive therapy in patients with sustained hypertension leads to a greater BP reduction compared with a standard treatment strategy using office BP, although fewer antihypertensive drugs were used in the ambulatory BP group. |
1 | TITLE: Liver dysfunction in paediatric obesity: a randomized, controlled trial of metformin.ABSTRACT: In a previous study we showed that metformin reduced BMI z-scores and fasting glucose and insulin concentrations, and increased whole body insulin sensitivity in obese adolescents with fasting hyperinsulinemia and a family history of type 2 diabetes. We analyzed the data from this study to determine (a) if metformin reduced serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) concentrations during the 6-month trial, and (b) if the response to pharmacotherapy varied along gender or ethnic lines.The 6-month trial was randomized, double blinded and placebo controlled; a total of 14 metformin-treated (500 mg bid) and 15 placebo-treated subjects completed the study. There were no dietary restrictions.In obese adolescents fed ad libitum, metformin (a) prevented the rise in ALT concentrations that were observed in placebo-treated subjects at the 3 to 5 month time-points (p < 0.05); (b) reduced (p < 0.01) the percentage of all ALT values exceeding 40 U/L; and (c) caused a modest (10%) but statistically significant (p < 0.05) reduction in serum ALT in Caucasian subjects. Metformin had no effect on ALT levels or the ALT to AST ratio in the five African American adolescents enrolled in the study but reduced their fasting insulin concentrations from 26.1 to 19.5 muU/mL (p < 0.05).Our findings suggest that metformin might reduce the rates or severity of liver dysfunction in selected high-risk adolescents. |
1 | TITLE: Antiinflammatory effect of sevoflurane in open lung surgery with one-lung ventilation.ABSTRACT: To prospectively assess the antiinflammatory effect of volatile anesthetic sevoflurane in patients undergoing open lung surgery with one lung ventilation (OLV).This prospective, randomized study included 40 patients undergoing thoracic surgery with OLV (NCT02188407). The patients were randomly allocated into two equal groups that received either propofol or sevoflurane. Four patients were excluded from the study because after surgery they received blood transfusion or non-steroid antiinflammatory drugs. Inflammatory mediators (interleukins 6, 8, and 10, C-reactive protein [CRP], and procalcitonin) were measured perioperatively. The infiltration of the nonoperated lung was assessed on chest x-rays and the oxygenation index was calculated. The major postoperative complications were counted.Interleukin 6 levels were significantly higher in propofol than in sevoflurane group (P=0.014). Preoperative CRP levels did not differ between the groups (P=0.351) and in all patients they were lower than 20 mg/L, but postoperative CRP was significantly higher in propofol group (31±6 vs 15±7 ng/L; P=0.035); Pre- and postoperative procalcitonin was within the reference range (<0.04 µg/L) in both groups. The oxygenation index was significantly lower in propofol group (339±139 vs 465±140; P=0.021). There was no significant difference between the groups in lung infiltrates (P=0.5849). The number of postoperative adverse events was higher in propofol group, but the difference was not-significant (5 vs 1; P=0.115).The study suggests an antiinflammatory effect of sevoflurane in patients undergoing thoracotomy with OLV. |
0 | TITLE: Choice stepping reaction time test using exergame technology for fall risk assessment in older people.ABSTRACT: Accidental falls remain an important problem in older people. Stepping is a common task to avoid a fall and requires good interplay between sensory functions, central processing and motor execution. Increased choice stepping reaction time has been associated with recurrent falls in older people. The aim of this study was to examine if a sensor-based Exergame Choice Stepping Reaction Time test can successfully discriminate older fallers from non-fallers. The stepping test was conducted in a cohort of 104 community-dwelling older people (mean age: 80.7 ± 7.0 years). Participants were asked to step laterally as quickly as possible after a light stimulus appeared on a TV screen. Spatial and temporal measurements of the lower and upper body were derived from a low-cost and portable 3D-depth sensor (i.e. Microsoft Kinect) and 3D-accelerometer. Fallers had a slower stepping reaction time (970 ± 228 ms vs. 858 ± 123 ms, P = 0.001) and a slower reaction of their upper body (719 ± 289 ms vs. 631 ± 166 ms, P = 0.052) compared to non-fallers. It took fallers significantly longer than non-fallers to recover their balance after initiating the step (2147 ± 800 ms vs. 1841 ± 591 ms, P = 0.029). This study demonstrated that a sensor-based, low-cost and easy to administer stepping test, with the potential to be used in clinical practice or regular unsupervised home assessments, was able to identify significant differences between performances by fallers and non-fallers. |
1 | TITLE: Imbalance between nitric oxide generation and oxidative stress in patients with peripheral arterial disease: effect of an antioxidant treatment.ABSTRACT: Nitric oxide (NO), a potent vasodilator produced by endothelial cells, is reduced in patients with peripheral arterial disease (PAD), but the mechanism has not been fully elucidated. Because NO is rapidly inactivated by superoxide anion, we speculated that enhanced oxidative stress could lower NO generation. The aim of our study was to investigate if an imbalance between oxidative stress and NO does exist in patients with PAD and if an increase of NO formation could be achieved by an antioxidant treatment.In a first study, serum levels of nitrite and nitrate (NOx), markers of NO generation, and 8-hydroxy-2-deoxyguanosine (8-OHdG), a marker of oxidative stress and maximal walking distance (MWD), were measured in 40 PAD patients and 40 controls. In a second study, 10 PAD patients were randomly allocated in a crossover design to intravenous propionyl-L-carnitine (6 g/day) or placebo for 7 days, with a washout of 30 days between the two phases of the trial. Serum levels of NOx and 8-OHdG were measured before and after the study.Compared with controls, serum levels of 8-OHdG (mean +/- SD) were significantly increased in PAD patients (4.4 +/- 3.1 ng/mL vs 2.4 +/- 1.2 ng/mL; P < .001), and serum levels of NOx were significantly decreased (11.6 +/- 6 microM vs 17 +/- 6.1 microM; P < .001). Levels of 8-OHdG and NOx were inversely correlated (r = -0.879; P < .001). Serum levels 8-OHdG were inversely correlated with MWD (r = -0.48, P = .002). The interventional trial showed no changes in the patients given placebo. Patients treated with propionyl-L-carnitine showed a significant increase of MWD from 101 +/- 31 meters to 129 +/- 35 meters (P = .007) and in NOx from 14.5 +/- 4.5 microM to 17.1 +/- 3.8 microM (P = .007). A significant decrease of 8-OHdG from 3.6 +/- 1.1 ng/mL to 2.6 +/- 1 ng/mL was also found (P = .005.)This study suggests that in PAD patients, the reduction of NO generation could be dependent upon enhanced oxidative stress. |
1 | TITLE: The effects of modified ultrafiltration on pulmonary function and transfusion requirements in patients underwent coronary artery bypass graft surgery.ABSTRACT: The inflammatory response after cardiac surgery increases vascular permeability leading to higher mortality and morbidity in the post operative time. The modified ultrafiltration (MUF) had shown benefits on respiratory, and hemodynamic in pediatric patients. This approach in adults is not well established yet. We hypothesize that modified ultrafiltration may improve respiratory, hemodynamic and coagulation function in adults after cardiac surgeries.A prospective randomized study was carried out with 37 patients who underwent coronary artery bypass graft surgery (CABG) were randomized either to MUF (n=20) at the end of bypass or to control (no MUF) (n=17). The anesthesia and ICU team were blinded for the group selection. The MUF were carried out for 15 minutes after the end of bypass. The patients data were taken at beginning of anesthesia, ending of bypass, ending MUF, 24 hours, and 48 hours after surgery. For clinical outcome the pulmonary, hemodynamic and coagulation function were evaluated.We observed lower drain loss in the MUF group compared to control group after 48 hours (598 +/- 123 ml vs. 848 +/- 455 ml; P=0.04) and required less red blood cells units transfusion compared to control group (0.6 +/- 0.6 units/patient vs.1.6 +/- 1.1 units/patient; P=0.03). The MUF group showed lower airway resistance (9.3 +/- 0.4 cmH2O.L-1s-1 vs. 12.1 +/- 0.8 cmH2O.L-1s-1; P=0.04). There were no deaths in both groups.The MUF reduces post operatory bleeding and red blood cells units transfusion, but with no differences on clinical outcome were observed. The routinely MUF employment was not associated with hemodynamic instability. |
1 | TITLE: Evaluation of the haemodynamic characteristics of drug-eluting stents at implantation and at follow-up.ABSTRACT: The aim of this study was to investigate the physiologic parameters: fractional flow reserve (FFR), hyperaemic trans-stent gradient (HTG), and wall shear stress (WSS) at implantation and at 6-month follow-up in the drug-eluting sirolimus stent and in its bare metal counterpart implanted in pairs within the same patient.Twenty patients, accepted for percutaneous coronary intervention of at least two coronary arteries with comparable vessel and stenosis characteristics, received at random one sirolimus-eluting stent and one bare metal stent (BMS). Coronary pressure, FFR, HTG, and WSS were measured just after stent implantation and at 6-month follow-up. At 6-month follow-up, FFR was significantly higher in the sirolimus group compared with the bare metal group (0.91+/-0.05 vs. 0.83+/-0.10, P=0.027) and HTG was significantly lower (1.2+/-1.2 vs. 7.5+/-8.1 mmHg, P<0.001). In-stent WSS at 6 months remained normal in the sirolimus group but was elevated in the bare metal group (1.6+/-0.7 vs 3.9+/-3.1 Pa, respectively, P=0.003).The physiologic characteristics of the drug-eluting sirolimus stents were superior to those of the equivalent BMS. Six months after implantation, FFR was significantly higher, HTG was significantly lower in arteries treated by a sirolimus stent, and normal WSS was maintained within the drug-eluting stent. |
1 | TITLE: Rates of luteolysis and pregnancy in dairy cows after treatment with cloprostenol or dinoprost.ABSTRACT: Our objective was to determine whether rates of luteolysis or pregnancy differed in lactating dairy cows of known progesterone status and either known or unknown luteal status after either cloprostenol or dinoprost was injected as part of a timed-insemination program. In Experiment 1, 2358 lactating dairy cows in six herds were given two injections of PGF(2 alpha) 14 d apart (Presynch), with the second injection given 12 to 14 d before the onset of a timed AI protocol (Ovsynch). Cows (n=1094) were inseminated when detected in estrus after the Presynch PGF(2 alpha) injections. Cows not inseminated (n=1264) were enrolled in the Ovsynch protocol and assigned randomly to be treated with either cloprostenol or dinoprost as part of the timed-AI protocol. In cows having pretreatment concentrations of progesterone >or= 1 ng/mL and potentially having a functional corpus luteum (CL) responsive to cloprostenol (n=558) or dinoprost (n=519), dinoprost increased (P<0.05) luteal regression from 86.6 to 91.3%. Despite a significant increase in luteolysis, pregnancies per AI did not differ between luteolytic agents (dinoprost=37.8% and cloprostenol=36.7%). Fertility was improved in cows of both treatments having reduced concentrations of progesterone at 72 h and in cows showing signs of estrus. In Experiment 2, an ovulation-resynchronization program was initiated with GnRH or saline in 427 previously inseminated lactating dairy cows of unknown pregnancy status in one herd. Seven days later, pregnancy was diagnosed and nonpregnant cows were blocked by number of CL and assigned randomly to be treated with cloprostenol or dinoprost. Compared with cloprostenol, dinoprost increased (P<0.05) luteal regression from 69.1 to 78.5%, regardless of the number of CL present or the total luteal volume per cow. Pregnancies per AI did not differ between dinoprost (32.8%) and cloprostenol (31.3%). Although dinoprost was more effective than cloprostenol at inducing luteolysis in lactating dairy cows exposed to an Ovsynch or ovulation-resynchronization protocol, resulting fertility did not differ between products. |
1 | TITLE: Comparison of naproxen with placebo for the management of noncyclical breast pain: a randomized, double-blind, controlled trial.ABSTRACT: Breast pain is a common symptom in patients attending breast clinics. Although most patients experience mastalgia of mild to moderate severity, approximately 15% of patients suffer from severe pain that causes significant distress and some disturbance in their daily life that lead them to seek treatment. Despite a considerable number of drugs suggested for decreasing the severity of mastalgia, there is no standard treatment for the complaint. In this study, we investigated the effect of naproxen on reducing the complaint of breast pain compared with placebo.Eighty-one women suffering from noncyclic breast pain were recruited to a randomized, double-blind, clinical trial between January 2002 and September 2004. All patients were suffering from this complaint for at least 3 months before the study. Patients were randomly assigned to two groups. Patients in the case group received naproxen 250 mg BD. Patients in the placebo group took placebo in a similar manner. The intensity of mastalgia was assessed before and twice after intervention by using a Visual Analogue Scale.Forty-two of 81 patients were recruited randomly as cases and the remaining 39 were assigned placebo. Of these 24 and 22 patients fulfilled the study protocol respectively. The mean age of patients was 35 (SD = 7.5; range, 19-55) years. The mean pain severity at the beginning of the study was 5.8 and 6.1 in naproxen and placebo groups, respectively. The severity of pain was decreased significantly at the end of the study in both groups (3.9 in patients and 3.7 in controls (P = 0.005 and 0.0001)). Although the decrease in pain severity in each individual group was statistically significant, it was not significant compared with one another (P = 0.64).Breast pain is a complex symptom that can be relieved significantly with reassurance. According to the result of this study, naproxen has no superiority over placebo in reducing noncyclic breast pain. |
1 | TITLE: Troponin levels after ICD implantation with and without defibrillation testing and their predictive value for outcomes: Insights from the SIMPLE trial.ABSTRACT: The Shockless IMPLant Evaluation trial randomized 2500 patients receiving a first implantable cardioverter-defibrillator (ICD)/cardiac resynchronization therapy-defibrillator device to have either defibrillation testing (DT) or no DT. It demonstrated that DT did not improve shock efficacy or reduce mortality.This prospective substudy evaluated the effect of DT on postoperative troponin levels and their predictive value for total and arrhythmic mortality.Troponin levels were measured between 6 and 24 hours after ICD implantation in 2200 of 2500 patients.A postoperative serum troponin level above the upper limit of normal (ULN) was more common in patients undergoing DT (n = 509 [46.4%]) than in those not subjected to DT (n = 456 [41.3%]; P = .02). After excluding patients with known preoperative troponin levels above the ULN, consistent findings were observed (42.1% vs 37.5%; P = .04). During a mean follow-up of 3.1 ± 1.0 years, the annual mortality rate was increased in patients with postoperative troponin levels above the ULN (adjusted hazard ratio [HR] 1.43; 95% confidence interval [CI] 1.15-1.76; P = .001) irrespective of DT or no DT. Likewise, patients with elevated troponin levels had a significantly higher risk of arrhythmic death (adjusted HR 1.80; 95% CI 1.23-2.63; P = .002). The rate of first appropriate ICD shock (adjusted HR 0.89; 95% CI 0.71-1.12; P = .32) or failed appropriate shock (adjusted HR 1.02; 95% CI 0.59-1.76; P = .95) was similar in patients with or without troponin elevation.DT at the time of ICD implantation is associated with increased troponin levels, indicating subclinical myocardial injury caused by the procedure. Elevated troponin levels but not DT seem to predict clinical outcomes in ICD recipients. |
1 | TITLE: Efficacy and safety of intravenous theophylline administration for treatment of mild acute exacerbation of bronchial asthma.ABSTRACT: The present study was designed to evaluate the efficacy and safety of intravenously administered theophylline (IAT) for the treatment of an acute exacerbation of bronchial asthma. The theophylline was solubilized and not combined with ethylenediamine.The subjects were 22 asthmatic patients with mild acute exacerbation of bronchial asthma. All patients had been taking oral sustained-release theophylline and their serum concentrations of theophylline were measured. The 16 patients whose serum theophylline concentrations were <13 microg/mL were randomly selected and treated with IAT (200 mg theophylline in 200 mL saline) for 2 h. Six patients were randomly selected as controls and received 200 mL of saline. Pulmonary function and asthma severity (Borg scale) before and after treatment were measured.After IAT, both PEF (before IAT, 313+/-79 L/min; after IAT, 335+/-107; P<0.05) and FEV(1) (before IAT, 1.66+/-0.47 L; after IAT, 1.83+/-0.44; P<0.05) increased significantly. Furthermore, their severity of asthma as assessed by the Borg scale (before IAT, 2.5+/-1.2; after IAT, 1.3+/-1.0; P<0.05) improved significantly. In contrast, neither FEV(1), PEF, severity of asthma or Borg scale changed significantly in the group who only received saline. None of the patients treated in this study had any adverse effects.These results suggest that IAT is useful for patients with mild acute exacerbation of bronchial asthma and is safe if serum theophylline concentrations are measured. |
1 | TITLE: Oral nutritional supplements containing (n-3) polyunsaturated fatty acids affect the nutritional status of patients with stage III non-small cell lung cancer during multimodality treatment.ABSTRACT: Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), (n-3) fatty acids from fish oil, have immune-modulating effects and may improve nutritional status in cancer. The objective of this study was to investigate the effects of an oral nutritional supplement containing (n-3) fatty acids on nutritional status and inflammatory markers in patients with non-small cell lung cancer (NSCLC) undergoing multimodality treatment. In a double-blind experiment, 40 patients with stage III NSCLC were randomly assigned to receive 2 cans/d of a protein- and energy-dense oral nutritional supplement containing (n-3) fatty acids (2.0 g EPA + 0.9 g DHA/d) or an isocaloric control supplement. EPA in plasma phospholipids, energy intake, resting energy expenditure (REE), body weight, fat free mass (FFM), mid-upper arm circumference (MUAC), and inflammatory markers were assessed. Effects of intervention were analyzed by generalized estimating equations and expressed as regression coefficients (B). The intervention group (I) had a better weight maintenance than the control (C) group after 2 and 4 wk (B = 1.3 and 1.7 kg, respectively; P < 0.05), a better FFM maintenance after 3 and 5 wk (B = 1.5 and 1.9 kg, respectively; P < 0.05), a reduced REE (B = -16.7% of predicted; P = 0.01) after 3 wk, and a trend for a greater MUAC (B = 9.1; P = 0.06) and lower interleukin-6 production (B = -27.9; P = 0.08) after 5 wk. After 4 wk, the I group had a higher energy and protein intake than the C group (B = 2456 kJ/24 h, P = 0.03 and B = 25.0 g, P = 0.01, respectively). In conclusion, a protein- and energy-dense oral nutritional supplement containing (n-3) fatty acids beneficially affects nutritional status during multimodality treatment in patients with NSCLC. |
1 | TITLE: Improvement in fibromyalgia symptoms with acupuncture: results of a randomized controlled trial.ABSTRACT: To test the hypothesis that acupuncture improves symptoms of fibromyalgia.We conducted a prospective, partially blinded, controlled, randomized clinical trial of patients receiving true acupuncture compared with a control group of patients who received simulated acupuncture. All patients met American College of Rheumatology criteria for fibromyalgia and had tried conservative symptomatic treatments other than acupuncture. We measured symptoms with the Fibromyalgia Impact Questionnaire (FIQ) and the Multidimensional Pain Inventory at baseline, immediately after treatment, and at 1 month and 7 months after treatment. The trial was conducted from May 28, 2002, to August 18, 2003.Fifty patients participated in the study: 25 in the acupuncture group and 25 in the control group. Total fibromyalgia symptoms, as measured by the FIQ, were significantly improved in the acupuncture group compared with the control group during the study period (P = .01). The largest difference in mean FIQ total scores was observed at 1 month (42.2 vs 34.8 in the control and acupuncture groups, respectively; P = .007). Fatigue and anxiety were the most significantly improved symptoms during the follow-up period. However, activity and physical function levels did not change. Acupuncture was well tolerated, with minimal adverse effects.This study paradigm allows for controlled and blinded clinical trials of acupuncture. We found that acupuncture significantly improved symptoms of fibromyalgia. Symptomatic improvement was not restricted to pain relief and was most significant for fatigue and anxiety. |
1 | TITLE: Perioperative pregabalin improves pain and functional outcomes 3 months after lumbar discectomy.ABSTRACT: Patient outcome after lumbar discectomy for radicular low back pain is variable and the benefit is inconsistent. Many patients continue to experience pain 3 months after surgery. Pregabalin, a membrane stabilizer, may decrease perioperative central sensitization and subsequent persistent pain.Forty patients undergoing lumbar discectomy were randomly allocated to receive either pregabalin (300 mg at 90 minutes preoperatively and 150 mg at 12 and 24 hours postoperatively) or placebo at corresponding times in a double-blinded manner. Our primary outcome was the change in the present pain intensity (PPI) (visual analog scale [VAS], 0-100 mm [PPI-VAS, McGill Pain Questionnaire]) from preoperatively to 3 months postoperatively.The decrease in PPI-VAS score at 3 months was greater in patients who received pregabalin (37.6 +/- 19.6 mm) (mean +/- sd) than those who received placebo (25.3 +/- 21.9 mm) (P = 0.08). The Roland Morris disability score at 3 months was less in patients who received pregabalin (2.7 +/- 2.4) than in those who received placebo (5.6 +/- 4.8) (P = 0.032). Pregabalin administration was associated with greater pain tolerance thresholds in both lower limbs compared with placebo at 24 hours postoperatively.Perioperative pregabalin administration is associated with less pain intensity and improved functional outcomes 3 months after lumbar discectomy. |
0 | TITLE: Urinary isoflavonoid excretion and soy consumption in three generations of Japanese women in Hawaii.ABSTRACT: To explore soy intake and urinary isoflavonoid excretion within several generations of American-Japanese women based on the hypothesis that earlier generations excrete higher levels of urinary isoflavonoids, in particular the metabolite equol, than later generations.A convenience sample of 43 women from 19 families aged 18-78 years, all of whom reported at least 50% Japanese ancestry.Each woman collected overnight urine samples at baseline and after consuming one serving of soymilk, both samples were analyzed for the isoflavonoids daidzein, genistein and equol using liquid chromatography-mass spectrometry.Median isoflavone intakes during the last year were 7.2 mg/day for the first generation, 7.3 mg/day for the second generation and 6.3 mg/day for the third generation (P=0.36). At baseline, the median isoflavonoid excretion for the first generation was nonsignificantly higher than for later generations (190, 86 and 42 nmol/h; P=0.20) but after intervention, the median urinary isoflavonoid excretion was very similar for the three groups: 2465, 1895 and 2775 nmol/h (P=0.70). Following intervention, a nonsignificantly higher proportion of older than younger women (53 vs 32 and 33%; P=0.41) excreted the metabolite equol. The respective median equol excretion rates by generation following intervention were 39.5, 4.2 and 3.5 nmol/h (P=0.04).This small investigation among three generations of Japanese-Americans detected a higher equol production among older women after a soy challenge, but no difference in the excretion of total isoflavonoids after a standardized dose of soymilk was observed. |
1 | TITLE: A randomized trial in patients undergoing percutaneous coronary angioplasty: roxithromycin does not reduce clinical restenosis but angioplasty increases antibody concentrations against Chlamydia pneumoniae.ABSTRACT: Elevated antibodies against Chlamydia pneumoniae have been associated with coronary artery disease. In patients undergoing percutaneous coronary angioplasty, we therefore investigated the effect of roxithromycin on symptomatic restenosis and determined antichlamydial antibodies as well as inflammatory and immunological parameters.A total of 327 patients undergoing coronary angioplasty were randomized to roxithromycin or placebo and followed-up for 1 year. Antibodies were determined by microimmunofluorescence and enzyme-linked immunosorbent assay; C-reactive protein, interleukin-10, tumor necrosis factor-alpha (TNF-alpha), and eotaxin were determined by enzyme-linked immunosorbent assay.Although the frequency of restenosis was not affected by roxithromycin (25 restenoses vs 32 in the control group), antichlamydial antibodies increased during follow-up (anti-CP IgG +12 +/- 2%, P < .001). Concentrations of TNF-alpha and eotaxin increased as well (TNF-alpha +9 +/- 1% and eotaxin +10 +/- 2%) and correlated with antichlamydial antibody concentrations (TNF-alpha, r = 0.23, P = .02; eotaxin, r = 0.32, P = .002).Treatment with roxithromycin was not associated with a reduction of symptomatic restenoses. During follow-up, a marked increase in antichlamydial antibodies, TNF-alpha, and eotaxin was observed, suggesting that angioplasty-induced plaque rupture induces a specific immunological response without activation of inflammatory mechanisms as represented by C-reactive protein. Whether this mechanism occurs in all plaque ruptures remains to be determined. |
1 | TITLE: Oral and Vaginal Tenofovir for Genital Herpes Simplex Virus Type 2 Shedding in Immunocompetent Women: A Double-Blind, Randomized, Cross-over Trial.ABSTRACT: Tenofovir is a potent anti-human immunodeficiency virus (HIV) agent that decreased risk of herpes simplex virus type 2 (HSV-2) acquisition in HIV pre-exposure prophylaxis trials. Whether tenofovir has utility in established HSV-2 disease is unclear.We randomized immunocompetent women with symptomatic HSV-2 infection to oral tenofovir disoproxil fumarate (TDF)/placebo vaginal gel, oral placebo/tenofovir (TFV) vaginal gel, or double placebo (ratio 2:2:1) in a one-way cross-over trial. Women collected genital swabs twice daily for HSV PCR during 4-week lead-in and 5-week treatment phases. The primary intent-to-treat end point was within-person comparison of genital HSV shedding and lesion rates.64 women completed the lead-in phase and were randomized. Neither TDF nor TFV gel decreased overall shedding or lesion rate in the primary analysis; TFV gel decreased quantity of HSV DNA by -0.50 (-0.86-0.13) log10 copies/mL. In the per-protocol analysis, TDF reduced shedding (relative risk [RR] = 0.74, P = .006) and lesion rates (RR = 0.75, P = .032); quantity of virus shed decreased by 0.41 log10 copies/mL.Oral TDF modestly decreased HSV shedding and lesion rate, and quantity of virus shed when used consistently. Vaginal TFV gel decreased quantity of virus shed by 60%. In contrast to effects on HSV-2 acquisition, tenofovir is unlikely to provide clinically meaningful reductions in the frequency of HSV shedding or genital lesions.NCT01448616. |
0 | TITLE: A replicate designed bioequivalence study to compare two fixed-dose combination products of artesunate and amodiaquine in healthy chinese volunteers.ABSTRACT: Artesun-Plus is a fixed-dose combination antimalarial agent containing artesunate and amodiaquine. The current study was conducted to compare the pharmacokinetic and safety profiles of Artesun-Plus and the WHO-designated comparator product Artesunate Amodiaquine Winthrop. To overcome the high intrasubject variability of artesunate, the study applied a two-sequence and four-period crossover (2 by 4), replicate study design to assess bioequivalence between the two products in 31 healthy male Chinese volunteers under fasting conditions. The results showed that the values of the geometric mean ratios of maximum concentration of drug in plasma (Cmax) and area under the concentration-time curve from time zero to the last blood sample collection (AUC0-last) for the artesunate component in the test and reference products were 95.9% and 93.9%, respectively, and that the corresponding 90% confidence intervals were 84.5% to 108.7% and 87.2% to 101.1%, while the geometric mean ratios for the amodiaquine component in the test and reference products were 95.0% and 100.0%, respectively, and the corresponding 90% confidence intervals were 86.7% to 104.1% and 93.5% to 107.0%. In conclusion, bioequivalence between the two artesunate and amodiaquine fixed-dose combination products was demonstrated for both components. The study also confirmed high intrasubject variability, especially for artesunate: the coefficients of variation (CV) of Cmax values for the test and reference products were 39.2% and 43.7%, respectively, while those for amodiaquine were 30.6% and 30.2%, respectively. |
1 | TITLE: Targeted temperature management at 33°C versus 36°C and impact on systemic vascular resistance and myocardial function after out-of-hospital cardiac arrest: a sub-study of the Target Temperature Management Trial.ABSTRACT: Cardiovascular dysfunction is common after out-of-hospital cardiac arrest as part of the postcardiac arrest syndrome, and hypothermia may pose additional impact on hemodynamics. The aim was to investigate systemic vascular resistance index (SVRI), cardiac index, and myocardial performance at a targeted temperature management of 33°C (TTM33) versus 36°C (TTM36).Single-center substudy of 171 patients included in the Target Temperature Management Trial (TTM Trial) randomly assigned to TTM33 or TTM36 for 24 hours after out-of-hospital cardiac arrest. Mean arterial pressure ≥65 mm Hg and central venous pressure of 10 to 15 mm Hg were hemodynamic treatment goals. Hemodynamic evaluation was performed by serial right heart catheterization and transthoracic echocardiography. Primary end point was SVRI after 24 hours of cooling and secondary end points included mean SVRI, cardiac index, systolic function, and lactate levels. The TTM33 group had a significant increase in SVRI compared with TTM36 (2595; 95% confidence interval, 2422-2767) versus 1960 (95% confidence interval, 1787-2134) dynes m(2)/s per cm(5); P<0.0001, respectively) after 24 hours of cooling with an overall difference of 556 dynes m(2)/s per cm(5) (P(group) <0.0001). TTM33 was associated with decreased cardiac index (-0.4 L/min per m(2); P(group) <0.0001), decreased heart rate (P(group)=0.01), and stroke volume index (P(group)=0.004) compared with TTM36. Left ventricular ejection fraction (P=0.39) and peak systolic myocardial velocity (P=0.62) did not differ between TTM groups. Lactate levels were significantly higher in the TTM33 group (P=0.0008).Targeted temperature management at 33°C with target mean arterial pressure ≥65 mm Hg is associated with increased SVRI and lower cardiac index because of lower heart rate with unaffected left ventricular systolic function compared with 36°C.http://www.clinicaltrials.gov. Unique identifier: NCT01020916. |
1 | TITLE: A double-blind, randomized clinical trial of dietary supplementation on cognitive and immune functioning in healthy older adults.ABSTRACT: Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity.This study investigated the effect of Ginkgo Synergy(®) plus Choline (n = 33) and OPC Synergy(®) plus Catalyn(®) (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling.No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy(®) plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy(®) plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p < 0.05) and for the OPC Synergy(®) plus Catalyn(®) arm from baseline to 3 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 4.0; p < 0.05). Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy(®) plus Choline arm (mean difference = 120.7; SE = 28.4; 95% CI: 62.6, 178.8; p < 0.001).Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits. Our trial was registered with clinicaltrials.gov (ID: NCT01672359). This study was supported by a grant from Standard Process, Inc. |
1 | TITLE: Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial.ABSTRACT: To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall).Follow up of a prospective, double-blind randomised controlled trial at 5 years.A teaching hospital in the UK.A total of 320 women eligible for and requesting endometrial ablation.Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database.The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery.Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%).At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation. |
1 | TITLE: Assessing the stability and safety of procedure during endoscopic submucosal dissection according to sedation methods: a randomized trial.ABSTRACT: Although endoscopic submucosal dissection (ESD) is routinely performed under sedation, the difference in ESD performance according to sedation method is not well known. This study attempted to prospectively assess and compare the satisfaction of the endoscopists and patient stability during ESD between two sedation methods.One hundred and fifty-four adult patients scheduled for ESD were sedated by either the IMIE (intermittent midazolam/propofol injection by endoscopist) or CPIA (continuous propofol infusion by anesthesiologist) method. The primary endpoint of this study was to compare the level of satisfaction of the endoscopists between the two groups. The secondary endpoints included level of satisfaction of the patients, patient's pain scores, events interfering with the procedure, incidence of unintended deep sedation, hemodynamic and respiratory events, and ESD outcomes and complications.Level of satisfaction of the endoscopists was significantly higher in the CPIA Group compared to the IMIE group (IMIE vs. CPIA; high satisfaction score; 63.2% vs. 87.2%, P=0.001). The incidence of unintended deep sedation was significantly higher in the IMIE Group compared to the CPIA Group (IMIE vs. CPIA; 17.1% vs. 5.1%, P=0.018) as well as the number of patients showing spontaneous movement or those requiring physical restraint (IMIE vs. CPIA; spontaneous movement; 60.5% vs. 42.3%, P=0.024, physical restraint; 27.6% vs. 10.3%, P=0.006, respectively). In contrast, level of satisfaction of the patients were found to be significantly higher in the IMIE Group (IMIE vs. CPIA; high satisfaction score; 85.5% vs. 67.9%, P=0.027). Pain scores of the patients, hemodynamic and respiratory events, and ESD outcomes and complications were not different between the two groups.Continuous propofol and remifentanil infusion by an anesthesiologist during ESD can increase the satisfaction levels of the endoscopists by providing a more stable state of sedation.ClinicalTrials.gov NCT01806753. |
0 | TITLE: A possible alternative exercise test for youths with cystic fibrosis: the steep ramp test.ABSTRACT: The steep ramp test (SRT) can be used to provide an indication of exercise capacity when gas exchange measurements are not possible. This study evaluated the clinical usefulness of the SRT in adolescents with cystic fibrosis (CF) and compared the physiological responses of the SRT with the standard cardiopulmonary exercise test (CPET).Forty patients with CF (17 boys and 23 girls; mean ± SD age, 14.7 ± 1.7 years; forced expiratory volume in 1 s, 86% ± 18% of predicted) performed an SRT and a CPET with respiratory gas analysis in a randomized balanced design. Peak work rate (WRpeak), HRpeak, peak minute ventilation (V˙Epeak), and peak oxygen uptake (V˙O2peak) were the main outcome measures.Patients with CF attained values for absolute and relative WRpeak during the SRT of 82% ± 14% and 92% ± 14% of predicted. Nutritional status and degree of airway obstruction did not influence SRT performance. Significantly higher values were attained for WRpeak during the SRT compared with those during the CPET (252 ± 60 vs 174 ± 46 W; P < 0.001), whereas significantly lower values were achieved for HRpeak (168 ± 14 vs 182 ± 12 bpm; P < 0.001), V˙Epeak (59.2 ± 19.5 vs 72.0 ± 20.2 L·min(-1); P = 0.006), and V˙O2peak (36.9 ± 7.5 vs 41.5 ± 7.6 mL·kg(-1)·min(-1); P = 0.008). A strong correlation between WRpeak attained at the SRT and the V˙O2peak achieved during the CPET was found (r = 0.822, P < 0.001).The SRT seems to be a quick, convenient, and low-cost exercise test that is well-tolerated in patients with CF with mild-to-moderate airway obstruction. It provides an indication of exercise capacity and can potentially be used when exercise testing using gas exchange measurements is not possible. |
1 | TITLE: Intravenous immunoglobulin treatment for secondary recurrent miscarriage: a randomised, double-blind, placebo-controlled trial.ABSTRACT: To determine whether infusions with intravenous immunoglobulin (IVIg) during early pregnancy increase live birth rate in women with secondary recurrent miscarriage compared with placebo.A single-centre, randomised, double-blind, placebo-controlled trial.A tertiary centre for recurrent miscarriage in Copenhagen, Denmark.A group of 82 women with unexplained secondary recurrent miscarriage and at least four miscarriages.Women were randomly assigned to repeated infusions with IVIg or placebo (albumin) from the time of positive pregnancy test to gestational week 15 or pregnancy loss.Primary outcome was birth with neonatal survival in all randomised women.In the intention-to-treat analyses, live birth rates were 23/42 (54.8%) in the IVIg and 20/40 (50.0%) in the placebo group, relative risk 1.11 (95% CI 0.70-1.74). In a per protocol analysis, almost identical results were found. The median gestational length at delivery was higher in the IVIg than the placebo group (282 versus 272 days, P = 0.02) but the mean birthweight was not significantly increased.In this trial, which is the largest so far, IVIg did not increase the live birth rate in patients with secondary recurrent miscarriage and the treatment cannot be recommended in clinical practice. |
1 | TITLE: A randomized study of temperature-controlled versus bipolar radiofrequency for inferior turbinate reduction.ABSTRACT: The objective of this study is to compare outcomes of temperature-controlled radiofrequency (TCRF) and bipolar radiofrequency (BRF) for inferior turbinate reduction in patients with chronic rhinitis (CR). This was a prospective, randomized non-inferiority trial. Eighty-four adult patients with CR refractory to medication were randomized into two intervention groups: TCRF(42) or BRF(42). Primary outcomes consisted of patient-orientated visual analog scale (VAS; 0-10) of nasal obstruction at 4th postoperative week. Secondary subjective outcomes included VAS of nasal discharge, sneezing, hyposmia, and postnasal drip. Objective outcomes included crusting, mucociliary transportation time, minimal cross-sectional area, total nasal volume, and nasal airway resistance performed by blind assessors before and at 4th postoperative week and 1-year follow-up. Baseline and perioperative data showed no statistically significant difference between both groups, except for longer operative time in TCRF (481.5 ± 36.2 vs. 37.1 ± 3.0 s, p < 0.001) and slightly more crusts in BRF group (p = 0.04). Both intention-to-treat and per-protocol analyses, TCRF(39) versus BRF(41), revealed no significant difference among subjective and objective outcomes between two groups at 4th postoperative week. The 95% confidence intervals of mean differences of VAS scores of all subjective symptoms were within defined margin (-1.5 to 1.5), except for nasal discharge. At 1-year follow-up, there was still no significant difference in the outcomes. Minimal pain and minor bleeding without serious adverse effects from both interventions were reported. Both BRF and TCRF resulted in similar short-term outcomes, while less operative time was found in BRF group. Further studies, particularly, on cost-effectiveness should be conducted for better treatment selection.1b. |
1 | TITLE: Use of cyclosporine 0.05% ophthalmic emulsion for contact lens-intolerant patients.ABSTRACT: To evaluate the effect of cyclosporine 0.05% ophthalmic emulsion (Restasis, Allergan, Inc., Irvine, CA) on contact lens comfort and reducing dry eye symptoms in patients with contact lens intolerance.A 5-week, randomized, investigator-masked study of 17 patients with self-reported contact lens-related dryness. Patients were randomized to cyclosporine twice per day or rewetting drops (carboxymethylcellulose 0.5%, Refresh Contacts) twice per day, to be used before and after lens wear. Changes from baseline in fluorescein staining of the cornea and conjunctiva and in tear breakup time were used to determine improvement of dry eye signs. Symptoms were assessed by lens wear time, use of rewetting drops during lens wear, subjective evaluation of dryness, and the completion of the Ocular Surface Disease Index questionnaire.Five weeks of cyclosporine treatment significantly improved dry eye symptoms (mean improvement of 0.88 +/- 0.64 with cyclosporine; no change of 0 +/- 0.58 [P = 0.01] with rewetting drops). Patients using cyclosporine decreased the use of rewetting drops by a mean 1.0 +/- 1.1 drops per day, and patients using rewetting drops increased their use (mean increase of 0.86 +/- 1.1 drops per day [P = 0.032]). Wearing time increased 1.9 +/- 2.1 hours per day with cyclosporine and 0.93 +/- 1.0 hours per day with rewetting drops (P = 0.258). There were no significant differences in mean corneal staining between groups. After 5 weeks, patients using cyclosporine showed statistically better improvements in temporal bulbar conjunctival fluorescein staining (decrease of 0.63 +/- 0.52 vs. increase of 0.57 +/- 0.67 [P = 0.002]) than patients using rewetting drops. Both treatments were tolerated well.The results of this pilot study indicate that cyclosporine 0.05% is beneficial for contact lens wearers with dry eye and reduces contact lens intolerance. |
1 | TITLE: Antiplatelet Efficacy of Fixed-Dose Aspirin-Clopidogrel Combination in Patients with Stable Coronary Artery Disease Treated with Drug-Eluting Stent Implantation.ABSTRACT: A fixed-dose combination (FDC) of aspirin and clopidogrel bisulfate may improve medication adherence. However, the absence of data on the relative antiplatelet efficacy of FDC and separate dual pills (SDP) of aspirin and clopidogrel in real-world patients with stable coronary artery disease is a major factor retarding clinical introduction of such an FDC.This was a single-centre, randomized, open-label, parallel-group, non-inferiority trial. Patients who maintained a regimen of separate aspirin and clopidogrel pills for at least 1 year after drug-eluting stent implantation without adverse events were enrolled. Patients were randomly assigned to either the FDC group or the SDP group. Antiplatelet efficacy and tolerability were assessed at baseline and at 4 weeks.Of the 93 enrolled patients, 83 (FDC group: n = 42; SDP group: n = 41) completed the study. The difference in the changes in P2Y12 percentage inhibition did not exceed the predetermined value for inferiority [mean difference -1.7; 95 % confidence interval (CI) -6.9 to 4.5, p < 0.001 for non-inferiority]. The changes from baseline to 4 weeks in P2Y12 reaction units (PRU) (mean difference 9.7 PRU, p = 0.46), maximal platelet aggregation (mean difference 2.0 %, p = 0.44) and aspirin reaction units (ARU) (mean difference -2.3 ARU, p = 0.88) did not differ significantly between the treatment groups. The tolerability of the FDC formulation was similar to that of SDP therapy (p = 0.68).In patients with prior percutaneous coronary intervention, the antiplatelet efficacy of the aspirin/clopidogrel FDC was non-inferior to that of SDP and the tolerability of the two regimens was similar after 4 weeks of treatment. |
1 | TITLE: A double blind randomised placebo controlled pilot study of oral co-trimoxazole in advanced fibrotic lung disease.ABSTRACT: In 1996, clinical improvement with oral co-trimoxazole was noted in a patient with biopsy proven advanced fibrotic lung disease who was awaiting a lung transplant. Subsequently, 14 patients with end stage fibrotic lung disease also responded to oral co-trimoxazole. This prompted a double blind randomised placebo controlled pilot study in patients with advanced stages of idiopathic interstitial pneumonias (IIP) to objectively measure benefit.Twenty patients (aged 49-84 years; 11 males) with progressive fibrotic lung disease who had differing subtype diagnosis from CT scans of progressive fibrotic IIP, and showed oxygen desaturation on exertion were selected.A detailed assessment of arterial gases, lung function, and progressive shuttle-walking tests combined with oxygen saturation monitoring. Quality of life data was recorded. Randomisation was to co-trimoxazole or identical placebo for 3 months followed by 6 weeks of pulmonary rehabilitation before decoding. Placebo patients received active treatment upon decoding with continued follow up of all patients.Primary 1. Shuttle walking test. Secondary 2. FVC and quality of life.Active treatment showed a significant improvement in shuttle walking test from 255 to 355 m (p=0.002) (95% CI 200-450) with reduced oxygen desaturations during exercise (p=0.003). FVC improved on treatment (+21%) from median 1.9 to 2.3 L (p=0.05) (95% CI 1.3-3.0) but TLC and DLCO were not significantly changed although stable at 12 months. The MRC 5 Point Dyspnoea Score showed improvement (p=0.05) at 3 months for the active group which was maintained at 12 months. The SGHRQ showed a significant reduction in symptom scores at 12 months (p=0.05). The placebo group showed no significant change in any parameters, but demonstrated identical improvement following oral co-trimoxazole. Serum vascular endothelial growth factor (VEGF) was reduced 50% in the active group at 3 months, but just failed to reach statistical significance. 'Out of study' HRCT scans in 12 patients showed significant reduction in ground glass changes (p=0.05) after 12 months of continuous co-trimoxazole treatment.The findings of the pilot study show significant improvements in objective and subjective parameters which fulfil the ATS/ERS (2000) criteria of 'a favourable response to treatment'. |
1 | TITLE: Uric acid and other renal function parameters in patients with stable angina pectoris participating in the ACTION trial: impact of nifedipine GITS (gastro-intestinal therapeutic system) and relation to outcome.ABSTRACT: Little data is available concerning the prognostic implications of renal function abnormalities, their evolution over time and the effects of nifedipine on such abnormalities in patients with stable angina pectoris.The previously published ACTION trial compared long-acting nifedipine GITS 60 mg once daily to placebo among 7,665 patients. Standard laboratory tests including creatinine and uric acid were assessed at baseline, after 6 months, 2 and 4 years, and at the end of follow-up. We assessed the impact of nifedipine on markers of renal dysfunction and determined whether evidence of renal failure alters the impact of nifedipine on the clinical outcome of patients with stable angina.Uric acid was not while creatinine level and estimated creatinine clearance were potent conditionally independent predictors of total mortality and of cardiovascular clinical events. Relative to placebo, nifedipine reduced 6-month uric acid levels by 3% (P < 0.001) of the baseline value. This difference was maintained during long-term follow-up, was present both in normotensives and in hypertensives, and was not explained by differences in diuretic therapy or allopurinol use. Nifedipine had no effect on the occurrence of clinical renal failure. Relative to placebo, the effects of nifedipine on cardiovascular death or myocardial infarction [hazard ratio (HR) = 1.01, 95% confidence interval (CI) 0.88-1.17], any stroke or transient ischaemic attack (HR = 0.73, 95% CI 0.60-0.88), new overt heart failure (HR = 0.72, 95% CI 0.55-0.95), and the need for any coronary procedure (HR = 0.81, 95% CI 0.75-0.88) were consistent across strata of markers of renal dysfunction.We conclude that, in patients with stable angina, nifedipine reduces uric acid levels and does not affect other markers of renal dysfunction. Renal dysfunction does not alter the effects of nifedipine on clinical outcome. |
1 | TITLE: A double-blind randomized controlled trial of mifepristone or placebo before buccal misoprostol for abortion at 14-21 weeks of pregnancy.ABSTRACT: To assess differences in outcomes of misoprostol with or without mifepristone for second-trimester abortion.A randomized, double-blind, placebo-controlled trial of buccal misoprostol following placebo or 200mg mifepristone was done in Tunisia among women presenting for abortions at 14-21 weeks of pregnancy between August 2009 and December 2011. Women with a live fetus, a closed cervical os, no cervical bleeding, and no contraindications to study drugs were eligible and underwent randomization (block size 10). Participants returned 24 hours later to receive 400 μg buccal misoprostol every 3 hours until complete fetal and placental expulsion (maximum 10 doses, five per 24-hour period). The primary outcomes were rates of complete uterine evacuation at 48 hours and time to expulsion.A total of 120 women were evenly randomized to treatment. Complete uterine evacuation at 48 hours was recorded in 55 (91.7%) women in the combined group versus 43 (71.7%) in the misoprostol alone group (relative risk 1.28; 95% confidence interval 1.07-1.53). Mean time to complete abortion was 10.4±6.6 hours in the group who received mifepristone versus 20.6±9.7 hours in the misoprostol alone group (P<0.001). Side effects were similar in both groups.Adding mifepristone before misoprostol can improve the quality of second-trimester abortion care by making the process faster. |
1 | TITLE: Probiotic prophylaxis to prevent ventilator associated pneumonia (VAP) in children on mechanical ventilation: an open-label randomized controlled trial.ABSTRACT: Ventilator associated pneumonia (VAP) is one of the most common nosocomial infections in the pediatric intensive care unit (PICU). It is associated with increased mortality and prolonged hospital stay. Several preventive strategies have been introduced to reduce VAP. One novel intervention is prophylactic administration of probiotics. Studies on the effect of probiotics on VAP in pediatric populations are lacking.This was an open-label randomized controlled trial. A total of 150 children no older than 12 years admitted to the PICU were recruited from November 2011 to July 2013. Children who were likely to require ventilation for more than 48 h were eligible for inclusion in the study. Patients were randomized into two groups after stratification based on age groups. Children in the intervention group received probiotic preparation twice a day beginning from the day of ICU admission till 7 days or discharge from ICU, whichever was earlier. The control group did not receive any placebo. Children were examined daily for evidence of VAP and were followed up till discharge from hospital. Incidence of VAP, duration of hospital stay, and mortality were compared.Children who received prophylactic probiotics had a lower incidence of VAP compared to the control group (17.1 % in the probiotics group vs 48.6 % in the control group, p < 0.001; 22 per 1,000 ventilated days vs 39 per 1,000 ventilated days, p = 0.02). On multiple logistic regression analysis, use of prophylactic probiotics decreased the incidence of VAP by 77 % and reduced the duration of ICU and hospital stays by an average of 2.1 and 3.3 days, respectively, after adjusting for the other confounders. No complications due to administration of probiotics were observed in the study.Prophylactic probiotics administration resulted in reduction of the incidence of VAP in critically ill children in a setting where baseline VAP rates are high. The intervention was found to be safe. |
1 | TITLE: Treatment for 24 months with recombinant human GH has a beneficial effect on bone mineral density in young adults with childhood-onset GH deficiency.ABSTRACT: Discontinuation of growth hormone (GH) therapy on completion of linear growth may adversely affect bone mineral density (BMD) in young adults with childhood-onset GH-deficiency (GHD). In the present study, we analyzed the impact of GH treatment on bone in young adults with GHD.BMD at the lumbar spine (L2-L4), total hip, and total body was measured at baseline and after 24 months in a cohort of young adults (18-25 years; n=160) with severe GHD treated with GH during childhood who were randomized to GH (n=109) or no treatment (n=51) in a multicenter, multinational, open-label study. GH starting doses (0.2 mg/day (males), 0.4 mg/day (females)) were increased after 1 month to 0.6 mg/day (males) and 0.9 mg/day (females) and then to 1.0 mg/day (males) and 1.4 mg/day (females) at 3 months for the remainder of the study.After 24 months, lumbar spine BMD had increased significantly more in GH-treated patients than in controls (6 vs 2%; estimated treatment difference; 3.5% (95% confidence interval, 1.52-5.51) P<0.001). GH also had a significant positive effect on total hip BMD (P=0.015). Total body BMD was unchanged from baseline (P=0.315).In young adults treated for childhood-onset GHD, there is a beneficial effect of continued GH treatment on BMD in adult life. Twenty-four months of GH treatment in these young adults was associated with an estimated 3.5% greater increase in BMD of the lumbar spine compared with controls. |
1 | TITLE: Acute Effects of Brief Mindfulness Intervention Coupled with Carbohydrate Ingestion to Re-Energize Soccer Players: A Randomized Crossover Trial.ABSTRACT: This field experiment investigated the acute effects of brief mindfulness-based intervention (MBI) coupled with carbohydrate (CHO) intake on players' recovery from half-time break in a simulated soccer competition. In a single-blinded randomized crossover experiment, 14 male players received 3 treatments (Control: non-carbohydrate solution + travelling introduction audio; CHO: CHO-electrolyte solution + travelling introduction audio; and CHO_M: CHO-electrolyte solution + MBI) during simulated half-time breaks. Vertical jump, sprint performance, mindfulness level, rate of perceived exertion, muscle pain, mental fatigue, blood glucose, and lactate were measured immediately before, during, and after the exercise. (1) MBI significantly increased participants' mindfulness level (Control vs. CHO_M, < 0.01; CHO vs. CHO_M, < 0.01) and decreased mental fatigue for CHO_M condition (pre vs. post, < 0.01); (2) participants in the CHO_M condition performed better in the repeated sprint tests than in the Control and CHO condition (Control vs. CHO_M, = 0.02; CHO vs. CHO_M, = 0.02). Findings of this study provide preliminary evidence of the positive effect of MBI coupled with CHO ingestion on athletes' recovery from fatigue in the early stage of the second half of a game. |
1 | TITLE: A 24-month randomized controlled trial on the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with the ART approach.ABSTRACT: To compare the success rates of restoring untreated and SDF-treated dentine caries lesions in primary teeth with atraumatic restorative treatment (ART) approach.Cavitated dentine caries lesions in preschool children were randomly allocated to two groups to be applied with either 38% silver diamine fluoride (SDF) solution or tonic water (control) ten weeks before being restored with the ART approach. Status of the restorations were assessed every six months by a blinded independent examiner. Multilevel logistic regression and multilevel survival analyses were conducted to assess the restoration success rates.A total of 194 children (SDF group, 101; control group, 93) were included, with 260 and 249 ART restorations placed in the SDF and the control groups, respectively. At 24-month follow-up, 88 (87 %) and 84 (90 %) children remained in the SDF and the control groups, respectively. There was no significant difference between the ART restoration success rates of the two study groups (p > 0.05). The success rate of ART restorations was associated with the class of restorations. Class I restorations had the highest success rate (∼50 %), followed by Class V (∼35 %), Class II (∼15 %) and Class III (<10 %). Besides, the mean time used to place an ART restoration in a SDF-treated caries lesion was shorter than that in untreated lesion (4.8 vs. 5.1 min, p = 0.006).Prior SDF application does not significantly affect the success rate of ART restorations placed in primary teeth. Besides, it is faster to place ART restorations in caries lesions that have been previously treated with SDF.Prior application of silver diamine fluoride solution on cavitated dentine caries lesions in primary teeth can shorten the average time required to place an ART restoration while not jeopardizing the success rate of the restorations. |
1 | TITLE: Omitting fentanyl reduces nausea and vomiting, without increasing pain, after sevoflurane for day surgery.ABSTRACT: Despite advantages of induction and maintenance of anaesthesia with sevoflurane, postoperative nausea and vomiting occurs frequently. Fentanyl is a commonly used supplement that may contribute to this, although it may also improve analgesia.This double-blind study examined the incidence and severity of postoperative nausea and vomiting and pain in the first 24 h after sevoflurane anaesthesia in 216 adult day surgery patients. Patients were randomly allocated to either receive or not receive 1 1 fentanyl, while a third group received dexamethasone in addition to fentanyl.Omission of fentanyl did not reduce the overall incidence of postoperative nausea and vomiting, but did reduce the incidence of vomiting and/or moderate to severe nausea prior to discharge from 20% and 17% with fentanyl and fentanyl-dexamethasone, respectively, to 5% (P = 0.013). Antiemetic requirements were reduced from 24% and 31% to 7% (P = 0.0012). Dexamethasone had no significant effect on the incidence or severity of postoperative nausea and vomiting. Combining the two fentanyl groups revealed further significant benefits from the avoidance of opioids, reducing postoperative nausea and vomiting and nausea prior to discharge from 35% and 33% to 22% and 19% (P = 0.049 and P = 0.035), respectively, while nausea in the first 24 h was decreased from 42% to 27% (P = 0.034). Pain severity and analgesic requirements were unaffected by the omission of fentanyl. Fentanyl did reduce minor intraoperative movement but had no sevoflurane-sparing effect and increased respiratory depression, hypotension and bradycardia.As fentanyl exacerbated postoperative nausea and vomiting without an improvement in postoperative pain and also had adverse cardiorespiratory effects, it appears to be an unnecessary and possibly detrimental supplement to sevoflurane in day surgery. |
1 | TITLE: Consolidation radiotherapy in patients with advanced Hodgkin's lymphoma: survival data from the UKLG LY09 randomized controlled trial (ISRCTN97144519).ABSTRACT: This study analyzed the outcomes of nonrandomized consolidation radiotherapy (RT) given after chemotherapy in the initial treatment of advanced Hodgkin's lymphoma (HL). The results were collected prospectively within a randomized controlled trial of induction chemotherapy.Patients were randomly assigned between doxorubicin, bleomycin, vinblastine, and dacarbazine and one of two prespecified multidrug regimens. At least six cycles of chemotherapy were planned, with up to eight for patients showing slower response. Involved-field RT was recommended for incomplete response to chemotherapy or bulk disease at presentation. The primary outcome measure was progression-free survival (PFS), landmarked from the end of chemotherapy.Among 807 patients randomly assigned, 702 achieved objective response. Postchemotherapy RT for consolidation was reported in 300 (43%). With median follow-up of 6.9 years, 161 PFS events and 83 deaths were reported. Baseline characteristics showed more patients with bulk disease having RT (190 [63%] v 111 [28%]) and only partial response after chemotherapy (150 [50%] v 36 [9%]). Other baseline characteristics were similar. PFS was superior for patients having RT (hazard ratio [HR], 0.43; 95% CI, 0.30 to 0.60) with 5-year PFS 71% without RT, 86% with RT. A similar advantage was seen for overall survival (HR, 0.47; 95% CI, 0.29 to 0.77). There was no evidence of heterogeneity of treatment effect across subgroups.Patients who received consolidation RT apparently had better outcomes, consistently across all prognostic groups which persisted in multivariate analysis. This suggests that RT contributes significantly to the cure rate for advanced HL, although patient selection for combined modality treatment requires better definition in prospective trials. |
1 | TITLE: Can postpartum pelvic floor muscle training reduce urinary and anal incontinence?: An assessor-blinded randomized controlled trial.ABSTRACT: Pelvic floor dysfunction, including urinary and anal incontinence, is a common postpartum complaint and likely to reduce quality of life.To study the effects of individualized physical therapist-guided pelvic floor muscle training in the early postpartum period on urinary and anal incontinence and related bother, as well as pelvic floor muscle strength and endurance.This was an assessor-blinded, parallel-group, randomized controlled trial evaluating effects of pelvic floor muscle training by a physical therapist on the rate of urinary and/or anal leakage (primary outcomes); related bother and muscle strength and endurance in the pelvic floor were secondary outcomes. Between 2016 and 2017, primiparous women giving birth at Landspitali University Hospital in Reykjavik, Iceland, were screened for eligibilty 6-10 weeks after childbirth. Of those identified as urinary incontinent, 95 were invited to participate, of whom 84 agreed. The intervention, starting at ∼9 weeks postpartum consisted of 12 weekly sessions with a physical therapist, after which the main outcomes were assessed (endpoint, ∼6 months postpartum). Additional follow-up was conducted at ∼12 months postpartum. The control group received no instructions after the initial assessment. The Fisher exact test was used to test differences in the proportion of women with urinary and anal incontinence between the intervention and control groups, and independent-sample t tests were used for mean differences in muscle strength and endurance. Significance levels were set as α = 0.05.A total of 41 and 43 women were randomized to the intervention and control groups, respectively. Three participants and 1 participant withdrew from these respective groups. Measurement variables and main delivery outcomes were not different at recruitment. At the endpoint, urinary incontinence was less frequent in the intervention group, with 21 participants (57%) still symptomatic, compared to 31 controls (82%) (P = .03), as was bladder-related bother with 10 participants (27%) in the intervention vs 23 (60%) in the control group (P = .005). Anal incontinence was not influenced by pelvic floor muscle training (P = .33), nor was bowel-related bother (P = .82). The mean differences between groups in measured pelvic floor muscle strength changes at endpoint was 5 hPa (95% confidence interval, 2-8; P = .003), and for pelvic floor muscle endurance changes, 50 hPa/s (95% confidence interval, 23-77; P = .001), both in favor of the intervention group. The mean between-group differences for anal sphincter strength changes was 10 hPa (95% confidence interval, 2-18; P = .01) and for anal sphincter endurance changes 95 hPa/s (95% confidence interval, 16-173; P = .02), both in favor of the intervention. At the follow-up visit 12 months postpartum, no differences were observed between the groups regarding rates of urinary and anal incontinence and related bother. Pelvic floor- and anal muscle strength and endurance favoring the intervention group were maintained.Postpartum pelvic floor mucle training decreased the rate of urinary incontinence and related bother 6 months postpartum and increased muscle strength and endurance. |
1 | TITLE: The effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in type 2 diabetic patients with coronary heart disease: A randomized, double-blind, placebo-controlled trial.ABSTRACT: This study was carried out to evaluate the effects of vitamin D and probiotic co-supplementation on mental health parameters and metabolic status in diabetic people with coronary heart disease (CHD).This randomized, double-blind, placebo-controlled trial was carried out among 60 diabetic people with CHD, aged 45-85 years old. Subjects were randomly allocated into two groups to receive either 50,000 IU vitamin D every 2 weeks plus 8 × 10 CFU/g probiotic of Lactocare Zisttakhmir Co (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were obtained at baseline and after the 12-week intervention to determine metabolic profiles.After the 12-week intervention, compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant improvements in beck depression inventory total score (-2.8 ± 3.8 vs. -0.9 ± 2.1, P = 0.01), beck anxiety inventory scores (-2.1 ± 2.3 vs. -0.8 ± 1.4, P = 0.009) and general health questionnaire scores (-3.9 ± 4.1 vs. -1.1 ± 3.4, P = 0.005). Compared with the placebo, vitamin D and probiotic co-supplementation resulted in significant reductions in serum insulin levels (-2.8 ± 3.8 vs. +0.2 ± 4.9 μIU/mL, P = 0.009), homeostasis model of assessment-estimated insulin resistance (-1.0 ± 1.6 vs. -0.1 ± 1.5, P = 0.02), and a significant increase in serum 25-OH-vitamin D (+11.8 ± 5.9 vs. +0.1 ± 1.4 ng/mL, P < 0.001), the quantitative insulin sensitivity check index (+0.03 ± 0.04 vs. -0.001 ± 0.01, P = 0.003) and serum HDL-cholesterol levels (+2.3 ± 3.5 vs. -0.5 ± 3.8 mg/dL, P = 0.004). In addition, changes in serum high sensitivity C-reactive protein (hs-CRP) (-950.0 ± 1811.2 vs. +260.5 ± 2298.2 ng/mL, P = 0.02), plasma nitric oxide (NO) (+1.7 ± 4.0 vs. -1.4 ± 6.7 μmol/L, P = 0.03) and plasma total antioxidant capacity (TAC) (+12.6 ± 41.6 vs. -116.9 ± 324.2 mmol/L, P = 0.03) in the supplemented group were significantly different from the changes in these indicators in the placebo group.Overall, vitamin D and probiotic co-supplementation after 12 weeks among diabetic people with CHD had beneficial effects on mental health parameters, serum hs-CRP, plasma NO, TAC, glycemic control and HDL-cholesterol levels.http://www.irct.ir: IRCT2017073033941N4. |
0 | TITLE: A paradoxical difference in relationship between anxiety, depression and thyroid function in subjects on and not on T4: findings from the HUNT study.ABSTRACT: There have been conflicting reports on the relationship between thyroid function and mood between studies in subjects on T4 and the general population not on T4. We investigated this relationship in a large catchment area-based study.We analysed data on serum TSH levels and Hospital Anxiety and Depression Scale (HADS) scores from the HUNT 2 study (age > or = 40 years). Following a test for interaction, analyses were performed separately in females on T4 (n = 1265) and in people not on T4 (males n = 9319 and females n = 17 694).More females on T4 had high depression and anxiety scores than females not on T4 (depression 18.4%vs. 13.0%, P < 0.001, anxiety 23.4%vs. 18.7%, P < 0.001). In those not on T4, there was an inverse association between serum TSH and depression score in males (B coefficient = -0.61, 95% CI -0.91 to -0.24, P = 0.001) though not in females (B coefficient = -0.07, -0.33 to 0.19), and an inverse association between TSH and anxiety score in both genders (B coefficient for males = 0.68, 95% CI -1.04 to -0.32, P < 0.001; females -0.37, 95% CI -0.67 to -0.08, P = 0.01). In contrast, in females on T4, TSH was positively associated with both depression (B coefficient = +0.27, 95% CI 0.02 to 0.51, P < 0.05) and anxiety (B coefficient = +0.29, 95% CI 0.01 to 0.56, P < 0.05).There is a different relationship between thyroid function and depression and anxiety in females on T4 compared with individuals with no thyroid disease. This group also has a higher prevalence of depression and anxiety. |
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