Evaluation of Interventions to Improve Solar Protection in Primary Schools.

ERIC Educational Resources Information Center

Girgis, Afaf; And Others

1993-01-01

An intensive intervention group (n=247) of 9-11 year olds were exposed to SKIN SAFE, a curriculum about sun protection. A standard group (n=180) received a lecture about skin cancer; control group numbered 185. The intensive group were significantly more likely to use high levels of protection; no differences were apparent between the standard and…

Low-dose ketamine improves pain relief in patients receiving intravenous opioids for acute pain in the emergency department: results of a randomized, double-blind, clinical trial.

PubMed

Beaudoin, Francesca L; Lin, Charlie; Guan, Wentao; Merchant, Roland C

2014-11-01

Low-dose ketamine has been used perioperatively for pain control and may be a useful adjunct to intravenous (IV) opioids in the control of acute pain in the emergency department (ED). The aim of this study was to determine the effectiveness of low-dose ketamine as an adjunct to morphine versus standard care with morphine alone for the treatment of acute moderate to severe pain among ED patients. A double-blind, randomized, placebo-controlled trial with three study groups was conducted at a large, urban academic ED over a 10-month period. Eligible patients were 18 to 65 years old with acute moderate to severe pain (score of at least 5 out of 10 on the numerical pain rating scale [NRS] and pain duration < 7 days) who were deemed by their treating physician to require IV opioids. The three study groups were: 1) morphine and normal saline placebo (standard care group), 2) morphine and 0.15 mg/kg ketamine (group 1), or 3) morphine and 0.3 mg/kg ketamine (group 2). Participants were assessed at 30, 60, and 120 minutes after study medication administration and received rescue analgesia as needed to target a 50% reduction in pain. The primary outcome measure of pain relief, or pain intensity reduction, was derived using the NRS and calculated as the summed pain-intensity (SPID) difference over 2 hours. The amount and timing of rescue opioid analgesia was evaluated as a secondary outcome. The occurrence of adverse events was also measured. Sixty patients were enrolled (n = 20 in each group). There were no differences between study groups with respect to age, sex, race/ethnicity, preenrollment analgesia, or baseline NRS. Over the 2-hour poststudy medication administration period, the SPIDs were higher (greater pain relief) for the ketamine study groups than the control group (standard care 4.0, interquartile range [IQR] = 1.8 to 6.5; group 1 7.0, IQR = 4.3 to 10.8; and group 2 7.8, IQR = 4.8 to 12.8; p < 0.02). The SPIDs for the ketamine groups were similar (p < 0.46). When compared to standard care, group 2 sustained the reduction in pain intensity up to 2 hours, whereas group 1 was similar to standard care by 2 hours. Similar numbers of patients received rescue analgesia: standard care group, seven of 20, 35%; group 1, four of 20, 20%; and group 2, four of 20, 20% (p = 0.48). Among those receiving rescue analgesia, those in the standard care group received analgesia sooner than either low-dose ketamine group, on average. More participants in the low-dose ketamine groups reported dysphoria and dizziness. Low-dose ketamine is a viable analgesic adjunct to morphine for the treatment of moderate to severe acute pain. Dosing of 0.3 mg/kg is possibly more effective than 0.15 mg/kg, but may be associated with minor adverse events. Future studies should evaluate additional outcomes, optimum dosing, and use in specific populations. © 2014 by the Society for Academic Emergency Medicine.

Baseline Equivalence. WWC Standards Brief

ERIC Educational Resources Information Center

What Works Clearinghouse, 2017

2017-01-01

The What Works Clearinghouse (WWC) uses the term "baseline equivalence" when determining if the intervention group (those that received the intervention of interest) and the comparison group (those that did not receive the intervention) had characteristics that were similar enough ("equivalent") at the start of the study (at…

Phosphate-containing dialysis solution prevents hypophosphatemia during continuous renal replacement therapy

PubMed Central

BROMAN, M; CARLSSON, O; FRIBERG, H; WIESLANDER, A; GODALY, G

2011-01-01

Background Hypophosphatemia occurs in up to 80% of the patients during continuous renal replacement therapy (CRRT). Phosphate supplementation is time-consuming and the phosphate level might be dangerously low before normophosphatemia is re-established. This study evaluated the possibility to prevent hypophosphatemia during CRRT treatment by using a new commercially available phosphate-containing dialysis fluid. Methods Forty-two heterogeneous intensive care unit patients, admitted between January 2007 and July 2008, undergoing hemodiafiltration, were treated with a new Gambro dialysis solution with 1.2 mM phosphate (Phoxilium) or with standard medical treatment (Hemosol B0). The patients were divided into three groups: group 1 (n=14) receiving standard medical treatment and intravenous phosphate supplementation as required, group 2 (n=14) receiving the phosphate solution as dialysate solution and Hemosol B0 as replacement solution and group 3 (n=14) receiving the phosphate-containing solution as both dialysate and replacement solutions. Results Standard medical treatment resulted in hypophosphatemia in 11 of 14 of the patients (group 1) compared with five of 14 in the patients receiving phosphate solution as the dialysate solution and Hemosol B0 as the replacement solution (group 2). Patients treated with the phosphate-containing dialysis solution (group 3) experienced stable serum phosphate levels throughout the study. Potassium, ionized calcium, magnesium, pH, pCO2 and bicarbonate remained unchanged throughout the study. Conclusion The new phosphate-containing replacement and dialysis solution reduces the variability of serum phosphate levels during CRRT and eliminates the incidence of hypophosphatemia. PMID:21039362

Petroselinum crispum extract attenuates hepatic steatosis in rats fed with fructose enriched diet.

PubMed

Nair, V Yuneesha; Balakrishanan, N; Antony Santiago, J Victor

2015-01-01

Non alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease and ongoing research efforts are focused on understanding the underlying pathophysiology of hepatic steatosis with the anticipation that these efforts will identify novel therapeutic targets. This study investigated the Petroselinum crispum extract in hepatic steatosis in rats fed with fructose enriched diet. Rats were divided into the 4 groups: Group 1 rats received standard pellet diet with corn starch for the entire experimental period of 8 weeks. Group 2 rats received standard pellet diet and 2 gm/kg body weight crude Parsley leaf ethanol extract for the entire experimental period of 8 weeks. Group 3 rats received modified fructose diet. Group 4 rats received modified fructose diet and 2gm/kg crude Parsley leaf ethanol extract. Hepatic function and structure was evaluated in these rats. Modified fructose diet produced dyslipidemia, hepatic steatosis and infiltration of inflammatory cells in the liver and higher plasma hepatic markers. Petroselinum crispum extract reversed metabolic changes such as abnormal crispum extract attenuated chronic changes in modified fructose diet induced NAFLD (Tab. 2, Fig. 3, Ref. 43).

Effect of Tribulus terrestris on Haloperidol-induced Catalepsy in Mice

PubMed Central

Nishchal, B. S.; Rai, S.; Prabhu, M. N.; Ullal, Sheetal D.; Rajeswari, S.; Gopalakrishna, H. N.

2014-01-01

Haloperidol, an antipsychotic drug, leads to the development of a behavioural state called catalepsy, in which the animal is not able to correct an externally imposed posture. In the present study we have attempted to evaluate the anticataleptic effect of Tribulus terrestris on haloperidol-induced catalepsy in albino mice. Mice were allocated to four groups, each group containing six animals. Both, the test drug, Tribulus terrestris and the standard drug trihexyphenidyl were uniformly suspended in 1% gum acacia solution. Catalepsy was induced in mice with haloperidol (1.0 mg/kg, intraperitoneally). The first group received the vehicle (10 ml/kg, orally), the second group received trihexyphenidyl (10 mg/kg, orally) and the remaining two groups received Tribulus terrestris (100, 200 mg/kg, orally). The animals were assessed after single and repeated dose administration for ten days, 30 min prior to haloperidol, using standard bar test. The result of the present study demonstrates Tribulus terrestris has a protective effect against haloperidol-induced catalepsy, which is comparable to the standard drug used for the same purpose. Our study indicates Tribulus terrestris can be used to prevent haloperidol-induced extrapyramidal side effects. PMID:25593394

Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study.

PubMed

Cutshall, Susanne M; Wentworth, Laura J; Engen, Deborah; Sundt, Thoralf M; Kelly, Ryan F; Bauer, Brent A

2010-05-01

To assess the role of massage therapy in the cardiac surgery postoperative period. Specific aims included determining the difference in pain, anxiety, tension, and satisfaction scores of patients before and after massage compared with patients who received standard care. A randomized controlled trial comparing outcomes before and after intervention in and across groups. Saint Marys Hospital, Mayo Clinic, Rochester, Minnesota. Patients undergoing cardiovascular surgical procedures (coronary artery bypass grafting and/or valvular repair or replacement) (N=58). Patients in the intervention group received a 20-minute session of massage therapy intervention between postoperative days 2 and 5. Patients in the control group received standard care and a 20-minute quiet time between postoperative days 2 and 5. Linear Analogue Self-assessment scores for pain, anxiety, tension, and satisfaction. Statistically and clinically significant decreases in pain, anxiety, and tension scores were observed for patients who received a 20-minute massage compared with those who received standard care. Patient feedback was markedly positive. This pilot study showed that massage can be successfully incorporated into a busy cardiac surgical practice. These results suggest that massage may be an important therapy to consider for inclusion in the management of postoperative recovery of cardiovascular surgical patients. Copyright 2009 Elsevier Ltd. All rights reserved.

[Development of a multimedia learning DM diet education program using standardized patients and analysis of its effects on clinical competency and learning satisfaction for nursing students].

PubMed

Hyun, Kyung Sun; Kang, Hyun Sook; Kim, Won Ock; Park, Sunhee; Lee, Jia; Sok, Sohyune

2009-04-01

The purpose of this study was to develop a multimedia learning program for patients with diabetes mellitus (DM) diet education using standardized patients and to examine the effects of the program on educational skills, communication skills, DM diet knowledge and learning satisfaction. The study employed a randomized control posttest non-synchronized design. The participants were 108 third year nursing students (52 experimental group, 56 control group) at K university in Seoul, Korea. The experimental group had regular lectures and the multimedia learning program for DM diet education using standardized patients while the control group had regular lectures only. The DM educational skills were measured by trained research assistants. The students who received the multimedia learning program scored higher for DM diet educational skills, communication skills and DM diet knowledge compared to the control group. Learning satisfaction of the experimental group was higher than the control group, but statistically insignificant. Clinical competency was improved for students receiving the multimedia learning program for DM diet education using standardized patients, but there was no statistically significant effect on learning satisfaction. In the nursing education system there is a need to develop and apply more multimedia materials for education and to use standardized patients effectively.

A randomized trial of goal directed vs. standard fluid therapy in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy.

PubMed

Colantonio, Luca; Claroni, Claudia; Fabrizi, Luana; Marcelli, Maria Elena; Sofra, Maria; Giannarelli, Diana; Garofalo, Alfredo; Forastiere, Ester

2015-04-01

The use of adequate fluid therapy during cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) remains controversial. The aim of the study was to assess whether the use of fluid therapy protocol combined with goal-directed therapy (GDT) is associated with a significant change in morbidity, length of hospital stay, and mortality compared to standard fluid therapy. Patients American Society of Anesthesiologists (ASA) II-III undergoing CRS and HIPEC were randomized into two groups. The GDT group (N = 38) received fluid therapy according to a protocol guided by monitored hemodynamic parameters. The control group (N = 42) received standard fluid therapy. We evaluated incidence of major complications, total length of hospital stay, total amount of fluids administered, and mortality rate. The incidence of major abdominal complications was 10.5% in GDT group and 38.1% in the control group (P = 0.005). The median duration of hospitalization was 19 days in GDT group and 29 days in the control group (P < 0.0001). The mortality rate was zero in GDT group vs. 9.5% in the control group (P = 0.12). GDT group received a significantly (P < 0.0001) lower amount of fluid (5812 ± 1244 ml) than the control group (8269 ± 1452 ml), with a significantly (P < 0.0001) lower volume of crystalloids (3884 ± 1003 vs. 68,528 ± 1413 ml). In CRS and HIPEC, the use of a GDT improves outcome in terms of incidence of major abdominal and systemic postoperative complications and length of hospital stay, compared to standard fluid therapy protocol.

Unannounced versus announced hospital surveys: a nationwide cluster-randomized controlled trial.

PubMed

Ehlers, Lars Holger; Simonsen, Katherina Beltoft; Jensen, Morten Berg; Rasmussen, Gitte Sand; Olesen, Anne Vingaard

2017-06-01

To evaluate the effectiveness of unannounced versus announced surveys in detecting non-compliance with accreditation standards in public hospitals. A nationwide cluster-randomized controlled trial. All public hospitals in Denmark were invited. Twenty-three hospitals (77%) (3 university hospitals, 5 psychiatric hospitals and 15 general hospitals) agreed to participate. Twelve hospitals were randomized to receive unannounced surveys (intervention group) and eleven hospitals to receive announced surveys (control group). We hypothesized that the hospitals receiving the unannounced surveys would reveal a higher degree of non-compliance with accreditation standards than the hospitals receiving announced surveys. Nine surveyors trained and employed by the Danish Institute for Quality and Accreditation in Healthcare (IKAS) were randomized into teams and conducted all surveys. The outcome was the surveyors' assessment of the hospitals' level of compliance with 113 performance indicators-an abbreviated set of the Danish Healthcare Quality Programme (DDKM) version 2, covering organizational standards, patient pathway standards and patient safety standards. Compliance with performance indicators was analyzed using binomial regression analysis with bootstrapped robust standard errors. In all, 16 202 measurements were acceptable for data analysis. The risk of observing non-compliance with performance indicators for the intervention group compared with the control group was statistically insignificant (risk difference (RD) = -0.6 percentage points [-2.51-1.31], P = 0.54). A converged analysis of the six patient safety critical standards, requiring 100% compliance to gain accreditation status revealed no statistically significant difference (RD = -0.78 percentage points [-4.01-2.44], P = 0.99). Unannounced hospital surveys were not more effective than announced surveys in detecting quality problems in Danish hospitals. ClinicalTrials.gov NCT02348567, https://clinicaltrials.gov/ct2/show/NCT02348567?term=NCT02348567. © The Author 2017. Published by Oxford University Press in association with the International Society for Quality in Health Care.

MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis.

PubMed

Kasivisvanathan, Veeru; Rannikko, Antti S; Borghi, Marcelo; Panebianco, Valeria; Mynderse, Lance A; Vaarala, Markku H; Briganti, Alberto; Budäus, Lars; Hellawell, Giles; Hindley, Richard G; Roobol, Monique J; Eggener, Scott; Ghei, Maneesh; Villers, Arnauld; Bladou, Franck; Villeirs, Geert M; Virdi, Jaspal; Boxler, Silvan; Robert, Grégoire; Singh, Paras B; Venderink, Wulphert; Hadaschik, Boris A; Ruffion, Alain; Hu, Jim C; Margolis, Daniel; Crouzet, Sébastien; Klotz, Laurence; Taneja, Samir S; Pinto, Peter; Gill, Inderbir; Allen, Clare; Giganti, Francesco; Freeman, Alex; Morris, Stephen; Punwani, Shonit; Williams, Norman R; Brew-Graves, Chris; Deeks, Jonathan; Takwoingi, Yemisi; Emberton, Mark; Moore, Caroline M

2018-05-10

Multiparametric magnetic resonance imaging (MRI), with or without targeted biopsy, is an alternative to standard transrectal ultrasonography-guided biopsy for prostate-cancer detection in men with a raised prostate-specific antigen level who have not undergone biopsy. However, comparative evidence is limited. In a multicenter, randomized, noninferiority trial, we assigned men with a clinical suspicion of prostate cancer who had not undergone biopsy previously to undergo MRI, with or without targeted biopsy, or standard transrectal ultrasonography-guided biopsy. Men in the MRI-targeted biopsy group underwent a targeted biopsy (without standard biopsy cores) if the MRI was suggestive of prostate cancer; men whose MRI results were not suggestive of prostate cancer were not offered biopsy. Standard biopsy was a 10-to-12-core, transrectal ultrasonography-guided biopsy. The primary outcome was the proportion of men who received a diagnosis of clinically significant cancer. Secondary outcomes included the proportion of men who received a diagnosis of clinically insignificant cancer. A total of 500 men underwent randomization. In the MRI-targeted biopsy group, 71 of 252 men (28%) had MRI results that were not suggestive of prostate cancer, so they did not undergo biopsy. Clinically significant cancer was detected in 95 men (38%) in the MRI-targeted biopsy group, as compared with 64 of 248 (26%) in the standard-biopsy group (adjusted difference, 12 percentage points; 95% confidence interval [CI], 4 to 20; P=0.005). MRI, with or without targeted biopsy, was noninferior to standard biopsy, and the 95% confidence interval indicated the superiority of this strategy over standard biopsy. Fewer men in the MRI-targeted biopsy group than in the standard-biopsy group received a diagnosis of clinically insignificant cancer (adjusted difference, -13 percentage points; 95% CI, -19 to -7; P<0.001). The use of risk assessment with MRI before biopsy and MRI-targeted biopsy was superior to standard transrectal ultrasonography-guided biopsy in men at clinical risk for prostate cancer who had not undergone biopsy previously. (Funded by the National Institute for Health Research and the European Association of Urology Research Foundation; PRECISION ClinicalTrials.gov number, NCT02380027 .).

Older Latinos' Attitudes toward and Comfort with End-of-Life Planning

ERIC Educational Resources Information Center

Heyman, Janna C.; Gutheil, Irene A.

2010-01-01

The purpose of this study was to determine which of two educational interventions delivered in Spanish would influence Latino elders' attitudes toward and comfort with end-of-life planning in comparison with a control group receiving only standard information routinely provided. Using a posttest-only control group design, elders receiving home…

Methodological considerations on descriptive studies of induced periodontal diseases in rats.

PubMed

Galvão, Mariane Ponzio; Chapper, Ana; Rösing, Cassiano Kuchenbecker; Ferreira, Maria Beatriz; de Souza, Maria Antonieta

2003-01-01

The aim of this study was to show the technique and the methodological approach used in describing histological characteristics of induced periodontal disease in rats. To reach that inflammatory process, periodontal disease was induced by ligature, with or without sucrose-rich diet. Twenty-four female adult (60 days old) Wistar rats were divided in four groups: Group 1, or control (which received standard diet), Group 2 (which received ligature around the upper second molars and a standard diet), Group 3 (which received a sucrose-rich diet), and Group 4 (which received ligature around the upper second molars and a sucrose-rich diet). The animals were followed for a period of 30 days, after which they were sacrificed. The upper second molars were removed, processed, and the histological characteristics were analyzed by a descriptive dichotomous method. The results were analyzed by the Fisher's exact test (significance level of 95%) and by a residual test, which showed the relation between groups and histological characteristics. The animals which received ligature (Groups 2 and 4) showed histological characteristics related with periodontitis, whilst the animals without ligatures showed no periodontal destruction. This was shown by a distribution of these groups in extremes of a graphic representation. The use of a ligature, as done in this study, was able to promote a chronic inflammatory process in the periodontium of rats, regardless of the adopted diet. The correspondence factorial analysis was capable of showing these characteristics, being one more tool to be used in histological research.

The efficacy of low dose azathioprine/6-mercaptopurine in patients with inflammatory bowel disease.

PubMed

Kim, Dong Uk; Kim, Young-Ho; Kim, Beom Jin; Chang, Dong Kyung; Son, Hee Jung; Rhee, Poong-Lyul; Kim, Jae J; Rhee, Jong Chul

2009-01-01

Azathioprine (AZA) and 6-mercaptopurine (6-MP) have been widely used in patients with ulcerative colitis (UC) and Crohn's disease (CD). However, some patients cannot tolerate standard doses (2-2.5 mg/kg for AZA or 1-1.5 mg/kg for 6-MP) due to side effects such as leukopenialneutropenia. The aim of this study was to evaluate the efficacy of low dose AZA/6-MP compared to the standard dose. From 1995 to 2005, 122 patients with UC or CD treated with AZA/6-MP at Samsung Medical Center in Korea were enrolled. We divided these patients into 2 groups (standard dose group versus low dose group) according to the maintenance dose. Among the 122 patients, 17 received the standard dose and 105 received a low dose. The mean maintenance doses were 2.25 mg/kg for the standard dose group and 1.35mg/kg for the low dose group. The clinical outcomes of remission induction, maintenance of remission and relapse rate showed no significant difference in comparisons between these two groups. Low dose AZA/6-MP was as effective as the standard dose for remission induction and maintenance of remission in patients with UC and CD. For patients that develop leukopenia/neutropenia during dose escalation, maintenance therapy with low dose AZA/6-MP should be considered.

The Effect of Upper Limb Massage on Infants' Venipuncture Pain.

PubMed

Chik, Yuen-Man; Ip, Wan-Yim; Choi, Kai-Chow

2017-02-01

The purpose of the study was to investigate the effect of upper limb massage on relieving pain among infants undergoing venipuncture in Hong Kong. This study was a crossover, double-blind, randomized controlled trial. Eighty infants at the neonatal intensive care unit were randomly assigned to 2 groups in different order to receive interventions. The massage first group (N = 40) received 2-minute massage before venipuncture on the first occasion then received usual care (control) on the second occasion, and vice versa in the massage second group (N = 40). The infants' behavior and physiological responses were recorded on two occasions: (1) right after the intervention and (2) during the first 30 seconds of venipuncture procedure. The mean pain scores (Premature Infant Pain Profile) were significantly lower in infants who received massage (massage first: 6.0 [standard deviation = 3.3]; massage second: 7.30 [standard deviation = 4.4]) versus control (massage first: 12.0 [standard deviation = 4.3]; massage second: 12.7 [standard deviation = 3.1]). The crude and adjusted generalized estimating equations model showed that the infants had significantly lower pain score when receiving massage as compared to receiving the control treatment, and there were no significant time and carryover effects: -6.03 (95% confidence interval: -7.67 to -4.38), p < .001 and -5.96 (95% confidence interval: -7.56 to -4.36), p < .001, respectively. Upper limb massage may be effective in decreasing infants' venipuncture pain perception. Copyright © 2016 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

tDCS combined with optokinetic drift reduces egocentric neglect in severely impaired post-acute patients.

PubMed

Turgut, Nergiz; Miranda, Marcela; Kastrup, Andreas; Eling, Paul; Hildebrandt, Helmut

2018-06-01

Visuospatial neglect is a disabling syndrome resulting in impaired activities of daily living and in longer durations of inpatient rehabilitation. Effective interventions to remediate neglect are still needed. The combination of tDCS and an optokinetic task might qualify as a treatment method. A total of 32 post-acute patients with left (n = 20) or right-sided neglect were allotted to an intervention or a control group (both groups n = 16). The intervention group received eight sessions of 1.5-2.0 mA parietal transcranial direct current stimulation (tDCS) during the performance of an optokinetic task distributed over two weeks. Additionally they received standard therapy for five hours per day. The control group received only the standard therapy. Patients were examined twice before (with 3-4 days between examinations) and twice after treatment (5-6 days between examinations). Compared to the control group and controlling for spontaneous remission, the intervention group improved on spontaneous body orientation and the Clock Drawing Test. Intragroup comparisons showed broad improvements on egocentric but not on allocentric symptoms only for the intervention group. A short additional application of tDCS during an optokinetic task led to improvements of severe neglect compared to a standard neurological early rehabilitation treatment. Improvements seem to concern primarily egocentric rather than allocentric neglect.

[Subcostal transversus abdominis plane block can improve analgesia after laparoscopic cholecystectomy].

PubMed

Vrsajkov, Vladimir; Mančić, Nedjica; Mihajlović, Dunja; Milićević, Suzana Tonković; Uvelin, Arsen; Vrsajkov, Jelena Pantić

After laparoscopic cholecystectomy, patients have moderate pain in the early postoperative period. Some studies shown beneficial effects of subcostal transversus abdominis plane block on reducing this pain. Our goal was to investigate influence of subcostal transversus abdominis plane block on postoperative pain scores and opioid consumption. We have randomized 76 patients undergoing laparoscopic cholecystectomy to receive either subcostal transversus abdominis plane block (n=38) or standard postoperative analgesia (n=38). First group received bilateral ultrasound guided subcostal transversus abdominis plane block with 20mL of 0.33% bupivacaine per side before operation and tramadol 1mg.kg -1 IV for pain breakthrough (≥6). Second group received after operation tramadol 1mg.kg -1 /6h as standard hospital analgesia protocol. Both groups received acetaminophen 1g/8h IV and metamizole 2.5g/12h. Pain at rest was recorded for each patient using NR scale (0-10) in period of 10min, 30min, 2h, 4h, 8h, 12h and 16h after the surgery. We obtained no difference between groups according age, weight, intraoperative fentanyl consumption and duration of surgery. Subcostal transversus abdominis plane block significantly reduced postoperative pain scores compared to standard analgesia in all periods after surgery. Tramadol consumption was significantly lower in the subcostal transversus abdominis plane (24.29±47.54g) than in the standard analgesia group (270.2±81.9g) (p=0.000). Our results show that subcostal transversus abdominis plane block can provide superior postoperative analgesia and reduction in opioid requirements after laparoscopic cholecystectomy. Copyright © 2017 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

[Psychotherapy of patients with personality disorders with predominance of hypochondria].

PubMed

Burno, M E; Igovskaia, A S

2008-01-01

A standard of psychotherapeutic help to patients with hypochondriac disorder developed in paranoid, schizoid, anxiety and dependent personality disorders is worked out. In this case, hypochondria is inseparable from the personality structure. Patients of investigated group (61 people) received traditional medical treatment, individual differential symptomatic psychotherapy and a short group course with a variant of the therapy by means of creative sell-expression (TCSEB) worked out by M. Burno. This course aimed at preventing new hypochondriac symptoms and acquiring spiritual creative ways to overcome themselves. The control group (70 people) differed from the index-group by not receiving CSEB. A statistical analysis revealed a significant therapeutic efficacy of the mentioned new clinical psychotherapeutic standard compared to the psychotherapeutic tactics without TCSEB.

A randomized phase II trial of personalized peptide vaccine plus low dose estramustine phosphate (EMP) versus standard dose EMP in patients with castration resistant prostate cancer.

PubMed

Noguchi, Masanori; Kakuma, Tatsuyuki; Uemura, Hirotsugu; Nasu, Yasutomo; Kumon, Hiromi; Hirao, Yasuhiko; Moriya, Fukuko; Suekane, Shigetaka; Matsuoka, Kei; Komatsu, Nobukazu; Shichijo, Shigeki; Yamada, Akira; Itoh, Kyogo

2010-07-01

Personalized peptide vaccination (PPV) combined with chemotherapy could be a novel approach for many cancer patients. In this randomized study, we evaluated the anti-tumor effect and safety of PPV plus low-dose estramustine phosphate (EMP) as compared to standard-dose EMP for HLA-A2- or -A24-positive patients with castration resistant prostate cancer. Patients were randomized into groups receiving either PPV plus low-dose EMP (280 mg/day) or standard-dose EMP (560 mg/day). After disease progression, patients were switched to the opposite regime. The primary end point was progression-free survival (PFS). We randomly assigned 28 patients to receive PPV plus low-dose EMP and 29 patients to receive standard-dose EMP. Nineteen events in the PPV group and 20 events in the EMP group occurred during the first treatment. Median PFS for the first treatment was 8.5 months in the PPV group and 2.8 months in the EMP group with a hazard ratio (HR) of 0.28 (95% CI, 0.14-0.61; log-rank P = 0.0012), while there was no difference for median PFS for the second treatment. The HR for overall survival was 0.3 (95% CI, 0.1-0.91) in favor of the PPV plus low-dose EMP group (log-rank, P = 0.0328). The PPV plus low-dose EMP was well tolerated without major adverse effects and with increased levels of IgG and cytotoxic-T cell responses to the vaccinated peptides. PPV plus low-dose EMP was associated with an improvement in PSA-based PFS as compared to the standard-dose EMP alone.

Clinical Trials in Vision Research

MedlinePlus

... the treatment group . If you are in the control group , you could receive the standard treatment for a ... Researchers randomly assign participants to the treatment and control groups. In most studies, you have an equal chance ...

Effect of Intensive Blood-Pressure Treatment on Patient-Reported Outcomes.

PubMed

Berlowitz, Dan R; Foy, Capri G; Kazis, Lewis E; Bolin, Linda P; Conroy, Molly B; Fitzpatrick, Peter; Gure, Tanya R; Kimmel, Paul L; Kirchner, Kent; Morisky, Donald E; Newman, Jill; Olney, Christine; Oparil, Suzanne; Pajewski, Nicholas M; Powell, James; Ramsey, Thomas; Simmons, Debra L; Snyder, Joni; Supiano, Mark A; Weiner, Daniel E; Whittle, Jeff

2017-08-24

The previously published results of the Systolic Blood Pressure Intervention Trial showed that among participants with hypertension and an increased cardiovascular risk, but without diabetes, the rates of cardiovascular events were lower among those who were assigned to a target systolic blood pressure of less than 120 mm Hg (intensive treatment) than among those who were assigned to a target of less than 140 mm Hg (standard treatment). Whether such intensive treatment affected patient-reported outcomes was uncertain; those results from the trial are reported here. We randomly assigned 9361 participants with hypertension to a systolic blood-pressure target of less than 120 mm Hg or a target of less than 140 mm Hg. Patient-reported outcome measures included the scores on the Physical Component Summary (PCS) and Mental Component Summary (MCS) of the Veterans RAND 12-Item Health Survey, the Patient Health Questionnaire 9-item depression scale (PHQ-9), patient-reported satisfaction with their blood-pressure care and blood-pressure medications, and adherence to blood-pressure medications. We compared the scores in the intensive-treatment group with those in the standard-treatment group among all participants and among participants stratified according to physical and cognitive function. Participants who received intensive treatment received an average of one additional antihypertensive medication, and the systolic blood pressure was 14.8 mm Hg (95% confidence interval, 14.3 to 15.4) lower in the group that received intensive treatment than in the group that received standard treatment. Mean PCS, MCS, and PHQ-9 scores were relatively stable over a median of 3 years of follow-up, with no significant differences between the two treatment groups. No significant differences between the treatment groups were noted when participants were stratified according to baseline measures of physical or cognitive function. Satisfaction with blood-pressure care was high in both treatment groups, and we found no significant difference in adherence to blood-pressure medications. Patient-reported outcomes among participants who received intensive treatment, which targeted a systolic blood pressure of less than 120 mm Hg, were similar to those among participants who received standard treatment, including among participants with decreased physical or cognitive function. (Funded by the National Institutes of Health; SPRINT ClinicalTrials.gov number, NCT01206062 .).

Hypercalcemia and hypophosphatemia among preterm infants receiving aggressive parenteral nutrition.

PubMed

Brener Dik, Pablo H; Galletti, María F; Bacigalupo, Leticia T; Fernández Jonusas, Silvia; L Mariani, Gonzalo

2018-06-01

Aggressive parenteral nutrition is the standard of care among very-low-birth weight preterm infants. However, in recent studies, its impact on short-term outcomes, has been evaluated. The objective was to compare the prevalence of hypercalcemia and hypophosphatemia among preterm infants receiving aggressive or standard parenteral nutrition. Observational, retrospective study comparing a group of preterm infants weighing less than 1250 grams who received aggressive parenteral nutrition with a historical control group. The prevalence of hypercalcemia was estimated and its association with aggressive parenteral nutrition was searched adjusting by confounders. The mean phosphate level was estimated for the control group by linear regression and was compared to the value in the other group. Forty patients per group were included. The prevalence of hypercalcemia was higher in the group who received aggressive parenteral nutrition (87.5% versus 35%, p= 0.001). Aggressive parenteral nutrition was associated with hypercalcemia when adjusting by birth weight, intrauterine growth restriction, amino acid, and calorie intake (adjusted odds ratio: 21.8, 95% confidence interval [CI]: 3.7-128). The mean calcium level was different between both groups (p= 0.002). Infants who received aggressive parenteral nutrition had more sepsis without reaching statistical significance and the mean phosphate level was lower than that estimated for the control group (p= 0.04). The prevalence of hypophosphatemia in this group was 90% (95% CI: 76-97%). Our data show an association between hypercalcemia/hypophosphatemia and aggressive parenteral nutrition. It is recommended to frequently monitor calcium and phosphate levels since they might be associated with adverse clinical outcomes. Sociedad Argentina de Pediatría.

Burn wound healing property of Cocos nucifera: An appraisal

PubMed Central

Srivastava, Pallavi; Durgaprasad, S.

2008-01-01

Objectives: The study was undertaken to evaluate the burn wound healing property of oil of Cocos nucifera and to compare the effect of the combination of oil of Cocos nucifera and silver sulphadiazine with silver sulphadiazine alone. Materials and Methods: Partial thickness burn wounds were inflicted upon four groups of six rats each. Group I was assigned as control, Group II received the standard silver sulphadiazine. Group III was given pure oil of Cocos nucifera , and Group IV received the combination of the oil and the standard. The parameters observed were epithelialization period and percentage of wound contraction. Results: It was noted that there was significant improvement in burn wound contraction in the group treated with the combination of Cocos nucifera and silver sulphadiazine. The period of epithelialization also decreased significantly in groups III and IV. Conclusion: It is concluded that oil of Cocos nucifera is an effective burn wound healing agent. PMID:20040946

Expected outcomes from topical haemoglobin spray in non-healing and worsening venous leg ulcers.

PubMed

Arenberger, P; Elg, F; Petyt, J; Cutting, K

2015-05-01

To evaluate the effect of topical haemoglobin spray on treatment response and wound-closure rates in patients with chronic venous leg ulcers. A linear regression model was used to forecast healing outcomes over a 12-month period. Simulated data were taken from normal distributions based on post-hoc analysis of a 72-patient study in non-healing and worsening wounds (36 patients receiving standard care and 36 receiving standard care plus topical haemoglobin spray). Using a simulated 25,000 'patients' from each group, the proportion of wound closure over time was projected. Simulation results predicted a 55% wound closure rate at six months in the haemoglobin group, compared with 4% in the standard care group. Over a 12-month simulation period, a 43% overall reduction in wound burden was predicted. With the haemoglobin spray, 85% of wounds were expected to heal in 12 months, compared with 13% in the standard care group. Topical haemoglobin spray promises a more effective treatment for chronic venous leg ulcers than standard care alone in wounds that are non-healing or worsening. Further research is required to validate these predictions and to identify achievable outcomes in other chronic wound types.

Increasing chlamydia test of re-infection rates using SMS reminders and incentives.

PubMed

Downing, Sandra Gaye; Cashman, Colette; McNamee, Heather; Penney, Debbie; Russell, Darren B; Hellard, Margaret E

2013-02-01

Clients diagnosed and treated for Chlamydia trachomatis are a recognised high-risk group for subsequent infection. An estimated 8% of clients treated for chlamydia at Cairns Sexual Health Service return for re-testing within the recommended 3-4-month period. There is no recall or reminder system in place. This study assesses the effectiveness of using short messaging service (SMS) reminders with and without incentive payments to increase re-testing rates. Eligible consenting clients were randomly allocated to one of three groups. Group 1 (controls) received the standard advice from the clinician to return for re-testing in 3-4 months. Group 2 received the standard advice and an SMS reminder at 10-12 weeks post-treatment. Group 3 received the standard advice and the SMS reminder, which also offered an incentive payment on clinic attendance. 32 participants were recruited to groups 1 and 2 and 30 participants to group 3. 62 SMS reminders were sent with 13 (21.0%) reported as undelivered. Re-testing rates were 6.3%, 28.1% and 26.7% for groups 1, 2 and 3, respectively. SMS reminders with or without an incentive payment increased re-testing rates in our clients who were diagnosed and treated for chlamydia. However, re-testing remained less than ideal, and the high rate of undelivered SMS reminders suggest that this intervention alone will not achieve desired re-testing rates and that a range of strategies will be required to increase re-testing in this population.

Evaluation of medical record quality and communication skills among pediatric interns after standardized parent training history-taking in China.

PubMed

Yu, Mu Xue; Jiang, Xiao Yun; Li, Yi Juan; Shen, Zhen Yu; Zhuang, Si Qi; Gu, Yu Fen

2018-02-01

The effect of using standardized parent training history-taking on the quality of medical records and communication skills among pediatric interns was determined. Fifth-year interns who were undertaking a pediatric clinical practice rotation were randomized to intervention and control groups. All of the pediatric interns received history-taking training by lecture and bedside teaching. The pediatric interns in the intervention group also received standardized parent history-taking training. The following two outcome measures were used: the scores of medical records, which were written by the pediatric interns after history-taking from real parents of pediatric patients; and the communication assessment tool (CAT) assessed by real parents. The general information, history of present illness (HPI), past medical history, personal history, family history, diagnosis, diagnostic analysis, and differential diagnosis scores in the intervention group were significantly higher than the control group (p < 0.05). Assessment of the CAT indicated that the real parents were more satisfied with the pediatric interns in the intervention group. Standardized parent training history-taking is effective in improving the quality of medical records by pediatric interns. Standardized parent training history-taking is a superior teaching tool for clinical reasoning ability, as well as communication skills in clinical pediatric practice.

Cognitive Training and Transcranial Direct Current Stimulation for Mild Cognitive Impairment in Parkinson's Disease: A Randomized Controlled Trial

PubMed Central

Gasson, Natalie; Johnson, Andrew R.; Booth, Leon; Loftus, Andrea M.

2018-01-01

This study examined whether standard cognitive training, tailored cognitive training, transcranial direct current stimulation (tDCS), standard cognitive training + tDCS, or tailored cognitive training + tDCS improved cognitive function and functional outcomes in participants with PD and mild cognitive impairment (PD-MCI). Forty-two participants with PD-MCI were randomized to one of six groups: (1) standard cognitive training, (2) tailored cognitive training, (3) tDCS, (4) standard cognitive training + tDCS, (5) tailored cognitive training + tDCS, or (6) a control group. Interventions lasted 4 weeks, with cognitive and functional outcomes measured at baseline, post-intervention, and follow-up. The trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR: 12614001039673). While controlling for moderator variables, Generalized Linear Mixed Models (GLMMs) showed that when compared to the control group, the intervention groups demonstrated variable statistically significant improvements across executive function, attention/working memory, memory, language, activities of daily living (ADL), and quality of life (QOL; Hedge's g range = 0.01 to 1.75). More outcomes improved for the groups that received standard or tailored cognitive training combined with tDCS. Participants with PD-MCI receiving cognitive training (standard or tailored) or tDCS demonstrated significant improvements on cognitive and functional outcomes, and combining these interventions provided greater therapeutic effects. PMID:29780572

A pilot randomized, controlled trial of the effectiveness of a psychoeducational intervention on family caregivers of patients with advanced cancer.

PubMed

Leow, Mabel; Chan, Sally; Chan, Moon

2015-03-01

To evaluate the effectiveness of a psychoeducational intervention, the Caring for the Caregiver Programme (CCP).
 A pilot randomized, controlled trial, two-group pretest, and repeated post-tests.
 Four home hospice organizations and an outpatient clinic in Singapore.
 80 caregivers were randomized into experimental and standard care groups.
 Outcomes were measured at baseline, week 4, and week 8 after the intervention. The standard care group received routine home hospice care, and the intervention group received the CCP in addition to routine care.
 Quality of life (QOL), social support, stress and depression, self-efficacy in self-care, closeness with the patient, rewards, and knowledge.
 Compared to the standard care group, the intervention group reported significantly higher QOL, social support satisfaction and number of supported people, closeness with the patient, self-efficacy in self-care, rewards of caregiving, and knowledge, and lower stress and depression. 
 The CCP had positive effects on family caregivers of patients with advanced cancer. 
 A psychoeducational intervention potentially could help caregivers cope with the demands of caregiving. 


Outcome evaluation of clarithromycin, metronidazole and lansoprazole regimens in Helicobacter pylori positive or negative children with resistant otitis media with effusion.

PubMed

Mel-Hennawi, D; Ahmed, M R

2015-11-01

To compare the efficacy of two treatment regimens among Helicobacter pylori stool antigen positive children suffering from resistant otitis media with effusion. The study comprised 258 children with bilateral otitis media with effusion; 134 were positive for H pylori stool antigen, and were equally and randomly allocated to the control group or study group. The control group received standard otitis media with effusion therapy (amoxicillin and clavulanate), while the study group received standard H pylori triple therapy (clarithromycin, metronidazole and lansoprazole). In the control group, there was a marked clinical response to treatment in 33 of the 67 children (49.3 per cent). In the study group, there was a marked response in a significantly higher number of children (46 out of 67, 68.7 per cent). The 124 H pylori stool antigen negative children not included in the 2 aforementioned groups received amoxicillin and clavulanate, and a marked response in symptoms was evident in 98 of these children (79 per cent). H pylori infection may lead to resistance to traditional otitis media with effusion treatment in some cases. H pylori eradication is associated with a high cure rate.

Efficacy of Parenting Education Compared to the Standard Method in Improvement of Reading and Writing Disabilities in Children

PubMed Central

Karahmadi, Mojgan; Shakibayee, Fereshteh; Amirian, Hushang; Bagherian-Sararoudi, Reza; Maracy, Mohammad Reza

2014-01-01

Objective: The present study aimed to evaluate the effect of parenting education on improvement of reading and writing disabilities in children. Methods: A randomized controlled trial was done on primary school students with reading and writing disabilities and their mothers. The subjects were divided into three groups with 26 members in each group. The first group (mothers’ education group) received 6 one-hour new educational sessions. The second group (standard group) received 12-15 standard educational sessions for learning disability, and the third group (control group) which consisted of students with learning disability did not receive any treatments. Research instruments included reading and writing tests, and demographic questionnaire. The three groups were evaluated via pretest and posttests at baseline and after one and three months of educational interventions. Data were analyzed using the chi-square, t-test, and repeated measures multivariate analysis of variance (MANOVA). Results: The mean reading speed had the most progression in the mothers' education group. Comparison among reading speed, reading accuracy, and spelling scores has been statistically significant (F 2, 6 = 90.64;p < 0.001) but the mean of these scores has been insignificant among the three groups (F 2, 67 = 0.583;p > 0.05). The mean reading accuracy, mostly increased after 3-month interventions in the mothers group. The control group had the lowest mean reading accuracy scores. Conclusion: Parenting education in mothers had a positive effect on the treatment of children with reading and writing disabilities. Declaration of interest: None. Clinical Trial Registration-URL: http://www.irct.ir. Unique identifier: IRCT201101205653N1. PMID:24995030

Double-blind, placebo-controlled immunotherapy with mixed grass-pollen allergoids. I. Rush immunotherapy with allergoids and standardized orchard grass-pollen extract.

PubMed

Bousquet, J; Hejjaoui, A; Skassa-Brociek, W; Guérin, B; Maasch, H J; Dhivert, H; Michel, F B

1987-10-01

Forty-five grass pollen-allergic patients were randomly assigned to three groups according to their skin test and RAST sensitivities and the severity of seasonal rhinitis. Eleven patients were treated with placebo (group 1), 19 patients (group 2) were treated with a six-mixed grass-pollen allergoid prepared by mild formalinization with a two-step procedure, and 15 other patients were treated with a standardized orchard grass-pollen extract (group 3). Because of a different immunotherapy schedule, only patients placed in groups 1 and 2 received the extracts in a double-blind fashion. Rush immunotherapy was performed in 3 to 6 days, and the maintenance dose was subsequently administered weekly for 4 weeks and every 2 weeks until the end of the grass-pollen season. During the season, a coseasonal treatment was administered. Systemic reactions occurred during the rush protocol in 36.8% of patients treated with allergoid and 20% of patients who received the standardized extract. Only patients treated with allergoid had systemic reactions during maintenance dose. The reactions observed with the standardized extract were more severe. Total doses of allergoid ranged from 2350 to 13,500 protein nitrogen units. Symptoms and medication scores during the peak of the season were analyzed. Patients treated with the standardized allergen had a significant reduction of the number of days of symptoms during the month of June (9.5 +/- 6.7 days; p less than 0.005) and of medication scores (1.3 +/- 1.4; p less than 0.01) compared to patients receiving placebo (19.4 +/- 8.1 days; medication score, 2.8 +/- 2.1).(ABSTRACT TRUNCATED AT 250 WORDS)

Is the American Society of Shoulder and Elbow Therapists' rehabilitation guideline better than standard care when applied to Bankart-operated patients? A controlled study.

PubMed

Damkjær, Lars; Petersen, Tom; Juul-Kristensen, Birgit

2015-02-01

To determine whether there is a difference in shoulder-related physical function and quality of life between postoperative rehabilitation patients receiving standard care and those receiving care according to the American Society of Shoulder and Elbow Therapists' rehabilitation guideline for arthroscopic anterior capsulolabral repair of the shoulder. Descriptive studies with comparison between a retrospective and a prospective cohort. Municipal outpatient rehabilitation centre. A total of 96 arthroscopic Bankart-operated patients. A total of 52 patients received standard care; 44 patients underwent rehabilitation according to the American Society of Shoulder and Elbow Therapists' rehabilitation guideline. Primary outcome variable was Western Ontario Shoulder Instability Index. Secondary outcome measures were Patient-Specific Functional Scale, shoulder range of motion, return to work, return to sports, and costs. There was no significant difference in adjusted mean change scores between the standard care group and the guideline group in the primary outcome variable (Western Ontario Shoulder Instability Index total = 574.85 vs. 644.48) or the secondary outcomes (Patient-Specific Functional Scale = 4.6 vs. 5.0; range of motion in forward flexion = 46.49° vs. 49.58°; external rotation in adduction = 28.58° vs. 34.18°; external rotation in abduction = 51.29° vs. 47.55°; weeks until return to work = 5.2 vs. 6.9; weeks until return to sports =13.9 vs. 13.1; costs = number of visits; 18.5 vs. 15.9). There were no significant between-group differences in shoulder-related physical function and quality of life between the standard care group and the guideline group, following Bankart operations. © The Author(s) 2014.

The Effect of Physiotherapy on Ventilatory Dependency and the Length of Stay in an Intensive Care Unit

ERIC Educational Resources Information Center

Malkoc, Mehtap; Karadibak, Didem; Yldrm, Yucel

2009-01-01

The aim of this study was to assess the effect of physiotherapy on ventilator dependency and lengths of intensive care unit (ICU) stay. Patients were divided into two groups. The control group, which received standard nursing care, was a retrospective chart review. The data of control patients who were not receiving physiotherapy were obtained…

WOUND HEALING ACTIVITY OF EXTRACT FROM THYMUS DAENENSIS IN BURN WOUND MODEL: AN EXPERIMENTAL ANIMAL STUDY.

PubMed

Babaeizadeh, Simin; Heydarnejhad, Saeed; Pirbalouti, Abdollah Ghasemi; Khamesipoor, Faham; Moghtadaei-Khorasgani, Elham; Heydari-Soureshjani, Parisa

2016-11-01

Bum wound is one of the most common complications and remains a major public health issue affecting all ages groups in both developed and developing countries. This study was aimed to evaluate the extract from Thymus daenensis and silver sulfadiazine on healing bum wounds in mice. In this experimental study, the ethanol extract from the aerial parts of T. daenensis (Lamiaceae) was used. Second-degree bum wounds were induced in three groups of eight Balb/C mice each. Group-I: the animals were treated with simple cream (control), Group-II: the animals were treated with simple cream containing the herb extract, and Group-III: the animals received the standard drug (silver sulfadiazine). The experimental groups were evaluated based on wound area, epithelialization time and histopathological characteristics. There were significant differences in surface area and the period of bum wound healing between the groups, particularly among Group-II when the animals received the extract of T. daenensis in comparison with control. At the 18" day, there was no significant improvement in healing percentage of the herb treated (94.6%) in comparison to the animals receiving the standard drug (95.8%). The best results of histopathological investigation were obtained with the extract of T. daenensis, when compared to the other group as well as to the control and standard drug. The herbal cream experimentally and histopathologically revealed a bum wound healing activity probably due to the antioxidant and anti-inflammatory activity of its phytochemical contents, especially phenolic compounds. Therefore, T. daenensis accelerated wound healing in mice and thus supports its traditional use.

Integrating GIS in the Middle School Curriculum: Impacts on Diverse Students' Standardized Test Scores

ERIC Educational Resources Information Center

Goldstein, Donna; Alibrandi, Marsha

2013-01-01

This case study conducted with 1,425 middle school students in Palm Beach County, Florida, included a treatment group receiving GIS instruction (256) and a control group without GIS instruction (1,169). Quantitative analyses on standardized test scores indicated that inclusion of GIS in middle school curriculum had a significant effect on student…

Nutritional supplementation in HIV-infected individuals in South India: a prospective interventional study.

PubMed

Swaminathan, S; Padmapriyadarsini, C; Yoojin, L; Sukumar, B; Iliayas, S; Karthipriya, J; Sakthivel, R; Gomathy, P; Thomas, B E; Mathew, M; Wanke, C A; Narayanan, P R

2010-07-01

Malnutrition in human immunodeficiency virus (HIV)-infected individuals is associated with faster disease progression, higher mortality rates, and suboptimal response to antiretroviral therapy (ART). We conducted a prospective interventional study to evaluate the effects of an oral macronutrient supplement among HIV-infected adults in South India. Patients attending Tuberculosis Research Centre clinics from June 2005 through December 2007 had baseline nutritional assessment and laboratory investigations performed. Patients at 1 center received nutritional counseling and standard care, whereas patients at 2 centers additionally received a macronutrient providing 400 cal and 15 g of protein daily. Study outcomes were changes in anthropometry, body composition, blood chemistry, and immune status at 6 months. In total, 636 ART-naive patients were enrolled in the study; 361 completed 6 months of follow-up (282 received supplements and 79 received standard care). Mean age +/- standard deviation (SD) was 31 +/- 7 years, mean weight +/- SD was 50 +/- 10 kg, and 42% were male. Significant increases in body weight, body mass index, midarm circumference, fat-free mass, and body cell mass were observed in the supplement group but not in the control group at 6 months; gains were greater in patients with CD4 cell counts <200 cells/microL. No changes were observed in lipid levels, whereas the CD4 cell count decreased in the control group. However, after adjusting for baseline differences, these changes were not statistically significantly different between the groups. Macronutrient supplementation did not result in significantly increased weight gain compared with standard care (including nutritional counseling) among patients with moderately advanced HIV disease. The effect of supplementation on specific subsets of patients and on preserving immune function needs further research.

[Erectile dysfunction and obstructive sleep apnea syndrome].

PubMed

Zhuravlev, V N; Frank, M A; Gomzhin, A I

2008-01-01

Of 72 patients with obstructive sleep apnea syndrome (OSAS) 32 had erectile dysfunction (ED). OSAS patients with erectile dysfunction had hypogonadism in 24 cases, in 8 men testosterone level was normal. A polysomnographic investigation with monitoring of nocturnal spontaneous erections showed that 32 patients had severe sleep fragmentation with reduced or complete absence of REM and deep sleep phases. In nocturnal penile tumescencia quantitative and qualitative characteristics were abnormal suggesting organic nature of erectile dysfunction in these patients. Eight ED and OSAS patients with normal testosterone received standard OSAS therapy with administration of FDE-5 type inhibitors. Six months later improvement of the erectile function was observed in 6 patients. OSAS patients with hypogonadism were divided into 2 groups. Group 1 (n = 5) received CPAP therapy and group 2 (n = 19) received OSAS standard therapy. Group 2 was treated with inhibitors of FDE-5 type. Three months later improvement of erectile function was seen only in 8. Group 1 received the inhibitors and testosterone replacement. Three months later all 5 patients had no ED complaints, their testosterone was normal. It is recommended to perform monitoring of nocturnal spontaneous erections in the algorithm of examination of all men with OSAS. All patients with OSAS, ED and documented hypogonadism need testosterone replacement therapy if its level persists low despite adequate therapy of OSAS.

Quadruple therapy for eradication of Helicobacter pylori

PubMed Central

Ma, Hai-Jun; Wang, Jin-Liang

2013-01-01

AIM: To investigate quadruple therapy with rabeprazole, amoxicillin, levofloxacin and furazolidone for the eradication of Helicobacter pylori (H. pylori) infection. METHODS: A total of 147 patients were divided into the experimental treatment group (n = 78) and the standard triple treatment group (n = 69). The experimental treatment group received rabeprazole 20 mg, amoxicillin 1.0 g, levofloxacin 0.2 g and furazolidone 0.1 g, twice daily. The standard triple treatment group received omeprazole 20 mg, amoxicillin 1.0 g and clarithromycin 0.5 g, twice daily. RESULTS: One month after treatment, the 13C urea breath test was carried out to detect H. pylori. The eradication rate using per-protocol analysis was 94.3% in the experimental treatment group and 73% in the standard triple treatment group (P < 0.05), and using intention to test analysis, these figures were 86% and 67% in the two groups, respectively. Side effects were observed in 34 patients, and included mild dizziness, nausea, diarrhea and increased bowel movement. Eleven of the 34 patients needed no treatment for their side effects. CONCLUSION: Rabeprazole, amoxicillin, levofloxacin and furazolidone quadruple therapy is a safe method for the eradication of H. pylori with high efficacy and good tolerability. PMID:23429422

A controlled trial of an expert system and self-help manual intervention based on the stages of change versus standard self-help materials in smoking cessation.

PubMed

Aveyard, Paul; Griffin, Carl; Lawrence, Terry; Cheng, K K

2003-03-01

To examine the population impact and effectiveness of the Pro-Change smoking cessation course based on the Transtheoretical Model (TTM) compared to standard self-help smoking cessation literature. Randomized controlled trial. Sixty-five West Midlands general practices. Randomly sampled patients recorded as smokers by their general practitioners received an invitation letter and 2471 current smokers agreed. Responders were randomized to one of four interventions. The control group received standard self-help literature. In the Manual intervention group, participants received the Pro-Change system, a self-help workbook and three questionnaires at 3-monthly intervals, which generated individually tailored feedback. In the Phone intervention group, participants received the Manual intervention plus three telephone calls. In the Nurse intervention group, participants received the Manual intervention plus three visits to the practice nurse. Biochemically confirmed point prevalence of being quit and 6-month sustained abstinence, 12 months after study commencement. A total of 9.1% of registered current smokers participated, of whom 83.0% were not ready to quit. Less than half of participants returned questionnaires to generate second and third individualized feedback. Telephone calls reached 75% of those scheduled, but few participants visited the nurse. There were small differences between the three Pro-Change arms. The odds ratio (95% confidence intervals) for all Pro-Change arms combined versus the control arm were 1.50 (0.85-2.67) and 1.53 (0.76-3.10), for point prevalence and 6-month abstinence, respectively. This constitutes 2.1% of the TTM group versus 1.4% of the control group achieving confirmed 6-month sustained abstinence. There was no statistically significant benefit of the intervention apparent in this trial and the high relapse of quitters means that any population impact is small.

Individual music therapy for depression: randomised controlled trial.

PubMed

Erkkilä, Jaakko; Punkanen, Marko; Fachner, Jörg; Ala-Ruona, Esa; Pöntiö, Inga; Tervaniemi, Mari; Vanhala, Mauno; Gold, Christian

2011-08-01

Music therapy has previously been found to be effective in the treatment of depression but the studies have been methodologically insufficient and lacking in clarity about the clinical model employed. Aims To determine the efficacy of music therapy added to standard care compared with standard care only in the treatment of depression among working-age people. Participants (n = 79) with an ICD-10 diagnosis of depression were randomised to receive individual music therapy plus standard care (20 bi-weekly sessions) or standard care only, and followed up at baseline, at 3 months (after intervention) and at 6 months. Clinical measures included depression, anxiety, general functioning, quality of life and alexithymia. ISRCTN84185937. Participants receiving music therapy plus standard care showed greater improvement than those receiving standard care only in depression symptoms (mean difference 4.65, 95% CI 0.59 to 8.70), anxiety symptoms (1.82, 95% CI 0.09 to 3.55) and general functioning (-4.58, 95% CI -8.93 to -0.24) at 3-month follow-up. The response rate was significantly higher for the music therapy plus standard care group than for the standard care only group (odds ratio 2.96, 95% CI 1.01 to 9.02). Individual music therapy combined with standard care is effective for depression among working-age people with depression. The results of this study along with the previous research indicate that music therapy with its specific qualities is a valuable enhancement to established treatment practices.

The psychological effects of aromatherapy-massage in healthy postpartum mothers.

PubMed

Imura, Masumi; Misao, Hanako; Ushijima, Hiroshi

2006-01-01

This study examined the effect of aromatherapy-massage in healthy postpartum mothers. A quasi-experimental between-groups design was used. Mothers who received aromatherapy-massage were compared with a control group who received standard postpartum care. Thirty-six healthy, first-time mothers with vaginal delivery of a full-term, healthy infant participated in this study. Sixteen mothers received a 30-minute aromatherapy-massage on the second postpartum day; 20 mothers were in the control group. All mothers completed the following four standardized questionnaires before and after the intervention: 1) Maternity Blues Scale; 2) State-Trait Anxiety Inventory; 3) Profile of Mood States (POMS); and 4) Feeling toward Baby Scale. In the aromatherapy-massage group, posttreatment scores significantly decreased for the Maternity Blues Scale, the State-Anxiety Inventory, and all but one of the Profile of Mood States subscales. Posttreatment scores in the intervention group significantly increased in Profile of Mood States-Vigor subscale and the Approach Feeling toward Baby subscale. Scores in the intervention group significantly decreased in Conflict Index of Avoidance/Approach Feeling toward Baby subscale. Our results suggest that aromatherapy-massage might be an effective intervention for postpartum mothers to improve physical and mental status and to facilitate mother-infant interaction.

A comparison of RUL ultrabrief pulse (0.3 ms) ECT and standard RUL ECT.

PubMed

Loo, Colleen K; Sainsbury, Kirby; Sheehan, Patrick; Lyndon, Bill

2008-11-01

An important goal in electroconvulsive therapy (ECT) research is to minimize associated cognitive side-effects while maintaining its high efficacy. This study explored the use of a novel approach, right unilateral (RUL) ECT with an ultrabrief pulsewidth (0.3 ms) (RUL-UB), in comparison with standard RUL ECT. Seventy-four depressed in-patients received RUL-UB ECT at six times seizure threshold, and 22 patients received standard RUL ECT (1.0 ms pulsewidth) at five times seizure threshold. Formal, prospective evaluations of mood and cognitive functioning over the treatment course were done by a rater blinded to treatment condition. Efficacy was maintained using the ultrabrief pulsewidth, with equivalent numbers of responders and remitters to the standard RUL ECT group, although the speed of response was slower. Cognitive outcomes were superior in the RUL-UB ECT group, particularly in the retention of verbal and visual information, as well as in retrograde autobiographical memory.

The effectiveness of a saline mouth rinse regimen and education programme on radiation-induced oral mucositis and quality of life in oral cavity cancer patients: A randomised controlled trial.

PubMed

Huang, B-S; Wu, S-C; Lin, C-Y; Fan, K-H; Chang, J T-C; Chen, S-C

2018-03-01

Radiation therapy (RT) and concurrent chemotherapy RT (CCRT) generate radiation-induced oral mucositis (OM) and lower quality of life (QOL). This study assessed the impact of a saline mouth rinse regimen and education programme on radiation-induced OM symptoms, and QOL in oral cavity cancer (OCC) patients receiving RT or CCRT. Ninety-one OCC patients were randomly divided into a group that received saline mouth rinses and an education programme and a control group that received standard care. OM symptoms and QOL were assessed with the WHO Oral Toxicity Scale, MSS-moo and UW-QOL. Data were collected at the first postoperative visit to the radiation department (T0) and at 4 weeks and 8 weeks after beginning RT or CCRT. Patients in both groups had significantly higher levels of physical and social-emotional QOL at 8 weeks after beginning RT or CCRT compared to the first visit. Patients in the saline rinse group had significantly better physical and social-emotional QOL as compared to the standard care group at 8 weeks. Radiation-induced OM symptoms and overall QOL were not different between the groups. We thus conclude the saline rinse and education programme promote better physical and social-emotional QOL in OCC patients receiving RT/CCRT. © 2018 John Wiley & Sons Ltd.

Multicomponent cognitive-behavioral group therapy with hypnosis for the treatment of fibromyalgia: long-term outcome.

PubMed

Castel, Antoni; Cascón, Rosalia; Padrol, Anna; Sala, José; Rull, Maria

2012-03-01

This study compared the efficacy of 2 psychological treatments for fibromyalgia with each other and with standard care. Ninety-three patients with fibromyalgia (FM) were randomly assigned to 1 of the 3 experimental conditions: 1) multicomponent cognitive-behavioral therapy (CBT); 2) multicomponent CBT with hypnosis; and 3) pharmacological treatment (standard care control group). The outcome measures of pain intensity, catastrophizing, psychological distress, functionality, and sleep disturbances were assessed before treatment, immediately after treatment, and at 3- and 6-month follow-up visits. CBT and CBT with hypnosis participants received the standard pharmacological management plus 14 weekly, 120-minute-long sessions of psychological treatment. All but 1 session followed a group format; the remaining session was individual. The analyses indicated that: 1) patients with FM who received multicomponent CBT alone or multicomponent CBT with hypnosis showed greater improvements than patients who received only standard care; and 2) adding hypnosis enhanced the effectiveness of multicomponent CBT. This study presents new evidence about the efficacy of multicomponent CBT for FM and about the additional effects of hypnosis as a complement to CBT. The relevance and implications of the obtained results are discussed. This article highlights the beneficial effects of adding hypnosis in a multicomponent cognitive-behavioral group treatment of fibromyalgia patients. Also, this research showed that by adding hypnosis the length of treatment did not increase. Copyright © 2012 American Pain Society. Published by Elsevier Inc. All rights reserved.

Cobedding of twin premature infants: calming effects on pain responses.

PubMed

Badiee, Zohreh; Nassiri, Zohreh; Armanian, Amirmohammad

2014-08-01

The purpose of this trial was to determine whether cobedding of preterm twins has analgesic effects during heel lancing or not. One hundred premature twins (50 sets) born between 26 weeks' and 34 weeks' gestation undergoing heel blood sampling were randomly assigned into two groups: the cobedding group (receiving care in the same incubator) and the standard care group (receiving care in separate incubators). Pain was assessed using the premature infant pain profile score. Duration of crying was measured after heel blood sampling, and salivary cortisol was measured prior to and after heel blood sampling. Infants in the standard care group cried for a longer time during heel lancing than those in the cobedding group (42.6 ± 19.8 seconds vs. 36.4 ± 21.7 seconds, p = 0.03). The mean premature infant pain profile score after heel lancing was significantly higher in the standard care group (9.8 ± 2.6 vs. 8.06 ± 2.8, p = 0.002). The mean salivary cortisol after heel lancing was also significantly higher in the standard care group (24.3 ± 7.4 nmol/L vs. 20.8 ± 7.4 nmol/L, p = 0.02). No significant adverse effects were seen with cobedding. Cobedding is a comforting measure for twin premature infants during heel lancing, which can be performed without any significant adverse effects. Copyright © 2014. Published by Elsevier B.V.

Setting Cut Scores on an EFL Placement Test Using the Prototype Group Method: A Receiver Operating Characteristic (ROC) Analysis

ERIC Educational Resources Information Center

Eckes, Thomas

2017-01-01

This paper presents an approach to standard setting that combines the prototype group method (PGM; Eckes, 2012) with a receiver operating characteristic (ROC) analysis. The combined PGM-ROC approach is applied to setting cut scores on a placement test of English as a foreign language (EFL). To implement the PGM, experts first named learners whom…

Early home-based group education to support informed decision-making among patients with end-stage renal disease: a multi-centre randomized controlled trial.

PubMed

Massey, Emma K; Gregoor, Peter J H Smak; Nette, Robert W; van den Dorpel, Marinus A; van Kooij, Anthony; Zietse, Robert; Zuidema, Willij C; Timman, Reinier; Busschbach, Jan J; Weimar, Willem

2016-05-01

The aim was to test the effectiveness of early home-based group education on knowledge and communication about renal replacement therapy (RRT). We conducted a randomized controlled trial using a cross-over design among 80 end-stage renal disease (ESRD) patients. Between T0 and T1 (weeks 1-4) Group 1 received the intervention and Group 2 received standard care. Between T1 and T2 (weeks 5-8) Group 1 received standard care and Group 2 received the intervention. The intervention was a group education session on RRT options held in the patient's home given by social workers. Patients invited members from their social network to attend. Self-report questionnaires were used at T0, T1 and T2 to measure patients' knowledge and communication, and concepts from the Theory of Planned Behaviour such as attitude. Comparable questionnaires were completed pre-post intervention by 229 attendees. Primary RRT was registered up to 2 years post-intervention. Multilevel linear modelling was used to analyse patient data and paired t-tests for attendee data. Statistically significant increases in the primary targets knowledge and communication were found among patients and attendees after receiving the intervention. The intervention also had a significant effect in increasing positive attitude toward living donation and haemodialysis. Of the 80 participants, 49 underwent RRT during follow-up. Of these, 34 underwent a living donor kidney transplant, of which 22 were pre-emptive. Early home-based group education supports informed decision-making regarding primary RRT for ESRD patients and their social networks and may remove barriers to pre-emptive transplantation. © The Author 2015. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved.

Post-operative shampoo effects in neurosurgical patients: a pilot experimental study.

PubMed

Palese, Alvisa; Moreale, Renzo; Noacco, Massimo; Pistrino, Flavia; Mastrolia, Irene; Sartor, Assunta; Scarparo, Claudio; Skrap, Miran

2015-04-01

Neurosurgical site infections are an important issue. Among the acknowledged preventive tactics, the non-shaving technique is well established in the neurosurgical setting. However, given that patient's hair around the surgical site may retain biologic material that emerges during the surgical procedure or that may simply become dirty, which may increase the risk of surgical site infections, if and when shampooing should be offered remains under debate. A pilot experimental study was undertaken from 2011 to 2012. A series of neurosurgical patients not affected by conditions that would increase the risk of post-operative infection were assigned randomly to the exposed group (receiving shampoo 72 h after surgical procedure) or control group (receiving standard dressing surveillance without shampooing). Comfort, surgical site contamination (measured as the number of colony-forming units [CFU]), and SSIs at 30 d after surgery were the main study outcomes. A total of 53 patients were included: 25 (47.2%) received a shampoo after 72 h whereas 28 (52.8%) received standard care. Patients who received a shampoo reported a similar level of comfort (average=8.04; standard deviation [SD] 1.05) compared with those receiving standard care (average 7.3; SD 3.2) although this was not statistically significant (p=0.345). No statistically significant difference emerged in the occurrence of surgical site contamination between the groups, and no SSIs were detected within 30 d. In our pilot study, the results of which are not generalizable because of the limited sample of patients involved, a gentle shampoo offered 72 h after the surgical procedure did not increase the SSIs occurrence or the contamination of the surgical site, although it may increase the perception of comfort by patients. Further studies are strongly recommended involving a larger sample size and designed to include more diversified neurosurgical patients undergoing surgical procedures in different centers.

Standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori eradication

PubMed Central

Gao, Xiao-Zhong; Qiao, Xiu-Li; Song, Wen-Chong; Wang, Xiao-Feng; Liu, Feng

2010-01-01

AIM: To compare the effectiveness of standard triple, bismuth pectin quadruple and sequential therapies for Helicobacter pylori (H. pylori) eradication in a randomized, double-blinded, comparative clinical trial in China. METHODS: A total of 215 H. pylori-positive patients were enrolled in the study and randomly allocated into three groups: group A (n = 72) received a 10-d bismuth pectin quadruple therapy (20 mg rabeprazole bid, 1000 mg amoxicillin bid, 100 mg bismuth pectin qid, and 500 mg levofloxacin qd); group B (n = 72) received the sequential therapy (20 mg omeprazole bid, 1000 mg amoxicillin bid, in 5 d, followed by 20 mg omeprazole bid, 500 mg tinidazole bid, 500 mg clarithromycin bid, for another 5 d); group C (n = 71) received a standard 1-wk triple therapy (20 mg omeprazole bid, 1000 mg amoxicillin bid, 500 mg clarithromycin bid). After all these treatments, 20 mg omeprazole bid was administrated for 3 wk. H. pylori status was assessed by histology, 13C-urea breath test and rapid urease test at baseline and 4-6 wk after completion of treatment. Ulcer cicatrization was assessed by gastroscopy. χ2 test (P < 0.05) was used to compare the eradication rates and ulcer cicatrisation rates among the three groups. RESULTS: The eradication rate was 83.33% (60/72) in group A, 88.89% (64/72) in group B, and 80.56% (58/71) in group C. The ulcer cicatrisation rate was 86.44% (51/59) in group A, 90.16% (55/61) in group B, and 84.91% (45/53) in group C. The sequential therapy yielded a higher eradication rate and ulcer cicatrisation rate than the standard triple and bismuth pectin quadruple therapies. Statistically, the eradication rate of group B was significantly different from groups A and C (P < 0.05), but the difference of ulcer cicatrisation rate and side effects was not statistically significant among the three groups (P > 0.05). The three protocols were generally well tolerated. CONCLUSION: The sequential therapy has achieved a significantly higher eradication rate, and is a more suitable first-line alternative protocol for anti-H. pylori infection compared with the standard triple and bismuth pectin quadruple therapies. PMID:20818821

Comparison of efficacy and safety of levofloxacin-containing versus standard sequential therapy in eradication of Helicobacter pylori infection in Korea.

PubMed

Lee, Hyuk; Hong, Sung Noh; Min, Byung-Hoon; Lee, Jun Haeng; Rhee, Poong-Lyul; Lee, Yong Chan; Kim, Jae J

2015-02-01

Declining of eradication rates for Helicobacter pylori in Korea may be partly from the increasing prevalence of antibiotic resistance, especially clarithromycin resistance. To compare the efficacy and the safety of using 10-day standard sequential therapy and levofloxacin-containing sequential therapy as a first-line treatment for Helicobacter pylori eradication in Korea. A total of 200 patients with proven Helicobacter pylori infection randomly received 10-day standard sequential therapy (n = 100) or levofloxacin-containing sequential therapy (n = 100). The standard sequential therapy group received rabeprazole and amoxicillin for 5 days, followed by rabeprazole, clarithromycin, and metronidazole for 5 more days. The levofloxacin-containing sequential therapy group was treated with rabeprazole and amoxicillin for 5 days, followed by rabeprazole, levofloxacin, and metronidazole for 5 more days. Intention-to-treat eradication rates were 79.0% and 78.0% for groups of standard sequential and levofloxacin-containing sequential therapy, respectively (P = 0.863). Per-protocol eradication rates were 84.9% and 81.3%, respectively, for these two therapies (P = 0.498). There were no significant differences between the groups in regard to the eradication rates and adverse events. The 10-day levofloxacin-containing sequential regimen and the standard sequential regimen showed the similar eradication rates of Helicobacter pylori in Korea. Copyright © 2014 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

The Effect of Data Format on Integration of Performance Data into Angoff Judgments

ERIC Educational Resources Information Center

Clauser, Brian E.; Mee, Janet; Margolis, Melissa J.

2013-01-01

This study investigated the extent to which the performance data format impacted data use in Angoff standard setting exercises. Judges from two standard settings (a total of five panels) were randomly assigned to one of two groups. The full-data group received two types of data: (1) the proportion of examinees selecting each option and (2) plots…

The Impact of New State Accountability Standards on Algebra I Students

ERIC Educational Resources Information Center

Heath, Kyle G.

2013-01-01

The purpose of this quasi-experimental quantitative study was to determine if a new Algebra I curriculum resulted in improved student performance on the state Algebra I exam. The treatment group consisted of 383 9th grade Algebra I students who received the college-ready standards-based (CRSB) curricula. The control group consisted of 338 9th…

The Effects of the Maryland Online Individualized Education Program Goal Wizard on Writing Standards Based Annual Goals

ERIC Educational Resources Information Center

Lewis, Kimberly A.

2011-01-01

The purpose of this study was to examine the efficacy of the Maryland Online Individualized Education Program Goal Wizard on writing standards based annual goals. Specifically, 100 novice special education teachers form a large urban school system in Maryland were randomly assigned to one of two groups. The experimental group received one…

Sedentary behavior, physical activity, and psychological health of Korean older adults with hypertension: effect of an empowerment intervention.

PubMed

Chang, Ae Kyung; Fritschi, Cynthia; Kim, Mi Ja

2013-04-01

The aim of this study was to determine the effect of an 8-week empowerment intervention on sedentary behavior, physical activity, and psychological health in Korean older adults with hypertension. Using a quasi-experimental design, older adults participated in either an experimental group (n = 27) or control group (n = 21). The experimental group received an empowerment intervention including lifestyle modification education, group discussion, and exercise training for 8 weeks, and the control group received standard hypertension education. After 8 weeks, participants in the experimental group had significantly decreased sedentary behavior, increased physical activity, increased self-efficacy for physical activity, and increased perceived health (p < 0.05). However, no significant group difference was found for depression. Findings from this study suggest that empowerment interventions may be more effective than standard education in decreasing sedentary behavior and increasing physical activity, self-efficacy for physical activity, and perceived health in Korean older adults with hypertension. Copyright 2013, SLACK Incorporated.

Effect of Unripe Plantain (Musa paradisiaca) and Ginger (Zingiber officinale) on Renal Dysfunction in Streptozotocin-Induced Diabetic Rats.

PubMed

Iroaganachi, Mercy; Eleazu, Chinedum; Okafor, Polycarp

2015-03-20

Although unripe plantain (Musa paradisiaca) and ginger (Zingiber officinale) are used as single plants to manage diabetes mellitus in Nigeria, the possibility of combining them in a typical diabetic diet and the glycemic response elicited as a result of such combination has not been investigated. To determine the effect of unripe plantain and ginger on serum total proteins, albumin, creatinine and urea levels of streptozotocin induced diabetic rats. Twenty four male albino rats were used and were divided into 4 groups of 6 rats each. Group 1 (non-diabetic) received standard rat feeds; Group 2 (diabetic) received standard rat feeds; Group 3 received unripe plantain pellets and Group 4 received unripe plantain+ginger pellets. There were significant increases (P=0.045) of both serum urea and creatinine, but significant decreases (P=0.045) of both serum total protein and albumin levels, in Group 2 rats compared with Group 1. There were significant decreases (P=0.033) of both serum urea and creatinine levels of Group 3 and 4 rats compared with Group 2. In addition, there were significant increases of both serum total protein and albumin levels (P=0.033) in Group 3 rats compared with Group 2, but the comparison of serum total protein and albumin levels between Group 4 and Group 2 did not reach the significant level (P=0.056 and P=0.065 for serum total protein and albumin levels, respectively. Combination of unripe plantain and ginger at the ratio used in the management of renal dysfunction in diabetics was not very effective compared with unripe plantain alone.

Effects of a Classroom-Embedded Occupational Therapist–Teacher Handwriting Program for First-Grade Students

PubMed Central

Weaver, Lindy; Holland, Terri

2014-01-01

This study examined the effectiveness of Write Start, a handwriting and writing program cotaught by teachers and occupational therapists for first-grade children. Four classrooms (n = 80) received the Write Start program, and four (n = 58) received standard handwriting and writing instruction. Two teachers and an occupational therapist implemented the 24-session manualized program, which included station teaching and individualized supports. The program emphasized practice in small groups in which the coteaching team provided students with frequent feedback, encouraged self-evaluation, and facilitated peer modeling and peer evaluation. Students who completed the Write Start program improved more in handwriting legibility and speed than the group receiving standard instruction. Writing fluency and written composition were no different between groups at posttest; however, writing fluency was significantly higher for Write Start students at 6-mo follow-up. Write Start students with low legibility at baseline made significant improvements, suggesting that the program may benefit students at risk for handwriting and writing problems. PMID:25397764

Effectiveness of a co-taught handwriting program for first grade students.

PubMed

Case-Smith, Jane; Holland, Terri; White, Susan

2014-02-01

Our study examined the effects of Write Start, a classroom-embedded handwriting/writing program on handwriting and writing fluency for first grade students, co-taught by occupational therapists and teachers. Two first grade classrooms received the Write Start and two received standard handwriting instruction. This co-taught program included specific feedback during handwriting practice, small group activities, student self-evaluation, and peer supports. The students were evaluated on handwriting legibility, fluency, and written expression at baseline, immediately after the program, and 6 months later. When performance was compared between the two groups, the students in the Write Start program improved significantly more in legibility (d = .57) and fluency (d = .75) than students who received standard instruction. Gains in handwriting speed (d = .18), average legibility (d = .26), and written expression (d = .25) did not differ significantly between the two groups. A co-taught, inclusive handwriting/writing program can promote first grade students' achievement of lower case legibility and writing fluency.

[EFFICACY OF CYTOFLAVIN IN COMPLEX TREATMENT OF DIABETIC FOOT SYNDROME].

PubMed

Skrypko, V; Kovalenko, A; Zaplutanov, V; Kharitonova, T; Myhaloyko, I

2017-04-01

The study involved 97 patients with severe diabetic foot syndrome (DFS) subcompensated type 2 diabetes. All patients were available mediacalcification foot and lower leg arteries of different severity. Depending on the treatment, all patients were divided into 2 groups by stratified randomization. The І group received standard therapy, which is indicated for the DFS. A ІІ group of patients additionally received basic therapy drug Cytoflavin 10 ml 0,9% NaCl 200 ml for 10 days, followed by transfer to tablet form Cytoflavin 2 tablets 2 times per day orally for one month. We noted a positive trend of treatment of patients who, in addition to standard therapy received the drug Cytoflavin. Thus, the use of complex surgical treatment of patients with mixed form of DFS Cytoflavin reduces the severity of distal polyneuropathy, improves oxygenation of tissues and restores the enzyme activity of antioxidant system, that manifested neuroprotective, antioxidant and anti-hypoxic effects of drugs, which substantiates the indications for its use in the this pathology.

The effect of melatonin and vitamin C treatment on the experimentally induced tympanosclerosis: study in rats.

PubMed

Koc, Sema; Kıyıcı, Halil; Toker, Aysun; Soyalıç, Harun; Aslan, Huseyin; Kesici, Hakan; Karaca, Zafer I

The ethiopathogenesis of tympanosclerosis has not been completely under- stood yet. Recent studies have shown that free oxygen radicals are important in the formation of tympanosclerosis. Melatonin and Vitamin C are known to be a powerful antioxidant, interacts directly with Reactive Oxygen Species and controls free radical-mediated tissue damage. To demonstrate the possible preventative effects of melatonin and Vitamin C on tympanosclerosis in rats by using histopathology and determination of total antioxidant status total antioxidant status. Standard myringotomy and standard injury were performed in the middle ear of 24 rats. The animals were divided into three groups: Group 1 received melatonin, Group 2 received vitamin C, and Group 3 received saline solution. The mean values of total antioxidant status were similar in the all study groups before the treatment period. The mean values of total antioxidant status were significantly higher in the melatonin and vitamin C groups compared to control group but vitamin C with melatonin groups were similar after the treatment period (p<0.001). Minimum and maximum wall thicknesses were lower in the melatonin and vitamin C groups compared to the control group but the differences were insignificant. Melatonin increases total antioxidant status level and might have some effect on tympanosclerosis that develops after myringotomy. Copyright © 2016 Associação Brasileira de Otorrinolaringologia e Cirurgia Cérvico-Facial. Published by Elsevier Editora Ltda. All rights reserved.

Investigation of standard care versus sham Reiki placebo versus actual Reiki therapy to enhance comfort and well-being in a chemotherapy infusion center.

PubMed

Catlin, Anita; Taylor-Ford, Rebecca L

2011-05-01

To determine whether provision of Reiki therapy during outpatient chemotherapy is associated with increased comfort and well-being. Double-blind, randomized clinical controlled trial. Outpatient chemotherapy center. 189 participants were randomized to actual Reiki, sham Reiki placebo, or standard care. Patients receiving chemotherapy were randomly placed into one of three groups. Patients received either standard care, a placebo, or an actual Reiki therapy treatment. A demographic tool and pre- and post-tests were given before and after chemotherapy infusion. Reiki therapy, sham Reiki placebo therapy, standard care, and self-reported levels of comfort and well-being pre- and postintervention. Although Reiki therapy was statistically significant in raising the comfort and well-being of patients post-therapy, the sham Reiki placebo also was statistically significant. Patients in the standard care group did not experience changes in comfort and well-being during their infusion session. The findings indicate that the presence of an RN providing one-on-one support during chemotherapy was influential in raising comfort and well-being levels, with or without an attempted healing energy field. An attempt by clinic nurses to provide more designated one-to-one presence and support for patients while receiving their chemotherapy infusions could increase patient comfort and well-being.

Integrating Technology into Standard Weight Loss Treatment: A Randomized Controlled Trial

PubMed Central

Spring, Bonnie; Duncan, Jennifer M.; Janke, E. Amy; Kozak, Andrea T.; McFadden, H. Gene; DeMott, Andrew; Pictor, Alex; Epstein, Leonard H.; Siddique, Juned; Pellegrini, Christine A.; Buscemi, Joanna; Hedeker, Donald

2013-01-01

Background A challenge in the delivery of intensive obesity treatment is making care scalable. Little is known about whether the outcome of clinician-directed weight loss treatment can be improved by adding mobile technology. Methods We conducted a 2-arm, 12-month study (between October, 2007 and September, 2010). Seventy adults (body mass index [BMI] >25 and ≤ 40 kg/m2) were randomly assigned to either standard of care group treatment alone (Standard) or Standard + connective mobile technology system (+Mobile). Participants attended biweekly weight loss groups held by the VA outpatient clinic. The +Mobile group was provided personal digital assistants (PDAs) to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months. Weight was measured at baseline, 3, 6, 9, and 12 months follow-up. Results Sixty-nine adults received intervention (mean age 57.7 years, 85.5% male). A longitudinal intent-to-treat analysis indicated that the +Mobile group lost on average 8.6 more pounds (representing 3.1% more weight loss relative to the control) than the Standard group at each post-baseline time point, 95% CI [4.9, 12.2]. As compared to the Standard group, the +Mobile group had significantly greater odds of having lost 5% or more of their baseline weight at each post-baseline time point [OR= 6.5; 95% CI = 2.3, 18.6]. Conclusions The addition of a PDA and telephone coaching can enhance short-term weight loss in combination with an existing system of care. Mobile connective technology holds promise as a scalable delivery mechanism to augment the impact of clinician-delivered weight loss treatment. PMID:23229890

High dose vitamin D may improve lower urinary tract symptoms in postmenopausal women.

PubMed

Oberg, Johanna; Verelst, Margareta; Jorde, Rolf; Cashman, Kevin; Grimnes, Guri

2017-10-01

Lower urinary tract symptoms (LUTS) are common in postmenopausal women, and have been reported inversely associated with vitamin D intake and serum 25-hydroxyvitamin D (25(OH)D) levels. The aim of this study was to investigate if high dose vitamin D supplementation would affect LUTS in comparison to standard dose. In a randomized controlled study including 297 postmenopausal women with low bone mineral density, the participants were allocated to receive capsules of 20 000IU of vitamin D 3 twice a week (high dose group) or similar looking placebo (standard dose group). In addition, all the participants received 1g of calcium and 800IU of vitamin D daily. A validated questionnaire regarding LUTS was filled in at baseline and after 12 months. At baseline, 76 women in the high dose group and 82 in the standard dose group reported any LUTS. Levels of serum 25(OH)D increased significantly more in the high dose group (from 64.7 to 164.1nmol/l compared to from 64.1 to 81.8nmol/l, p<0.01). No differences between the groups were seen regarding change in LUTS except for a statistically significant reduction in the reported severity of urine incontinence in the high dose group as compared to the standard dose group after one year (p<0.05). The results need confirmation in a study specifically designed for this purpose. Copyright © 2017 Elsevier Ltd. All rights reserved.

Collagen sealant patch to reduce lymphatic drainage after lymph node dissection.

PubMed

Di Monta, Gianluca; Caracò, Corrado; Crispo, Anna; Marone, Ugo; Mozzillo, Nicola

2012-12-19

Seroma formation is a frequent complication following radical lymph node dissection (RLND) in patients with metastatic melanoma. Several strategies have been used to prevent fluid accumulation and thereby reduce the duration of postoperative drainage, including fibrin sealants. This was a prospective, single-center study in which consecutive patients undergoing surgical treatment of stage III metastatic melanoma by axillary or ilio-inguinal RLND were randomized to receive standard treatment plus fibrinogen/thrombin-coated collagen sealant patch (CSP) or standard treatment alone. The primary endpoint of the study was postoperative duration of drainage. A total of 70 patients underwent axillary (n = 47) or ilio-inguinal (n = 23) RLND and received CSP plus standard treatment (n = 37) or standard treatment alone (n = 33). Mean duration of drainage was significantly reduced in the CSP group compared with standard treatment (ITT analysis: 20.1 ± 5.1 versus 23.3 ± 5.1 days; p = 0.010). The percentage of patients drainage-free on day 21 was significantly higher in the CSP group compared with the standard treatment group (86% versus 67%; p = 0.049). Use of the tissue sealant resulted in a significant reduction in duration of drainage. Further studies are warranted to confirm these results in different and selected types of lymphadenectomy.

Collagen sealant patch to reduce lymphatic drainage after lymph node dissection

PubMed Central

2012-01-01

Background Seroma formation is a frequent complication following radical lymph node dissection (RLND) in patients with metastatic melanoma. Several strategies have been used to prevent fluid accumulation and thereby reduce the duration of postoperative drainage, including fibrin sealants. Methods This was a prospective, single-center study in which consecutive patients undergoing surgical treatment of stage III metastatic melanoma by axillary or ilio-inguinal RLND were randomized to receive standard treatment plus fibrinogen/thrombin-coated collagen sealant patch (CSP) or standard treatment alone. The primary endpoint of the study was postoperative duration of drainage. Results A total of 70 patients underwent axillary (n = 47) or ilio-inguinal (n = 23) RLND and received CSP plus standard treatment (n = 37) or standard treatment alone (n = 33). Mean duration of drainage was significantly reduced in the CSP group compared with standard treatment (ITT analysis: 20.1 ± 5.1 versus 23.3 ± 5.1 days; p = 0.010). The percentage of patients drainage-free on day 21 was significantly higher in the CSP group compared with the standard treatment group (86% versus 67%; p = 0.049). Conclusions Use of the tissue sealant resulted in a significant reduction in duration of drainage. Further studies are warranted to confirm these results in different and selected types of lymphadenectomy. PMID:23253298

The effects of Snoezelen (multi-sensory behavior therapy) and psychiatric care on agitation, apathy, and activities of daily living in dementia patients on a short term geriatric psychiatric inpatient unit.

PubMed

Staal, Jason A; Sacks, Amanda; Matheis, Robert; Collier, Lesley; Calia, Tina; Hanif, Henry; Kofman, Eugene S

2007-01-01

A randomized, controlled, single-blinded, between group study of 24 participants with moderate to severe dementia was conducted on a geriatric psychiatric unit. All participants received pharmacological therapy, occupational therapy, structured hospital environment, and were randomized to receive multi sensory behavior therapy (MSBT) or a structured activity session. Greater independence in activities of daily living (ADLs) was observed for the group treated with MSBT and standard psychiatric inpatient care on the Katz Index of Activities of Daily Living (KI-ADL; P = 0.05) than standard psychiatric inpatient care alone. The combination treatment of MSBT and standard psychiatric care also reduced agitation and apathy greater than standard psychiatric inpatient care alone as measured with the Pittsburgh Agitation Scale and the Scale for the Assessment of Negative Symptoms in Alzheimer's Disease (P = 0.05). Multiple regression analysis predicted that within the multi-sensory group, activities of daily living (KI-ADL) increased as apathy and agitation reduced (R2 = 0.42; p = 0.03). These data suggest that utilizing MSBT with standard psychiatric inpatient care may reduce apathy and agitation and additionally improve activities of daily living in hospitalized people with moderate to severe dementia more than standard care alone.

[Model of experimental nonalcoholic steatohepatitis from use of methionine and choline deficient diet].

PubMed

Zamin, Idilio; Mattos, Angelo Alves de; Mattos, Angelo Zambam de; Migon, Eduardo; Soares, Ernesto; Perry, Marcos Luiz Santos

2009-01-01

There are still many unknown aspects about nonalcoholic steatohepatitis, especially regarding its pathophysiology and pharmacological treatment. Thus, experimental models are important for a better understanding of this disease and the evaluation of the effects of drugs. To develop a model of experimental nonalcoholic steatohepatitis from use of methionine and choline deficient diet. Fifty Wistar male rats were studied. A methionine and choline deficient diet has been processed in a craft. A group of 40 animals received the deficient diet for 90 days, and a group of 10 rats (control group) received the standardized ration in the same period. After, the animals were killed by decapitation, and laparotomy was performed. Hepatectomy was performed and the liver was studied by macroscopy and microscopy. The level of significance considered was of 0,05. The rats that received the deficient diet showed significant loss of weight with findings from malnutrition and all of them had at least some degree of macrovesicular steatosis. The diagnosis of nonalcoholic steatohepatitis was performed in 27 (70%) of the 39 rats that received this deficient diet (1 rat died during the study). None of the 10 rats that received the standardized diet had histological abnormalities. The diet restricted in methionine and choline induced steatosis and steatohepatitis in an animal model with low cost.

Neurodegeneration Alters Metabolic Profile and Sirt 1 Signaling in High-Fat-Induced Obese Mice.

PubMed

Lima, Leandro Ceotto Freitas; Saliba, Soraya Wilke; Andrade, João Marcus Oliveira; Cunha, Maria Luisa; Cassini-Vieira, Puebla; Feltenberger, John David; Barcelos, Lucíola Silva; Guimarães, André Luiz Sena; de-Paula, Alfredo Mauricio Batista; de Oliveira, Antônio Carlos Pinheiro; Santos, Sérgio Henrique Sousa

2017-07-01

Different factors may contribute to the development of neurodegenerative diseases. Among them, metabolic syndrome (MS), which has reached epidemic proportions, has emerged as a potential element that may be involved in neurodegeneration. Furthermore, studies have shown the importance of the sirtuin family in neuronal survival and MS, which opens the possibility of new pharmacological targets. This study investigates the influence of sirtuin metabolic pathways by examining the functional capacities of glucose-induced obesity in an excitotoxic state induced by a quinolinic acid (QA) animal model. Mice were divided into two groups that received different diets for 8 weeks: one group received a regular diet, and the other group received a high-fat diet (HF) to induce MS. The animals were submitted to a stereotaxic surgery and subdivided into four groups: Standard (ST), Standard-QA (ST-QA), HF and HF-QA. The QA groups were given a 250 nL quinolinic acid injection in the right striatum and PBS was injected in the other groups. Obese mice presented with a weight gain of 40 % more than the ST group beyond acquiring an insulin resistance. QA induced motor impairment and neurodegeneration in both ST-QA and HF-QA, although no difference was observed between these groups. The HF-QA group showed a reduction in adiposity when compared with the groups that received PBS. Therefore, the HF-QA group demonstrated a commitment-dependent metabolic pathway. The results suggest that an obesogenic diet does not aggravate the neurodegeneration induced by QA. However, the excitotoxicity induced by QA promotes a sirtuin pathway impairment that contributes to metabolic changes.

The effect of stimulation therapy and donepezil on cognitive function in Alzheimer's disease. A community based RCT with a two-by-two factorial design.

PubMed

Andersen, Fred; Viitanen, Matti; Halvorsen, Dag S; Straume, Bjørn; Wilsgaard, Tom; Engstad, Torgeir A

2012-07-19

Progressive neurodegeneration in Alzheimer's disease (AD) induces cognitive deterioration, and there is controversy regarding the optimal treatment strategy in early AD. Stimulation therapy, including physical exercise and cholinesterase inhibitors are both reported to postpone cognitive deterioration in separate studies. We aimed to study the effect of stimulation therapy and the additional effect of donepezil on cognitive function in early AD. A two-by-two factorial trial comprising stimulation therapy for one year compared to standard care to which a randomized double-blinded placebo controlled trial with donepezil was added. Nine rural municipalities in Northern Norway. 187 participants 65 years and older with a recent diagnosis of mild or moderate AD were included in the study of which 146 completed a one-year follow-up. In five municipalities the participants received stimulation therapy whereas participants in four received standard care. All participants were randomised double-blindly to donepezil or placebo and tested with three different cognitive tests four times during the one-year study period. Changes in MMSE sum score.Secondary outcome: Changes in ADAS-Cog and Clock Drawing Test. MMSE scores remained unchanged amongst AD participants receiving stimulation therapy and those receiving standard care. The results were consistent for ADAS-Cog and Clock Drawing Test. No time trend differences were found during one-year follow-up between groups receiving stimulation therapy versus standard care or between donepezil versus placebo. In rural AD patients non-pharmacological and pharmacological therapy did not improve outcome compared with standard care but all groups retained cognitive function during one year follow-up. Other studies are needed to confirm these results. ClinicalTrials.gov (Identifier: NCT00443014). EudraCT database (no 2004-002613-37).

Tissue Fatty Acid Profile is Differently Modulated from Olive Oil and Omega-3 Polyunsaturated Fatty Acids in ApcMin/+ Mice.

PubMed

Tutino, Valeria; Caruso, Maria G; De Leonardis, Giampiero; De Nunzio, Valentina; Notarnicola, Maria

2017-11-16

Fatty acid profile can be considered an appropriate biomarker for investigating the relations between the patterns of fatty acid metabolism and specific diseases, as cancer, cardiovascular and degenerative diseases. Aim of this study was to test the effects of diets enriched with olive oil and omega-3 Polyunsaturated Fatty Acids (PUFAs) on fatty acid profile in intestinal tissue of ApcMin/+ mice. Three groups of animals were considered: control group, receiving a standard diet; olive oilgroup, receiving a standard diet enriched with olive oil; omega-3 group, receiving a standard diet enriched with salmon fish. Tissue fatty acid profile was evaluated by gas chromatography method. Olive oil and omega-3 PUFAs in the diet differently affect the tissue fatty acid profile. Compared to control group, the levels of Saturated Fatty Acids (SFAs) were lower in olive oil group, while an increase of SFAs was found in omega-3 group. Monounsaturated Fatty Acids (MUFAs) levels were enhanced after olive oil treatment, and in particular, a significant increase of oleic acid levels was detected; MUFAs levels were instead reduced in omega-3 group in line with the decrease of oleic acid levels. The total PUFAs levels were lower in olive oil respect to control group. Moreover, a significant induction of Saturation Index (SI) levels was observed after omega-3 PUFAs treatment, while its levels were reduced in mice fed with olive oil. Our data demonstrated a different effect of olive oil and omega-3 PUFAs on tissue lipid profile in APCMin/+ mice. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

Responses of Juvenile Black-tailed Prairie Dogs ( Cynomys ludovicianus ) to a Commercially Produced Oral Plague Vaccine Delivered at Two Doses.

PubMed

Cárdenas-Canales, Elsa M; Wolfe, Lisa L; Tripp, Daniel W; Rocke, Tonie E; Abbott, Rachel C; Miller, Michael W

2017-10-01

We confirmed safety and immunogenicity of mass-produced vaccine baits carrying an experimental, commercial-source plague vaccine (RCN-F1/V307) expressing Yersinia pestis V and F1 antigens. Forty-five juvenile black-tailed prairie dogs ( Cynomys ludovicianus ) were randomly divided into three treatment groups (n=15 animals/group). Animals in the first group received one standard-dose vaccine bait (5×10 7 plaque-forming units [pfu]; STD). The second group received a lower-dose bait (1×10 7 pfu; LOW). In the third group, five animals received two standard-dose baits and 10 were left untreated but in contact. Two vaccine-treated and one untreated prairie dogs died during the study, but laboratory analyses ruled out vaccine involvement. Overall, 17 of 33 (52%; 95% confidence interval for binomial proportion [bCI] 34-69%) prairie dogs receiving vaccine-laden bait showed a positive anti-V antibody response on at least one sampling occasion after bait consumption, and eight (24%; bCI 11-42%) showed sustained antibody responses. The STD and LOW groups did not differ (P≥0.78) in their proportions of overall or sustained antibody responses after vaccine bait consumption. Serum from one of the nine (11%; bCI 0.3-48%) surviving untreated, in-contact prairie dogs also had detectable antibody on one sampling occasion. We did not observe any adverse effects related to oral vaccination.

Responses of juvenile black-tailed prairie dogs (Cynomys ludovicianus) to a commercially produced oral plague vaccine delivered at two doses

USGS Publications Warehouse

Cárdenas-Canales, Elsa M.; Wolfe, Lisa L.; Tripp. Daniel W.,; Rocke, Tonie E.; Abbott, Rachel C.; Miller, Michael W.

2017-01-01

We confirmed safety and immunogenicity of mass-produced vaccine baits carrying an experimental, commercial-source plague vaccine (RCN-F1/V307) expressing Yersinia pestis V and F1 antigens. Forty-five juvenile black-tailed prairie dogs (Cynomys ludovicianus) were randomly divided into three treatment groups (n=15 animals/group). Animals in the first group received one standard-dose vaccine bait (5×107 plaque-forming units [pfu]; STD). The second group received a lower-dose bait (1×107 pfu; LOW). In the third group, five animals received two standard-dose baits and 10 were left untreated but in contact. Two vaccine-treated and one untreated prairie dogs died during the study, but laboratory analyses ruled out vaccine involvement. Overall, 17 of 33 (52%; 95% confidence interval for binomial proportion [bCI] 34−69%) prairie dogs receiving vaccine-laden bait showed a positive anti-V antibody response on at least one sampling occasion after bait consumption, and eight (24%; bCI 11–42%) showed sustained antibody responses. The STD and LOW groups did not differ (P≥0.78) in their proportions of overall or sustained antibody responses after vaccine bait consumption. Serum from one of the nine (11%; bCI 0.3–48%) surviving untreated, in-contact prairie dogs also had detectable antibody on one sampling occasion. We did not observe any adverse effects related to oral vaccination.

The effectiveness of spaced retrieval combined with Montessori-based activities in improving the eating ability of residents with dementia.

PubMed

Wu, Hua Shan; Lin, Li Chan; Wu, Shiao Chi; Lin, Ke Neng; Liu, Hsiu Chih

2014-08-01

To explore the long-term effects of standardized and individualized spaced retrieval combined with Montessori-based activities on the eating ability of residents with dementia. Eating difficulty is common in residents with dementia, resulting in low food intake, followed by eating dependence, weight loss and malnutrition. A single-blinded and quasi-experimental design with repeated measures. Ninety residents with dementia from four veterans' homes in Taiwan took part in this study. The intervention consisted of spaced retrieval combined with Montessori-based activities. Twenty-five participants in the standardized group received 24 intervention sessions over 8 weeks. Thirty-eight participants in the individualized group received tailored intervention sessions. The number of intervention sessions was adjusted according to the participant's recall responses in spaced retrieval. Twenty-seven participants in the control group received no treatment. The Chinese version of the Edinburgh Feeding Evaluation in Dementia was used, and eating amounts and body weight were measured pre-test, posttest and at 1-, 3- and 6-month follow-ups. Data were collected between July 2008-February 2010. Repeated measures of all dependent variables for the three groups were analysed by the linear mixed model. The standardized and individualized interventions could significantly decrease the scores for the Chinese version of the Edinburgh Feeding Evaluation in Dementia and increase the eating amount and body weight over time. Trained nurses in institutions can schedule the standardized or individualized intervention in usual activity time to ameliorate eating difficulty and its sequels. © 2014 John Wiley & Sons Ltd.

Low-dose D-methionine and N-acetyl-L-cysteine for protection from permanent noise-induced hearing loss in chinchillas.

PubMed

Clifford, Royce E; Coleman, John K M; Balough, Ben J; Liu, Jianzhong; Kopke, Richard D; Jackson, Ronald L

2011-12-01

Despite efforts at public health awareness and stringent industrial standards for hearing protection, noise-induced hearing loss (NIHL) remains a formidable public health concern. Although many antioxidants have proven to be beneficial in the laboratory for prevention of permanent NIHL, low-dose combinations of compounds with different biochemical mechanisms of action may allow long-term administration with fewer side effects and equal efficacy. The mixture of D-methionine and N-acetyl-L-cysteine administered at levels less than 10% of standard dosing has not been previously reported. Twenty-six female adult Chinchilla laniger were placed in 4 study groups, consisting of (1) a group receiving combination 12.5 mg/kg each D-methionine and N-acetyl-L-cysteine (DMET/NAC group), (2) a group receiving 12.5 mg/kg D-methionine (DMET-only group), (3) a group receiving 12.5 mg/kg N-acetyl-L-cysteine (NAC-only group), and (4) saline controls. Laboratory. All groups received twice-daily intraperitoneal injections 2 days prior to noise exposure, 1 hour before and after exposure on day 3, and for 2 days subsequently, totaling 10 doses of 125 mg/kg for each antioxidant over 5 days. Although NAC-only animals paralleled saline control recovery during 3 weeks, the DMET-only group revealed gradual improvement with statistically significant recovery in the middle frequencies. The DMET/NAC group showed significant improvement at most frequencies compared with controls (P < .001 and P < .05). Significant recovery of hearing was observed following continuous noise exposure with either DMET only or a combination of low-dose DMET/NAC, demonstrating a considerably lower dose of antioxidants required than previously reported for hearing recovery following acoustic trauma.

The effects of Alkanna tinctoria Tausch on split-thickness skin graft donor site management: a randomized, blinded placebo-controlled trial.

PubMed

Kheiri, Aliasghar; Amini, Shahideh; Javidan, Abbas Norouzi; Saghafi, Mohammad Mehdi; Khorasani, Ghasemali

2017-05-08

A prospective, randomized, placebo-controlled clinical trial was conducted to compare the healing effectiveness of Alkanna tinctoria (L.) Tausch (Boraginaceae) with standard dressing on wound healing at the donor site after removal of the skin graft. Enrolled patients were randomly allocated to receive topicalA. tinctoria extract ointment (20%) or standard dressing (dressing with base ointment) daily. Wound healing was assessed using the Bates-Jenson assessment tool at the 2 nd and 4 th weeks after intervention. Decreases in wound score were significantly greater in the A. tinctoria group compared with the placebo group (P <0.05). The surface areas of graft donor sites in the A. tinctoria group were significantly reduced as compared with the control group at day 28 of the intervention (P < 0.05). The proportion of patients in the A. tinctoria group achieving complete wound healing within 2 to 4 weeks was 50% and 96.66%, respectively, significantly higher than in patients receiving standard care: 0% and 23.3%, respectively. This clinical study showed that A. tinctoria dressing accelerates wound healing after graft harvesting. IRCT ID: IRCT201511165781N2 .

A comparison of 2 influenza vaccine schedules in 6- to 23-month-old children.

PubMed

Englund, Janet A; Walter, Emmanuel B; Fairchok, Mary P; Monto, Arnold S; Neuzil, Kathleen M

2005-04-01

Trivalent inactivated influenza vaccine (TIV) is recommended for all children ages 6 to 23 months. Delivering 2 doses of TIV at least 4 weeks apart to young children receiving this vaccine for the first time is challenging. We compared the immunogenicity and reactogenicity of the standard 2-dose regimen of TIV administered in the fall with an early schedule of a single spring dose followed by a fall dose of the same vaccine in healthy toddlers 6 to 23 months of age. Children were recruited in the spring to be randomized into either the standard or early schedule. An additional group was also enrolled in the fall as part of a nonrandomized standard comparison group. The 2002-2003 licensed TIV was administered in the spring; the fall 2003-2004 vaccine contained the same 3 antigenic components. Reactogenicity was assessed by parental diaries and telephone surveillance. Blood was obtained after the second dose of TIV for all children. The primary outcome measure was antibody response to influenza A/H1N1, A/H3N2, and B after 2 doses of vaccine, as determined by hemagglutination-inhibition titers > or =1:32 and geometric mean titer (GMT). Two hundred nineteen children were randomized to receive either the standard or early TIV schedule; 40 additional children were enrolled in the fall in the nonrandomized standard group. Response rates in the combined standard versus early groups were similar overall: 78% (GMT: 48) vs 76% (GMT: 57) to H1N1, 89% (GMT: 115) vs 88% (GMT: 129) to H3N2, and 52% (GMT: 24) vs 60% (GMT: 28) to B. Reactogenicity after TIV in both groups of children was minimal and did not differ by dose, age, or time between doses. Reaction rates were higher in those receiving TIV and concomitant vaccines compared with those receiving TIV alone. Overall rates of fever >38 degrees C axillary and injection-site pain, redness, or swelling were 5.4%, 3.1%, 0.9%, and 1.1%, respectively. When the spring and fall influenza vaccines had the same 3 antigenic components, the early vaccine schedule resulted in similar immunogenicity and reactogenicity compared with the standard schedule. When the vaccine components do not change between years, initiating influenza vaccine in the spring at the time of routine office visits would facilitate full immunization of children against influenza earlier in the season.

Project RED Impacts Patient Experience.

PubMed

Cancino, Ramon S; Manasseh, Chris; Kwong, Lana; Mitchell, Suzanne E; Martin, Jessica; Jack, Brian W

2017-12-01

Hospitalized patients are frequently unprepared to care for themselves after discharge often leading to unplanned hospital readmission. One strategy to reduce readmission rates is improving the quality of patient education and preparation before hospital discharge. The ReEngineered Discharge (RED) is a standardized hospital-based program designed to provide patients and caregivers the information they need to continue care at home. We sought to study the impact of the RED intervention on posthospitalization adult patient experience scores in an urban academic safety-net hospital. We conducted a descriptive study of a pilot program that compared posthospitalization survey responses to the Press Ganey survey item "Instructions were given about how to care for yourself at home." We compared the survey results for 3 groups of adult patients: those receiving the RED program, those receiving a standard discharge on the same hospital unit, and those receiving a standard discharge on other hospital units. A greater percentage of adult patients who received the RED discharge program rated the quality of their discharge as "very good" as compared to those receiving a standard discharge on the same hospital unit and those receiving a standard discharge on other hospital units (61%, 35%, and 41%, respectively, P = .0001). Delivery of a standardized hospital discharge program resulted in a larger proportion of top-box "very good" responses on a Press Ganey posthospitalization survey. Future research should examine whether hospital-based transition programs can sustain improvement in patient experience measures and whether these improvements can be observed in other patient populations.

Oregon Indigenous Farmworkers: Results of Promotor Intervention on Pesticide Knowledge and Organophosphate Metabolite Levels

PubMed Central

McCauley, Linda; Runkle, Jennifer D.; Samples, Julie; Williams, Bryan; Muniz, Juan F; Semple, Marie; Shadbeh, Nargess

2013-01-01

Objectives Examine changes in health beliefs, pesticide safety knowledge, and biomarkers of pesticide exposure in indigenous farmworker who received enhanced pesticide safety training compared to those receiving the standard training. Methods Farmworkers in Oregon were randomly assigned to either a promotores pesticide safety training program or a standard video-based training. Spot urine samples were analyzed for dialkylphosphate (DAP) urinary metabolites. Pre/post intervention questionnaires were used to measure pesticide safety knowledge, health beliefs and work practices. Results Baseline to follow-up improvements in total pesticide knowledge scores were higher in the promotor group compared to the video. Pairwise differences in mean concentrations of DAP metabolite levels showed declines from baseline to follow-up for both intervention groups. Conclusions Results showed reductions in pesticide exposure in indigenous-language speaking farmworkers who receive enhanced pesticide safety training. PMID:24064776

The effect of a supersaturated calcium phosphate mouth rinse on the development of oral mucositis in head and neck cancer patients treated with (chemo)radiation: a single-center, randomized, prospective study of a calcium phosphate mouth rinse + standard of care versus standard of care.

PubMed

Lambrecht, Maarten; Mercier, Carole; Geussens, Yasmyne; Nuyts, Sandra

2013-10-01

Mucosal damage is an important and debilitating side effect when treating head and neck cancer patients with (chemo-)radiation. The aim of this randomized clinical trial was to investigate whether the addition of a neutral, supersaturated, calcium phosphate (CP) mouth rinse benefits the severity and duration of acute mucositis in head and neck cancer patients treated with (chemo)radiation. A total of 60 patients with malignant neoplasms of the head and neck receiving (chemo)radiation were included in this study. Fifty-eight patients were randomized into two treatment arms: a control group receiving standard of care (n = 31) and a study group receiving standard of care + daily CP mouth rinses (n = 27) starting on the first day of (chemo-)radiation. Oral mucositis and dysphagia were assessed twice a week using the National Cancer Institute common toxicity criteria scale version 3, oral pain was scored with a visual analogue scale. No significant difference in grade III mucositis (59 vs. 71 %; p = 0.25) and dysphagia (33 vs. 42 %, p = 0.39) was observed between the study group compared to the control group. Also no significant difference in time until development of peak mucositis (28.6 vs. 28.7 days; p = 0.48), duration of peak mucositis (22.7 vs. 24.6 days; p = 0.31), recuperation of peak dysphagia (20.5 vs 24.2 days; p = 0.13) and occurrence of severe pain (56 vs. 52 %, p = 0.5). In this randomized study, the addition of CP mouth rinse to standard of care did not improve the frequency, duration or severity of the most common acute toxicities during and early after (chemo)radiation. There is currently no evidence supporting its standard use in daily practice.

Photodynamic therapy in treatment of severe oral lichen planus.

PubMed

Rabinovich, O F; Rabinovich, I M; Guseva, A V

2016-01-01

The aim of the study was to elaborate the rationale for the application of photodynamic therapy in complex treatment of patient with severe oral lichen planus. Complex clinical and laboratory examination and treatment was performed in 54 patients divided on 3 groups. Diagnosis of oral lichen planus was based on clinical, histological and immunohistochemical features. Group 1 received standard treatment, in the second group photodynamic therapy was conducted in addition to conventional treatment, patients in the third group received only photodynamic therapy. The study results proved photodynamic therapy to be useful tool in complex treatment of severe oral lichen planus.

Effects of kinesio tape to reduce hand edema in acute stroke.

PubMed

Bell, Alison; Muller, Melissa

2013-01-01

The purpose of the study was to evaluate the effi cacy of Kinesio Tape (Kinesio USA, Albequerque, NM) for reducing hand edema in individuals with hemiplegia post stroke. Seventeen individuals who experienced acute stroke were screened for visual signs of edema and were randomly assigned to experimental and control groups. The experimental group received Kinesio Tape that was applied to hand and forearm for 6 days in combination with standard therapy; the control group received standard therapy. Blinded raters assessed edema reduction via circumferential measurements. Application of Kinesio Tape did not result in statistically signifi cant reduction in edema. Large and medium effect sizes were seen for edema reduction at the metacarpophalangeal and wrist joints, respectively, with Kinesio Tape. Further research is warranted to investigate the utility of Kinesio Tape in edema reduction.

Rehabilitation of patients admitted to a respiratory intensive care unit.

PubMed

Nava, S

1998-07-01

Pulmonary rehabilitation has been shown to be of benefit to clinically stable patients with chronic obstructive pulmonary disease (COPD). This study examined the effect of pulmonary rehabilitation on some physiologic variables in COPD patients recovering from an episode of acute respiratory failure. A prospective, randomized study. A respiratory intensive care unit (RICU). Eighty COPD patients recovering from an episode of acute respiratory failure were randomized in a 3:1 fashion to receive stepwise pulmonary rehabilitation (group A, n=60 patients) or standard medical therapy (group B, n=20 patients). Improvements in exercise tolerance, sense of breathlessness, respiratory muscle function, and pulmonary function test values were measured, respectively, by exercise capacity (6-minute walking distance [6MWD]), dyspnea score (Visual Analog Scale [VAS]), maximal inspiratory pressure (MIP), forced expiratory volume in 1 second (FEV1), and forced vital capacity (FVC). Group A received pulmonary rehabilitation that consisted of passive mobilization (step I), early deambulation (step II), respiratory and lower skeletal muscle training (step III), and if the patients were able, complete lower extremity training on a treadmill (step IV). Group B received standard medical therapy plus a basic deambulation program. Sixty-one of 80 patients were mechanically ventilated at admission to the unit and most of them were bedridden. Twelve of the 60 group A patients and 4 of the 20 group B patients died during their RICU stay, and 9 patients required invasive mechanical ventilation at home after their discharge. The total length of RICU stay was 38+/-14 days for patients in group A versus 33.2+/-11 days for those in group B. Most patients from both groups regained the ability to walk, either unaided or aided. At discharge, 6 MWD results were significantly improved (p < .001) in Group A only. MIP improved in Group A only (p < .05), while VAS scores improved in both groups, but the improvement was more marked in group A (p < .001) than in group B (p < .05). COPD patients who were admitted to a RICU in critical condition after an episode of acute respiratory failure and who, in most cases, required mechanical ventilation benefited from comprehensive early pulmonary rehabilitation, compared with patients who received standard medical therapy and progressive ambulation.

ERCC1 protein as a guide for individualized therapy of late-stage advanced non-small cell lung cancer.

PubMed

Gao, Zhiqiang; Han, Baohui; Shen, Jie; Gu, Aiqin; Qi, Dajiang; Huang, Jinsu; Shi, Chunlei; Xiong, Liwen; Zhao, Yizhuo; Jiang, Liyan; Wang, Huimin; Chen, Yurong

2011-09-01

Excision repair cross-complementation group 1 (ERCC1) protein has been associated with cisplatin resistance. The objective of this study was to investigate the correlation between ERCC1 protein levels and the therapeutic effect of individualized therapy in advanced non-small cell lung cancer (NSCLC). A total of 190 advanced NSCLC patients were included in this study. Patients were randomized into either the individualized therapy group or the standard therapy group at a ratio of 2:1. Patients in the standard therapy group were treated with either gemcitabine plus cisplatin or vinorelbine plus cisplatin. The expression of ERCC1 protein in lung cancer tissues of patients from the individualized therapy group was detected with immunohistochemistry. Patients with low ERCC1 levels received either gemcitabine plus cisplatin or vinorelbine plus cisplatin, and patients with high levels received gemcitabine plus vinorelbine. The main outcome assessments were response rate (RR), overall survival (OS) and time to progression (TTP). Follow-up data were recorded until September 30, 2010. RR, 1-year survival rate and TTP were not statistically significant. The median survival time was 10.10 months in the standard therapy group (95% CI 8.48-11.92) and 13.59 months in the individualized therapy group (95% CI 11.86-14.74). The difference in median survival time was significantly different between these groups (P=0.036). The median survival time was longer in the individualized group compared to the standard therapy group. ERCC1 protein expression in advanced NSCLC patients, however, was not significantly correlated with RR, OS and TTP in the individualized therapy group. Therefore, this study suggests that ERCC1 protein levels should be assessed in combination with additional biomarkers to determine an optimal index for individualized therapy in advanced NSCLC patients.

A randomized controlled trial investigating the effects of craniosacral therapy on pain and heart rate variability in fibromyalgia patients.

PubMed

Castro-Sánchez, Adelaida María; Matarán-Peñarrocha, Guillermo A; Sánchez-Labraca, Nuria; Quesada-Rubio, José Manuel; Granero-Molina, José; Moreno-Lorenzo, Carmen

2011-01-01

Fibromyalgia is a prevalent musculoskeletal disorder associated with widespread mechanical tenderness, fatigue, non-refreshing sleep, depressed mood and pervasive dysfunction of the autonomic nervous system: tachycardia, postural intolerance, Raynaud's phenomenon and diarrhoea. To determine the effects of craniosacral therapy on sensitive tender points and heart rate variability in patients with fibromyalgia. A randomized controlled trial. Ninety-two patients with fibromyalgia were randomly assigned to an intervention group or placebo group. Patients received treatments for 20 weeks. The intervention group underwent a craniosacral therapy protocol and the placebo group received sham treatment with disconnected magnetotherapy equipment. Pain intensity levels were determined by evaluating tender points, and heart rate variability was recorded by 24-hour Holter monitoring. After 20 weeks of treatment, the intervention group showed significant reduction in pain at 13 of the 18 tender points (P < 0.05). Significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement versus baseline values were observed in the intervention group but not in the placebo group. At two months and one year post therapy, the intervention group showed significant differences versus baseline in tender points at left occiput, left-side lower cervical, left epicondyle and left greater trochanter and significant differences in temporal standard deviation of RR segments, root mean square deviation of temporal standard deviation of RR segments and clinical global impression of improvement. Craniosacral therapy improved medium-term pain symptoms in patients with fibromyalgia.

High-dose versus standard-dose radiotherapy with concurrent chemotherapy in stages II-III esophageal cancer.

PubMed

Suh, Yang-Gun; Lee, Ik Jae; Koom, Wong Sub; Cha, Jihye; Lee, Jong Young; Kim, Soo Kon; Lee, Chang Geol

2014-06-01

In this study, we investigated the effects of radiotherapy ≥60 Gy in the setting of concurrent chemo-radiotherapy for treating patients with Stages II-III esophageal cancer. A total of 126 patients treated with 5-fluorouracilbased concurrent chemo-radiotherapy between January 1998 and February 2008 were retrospectively reviewed. Among these patients, 49 received a total radiation dose of <60 Gy (standard-dose group), while 77 received a total radiation dose of ≥60 Gy (high-dose group). The median doses in the standard- and high-dose groups were 54 Gy (range, 45-59.4 Gy) and 63 Gy (range, 60-81 Gy), respectively. The high-dose group showed significantly improved locoregional control (2-year locoregional control rate, 69 versus 32%, P < 0.01) and progression-free survival (2-year progression-free survival, 47 versus 20%, P = 0.01) than the standard-dose group. Median overall survival in the high- and the standard-dose groups was 28 and 18 months, respectively (P = 0.26). In multivariate analysis, 60 Gy or higher radiotherapy was a significant prognostic factor for improved locoregional control, progression-free survival and overall survival. No significant differences were found in frequencies of late radiation pneumonitis, post-treatment esophageal stricture or treatment-related mortality between the two groups. High-dose radiotherapy of 60 Gy or higher with concurrent chemotherapy improved locoregional control and progression-free survival without a significant increase of in treatment-related toxicity in patients with Stages II-III esophageal cancer. Our study could provide the basis for future randomized clinical trials. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Adverse drug reactions and outcome of short course anti-tuberculosis drugs between single daily dose and split drug dose (BID) in pulmonary tuberculosis.

PubMed

Chuchottaworn, Charoen; Saipan, Benjawan; Kittisup, Chomnapa; Cheewakul, Krisana

2012-08-01

Standard six months short course regimen for treatment of pulmonary tuberculosis is very effective and is recommended as standard treatment. But this regimen composes of many drugs and causes high adverse drug reactions especially gastrointestinal irritation. Spitted administration of drugs to two times a day may reduce adverse drug reactions. To study adverse drug reactions and outcome of single daily versus split drug (two times a day) administration of standard six month short course regimen in newly diagnosed pulmonary tuberculosis. Newly diagnosed pulmonary tuberculosis patients of the Central Chest Institute of Thailand were randomized to receive standard six months regimen once daily or two times a day (split drug). Patients were followed-up every two weeks and a questionnaire was used to detect adverse drug reactions. Outcome of treatment was evaluated according to national tuberculosis treatment guideline. 122 pulmonary tuberculosis were eligible for the present study and 61 patients were enrolled to each group of once daily or split drug regimen. Pulmonary tuberculosis patients who received split drug regimen had a higher cure rate but not statistical significance because of lower transfer out rate. Adverse drug reactions were similar in both groups of patients who received once daily and split drug regimen. Although split drug group had lower gastrointestinal adverse drug reactions. Split drug regimen has the same cure rate of treatment as single daily regimen and same adverse drug reactions.

Effect of Unripe Plantain (Musa paradisiaca) and Ginger (Zingiber officinale) on Blood Glucose, Body Weight and Feed Intake of Streptozotocin-induced Diabetic Rats.

PubMed

M, Iroaganachi; C O, Eleazu; P N, Okafor; N, Nwaohu

2014-01-01

To determine the effect of unripe plantain (Musa paradisiaca) and ginger (Zingiber officinale) on blood glucose (BG), feed intake (FI) and weight of streptozotocin (STZ) induced diabetic rats. Twenty four male albino rats were used and were divided into 4 groups of 6 rats each. Group 1 (non-diabetic) and Group 2 (diabetic) received standard rat feed; Group 3 received unripe plantain incorporated feed (810 /kg body weight) and Group 4 received unripe plantain+ginger incorporated feed (710:100 g/kg body weight). The weights and FI of the rats were measured daily throughout the experimentation. Groups 3 and 4 rats had 159.52% and 71.83% decreases in BG but 24.91% and 35.32% decreases in weights compared with groups 1 and 2 rats that had 2.09% and 22.94% increases in BG with 13.42% increase and 45.36% decrease in weights respectively. The FI of the experimental rats did not differ significantly from each other (P>0.05) at the end of experimentation. The standard rat feed contained higher amounts of Ca but lower amounts of Mg and Fe compared with the unripe plantain and unripe plantain+ginger incorporated feeds. Combination of unripe plantain and ginger at the dose used in the management of diabetes was not very effective compared with unripe plantain alone.

Double oral esomeprazole after a 3-day intravenous esomeprazole infusion reduces recurrent peptic ulcer bleeding in high-risk patients: a randomised controlled study.

PubMed

Cheng, Hsiu-Chi; Wu, Chung-Tai; Chang, Wei-Lun; Cheng, Wei-Chun; Chen, Wei-Ying; Sheu, Bor-Shyang

2014-12-01

Patients with high Rockall scores have increased risk of ulcer rebleeding after 3-day esomeprazole infusions. To investigate whether double oral esomeprazole given after a 3-day esomeprazole infusion decreases ulcer rebleeding for patients with high Rockall scores. We prospectively enrolled 293 patients with peptic ulcer bleeding who had achieved endoscopic haemostasis. After a 3-day esomeprazole infusion, patients with Rockall scores ≥6 were randomised into the oral double-dose group (n=93) or the oral standard-dose group (n=94) to receive 11 days of oral esomeprazole 40 mg twice daily or once daily, respectively. The patients with Rockall scores <6 served as controls (n=89); they received 11 days of oral esomeprazole 40 mg once daily. Thereafter, all patients received oral esomeprazole 40 mg once daily for two more weeks until the end of the 28-day study period. The primary end point was peptic ulcer rebleeding. Among patients with Rockall scores ≥6, the oral double-dose group had a higher cumulative rebleeding-free proportion than the oral standard-dose group (p=0.02, log-rank test). The proportion of patients free from recurrent bleeding during the 4th-28th day in the oral double-dose group remained lower than that of the group with Rockall scores <6 (p=0.03, log-rank test). Among patients with Rockall scores ≥6, the rebleeding rate was lower in the oral double-dose group than in the oral standard-dose group (4th-28th day: 10.8% vs 28.7%, p=0.002). Double oral esomeprazole at 40 mg twice daily after esomeprazole infusion reduced recurrent peptic ulcer bleeding in high-risk patients with Rockall scores ≥6. NCT01591083. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Mandibular single-implant overdentures: preliminary results of a randomised-control trial on early loading with different implant diameters and attachment systems.

PubMed

Alsabeeha, Nabeel H M; Payne, Alan G T; De Silva, Rohana K; Thomson, W Murray

2011-03-01

To determine surgical and prosthodontic outcomes of mandibular single-implant overdentures, opposing complete maxillary dentures, using a wide diameter implant and large ball attachment system compared with different regular diameter implants with standard attachment systems. Thirty-six edentulous participants (mean age 68 years, SD 9.2) were randomly assigned into three treatment groups (n=12). A single implant was placed in the mandibular midline of participants to support an overdenture using a 6-week loading protocol. The control group received Southern regular implants and standard ball attachments. One group received Southern 8-mm-wide implants and large ball attachments. Another group received Neoss regular implants and Locator attachments. Parametric and non-parametric tests of a statistical software package (SPSS) were used to determine between groups differences in marginal bone loss, implant stability, implant, and prosthodontic success (P<0.05). Implant success after 1 year was 75% for Southern regular implant (control) group; and 100% for the Southern wide and Neoss regular implant groups (P=0.038). Mean marginal bone loss at 1 year was 0.19 mm (SD 0.39) without significant differences observed. Implant stability quotient (ISQ) at baseline was significantly lower for the Southern regular (control) group than the other two groups (P=0.001; P=0.009). At 1 year, no significant difference in implant stability was observed (mean ISQ 74.6, SD 6.1). The change in implant stability from baseline to 1 year was significant for the control group (P=0.025). Prosthodontic success was comparable between the groups but the maintenance (41 events overall, mean 1.2) was greater for the Locator and the standard ball attachments. Mandibular single-implant overdentures are a successful treatment option for older edentulous adults with early loading protocol using implants of different diameters and with different attachment systems. © 2010 John Wiley & Sons A/S.

Multi-antioxidant supplementation does not prevent an increase in gut permeability after lower torso ischemia and reperfusion in humans.

PubMed

Wijnen, M H W A; Vader, H L; Roumen, R M H

2002-01-01

An increase in gut permeability can have serious consequences leading to sepsis and multiple organ failure. After lower torso ischemia an increase in gut permeability is seen in both animals and humans. There is proof that this can be modified by antioxidant supplementation. In this prospective, randomized study we have looked at the influence of a multiantioxidant supplementation regime, using allopurinol, vitamins E and C, mannitol and N-acetylcysteine, perioperatively. Twenty-two patients received standard treatment and 20 patients received supplementation. Gut permeability was determined using a double sugar test with lactulose and rhamnose. A significant increase in gut permeability was found neither in the non-treatment group (p = 0.012) nor in the treatment group (p = 0.006) after 6 and 24 h. No difference was found between the group receiving antioxidants and the standard treatment group. p = 0.93 6 h post clamp; p = 0.97 24 h post clamp. In this study we have not found an influence of multiantioxidant supplementation on gut permeability after lower torso ischemia. Possible explanations for this negative result are being discussed. Copyright 2002 S. Karger AG, Basel

Comprehensive behavioral-motivational nutrition education improves depressive symptoms following bariatric surgery: a randomized, controlled trial of obese Hispanic Americans.

PubMed

Petasne Nijamkin, Monica; Campa, Adriana; Samiri Nijamkin, Shani; Sosa, Jorge

2013-01-01

To evaluate the effect of 2 post-bariatric support interventions on depressive symptoms of Hispanic Americans treated with gastric bypass for morbid or severe obesity. Prospective randomized, controlled trial conducted in a laparoscopic institution. During the Phase 1 clinical trial (from preoperative evaluation to 6 months after surgery), all participants received standard care. During Phase 2 (6-12 months after surgery), participants were randomly assigned to receive either standard care (n = 72) or comprehensive support (n = 72). Comprehensive group participants received 6 educational sessions focused on behavior change strategies and motivation with nutrition counseling. Depression scores and weight change over time. Independent samples t tests and regression analysis assessed relationships among depression scores and excess weight loss. Participants receiving behavioral-motivational intervention scored significantly lower on Beck's Depression Inventory questionnaire scores than those receiving standard care. For those with depressive symptoms at randomization, 24% of participants who received the comprehensive intervention reported no depressive symptoms at 12 months after surgery, compared with 6% of those who received standard care (P < .001). Patients' depressive mood improvement was significantly and positively associated with excess weight loss and attendance at educational sessions (P < .001). Findings support the importance of post-bariatric comprehensive behavioral-motivational nutrition education for decreasing risk for depression and improving weight loss. Copyright © 2013 Society for Nutrition Education and Behavior. Published by Elsevier Inc. All rights reserved.

Effects of a classroom-embedded occupational therapist-teacher handwriting program for first-grade students.

PubMed

Case-Smith, Jane; Weaver, Lindy; Holland, Terri

2014-01-01

This study examined the effectiveness of Write Start, a handwriting and writing program cotaught by teachers and occupational therapists for first-grade children. Four classrooms (n = 80) received the Write Start program, and four (n = 58) received standard handwriting and writing instruction. Two teachers and an occupational therapist implemented the 24-session manualized program, which included station teaching and individualized supports. The program emphasized practice in small groups in which the coteaching team provided students with frequent feedback, encouraged self-evaluation, and facilitated peer modeling and peer evaluation. Students who completed the Write Start program improved more in handwriting legibility and speed than the group receiving standard instruction. Writing fluency and written composition were no different between groups at posttest; however, writing fluency was significantly higher for Write Start students at 6-mo follow-up. Write Start students with low legibility at baseline made significant improvements, suggesting that the program may benefit students at risk for handwriting and writing problems. Copyright © 2014 by the American Occupational Therapy Association, Inc.

Improved outcomes for elderly patients who received care on a transitional care unit.

PubMed

Manville, Margaret; Klein, Michael C; Bainbridge, Lesley

2014-05-01

To determine whether providing elderly alternate level of care (ALC) patients with interdisciplinary care on a transitional care unit (TCU) achieves better clinical outcomes and lowers costs compared with providing them with standard hospital care. Before-and-after structured retrospective chart audit. St Joseph's Hospital in Comox, BC. One hundred thirty-five consecutively admitted patients aged 70 years and older with ALC designation during 5-month periods before (n = 49) and after (n = 86) the opening of an on-site TCU. Length of stay, discharge disposition, complications of the acute and ALC portions of the patients' hospital stays, activities of daily living (mobility, transfers, and urinary continence), psychotropic medications and vitamin D prescriptions, and ALC patient care costs, as well as annual hospital savings, were examined. Among the 86 ALC patients receiving care during the postintervention period, 57 (66%) were admitted to the TCU; 29 of the 86 (34%) patients in the postintervention group received standard care (SC). All 86 ALC patients in the postintervention group were compared with the 49 preintervention ALC patients who received SC. Length of stay reduction occurred among the postintervention group during the acute portion of the hospital stay (14.0 days postintervention group vs 22.5 days preintervention group; P < .01). Discharge home or to an assisted-living facility increased among the postintervention group (30% postintervention group vs 12% preintervention group; P < .01). Patients' ability to transfer improved among the postintervention group (55% postintervention group vs 14% preintervention group; P < .01). At discharge, 48% of ALC patients in the postintervention group were able to transfer independently compared with 17% of ALC patients in the preintervention group. Hospital-acquired infections among the postintervention group decreased during the acute phase (14% postintervention group vs 33% preintervention group; P < .01) and in the ALC phase of hospital stay (16% postintervention group vs 31% preintervention group; P = .011). Antipsychotic prescriptions decreased among the postintervention group (45% postintervention group vs 66% preintervention group; P = .026). Despite greater use of rehabilitation services, TCU costs per patient were lower ($155/d postintervention period vs $273/d preintervention period). Elderly ALC patients experienced improvements in health and function at reduced cost after the creation of an interdisciplinary TCU, to which most of the nonpalliative ALC patients were transferred. Although all the postintervention ALC patients (those admitted to the TCU and those who received SC) were analyzed together, it is very likely that the greatest gains were made in the ALC patients who received care in the TCU. Copyright© the College of Family Physicians of Canada.

Randomized trial of human milk cream as a supplement to standard fortification of an exclusive human milk-based diet in infants 750-1250 g birth weight.

PubMed

Hair, Amy B; Blanco, Cynthia L; Moreira, Alvaro G; Hawthorne, Keli M; Lee, Martin L; Rechtman, David J; Abrams, Steven A

2014-11-01

To evaluate whether premature infants who received an exclusive human milk (HM)-based diet and a HM-derived cream supplement (cream) would have weight gain (g/kg/d) at least as good as infants receiving a standard feeding regimen (control). In a prospective noninferiority, randomized, unmasked study, infants with a birth weight 750-1250 g were randomly assigned to the control or cream group. The control group received mother's own milk or donor HM with donor HM-derived fortifier. The cream group received a HM-derived cream supplement if the energy density of the HM tested <20 kcal/oz using a near infrared HM analyzer. Infants were continued on the protocol until 36 weeks postmenstrual age. Primary outcomes included growth velocities and amount of donor HM-derived fortifier used. The hypothesis of noninferiority was established if the lower bound of the one-sided 95% CI for the difference in weight velocities exceeded -3 g/kg/day. There were no differences between groups in baseline demographics for the 78 infants studied except racial distribution (P = .02). The cream group (n = 39) had superior weight (14.0 ± 2.5 vs 12.4 ± 3.0 g/kg/d, P = .03) and length (1.03 ± 0.33 vs 0.83 ± 0.41 cm/wk, P = .02) velocity compared with the control group (n = 39). There were no significant differences in amount of fortifier used between study groups. The 1-sided 95% lower bound of the CI for the difference in mean velocity (cream-control) was 0.38 g/kg/d. Premature infants who received HM-derived cream to fortified HM had improved weight and length velocity compared with the control group. HM-derived cream should be considered an adjunctive supplement to an exclusive HM-based diet to improve growth rates in premature infants. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Innovative approach to teaching communication skills to nursing students.

PubMed

Zavertnik, Jean Ellen; Huff, Tanya A; Munro, Cindy L

2010-02-01

This study assessed the effectiveness of a learner-centered simulation intervention designed to improve the communication skills of preprofessional sophomore nursing students. An innovative teaching strategy in which communication skills are taught to nursing students by using trained actors who served as standardized family members in a clinical learning laboratory setting was evaluated using a two-group posttest design. In addition to current standard education, the intervention group received a formal training session presenting a framework for communication and a 60-minute practice session with the standardized family members. Four domains of communication-introduction, gathering of information, imparting information, and clarifying goals and expectations-were evaluated in the control and intervention groups in individual testing sessions with a standardized family member. The intervention group performed better than the control group in all four tested domains related to communication skills, and the difference was statistically significant in the domain of gathering information (p = 0.0257). Copyright 2010, SLACK Incorporated.

The impact of testing accommodations on MCAT scores: descriptive results.

PubMed

Julian, Ellen R; Ingersoll, Deborah J; Etienne, Patricia M; Hilger, Anthony E

2004-04-01

Medical College Admission Test (MCAT) examinees with disabilities who receive accommodations receive flagged scores indicating nonstandard administration. This report compares MCAT examinees who received accommodations and their performances with standard examinees. Aggregate history records of all 1994-2000 MCAT examinees were identified as flagged (2,401) or standard (297,880), then further sorted by race/ethnicity (broadly identified as underrepresented minority and non-URM, at the time of testing) and gender. Those with flagged scores were also classified by disability (LD = learning disability, ADHD = attention deficit hyperactivity disorder, LD/ADHD = learning disability and attention deficit hyperactivity disorder, and Other = other disability) and type of accommodation. Mean MCAT scores were calculated for all groups. A group of 866 examinees took the MCAT first as a standard administration and subsequently with accommodations. In a separate analysis, their two sets of scores were compared. Less than 1% of examinees (2,401) had accommodations; of these, 55% were LD, 17% ADHD, 5% LD/ADHD, and 23% Other. Extended time was the most frequently provided accommodation. Mean flagged scores slightly exceeded mean standard scores on all MCAT sections. Examinees who retook the MCAT with accommodations after a standard administration increased their scores by six points, quadrupling the average gain Standard-Standard retest cohort from another study. The small but statistically significant different higher flagged scores may reflect either appropriate compensation or overly generous accommodations. Extended time had a positive impact on the scores of those who retested with this accommodation. The validity the flagged MCAT in predicting success in medical school is not known, and further investigation is underway.

[Effectiveness of a micronized purified flavonoid fraction (MPFF) in the healing process of lower limb ulcers. An open multicentre study, controlled and randomized].

PubMed

Glinski, W; Chodynicka, B; Roszkiewicz, J; Bogdanowski, T; Lecewicz-Torun, B; Kaszuba, A; Bowszyc, J; Nowak, A; Wnorowski, J; Wasik, F; Glinska-Ferenz, M; Blaszczyk, M; Strzyga, P; Pachocki, R

2001-04-01

To determine the increase in healing rate of venous ulcer in patients receiving a micronised purified flavonoid fraction (MPFF) as supplementation to standard local care. A randomised, open, controlled, multicentre study. Departments of Dermatology and University Outpatients Clinics. One hundred and forty patients with chronic venous insufficiency and venous ulcers. PATIENTS received standard compressive therapy plus external treatment alone or 2 tablets of MPFF daily in addition to the above treatment for 24 weeks. Healing of ulcers and their reduction in size after 24 weeks of treatment. The percentage of patients whose ulcers healed completely was found to be markedly higher in those receiving MPFF in addition to standard external and compressive treatment than in those treated with conventional therapy alone (46.5% vs 27.5%; p<0.05. OR=2.3, 95% CI 1.1-4.6). Ulcers with diameters <3 cm were cured in 71% of patients in the MPFF group and in 50% of patients in the control group, whereas ulcers between 3 and 6 cm in diameter were cured in 60% and 32% of patients (p<0.05), respectively. The mean reduction in ulcer size was also found to be greater in patients treated with MPFF (80%) than in the control group (65%) (p<0.05). The cost-effectiveness ratio (cost per healed ulcer) in the MPFF group was 1026.2 compared with 1871.8 in the control group. These results indicate that MPFF significantly improves the cure rate in patients with chronic venous insufficiency.

Compressed air massage hastens healing of the diabetic foot.

PubMed

Mars, M; Desai, Y; Gregory, M A

2008-02-01

The management of diabetic foot ulcers remains a problem. A treatment modality that uses compressed air massage has been developed as a supplement to standard surgical and medical treatment. Compressed air massage is thought to improve local tissue oxygenation around ulcers. The aim of this study was to determine whether the addition of compressed air massage influences the rate of healing of diabetic ulcers. Sixty consecutive patients with diabetes, admitted to one hospital for urgent surgical management of diabetic foot ulcers, were randomized into two groups. Both groups received standard medical and surgical management of their diabetes and ulcer. In addition, one group received 15-20 min of compressed air massage, at 1 bar pressure, daily, for 5 days a week, to the foot and the tissue around the ulcer. Healing time was calculated as the time from admission to the time of re-epithelialization. Fifty-seven patients completed the trial; 28 received compressed air massage. There was no difference in the mean age, Wagner score, ulcer size, pulse status, or peripheral sensation in the two groups. The time to healing in the compressed air massage group was significantly reduced: 58.1 +/- 22.3 days (95% confidence interval: 49.5-66.6) versus 82.7 +/- 30.7 days (95% confidence interval: 70.0-94.3) (P = 0.001). No adverse effects in response to compressed air massage were noted. The addition of compressed air massage to standard medical and surgical management of diabetic ulcers appears to enhance ulcer healing. Further studies with this new treatment modality are warranted.

Comparative effects of vildagliptin and sitagliptin determined by continuous glucose monitoring in patients with type 2 diabetes mellitus.

PubMed

Koyanagawa, Naohide; Miyoshi, Hideaki; Ono, Kota; Nakamura, Akinobu; Cho, Kyu Yong; Yamamoto, Kohei; Takano, Yoshinari; Dan-Noura, Midori; Atsumi, Tatsuya

2016-08-31

The dipeptidyl peptidase-4 inhibitors vildagliptin and sitagliptin are effective in treating patients with type 2 diabetes mellitus. Patients receiving standard doses of sitagliptin plus insulin may require increased doses of sitagliptin or switching to vildagliptin to improve blood glucose control. This study compared the effects of increasing sitagliptin and switching to vildagliptin in type 2 diabetes patients receiving standard doses of sitagliptin plus insulin. This prospective, randomized, parallel-group comparison trial enrolled 33 type 2 diabetes patients receiving 50 mg sitagliptin once daily plus insulin. Seventeen patients were randomized to 50 mg vildagliptin twice daily, and 16 to 100 mg sitagliptin once daily, and evaluated by continuous glucose monitoring at baseline and after 8 weeks. The primary end-point was the change in mean amplitude of glycemic excursions (MAGE). MAGE decreased from baseline in both the vildagliptin (-13.4 ± 35.7 mg/dL) and sitagliptin (-8.4 ± 24.3 mg/dL) groups, but neither within- nor between-group changes were statistically significant. Similarly, the areas under the curve for blood glucose levels ≥180 mg/dL and <70 mg/dL tended to improve in both groups, but these differences were not statistically significant. In contrast, HbA1c was significantly reduced only in the vildagliptin group, from 7.1 ± 0.6% at baseline to 6.8 ± 0.6% at 8 weeks (p=0.006). Increasing sitagliptin dose and switching to vildagliptin had limited effects in improving MAGE in type 2 diabetic patients treated with standard doses of sitagliptin.

Can an evidence-based book club intervention delivered via a tablet computer improve physical activity in middle-aged women?

PubMed

Ehlers, Diane K; Huberty, Jennifer L; de Vreede, Gert-Jan

2015-02-01

Fewer than 50% of middle-aged women participate in regular physical activity (PA). Innovative approaches that engage women who may not otherwise participate in PA programs are warranted. The purpose of this study was to explore the acceptability and feasibility of a 12-week tablet-based book club for improving middle-aged women's PA. Thirty women (35-64 years of age) were randomized to the Fit Minded Tablet (n=15) and the Standard Fit Minded (i.e., face-to-face intervention) (n=15) groups. The Fit Minded Tablet was adapted from the Standard Fit Minded, a previously tested, theory-based book club intervention using books as a platform for discussion and group support to help women adopt regular PA. Both interventions met weekly for 3 months, for a total of 12 sessions. Tablet group participants accessed materials (e.g., e-books, workbook, live/recorded videoconferencing) via a tablet computer; Standard group participants received materials (e.g., printed books, workbook, live face-to-face meetings) in person. Feasibility (i.e., implementation and expansion) was assessed using process evaluation, qualitative interviews, satisfaction surveys, and quantitative outcome assessments. Women in the Tablet group attended fewer meetings (mean, 8.25) than women in the Standard group (mean, 9.9). Videoconferencing, digital literacy, and participant engagement limitations were observed in the Tablet group. Tablet participants enjoyed the e-books but thought technology barriers hindered their engagement during meetings. Women in both groups valued the support they received from other group members. Standard participants cited this support as a key contributor to their PA changes, whereas Tablet participants reported needing in-person contact to feel more connected. Given the popularity of tablet computers and the value that middle-aged women place on group interaction to support their PA behaviors, additional research is warranted to determine best strategies for optimizing social support, mitigating technology barriers, and improving engagement in online and mobile health promotion programs targeting middle-aged women.

The effect of standard care, ibuprofen, and distraction on pain relief and patient satisfaction in children with musculoskeletal trauma.

PubMed

Tanabe, Paula; Ferket, Kathleen; Thomas, Ronald; Paice, Judith; Marcantonio, Richard

2002-04-01

The purpose of this study was to determine the effectiveness of nursing interventions in decreasing pain for children with minor musculoskeletal trauma and moderate pain and to examine patient satisfaction. Children were assigned to 1 of 3 intervention groups: (1) standard care (ice, elevation, and immobilization) only; (2) standard care and ibuprofen; or (3) standard care and distraction. Children were monitored for pain ratings for 60 minutes. Children who sustained minor musculoskeletal trauma within the past 24 hours and presented with pain ratings of 2 or greater using the 0-5 Wong/Baker faces scale were included. Two patient satisfaction questions were asked of parents upon their child's discharge from the emergency department. A statistically significant decrease in pain for all patients (76) occurred at 30 minutes (F = 4.39, P <.05) and was maintained at 60 minutes. The distraction group demonstrated a statistically significant reduction in pain compared with the other groups at 30 minutes; this reduction was maintained at 60 minutes (F = 47.07, P <.05). Parents of only 6 children expressed dissatisfaction with overall pain management. Twelve percent of children who were not in the group receiving medication received analgesics while in the emergency department. At discharge, only 37% of children with fractures and/or sprains had received medications for pain. Children with musculoskeletal trauma may be under-medicated. Distraction techniques can be an effective adjunct to analgesia for children with musculoskeletal pain in the emergency department and should be made available. Ibuprofen may not be an effective analgesic for children with these injuries; stronger analgesics may be required.

Does therapeutic hypothermia reduce acute kidney injury among term neonates with perinatal asphyxia?--a randomized controlled trial.

PubMed

Tanigasalam, Vasanthan; Bhat, Vishnu; Adhisivam, Bethou; Sridhar, M G

2016-01-01

The objective of this study is to evaluate whether therapeutic hypothermia reduces the incidence of acute kidney injury (AKI) among term neonates perinatal asphyxia. This randomized controlled trial conducted in a tertiary care teaching hospital, south India included 120 term neonates with perinatal asphyxia who were randomized to receive either therapeutic hypothermia or standard supportive care. Renal parameters of neonates in both the groups were monitored and AKI was ascertained as per Acute Kidney Injury Network criteria. The incidence of AKI was less in therapeutic hypothermia group compared to standard treatment group (32% versus 60%, p < 0.05). The incidence of Stages 1, 2, and 3 AKI was 22%, 5%, and 5% in therapeutic hypothermia group compared with 52%, 5%, and 3%, respectively, in the standard treatment group. The mortality was less in therapeutic hypothermia group compared with the standard treatment group (26% versus 50%, p < 0.05). Therapeutic hypothermia reduces the incidence and severity of AKI among term neonates with perinatal asphyxia.

Functional and clinical outcomes of telemedicine in patients with spinal cord injury.

PubMed

Dallolio, Laura; Menarini, Mauro; China, Sandra; Ventura, Manfredi; Stainthorpe, Andy; Soopramanien, Anba; Rucci, Paola; Fantini, Maria Pia

2008-12-01

To compare the 6-month outcomes of telerehabilitation intervention with those of standard care for spinal cord injury (SCI). Multicenter randomized controlled trial. Home, nursing, or unspecialized hospital care provided after discharge from a spinal cord unit. Adult patients with nonprogressive, complete, or incomplete SCI discharged for the first time from the spinal cord unit to their homes (Belgium and Italy) or to their homes or another facility (England). All patients received the standard care they would have normally received after discharge from the spinal cord unit. In addition, patients in the telemedicine group received 8 telemedicine weekly sessions in the first 2 months, followed by biweekly telemedicine sessions for 4 months. Functional status at 6 months, clinical complications during the postdischarge period, and patient satisfaction. No significant differences in the occurrence of clinical complications were found between the study groups. A higher improvement of functional scores in the telemedicine group was found only at the Italian site: FIM total score 3.38+/-4.43 (controls) versus 7.69+/-6.88 (telemedicine group), FIM motor score 3.24+/-4.38 (controls) versus 7.55+/-7.00 (telemedicine group; P<.05). Items contributing to this difference were grooming, dressing upper body, dressing lower body, and bed/chair/wheelchair transfer. Higher satisfaction with care was reported by patients in the telemedicine group across all sites. Our study provides some of the first quantitative evidence, based on results from 1 site, that telerehabilitation may offer benefits to patients discharged from a spinal cord unit compared with standard care in terms of functional improvement. Further research is warranted to confirm or disprove this finding.

Whole body vibration versus magnetic therapy on bone mineral density in elderly osteoporotic individuals.

PubMed

Shanb, Alsayed Abdelhameed; Youssef, Enas Fawzy; Muaidi, Qassim Ibrahim; Alothman, Abdullah Ahmed

2017-08-03

Osteoporosis usually develops gradually and progresses without significant signs and symptoms. It is one of the most common musculoskeletal conditions associated with aging. To evaluate the effects of whole body vibration (WBV) or magnetic therapy in addition to standard pharmacological treatment on bone mineral density (BMD) in elderly individuals being treated for osteoporosis. Eighty-five participants, 60-75 years of age, were randomly divided into three groups. All three groups received the same standard pharmacological treatment comprised of vitamin D, calcium, and alendronate sodium. In Group I, thirty participants were also exposed to WBV for 25 minutes in each session with two sessions per week for 4 months. In Group II, thirty participants were exposed to magnetic therapy for 50 minutes in each session with two sessions per week for 4 months. In Group III, twenty-five participants received only pharmacological treatment. Dual-energy X-ray absorptiometry was used to measure BMD of the lumbar spine and femoral heads before and after interventions. Venus blood sample was drawn for analysis of calcium and vitamin D. An ANOVA test detected significant (p< 0.05) differences in BMD after treatment among the three groups with no significant difference was detected between patients receiving WBV and magnetic therapy. Statistical t-tests detected significant (p< 0.05) increases in BMD after application of WBV or magnetic therapy in combination with pharmacological treatment, but no significant increase after pharmacological treatment alone. Addition of either WBV or magnetic therapy to standard pharmacological treatment for osteoporosis significantly increased BMD in elderly subjects. No significant difference in effectiveness was detected between these two alternative therapy modalities. Consequently, either WBV or magnetic therapy could be effectively applied in conjunction with pharmacological treatment to increase BMD in elderly osteoporotic patients.

Combination of Vancomycin and β-Lactam Therapy for Methicillin-Resistant Staphylococcus aureus Bacteremia: A Pilot Multicenter Randomized Controlled Trial.

PubMed

Davis, Joshua S; Sud, Archana; O'Sullivan, Matthew V N; Robinson, James O; Ferguson, Patricia E; Foo, Hong; van Hal, Sebastiaan J; Ralph, Anna P; Howden, Benjamin P; Binks, Paula M; Kirby, Adrienne; Tong, Steven Y C; Tong, Steven; Davis, Joshua; Binks, Paula; Majumdar, Suman; Ralph, Anna; Baird, Rob; Gordon, Claire; Jeremiah, Cameron; Leung, Grace; Brischetto, Anna; Crowe, Amy; Dakh, Farshid; Whykes, Kelly; Kirkwood, Maria; Sud, Archana; Menon, Mahesh; Somerville, Lucy; Subedi, Shrada; Owen, Shirley; O'Sullivan, Matthew; Liu, Eunice; Zhou, Fei; Robinson, Owen; Coombs, Geoffrey; Ferguson, Patrician; Ralph, Anna; Liu, Eunice; Pollet, Simon; Van Hal, Sebastian; Foo, Hong; Van Hal, Sebastian; Davis, Rebecca

2016-01-15

In vitro laboratory and animal studies demonstrate a synergistic role for the combination of vancomycin and antistaphylococcal β-lactams for methicillin-resistant Staphylococcus aureus (MRSA) bacteremia. Prospective clinical data are lacking. In this open-label, multicenter, clinical trial, adults with MRSA bacteremia received vancomycin 1.5 g intravenously twice daily and were randomly assigned (1:1) to receive intravenous flucloxacillin 2 g every 6 hours for 7 days (combination group) or no additional therapy (standard therapy group). Participants were stratified by hospital and randomized in permuted blocks of variable size. Randomization codes were kept in sealed, sequentially numbered, opaque envelopes. The primary outcome was the duration of MRSA bacteremia in days. We randomly assigned 60 patients to receive vancomycin (n = 29), or vancomycin plus flucloxacillin (n = 31). The mean duration of bacteremia was 3.00 days in the standard therapy group and 1.94 days in the combination group. According to a negative binomial model, the mean time to resolution of bacteremia in the combination group was 65% (95% confidence interval, 41%-102%; P = .06) that in the standard therapy group. There was no difference in the secondary end points of 28- and 90-day mortality, metastatic infection, nephrotoxicity, or hepatotoxicity. Combining an antistaphylococcal β-lactam with vancomycin may shorten the duration of MRSA bacteremia. Further trials with a larger sample size and objective clinically relevant end points are warranted. Australian New Zealand Clinical Trials Registry: ACTRN12610000940077 (www.anzctr.org.au). © The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.

The effect of constructivist teaching strategies on science test scores of middle school students

NASA Astrophysics Data System (ADS)

Vaca, James L., Jr.

International studies show that the United States is lagging behind other industrialized countries in science proficiency. The studies revealed how American students showed little significant gain on standardized tests in science between 1995 and 2005. Little information is available regarding how reform in American teaching strategies in science could improve student performance on standardized testing. The purpose of this quasi-experimental quantitative study using a pretest/posttest control group design was to examine how the use of a hands-on, constructivist teaching approach with low achieving eighth grade science students affected student achievement on the 2007 Ohio Eighth Grade Science Achievement Test posttest (N = 76). The research question asked how using constructivist teaching strategies in the science classroom affected student performance on standardized tests. Two independent samples of 38 students each consisting of low achieving science students as identified by seventh grade science scores and scores on the Ohio Eighth Grade Science Half-Length Practice Test pretest were used. Four comparisons were made between the control group receiving traditional classroom instruction and the experimental group receiving constructivist instruction including: (a) pretest/posttest standard comparison, (b) comparison of the number of students who passed the posttest, (c) comparison of the six standards covered on the posttest, (d) posttest's sample means comparison. A Mann-Whitney U Test revealed that there was no significant difference between the independent sample distributions for the control group and the experimental group. These findings contribute to positive social change by investigating science teaching strategies that could be used in eighth grade science classes to improve student achievement in science.

Outcomes of a pilates-based intervention for individuals with lateral epicondylosis: A pilot study.

PubMed

Dale, Lucinda M; Mikuski, Connie; Miller, Jacqueline

2015-01-01

Core stability and flexibility, features of Pilates exercise, can reduce loads to the upper extremities. Reducing loads is essential to improve symptoms for individuals with lateral epicondylosis. Although Pilates exercise has gained popularity in healthy populations, it has not been studied for individuals with lateral epicondylosis. The purpose of this study was to determine if adding Pilates-based intervention to standard occupational therapy intervention improved outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) more than standard intervention for individuals with lateral epicondylosis. Participants (N= 17) were randomized to the standard intervention group or Pilates-based intervention group. All participants received standard intervention. The Pilates-based intervention group additionally completed abdominal strengthening, postural correction, and flexibility. For both groups, paired t-tests showed significantly improved PRTEE scores, 38.1 for the Pilates-based intervention group, and 22.9 for the standard intervention group. Paired t-test showed significantly improved provocative grip strength and pain for both groups. Independent t-tests showed no significant difference between groups in improved scores of PRTEE, pain, and provocative grip. Although the Pilates-based intervention group showed greater improvement in PRTEE outcome, provocative grip, and pain, scores were not significantly better than those of the standard intervention group, warranting further research.

Relational Psychotherapy Mothers’ Group: A developmentally informed intervention for at-risk mothers

PubMed Central

Luthar, Suniya S.; Suchman, Nancy E.

2012-01-01

The Relational Psychotherapy Mothers’ Group (RPMG), a developmentally informed, supportive psychotherapy designed to serve heroin-addicted mothers with children up to 16 years of age, aims at addressing psychosocial vulnerabilities, and facilitating optimal parenting, among at-risk mothers. We present preliminary evidence on the efficacy of RPMG as an “add on” treatment in comparison with standard methadone counseling alone. At the end of the 24-week treatment period, mothers receiving RPMG plus standard methadone counseling demonstrated lower levels of risk for child maltreatment, greater involvement with their children, and more positive psychosocial adjustment than women who received methadone counseling alone. Children of RPMG participants also reflected fewer problems in multiple areas. At 6 months posttreatment, RPMG recipients continued to be at a relative advantage, although the magnitude of group differences was often attenuated. Notably, urinalyses indicated that RPMG mothers showed greater improvements in levels of opioid use over time than comparison mothers. PMID:10847626

Tolerance, effectiveness, and acceptability of sulfate-free electrolyte lavage solution for colon cleaning before colonoscopy.

PubMed

Raymond, J M; Beyssac, R; Capdenat, E; Pineau, C H; Kerjean, A; Saux, M C; Couzigou, P; Amouretti, M

1996-09-01

The unpleasant taste of the solution used for preparation before colonoscopy may limit patients' compliance with the procedure. However, the published results concerning the acceptability of sulfate-free electrolyte lavage solution (SF-ELS) for colon cleansing before colonoscopy are conflicting. The aim of this study was to compare SF-ELS with the standard polyethylene glycol (PEG) solution with regard to tolerance, effectiveness, and acceptability. In the first part of the study, 24 patients were assigned to receive either one liter of SF-ELS or one liter of the standard PEG solution. After two hours, the patients had to choose two further liters (of either the first or second solution), and preparation for colonoscopy was completed. In the second part, fifty further patients were randomized into two groups: 25 patients received four liters of standard solution, and 25 patients received four liters of SF-ELS. The patients' opinions regarding the preparation and their willingness to repeat the use of the same preparation were recorded by questionnaire. The quality of the colon preparation was assessed by the endoscopists. Seventeen patients (71%; P < 0.05) preferred SF-ELS. The compliance rate in the two groups was 96%, and the frequency of occurrence of adverse effects was also similar. Colonoscopy was completed in 24 of the 25 patients in the SF-ELS group and 22 of the 25 patients in the standard PEG group (the difference was not significant). Visualization of the mucosa in the areas explored was perfect in 20 of the 25 patients in the SF-ELS group and in 17 of the 25 patients in the PEG group (not significant). Patients had a significant preference for SF-ELS. Eighteen of the 25 patients in the SF-ELS group were willing to accept the same preparation for a further colonoscopy, compared with 11 of the 25 in the other group (P < 0.05). Improving the acceptability of colonic preparation before colonoscopy could improve patients' compliance and the quality of the follow-up. The results of this study justify further investigation of SF-ELS.

Enhancing the efficacy of treatment for temporomandibular patients with muscular diagnosis through cognitive-behavioral intervention, including hypnosis: a randomized study.

PubMed

Ferrando, Maite; Galdón, María José; Durá, Estrella; Andreu, Yolanda; Jiménez, Yolanda; Poveda, Rafael

2012-01-01

This study evaluated the efficacy of a cognitive-behavioral therapy (CBT), including hypnosis, in patients with temporomandibular disorders (TMDs) with muscular diagnosis. Seventy-two patients (65 women and 7 men with an average age of 39 years) were selected according to the Research Diagnostic Criteria for TMD, and assigned to the experimental group (n = 41), receiving the 6-session CBT program, and the control group (n = 31). All patients received conservative standard treatment for TMD. The assessment included pain variables and psychologic distress. There were significant differences between the groups, the experimental group showing a higher improvement in the variables evaluated. Specifically, 90% of the patients under CBT reported a significant reduction in frequency of pain and 70% in emotional distress. The improvement was stable over time, with no significant differences between posttreatment and 9-month follow-up. CBT, including hypnosis, significantly improved conservative standard treatment outcome in TMD patients. Copyright © 2012 Elsevier Inc. All rights reserved.

REDUCTION OF CLASSROOM NOISE LEVELS USING GROUP CONTINGENCIES

PubMed Central

Ring, Brandon M.; Sigurdsson, Sigurdur O.; Eubanks, Sean L.; Silverman, Kenneth

2016-01-01

The therapeutic workplace is an employment-based abstinence reinforcement intervention for unemployed drug users where trainees receive on-the-job employment skills training in a classroom setting. The study is an extension of prior therapeutic workplace research, which suggested that trainees frequently violated noise standards. Participants received real-time graphed feedback of noise levels and had the opportunity to earn monetary group reinforcement for maintaining a low number of noise violations. Results suggested that feedback and monetary reinforcement reduced the number of noise violations. PMID:25175843

Effect of a randomised exclusive breastfeeding counselling intervention nested into the MINIMat prenatal nutrition trial in Bangladesh.

PubMed

Khan, Ashraful Islam; Kabir, Iqbal; Eneroth, Hanna; El Arifeen, Shams; Ekström, Eva-Charlotte; Frongillo, Edward A; Persson, Lars Åke

2017-01-01

It is unknown whether maternal malnutrition reduces the effect of counselling on exclusive breastfeeding. This study evaluated the effect of breastfeeding counselling on the duration of exclusive breastfeeding, and whether the timing of prenatal food and different micronutrient supplements further prolonged this duration. Pregnant women in Matlab, Bangladesh, were randomised to receive daily food supplements of 600 kcal at nine weeks of gestation or at the standard 20 weeks. They also were allocated to either 30 mg of iron and 400 μg folic acid, or the standard programme 60 mg of iron and folic acid or multiple micronutrients. At 30 weeks of gestation, 3188 women were randomised to receive either eight breastfeeding counselling sessions or the usual health messages. The median duration of exclusive breastfeeding was 135 days in the counselling group and 75 days in the usual health message group (p < 0.001). Prenatal supplements did not modify the effects of counselling. Women in the usual health message group who were randomised to multiple micronutrients exclusively breastfed for 12 days longer than mothers receiving the standard iron-folate combination (p = 0.003). Breastfeeding counselling increased the duration of exclusive breastfeeding by 60 days. This duration was not influenced by the supplements. ©2016 The Authors. Acta Paediatrica published by John Wiley & Sons Ltd on behalf of Foundation Acta Paediatrica.

Decreases in smoking during treatment for methamphetamine-use disorders: preliminary evidence.

PubMed

McPherson, Sterling; Orr, Michael; Lederhos, Crystal; McDonell, Michael; Leickly, Emily; Hirchak, Katherine; Oluwoye, Oladunni A; Murphy, Sean M; Layton, Matthew; Roll, John M

2018-06-01

Despite high rates of smoking (70-90%) and the severely negative impact of smoking on physical and mental health, only 12% of individuals receiving stimulant-use disorder treatment also receive smoking-cessation treatment. The aim of this investigation was to examine the effect of a contingency management (CM) intervention targeting methamphetamine (MA) use on cigarette smoking. Sixty-one adults with MA-use disorders who were smokers were assigned to CM or standard psychosocial treatment. Rates of smoking-negative breath samples (carbon monoxide <3 ppm) were compared between the two groups while controlling for baseline carbon monoxide level, marijuana use, MA use, and time. This subgroup of mostly male (59%) participants included 44 participants in the CM group and 17 participants in the standard psychosocial treatment. Tobacco smoking participants who received CM targeting MA use were 140% (odds ratio: 2.395; 95% confidence interval: 1.073-5.346) more likely to submit a smoking-negative breath sample relative to standard psychosocial treatment during the treatment period, holding constant several other prespecified covariates. This study provides evidence that a behavioral treatment for MA use results in reductions in cigarette smoking in adults with MA-use disorder.

Using Ultrasound to Enhance Medical Students' Femoral Vascular Physical Examination Skills.

PubMed

Ahn, Justin S; French, Andrew J; Thiessen, Molly E W; Browne, Vaughn; Deutchman, Mark; Guiton, Gretchen; Madigosky, Wendy; Kendall, John L

2015-10-01

To determine whether the addition of ultrasound to traditional physical examination instruction improves junior medical students' abilities to locate the femoral pulse. Initially, 150 second-year medical students were taught the femoral pulse examination using traditional bedside teaching on standardized patients and online didactic videos. Students were then randomized into 2 groups: group 1 received ultrasound training first and then completed the standardized examination; and group 2 performed the standardized examination first and then received ultrasound training. On the standardized patients, the femoral artery was marked with invisible ink before the sessions using ultrasound. Compared to these markers, students were then evaluated on the accuracy of femoral artery pulse palpation and the estimated location of the femoral vein. All students completed a self-assessment survey after the ultrasound sessions. Ultrasound training improved the students' ability to palpate the femoral pulse (P= .02). However, ultrasound did not facilitate correct estimation of the femoral vein's anatomic location (P = .09). Confidence levels in localizing the femoral artery and vein were equal between groups at baseline, and both increased after the ultrasound sessions. The addition of ultrasound teaching to traditional physical examination instruction enhanced medical student competency and confidence with the femoral vascular examination. However, understanding of anatomy may require emphasis on precourse didactic material, but further study is required. © 2015 by the American Institute of Ultrasound in Medicine.

The Effect of Directed Medical Play on Young Children's Pain and Distress during Burn Wound Care

PubMed Central

Moore, Elizabeth R.; Bennett, Katherine; Dietrich, Mary S.; Wells, Nancy

2015-01-01

Directed medical play is used to reduce children's pain and distress during medical treatment. In this pilot study, young children who attended the burn clinic received either directed medical play provided by a child life specialist or standard preparation from the burn clinic nurse, to prepare for their first dressing change. Data were collected using validated instruments. Children who participated in medical play experienced less distress during their dressing change (M= 0.5, n=12) than those receiving standard preparation (M=2.0, n=9). Children who received standard care reported a 2 point increase in pain during the procedure whereas children who participated in medical play reported a 1 point increase. Change in parental anxiety was similar for both groups. Parent satisfaction was higher for caregivers who observed medical play than standard preparation. Although all findings were in the hypothesized direction, none were statically significant, most likely because of the small sample size. PMID:25631102

Preoperative chemoradiotherapy and postoperative chemotherapy with fluorouracil and oxaliplatin versus fluorouracil alone in locally advanced rectal cancer: initial results of the German CAO/ARO/AIO-04 randomised phase 3 trial.

PubMed

Rödel, Claus; Liersch, Torsten; Becker, Heinz; Fietkau, Rainer; Hohenberger, Werner; Hothorn, Torsten; Graeven, Ullrich; Arnold, Dirk; Lang-Welzenbach, Marga; Raab, Hans-Rudolf; Sülberg, Heiko; Wittekind, Christian; Potapov, Sergej; Staib, Ludger; Hess, Clemens; Weigang-Köhler, Karin; Grabenbauer, Gerhard G; Hoffmanns, Hans; Lindemann, Fritz; Schlenska-Lange, Anke; Folprecht, Gunnar; Sauer, Rolf

2012-07-01

Preoperative chemoradiotherapy, total mesorectal excision surgery, and adjuvant chemotherapy with fluorouracil is the standard combined modality treatment for rectal cancer. With the aim of improving disease-free survival (DFS), this phase 3 study (CAO/ARO/AIO-04) integrated oxaliplatin into standard treatment. This was a multicentre, open-label, randomised, phase 3 study in patients with histologically proven carcinoma of the rectum with clinically staged T3-4 or any node-positive disease. Between July 25, 2006, and Feb 26, 2010, patients were randomly assigned to two groups: a control group receiving standard fluorouracil-based combined modality treatment, consisting of preoperative radiotherapy of 50·4 Gy plus infusional fluorouracil (1000 mg/m(2) days 1-5 and 29-33), followed by surgery and four cycles of bolus fluorouracil (500 mg/m(2) days 1-5 and 29; fluorouracil group); and an experimental group receiving preoperative radiotherapy of 50·4 Gy plus infusional fluorouracil (250 mg/m(2) days 1-14 and 22-35) and oxaliplatin (50 mg/m(2) days 1, 8, 22, and 29), followed by surgery and eight cycles of adjuvant chemotherapy with oxaliplatin (100 mg/m(2) days 1 and 15), leucovorin (400 mg/m(2) days 1 and 15), and infusional fluorouracil (2400 mg/m(2) days 1-2 and 15-16; fluorouracil plus oxaliplatin group). Randomisation was done with computer-generated block-randomisation codes stratified by centre, clinical T category (cT1-4 vs cT4), and clinical N category (cN0 vs cN1-2) without masking. DFS is the primary endpoint. Secondary endpoints, including toxicity, compliance, and histopathological response are reported here. Safety and compliance analyses included patients as treated, efficacy endpoints were analysed according to the intention-to-treat principle. This study is registered with ClinicalTrials.gov, number NCT00349076. Of the 1265 patients initially enrolled, 1236 were evaluable (613 in the fluorouracil plus oxaliplatin group and 623 in the fluorouracil group). Preoperative grade 3-4 toxic effects occurred in 140 (23%) of 606 patients who actually received fluorouracil and oxaliplatin during chemoradiotherapy and in 127 (20%) of 624 patients who actually received fluorouracil chemoradiotherapy. Grade 3-4 diarrhoea was more common in those who received fluorouracil and oxaliplatin during chemoradiotherapy than in those who received fluorouracil during chemoradiotherapy (73 patients [12%] vs 52 patients [8%]), as was grade 3-4 nausea or vomiting (23 [4%] vs nine [1%]). 516 (85%) of the 606 patients who received fluorouracil and oxaliplatin-based chemoradiotherapy had the full dose of chemotherapy, and 571 (94%) had the full dose of radiotherapy; as did 495 (79%) and 601 (96%) of 624 patients who received fluorouracil-based chemoradiotherapy, respectively. A pathological complete response was achieved in 103 (17%) of 591 patients who underwent surgery in the fluorouracil and oxaliplatin group and in 81 (13%) of 606 patients who underwent surgery in the fluorouracil group (odds ratio 1·40, 95% CI 1·02-1·92; p=0·038). In the fluorouracil and oxaliplatin group, 352 (81%) of 435 patients who began adjuvant chemotherapy completed all cycles (with or without dose reduction), as did 386 (83%) of 463 patients in the fluorouracil group. Inclusion of oxaliplatin into modified fluorouracil-based combined modality treatment was feasible and led to more patients achieving a pathological complete response than did standard treatment. Longer follow-up is needed to assess DFS. German Cancer Aid (Deutsche Krebshilfe). Copyright © 2012 Elsevier Ltd. All rights reserved.

Effect of Unripe Plantain (Musa paradisiaca) and Ginger (Zingiber officinale) on Blood Glucose, Body Weight and Feed Intake of Streptozotocin-induced Diabetic Rats

PubMed Central

M, Iroaganachi; C.O, Eleazu; P.N, Okafor; N, Nwaohu

2015-01-01

Objective: To determine the effect of unripe plantain (Musa paradisiaca) and ginger (Zingiber officinale) on blood glucose (BG), feed intake (FI) and weight of streptozotocin (STZ) induced diabetic rats. Methods: Twenty four male albino rats were used and were divided into 4 groups of 6 rats each. Group 1 (non-diabetic) and Group 2 (diabetic) received standard rat feed; Group 3 received unripe plantain incorporated feed (810 /kg body weight) and Group 4 received unripe plantain+ginger incorporated feed (710:100 g/kg body weight). The weights and FI of the rats were measured daily throughout the experimentation. Results: Groups 3 and 4 rats had 159.52% and 71.83% decreases in BG but 24.91% and 35.32% decreases in weights compared with groups 1 and 2 rats that had 2.09% and 22.94% increases in BG with 13.42% increase and 45.36% decrease in weights respectively. The FI of the experimental rats did not differ significantly from each other (P>0.05) at the end of experimentation. The standard rat feed contained higher amounts of Ca but lower amounts of Mg and Fe compared with the unripe plantain and unripe plantain+ginger incorporated feeds. Conclusion: Combination of unripe plantain and ginger at the dose used in the management of diabetes was not very effective compared with unripe plantain alone. PMID:25674161

The obviously ill patient in need of treatment: a fourth standard for civil commitment.

PubMed

Treffert, D A

1985-03-01

The three relatively standard criteria currently contained in most state civil commitment laws (danger to self, danger to others, and gravely disabled) have forced many obviously ill patients to deteriorate to the point of dangerousness before receiving treatment, to become criminalized, or to wander the streets untreated. After discussing the origins of present civil commitment laws and the plight of obviously ill patients, the author details the cooperative effort of several groups in Wisconsin to codify a fourth standard for civil commitment that would ensure that obviously ill patients receive treatment with proper procedural and due process safeguards. Other statutory alternatives to remedy the plight of obviously ill patients are also discussed.

Effectiveness of a new standardised Urinary Continence Physiotherapy Programme for community-dwelling older women in Hong Kong.

PubMed

Leong, B S; Mok, Nicola W

2015-02-01

To examine the effectiveness of a standardised Urinary Continence Physiotherapy Programme for older Chinese women with stress, urge, or mixed urinary incontinence. A controlled trial. Six elderly community health centres in Hong Kong. A total of 55 women aged over 65 years with mild-to-moderate urinary incontinence. Participants were randomly assigned to the intervention group (n=27) where they received eight sessions of Urinary Continence Physiotherapy Programme for 12 weeks. This group received education about urinary incontinence, pelvic floor muscle training with manual palpation and verbal feedback, and behavioural therapy. The control group (n=28) was given advice and an educational pamphlet on urinary incontinence. There was significant improvement in urinary symptoms in the intervention group, especially in the first 5 weeks. Compared with the control group, participants receiving the intervention showed significant reduction in urinary incontinence episodes per week with a mean difference of -6.4 (95% confidence interval, -8.9 to -3.9; t= -5.3; P<0.001) and significant improvement of quality of life with a mean difference of -3.93 (95% confidence interval, -5.08 to -2.78; t= -6.9; P<0.001) measured by Incontinence Impact Questionnaire Short Form modified Chinese (Taiwan) version. The subjective perception of improvement, measured by an 11-point visual analogue scale, was markedly better in the intervention group (mean, 8.7; standard deviation, 1.0; 95% confidence interval, 8.4-9.1) than in the control group (mean, 1.4; standard deviation, 0.7; 95% confidence interval, 1.2-1.7; t=33.9; P<0.001). The mean treatment satisfaction in the intervention group was 9.5 (standard deviation, 0.8) as measured by an 11-point visual analogue scale. This study demonstrated that the Urinary Continence Physiotherapy Programme was effective in alleviating urinary symptoms among older Chinese women with mild-to-moderate heterogeneous urinary incontinence.

Making Nasopalatine Blocks Comfortable: A Randomised Prospective Clinical Comparison of Pain Associated with the Injection Using an Insulin Syringe and a Standard Disposable 3 mL Syringe.

PubMed

Prabhu, Sundararaman; Faizel, Syed; Pahlajani, Vedant; Prabhu, Shweta Jha

2013-12-01

This study was conducted to compare and evaluate the pain associated with administration of Nasopalatine blocks using a disposable insulin syringe and the conventional disposable 3 mL syringe. Forty patients requiring intraalveolar extractions of maxillary central incisors were randomly assigned to two groups of 20 patients each; one (Group A) received the nasopalatine block with a standard 3mL syringe and the other (Group B) received the block with an insulin syringe. Patients were asked to rate the pain associated with the injection on a visual analog scale (VAS) and the results were analysed using a Chi Square Test. The mean VAS score for Group A and B was 1.55 and 1 respectively. Chi Square value was calculated to be 8.603 (degree of freedom= 3, P value= 0.0351). There were no differences in the effectiveness of anesthesia between the groups. Pain associated with administration of the nasopalatine blocks may be significantly mitigated by using the Insulin syringe.

Effect of attention therapy on reading comprehension.

PubMed

Solan, Harold A; Shelley-Tremblay, John; Ficarra, Anthony; Silverman, Michael; Larson, Steven

2003-01-01

This study quantified the influence of visual attention therapy on the reading comprehension of Grade 6 children with moderate reading disabilities (RD) in the absence of specific reading remediation. Thirty students with below-average reading scores were identified using standardized reading comprehension tests. Fifteen children were placed randomly in the experimental group and 15 in the control group. The Attention Battery of the Cognitive Assessment System was administered to all participants. The experimental group received 12 one-hour sessions of individually monitored, computer-based attention therapy programs; the control group received no therapy during their 12-week period. Each group was retested on attention and reading comprehension measures. In order to stimulate selective and sustained visual attention, the vision therapy stressed various aspects of arousal, activation, and vigilance. At the completion of attention therapy, the mean standard attention and reading comprehension scores of the experimental group had improved significantly. The control group, however, showed no significant improvement in reading comprehension scores after 12 weeks. Although uncertainties still exist, this investigation supports the notion that visual attention is malleable and that attention therapy has a significant effect on reading comprehension in this often neglected population.

Impact of relaxation training according to Yoga In Daily Life® system on perceived stress after breast cancer surgery.

PubMed

Kovačič, Tine; Kovačič, Miha

2011-03-01

The purpose of this pilot study was to gather information on the immediate and short-term effects of relaxation training according to Yoga In Daily Life(®) (YIDL) system on the psychological distress of breast cancer patients. 32 patients at the Institute for Oncology of Ljubljana were randomized to the experimental (N=16) and to the control group (N=16). Both groups received the same standard physiotherapy for 1 week, while the experimental group additionally received a group relaxation training sessions according to YIDL(®) system. At discharge the experimental group was issued with audiocassette recordings containing the similar instructions for relaxation training to be practiced individually at home (for further 3 weeks). An experimental repeated measures design was used to investigate the differences over 1 month period in stress levels, changes in mental health and psychological parameters. Measures were obtained at three time points during the study period: baseline, at 1 week, and at 4 weeks, by blinded investigators using standardized questionnaires General Health Questionnaire-12 (GHQ-12), Rotterdam Symptom Checklist (RSCL) psychological subscale, Perceived Stress Scale (PSS). Patients who received relaxation training reported feeling significantly less distressed during hospitalization and after discharge-period than did the controls that did not receive relaxation training. The results indicate that relaxation training according to Yoga in Daily Life(®) system could be useful clinical physiotherapy intervention for breast cancer patients experiencing psychological distress. Although this kind of relaxation training can be applied to clinical oncology in Slovenia, more studies need to be done. © The Author(s) 2011

The effect of inflatable obstetric belts in nulliparous pregnant women receiving patient-controlled epidural analgesia during the second stage of labor.

PubMed

Kim, Jong-Woon; Kim, Yoon Ha; Cho, Hye Yon; Shin, Hee-Young; Shin, Jong Chul; Choi, Sea Kyung; Lee, Keun-Young; Song, Ji-Eun; Lee, Pil-Ryang

2013-11-01

The aim of this study was to evaluate the effect of inflatable obstetric belts on uterine fundal pressure in the management of the second stage of labor. Between July 2009 and December 2010, 188 nulliparous women with a singleton pregnancy at term were enrolled and only one dropped. The participants were randomized to receive either standard care (control group, n = 91) or uterine fundal pressure by the Labor Assister (Baidy M-520/Curexo, Inc., Seoul, Korea; active group, n = 97) during the second stage of labor in addition to standard care. The Labor Assister is an inflatable obstetric belt that is synchronized to apply constant fundal pressure during a uterine contraction. The primary endpoint was duration of the second stage of labor in women who delivered vaginally (control, n = 80 versus active, n = 93). It was not analyzed in women who delivered by cesarean section (n = 14) and delivered precipitously (n = 1). The secondary outcomes are perinatal outcomes and perineal laceration. Participants received patient-controlled epidural analgesia. The 93 women in the active group spent less time in the second stage of labor when compared to the 80 women in the control group (46.51 ± 28.01 min versus 75.02 ± 37.48 min, p < 0.001). There was no significant difference in perinatal outcomes and perineal laceration between the two groups. The uterine fundal pressure exerted by the inflatable obstetric belt reduces the duration of the second stage of labor without complications in nulliparous women who receive patient-controlled epidural analgesia.

A real-life observational study of the effectiveness of FACT in a Dutch mental health region.

PubMed

Drukker, Marjan; Maarschalkerweerd, Myrte; Bak, Maarten; Driessen, Ger; à Campo, Joost; de Bie, Arthur; Poddighe, Giovanni; van Os, Jim; Delespaul, Philippe

2008-12-04

ACT is an effective community treatment but causes discontinuity of care between acutely ill and currently stable patient groups. The Dutch variant of ACT, FACT, combines both intensive ACT treatment and care for patients requiring less intensive care at one time point yet likely to need ACT in the future. It may be hypothesised that this case mix is not beneficial for patients requiring intensive care, as other patient groups may "dilute" care provision. The effectiveness of FACT was compared with standard care, with a particular focus on possible moderating effects of patient characteristics within the case mix in FACT. In 2002, three FACT teams were implemented in a Dutch region in which a cumulative routine outcome measurement system was in place. Patients receiving FACT were compared with patients receiving standard treatment, matched on "baseline" symptom severity and age, using propensity score matching. Outcome was the probability of being in symptomatic remission of psychotic symptoms. The probability of symptomatic remission was higher for SMI patients receiving FACT than for controls receiving standard treatment, but only when there was an unmet need for care with respect to psychotic symptoms (OR = 6.70, p = 0.002; 95% CI = 1.97-22.7). Compared to standard care, FACT was more rather than less effective, but only when a need for care with respect to psychotic symptoms is present. This suggests that there is no adverse effect of using broader patient mixes in providing continuity of care for all patients with severe mental illness in a defined geographical area.

Safety of nicotine replacement therapy in critically ill smokers: a retrospective cohort study.

PubMed

Kerr, A; McVey, J T; Wood, A M; Van Haren, Fmp

2016-11-01

Nicotine replacement therapy (NRT) is a common first-line treatment to prevent nicotine withdrawal in smokers. However, available literature reports conflicting results regarding its efficacy and safety in critically ill patients. The objective of this study was to evaluate the relationship between NRT in smokers in the intensive care unit (ICU) and outcomes. This case-control study was conducted in a university-affiliated tertiary hospital ICU. Over a period of five years, 126 active smokers who received transdermal NRT were matched to 126 active smokers who did not receive NRT. The groups were case-matched for sex, age and Acute Physiology and Chronic Health Evaluation II (APACHE II) score. The primary outcome was administration of antipsychotic medication. Secondary outcomes included use of physical restraints, 30-day mortality, and ventilation requirements. Antipsychotic medication was prescribed in 43 (34.1%) patients who received NRT compared to 14 (11.1%) in controls ( P <0.01). Physical restraints were used in 37 (29.4%) patients who received NRT, compared to 12 (9.5%) of controls ( P <0.01). The 30-day mortality and number of patients intubated was not statistically different between groups. Average length of intubation time was greater in the NRT group (2.56 days; standard deviation 4.16) compared to the control group (1.44 days; standard deviation 2.68) ( P =0.012). The use of NRT to prevent nicotine withdrawal in ICU patients is associated with increased use of antipsychotic medication and physical restraint, and with prolonged mechanical ventilation.

Effectiveness of a standardized back school program for patients with chronic low back pain after implementation in routine rehabilitation care.

PubMed

Meng, Karin; Peters, Stefan; Faller, Hermann

2017-06-01

To evaluate the effectiveness of a standardized, patient-oriented, biopsychosocial back school after implementation in inpatient orthopedic rehabilitation. A multi-center, quasi-experimental controlled study of patients with low back pain (n=535) was conducted. Patients in the control group received the traditional back school before implementation of the new program (usual care); patients in the intervention group received the new standardized back school after implementation into routine care. Patients' illness knowledge and conduct of back exercises (primary outcomes) and secondary self-management outcomes and treatment satisfaction were obtained at admission, discharge, and 6 and 12 months after rehabilitation. We found a significant small between-group intervention effect on patients' illness knowledge in medium- to long term (6 months: η 2 =0.015; 12 months: η 2 =0.013). There were trends for effects on conduct of back exercises among men (6 and 12 months: η 2 =0.008 both). Furthermore, significant small effects were observed for treatment satisfaction at discharge and physical activity after 6 months. The standardized back school seems to be more effective in certain outcomes than a usual care program despite heterogeneous program implementation. Further dissemination within orthopedic rehabilitation may be encouraged to foster self-management outcomes. Copyright © 2017 Elsevier B.V. All rights reserved.

Effects of prophylactic antibiotics on endometrial flora in women with postcesarean endometritis.

PubMed

Newton, E R; Wallace, P A

1998-08-01

To determine the effect of prophylactic antibiotics on endometrial and endocervical microflora upon diagnosis of postcesarean endometritis. The medical records of patients enrolled in open-label comparative trials of therapeutic antibiotics for postpartum endometritis between 1989 and 1994 were reviewed (n = 682). Endometritis was diagnosed by a standard definition that included fever and localizing signs. Endometrial cultures were obtained by a sheathed injection/aspiration technique. Aerobes and anaerobes were isolated by standard microbiologic techniques. The primary outcome, endometrial and endocervical microflora, was compared in women who received intravenous ampicillin (2 g every 6 hours for 1-3 doses), cephalosporin (2 g every 6 hours for 1-3 doses), or no prophylaxis. Secondary outcomes included the cure of endometritis and the prevalence of wound infection in the three groups. Four hundred sixty-five of 682 patients (67%) had a cesarean delivery. One hundred fifty-one patients received ampicillin prophylaxis, 100 patients received cefazolin prophylaxis, 18 patients received extended-spectrum antibiotics, and 196 patients received no prophylaxis. Patients who received cefazolin prophylaxis had a significant increase in enterococcus (P < .05) and a significant decrease in Proteus species (P < .05) from endometrial samples. Patients who received ampicillin prophylaxis had a significant increase of Mycoplasma species (P < .05), Klebsiella pneumoniae (P < .0001), Escherichia coli (P = .04), and any aerobic gram-negative rod (P = .003) from endometrial samples. Ampicillin prophylaxis was associated with a decrease in Prevotella bivia (P < .05) and any anaerobe (P < .01). Endometritis cure rates were similar between prophylaxis groups and between prophylaxis and treatment groups. However, the cefazolin prophylaxis followed by cephalosporin treatment was associated with more wound infections (19%) than other prophylaxis and treatment groups, (6%, P < .01). Ampicillin and cefazolin prophylaxis alters endometrial and endocervical microflora of women who develop endometritis. Whereas these changes had no effect on endometritis cure rate (power > 80%), the association between cefazolin prophylaxis followed by an extended-spectrum cephalosporin and wound infection may warrant caution against the use of the combination.

Could lengthening minocycline therapy better treat early syphilis?

PubMed

Shao, Li-Li; Guo, Rui; Shi, Wei-Jie; Liu, Yuan-Jun; Feng, Bin; Han, Long; Liu, Quan-Zhong

2016-12-01

Syphilis is a sexually transmitted disease caused by Treponema pallidum. Minocycline, a representative tetracycline derivative, has the greatest antimicrobial activity among all tetracyclines. There are few reports about treating syphilis with minocycline because there is a lack of efficacy data from controlled trials. We compared the rates of serological cure in patients with early syphilis who were treated with minocycline or benzathine penicillin G (BPG).During the study period, a total of 40 syphilis patients received the BPG treatment, which was a single intramuscular dose of 2.4 million units of BPG, and 156 patients were treated with minocycline; 77 patients were placed in the 2-week, standard minocycline therapy group and received 100 mg of minocycline orally, twice daily for 14 days, and 79 patients were placed in the 4-week, lengthened minocycline therapy group and received 100 mg of minocycline orally, twice daily for 28 days. The outcome of interest was the rate of serological cure in these patients.At the end of the 2-year follow-up, the serological cure rate of the 4-week, lengthened minocycline therapy group (87.34%) was higher than that of both the 2-week, standard minocycline therapy group (72.73%) and the BPG treatment group (77.50%). In addition, the curative effect of the 4-week, lengthened minocycline therapy was significantly greater than that of the 2-week, standard minocycline therapy in patients who were aged >40 years; exhibited an initial rapid plasma reagin titer ≥1: 32; or exhibited secondary syphilis (P = 0.000, 0.008, 0.000; <0.05).Minocycline appears to be an effective agent for treating early syphilis, especially when applied as a 4-week, lengthened therapy.

Ultrasound-guided rectus sheath and transversus abdominis plane blocks for perioperative analgesia in upper abdominal surgery: A randomized controlled study.

PubMed

Abdelsalam, Khaled; Mohamdin, O W

2016-01-01

Regional anesthetic techniques can be used to alleviate postoperative pain in patients undergoing major upper abdominal surgery. Our aim was to evaluate the efficacy of bilateral ultrasound (US)-guided rectus sheath (RS) and transversus abdominis plane (TAP) blocks for better perioperative analgesia. It is a prospective, observer-blinded, randomized clinical study. 40 eligible patients undergoing elective liver resection or Whipple procedure were included. All patients received a standardized anesthetic technique. Group 1 (n = 20) received preincisional US-guided bilateral RS and TAP blocks using 20 ml volume of bupivacaine 0.25% for each, and group 2 (n = 20) received local wound infiltration at end of surgery with 40 ml of bupivacaine 0.25%. A standardized postoperative analgesic regimen composed of intravenous paracetamol and a morphine patient-controlled analgesia (PCA). The use of intraoperative fentanyl and recovery room morphine boluses, PCA-administered morphine, pain scores as well as number of patients' experienced postoperative nausea and vomiting in the ward at 6 and 24 h were recorded. Group 1 patients received a significantly lower cumulative intraoperative fentanyl, significantly lesser boluses of morphine in postanesthesia care unit, as well, significantly lower cumulative 24 h postoperative morphine dosage than the group 2 patients. Pain visual analog scale scores were significantly lower at both 6 and 24 h postoperatively in TAP group when compared with the no-TAP group. There were no complications related to the TAP block procedures. No signs or symptoms of local anesthetic systemic toxicity were detected. The combination of bilateral US-guided RS and TAP blocks provides excellent perioperative analgesia for major upper abdominal surgery.

Combination of arginine, glutamine, and omega-3 fatty acid supplements for perioperative enteral nutrition in surgical patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST): A prospective, randomized, double-blind study.

PubMed

Ma, C; Tsai, H; Su, W; Sun, L; Shih, Y; Wang, J

2018-05-31

Perioperative enteral nutrition (EN) enriched with immune-modulating substrates is preferable for patients undergoing major abdominal cancer surgery. In this study, perioperative EN enriched with immune-modulating nutrients such as arginine, glutamine, and omega-3 fatty acids was evaluated for its anti-inflammatory efficacy in patients with gastric adenocarcinoma or gastrointestinal stromal tumor (GIST) receiving curative surgery. This prospective, randomized, double-blind study recruited 34 patients with gastric adenocarcinoma or gastric GIST undergoing elective curative surgery. These patients were randomly assigned to the study group, receiving immune-modulating nutrient-enriched EN, or the control group, receiving standard EN from 3 days before surgery (preoperative day 3) to up to postoperative day 14 or discharge. Laboratory and inflammatory parameters were assessed on preoperative day 3 and postoperative day 14 or at discharge. Adverse events (AEs) and clinical outcomes were documented daily and compared between groups. No significant differences were observed between the two groups in selected laboratory and inflammatory parameters, or in their net change, before and after treatment. AEs and clinical outcomes, including infectious complications, overall complications, time to first bowel action, and length of hospital stay after surgery, were comparable between treatment groups (all P > 0.05). Immune-modulating nutrient-enriched EN had no prominent immunomodulation effect compared with that of standard EN.

A Trypsin Inhibitor from Tamarind Reduces Food Intake and Improves Inflammatory Status in Rats with Metabolic Syndrome Regardless of Weight Loss.

PubMed

Carvalho, Fabiana M C; Lima, Vanessa C O; Costa, Izael S; Medeiros, Amanda F; Serquiz, Alexandre C; Lima, Maíra C J S; Serquiz, Raphael P; Maciel, Bruna L L; Uchôa, Adriana F; Santos, Elizeu A; Morais, Ana H A

2016-09-27

Trypsin inhibitors are studied in a variety of models for their anti-obesity and anti-inflammatory bioactive properties. Our group has previously demonstrated the satietogenic effect of tamarind seed trypsin inhibitors (TTI) in eutrophic mouse models and anti-inflammatory effects of other trypsin inhibitors. In this study, we evaluated TTI effect upon satiety, biochemical and inflammatory parameters in an experimental model of metabolic syndrome (MetS). Three groups of n = 5 male Wistar rats with obesity-based MetS received for 10 days one of the following: (1) Cafeteria diet; (2) Cafeteria diet + TTI (25 mg/kg); and (3) Standard diet. TTI reduced food intake in animals with MetS. Nevertheless, weight gain was not different between studied groups. Dyslipidemia parameters were not different with the use of TTI, only the group receiving standard diet showed lower very low density lipoprotein (VLDL) and triglycerides (TG) (Kruskal-Wallis, p < 0.05). Interleukin-6 (IL-6) production did not differ between groups. Interestingly, tumor necrosis factor-alpha (TNF-α) was lower in animals receiving TTI. Our results corroborate the satietogenic effect of TTI in a MetS model. Furthermore, we showed that TTI added to a cafeteria diet may decrease inflammation regardless of weight loss. This puts TTI as a candidate for studies to test its effectiveness as an adjuvant in MetS treatment.

A Trypsin Inhibitor from Tamarind Reduces Food Intake and Improves Inflammatory Status in Rats with Metabolic Syndrome Regardless of Weight Loss

PubMed Central

Carvalho, Fabiana M. C.; Lima, Vanessa C. O.; Costa, Izael S.; Medeiros, Amanda F.; Serquiz, Alexandre C.; Lima, Maíra C. J. S.; Serquiz, Raphael P.; Maciel, Bruna L. L.; Uchôa, Adriana F.; Santos, Elizeu A.; Morais, Ana H. A.

2016-01-01

Trypsin inhibitors are studied in a variety of models for their anti-obesity and anti-inflammatory bioactive properties. Our group has previously demonstrated the satietogenic effect of tamarind seed trypsin inhibitors (TTI) in eutrophic mouse models and anti-inflammatory effects of other trypsin inhibitors. In this study, we evaluated TTI effect upon satiety, biochemical and inflammatory parameters in an experimental model of metabolic syndrome (MetS). Three groups of n = 5 male Wistar rats with obesity-based MetS received for 10 days one of the following: (1) Cafeteria diet; (2) Cafeteria diet + TTI (25 mg/kg); and (3) Standard diet. TTI reduced food intake in animals with MetS. Nevertheless, weight gain was not different between studied groups. Dyslipidemia parameters were not different with the use of TTI, only the group receiving standard diet showed lower very low density lipoprotein (VLDL) and triglycerides (TG) (Kruskal–Wallis, p < 0.05). Interleukin-6 (IL-6) production did not differ between groups. Interestingly, tumor necrosis factor-alpha (TNF-α) was lower in animals receiving TTI. Our results corroborate the satietogenic effect of TTI in a MetS model. Furthermore, we showed that TTI added to a cafeteria diet may decrease inflammation regardless of weight loss. This puts TTI as a candidate for studies to test its effectiveness as an adjuvant in MetS treatment. PMID:27690087

Improved outcomes for elderly patients who received care on a transitional care unit

PubMed Central

Manville, Margaret; Klein, Michael C.; Bainbridge, Lesley

2014-01-01

Abstract Objective To determine whether providing elderly alternate level of care (ALC) patients with interdisciplinary care on a transitional care unit (TCU) achieves better clinical outcomes and lowers costs compared with providing them with standard hospital care. Design Before-and-after structured retrospective chart audit. Setting St Joseph’s Hospital in Comox, BC. Participants One hundred thirty-five consecutively admitted patients aged 70 years and older with ALC designation during 5-month periods before (n = 49) and after (n = 86) the opening of an on-site TCU. Main outcome measures Length of stay, discharge disposition, complications of the acute and ALC portions of the patients’ hospital stays, activities of daily living (mobility, transfers, and urinary continence), psychotropic medications and vitamin D prescriptions, and ALC patient care costs, as well as annual hospital savings, were examined. Results Among the 86 ALC patients receiving care during the postintervention period, 57 (66%) were admitted to the TCU; 29 of the 86 (34%) patients in the postintervention group received standard care (SC). All 86 ALC patients in the postintervention group were compared with the 49 preintervention ALC patients who received SC. Length of stay reduction occurred among the postintervention group during the acute portion of the hospital stay (14.0 days postintervention group vs 22.5 days preintervention group; P < .01). Discharge home or to an assisted-living facility increased among the postintervention group (30% postintervention group vs 12% preintervention group; P < .01). Patients’ ability to transfer improved among the postintervention group (55% postintervention group vs 14% preintervention group; P < .01). At discharge, 48% of ALC patients in the postintervention group were able to transfer independently compared with 17% of ALC patients in the preintervention group. Hospital-acquired infections among the postintervention group decreased during the acute phase (14% postintervention group vs 33% preintervention group; P < .01) and in the ALC phase of hospital stay (16% postintervention group vs 31% preintervention group; P = .011). Antipsychotic prescriptions decreased among the postintervention group (45% postintervention group vs 66% preintervention group; P = .026). Despite greater use of rehabilitation services, TCU costs per patient were lower ($155/d postintervention period vs $273/d preintervention period). Conclusion Elderly ALC patients experienced improvements in health and function at reduced cost after the creation of an interdisciplinary TCU, to which most of the nonpalliative ALC patients were transferred. Although all the postintervention ALC patients (those admitted to the TCU and those who received SC) were analyzed together, it is very likely that the greatest gains were made in the ALC patients who received care in the TCU. PMID:24829021

Community reinforcement approach plus vouchers for cocaine dependence in a community setting in Spain: six-month outcomes.

PubMed

Secades-Villa, Roberto; García-Rodríguez, Olaya; Higgins, Stephen T; Fernández-Hermida, José R; Carballo, José L

2008-03-01

The aim of this study was to assess the efficacy of the community reinforcement approach (CRA) plus vouchers treatment in achieving cocaine abstinence and treatment retention among patients enrolled in an outpatient program for cocaine dependence in Spain. Forty-three patients were randomly assigned to one of two treatment conditions in a community setting: CRA plus vouchers or standard care. Of the patients who received the CRA plus vouchers program, 73% completed 24 weeks of treatment, as compared with 42% of the patients who received standard care who did. In the CRA plus vouchers group, 40% of the patients achieved 24 weeks of continuous cocaine abstinence, as compared with 21% of the patients in the standard care group who did. These results support the effectiveness and generalizability of the CRA plus vouchers treatment in a community setting outside of the United States. Further follow-up is required to confirm the long-term maintenance of the results.

The effects of simultaneous exercise and psychotherapy on depressive symptoms in inpatient, psychiatric older adults.

PubMed

Jacquart, Son D; Marshak, Helen H; Dos Santos, Hildemar; Luu, Sen M; Berk, Lee S; McMahon, Paul T; Riggs, Matt

2014-01-01

Depression is the leading cause of early death, affecting 15% of Americans older than 65 y and costing $43 billion each year. The current mental health service system for seniors, particularly for the population hospitalized in acute inpatient psychiatric units, is fragmented because of poor funding and a shift to a transitory health care paradigm, leading to inadequate treatment modalities, questionable quality of care, and lack of research demonstrating the superiority of a particular treatment. These issues are likely to lead to a public health crisis in the coming years. To investigate the effectiveness of combining exercise and psychotherapy in improving acute depressive symptoms among older adults who were receiving treatment in an inpatient psychiatric unit. Based on rolling admissions, inpatients were randomly assigned to 1 of 3 treatment groups. The study was blinded and controlled. This study took place in inpatient psychiatric units at the Loma Linda University's Behavioral Medicine Center (LLUBMC) in Redlands, California. Participants were 78 inpatients, aged 50-89 y. Participants in the simultaneous exercise and psychotherapy (STEP) group (n = 26) took part in exercise and received psychotherapy for 30 min per session, whereas those in the TALK group (n = 26) received individual psychotherapy for 30 min per session. Participants in the control group (n = 26) served as a comparison group, receiving standard therapy. The effects of the interventions were determined by assessing differences from baseline to postintervention in the symptomatology of all 3 groups. The research team also administered the Behavioral and Symptom Identification Scale (BASIS-32) and the Geriatric Depression Scale (GDS) pre- and postintervention. At posttest, the STEP group (M = 4.24, SE = 0.62) had a better response than the TALK group (M = 11.34, SE = 0.62, P < .001), which in turn showed greater improvement than the control group (M = 14.84, SE = 0.62, P < .001). Overall, these results indicate that patients' posttreatment depression scores were significantly lower in those receiving the STEP treatment compared with those receiving individual psychotherapy only or standard care. A short-term exercise program consisting of 30 min of walking in conjunction with individual psychotherapy was an effective intervention for depression among older adults in inpatient psychiatric units.

Does preoperative enteral or parenteral nutrition reduce postoperative complications in Crohn's disease patients: a meta-analysis.

PubMed

Brennan, Gregory T; Ha, Iris; Hogan, Christopher; Nguyen, Emily; Jamal, M M; Bechtold, Matthew L; Nguyen, Douglas L

2018-05-07

Crohn's disease (CD) patients frequently develop complications that require surgery for management. The high prevalence of malnutrition in CD patients presents a challenge because poor preoperative nutritional status has been shown to increase postoperative complications. In this study, we assessed whether preoperative enteral nutrition (EN) or total parenteral nutrition (TPN) decreases postoperative complications in CD patients. A three-point systematic and comprehensive literature search was carried out on multiple databases followed by a meta-analysis with results presented as odds ratio (OR) using two models, the Mantel-Haenszel model and the DerSimonian and Laird model. The I measure of inconsistency was utilized to assess heterogeneity. If statistically significant heterogeneity was identified, the results underwent a separate sensitivity analysis. Five studies met inclusion criteria totaling 1111 CD patients. The rate of postoperative complications in the group receiving preoperative nutrition (EN or TPN) support was 20.0% compared with 61.3% in the group who had standard care without nutrition support [OR=0.26, 95% confidence interval (CI): 0.07-0.99, P<0.001]. Postoperative complications occurred in 15.0% of patients in the group who received preoperative TPN compared with 24.4% in the group who did not (OR=0.65, 95% CI: 0.23-1.88, P=0.43). Postoperative complications occurred in 21.9% in the group who received preoperative EN compared with 73.2% in the group that did not received preoperative EN (OR=0.09, 95% CI: 0.06-0.13, P<0.001). Preoperative nutrition supplementation reduces postoperative complications in CD patients. In particular, EN in CD patients before undergoing surgery is superior to standard of care without nutrition support with a number needed to treat of 2. There is a trend toward TPN being superior to standard of care without nutrition support, but this trend did not reach statistical significance. Further studies are necessary to evaluate specific components in EN or TPN that may be most beneficial for CD patients requiring surgical intervention.

Crohn's disease management after intestinal resection: a randomised trial.

PubMed

De Cruz, Peter; Kamm, Michael A; Hamilton, Amy L; Ritchie, Kathryn J; Krejany, Efrosinia O; Gorelik, Alexandra; Liew, Danny; Prideaux, Lani; Lawrance, Ian C; Andrews, Jane M; Bampton, Peter A; Gibson, Peter R; Sparrow, Miles; Leong, Rupert W; Florin, Timothy H; Gearry, Richard B; Radford-Smith, Graham; Macrae, Finlay A; Debinski, Henry; Selby, Warwick; Kronborg, Ian; Johnston, Michael J; Woods, Rodney; Elliott, P Ross; Bell, Sally J; Brown, Steven J; Connell, William R; Desmond, Paul V

2015-04-11

Most patients with Crohn's disease need an intestinal resection, but a majority will subsequently experience disease recurrence and require further surgery. This study aimed to identify the optimal strategy to prevent postoperative disease recurrence. In this randomised trial, consecutive patients from 17 centres in Australia and New Zealand undergoing intestinal resection of all macroscopic Crohn's disease, with an endoscopically accessible anastomosis, received 3 months of metronidazole therapy. Patients at high risk of recurrence also received a thiopurine, or adalimumab if they were intolerant to thiopurines. Patients were randomly assigned to parallel groups: colonoscopy at 6 months (active care) or no colonoscopy (standard care). We used computer-generated block randomisation to allocate patients in each centre to active or standard care in a 2:1 ratio. For endoscopic recurrence (Rutgeerts score ≥i2) at 6 months, patients stepped-up to thiopurine, fortnightly adalimumab with thiopurine, or weekly adalimumab. The primary endpoint was endoscopic recurrence at 18 months. Patients and treating physicians were aware of the patient's study group and treatment, but central reading of the endoscopic findings was undertaken blind to the study group and treatment. Analysis included all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00989560. Between Oct 13, 2009, and Sept 28, 2011, 174 (83% high risk across both active and standard care groups) patients were enrolled and received at least one dose of study drug. Of 122 patients in the active care group, 47 (39%) stepped-up treatment. At 18 months, endoscopic recurrence occurred in 60 (49%) patients in the active care group and 35 (67%) patients in the standard care group (p=0.03). Complete mucosal normality was maintained in 27 (22%) of 122 patients in the active care group versus four (8%) in the standard care group (p=0.03). In the active care arm, of those with 6 months recurrence who stepped up treatment, 18 (38%) of 47 patients were in remission 12 months later; conversely, of those in remission at 6 months who did not change therapy recurrence occurred in 31 (41%) of 75 patients 12 months later. Smoking (odds ratio [OR] 2.4, 95% CI 1.2-4.8, p=0.02) and the presence of two or more clinical risk factors including smoking (OR 2.8, 95% CI 1.01-7.7, p=0.05) increased the risk of endoscopic recurrence. The incidence and type of adverse and severe adverse events did not differ significantly between patients in the active care and standard care groups (100 [82%] of 122 vs 45 [87%] of 52; p=0.51) and (33 [27%] of 122 vs 18 [35%] of 52; p=0.36), respectively. Treatment according to clinical risk of recurrence, with early colonoscopy and treatment step-up for recurrence, is better than conventional drug therapy alone for prevention of postoperative Crohn's disease recurrence. Selective immune suppression, adjusted for early recurrence, rather than routine use, leads to disease control in most patients. Clinical risk factors predict recurrence, but patients at low risk also need monitoring. Early remission does not preclude the need for ongoing monitoring. AbbVie, Gutsy Group, Gandel Philanthropy, Angior Foundation, Crohn's Colitis Australia, and the National Health and Medical Research Council. Copyright © 2015 Elsevier Ltd. All rights reserved.

Two-year outcome of team-based intensive case management for patients with schizophrenia.

PubMed

Aberg-Wistedt, A; Cressell, T; Lidberg, Y; Liljenberg, B; Osby, U

1995-12-01

Two-year outcomes of patients with schizophrenic disorders who were assigned to an intensive, team-based case management program and patients who received standard psychiatric services were assessed. The case management model featured increased staff contact time with patients, rehabilitation plans based on patients' expressed needs, and patients' attendance at team meetings where their rehabilitation plan was discussed. Forty patients were randomly assigned to either the case management group or the control group that received standard services. Patients' use of emergency and inpatient services, their quality of life, the size of their social networks, and their relatives' burden of care were assessed at assignment to the study groups and at two-year follow-up. Patients in the case management group had significantly fewer emergency visits compared with the two years before the study, and their relatives reported significantly reduced burden of care associated with relationships with psychiatric services over the two-year period. The size of patients' social networks increased for the case management group and decreased for the control group. A team-based intensive case management model is an effective intervention in the rehabilitation of patients with chronic schizophrenia.

Effect of high saturated free fatty acids feeding on progression of renal failure in rat model of experimental nephrotoxicity.

PubMed

Ibraheem, Zaid O; Sattar, Munavvar A; Abdullah, Nor A; Rathore, Hassaan A; Johns, Edward J

2012-02-01

The current study evaluates the impact of high saturated fat feeding in rat model of experimental nephrotoxicity induced by gentamicin. Sprague-Dawley rats weighing 200 g were randomized into four groups; the first one received the standard rodents chow for 8 weeks and was treated as control, the second group (HFD)received an experimental high fat diet rich in palm kernel oil (40% of Calories as fat) for the same period. The third group (HFDG) was given 80 mg/kg (body weight)/day gentamicin sulphate intraperitoneally during the last 24 days of the feeding period while the fourth group was given gentamicin as above along with the standard rodents chow. Renal function was assessed through measuring serum creatinine, creatinine clearance and absolute and fractional excretion of both sodium and potassium. At the end, rats underwent a surgical procedure for blood pressure measurement. Renal function study showed a stronger nephrotoxicity for HFDG group. Hypertension was observed in HFD group while the pressure declined after gentamicin co-administration. Overall, changing the feeding behavior toward using more SAFFAs for rats injected with gentamicin promotes the progression of renal failure.

Effect of high saturated free fatty acids feeding on progression of renal failure in rat model of experimental nephrotoxicity

PubMed Central

Ibraheem, Zaid O.; Sattar, Munavvar A.; Abdullah, Nor A.; Rathore, Hassaan A.; Johns, Edward J.

2012-01-01

The current study evaluates the impact of high saturated fat feeding in rat model of experimental nephrotoxicity induced by gentamicin. Sprague-Dawley rats weighing 200 g were randomized into four groups; the first one received the standard rodents chow for 8 weeks and was treated as control, the second group (HFD)received an experimental high fat diet rich in palm kernel oil (40% of Calories as fat) for the same period. The third group (HFDG) was given 80 mg/kg (body weight)/day gentamicin sulphate intraperitoneally during the last 24 days of the feeding period while the fourth group was given gentamicin as above along with the standard rodents chow. Renal function was assessed through measuring serum creatinine, creatinine clearance and absolute and fractional excretion of both sodium and potassium. At the end, rats underwent a surgical procedure for blood pressure measurement. Renal function study showed a stronger nephrotoxicity for HFDG group. Hypertension was observed in HFD group while the pressure declined after gentamicin co-administration. Overall, changing the feeding behavior toward using more SAFFAs for rats injected with gentamicin promotes the progression of renal failure. PMID:22364300

Nasal Continuous Positive Airway Pressure in Bronchiolitis: A Randomized Controlled Trial.

PubMed

Lal, Sandeep Narayan; Kaur, Jaspreet; Anthwal, Pooja; Goyal, Kanika; Bahl, Pinky; Puliyel, Jacob M

2018-01-15

To evaluate the efficacy of nasal continuous positive airway pressure (nCPAP) in decreasing respiratory distress in bronchiolitis. Randomized controlled trial. Tertiary-care hospital in New Delhi, India. Participants: 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. 72 infants (age <1y) hospitalized with a clinical diagnosis of bronchiolitis were randomized to receive standard care, or nCPAP in addition to standard care, in the first hour after admission. 23 parents refused to give consent for participation. 2 infants did not tolerate nCPAP. The outcome was assessed after 60 minutes. If nCPAP was not tolerated or the distress increased, the infant was switched to standard care. Analysis was done on intention-to-treat basis. Change in respiratory rate, Silverman-Anderson score and a Modified Pediatric Society of New Zealand Severity Score. 14 out of 32 in nCPAP group and 5 out of 35 in standard care group had change in respiratory rate ≥10 (P=0.008). The mean (SD) change in respiratory rate [8.0 (5.8) vs 5.1 (4.0), P=0.02] in Silverman-Anderson score [0.78 (0.87) vs 0.39 (0.73), P=0.029] and in Modified Pediatric Society of New Zealand Severity Score [2.5 (3.01) vs. 1.08 (1.3), P=0.012] were significantly different in the nCPAP and standard care groups, respectively. nCPAP helped reduce respiratory distress significantly compared to standard care.

The effects of professional development related to classroom assessment on student achievement in science

NASA Astrophysics Data System (ADS)

Mazzie, Dawn Danielle

This study investigated the relationship between students' standardized test scores in science and (a) increases in teacher assessment literacy and (b) teacher participation in a Teacher Quality Research (TQR) project on classroom assessment. The samples for these studies were teachers from underperforming schools who volunteered to take part in a professional development program in classroom assessment. School groups were randomly assigned to the treatment group. For Study 1, teachers in the treatment received professional development in classroom assessment from a trained assessment coach. Teachers in the control received no professional development. For Study 2, teachers in Treatment 1 received professional development in classroom assessment from a trained assessment coach and teachers in Treatment 2 received professional development in classroom assessment from a facilitator with one day of training. Teachers in both groups completed a measure of assessment literacy, the Teacher Quality Research Test of Assessment Literacy Skills (TQR_TALS), prior to the beginning and then again at the conclusion of the four month professional development program. A hierarchical linear model (HLM) analysis was conducted to determine the relationship between students' standardized test scores in science and (a) increases in teacher assessment literacy and (b) teacher TQR status. Based upon these analyses, the professional development program increased teachers' assessment literacy skills; however, the professional development had no significant impact on students' achievement.

Dividing Attention Lowers Children's but Increases Adults' False Memories

ERIC Educational Resources Information Center

Otgaar, Henry; Peters, Maarten; Howe, Mark L.

2012-01-01

The present study examined the impact of divided attention on children's and adults' neutral and negative true and false memories in a standard Deese/Roediger-McDermott paradigm. Children (7- and 11-year-olds; n = 126) and adults (n = 52) received 5 neutral and 5 negative Deese/Roediger-McDermott word lists; half of each group also received a…

The Maudsley Model of Family-Based Treatment for Anorexia Nervosa: A Qualitative Evaluation of Parent-to-Parent Consultation

ERIC Educational Resources Information Center

Rhodes, Paul; Brown, Jac; Madden, Sloane

2009-01-01

This article describes the qualitative analysis of a randomized control trial that explores the use of parent-to-parent consultations as an augmentation to the Maudsley model of family-based treatment for anorexia. Twenty families were randomized into two groups, 10 receiving standard treatment and 10 receiving an additional parent-to-parent…

Diuretic activity and toxicity study of the aqueous extract of Cola nitida seed on markers of renal function and electrolytes in rats.

PubMed

Nnemdi Ashibuogwu, Mirian; Isaac Adeosun, Olukayode; Ojo Akomolafe, Rufus; Olaniyi Sanni, Douglas; Sesan Olukiran, Olaoluwa

2016-12-01

BackgroundCola nitida is a plant, conventionally used in Africa in the treatment of various ailments such as migraine, morning sickness and indigestion. The aim of the present study was to explore the diuretic activity of the aqueous extract of C. nitida seed (AECONS) and alteration caused by its subchronic administration on the structure and function of the kidney of male Wistar rats. MethodsThe study was divided into diuretic and subchronic studies. Twenty-five male Wistar rats weighing between 140 and 180 g were divided into five groups of five rats each. The first 24 h of this study investigated the possible diuretic activity of C. nitida seed. Group I (the control) received 25 mL/kg of normal saline. Group II (the standard) received 20 mg/kg/day of furosemide. Groups III, IV, V received 400, 600 and 800 mg/kg/day of AECONS, respectively, and orally. Urine volume, pH, specific gravity and electrolytes were estimated in the samples of urine collected after 6 h of the study. From the second day onward and up to a period of 4 weeks, the rats in each group were given normal saline, furosemide and AECONS once daily as was done on the first day. At the end of the 4-week treatment period, blood and urine samples were collected for the determination of creatinine, urea, Na+, K+ and Cl- concentrations. Results The results of the diuretic study showed that the AECONS at all doses used and furosemide produced a significant increase in urine output with respect to the control group. AECONS also induced a significant increase in the urine concentrations of Na+, K+, Cl- in the experimental and standard groups when compared with the control group, except for group III which showed no significant variation in K+ concentration. In the subchronic study, AECONS caused a significant increase in the urine levels of Na+, K+, Cl- in the experimental and standard groups when compared with the control rats. The plasma Na+ concentration of groups IV and V was significantly lower than that of the control group. Photomicrographs of the kidneys of the experimental and standard groups revealed no significant alterations in the histology of their kidney tissues. Conclusions It is concluded that AECONS induced diuresis which is associated with increased Na+, K+ and Cl- loss in rats without any significant alteration in the structure of their kidneys.

Cost-effectiveness analysis of an enteral nutrition protocol for children with common gastrointestinal diseases in China: good start but still a long way to go.

PubMed

Yang, Min; Chen, Pei-Yu; Gong, Si-Tang; Lyman, Beth; Geng, Lan-Lan; Liu, Li-Ying; Liang, Cui-Ping; Xu, Zhao-Hui; Li, Hui-Wen; Fang, Tie-Fu; Li, Ding-You

2014-11-01

A standard nutrition screening and enteral nutrition (EN) protocol was implemented in January 2012 in a tertiary children's center in China. The aims of the present study were to evaluate the cost-effectiveness of a standard EN protocol in hospitalized patients. A retrospective chart review was performed in the gastroenterology inpatient unit. We included all inpatient children requiring EN from January 1, 2010, to December 31, 2013, with common gastrointestinal (GI) diseases. Children from January 1, 2012, to December 31, 2013, served as the standard EN treatment group, and those from January 1, 2010, to December 31, 2011, were the control EN group. Pertinent patient information was collected. We also analyzed the length of hospital stay, cost of care, and in-hospital infection rates. The standard EN treatment group received more nasojejunal tube feedings. There was a tendency for the standard EN treatment group to receive more elemental and hydrolyzed protein formulas. Implementation of a standard EN protocol significantly reduced the time to initiate EN (32.38 ± 24.50 hours vs 18.76 ± 13.53 hours; P = .011) and the time to reach a targeted calorie goal (7.42 ± 3.98 days vs 5.06 ± 3.55 days; P = .023); length of hospital stay was shortened by 3.2 days after implementation of the standard EN protocol but did not reach statistical significance. However, the shortened length of hospital stay contributed to a significant reduction in the total cost of hospital care (13,164.12 ± 6722.95 Chinese yuan [CNY] vs 9814.96 ± 4592.91 CNY; P < .032). Implementation of a standard EN protocol resulted in early initiation of EN, shortened length of stay, and significantly reduced total cost of care in hospitalized children with common GI diseases. © 2014 American Society for Parenteral and Enteral Nutrition.

The Study of Influence of Different Methods of Local Treatment on Wound Healing in Patients with Diabetic Foot Ulcers.

PubMed

Zaitseva, E L; Tokmakova, A Y; Shestakova, M V; Galstyan, G R; Doronina, L P

To evaluate the influence of different methods of local treatment on tissue repair in patients with diabetic foot ulcers. We evaluated such clinical characteristics as wound size and local perfusion after using negative pressure wound therapy (NPWT), local collagen, and standard care in patients with diabetic foot ulcers. We observed 63 patients with neuropathic and neuroischemic forms of diabetic foot (without critical ischemia) after surgical debridement. After that 21 patients received NPWT, 21 local collagen treatment and 21 ― standard care. After using NPWT wound area and depth decreased in 19,8% and 42,8% (p<0.05), in group of collagen dressings in 26,4 and 30,4% (p<0.05). In control group those parameters were 17,0 и 16.6% respectively (p<0.05). There was found the significant increase of local perfusion according to oxygen monitoring in group of NPWT (p<0.05). The received data showed that the intensity of lower limb tissue repair processes increases more significant after using NPWT and collagen dressings in comparison to standard care which is found according to wound size and tissue perfusion alterations.

Rivaroxaban for the treatment of symptomatic deep-vein thrombosis and pulmonary embolism in Chinese patients: a subgroup analysis of the EINSTEIN DVT and PE studies.

PubMed

Wang, Yuqi; Wang, Chen; Chen, Zhong; Zhang, Jiwei; Liu, Zhihong; Jin, Bi; Ying, Kejing; Liu, Changwei; Shao, Yuxia; Jing, Zhicheng; Meng, Isabelle Ling; Prins, Martin H; Pap, Akos F; Müller, Katharina; Lensing, Anthonie Wa

2013-12-16

The worldwide EINSTEIN DVT and EINSTEIN PE studies randomized 8282 patients with acute symptomatic deep-vein thrombosis (DVT) and/or pulmonary embolism (PE) and, for the first time in trials in this setting, included patients in China. This analysis evaluates the results of these studies in this subgroup of patients. A total of 439 Chinese patients who had acute symptomatic DVT (n=211), or PE with or without DVT (n=228), were randomized to receive rivaroxaban (15 mg twice daily for 21 days, followed by 20 mg once daily) or standard therapy of enoxaparin overlapping with and followed by an adjusted-dose vitamin K antagonist, for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or non-major clinically relevant bleeding. The primary efficacy outcome occurred in seven (3.2%) of the 220 patients in the rivaroxaban group and in seven (3.2%) of the 219 patients in the standard-therapy group (hazard ratio, 1.04; 95% confidence interval 0.36-3.0; p=0.94). The principal safety outcome occurred in 13 (5.9%) patients in the rivaroxaban group and in 20 (9.2%) patients in the standard-therapy group (hazard ratio, 0.63; 95% confidence interval 0.31-1.26; p=0.19). Major bleeding was observed in no patients in the rivaroxaban group and in five (2.3%) patients in the standard-therapy group. In fragile patients (defined as age >75 years, creatinine clearance <50 mL/min, and/or body weight ≤50 kg), the principal safety outcome occurred in four (8.9%) of the 45 patients who received rivaroxaban compared with seven (15.2%) of the 46 patients who received standard therapy. In Chinese patients with acute symptomatic DVT and/or PE, rivaroxaban was as efficacious as enoxaparin followed by vitamin K antagonist therapy, with a similar safety profile. The relative efficacy and safety of rivaroxaban compared with enoxaparin/vitamin K antagonist were consistent with that found in the rest of the world. EINSTEIN PE, ClinicalTrials.gov NCT00439777; EINSTEIN DVT, ClinicalTrials.gov NCT00440193.

Reducing therapist contact in cognitive behaviour therapy for panic disorder and agoraphobia in primary care: global measures of outcome in a randomised controlled trial.

PubMed Central

Sharp, D M; Power, K G; Swanson, V

2000-01-01

BACKGROUND: Panic disorder, with and without agoraphobia, is a prevalent condition presenting in general practice. Psychological treatments are effective but are limited by restricted availability. Interest has grown in methods by which the efficiency and thus availability of psychological treatments can be improved, with particular emphasis on reduced therapist contact formats. AIM: To evaluate the relative efficacy in a primary care setting of a cognitive behaviour therapy (CBT) delivered at three levels of therapist contact: standard contact, minimum contact, and bibliotherapy. METHOD: A total of 104 patients were randomly allocated to receive standard therapist contact, minimum therapist contact or bibliotherapy, with 91 patients completing treatment. All patients received an identical treatment manual and were seen by the same psychologist therapist. Outcome was reported in terms of brief global ratings of severity of illness, change in symptoms, and levels of social disruption. These brief measures were chosen to be suitable for use in general practice and were used at treatment entry and endpoint. RESULTS: The standard therapist contact group had the strongest and most comprehensive treatment response, showing significant differences from the bibliotherapy group on all, and the minimum therapist contact group on some, endpoint measures. Some reduction in efficacy was therefore found for the reduced therapist contact groups. CONCLUSION: The standard therapist contact group showed the greatest treatment efficacy in the present study. As it was of notably shorter duration than many other current formulations of CBT, it represents a useful and efficient treatment for panic disorder and agoraphobia in primary care. PMID:11224967

Outcome analysis of hemoglobin A1c, weight, and blood pressure in a VA diabetes education program.

PubMed

North, Susan L; Palmer, Glen A

2015-01-01

To determine the effect of a specific diabetes education class (Basics) on hemoglobin A1c values, weight, and systolic blood pressure. In this retrospective study, the researchers compared 2 groups of male veterans with a recent diagnosis of type 2 diabetes. One group received diabetes group education (n = 175) over a 4-month period, and the other received standard diabetes management follow-up (n = 184). Outpatient clinic setting in the Midwest. Basics class compared with standard level of care. Pre- and post-laboratory values for hemoglobin A1c, weight, and systolic blood pressure. Multivariate analysis of covariance and follow-up univariate statistics for significant differences. Findings revealed significant differences in hemoglobin A1c (P < .001) and weight (P < .001) in the treatment group compared with the control group. No significant difference was found in systolic blood pressure readings between the 2 groups. There was a significant difference in weight change between groups, with the treatment group demonstrating greater weight loss. There was an association between participation in the Basics diabetes education curriculum and reduction of hemoglobin A1c values. Some participants also had added benefit of significant weight loss. Published by Elsevier Inc.

Diuretic Activity of Ethanolic Root Extract of Mimosa Pudica in Albino Rats

PubMed Central

SL, Shruthi; PS, Vaibhavi; VH, Pushpa; AM, Satish; Sibgatullah, Mohammad

2015-01-01

Introducation Diuretics are the drugs which increase the urine output. This property is useful in various pathological conditions of fluid overload. The presently available diuretics have lot of adverse effects. Our study has evaluated the diuretic activity of ethanolic root extract of Mimosa pudica as an alternative/new drug which may induce diuresis. Aim To evaluate the diuretic activity of ethanolic root extract of Mimosa pudicaa in albino rats. Materials and Methods Ethanolic root extract of Mimosa pudica (EEMP) was prepared using soxhlet’s apparatus. Albino rats were divided into 5 groups of 6 rats each. Group-I (Control) received distilled water 25ml/kg orally. Group-II (Standard) received Furosemide 20mg/kg orally. Group-III received EEMP 100 mg/kg, Group-IV received EEMP 200 mg/kg and Group-V received EEMP 400 mg/kg. The urine samples were collected for all the groups upto 5 hours after dosing and urine volume was measured. Urine was analysed for electrolytes (Na+, K+ and Cl-). ANOVA, Dunnet’s test and p-values were measured and data was analysed. Results EEMP exhibited significant diuretic activity by increasing urine volume and also by enhancing elimination of Sodium (Na+), Potassium (K+) and Chloride (Cl-) at doses of 100 and 200mg/kg. Conclusion EEMP possesses significant diuretic activity and has a beneficial role in volume overload conditions. PMID:26870704

Folinic acid improves verbal communication in children with autism and language impairment: a randomized double-blind placebo-controlled trial.

PubMed

Frye, R E; Slattery, J; Delhey, L; Furgerson, B; Strickland, T; Tippett, M; Sailey, A; Wynne, R; Rose, S; Melnyk, S; Jill James, S; Sequeira, J M; Quadros, E V

2018-02-01

We sought to determine whether high-dose folinic acid improves verbal communication in children with non-syndromic autism spectrum disorder (ASD) and language impairment in a double-blind placebo control setting. Forty-eight children (mean age 7 years 4  months; 82% male) with ASD and language impairment were randomized to receive 12 weeks of high-dose folinic acid (2 mg kg -1 per day, maximum 50 mg per day; n=23) or placebo (n=25). Children were subtyped by glutathione and folate receptor-α autoantibody (FRAA) status. Improvement in verbal communication, as measured by a ability-appropriate standardized instrument, was significantly greater in participants receiving folinic acid as compared with those receiving placebo, resulting in an effect of 5.7 (1.0,10.4) standardized points with a medium-to-large effect size (Cohen's d=0.70). FRAA status was predictive of response to treatment. For FRAA-positive participants, improvement in verbal communication was significantly greater in those receiving folinic acid as compared with those receiving placebo, resulting in an effect of 7.3 (1.4,13.2) standardized points with a large effect size (Cohen's d=0.91), indicating that folinic acid treatment may be more efficacious in children with ASD who are FRAA positive. Improvements in subscales of the Vineland Adaptive Behavior Scale, the Aberrant Behavior Checklist, the Autism Symptom Questionnaire and the Behavioral Assessment System for Children were significantly greater in the folinic acid group as compared with the placebo group. There was no significant difference in adverse effects between treatment groups. Thus, in this small trial of children with non-syndromic ASD and language impairment, treatment with high-dose folinic acid for 12 weeks resulted in improvement in verbal communication as compared with placebo, particularly in those participants who were positive for FRAAs.

Superior survival of unmanipulated haploidentical hematopoietic stem cell transplantation compared with chemotherapy alone used as post-remission therapy in adults with standard-risk acute lymphoblastic leukemia in first complete remission.

PubMed

Yan, Chen-Hua; Jiang, Qian; Wang, Jing; Xu, Lan-Ping; Liu, Dai-Hong; Jiang, Hao; Chen, Huan; Zhang, Xiao-Hui; Liu, Kai-Yan; Huang, Xiao-Jun

2014-09-01

We wanted to compare the efficacy of haploidentical hematopoietic stem cell transplantation (HSCT) with chemotherapy alone in adults with standard-risk acute lymphoblastic leukemia (ALL) in first complete remission (CR1). One hundred thirty-eight consecutive adult patients with standard-risk ALL in CR1 were retrospectively investigated. Of these patients, 59 received chemotherapy alone (group A) and 79 received unmanipulated haploidentical HSCT (group B). Cumulative incidence of relapse at 5 years in group A was significantly higher than that in group B (66.3% versus 29.9%, P < .0001). Overall and disease-free survival in group A were significantly inferior to group B (P < .0001). Moreover, multivariate analyses demonstrated that central nervous system leukemia (P = .002), T cell immunophenotype (P = .044), expression of E2A-PBX1 (P = .007), and positive minimal residual disease after the first cycle of consolidation (P = .004) were correlated with relapse. Patients with 1 of 4 risk factors were assigned to the high-risk group. Otherwise, patients without risk factors were assigned to the low-risk group. In the high-risk group, HSCT had lower relapse rates and superior DFS compared with chemotherapy (P < .05), but in the low-risk group, there were no differences between HSCT and chemotherapy (P > .05). This study is the first to demonstrate that compared with chemotherapy alone, haploidentical HSCT is a better postremission therapy in adults with standard-risk ALL in CR1. Moreover, based on the 4 risk factors, the establishment of risk stratification could identify the subgroup of patients with a higher risk of relapse in adults with standard-risk ALL in CR1. Furthermore, risk stratification-directed postremission therapies using haploidentical HSCT or chemotherapy alone not only reduce relapse rate but also avoid unnecessary treatment-related mortality and improve survival. Copyright © 2014 American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Premature Infants 750–1,250 g Birth Weight Supplemented with a Novel Human Milk-Derived Cream Are Discharged Sooner

PubMed Central

Bergner, Erynn M.; Lee, Martin L.; Moreira, Alvaro G.; Hawthorne, Keli M.; Rechtman, David J.; Abrams, Steven A.; Blanco, Cynthia L.

2016-01-01

Abstract Objective: Infants may benefit from early nutritional intervention to decrease hospital stay. To evaluate the effects of adding a human milk (HM)-derived cream (Cream) product to a standard feeding regimen in preterm infants. Materials and Methods: In a prospective multicenter randomized study, infants with birth weights 750–1,250 g were assigned to a Control or Cream group. The Control group received a standard feeding regimen consisting of mother's own milk or donor HM with donor HM-derived fortifier. The Cream group received the standard feeding regimen along with an additional HM-derived cream supplement when the HM they received was <20 kcal/oz. Primary outcomes of this secondary analysis included comorbidities, length of stay (LOS), and postmenstrual age (PMA) at discharge. Results: We enrolled 75 infants (Control n = 37, Cream n = 38) with gestational age 27.7 ± 1.8 weeks and birth weight 973 ± 145 g (mean ± SD). After adjusting for gestational age, birth weight, and presence of bronchopulmonary dysplasia (BPD), the Cream group had a decreased PMA at discharge (39.9 ± 4.8 versus 38.2 ± 2.7 weeks, p = 0.03) and LOS (86 ± 39 versus 74 ± 22 days, p = 0.05). For 21 infants with BPD, these values trended toward significance for PMA at discharge (44.2 ± 6.1 versus 41.3 ± 2.7 weeks, p = 0.08) and LOS (121 ± 49 versus 104 ± 23 days, p = 0.08). Conclusions: Very preterm infants who received an HM-derived cream supplement were discharged earlier. Infants with BPD may have benefited the most. PMID:26982282

Risk of Nonfatal Stroke in Type 2 Diabetes Mellitus Patients: A Retrospective Comparison Between Disease Management Programs and Standard Care

PubMed Central

Wiefarn, Stefan; Heumann, Christian; Rettelbach, Anja; Kostev, Karel

2017-01-01

Objective: The present retrospective study examines the influence of disease management programs on nonfatal stroke in type 2 diabetes mellitus (T2DM) patients in Germany. Methods: The evaluation is based on retrospective patient data from the Disease Analyzer (IMS Health). The analysis included 169 414 T2DM patients aged 40 years and older with an initial prescription of antihyperglycemic therapy between January 2004 and December 2014. A total of 86 713 patients participated in a disease management program (DMP) for T2DM and 82 701 patients received standard care. The main outcome measure of this study was nonfatal stroke. Kaplan-Meier curves of DMP and SC patients were compared using log rank test. The Cox proportional hazards model was used to provide an adjusted estimate of the DMP effect. Results: It is apparent from the baseline characteristics that the general health of patients receiving standard care was poorer than that of patients participating in a DMP. The baseline HbA1c value was 7.6% in the DMP group and 7.8% in the SC group. Furthermore, the SC group had a higher proportion of preexisting conditions, such as coronary heart disease (CHD), peripheral arterial occlusive disease (pAOD), and renal insufficiency. The proportion of patients who received insulin in first year therapy was higher in the SC group. Time to event analysis showed that DMP was associated with a delayed occurrence of stroke, because stroke occurred an average of 350 days later in DMP patients than in patients receiving SC (DMP: 1.216 days, RV: 866 days). The Cox model with covariable adjustment confirmed the significant association of DMPs with nonfatal stroke in patients with type 2 diabetes mellitus (HR 0.71; 95% CI: 0.69-0.74). Conclusion: The present study indicates that DMPs are positively associated with stroke. The possible reasons for this must be verified in further studies. PMID:28300432

Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

PubMed

Slamon, D J; Leyland-Jones, B; Shak, S; Fuchs, H; Paton, V; Bajamonde, A; Fleming, T; Eiermann, W; Wolter, J; Pegram, M; Baselga, J; Norton, L

2001-03-15

The HER2 gene, which encodes the growth factor receptor HER2, is amplified and HER2 is overexpressed in 25 to 30 percent of breast cancers, increasing the aggressiveness of the tumor. We evaluated the efficacy and safety of trastuzumab, a recombinant monoclonal antibody against HER2, in women with metastatic breast cancer that overexpressed HER2. We randomly assigned 234 patients to receive standard chemotherapy alone and 235 patients to receive standard chemotherapy plus trastuzumab. Patients who had not previously received adjuvant (postoperative) therapy with an anthracycline were treated with doxorubicin (or epirubicin in the case of 36 women) and cyclophosphamide alone (138 women) or with trastuzumab (143 women). Patients who had previously received adjuvant anthracycline were treated with paclitaxel alone (96 women) or paclitaxel with trastuzumab (92 women). The addition of trastuzumab to chemotherapy was associated with a longer time to disease progression (median, 7.4 vs. 4.6 months; P<0.001), a higher rate of objective response (50 percent vs. 32 percent, P<0.001), a longer duration of response (median, 9.1 vs. 6.1 months; P<0.001), a lower rate of death at 1 year (22 percent vs. 33 percent, P=0.008), longer survival (median survival, 25.1 vs. 20.3 months; P=0.01), and a 20 percent reduction in the risk of death. The most important adverse event was cardiac dysfunction of New York Heart Association class III or IV, which occurred in 27 percent of the group given an anthracycline, cyclophosphamide, and trastuzumab; 8 percent of the group given an anthracycline and cyclophosphamide alone; 13 percent of the group given paclitaxel and trastuzumab; and 1 percent of the group given paclitaxel alone. Although the cardiotoxicity was potentially severe and, in some cases, life-threatening, the symptoms generally improved with standard medical management. Trastuzumab increases the clinical benefit of first-line chemotherapy in metastatic breast cancer that overexpresses HER2.

Risk of Nonfatal Stroke in Type 2 Diabetes Mellitus Patients: A Retrospective Comparison Between Disease Management Programs and Standard Care.

PubMed

Wiefarn, Stefan; Heumann, Christian; Rettelbach, Anja; Kostev, Karel

2017-07-01

The present retrospective study examines the influence of disease management programs on nonfatal stroke in type 2 diabetes mellitus (T2DM) patients in Germany. The evaluation is based on retrospective patient data from the Disease Analyzer (IMS Health). The analysis included 169 414 T2DM patients aged 40 years and older with an initial prescription of antihyperglycemic therapy between January 2004 and December 2014. A total of 86 713 patients participated in a disease management program (DMP) for T2DM and 82 701 patients received standard care. The main outcome measure of this study was nonfatal stroke. Kaplan-Meier curves of DMP and SC patients were compared using log rank test. The Cox proportional hazards model was used to provide an adjusted estimate of the DMP effect. It is apparent from the baseline characteristics that the general health of patients receiving standard care was poorer than that of patients participating in a DMP. The baseline HbA1c value was 7.6% in the DMP group and 7.8% in the SC group. Furthermore, the SC group had a higher proportion of preexisting conditions, such as coronary heart disease (CHD), peripheral arterial occlusive disease (pAOD), and renal insufficiency. The proportion of patients who received insulin in first year therapy was higher in the SC group. Time to event analysis showed that DMP was associated with a delayed occurrence of stroke, because stroke occurred an average of 350 days later in DMP patients than in patients receiving SC (DMP: 1.216 days, RV: 866 days). The Cox model with covariable adjustment confirmed the significant association of DMPs with nonfatal stroke in patients with type 2 diabetes mellitus (HR 0.71; 95% CI: 0.69-0.74). The present study indicates that DMPs are positively associated with stroke. The possible reasons for this must be verified in further studies.

Dose-Response Relationship between Radiation Dose and Loco-regional Control in Patients with Stage II-III Esophageal Cancer Treated with Definitive Chemoradiotherapy.

PubMed

Kim, Hyun Ju; Suh, Yang-Gun; Lee, Yong Chan; Lee, Sang Kil; Shin, Sung Kwan; Cho, Byung Chul; Lee, Chang Geol

2017-07-01

The correlation between radiation dose and loco-regional control (LRC) was evaluated in patients with stage II-III esophageal cancer treated with definitive concurrent chemoradiotherapy (CRT). Medical records of 236 stage II-III esophageal cancer patients treated with definitive CRT at Yonsei Cancer Center between 1994 and 2013 were retrospectively reviewed. Among these, 120 received a radiation dose of < 60 Gy (standard-dose group), while 116 received ≥ 60 Gy (high-dose group). The median doses of radiation in the standard- and high-dose groups were 50.4 and 63 Gy, respectively. Concurrent 5-fluorouracil/cisplatin chemotherapy was administered to most patients. There were no differences in patient characteristics between the two groups except for high Karnofsky performance status and lower-thoracic lesions being more prevalent in the standard-dose group. The median progression-free survival (PFS) and overall survival (OS) times were 13.2 months and 26.2 months, respectively. Patients in the high-dose group had significantly better 2-year LRC (69.1% vs. 50.3%, p=0.002), median PFS (16.7 months vs. 11.7 months, p=0.029), and median OS (35.1 months vs. 22.3 months, p=0.043). Additionally, LRC exhibited a dose-response relationship and the complete response rate was significantly higher in the high-dose group (p=0.006). There were no significant differences in treatment-related toxicities between the groups. A higher radiation dose (> 60 Gy) is associated with increased LRC, PFS, and OS in patients with stage II-III esophageal cancer treated with definitive CRT.

Effects of escitalopram on symptoms and quality of life in patients with allergic rhinitis.

PubMed

Erkul, Evren; Cingi, Cemal; Özçelik Korkmaz, Müge; Çekiç, Tuğba; Çukurova, Ibrahim; Yaz, Aytekin; Erdoğmuş, Nagehan; Bal, Cengiz

2012-01-01

Insufficient response to treatment and declining quality of life illustrate the continuing need to find new treatment modalities for allergic rhinitis (AR). The purpose of this study was to assess how escitalopram affects symptoms and quality of life among AR patients. This study included 120 patients with AR, who were divided into four treatment groups of 30 patients each. Patients were assessed before treatment and at the end of the 3rd month based on nasal symptom scores, otorhinolaryngological examination, the Rhinoconjunctivitis Quality of Life Questionnaire, and the Beck Depression and Anxiety Inventory. All patients received standardized treatments. Group A patients with positive Beck Depression and Anxiety Inventory scores received escitalopram, and group B patients with positive Beck Depression and Anxiety Inventory scores received placebo. Group C patients with negative Beck Depression and Anxiety Inventory scores received escitalopram, and group D patients with negative Beck Depression and Anxiety Inventory scores received placebo. Anxiety scores pre- and posttreatment revealed a statistically significant reduction in groups A, C, and D. All four groups exhibited reduced posttreatment scores for sleep, nonnasal and noneye symptoms, eye symptoms, and emotions. A statistically significant difference appeared between groups A and B in terms of general complaints and nasal symptom scores. The positive effects of escitalopram on posttreatment quality of life in the Beck-positive patient group were a predictable outcome. Otolaryngologists should pay more attention to the moods of their patients with AR while they evaluate treatment during clinical follow-up visits.

Chromium picolinate and chromium histidinate protects against renal dysfunction by modulation of NF-κB pathway in high-fat diet fed and Streptozotocin-induced diabetic rats.

PubMed

Selcuk, Mustafa Yavuz; Aygen, Bilge; Dogukan, Ayhan; Tuzcu, Zeynep; Akdemir, Fatih; Komorowski, James R; Atalay, Mustafa; Sahin, Kazim

2012-04-08

Diabetic nephropathy is one of major complications of diabetes mellitus. Although chromium is an essential element for carbohydrate and lipid metabolism, its effects on diabetic nephropathy are not well understood. The present study was conducted to investigate the effects of chromium picolinate (CrPic) and chromium histidinate (CrHis) on nuclear factor-kappa B (NF-κB) and nuclear factor-E2-related factor-2 (Nrf2) pathway in the rat kidney. Male Wistar rats were divided into six groups. Group I received a standard diet (8% fat) and served as a control; Group II was fed with a standard diet and received CrPic; Group III was fed with a standard diet and received CrHis; Group IV received a high fat diet (HFD, 40% fat) for 2 weeks and then were injected with streptozotocin (STZ) (HFD/STZ); Group V was treated as group IV (HFD/STZ) but supplemented with CrPic for 12 weeks. Group VI was treated as group IV (HFD/STZ) but supplemented with CrHis. The increased NF-κβ p65 in the HFD/STZ group was inhibited by CrPic and CrHis supplementation (P < 0.05). In STZ-treated rats, a significant decrease in levels of nuclear factor of kappa light polypeptide gene enhancer in B-cells inhibitor, alpha (IκBα) was found in kidney tissues when compared to control rats (P < 0.05). A significant increase in the levels of IκBα was observed in CrPic- and CrHis-treated rats when compared with STZ-treated rats. Renal Nrf2 levels were significantly decreased in diabetic rats compared with the control rats. There was a higher tendency for increase of kidney Nrf2 level and decrease in kidney NFκBp65 levels and 4- hydroxyl nonenal (4-HNE) protein adducts (P < 0.05) in diabetic rats. Our result show that in kidney tissue CrHis/CrPic increases Nrf2 level, parallelly decreases NF-κB and partially restores IκBα levels in HFD/STZ group, suggesting that CrPic and CrHis may play a role in antioxidant defense system via the Nrf2 pathway by reducing inflammation through NF-κβ p65 inhibition. Moreover, a greater reduction in NF-κB expression and greater increases in expressions of IκBα and Nrf2 in diabetic rats supplemented with CrHis than rats supplemented with CrPic suggest that CrHis has more favorable effects than CrPic.

Does Mobile Care ('mCare') Improve Quality of Life and Treatment Satisfaction Among Service Members Rehabilitating in the Community? Results from a 36-Wk, Randomized Controlled Trial.

PubMed

Little, Jeanette R; Pavliscsak, Holly H; Cooper, Mabel R; Goldstein, Lois A; Fonda, Stephanie J

2018-03-01

Research has shown that mobile phones can help with management of numerous health problems. As an adjunct to care management provided to injured service members rehabilitating in their communities, particularly those with mild traumatic brain injury (mTBI), post-traumatic stress (PTS), and/or behavioral health problems, the Army developed a mobile phone application called "mCare." This study examined whether service members who received mCare had higher well-being, were more satisfied with their care, and viewed mCare as a valuable part of their care management as compared with their counterparts who received standard care management alone, and whether those with mTBI, PTS, and/or behavioral health problems benefited differently from mCare. In-processing service members at four community-based warrior transition units were recruited for participation in a 36-wk, randomized, controlled trial and allocated to receive standard care management plus mCare (n = 95) or standard care management alone (n = 87). Participants in the mCare group received daily questionnaires, tips, and appointment reminders. All participants were asked to complete the General Well-being Schedule (GWS) at baseline, 12, 24, and 36 wk, and the Case Management Quality Questionnaire (CMQQ) at 12, 24, and 36 wk. All participants and care managers were approached to complete interviews about the usability/likeability of mCare or standard care management. The analyses tested for group differences in completion of the intervention, graphed means for the GWS and CMQQ by group/subgroup, and statistically compared the longitudinal trends in these outcomes using mixed models in which group, time, and group*time were included as regression variables. The analyses also tallied interview responses and identified thematic quotes. The study protocol was reviewed and approved by the Walter Reed National Military Medical Center's Institutional Review Board. Estimated rate of change in GWS scores was -2.2 (standard error = 1.0; t = -2.1; p = 0.0382). Estimated rate of change in CMQQ scores was -0.8 (standard error = 0.5; t = -1.52; p = 0.1299). Neither change was meaningful. Rates of change in the GWS and CMQQ scores did not differ by group or by behavioral health, mTBI, and PTS subgroups within the groups. The interviews found that 83% of mCare participants liked the communication with their care managers versus 73% of standard care management participants. Participants in both the mCare group and the care managers said that they liked the application's appointment tracking and reminders. Care managers thought mCare was particularly useful for people with mTBI, PTS, and cognitive problems. mCare did not result in differences in general well-being and satisfaction with care management among service members rehabilitating in their communities, some with mTBI, PTS, and/or behavioral health problems. But participants and care managers who used mCare said that they found it useful. Study limitations included the diversity of clinical issues of the participants, greater missing data among mCare participants, and the high baseline quality of care management in the settings observed. The fact that patients and care managers liked mCare, apart from no changes in outcomes, is important because health care is increasingly adopting mobile solutions.

Effects of topical hyaluronic acid on corneal wound healing in dogs: a pilot study.

PubMed

Gronkiewicz, Kristina M; Giuliano, Elizabeth A; Sharma, Ajay; Mohan, Rajiv R

2017-03-01

To investigate the efficacy of topical 0.2% hyaluronic acid in canine corneal ulcers in vivo. Six purpose-bred beagles were randomly assigned into two groups (three dogs/group): group A received experimental product (Optimend ™ , containing 0.2% hyaluronic acid, KineticVet ™ ); group B received control product (Optimend ™ without 0.2% hyaluronic acid and supplemented with carboxymethylcellulose). The clinical scorer was masked to product content and subject assignment. Under sedation and topical anesthesia, 6-mm axial corneal epithelial debridements were performed in the left eye. Wounded corneas received standard ulcer treatment and topical product (group A) or control product (group B) three times a day (TID) until ulcers were healed. Slit-lamp biomicroscopy was performed 6 h after wounding and then every 12 h; findings were graded according to modified McDonald-Shadduck scoring system; extraocular photography was performed after fluorescein stain application at all examination time points. Images were analyzed using NIH image j software to quantify rate of corneal epithelialization. Gelatin zymography was used to analyze matrix metalloproteinase (MMP) 2 and 9 protein expression in tears collected at set time points during the study period. No statistical differences in clinical ophthalmic examination scores, rate of corneal epithelialization, or MMP2 or MMP9 protein expression were found between groups at any tested time point. The application of 0.2% hyaluronic acid to standard ulcer medical management is well tolerated. Topical addition of the viscoelastic did not accelerate corneal wound healing compared to a topical control with similar viscosity in this study. © 2016 American College of Veterinary Ophthalmologists.

The effect of standardized patient feedback in teaching surgical residents informed consent: results of a pilot study.

PubMed

Leeper-Majors, Kristine; Veale, James R; Westbrook, Thomas S; Reed, Kendall

2003-01-01

The purpose of this pilot study was to determine the effectiveness of using feedback from a standardized patient (SP) to teach a surgical resident (SR) informed consent (IC) protocol. Four general case types of increasing difficulty were tested in a longitudinal experimental design format. The four types of cases were appendectomy, cholecystectomy, colorectal cancer, and breast cancer. Eight SRs of varying years of completion in medical school served as subjects-four in the experimental group (received performance feedback from an SP) and four in the control group (received no SP feedback). Both the control and experimental groups participated in two patient encounters per case type. The first patient encounter served as the pretest, and the second patient encounter was the posttest. In each encounter, an SP rated the resident on 14 measures using an open-ended seven-point rating scale adopted and modified from the Brown University Interpersonal Skill Evaluation (BUISE). Each resident also reviewed a videotape of an expert giving IC between pretest and the posttest for basic instructional protocol. Random stratified sampling was used to equally distribute the residents by postgraduate years. A total of 16 SPs were used in this study. All patient/SR encounters were videotaped. There was a statistically significant overall change--pretest to posttest and across cases (p = 0.001). The group effect was statistically significant (p = 0.000), with the experimental group averaging about 10 points greater than the control group. Standardized patient feedback is an effective modality in teaching surgical residents informed consent protocol. This conclusion is tentative, due to the limitations of sample size. The results of this study support continued research on the effects of standardized patient feedback to teach informed consent to surgical residents.

The costs and benefits of technology-enabled, home-based cardiac rehabilitation measured in a randomised controlled trial.

PubMed

Whittaker, Frank; Wade, Victoria

2014-10-01

We conducted a cost benefit analysis of a home telehealth-based cardiac rehabilitation programme compared to the standard hospital-based programme. A total of 120 participants were enrolled in a trial, with 60 randomised to the telehealth group and 60 randomised to usual care. Participants in the telehealth group received a mobile phone, Wellness Diary and a Wellness web portal, with daily text messaging. Participants in the usual care group received the standard 6-week hospital-based outpatient cardiac rehabilitation programme, including gym sessions. The cost of delivery by telehealth was slightly lower than for patients attending a rehabilitation service in person. From the provider's perspective, the telehealth intervention could be delivered for $1633 per patient, compared to $1845 for the usual care group. From the participant's perspective, patient travel costs for home rehabilitation were substantially less than for hospital attendance ($80 vs $400). Cardiac rehabilitation by telehealth offers obvious advantages and the option should be available to all patients who are eligible for cardiac rehabilitation. © The Author(s) 2014 Reprints and permissions:]br]sagepub.co.uk/journalsPermissions.nav.

Comparison and Efficacy of Low-Dose and Standard-Dose Tamsulosin and Alfuzosin in Medical Expulsive Therapy for Lower Ureteral Calculi: Prospective, Randomized, Comparative Study

PubMed Central

Cha, Woo Heon; Choi, Jae Duck; Seo, Young Jin; Lee, Kyungseop

2012-01-01

Purpose Typically in Korea, for a standard dose (0.4 mg) of tamsulosin, two low doses (0.2 mg) are administered. The aim of this study was to evaluate and compare the efficacy of tamsulosin (0.2 mg and 0.4 mg) and alfuzosin (10 mg) in the treatment of lower ureteral stones. Materials and Methods A total of 141 patients presenting with a single 4- to 10-mm sized lower ureteral stone were randomly assigned to 4 groups. Patients in group 1 (n=41) and group 2 (n=30) received an oral dose of 0.2 mg tamsulosin once and twice daily, respectively, and patients in group 3 (n=36) received a daily oral dose of 10 mg alfuzosin. Patients in group 4 (n=34) received trospium chloride only. The spontaneous passage of stones, the stone expulsion time, and adverse effects were evaluated. Results There were no significant differences in patient background, including age, sex, BMI, stone size, stone side, and symptom duration. The spontaneous stone passage rate through the ureter was higher and the stone expulsion time was faster in groups 1, 2, and 3 than in group 4. There were no statistically different changes in groups 1, 2, and 3. The adverse effects observed in all groups were comparable and were mild. Conclusions Tamsulosin at 0.2 mg and 0.4 mg and alfuzosin (10 mg) proved to be safe and effective. A first cycle of medical expulsive therapy with tamsulosin 0.2 mg could be considered as an option in the management of single lower ureteral stone. PMID:22670195

Preoperative cryotherapy use in anterior cruciate ligament reconstruction.

PubMed

Koyonos, Loukas; Owsley, Kevin; Vollmer, Emily; Limpisvasti, Orr; Gambardella, Ralph

2014-12-01

Unrelieved postoperative pain may impair rehabilitation, compromise functional outcomes, and lead to patient dissatisfaction. Preemptive multimodal analgesic techniques may improve outcomes after surgery. We hypothesized that patients using preoperative cryotherapy plus a standardized postoperative treatment plan will have lower pain scores and require less pain medication compared with patients receiving a standardized postoperative treatment plan alone after arthroscopically assisted anterior cruciate ligament reconstruction (ACLR). A total of 53 consecutive patients undergoing arthroscopically assisted ACLR performed by one of seven surgeons were randomly assigned to one of two groups. Group 1 received no preoperative cryotherapy and group 2 received 30 to 90 minutes of preoperative cryotherapy to the operative leg using a commercial noncompressive cryotherapy unit. Visual analog scale pain scores and narcotic use were recorded for the first 4 days postoperatively. Total hours of cold therapy and continuous passive motion (CPM) use and highest degree of flexion achieved were recorded as well. Group 1 consisted of 26 patients (15 allograft Achilles tendon and 11 autograft bone patellar tendon bone [BPTB]), and group 2 consisted of 27 patients (16 allograft Achilles tendon and 11 autograft BPTB). Group 2 patients reported less pain (average 1.3 units, p < 0.02) and used less narcotic use (average 1.7 tablets, p < 0.02) for the first 36 hours compared with group 1. No statistically significant differences were identified between the two groups with regard to demographics, hours of postoperative cryotherapy, hours of CPM use, or maximum knee flexion achieved. Complications did not occur in either group. This is the first report we are aware of showing the postoperative effects of preoperative cryotherapy. Our results support the safety and efficacy of preoperative cryotherapy in a multimodal pain regimen for patients undergoing ACL reconstruction. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Belimumab in kidney transplantation: an experimental medicine, randomised, placebo-controlled phase 2 trial.

PubMed

Banham, Gemma D; Flint, Shaun M; Torpey, Nicholas; Lyons, Paul A; Shanahan, Don N; Gibson, Adele; Watson, Christopher J E; O'Sullivan, Ann-Marie; Chadwick, Joseph A; Foster, Katie E; Jones, Rachel B; Devey, Luke R; Richards, Anna; Erwig, Lars-Peter; Savage, Caroline O; Smith, Kenneth G C; Henderson, Robert B; Clatworthy, Menna R

2018-06-14

B cells produce alloantibodies and activate alloreactive T cells, negatively affecting kidney transplant survival. By contrast, regulatory B cells are associated with transplant tolerance. Immunotherapies are needed that inhibit B-cell effector function, including antibody secretion, while sparing regulators and minimising infection risk. B lymphocyte stimulator (BLyS) is a cytokine that promotes B-cell activation and has not previously been targeted in kidney transplant recipients. We aimed to determine the safety and activity of an anti-BLyS antibody, belimumab, in addition to standard-of-care immunosuppression in adult kidney transplant recipients. We used an experimental medicine study design with multiple secondary and exploratory endpoints to gain further insight into the effect of belimumab on the generation of de-novo IgG and on the regulatory B-cell compartment. We undertook a double-blind, randomised, placebo-controlled phase 2 trial of belimumab, in addition to standard-of-care immunosuppression (basiliximab, mycophenolate mofetil, tacrolimus, and prednisolone) at two centres, Addenbrooke's Hospital, Cambridge, UK, and Guy's and St Thomas' Hospital, London, UK. Participants were eligible if they were aged 18-75 years and receiving a kidney transplant and were planned to receive standard-of-care immunosuppression. Participants were randomly assigned (1:1) to receive either intravenous belimumab 10 mg per kg bodyweight or placebo, given at day 0, 14, and 28, and then every 4 weeks for a total of seven infusions. The co-primary endpoints were safety and change in the concentration of naive B cells from baseline to week 24, both of which were analysed in all patients who received a transplant and at least one dose of drug or placebo (the modified intention-to-treat [mITT] population). This trial has been completed and is registered with ClinicalTrials.gov, NCT01536379, and EudraCT, 2011-006215-56. Between Sept 13, 2013, and Feb 8, 2015, of 303 patients assessed for eligibility, 28 kidney transplant recipients were randomly assigned to receive belimumab (n=14) or placebo (n=14). 25 patients (12 [86%] patients assigned to the belimumab group and 13 [93%] patients assigned to the placebo group) received a transplant and were included in the mITT population. We observed similar proportions of adverse events in the belimumab and placebo groups, including serious infections (one [8%] of 12 in the belimumab group and five [38%] of 13 in the placebo group during the 6-month on-treatment phase; and none in the belimumab group and two [15%] in the placebo group during the 6-month follow-up). In the on-treatment phase, one patient in the placebo group died because of fatal myocardial infarction and acute cardiac failure. The co-primary endpoint of a reduction in naive B cells from baseline to week 24 was not met. Treatment with belimumab did not significantly reduce the number of naive B cells from baseline to week 24 (adjusted mean difference between the belimumab and placebo treatment groups -34·4 cells per μL, 95% CI -109·5 to 40·7). Belimumab might be a useful adjunct to standard-of-care immunosuppression in renal transplantation, with no major increased risk of infection and potential beneficial effects on humoral alloimmunity. GlaxoSmithKline. Copyright © 2018 Elsevier Ltd. All rights reserved.

Evaluation of metoclopramide and ranitidine on the prevention of gastroesophageal reflux episodes in anesthetized dogs.

PubMed

Favarato, E S; Souza, M V; Costa, P R S; Favarato, L S C; Nehme, R C; Monteiro, B S; Bonfá, L P

2012-08-01

This research aimed to evaluate the effect of metoclopramide and ranitidine in the prevention of gastroesophageal reflux episodes during anesthetic procedures. Ninety healthy female dogs were submitted to elective ovariosalpingohisterectomy, randomly divided into three groups of 30 animals. The control group received only the anesthetic protocol. The metoclopramide group received an intravenous bolus of 1mg/kg, and continuous infusion (1 mg/kg/h intravenously) immediately after anesthetic induction. The ranitidine group received an intravenous bolus of 2 mg/kg, 6 h before anesthesia. Anesthesia (acepromazine, propofol and isofluorane) was standardized and the esophageal pH variations were recorded. Esophagoscopy was carried out after surgery. No difference (p<0.05) was verified in the reflux episodes between the groups. Seven animals presented reflux. Metoclopramide in bolus and continuous infusion, as well as ranitidine, 6 h before anesthesia, did not influence the reduction of the incidence of gastroesophageal reflux. Copyright © 2011 Elsevier Ltd. All rights reserved.

Sugammadex Improves Neuromuscular Function in Patients Receiving Perioperative Steroids.

PubMed

Ozer, A B; Bolat, E; Erhan, O L; Kilinc, M; Demirel, I; Toprak, G Caglar

2018-02-01

Sugammadex has steroid-encapsulating effect. This study was undertaken to assess whether the clinical efficacy of sugammadex was altered by the administration of steroids. Sixty patients between 18 and 60 years of age with the American Society of Anesthesiologists I-IV and undergoing elective direct laryngoscopy/biopsy were included in this study. Patients were assigned to two groups based on the intraoperative steroid use: those who received steroid (Group S) and who did not (Group C). After standard general anesthesia, patients were monitored with the train of four (TOF) monitoring. The preferred steroid and its dose, timing of steroid administration, and TOF value before and after sugammadex as well as the time to recovery (TOF of 0.9) were recorded. SPSS software version 17.0 was used for statistical analysis. There is no statistically significant difference between groups in terms of age, gender, preoperative medication use, and TOF ratio just before administering sugammadex. The reached time to TOF 0.9 after sugammadex administration was significantly shorter in Group S than Group C (P < 0.05). A within-group comparison in Group S showed no difference in TOF ratio immediately before sugammadex as well as the dose of sugammadex in those who received prednisolone; time to TOF 0.9 was higher in prednisolone receivers as compared to dexamethasone receivers (P < 0.05). In patients receiving steroids, and particularly dexamethasone, an earlier reversal of neuromuscular block by sugammadex was found, in contrast with what one expect. Further studies are required to determine the cause of this effect which is probably due to a potential interaction between sugammadex and steroids.

Adjunctive cholestyramine therapy for thyrotoxicosis.

PubMed

Solomon, B L; Wartofsky, L; Burman, K D

1993-01-01

Initial therapy of thyrotoxicosis usually includes beta-blockade for symptom relief and thionamides to block new thyroid hormone synthesis. In view of the increased enterohepatic circulation of thyroxine (T4) and triiodothyronine (T3) in thyrotoxicosis, we proposed that cholestyramine, an anion exchange resin which binds iodothyronines, when used adjunctively with thionamides and a beta-blocker, would lower serum iodothyronine levels faster than would standard therapy alone. A double blind placebo-controlled cross-over design was used with patients randomly assigned to either the treatment or control groups. They received their initial treatment for two weeks (Phase 1) followed by a one-week washout period, and then crossed to the opposite treatment for two weeks (Phase 2). Standard therapy included atenolol 50 mg daily, individualized dosages of methimazole and either 4 g of cholestyramine or 4 g of placebo powder four times per day. Fifteen patients with thyrotoxicosis (14 Graves' disease, 1 toxic adenoma) participated in this study. Total and free thyroxine and triiodothyronine, as well as thyroid-stimulating immunoglobulin and thyrotrophin-binding inhibitory immunoglobulin, were measured weekly. Seven patients received cholestyramine and eight patients received placebo during Phase 1. A more rapid decline in all thyroid hormone levels was seen in the cholestyramine-treated group (F = 4-7, P < 0.01) than in the placebo group (F = 2-3.1, P = 0.05). In Phase 2, the eight patients who received cholestyramine showed an additional decline in free thyroxine from weeks one to two, but the overall rate of decline in hormone levels was not different between the groups. Immunoglobulin levels remained unaffected regardless of group, treatment, or time. We conclude that cholestyramine is a safe and effective adjunctive agent in the treatment of thyrotoxicosis and that its greatest efficacy may be during the first few weeks of treatment.

Delivery of Instructions via Mobile Social Media App Increases Quality of Bowel Preparation.

PubMed

Kang, Xiaoyu; Zhao, Lina; Leung, Felix; Luo, Hui; Wang, Limei; Wu, Ji; Guo, Xiaoyang; Wang, Xiangping; Zhang, Linhui; Hui, Na; Tao, Qin; Jia, Hui; Liu, Zhiguo; Chen, Zhangqin; Liu, Junjun; Wu, Kaichun; Fan, Daiming; Pan, Yanglin; Guo, Xuegang

2016-03-01

Bowel preparation is closely linked to the quality of colonoscopy. We investigated whether delivery of instructions via a social media app increases the quality of colonoscopy by improving adequacy of bowel preparation. We performed a prospective study at 3 endoscopic centers in China of 770 colonoscopy outpatients (18-80 years old) with convenient access to Wechat (a widely used mobile social media app) from May through November 2014. Patients were randomly assigned to groups that received standard education along with delivery of interactive information via Wechat (n = 387) or standard education (controls, n = 383). The primary outcome was proportion of patients with adequate bowel preparation (Ottawa score <6). Secondary outcomes included rates of adenoma detection and cecal intubation, cecal intubation time, rates of incomplete compliance with instructions, and patient willingness to repeat bowel preparation. Demographic features were comparable between the groups. A higher proportion of patients in the group that received social media instruction had adequate bowel preparation than the control group (82.2% vs 69.5%, P < .001). Among patients with successful colonoscopies, the group that received social media instruction had lower mean total and segmental Ottawa scores (P < .05). A higher proportion of patients receiving social media instruction also had cecal intubation (97.2% vs 93.2% in controls, P = .014) and were found to have adenomas (18.6% vs 12.0% in controls, P = .012). Instruction via a mobile social media app, in conjunction with regular instruction, increases subjective measures of adequacy of bowel preparation. Use of the app significantly increased the proportion of patients with successful cecal intubation and in whom adenomas were detected, indicating increased quality of colonoscopy. ClinicalTrials.gov number: NCT02140827. Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.

Effectiveness of integrating individualized and generic complementary medicine treatments with standard care versus standard care alone for reducing preoperative anxiety.

PubMed

Attias, Samuel; Keinan Boker, Lital; Arnon, Zahi; Ben-Arye, Eran; Bar'am, Ayala; Sroka, Gideon; Matter, Ibrahim; Somri, Mostafa; Schiff, Elad

2016-03-01

Preoperative anxiety is commonly reported by people undergoing surgery. A significant number of studies have found a correlation between preoperative anxiety and post-operative morbidity. Various methods of complementary and alternative medicine (CAM) were found to be effective in alleviating preoperative anxiety. This study examined the relative effectiveness of various individual and generic CAM methods combined with standard treatment (ST) in relieving preoperative anxiety, in comparison with ST alone. Randomized controlled trial. Holding room area Three hundred sixty patients. Patients were randomly divided into 6 equal-sized groups. Group 1 received the standard treatment (ST) for anxiety alleviation with anxiolytics. The five other groups received the following, together with ST (anxiolytics): Compact Disk Recording of Guided Imagery (CDRGI); acupuncture; individual guided imagery; reflexology; and individual guided imagery combined with reflexology, based on medical staff availability. Assessment of anxiety was taken upon entering the holding room area (surgery preparation room) ('pre-treatment assessment'), and following the treatment, shortly before transfer to the operating room ('post-treatment assessment'), based on the Visual Analogue Scale (VAS) questionnaire. Data processing included comparison of VAS averages in the 'pre' and 'post' stages among the various groups. Preoperatively, CAM treatments were associated with significant reduction of anxiety level (5.54-2.32, p<0.0001). In contrast, no significant change was noted in the standard treatment group (4.92-5.44, p=0.15). Individualized CAM treatments did not differ significantly in outcomes. However, CDRGI was less effective than individualized CAM (P<0.001), but better than ST (p=0.005). Individual CAM treatments integrated within ST reduce preoperative anxiety significantly, compared to standard treatment alone, and are more effective than generic CDRGI. In light of the scope of preoperative anxiety and its implications for public health, integration of CAM therapies with ST should be considered for reducing preoperative anxiety. Copyright © 2016 Elsevier Inc. All rights reserved.

How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes.

PubMed

Ayling, K; Brierley, S; Johnson, B; Heller, S; Eiser, C

2015-01-01

Poor descriptions of standard care may compromise interpretation of results in randomised controlled trials (RCTs) of health interventions. We investigated quality of standard care in RCTs of behaviour change interventions for young people with type 1 diabetes and consider implications for evaluating trial outcomes. We conducted systematic searches for articles published between 1999 and 2012. We extracted standard care descriptions and contacted trial authors to complete a checklist of standard care activities. The relationship between standard care quality and outcomes was examined via subgroup meta-analyses and meta-regression. Standard care descriptions, standard care quality, and relationships between standard care quality with medical and psychological outcomes. We identified 20 RCTs described across 26 articles. Published descriptions of standard care were limited to service-level features. Author responses indicated standard care provision extended beyond published accounts. Subgroup analyses suggested control groups receiving higher standard care quality showed larger improvements in both medical and psychological outcomes, although standard care quality did not predict outcomes significantly. The quality of care delivered to control group participants can influence outcomes of RCTs. Inadequate reporting exacerbates this issue by masking variations between trials. We argue for increased clarity in reporting standard care in future trials.

A Randomized Controlled Trial to Compare e-Feedback Versus "Standard" Face-to-Face Verbal Feedback to Improve the Acquisition of Procedural Skill.

PubMed

Al-Jundi, Wissam; Elsharif, Mohamed; Anderson, Melanie; Chan, Phillip; Beard, Jonathan; Nawaz, Shah

Constructive feedback plays an important role in learning during surgical training. Standard feedback is usually given verbally following direct observation of the procedure by a trained assessor. However, such feedback requires the physical presence of expert faculty members who are usually busy and time-constrained by clinical commitments. We aim to evaluate electronic feedback (e-feedback) after video observation of surgical suturing in comparison with standard face-to-face verbal feedback. A prospective, blinded, randomized controlled trial comparing e-feedback with standard verbal feedback was carried out in February 2015 using a validated pro formas for assessment. The study participants were 38 undergraduate medical students from the University of Sheffield, UK. They were recorded on video performing the procedural skill, completed a self-evaluation form, and received e-feedback on the same day (group 1); observed directly by an assessor, invited to provide verbal self-reflection, and then received standard verbal feedback (group 2). In both groups, the feedback was provided after performing the procedure. The participants returned 2 days later and performed the same skill again. Poststudy questionnaire was used to assess the acceptability of each feedback among the participants. Overall, 19 students in group 1 and 18 students in group 2 completed the study. Although there was a significant improvement in the overall mean score on the second performance of the task for all participants (first performance mean 11.59, second performance mean 15.95; p ≤ 0.0001), there was no difference in the overall mean improvement score between group 1 and group 2 (4.74 and 3.94, respectively; p = 0.49). The mean overall scores for the e-feedback group at baseline recorded by 2 independent investigators showed good agreement (mean overall scores of 12.84 and 11.89; Cronbach α = 0.86). Poststudy questionnaire demonstrated that both e-feedback and standard verbal feedback achieved high mean Likert grades as recorded by the participants (4.42 [range: 2-5] and 4.71 [range: 4-5], respectively; p = 0.274). e-Feedback after watching a video recording appears to be acceptable and is not quantitatively different than standard feedback in improving suturing skills among novice trainees. Video assessment of procedural skills is reliable. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

AFCF and clinoptilolite use in reduction of (137)Cs deposition in several days' contaminated broiler chicks.

PubMed

Mitrovic, B; Vitorovic, G; Vitorovic, D; Dakovic, A; Stojanovic, M

2007-01-01

The objective of this study was to investigate the binding efficiency of AFCF and clinoptilolite, mixed to the feed and administered orally using gastric tube to chronically (137)Cs alimentary contaminated broiler chicks. Seventy-five male Hybro broiler chicks, between 35 and 47 days of age were divided into five groups (15 birds per group) reared in cages (five birds in a cage) and fed a standard diet. Every day during 13 days of the experimental period all chicks received orally 1 ml CsCl water solution with activity of 1310 Bq ml(-1)(137)Cs (gastric tube). Group 1 was the control group and received no binders. The experimental groups received the binders. Group 2 received 0.2 g of AFCF in the form of water solution (gastric tube); group 3 received 0.2% AFCF in the feed; group 4 received 2g clinoptilolite in the form of water suspension (gastric tube) and group 5 received 2% clinoptilolite in the feed. Five chicks from each group were sacrificed on days 4, 10 and 13 of the experimental period. Using gamma spectrometric methods specific activity of (137)Cs was determined in the samples of breast meat, liver and gizzard. The results obtained showed that administering binders to the chronically contaminated broiler chicks significantly (p<0.01) reduced (137)Cs transfer and deposition in breast meat, liver and gizzard. Decreasing deposition of (137)Cs in breast meat and internal organs increased with time of contamination and binders' administration. With AFCF as a cesium binder, on day 13 of measuring the (137)Cs activity in breast meat was 80-83% lower than that in the control group, 89% in liver and 83-84% in gizzard. Natural clinoptilolite demonstrated lower binding efficiency. On day 13 of measuring the (137)Cs activity in breast meat was 53-69% lower than that in the control group, 67-60% in liver and 59-71% in gizzard.

Sources of Biased Inference in Alcohol and Drug Services Research: An Instrumental Variable Approach

PubMed Central

Schmidt, Laura A.; Tam, Tammy W.; Larson, Mary Jo

2012-01-01

Objective: This study examined the potential for biased inference due to endogeneity when using standard approaches for modeling the utilization of alcohol and drug treatment. Method: Results from standard regression analysis were compared with those that controlled for endogeneity using instrumental variables estimation. Comparable models predicted the likelihood of receiving alcohol treatment based on the widely used Aday and Andersen medical care–seeking model. Data were from the National Epidemiologic Survey on Alcohol and Related Conditions and included a representative sample of adults in households and group quarters throughout the contiguous United States. Results: Findings suggested that standard approaches for modeling treatment utilization are prone to bias because of uncontrolled reverse causation and omitted variables. Compared with instrumental variables estimation, standard regression analyses produced downwardly biased estimates of the impact of alcohol problem severity on the likelihood of receiving care. Conclusions: Standard approaches for modeling service utilization are prone to underestimating the true effects of problem severity on service use. Biased inference could lead to inaccurate policy recommendations, for example, by suggesting that people with milder forms of substance use disorder are more likely to receive care than is actually the case. PMID:22152672

Alternative dosing of prophylactic enoxaparin in the trauma patient: is more the answer?

PubMed

Kopelman, Tammy R; O'Neill, Patrick J; Pieri, Paola G; Salomone, Jeffrey P; Hall, Scott T; Quan, Asia; Wells, Jordan R; Pressman, Melissa S

2013-12-01

Inadequate anti-factor Xa levels and increased venous thromboembolic events occur in trauma patients receiving standard prophylactic enoxaparin dosing. The aim of this study was to test the hypothesis that higher dosing (40 mg twice daily) would improve peak anti-Xa levels and decrease venous thromboembolism. A retrospective review was performed of trauma patients who received prophylactic enoxaparin and peak anti-Xa levels over 27 months. Patients were divided on the basis of dose: group A received 30 mg twice daily, and group B received 40 mg twice daily. Demographics and rates of venous thromboembolism were compared between dose groups and patients with inadequate or adequate anti-Xa levels. One hundred twenty-four patients were included, 90 in group A and 34 in group B. Demographics were similar, except that patients in group B had a higher mean body weight. Despite this, only 9% of group B patients had inadequate anti-Xa levels, compared with 33% of those in group A (P = .01). Imaging studies were available in 69 patients and revealed 8 venous thromboembolic events (P = NS, group A vs group B) with significantly more venous thromboembolic events occurring in patients with low anti-Xa levels (P = .02). Although higher dosing of enoxaparin led to improved anti-Xa levels, this did not equate to a statistical decrease in venous thromboembolism. Copyright © 2013 Elsevier Inc. All rights reserved.

Prophylactic dressing application to reduce pressure ulcer formation in cardiac surgery patients.

PubMed

Brindle, C Tod; Wegelin, Jacob A

2012-01-01

The study was designed to determine if application of a self-adherent silicone border foam dressing would reduce pressure ulcer incidence when compared to standard preventive interventions among patients managed in a cardiac surgery intensive care unit (CSICU). One hundred consecutive patients in the CSICU at Virginia Commonwealth University Medical Center in Richmond participated in the study. Fifteen were subsequently excluded due to incomplete data or failure to remain in the CSICU for at least 48 hours. Of the 100 subjects consecutively enrolled, 56 subjects were assigned to the intervention group with attrition of 6 subjects (6/56), and 39 were assigned to the standard care comparison group with attrition of 4 subjects (4/39). Five study forms were lost and the group assignment of those subjects is unknown. Patients admitted to the CSICU were assigned to either standard treatment or an intervention group consisting of standard preventive care plus application of the silicone border foam dressing. The assignment of subjects to these groups was done in a nonrandom manner, via prestudy room designation (7 intervention rooms/7 standard practice rooms) and room availability on call from the operating room. The charge nurse and bed management staff were unaware of room designation, and staff did not know which group the subjects were assigned to until they admitted the patient and opened the bedside chart that indicated group assignment. Twenty-one covariates were compared between the 2 groups. A Cox proportional hazards model was computed to compare the hazard (risk per unit time) of developing a pressure ulcer between these groups. Propensity score covariate adjustment was performed to adjust for any imbalance between the groups. Nine pressure ulcers developed during the course of the study. Eight pressure ulcers developed in 4 out of 35 patients who received standard preventive care; 5 were classified as suspected deep tissue injuries and 3 were classified as stage II pressure ulcers. One pressure ulcer developed in 1 out of 50 patients in the intervention group; it was classified as suspected deep tissue injury. No statistically significant difference in any covariate was found between the groups (all P > .058). The group that received standard care had a hazard ratio of 3.6 in relation to the intervention group, but this difference was not statistically significant (P = .3). Pressure ulcer incidence was lower than anticipated over the study period for both groups. No statistically significant difference in pressure ulcer incidence between the intervention and control groups was found. A randomized controlled trial based on a power analysis is needed to more precisely determine the efficacy of a silicone border foam dressing for prevention of pressure ulcers in the intensive care unit.

Ondansetron, granisetron, and dexamethasone compared for the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy : A randomized placebo-controlled study.

PubMed

Erhan, Yamac; Erhan, Elvan; Aydede, Hasan; Yumus, Okan; Yentur, Alp

2008-06-01

Laparoscopic cholecystectomies are associated with an appreciably high rate of postoperative nausea and vomiting (PONV). This study was designed to compare the effectiveness of ondansetron, granisetron, and dexamethasone for the prevention of PONV in patients after laparoscopic cholecystectomy. A total of 80 American Society of Anesthesiologists (ASA) physical class I-II patients scheduled for laparoscopic cholecystectomy were included in this randomized, double blind, placebo-controlled study. All patients received a similar standardized anesthesia and operative treatment. Patients were randomly divided into four groups (n = 20 each). Group 1, consisting of control patients, received 0.9% NaCl; group 2 patients received ondansetron 4 mg i.v.; group 3 patients received granisetron 3 mg i.v.; and group 4 patients received dexamethasone 8 mg i.v., all before the induction of anesthesia. Both nausea and vomiting were assessed during the first 24 h after the procedure. The total incidence of PONV was 75% with placebo, 35% with ondansetron, 30% with granisetron, and 25% with dexamethasone. The incidence of PONV was significantly less frequent in groups receiving antiemetics (p < 0.05). The differences between dexamethasone, granisetron, and ondansetron were not significant. Prophylactic dexamethasone 8 mg i.v. significantly reduced the incidence of PONV in patients undergoing laparoscopic cholecystectomy. Dexamethasone 8 mg was as effective as ondansetron 4 mg and granisetron 3 mg, and it was more effective than placebo.

Phase II study of magnesium sulfate in acute organophosphate pesticide poisoning.

PubMed

Basher, A; Rahman, S H; Ghose, A; Arif, S M; Faiz, M A; Dawson, A H

2013-01-01

Acute organophosphorus (OP) poisoning is relatively common and a major cause of death from poisoning in developing countries. Magnesium has been shown to be of benefit in animal models. We conducted a phase II study of bolus doses of (MgSO4) in 50 patients with acute organophosphate poisoning. Patients eligible for inclusion had ingested OP and had cholinergic symptoms consistent with moderate or severe poisoning. All patients received standard care of atropinization titrated to control muscarinic symptoms and pralidoxime. The trial was run in 4 sequential groups of patients. Participants in each group received a different total dose of MgSO4 (20%) administered as intermittent bolus doses infused over 10-15 min or placebo. There was one control patient for every 4 patients who received MgSO4. Group A (16 patients) received a total of 4 gm MgSO4 as a single bolus, group B (8 patients) received 8 gm (in two 4 gm doses q4H), group C (8 patients) received 12 gm (in three 4 gm doses q4H) group D (8 patients) received 16 gm (in four 4 gm doses q4H) and control (10 patients) received placebo). Patients were closely monitored for any adverse reaction like significant clinical neuromuscular disturbance and respiratory depression. No adverse reactions to magnesium were observed. The 24 hour urinary magnesium concentration were statistically different between 16 gm (234.74 ± 74.18 mg/dl) and control (118.06 ± 30.76 mg/dl) (p = 0.019), while it was much lower than the 80% of the intravenous magnesium load. Six patients died in control group compared to 3 in 4 gm, 2 in 8 gm and 1 in 12 gm group. There was no mortality in 16 gm group. Magnesium was well tolerated in this study. Larger studies are required to examine for efficacy.

A pilot randomized trial of pentoxifylline for the reduction of periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention.

PubMed

Aslanabadi, Naser; Shirzadi, Hamid Reza; Asghari-Soufi, Hossein; Dousti, Samaneh; Ghaffari, Samad; Sohrabi, Bahram; Mashayekhi, Simin Ozar; Hamishehkar, Hadi; Entezari-Maleki, Taher

2015-02-01

Periprocedural myocardial injury (PMI) following percutaneous coronary intervention (PCI) has received great attention due to its significant association with mortality and morbidity. Accordingly, cardioprotection during PCI is one of the important therapeutic concerns. Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI. A randomized clinical trial on 85 patients undergoing elective PCI was performed. The intervention group (n = 41) received 1200 mg pentoxifylline in divided doses plus the standard treatment before PCI, while the control group (n = 44) received the standard treatment. For assessing myocardial damage during PCI, the levels of CK-MB and troponin-I were measured at baseline, 8, and 24 h after the procedure. Then, patients were followed up for a 1-month period regarding the major adverse cardiac effect. Comparing with the control group, no significant change of CK-MB at 8 (p = 0.315) and 24 h (p = 0.896) after PCI was documented in pentoxifylline group. Similarly, no significant change was found in troponin-I at 8 (p = 0.141) and 24 h (p = 0.256) after PCI. This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI. However, the trend was toward the potential benefit of pentoxifylline.

Enteral High Fat-Polyunsaturated Fatty Acid Blend Alters the Pathogen Composition of the Intestinal Microbiome in Premature Infants with an Enterostomy

PubMed Central

Younge, Noelle; Yang, Qing; Seed, Patrick C.

2016-01-01

Objective To determine the effect of enteral fish oil and safflower oil supplementation on the intestinal microbiome in premature infants with an enterostomy. Study design Premature infants with an enterostomy were randomized to receive early enteral supplementation with a high fat-polyunsaturated fatty acid (HF-PUFA) blend of fish oil and safflower oil versus standard nutritional therapy. We used 16S rRNA gene sequencing for longitudinal profiling of the microbiome from the time of study entry until bowel reanastomosis. We used weighted gene co-expression network analysis to identify microbial community modules that differed between study groups over time. We performed imputed metagenomic analysis to determine metabolic pathways associated with the microbial genes. Results Sixteen infants were randomized to receive enteral HF-PUFA supplementation and 16 infants received standard care. The intestinal microbiota of infants in the treatment group differed from those in the control group, with greater bacterial diversity and lower abundance of Streptococcus, Clostridium, and many pathogenic genera within the Enterobacteriaceae family. We identified four microbial community modules with significant differences between groups over time. Imputed metagenomic analysis of the microbial genes revealed metabolic pathways that differed between groups, including metabolism of amino acids, carbohydrates, fatty acids, and secondary bile acid synthesis. Conclusion Enteral HF-PUFA supplementation was associated with decreased abundance of pathogenic bacteria, greater bacterial diversity, and shifts in the potential metabolic functions of intestinal microbiota. Trial registration ClinicalTrials.gov: NCT01306838 PMID:27856001

Enteral High Fat-Polyunsaturated Fatty Acid Blend Alters the Pathogen Composition of the Intestinal Microbiome in Premature Infants with an Enterostomy.

PubMed

Younge, Noelle; Yang, Qing; Seed, Patrick C

2017-02-01

To determine the effect of enteral fish oil and safflower oil supplementation on the intestinal microbiome in infants with an enterostomy born premature. Infants with an enterostomy born premature were randomized to receive early enteral supplementation with a high-fat polyunsaturated fatty acid (HF-PUFA) blend of fish oil and safflower oil vs standard nutritional therapy. We used 16S rRNA gene sequencing for longitudinal profiling of the microbiome from the time of study entry until bowel reanastomosis. We used weighted gene coexpression network analysis to identify microbial community modules that differed between study groups over time. We performed imputed metagenomic analysis to determine metabolic pathways associated with the microbial genes. Sixteen infants were randomized to receive enteral HF-PUFA supplementation, and 16 infants received standard care. The intestinal microbiota of infants in the treatment group differed from those in the control group, with greater bacterial diversity and lower abundance of Streptococcus, Clostridium, and many pathogenic genera within the Enterobacteriaceae family. We identified 4 microbial community modules with significant differences between groups over time. Imputed metagenomic analysis of the microbial genes revealed metabolic pathways that differed between groups, including metabolism of amino acids, carbohydrates, fatty acids, and secondary bile acid synthesis. Enteral HF-PUFA supplementation was associated with decreased abundance of pathogenic bacteria, greater bacterial diversity, and shifts in the potential metabolic functions of intestinal microbiota. ClinicalTrials.gov:NCT01306838. Copyright © 2016 Elsevier Inc. All rights reserved.

The effect of topical application of pure honey on radiation-induced mucositis: a randomized clinical trial.

PubMed

Motallebnejad, M; Akram, S; Moghadamnia, A; Moulana, Z; Omidi, S

2008-03-01

Radiation-induced mucositis is an early effect of head and neck radiotherapy. Mucositis can cause ulcers, and patients may experience pain and dysphasia which need treatment. The aim of this study is to evaluate the effect of pure natural honey on radiation induced mucositis. In this randomized single blind (examiner blind) clinical trial 40 patients with head and neck cancer requiring radiation to the oropharyngeal mucosa were randomly assigned to two groups. Twenty patients assigned to the study group received honey, while both the study and control groups received standard head and neck radiation therapy based on a standard protocol. In the study group patients were instructed to take 20 ml of honey 15 minutes before radiation therapy, then again at intervals of 15 minutes and six hours after radiation. In the control group patients were instructed to rinse with 20 ml of saline before and after radiation. Patients were evaluated weekly for progression of mucositis using the Oral Mucositis Assessing Scale (OMAS). Data were analyzed using the independent t-test, Mann-Whitney, and Friedman tests. A significant reduction in mucositis among honey-received patients compared with controls (p=0.000) occurred. Within the limits of this study the results showed the application of natural honey is effective in managing radiation induced mucositis. Natural honey is a product with rich nutritional qualities that could be a pleasant, simple, and economic modality for the management of radiation mucositis.

A cluster randomized pilot trial of a tailored worksite smoking cessation intervention targeting Hispanic/Latino construction workers: Intervention development and research design.

PubMed

Asfar, Taghrid; Caban-Martinez, Alberto J; McClure, Laura A; Ruano-Herreria, Estefania C; Sierra, Danielle; Gilford Clark, G; Samano, Daniel; Dietz, Noella A; Ward, Kenneth D; Arheart, Kristopher L; Lee, David J

2018-04-01

Construction workers have the highest smoking rate among all occupations (39%). Hispanic/Latino workers constitute a large and increasing group in the US construction industry (over 2.6 million; 23% of all workers). These minority workers have lower cessation rates compared to other groups due to their limited access to cessation services, and lack of smoking cessation interventions adapted to their culture and work/life circumstances. Formative research was conducted to create an intervention targeting Hispanic/Latino construction workers. This paper describes the intervention development and the design, methods, and data analysis plans for an ongoing cluster pilot two-arm randomized controlled trial comparing an Enhanced Care worksite cessation program to Standard Care. Fourteen construction sites will be randomized to either Enhanced Care or Standard Care and 126 participants (63/arm) will be recruited. In both arms, recruitment and intervention delivery occur around "food trucks" that regularly visit the construction sites. Participants at Enhanced Care sites will receive the developed intervention consisting of a single face-to-face group counseling session, 2 phone calls, and a fax referral to Florida tobacco quitline (QL). Participants at Standard Care sites will receive a fax referral to the QL. Both groups will receive eight weeks of nicotine replacement treatment and two follow-up assessments at three and six months. Feasibility outcomes are estimated recruitment yield, barriers to delivering the intervention onsite, and rates of adherence/compliance to the intervention, follow-ups, and QL enrollment. Efficacy outcomes are point-prevalence and prolonged abstinence rates at six month follow-up confirmed by saliva cotinine <15 ng/ml. Copyright © 2018. Published by Elsevier Inc.

Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.

PubMed

Majeed, Muhammed; Nagabhushanam, Kalyanam; Natarajan, Sankaran; Sivakumar, Arumugam; Ali, Furqan; Pande, Anurag; Majeed, Shaheen; Karri, Suresh Kumar

2016-02-27

Bacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients. Thirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 10(9) cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician's global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires. Laboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p < 0.01). Similarly, disease severity also decreased and the quality of life increased in the patient group receiving B. coagulans MTCC 5856 when compared to placebo group. The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 10(9) cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

Cognitive Behavioral Therapy for Psychosis (CBT-p) Delivered in a Community Mental Health Setting: A Case Comparison of Clients Receiving CBT Informed Strategies by Case Managers Prior to Therapy.

PubMed

Sivec, Harry J; Montesano, Vicki L; Skubby, David; Knepp, Kristen A; Munetz, Mark R

2017-02-01

This exploratory case comparison examines the influence of case management activities on engagement and progress in psychotherapy for clients with schizophrenia. Six clients were recruited to participate in ten sessions of Cognitive Behavioral Therapy for psychosis (CBT-p). Three clients who had received Cognitive Behavioral techniques for psychosis (CBt-p, a low-intensity case management intervention) prior to receiving therapy were selected from referrals. A comparison group of three clients who had received standard case management services was selected from referrals. Cases within and across groups were compared on outcome measures and observations from case review were offered to inform future research. Delivering CBT-p services on a continuum from low- to high-intensity is discussed.

Efficacy and Safety of 1-Hour Infusion of Recombinant Human Atrial Natriuretic Peptide in Patients With Acute Decompensated Heart Failure

PubMed Central

Wang, Guogan; Wang, Pengbo; Li, Yishi; Liu, Wenxian; Bai, Shugong; Zhen, Yang; Li, Dongye; Yang, Ping; Chen, Yu; Hong, Lang; Sun, Jianhui; Chen, Junzhu; Wang, Xian; Zhu, Jihong; Hu, Dayi; Li, Huimin; Wu, Tongguo; Huang, Jie; Tan, Huiqiong; Zhang, Jian; Liao, Zhongkai; Yu, Litian; Mao, Yi; Ye, Shaodong; Feng, Lei; Hua, Yihong; Ni, Xinhai; Zhang, Yuhui; Wang, Yang; Li, Wei; Luan, Xiaojun; Sun, Xiaolu; Wang, Sijia

2016-01-01

Abstract The aim of the study was to evaluate the efficacy and safety of 1-h infusion of recombinant human atrial natriuretic peptide (rhANP) in combination with standard therapy in patients with acute decompensated heart failure (ADHF). This was a phase III, randomized, double-blind, placebo-controlled, multicenter trial. Eligible patients with ADHF were randomized to receive a 1-h infusion of either rhANP or placebo at a ratio of 3:1 in combination with standard therapy. The primary endpoint was dyspnea improvement (a decrease of at least 2 grades of dyspnea severity at 12 h from baseline). Reduction in pulmonary capillary wedge pressure (PCWP) 1 h after infusion was the co-primary endpoint for catheterized patients. Overall, 477 patients were randomized: 358 (93 catheterized) patients received rhANP and 118 (28 catheterized) received placebo. The percentage of patients with dyspnea improvement at 12 h was higher, although not statistically significant, in the rhANP group than in the placebo group (32.0% vs 25.4%, odds ratio=1.382, 95% confidence interval [CI]: 0.863–2.212, P = 0.17). Reduction in PCWP at 1 h was significantly greater in patients treated with rhANP than in patients treated with placebo (−7.74 ± 5.95 vs −1.82 ± 4.47 mm Hg, P < 0.001). The frequencies of adverse events and renal impairment within 3 days of treatment were similar between the 2 groups. Mortality at 1 month was 3.1% in the rhANP group vs 2.5% in the placebo group (hazard ratio = 1.21, 95% CI: 0.34–4.26; P > 0.99). 1-h rhANP infusion appears to result in prompt, transient hemodynamic improvement with a small, nonsignificant, effect on dyspnea in ADHF patients receiving standard therapy. The safety of 1-h infusion of rhANP seems to be acceptable. (WHO International Clinical Trials Registry Platform [ICTRP] number, ChiCTR-IPR-14005719.) PMID:26945407

Randomized Prospective Trial Comparing the Use of Intravenous versus Oral Acetaminophen in Total Joint Arthroplasty.

PubMed

Politi, Joel R; Davis, Richard L; Matrka, Alexis K

2017-04-01

Multimodal pain management has had a significant effect on improving total joint arthroplasty recovery and patient satisfaction. There is literature supporting that intravenous (IV) acetaminophen reduces postoperative pain and narcotic use in the total joint population. However, there are no studies comparing the effectiveness of IV vs oral (PO) acetaminophen as part of a standard multimodal perioperative pain regimen. One hundred twenty patients undergoing hip and knee arthroplasty surgeries performed by one joint arthroplasty surgeon were prospectively randomized into 2 groups. Group 1 (63 patients) received IV and group 2 (57 patients) received PO acetaminophen in addition to a standard multimodal perioperative pain regimen. Each group received 1 gram of acetaminophen preoperatively and then every 6 hours for 24 hours. Total narcotic use and visual analog scale (VAS) scores were collected every 4 hours postoperatively. The 24-hour average hydromorphone equivalents given were not different between groups (3.71 vs 3.48) at 24 hours (P = .76), or at any of the individual 4-hour intervals. The 24-hour average visual analog scale scores in group 1 (IV) was 3.00 and in group 2 (PO) was 3.40 (P = .06). None of the 4-hour intervals were significantly different except the first interval (0-4 hour postoperatively), which favored the IV group (P = .03). The use of IV acetaminophen may have a role when given intraoperatively to reduce the immediate pain after surgery. Following that, it does not provide a significant benefit in reducing pain or narcotic use when compared with the much less expensive PO form. Copyright © 2016 Elsevier Inc. All rights reserved.

Potential effectiveness of Community Health Strategy to promote exclusive breastfeeding in urban poor settings in Nairobi, Kenya: a quasi-experimental study.

PubMed

Kimani-Murage, E W; Norris, S A; Mutua, M K; Wekesah, F; Wanjohi, M; Muhia, N; Muriuki, P; Egondi, T; Kyobutungi, C; Ezeh, A C; Musoke, R N; McGarvey, S T; Madise, N J; Griffiths, P L

2016-04-01

Early nutrition is critical for later health and sustainable development. We determined potential effectiveness of the Kenyan Community Health Strategy in promoting exclusive breastfeeding (EBF) in urban poor settings in Nairobi, Kenya. We used a quasi-experimental study design, based on three studies [Pre-intervention (2007-2011; n=5824), Intervention (2012-2015; n=1110) and Comparison (2012-2014; n=487)], which followed mother-child pairs longitudinally to establish EBF rates from 0 to 6 months. The Maternal, Infant and Young Child Nutrition (MIYCN) study was a cluster randomized trial; the control arm (MIYCN-Control) received standard care involving community health workers (CHWs) visits for counselling on antenatal and postnatal care. The intervention arm (MIYCN-Intervention) received standard care and regular MIYCN counselling by trained CHWs. Both groups received MIYCN information materials. We tested differences in EBF rates from 0 to 6 months among four study groups (Pre-intervention, MIYCN-Intervention, MIYCN-Control and Comparison) using a χ(2) test and logistic regression. At 6 months, the prevalence of EBF was 2% in the Pre-intervention group compared with 55% in the MIYCN-Intervention group, 55% in the MIYCN-Control group and 3% in the Comparison group (P<0.05). After adjusting for baseline characteristics, the odds ratio for EBF from birth to 6 months was 66.9 (95% CI 45.4-96.4), 84.3 (95% CI 40.7-174.6) and 3.9 (95% CI 1.8-8.4) for the MIYCN-Intervention, MIYCN-Control and Comparison group, respectively, compared with the Pre-intervention group. There is potential effectiveness of the Kenya national Community Health Strategy in promoting EBF in urban poor settings where health care access is limited.

Efficacy of a multicomponent support programme for the caregivers of disabled persons: a randomised controlled study.

PubMed

Ryynänen, O-P; Nousiainen, P; Soini, E J O; Tuominen, S

2013-07-01

The goal of the present work was to measure the efficacy of a multicomponent programme designed to provide tailored support for the caregivers of disabled persons. A total of 135 caregivers-care receiver dyads were randomly divided into an intervention group (n = 66) and a control group (n = 69). One-third of the care receivers were demented, and two-thirds had other diseases. Health centres (publicly funded primary health care systems) in 8 rural and urban communities in southeast Finland. The multicomponent support programme for the caregivers consisted of a 2-week rehabilitation period. The control group received standard care. Continuation of the caregiver and care receiver relationship, care receiver mortality at the 2-year follow-up as well as the health-related quality of life (15D scale) and Zung's depression scale of the caregiver at the 1-year follow-up were evaluated. At the 2-year follow-up, the caregiver-care receiver relationship was terminated for any reason in 11 cases (17%) in the intervention group, and in 25 cases (36%) in the control group. After adjusting, the primary outcome (i.e., termination of care giving for any reason) indicated statistical significance (p = 0.04) with a hazard rate of 1.83 (95% confidence interval 1.03-3.29). With a similar adjustment, the difference in mortality and placement to institutional care between the two groups demonstrated a trend towards statistical significance. The caregivers' health, as related to quality of life and depressive symptoms, remained unchanged in both groups at the 1-year follow-up. These results indicate that a tailored support programme for caregivers may help the caregiver to continue the caregiver-care receiver relationship and delay institutionalization.

Chronic graft-versus-host disease: long-term results from a randomized trial on graft-versus-host disease prophylaxis with or without anti-T-cell globulin ATG-Fresenius.

PubMed

Socié, Gérard; Schmoor, Claudia; Bethge, Wolfgang A; Ottinger, Hellmut D; Stelljes, Matthias; Zander, Axel R; Volin, Liisa; Ruutu, Tapani; Heim, Dominik A; Schwerdtfeger, Rainer; Kolbe, Karin; Mayer, Jiri; Maertens, Johan A; Linkesch, Werner; Holler, Ernst; Koza, Vladimir; Bornhäuser, Martin; Einsele, Hermann; Kolb, Hans-Jochem; Bertz, Hartmut; Egger, Matthias; Grishina, Olga; Finke, Jürgen

2011-06-09

Previous randomized graft-versus-host disease (GVHD)-prophylaxis trials have failed to demonstrate reduced incidence and severity of chronic GVHD (cGVHD). Here we reanalyzed and updated a randomized phase 3 trial comparing standard GVHD prophylaxis with or without pretransplantation ATG-Fresenius (ATG-F) in 201 adult patients receiving myeloablative conditioning before transplantation from unrelated donors. The cumulative incidence of extensive cGVHD after 3 years was 12.2% in the ATG-F group versus 45.0% in the control group (P < .0001). The 3-year cumulative incidence of relapse and of nonrelapse mortality was 32.6% and 19.4% in the ATG-F group and 28.2% and 33.5% in the control group (hazard ratio [HR] = 1.21, P = .47, and HR = 0.68, P = .18), respectively. This nonsignificant reduction in nonrelapse mortality without increased relapse risk led to an overall survival rate after 3 years of 55.2% in the ATG-F group and 43.3% in the control group (HR = 0.84, P = .39, nonsignificant). The HR for receiving immunosuppressive therapy (IST) was 0.31 after ATG-F (P < .0001), and the 3-year probability of survival free of IST was 52.9% and 16.9% in the ATG-F versus control, respectively. The addition of ATG-F to standard cyclosporine, methotrexate GVHD prophylaxis lowers the incidence and severity of cGVHD, and the risk of receiving IST without raising the relapse rate. ATG-F prophylaxis reduces cGVHD morbidity.

The Application of an Evidence-Based Clinical Nursing Path for Improving the Preoperative and Postoperative Quality of Care of Pediatric Retroperitoneal Neuroblastoma Patients: A Randomized Controlled Trial at a Tertiary Medical Institution.

PubMed

Liu, Yang; Mo, Lin; Tang, Yan; Wang, Qiuhong; Huang, Xiaoyan

A clinical nursing path (CNP) that encourages patients and their families to become actively involved in healthcare decision-making processes may improve outcomes of pediatric retroperitoneal neuroblastoma (NB) patients. The aim of this study was to evaluate the utility and value of an evidence-based CNP provided to pediatric retroperitoneal NB patients undergoing resection surgery. One hundred twenty NB cases were assigned to a control group or a CNP group. The control group was provided with standard nursing care. The CNP group was provided with nursing care in accordance with an evidence-based CNP. The utility and value of the CNP were compared with standard nursing care. Outcome measures included rates of postoperative complications, lengths of hospital stay, and cost of hospitalization, as well as preoperative and postoperative quality of care and patient satisfaction with care. The rates of postoperative complications, length of preoperative hospitalization, total length of hospital stay, and costs of hospitalization were significantly lower for patients receiving the CNP compared with the control group. Preoperative and postoperative quality of care and patient satisfaction with care were significantly higher in patients receiving the CNP compared with the control group. Adoption of a CNP for preoperative and postoperative care of pediatric retroperitoneal NB patients undergoing resection surgery improves clinical outcomes and patient satisfaction with care. A CNP can increase families' participation in a patient's recovery process, enhance nurses' understanding of the services they are providing, and improve the quality of healthcare received by patients.

Virtual reality-based therapy for the treatment of balance deficits in patients receiving inpatient rehabilitation for traumatic brain injury.

PubMed

Cuthbert, Jeffrey P; Staniszewski, Kristi; Hays, Kaitlin; Gerber, Don; Natale, Audrey; O'Dell, Denise

2014-01-01

To evaluate the feasibility and safety of utilizing a commercially available virtual reality gaming system as a treatment intervention for balance training. A randomized controlled trial in which assessment and analysis were blinded. An inpatient rehabilitation facility. Interventions included balance-based physical therapy using a Nintendo Wii, as monitored by a physical therapist, and receipt of one-on-one balance-based physical therapy using standard physical therapy modalities available for use in the therapy gym. Participants in the standard physical therapy group were found to have slightly higher enjoyment at mid-intervention, while those receiving the virtual reality-based balance intervention were found to have higher enjoyment at study completion. Both groups demonstrated improved static and dynamic balance over the course of the study, with no significant differences between groups. Correlational analyses suggest a relationship exists between Wii balance board game scores and BBS scores for measures taken beyond the baseline assessment. This study provides a modest level of evidence to support using commercially available VR gaming systems for the treatment of balance deficits in patients with a primary diagnosis of TBI receiving inpatient rehabilitation. Additional research of these types of interventions for the treatment of balance deficits is warranted.

Single-Center Experience Using Marginal Liver Grafts in Korea.

PubMed

Park, P-J; Yu, Y-D; Yoon, Y-I; Kim, S-R; Kim, D-S

2018-05-01

Liver transplantation (LT) is an established therapeutic modality for patients with end-stage liver disease. The use of marginal donors has become more common worldwide due to the sharp increase in recipients, with a consequent shortage of suitable organs. We analyzed our single-center experience over the last 8 years in LT to evaluate the outcomes of using so-called "marginal donors." We retrospectively analyzed the database of all LTs performed at our institution from 2009 to 2017. Only patients undergoing deceased-donor LTs were analyzed. Marginal grafts were defined as livers from donors >60 years of age, livers from donors with serum sodium levels >155 mEq, graft steatosis >30%, livers with cold ischemia time ≥12 hours, livers from donors who were hepatitis B or C virus positive, livers recovered from donation after cardiac death, and livers split between 2 recipients. Patients receiving marginal grafts (marginal group) were compared with patients receiving standard grafts (standard group). A total of 106 patients underwent deceased-donor LT. There were 55 patients in the standard group and 51 patients in the marginal group. There were no significant differences in terms of age, sex, Model for End-Stage Liver Disease score, underlying liver disease, presence of hepatocellular carcinoma, and hospital stay between the 2 groups. Although the incidence of acute cellular rejection, cytomegalovirus infection, and postoperative complications was similar between the 2 groups, the incidence of early allograft dysfunction was higher in the marginal group. With a median follow-up of 26 months, the 1-, 3-, and 5-year overall and graft (death-censored) survivals in the marginal group were 85.5%, 75%, and 69.2% and 85.9%, 83.6%, and 77.2%, respectively. Patient overall survival and graft survival (death-censored) were significantly lower in the marginal group (P = .023 and P = .048, respectively). On multivariate analysis, receiving a marginal graft (hazard ratio [HR], 4.862 [95% confidence interval (CI), 1.233-19.171]; P = .024) and occurrence of postoperative complications (HR, 4.547 [95% CI, 1.279-16.168]; P = .019) were significantly associated with worse patient overall survival. Also, when factors associated with marginal graft were analyzed separately, graft steatosis >30% was independently associated with survival (HR, 5.947 [95% CI, 1.481-23.886]; P = .012). Patients receiving marginal grafts showed lower but acceptable overall survival and graft survival. However, because graft steatosis >30% was independently associated with worse survival, caution must be exercised when using this type of marginal graft by weighing the risk and benefits. Copyright © 2018 Elsevier Inc. All rights reserved.

Does vaginal irrigation with saline solution in women with infectious vaginitis contribute to the clinical and microbiological results of antibiotic therapy?

PubMed

Derbent, Aysel Uysal; Ulukanlıgil, Mustafa; Keskin, Esra Aktepe; Soylu, Gül; Kafalı, Hasan

2012-01-01

To compare the clinical and microbiological results between patients with infectious vaginitis receiving vaginal irrigation with saline or no irrigation before standard antibiotic therapy. Women with vaginitis (n = 109) were randomized to receive vaginal irrigation with saline or no irrigation before standard antibiotic therapy. The vaginal symptoms perceived by subjects and clinical findings were assessed with a standardized scale during four follow-up visits, and Gram stain Nugent scores and vaginal fluid cultures were analyzed at each visit. Vaginal discharge (z = 7.159; p < 0.001), pruritus (z = 5.169; p < 0.001), itching (z = 2.969; p < 0.003) and odor scores (z = 2.303; p < 0.021) were significantly reduced in the study group compared to the control group between the first visit and 3-5 days after irrigation, before the start of antibiotic therapy. The second and third visits (15 and 30-45 days after antibiotic therapy) showed that the patients' symptoms and amounts of visible vaginal discharge did not differ between the two groups. Moreover, the microbiological cures of patients in each group did not differ at these visits (z = 0.447; p = 0.655). Vaginal irrigation with saline significantly reduces self-reported symptoms in the short term but has no effect on long-term clinical and laboratory results in women with infectious vaginitis. Copyright © 2012 S. Karger AG, Basel.

Anticipatory guidance through DVD.

PubMed

Franz, Sandra; McMahon, Pamela M; Calongne, Laurinda; Steele-Moses, Susan K

2014-03-01

The major purpose of the study was to determine if a 5-minute DVD is an effective method for communicating anticipatory guidance to parents at their child's 4-month well-child visit. A total of 84 caregivers were randomly assigned to receive anticipatory guidance through standard care (written anticipatory guidance handout and free talk) or DVD (DVD format + standard care). Participants completed a brief questionnaire immediately before and after their visit. As anticipated, knowledge scores improved significantly from pre-test to post-test. There was also a significant interaction between format used for anticipatory guidance and time. Specifically, there was greater improvement in knowledge over time for parents in the DVD group as compared with the standard care group. Additionally, the mean knowledge level of those in the DVD group as compared with those in the standard care group trended toward significance. Finally, visit length was shortened by nearly 3 minutes in the DVD group, and close to 100% of all respondents, regardless of anticipatory guidance format, indicated that they were very satisfied with their visit and amount of information learned.

The impact of comprehensive geriatric assessment interventions on tolerance to chemotherapy in older people.

PubMed

Kalsi, T; Babic-Illman, G; Ross, P J; Maisey, N R; Hughes, S; Fields, P; Martin, F C; Wang, Y; Harari, D

2015-04-28

Although comorbidities are identified in routine oncology practice, intervention plans for the coexisting needs of older people receiving chemotherapy are rarely made. This study evaluates the impact of geriatrician-delivered comprehensive geriatric assessment (CGA) interventions on chemotherapy toxicity and tolerance for older people with cancer. Comparative study of two cohorts of older patients (aged 70+ years) undergoing chemotherapy in a London Hospital. The observational control group (N=70, October 2010-July 2012) received standard oncology care. The intervention group (N=65, September 2011-February 2013) underwent risk stratification using a patient-completed screening questionnaire and high-risk patients received CGA. Impact of CGA interventions on chemotherapy tolerance outcomes and grade 3+ toxicity rate were evaluated. Outcomes were adjusted for age, comorbidity, metastatic disease and initial dose reductions. Intervention participants undergoing CGA received mean of 6.2±2.6 (range 0-15) CGA intervention plans each. They were more likely to complete cancer treatment as planned (odds ratio (OR) 4.14 (95% CI: 1.50-11.42), P=0.006) and fewer required treatment modifications (OR 0.34 (95% CI: 0.16-0.73), P=0.006). Overall grade 3+ toxicity rate was 43.8% in the intervention group and 52.9% in the control (P=0.292). Geriatrician-led CGA interventions were associated with improved chemotherapy tolerance. Standard oncology care should shift towards modifying coexisting conditions to optimise chemotherapy outcomes for older people.

An embedded randomised controlled trial of a Teaser Campaign to optimise recruitment in primary care.

PubMed

Lee, Hopin; Hübscher, Markus; Moseley, G Lorimer; Kamper, Steven J; Traeger, Adrian C; Skinner, Ian W; Williams, Christopher M; McAuley, James H

2017-04-01

Marketing communication and brand identity is a fundamental principle of advertising and end-user engagement. Health researchers have begun to apply this principle to trial recruitment in primary care. The aim of this study was to evaluate whether a Teaser Campaign using a series of postcards in advance of a conventional mail-out increases the number of primary care clinics that engage with a clinical trial. Embedded randomised recruitment trial across primary care clinics (general practitioners and physiotherapists) in the Sydney metropolitan area. Clinics in the Teaser Campaign group received a series of branded promotional postcards in advance of a standard letter inviting them to participate in a clinical trial. Clinics in the Standard Mail group did not receive the postcards. From a total of 744 clinics that were sent an invitation letter, 46 clinics in the Teaser Campaign group and 40 clinics in the Standard Mail group responded (11.6% total response rate). There was no between-group difference in the odds of responding to the invitation letter (odds ratio = 1.18, 95% confidence interval = 0.75-1.85, p = 0.49). For physiotherapy clinics and general practice clinics, the odds ratios were 1.43 (confidence interval = 0.82-2.48, p = 0.21) and 0.77 (confidence interval = 0.34-1.75, p  = 0.54), respectively. A Teaser Campaign using a series of branded promotional postcards did not improve clinic engagement for a randomised controlled trial in primary care.

Beneficial effects of hypnosis and adverse effects of empathic attention during percutaneous tumor treatment: when being nice does not suffice.

PubMed

Lang, Elvira V; Berbaum, Kevin S; Pauker, Stephen G; Faintuch, Salomao; Salazar, Gloria M; Lutgendorf, Susan; Laser, Eleanor; Logan, Henrietta; Spiegel, David

2008-06-01

To determine how hypnosis and empathic attention during percutaneous tumor treatments affect pain, anxiety, drug use, and adverse events. For their tumor embolization or radiofrequency ablation, 201 patients were randomized to receive standard care, empathic attention with defined behaviors displayed by an additional provider, or self-hypnotic relaxation including the defined empathic attention behaviors. All had local anesthesia and access to intravenous medication. Main outcome measures were pain and anxiety assessed every 15 minutes by patient self-report, medication use (with 50 mug fentanyl or 1 mg midazolam counted as one unit), and adverse events, defined as occurrences requiring extra medical attention, including systolic blood pressure fluctuations (> or =50 mm Hg change to >180 mm Hg or <105 mm Hg), vasovagal episodes, cardiac events, and respiratory impairment. Patients treated with hypnosis experienced significantly less pain and anxiety than those in the standard care and empathy groups at several time intervals and received significantly fewer median drug units (mean, 2.0; interquartile range [IQR], 1-4) than patients in the standard (mean, 3.0; IQR, 1.5-5.0; P = .0147) and empathy groups (mean, 3.50; IQR, 2.0-5.9; P = .0026). Thirty-one of 65 patients (48%) in the empathy group had adverse events, which was significantly more than in the hypnosis group (eight of 66; 12%; P = .0001) and standard care group (18 of 70; 26%; P = .0118). Procedural hypnosis including empathic attention reduces pain, anxiety, and medication use. Conversely, empathic approaches without hypnosis that provide an external focus of attention and do not enhance patients' self-coping can result in more adverse events. These findings should have major implications in the education of procedural personnel.

Effects of Individualized and Standardized Interventions on Middle School Students With Reading Disabilities

PubMed Central

VAUGHN, SHARON; WEXLER, JADE; ROBERTS, GREG; BARTH, AMY A.; CIRINO, PAUL T.; ROMAIN, MELISSA A.; FRANCIS, DAVID; FLETCHER, JACK; DENTON, CAROLYN A.

2011-01-01

This study reports the effectiveness of a year-long, small-group, tertiary (Tier 3) intervention that examined 2 empirically derived but conceptually different treatments and a comparison condition. The researchers had randomly assigned all students to treatment or comparison conditions. The participants were seventh- and eighth-grade students from the previous year who received an intervention and did not meet exit criteria. The researchers assigned them to one of two treatments: standardized (n = 69) or individualized (n = 71) for 50 min a day, in group sizes of 5, for the entire school year. Comparison students received no researcher-provided intervention (n = 42). The researchers used multigroup modeling with nested comparisons to evaluate the statistical significance of Time 3 estimates. Students in both treatments outperformed the comparison students on assessments of decoding, fluency, and comprehension. Intervention type did not moderate the pattern of effects, although students in the standardized treatment had a small advantage over individualized students on word attack. This study provides a framework from which to refine further interventions for older students with reading disabilities. PMID:23125463

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

PubMed Central

Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

2012-01-01

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7 (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone. PMID:22778774

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

PubMed

Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

2012-01-01

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

Triadic Gaze Intervention for Young Children with Physical Disabilities

PubMed Central

Olswang, Lesley B.; Dowden, Patricia; Feuerstein, Julie; Greenslade, Kathryn; Pinder, Gay Lloyd; Fleming, Kandace

2018-01-01

Purpose This randomized controlled study investigated whether a supplemental treatment designed to teach triadic gaze (TG) as a signal of coordinated joint attention (CJA) would yield a significantly greater increase in TG in the experimental versus control group. Method Eighteen 10- to 24-month-old children with severe motor impairments were randomly assigned to an experimental (n=9) or control group (n=9). For approximately 29 sessions over 17 weeks, experimental participants received TG treatment twice weekly with a speech-language pathologist (SLP) in addition to standard practice. Controls received only standard practice from birth-to-three therapists. Coders masked to group assignment coded TG productions with an unfamiliar SLP at baseline, every three weeks during the experimental phase, and at the final measurement session. Results TG increased across groups from baseline to final measurement, with the experimental group showing slightly greater change. Performance trends were examined using experimental phase moving averages. Comparisons revealed significant differences between groups at two time points (at 12 weeks, r= .30, a medium effect and at the end of the phase r=.50, large effect). Conclusion Results suggest the promise of a short-term, focused treatment to teach TG as a behavioral manifestation of CJA to children with severe physical disabilities. PMID:24686825

Comparison among the efficacy of interventions for the return rate to receive the pap test report: randomized controlled clinical trial 1

PubMed Central

Vasconcelos, Camila Teixeira Moreira; Pinheiro, Ana Karina Bezerra; Nicolau, Ana Izabel Oliveira; Lima, Thaís Marques; Barbosa, Denise de Fátima Fernandes

2017-01-01

ABSTRACT Objective: to test the effects of a behavioral, an educative and a comparative intervention on women's adherence to the return appointment to receive the pap test report. Methods: randomized controlled clinical trial at a Primary Health Care Service, involving three groups: EG (educative session and test demonstration), BG (recall ribbon) and standard intervention (card containing the return appointment - graphical reminder), called comparative group here (CG). To select the sample, the following was established: having started sexual activity and undergoing the pap smear during the study, resulting in 775 women. Results: among the 775 women, 585 (75.5%) returned to receive the test result within 65 days. The educative group presented the highest return rate (EG=82%/CG=77%/BG=66%), statistically significant only when compared to the behavioral group (p=0.000). The educative group obtained the smallest interval (p<0.05) concerning the mean number of days of return to receive the test result (EG:M=43days/BG:M=47.5days/CG:M=44.8 days). Conclusion: the educative group reached higher return rates and the women returned earlier, but the behavioral intervention showed to be the least effective. Brazilian Clinical Trial Register: RBR-93ykhs. PMID:28301035

Nephroprotective activity of Bilvādi agada in gentamicin induced nephrotoxicity in male Wistar rats.

PubMed

Kanna, Sangeeta; Hiremath, S K; Unger, Banappa S

2015-01-01

Gentamicin (GM) nephrotoxicity accounts for 10-30% of the acute renal failure (ARF) among drug-induced ARF. In Ayurveda such side effects are considered as the poisonous effects of low potent poisons called gara viṣa. Bilvādi agada (BA), a classical formulation is indicated in gara viṣa and most of its ingredients have proven for their nephroprotective activity. The aim was to evaluate the effect of BA in GM-induced nephrotoxicity in male Wistar rats. BA, GM, normal saline were procured from standard companies. Eighteen male Wistar rats were randomly divided into three groups, viz. Control group which received normal saline intraperitoneal (i.p.) daily for 8 days; toxic group received GM 80 mg/kg/day i.p. for 8 days, and trial group received both GM 80 mg/kg/day i.p. and BA 216 mg/each rat weighing ~200 g orally 1 h after administration of GM. All the values were expressed as mean ± standard error and data were analyzed by applying one-way analysis of variance followed by Dunnett's test for multiple comparison. BA treated group showed a significant change (P < 0.05) in levels of serum creatinine, urine creatinine, and urine potassium. There was no significant change (P > 0.05) seen in serum potassium, sodium, chloride, calcium and phosphorus and urine sodium, chloride in all three groups. Glomerular congestion, interstitial edema, tubular necrosis, interstitial hemorrhage was reduced in BA treated group. The results of this study indicate that BA reduces GM-induced nephrotoxicity and it may be due to anti-inflammatory, immunomodulatory, diuretic and anti-oxidant properties of drugs. Further studies are necessary to explore the exact mechanism of BA in nephroprotection.

Nephroprotective activity of Bilvādi agada in gentamicin induced nephrotoxicity in male Wistar rats

PubMed Central

Kanna, Sangeeta; Hiremath, S. K.; Unger, Banappa S.

2015-01-01

Background: Gentamicin (GM) nephrotoxicity accounts for 10–30% of the acute renal failure (ARF) among drug-induced ARF. In Ayurveda such side effects are considered as the poisonous effects of low potent poisons called gara viṣa. Bilvādi agada (BA), a classical formulation is indicated in gara viṣa and most of its ingredients have proven for their nephroprotective activity. Aim: The aim was to evaluate the effect of BA in GM-induced nephrotoxicity in male Wistar rats. Materials and Methods: BA, GM, normal saline were procured from standard companies. Settings and Designs: Eighteen male Wistar rats were randomly divided into three groups, viz. Control group which received normal saline intraperitoneal (i.p.) daily for 8 days; toxic group received GM 80 mg/kg/day i.p. for 8 days, and trial group received both GM 80 mg/kg/day i.p. and BA 216 mg/each rat weighing ~200 g orally 1 h after administration of GM. Statistics: All the values were expressed as mean ± standard error and data were analyzed by applying one-way analysis of variance followed by Dunnett's test for multiple comparison. Results: BA treated group showed a significant change (P < 0.05) in levels of serum creatinine, urine creatinine, and urine potassium. There was no significant change (P > 0.05) seen in serum potassium, sodium, chloride, calcium and phosphorus and urine sodium, chloride in all three groups. Glomerular congestion, interstitial edema, tubular necrosis, interstitial hemorrhage was reduced in BA treated group. The results of this study indicate that BA reduces GM-induced nephrotoxicity and it may be due to anti-inflammatory, immunomodulatory, diuretic and anti-oxidant properties of drugs. Further studies are necessary to explore the exact mechanism of BA in nephroprotection. PMID:26120225

Zinc Supplementation in Treatment of Children With Urinary Tract Infection.

PubMed

Yousefichaijan, Parsa; Naziri, Mahdyieh; Taherahmadi, Hassan; Kahbazi, Manijeh; Tabaei, Aram

2016-07-01

Urinary tract infection (UTI) is very common in children. Precocious diagnosis and appropriate treatment are important because of the permanent disease complications. Zinc increases the response to treatment in many infections. In this study, we explored the effect of zinc in treating UTI. Two hundred children with UTI were divided into 2 groups of 100 who were comparable in terms of age, sex, urine laboratory profiles, and clinical signs and symptoms. The control group received a standard treatment protocol for UTI and the intervention group received oral zinc sulfate syrup plus routine treatment of UTI. A faster recovery was observed in the patients receiving zinc, but abdominal pain was exacerbated by zinc and lasted longer. Three months after the treatment, there was no significant difference between the two groups in the time of fever stop and negative urine culture. In children with UTI, zinc supplementation has a positive effect in ameliorating severe dysuria and urinary frequency while the use of this medication is not recommended in the presence of abdominal pain.

Infusion fluids contain harmful glucose degradation products

PubMed Central

Bryland, Anna; Broman, Marcus; Erixon, Martin; Klarin, Bengt; Lindén, Torbjörn; Friberg, Hans; Wieslander, Anders; Kjellstrand, Per; Ronco, Claudio; Carlsson, Ola

2010-01-01

Purpose Glucose degradation products (GDPs) are precursors of advanced glycation end products (AGEs) that cause cellular damage and inflammation. We examined the content of GDPs in commercially available glucose-containing infusion fluids and investigated whether GDPs are found in patients’ blood. Methods The content of GDPs was examined in infusion fluids by high-performance liquid chromatography (HPLC) analysis. To investigate whether GDPs also are found in patients, we included 11 patients who received glucose fluids (standard group) during and after their surgery and 11 control patients receiving buffered saline (control group). Blood samples were analyzed for GDP content and carboxymethyllysine (CML), as a measure of AGE formation. The influence of heat-sterilized fluids on cell viability and cell function upon infection was investigated. Results All investigated fluids contained high concentrations of GDPs, such as 3-deoxyglucosone (3-DG). Serum concentration of 3-DG increased rapidly by a factor of eight in patients receiving standard therapy. Serum CML levels increased significantly and showed linear correlation with the amount of infused 3-DG. There was no increase in serum 3-DG or CML concentrations in the control group. The concentration of GDPs in most of the tested fluids damaged neutrophils, reducing their cytokine secretion, and inhibited microbial killing. Conclusions These findings indicate that normal standard fluid therapy involves unwanted infusion of GDPs. Reduction of the content of GDPs in commonly used infusion fluids may improve cell function, and possibly also organ function, in intensive-care patients. Electronic supplementary material The online version of this article (doi:10.1007/s00134-010-1873-x) contains supplementary material, which is available to authorized users. PMID:20397009

The Human Variome Project (HVP) 2009 Forum "Towards Establishing Standards".

PubMed

Howard, Heather J; Horaitis, Ourania; Cotton, Richard G H; Vihinen, Mauno; Dalgleish, Raymond; Robinson, Peter; Brookes, Anthony J; Axton, Myles; Hoffmann, Robert; Tuffery-Giraud, Sylvie

2010-03-01

The May 2009 Human Variome Project (HVP) Forum "Towards Establishing Standards" was a round table discussion attended by delegates from groups representing international efforts aimed at standardizing several aspects of the HVP: mutation nomenclature, description and annotation, clinical ontology, means to better characterize unclassified variants (UVs), and methods to capture mutations from diagnostic laboratories for broader distribution to the medical genetics research community. Methods for researchers to receive credit for their effort at mutation detection were also discussed. (c) 2010 Wiley-Liss, Inc.

[Dental health maintenance of military personnel under orthodontic treatment].

PubMed

Soldatova, L N; Horoshilkina, F Ya; Iordanishvili, A K

The aim of the study was to estimate dental health of servicemen of young and middle age using PMA index, Schiller-Pisarev assay, iodic number of Svrakov, OHI-S. Hundred and six servicemen were enrolled in the study: control group (n=35) with no orthodontic treatment and groups 2 (n=34) and 3 (n=37) group undergoing orthodontic treatment with bracket-systems. All patients had professional oral hygiene and received standard oral care recommendations. Group 3 participants additionally used dental foam (Splat, Russia) after meal. All patients were examined at baseline and 12 months later. In the presence of orthodontic appliances standard oral care products were not enough to maintain proper oral health. Dental foam improved both periodontal condition and OHI-S.

Teaching clinical skills through videotape review: a randomized trial of group versus individual reviews.

PubMed

Parish, Sharon J; Weber, Catherine M; Steiner-Grossman, Penny; Milan, Felise B; Burton, William B; Marantz, Paul R

2006-01-01

Video review is a valuable educational tool for teaching communication skills. Many studies have demonstrated its efficacy with individual learners, but few studies have addressed its use in a group format. To assess the educational benefits of group versus individual video review of standardized patient encounters through the evaluations of 4th-year students at the Albert Einstein College of Medicine. Students (128) who participated in a 7-station, standardized patient, clinical competency exam were randomly assigned to an individual or small group video review of selected segments of these encounters in 2000-2001. Students filled out an anonymous 13-item questionnaire assessing the experience and provided open-ended responses. With both review formats, most students had a positive learning experience (80%), found it less stressful than they expected (67%), and would not have preferred to do the review the other way (84%). Students randomized to individual reviews had a significantly higher level of satisfaction with the amount of time for the session (91% vs. 78%, p < .05) and the amount of feedback they received (95% vs. 79%, p = .01) and were more likely to view the session as a positive learning experience (88% vs. 73%, p < .05). Students in the individual review format were more likely to choose self-assessed weak segments (63% vs. 49%, p = .01). Students' comments indicated that they appreciated the value of peer review in a group setting. Although both group reviews and individual reviews of videotaped standardized patient encounters were received well by the students, there were several statistical differences in favor of the individual format.

Ventilator-associated pneumonia risk decreased by use of oral moisture gel in oral health care.

PubMed

Takeyasu, Yoshihiro; Yamane, Gen-Yuki; Tonogi, Morio; Watanabe, Yutaka; Nishikubo, Shuichi; Serita, Ryohei; Imura, Kumiko

2014-01-01

Although oral health care has a preventive effect against ventilator-associated pneumonia (VAP), the most effective method of oral health care in this respect remains to be established. The objective of this single-center, randomized, controlled trial was to investigate the relationship between VAP and various methods of oral health care. All patients included in the study (n=142) were on mechanical ventilation with oral intubation at the intensive care unit of the Tokyo Dental College Ichikawa General Hospital. They were divided into two groups, one receiving standard oral health care (Standard group), and the other receiving oral health care using an oral moisture gel instead of water (Gel group). After removal of the intubation tube, biofilm on cuff of the tube was stained with a disclosing agent to determine the contamination level. Factors investigated included sex, age, number of remaining teeth, intubation time, fever ≥38.5°C, VAP, cuff contamination level, and time required for one oral health care session. No VAP occurred in either group during the study period. The level of cuff contamination was significantly lower in the Gel group than the Standard group, and the time required for one session of oral health care was shorter (p<0.001). Multivariate analysis revealed use of the oral moisture gel as a factor affecting cuff contamination level. Use of an oral moisture gel decreased invasion of the pharynx by bacteria and contaminants together with biofilm formation on the intubation tube cuff. These results suggest that oral health care using an oral moisture gel is effective in preventing cuff contamination.

Conditioned pharmacotherapeutic effects: a preliminary study.

PubMed

Ader, Robert; Mercurio, Mary Gail; Walton, James; James, Deborra; Davis, Michael; Ojha, Valerie; Kimball, Alexa Boer; Fiorentino, David

2010-02-01

To test the hypothesize that psoriasis patients treated under a partial schedule of pharmacologic (corticosteroid) reinforcement would show less severe symptoms and relapse than those given the same amount of drug under standard conditions. Behavioral conditioning as an inherent component of many pharmacotherapeutic protocols has never been examined. A double-blind, simple randomization intervention was conducted with 46 patients from California and New York. Initially, lesions were treated with 0.1% acetonide triamcinolone under standard treatment conditions. Thereafter, a Standard Therapy group continued on continuous reinforcement (active drug every treatment) with 100% of the initial dose; Partial Reinforcement patients received a full dose 25% to 50% of the time and placebo medication other times; Dose Control patients received continuous reinforcement with 25% to 50% of the initial dose. Severity of disease scores in California neither supported nor refuted the hypothesis. In New York, where there was no difference between Partial Reinforcement and Dose Control groups at baseline, partial reinforcement effected a greater reduction in lesion severity than Dose Control conditions and did not differ from Standard Therapy patients receiving two to four times more drug. For the entire population, the frequency of relapse under partial reinforcement (26.7%) was lower than in Dose Control patients (61.5%) and did not differ from full-dose treatment (22.2%). A partial schedule of pharmacotherapeutic reinforcement could maintain psoriasis patients with a cumulative amount of corticosteroid that was relatively ineffective when administered under standard treatment conditions. Conceivably, corticosteroid administration only one quarter or half as frequently as currently prescribed is sufficient to treat psoriasis. We posit, however, that these preliminary observations implicate conditioning processes in-and for the design of-regimens of pharmacotherapy.

The Anesthetic Efficacy of Articaine and Lidocaine in Equivalent Doses as Buccal and Non-Palatal Infiltration for Maxillary Molar Extraction: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

PubMed

Majid, Omer Waleed; Ahmed, Aws Mahmood

2018-04-01

The purpose of the present study was to evaluate the anesthetic adequacy of 4% articaine 1.8 mL versus 2% lidocaine 3.6 mL without palatal injection compared with the standard technique for the extraction of maxillary molar teeth. This randomized, double-blinded, placebo-controlled clinical trial included patients requiring extraction of 1 maxillary molar under local anesthesia. Patients were randomly distributed into 1 of 3 groups: group A received 4% articaine 1.8 mL as a buccal injection and 0.2 mL as a palatal injection, group B received 4% articaine 1.8 mL plus normal saline 0.2 mL as a palatal injection, and group C received 2% lidocaine 3.6 mL plus normal saline 0.2 mL as a palatal injection. Pain was measured during injection, 8 minutes afterward, and during extraction using a visual analog scale. Initial palatal anesthesia and patients' satisfaction were measured using a 5-score verbal rating scale. Statistical analyses included descriptive statistics, analysis of variance, and Pearson χ 2 test. Differences with a P value less than .05 were considered significant. Eighty-four patients were included in the study. The average pain of injection was comparable among all study groups (P = .933). Pain during extraction in the articaine group was significantly less than that experienced in the placebo groups (P < .001), although the differences between placebo groups were insignificant. Satisfaction scores were significantly higher in the articaine group compared with the placebo groups (P < .001), with comparable results between placebo groups. Although the anesthetic effects of single placebo-controlled buccal injections of 4% articaine and 2% lidocaine were comparable, the level of anesthetic adequacy was statistically less than that achieved by 4% articaine given by the standard technique. These results do not justify the buccal and non-palatal infiltration of articaine or lidocaine as an effective alternative to the standard technique in the extraction of maxillary molar teeth. Copyright © 2017 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty‐Two–Week Randomized, Double‐Blind, Placebo‐Controlled Study

PubMed Central

Schwarting, Andreas; Okada, Masato; Scheinberg, Morton; Doria, Andrea; Hammer, Anne E.; Kleoudis, Christi; Groark, James; Bass, Damon; Fox, Norma Lynn; Roth, David; Gordon, David

2017-01-01

Objective To assess the efficacy and safety of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Methods Patients with moderate‐to‐severe SLE (score of ≥8 on the Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] version of the SLE Disease Activity Index [SLEDAI]) were randomized 2:1 to receive weekly SC belimumab 200 mg or placebo by prefilled syringe in addition to standard SLE therapy for 52 weeks. The primary end point was the SLE Responder Index (SRI4) at week 52. Secondary end points were reduction in the corticosteroid dosage and time to severe flare. Safety was assessed according to the adverse events (AEs) reported and the laboratory test results. Results Of 839 patients randomized, 836 (556 in the belimumab group and 280 in the placebo group) received treatment. A total of 159 patients withdrew before the end of the study. At entry, mean SELENA–SLEDAI scores were 10.5 in the belimumab group and 10.3 in the placebo group. More patients who received belimumab were SRI4 responders than those who received placebo (61.4% versus 48.4%; odds ratio [OR] 1.68 [95% confidence interval (95% CI) 1.25–2.25]; P = 0.0006). In the belimumab group, both time to and risk of severe flare were improved (median 171.0 days versus 118.0 days; hazard ratio 0.51 [95% CI 0.35–0.74]; P = 0.0004), and more patients were able to reduce their corticosteroid dosage by ≥25% (to ≤7.5 mg/day) during weeks 40–52 (18.2% versus 11.9%; OR 1.65 [95% CI 0.95–2.84]; P = 0.0732), compared with placebo. AE incidence was comparable between treatment groups; serious AEs were reported by 10.8% of patients taking belimumab and 15.7% of those taking placebo. A worsening of IgG hypoglobulinemia by ≥2 grades occurred in 0.9% of patients taking belimumab and 1.4% of those taking placebo. Conclusion In patients with moderate‐to‐severe SLE, weekly SC doses of belimumab 200 mg plus standard SLE therapy significantly improved their SRI4 response, decreased severe disease flares as compared with placebo, and had a safety profile similar to placebo plus standard SLE therapy. PMID:28118533

Cognitive–Behavioral Treatment for Depression in Smoking Cessation

PubMed Central

Brown, Richard A.; Kahler, Christopher W.; Niaura, Raymond; Abrams, David B.; Sales, Suzanne D.; Ramsey, Susan E.; Goldstein, Michael G.; Burgess, Ellen S.; Miller, Ivan W.

2007-01-01

Cigarette smokers with past major depressive disorder (MDD) received 8 group sessions of standard, cognitive–behavioral smoking cessation treatment (ST; n = 93) or standard, cognitive–behavioral smoking cessation treatment plus cognitive–behavioral treatment for depression (CBT-D; n = 86). Although abstinence rates were high in both conditions (ST, 24.7%; CBT-D, 32.5%, at 1 year) for these nonpharmacological treatments, no main effect of treatment was found. However, secondary analyses revealed significant interactions between treatment condition and both recurrent depression history and heavy smoking (≥25 cigarettes a day) at baseline. Smokers with recurrent MDD and heavy smokers who received CBT-D were significantly more likely to be abstinent than those receiving ST (odds ratios = 2.3 and 2.6, respectively). Results suggest that CBT-D provides specific benefits for some, but not all, smokers with a history of MDD. PMID:11495176

Effectiveness of a long-lasting piperonyl butoxide-treated insecticidal net and indoor residual spray interventions, separately and together, against malaria transmitted by pyrethroid-resistant mosquitoes: a cluster, randomised controlled, two-by-two factorial design trial.

PubMed

Protopopoff, Natacha; Mosha, Jacklin F; Lukole, Eliud; Charlwood, Jacques D; Wright, Alexandra; Mwalimu, Charles D; Manjurano, Alphaxard; Mosha, Franklin W; Kisinza, William; Kleinschmidt, Immo; Rowland, Mark

2018-04-21

Progress in malaria control is under threat by wide-scale insecticide resistance in malaria vectors. Two recent vector control products have been developed: a long-lasting insecticidal net that incorporates a synergist piperonyl butoxide (PBO) and a long-lasting indoor residual spraying formulation of the insecticide pirimiphos-methyl. We evaluated the effectiveness of PBO long-lasting insecticidal nets versus standard long-lasting insecticidal nets as single interventions and in combination with the indoor residual spraying of pirimiphos-methyl. We did a four-group cluster randomised controlled trial using a two-by-two factorial design of 48 clusters derived from 40 villages in Muleba (Kagera, Tanzania). We randomly assigned these clusters using restricted randomisation to four groups: standard long-lasting insecticidal nets, PBO long-lasting insecticidal nets, standard long-lasting insecticidal nets plus indoor residual spraying, or PBO long-lasting insecticidal nets plus indoor residual spraying. Both standard and PBO nets were distributed in 2015. Indoor residual spraying was applied only once in 2015. We masked the inhabitants of each cluster to the type of nets received, as well as field staff who took blood samples. Neither the investigators nor the participants were masked to indoor residual spraying. The primary outcome was the prevalence of malaria infection in children aged 6 months to 14 years assessed by cross-sectional surveys at 4, 9, 16, and 21 months after intervention. The endpoint for assessment of indoor residual spraying was 9 months and PBO long-lasting insecticidal nets was 21 months. This trial is registered with ClinicalTrials.gov, number NCT02288637. 7184 (68·0%) of 10 560 households were selected for post-intervention survey, and 15 469 (89·0%) of 17 377 eligible children from the four surveys were included in the intention-to-treat analysis. Of the 878 households visited in the two indoor residual spraying groups, 827 (94%) had been sprayed. Reported use of long-lasting insecticidal nets, across all groups, was 15 341 (77·3%) of 19 852 residents after 1 year, decreasing to 12 503 (59·2%) of 21 105 in the second year. Malaria infection prevalence after 9 months was lower in the two groups that received PBO long-lasting insecticidal nets than in the two groups that received standard long-lasting insecticidal nets (531 [29%] of 1852 children vs 767 [42%] of 1809; odds ratio [OR] 0·37, 95% CI 0·21-0·65; p=0·0011). At the same timepoint, malaria prevalence in the two groups that received indoor residual spraying was lower than in groups that did not receive indoor residual spraying (508 [28%] of 1846 children vs 790 [44%] of 1815; OR 0·33, 95% CI 0·19-0·55; p<0·0001) and there was evidence of an interaction between PBO long-lasting insecticidal nets and indoor residual spraying (OR 2·43, 95% CI 1·19-4·97; p=0·0158), indicating redundancy when combined. The PBO long-lasting insecticidal net effect was sustained after 21 months with a lower malaria prevalence than the standard long-lasting insecticidal net (865 [45%] of 1930 children vs 1255 [62%] of 2034; OR 0·40, 0·20-0·81; p=0·0122). The PBO long-lasting insecticidal net and non-pyrethroid indoor residual spraying interventions showed improved control of malaria transmission compared with standard long-lasting insecticidal nets where pyrethroid resistance is prevalent and either intervention could be deployed to good effect. As a result, WHO has since recommended to increase coverage of PBO long-lasting insecticidal nets. Combining indoor residual spraying with pirimiphos-methyl and PBO long-lasting insecticidal nets provided no additional benefit compared with PBO long-lasting insecticidal nets alone or standard long-lasting insecticidal nets plus indoor residual spraying. UK Department for International Development, Medical Research Council, and Wellcome Trust. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Clinical and economic outcomes of rabbit antithymocyte globulin induction in adults who received kidney transplants from living unrelated donors and received cyclosporine-based immunosuppression.

PubMed

Miller, James T; Collins, Curtis D; Stuckey, Linda J; Luan, Fu L; Englesbe, Michael J; Magee, John C; Park, Jeong M

2009-10-01

To evaluate the efficacy, safety, and costs of rabbit antithymocyte globulin (TMG) induction in patients who received kidney transplants from living unrelated donors. Retrospective cohort study. Large academic medical center. Eighty-seven patients who received kidney transplants from living unrelated donors: 40 of the recipients underwent transplantation between January 1, 2003, and December 31, 2004, and did not receive TMG induction (no induction group); 47 underwent transplantation between January 1, 2005, and June 30, 2006, and received TMG induction (induction group). All patients received cyclosporine-based immunosuppression. Biopsy-proven acute rejection, posttransplantation complications, and inpatient hospital costs for the first 12 months after transplantation were compared between groups using standard univariate statistical analyses. Induction significantly decreased the occurrence of biopsy-proven acute rejection versus no induction (2% vs 48%, p<0.001). Fifty percent of rejection episodes in the no induction group required hospitalization, and 46% of rejection episodes required TMG treatment. Slightly elevated initial costs associated with TMG induction were offset by lower costs related to rejection treatment. Total inpatient costs for the 12 months after transplantation were comparable between the groups (no induction $66,038 vs induction $74,183, p>0.05). For the no induction versus induction groups, no significant differences in cytomegalovirus disease (5% vs 6%), malignancy (3% vs 2%), graft failures (5% vs 6%), mortality (5% vs 4%), and serum creatinine concentrations (mean +/- SD 1.4 +/- 0.3 vs 1.5 +/- 0.3 mg/dl) were observed at 12 months (p>0.05 for all comparisons). Five-day TMG induction effectively reduced the 1-year acute rejection rate without significantly increasing total inpatient costs or posttransplantation complications among recipients of kidney transplants from living unrelated donors.

Titration of Intravenous Oxytocin Infusion for Postdates Induction of Labor Across Body Mass Index Groups.

PubMed

Maeder, Angela B; Vonderheid, Susan C; Park, Chang G; Bell, Aleeca F; McFarlin, Barbara L; Vincent, Catherine; Carter, C Sue

To evaluate whether oxytocin titration for postdates labor induction differs among women who are normal weight, overweight, and obese and whether length of labor and birth method differ by oxytocin titration and body mass index (BMI). Retrospective cohort study. U.S. university-affiliated hospital. Of 280 eligible women, 21 were normal weight, 134 were overweight, and 125 were obese at labor admission. Data on women who received oxytocin for postdates induction between January 1, 2013 and June 30, 2013 were extracted from medical records. Oxytocin administration and labor outcomes were compared across BMI groups, controlling for potential confounders. Data were analyzed using χ 2 , analysis of variance, analysis of covariance, and multiple linear and logistic regression models. Women who were obese received more oxytocin than women who were overweight in the unadjusted analysis of variance (7.50 units compared with 5.92 units, p = .031). Women who were overweight had more minutes between rate changes from initiation to maximum than women who were obese (98.19 minutes compared with 83.39 minutes, p = .038). Length of labor increased with BMI (p = .018), with a mean length of labor for the normal weight group of 13.96 hours (standard deviation = 8.10); for the overweight group, 16.00 hours (standard deviation = 7.54); and for the obese group, 18.30 hours (standard deviation = 8.65). Cesarean rate increased with BMI (p = .001), with 4.8% of normal weight, 33.6% of overweight, and 42.4% of obese women having cesarean births. Women who were obese and experienced postdates labor induction received more oxytocin than women who were non-obese and had longer length of labor and greater cesarean rates. Copyright © 2017 AWHONN, the Association of Women's Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

[Impact of permissive underfeeding versus standard enteral feeding on outcomes in critical patients requiring mechanical ventilation: a prospective randomized controlled study].

PubMed

Ma, Nianbin; Shen, Mingfu; Wan, Zhen; Pan, Sijun; Liu, Xian; Yao, Zhongxiang

2018-02-01

To compare the impact of permissive underfeeding versus standard enteral feeding on outcomes in critical patients requiring mechanical ventilation (MV). A prospective randomized controlled study was conducted. Eighty-two patients requiring MV admitted to intensive care unit (ICU) of Anji People's Hospital from January 2015 to March 2017 were enrolled, and they were randomly divided into the permissive underfeeding group (n = 40, non-protein heat was 52.3-62.8 kJ×kg -1 ×d -1 , protein was 1.2-1.5 g×kg -1 ×d -1 ) and standard enteral feeding group (n = 42, non-protein heat was 104.6-125.5 kJ×kg -1 ×d -1 , protein was 1.2-1.5 g×kg -1 ×d -1 ). Permissive underfeeding group received 50% of their daily energy expenditure via enteral nutrition (EN) and standard enteral feeding group received 100% of their daily energy expenditure via EN in 24-48 hours after admitted to ICU. Nutritional status [pro-albumin (PA), serum albumin (ALB)], inflammation state [procalcitonin (PCT), hypersensitive C-reactive protein (hs-CRP)] were detected before treatment and 7 days after treatment. Duration of MV, length of ICU stay, daily insulin dosage, 28-day mortality, hospital acquired pneumonia (HAP), urinary tract infection, septic shock and other secondary infection, and the nutrition related complications were recorded. Compared with before treatment, the levels of serum PA (mg/L) and ALB (g/L) were significantly increased, the levels of PCT (ng/L) and hs-CRP (mg/L) were significantly decreased at 7 days after treatment in both groups [permissive underfeeding group: PA was 127.42±65.83 vs. 80.92±60.14, ALB was 30.16±4.32 vs. 25.36±6.21, PCT was 375.8±227.2 vs. 762.3±314.5, hs-CRP was 32.19±7.53 vs. 120.48±60.24; standard enteral feeding group: PA was 132.56±61.32 vs. 86.78±47.06, ALB was 31.25±4.63 vs. 26.71±5.48, PCT was 412.1±323.4 vs. 821.7±408.6, hs-CRP was 35.86±5.69 vs. 116.38±72.16, all P < 0.05], but there was no significant difference in PA, ALB, PCT or hs-CRP at 7 days after treatment between two groups (all P > 0.05). There was no significant difference in the duration of MV, length of ICU stay, 28-day mortality or ICU-associated infection between two groups [duration of MV (hours): 162.35±20.37 vs. 153.48±18.65, length of ICU stay (days): 7.52±1.61 vs. 6.34±1.87, 28-day mortality: 17.5% vs. 19.0%, ICU-associated infection: 45.0% vs. 47.6%, all P > 0.05]. Compared with standard enteral feeding, insulin demand was significantly decreased (U/d: 13.68±10.36 vs. 26.24±18.53), and gastrointestinal intolerance was less frequent (32.5% vs. 54.8%) in the permissive underfeeding group (both P < 0.05). Kaplan-Meier survival curve analysis showed that there was no significant difference between the two groups (χ 2 = 3.216, P = 0.068). The curative effect and prognosis of MV severe patients receiving permissive underfeeding are similar to those of standard enteral feeding, but it can reduce the dosage of insulin with better gastrointestinal tolerance.

Comparison of the 9-month intra-stent conditions and 2-year clinical outcomes after Resolute zotarolimus-eluting stent implantation between 3-month and standard dual antiplatelet therapy.

PubMed

Fujimoto, Wataru; Sawada, Takahiro; Toba, Takayoshi; Takahashi, Yu; Miyata, Taishi; Oishi, Shogo; Osue, Tsuyoshi; Onishi, Tetsuari; Takaya, Tomofumi; Shimane, Akira; Taniguchi, Yasuyo; Kawai, Hiroya; Yasaka, Yoshinori

2018-07-01

The use of short-duration dual antiplatelet therapy (DAPT) remains controversial. To investigate efficacy and safety of short-duration DAPT, we performed a detailed comparison of intra-stent conditions by optical coherence tomography (OCT) after second-generation drug-eluting stent implantation with short-term and standard DAPT. Eighty-two consecutive patients with stable angina pectoris who received Resolute zotarolimus-eluting stents (R-ZESs; Medtronic Cardiovascular, Santa Rosa, CA, USA) were enrolled. Patients were assigned to 3-month (3M group: 41 patients) and standard (standard group: 41 patients) DAPT. In the 3M group, clopidogrel was discontinued 3 months after stent implantation. In the standard group, DAPT was maintained until follow-up OCT. At 9 months, neointimal proliferation was significantly larger in the 3M group, but there were no significant between-group differences in the proportion of uncovered and malapposed strut. The prevalence of abnormal intra-stent tissue (AIT) at 9 months was equivalent between groups. A multiple regression analysis revealed malapposition at 9 months as the strongest independent predictor of AIT at 9 months, and the prevalence of AIT was not associated with DAPT duration. Over 2 years, cardiac events were equal between groups; however, major bleeding was higher tendency in the standard group than in the 3M group. This OCT study indicated that reducing DAPT's duration may provide acceptable arterial healing in patients with implanted R-ZESs. Copyright © 2018 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

Hydroxycarbamide versus chronic transfusion for maintenance of transcranial doppler flow velocities in children with sickle cell anaemia-TCD With Transfusions Changing to Hydroxyurea (TWiTCH): a multicentre, open-label, phase 3, non-inferiority trial.

PubMed

Ware, Russell E; Davis, Barry R; Schultz, William H; Brown, R Clark; Aygun, Banu; Sarnaik, Sharada; Odame, Isaac; Fuh, Beng; George, Alex; Owen, William; Luchtman-Jones, Lori; Rogers, Zora R; Hilliard, Lee; Gauger, Cynthia; Piccone, Connie; Lee, Margaret T; Kwiatkowski, Janet L; Jackson, Sherron; Miller, Scott T; Roberts, Carla; Heeney, Matthew M; Kalfa, Theodosia A; Nelson, Stephen; Imran, Hamayun; Nottage, Kerri; Alvarez, Ofelia; Rhodes, Melissa; Thompson, Alexis A; Rothman, Jennifer A; Helton, Kathleen J; Roberts, Donna; Coleman, Jamie; Bonner, Melanie J; Kutlar, Abdullah; Patel, Niren; Wood, John; Piller, Linda; Wei, Peng; Luden, Judy; Mortier, Nicole A; Stuber, Susan E; Luban, Naomi L C; Cohen, Alan R; Pressel, Sara; Adams, Robert J

2016-02-13

For children with sickle cell anaemia and high transcranial doppler (TCD) flow velocities, regular blood transfusions can effectively prevent primary stroke, but must be continued indefinitely. The efficacy of hydroxycarbamide (hydroxyurea) in this setting is unknown; we performed the TWiTCH trial to compare hydroxyurea with standard transfusions. TWiTCH was a multicentre, phase 3, randomised, open-label, non-inferiority trial done at 26 paediatric hospitals and health centres in the USA and Canada. We enrolled children with sickle cell anaemia who were aged 4-16 years and had abnormal TCD flow velocities (≥ 200 cm/s) but no severe vasculopathy. After screening, eligible participants were randomly assigned 1:1 to continue standard transfusions (standard group) or hydroxycarbamide (alternative group). Randomisation was done at a central site, stratified by site with a block size of four, and an adaptive randomisation scheme was used to balance the covariates of baseline age and TCD velocity. The study was open-label, but TCD examinations were read centrally by observers masked to treatment assignment and previous TCD results. Participants assigned to standard treatment continued to receive monthly transfusions to maintain 30% sickle haemoglobin or lower, while those assigned to the alternative treatment started oral hydroxycarbamide at 20 mg/kg per day, which was escalated to each participant's maximum tolerated dose. The treatment period lasted 24 months from randomisation. The primary study endpoint was the 24 month TCD velocity calculated from a general linear mixed model, with the non-inferiority margin set at 15 cm/s. The primary analysis was done in the intention-to-treat population and safety was assessed in all patients who received at least one dose of assigned treatment. This study is registered with ClinicalTrials.gov, number NCT01425307. Between Sept 20, 2011, and April 17, 2013, 159 patients consented and enrolled in TWiTCH. 121 participants passed screening and were then randomly assigned to treatment (61 to transfusions and 60 to hydroxycarbamide). At the first scheduled interim analysis, non-inferiority was shown and the sponsor terminated the study. Final model-based TCD velocities were 143 cm/s (95% CI 140-146) in children who received standard transfusions and 138 cm/s (135-142) in those who received hydroxycarbamide, with a difference of 4·54 (0·10-8·98). Non-inferiority (p=8·82 × 10(-16)) and post-hoc superiority (p=0·023) were met. Of 29 new neurological events adjudicated centrally by masked reviewers, no strokes were identified, but three transient ischaemic attacks occurred in each group. Magnetic resonance brain imaging and angiography (MRI and MRA) at exit showed no new cerebral infarcts in either treatment group, but worsened vasculopathy in one participant who received standard transfusions. 23 severe adverse events in nine (15%) patients were reported for hydroxycarbamide and ten serious adverse events in six (10%) patients were reported for standard transfusions. The most common serious adverse event in both groups was vaso-occlusive pain (11 events in five [8%] patients with hydroxycarbamide and three events in one [2%] patient for transfusions). For high-risk children with sickle cell anaemia and abnormal TCD velocities who have received at least 1 year of transfusions, and have no MRA-defined severe vasculopathy, hydroxycarbamide treatment can substitute for chronic transfusions to maintain TCD velocities and help to prevent primary stroke. National Heart, Lung, and Blood Institute, National Institutes of Health. Copyright © 2016 Elsevier Ltd. All rights reserved.

Irinotecan and Oxaliplatin Might Provide Equal Benefit as Adjuvant Chemotherapy for Patients with Resectable Synchronous Colon Cancer and Liver-confined Metastases: A Nationwide Database Study.

PubMed

Liang, Yi-Hsin; Shao, Yu-Yun; Chen, Ho-Min; Cheng, Ann-Lii; Lai, Mei-Shu; Yeh, Kun-Huei

2017-12-01

Although irinotecan and oxaliplatin are both standard treatments for advanced colon cancer, it remains unknown whether either is effective for patients with resectable synchronous colon cancer and liver-confined metastasis (SCCLM) after curative surgery. A population-based cohort of patients diagnosed with de novo SCCLM between 2004 and 2009 was established by searching the database of the Taiwan Cancer Registry and the National Health Insurance Research Database of Taiwan. Patients who underwent curative surgery as their first therapy followed by chemotherapy doublets were classified into the irinotecan group or oxaliplatin group accordingly. Patients who received radiotherapy or did not receive chemotherapy doublets were excluded. We included 6,533 patients with de novo stage IV colon cancer. Three hundred and nine of them received chemotherapy doublets after surgery; 77 patients received irinotecan and 232 patients received oxaliplatin as adjuvant chemotherapy. The patients in both groups exhibited similar overall survival (median: not reached vs. 40.8 months, p=0.151) and time to the next line of treatment (median: 16.5 vs. 14.3 months, p=0.349) in both univariate and multivariate analyses. Additionally, patients with resectable SCCLM had significantly shorter median overall survival than patients with stage III colon cancer who underwent curative surgery and subsequent adjuvant chemotherapy, but longer median overall survival than patients with de novo stage IV colon cancer who underwent surgery only at the primary site followed by standard systemic chemotherapy (p<0.001). Irinotecan and oxaliplatin exhibited similar efficacy in patients who underwent curative surgery for resectable SCCLM. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Ultrasound-guided transversus abdominal plane block with multimodal analgesia for pain management after total abdominal hysterectomy.

PubMed

Gasanova, Irina; Grant, Erica; Way, Megan; Rosero, Eric B; Joshi, Girish P

2013-07-01

Transversus abdominis plane (TAP) block has been shown to provide pain relief after abdominal procedures. However, TAP block combined with multimodal analgesia technique have not been assessed in a randomized controlled trial. This randomized, controlled, observer-blinded study was designed to evaluate the analgesic efficacy of bilateral ultrasound-guided TAP blocks with or without acetaminophen and non-steroidal anti-inflammatory drug (NSAID) combination. Patients undergoing total abdominal hysterectomy were randomized to one of three groups. Group 1 (n = 25) received a TAP block and ketorolac 30 mg, IV at the end of surgery and then ketorolac plus paracetamol 650 mg, orally, every 6 h for 24 h. Group 2 (n = 24) received only TAP block at the end of surgery. Group 3 (n = 25) received ketorolac 30 mg, IV at the end of surgery and then ketorolac plus paracetamol 650 mg, orally, every 6 h for 24 h. All patients received IV-PCA morphine for 24-h, postoperatively. All patients received a standardized general anaesthetic technique and dexamethasone 4 mg and ondansetron 4 mg, IV for antiemetic prophylaxis. There were no statistically significant differences in pain at rest between the groups. However, the pain on coughing (dynamic pain) in Group 1 was significantly less variable, compared with the other two groups (P = 0.012). Opioid consumption and occurrences of nausea, vomiting, and rescue antiemetic were similar in three the groups. The combination of TAP block and acetaminophen and NSAID provided less variability in dynamic pain compared with either treatment alone.

Analgesic duration and kinetics of liposomal bupivacaine after subcutaneous injection in mice.

PubMed

Grant, G J; Piskoun, B; Bansinath, M

2003-12-01

1. The objective of the present study was to assess the time-course profile of analgesia and bupivacaine concentrations at the site of injection after subcutaneous administration of a single dose of standard bupivacaine or a novel controlled-release liposomal bupivacaine formulation. 2. Groups of mice were injected subcutaneously with 0.2 mL of 0.5% standard bupivacaine or 0.5, 1 or 2% liposomal bupivacaine. 3. A prolonged duration of analgesia occurred in mice receiving liposomal bupivacaine. In the liposomal groups, the bupivacaine remained at the injection site for more than 96 h, compared with approximately 8 h in groups injected with standard bupivacaine. 4. These results confirm that the prolonged analgesia observed after injection of the liposomal formulation is associated with sustained higher levels of bupivacaine at the site of injection.

Diet composition modifies the toxicity of repeated soman exposure in rats.

PubMed

Langston, Jeffrey L; Myers, Todd M

2011-12-01

It was previously demonstrated that diet potently modulates the toxic effects of an acute lethal dose of the nerve agent soman. The current investigation was undertaken to examine the influence of diet on the cumulative toxicity of repeated soman administration. Rats were fed one of four distinct diets (standard, choline-enriched, glucose-enriched, or ketogenic) for four weeks prior to and throughout a repeated soman dosing and recovery regimen. Each diet group included animals exposed to an equivalent volume of saline that served as negative controls. In exposure Week 1, animals received three consecutive daily doses of 0.4 LD(50) soman. In exposure Week 2, animals received four consecutive daily doses of 0.5 LD(50) soman. In exposure Week 3, animals received five consecutive daily doses of 0.5 LD(50) soman. Week 4 constituted a post-exposure recovery evaluation. Throughout the experiment, behavioral function was assessed by a discriminated avoidance test that required intact sensory and motor function. Survival and body weight changes were recorded daily. Differences in toxicity as a function of diet composition became apparent during the first week. Specifically, rats fed the glucose-enriched diet showed pronounced intoxication during Week 1, resulting in imperfect survival, weight loss, and deteriorated avoidance performance relative to all other groups. All rats fed the glucose-enriched diet died by the end of exposure Week 2. In contrast, only 10% of animals fed the standard diet died by the end of Week 2. Also in Week 2, weight loss and disrupted avoidance performance were apparent for all groups except for those fed the ketogenic diet. This differential effect of diet composition became even more striking in Week 3 when survival in the standard and choline diet groups approximated 50%, whereas survival equaled 90% in the ketogenic diet group. Avoidance performance and weight loss measures corroborated the differential toxicity observed across diet groups. Upon cessation of soman exposure during the final week, recovery of weight and avoidance performance in survivors was comparable across diet groups. These results systematically replicate previous findings demonstrating that diet composition exacerbates or attenuates toxicity in rodents exposed acutely to organophosphorus compounds. Published by Elsevier B.V.

Automated pictographic illustration of discharge instructions with Glyph: impact on patient recall and satisfaction

PubMed Central

Perri-Moore, Seneca; Kuang, Jinqiu; Bray, Bruce E; Ngo, Long; Doig, Alexa; Zeng-Treitler, Qing

2016-01-01

Objectives First, to evaluate the effect of standard vs pictograph-enhanced discharge instructions on patients’ immediate and delayed recall of and satisfaction with their discharge instructions. Second, to evaluate the effect of automated pictograph enhancement on patient satisfaction with their discharge instructions. Materials and Methods Glyph, an automated healthcare informatics system, was used to automatically enhance patient discharge instructions with pictographs. Glyph was developed at the University of Utah by our research team. Patients in a cardiovascular medical unit were randomized to receive pictograph-enhanced or standard discharge instructions. Measures of immediate and delayed recall and satisfaction with discharge instructions were compared between two randomized groups: pictograph (n = 71) and standard (n = 73). Results Study participants who received pictograph-enhanced discharge instructions recalled 35% more of their instructions at discharge than those who received standard discharge instructions. The ratio of instructions at discharge was: standard = 0.04 ± 0.03 and pictograph-enhanced = 0.06 ± 0.03. The ratio of instructions at 1 week post discharge was: standard = 0.04 ± 0.02 and pictograph-enhanced 0.04 ± 0.02. Additionally, study participants who received pictograph-enhanced discharge instructions were more satisfied with the understandability of their instructions at 1 week post-discharge than those who received standard discharge instructions. Discussion Pictograph-enhanced discharge instructions have the potential to increase patient understanding of and satisfaction with discharge instructions. Conclusion It is feasible to automatically illustrate discharge instructions and provide them to patients in a timely manner without interfering with clinical work. Illustrations in discharge instructions were found to improve patients’ short-term recall of discharge instructions and delayed satisfaction (1-week post hospitalization) with the instructions. Therefore, it is likely that patients’ understanding of and interaction with their discharge instructions is improved by the addition of illustrations. PMID:27234601

Automated pictographic illustration of discharge instructions with Glyph: impact on patient recall and satisfaction.

PubMed

Hill, Brent; Perri-Moore, Seneca; Kuang, Jinqiu; Bray, Bruce E; Ngo, Long; Doig, Alexa; Zeng-Treitler, Qing

2016-11-01

First, to evaluate the effect of standard vs pictograph-enhanced discharge instructions on patients' immediate and delayed recall of and satisfaction with their discharge instructions. Second, to evaluate the effect of automated pictograph enhancement on patient satisfaction with their discharge instructions. Glyph, an automated healthcare informatics system, was used to automatically enhance patient discharge instructions with pictographs. Glyph was developed at the University of Utah by our research team. Patients in a cardiovascular medical unit were randomized to receive pictograph-enhanced or standard discharge instructions. Measures of immediate and delayed recall and satisfaction with discharge instructions were compared between two randomized groups: pictograph (n = 71) and standard (n = 73). Study participants who received pictograph-enhanced discharge instructions recalled 35% more of their instructions at discharge than those who received standard discharge instructions. The ratio of instructions at discharge was: standard = 0.04 ± 0.03 and pictograph-enhanced = 0.06 ± 0.03. The ratio of instructions at 1 week post discharge was: standard = 0.04 ± 0.02 and pictograph-enhanced 0.04 ± 0.02. Additionally, study participants who received pictograph-enhanced discharge instructions were more satisfied with the understandability of their instructions at 1 week post-discharge than those who received standard discharge instructions. Pictograph-enhanced discharge instructions have the potential to increase patient understanding of and satisfaction with discharge instructions. It is feasible to automatically illustrate discharge instructions and provide them to patients in a timely manner without interfering with clinical work. Illustrations in discharge instructions were found to improve patients' short-term recall of discharge instructions and delayed satisfaction (1-week post hospitalization) with the instructions. Therefore, it is likely that patients' understanding of and interaction with their discharge instructions is improved by the addition of illustrations. Published by Oxford University Press on behalf of the American Medical Informatics Association 2015. This work is written by US Government employees and is in the public domain in the United States.

Standard cardiopulmonary resuscitation versus active compression-decompression cardiopulmonary resuscitation with augmentation of negative intrathoracic pressure for out-of-hospital cardiac arrest: a randomised trial.

PubMed

Aufderheide, Tom P; Frascone, Ralph J; Wayne, Marvin A; Mahoney, Brian D; Swor, Robert A; Domeier, Robert M; Olinger, Michael L; Holcomb, Richard G; Tupper, David E; Yannopoulos, Demetris; Lurie, Keith G

2011-01-22

Active compression-decompression cardiopulmonary resuscitation (CPR) with decreased intrathoracic pressure in the decompression phase can lead to improved haemodynamics compared with standard CPR. We aimed to assess effectiveness and safety of this intervention on survival with favourable neurological function after out-of-hospital cardiac arrest. In our randomised trial of 46 emergency medical service agencies (serving 2·3 million people) in urban, suburban, and rural areas of the USA, we assessed outcomes for patients with out-of-hospital cardiac arrest according to Utstein guidelines. We provisionally enrolled patients to receive standard CPR or active compression-decompression CPR with augmented negative intrathoracic pressure (via an impedance-threshold device) with a computer-generated block randomisation weekly schedule in a one-to-one ratio. Adults (presumed age or age ≥18 years) who had a non-traumatic arrest of presumed cardiac cause and met initial and final selection criteria received designated CPR and were included in the final analyses. The primary endpoint was survival to hospital discharge with favourable neurological function (modified Rankin scale score of ≤3). All investigators apart from initial rescuers were masked to treatment group assignment. This trial is registered with ClinicalTrials.gov, number NCT00189423. 2470 provisionally enrolled patients were randomly allocated to treatment groups. 813 (68%) of 1201 patients assigned to the standard CPR group (controls) and 840 (66%) of 1269 assigned to intervention CPR received designated CPR and were included in the final analyses. 47 (6%) of 813 controls survived to hospital discharge with favourable neurological function compared with 75 (9%) of 840 patients in the intervention group (odds ratio 1·58, 95% CI 1·07-2·36; p=0·019]. 74 (9%) of 840 patients survived to 1 year in the intervention group compared with 48 (6%) of 813 controls (p=0·03), with equivalent cognitive skills, disability ratings, and emotional-psychological statuses in both groups. The overall major adverse event rate did not differ between groups, but more patients had pulmonary oedema in the intervention group (94 [11%] of 840) than did controls (62 [7%] of 813; p=0·015). On the basis of our findings showing increased effectiveness and generalisability of the study intervention, active compression-decompression CPR with augmentation of negative intrathoracic pressure should be considered as an alternative to standard CPR to increase long-term survival after cardiac arrest. US National Institutes of Health grant R44-HL065851-03, Advanced Circulatory Systems. Copyright © 2011 Elsevier Ltd. All rights reserved.

Efficacy of Synbiotics for Treatment of Bacillary Dysentery in Children: A Double-Blind, Randomized, Placebo-Controlled Study.

PubMed

Kahbazi, Manijeh; Ebrahimi, Marzieh; Zarinfar, Nader; Arjomandzadegan, Mohammad; Fereydouni, Taha; Karimi, Fatemeh; Najmi, Amir Reza

2016-01-01

Bacillary dysentery is a major cause of children's admission to hospitals. To assess the probiotic and prebiotic (synbiotics) effects in children with dysentery in a randomized clinical trial, 200 children with dysentery were studied in 2 groups: the synbiotic group received 1 tablet/day of synbiotic for 3-5 days and the placebo group received placebo tablets (identical tablet form like probiotics). The standard treatment was administered for all patients. Duration of hospitalization, dysentery, fever, and the weight loss were assessed in each group. It was concluded that there was no significant difference in both groups in the baseline characteristics. The mean duration of dysentery reduced ( P < 0.05). The mean duration of fever has been significantly reduced in the synbiotic group (1.64 ± 0.87 days) in comparison to the placebo group (2.13 ± 0.94 days) ( P < 0.001). Average amount of weight loss was significantly lower in the synbiotic group in comparison to that in the placebo group (129.5 ± 23.388 grams and 278 ± 28.385 grams, resp.; P < 0.001). There was no significant difference in the mean duration of hospitalization in both groups ( P > 0.05). The use of synbiotics as an adjuvant therapy to the standard treatment of dysentery significantly reduces the duration of dysentery, fever, and rate of weight losses. The trial is registered with IRCT201109267647N1.

[Physical therapy intervention during hospitalization in patients with acute exacerbation of chronic obstructive pulmonary disease and pneumonia: A randomized clinical trial].

PubMed

Martín-Salvador, Adelina; Colodro-Amores, Gloria; Torres-Sánchez, Irene; Moreno-Ramírez, M Paz; Cabrera-Martos, Irene; Valenza, Marie Carmen

2016-04-01

Respiratory infections involve not only hospitalization due to pneumonia, but also acute exacerbations of COPD (AECOPD). The objective of the present study was to evaluate the effectiveness of a physical therapy intervention during hospitalization in patients admitted due to community-acquired pneumonia (CAP) and AECOPD. Randomized clinical trial, 44 patients were randomized into 2 groups: a control group which received standard medical therapy (oxygen therapy and pharmacotherapy) and an experimental group that received standard treatment and a physical therapy intervention (breathing exercises, electrostimulation, exercises with elastic bands and relaxation). Between-groups analysis showed that after the intervention (experimental vs. control) significant differences were found in perceived dyspnoea (P=.041), and right and left quadriceps muscle strength (P=.008 and P=.010, respectively). In addition, the subscale of "domestic activities" of the functional ability related to respiratory symptoms questionnaire showed significant differences (P=.036). A physical therapy intervention during hospitalization in patients with AECOPD and CAP can generate skeletal muscle level gains that exceed the deterioration caused by immobilization during hospitalization. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Comparison of the variability of the onset and recovery from neuromuscular blockade with cisatracurium versus rocuronium in elderly patients under total intravenous anesthesia

PubMed Central

Xiaobo, Feng; Jianjuan, Ke; Yanlin, Wang

2012-01-01

This study was designed to compare the variability of the onset and offset of the effect of two neuromuscular blocking drugs with different elimination pathways in adult and elderly patients during total intravenous anesthesia (TIVA). After Ethics Committee approval and patients' informed consent, the drugs were compared in 40 adult and 40 elderly patients scheduled for elective surgery under TIVA with tracheal intubation who were randomized to receive a single bolus dose of 0.15 mg/kg cisatracurium or 0.9 mg/kg rocuronium. The time of onset of maximum depression, duration of action, and recovery index time were measured and recorded for each patient and variability is reported as means ± standard deviation. Time of onset was significantly shorter for rocuronium than cisatracurium for the adult and elderly groups (P = 0.000), but the variability of cisatracurium was significantly greater compared with rocuronium for the same age groups (93.25 vs 37.01 s in the adult group and 64.56 vs 33.75 s in the elderly group; P = 0.000). The duration of the effect in the elderly group receiving rocuronium was significantly longer than in the elderly group receiving cisatracurium, and the variability of the duration was significantly greater in the rocuronium group than in the cisatracurium group. Mean time of recovery was significantly longer for the elderly group receiving rocuronium than for the elderly group receiving cisatracurium (P = 0.022), and variability was also greater (P = 0.002). Both drugs favored good intubating conditions. In conclusion, cisatracurium showed less variability in these parameters than rocuronium, especially in the elderly, a fact that may be of particular clinical interest. PMID:22584638

NEOADJUVANT СHEMOTHERAPY FOR LOCALLY ADVANCED BREAST CANCER.

PubMed

Fomenko, Y; Sirota, V; Omarova, I; Kabildina, N; Amanov, A

2017-03-01

93 patients with LABC (T2N1-2M0, T3N0-2M0) at the age from 35 to 75 years were included in the trial. With 2 stage - 60 patients, with the third stage - 33 patients. All patients were randomized into 3 groups: The I control group (n=36) received 4 courses of neoadjuvant chemotherapy according to AC-protocol (doxorubicin 50 mg/m2, cyclophosphan-500 mg/m2 on day 1, repeated every three weeks) followed by radical mastectomy, 4 courses of adjuvant chemotherapy (АС), radiotherapy and hormone therapy if indicated. II investigative group (n=30) received the same CTX but in combination with Arglabin at a dose of 370 mg/m2 for 7 days. III investigative group (n=27) received Arglabin as monotherapy. The clinical efficacy of neoadjuvant chemotherapy according to the scheme of AC and AC + arglabin was the same and significantly exceeded Arlabine monotherapy. There was no statistically significant difference in pathological response in patients of all three groups. Arglabin has very low toxicity and eliminates the toxic effects of standard chemotherapy.

Effect of probiotic supplement on aflatoxicosis and gene expression in the liver of broiler chicken.

PubMed

Salem, Ramadan; El-Habashi, Nagwan; Fadl, Sabreen E; Sakr, Osama A; Elbialy, Zizy I

2018-06-01

The present study aimed to investigate the toxic effect of aflatoxin B1 (AFB1) and the effectiveness of a biological mycotoxin binder (Nutritox ® ) in detoxifying aflatoxicosis. Ninety one-day-old chicks were chosen and divided into 3 groups. The first group received standard basal diet only, the second group received a basal diet with AFB1 (0.25 mg/kg diet), and the third group received a basal diet with AFB1 (0.25 mg/kg diet) and Nutritox ® (1 kg/ton diet). AFB1 feed contamination significantly reduced growth performance and deteriorated FCR. Moreover, it significantly increased serum AST, ALT, and malondialdehyde and significantly decreased serum total protein, albumin, globulin, SOD, CAT activities and glutathione peroxidase gene expression as well. Aflatoxin residues were detected in the liver tissues. Furthermore, the liver and kidney of AFB1 treated group showed pathological changes. The supplementation of Nutritox ® significantly reduced aflatoxin levels in the liver and counteracted the negative effects of AFB1. Copyright © 2018 Elsevier B.V. All rights reserved.

Dose- and time-dependent effects of ethanolic extract of Mucuna pruriens Linn. seed on sexual behaviour of normal male rats.

PubMed

Suresh, Sekar; Prithiviraj, Elumalai; Prakash, Seppan

2009-04-21

According to Indian Systems of Medicine, Mucuna pruriens Linn., belonging to the leguminous family (Papilionaceae), were used for treating male sexual disorders since ancient times. In this study, the effects of ethanolic extracts of the Mucuna pruriens Linn. seed on general mating behaviour, libido and potency of normal male Wister albino rats were investigated and also compared with the standard reference drug, Sildenafil citrate. Animals were divided into one control group (Group I--received saline) and four experimental groups (Groups II-V). Experimental groups were divided on the basis of the dosage of extract to the animals as follows: 150 mg/kg body weight (Group I), 200mg/kg body weight (Group II) and 250 mg/kg body weight (Group IV) while Group V received Sildenafil citrate (5mg/kg body weight). Animals were fed PO with saline or extract or standard drug once in a day for 45 days. To analyse the mating behaviour, female rats with oestrus phase were used. The extract administered PO significantly increased the mounting frequency, intromission frequency and ejaculation latency, and decreased the mounting latency, intromission latency, post-ejaculatory interval and inter-intromission interval. The potency test significantly increased erections, quick flips, long flips and total reflex. Therefore, the results indicated that the ethanolic extracts of Mucuna pruriens Linn. seed produced a significant and sustained increase in the sexual activity of normal male rats at a particular dose (200mg/kg). When compared to control, all the drug-treated groups have shown drug-induced effects for a few parameters. However in Group II, there was an obvious enhancement in all parameters, without affecting the normal behaviour. When compared with the standard drug, the net effect of extract is even less than that in Group II. Therefore, the resulting aphrodisiac activity of the extract lends support to the claim that it has traditionally been used for the treatment of sexual disorders.

Improved guideline adherence to pharmacotherapy of chronic systolic heart failure in general practice--results from a cluster-randomized controlled trial of implementation of a clinical practice guideline.

PubMed

Peters-Klimm, Frank; Müller-Tasch, Thomas; Remppis, Andrew; Szecsenyi, Joachim; Schellberg, Dieter

2008-10-01

Clinical practice guidelines (CPG) reflect the evidence of effective pharmacotherapy of chronic (systolic) heart failure (CHF) which needs to be implemented. This study aimed to evaluate the effect of a new, multifaceted intervention (educational train-the-trainer course plus pharmacotherapy feedback = TTT) compared with standard education on guideline adherence (GA) in general practice. Thirty-seven participating general practitioners (GPs) were randomized (18 vs. 19) and included 168 patients with ascertained symptomatic CHF [New York Heart Association (NYHA) II-IV]. Groups received CPG, the TTT intervention consisted of four interactive educational meetings and a pharmacotherapy feedback, while the control group received a usual lecture (Standard). Outcome measure was GA assessed by prescription rates and target dosing of angiotensin converting enzyme (ACE) inhibitors (ACE-I) or angiotensin receptor blockers (ARB), beta-blockers (BB) and aldosterone antagonists (AA) at baseline and 7-month follow-up. Group comparisons at follow-up were adjusted to GA, sex, age and NYHA stage at baseline. Prescription rates at baseline (n = 168) were high (ACE-I/ARB 90, BB 79 and AA 29%) in both groups. At follow up (n = 146), TTT improved compared with Standard regarding AA (43% vs. 23%, P = 0.04) and the rates of reached target doses of ACE-I/ARB (28% vs. 15%, P = 0.04). TTT group achieved significantly higher mean percentages of daily target dose (52% vs. 42%, mean difference 10.3%, 95% CI 0.84-19.8, P = 0.03). Despite of pre-existing high GA in both groups and an active control group, the multifaceted intervention was effective in quality of care measured by GA. Further research is needed on the choice of interventions in different provider populations.

Does transcutaneous electrical nerve stimulation (TENS) alleviate the pain experienced during bone marrow sampling in addition to standard techniques? A randomised, double-blinded, controlled trial.

PubMed

Tucker, David L; Rockett, Mark; Hasan, Mehedi; Poplar, Sarah; Rule, Simon A

2015-06-01

Bone marrow aspiration and trephine (BMAT) biopsies remain important tests in haematology. However, the procedures can be moderately to severely painful despite standard methods of pain relief. To test the efficacy of transcutaneous electrical nerve stimulation (TENS) in alleviating the pain from BMAT in addition to standard analgesia using a numerical pain rating scale (NRS). 70 patients requiring BMAT were randomised (1:1) in a double-blind, placebo-controlled trial. -35 patients received TENS impulses at a strong but comfortable amplitude (intervention group) and 35 patients received TENS impulses just above the sensory threshold (control group) (median pulse amplitude 20 and 7 mA, respectively). Patients and operators were blinded to group allocation. Pain assessments were made using a numerical pain scale completed after the procedure. No significant difference in NRS pain recalled after the procedure was detected (median pain score 5.7 (95% CI 4.8 to 6.6) in control vs 5.6 (95% CI 4.8 to 6.4) in the intervention group). However, 100% of patients who had previous experience of BMAT and >94% of participants overall felt they benefited from using TENS and would recommend it to others for this procedure. There were no side effects from the TENS device, and it was well tolerated. TENS is a safe, non-invasive adjunct to analgesia for reducing pain during bone marrow biopsy and provides a subjective benefit to most users; however, no objective difference in pain scores was detected when using TENS in this randomised controlled study. NCT02005354. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

PubMed

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Chromium picolinate modulates serotonergic properties and carbohydrate metabolism in a rat model of diabetes.

PubMed

Komorowski, James R; Tuzcu, Mehmet; Sahin, Nurhan; Juturu, Vijaya; Orhan, Cemal; Ulas, Mustafa; Sahin, Kazim

2012-10-01

Chromium picolinate (CrPic) has shown both antidepressant and antidiabetic properties. In this study, the effects of CrPic on serotonergic properties and carbohydrate metabolism in diabetic rats were evaluated. Sixty male Sprague-Dawley rats were divided into four groups. (1) The control group received only standard diet (8 % fat). (2) The CrPic group was fed standard diet and CrPic (80 μg CrPic per kilogram body mass (b.m.)/day), for 10 weeks (microgram/kilogram b.m./day). (3) The HFD/STZ group fed a high-fat diet (HFD, 40 % fat) for 2 weeks and then received streptozotocin (STZ, 40 mg/kg, i.p.) (i.v.) HFD-STZ-CrPic group treated as the previous group and then were administered CrPic. CrPic administration to HFD/STZ-treated rats increased brain chromium levels and improved all measurements of carbohydrate metabolism and serotonergic properties (P<0.001). CrPic also significantly increased levels of insulin, tryptophan, and serotonin (P<0.001) in the serum and brain, and decreased cortisol levels in the serum (P<0.01). Except chromium levels, no significant effect of CrPic supplementation was detected on the overall measured parameters in the control group. CrPic administration was well tolerated without any adverse events. The results support the use of CrPic supplementation which improves serotonergic properties of brain in diabetes.

Efficacy of combined electrostimulation in patients with acute exacerbation of COPD: randomised clinical trial.

PubMed

Lopez Lopez, Laura; Granados Santiago, Maria; Donaire Galindo, Maria; Torres Sanchez, Irene; Ortiz Rubio, Araceli; Valenza, Marie Carmen

2018-04-25

Muscle dysfunction is very common in patients with chronic obstructive pulmonary disease (COPD). Muscular strength depletion is a result of numerous hospitalisations and this causes an increase in the symptomatology. Numerous interventions have been used in these patients, but there is no consensus on the best. The main objective of this study is to compare the effectiveness of two physiotherapy interventions during hospitalisation in COPD patients. In this clinical trial, we included 39 patients who were randomised into three groups. A control group received standard medical treatment (oxygen therapy and pharmacotherapy), and two groups received, in addition to standard medical treatment, a physiotherapy intervention, one with functional electrostimulation and one with calisthenic exercises. The main variables were the ability to exercise using the Five-time sit-to-stand test as well as the functionality associated with symptomatology, as measured by the London Chest Activity of Daily Living Scale. After comparing the results, there was a significant improvement in dyspnea on discharge versus admission in all three groups. In addition, we found significant differences in functionality, exercise capacity, and fatigue in both intervention groups, being better in the electrostimulation with calisthenic exercises group than in the functional group. An electrostimulation treatment improves the exercise capacity, functionality and fatigue in hospitalised AECOPD patients. Copyright © 2018 Elsevier España, S.L.U. All rights reserved.

Impact of TimeSlips creative expression program on behavioral symptoms and psychotropic medication use in persons with dementia in long-term care: a cluster-randomized pilot study.

PubMed

Houser, Winona S; George, Daniel R; Chinchilli, Vernon M

2014-04-01

To evaluate whether involvement in TimeSlips, a creative storytelling program, reduced mood and behavioral symptoms as well as psychotropic medication use in persons with dementia. A cluster-randomized pilot study compared two discrete dementia care units in one nursing home. The control cohort (N = 10) received standard-of-care activity programming, and the intervention cohort (N = 10) received standard-of-care plus two one-hour TimeSlips sessions per week for six weeks. Data on mood and behavioral symptoms and psychotropic drug prescriptions were collected, and within-group and between-group comparisons were performed. Between-group comparisons did not reveal statistically significant differences in mood and behavioral symptoms. No differences in psychotropic drug prescriptions were found. Larger trials of longer duration are needed to determine whether involvement in TimeSlips reduces mood and behavioral symptoms that compromise quality of life for persons with dementia. Copyright © 2014 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

Transfer of Minibeam Radiation Therapy into a cost-effective equipment for radiobiological studies: a proof of concept.

PubMed

Prezado, Y; Dos Santos, M; Gonzalez, W; Jouvion, G; Guardiola, C; Heinrich, S; Labiod, D; Juchaux, M; Jourdain, L; Sebrie, C; Pouzoulet, F

2017-12-11

Minibeam radiation therapy (MBRT) is an innovative synchrotron radiotherapy technique able to shift the normal tissue complication probability curves to significantly higher doses. However, its exploration was hindered due to the limited and expensive beamtime at synchrotrons. The aim of this work was to develop a cost-effective equipment to perform systematic radiobiological studies in view of MBRT. Tumor control for various tumor entities will be addressable as well as studies to unravel the distinct biological mechanisms involved in normal and tumor tissues responses when applying MBRT. With that aim, a series of modifications of a small animal irradiator were performed to make it suitable for MBRT experiments. In addition, the brains of two groups of rats were irradiated. Half of the animals received a standard irradiation, the other half, MBRT. The animals were followed-up for 6.5 months. Substantial brain damage was observed in the group receiving standard RT, in contrast to the MBRT group, where no significant lesions were observed. This work proves the feasibility of the transfer of MBRT outside synchrotron sources towards a small animal irradiator.

The efficacy of intravitreal interferon alpha-2b for the treatment of experimental endotoxin-induced uveitis.

PubMed

Afarid, Mehrdad; Lashkarizadeh, Hamid; Ashraf, Mohammad J; Nowroozzadeh, Mohammad Hossein; Shafiee, Sayed M

2016-05-01

To study the efficacy of intravitreal interferon alpha-2b for endotoxin-induced uveitis. A total of 36 rabbits were randomly allocated to one of the three groups: (1) received interferon plus balanced-salt solution; (2) received lipopolysaccharide (LPS) plus interferon; and (3) received LPS plus balanced-salt solution. Intraocular inflammation was evaluated by slit-lamp biomicroscopy (standardization of uveitis nomenclature grading), binocular indirect ophthalmoscopy (BIO) score, and histopathology. Group 2 showed significantly lower mean (±standard deviation) anterior chamber reaction than Group 3 (3.1 ± 0.9 vs. 3.8 ± 0.4) on day 1 postinjection, lower vitreous cells on days 1 through 7 (day 1: 3.1 ± 0.9 vs. 3.8 ± 0.4; day 3: 2.1 ± 1.6 vs. 3.8 ± 0.4; day 7: 1.9 ± 1.3 vs. 3.6 ± 0.7), and lower BIO score on days 1-7 (day 1: 3.3 ± 1.2 vs. 4.4 ± 0.7; day 3: 3.0 ± 1.4 vs. 4.3 ± 0.9; day 7: 2.4 ± 1.4 vs. 3.7 ± 1.2). The protein content of anterior and vitreous aspirates was lower in Group 2 than 3 (1618.5 ± 411.4 vs. 2567.3 ± 330.8 and 2157.0 ± 283.3 vs. 3204.6 ± 259.5, respectively). Intravitreal interferon alpha-2b was effective in controlling endotoxin-induced uveitis.

Economic Evaluation of Manitoba Health Lines in the Management of Congestive Heart Failure

PubMed Central

Cui, Yang; Doupe, Malcolm; Katz, Alan; Nyhof, Paul; Forget, Evelyn L.

2013-01-01

Objective: This one-year study investigated whether the Manitoba Provincial Health Contact program for congestive heart failure (CHF) is a cost-effective intervention relative to the standard treatment. Design: Individual patient-level, randomized clinical trial of cost-effective model using data from the Health Research Data Repository at the Manitoba Centre for Health Policy, University of Manitoba. Methods: A total of 179 patients aged 40 and over with a diagnosis of CHF levels II to IV were recruited from Winnipeg and Central Manitoba and randomized into three treatment groups: one receiving standard care, a second receiving Health Lines (HL) intervention and a third receiving Health Lines intervention plus in-house monitoring (HLM). A cost-effectiveness study was conducted in which outcomes were measured in terms of QALYs derived from the SF-36 and costs using 2005 Canadian dollars. Costs included intervention and healthcare utilization. Bootstrap-resampled incremental cost-effectiveness ratios were computed to take into account the uncertainty related to small sample size. Results: The total per-patient mean costs (including intervention cost) were not significantly different between study groups. Both interventions (HL and HLM) cost less and are more effective than standard care, with HL able to produce an additional QALY relative to HLM for $2,975. The sensitivity analysis revealed that there is an 85.8% probability that HL is cost-effective if decision-makers are willing to pay $50,000. Conclusion: Findings demonstrate that the HL intervention from the Manitoba Provincial Health Contact program for CHF is an optimal intervention strategy for CHF management compared to standard care and HLM. PMID:24359716

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a study protocol.

PubMed

da Costa, Bruno R; Resta, Nina M; Beckett, Brooke; Israel-Stahre, Nicholas; Diaz, Alison; Johnston, Bradley C; Egger, Matthias; Jüni, Peter; Armijo-Olivo, Susan

2014-12-13

The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this investigation and present an intensive standardized training package for risk of bias assessment that could be used by contributors to the Cochrane Collaboration and other reviewers. This is a pilot study. We will first perform a systematic literature review to identify randomized clinical trials (RCTs) that will be used for risk of bias assessment. Using the identified RCTs, we will then do a randomized experiment, where raters will be allocated to two different training schemes: minimal training and intensive standardized training. We will calculate the chance-corrected weighted Kappa with 95% confidence intervals to quantify within- and between-group Kappa agreement for each of the domains of the risk of bias tool. To calculate between-group Kappa agreement, we will use risk of bias assessments from pairs of raters after resolution of disagreements. Between-group Kappa agreement will quantify the agreement between the risk of bias assessment of raters in the training groups and the risk of bias assessment of experienced raters. To compare agreement of raters under different training conditions, we will calculate differences between Kappa values with 95% confidence intervals. This study will investigate whether the reliability of the risk of bias tool can be improved by training raters using standardized instructions for risk of bias assessment. One group of inexperienced raters will receive intensive training on risk of bias assessment and the other will receive minimal training. By including a control group with minimal training, we will attempt to mimic what many review authors commonly have to do, that is-conduct risk of bias assessment in RCTs without much formal training or standardized instructions. If our results indicate that an intense standardized training does improve the reliability of the RoB tool, our study is likely to help improve the quality of risk of bias assessments, which is a central component of evidence synthesis.

Effects of foot massage applied in two different methods on symptom control in colorectal cancer patients: Randomised control trial.

PubMed

Uysal, Neşe; Kutlutürkan, Sevinç; Uğur, Işıl

2017-06-01

This randomized controlled clinical study aimed to determine the effect of 2 foot massage methods on symptom control in people with colorectal cancer who received chemoradiotherapy. Data were collected between June 16, 2015, and February 10, 2016, in the Department of Radiation Oncology of an oncology training and research hospital. The sample comprised 60 participants. Data were collected using an introductory information form, common terminology criteria for adverse events and European Organization for Research and Treatment of Cancer Quality of Life Questionnaires C30 and CR29. Participants were randomly allocated to 3 groups: classical foot massage, reflexology, and standard care control. The classical massage group received foot massage using classical massage techniques, and the reflexology group received foot reflexology focusing on symptom-oriented reflexes twice a week during a 5-week chemoradiotherapy treatment schedule. The control group received neither classical massage nor reflexology. All patients were provided with the same clinic routine care. The classical massage was effective in reducing pain level and distension incidence while foot reflexology was effective in reducing pain and fatigue level, lowering incidence of distension and urinary frequency and improving life quality. © 2017 John Wiley & Sons Australia, Ltd.

Effect of an Intensive Lifestyle Intervention on Glycemic Control in Patients With Type 2 Diabetes: A Randomized Clinical Trial.

PubMed

Johansen, Mette Yun; MacDonald, Christopher Scott; Hansen, Katrine Bagge; Karstoft, Kristian; Christensen, Robin; Pedersen, Maria; Hansen, Louise Seier; Zacho, Morten; Wedell-Neergaard, Anne-Sophie; Nielsen, Signe Tellerup; Iepsen, Ulrik Wining; Langberg, Henning; Vaag, Allan Arthur; Pedersen, Bente Klarlund; Ried-Larsen, Mathias

2017-08-15

It is unclear whether a lifestyle intervention can maintain glycemic control in patients with type 2 diabetes. To test whether an intensive lifestyle intervention results in equivalent glycemic control compared with standard care and, secondarily, leads to a reduction in glucose-lowering medication in participants with type 2 diabetes. Randomized, assessor-blinded, single-center study within Region Zealand and the Capital Region of Denmark (April 2015-August 2016). Ninety-eight adult participants with non-insulin-dependent type 2 diabetes who were diagnosed for less than 10 years were included. Participants were randomly assigned (2:1; stratified by sex) to the lifestyle group (n = 64) or the standard care group (n = 34). All participants received standard care with individual counseling and standardized, blinded, target-driven medical therapy. Additionally, the lifestyle intervention included 5 to 6 weekly aerobic training sessions (duration 30-60 minutes), of which 2 to 3 sessions were combined with resistance training. The lifestyle participants received dietary plans aiming for a body mass index of 25 or less. Participants were followed up for 12 months. Primary outcome was change in hemoglobin A1c (HbA1c) from baseline to 12-month follow-up, and equivalence was prespecified by a CI margin of ±0.4% based on the intention-to-treat population. Superiority analysis was performed on the secondary outcome reductions in glucose-lowering medication. Among 98 randomized participants (mean age, 54.6 years [SD, 8.9]; women, 47 [48%]; mean baseline HbA1c, 6.7%), 93 participants completed the trial. From baseline to 12-month follow-up, the mean HbA1c level changed from 6.65% to 6.34% in the lifestyle group and from 6.74% to 6.66% in the standard care group (mean between-group difference in change of -0.26% [95% CI, -0.52% to -0.01%]), not meeting the criteria for equivalence (P = .15). Reduction in glucose-lowering medications occurred in 47 participants (73.5%) in the lifestyle group and 9 participants (26.4%) in the standard care group (difference, 47.1 percentage points [95% CI, 28.6-65.3]). There were 32 adverse events (most commonly musculoskeletal pain or discomfort and mild hypoglycemia) in the lifestyle group and 5 in the standard care group. Among adults with type 2 diabetes diagnosed for less than 10 years, a lifestyle intervention compared with standard care resulted in a change in glycemic control that did not reach the criterion for equivalence, but was in a direction consistent with benefit. Further research is needed to assess superiority, as well as generalizability and durability of findings. clinicaltrials.gov Identifier: NCT02417012.

A randomized controlled trial of simulation-based training for ear, nose, and throat emergencies.

PubMed

Smith, Matthew Edward; Navaratnam, Annakan; Jablenska, Lily; Dimitriadis, Panagiotis A; Sharma, Rishi

2015-08-01

Life-threatening ear, nose, and throat (ENT) emergencies are uncommon but require immediate skilled management. We investigated if traditional lecture-based teaching can be improved by a simulation and lecture hybrid approach. A single-blinded, prospective, randomized controlled trial. Two groups of interns with no previous ENT experience were randomized to one of two training groups: a simulation/lecture hybrid group or a lecture-only control group. Both groups received 90 minutes of training covering the assessment of critically ill patients and four ENT emergency topics. Both groups received the same initial lecture slides. The control group received additional slides, and the simulation group received simulated emergency scenario training using basic mannequins. Following the training, candidates were asked to provide feedback on their perception of training, and they were formally assessed with a standardized one-to-one viva. Thirty-eight interns were recruited: 18 in the control group and 20 in the simulation group. The candidates in the simulation group performed significantly better in all viva situations (P < .05) and had better perception of learning (P < .05). Additionally, the simulation group was more likely to recommend the training to a colleague (P < .05). We have demonstrated that replacing traditional lecture-based training with a mixture of lectures and emergency scenario simulation is more effective at preparing junior doctors for ENT emergencies, and better met their learning needs. Implementing this kind of teaching is feasible with a minimum of additional resources or time. 1b © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

The effect of oral honey and pollen on postoperative intraabdominal adhesions.

PubMed

Celeplı, Salih; Kismet, Kemal; Kaptanoğlu, Buğra; Erel, Serap; Ozer, Saadet; Celeplı, Pınar; Kaygusuz, Gülşah; Devrım, Erdinç; Gencay, Omür; Sorkun, Kadriye; Durak, Ilker; Akkuş, Mehmet Ali

2011-02-01

We evaluated the effect of oral usage of honey and pollen, either separately or together, on postoperative intraabdominal adhesions. Forty rats were randomly separated into 4 groups of 10 rats each. Abrasion was performed on the cecum, and a patch of peritoneum located opposite to the cecal abrasion was completely dissected. Group 1 rats received no treatment; Group 2 rats received 4 g/kg/day honey; Group 3 rats received 4 g/kg/day pollen; and Group 4 rats received 4 g/kg/day honey and pollen mixed in equal amounts, in addition to the standard feeding for postoperative 21 days. All the rats were sacrificed on the 21st day. Following the adhesion scoring, tissue specimens of the peritoneum and bowel were subjected to histopathological investigation. The tissue and blood specimens were also taken for biochemical analysis to investigate the antioxidant capacity. Adhesion scores were significantly different between the control and other groups. No dense adhesion was observed in the treatment groups. Tissue malondialdehyde levels were significantly different between the control and honey and honey+pollen groups. Superoxide dismutase and glutathione-peroxidase levels were significantly different between the control and other groups. Catalase levels were different between the control and honey groups. Plasma antioxidant levels were different between the control and other groups. The pathological scores for fibrosis and inflammation were significantly different between the control and other groups. Honey and pollen were found to be effective in preventing postoperative intraabdominal adhesions, and these effects were thought to be a result of their antiinflammatory and antioxidant properties.

Influence Of Implantation Age On School-Age Language Performance In Pediatric Cochlear Implant Users

PubMed Central

Tobey, Emily A.; Thal, Donna; Niparko, John K.; Eisenberg, Laurie S.; Quittner, Alexandra L.; Wang, Nae-Yuh

2013-01-01

Objective This study examined specific spoken language abilities of 160 children with severe-to-profound sensorineural hearing loss followed prospectively 4, 5, or 6 years after cochlear implantation. Study sample Ninety-eight children received implants before 2.5 years, and 62 children received implants between 2.5 and 5 years of age. Design Language was assessed using four subtests of the Comprehensive Assessment of Spoken Language (CASL). Standard scores were evaluated by contrasting age of implantation and follow-up test time. Results Children implanted under 2.5 years of age achieved higher standard scores than children with older ages of implantation for expressive vocabulary, expressive syntax, and pragmatic judgments. However, in both groups, some children performed more than two standard deviations below the standardization group mean, while some scored at or well above the mean. Conclusions Younger ages of implantation are associated with higher levels of performance, while later ages of implantation are associated with higher probabilities of continued language delays, particularly within subdomains of grammar and pragmatics. Longitudinal data from this cohort study demonstrate that after 6 years of implant experience, there is large variability in language outcomes associated with modifiers of rates of language learning that differ as children with implants age. PMID:23448124

Going beyond: an adventure- and recreation-based group intervention promotes well-being and weight loss in schizophrenia.

PubMed

Voruganti, Lakshmi N P; Whatham, Jeff; Bard, Eleanor; Parker, Gayle; Babbey, Candice; Ryan, Janet; Lee, Suganya; MacCrimmon, Duncan J

2006-08-01

To undertake a preliminary study to assess the feasibility of clinical implementation and evaluate the effectiveness of a novel adventure- and recreation-based group intervention in the rehabilitation of individuals with schizophrenia. In a 2-year, prospective, case-control study, 23 consecutively referred, clinically stabilized schizophrenia patients received the new intervention over an 8-month period; 31 patients on the wait list, considered the control group, received standard clinical care that included some recreational activities. Symptom severity, self-esteem, self-appraised cognitive abilities, and functioning were documented for both groups with standardized rating scales administered at baseline, on completion of treatment, and at 12 months posttreatment. Treatment adherence was 97%, and there were no dropouts. Patients in the study group showed marginal improvement in perceived cognitive abilities and on domain-specific functioning measures but experienced a significant improvement in their self-esteem and global functioning (P < 0.05), as well as a weight loss of over 12 lb. Improvement was sustained over 1 year with further occupational and social gains. In the context of overcoming barriers to providing early intervention for youth and preventing metabolic problems among older adults with schizophrenia, adventure- and recreation-based interventions could play a useful complementary role.

Effectiveness of Visual Methods in Information Procedures for Stem Cell Recipients and Donors

PubMed Central

Sarıtürk, Çağla; Gereklioğlu, Çiğdem; Korur, Aslı; Asma, Süheyl; Yeral, Mahmut; Solmaz, Soner; Büyükkurt, Nurhilal; Tepebaşı, Songül; Kozanoğlu, İlknur; Boğa, Can; Özdoğu, Hakan

2017-01-01

Objective: Obtaining informed consent from hematopoietic stem cell recipients and donors is a critical step in the transplantation process. Anxiety may affect their understanding of the provided information. However, use of audiovisual methods may facilitate understanding. In this prospective randomized study, we investigated the effectiveness of using an audiovisual method of providing information to patients and donors in combination with the standard model. Materials and Methods: A 10-min informational animation was prepared for this purpose. In total, 82 participants were randomly assigned to two groups: group 1 received the additional audiovisual information and group 2 received standard information. A 20-item questionnaire was administered to participants at the end of the informational session. Results: A reliability test and factor analysis showed that the questionnaire was reliable and valid. For all participants, the mean overall satisfaction score was 184.8±19.8 (maximum possible score of 200). However, for satisfaction with information about written informed consent, group 1 scored significantly higher than group 2 (p=0.039). Satisfaction level was not affected by age, education level, or differences between the physicians conducting the informative session. Conclusion: This study shows that using audiovisual tools may contribute to a better understanding of the informed consent procedure and potential risks of stem cell transplantation. PMID:27476890

Effect of Memantine on Serum Levels of Neuron-Specific Enolase and on the Glasgow Coma Scale in Patients With Moderate Traumatic Brain Injury.

PubMed

Mokhtari, Majid; Nayeb-Aghaei, Hossein; Kouchek, Mehran; Miri, Mir Mohammad; Goharani, Reza; Amoozandeh, Arash; Akhavan Salamat, Sina; Sistanizad, Mohammad

2018-01-01

Traumatic brain injury (TBI) is a major cause of disability and death globally. Despite significant progress in neuromonitoring and neuroprotection, pharmacological interventions have failed to generate favorable results. We examined the effect of memantine on serum levels of neuron-specific enolase (NSE), a marker of neuronal damage, and the Glasgow Coma Scale (GCS) in patients with moderate TBI. Patients were randomly assigned to the control group (who received standard TBI management) and the treatment group (who, alongside their standard management, received enteral memantine 30 mg twice daily for 7 days). Patients' clinical data, GCS, findings of head computed tomography, and serum NSE levels were collected during the study. Forty-one patients were randomized into the control and treatment groups, 19 and 22 patients respectively. Baseline characteristics and serum NSE levels were not significantly different between the 2 groups. The mean serum NSE levels for the memantine and the control groups on day 3 were 7.95 ± 2.86 and 12.33 ± 7.09 ng/mL, respectively (P = .05), and on day 7 were 5.03 ± 3.25 and 10.04 ± 5.72 ng/mL, respectively (P = .003). The mean GCS on day 3 was 12.3 ± 2.0 and 10.9 ± 1.9 in the memantine and control groups, respectively (P = .03). Serum NSE levels and GCS changes were negatively correlated (r = -0.368, P = .02). Patients with moderate TBI who received memantine had significantly reduced serum NSE levels by day 7 and marked improvement in their GCS scores on day 3 of the study. © 2017, The American College of Clinical Pharmacology.

Vitamin K antagonists in children with central venous catheter on chronic haemodialysis: a pilot study.

PubMed

Paglialonga, Fabio; Artoni, Andrea; Braham, Simon; Consolo, Silvia; Giannini, Alberto; Chidini, Giovanna; Napolitano, Luisa; Martinelli, Ida; Montini, Giovanni; Edefonti, Alberto

2016-05-01

To date, no study has investigated the use of vitamin K antagonists (VKA) in children undergoing chronic haemodialysis (HD) with a central venous catheter (CVC). Consecutive patients aged <18 years with a newly placed tunnelled CVC for chronic HD were enrolled over a 3-year period. Children with active nephrotic syndrome or a history of venous thrombosis received warfarin (VKA group) with therapeutic target international normalised ratios of between 2.0 and 3.0. Patients at standard risk of CVC malfunction were not treated with VKA (standard group). The primary end-point was overall CVC survival. The VKA group consisted of nine patients (median age 10.6 years; range 1.2-15.3 years) with 11 CVC, and the standard group comprised eight patients (11.8 years; 6.1-17.3 years) with ten CVC. The 6- and 12-month CVC survival was significantly longer in the VKA group than in the standard group (100 vs. 60 % and 83.3 vs. 16.7 %, respectively; p < 0.05), with a median survival of 369 and 195 days, respectively (p < 0.05). None of the CVC in the VKA group required removal due to malfunction, as compared to four in the standard group. No major bleeding episodes occurred in either group. Therapy with VKA would appear to be safe in children on chronic HD and may improve CVC survival in patients at increased risk of CVC thrombosis.

Effects of intensive glucose lowering on brain structure and function in people with type 2 diabetes (ACCORD MIND): a randomised open-label substudy.

PubMed

Launer, Lenore J; Miller, Michael E; Williamson, Jeff D; Lazar, Ron M; Gerstein, Hertzel C; Murray, Anne M; Sullivan, Mark; Horowitz, Karen R; Ding, Jingzhong; Marcovina, Santica; Lovato, Laura C; Lovato, James; Margolis, Karen L; O'Connor, Patrick; Lipkin, Edward W; Hirsch, Joy; Coker, Laura; Maldjian, Joseph; Sunshine, Jeffrey L; Truwit, Charles; Davatzikos, Christos; Bryan, R Nick

2011-11-01

People with type 2 diabetes are at risk of cognitive impairment and brain atrophy. We aimed to compare the effects on cognitive function and brain volume of intensive versus standard glycaemic control. The Memory in Diabetes (MIND) study was done in 52 clinical sites in North America as part of Action to Control Cardiovascular Risk in Diabetes (ACCORD), a double two-by-two factorial parallel group randomised trial. Participants (aged 55-80 years) with type 2 diabetes, high glycated haemoglobin A(1c) (HbA(1c)) concentrations (>7·5%; >58 mmol/mol), and a high risk of cardiovascular events were randomly assigned to receive intensive glycaemic control targeting HbA(1c) to less than 6·0% (42 mmol/mol) or a standard strategy targeting HbA(1c) to 7·0-7·9% (53-63 mmol/mol). Randomisation was via a centralised web-based system and treatment allocation was not masked from clinic staff or participants. We assessed our cognitive primary outcome, the Digit Symbol Substitution Test (DSST) score, at baseline and at 20 and 40 months. We assessed total brain volume (TBV), our primary brain structure outcome, with MRI at baseline and 40 months in a subset of participants. We included all participants with follow-up data in our primary analyses. In February, 2008, raised mortality risk led to the end of the intensive treatment and transition of those participants to standard treatment. We tested our cognitive function hypotheses with a mixed-effects model that incorporated information from both the 20 and 40 month outcome measures. We tested our MRI hypotheses with an ANCOVA model that included intracranial volume and factors used to stratify randomisation. This study is registered with ClinicalTrials.gov, number NCT00182910. We consecutively enrolled 2977 patients (mean age 62·5 years; SD 5·8) who had been randomly assigned to treatment groups in the ACCORD study. Our primary cognitive analysis was of patients with a 20-month or 40-month DSST score: 1378 assigned to receive intensive treatment and 1416 assigned to receive standard treatment. Of the 614 patients with a baseline MRI, we included 230 assigned to receive intensive treatment and 273 assigned to receive standard treatment in our primary MRI analysis at 40 months. There was no significant treatment difference in mean 40-month DSST score (difference in mean 0·32, 95% CI -0·28 to 0·91; p=0·2997). The intensive-treatment group had a greater mean TBV than the standard-treatment group (4·62, 2·0 to 7·3; p=0·0007). Although significant differences in TBV favoured the intensive treatment, cognitive outcomes were not different. Combined with the non-significant effects on other ACCORD outcomes, and increased mortality in participants in the intensive treatment group, our findings do not support the use of intensive therapy to reduce the adverse effects of diabetes on the brain in patients with similar characteristics to those of our participants. US National Institute on Aging and US National Heart, Lung, and Blood Institute. Copyright © 2011 Elsevier Ltd. All rights reserved.

Preventive effects of dexmedetomidine on the liver in a rat model of acid-induced acute lung injury.

PubMed

Sen, Velat; Güzel, Abdulmenap; Şen, Hadice Selimoğlu; Ece, Aydın; Uluca, Unal; Söker, Sevda; Doğan, Erdal; Kaplan, İbrahim; Deveci, Engin

2014-01-01

The aim of this study was to examine whether dexmedetomidine improves acute liver injury in a rat model. Twenty-eight male Wistar albino rats weighing 300-350 g were allocated randomly to four groups. In group 1, normal saline (NS) was injected into the lungs and rats were allowed to breathe spontaneously. In group 2, rats received standard ventilation (SV) in addition to NS. In group 3, hydrochloric acid was injected into the lungs and rats received SV. In group 4, rats received SV and 100 µg/kg intraperitoneal dexmedetomidine before intratracheal HCl instillation. Blood samples and liver tissue specimens were examined by biochemical, histopathological, and immunohistochemical methods. Acute lung injury (ALI) was found to be associated with increased malondialdehyde (MDA), total oxidant activity (TOA), oxidative stress index (OSI), and decreased total antioxidant capacity (TAC). Significantly decreased MDA, TOA, and OSI levels and significantly increased TAC levels were found with dexmedetomidine injection in group 4 (P < 0.05). The highest histologic injury scores were detected in group 3. Enhanced hepatic vascular endothelial growth factor (VEGF) expression and reduced CD68 expression were found in dexmedetomidine group compared with the group 3. In conclusion, the presented data provide the first evidence that dexmedetomidine has a protective effect on experimental liver injury induced by ALI.

Meta-analysis of five photodisinfection clinical trials for periodontitis

NASA Astrophysics Data System (ADS)

Andersen, Roger C.; Loebel, Nicolas G.; Andersen, Dane M.

2009-06-01

Photodynamic therapy(PDT) has been demonstrated to effectively kill human periopathogens in vitro. To evaluate the efficacy of PDT in vivo a series of clinical trials was carried out in multiple centers and populations. Clinical parameters including clinical attachment level, pocket probing depth and bleeding on probing were all evaluated. All groups received the standard of care, scaling and root planing, and the treatment group additionally received a single treatment of PDT. Of the total 309 patients and over 40,000 pockets treated in these 5 trials it was determined that photodynamic therapy provided a statistically significant improvement in clinical parameters over scaling and root planing alone.

Does habituation really happen? Investigation of psycho-biological responses to body exposure in bulimia nervosa.

PubMed

Trentowska, Monika; Svaldi, Jennifer; Blechert, Jens; Tuschen-Caffier, Brunna

2017-03-01

Body exposure is a common and effective treatment for body image disturbance in bulimia nervosa (BN). However, little is known about treatment mechanisms. Based on models of emotional processing and neurovisceral integration, we expected to observe a) initial activation and b) habituation of cognitive-affective and autonomic responding within one and between two standardized body exposure sessions. A group of 13 women with BN and 13 healthy controls (HC) were repeatedly exposed to their bodies. Prior to and after treatment with three individualized mirror exposure sessions participants received a session of standardized exposure to videographic recordings of their body. Subjective ratings of body-related emotions and thoughts were assessed repeatedly throughout the standardized exposure sessions and autonomic responses were recorded continuously. Subjective and sympathetic responses were activated initially in both groups. Cognitive-affective responses habituated within the standardized sessions in both groups, whereas between the standardized sessions habituation was only found in women with BN. Increasing sympathetic responses were found within the sessions in both groups. The results support cognitive-affective habituation during body exposure in BN and to a lesser extent in HC. Autonomic responses however did not show a corresponding pattern and did not distinguish between groups. Implications for body exposure research and practice are discussed. Copyright © 2016 Elsevier Ltd. All rights reserved.

High-fat semielemental diet in the treatment of protracted diarrhea of infancy.

PubMed

Jirapinyo, P; Young, C; Srimaruta, N; Rossi, T M; Cardano, A; Lebenthal, E

1990-12-01

The capacity for greater fat absorption relative to carbohydrate absorption in protracted diarrhea of infancy was studied in a developed and a developing country (Buffalo, NY, and Bangkok, Thailand). Fifty patients with protracted diarrhea in the first year of life (defined as liquid stools of more than 20 mL/kg per day with more than a 14-day duration) were randomly assigned to receive either a standard semielemental diet (Pregestimil) or a high-fat semielemental diet that contained 40% more fat. The increased fat was largely in the form of medium-chain triglycerides, with the new diet providing 60% of the fat as medium-chain triglycerides compared with 40% in the standard diet. Tolerance to both diets was good in both studies. Both groups showed adequate weight gain and an improvement in anthropometric and biochemical parameters. The patients receiving the high-fat diet showed no initial weight loss, however, and their weight gain was initiated earlier. Cumulative weight gain was also higher in the group receiving the high-fat semielemental diet. Fecal fat analyses were performed after 1 week of therapy. There was no difference observed in the coefficient of fat absorption between the groups receiving the two formulas, indicating that infants with protracted diarrhea may be able to tolerate a higher fat intake than is normally provided. As carbohydrate intolerance is known to be a complicating factor when using semielemental enteral feeds for infants with protracted diarrhea, a higher-fat semielemental diet may be the most appropriate way to provide adequate caloric intake.

High-dose rapid and standard induction chemotherapy for patients aged over 1 year with stage 4 neuroblastoma: a randomised trial.

PubMed

Pearson, Andrew D J; Pinkerton, C Ross; Lewis, Ian J; Imeson, John; Ellershaw, Caroline; Machin, David

2008-03-01

The current standard treatment for patients with high-risk neuroblastoma includes initial induction chemotherapy with a 21-day interval between induction treatments. We aimed to assess whether an intensive chemotherapy protocol that had a 10-day interval between treatments would improve event-free survival (EFS) in patients aged 1 year or over with high-risk neuroblastoma. Between Oct 30, 1990, and March 18, 1999, patients with stage 4 neuroblastoma who had not received previous chemotherapy were enrolled from 29 centres in Europe. Patients were randomly assigned to rapid treatment (cisplatin [C], vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C], known as COJEC) or standard treatment (vincristine [O], cisplatin [P], etoposide [E], and cyclophosphamide [C], ie, OPEC, alternated with vincristine [O], carboplatin [J], etoposide [E], and cyclophosphamide [C], ie, OJEC). Both regimens used the same total cumulative doses of each drug (except vincristine), but the dose intensity of the rapid regimen was 1.8-times higher than that of the standard regimen. The standard regimen was given every 21 days if patients showed haematological recovery, whereas the rapid regimen was given every 10 days irrespective of haematological recovery. Response to chemotherapy was assessed according to the conventional International Neuroblastoma Response Criteria (INRC). In responders, surgical excision of the primary tumour was attempted, followed by myeloablation (with 200 mg/m2 of melphalan) and haemopoietic stem-cell rescue. Primary endpoints were 3-year, 5-year, and 10-year EFS. Data were analysed by intention to treat. This trial is registered on the clinical trials site of the US National Cancer Institute website, number NCT00365755, and also as EU-20592 and CCLG-NB-1990-11. 262 patients, of median age 2.95 years (range 1.03-20.97), were randomly assigned-132 patients to standard and 130 patients to rapid treatment. 111 patients in the standard group and 109 patients in the rapid group completed chemotherapy. Chemotherapy doses were recorded for 123 patients in the standard group and 126 patients in the rapid group. 97 of 123 (79%) patients in the standard group and 84 of 126 (67%) patients in the rapid group received at least 90% of the scheduled chemotherapy, and the relative dose intensity was 1.94 compared with the standard regimen. 3-year EFS was 24.2% for patients in the standard group and 31.0% for those in the rapid group (hazard ratio [HR] 0.86 [95% CI 0.66-1.14], p=0.30. 5-year EFS was 18.2% in the standard group and 30.2% in the rapid group, representing a difference of 12.0% (1.8 to 22.3), p=0.022. 10-year EFS was 18.2% in the standard group and 27.1% in the rapid group, representing a difference of 8.9% (-1.2 to 19.0), p=0.085. Myeloablation was given a median of 55 days earlier in patients assigned rapid treatment than those assigned standard treatment. Infective complications (numbers of patients with febrile neutropenia and septicaemia, and if given, time on antibiotic and antifungal treatment) and time in hospital were greater with rapid treatment. Occurrence of fungal infection was the same in both regimens. Dose intensity can be increased with a rapid induction regimen in patients with high-risk neuroblastoma. There was no significant difference in OS between the rapid and standard regimens at 5 years and 10 years. However, an increasing difference in EFS after 3 years suggests that the efficacy of the rapid regimen is better than the standard regimen. A rapid induction regimen enables myeloablation to be given much earlier, which might contribute to a better outcome.

Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes.

PubMed

Zinman, Bernard; Wanner, Christoph; Lachin, John M; Fitchett, David; Bluhmki, Erich; Hantel, Stefan; Mattheus, Michaela; Devins, Theresa; Johansen, Odd Erik; Woerle, Hans J; Broedl, Uli C; Inzucchi, Silvio E

2015-11-26

The effects of empagliflozin, an inhibitor of sodium-glucose cotransporter 2, in addition to standard care, on cardiovascular morbidity and mortality in patients with type 2 diabetes at high cardiovascular risk are not known. We randomly assigned patients to receive 10 mg or 25 mg of empagliflozin or placebo once daily. The primary composite outcome was death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, as analyzed in the pooled empagliflozin group versus the placebo group. The key secondary composite outcome was the primary outcome plus hospitalization for unstable angina. A total of 7020 patients were treated (median observation time, 3.1 years). The primary outcome occurred in 490 of 4687 patients (10.5%) in the pooled empagliflozin group and in 282 of 2333 patients (12.1%) in the placebo group (hazard ratio in the empagliflozin group, 0.86; 95.02% confidence interval, 0.74 to 0.99; P=0.04 for superiority). There were no significant between-group differences in the rates of myocardial infarction or stroke, but in the empagliflozin group there were significantly lower rates of death from cardiovascular causes (3.7%, vs. 5.9% in the placebo group; 38% relative risk reduction), hospitalization for heart failure (2.7% and 4.1%, respectively; 35% relative risk reduction), and death from any cause (5.7% and 8.3%, respectively; 32% relative risk reduction). There was no significant between-group difference in the key secondary outcome (P=0.08 for superiority). Among patients receiving empagliflozin, there was an increased rate of genital infection but no increase in other adverse events. Patients with type 2 diabetes at high risk for cardiovascular events who received empagliflozin, as compared with placebo, had a lower rate of the primary composite cardiovascular outcome and of death from any cause when the study drug was added to standard care. (Funded by Boehringer Ingelheim and Eli Lilly; EMPA-REG OUTCOME ClinicalTrials.gov number, NCT01131676.).

A randomised controlled trial evaluating a rehabilitation complex intervention for patients following intensive care discharge: the RECOVER study

PubMed Central

Salisbury, Lisa G; Boyd, Julia; Ramsay, Pamela; Merriweather, Judith; Huby, Guro; Forbes, John; Rattray, Janice Z; Griffith, David M; Mackenzie, Simon J; Hull, Alastair; Lewis, Steff; Murray, Gordon D

2012-01-01

Introduction Patients who survive an intensive care unit admission frequently suffer physical and psychological morbidity for many months after discharge. Current rehabilitation pathways are often fragmented and little is known about the optimum method of promoting recovery. Many patients suffer reduced quality of life. Methods and analysis The authors plan a multicentre randomised parallel group complex intervention trial with concealment of group allocation from outcome assessors. Patients who required more than 48 h of mechanical ventilation and are deemed fit for intensive care unit discharge will be eligible. Patients with primary neurological diagnoses will be excluded. Participants will be randomised into one of the two groups: the intervention group will receive standard ward-based care delivered by the NHS service with additional treatment by a specifically trained generic rehabilitation assistant during ward stay and via telephone contact after hospital discharge and the control group will receive standard ward-based care delivered by the current NHS service. The intervention group will also receive additional information about their critical illness and access to a critical care physician. The total duration of the intervention will be from randomisation to 3 months postrandomisation. The total duration of follow-up will be 12 months from randomisation for both groups. The primary outcome will be the Rivermead Mobility Index at 3 months. Secondary outcomes will include measures of physical and psychological morbidity and function, quality of life and survival over a 12-month period. A health economic evaluation will also be undertaken. Groups will be compared in relation to primary and secondary outcomes; quantitative analyses will be supplemented by focus groups with patients, carers and healthcare workers. Ethics and dissemination Consent will be obtained from patients and relatives according to patient capacity. Data will be analysed according to a predefined analysis plan. Trial registration The trial is registered as ISRCTN09412438 and funded by the Chief Scientist Office, Scotland. PMID:22761291

Naked aggression: Personality and portfolio manager performance.

PubMed

Noe, Thomas; Vulkan, Nir

2018-01-01

We provide evidence that a personality trait, aggression, has a first-order effect on group financial decision making. In a laboratory experiment on group portfolio choice, highly aggressive subjects (measured by a standard psychology test) were much more likely to recommend risky investment strategies consistent with their own personal information, regardless of the information received by other group members. Outside of this group context, aggression had no effect on subject behavior. Thus, our aggression measure appears to capture an aggressive disposition, which seeks to dominate group decisions, rather than simply reflect risk attitudes or cognitive biases.

Measles virus antibody responses in children randomly assigned to receive standard-titer edmonston-zagreb measles vaccine at 4.5 and 9 months of age, 9 months of age, or 9 and 18 months of age.

PubMed

Martins, Cesario; Garly, May-Lill; Bale, Carlitos; Rodrigues, Amabelia; Njie-Jobe, Jainaba; Benn, Christine S; Whittle, Hilton; Aaby, Peter

2014-09-01

The World Health Organization recommends administration of measles vaccine (MV) at age 9 months in low-income countries. We tested the measles virus antibody response at 4.5, 9, 18, and 24 months of age for children randomly assigned to receive standard-titer Edmonston-Zagreb MV at 4.5 and 9 months, at 9 months, or at 9 and 18 months of age. At 4.5 months of age, 75% had nonprotective measles virus antibody levels. Following receipt of MV at 4.5 months of age, 77% (316/408) had protective antibody levels at 9 months of age; after a second dose at 9 months of age, 97% (326/337) had protective levels at 24 months of age. In addition, the response at both 9 and 24 months of age was inversely correlated with the antibody level at receipt of the first dose of MV, and the second dose of MV, received at 9 months of age, provided a significant boost in antibody level to children who had low antibody levels. In the group of 318 children who received MV at 9 months of age, with or without a second dose at 18 months of age, 99% (314) had protective levels at 24 months of age. The geometric mean titer at 24 months of age was significantly lower in the group that received MV at 4.5 and 9 months of age than in the group that received MV at 9 months of age (P = .0001). In conclusion, an early 2-dose MV schedule was associated with protective measles virus antibody levels at 24 months of age in nearly all children. Clinical Trials Registration. NCT00168558. © The Author 2014. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Risks of high-dose stimulants in the treatment of disorders of excessive somnolence: a case-control study.

PubMed

Auger, R Robert; Goodman, Scott H; Silber, Michael H; Krahn, Lois E; Pankratz, V Shane; Slocumb, Nancy L

2005-06-01

To ascertain complications associated with high-dose stimulant therapy in patients with narcolepsy or idiopathic hypersomnia. Case-control, retrospective chart review. Sleep center in an academic hospital. 116 patients with narcolepsy or idiopathic hypersomnia were individually matched by sex, diagnosis, age of onset, and duration of follow-up from both onset and diagnosis. Members of the high-dose group (n = 58) had received at least 1 stimulant at a dosage > or = 120% of the maximum recommended by the American Academy of Sleep Medicine Standards of Practice Committee. The standard-dose control group (n = 58) had received stimulants at a dosage < or = 100% of the American Academy of Sleep Medicine guidelines. N/A. The prevalence of psychosis (odds ratio = 12.0 [1.6-92.0]), alcohol or polysubstance misuse (odds ratio = 4.3 [1.2-15.2]), and psychiatric hospitalization (odds ratio = 3.2 [1.1-10.0]) was significantly increased in the high-dose group. More high-dose patients also experienced tachyarrhythmias (odds ratio = 3.3 [0.92-12.1] and anorexia or weight loss (odds ratio = 11.0 [1.4-85.2]). The frequency of physician-diagnosed depression, drug-seeking and suicide-related behaviors, hypertension, and cardiovascular disease did not differ significantly between the groups. This study demonstrated a significantly higher occurrence of psychosis, substance misuse, and psychiatric hospitalizations in patients using high-dose stimulants compared to those using standard doses. Tachyarrhythmias and anorexia or weight loss were also more common in this group as compared with controls. Clinicians should be very cautious in prescribing dosages that exceed maximum guidelines.

A multifaceted feedback strategy alone does not improve the adherence to organizational guideline-based standards: a cluster randomized trial in intensive care.

PubMed

de Vos, Maartje L G; van der Veer, Sabine N; Wouterse, Bram; Graafmans, Wilco C; Peek, Niels; de Keizer, Nicolette F; Jager, Kitty J; Westert, Gert P; van der Voort, Peter H J

2015-07-08

Organizational data such as bed occupancy rate and nurse-to-patient ratio are related to clinical outcomes and to the efficient use of intensive care unit (ICU) resources. Standards for these performance indicators are provided in guidelines. We studied the effects of a multifaceted feedback strategy to improve the adherence to these standards. In a cluster randomized controlled study design the intervention ICUs received extensive monthly feedback reports, they received outreach visits and initiated a quality improvement team. The control ICUs received limited quarterly feedback reports only. We collected primary data prospectively within the setting of a Dutch national ICU registry over a 14-month study period. The target indicators were bed occupancy rate (aiming at 80 % or below) and nurse-to-patient ratio (aiming at 0.5 or higher). Data were collected per 8-h nursing shift. Logistic regression analysis was performed. For both study end points, the odds ratios (OR) for improvements at follow-up versus at baseline were calculated separately for control and intervention ICUs. We analyzed data on 67,237 nursing shifts. The bed occupancy rate did not improve in the intervention group compared to baseline (adjusted OR 0.88; 95 % confidence interval (CI), 0.62-1.27) or compared to control group (OR 0.67; 95 % CI 0.39-1.15). The nurse-to-patient ratio did not improve (OR 0.72; 95 % CI 0.41-1.26 compared to baseline and OR 0.65; 95 % CI 0.35-1.19 compared to control group). A multifaceted feedback intervention did not improve the adherence to guideline-based standards on the organizational issues bed occupancy rate and nurse-to-patient ratio in the ICU. The reasons may be a limited confidence in data quality, the lack of practical tools for improvement, and the relatively short follow-up. ISRCTN50542146.

Comparison of intra-articular bupivacaine-morphine with bupivacaine-tenoxicam combinations on post-operative analgesia in patients with arthroscopic meniscectomy: a prospective, randomised study.

PubMed

Sanel, Selim; Arpaz, Osman; Unay, Koray; Turkmen, Ismail; Simsek, Selcuk; Ugutmen, Ender

2016-03-01

There are many alternatives for post-operative pain relief in patients who have had general anaesthesia. The aim of this study was to evaluate the efficacy of intra-articular bupivacaine + morphine and bupivacaine + tenoxicam applications in post-operative pain control in patients undergoing knee arthroscopy with general anaesthesia. This was a prospective study. Standard anaesthesia procedures were applied to each patient, and the 240 patients chosen at random were then divided into two groups. Each group received a different combination of drugs for this double-blind study. The first group (group A: 120 patients) received 0.5% bupivacaine 100 mg + tenoxicam 20 mg (22 ml); the second group (group B) received 0.5% bupivacaine 100 mg + morphine 2 mg (22 ml); both groups received their drugs at the end of the intra-articular operation before tourniquet deflation. Before the operation, patients were asked about their post-operative pain at particular periods over the following 24 hours using the visual analogue scale (VAS) and the numeric rating scale (NRS). An additional analgaesic requirement and possible side effects were also recorded. Group A patients needed analgaesics sooner after operation than patients in group B. In Group B, VAS and NRS values were statistically higher compared with group A at the 12th hour. There were also fewer side effects seen in group A versus group B. Effective and reliable results were obtained in post-operative pain control in bupivacaine added to the morphine or tenoxicam groups following arthroscopic meniscectomy. In the tenoxicam group, patients reported less pain, fewer side effects and less need for analgesics at 12 hours after the operation. level 1, therapeutic, randomised, multicentric study.

Elemental concentrations in kidney and liver of mice fed with cafeteria or standard diet determined by particle induced X-ray emission

NASA Astrophysics Data System (ADS)

Leffa, Daniela Dimer; dos Santos, Carla Eliete Iochims; Debastiani, Rafaela; Amaral, Livio; Yoneama, Maria Lucia; Dias, Johnny Ferraz; Andrade, Vanessa Moraes

2014-01-01

The importance of trace elements in human health is well known and their main source is daily diet. Nowadays, one of the biggest issues is the presence of these micronutrients in levels much higher than required, leading to potential toxic effects. The aim of this work was to investigate the elemental content in organs of mice fed with cafeteria or standard diet using PIXE. Twelve male Swiss mice were divided into two groups: control group (standard chow) and cafeteria group (high-caloric diet). After 17 weeks, samples of different organs (kidney and liver) were collected and prepared for PIXE analysis. The Fe concentration in kidney and liver was statistically higher in animals that received the cafeteria diet (p < 0.001). The Al and Si kidney contents were significantly higher for cafeteria diet in relation to standard diet (p < 0.05). Moreover, the standard diet showed significant differences for Cl and K (p < 0.05) in comparison to cafeteria diet in kidney, and for P, S and Zn (p < 0.005) in liver.

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study—A Two-Year Randomized Controlled Clinical Trial

PubMed Central

Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B.

2015-01-01

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (−11.3% versus −1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was −29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24. PMID:26257780

An Intensive Lifestyle Intervention Is an Effective Treatment of Morbid Obesity: The TRAMOMTANA Study-A Two-Year Randomized Controlled Clinical Trial.

PubMed

Burguera, Bartolomé; Jesús Tur, Juan; Escudero, Antonio Jorge; Alos, María; Pagán, Alberto; Cortés, Baltasar; González, Xavier Francesc; Soriano, Joan B

2015-01-01

Bariatric surgery is currently the most effective therapy to induce weight loss in morbidly obese patients. Objective. This controlled, clinical trial with a two-year intervention was aimed at comparing the efficacy of two nonsurgical approaches versus bariatric surgery, on body weight changes and metabolic parameters in morbidly obese patients. Methods. Patients were randomized to an Intensive Lifestyle Intervention (ILI) (n = 60) or Conventional Obesity Therapy (COT) (n = 46). The ILI group received behavioral therapy and nutritional counseling. The COT group received standard medical treatment. They were compared with a third group, Surgical Obesity Group (SOG) (n = 37). Results. Patients who received ILI had a greater percentage of weight loss than patients receiving COT (-11.3% versus -1.6%; p < 0.0044). Interestingly 31.4% of patients included in the ILI group were no longer morbidly obese after just six months of intervention, increasing to 44.4% after 24 months of intervention. The percentage weight loss in SOG was -29.6% after that same period of time. Conclusions. ILI was associated with significant weight loss when compared to COT, in a group of patients with obesity. An ILI approach could be an alternative therapy to patients with obesity, who are not candidates to undergo bariatric surgery. This trial is registered with EudraCT 2009-013737-24.

A Randomized, Open-Label, Multicenter, Phase III Study of Epoetin Alfa Versus Best Standard of Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy.

PubMed

Leyland-Jones, Brian; Bondarenko, Igor; Nemsadze, Gia; Smirnov, Vitaliy; Litvin, Iryna; Kokhreidze, Irakli; Abshilava, Lia; Janjalia, Mikheil; Li, Rubi; Lakshmaiah, Kuntegowda C; Samkharadze, Beka; Tarasova, Oksana; Mohapatra, Ranjan Kumar; Sparyk, Yaroslav; Polenkov, Sergey; Vladimirov, Vladimir; Xiu, Liang; Zhu, Eugene; Kimelblatt, Bruce; Deprince, Kris; Safonov, Ilya; Bowers, Peter; Vercammen, Els

2016-04-10

An open-label, noninferiority study to evaluate the impact of epoetin alfa (EPO) on tumor outcomes when used to treat anemia in patients receiving chemotherapy for metastatic breast cancer. Women with hemoglobin ≤ 11.0 g/dL, receiving first- or second-line chemotherapy for metastatic breast cancer, were randomly assigned to EPO 40,000 IU subcutaneously once a week or best standard of care. The primary end point was progression-free survival (PFS). Secondary end points included overall survival, time to tumor progression, overall response rate, RBC transfusions, and thrombotic vascular events. In 2,098 patients randomly assigned, median PFS (based on investigator-determined disease progression [PD]) was 7.4 months in both groups (hazard ratio [HR], 1.089; 95% CI, 0.988 to 1.200); upper bound exceeded prespecified noninferiority margin of 1.15. Median PFS per independent review committee-determined PD was 7.6 months in both groups (HR, 1.028; 95% CI, 0.922 to 1.146); upper bound did not exceed prespecified noninferiority margin. Median overall survival at clinical cutoff (1,337 deaths) was 17.2 months in the EPO and 17.4 months in the best standard of care group (HR, 1.057; 95% CI, 0.949 to 1.177), median time to tumor progression was 7.5 months in both groups (HR, 1.094; 95% CI, 0.991 to 1.209), and overall response rate was 50% versus 51% (odds ratio, 0.950; 95% CI, 0.799 to 1.130). RBC transfusions were 5.8% versus 11.4% (P < .001), and thrombotic vascular events were 2.8% versus 1.4% (P = .038), respectively. The primary end point, PFS based on investigator-determined PD, did not meet noninferiority criteria. As a consistency assessment with the primary finding, PFS based on independent review committee-determined PD met noninferiority criteria. Overall, this study did not achieve noninferiority objective in ruling out a 15% increased risk in PD/death. RBC transfusion should be the preferred approach for the management of anemia in this population. © 2016 by American Society of Clinical Oncology.

A Randomized Trial Comparing Acupuncture, Simulated Acupuncture, and Usual Care for Chronic Low Back Pain

PubMed Central

Cherkin, Daniel C.; Sherman, Karen J.; Avins, Andrew L.; Erro, Janet H.; Ichikawa, Laura; Barlow, William E.; Delaney, Kristin; Hawkes, Rene; Hamilton, Luisa; Pressman, Alice; Khalsa, Partap S.; Deyo, Richard A.

2009-01-01

Background Acupuncture is a popular complementary and alternative treatment for chronic back pain. Recent European trials suggest similar short-term benefits from real and sham acupuncture needling. This trial addresses the importance of needle placement and skin penetration in eliciting acupuncture effects for patients with chronic low back pain. Methods 638 adults with chronic mechanical low back pain were randomized to: individualized acupuncture, standardized acupuncture, simulated acupuncture, or usual care. Ten treatments were provided over 7 weeks by experienced acupuncturists. The primary outcomes were back-related dysfunction (Roland Disability score, range: 0 to 23) and symptom bothersomeness (0 to 10 scale). Outcomes were assessed at baseline and after 8, 26 and 52 weeks. Results At 8 weeks, mean dysfunction scores for the individualized, standardized, and simulated acupuncture groups improved by 4.4, 4.5, and 4.4 points, respectively, compared with 2.1 points for those receiving usual care (P<0.001). Participants receiving real or simulated acupuncture were more likely than those receiving usual care to experience clinically meaningful improvements on the dysfunction scale (60% vs. 39%, P<0.0001). Symptoms improved by 1.6 to 1.9 points in the treatment groups compared with 0.7 points in the usual care group (P<0.0001). After one year, participants in the treatment groups were more likely than those receiving usual care group to experience clinically meaningful improvements in dysfunction (59% to 65% versus 50%, respectively, P=0.02) but not in symptoms (P>0.05). Conclusions Although acupuncture was found effective for chronic low back pain, tailoring needling sites to each patient and penetration of the skin appear to be unimportant in eliciting therapeutic benefits. These findings raise questions about acupuncture’s purported mechanisms of action. It remains unclear whether acupuncture, or our simulated method of acupuncture, provide physiologically important stimulation or represent placebo or non-specific effects. PMID:19433697

The effect of antenatal lifestyle advice for women who are overweight or obese on secondary measures of neonatal body composition: the LIMIT randomised trial

PubMed Central

Dodd, Jodie M; Deussen, Andrea R; Mohomad, Izyan; Rifas-Shiman, Sheryl L; Yelland, Lisa N; Louise, Jennie; McPhee, Andrew J; Grivell, Rosalie M; Owens, Julie A; Gillman, Matthew W; Robinson, Jeffrey S

2016-01-01

Objective To evaluate the effect of providing antenatal dietary and lifestyle advice on neonatal anthropometry, and to determine the inter-observer variability in obtaining anthropometric measurements. Design Randomised controlled trial Setting Public maternity hospitals across metropolitan Adelaide, South Australia Population Pregnant women with a singleton gestation between 10+0–20+0, and body mass index (BMI) ≥25kg/m2. Methods Women were randomised to either Lifestyle Advice (comprehensive dietary and lifestyle intervention over the course of pregnancy including dietary, exercise and behavioral strategies, delivered by a research dietician and research assistants) or continued Standard Care. Analyses were conducted using intention to treat principles. Main Outcome Measures Secondary outcome measures for the trial included assessment of infant body composition using body circumference and skinfold thickness measurements (SFTM), percentage body fat, and bio-impedance analysis of fat free mass. Results Anthropometric measurements were obtained from 970 neonates (488 Lifestyle Advice Group, and 482 Standard Care Group). In 394 of these neonates (215 Lifestyle Advice Group, and 179 Standard Care Group) bio-impedance analysis was also obtained. There were no statistically significant differences identified between those neonates born to women receiving Lifestyle Advice and those receiving Standard Care, in terms of body circumference measures, SFTM, percentage body fat, fat mass, or fat free mass. The intra-class correlation coefficient for SFTM was moderate to excellent (ICC 0.55 to 0.88). Conclusions Among neonates born to women who are overweight or obese, anthropometric measures of body composition were not modified by an antenatal dietary and lifestyle intervention. PMID:26841217

[Timing of Brain Radiation Therapy Impacts Outcomes in Patients with 
Non-small Cell Lung Cancer Who Develop Brain Metastases].

PubMed

Wang, Yang; Fang, Jian; Nie, Jun; Dai, Ling; Hu, Weiheng; Zhang, Jie; Ma, Xiangjuan; Han, Jindi; Chen, Xiaoling; Tian, Guangming; Wu, Di; Han, Sen; Long, Jieran

2016-08-20

Radiotherapy combined with chemotherapy or molecular targeted therapy remains the standard of treatment for brain metastases from non-small cell lung cancer (NSCLC). The aim of this study is to determine if the deferral of brain radiotherapy impacts patient outcomes. Between May 2003 and December 2015, a total of 198 patients with brain metastases from NSCLC who received both brain radiotherapy and systemic therapy (chemotherapy or targeted therapy) were identified. The rate of grade 3-4 adverse reactions related to chemotherapy and radiotherapy had no significant difference between two groups. 127 patients received concurrent brain radiotherapy and systemic therapy, and 71 patients received deferred brain radiotherapy after at least two cycles of chemotherapy or targeted therapy. Disease specific-graded prognostic assessment was similar in early radiotherapy group and deferred radiotherapy group. Median overall survival (OS) was longer in early radiotherapy group compared to deferred radiotherapy group (17.9 months vs 12.6 months; P=0.038). Progression free survival (PFS) was also improved in patients receiving early radiotherapy compared to those receiving deferred radiotherapy (4.0 months vs 3.0 months; P<0.01). Receiving tyrosine kinase inhibitor (TKI) therapy after the diagnosis of brain metastases as any line therapy improved the OS (20.0 months vs 10.7 months; P<0.01), whereas receiving TKI as first line therapy did not (17.9 months vs 15.2 months; P=0.289). Our study suggests that the use of deferred brain radiotherapy may resulted in inferior OS in patients with NSCLC who develop brain metastases. A prospective multi-central randomized study is imminently needed.

Single-port video-assisted thoracoscopic wedge resection: novel approaches in different genders.

PubMed

Xu, Kai; Bian, Wen; Xie, Hongya; Ma, Haitao; Ni, Bin

2016-08-01

To discuss the feasibility, safety and superiority of novel approaches in single-port video-assisted thoracoscopic wedge resection in different genders. The clinical data of patients who underwent thoracoscopic pulmonary wedge resection were analysed. A total of 197 consecutive male patients from January 2012 to December 2014, and 72 female patients from June 2013 to December 2014 were included retrospectively. Of the males, 65 received a transareolar single-port procedure (TASP Group) and 132 received a standard two-port procedure (Standard Group A). Among the females, 18 were treated with a subxiphoid single-port procedure (SXSP Group), and 54 were treated with the standard procedure (Standard Group B). The general clinical materials and surgical outcomes were evaluated. All patients underwent total thoracoscopic wedge resection successfully, and no severe complications were observed. In men, there were no significant differences in operation time, blood loss, postoperative drainage amount, chest drainage duration, postoperative hospital stay or pain score on the first postoperative day (P = 0.827; 0.423; 0.174; 0.440; 0.115; 0.159, respectively). The pain scores of the TASP Group on the day before and after removal of the chest tube were lower (P = 0.006; 0.023, respectively) than those of Standard Group A, and the incision-associated paraesthesia in the third and sixth month after operation was reduced (P = 0.041; 0.026, respectively). The incision satisfaction degree was significantly improved in the TASP Group (P = 0.001). In women, there were no significant differences in blood loss, drainage amount, chest drainage duration or postoperative hospital stay (P = 0.680; 0.757; 0.651; 0.608, respectively). The operation time of the SXSP Group was longer (P = 0.000), and the pain scores on the first postoperative day and the days before and after removal were all significantly lower (P = 0.000; 0.000; 0.000, respectively) than those of the Standard Group B. Furthermore, the incision paraesthesia 3 and 6 months after surgery was greatly reduced (P = 0.001; 0.001, respectively), although the patients were not very satisfied with the cosmetic results (P = 0.577). In single-port thoracoscopic pulmonary wedge resection, we performed 'individualized' procedures based on gender, namely, the transareolar approach in males and the subxiphoid approach in females. These procedures were considered feasible and safe, and showed superiority in reducing postoperative pain. However, the cosmetic results of the subxiphoid approach require further improvement. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

The comparison of the effects of standard 20 mg atorvastatin daily and 20 mg atorvastatin every other day on serum LDL-cholesterol and high sensitive C-reactive protein levels.

PubMed

Keleş, Telat; Akar Bayram, Nihal; Kayhan, Tuğba; Canbay, Alper; Sahin, Deniz; Durmaz, Tahir; Ozdemir, Ozcan; Aydoğdu, Sinan; Diker, Erdem

2008-12-01

In this study, we aimed at comparing the effects of standard once daily 20 mg atorvastatin treatment with that of atorvastatin 20 mg administered every other day on serum lipids and high sensitive C-reactive protein (hs-CRP) levels. Sixty-one patients with serum total cholesterol levels of above 200 mg/dl and low density lipoprotein (LDL)--cholesterol levels of above 130 mg/dl were included in this prospective, randomized study. The patients were randomized into daily treatment of 20 mg atorvastatin (standard treatment) and 20 mg atorvastatin every other day (every other day treatment) groups. Before the treatment and at each visit, serum lipids and hs-CRP levels of all the patients were measured. Statistical analyses were performed Chi-square, unpaired t and two-way repeated measurements ANOVA tests. In the every other day treatment group, there was a 36.1% reduction in LDL-cholesterol levels by the end of first month (p<0.01). At the end of three months there was further decrease of 10.2% in LDL-cholesterol levels when compared to 1 month levels (p>0.05). The LDL cholesterol levels of the group receiving 20 mg atorvastatin every day was reduced by %41 by the end of 1 month (p<0.01). At the end of three months, the difference between the changes in the all lipid parameters of the two groups was not found to be of statistical significance. In the group receiving the medication every other day, there was a 21% decrease in hs-CRP levels compared to the basal measurements at the end of first month (p<0.05). In the group, receiving the medication every day the decrease in hs-CRP levels at the end of one month was more striking (37%, p<0.05). However, the effects of both treatment arms on hs-CRP levels, did not differ significantly (p>0.05). Alternate-day dosing of atorvastatin causes a significant lipid-lowering and antiinflammatory effects similar to that of daily administration and yet may provide some cost savings.

Role of the bacterial vaccine Solco-Urovac® in treatment and prevention of recurrent urinary tract infections of bacterial origin.

PubMed

Kochiashvili, D; Khuskivadze, A; Kochiashvili, G; Koberidze, G; Kvakhajelidze, V

2014-06-01

Urinary Tract Infections (UTI) represent a serious medical problem with considerably high rate of morbidity. Recurrent episodes of urinary tract infection (rUTI) may commonly develop in the way of relapse or reinfection. For patients, rUTI is always associated with costs, discomfort and decreased quality of life. Standard treatment of rUTI is through antibiotics and usually such treatment is required repeatedly. Repeat course of antibiotics leads to increase of resistance of uropathogenic strains. According to the European Association of Urology, "the present state of microbial resistance development is alarming". Our post-marketing trial was designed to demonstrate the substantial effect of the bacterial vaccine Solco-Urovac® both with independent administration and in conjunction with standard antibacterial medication within therapy and prevention of rUTI. Total of 115 patients (men and non-pregnant women) were enrolled in our open-label post-marketing trial. Each patient had more than one year history of rUTI and in the past had already taken appropriate course of standard therapy. The trial group included 50 patients: 32 men, 18 women (average age ± 32.5). 32 patients (men) of the trial group received vaccination with Solco-Urovac® together with the standard antibacterial medication. According to bacteriologic tests, in 62% cases infection was caused by Escherichia coli, and in 38% cases by Morganella morganii, Proteus mirabilis, Klebsiella pneumoniae, Enterococcus faecalis. 18 patients within the trial group were women with no recurrence episode at the start and during the trial period. Each woman was involved as the intercourse partner of the respective man within the trial group. The women received only vaccination with Solco-Urovac®. 65 patients of the control group had more than one year history of rUTI and had been treated earlier, too. Patients of the control group received appropriate antibacterial medication without Solco-Urovac®. After therapy and follow-up examination, results in the both groups were classified, also in consideration of the pathogen-specified subgroups, and then summarized and compared respectively. During the follow-up period no case of rUTI was noticed in women. In total, analysis of the medical records of 50 patients of the trial group demonstrated no case of rUTI in 46 patients during the follow-up period. Altogether, the rate of improvement of symptoms was as follows: the trial group - 92%, the control group - 74%. Through comparison with the past medical histories of patients, the higher rate of improvement and longer absence of rUTI episodes after treatment were certainly associated with the effect of Solco-Urovac®. The results of our post-marketing trial allow recommending Solco-Urovac® for appropriate reference within the Georgian National Guideline on Urologic Infections.

Petrography and physical properties of selected rock types associated with the Hayward Fault, California

USGS Publications Warehouse

Moore, Diane E.; Ponce, David A.

2001-01-01

A larger group of samples, most of them 1"-diameter cores, on which density and magnetic susceptibility measurements were made as part of gravity and magnetic surveys of the Hayward Fault. Because this second group of samples received less extensive laboratory study, examination of them was limited to standard petrographic microscope examination of covered thin sections. The density and susceptibility measurements of this second group of samples are included in this report.

Pharmacokinetics and Analgesic Effects of Methadone in Children and Adults with Sickle Cell Disease

PubMed Central

Horst, Jennifer; Frei-Jones, Melissa; Deych, Elena; Shannon, William; Kharasch, Evan D.

2017-01-01

Background Vaso-occlusive episodes (VOE) are a significant source of morbidity among children and adults with sickle cell disease (SCD). There is little information on methadone use for SCD pain. This investigation evaluated methadone pharmacokinetics in children and adults with SCD, with a secondary aim to assess pain relief and opioid consumption. Procedure Participants included children (<18 yr) and adults with a VOE requiring hospitalization. Patients were randomly assigned to receive standard care (opioid patient controlled analgesia; control group) or one dose of intravenous methadone (0.1–0.125 mg/kg) in addition to standard care (methadone group). Venous methadone and metabolite concentrations were measured. Pain scores, pain relief scores, and opioid consumption were recorded. Results Twenty-four children (12 methadone, 12 controls) and twenty-three adults (11 methadone, 12 controls) were studied. In children, the half-life of R-and S-methadone enantiomers was 34±16 and 24±9 hr, respectively. In adults, R- and S-methadone half-lives were 52±17 and 38±12 hr. Pain scores were lower (p=0.002) and pain relief scores were higher (p=0.0396) in children receiving methadone vs controls. There was no difference in pain scores and pain relief in adults receiving methadone vs controls. There was no difference in opioid consumption between methadone and control groups, in both adults and children. Conclusions Intravenous methadone disposition in children and adults with SCD was comparable to subjects without SCD from prior studies. Methadone produced more pain relief than standard care in children with SCD. Higher methadone doses may be more effective and should be evaluated in both children and adults with SCD. PMID:27572136

Effect of a decision aid with patient narratives in reducing decisional conflict in choice for surgery among early-stage breast cancer patients: A three-arm randomized controlled trial.

PubMed

Osaka, Wakako; Nakayama, Kazuhiro

2017-03-01

We aimed to evaluate the effect of a decision aid (DA) with patient narratives on decisional conflict in surgery choice for Japanese women with early-stage breast cancer. Two hundred ten women with early-stage breast cancer were randomly assigned to an intervention or control group. Groups 1 and 2 received standard information and a DA, with or without patient narratives, and Group 3 received standard information (control) before surgery choice. At baseline, post-intervention (Time 2), and 1 month after surgery (Time 3), we evaluated decisional conflict as the primary outcome using a decisional conflict scale (DCS). Sidak corrections for multiple comparisons in analysis of covariate were used to compare Time 2 and Time 3 DCS mean scores between each pair of groups. At Time 3, decisional conflict was significantly reduced for Group 1 vs control (P=0.021, Cohen's d =0.26) and Group 2 vs control (P=0.008, Cohen's d=0.40). The DAs with and without patient narratives are equivalently effective at reducing postoperative decisional conflict in Japanese women with early-stage breast cancer. The DAs with and without patient narratives can be used in clinical practice for women with early-stage breast cancer. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The efficacy and safety of lixivaptan in outpatients with heart failure and volume overload: results of a multicentre, randomized, double-blind, placebo-controlled, parallel-group study.

PubMed

Ghali, Jalal K; Orlandi, Cesare; Abraham, William T

2012-06-01

Volume overload is the dominant feature of decompensated heart failure (HF) and it often results in adverse clinical outcomes. Vasopressin receptor antagonists such as lixivaptan may provide effective volume unloading. This study assessed weight loss after 1 day and 8 weeks of treatment with lixivaptan in outpatients with HF and volume overload. This phase II, 8-week, multicentre, double-blind, parallel-group study randomized participants (2:1) to receive lixivaptan 100 mg or placebo once daily (in addition to standard HF therapy). Body weight and cardiovascular assessments were made at baseline, Day 1 (not cardiovascular), Weeks 1, 2, 4, and 8, and 7 days post-treatment. The Trail-making Test, part B (TMT-B) and the Medical Outcomes Survey 6-item cognitive function scale (MOS-6) were assessed at baseline and Week 4. The study randomized 170 participants (lixivaptan, n = 111; placebo, n = 59). Most (97.1%) were receiving pharmacological therapy for HF at baseline. Demographic characteristics were generally similar between the two groups. Body weight decreased significantly from baseline to Day 1 with lixivaptan vs. placebo (least-square mean change ± standard error: - 0.38 ± 0.08 kg vs. +0.13 ± 0.11 kg; P < 0.001) and at Weeks 1, 2, and 4 (P < 0.01). Cardiovascular changes were generally similar in both groups, though orthopnoea and dyspnoea improved in the lixivaptan group vs. placebo. The TMT-B and MOS-6 showed no significant differences between groups. Lixivaptan was well tolerated-thirst and polyuria occurred more frequently vs. placebo. In outpatients with HF and volume overload, lixivaptan 100 mg once daily, when added to standard therapy, reduced body weight, improved dyspnoea and orthopnoea, and was well tolerated. NCT01055912.

Randomized clinical trial of arginine-supplemented enteral nutrition versus standard enteral nutrition in patients undergoing gastric cancer surgery.

PubMed

Zhao, Hongyan; Zhao, Hongying; Wang, Yu; Jing, Huang; Ding, Qian; Xue, Jun

2013-09-01

Significant malnutrition exists in a high percentage of patients with gastric cancer. It is, therefore, crucial to establish an effective means to provide nutrition for these patients. This prospective, randomized, double-blinded clinical trial aims to assess the long-term survival of arginine-supplementation enteral nutrition versus standard enteral nutrition in malnourished patients with gastric cancer. The control group (36 cases) received postoperative standard enteral nutrition. Meanwhile, the arginine-supplementation group (37 cases) adopted the same nutrition product but enriched with arginine (9.0 g/L). The primary study objective was overall survival (OS). Secondary endpoints were progression-free survival (PFS); serum parameters including total protein, albumin, proalbumin, and transferrin obtained on preoperative day 1, postoperative day 2, and day 12; CD4(+) and CD8(+) T cells, natural killer (NK) cells, immunoglobulin M (IgM), and immunoglobulin G (IgG) obtained on preoperative day 1 and postoperative day 7. No significant differences in baseline characteristics were observed between groups. The group receiving arginine-enriched nutrition had a significantly better OS (P = 0.03, 41 vs. 30.5 months) and better PFS (P = 0.02, 18 vs. 11.5 months). On postoperative day 7, CD4(+) T cells, NK cells, IgM and IgG levels of the arginine-supplemented group increased prominently and were significantly higher than those of the control group and those on preoperative day 1. There is no significant difference in the serum total protein, albumin, proalbumin, and transferrin levels between the two arms. Arginine-supplemented enteral nutrition significantly improves long-term survival and restores immunity in malnourished gastric cancer.

Immunomodulatory activity of methanolic leaf extract of Moringa oleifera in Wistar albino rats

PubMed Central

Nfambi, Joshua; Bbosa, Godfrey S.; Sembajwe, Lawrence Fred; Gakunga, James; Kasolo, Josephine N.

2015-01-01

Background Globally, Moringa oleifera is used by different communities to treat various ailments including modulation of the immune system though with limited scientific evidence. Aim To study the immunomodulatory activity of M. oleifera methanolic leaf extract in Wistar albino rats. Methods An experimental laboratory-based study was done following standard methods and procedures. Nine experimental groups (I, II, III, IV, V, VI, VII, VIII, IX) each comprising of six animals were used. Group I received normal saline. Groups II to IX received 200 mg/kg bwt cyclophosphamide at the beginning of the study. Group III received 50 mg/kg bwt of an immunostimulatory drug levamisole. Groups IV to IX were dosed daily for 14 days with extract at doses of 250, 500, and 1000 mg/kg bwt, respectively, using an intragastric tube. Complete blood count (CBC), delayed-type hypersensitivity reaction (DTH), neutrophil adhesion test, and hemagglutination antibody titer were determined using standard methods and procedures. Statistical analysis was performed using GraphPad prism 5.0a Software. Results There was an increment in WBC, lymphocyte, and neutrophil counts at a dose of 1000 mg/kg bwt similar to the levamisole-positive control group. The neutrophil adhesion was statistically significant (p ≤ 0.05) for treatment groups that received 1000 mg/kg bwt (29.94%) and 500 mg/kg bwt at 17.28%. The mean percentage increment in footpad thickness was highest (26.9%) after 8 h of injection of antigen in the footpad of rats dosed 500 mg/kg bwt and this later reduced to 25.6% after 24 h. There was a dose-dependent increment in the mean hemagglutination antibody titer to sheep red blood cells (SRBC) from 10.73±0.57 HA units/μL for the 250 mg/kg bwt to 26.22±1.70 HA units/μL for the 1000 mg/kg bwt. Conclusions Methanolic leaf extract of M. oleifera caused a significant immunostimulatory effect on both the cell-mediated and humoral immune systems in the Wistar albino rats. PMID:26103628

Immunomodulatory activity of methanolic leaf extract of Moringa oleifera in Wistar albino rats.

PubMed

Nfambi, Joshua; Bbosa, Godfrey S; Sembajwe, Lawrence Fred; Gakunga, James; Kasolo, Josephine N

2015-11-01

Globally, Moringa oleifera is used by different communities to treat various ailments including modulation of the immune system though with limited scientific evidence. The aim was to study the immunomodulatory activity of M. oleifera methanolic leaf extract in Wistar albino rats. An experimental laboratory-based study was done following standard methods and procedures. Nine experimental groups (I, II, III, IV, V, VI, VII, VIII, IX) each comprising of six animals were used. Group I received normal saline. Groups II to IX received 200 mg/kg bwt cyclophosphamide at the beginning of the study. Group III received 50 mg/kg bwt of an immunostimulatory drug levamisole. Groups IV to IX were dosed daily for 14 days with extract at doses of 250, 500, and 1000 mg/kg bwt, respectively, using an intragastric tube. Complete blood count (CBC), delayed-type hypersensitivity reaction (DTH), neutrophil adhesion test, and hemagglutination antibody titer were determined using standard methods and procedures. Statistical analysis was performed using GraphPad prism 5.0a Software. There was an increment in WBC, lymphocyte, and neutrophil counts at a dose of 1000 mg/kg bwt similar to the levamisole-positive control group. The neutrophil adhesion was statistically significant (p≤0.05) for treatment groups that received 1000 mg/kg bwt (29.94%) and 500 mg/kg bwt at 17.28%. The mean percentage increment in footpad thickness was highest (26.9%) after 8 h of injection of antigen in the footpad of rats dosed 500 mg/kg bwt and this later reduced to 25.6% after 24 h. There was a dose-dependent increment in the mean hemagglutination antibody titer to sheep red blood cells (SRBC) from 10.73±0.57 HA units/μL for the 250 mg/kg bwt to 26.22±1.70 HA units/μL for the 1000 mg/kg bwt. Methanolic leaf extract of M. oleifera caused a significant immunostimulatory effect on both the cell-mediated and humoral immune systems in the Wistar albino rats.

A new prototype of an electronic jet-ventilator and its humidification system

PubMed Central

Kraincuk, Paul; Kepka, Anton; Ihra, Gerald; Schabernig, Christa; Aloy, Alexander

1999-01-01

Background: Adequate humidification in long-term jet ventilation is a critical aspect in terms of clinical safety. Aim: To assess a prototype of an electronic jet-ventilator and its humidification system. Methods: Forty patients with respiratory insufficiency were randomly allocated to one of four groups. The criterion for inclusion in this study was respiratory insufficiency exhibiting a Murray score above 2. The four groups of patients were ventilated with three different respirators and four different humidification systems. Patients in groups A and B received superimposed high-frequency jet ventilation (SHFJV) by an electronic jet-ventilator either with (group A) or without (group B) an additional humidification system. Patients in group C received high-frequency percussive ventilation (HFPV) by a pneumatic high-frequency respirator, using a hot water humidifier for warming and moistening the inspiration gas. Patients in group D received conventional mechanical ventilation using a standard intensive care unit respirator with a standard humidification system. SHFJV and HFPV were used for a period of 100 h (4days). Results: A significantly low inspiration gas temperature was noted in patients in group B, initially (27.2 ± 2.5°C) and after 2 days (28.0 ± 1.6°C) (P < 0.05). The percentage of relative humidity of the inspiration gas in patients in group B was also initially significantly low (69.8 ± 4.1%; P < 0.05) but rose to an average of 98 ± 2.8% after 2 h. The average percentage across all four groups amounted to 98 ± 0.4% after 2 h. Inflammation of the tracheal mucosa was found in patients in group B and the mucosal injury score (MIS) was significantly higher than in all the other groups. Patients in groups A, C and D showed no severe evidence of airway damage, exhibiting adequate values of relative humidity and temperature of the inspired gas. Conclusion: The problems of humidification associated with jet ventilation can be fully prevented by using this new jet-ventilator. These data were sustained by nondeteriorating MIS values at the end of the 4-day study period in groups A, C and D. PMID:11056732

Comparison of ultrarapid and rapid intravenous hydration in pediatric patients with dehydration.

PubMed

Nager, Alan L; Wang, Vincent J

2010-02-01

The purpose of this study is to test the efficacy of ultrarapidly infused vs rapidly infused intravenous (IV) hydration in pediatric patients with acute gastroenteritis and moderate dehydration. Patients 3 to 36 months, with vomiting and/or diarrhea and moderate dehydration, were eligible. Subjects were randomly assigned "ultra" (50 mL/kg normal saline for 1 hour) vs "standard" (50 mL/kg normal saline for 3 hours) after failing an oral fluid challenge. Subjects were weighed and had serum electrolyte testing, and urine was obtained before/after IV hydration. Input/output and vital signs were tabulated hourly during the study. Subjects were discharged after fulfilling specified criteria. A follow-up questionnaire was completed 24 hours after discharge. Comparison data included success and timing of rehydration, number of patients who returned and/or were admitted, output during the rehydration period, laboratory differences, and serious complications. Eighty-eight of 92 subjects completed the study: 45 ultra and 43 standard. Four patients failed treatment (1 ultra and 3 standard), were hospitalized, and excluded from the study. Groups were similar regarding sex, days of symptoms, episodes of vomiting/diarrhea before treatment, capillary refill time, tears, and vital signs and laboratory results. No subject had evidence of serious complications. Ninety-one percent of subjects completed the follow-up questionnaire. Seven ultra and 6 standard subjects returned. Six ultra subjects received oral fluid, one received IV fluid, and all were discharged. Five standard subjects received oral fluid, one received IV fluid, and all were discharged. Based on this pilot study, ultrarapid hydration for 1 hour preliminarily appears to be an efficacious alternative to standard rapid hydration for 3 hours and improves emergency department throughput time. Copyright 2010 Elsevier Inc. All rights reserved.

Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial

PubMed Central

Garcia, Hector H; Gonzales, Isidro; Lescano, Andres G; Bustos, Javier A; Zimic, Mirko; Escalante, Diego; Saavedra, Herbert; Gavidia, Martin; Rodriguez, Lourdes; Najar, Enrique; Umeres, Hugo; Pretell, E Javier

2014-01-01

Summary Background Neurocysticercosis causes a substantial burden of seizure disorders worldwide. Treatment with either praziquantel or albendazole has suboptimum efficacy. We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures. We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations. Methods In this double-blind, placebo-controlled, phase 3 trial, patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole (15 mg/kg per day) plus praziquantel (50 mg/kg per day), standard albendazole (15 mg/kg per day), or increased dose albendazole (22·5 mg/kg per day). Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug. Patients and investigators were masked to group assignment. The primary outcome was complete cyst resolution on 6-month MRI. Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group. Analysis excluded patients lost to follow-up before the 6-month MRI. This trial is registered with ClinicalTrials.gov, number NCT00441285. Findings Between March 3, 2010 and Nov 14, 2011, 124 patients were randomly assigned to study groups (41 to receive combined albendazole plus praziquantel [39 analysed], 43 standard albendazole [41 analysed], and 40 increased albendazole [38 analysed]). 25 (64%) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 (37%) of 41 patients in the standard albendazole group (rate ratio [RR] 1·75, 95% CI 1·10–2·79, p=0·014). 20 (53%) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 (37%) of 41 patients in the standard albendazole group (RR 1·44, 95% CI 0·87–2·38, p=0·151). No significant differences in adverse events were reported between treatment groups (18 in combined treatment group, 11 in standard albendazole group, and 19 in increased albendazole group). Interpretation Combination of albendazole plus praziquantel increases the parasiticidal effect in patients with multiple brain cysticercosis cysts without increased side-effects. A more efficacious parasiticidal regime without increased treatment-associated side-effects should improve the treatment and long term prognosis of patients with neurocysticercosis. Funding National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health. PMID:24999157

Efficacy of combined antiparasitic therapy with praziquantel and albendazole for neurocysticercosis: a double-blind, randomised controlled trial.

PubMed

Garcia, Hector H; Gonzales, Isidro; Lescano, Andres G; Bustos, Javier A; Zimic, Mirko; Escalante, Diego; Saavedra, Herbert; Gavidia, Martin; Rodriguez, Lourdes; Najar, Enrique; Umeres, Hugo; Pretell, E Javier

2014-08-01

Neurocysticercosis causes a substantial burden of seizure disorders worldwide. Treatment with either praziquantel or albendazole has suboptimum efficacy. We aimed to establish whether combination of these drugs would increase cysticidal efficacy and whether complete cyst resolution results in fewer seizures. We added an increased dose albendazole group to establish a potential effect of increased albendazole concentrations. In this double-blind, placebo-controlled, phase 3 trial, patients with viable intraparenchymal neurocysticercosis were randomly assigned to receive 10 days of combined albendazole (15 mg/kg per day) plus praziquantel (50 mg/kg per day), standard albendazole (15 mg/kg per day), or increased dose albendazole (22·5 mg/kg per day). Randomisation was done with a computer generated schedule balanced within four strata based on number of cysts and concomitant antiepileptic drug. Patients and investigators were masked to group assignment. The primary outcome was complete cyst resolution on 6-month MRI. Enrolment was stopped after interim analysis because of parasiticidal superiority of one treatment group. Analysis excluded patients lost to follow-up before the 6-month MRI. This trial is registered with ClinicalTrials.gov, number NCT00441285. Between March 3, 2010 and Nov 14, 2011, 124 patients were randomly assigned to study groups (41 to receive combined albendazole plus praziquantel [39 analysed], 43 standard albendazole [41 analysed], and 40 increased albendazole [38 analysed]). 25 (64%) of 39 patients in the combined treatment group had complete resolution of brain cysts compared with 15 (37%) of 41 patients in the standard albendazole group (rate ratio [RR] 1·75, 95% CI 1·10-2·79, p=0·014). 20 (53%) of 38 patients in the increased albendazole group had complete cyst resolution at 6-month MRI compared with 15 (37%) of 41 patients in the standard albendazole group (RR 1·44, 95% CI 0·87-2·38, p=0·151). No significant differences in adverse events were reported between treatment groups (18 in combined treatment group, 11 in standard albendazole group, and 19 in increased albendazole group). Combination of albendazole plus praziquantel increases the parasiticidal effect in patients with multiple brain cysticercosis cysts without increased side-effects. A more efficacious parasiticidal regime without increased treatment-associated side-effects should improve the treatment and long term prognosis of patients with neurocysticercosis. National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health. Copyright © 2014 Elsevier Ltd. All rights reserved.

The effect of Kombucha on post-operative intra-abdominal adhesion formation in rats.

PubMed

Maghsoudi, Hemmat; Mohammadi, Hussein Benagozar

2009-04-01

Peritoneal adhesions are fibrous bands of tissues formed between organs that are normally separated and/or between organs and the internal body wall after peritoneal injury. The aim of the study was to investigate the effect of intra-peritoneal administration of Kombucha on intra-peritoneal adhesions. Eighty Wistar rats were subjected to standardized lesion by scraping model and were randomly divided into two groups. Group I received no treatment, and Group II received 15 ml of Kombucha solution intra-peritoneally. On the post-operative 14th day adhesion intensity score, inflammatory cell reaction and number of adhesion bands were determined. In the control group, there were no rats with grade 0 and I adhesions. In the group II, there were 26 rats (78.8%) with grade 0-2 adhesions. Adhesion intensity was significantly less in group II (P<0.0001). Number of adhesion bands was significantly less in group II (P<0.001). It was concluded that intra-peritoneal administration of Kombucha might be useful for preventing peritoneal adhesions.

A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

PubMed

Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

2009-12-01

A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

Group treatment for depression in mothers of young children compared to standard individual therapy.

PubMed

Frisch, Ulrike; Hofecker-Fallahpour, Maria; Stieglitz, Rolf-Dieter; Riecher-Rössler, Anita

2013-01-01

Studies on specific psychotherapy for depressed mothers of small children are rare. The aim of the present study was to investigate the effectiveness of a newly developed cognitive-behavioral group intervention for depressed mothers compared to standard individual therapy. In a naturalistic design, 31 mothers suffering from depressive disorders with children aged ≤4 years who had consecutively been admitted to our specialized clinic for mentally ill mothers were assigned to the group treatment, and the following 21 were admitted to the control group receiving standard individual therapy. The group treatment consisted of 12 group sessions and 1 couple session and was administered to five consecutive groups. Participants completed interviews and questionnaires - the Beck Depression Inventory and the Symptom Checklist- 90-R - before and 3 months after therapy. The treatment group and the control group showed a significant improvement in their depression, with no significant differences between the two treatment strategies. The women in group therapy, however, required fewer antidepressants, and group treatment was observed to be more effective in reducing anger and hostility. This form of group treatment for depressed women in early motherhood may have some important advantages over individual therapy; effects were small, however, and should be replicated in a further study. Copyright © 2012 S. Karger AG, Basel.

Effects of substituting a portion of standard physiotherapy time with virtual reality games among community-dwelling stroke survivors.

PubMed

Singh, Devinder Kaur Ajit; Mohd Nordin, Nor Azlin; Abd Aziz, Noor Azah; Lim, Beng Kooi; Soh, Li Ching

2013-12-13

Evidence indicates that the continuation of therapy among community-dwelling stroke survivors improves physical function. Community rehabilitation programmes often face limitations in terms of resources. It is imperative to include new motivational interventions to encourage some level of non-clinician management. The aim of this study was to determine whether there were any changes in physical function and activities of daily living when substituting a portion of the standard physiotherapy time with virtual reality games among community-dwelling stroke survivors. In this controlled trial, the experimental group received 30 minutes of virtual reality balance games in addition to 90 minutes of standard physiotherapy. The control group continued with their two hours of routine standard physiotherapy. Both groups received 12 therapy sessions: two-hour sessions twice per week for six continuous weeks. Changes in physical function, activities of daily living and balance ability were assessed using the Timed Up and Go test, 30-second Sit to Stand test, Timed Ten-Metre Walk test, Six-Minute Walk test and the Barthel Index, and static balance was assessed using a probalance board. Twenty-eight participants completed post-intervention assessments. The results showed a significant within-subject effect on the Timed Up and Go test: F (1, 26) = 5.83, p = 0.02; and the 30-second Sit to Stand test; F (1, 26) = 13.50, p = 0.001. The between-subject effect was not significant (p > 0.05) for any of the outcome measurements. Substituting a portion of the standard physiotherapy time with virtual reality games was equally effective in maintaining physical function outcomes and activities of daily living among community-dwelling stroke survivors. Australia and New Zealand Clinical Trials Register, ACTRN12613000478718.

Teaching cross-cultural communication skills online: a multi-method evaluation.

PubMed

Lee, Amy L; Mader, Emily M; Morley, Christopher P

2015-04-01

Cultural competency education is an important and required part of undergraduate medical education. The objective of this study was to evaluate whether an online cross-cultural communication module could increase student use of cross-cultural communication questions that assess the patient's definition of the problem, the way the problem affects their life, their concerns about the problem, and what the treatment should be (PACT). We used multi-method assessment of students assigned to family medicine clerkship blocks that were randomized to receive online cultural competency and PACT training added to their standard curriculum or to a control group receiving the standard curriculum only. Outcomes included comparison, via analysis of variance, of number of PACT questions used during an observed Standardized Patient Exercise, end-of-year OSCE scores, and qualitative analysis of student narratives. Students (n=119) who participated in the online module (n=60) demonstrated increased use of cross-cultural communication PACT questions compared to the control group (n=59) and generally had positive themes emerge from their reflective writing. The module had the biggest impact on students who later went on to match in high communication specialties. Online teaching of cross-cultural communication skills can be effective at changing medical student behavior.

Improved meal presentation increases food intake and decreases readmission rate in hospitalized patients.

PubMed

Navarro, Daniela Abigail; Boaz, Mona; Krause, Ilan; Elis, Avishay; Chernov, Karina; Giabra, Mursi; Levy, Miriam; Giboreau, Agnes; Kosak, Sigrid; Mouhieddine, Mohamed; Singer, Pierre

2016-10-01

Reduced food intake is a frequent problem at a hospital setting, being a cause and/or consequence of malnutrition. Food presentation can affect food intake and induce nutritional benefit. To investigate the effect of improved meal presentation supported by gastronomy expertise on the food intake in adults hospitalized in internal medicine departments. Controlled before and after study. Two hundred and six newly hospitalized patients in internal medicine departments were included and divided in two groups, a) control: receiving the standard lunch from the hospital and b) experimental: receiving a lunch improved in terms of presentation by the advices received by the Institut Paul Bocuse, Ecully, Lyon, France together with the hospital kitchen of the Beilinson Hospital, without change in the composition of the meal. The amount of food left at the participants' plates was estimated using the Digital Imaging Method, which consisted in photographing the plates immediately to previous tray collection by the researcher. In addition, the nutritionDay questionnaire was used to measure other variables concerned to their food intake during hospitalization. Charlson Comorbidity Index was calculated. There was no significant difference between the groups regarding demography or Charlson Comorbidity Index. Patients who received the meal with the improved presentation showed significantly higher food intake than those who received the standard meal, despite reported loss in appetite. Participants from the experimental group left on their plate less starch (0.19 ± 0.30 vs. 0.52 + 0.41) (p < 0.05) and less from the main course than the control group (0.18 + 0.31 vs. 0.46 + 0.41) (p < 0.05). However, both of the groups left the same amount of vegetables (0.37 + 0.36 vs. 0.29 + 0.35) (p > 0.05). Both of the groups were asked how hungry they were before the meal and no significance was shown. More participants from the experimental group reported their meal to be tasty in comparison to those in the control group (49.5% vs. 33.7% p < 0.005). Length of stay was not different but readmission rate decreased significantly in the study group (p < 0.02) from 31.2% to 13.5%. Improvement of meal presentation at a hospital setting can increase food intake, reduce waste food substantially and reduce readmission rate to hospital. Copyright © 2015 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

Tomato (Lycopersicon esculentum) or lycopene supplementation attenuates ventricular remodeling after myocardial infarction through different mechanistic pathways.

PubMed

Pereira, Bruna L B; Reis, Patrícia P; Severino, Fábio E; Felix, Tainara F; Braz, Mariana G; Nogueira, Flávia R; Silva, Renata A C; Cardoso, Ana C; Lourenço, Maria A M; Figueiredo, Amanda M; Chiuso-Minicucci, Fernanda; Azevedo, Paula S; Polegato, Bertha F; Okoshi, Katashi; Fernandes, Ana A H; Paiva, Sergio A R; Zornoff, Leonardo A M; Minicucci, Marcos F

2017-08-01

The objective of this study was to evaluate the influence of tomato or lycopene supplementation on cardiac remodeling after myocardial infarction (MI). Male Wistar rats were assigned to four groups: the sham group (animals that underwent simulated surgery) that received a standard chow (S; n=18), the infarcted group that received a standard chow (MI; n=13), the infarcted group supplemented with lycopene (1 mg of lycopene/kg body weight/day) (MIL; n=16) and the infarcted group supplemented with tomato (MIT; n=16). After 3 months, morphological, functional and biochemical analyses were performed. The groups MIL and MIT showed decreased interstitial fibrosis induced by infarction. Tomato supplementation attenuated the hypertrophy induced by MI. In addition, tomato and lycopene improved diastolic dysfunction evaluated by echocardiographic and isolated heart studies, respectively. The MI group showed higher levels of cardiac TNF-α compared to the MIL and MIT groups. Decreased nuclear factor E2-related factor 2 was measured in the MIL group. Lipid hydroperoxide levels were higher in the infarcted groups; however, the MIT group had a lower concentration than did the MI group [S=223±20.8, MI=298±19.5, MIL=277±26.6, MIT=261±28.8 (nmol/g); n=8; P<.001]. We also examined left ventricle miRNA expression; when compared to the S group, the MIL group uniquely down-regulated the expression of eight miRNAs. No miRNA was found to be up-regulated uniquely in the MIT and MIL groups. In conclusion, tomato or lycopene supplementation attenuated the cardiac remodeling process and improved diastolic function after MI. However, the effect of lycopene and tomato supplementation occurred through different mechanistic pathways. Copyright © 2017 Elsevier Inc. All rights reserved.

Early experience with stretch polytetrafluoroethylene grafts for haemodialysis access surgery: results of a prospective randomised study.

PubMed

Tordoir, J H; Hofstra, L; Leunissen, K M; Kitslaar, P J

1995-04-01

The purpose of this study was to evaluate the results and complications of standard ePTFE versus stretch ePTFE AV fistulas. Prospective randomised trial. University Hospital. During a 2-year period 37 patients received 17 stretch and 20 standard ePTFE graft AV fistulas. Patients were evaluated for the occurrence of complications and graft patency. Regular Duplex scans were performed to detect stenoses in the fistula circuit. Thrombotic events occurred in 40% of the standard ePTFE grafts, compared to 12% of the stretch ePTFE prostheses (p < 0.001). The incidence of puncture complications was similar in both groups. The cumulative primary patency rate in the stretch ePTFE group was significantly higher compared to the standard ePTFE group (1-year patency rates of 59% and 29%, respectively; p < 0.01). No differences in the duration of puncture site bleeding were observed. Duplex scanning showed a significantly greater number of stenoses in the standard ePTFE grafts. The new stretch ePTFE prosthesis has better primary patency rates and less stenoses due to intimal hyperplasia as compared to standard ePTFE grafts.

A 'mystery shopper' project to evaluate sexual health and contraceptive services for young people in Croydon.

PubMed

Sykes, Susie; O'Sullivan, Karin

2006-01-01

The purpose of the study was to evaluate the accessibility of, and advice provided by, sexual health and advice services for young people in Croydon, UK using a 'mystery shopper' approach. Nineteen young people aged 13-21 years were trained as mystery shoppers. The group developed a set of standards, based in part on existing guidelines of best practice, that should be met when working with young people. The group accessed local sexual health services in pairs posing as genuine patients. Using one of four scenarios, the mystery shoppers assessed the service they received against the predefined standards. The main access difficulties occurred in the reception area. Confidentiality was a major concern and was frequently not explained. The advice and information received was generally clearly given and with an appropriate level of detail. Additional training and support needs to be offered to receptionists. Confidentiality policies and statements need to be more effectively communicated.

Improving comprehension and recall of information for an HIV vaccine trial among women at risk for HIV: reading level simplification and inclusion of pictures to illustrate key concepts.

PubMed

Murphy, D A; O'Keefe, Z H; Kaufman, A H

1999-10-01

A simplified version of the prototype HIV vaccine material was developed through (a) reducing reading grade level, (b) restructuring of the organization and categorization of the material, (c) adding pictures designed to emphasize key concepts, and (d) obtaining feedback on the simplified version through focus groups with the target population. Low-income women at risk for HIV (N = 141) recruited from a primary care clinic were randomly assigned to be presented the standard or the simplified version. There were no significant differences between the groups in terms of education or Vocabulary, Block Design, and Passage Comprehension scores. Women who received the simplified version had significantly higher comprehension scores immediately following presentation of the material than did women who received the standard version and were also significantly more likely to recall study benefits and risks. These findings were maintained at 3-month follow-up. Implications for informed consent are discussed.

Narrowing the gap: effects of intervention on developmental trajectories in autism.

PubMed

Klintwall, Lars; Eldevik, Sigmund; Eikeseth, Svein

2015-01-01

Although still a matter of some debate, there is a growing body of research supporting Early and Intensive Behavioral Intervention as the intervention of choice for children with autism. Learning rate is an alternative to change in standard scores as an outcome measure in studies of early intervention. Learning rates can be displayed graphically as developmental trajectories, which are easy to understand and avoid some of the counter-intuitive properties of changes in standard scores. The data used in this analysis were from 453 children with autism, previously described by Eldevik et al. Children receiving Early and Intensive Behavioral Intervention exhibited significantly steeper developmental trajectories than children in the control group, in both intelligence and adaptive behaviors. However, there was a considerable variability in individual learning rates within the group receiving Early and Intensive Behavioral Intervention. This variability could partly be explained by the intensity of the treatment, partly by children's intake intelligence quotient age-equivalents. Age at intake did not co-vary with learning rate. © The Author(s) 2013.

A comparison of two methods of infiltration in breast reduction surgery.

PubMed

Armour, A D; Rotenberg, B W; Brown, M H

2001-08-01

The superwet technique has been shown in previous studies to dramatically reduce blood loss in breast reduction surgery, compared with standard infiltration. A retrospective chart review of 303 consecutive patients undergoing bilateral breast reduction surgery was undertaken to demonstrate additional differences in complication rate, operative time, or sponge use in the operating room. In this series, 132 consecutive patients received standard infiltration along incision lines (25 cc per breast of 1:100,000 epinephrine), and 171 patients received superwet infiltration with 240 cc per breast of 1:1,000,000 epinephrine. The average operative time was significantly reduced in the superwet group, from 78.5 minutes to 70.7 minutes (p < 0.01 level). The average number of sponges used intraoperatively was also decreased significantly (p < 0.01), from 26 to 20 sponges. Complication rates were equally low in both groups, demonstrating the safety of the superwet technique. In addition to limiting blood loss, the superwet infiltration effectively reduces operative time and sponge use without increasing complications in breast reduction surgery.

Intensive nutrition education with or without supplementary feeding improves the nutritional status of moderately-malnourished children in Bangladesh.

PubMed

Roy, S K; Fuchs, G J; Mahmud, Zeba; Ara, Gulshan; Islam, Sumaya; Shafique, Sohana; Akter, Syeda Sharmin; Chakraborty, Barnali

2005-12-01

This prospective randomized trial was carried out to test the efficacy of a specific intervention for reducing the extent of their malnutrition and to change behaviour of mothers relating to child-feeding practices, care-giving, and health-seeking practices under the Bangladesh Integrated Nutrition Project (BINP). The study was conducted in rural Bangladesh among 282 moderately-malnourished (weight-for-age between 61% and 75% of median of the National Center for Health Statistics standard) children aged 6-24 months. Mothers of the first intervention group received intensive nutrition education (INE group) twice a week for three months. The second intervention group received the same nutrition education, and their children received additional supplementary feeding (INE+SF group). The comparison group received nutrition education from the community nutrition promoters twice a month according to the standard routine service of BINP. The children were observed for a further six months. After three months of interventions, a significantly higher proportion of children in the INE and INE+SF groups improved (37% and 47% respectively) from moderate to mild or normal nutrition compared to the comparison group (18%) (p < 0.001). At the end of six months of observation, the nutritional status of children in the intervention groups improved further from moderate to mild or normal nutrition compared to the comparison group (59% and 86% vs 30%, p < 0.0001). As the intensive nutrition education and supplementation given were highly effective, more children improved from moderate malnutrition to mild or normal nutritional status despite a higher incidence of morbidity. The frequency of child feeding and home-based complementary feeding improved significantly (p < 0.001) in both the intervention groups after three months of interventions and six months of observation. Body-weight gain was positively associated with age, length-for-age, weight-for-length, frequency of feeding of khichuri, egg, and potato (p < 0.05). Ability of mothers to identify malnutrition improved from 15% to 99% in the INE group and from 15% to 100% in the INE+SF group, but reduced from 24% to 21% in the comparison group. Use of separate feed pots, frequency of feeding, and cooking of additional complementary feeds improved significantly in the INE and INE+SF groups compared to the comparison group after three months of interventions and six months of observation. It can be concluded from the findings of the study that intensive nutrition education significantly improves the status of moderately-malnourished children with or without supplementary feeding.

Evaluation of a Self-Management Program for Gastroesophageal Reflux Disease in China.

PubMed

Xu, Wenhong; Sun, Changxian; Lin, Zheng; Lin, Lin; Wang, Meifeng; Zhang, Hongjie; Song, Yulei

2016-01-01

Gastroesophageal reflux disease is a chronic disease with a high incidence worldwide. The various symptoms have substantial impact on the quality of life of affected individuals. A long-term self-management program can increase the ability of patients to make behavioral changes, and health outcomes can improve as a consequence. This study's aim was to evaluate the effectiveness of a self-management program for gastroesophageal reflux disease. A total of 115 patients with gastroesophageal reflux disease were allocated to the experimental group and the control group. The former received self-management intervention along with conventional drug therapy, whereas the latter received standard outpatient care and conventional drug therapy. After the clinical trial, the control group also received the same self-management intervention. The levels of self-management behaviors, self-efficacy, gastroesophageal reflux disease symptoms, and psychological condition were compared. Those in the experimental group demonstrated significantly higher self-efficacy for managing their illness, showed positive changes in self-management behaviors, and had comparatively better remission of symptoms and improvement in psychological distress. The program helped patients with gastroesophageal reflux disease self-manage their illness as possible.

The Effect of a Community Health Worker Utilized Mobile Health Application on Maternal Health Knowledge and Behavior: A Quasi-Experimental Study.

PubMed

Ilozumba, Onaedo; Van Belle, Sara; Dieleman, Marjolein; Liem, Loan; Choudhury, Murari; Broerse, Jacqueline E W

2018-01-01

Mobile technology (mHealth) is increasingly being used to achieve improved access and quality of maternal care, particularly in rural areas of low- and middle-income countries. In 2011, a mobile application-Mobile for Mothers (MfM)-was implemented in Jharkhand, India to support home visits by community health workers. The objective of this study is to assess the impact of the mHealth intervention on maternal health. Households from three subdistricts in the Deoghar district of Jharkhand were selected using a multistage cluster sampling approach. Households from the Sarwan subdistrict received the MfM intervention, those from Devipur subdistrict received other interventions asides MfM from the implementing non-governmental organization (NGO), while households from Mohanpur subdistrict received the current standard of care. Women ( n  = 2,200) between the ages of 18 and 45 who had delivered a baby in the past 1 year were enrolled into the study. The primary outcomes of interest were maternal health knowledge, antenatal care (ANC) attendance, and delivery in a health facility. Post-intervention, women in the MfM group had higher maternal health knowledge, were more likely to attend four or more ANC visits, and deliver at the health facility when compared with the NGO and standard care group. After controlling for predictors, women in the intervention group significantly performed better than both the NGO and standard care groups on all three-outcome variables (all P  > 0.05). The results indicate that although the MfM mHealth intervention could influence adherence and practice of recommended maternal health behaviors, it could not overcome key sociocultural determinants of maternal health such as caste and educational status, which are specific to the Indian context. mHealth holds continued promise for maternal health but implementers and policy makers must additionally address health system and sociocultural factors that play a significant role in the uptake of recommended maternal health practices.

Efficacy of a Social Self-Value Empowerment Intervention to Improve Quality of Life of HIV Infected People Receiving Antiretroviral Treatment in Nepal: A Randomized Controlled Trial.

PubMed

Bhatta, Dharma Nand; Liabsuetrakul, Tippawan

2017-06-01

We developed a comprehensive and culturally applicable empowerment intervention social self-value package with an aim to assess its efficacy in order to improve the quality of life (QoL) of HIV infected people receiving antiretroviral treatment. Participants were randomly allocated to receive either six weekly intervention sessions or standard care. Nonlinear mixed-effects models were performed to compare changes in empowerment scores over time. Between September and November 2014, 1447 individuals were screened, of whom 132 were randomly assigned to either the intervention or control group. The mean scores of empowerment, social support and quality of life increased and stigma scores were reduced in the intervention group at 3- and 6-months. An intervention effect on social support, stigma and QoL was significantly increased by time and group with low and high empowerment. No adverse events were reported. The empowerment intervention was efficacious in improving QoL of HIV infected people.

Acupuncture at local and distal points for chronic shoulder pain: study protocol for a randomized controlled trial.

PubMed

Fu, Qing-Nan; Shi, Guang-Xia; Li, Qian-Qian; He, Tian; Liu, Bao-Zhen; Sun, San-Feng; Wang, Jun; Tan, Cheng; Yang, Bo-Feng; Liu, Cun-Zhi

2014-04-17

Chronic shoulder pain (CSP) is the third most common type of musculoskeletal pain. It has a major impact on health-related quality of life. In Chinese medicine, CSP is considered one of the conditions most amenable to treatment with acupuncture. The purpose of this study is to evaluate the efficacy of local acupoints in combination with distal acupoints in pain relief and shoulder function improvement in CSP patients. This is a multicenter, single blind, factorial randomized controlled clinical trial. A total of 164 participants will be randomly allocated to four different groups: Group A will receive acupuncture at local acupoints in combination with distal acupoint. Group B will receive acupuncture at local acupoints in combination with distal non-acupoint. Group C will receive acupuncture at local non-acupoints in combination with distal acupoint. Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoint. Each group will receive 12 treatments of acupuncture one to three times per week for six weeks in total. The primary outcome is shoulder pain intensity, which is graded using a 100 -mm Visual Analogue Scale. The assessment is at baseline (before treatment initiation), 6 weeks after the first acupuncture, 10 weeks after the first acupuncture and 18 weeks after the first acupuncture. This trial will be helpful in identifying whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately. International Standard Randomized Controlled Trial Number Register: ISRCTN61861069 (http://www.controlled-trials.com).

Electromagnetic treatment of shoulder periarthritis: a randomized controlled trial of the efficiency and tolerance of magnetotherapy.

PubMed

Leclaire, R; Bourgouin, J

1991-04-01

The potential benefit of magnetotherapy was investigated in 47 consecutive outpatients with periarthritis of the shoulder. Using a controlled triple-blind study design, one group of patients received hot pack applications and passive manual stretching and pulley exercises; the other group received the same therapy plus magnetotherapy. Treatment was administered three times a week. For a maximum of three months, a standardized treatment protocol was used. There was no significant improvement in pain reduction or in range of motion with electromagnetic field therapy. After 12 weeks of therapy, the patients who received magnetotherapy showed mean pain scores of 1.5 (+/- .61 SD) at rest, 2.2 (+/- .76 SD) on movement, and 1.9 (+/- .94 SD), on lying, compared to scores for the control group of 1.4 (+/- .65 SD), 2.2 (+/- .7 SD), and 1.9 (+/- .95 SD), respectively. Linear pain scale scores improved from 71 to 21 for both groups. At 12 weeks the gain in range of motion was mean 109 degrees +/- 46.8 in patients receiving electromagnetic field therapy, compared to 122 degrees +/- 33.4 for the controls (not significant). At entry, the functional handicap score was 53.5 for both groups. At 12 weeks, it was 24 for the magnetotherapy group and 17 for the control group (difference not significant). In conclusion, this study showed no benefit from magnetotherapy in the pain score, range of motion, or improvement of functional status in patients with periarthritis of the shoulder.

Evaluation of a telenovela designed to improve knowledge and behavioral intentions among Hispanic patients with end-stage renal disease in Southern California.

PubMed

Forster, Myriam; Allem, Jon-Patrick; Mendez, Nicole; Qazi, Yasir; Unger, Jennifer B

2016-01-01

Culturally relevant education is needed to improve rates of successful kidney transplantation among Hispanic patients with end-stage renal disease (ESRD). This study examined whether patients' knowledge about kidney disease, postoperative care, and proactive health practices improved after watching a telenovela series about ESRD. 334 ESRD patients and 94 family members/caregivers were assigned to watch a telenovela ('Fixing Paco,' a bilingual health education film) or receive standard of care at a transplant center or at a dialysis clinic. Outcomes for pre-transplant patients assigned to standard of care at dialysis centers or at a transplant center were compared to pre-transplant patients in the treatment condition (standard of care + telenovela). Knowledge and behavioral intention scores at baseline across conditions and locations were similar, suggesting that assignment resulted in comparable groups at baseline. Using linear regression, this study found statistically significant improvements in knowledge scores among the telenovela group as compared to the standard of care groups. The telenovela group also had greater improvements in behavioral intention scores compared to the standard of care groups. Family members assigned to the telenovela group had significant improvements in knowledge scores as compared to the standard of care groups. Being well informed about ESRD and adopting proactive health behaviors are important mechanisms in improving transplantation outcomes. These findings suggest that knowledge about kidney disease, postoperative care, and proactive health practices could be improved by viewing a telenovela. Implications, limitations, and directions for future research are discussed.

Outcomes of Physician-Staffed Versus Non-Physician-Staffed Helicopter Transport for ST-Elevation Myocardial Infarction.

PubMed

Gunnarsson, Sverrir I; Mitchell, Joseph; Busch, Mary S; Larson, Brenda; Gharacholou, S Michael; Li, Zhanhai; Raval, Amish N

2017-02-02

The effect of physician-staffed helicopter emergency medical service (HEMS) on ST-elevation myocardial infarction (STEMI) patient transfer is unknown. The purpose of this study was to evaluate the characteristics and outcomes of physician-staffed HEMS (Physician-HEMS) versus non-physician-staffed (Standard-HEMS) in patients with STEMI. We studied 398 STEMI patients transferred by either Physician-HEMS (n=327) or Standard-HEMS (n=71) for primary or rescue percutaneous coronary intervention at 2 hospitals between 2006 and 2014. Data were collected from electronic medical records and each institution's contribution to the National Cardiovascular Data Registry. Baseline characteristics were similar between groups. Median electrocardiogram-to-balloon time was longer for the Standard-HEMS group than for the Physician-HEMS group (118 vs 107 minutes; P=0.002). The Standard-HEMS group was more likely than the Physician-HEMS group to receive nitroglycerin (37% vs 15%; P<0.001) and opioid analgesics (42.3% vs 21.7%; P<0.001) during transport. In-hospital adverse outcomes, including cardiac arrest, cardiogenic shock, and serious arrhythmias, were more common in the Standard-HEMS group (25.4% vs 11.3%; P=0.002). After adjusting for age, sex, Killip class, and transport time, patients transferred by Standard-HEMS had increased risk of any serious in-hospital adverse event (odds ratio=2.91; 95% CI=1.39-6.06; P=0.004). In-hospital mortality was not statistically different between the 2 groups (9.9% in the Standard-HEMS group vs 4.9% in the Physician-HEMS group; P=0.104). Patients with STEMI transported by Standard-HEMS had longer transport times, higher rates of nitroglycerin and opioid administration, and higher rates of adjusted in-hospital events. Efforts to better understand optimal transport strategies in STEMI patients are needed. © 2017 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Postpartum weight retention and breastfeeding among obese women from the randomized controlled Lifestyle in Pregnancy (LiP) trial.

PubMed

Vinter, Christina Anne; Jensen, Dorte Møller; Ovesen, Per; Beck-Nielsen, Henning; Tanvig, Mette; Lamont, Ronald F; Jørgensen, Jan Stener

2014-08-01

To study the effects of lifestyle intervention in pregnancy on weight retention 6 months postpartum among obese women from the "Lifestyle in Pregnancy" (LiP) study, and to determine associations between breastfeeding with postpartum maternal weight. Six months postpartum follow up after a randomized controlled intervention trial. Two university hospitals in Denmark. A total of 360 women with pregestational body mass index ≥30 kg/m(2) . The intervention involved lifestyle changes (diet and exercise) during pregnancy. The control group received routine pregnancy care. Both groups received standard postnatal care. Gestational weight gain, postpartum weight retention and breastfeeding. Follow up was completed in 238 women of whom 46% in the intervention group and 57% in the control group had retained weight 6 months postpartum (p = 0.088). Women with gestational weight gain ≤9 kg, (recommended by the Institute of Medicine), retained less postpartum weight compared with those who exceeded 9 kg (median -0.7 vs. 1.5, p < 0.001). Ninety-two percent in both weight gain groups initiated breastfeeding. The number of breastfeeding mothers was higher among women with postpartum weight retention ≤5 kg compared with those with weight retention > 5 kg (94% vs. 85%, p = 0.034). We could not detect sustained weight control at 6 months postpartum despite a lower gestational weight gain for obese women during pregnancy who received a lifestyle intervention rather than standard care. Women who adhered to gestational weight gain recommendations had significantly lower postpartum weight retention. Breastfeeding for 6 months was negatively associated with postpartum weight retention. © 2014 Nordic Federation of Societies of Obstetrics and Gynecology.

Effects of Task-Specific Augmented Feedback on Deficit Modification During Performance of the Tuck-Jump Exercise

PubMed Central

Stroube, Benjamin W.; Myer, Gregory D.; Brent, Jensen L.; Ford, Kevin R.; Heidt, Robert S.; Hewett, Timothy E.

2014-01-01

Context Anterior cruciate ligament (ACL) injuries are prevalent in female athletes. Specific factors have possible links to increasing a female athlete’s chances of suffering an ACL injury. However, it is unclear if augmented feedback may be able to decrease possible risk factors. Objective To compare the effects of task-Specific feedback on a repeated tuck-jump maneuver. Design Double-blind randomized controlled trial. Setting Sports-medicine biodynamics center. Patients 37 female subjects (14.7 ± 1.5 y, 160.9 ± 6.8 cm, 54.5 ± 7.2 kg). Intervention All athletes received standard off-season training consisting of strength training, plyometrics, and conditioning. They were also videotaped during each session while running on a treadmill at a standardized speed (8 miles/h) and while performing a repeated tuck-jump maneuver for 10 s. The augmented feedback group (AF) received feedback on deficiencies present in a 10-s tuck jump, while the control group (CTRL) received feedback on 10-s treadmill running. Main Outcome Measures Outcome measurements of tuck-jump deficits were scored by a blinded rater to determine the effects of group (CTRL vs AF) and time (pre- vs posttesting) on changes in measured deficits. Results A significant interaction of time by group was noted with the task-Specific feedback training (P = .03). The AF group reduced deficits measured during the tuck-jump assessment by 23.6%, while the CTRL training reduced deficits by 10.6%. Conclusions The results of the current study indicate that task-Specific feedback is effective for reducing biomechanical risk factors associated with ACL injury. The data also indicate that Specific components of the tuck-jump assessment are potentially more modifiable than others. PMID:23238301

Using real-time ultrasound imaging as adjunct teaching tools to enhance physical therapist students' ability and confidence to perform traction of the knee joint.

PubMed

Markowski, Alycia; Watkins, Maureen K; Burnett, Todd; Ho, Melissa; Ling, Michael

2018-04-01

Often, physical therapy students struggle with the skill and the confidence to perform manual techniques for musculoskeletal examination. Current teaching methods lack concurrent objective feedback. Real-time ultrasound imaging (RTUI) has the advantage of generating visualization of anatomical structures in real-time in an efficient and safe manner. We hypothesize that the use of RTUI to augment teaching with concurrent objective visual feedback will result in students' improved ability to create a change in joint space when performing a manual knee traction and higher confidence scores. Eighty-six students were randomly allocated to a control or an experimental group. All participants received baseline instructions on how to perform knee traction. The control group received standardized lab instruction (visual, video, and instructor/partner feedback). The experimental group received standardized lab instruction augmented with RTUI feedback. Pre-data and post-data collection consisted of measuring participants' ability to create changes in joint space when performing knee traction, a confidence survey evaluating perceived ability and a reflection paper. Joint space changes between groups were compared using a paired t-test. Surveys were analyzed with descriptive statistics and compared using Wilcoxon Rank Sum and for the reflection papers, themes were identified and descriptive statistics reported. Although there were no statistically significant differences between the control and the experimental group, overall scores improved. Qualitative data suggests students found the use of ultrasound imaging beneficial and would like more exposure. This novel approach to teaching knee traction with RTUI has potential and may be a basis for further studies. Copyright © 2018 Elsevier Ltd. All rights reserved.

Web-Based Tailored Intervention for Preparation of Parents and Children for Outpatient Surgery (WebTIPS): Formative Evaluation and Randomized Controlled Trial

PubMed Central

Fortier, Michelle A.; Bunzli, Elizabeth; Walthall, Jessica; Olshansky, Ellen; Saadat, Haleh; Santistevan, Ricci; Mayes, Linda; Kain, Zeev N.

2015-01-01

Background The purpose of this two-phase project was to conduct formative evaluation and test the preliminary efficacy of a newly developed web-based, tailored behavioral preparation program (WebTIPS) for children undergoing outpatient surgery and their parents Methods Phase I enrolled 13 children aged 2–7 years undergoing outpatient elective surgery and their parents for formative evaluation of WebTIPS. Parent participation focus groups which are common in qualitative research and are a method of asking research participants about their perceptions and attitudes regarding a product or concept. In phase II, children age 2–7 years in two medical centers were randomly assigned to receive the WebTIPS program (n = 38) compared to children receiving standard of care (n = 44). The primary outcome of phase II was child and parent preoperative anxiety. Results In phase I, parents reported WebTIPS to be both helpful (p < 0.001) and easy to use (p < 0.001). In phase II, children in the WebTIPS group (36.2 ± 14.1) were less anxious than children in the standard of care group (46.0 ± 19.0) at entrance to the operating room (p = 0.02; Cohen’s d = 0.59) and introduction of the anesthesia mask (43.5 ± 21.7 vs. 57.0 ± 21.2, respectively, p = 0.01; Cohen’s d = 0.63). Parents in the WebTIPS group (32.1 ± 7.4) also experienced less anxiety compared to parents in the control group (36.8 ± 7.1) in the preoperative holding area (p = 0.004; Cohen’s d = 0.65). Conclusions WebTIPS was well received by parents and children and led to reductions in preoperative anxiety. PMID:25790213

Levofloxacin-Based First-Line Therapy versus Standard First-Line Therapy for Helicobacter pylori Eradication: Meta-Analysis of Randomized Controlled Trials

PubMed Central

Peedikayil, Musthafa Chalikandy; AlSohaibani, Fahad Ibrahim; Alkhenizan, Abdullah Hamad

2014-01-01

Background First-line levofloxacin-based treatments eradicate Helicobacter pylori with varying success. We examined the efficacy and safety of first-line levofloxacin-based treatment in comparison to standard first-line therapy for H pylori eradication. Materials and Methods We searched literature databases from Medline, EMBASE, and the Cochrane Register of Randomized Controlled Trials through March 2013 for randomized controlled trials comparing first-line levofloxacin and standard therapy. We included randomized controlled trials conducted only on naïve H pylori infected patients in adults. A systematic review was conducted. Meta-analysis was performed with Review Manager 5.2. Treatment effect was determined by relative risk with a random or fixed model by the Mantel-Haenszel method. Results Seven trials were identified with 888 patients receiving 7 days of first-line levofloxacin and 894 treated with standard therapy (Amoxicillin, Clarithromycin and proton pump inhibitor) for 7 days. The overall crude eradication rate in the Levofloxacin group was 79.05% versus 81.4% in the standard group (risk ratio 0.97; 95% CI; 0.93, 1.02). The overall dropout was 46 (5.2%) in the levofloxacin group and 52 (5.8%) for standard therapy. The dizziness was more common among group who took Levofloxacin based treatment and taste disturbance was more common among group who took standard therapy. Meta-analysis of overall adverse events were similar between the two groups with a relative risk of 1.06 (95% CI 0.72, 1.57). Conclusion Helicobacter pylori eradication with 7 days of Levofloxacin-based first line therapy was safe and equal compared to 7 days of standard first-line therapy. PMID:24465624

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa J; Knight, Laura D; Presneill, Jeffrey; Rechnitzer, Thomas; Forsyth, Adrienne; Gill, Benjamin M T; Mourtzakis, Marina; MacIsaac, Christopher

2018-04-27

International guidelines recommend greater protein delivery to critically ill patients than they currently receive. This pilot randomized clinical trial aimed to determine whether a volume-target enteral protocol with supplemental protein delivered greater amounts of protein and energy to critically ill patients compared with standard care. Sixty participants received either the intervention (volume-based protocol, with protein supplementation) or standard nutrition care (hourly-rate-based protocol, without protein supplementation) in the intensive care unit (ICU). Coprimary outcomes were average daily protein and energy delivery. Secondary outcomes included change in quadriceps muscle layer thickness (QMLT, ultrasound) and malnutrition (subjective global assessment) at ICU discharge. Mean (SD) protein and energy delivery per day from nutrition therapy for the intervention were 1.2 (0.30) g/kg and 21 (5.2) kcal/kg compared with 0.75 (0.11) g/kg and 18 (2.7) kcal/kg for standard care. The mean difference between groups in protein and energy delivery per day was 0.45 g/kg (95% CI, 0.33-0.56; P < .001) and 2.8 kcal/kg (95% CI, 0.67-4.9, P = .01). Muscle loss (QMLT) at discharge was attenuated by 0.22 cm (95% CI, 0.06-0.38, P = .01) in patients receiving the intervention compared with standard care. The number of malnourished patients was fewer in the intervention [2 (7%) vs 8 (28%); P = .04]. Mortality and duration of admission were similar between groups. A high-protein volume-based protocol with protein supplementation delivered greater amounts of protein and energy. This intervention was associated with attenuation of QMLT loss and reduced prevalence of malnutrition at ICU discharge. © 2018 American Society for Parenteral and Enteral Nutrition.

Perceived levels of pain associated with bone marrow aspirates and biopsies.

PubMed

Talamo, Giampaolo; Liao, Jason; Joudeh, Jamal; Lamparella, Nicholas E; Dinh, Hoang; Malysz, Jozef; Ehmann, W Christopher

2012-01-01

Little is known about the degree of pain experienced by patients undergoing a bone marrow aspiration and biopsy (BMAB). To evaluate the effectiveness of several strategies aimed at reducing the pain score. We conducted a retrospective analysis of 258 consecutive adult patients who underwent BMAB via 6 different approaches, the first 5 of which were performed by one physician. Group A received local anesthesia with 1% lidocaine hydrochloride (5 mL) and a 5-minute wait time before the procedure; group B received local anesthesia with a double dose (10 mL) of lidocaine; group C received 5 mL of local anesthesia with a 10-minute wait; group D received 5 mL of local anesthesia plus a topical spray with ethyl chloride; group E received oral analgesia and anxiolysis 30 minutes before the procedure in addition to the group A dosage of lidocaine; and group F received the same anesthesia as did group A, but the BMAD was performed by a less experienced practitioner. On a 0 to 10 scale, the mean pain level among the 258 patients was 3.2 (standard deviation = 2.6). Rate of complications was low (<1%). Several strategies failed to improve the pain level, including the administration of a double dose of local anesthesia, waiting longer for the anesthesia effect, and the additional use of a topical anesthetic spray or oral analgesia and anxiolysis. Pain levels were not increased when the procedure was done by a less experienced practitioner. Younger age and female gender were associated with higher pain levels. Given that the average level of perceived pain during BMAB is low to moderate (approximately 3 on a 0-10 scale), the routine use of conscious sedation for this procedure may not be indicated. Several strategies aimed at reducing the pain level, including doubling the dose of anesthesia and using an oral prophylactic regimen of analgesia and anxiolysis, failed to improve pain scores. Copyright © 2012 Elsevier Inc. All rights reserved.

Continuous delivery of ropinirole reverses motor deficits without dyskinesia induction in MPTP-treated common marmosets.

PubMed

Stockwell, K A; Virley, D J; Perren, M; Iravani, M M; Jackson, M J; Rose, S; Jenner, P

2008-05-01

L-DOPA treatment of Parkinson's disease induces a high incidence of motor complications, notably dyskinesia. Longer acting dopamine agonists, e.g. ropinirole, are thought to produce more continuous dopaminergic stimulation and less severe dyskinesia. However, standard oral administration of dopamine agonists does not result in constant plasma drug levels, therefore, more continuous drug delivery may result in both prolonged reversal of motor deficits and reduced levels of dyskinesia. Therefore, we compared the effects of repeated oral administration of ropinirole to constant subcutaneous infusion in MPTP-treated common marmosets. Animals received oral administration (0.4 mg/kg, BID) or continuous infusion of ropinirole (0.8 mg/kg/day) via osmotic minipumps for 14 days (Phase I). The treatments were then switched and continued for a further 14 days (Phase II). In Phase I, locomotor activity was similar between treatment groups but reversal of motor disability was more pronounced in animals receiving continuous infusion. Dyskinesia intensity was low in both groups however there was a trend suggestive of less marked dyskinesia in those animals receiving continuous infusion. In Phase II, increased locomotor activity was maintained but animals switched from oral to continuous treatment showing an initial period of enhanced locomotor activity. The reversal of motor disability was maintained in both groups, however, motor disability tended towards greater improvement following continuous infusion. Importantly, dyskinesia remained low in both groups suggesting that constant delivery of ropinirole neither leads to priming nor expression of dyskinesia. These results suggest that a once-daily controlled-release formulation may provide improvements over existing benefits with standard oral ropinirole in Parkinson's disease patients.

Ethnic Differences in HIV Risk Behaviors Among Methadone-Maintained Women Receiving Contingency Management for Cocaine Use Disorders

PubMed Central

Barry, Danielle; Weinstock, Jeremiah; Petry, Nancy M.

2008-01-01

Objective To identify ethnic differences in HIV risk behaviors among cocaine using women receiving methadone maintenance for opioid dependence, and to evaluate the efficacy of contingency management (CM) for cocaine use disorders in reducing HIV risk behaviors. Methods African American (N=47), Hispanic (N=47), and White women (N = 29) were randomized to standard methadone treatment or standard methadone treatment plus a CM intervention. They completed the HIV Risk Behavior Scale (HRBS) indicating frequency of drug use and sexual behaviors across the lifetime, in the month before baseline, and in the 3 months following clinical trial participation. Ethnic group differences and the effect of CM on change in HIV risk behaviors between baseline and follow-up were evaluated. Results White women reported significantly higher lifetime rates of risky drug use and sexual behaviors on the HRBS than African American women; neither group differed significantly from Hispanic women. No ethnic group differences in HIV risk behaviors were identified in the month prior to baseline. At follow-up, African American women reported fewer high-risk drug use behaviors than White or Hispanic women, and Hispanic women reported more high-risk sexual behaviors than White or African American women. CM was associated with reduction in high-risk drug use behaviors regardless of ethnicity, but did not affect high-risk sexual behaviors. Conclusions White women receiving methadone maintenance engage in more lifetime HIV risk behaviors than African American women. CM for cocaine use reduces risky drug use behaviors, but certain ethnic groups may benefit from additional targeted HIV prevention efforts. PMID:18684571

Increased bone mineral content of preterm infants fed with a nutrient enriched formula after discharge from hospital.

PubMed Central

Bishop, N J; King, F J; Lucas, A

1993-01-01

Bone disease with persistent reduced bone mineralisation is common in premature infants. To test the hypothesis that enhancement of nutritional intake after discharge from hospital improves bone mineralisation, 31 formula fed preterm infants were randomly assigned to receive standard or multinutrient enriched milk from the time of discharge. The calcium and phosphorus contents of the enriched milk were 70 and 35 mg/100 ml v 35 and 29 mg/100 ml for the standard formula. Bone mineral content was measured before discharge from hospital in 21 of the infants; there was no difference in the bone mineral content between the groups at that time (35 mg/cm for the two groups). There was a significant increase in bone mineral content for those infants receiving the enriched v standard formula at 3 and 9 months corrected postnatal age: at 3 months the bone mineral content was 83 v 63 mg/cm and at 9 months 115 v 95 mg/cm. The difference between the groups was thus maintained although not increased at a corrected age of 9 months, when the bone mineral content of infants fed the enriched but not the standard formula was no longer significantly different from that of normal infants after adjusting for body size. The difference was not explained by the larger body size in infants fed the enriched formula. The results suggest that the use of a special nutrient enriched postdischarge formula has a significant positive effect on bone growth and mineralisation during a period of rapid skeletal development. PMID:8323358

The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation

DTIC Science & Technology

2016-10-01

non-myeloablative conditioning plus bone marrow infusion (BMI) and intermediate dose tacrolimus (10-15 ng/ml) for 30 days only. Group VIII received the...induction regimen, BMI and CTLA4-Ig and a short-term dose of tacrolimus (30 days ). In all groups, graft rejection was monitored by clinical...long-term graft survival (>230 days ). In the current reporting period (Aim 2 and Aim 3), 3/3 animals in group IV and 4/5 animals in Group V achieved

The effect of live music on decreasing anxiety in patients undergoing chemotherapy treatment.

PubMed

Ferrer, Alejandra J

2007-01-01

The purpose of this study was to investigate the effects of familiar live music on the anxiety levels of patients undergoing chemotherapy treatment. Randomly selected patients were assigned to experimental (n = 25) and control (n = 25) conditions. Pre and posttests consisted of questionnaires and the recording of the patient's heart rate and blood pressures. Subjects in the experimental group received 20 minutes of familiar live music during their chemotherapy treatment. Subjects in the control group received standard chemotherapy. It was assumed that those patients receiving music intervention would: (a) lower their anxiety levels; (b) experience a decrease in heart rate and blood pressure; (c) improve their levels of negative reactions including fatigue, worry, and fear; and (d) improve their levels of positive reactions including comfort and relaxation. Results of the study showed statistically significant improvement for the experimental group on the measures of anxiety, fear, fatigue, relaxation, and diastolic blood pressure. No significant differences between groups were found for heart rate and systolic blood pressure. Descriptive values indicated that, on average, the experimental group was influenced positively by the music intervention, and participants improved their quality of life while undergoing chemotherapy treatment.

The effect of a natural food based tube feeding in minimizing diarrhea in critically ill neurological patients.

PubMed

Schmidt, Simone B; Kulig, Willibald; Winter, Ralph; Vasold, Antje S; Knoll, Anette E; Rollnik, Jens D

2018-01-09

Diarrhea has negative consequences for patients, health care staff and health care costs when neurological patients are fed enterally over long periods. We examined the effect of tube feeding with natural foods in reducing the number of fluid stool evacuations and diarrhea in critically ill neurological patients. A multicenter, prospective, open-label and randomized controlled trial (RCT) was conducted at facilities in Germany specializing in early rehabilitation after neurological damage. Patients of the INTERVENTION group were fed by tube using a commercially available product based on real foods such as milk, meat, carrots, whereas CONTROL patients received a standard tube-feed made of powdered raw materials. All received enteral nutrition over a maximum of 30 days. The number of defecations and the consistency of each stool according to the Bristol Stool Chart (BSC) were monitored. In addition, daily calories, liquids and antibiotic-use were recorded. 118 Patients who had suffered ischemic stroke, intracerebral hemorrhage, traumatic brain injury or hypoxic brain damage and requiring enteral nutrition were enrolled; 59 were randomized to receive the intervention and 59 control feed. There were no significant differences in clinical screening data, age, sex, observation period or days under enteral nutrition between the groups. Patients in both groups received equivalent amount of calories and fluids. In both groups antibiotics were frequently prescribed (69.5% in the INTERVENTION group and 75.7% in the CONTROL group) for 10-11 days on average. In comparison to the CONTROL group, patients in the INTERVENTION group had a significant reduction of the number of watery stool evacuations (type 7 BSC) (minus 61%, IRR = 0.39, p < 0.001). Further statistical evaluations using the following corrections: major diarrhea-associated confounders (number and duration of antibiotics); shorter observation period of 15 days; excluding patients with Clostridiumdifficile associated diarrhea (CDAD) and the Per Protocol Population, confirmed the primary hypothesis. The number of days with diarrhea was significantly lower in the INTERVENTION group (0.8 ± 1.60 days versus 2.0 ± 3.46 days). Tube feeding with natural based food was effective in reducing the number of watery defecations and diarrhea in long term tube-fed critically ill neurological patients, compared to those fed with standard tube feeding. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Modulation of the gut microbiota by the mixture of fish oil and krill oil in high-fat diet-induced obesity mice.

PubMed

Cui, Chenxi; Li, Yanyan; Gao, Hang; Zhang, Hongyan; Han, Jiaojiao; Zhang, Dijun; Li, Ye; Zhou, Jun; Lu, Chenyang; Su, Xiurong

2017-01-01

Previous studies confirmed that dietary supplements of fish oil and krill oil can alleviate obesity in mice, but the underlying mechanism remains unclear. This study aims to discern whether oil treatment change the structure of the gut microbiota during the obesity alleviation. The ICR mice received high-fat diet (HFD) continuously for 12 weeks after two weeks of acclimatization with a standard chow diet, and the mice fed with a standard chow diet were used as the control. In the groups that received HFD with oil supplementation, the weight gains were attenuated and the liver index, total cholesterol, triglyceride and low-density lipoprotein cholesterol were reduced stepwise compared with the HFD group, and the overall structure of the gut microbiota, which was modulated in the HFD group, was shifted toward the structure found in the control group. Moreover, eighty-two altered operational taxonomic units responsive to oil treatment were identified and nineteen of them differing in one or more parameters associated with obesity. In conclusion, this study confirmed the effect of oil treatment on obesity alleviation, as well as on the microbiota structure alterations. We proposed that further researches are needed to elucidate the causal relationship between obesity alleviation and gut microbiota modulation.

Reduction of Classroom Noise Levels Using Group Contingencies

ERIC Educational Resources Information Center

Ring, Brandon M.; Sigurdsson, Sigurdur O.; Eubanks, Sean L.; Silverman, Kenneth

2014-01-01

The therapeutic workplace is an employment-based abstinence reinforcement intervention for unemployed drug users where trainees receive on-the-job employment skills training in a classroom setting. The study is an extension of prior therapeutic workplace research, which suggested that trainees frequently violated noise standards. Participants…

Efficacy and Safety of Subcutaneous Belimumab in Systemic Lupus Erythematosus: A Fifty-Two-Week Randomized, Double-Blind, Placebo-Controlled Study.

PubMed

Stohl, William; Schwarting, Andreas; Okada, Masato; Scheinberg, Morton; Doria, Andrea; Hammer, Anne E; Kleoudis, Christi; Groark, James; Bass, Damon; Fox, Norma Lynn; Roth, David; Gordon, David

2017-05-01

To assess the efficacy and safety of subcutaneous (SC) belimumab in patients with systemic lupus erythematosus (SLE). Patients with moderate-to-severe SLE (score of ≥8 on the Safety of Estrogens in Lupus Erythematosus National Assessment [SELENA] version of the SLE Disease Activity Index [SLEDAI]) were randomized 2:1 to receive weekly SC belimumab 200 mg or placebo by prefilled syringe in addition to standard SLE therapy for 52 weeks. The primary end point was the SLE Responder Index (SRI4) at week 52. Secondary end points were reduction in the corticosteroid dosage and time to severe flare. Safety was assessed according to the adverse events (AEs) reported and the laboratory test results. Of 839 patients randomized, 836 (556 in the belimumab group and 280 in the placebo group) received treatment. A total of 159 patients withdrew before the end of the study. At entry, mean SELENA-SLEDAI scores were 10.5 in the belimumab group and 10.3 in the placebo group. More patients who received belimumab were SRI4 responders than those who received placebo (61.4% versus 48.4%; odds ratio [OR] 1.68 [95% confidence interval (95% CI) 1.25-2.25]; P = 0.0006). In the belimumab group, both time to and risk of severe flare were improved (median 171.0 days versus 118.0 days; hazard ratio 0.51 [95% CI 0.35-0.74]; P = 0.0004), and more patients were able to reduce their corticosteroid dosage by ≥25% (to ≤7.5 mg/day) during weeks 40-52 (18.2% versus 11.9%; OR 1.65 [95% CI 0.95-2.84]; P = 0.0732), compared with placebo. AE incidence was comparable between treatment groups; serious AEs were reported by 10.8% of patients taking belimumab and 15.7% of those taking placebo. A worsening of IgG hypoglobulinemia by ≥2 grades occurred in 0.9% of patients taking belimumab and 1.4% of those taking placebo. In patients with moderate-to-severe SLE, weekly SC doses of belimumab 200 mg plus standard SLE therapy significantly improved their SRI4 response, decreased severe disease flares as compared with placebo, and had a safety profile similar to placebo plus standard SLE therapy. © 2017 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of American College of Rheumatology.

Specialty Engineering Supplement to IEEE-15288.1

DTIC Science & Technology

2015-05-15

receiver required to work in a dense EMI environment. (15) Any RF receiver with a burnout level of less than 30 dBm (1 mW). b. A summary of all...Context 2.1 ISO-IEC-IEEE-15288: 2015, Systems and Software Engineering — System life cycle processes ISO-IEC-IEEE 15288 is the DOD-adopted standard for...to ISO-15288 for application of systems engineering on defense programs that was developed by a joint services working group under the auspices of the

The INPE handouts to the 6th LANDSAT Technical Working Group (LTWG) Meeting

NASA Technical Reports Server (NTRS)

Debarrosaguirre, J. L. (Principal Investigator); Parada, L. E. M.; Depaulapereira, S.

1984-01-01

LANDSAT receiving and processing system in its present configuration and status are described, as well as the experience already obtained with LANDSATs 4 and 5. The revised table of station plans for TM reception and products and of implementation schedule for data formats employing superstructure conventions is updated. Standardization of the worldwide reference systems is proposed. The INPE preliminary TM products price list is included. A TM image received and processed is shown to illustrate the appearance of the products offered.

[Ultrasound dynamics lysis apex thrombus as an objective criterion of effectiveness of anticoagulation therapy in venous thrombosis].

PubMed

Kalinin, R E; Suchkov, I A; Pshennikov, A S; Agapov, A B

2016-01-01

To assess the effectiveness of anticoagulant therapy (ACT) for the treatment of patients with deep venous thrombosis (DVT) of the lower extremities. The study considered ultrasonic characteristics of lysis of the proximal part of thrombus: localization and nature of venous thrombosis, the length and diameter of the proximal floating part of the thrombus, and duration of the venous thrombosis. Depending on the ACT options patients were divided into 3 groups: Group 1 (18 patients) received rivaroxaban, group 2 (19 patients) received enoxaparin sodium with subsequent transition to warfarin, and 3 group (19 patietns) received enoxaparin sodium, followed by administration of rivaroxaban. Treatment with rivaroxaban was preferable over standard ACT with enoxaparin/warfarin with regards to the lysis of thrombus when duration of thrombosis did not exceed 10 days. In 10.5% of patients who received warfarin flotation of thrombi remained for 14 days; the length of the floating part of the thrombi did not exceed 3 cm. Such circumstances and inability to reach a therapeutic INR value required cava filter placement. Treatment with enoxaparin sodium followed by the administration of rivaroxaban was found to be the most efficient ACT regimen as there was no negative dynamics of ultrasound characteristics of lysis of thrombi at any duration of the disease.

Is periprostatic nerve block a gold standard in case of transrectal ultrasound-guided prostate biopsy?

PubMed Central

Kumar, Ashok; Griwan, Mahavir Singh; Singh, Santosh Kumar; Sen, Jyotsna; Pawar, D. S.

2013-01-01

Introduction: Controversy exists over the pain during prostate biopsy. Periprostatic nerve block (PNB) is a gold standard anesthetic technique during transrectal ultrasound (TRUS)-guided prostate biopsy. Recent studies showed that PNB alone is insufficient as analgesic. We compared the efficacy of tramadol and intraprostatic nerve block (INB) in addition to PNB. Materials and Methods: We conducted a prospective double blinded placebo controlled study at our institute in 150 consecutive patients. Patients were randomized into three groups. Group A received PNB with INB with 1% lignocaine. Group B received oral tramadol with PNB. Group C patients were administered PNB only with 1% lignocaine. Patients were asked to grade the pain level using 11 point linear visual analog scale (VAS) at the time of ultrasound probe insertion, at time of anesthesia, during biopsy, and 30 min after biopsy. Results: The study groups were comparable in demographic profile, prostate-specific antigen (PSA) levels, and prostate size. Group A recorded the minimum mean pain score of 2.66 during prostate biopsy which was significantly lower than group 3 (P < 0.001). Group B recorded significantly lower pain score at time of probe insertion and at anesthetic needle insertion than other two groups. Conclusions: PNB provides better pain control in TRUS-guided prostate biopsy but still there is need of additional analgesic in the form of tramadol or INB. Tramadol has advantage of oral intake and analgesic effect at time of probe insertion and at nerve block. Both tramadol and INB may be used in combination along with PNB. PMID:24049376

Standardized versus custom parenteral nutrition: impact on clinical and cost-related outcomes.

PubMed

Blanchette, Lisa M; Huiras, Paul; Papadopoulos, Stella

2014-01-15

Results of a study comparing clinical and cost outcomes with the use of standardized versus custom-prepared parenteral nutrition (PN) in an acute care setting are reported. In a retrospective pre-post analysis, nutritional target attainment, electrolyte abnormalities, and other outcomes were compared in patients 15 years of age or older who received custom PN (n = 49) or a standardized PN product (n = 57) for at least 72 hours at a large medical center over a 13-month period; overall, 45% of the cases were intensive care unit (ICU) admissions. A time-and-motion assessment was conducted to determine PN preparation times. There were no significant between-group differences in the percentage of patients who achieved estimated caloric requirements or in mean ICU or hospital length of stay. However, patients who received standardized PN were significantly less likely than those who received custom PN to achieve the highest protein intake goal (63% versus 92%, p = 0.003) and more likely to develop hyponatremia (37% versus 14%, p = 0.01). Pharmacy preparation times averaged 20 minutes for standardized PN and 80 minutes for custom PN; unit costs were $61.06 and $57.84, respectively. A standardized PN formulation was as effective as custom PN in achieving estimated caloric requirements, but it was relatively less effective in achieving 90% of estimated protein requirements and was associated with a higher frequency of hyponatremia. The standardized PN product may be a cost-effective formulation for institutions preparing an average of five or fewer PN orders per day.

Assisted autogenic drainage in infants and young children hospitalized with uncomplicated pneumonia, a pilot study.

PubMed

Corten, Lieselotte; Jelsma, Jennifer; Human, Anri; Rahim, Sameer; Morrow, Brenda M

2018-01-01

Pneumonia is the most important respiratory problem in low-to-middle income countries. Airway clearance therapy continues to be used in children with pneumonia and secretion retention; however, there is lack of evidence to support or reject this treatment. This study aimed to investigate the feasibility of a randomized controlled trial (RCT) on the efficacy and safety of assisted autogenic drainage (AAD) compared to standard nursing care in children hospitalized with uncomplicated pneumonia. A single-blinded pilot RCT was conducted on 29 children (median age 3.5 months, IQR 1.5-9.4) hospitalized with uncomplicated pneumonia. The intervention group received standard nursing care with additional bi-daily AAD, for 10 to 30 min. The control group only received standard nursing care, unless otherwise deemed necessary by the physician or physiotherapist. The primary outcome measure was duration of hospitalization. The secondary outcome measures included days of fever and supplemental oxygen support; respiratory rate (RR) and heart rate adjusted for age; RR and oxygen saturation pre-, post-, and 1-hr post-treatment; oxygen saturation; adverse events; and mortality. No difference was found for duration of hospitalization (median 7.5 and 7.0 days for the control and intervention groups, respectively); however, Kaplan-Meier analysis revealed a strong tendency towards a shorter time to discharge in the intervention group (p = .06). No significant differences were found for the other outcome measures at time of discharge. No adverse events were reported. Within the intervention group, a significant reduction in RR adjusted for age was found. As no adverse events were reported, and AAD did not prolong hospitalization; AAD might be considered as safe and effective in young children with uncomplicated pneumonia. However, a larger multicentred RCT is warranted to determine the efficacy of AAD compared to standard nursing care. Copyright © 2017 John Wiley & Sons, Ltd.

Efficacy of a videoconferencing intervention compared with standard postnatal care at primary care health centres in Catalonia.

PubMed

Seguranyes, Gloria; Costa, Dolors; Fuentelsaz-Gallego, Carmen; Beneit, Juan Vicente; Carabantes, David; Gómez-Moreno, Carme; Palacio-Tauste, Alicia; Pauli, Angels; Abella, Montserrat

2014-06-01

to evaluate the efficacy of an intervention combining videoconferencing and telephone contact compared to standard post partum care of recent mothers attending health centres in Catalonia were recorded. multicentre, randomised parallel controlled clinical trial. 1598 post partum women with Internet access attending eight 'Attention to Sexual and Reproductive Health' (Catalan acronym ASSIR) units at Primary Health Care centres, in Catalonia (Spain). at each of the eight ASSIR units, 100 women were randomly assigned to the intervention group (IG) and 100 to the control group (CG). Women in the IG could consult midwives by videoconference or telephone and could also receive standard care. Women in the control group received standard care from midwives at their health centres or at home. number and type of visits, reasons for consultation, type of feeding at six weeks and women's satisfaction with the intervention on a scale of 1 to 5. 1401 women were studied (80.9% of the initial sample), 683 in the IG and 718 in the CG. Two hundred and seventy-six women (40.4%) used videoconferencing or telephone in the IG. The mean total visits, virtual and face-to-face, was higher in IG women than in controls (2.74 versus 1.22). IG women made fewer visits to the health centre (mean=1) than CG women (mean=1.17). Both differences were statistically significant, with p<0.001 and p=0.002 respectively. The prevalence of breast feeding was similar in the two groups (IG 64.5%, and CG 65.4%). The mean overall satisfaction of women with midwife care was very high in both groups (IG 4.77, CG 4.76). virtual care via videoconferencing is effective for post partum women. It reduces the number of health centre visits and allows mothers to consult health staff immediately and from their own home. © 2013 Elsevier Ltd. All rights reserved.

Moms in motion: a group-mediated cognitive-behavioral physical activity intervention.

PubMed

Cramp, Anita G; Brawley, Lawrence R

2006-08-22

When examining the prevalence of physical inactivity by gender and age, women over the age of 25 are at an increased risk for sedentary behavior. Childbearing and motherhood have been explored as one possible explanation for this increased risk. Post natal exercise studies to date demonstrate promising physical and psychological outcomes, however few physical activity interventions have been theory-driven and tailored to post natal exercise initiates. The purpose of this study was to compare the effects of a group-mediated cognitive behavioral intervention based upon social-cognitive theory and group dynamics (GMCB) to a standard care postnatal exercise program (SE). A randomized, two-arm intervention design was used. Fifty-seven post natal women were randomized to one of two conditions: (1) a standard exercise treatment (SE) and (2) a standard exercise treatment plus group-mediated cognitive behavioral intervention (GMCB). Participants in both conditions participated in a four-week intensive phase where participants received standard exercise training. In addition, GMCB participants received self-regulatory behavioral skills training via six group-mediated counseling sessions. Following the intensive phase, participants engaged in a four-week home-based phase of self-structured exercise. Measures of physical activity, barrier efficacy, and proximal outcome expectations were administered and data were analyzed using ANCOVA procedures. ANCOVA of change scores for frequency, minutes, and volume of physical activity revealed significant treatment effects over the intensive and home-based phases (p's < 0.01). In addition, ANCOVA of change in mean barrier efficacy and proximal outcome expectations at the conclusion of the intensive phase demonstrated that GMCB participants increased their initial level of barrier efficacy and outcome expectations while SE participants decreased (p < 0.05). While both exercise programs resulted in improvements to exercise participation, the GMCB intervention produced greater improvement in overall physical activity, barrier efficacy and proximal outcome expectations.

Reporting 'Denominator' data is essential for benchmarking and quality standards in ovarian cancer.

PubMed

Phillips, Andrew; Balega, Janos; Nevin, James; Singh, Kavita; Elattar, Ahmed; Kehoe, Sean; Sundar, Sudha

2017-07-01

Combined surgery and platinum-based chemotherapy is the internationally agreed standard therapy for advanced ovarian cancer (AOC). However international cancer registry datasets demonstrate a significant proportion of patients do not receive both or either therapies. Our objective was to evaluate the effect of total patient cohort data ('Denominator') on median overall survival (OS) and determine how frequently this was reported in literature. We retrospectively reviewed OS outcomes for 593 patients diagnosed with AOC for 77 months at a regional cancer centre. Patients were stratified into five progressively overlapping categories based on treatment received - Primary debulking surgery (PDS), PDS or Interval debulking (IDS), all surgery and those considered for IDS, patients receiving any treatment and total patient cohort. A systematic search of literature was performed. Median OS progressively decreased from 54.5 months in patients receiving PDS, 38.7 months in the PDS+IDS group, 35.4 months in the PDS/IDS+patients considered for IDS, 33.3 months in patients receiving any treatment and 30.2 months in the total patient cohort. OS in the surgically treated group was statistically significantly different from the OS in the total patient cohort (Denominator)(p=0.000353). Denominator descriptors were identified in 11% of studies. Denominator data is critical to understanding selection and OS in AOC. Published outcomes of selected cohorts should routinely incorporate outcomes for all women managed within the reporting Centre. This is essential for benchmarking and quality assurance in gynaecological cancer and should be an integral part of any publication on outcomes from AOC. Copyright © 2017 Elsevier Inc. All rights reserved.

Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis.

PubMed

Park, Hyoung-Chul; Kim, Min Jeong; Lee, Bong Hwa

Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively. We enrolled 1,343 patients who underwent laparoscopic surgery for complicated appendicitis between January 2009 and December 2014. At the beginning of the new protocol, the patients were divided into two groups; 10 days of various antibiotic regimens (between January 2009 and June 2012, called the non-standardized protocol; n = 730) and five days of cefuroxime and metronidazole regimen (between July 2012 and December 2014; standardized protocol; n = 613). We compared the clinical outcomes, including surgical site infection (SSI) (superficial and deep organ/space infections) in the two groups. The standardized protocol group had a slightly shorter operative time (67 vs. 69 min), a shorter hospital stay (5 vs. 5.4 d), and lower medical cost (US$1,564 vs. US$1,654). Otherwise, there was no difference between the groups. No differences were found in the non-standardized and standard protocol groups with regard to the rate of superficial infection (10.3% vs. 12.7%; p = 0.488) or deep organ/space infection (2.3% vs. 2.1%; p = 0.797). In patients undergoing laparoscopic surgery for complicated appendicitis, five days of cefuroxime and metronidazole did not lead to more SSIs, and it decreased the medical costs compared with non-standardized antibiotic regimens.

The effects of a three-year smoking prevention programme in secondary schools in Helsinki.

PubMed

Vartiainen, Erkki; Pennanen, Marjaana; Haukkala, Ari; Dijk, Froukje; Lehtovuori, Riku; De Vries, Hein

2007-06-01

This study evaluates the effects of a 3-year smoking prevention programme in secondary schools in Helsinki. The study is part of the European Smoking prevention Framework Approach (ESFA), in which Denmark, Finland, the Netherlands, Portugal, Spain and the UK participated. A total of 27 secondary schools in Finland participated in the programme (n = 1821). Schools were randomised into experimental (13) and control groups (14). The programme included 14 information lessons about smoking and refusal skills training. The 3-year smoking prevention programme was also integrated into the standard curriculum. The community-element of the programme included parents, parish confirmation camps and dentists. The schools in the experimental group received the prevention programme and the schools in the control group received the standard health education curriculum. Among baseline never smokers (60.8%), the programme had a significant effect on the onset of weekly smoking in the experimental group [OR = 0.63 (0.45-0.90) P = 0.009] when compared with the control group. Being female, doing poorly at school, having parents and best friends who smoke and more pocket money to spend compared with others were associated with an increased likelihood of daily and weekly smoking onset. These predictors did not have an interaction effect with the experimental condition. This study shows that a school- and community-based smoking prevention programme can prevent smoking onset among adolescents.

[Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

PubMed

Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

2014-01-01

Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Topical oxygen therapy results in complete wound healing in diabetic foot ulcers.

PubMed

Yu, Janelle; Lu, Suzanne; McLaren, Ann-Marie; Perry, Julie A; Cross, Karen M

2016-11-01

Diabetic foot ulcers (DFUs) are a significant problem in an aging population. Fifteen percent of diabetics develop a DFU over their lifetime, which can lead to potential amputation. The 5-year survival rate after amputation is 31%, which is greater than the lifetime risk of mortality from cancer. Topical oxygen is a promising technique for the adjunctive therapy of chronic wounds including DFUs, but few controlled studies exist to support its clinical adoption. The aim of this study was to compare a portable topical oxygen delivery system in patients with nonhealing DFUs to standard best practice. Twenty patients were randomized into a topical oxygen group (n = 10), and a nonplacebo control group with regular dressings and standard care (n = 10), and attended the diabetic foot clinic once weekly for 8 weeks. Ulcer surface area over time was analyzed using standardized digital imaging software. DFUs were present without healing for a mean duration of 76 weeks prior to the study. They found a significant difference in healing rate between patients receiving topical oxygen and those receiving standard care. Topical oxygen, therefore, represents a potentially exciting new technology to shorten healing time in patients with nonhealing DFUs. More prospective randomized and powered studies are needed to determine the benefits of topical oxygen, but our current results are very promising. © 2016 by the Wound Healing Society.

Order information and free recall: evaluating the item-order hypothesis.

PubMed

Mulligan, Neil W; Lozito, Jeffrey P

2007-05-01

The item-order hypothesis proposes that order information plays an important role in recall from long-term memory, and it is commonly used to account for the moderating effects of experimental design in memory research. Recent research (Engelkamp, Jahn, & Seiler, 2003; McDaniel, DeLosh, & Merritt, 2000) raises questions about the assumptions underlying the item-order hypothesis. Four experiments tested these assumptions by examining the relationship between free recall and order memory for lists of varying length (8, 16, or 24 unrelated words or pictures). Some groups were given standard free-recall instructions, other groups were explicitly instructed to use order information in free recall, and other groups were given free-recall tests intermixed with tests of order memory (order reconstruction). The results for short lists were consistent with the assumptions of the item-order account. For intermediate-length lists, explicit order instructions and intermixed order tests made recall more reliant on order information, but under standard conditions, order information played little role in recall. For long lists, there was little evidence that order information contributed to recall. In sum, the assumptions of the item-order account held for short lists, received mixed support with intermediate lists, and received no support for longer lists.

The p-Value You Can't Buy.

PubMed

Demidenko, Eugene

2016-01-02

There is growing frustration with the concept of the p -value. Besides having an ambiguous interpretation, the p- value can be made as small as desired by increasing the sample size, n . The p -value is outdated and does not make sense with big data: Everything becomes statistically significant. The root of the problem with the p- value is in the mean comparison. We argue that statistical uncertainty should be measured on the individual, not the group, level. Consequently, standard deviation (SD), not standard error (SE), error bars should be used to graphically present the data on two groups. We introduce a new measure based on the discrimination of individuals/objects from two groups, and call it the D -value. The D -value can be viewed as the n -of-1 p -value because it is computed in the same way as p while letting n equal 1. We show how the D -value is related to discrimination probability and the area above the receiver operating characteristic (ROC) curve. The D -value has a clear interpretation as the proportion of patients who get worse after the treatment, and as such facilitates to weigh up the likelihood of events under different scenarios. [Received January 2015. Revised June 2015.].

Frontal lesions predict response to prism adaptation treatment in spatial neglect: A randomised controlled study.

PubMed

Goedert, Kelly M; Chen, Peii; Foundas, Anne L; Barrett, A M

2018-03-20

Spatial neglect commonly follows right hemisphere stroke. It is defined as impaired contralesional stimulus detection, response, or action, causing functional disability. While prism adaptation treatment is highly promising to promote functional recovery of spatial neglect, not all individuals respond. Consistent with a primary effect of prism adaptation on spatial movements, we previously demonstrated that functional improvement after prism adaptation treatment is linked to frontal lobe lesions. However, that study was a treatment-only study with no randomised control group. The current study randomised individuals with spatial neglect to receive 10 days of prism adaptation treatment or to receive only standard care (control group). Replicating our earlier results, we found that the presence of frontal lesions moderated response to prism adaptation treatment: among prism-treated patients, only those with frontal lesions demonstrated functional improvements in their neglect symptoms. Conversely, among individuals in the standard care control group, the presence of frontal lesions did not modify recovery. These results suggest that further research is needed on how frontal lesions may predict response to prism adaptation treatment. Additionally, the results help elucidate the neural network involved in spatial movement and could be used to aid decisions about treatment.

Ameliorative effects of l-carnitine on rats raised on a diet supplemented with lead acetate.

PubMed

El-Sherbini, El-Said; El-Sayed, Gehad; El Shotory, Rehab; Gheith, Nervana; Abou-Alsoud, Mohamed; Harakeh, Steve Mustapha; Karrouf, Gamal I

2017-09-01

Lead intoxication has been a major health hazard in humans. It affects people at all ages. Its toxicity is associated with various organs of the body and affects different metabolic pathways. Based on histological data, l-carnitine reduced the severity of tissue damage produced as a result of exposure of rats to lead acetate. The main objective of this study was to evaluate the underlying mechanism of protection offered by l-carnitine against lead acetate intoxication using male Sprague-Dawley rats. Forty male Sprague-Dawley rats were randomly divided into four groups with ten rats in each. The first group (G1) served as the control group and animals received standard diet only. The second group (G2) received lead acetate in their diet. The third group (G3) was the l-carnitine treated group and received the normal standard diet supplemented with l-carnitine. While the fourth group (G4) had a diet supplemented with both lead acetate and l-carnitine. At the end of each experiment, blood (serum and whole blood) were collected from each animal and analyzed for the following parameters: serum testosterone levels, serum nitric oxide and serum malondialdehyde. This is in addition to looking at the enzymatic activities of two important enzymes (superoxide dismutase and catalase) and on (glutathione reductase) which are indicative of the antioxidant activities in the whole blood. The results indicated that l-carnitine will counteract the undesirable effects of lead intoxication. It exerted its antioxidant potential by reducing the production of ROS and scavenging free radicals by maintaining and protecting the level of the of antioxidant enzymes SOD, CAT and glutathione peroxidase. Conclusion: l-Carnitine may play an important role in reversing the undesirable effects of lead intoxication. Future studies should be conducted to see whether such an effect is applicable in humans exposed to lead poising.

Naked aggression: Personality and portfolio manager performance

PubMed Central

2018-01-01

We provide evidence that a personality trait, aggression, has a first-order effect on group financial decision making. In a laboratory experiment on group portfolio choice, highly aggressive subjects (measured by a standard psychology test) were much more likely to recommend risky investment strategies consistent with their own personal information, regardless of the information received by other group members. Outside of this group context, aggression had no effect on subject behavior. Thus, our aggression measure appears to capture an aggressive disposition, which seeks to dominate group decisions, rather than simply reflect risk attitudes or cognitive biases. PMID:29432449

Therapeutic effect of alkaloids and glycosides of colocynth seeds on liver injury, associated with metabolic syndrome in wistar rats, subject to nutritional stress.

PubMed

Tabani, Khadidja; Birem, Zahia; Halzoune, Hanane; Saiah, Wassila; Lahfa, Farid; Koceir, Elhadj Ahmed; Omari, Naima

2018-01-01

The Citrullus colocynthis, commonly called colocynth, is known because of its purgative effects and whose seeds are commonly used as certain diseases treatment, namely liver diseases, in the Mediterranean countries traditional medicine. This study aims to analyze the effect of two colocynth extracts « glycosides » and « alkaloids » on metabolic and histological disorders associated with liver function in Wistar rats (Rattus norvegicus). This pathology is due to an enriched oil palm diet. For this purpose, Wistar male rats n = 18, weighing between 130g and 150g, are divided into two lots. A control group (C) n = 6, receives a standard laboratory diet ; an experimental group (E) n = 12, receives a standard laboratory diet supplemented with palm oil. After seven months of experimentation, 8 experimental rats were sacrificed for the morphological study and the remaining 12 rats undergo a colocynth treatment (Tr) for eight weeks. They are subdivided into: The first six experimental rats receive a 70mg/kg single intraperitoneal injection of ethanol extract of cucurbitacin glycosides (Glc). The second lot receives a 70mg/kg single intraperitoneal injection of total alkaloids extract (Alc). The animals of (E) group showed hyperglycemia, hyperinsulinemia, hyperlipemia, dyslipoproteinemia, a significant increase of the enzymatic activity of transaminase (AST and ALT) and alkaline phosphatase (ALP). Histological examination of the liver gland shows major damages Non-alcoholic steatohepatitis [NASH]. Treatment with colocynth glycosides and alkaloids reveals a significant improvement at different levels in plasma as well as in tissue. Treatment with colocynth glycosides and alkaloids shows a hypoglycemic effect, lipid-lowering a well as a hepato-protective effect.

Kefir reduces insulin resistance and inflammatory cytokine expression in an animal model of metabolic syndrome.

PubMed

Rosa, Damiana D; Grześkowiak, Łukasz M; Ferreira, Célia L L F; Fonseca, Ana Carolina M; Reis, Sandra A; Dias, Mariana M; Siqueira, Nathane P; Silva, Leticia L; Neves, Clóvis A; Oliveira, Leandro L; Machado, Alessandra B F; Peluzio, Maria do Carmo G

2016-08-10

There is growing evidence that kefir can be a promising tool in decreasing the risk of many diseases, including metabolic syndrome (MetS). The aim of the present study was to evaluate the effect of kefir supplementation in the diet of Spontaneously Hypertensive Rats (SHR) in which MetS was induced with monosodium glutamate (MSG), and to determine its effect on metabolic parameters, inflammatory and oxidation marker expression and glycemic index control. Thirty animals were used in this experiment. For the induction of MetS, twenty two-day-old male SHR received five consecutive intradermal injections of MSG. For the Negative Control, ten newborn male SHR received intradermal injections of saline solution (0.9% saline solution). After weaning, animals received standard diet and water ad libitum until reaching 3 months old, for the development of MetS. They were then divided into three groups (n = 10): negative control (NC, 1 mL saline solution per day), positive control (PC, 1 mL saline solution per day) and the Kefir group (1 mL kefir per day). Feeding was carried out by gavage for 10 weeks and the animals received standard food and water ad libitum. Obesity, insulin resistance, pro- and anti-inflammatory markers, and the histology of pancreatic and adipose tissues were among the main variables evaluated. Compared to the PC group, kefir supplementation reduced plasma triglycerides, liver lipids, liver triglycerides, insulin resistance, fasting glucose, fasting insulin, thoracic circumference, abdominal circumference, products of lipid oxidation, pro-inflammatory cytokine expression (IL-1β) and increased anti-inflammatory cytokine expression (IL-10). The present findings indicate that kefir has the potential to benefit the management of MetS.

Evaluation of the benefits of low back pain patients' education workshops during spa therapy.

PubMed

Gremeaux, Vincent; Benaïm, Charles; Poiraudeau, Serge; Hérisson, Christian; Dupeyron, Arnaud; Coudeyre, Emmanuel

2013-01-01

To evaluate the medium-term impact of education workshops on low back pain (LBP) in the setting of a thermal spa on: fear-avoidance beliefs, disability, pain, and satisfaction. Randomized prospective alternate-month design-type study including 360 individuals having thermal spa therapy for LBP: 188 in the intervention group (three standardized education workshops lasting 1 h 30 each and usual thermal therapy for 3 weeks), 172 in the control group (usual thermal therapy and non-standardized verbal information). The principal analysis criterion was the difference in the fear-avoidance beliefs (physical FABQ) score between baseline and 6 months after the therapy; secondary criteria were: evolution of disability (Quebec Scale) and pain intensity (Visual Analogue Scale), and satisfaction with the information received. There was a significant reduction in the physical FABQ score at 6 months (P<0.05), and this reduction was more marked in the intervention group (-5.8±0.7 vs. -2±0.72 points out of 24; P<0.0001). Disability and pain significantly decreased in both groups (P<0.05), with no difference between groups. These workshops also had a significant effect on satisfaction with the information received. Standardized education workshops have a beneficial impact on LBP and contribute to an improvement in the medical services provided during spa therapy by reducing the effect of fear-avoidance beliefs as well as relieving pain. Extending the use of such workshops could contribute to enhance the positive impact of spa therapy in the management of chronic disabling diseases. Copyright © 2012 Société française de rhumatologie. Published by Elsevier SAS. All rights reserved.

Effect of an oxygen pressure injection (OPI) device on the oxygen saturation of patients during dermatological methyl aminolevulinate photodynamic therapy.

PubMed

Blake, E; Allen, J; Thorn, C; Shore, A; Curnow, A

2013-05-01

Methyl aminolevulinate photodynamic therapy (MAL-PDT) (a topical treatment used for a number of precancerous skin conditions) utilizes the combined interaction of a photosensitizer (protoporphyrin IX (PpIX)), light of the appropriate wavelength, and molecular oxygen to produce singlet oxygen and other reactive oxygen species which induce cell death. During treatment, localized oxygen depletion occurs and is thought to contribute to decreased efficacy. The aim of this study was to investigate whether an oxygen pressure injection (OPI) device had an effect on localized oxygen saturation levels and/or PpIX fluorescence of skin lesions during MAL-PDT. This study employed an OPI device to apply oxygen under pressure to the skin lesions of patients undergoing standard MAL-PDT. Optical reflectance spectrometry and fluorescence imaging were used to noninvasively monitor the localized oxygen saturation and PpIX fluorescence of the treatment area, respectively. No significant changes in oxygen saturation were observed when these data were combined for the group with OPI and compared to the group that received standard MAL-PDT without OPI. Additionally, no significant difference in PpIX photobleaching or clinical outcome at 3 months between the groups of patients was observed, although the group that received standard MAL-PDT demonstrated a significant increase (p<0.05) in PpIX fluorescence initially and both groups produced a significant decrease (p<0.05) after light irradiation. In conclusion, with this sample size, this OPI device was not found to be an effective method with which to improve tissue oxygenation during MAL-PDT. Further investigation is therefore required to find a more effective method of MAL-PDT enhancement.

Deep water running and general practice in primary care for non-specific low back pain versus general practice alone: randomized controlled trial.

PubMed

Cuesta-Vargas, A I; Adams, N; Salazar, J A; Belles, A; Hazañas, S; Arroyo-Morales, M

2012-07-01

There is equivocal evidence regarding the benefits of aquatic aerobic exercise for non-specific chronic low back pain (NSCLBP) in addition to standard care in general practice consisting of education and advice. The purpose of this study was to compare the addition of deep water running (DWR) to standard general practice (GP) on NSCLBP versus GP care alone on pain, physical and mental health and disability. In this single-blind randomised controlled trial, 58 subjects with NSCLBP were recruited from primary care. The control group received GP care consisting of a physician's consultation and educational booklet only. The experimental group received additional 30-min sessions of DWR three times a week for 15 weeks at the individualized aerobic threshold. Measurements were made pre- and post-intervention and at 1-year follow-up. Both groups showed improvement. The difference between treatment effects at longest follow-up of 1 year was -26.0 (-40.9 to -11.1) mm on the VAS (p < 0.05), -2.5 (-5.7 to -0.2) points in RMQ for disability (p < 0.05), 3.3 (10.0 to 24.7) points on physical health in the physical summary component of the Spanish Short Form 12 (SF-12; p < 0.05) and 5.8 (8.6 to 34.7) points on the mental summary component of the SF-12 (p < 0.05), in favour of the DWR group. For patients with NSCLBP, the addition of DWR to GP was more effective in reducing pain and disability than standard GP alone, suggesting the effectiveness and acceptability of this approach with this group of patients.

Survival benefit of patients with early-stage ovarian carcinoma treated with paclitaxel chemotherapeutic regimens

PubMed Central

2018-01-01

Objective Adjuvant chemotherapy was introduced in patients with early-stage ovarian cancer (OC). The benefit of standard chemotherapeutic regimens including taxane has not been established. Methods Patients with early-stage OC from the National Health Insurance Research database of Taiwan who received platinum plus cyclophosphamide (CP) or platinum plus paclitaxel (PT) for 3–6 cycles were recruited, and the disease-free survival (DFS) and overall survival (OS) were determined. Results A total of 1,510 early-stage OC patients, including 841 who received CP regimen and 699 who received PT regimen, were included. The 2 groups had a similar estimated probability of 5-year DFS (PT vs. CP, 79.0% vs. 77.6%; p=0.410) and OS (84.6% vs. 84.3%; p=0.691). Patients >50 years of age who received the CP regimen had a lower 5-year DFS than the patients ≤50 years of age who received the CP (p<0.001) or PT regimens (p=0.001). Additionally, patients >50 years of age who received the CP regimen had a worse 5-year OS compared with the other 3 groups (p=0.019) (p=0.179 for patients >50 years of age in the PT group; p=0.002 for patients ≤50 years of age in the CP group; and p=0.061 for patients ≤50 years of age in the PT group). Patients with the CP or PT regimen for 3–5 cycles had a similar 5-year DFS and OS compared to 6 cycles (p>0.050). Conclusion Chemotherapeutic regimens with taxane could be recommended for early-stage OC patients >50 years of age. PMID:29185274

The effect of duration of dose delivery with patient-controlled analgesia on the incidence of nausea and vomiting after hysterectomy

PubMed Central

Woodhouse, Annie; Mather, Laurence E

1998-01-01

Aims Postoperative nausea and vomiting (PONV) may be exacerbated by postoperative opioid analgesics and may limit patients’ successful use of these medications when used with patient controlled analgesia (PCA). We tested the hypothesis that the rapid change in blood morphine concentration associated with PCA bolus delivery contributed to PONV, and that prolonging its delivery to a brief infusion would result in decreased PONV. Methods Patients, who were receiving morphine for pain relief via patient-controlled analgesia (PCA) after total abdominal hysterectomy, received 1 mg morphine sulphate incremental doses either over 40 s with a 5 min lockout interval or over 5 min delivery with a 1 min lockout interval. Episodes of nausea, retching and vomiting, along with the use of morphine and the pain relief obtained, were recorded. Results Data from 20 patients in each group were analysed. Contrary to expectations, most patients in both groups reported nausea postoperatively. Those patients receiving morphine over 5 min experienced more episodes of emesis (36) than those receiving the dose over 40 s (17). Most patients receiving the 40 s doses vomited in the first 12 h (median time 8 h), while those receiving the 5 min doses vomited between 12 and 24 h (median time 19 h) (P=0.01). There were no differences between groups in the visual analogue pain scores or use of morphine between groups. Conclusions Reasons for these unexpected findings remain speculative. The high incidence of PONV appears to be inherently high in gynaecological surgery patients and standard antiemetic medication regimens appear to be poorly efficacious. Reasons for the differences in the time-course of emetic episodes between the two groups may be related to differences in the time-course of central opioid receptor occupancy. PMID:9489595

Enhanced invitation methods to increase uptake of NHS health checks: study protocol for a randomized controlled trial.

PubMed

Forster, Alice S; Burgess, Caroline; McDermott, Lisa; Wright, Alison J; Dodhia, Hiten; Conner, Mark; Miller, Jane; Rudisill, Caroline; Cornelius, Victoria; Gulliford, Martin C

2014-08-30

NHS Health Checks is a new program for primary prevention of heart disease, stroke, diabetes, chronic kidney disease, and vascular dementia in adults aged 40 to 74 years in England. Individuals without existing cardiovascular disease or diabetes are invited for a Health Check every 5 years. Uptake among those invited is lower than anticipated. The project is a three-arm randomized controlled trial to test the hypothesis that enhanced invitation methods, using the Question-Behaviour Effect (QBE), will increase uptake of NHS Health Checks compared with a standard invitation. Participants comprise individuals eligible for an NHS Health Check registered in two London boroughs. Participants are randomized into one of three arms. Group A receives the standard NHS Health Check invitation letter, information sheet, and reminder letter at 12 weeks for nonattenders. Group B receives a QBE questionnaire 1 week before receiving the standard invitation, information sheet, and reminder letter where appropriate. Group C is the same as Group B, but participants are offered a £5 retail voucher if they return the questionnaire. Participants are randomized in equal proportions, stratified by general practice. The primary outcome is uptake of NHS Health Checks 6 months after invitation from electronic health records. We will estimate the incremental health service cost per additional completed Health Check for trial groups B and C versus trial arm A, as well as evaluating the impact of the QBE questionnaire, and questionnaire plus voucher, on the socioeconomic inequality in uptake of Health Checks.The trial includes a nested comparison of two methods for implementing allocation, one implemented manually at general practices and the other implemented automatically through the information systems used to generate invitations for the Health Check. The research will provide evidence on whether asking individuals to complete a preliminary questionnaire, by using the QBE, is effective in increasing uptake of Health Checks and whether an incentive alters questionnaire return rates as well as uptake of Health Checks. The trial interventions can be readily translated into routine service delivery if they are shown to be cost-effective. Current Controlled Trials ISRCTN42856343. Date registered: 21.03.2013.

Salovum egg yolk containing antisecretory factor as an adjunct therapy in severe cholera in adult males: a pilot study.

PubMed

Alam, Nur H; Ashraf, Hasan; Olesen, Maryam; Salam, Mohammed A; Gyr, Niklaus; Meier, Remy

2011-08-01

Cholera involves stimulation of intestinal secretory process in response to cholera toxin leading to profuse watery diarrhoea that might cause death due to dehydration unless timely rehydration therapy is initiated. Efforts to identify and test potential antisecretory agents are ongoing. Antisecretory factor (AF) is a naturally-occurring protein produced in the human secretory organs, including the intestine, with antisectory properties demonstrated in animal and human models of secretory diarrhoea. Salovum egg yolk powder contains antisecretory proteins in a much higher (500 times) concentration than that of normal hen eggs. This is achieved by feeding hens with specially-processed cereals, capable of inducing antisecretory proteins in the yolk. The aim of the study was to examine the effect of Salovum egg yolk powder containing AF in the treatment of adult cholera patients. In an open, randomized controlled trial (pilot study), 40 adult male patients with severe cholera were studied: 20 received standard treatment (oral rehydration solution, antibiotic, and usual hospital diet) plus Salovum egg yolk powder (study group) and 20 received standard treatment alone (control group). All the patients received tablet doxycycline (300 mg) once immediately after randomization. Written informed consent was obtained from each subject before enrollment. The main outcome measures were stool weight and duration of diarrhoea. The demographic and baseline clinical characteristics of the study patients were comparable between the groups. No significant differences were found in the mean stool weight, g/kg of body-weight during the first 24 hours [study vs control group, mean +/- standard deviation (SD), 218 +/- 119 vs 195 +/- 136], second 24 hours (mean +/- SD, 23 +/- 39 vs 22 +/- 34), and cumulative up to 72 hours (mean +/- SD, 245 +/- 152 vs 218 +/- 169). The duration (hours) of diarrhoea after admission in the hospital was also similar in both the groups (mean +/- SD, 33 +/- 14 vs 32 +/- 10). No adverse effect was observed. Salovum egg powder containing AF as an adjunct therapy in the treatment of severe cholera could not demonstrate any beneficial effect. Further studies with higher doses of Salovum egg yolk powder might be considered in future to establish its antisecretory effect.

Injury risk in runners using standard or motion control shoes: a randomised controlled trial with participant and assessor blinding.

PubMed

Malisoux, Laurent; Chambon, Nicolas; Delattre, Nicolas; Gueguen, Nils; Urhausen, Axel; Theisen, Daniel

2016-04-01

This randomised controlled trial investigated if the usage of running shoes with a motion control system modifies injury risk in regular leisure-time runners compared to standard shoes, and if this influence depends on foot morphology. Recreational runners (n=372) were given either the motion control or the standard version of a regular running shoe model and were followed up for 6 months regarding running activity and injury. Foot morphology was analysed using the Foot Posture Index method. Cox regression analyses were used to compare injury risk between the two groups, based on HRs and their 95% CIs, controlling for potential confounders. Stratified analyses were conducted to evaluate the effect of motion control system in runners with supinated, neutral and pronated feet. The overall injury risk was lower among the participants who had received motion control shoes (HR=0.55; 95% CI 0.36 to 0.85) compared to those receiving standard shoes. This positive effect was only observed in the stratum of runners with pronated feet (n=94; HR=0.34; 95% CI 0.13 to 0.84); there was no difference in runners with neutral (n=218; HR=0.78; 95% CI 0.44 to 1.37) or supinated feet (n=60; HR=0.59; 95% CI 0.20 to 1.73). Runners with pronated feet using standard shoes had a higher injury risk compared to those with neutral feet (HR=1.80; 95% CI 1.01 to 3.22). The overall injury risk was lower in participants who had received motion control shoes. Based on secondary analysis, those with pronated feet may benefit most from this shoe type. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Quality standards for rheumatology outpatient clinic. The EXTRELLA project.

PubMed

Nolla, Joan M; Martínez, Carmen; García-Vicuña, Rosario; Seoane-Mato, Daniel; Rosario Lozano, M Piedad; Alonso, Alberto; Alperi, Mercedes; Barbazán, Ceferino; Calvo, Jaime; Delgado, Concepción; Fernández-Nebro, Antonio; Mateo, Lourdes; Pérez Sandoval, Trinidad; Pérez Venegas, José; Rodríguez Lozano, Carlos; Rosas, José

2016-01-01

In recent years, outpatient clinics have undergone extensive development. At present, patients with rheumatic diseases are mainly assisted in this area. However, the quality standards of care are poorly documented. To develop specific quality criteria and standards for an outpatient rheumatology clinic. The project was based on the two-round Delphi method. The following groups of participants took part: scientific committee (13 rheumatologists), five nominal groups (45 rheumatologists and 12 nurses) and a group of discussion formed by 9 patients. Different drafts were consecutively generated until a final document was obtained that included the standards that received a punctuation equal or over 7 in at least 70% of the participants. 148 standards were developed, grouped into the following 9 dimensions: a) structure (22), b) clinical activity and relationship with the patients (34), c) planning (7), d) levels of priority (5), e) relations with primary care physicians, with Emergency Department and with other clinical departments, f) process (26), g) nursing (13), h) teaching and research (13) and i) activity measures (8). This study established specific quality standards for rheumatology outpatient clinic. It can be a useful tool for organising this area in the Rheumatology Department and as a reference when proposing improvement measures to health administrators. Copyright © 2015 Elsevier España, S.L.U. and Sociedad Española de Reumatología y Colegio Mexicano de Reumatología. All rights reserved.

Training in Basic Laparoscopic Surgical Skills: Residents Opinion of the New Nintendo Wii-U Laparoscopic Simulator.

PubMed

Overtoom, Evelien M; Jansen, Frank-Willem; van Santbrink, Evert J P; Schraffordt Koops, Steven E; Veersema, Sebastiaan; Schreuder, Henk W R

Serious games are new in the field of laparoscopic surgical training. We evaluate the residents׳ opinion of a new laparoscopic simulator for the Nintendo Wii-U platform. Prospective questionnaire study. Participants received a standardized introduction and completed level 3 and 4 of the game "Underground." They filled out a questionnaire concerning demographics and their opinion on realism, usefulness, suitability, haptic feedback, and home training-use of the game. Two tertiary teaching hospitals. Obstetrics and gynaecology residents postgraduate year 1 to 6 (n = 59) from several European countries. Subjects (n = 59) were divided into 2 groups based on laparoscopic experience: Group A (n = 38) and Group B (n = 21). The realism of different aspects of the game received mean scores around 3 on a 5-point Likert scale. The hand-eye coordination was regarded most useful for training with a mean of 3.92 (standard deviation 0.93) and the game was considered most suitable for residents in the first part of their postgraduate training with a mean of 3.73 (standard deviation 0.97). Both groups differed especially concerning their opinion of the usefulness of the game as a training tool. Most residents liked the new serious game for the Nintendo Wii-U. The usefulness and suitability as a laparoscopic training tool were rated at an acceptable to high level. However, the game does require improvements such as inclusion of a good scoring system before it can be integrated in resident training curricula. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Literacy Messages, the Messenger and the Receiver.

ERIC Educational Resources Information Center

Fagan, William T.

The message about general literacy standards in Canada (as reported in the Southam Literacy Survey) is that approximately five million Canadians are illiterate. The validity of this message must be challenged because a group of middle-class Canadians with middle-class values established the criteria for being "literate" and felt that all…

Clinical Supervision for School Psychologists: National Practices, Trends and Future Implications.

ERIC Educational Resources Information Center

Fischetti, Barbara A.; Crespi, Tony D.

1999-01-01

Survey assesses current practice trends in the clinical supervision of school psychologists. Data indicates that while ten percent of practicing school psychologists were participating in individual and/or group clinical supervision nationwide, respondents were receiving less supervision than recommended by APA or NASP professional standards.…

Effects of Pilates-Based Core Stability Training in Ambulant People With Multiple Sclerosis: Multicenter, Assessor-Blinded, Randomized Controlled Trial.

PubMed

Fox, Esther E; Hough, Alan D; Creanor, Siobhan; Gear, Margaret; Freeman, Jennifer A

2016-08-01

Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=-0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation. © 2016 American Physical Therapy Association.

Needle-less local anesthesia: clinical evaluation of the effectiveness of the jet anesthesia Injex in local anesthesia in dentistry.

PubMed

Dabarakis, Nikolaos N; Alexander, Veis; Tsirlis, Anastasios T; Parissis, Nikolaos A; Nikolaos, Maroufidis

2007-01-01

To clinically evaluate the jet injection Injex (Rösch AG Medizintechnik) using 2 different anesthetic solutions, and to compare the jet injection and the standard needle injection techniques. Of the 32 patients in the study, 10 received mepivacaine 3% anesthetic solution by means of the jet injection technique, while the remaining 22 patients received lidocaine 2% with epinephrine 1:80,000 by the same method. The 14 patients in whom pulp anesthesia was achieved were selected for an additional evaluation of the pulp reaction using standard needle injection anesthesia. The differences between the 2 compounds with Injex were statistically evaluated by means of independent-samples t test analysis. The differences between subgroups receiving both jet injection and needle injection anesthesia were evaluated by means of paired t test analysis. The administration of mepivacaine 3% using Injex did not achieve pulp anesthesia in any of the 10 patients, although the soft tissue anesthesia was successful. The administration of lidocaine with epinephrine using Injex resulted in pulp anesthesia in only 14 patients; soft tissue anesthesia was observed in all patients of this group. There was no statistically significant difference between Injex and the needle injection technique in onset of anesthesia. However, the duration of anesthesia was significantly longer for the needle infiltration group than for the Injex injection group. The anesthetic solution should be combined with a vasoconstriction agent when the Injex technique is implemented.

A randomized clinical trial of self-help intervention for smoking cessation: research design, interventions, and baseline data.

PubMed

Unrod, Marina; Simmons, Vani N; Sutton, Steven K; Meltzer, Lauren R; Harrell, Paul T; Meade, Cathy D; Craig, Benjamin M; Lee, Ji-Hyun; Brandon, Thomas H

2014-07-01

Tobacco smoking is the leading preventable cause of mortality and morbidity. Although behavioral counseling combined with pharmacotherapy is the most effective approach to aiding smoking cessation, intensive treatments are rarely chosen by smokers, citing inconvenience. In contrast, minimal self-help interventions have the potential for greater reach, with demonstrated efficacy for relapse prevention, but not for smoking cessation. This paper summarizes the design and methods used for a randomized controlled trial to assess the efficacy of a minimal self-help smoking cessation intervention that consists of a set of booklets delivered across time. Baseline participant recruitment data are also presented. Daily smokers were recruited nationally via multimedia advertisements and randomized to one of three conditions. The Usual Care (UC) group received a standard smoking-cessation booklet. The Standard Repeated Mailings (SRM) group received 8 booklets mailed over a 12-month period. The Intensive Repeated Mailings (IRM) group received 10 booklets and additional supplemental materials mailed monthly over 18months. A total of 2641 smokers were screened, 2349 were randomized, and 1874 provided data for analyses. Primary outcomes will be self-reported abstinence at 6-month intervals up to 30months. If the self-help booklets are efficacious, this minimal, low cost intervention can be widely disseminated and, hence, has the potential for significant public health impact with respect to reduction in smoking-related illness and mortality. Copyright © 2014 Elsevier Inc. All rights reserved.

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery.

PubMed

Labetoulle, Marc; Findl, Oliver; Malecaze, François; Alió, Jorge; Cochener, Béatrice; Lobo, Conceição; Lazreg, Sihem; Hartani, Dahbia; Colin, Joseph; Tassignon, Marie-José; Behndig, Anders

2016-07-01

To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen. In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety. Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as 'routine' in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups. Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane. NCT02101359; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Effect of High Intensity Interval and Continuous Swimming Training on Body Mass Adiposity Level and Serum Parameters in High-Fat Diet Fed Rats.

PubMed

da Rocha, Guilherme L; Crisp, Alex H; de Oliveira, Maria R M; da Silva, Carlos A; Silva, Jadson O; Duarte, Ana C G O; Sene-Fiorese, Marcela; Verlengia, Rozangela

2016-01-01

This study aimed to investigate the effects of interval and continuous training on the body mass gain and adiposity levels of rats fed a high-fat diet. Forty-eight male Sprague-Dawley rats were randomly divided into two groups, standard diet and high-fat diet, and received their respective diets for a period of four weeks without exercise stimuli. After this period, the animals were randomly divided into six groups (n = 8): control standard diet (CS), control high-fat diet (CH), continuous training standard diet (CTS), continuous training high-fat diet (CTH), interval training standard diet (ITS), and interval training high-fat diet (ITH). The interval and continuous training consisted of a swimming exercise performed over eight weeks. CH rats had greater body mass gain, sum of adipose tissues mass, and lower serum high density lipoprotein values than CS. The trained groups showed lower values of feed intake, caloric intake, body mass gain, and adiposity levels compared with the CH group. No significant differences were observed between the trained groups (CTS versus ITS and CTH versus ITH) on body mass gains and adiposity levels. In conclusion, both training methodologies were shown to be effective in controlling body mass gain and adiposity levels in high-fat diet fed rats.

Internet of things and bariatric surgery follow-up: Comparative study of standard and IoT follow-up.

PubMed

Vilallonga, Ramon; Lecube, Albert; Fort, José Manuel; Boleko, Maria Angeles; Hidalgo, Marta; Armengol, Manel

2013-09-01

Follow-up of obese patient is difficult. There is no literature related to patient follow-up that incorporates the concept of Internet of Things (IoT), use of WiFi, Internet, or portable devices for this purpose. This prospective observational study commenced in June 2011. Patients were prospectively offered to participate in the IoT study group, in which they received a WiFi scale (Withing®, Paris) that provides instant WiFi data to the patient and surgeon. Other patients were admitted to the standard follow-up group at the outpatient clinic. A total of 33 patients were included in our study (ten in the IoT group). Twelve patients did not have WiFi at home, ten lacked of computer knowledge, and seven preferred standard for follow-up. All patients underwent different surgical procedures. There were no complications. Excess weight loss (EWL) was similar in both groups. More than 90% of patients were satisfied. In the IoT group, patients considered it valuable in saving time, and considered seeing their evolution graphics extremely motivating. IoT technology can monitor medical parameters remotely and collect data. A WiFi scale can facilitate preoperative and follow-up. Standard follow-up in a classical outpatient clinic setting with the surgeon was preferred globally.

[Analgesic effect of TES therapy in the early postoperative period in patients who underwent tonsillectomy].

PubMed

Semënov, F V; Kade, A Kh; Banashek-Meshchiarkova, T V; Vartanian, M S

2013-01-01

The objective of the present work was to study peculiarities of the analgesic action of therapeutic electrical stimulation (TES therapy) in the early postoperative period in the patients who underwent tonsillectomy. A total of 60 patients admitted for this surgery to the specialized otorhinolaryngological department were available for observation. They were divided into two groups depending on the pain relief strategy. The patients of the study group (n=30) underwent courses of transcranial electrical stimulation on a daily basis (from the onset of hospitalization) in addition to the administration of a standard analgetic. The standard dose of tramadol (2.0 ml) was given to the patients of the control group (n=30) who complained of strong pain. The results of the objective and subjective estimations indicate that the degree of pharyngeal pain in the patients treated with TES therapy and the standard analgetic was significantly different. The patients receiving TES therapy could sooner resume their habitual diet and required smaller amounts of the analgetic which makes this modality a cost-effective supplement to the standard postoperative treatment.

Choice of antibiotics for infection prophylaxis in emergency cesarean sections in low-income countries: a cost-benefit study in Mozambique.

PubMed

Kayihura, Vicente; Osman, Nafissa Bique; Bugalho, Antonio; Bergström, Staffan

2003-07-01

There is a need to assess the cost-benefit of different models of antibiotic administration for the prevention of post cesarean infection, particularly in resource-scarce settings. Randomized, nonblinded comparative study of a single combined preoperative dose of gentamicin and metronidazole vs. a post cesarean scheme for infection prophylaxis. Pregnant women (n = 288) with indication for emergency cesarean section were randomly allotted to two groups. Group 1 (n = 143) received the single, combined dose of prophylactic antibiotics and group 2 (n = 145) received, over 7 days, the postoperative standard scheme of antibiotics followed in the department. Both groups were followed up during 7 days for detection of signs of wound infection, endometritis, peritonitis and urinary tract infection. Prevalence of postoperative infection, mean hospital stay and costs of antibiotics used. Women completing the study (n = 241) were distributed into group 1 (n = 116) and group 2 (n = 125). No significant difference was found neither in the prevalence of postoperative infection nor in the mean hospital stay. No death occurred. The cost of the single dose of prophylactic antibiotics was less than one-tenth of the cost of the standard postoperative scheme. In our setting, the administration of a single dose of 160 mg of gentamicin in combination with 500 mg of metronidazole before emergency cesarean section for prevention of infection is clinically equivalent to existing conventional week-long postoperative therapy, but at approximately one-tenth of the cost.

[The assessment of the effectiveness of fenspiride (erespal) for the combined treatment of the patients presenting with exudative otitis media].

PubMed

Mel'chinskiĭ, A N; Vasilenko, D Iu; Kiseleva, G V

2013-01-01

The objective of the present work was to estimate the effectiveness and safety of combined anti-inflammatory therapy of exudative otitis media with the use of fenspiride (erespal). The study included 75 patients of whom 35 (group 1) were given standard therapy supplemented by erespal (80 mg thrice daily); the remaining patients receiving standard therapy alone formed group 2 (control). The patients treated with erespal reported the subjective improvement of hearing and reduced congestion on days 7 - 8. Similar changes in group 2 occurred on day 10. It is concluded that the use of erespal for the combined treatment of the patients presenting with exudative otitis media reduces the duration of hospital stay, accelerates recovery, and promotes rapid normalization of hearing.

Use of a web-based educational intervention to improve knowledge of healthy diet and lifestyle in women with Gestational Diabetes Mellitus compared to standard clinic-based education.

PubMed

Sayakhot, Padaphet; Carolan-Olah, Mary; Steele, Cheryl

2016-08-05

This study introduced a web-based educational intervention for Australian women with gestational diabetes mellitus (GDM). The aim was to improve knowledge on healthy diet and lifestyle in GDM. Evaluation of the intervention explored women's knowledge and understanding of GDM, healthy diet, healthy food, and healthy lifestyle, after using the web-based program compared to women receiving standard clinic-based GDM education. A total of 116 women, aged 18-45 years old, newly diagnosed with GDM, participated (Intervention (n) = 56 and control (n) = 60). Women were randomly allocated to the intervention or control groups and both groups attended a standard GDM education class. Group 1(Intervention) additionally used an online touch screen/computer program. All women completed a questionnaire following the computer program and/or the education class. All questions evaluating levels of knowledge had more than one correct answer and scores were graded from 0 to 1, with each correct component receiving a score, eg. 0.25 per each correct answer in a 4 answer question. Chi-square test was performed to compare the two groups regarding knowledge of GDM. Findings indicated that the majority of women in the intervention group reported correct answers for "types of carbohydrate foods" for pregnant women with GDM, compared to the control group (62.5 % vs 58.3 %, respectively). Most women in both groups had an excellent understanding of "fruits and vegetables" (98.2 % vs 98.3 %), and the majority of women in the intervention group understood that they should exercise daily for 30 min, compared to the control group (92.9 % vs 91.7 %). Both groups had a good understanding across all categories, however, the majority of women in the intervention group scored all correct answers (score = 1) in term of foetal effects (17.9 % vs 13.3 %, respectively), maternal predictors (5.4 % vs 5 %), care requirements (39.3 % vs 23.3 %), GDM perceptions (48.2 % vs 46.7 %) and GDM treatment (67.9 % vs 61.7 %), compared to women in the control group. The study suggested that both approaches, standard education and standard education plus web-based program, resulted in excellent knowledge scores, but not statistically significant difference between groups. Multiple and immediate access to the web-based education program at home may prove useful as a source of reference for women with GDM. Future study comparing results pre and post intervention is needed. ACTRN12615000697583 ; Date registered: 03/07/2015; Retrospectively registered.

The need for GPS standardization

NASA Technical Reports Server (NTRS)

Lewandowski, Wlodzimierz W.; Petit, Gerard; Thomas, Claudine

1992-01-01

A desirable and necessary step for improvement of the accuracy of Global Positioning System (GPS) time comparisons is the establishment of common GPS standards. For this reason, the CCDS proposed the creation of a special group of experts with the objective of recommending procedures and models for operational time transfer by GPS common-view method. Since the announcement of the implementation of Selective Availability at the end of last spring, action has become much more urgent and this CCDS Group on GPS Time Transfer Standards has now been set up. It operates under the auspices of the permanent CCDS Working Group on TAI and works in close cooperation with the Sub-Committee on Time of the Civil GPS Service Interface Committee (CGSIC). Taking as an example the implementation of SA during the first week of July 1991, this paper illustrates the need to develop urgently at least two standardized procedures in GPS receiver software: monitoring GPS tracks with a common time scale and retaining broadcast ephemeris parameters throughout the duration of a track. Other matters requiring action are the adoption of common models for atmospheric delay, a common approach to hardware design and agreement about short-term data processing. Several examples of such deficiencies in standardization are presented.

Electrically Assisted Movement Therapy in Chronic Stroke Patients With Severe Upper Limb Paresis: A Pilot, Single-Blind, Randomized Crossover Study.

PubMed

Carda, Stefano; Biasiucci, Andrea; Maesani, Andrea; Ionta, Silvio; Moncharmont, Julien; Clarke, Stephanie; Murray, Micah M; Millán, José Del R

2017-08-01

To evaluate the effects of electrically assisted movement therapy (EAMT) in which patients use functional electrical stimulation, modulated by a custom device controlled through the patient's unaffected hand, to produce or assist task-specific upper limb movements, which enables them to engage in intensive goal-oriented training. Randomized, crossover, assessor-blinded, 5-week trial with follow-up at 18 weeks. Rehabilitation university hospital. Patients with chronic, severe stroke (N=11; mean age, 47.9y) more than 6 months poststroke (mean time since event, 46.3mo). Both EAMT and the control intervention (dose-matched, goal-oriented standard care) consisted of 10 sessions of 90 minutes per day, 5 sessions per week, for 2 weeks. After the first 10 sessions, group allocation was crossed over, and patients received a 1-week therapy break before receiving the new treatment. Fugl-Meyer Motor Assessment for the Upper Extremity, Wolf Motor Function Test, spasticity, and 28-item Motor Activity Log. Forty-four individuals were recruited, of whom 11 were eligible and participated. Five patients received the experimental treatment before standard care, and 6 received standard care before the experimental treatment. EAMT produced higher improvements in the Fugl-Meyer scale than standard care (P<.05). Median improvements were 6.5 Fugl-Meyer points and 1 Fugl-Meyer point after the experimental treatment and standard care, respectively. The improvement was also significant in subjective reports of quality of movement and amount of use of the affected limb during activities of daily living (P<.05). EAMT produces a clinically important impairment reduction in stroke patients with chronic, severe upper limb paresis. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Early ICU Standardized Rehabilitation Therapy for the Critically Injured Burn Patient

DTIC Science & Technology

2016-10-01

physical therapy , respiratory therapy and related disciplines. Accordingly, the investigators feel that the proposed continuation plan will both fall... physical therapy , and progressive resistance exercise. The usual care group received weekday physical therapy when ordered by the clinical team. For the... physical therapy , and 3.0 (1.0-5.0) for progressive resistance exercise. Themedian days of delivery of physical therapy for the usual care group was 1.0

Randomized Controlled Trial Comparing Collagen/Oxidized Regenerated Cellulose/Silver to Standard of Care in the Management of Venous Leg Ulcers.

PubMed

Cullen, Breda M; Serena, Thomas E; Gibson, Molly C; Snyder, Robert J; Hanft, Jason R; Yaakov, Raphael A

2017-10-01

To assess healing outcomes in venous leg ulcers (VLUs) treated with a combination of collagen, oxidized regenerated cellulose, and silver in conjunction with standard of care (SOC; intervention group) compared with SOC alone (control group). Standard of care included ADAPTIC nonadhering dressing (Acelity, San Antonio, Texas) and compression. Randomized controlled trial that followed patients in 3 US facilities for 12 weeks or until complete healing. Forty-nine patients with VLUs were randomized to either the intervention group (n = 22) or the control group (n = 27). Wound healing over 12 weeks. Intent-to-treat analysis showed a mean percentage wound area reduction at 12 weeks of 85.6% (SD, 28.6%) for the intervention group and 72.5% (SD, 77.8%) for the control group. There was a higher healing rate in the intervention group compared with patients who received SOC only at both week 4 (23% vs 11%) and week 12 (64% vs 59%). There were no adverse events related to the study therapy. Although the results were not significant, there was a trend toward faster healing in the intervention group. The results of this study indicate that collagen/oxidized regenerated cellulose/silver is a suitable and safe adjunctive intervention for use with SOC to manage VLUs.

Efficacy of Different Primaquine Regimens to Control Plasmodium falciparum Gametocytemia in Colombia.

PubMed

Arroyo-Arroyo, Maria; Arango, Eliana; Carmona-Fonseca, Jaime; Aristizabal, Beatriz; Yanow, Stephanie; Maestre, Amanda

2017-09-01

Treatment against Plasmodium falciparum malaria includes blood schizonticides to clear asexual parasites responsible for disease. The addition of gametocytocidal drugs can eliminate infectious sexual stages with potential for transmission and the World Health Organization recommends a single dose (SD) of primaquine (PQ) to this end. The efficacy of PQ at 0.75 mg/kg to suppress gametocytemia when administered in single or fractionated doses was evaluated. A clinical controlled study with an open-label design was executed; three groups of 20 subjects were studied sequentially. All subjects were treated with the standard dose of artemether-lumefantrine plus the total dose of 0.75 mg/kg of PQ administered (without previous G6PD testing) in three different ways: Group "0.75d-3" received 0.75 mg/kg on day 3; Group "0.50d-1 + 0.25d-3" received 0.50 mg/kg on day 1 and 0.25 mg/kg on day 3; Group "0.25d-1,2,3" received 0.25 mg/kg on days 1, 2, and 3. Subjects were evaluated on days 1, 4, and 7 by thick smear microscopy and quantitative polymerase chain reaction to determine the carriage of immature and mature gametocytes. There were no adverse events. The three schemes caused a marked reduction (75-85%) in prevalence of gametocytes on day 4 compared with day 1, but only the group that received 0.75 mg/kg on day 3 maintained the reduced gametocyte burden until day 7. None of the three treatments were able to clear gametocyte carriage on days 4 or 7, but the group that received the SD had the lowest prevalence of gametocytes (15%). Further studies are needed to establish a PQ regimen with complete efficacy against gametocytes.

Low-dose rapamycin (sirolimus) effects in autosomal dominant polycystic kidney disease: an open-label randomized controlled pilot study.

PubMed

Braun, William E; Schold, Jesse D; Stephany, Brian R; Spirko, Rita A; Herts, Brian R

2014-05-01

The two largest studies of mammalian target of rapamycin inhibitor treatment of autosomal dominant polycystic kidney disease (ADPKD) demonstrated no clear benefit on the primary endpoint of total kidney volume (TKV) or on eGFR. The present study evaluated two levels of rapamycin on the 12-month change in (125)I-iothalamate GFR (iGFR) as the primary endpoint and TKV secondarily. In a 12-month open-label pilot study, 30 adult patients with ADPKD were randomly assigned to low-dose (LD) rapamycin (rapamycin trough blood level, 2-5 ng/ml) (LD group, n=10), standard-dose (STD) rapamycin trough level (>5-8 ng/ml) (STD group, n=10), or standard care (SC group, n=10). They were evaluated with iGFR and noncontrast computed tomography. Change in iGFR at 12 months was significantly higher in the LD group (7.7±12.5 ml/min per 1.73 m(2); n=9) than in the SC group (-11.2 ± 9.1 ml/min per 1.73 m(2); n=9) (LD versus SC: P<0.01). Change in iGFR at 12 months in the STD group (1.6 ± 12.1 ml/min per 1.73 m(2); n=8) was not significantly greater than that in the SC group (P=0.07), but it was in the combined treatment groups (LD+STD versus SC: P<0.01). Neither eGFR calculated by the CKD-Epidemiology Collaboration equation nor TKV (secondary endpoint) changed significantly from baseline to 12 months in any of the groups. On the basis of results of the mixed model, during the study, patients in the LD group had significantly lower trough blood levels of rapamycin (mean range ± SD, 2.40 ± 0.64 to 2.90 ± 1.20 ng/ml) compared with those in the STD group (3.93 ± 2.27 to 5.77 ± 1.06 ng/ml) (P<0.01). Patients with ADPKD receiving LD rapamycin demonstrated a significant increase in iGFR compared with those receiving standard care, without a significant effect on TKV after 12 months.

Gender and the nocebo response following conditioning and expectancy.

PubMed

Klosterhalfen, Sibylle; Kellermann, Sandra; Braun, Silke; Kowalski, Axel; Schrauth, Markus; Zipfel, Stephan; Enck, Paul

2009-04-01

To investigate the role of Pavlovian conditioning and expectancy and of gender on the nocebo effects. Conditioning experiment: Forty-eight healthy male and female volunteers were investigated for 3 days using a standard rotation procedure. Subjects in the experimental group received a salient oral stimulus prior to rotation; subjects in the control group received the stimulus 12 h after rotations on Days 1 and 2; on Day 3, all subjects received the stimulus prior to rotation. Expectancy experiment: Another 48 healthy subjects were rotated 5 x 1 min once only. All subjects received the same oral stimulus immediately prior to rotation; subjects in the experimental group were told that the symptoms might worsen with the stimulus; controls did not receive additional information. In both experiments, symptom rating (SR) and rotation tolerance (RT) were determined. Conditioning significantly reduced RT (P=.015) and increased SR (P=.024). For both RT and SR, a significant "day x group x gender" effect was found (P=.044; SR: P=.011) indicating that conditioning was more effective in women. Expectancies lowered RT (P=.085) without affecting SR. There was a significant "rotation x gender" interaction on RT (P=.005) indicating that the expectancy was more effective in men. Women responded stronger to conditioning while men responded to expectancies, but to a lesser degree. It needs to be determined whether this is restricted to nausea-specific conditions or can be generalized across clinical and experimental conditions.

Low-dose CT for the diagnosis of appendicitis in adolescents and young adults (LOCAT): a pragmatic, multicentre, randomised controlled non-inferiority trial.

PubMed

2017-11-01

CT radiation is arguably carcinogenic. Results from single-centre studies, mostly retrospective, have advocated lowering the CT radiation dose for the diagnosis of appendicitis. However, adoption of low-dose CT has been slow. We aimed to assess the effectiveness of low-dose CT compared with standard-dose CT in the diagnosis of appendicitis in adolescents and young adults. We did this pragmatic, multicentre, randomised controlled non-inferiority trial at 20 South Korean teaching hospitals with little experience with low-dose CT. Patients aged 15-44 years with suspected appendicitis were randomly assigned (1:1), via computer-generated random assignments (permuted block sizes of two, four, six, and eight) concealed in sequentially numbered envelopes, to receive low-dose CT (2 mSv) or standard-dose CT (≤8 mSv). Randomisation was stratified by site. Group allocation was concealed from patients, outcome assessors, and adverse event adjudicators; care providers, site pathologists, and data collectors were aware of allocation. The primary endpoint was the negative (unnecessary) appendectomy rate among all appendectomies, with a non-interiority margin of 4·5% for low-dose versus standard-dose CT. Primary analysis was by modified intention to treat, which included all patients who received an appendectomy in the group to which they were assigned. This trial is registered with ClinicalTrials.gov, number NCT01925014. Between Dec 4, 2013, and Aug 18, 2016, we assigned 1535 patients to the low-dose CT group and 1539 patients to the standard-dose CT group. 22 (3·9%) of 559 patients had a negative appendectomy in the low-dose group versus 16 (2·7%) of 601 patients in the standard-dose group (difference 1·3%, 95% CI -0·8 to 3·3; p=0·0022 for the non-inferiority test). We recorded 43 adverse events in 43 (2·8%) of 1535 patients in the low-dose group and 41 adverse events in 40 (2·6%) of 1539 patients in the standard-dose group. One life-threatening adverse event of anaphylaxis caused by an iodinated contrast material occurred in the low-dose group. Radiation dose of appendiceal CT for adolescents and young adults can be reduced to 2 mSv without impairing clinical outcomes. In view of the vast number of appendiceal CT examinations done worldwide, use of low-dose CT could prevent a sizeable number of radiation-associated cancers in the future. Korea Health Industry Development Institute, Seoul National University Bundang Hospital, Dasol Life Science, and Bracco Imaging Korea. Copyright © 2017 Elsevier Ltd. All rights reserved.

The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer: A Randomized Control Study.

PubMed

Eraydin, Şahizer; Avşar, Gülçin

The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer. Prospective, randomized controlled study. Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included in the final analysis. Subjects were followed up between February 2014 and June 2015. Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received standard wound care but no exercises. The ulcers of the patients in both the intervention and control groups were examined and measured at the 4th, 8th, and 12th weeks. The groups were compared in terms of the ulcer size and depth. To analyze and compare the data, frequency distribution, mean (standard deviation), variance analysis, and the independent samples t test and the χ test were used. The mean ulcer areas were 12.63 (14.43), 6.91 (5.44), 4.30 (3.70), and 3.29 (3.80) cm (P < .05) in the study intervention group, and 24.67 (20.70), 24.75 (20.84), 20.33 (20.79), and 18.52 (21.49) cm in the control group in the 4th, 8th, and 12th weeks, respectively. Significant differences were found between diabetic foot ulcer sizes in the study intervention group in the 4th and 12th weeks compared to beginning baseline (P ≤ .05). However, only the 12th week was different from the beginning in the control group (P = .000). The mean depths of the ulcers were 0.56 (0.85), 0.42 (0.68), 0.36 (0.50), and 0.28 (0.38) cm in the study intervention group (P < .05) and 0.61 (0.84), 0.82 (1.07), 0.83 (1.21), and 0.80 (1.26) cm in the control group, respectively, at the baseline, and at the 4th, 8th, and 12th weeks, respectively (P = .000). The ulcer areas decreased significantly in the study intervention group compared to the control group during the 3 follow-up measurements. An important finding in this study was the DFU area decreased more in those who exercised more. Findings suggests foot exercises should be included in the treatment plan when managing patients with diabetic foot ulcers.

The Effect of Foot Exercises on Wound Healing in Type 2 Diabetic Patients With a Foot Ulcer.

PubMed

Eraydin, Şahizer; Avşar, Gülçin

2017-12-19

The purpose of this study was to investigate the effect of foot exercises on wound healing in type 2 diabetic patients with a diabetic foot ulcer. Prospective, randomized controlled study. Sixty-five patients from an outpatient clinic with grade 1 or 2 ulcers (Wagner classification) who met study criteria agreed to participate; 60 patients completed the study and were included in the final analysis. Subjects were followed up between February 2014 and June 2015. Subjects were recruited by the researchers in the clinics where they received treatment. Subjects were randomly allocated to either the control or intervention group. Data were collected using investigator-developed forms: patient information form and the diabetic foot exercises log. Patients in the intervention group received standard wound care and performed daily foot exercises for 12 weeks; the control group received standard wound care but no exercises. The ulcers of the patients in both the intervention and control groups were examined and measured at the 4th, 8th, and 12th weeks. The groups were compared in terms of the ulcer size and depth. To analyze and compare the data, frequency distribution, mean (standard deviation), variance analysis, and the independent samples t test and the χ test were used. The mean ulcer areas were 12.63 (14.43), 6.91 (5.44), 4.30 (3.70), and 3.29 (3.80) cm (P < .05) in the study intervention group, and 24.67 (20.70), 24.75 (20.84), 20.33 (20.79), and 18.52 (21.49) cm in the control group in the 4th, 8th, and 12th weeks, respectively. Significant differences were found between diabetic foot ulcer sizes in the study intervention group in the 4th and 12th weeks compared to beginning baseline (P ≤ .05). However, only the 12th week was different from the beginning in the control group (P = .000). The mean depths of the ulcers were 0.56 (0.85), 0.42 (0.68), 0.36 (0.50), and 0.28 (0.38) cm in the study intervention group (P < .05) and 0.61 (0.84), 0.82 (1.07), 0.83 (1.21), and 0.80 (1.26) cm in the control group, respectively, at the baseline, and at the 4th, 8th, and 12th weeks, respectively (P = .000). The ulcer areas decreased significantly in the study intervention group compared to the control group during the 3 follow-up measurements. An important finding in this study was the DFU area decreased more in those who exercised more. Findings suggests foot exercises should be included in the treatment plan when managing patients with diabetic foot ulcers.

A randomised, double-blinded clinical study on the efficacy of multimedia presentation using an iPad for patient education of postoperative hip surgery patients in a public hospital in Singapore.

PubMed

Dallimore, Rachel-Kim; Asinas-Tan, Marxengel Leonin; Chan, Daryl; Hussain, Suharti; Willett, Catherine; Zainuldin, Rahizan

2017-09-01

This study compared patient satisfaction and recall of physiotherapy patient education among patients who had undergone hip surgery, with information presented via an iPad versus a standard paper booklet. Patients who had undergone hip surgery joined and completed this single-centre study, which utilised a randomised parallel group design. They were randomly allocated to either Group A (received information on hip surgery physiotherapy via an iPad) or Group B (received the same information via a paper booklet). The participants were blinded to the intervention received by the other group and the testers were blinded to the intervention received by the participants. The interventions were carried out during the patients' first four postoperative physiotherapy sessions. The outcome measures were recorded using pre-validated questionnaires. A total of 42 participants (mean age 70 ± 12 years) were recruited. After the intervention, patients in both groups had improved recall of the information presented during patient education. However, the patients in Group A had a significantly better recall score than those in Group B (4.0 points higher, p < 0.001). The level of patient satisfaction was also significantly higher in Group A than in Group B (8.5 points higher, p < 0.001). While the use of an iPad and a paper booklet both had positive outcomes for patient recall and satisfaction, the use of an iPad was found to be more effective at improving patient satisfaction and recall of physiotherapy patient education in the present study. Copyright: © Singapore Medical Association

Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery

PubMed Central

Labetoulle, Marc; Findl, Oliver; Malecaze, François; Alió, Jorge; Cochener, Béatrice; Lobo, Conceição; Lazreg, Sihem; Hartani, Dahbia; Colin, Joseph; Tassignon, Marie-José; Behndig, Anders

2016-01-01

Background/aims To compare the efficacy and safety of intracameral (IC) administration at the beginning of cataract surgery, of Mydrane, a standardised ophthalmic combination of tropicamide 0.02%, phenylephrine 0.31% and lidocaine 1%, to a standard topical regimen. Methods In this international phase III, prospective, randomised study, the selected eye of 555 patients undergoing phacoemulsification with intraocular lens (IOL) implantation received 200 μL of Mydrane (Mydrane group) just after the first incision or a topical regimen of one drop each of tropicamide 0.5% and phenylephrine 10% repeated three times (reference group). The primary efficacy variable was achievement of capsulorhexis without additional mydriatics. The non-inferiority of Mydrane to the topical regimen was tested. The main outcome measures were pupil size, patient perception of ocular discomfort and safety. Results Capsulorhexis without additional mydriatics was performed in 98.9% of patients and 94.7% in the Mydrane and reference groups, respectively. Both groups achieved adequate mydriasis (>7 mm) during capsulorhexis, phacoemulsification and IOL insertion. IOL insertion was classified as ‘routine’ in a statistically greater number of eyes in the Mydrane group compared with the reference group (p=0.047). Patients in the Mydrane group reported statistically greater comfort than the reference group before IOL insertion (p=0.034). Safety data were similar between groups. Conclusions Mydrane is an effective and safe alternative to standard eye drops for initiating and maintaining intraoperative mydriasis and analgesia. Patients who received IC Mydrane were significantly more comfortable before IOL insertion than the reference group. Surgeons found IOL insertion less technically challenging with IC Mydrane. Trial registration number NCT02101359; Results. PMID:26531052

Effect of SeptimebTM as a new natural extract on severe sepsis: A randomized clinical trial.

PubMed

Pourdast, Alieh; Sanaei, Maryam; Jafari, Sirous; Mohammadi, Mostafa; Khalili, Hossein; Shafiee, Gita; Ahadi, Zeinab; Rostami, Mahsa; Alizad, Saba; Heshmat, Ramin; Mohraz, Minoo

2017-01-01

Septimeb as a herbal medicine has regulatory effects on inflammation. This study set to evaluate the effects of Septimeb among patients with sepsis on inflammatory biomarkers and survival rate. In this randomized clinical trial, 51 patients with sepsis from the ICU and medical ward of Imam Khomeini Hospital were divided into two groups: Septimeb (n=25) and control group (n=26). In the control group, the patients received a standard treatment only for 7 days, while Septimeb group received Septimeb (6cc vial with 500cc serum glucose infusion 5% daily for one to two hours) plus standard treatment of sepsis for 7 days. Then, blood samples were analyzed. APACHE (Acute Physiologic and Chronic Health Evaluation), SOFA (Sequential Organ Failure Assessment), and GCS (Glasgow Coma Score) values were calculated daily. Treatment with Septimeb showed a significant decrease in SOFA value (1.54±0.83) compared to the control group (2.39±0.88) (P<0.001) and a significant increase in GCS value (14.46±0.88) compared to the control group (12.86±1.78) (P<0.001). Improvements of these values can confirm the potential of Septimeb in the reduction of severity of sepsis (P<0.05). There were significant decreases in lactate and blood sugar and WBC levels. In addition, inflammatory factors such as ESR (Septimeb group: 52.07±34.80, control group: 51.75±42.10, P=0.98) and CRP (Septimeb group: 48.86±23.21, control group: 49.93±36.22, P=0.92) decreased, but did not show a significant reduction. Septimeb has positive effects on reduction of the severity of sepsis which leads to reduction of patients' mortality rates.

Effect of SeptimebTM as a new natural extract on severe sepsis: A randomized clinical trial

PubMed Central

Pourdast, Alieh; Sanaei, Maryam; Jafari, Sirous; Mohammadi, Mostafa; Khalili, Hossein; Shafiee, Gita; Ahadi, Zeinab; Rostami, Mahsa; Alizad, Saba; Heshmat, Ramin; Mohraz, Minoo

2017-01-01

Background: Septimeb as a herbal medicine has regulatory effects on inflammation. This study set to evaluate the effects of Septimeb among patients with sepsis on inflammatory biomarkers and survival rate. Methods: In this randomized clinical trial, 51 patients with sepsis from the ICU and medical ward of Imam Khomeini Hospital were divided into two groups: Septimeb (n=25) and control group (n=26). In the control group, the patients received a standard treatment only for 7 days, while Septimeb group received Septimeb (6cc vial with 500cc serum glucose infusion 5% daily for one to two hours) plus standard treatment of sepsis for 7 days. Then, blood samples were analyzed. APACHE (Acute Physiologic and Chronic Health Evaluation), SOFA (Sequential Organ Failure Assessment), and GCS (Glasgow Coma Score) values were calculated daily. Results: Treatment with Septimeb showed a significant decrease in SOFA value (1.54±0.83) compared to the control group (2.39±0.88) (P<0.001) and a significant increase in GCS value (14.46±0.88) compared to the control group (12.86±1.78) (P<0.001). Improvements of these values can confirm the potential of Septimeb in the reduction of severity of sepsis (P<0.05). There were significant decreases in lactate and blood sugar and WBC levels. In addition, inflammatory factors such as ESR (Septimeb group: 52.07±34.80, control group: 51.75±42.10, P=0.98) and CRP (Septimeb group: 48.86±23.21, control group: 49.93±36.22, P=0.92) decreased, but did not show a significant reduction. Conclusion: Septimeb has positive effects on reduction of the severity of sepsis which leads to reduction of patients’ mortality rates. PMID:28503281

Evaluation of Hematopoietic Stem Cell Mobilization Rates with Early Plerixafor Administration for Adult Stem Cell Transplantation.

PubMed

Stover, Jessica T; Shaw, J Ryan; Kuchibhatla, Maragatha; Horwitz, Mitchell E; Engemann, Ashley M

2017-08-01

The addition of plerixafor to high-dose colony-stimulating growth factor has been shown to improve stem cell mobilization rates in autologous transplant patients with multiple myeloma and non-Hodgkin lymphoma. This study evaluates the change in administration time of plerixafor to determine if cell mobilization rates are similar between the US Food and Drug Administration-approved administration time of 11 hours before apheresis and an earlier administration time of 16 hours before apheresis. Medical records of patients age ≥ 18 years undergoing autologous stem cell transplantation requiring the use of plerixafor after at least 4 days of granulocyte colony-stimulating factor therapy to complete stem cell mobilization from January 1, 2010 through September 30, 2014 were retrospectively reviewed. The primary outcome was CD34 + cell mobilization success rates when plerixafor was administered 11 ± 2 hours (standard administration group) compared with 16 ± 2 hours before cell apheresis (early administration group), as defined as collection of  ≥2 × 10 6 CD34 + cells/kg. Secondary outcomes included the number of plerixafor therapy days required to collect a total of ≥2 × 10 6 CD34 + cells/kg, the number of apheresis cycles required to achieve ≥2 × 10 6 CD34 + cells/kg, the median CD34 + cells/kg collected in each apheresis session, and the rates of reported adverse events that occurred in the standard administration time group compared with the early administration time group. Of the 197 patients included, 114 patients received plerixafor 11 ± 2 hours before apheresis and 83 patients received plerixafor 16 hours ± 2 hours before apheresis. Ninety-four percent of patients in the early administration group achieved successful stem cell mobilization compared with 81.6% in the standard administration group (P = .0111). The median number of plerixafor days to reach the collection goal of  ≥2 × 10 6 CD34 + cells/kg was 1 day for each group (P = .323), and the median number of apheresis days to reach the collection goal was 2 days for the standard administration group compared with 1 day for the early administration group (P = .0156). Most adverse events were similar between the 2 groups except for fever, which occurred in 4.8% of the patients in the early administration group and none of the patients in the standard administration group. This study demonstrates plerixafor effectively mobilizes peripheral blood stem cells when given at an early administration time of 16 hours before apheresis compared with standard administration of 11 hours before apheresis. However, further prospective studies could strengthen these results. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

A family-oriented therapy program for youths with substance abuse: long-term outcomes related to relapse and academic or social status

PubMed Central

Wang, Liang-Jen; Lu, Shing-Fang; Chong, Mian-Yoon; Chou, Wen-Jiun; Hsieh, Yu-Lian; Tsai, Tung-ning; Chen, Ching; Lee, Yi-Hsuan

2016-01-01

Objective The abuse of illegal substances by youths in Taiwan has become a major public health issue. This study explores the outcomes (relapse rate and academic or social status) of a family-oriented therapy program conducted for substance-using youths who were referred by a judge to participate in it. Methods The present study includes 121 participants categorized into three groups: 36 youths underwent a weekly ten-session outpatient motivational enhancement psychotherapy (MEP) group program; 41 youths participated in a program that combined the aforementioned MEP program with an additional weekly ten-session parenting skill training (PST) program for their guardians (MEP + PST group); and 44 adolescents who received standard supervision by the court served as the control group. All participants were followed-up for a maximum of 2 years. Results Of the 121 participants (mean age: 16.1±1.1 years), 33.1% relapsed into substance use during the follow-up period. The probability of relapse did not differ significantly between the MEP group (36.1%) and the control group (40.9%), but the youths in the MEP + PST group (22.0%) were at a lower risk of relapse than the control group participants (adjusted hazard ratio =0.48, 95% confidence interval [CI] =0.21–1.09). By the end of the study follow-up period, participants in both the MEP group and the MEP + PST group were more likely to be attending school (MEP group: adjusted odds ratio [aOR] =6.61, 95% CI =1.60–27.35; MEP + PST group: aOR =8.57, 95% CI =1.94–37.82) or employed (MEP group: aOR =7.75, 95% CI =1.95–30.75; MEP + PST group: aOR =7.27, 95% CI =1.76–29.97), when compared to the control group. Conclusion This study revealed that a family-oriented treatment approach may be a more effective option for preventing youths’ relapsing into substance abuse. In comparison to individuals who received standard supervision by the court, those who received MEP experienced a better school attendance or social outcome over the follow-up period. PMID:27099500

Pressure ulcer management in paraplegic patients with a novel negative pressure device: a randomised controlled trial.

PubMed

Dwivedi, M K; Srivastava, R N; Bhagat, A K; Agarwal, R; Baghel, K; Jain, A; Raj, S

2016-04-01

A randomised controlled trial to compare negative pressure wound therapy (NPWT) using our innovative negative pressure device (NPD) and the standard pressure ulcer (PU) wound dressing of in traumatic paraplegia patients. This study was conducted in the Department of Orthopaedic Surgery at King George's Medical University, Lucknow, India. Traumatic paraplegia patients with sacral pressure ulcers of stage 3 and 4 were randomised into two groups, receiving either standard wound dressings or NPWT with NPD. The outcomes monitored were length, width (surface area), depth of PU, exudates, discharge, tissue type (necrotic, slough and red granulating tissue), and cost-effectiveness during 0 to 9 weeks follow-up. Length and width were significantly (p<0.01) decreased in NPWT group as compared with standard care group at week 9. At weeks 1, 2 and 3, depth was significantly (p<0.05) higher in NPWT group, whereas at week 9 a significant reduction (p=0.01) was observed. Exudates were significantly (p=0.001) lower in NPWT group at weeks 4 and 9. Conversion of slough into red granulation tissue was significantly higher in NPWT group (p=0.001). Discharge became significantly (p=0.001) lower in NPWT at week 2 and no discharge was observed after week 6. In all parameters, decrease was larger in NPWT group compared with standard care, which was significant for exudates type (p=0.03) and tissue type (p=0.004). Our NPD is better than standard wound care procedures and cost-effective for management of PU.

Hand 'stress' arthritis in young subjects: effects of Flexiqule (pharma-standard Boswellia extract). A preliminary case report.

PubMed

Belcaro, G; Feragalli, B; Cornelli, U; Dugall, M

2015-10-22

This case report (supplement registry study) evaluated subjects with painful 'stress' arthritis of the hand mainly localized at the joints. The patients received a suggestion to follow a rehabilitation plan (standard management; SM). A second group also used the same SM in association with the oral, pharma-standard supplement FlexiQule (Alchem) a new standardized, phytosomal preparation manufactured from the Boswellia plant, which can be used for self-management in inflammatory conditions (150 mg / 3 times daily). The two resulting registry groups included 12 subjects using SM+Flexiqule and and 11 controls (SM only). The groups were comparable. Serology showed no significant alterations: only ESR was slightly elevated (minimal elevation). After 2 weeks, the ESR was normal in the supplement group and mildly elevated in controls (p<0.05%). The decrease in hypertermic areas was greater/faster (p<0.05) in the supplement group. The identification of a working stress and the localization to the dominant hand was comparable in both groups. At 2 weeks, the decrease in pain was significantly faster and more important with the supplement (p<0.05). The hand became more usable in time and the score was better with the supplement (p<0.05). No supplemented patient had to use other drugs, while in the control group 3 subjects eventually used NSAIDs to control pain and stiffness and one used corticosteroids. In conclusion, the natural extract Flexiqule was effective in controlling work-related stress arthritis (without inflammaìtory signs) over a 2 weeks period, better than only Standard Management. More prolonged and larger studies are needed.

Zinc and Vitamin Supplementation in an Under-5 Indigenous Population of Guatemala: Influence of Lay Health Promoters in Decreasing Incidence of Diarrhea.

PubMed

Grossmann, Vicki M; Turner, Barbara S; Snyder, Denise; Stewart, Robert D; Bowen, Toni; Cifuentes, Ariadna A; Cliff, Cheryl

2015-09-01

Malnutrition is an urgent problem in the developing world, especially for children under 5 years of age. The article describes the utilization of a standard of practice designed to prevent illness in a malnourished, under-5 indigenous population and reinforced by weekly basic health messages taught by lay community health promoters. The two villages were chosen for observation after administration of the standard of care among the Maya-Kíché, the most numerous Mayan group in Guatemala. The standard of practice, 20 mg of daily oral zinc, was administered for 10 days in the home and followed by daily vitamin supplementation that continued throughout the 3 months of the project. All patients received four monthly clinic visits, with one of the village groups receiving weekly health promoter visits. Data evaluated after the quality improvement project showed significant differences in adherence to the zinc regimen (χ(2) = 3.677, p ≤ .05) as well as lower rates of diarrheal illnesses (χ(2) = 5.850, p ≤ .05), with both of these improved in the health promoter group. This study suggests that the training and implementation of para-health professionals from the lay community in response to specific health care needs could be considered a best practice in developing countries. Public health professionals are key to health promoter training and direction, and their importance in the global setting cannot be understated. © The Author(s) 2014.

Effect of an intervention based on basic Buddhist principles on the spiritual well-being of patients with terminal cancer.

PubMed

Chimluang, Janya; Thanasilp, Sureeporn; Akkayagorn, Lanchasak; Upasen, Ratchaneekorn; Pudtong, Noppamat; Tantitrakul, Wilailuck

2017-12-01

To evaluate the effect of an intervention based on basic Buddhist principles on the spiritual well-being of patients with terminal cancer. This quasi-experimental research study had pre- and post-test control groups. The experimental group received conventional care and an intervention based on basic Buddhist principles for three consecutive days, including seven activities based on precept activities, concentration activities and wisdom activities. The control group received conventional care alone. Forty-eight patients participated in this study: 23 in the experimental group and 25 in the control group. Their mean age was 53 (standard deviation 10) years. The spiritual well-being of participants in the experimental group was significantly higher than that of participants in the control group at the second post-test (P < 0.05). An intervention based on basic Buddhist principles improved the spiritual well-being of patients with terminal cancer. This result supports the beneficial effects of implementing this type of intervention for patients with terminal cancer. Copyright © 2017 Elsevier Ltd. All rights reserved.

Effects of a Clown-Nurse Educational Intervention on the Reduction of Postoperative Anxiety and Pain Among Preschool Children and Their Accompanying Parents in South Korea.

PubMed

Yun, O Bok; Kim, Shin-Jeong; Jung, Dukyoo

2015-01-01

This study examined the effects of a clown-nurse educational intervention on children undergoing day surgery for strabismus. This was a quasi-experimental study, using a nonequivalent control group, non-synchronized design. Fifty preschool children and their parents were invited to participate. The children in the intervention group (n=23) received clown therapy and subsequently reported significantly lower states of physiological anxiety, which was evidenced by systolic blood pressure, standardized behavioral anxiety tests, and post-surgery pain, than the control group (n=27). In addition, the parents in the experimental group showed a low state of physiological anxiety, evidenced by systolic blood pressure, pulse rates, standardized behavioral anxiety tests, and state-trait anxiety. The use of preoperative clown intervention may alleviate postoperative problems, not only for children, but also for their parents. Copyright © 2015 Elsevier Inc. All rights reserved.

Research Participants' Understanding of and Reactions to Certificates of Confidentiality.

PubMed

Beskow, Laura M; Check, Devon K; Ammarell, Natalie

2014-01-01

Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms. To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description. Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information's substance. Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons.

Research Participants’ Understanding of and Reactions to Certificates of Confidentiality

PubMed Central

Check, Devon K.; Ammarell, Natalie

2013-01-01

Background Certificates of Confidentiality are intended to facilitate participation in critical public health research by protecting against forced disclosure of identifying data in legal proceedings, but little is known about the effect of Certificate descriptions in consent forms. Methods To gain preliminary insights, we conducted qualitative interviews with 50 HIV-positive individuals in Durham, North Carolina to explore their subjective understanding of Certificate descriptions and whether their reactions differed based on receiving a standard versus simplified description. Results Most interviewees were neither reassured nor alarmed by Certificate information, and most said it would not influence their willingness to participate or provide truthful information. However, compared with those receiving the simplified description, more who read the standard description said it raised new concerns, that their likelihood of participating would be lower, and that they might be less forthcoming. Most interviewees said they found the Certificate description clear, but standard-group participants often found particular words and phrases confusing, while simplified-group participants more often questioned the information’s substance. Conclusions Valid informed consent requires comprehension and voluntariness. Our findings highlight the importance of developing consent descriptions of Certificates and other confidentiality protections that are simple and accurate. These qualitative results provide rich detail to inform a larger, quantitative study that would permit further rigorous comparisons. PMID:24563806

Determinants of Pain Treatment Response and Non-Response: Identification of TMD Patient Subgroups

PubMed Central

Litt, Mark D.; Porto, Felipe B.

2013-01-01

The purpose of the present study was to determine if we could identify a specific subtype of temporomandibular disorder (TMD) pain patients that does not respond to treatment. Patients were 101 men and women with chronic TMD pain recruited from the community and randomly assigned to one of two treatment conditions: a standard conservative care (STD) condition or a standard care plus cognitive-behavioral treatment condition (STD+CBT) in which patients received all elements of STD, but also received cognitive-behavioral coping skills training. Growth mixture modeling, incorporating a series of treatment-related predictors, was used to distinguish several distinct classes of responders or non-responders to treatment based on reported pain over a one-year follow-up period. Results indicated that treatment non-responders accounted for 16% of the sample, and did not differ from treatment responders on demographics or temporomandibular joint pathology, but that they reported more psychiatric symptoms, poorer coping, and higher levels of catastrophizing. Treatment-related predictors of membership in treatment responder groups versus the non-responder group included the addition of CBT to standard treatment, treatment attendance, and decreasing catastrophization. It was concluded that CBT may be made more efficacious for TMD patients by placing further emphasis on decreasing catastrophization and on individualizing care. PMID:24094979

Motivational Interviewing to Promote Long-Acting Reversible Contraception in Postpartum Teenagers.

PubMed

Tomlin, Kristl; Bambulas, Tammalynn; Sutton, Maureen; Pazdernik, Vanessa; Coonrod, Dean V

2017-06-01

To determine if teenage patients receiving prenatal care in an adolescent-focused clinic, emphasizing long-acting reversible contraception (LARC) using motivational interviewing techniques, had higher rates of uptake of postpartum LARC than a control group. Retrospective cohort study comparing young women who received prenatal care in an adolescent-focused setting with those enrolled in standard prenatal care. Adolescents between the ages of 13 and 17 years receiving prenatal care within the Maricopa Integrated Health safety-net system between 2007 and 2014. Motivational interviewing within the context of adolescent-focused prenatal care. Rates of uptake of LARC within 13 postpartum weeks. The adjusted rate of LARC for adolescent-focused prenatal care participants by 13 weeks postpartum was 38% (95% confidence interval [CI], 29%-47%) compared with 18% (95% CI, 11%-28%) for standard care participants, with an adjusted odds ratio of LARC use of 2.8 (95% CI, 1.5-5.2). Among patients who received adolescent-focused prenatal care, most (27% vs 12.7%) were using an intrauterine device as opposed to an implantable contraceptive device. Participation in an adolescent-focused antepartum setting using motivational interviewing to emphasize postpartum LARC resulted in nearly 3 times higher rates of uptake compared with standard prenatal care. Copyright © 2016 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Levosimendan for Hemodynamic Support after Cardiac Surgery.

PubMed

Landoni, Giovanni; Lomivorotov, Vladimir V; Alvaro, Gabriele; Lobreglio, Rosetta; Pisano, Antonio; Guarracino, Fabio; Calabrò, Maria G; Grigoryev, Evgeny V; Likhvantsev, Valery V; Salgado-Filho, Marcello F; Bianchi, Alessandro; Pasyuga, Vadim V; Baiocchi, Massimo; Pappalardo, Federico; Monaco, Fabrizio; Boboshko, Vladimir A; Abubakirov, Marat N; Amantea, Bruno; Lembo, Rosalba; Brazzi, Luca; Verniero, Luigi; Bertini, Pietro; Scandroglio, Anna M; Bove, Tiziana; Belletti, Alessandro; Michienzi, Maria G; Shukevich, Dmitriy L; Zabelina, Tatiana S; Bellomo, Rinaldo; Zangrillo, Alberto

2017-05-25

Acute left ventricular dysfunction is a major complication of cardiac surgery and is associated with increased mortality. Meta-analyses of small trials suggest that levosimendan may result in a higher rate of survival among patients undergoing cardiac surgery. We conducted a multicenter, randomized, double-blind, placebo-controlled trial involving patients in whom perioperative hemodynamic support was indicated after cardiac surgery, according to prespecified criteria. Patients were randomly assigned to receive levosimendan (in a continuous infusion at a dose of 0.025 to 0.2 μg per kilogram of body weight per minute) or placebo, for up to 48 hours or until discharge from the intensive care unit (ICU), in addition to standard care. The primary outcome was 30-day mortality. The trial was stopped for futility after 506 patients were enrolled. A total of 248 patients were assigned to receive levosimendan and 258 to receive placebo. There was no significant difference in 30-day mortality between the levosimendan group and the placebo group (32 patients [12.9%] and 33 patients [12.8%], respectively; absolute risk difference, 0.1 percentage points; 95% confidence interval [CI], -5.7 to 5.9; P=0.97). There were no significant differences between the levosimendan group and the placebo group in the durations of mechanical ventilation (median, 19 hours and 21 hours, respectively; median difference, -2 hours; 95% CI, -5 to 1; P=0.48), ICU stay (median, 72 hours and 84 hours, respectively; median difference, -12 hours; 95% CI, -21 to 2; P=0.09), and hospital stay (median, 14 days and 14 days, respectively; median difference, 0 days; 95% CI, -1 to 2; P=0.39). There was no significant difference between the levosimendan group and the placebo group in rates of hypotension or cardiac arrhythmias. In patients who required perioperative hemodynamic support after cardiac surgery, low-dose levosimendan in addition to standard care did not result in lower 30-day mortality than placebo. (Funded by the Italian Ministry of Health; CHEETAH ClinicalTrials.gov number, NCT00994825 .).

The effect of a multifaceted empowerment strategy on decision making about the number of embryos transferred in in vitro fertilisation: randomised controlled trial.

PubMed

van Peperstraten, Arno; Nelen, Willianne; Grol, Richard; Zielhuis, Gerhard; Adang, Eddy; Stalmeier, Peep; Hermens, Rosella; Kremer, Jan

2010-09-30

To evaluate the effects of a multifaceted empowerment strategy on the actual use of single embryo transfer after in vitro fertilisation. Randomised controlled trial. Five in vitro fertilisation clinics in the Netherlands. 308 couples (women aged <40) on the waiting list for a first in vitro fertilisation cycle. The multifaceted strategy aimed to empower couples in deciding how many embryos should be transferred. The strategy consisted of a decision aid, support of a nurse specialising in in vitro fertilisation, and the offer of reimbursement by way of an extra treatment cycle. The control group received standard care for in vitro fertilisation. Use of single embryo transfer in the first and second treatment cycles as well as decision making variables and costs of the empowerment strategy. After the first treatment cycle, single embryo transfer was used by 43% (65/152) of couples in the intervention group and 32% (50/156) in the control group (difference 11%, 95% confidence interval 0% to 22%; P=0.05). After the second treatment cycle, single embryo transfer was used by 26% (14/154) of couples in the intervention group compared with 16% (8/51) in the control group (difference 10%, -6% to 26%; P=0.20). Compared with couples receiving standard care, those receiving the empowerment strategy had significantly higher empowerment and knowledge levels but no differences in anxiety levels. Mean total savings per couple in the intervention group were calculated to be €169.75 (£146.77; $219.12). A multifaceted empowerment strategy encouraged use of single embryo transfer, increased patients' knowledge, reduced costs, and had no effect on levels of anxiety or depression. This strategy could therefore be an important tool to reduce the twin pregnancy rate after in vitro fertilisation. This trial did not, however, demonstrate the anticipated 25% difference in use of single embryo transfer of the power calculation. ClinicalTrials.gov NCT00315029.

Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children

PubMed Central

Aglipay, Mary; Birken, Catherine S.; Parkin, Patricia C.; Loeb, Mark B.; Thorpe, Kevin; Chen, Yang; Laupacis, Andreas; Mamdani, Muhammad; Macarthur, Colin; Hoch, Jeffrey S.; Mazzulli, Tony

2017-01-01

Importance Epidemiological studies support a link between low 25-hydroxyvitamin D levels and a higher risk of viral upper respiratory tract infections. However, whether winter supplementation of vitamin D reduces the risk among children is unknown. Objective To determine whether high-dose vs standard-dose vitamin D supplementation reduces the incidence of wintertime upper respiratory tract infections in young children. Design, Setting, and Participants A randomized clinical trial was conducted during the winter months between September 13, 2011, and June 30, 2015, among children aged 1 through 5 years enrolled in TARGet Kids!, a multisite primary care practice–based research network in Toronto, Ontario, Canada. Interventions Three hundred forty-nine participants were randomized to receive 2000 IU/d of vitamin D oral supplementation (high-dose group) vs 354 participants who were randomized to receive 400 IU/d (standard-dose group) for a minimum of 4 months between September and May. Main Outcome Measures The primary outcome was the number of laboratory-confirmed viral upper respiratory tract infections based on parent-collected nasal swabs over the winter months. Secondary outcomes included the number of influenza infections, noninfluenza infections, parent-reported upper respiratory tract illnesses, time to first upper respiratory tract infection, and serum 25-hydroxyvitamin D levels at study termination. Results Among 703 participants who were randomized (mean age, 2.7 years, 57.7% boys), 699 (99.4%) completed the trial. The mean number of laboratory-confirmed upper respiratory tract infections per child was 1.05 (95% CI, 0.91-1.19) for the high-dose group and 1.03 (95% CI, 0.90-1.16) for the standard-dose group, for a between-group difference of 0.02 (95% CI, −0.17 to 0.21) per child. There was no statistically significant difference in number of laboratory-confirmed infections between groups (incidence rate ratio [RR], 0.97; 95% CI, 0.80-1.16). There was also no significant difference in the median time to the first laboratory-confirmed infection: 3.95 months (95% CI, 3.02-5.95 months) for the high-dose group vs 3.29 months (95% CI, 2.66-4.14 months) for the standard-dose group, or number of parent-reported upper respiratory tract illnesses between groups (625 for high-dose vs 600 for standard-dose groups, incidence RR, 1.01; 95% CI, 0.88-1.16). At study termination, serum 25-hydroxyvitamin D levels were 48.7 ng/mL (95% CI, 46.9-50.5 ng/mL) in the high-dose group and 36.8 ng/mL (95% CI, 35.4-38.2 ng/mL) in the standard-dose group. Conclusions and Relevance Among healthy children aged 1 to 5 years, daily administration of 2000 IU compared with 400 IU of vitamin D supplementation did not reduce overall wintertime upper respiratory tract infections. These findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infections. Trial Registration clinicaltrials.gov Identifier: NCT01419262 PMID:28719693

Effect of High-Dose vs Standard-Dose Wintertime Vitamin D Supplementation on Viral Upper Respiratory Tract Infections in Young Healthy Children.

PubMed

Aglipay, Mary; Birken, Catherine S; Parkin, Patricia C; Loeb, Mark B; Thorpe, Kevin; Chen, Yang; Laupacis, Andreas; Mamdani, Muhammad; Macarthur, Colin; Hoch, Jeffrey S; Mazzulli, Tony; Maguire, Jonathon L

2017-07-18

Epidemiological studies support a link between low 25-hydroxyvitamin D levels and a higher risk of viral upper respiratory tract infections. However, whether winter supplementation of vitamin D reduces the risk among children is unknown. To determine whether high-dose vs standard-dose vitamin D supplementation reduces the incidence of wintertime upper respiratory tract infections in young children. A randomized clinical trial was conducted during the winter months between September 13, 2011, and June 30, 2015, among children aged 1 through 5 years enrolled in TARGet Kids!, a multisite primary care practice-based research network in Toronto, Ontario, Canada. Three hundred forty-nine participants were randomized to receive 2000 IU/d of vitamin D oral supplementation (high-dose group) vs 354 participants who were randomized to receive 400 IU/d (standard-dose group) for a minimum of 4 months between September and May. The primary outcome was the number of laboratory-confirmed viral upper respiratory tract infections based on parent-collected nasal swabs over the winter months. Secondary outcomes included the number of influenza infections, noninfluenza infections, parent-reported upper respiratory tract illnesses, time to first upper respiratory tract infection, and serum 25-hydroxyvitamin D levels at study termination. Among 703 participants who were randomized (mean age, 2.7 years, 57.7% boys), 699 (99.4%) completed the trial. The mean number of laboratory-confirmed upper respiratory tract infections per child was 1.05 (95% CI, 0.91-1.19) for the high-dose group and 1.03 (95% CI, 0.90-1.16) for the standard-dose group, for a between-group difference of 0.02 (95% CI, -0.17 to 0.21) per child. There was no statistically significant difference in number of laboratory-confirmed infections between groups (incidence rate ratio [RR], 0.97; 95% CI, 0.80-1.16). There was also no significant difference in the median time to the first laboratory-confirmed infection: 3.95 months (95% CI, 3.02-5.95 months) for the high-dose group vs 3.29 months (95% CI, 2.66-4.14 months) for the standard-dose group, or number of parent-reported upper respiratory tract illnesses between groups (625 for high-dose vs 600 for standard-dose groups, incidence RR, 1.01; 95% CI, 0.88-1.16). At study termination, serum 25-hydroxyvitamin D levels were 48.7 ng/mL (95% CI, 46.9-50.5 ng/mL) in the high-dose group and 36.8 ng/mL (95% CI, 35.4-38.2 ng/mL) in the standard-dose group. Among healthy children aged 1 to 5 years, daily administration of 2000 IU compared with 400 IU of vitamin D supplementation did not reduce overall wintertime upper respiratory tract infections. These findings do not support the routine use of high-dose vitamin D supplementation in children for the prevention of viral upper respiratory tract infections. clinicaltrials.gov Identifier: NCT01419262.

How are scientific thinking skills best developed? Direct instruction vs. inquiry practice

NASA Astrophysics Data System (ADS)

Dean, David Worth, Jr.

Despite its support and adoption by most major scientific and educational organizations, some researchers have questioned whether inquiry learning is indeed the best method for acquiring the skills of inquiry. Klahr and colleagues have investigated the development of the control of variables strategy, or controlled comparison (CC), and claim that a brief session of direct instruction, characterized by explicit training of CC, as opposed to allowing children to discover CC through inquiry learning, is sufficient for acquisition, maintenance, and transfer of this core aspect of inquiry. Kuhn and colleagues, however, argue that direct instruction may be insufficient for development of the metastrategic level of understanding necessary to adequately maintain and transfer inquiry skills. In the present study, I attempt to identify the intervention most effective in supporting acquisition, maintenance, and transfer of these skills. Three groups of students received either a direct instruction session followed by standard classroom instruction (DI-only), an introductory session (without direct instruction) followed by practice sessions only (PR-only), or a direct instruction session followed by practice sessions (DI+PR). Practice sessions involved the use of a computer-based inquiry task requiring students to investigate the effects of five potential causal variables on an outcome. The two practice groups worked with this program during 12 sessions over nine weeks. They worked with structurally identical software programs during five weekly maintenance sessions. During this time, the DI-only group received standard classroom instruction. All groups were assessed on familiar and unfamiliar computer-based inquiry tasks at the conclusion of intervention (immediate assessment) and maintenance sessions (delayed assessment). Students in the two practice groups demonstrated improvement in an integrative measure of inquiry skill (valid intent, valid strategy, valid inference, and valid explanation, in combination) as well as most component measures of this skill. Performance of the two practice groups was superior to that of the DI-only group. Direct instruction conferred no additional benefit to the group receiving both direct instruction and practice compared to the practice-only group. Examined over an extended time interval, the merits of brief direct instruction are thus brought into question.

Effect of high-dose vs standard-dose multivitamin supplementation at the initiation of HAART on HIV disease progression and mortality in Tanzania: a randomized controlled trial.

PubMed

Isanaka, Sheila; Mugusi, Ferdinand; Hawkins, Claudia; Spiegelman, Donna; Okuma, James; Aboud, Said; Guerino, Chalamilla; Fawzi, Wafaie W

2012-10-17

Large randomized trials have previously shown that high-dose micronutrient supplementation can increase CD4 counts and reduce human immunodeficiency virus (HIV) disease progression and mortality among individuals not receiving highly active antiretroviral therapy (HAART); however, the safety and efficacy of such supplementation has not been established in the context of HAART. To test the hypothesis that high-dose multivitamin supplementation vs standard-dose multivitamin supplementation decreases the risk of HIV disease progression or death and improves immunological, virological, and nutritional parameters in patients with HIV initiating HAART. A randomized, double-blind, controlled trial of high-dose vs standard-dose multivitamin supplementation for 24 months in 3418 patients with HIV initiating HAART between November 2006 and November 2008 in 7 clinics in Dar es Salaam, Tanzania. INTERVENTION The provision of daily oral supplements of vitamin B complex, vitamin C, and vitamin E at high levels or standard levels of the recommended dietary allowance. The composite of HIV disease progression or death from any cause. The study was stopped early in March 2009 because of evidence of increased levels of alanine transaminase (ALT) in patients receiving the high-dose multivitamin supplement. At the time of stopping, 3418 patients were enrolled (median follow-up, 15 months), and there were 2374 HIV disease progression events and 453 observed deaths (2460 total combined events). Compared with standard-dose multivitamin supplementation, high-dose supplementation did not reduce the risk of HIV disease progression or death. The absolute risk of HIV progression or death was 72% in the high-dose group vs 72% in the standard-dose group (risk ratio [RR], 1.00; 95% CI, 0.96-1.04). High-dose supplementation had no effect on CD4 count, plasma viral load, body mass index, or hemoglobin level concentration, but increased the risk of ALT elevations (1239 events per 1215 person-years vs 879 events per 1236 person-years; RR, 1.44; 95% CI, 1.11-1.87) vs standard-dose supplementation. CONCLUSION In adults receiving HAART, use of high-dose multivitamin supplements compared with standard-dose multivitamin supplements did not result in a decrease in HIV disease progression or death but may have resulted in an increase in ALT levels. Clinicaltrials.gov Identifier: NCT00383669.

[Probiotics as an items of increasing the effectiveness of treatment of community-acquired pneumonia in adolescents].

PubMed

Gonchar, N V; Kassner, L N; Korenev, P B; Il'kovich, Iu M; Mogilina, S V; Petrov, L N

2011-01-01

The aim of the work was to evaluate the efficiency of microbial probiotics Vitaflor and metabolic probiotic Aktoflor-C in complex treatment of community-acquired pneumonia in adolescents in a hospital. The observation involved 38 children aged 11 to 18 years with radiologically verified community-acquired pneumonia, including 23 boys and 15 girls. Patients were divided in 3 groups. Patients in group 1 (n = 13) simultaneously with the antibiotic therapy received per os Vitaflor probiotic containing symbiotic strains of Lactobacillus acidophilus; patients in group 2 (n = 10) along with antibiotic therapy received per os metabolic probiotic Aktoflor-C, containing low molecular weight exometabolites bacteria; patient of the comparison group (n = 15) received antibiotic therapy only. The effectiveness of the used treatment schemes was assessed on the dynamics of the gut state microbiot acoarding to an extended bacteriological examination of faecal flora, level of saliva IgA secretory (before and after treatment), the dynamics of SF-36 quality of life 1 month after discharge from hospital. Was conducted a study of economic efficiency of different modes of therapy. Results showed that adolescents with community-acquired pneumonia during standard antibiotic therapy indicated development of dysbiotic bowel disturbances in the form of reliable oppression of the bifidobacteria and laktoflora. Dysbiosis of the microbial associations are not conducive to proper implementation of immune and nutritional functions of the intestine that shows the imperfection of rehabilitation of patients with pneumonia according to the evaluation of SF-36 quality of life. Pharmacoeconomic analysis revealed the benefits of probiotic metabolic type "Aktoflor" used in addition to standard therapy of community-acquired pneumonia in adolescents.

AMP!: A Cross-site Analysis of the Effects of a Theater-based Intervention on Adolescent Awareness, Attitudes, and Knowledge about HIV.

PubMed

Taggart, Tamara; Taboada, Arianna; Stein, Judith A; Milburn, Norweeta G; Gere, David; Lightfoot, Alexandra F

2016-07-01

AMP! (Arts-based, Multiple component, Peer-education) is an HIV intervention developed for high school adolescents. AMP! uses interactive theater-based scenarios developed by trained college undergraduates to deliver messages addressing HIV/STI prevention strategies, healthy relationships, and stigma reduction towards people living with HIV/AIDS. We used a pre-test/post-test, control group study design to simultaneously assess intervention effect on ninth grade students in an urban county in California (N = 159) and a suburban county in North Carolina (N = 317). In each location, the control group received standard health education curricula delivered by teachers; the intervention group received AMP! in addition to standard health education curricula. Structural equation modeling was used to determine intervention effects. The post-test sample was 46 % male, 90 % self-identified as heterosexual, 32 % reported receiving free or reduced lunch, and 49 % White. Structural models indicated that participation in AMP! predicted higher scores on HIV knowledge (p = 0.05), HIV awareness (p = 0.01), and HIV attitudes (p = 0.05) at the post-test. Latent means comparison analyses revealed post-test scores were significantly higher than pre-test scores on HIV knowledge (p = 0.001), HIV awareness (p = 0.001), and HIV attitudes (p = 0.001). Further analyses indicated that scores rose for both groups, but the post-test scores of intervention participants were significantly higher than controls (HIV knowledge (p = 0.01), HIV awareness (p = 0.01), and HIV attitudes (p = 0.05)). Thus, AMP!'s theater-based approach shows promise for addressing multiple adolescent risk factors and attitudes concerning HIV in school settings.

The effect of a program to promote play to reduce children's post-surgical pain: with plush toys, it hurts less.

PubMed

Ullán, Ana M; Belver, Manuel H; Fernández, Esperanza; Lorente, Felix; Badía, Marta; Fernández, Beatriz

2014-03-01

Various nonpharmacological strategies to relieve hospitalized children's pain propose play as a central element. Play is considered an essential resource to improve the negative psychosocial effects of the disease and the hospitalization itself. However, the empirical research of play in health settings has not received much attention. The goal of this study was to determine the effect of a program to promote play in the hospital on postsurgical pain in pediatric patients. The research hypothesis was that children will manifest less pain if they are distracted through play during the postsurgical period. We carried out a randomized parallel trial with two groups, an experimental group and a control group. The control group did not receive any specific treatment, only the standard attention contemplated in the hospital. The parents of the children from the experimental group received instructions to play with their children in the postsurgical period and specific play material with which to play. The results obtained support the research hypothesis. On average, the children from the experimental group scored lower on a pain scale than the children from the control group. This occurred in the three postsurgical measurements of pain. It is concluded that the program to promote play can decrease children's perception of pain. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Comparative hypoglycemic potentials and phytochemical profiles of 12 common leafy culinary vegetables consumed in Nsukka, Southeastern Nigeria.

PubMed

Aba, Patrick Emeka; Udechukwu, Ifeanyi Ronald

2018-04-11

Metabolic disease like diabetes mellitus is on the increase in developing countries due to lack of access to orthodox medicine owing to its high cost. Health benefits of culinary vegetables cannot be overemphasized. This study therefore aims to profile the hypoglycaemic potentials of 12 common leafy vegetables consumed in Nsukka, Southeastern Nigeria and advise diabetic patients accordingly. A total of 75 albino Wistar rats assigned to 15 groups of five rats per group were used for the study. Diabetes was induced in groups 1-14 rats by intraperitoneal injection of alloxan monohydrate (160 mg/kg), and rats in group 15 were not made diabetic. Groups 1-12 rats were treated with aqueous extracts of the vegetables (200 mg/kg), and group 13 rats received glibenclamide at 2 mg/kg and served as standard control. Rats in groups 14 and 15 received distilled water (10 mL/kg) to serve as negative and normal controls, respectively. The fasting blood glucose (FBG) values of the rats were determined 3, 6 and 24 h post-treatment. Phytochemical studies on the vegetables were also carried out. Results revealed that the hypoglycaemic activities of Gongronema latifolium, Pterocarpus santalinoides, Ocimum gratissimum, Pterocarpus mildbraedii and Vernonia amygdalina were comparable (p>0.05) to that obtained for glibenclamide (standard anti-diabetic drug) while Gnetum africanum and Piper guineense did not show significant hypoglycaemic activities. Phytochemicals such as flavonoids, alkaloids, tannins, saponins, glycosides, and terpenes were present in the vegetables. It was concluded that the vegetables possess hypoglycaemic activities at different capacities with G. latifolium being the most potent.

Lactulose vs polyethylene glycol 3350--electrolyte solution for treatment of overt hepatic encephalopathy: the HELP randomized clinical trial.

PubMed

Rahimi, Robert S; Singal, Amit G; Cuthbert, Jennifer A; Rockey, Don C

2014-11-01

Hepatic encephalopathy (HE) is a common cause of hospitalization in patients with cirrhosis. Pharmacologic treatment for acute (overt) HE has remained the same for decades. To compare polyethylene glycol 3350-electrolyte solution (PEG) and lactulose treatments in patients with cirrhosis admitted to the hospital for HE. We hypothesized that rapid catharsis of the gut using PEG may resolve HE more effectively than lactulose. The HELP (Hepatic Encephalopathy: Lactulose vs Polyethylene Glycol 3350-Electrolyte Solution) study is a randomized clinical trial in an academic tertiary hospital of 50 patients with cirrhosis (of 186 screened) admitted for HE. Participants were block randomized to receive treatment with PEG, 4-L dose (n = 25), or standard-of-care lactulose (n = 25) during hospitalization. The primary end point was an improvement of 1 or more in HE grade at 24 hours, determined using the hepatic encephalopathy scoring algorithm (HESA), ranging from 0 (normal clinical and neuropsychological assessments) to 4 (coma). Secondary outcomes included time to HE resolution and overall length of stay. A total of 25 patients were randomized to each treatment arm. Baseline clinical features at admission were similar in the groups. Thirteen of 25 patients in the standard therapy arm (52%) had an improvement of 1 or more in HESA score, thus meeting the primary outcome measure, compared with 21 of 23 evaluated patients receiving PEG (91%) (P < .01); 1 patient was discharged before final analysis and 1 refused participation. The mean (SD) HESA score at 24 hours for patients receiving standard therapy changed from 2.3 (0.9) to 1.6 (0.9) compared with a change from 2.3 (0.9) to 0.9 (1.0) for the PEG-treated groups (P = .002). The median time for HE resolution was 2 days for standard therapy and 1 day for PEG (P = .01). Adverse events were uncommon, and none was definitely study related. PEG led to more rapid HE resolution than standard therapy, suggesting that PEG may be superior to standard lactulose therapy in patients with cirrhosis hospitalized for acute HE. clinicaltrials.gov Identifier: NCT01283152.

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial.

PubMed

Borius, Pierre-Yves; Garnier, Stéphanie Ranque; Baumstarck, Karine; Castinetti, Frédéric; Donnet, Anne; Guedj, Eric; Cornu, Philippe; Blond, Serge; Salas, Sébastien; Régis, Jean

2017-08-02

Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life. Copyright © 2017 by the Congress of Neurological Surgeons

Association of Implementation of Practice Standards for Electrocardiographic Monitoring With Nurses' Knowledge, Quality of Care, and Patient Outcomes: Findings From the Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial.

PubMed

Funk, Marjorie; Fennie, Kristopher P; Stephens, Kimberly E; May, Jeanine L; Winkler, Catherine G; Drew, Barbara J

2017-02-01

Although continuous electrocardiographic (ECG) monitoring is ubiquitous in hospitals, monitoring practices are inconsistent. We evaluated implementation of American Heart Association practice standards for ECG monitoring on nurses' knowledge, quality of care, and patient outcomes. The PULSE (Practical Use of the Latest Standards of Electrocardiography) Trial was a 6-year multisite randomized clinical trial with crossover that took place in 65 cardiac units in 17 hospitals. We measured outcomes at baseline, time 2 after group 1 hospitals received the intervention, and time 3 after group 2 hospitals received the intervention. Measurement periods were 15 months apart. The 2-part intervention consisted of an online ECG monitoring education program and strategies to implement and sustain change in practice. Nurses' knowledge (N=3013 nurses) was measured by a validated 20-item online test, quality of care related to ECG monitoring (N=4587 patients) by on-site observation, and patient outcomes (mortality, in-hospital myocardial infarction, and not surviving a cardiac arrest; N=95 884 hospital admissions) by review of administrative, laboratory, and medical record data. Nurses' knowledge improved significantly immediately after the intervention in both groups but was not sustained 15 months later. For most measures of quality of care (accurate electrode placement, accurate rhythm interpretation, appropriate monitoring, and ST-segment monitoring when indicated), the intervention was associated with significant improvement, which was sustained 15 months later. Of the 3 patient outcomes, only in-hospital myocardial infarction declined significantly after the intervention and was sustained. Online ECG monitoring education and strategies to change practice can lead to improved nurses' knowledge, quality of care, and patient outcomes. URL: http://www.clinicaltrials.gov. Unique identifier: NCT01269736. © 2017 American Heart Association, Inc.

Working memory training and semantic structuring improves remembering future events, not past events.

PubMed

Richter, Kim Merle; Mödden, Claudia; Eling, Paul; Hildebrandt, Helmut

2015-01-01

Objectives. Memory training in combination with practice in semantic structuring and word fluency has been shown to improve memory performance. This study investigated the efficacy of a working memory training combined with exercises in semantic structuring and word fluency and examined whether training effects generalize to other cognitive tasks. Methods. In this double-blind randomized control study, 36 patients with memory impairments following brain damage were allocated to either the experimental or the active control condition, with both groups receiving 9 hours of therapy. The experimental group received a computer-based working memory training and exercises in word fluency and semantic structuring. The control group received the standard memory therapy provided in the rehabilitation center. Patients were tested on a neuropsychological test battery before and after therapy, resulting in composite scores for working memory; immediate, delayed, and prospective memory; word fluency; and attention. Results. The experimental group improved significantly in working memory and word fluency. The training effects also generalized to prospective memory tasks. No specific effect on episodic memory could be demonstrated. Conclusion. Combined treatment of working memory training with exercises in semantic structuring is an effective method for cognitive rehabilitation of organic memory impairment. © The Author(s) 2014.

Evaluation of a Self-Management Program for Gastroesophageal Reflux Disease in China

PubMed Central

Xu, Wenhong; Sun, Changxian; Lin, Lin; Wang, Meifeng; Zhang, Hongjie; Song, Yulei

2016-01-01

Gastroesophageal reflux disease is a chronic disease with a high incidence worldwide. The various symptoms have substantial impact on the quality of life of affected individuals. A long-term self-management program can increase the ability of patients to make behavioral changes, and health outcomes can improve as a consequence. This study's aim was to evaluate the effectiveness of a self-management program for gastroesophageal reflux disease. A total of 115 patients with gastroesophageal reflux disease were allocated to the experimental group and the control group. The former received self-management intervention along with conventional drug therapy, whereas the latter received standard outpatient care and conventional drug therapy. After the clinical trial, the control group also received the same self-management intervention. The levels of self-management behaviors, self-efficacy, gastroesophageal reflux disease symptoms, and psychological condition were compared. Those in the experimental group demonstrated significantly higher self-efficacy for managing their illness, showed positive changes in self-management behaviors, and had comparatively better remission of symptoms and improvement in psychological distress. The program helped patients with gastroesophageal reflux disease self-manage their illness as possible. PMID:27684637

A clinical trial gone awry: the Chocolate Happiness Undergoing More Pleasantness (CHUMP) study.

PubMed

Chan, Kevin

2007-12-04

The randomized controlled trial is the "gold standard" for evaluating the benefits and harms of interventions. The Chocolate Happiness Undergoing More Pleasantness (CHUMP) study was designed to compare the effects of dark chocolate, milk chocolate and normal chocolate consumption on happiness. Although the intention-to-treat analysis showed that participants who received either dark or milk chocolate were happier than those who received no additional chocolate, the actual-consumption analysis showed that there were no differences between any of the groups. The reason for this result is that many participants switched groups mid-study because of their personal chocolate preferences. Although the CHUMP study was pleasurable, it demonstrated the difficulties associated with performing a truly blinded clinical trial.

[Evaluation of antioxidant properties of enriched bakery products in experiment on laboratory animals].

PubMed

Nilova, L P; Pilipenko, T V

2016-01-01

The purpose was to study the effect of enriched bakery products in the diet of rats on indicators of prooxidant-antioxidant system of blood serum. Experiment was carried out on male Wistar rats with initial weight 140-180 g. After a quarantine during the preparatory period rats for 14 days were accustomed to the partial (50%) replacement of the standard diet by bakery products with standard compound­ing. Then, 7 groups of rats were formed: the 1st group of rats (control group, n=10) continued to receive bakery products of a standard composition; groups with the 2nd on 7th (experimental, n=8 in everyone) received enriched bakery products: the 2nd group - with blueberry powder; the 3rd group - with mountain ash powder; the 4th group - with sea-buckthorn powder; the 5th group - with flour of a pine nut; the 6th group - with rice bran oil; the 7th group - with pumpkin oil. The intensity of free radical oxidation and antioxidant activity (by chemiluminescence method), activity of superoxide dismutase and level of secondary oxidation products reacted with thiobarbituric acid (by spectrophotometry) were monitored in rat blood serum. It has been shown that the use of bakery products with different compounding in the animal diet had different effects on indicators of prooxidant-antioxidant system of blood serum. Bakery products containing sea buckthorn pomace powder, flour of pine nut and rice bran oil reduced intensity of free radical oxidation in rat blood serum by 36.0, 24.6 and 18.8%, respectively. It is suggested that bakery products containing flour of pine nut products brake a free radical oxidation in rat blood serum in case of simultaneous content of natural antioxidants and melanoidins. The anthocyanins of powder from blueberry berries can render antioxidant effect and slow down formation of by-products of oxidation. No statistically significant change on indicators of prooxidant-antioxidant system of blood serum of rats treated with bakery products with rowan powder or pumpkin oil was found, that may be due to animal refusal to eat such products.

Imaging-Guided Core-Needle Breast Biopsy: Impact of Meditation and Music Interventions on Patient Anxiety, Pain, and Fatigue.

PubMed

Soo, Mary Scott; Jarosz, Jennifer A; Wren, Anava A; Soo, Adrianne E; Mowery, Yvonne M; Johnson, Karen S; Yoon, Sora C; Kim, Connie; Hwang, E Shelley; Keefe, Francis J; Shelby, Rebecca A

2016-05-01

To evaluate the impact of guided meditation and music interventions on patient anxiety, pain, and fatigue during imaging-guided breast biopsy. After giving informed consent, 121 women needing percutaneous imaging-guided breast biopsy were randomized into three groups: (1) guided meditation; (2) music; (3) standard-care control group. During biopsy, the meditation and music groups listened to an audio-recorded, guided, loving-kindness meditation and relaxing music, respectively; the standard-care control group received supportive dialogue from the biopsy team. Immediately before and after biopsy, participants completed questionnaires measuring anxiety (State-Trait Anxiety Inventory Scale), biopsy pain (Brief Pain Inventory), and fatigue (modified Functional Assessment of Chronic Illness Therapy-Fatigue). After biopsy, participants completed questionnaires assessing radiologist-patient communication (modified Questionnaire on the Quality of Physician-Patient Interaction), demographics, and medical history. The meditation and music groups reported significantly greater anxiety reduction (P values < .05) and reduced fatigue after biopsy than the standard-care control group; the standard-care control group reported increased fatigue after biopsy. The meditation group additionally showed significantly lower pain during biopsy, compared with the music group (P = .03). No significant difference in patient-perceived quality of radiologist-patient communication was noted among groups. Listening to guided meditation significantly lowered biopsy pain during imaging-guided breast biopsy; meditation and music reduced patient anxiety and fatigue without compromising radiologist-patient communication. These simple, inexpensive interventions could improve women's experiences during core-needle breast biopsy. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Standard (60 Gy) or Short-Course (40 Gy) Irradiation Plus Concomitant and Adjuvant Temozolomide for Elderly Patients With Glioblastoma: A Propensity-Matched Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Minniti, Giuseppe, E-mail: gminniti@ospedalesantandrea.it; Scientific Institute for Research, Hospitalization and Health Care; Scaringi, Claudia

Purpose: To evaluate 2 specific radiation schedules, each combined with temozolomide (TMZ), assessing their efficacy and safety in patients aged ≥65 years with newly diagnosed glioblastoma (GBM). Methods and Materials: Patients aged ≥65 years with Karnofsky performance status (KPS) ≥60 who received either standard (60 Gy) or short-course (40 Gy) radiation therapy (RT) with concomitant and adjuvant TMZ between June 2004 and October 2013 were retrospectively analyzed. A propensity score analysis was executed for a balanced comparison of treatment outcomes. Results: A total of 127 patients received standard RT-TMZ, whereas 116 patients underwent short-course RT-TMZ. Median overall survival and progression-free survival times were similar: 12 monthsmore » and 5.6 months for the standard RT-TMZ group and 12.5 months and 6.7 months for the short-course RT-TMZ group, respectively. Radiation schedule was associated with similar survival outcomes in either unadjusted or adjusted analysis. O{sup 6}-methylguanine-DNA methyltransferase promoter methylation was the most favorable prognostic factor (P=.0001). Standard RT-TMZ therapy was associated with a significant rise in grade 2 and 3 neurologic toxicity (P=.01), lowering of KPS scores during the study (P=.01), and higher posttreatment dosing of corticosteroid (P=.02). Conclusions: In older adults with GBM, survival outcomes of standard and short-course RT-TMZ were similar. An abbreviated course of RT plus TMZ may represent a reasonable therapeutic approach for these patients, without loss of survival benefit and acceptable toxicity.« less

Postburn itching, pain, and psychological symptoms are reduced with massage therapy.

PubMed

Field, T; Peck, M; Scd; Hernandez-Reif, M; Krugman, S; Burman, I; Ozment-Schenck, L

2000-01-01

Twenty patients with burn injuries were randomly assigned to a massage therapy or a standard treatment control group during the remodeling phase of wound healing. The massage therapy group received a 30-minute massage with cocoa butter to a closed, moderate-sized scar tissue area twice a week for 5 weeks. The massage therapy group reported reduced itching, pain, and anxiety and improved mood immediately after the first and last therapy sessions, and their ratings on these measures improved from the first day to the last day of the study.

The effect of levamisole on mortality rate among patients with severe burn injuries

PubMed Central

Fatemi, Mohammad Javad; Salehi, Hamid; Akbari, Hossein; Alinejad, Faranak; Saberi, Mohsen; Mousavi, Seyed Jaber; Soltani, Majid; Taghavi, Shahrzad; Payandan, Hossein

2013-01-01

Background: Burn injuries are one of the main causes of mortality and morbidity throughout the world and burn patients have higher chances for infection due to their decreased immune resistance. Levamisole, as an immunomodulation agent, stimulates the immune response against infection. Materials and Methods: This randomized clinical trial was conducted in Motahari Burn Center, Tehran, Iran. Patients who had second- or third-degree burn with involvement of more than 50% of total body surface area (TBSA) were studied. The levamisole group received levamisole tablet, 100 mg per day. Meantime, both the levamisole and control groups received the standard therapy of the Burn Center, based on a standard protocol. Then, the outcome of the patients was evaluated. Results: 237 patients entered the study. After excluding 42 patients with inhalation injury, electrical and chemical burns, and the patients who died in the first 72 h, 195 patients remained in the study, including 110 patients in the control group and 85 in the treatment group. The mean age of all patients (between 13 to 64 years) was 33.29 ± 11.39 years (Mean ± SD), and it was 33.86 ± 11.45 years in the control group and 32.57 ± 11.32 years in the treatment group. The mean percentage of TBSA burn was 64.50 ± 14.34 and 68.58 ± 14.55 for the levamisole and control groups, respectively, with the range of 50-100% and 50-95% TBSA. The mortality rate was 68 (61.8%) patients in the control group and 50 (58.8%) patients in the treatment group (P = 0.8). Conclusion: According to this study, there was no significant relationship between improvement of mortality and levamisole consumption. PMID:24381625

An open-label comparative pilot study of oral voriconazole and itraconazole for long-term treatment of paracoccidioidomycosis.

PubMed

Queiroz-Telles, Flavio; Goldani, Luciano Z; Schlamm, Haran T; Goodrich, James M; Espinel-Ingroff, Ana; Shikanai-Yasuda, Maria A

2007-12-01

In previous studies, itraconazole was revealed to be an effective therapy and was considered to be the gold standard treatment for mild-to-moderate acute and chronic clinical forms of paracoccidioidomycosis. A pilot study was conducted to investigate the efficacy, safety, and tolerability of voriconazole for the long-term treatment of acute or chronic paracoccidioidomycosis, with itraconazole as the control treatment. A randomized, open-label study was conducted at 3 Brazilian tertiary care hospitals. Patients were randomized (at a 2 : 1 ratio) to receive oral therapy with voriconazole or itraconazole for 6 months. Patients receiving >or=1 dose of study drug were evaluated for safety; patients with confirmed paracoccidioidomycosis who completed >or=6 months of therapy (treatment-evaluable patients) were evaluated for treatment efficacy. Satisfactory global response was assessed at the end of treatment. Fifty-three patients were evaluated for treatment safety (35 received voriconazole, and 18 received itraconazole). Both drugs were well tolerated. The most common treatment-related adverse events in the voriconazole group included abnormal vision, chromatopsia, rash, and headache; the most common treatment-related adverse events in the itraconazole group included bradycardia, diarrhea, and headache. Liver function test values were slightly higher in patients receiving voriconazole than in those receiving itraconazole; 2 patients in the voriconazole group were withdrawn from treatment because of increased liver function test values. In the intent-to-treat populations, the satisfactory response rate (i.e., complete or partial global response) was 88.6% among the voriconazole group and 94.4% among the itraconazole group. The response rate among treatment-evaluable patients was 100% for both treatment groups; no relapses were observed after 8 weeks of follow-up. This is, to our knowledge, the first study to demonstrate that voriconazole is as well tolerated and effective as itraconazole for the long-term treatment of paracoccidioidomycosis.

Efficacy and safety of procalcitonin guidance in reducing the duration of antibiotic treatment in critically ill patients: a randomised, controlled, open-label trial.

PubMed

de Jong, Evelien; van Oers, Jos A; Beishuizen, Albertus; Vos, Piet; Vermeijden, Wytze J; Haas, Lenneke E; Loef, Bert G; Dormans, Tom; van Melsen, Gertrude C; Kluiters, Yvette C; Kemperman, Hans; van den Elsen, Maarten J; Schouten, Jeroen A; Streefkerk, Jörn O; Krabbe, Hans G; Kieft, Hans; Kluge, Georg H; van Dam, Veerle C; van Pelt, Joost; Bormans, Laura; Otten, Martine Bokelman; Reidinga, Auke C; Endeman, Henrik; Twisk, Jos W; van de Garde, Ewoudt M W; de Smet, Anne Marie G A; Kesecioglu, Jozef; Girbes, Armand R; Nijsten, Maarten W; de Lange, Dylan W

2016-07-01

In critically ill patients, antibiotic therapy is of great importance but long duration of treatment is associated with the development of antimicrobial resistance. Procalcitonin is a marker used to guide antibacterial therapy and reduce its duration, but data about safety of this reduction are scarce. We assessed the efficacy and safety of procalcitonin-guided antibiotic treatment in patients in intensive care units (ICUs) in a health-care system with a comparatively low use of antibiotics. We did a prospective, multicentre, randomised, controlled, open-label intervention trial in 15 hospitals in the Netherlands. Critically ill patients aged at least 18 years, admitted to the ICU, and who received their first dose of antibiotics no longer than 24 h before inclusion in the study for an assumed or proven infection were eligible to participate. Patients who received antibiotics for presumed infection were randomly assigned (1:1), using a computer-generated list, and stratified (according to treatment centre, whether infection was acquired before or during ICU stay, and dependent on severity of infection [ie, sepsis, severe sepsis, or septic shock]) to receive either procalcitonin-guided or standard-of-care antibiotic discontinuation. Both patients and investigators were aware of group assignment. In the procalcitonin-guided group, a non-binding advice to discontinue antibiotics was provided if procalcitonin concentration had decreased by 80% or more of its peak value or to 0·5 μg/L or lower. In the standard-of-care group, patients were treated according to local antibiotic protocols. Primary endpoints were antibiotic daily defined doses and duration of antibiotic treatment. All analyses were done by intention to treat. Mortality analyses were completed for all patients (intention to treat) and for patients in whom antibiotics were stopped while being on the ICU (per-protocol analysis). Safety endpoints were reinstitution of antibiotics and recurrent inflammation measured by C-reactive protein concentrations and they were measured in the population adhering to the stopping rules (per-protocol analysis). The study is registered with ClinicalTrials.gov, number NCT01139489, and was completed in August, 2014. Between Sept 18, 2009, and July 1, 2013, 1575 of the 4507 patients assessed for eligibility were randomly assigned to the procalcitonin-guided group (761) or to standard-of-care (785). In 538 patients (71%) in the procalcitonin-guided group antibiotics were discontinued in the ICU. Median consumption of antibiotics was 7·5 daily defined doses (IQR 4·0-12·7) in the procalcitonin-guided group versus 9·3 daily defined doses (5·0-16·6) in the standard-of-care group (between-group absolute difference 2·69, 95% CI 1·26-4·12, p<0·0001). Median duration of treatment was 5 days (3-9) in the procalcitonin-guided group and 7 days (4-11) in the standard-of-care group (between-group absolute difference 1·22, 0·65-1·78, p<0·0001). Mortality at 28 days was 149 (20%) of 761 patients in the procalcitonin-guided group and 196 (25%) of 785 patients in the standard-of-care group (between-group absolute difference 5·4%, 95% CI 1·2-9·5, p=0·0122) according to the intention-to-treat analysis, and 107 (20%) of 538 patients in the procalcitonin-guided group versus 121 (27%) of 457 patients in the standard-of-care group (between-group absolute difference 6·6%, 1·3-11·9, p=0·0154) in the per-protocol analysis. 1-year mortality in the per-protocol analysis was 191 (36%) of 538 patients in the procalcitonin-guided and 196 (43%) of 457 patients in the standard-of-care groups (between-group absolute difference 7·4, 1·3-13·8, p=0·0188). Procalcitonin guidance stimulates reduction of duration of treatment and daily defined doses in critically ill patients with a presumed bacterial infection. This reduction was associated with a significant decrease in mortality. Procalcitonin concentrations might help physicians in deciding whether or not the presumed infection is truly bacterial, leading to more adequate diagnosis and treatment, the cornerstones of antibiotic stewardship. Thermo Fisher Scientific. Copyright © 2016 Elsevier Ltd. All rights reserved.

Controlled study on the effect of pentoxifylline and an ergot alkaloid derivative on regional cerebral blood flow in patients with chronic cerebrovascular disease

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hartmann, A.; Tsuda, Y.

Regional cerebral blood flow (rCBF) in 90 patients with CBF decreased due to vascular diseases was studied by using the xenon 133 inhalation technique and a 32-detector setup. Whereas 30 patients received their standard basic therapy only and were regarded as controls, 30 others received 3 x 2 mg/day of an ergot alkaloid (co-dergocrine mesylate), and 30 others received 3 x 400 mg pentoxifylline (slow-release formulation)/day orally. Therapy was performed for eight weeks and CBF measured before start of treatment, after a four-week treatment period, and at the end of the study. CBF did not change significantly in the controlmore » group; both the pentoxifylline and the ergot alkaloid group presented with a significant increase in the CBF. This positive effect was significantly more pronounced in the pentoxifylline group and affected more ischemic than other brain tissues. In addition, symptoms like sleep disturbances, vertigo, and tinnitus improved significantly during the pentoxifylline observation period.« less

Effect of a preoperative protocol of aerobic physical therapy on the quality of life of patients with adolescent idiopathic scoliosis: a randomized clinical study.

PubMed

dos Santos Alves, Vera Lucia; Alves da Silva, Renato Jose Azevedo Leite; Avanzi, Osmar

2014-06-01

Patients with adolescent idiopathic scoliosis (AIS) have lower potential for physical activity because of lung dysfunction and lower muscle strength, which can be reversed by the cardiorespiratory and musculoskeletal conditioning provided by standardized physical activities. We conducted a study to determine if a preoperative protocol of aerobic exercise would improve quality of life (QoL) both before and after training and if there would be any differences between patients who received the therapy and those who did not. Patients with the indication of surgical correction of AIS were randomized to receive or not receive a 4-month preoperative course of aerobic physical training. At baseline and after 4 months, they were evaluated with the Short Form-36 questionnaire (SF-36). QoL scores improved for the study group but did not change for the control group. In all QoL domains, the study group's mean score increased significantly between baseline and 4 months. We concluded that the proposed preoperative physical therapy protocol improved the QoL of patients with AIS.

45 CFR 164.520 - Notice of privacy practices for protected health information.

Code of Federal Regulations, 2013 CFR

2013-10-01

... Health Information § 164.520 Notice of privacy practices for protected health information. (a) Standard... legal duties with respect to protected health information. (2) Exception for group health plans. (i) An... receive protected health information other than summary health information as defined in § 164.504(a) or...

45 CFR 164.520 - Notice of privacy practices for protected health information.

Code of Federal Regulations, 2012 CFR

2012-10-01

... Health Information § 164.520 Notice of privacy practices for protected health information. (a) Standard... legal duties with respect to protected health information. (2) Exception for group health plans. (i) An... receive protected health information other than summary health information as defined in § 164.504(a) or...

Dialectical Behavior Therapy Adapted for the Vocational Rehabilitation of Significantly Disabled Mentally Ill Adults

ERIC Educational Resources Information Center

Koons, Cedar R.; Chapman, Alexander L.; Betts, Bette B.; O'Rourke, Beth; Morse, Nesha; Robins, Clive J.

2006-01-01

Twelve vocational rehabilitation clients with severe mental illness received a comprehensive adaptation of dialectical behavior therapy (DBT) delivered in a group format. Treatment consisted of 2 hours of standard DBT skills training per week and 90 minutes of diary card review, chain analysis, and behavioral rehearsal. Participants were selected…

Rehearsal Processes in Children's Memory.

ERIC Educational Resources Information Center

Ornstein, Peter A.; Liberty, Charles

This study investigates developmental trends in free recall, with emphasis on rehearsal processes. An overt rehearsal technique was used in which 28 children in grades 3, 6, and 8 were instructed to rehearse out loud while trying to memorize a list of unrelated nouns. Control groups at each age level received standard free recall instructions,…

Special Education Referrals for African American Students: Behavior versus Academic Performance

ERIC Educational Resources Information Center

Curtis, Charmaine D.

2012-01-01

A higher percentage of African American students in a local school district were referred to special education than were students in other ethnic groups. Placement of a student in a special education program results in that student receiving a curriculum that has modified achievement standards. This correlational study examined patterns in…

Role of Inflammation and Insulin Resistance in Mouse Models of Breast Cancer

DTIC Science & Technology

2012-04-01

understood. We have found that the anti-inflammatory and insulin sensitizing effects of omega-3 fatty acids (ω3 FAs) are mediated by a specific G...the test group receive standard diet supplemented with ω3 FA (EPA and DHA ) while preserving total calories from fat. BODY: Task 1: Treating mice

78 FR 7348 - Patient Protection and Affordable Care Act; Exchange Functions: Eligibility for Exemptions...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-01

... se and those that may apply for recognition are neither group health insurance coverage nor.... 156.602) c. Requirements for Recognition as Minimum Essential Coverage for Coverage Not Otherwise... recognition that they meet the standards under section 5000A(d)(2)(B) of the Code. We also received...

A randomized controlled trial of four different regimes of biofeedback programme in the treatment of faecal incontinence.

PubMed

Young, C J; Zahid, A; Koh, C E; Young, J M; Byrne, C M; Solomon, M J; Rex, J; Candido, J

2018-04-01

Biofeedback is an established, effective and non-invasive treatment for faecal incontinence (FI). The aim was to compare the effectiveness of four different biofeedback treatment regimes. This was a randomized control trial of patients with FI, stratified into two groups (metropolitan and rural) and then randomized into two subgroups (groups 1 and 2 within metropolitan, groups 3 and 4 within rural) with varying face-to-face and telephone biofeedback components. All patients received standardized counselling and education, dietary modification and the use of anti-diarrhoeal medications. Group 1 received four monthly face-to-face biofeedback treatments, groups 2 and 3 received one face-to-face biofeedback followed by telephone biofeedback and group 4 received a one-off face-to-face biofeedback treatment. Primary outcomes were patient-assessed severity of FI and quality of life as assessed by the 36-item Short Form Health Survey and direct questioning of objectives. Secondary outcomes included St Mark's incontinence score, anxiety, depression and anorectal physiology measures (resting, squeeze pressures; isotonic, isometric fatigue times). Between 2006 and 2012, 351 patients were recruited. One patient died leaving 350 for analysis. 332 (95%) were women. Mean age was 60 (SD = 14). All groups had significant improvements in FI, quality of life, incontinence score and mental status (P < 0.001 each). There were no differences in improvements in FI between groups although patient satisfaction was less with reduced face-to-face contact. There were modest improvements in isotonic and isometric fatigue times suggesting improved sphincter endurance (both P < 0.001). Biofeedback is effective for FI. Although face-to-face and telephone biofeedback is not necessary to improve FI, it is important for patient satisfaction. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Tailored chemotherapy information faxed to general practitioners improves confidence in managing adverse effects and satisfaction with shared care: results from a randomized controlled trial.

PubMed

Jefford, Michael; Baravelli, Carl; Dudgeon, Paul; Dabscheck, Adrian; Evans, Melanie; Moloney, Michael; Schofield, Penelope

2008-05-10

General practitioners (GPs) play a critical role in the treatment of patients with cancer; yet often lack information for optimal care. We developed standardized information for GPs about chemotherapy (CT). In a randomized controlled trial we assessed the impact of sending, by fax, information tailored to the particular patient's CT regimen. Primary end points were: confidence treating patients who were receiving CT (confidence), knowledge of adverse effects and reasons to refer the patient to the treatment center (knowledge), and satisfaction with information and shared care of patients (satisfaction). Focus group work informed the development of the CT information which focused on potential adverse effects and recommended management strategies. GPs of patients due to commence CT were randomly assigned to receive usual correspondence with or without the faxed patient/regimen-specific information. Telephone questionnaire at baseline and 1 week postintervention assessed knowledge, confidence, and satisfaction. Ninety-seven GPs managed 97 patients receiving 23 types of CT. Eighty-one (83.5%) completed the follow-up questionnaire. GPs in the intervention group demonstrated a significantly greater increase in confidence (mean difference, 0.28; 95% CI, 0.10 to 0.47) and satisfaction (mean difference, 0.57; 95% CI, 0.27 to 0.88) compared with usual care, reflecting a 7.1% and 10.5% difference in score, respectively. No differences were detected for knowledge. GPs receiving the CT sheet found correspondence significantly more useful (P < .001) and instructive (P < .001) than GPs who received standard correspondence alone. Information about CT faxed to GPs is a simple, inexpensive intervention that increases confidence managing CT adverse effects and satisfaction with shared care. This intervention could have widespread application.

Cyclosporine-induced changes in drug metabolizing enzymes in hyperlipemic rabbit kidneys could explain its toxicity.

PubMed

Elbarbry, Fawzy; Ragheb, Ahmed; Attia, Ahmed; Chibbar, Rajni; Marfleet, Travis; Shoker, Ahmed

2010-11-01

This study investigates the mechanism of cyclosporine A (CsA)-mediated nephrotoxicity by examining the hypothesis that CsA toxicity is mediated through its effect on the kidney drug metabolizing enzymes in a hyperlipemic rabbit model. Twenty-four female New Zealand white rabbits divided into four groups. Group 1 received regular diet. Group 2 received 1% cholesterol diet. Group 3 received CsA (25 mg/kg, orally once daily) and group 4 received 1% cholesterol diet and CsA (25 mg/kg, orally once daily). Cytochrome P450 2E1 (CYP2E1) activity in kidney microsomes was assessed by measuring p-nitrophenol hydroxylase activity. Generation of reactive oxygen species (ROS) was assessed by measuring malondialdehyde (MDA) and the protein carbonyl. Effect of CsA and hyperlipidemia on the antioxidant proteins were also assessed using standard techniques. CsA but not the high-cholesterol diet induced significant elevation in MDA, protein carbonyl and CYP2E1 activities in the kidney. The addition of cholesterol to CsA normalized ROS markers without affecting the CsA-enhanced CYP2E1 activity. Alone, CsA caused characteristic tubular injury, whereas the addition of high-cholesterol diet to CsA nearly abolished the tubular damage. CsA-enhanced rabbit kidney ROS and CYP2E1 activities. Hyperlipidemia attenuates CsA tubular injury, most probably due to normalization of renal ROS, but not CYP2E1 activity.

Applied Research on Laparoscopic Simulator in the Resident Surgical Laparoscopic Operation Technical Training.

PubMed

Fu, Shangxi; Liu, Xiao; Zhou, Li; Zhou, Meisheng; Wang, Liming

2017-08-01

The purpose of this study was to estimate the effects of surgical laparoscopic operation course on laparoscopic operation skills after the simulated training for medical students with relatively objective results via data gained before and after the practice course of laparoscopic simulator of the resident standardized trainees. Experiment 1: 20 resident standardized trainees with no experience in laparoscopic surgery were included in the inexperienced group and finished simulated cholecystectomy according to simulator videos. Simulator data was collected (total operation time, path length, average speed of instrument movement, movement efficiency, number of perforations, the time cautery is applied without appropriate contact with adhesions, number of serious complications). Ten attending doctors were included in the experienced group and conducted the operation of simulated cholecystectomy directly. Data was collected with simulator. Data of two groups was compared. Experiment 2: Participants in inexperienced group were assigned to basic group (receiving 8 items of basic operation training) and special group (receiving 8 items of basic operation training and 4 items of specialized training), and 10 persons for each group. They received training course designed by us respectively. After training level had reached the expected target, simulated cholecystectomy was performed, and data was collected. Experimental data between basic group and special group was compared and then data between special group and experienced group was compared. Results of experiment 1 showed that there is significant difference between data in inexperienced group in which participants operated simulated cholecystectomy only according to instructors' teaching and operation video and data in experienced group. Result of experiment 2 suggested that, total operation time, number of perforations, number of serious complications, number of non-cauterized bleeding and the time cautery is applied without appropriate contact with adhesions in special group were all superior to those in basic group. There was no statistical difference on other data between special group and basic group. Comparing special group with experienced group, data of total operation time and the time cautery is applied without appropriate contact with adhesions in experienced group was superior to that in special group. There was no statistical difference on other data between special group and experienced group. Laparoscopic simulators are effective for surgical skills training. Basic courses could mainly improve operator's hand-eye coordination and perception of sense of the insertion depth for instruments. Specialized training courses could not only improve operator's familiarity with surgeries, but also reduce operation time and risk, and improve safety.

Effects of speech and language treatment on recovery from aphasia.

PubMed

Shewan, C M; Kertesz, A

1984-11-01

Language recovery in aphasic patients who received one of three types of speech and language treatment was compared with that in aphasic patients who received no treatment. One hundred aphasic patients were followed from 2 to 4 weeks postonset for 1 year or until recovery, using a standardized test battery administered at systematic intervals. Both treatment methods provided by trained speech-language pathologists were efficacious, while the method provided by trained nonprofessionals approached statistical significance. Small group size prevented resolution of the question of whether one type of treatment was superior to another.

Comparing the effects of minimal handling protocols on the physiological parameters of preterm infants receiving exogenous surfactant therapy

PubMed Central

Cabral, Laura A.; Velloso, Marcelo

2014-01-01

Background The practice of minimal handling is recommended for preterm infants (PTIs). However, few studies have investigated the effects of this practice among these infants or the time needed to ensure greater physiological stability, especially after exogenous surfactant treatments. Objective The current study compared the effects of two protocols of minimal handling on the physiological variables of PTIs after surfactant therapy. Method An exploratory prospective observational study was performed with 40 PTIs weighing less than 1,500 g. The infants were divided into two groups and monitored for 72 hours. One group received the standard minimal handling procedure during the first 12 hours after surfactant therapy; the other group (i.e., the modified group) received minimal handling within 72 hours after surfactant therapy. Infant heart rate (HR), oxygen saturation, body temperature, and the adverse events associated with changes to these variables were monitored every 10 minutes. Results Significant between-group differences were not found with regard to the occurrence of the adverse events associated with physiological changes (p>0.05). Conclusion The practice of minimal handling among very low birth weight infants did not alter their physiological stability when performed either 12 or 72 hours after surfactant therapy. PMID:24839044

Solar UV exposure of primary schoolchildren in Valencia, Spain.

PubMed

Serrano, María-Antonia; Cañada, Javier; Moreno, Juan Carlos

2011-04-01

To quantify schoolchildren's exposure to ultraviolet erythemal radiation (UVER), personal dosimeters (VioSpor) were used to measure biologically effective ultraviolet (UV) radiation received in the course of their daily school activities. The study took place in two primary schools in Valencia (39°28'N), Spain, for several weeks from March 2008 until May 2009, with two age groups (6-8 years and 10-11 years) and involved about 47 schoolchildren. The median daily UV exposure values for all age groups and solar height intervals considered in the study ranged from 1.31 to 2.11 standard erythemal doses (SEDs). Individual UV exposure was analyzed as a function of age, gender and dosimeter position. Significant statistical differences were found between different age groups, with the younger age group receiving higher statistically significant UVER exposure. It was also found that boys received significantly higher UVER exposure than girls. It was also noted that shoulder dosimeters registered higher readings than wrist dosimeters. Exposure ratio (ER) is defined as the ratio between the personal dose on a selected anatomical site and the corresponding ambient dose on a horizontal plane. The median ER for all age groups and solar height intervals in the study range from 4.5% to 10.7%, with higher values at lower solar heights.

Randomized, Multicenter Study of Gefitinib Dose-escalation in Advanced Non-small-cell Lung Cancer Patients Achieved Stable Disease after One-month Gefitinib Treatment

PubMed Central

Xue, Cong; Hong, Shaodong; Li, Ning; Feng, Weineng; Jia, Jun; Peng, Jiewen; Lin, Daren; Cao, Xiaolong; Wang, Siyang; Zhang, Weimin; Zhang, Hongyu; Dong, Wei; Zhang, Li

2015-01-01

There is no consensus on the optimal treatment for patients with advanced non-small-cell lung cancer (NSCLC) and stable disease (SD) after gefitinib therapy. This randomized, open-label, multicenter study aimed to explore whether dose-escalation of gefitinib would improve response and survival in NSCLC patients who achieved SD after one-month of standard gefitinib dosage. Between May 2009 and January 2012, 466 patients were enrolled and 100 eligible patients were randomized (1:1) to receive either a higher dose (500 mg/d; H group) or to continue standard dose (250 mg/d; S group) of gefitinib. Objective response rate (ORR) was similar between the two groups (12.5% vs 12.5%, p = 1.000). There were no significant differences regarding progression-free survival (PFS) and overall survival (OS) between both arms (H group vs S group: median PFS, 5.30 months vs 6.23 months, p = 0.167; median OS, 13.70 months vs 18.87 months, p = 0.156). Therefore, dose-escalation of gefitinib does not confer a response or survival advantage in patients who achieve SD with one month of standard-dose gefitinib treatment. PMID:26216071

Response evaluation after primary systemic therapy of Her2 positive breast cancer – an observational cross-sectional study.

PubMed

Tőkés, Tímea; Szentmártoni, Gyöngyvér; Torgyík, László; Kajáry, Kornélia; Lengyel, Zsolt; Györke, Tamás; Molnár, Béla Á; Tőkés, Anna-Mária; Kulka, Janina; Dank, Magdolna

2015-04-01

To evaluate (I) trastuzumab-containing primary systemic therapy (PST) in human epidermal growth factor receptor 2 (Her2) overexpressing breast carcinomas.; (II) compare the patients who achieved and those who did not achieve pathological complete remission (pCR), and (III) analyze the accuracy of different clinical-imaging modalities in tumor response monitoring. 188 patients who received PST between 2008 and 2014 were reviewed and 43 Her2 overexpressing breast cancer patients (28 Luminal B/Her2-positive and 15 Her2-positive) were enrolled. 26 patients received mostly taxane-based PST without trastuzumab (Group 1) and 17 patients received trastuzumab-containing PST (Group 2). We compared the concordance between pCR and complete remission (CR) defined by breast-ultrasound, CR defined by standard 18F-fluoro-deoxy-glucose positron emission tomography and computerized tomography (FDG-PET/CT) criteria (Method 1) and CR defined by a novel, breast cancer specific FDG-PET/CT criteria (Method 2). Sensitivity (sens), specificity (spec), and positive (PPV) and negative predictive values (NPV) were calculated. Ten patients (38.5%) in Group 1 and eight (47%) in Group 2 achieved pCR. pCR was significantly more frequent in Her2-positive than in Luminal B/Her2-positive tumors in both Group 1: (P=0.043) and Group 2: (P=0.029). PET/CT evaluated by the breast cancer specific criteria (Method 2) differentiated pCR from non-pCR more accurately in both groups (Group 1: sens=77.8%, spec=%, PPV=100%, NPV=71.4%; Group 2: sens=87.5%, spec=62.5%, PPV=70%, NPV=83.3%) than standard PET/CT criteria (Method 1) (Group 1: sens=22.2% spec=100% PPV=100% NPV=41.7%; in Group 2: sens=37.5%, spec=87.5%, PPV=75% NPV=58.3%) or breast ultrasound (Group 1, sens=83.3% spec=25% PPV=62.5% NPV=50%; Group 2, sens=100% spec=12.5% PPV=41.6% NPV=100%). The benefit of targeted treatment with trastuzumab-containing PST in Her2 overexpressing breast cancer was defined in terms of pCR rate. Luminal B/Her2-positive subtype needs further subdivision to identify patients who would benefit from PST. Combined evaluation of tumor response by our novel, breast cancer specific FDG-PET/CT criteria accurately differentiated pCR from non-pCR patients.

Deviation from the Standard of Care for Early Breast Cancer in the Elderly: What are the Consequences?

PubMed

Sun, Susie X; Hollenbeak, Christopher S; Leung, Anna M

2015-08-01

For elderly patients with early-stage breast cancer, the standards of care often are not strictly followed due to either clinician biases or patient preferences. The authors hypothesized that forgoing radiation and lymph node (LN) staging for elderly patients with early-stage breast cancer would have a negative impact on survival. From the Surveillance, Epidemiology, and End Results Program database, 53,619 women older than 55 years with stage 1 breast cancer who underwent breast conservation surgery were identified. Analyses were performed to compare the characteristics and outcomes of patients who received the standards of care with LN sampling and radiation and those of patients who did not, with control used for confounders. To account for selection bias from covariate imbalance, propensity score matching was performed. Survival was analyzed using the Kaplan-Meier method. Older patients were less likely to receive radiation and LN sampling. These standards of care were associated with improved overall survival rates of 15.8 and 27.1 % after 10 years, respectively (p ≤ 0.0001). This survival advantage persisted after propensity score matching, with a 7.4 % higher survival rate for patients who received radiation and a 16.8 % higher survival rate for those who underwent LN staging (p < 0.0001). Lymph node sampling and radiation therapy also conferred a statistically significant improvement in breast cancer-specific survival, with 1.3 and 2.6 % lower mortality rates respectively in the radiated and LN biopsy groups (p < 0.0001). As patients age, they are less likely to receive the standard of care for stage 1 breast cancer. Even after controlling for other factors, the study showed that failure to adhere to the standards of LN sampling and radiation therapy may have a negative impact in survival.

Combined use of fluorescence with a magnetic tracer and dilution effect upon sentinel node localization in a murine model.

PubMed

Kuwahata, Akihiro; Ahmed, Muneer; Saeki, Kohei; Chikaki, Shinichi; Kaneko, Miki; Qiu, Wenqi; Xin, Zonghao; Yamaguchi, Shinji; Kaneko, Akiko; Douek, Michael; Kusakabe, Moriaki; Sekino, Masaki

2018-01-01

Sentinel node biopsy using radioisotope and blue dye remains a gold standard for axillary staging in breast cancer patients with low axillary burden. However, limitations in the use of radioisotopes have resulted in emergence of novel techniques. This is the first in vivo study to assess the feasibility of combining the two most common novel techniques of using a magnetic tracer and indocyanine green (ICG) fluorescence. A total of 48 mice were divided into eight groups. Groups 1 and 2, the co-localization groups, received an injection of magnetic tracers (Resovist ® and Sienna+ ® , respectively) and ICG fluorescence; distilled water was used as the solvent of ICG. Groups 3 and 4, the diluted injection groups, received an injection of magnetic tracers (Resovist and Sienna+, respectively) and saline for dilution. Groups 5, 6, and 7, the control groups, received magnetic tracer (Resovist, Sienna+) and ICG alone, respectively. Fluorescent intensity assessment and iron quantification of excised popliteal lymph nodes were performed. Group 1', a co-localization group, received an injection of magnetic tracers (Resovist) and ICG' fluorescence: saline was used as the solvent for ICG. Lymphatic uptake of all tracers was confined to the popliteal nodes only, with co-localization confirmed in all cases and no significant difference in fluorescent intensity or iron content of ex vivo nodes between the groups (except for Group 1'). There was no impact of dilution on the iron content in the diluted Sienna+ group, but it significantly enhanced Resovist uptake ( P =0.005). In addition, there was a significant difference in iron content ( P =0.003) in Group 1'. The combination of a magnetic tracer (Resovist or Sienna+) and ICG fluorescence is feasible for sentinel node biopsy and will potentially allow for precise transcutaneous node identification, in addition to accurate intraoperative assessment. This radioisotope-free "combined technique" warrants further assessment within a clinical trial.

Health behavior change counseling in surgery for degenerative lumbar spinal stenosis. Part II: patient activation mediates the effects of health behavior change counseling on rehabilitation engagement.

PubMed

Skolasky, Richard L; Maggard, Anica M; Li, David; Riley, Lee H; Wegener, Stephen T

2015-07-01

To determine the effect of health behavior change counseling (HBCC) on patient activation and the influence of patient activation on rehabilitation engagement, and to identify common barriers to engagement among individuals undergoing surgery for degenerative lumbar spinal stenosis. Prospective clinical trial. Academic medical center. Consecutive lumbar spine surgery patients (N=122) defined in our companion article (Part I) were assigned to a control group (did not receive HBCC, n=59) or HBCC group (received HBCC, n=63). Brief motivational interviewing-based HBCC versus control (significance, P<.05). We assessed patient activation before and after intervention. Rehabilitation engagement was assessed using the physical therapist-reported Hopkins Rehabilitation Engagement Rating Scale and by a ratio of self-reported physical therapy and home exercise completion. Common barriers to rehabilitation engagement were identified through thematic analysis. Patient activation predicted engagement (standardized regression weight, .682; P<.001). Postintervention patient activation was predicted by baseline patient activation (standardized regression weight, .808; P<.001) and receipt of HBCC (standardized regression weight, .444; P<.001). The effect of HBCC on rehabilitation engagement was mediated by patient activation (standardized regression weight, .079; P=.395). One-third of the HBCC group did not show improvement compared with the control group. Thematic analysis identified 3 common barriers to engagement: (1) low self-efficacy because of lack of knowledge and support (62%); (2) anxiety related to fear of movement (57%); and (3) concern about pain management (48%). The influence of HBCC on rehabilitation engagement was mediated by patient activation. Despite improvements in patient activation, one-third of patients reported low rehabilitation engagement. Addressing these barriers should lead to greater improvements in rehabilitation engagement. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A randomized controlled trial of 6-week Chlorella vulgaris supplementation in patients with major depressive disorder.

PubMed

Panahi, Yunes; Badeli, Roghayeh; Karami, Gholam-Reza; Badeli, Zeinab; Sahebkar, Amirhossein

2015-08-01

Major depressive disorder (MDD) is a widespread psychiatric disorder with incapacitating symptoms. Oxidative stress has been identified to play a role in the pathophysiology of MDD. To evaluate the therapeutic effectiveness of a chemically defined and antioxidant-rich Chlorella vulgaris extract (CVE) as adjunct to standard treatment in patients suffering from MDD. Subjects with MDD diagnosis according to DSM-IV criteria who were receiving standard antidepressant therapy were assigned to add-on therapy with CVE (1800 mg/day; n=42), or continued standard antidepressant therapy alone (n=50) for a period of 6 weeks. Changes in the frequency of depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS) and Beck Depression Inventory II (BDI-II) scale. There were significant reductions in total and subscale BDI-II and HADS scores in both CVE and control groups by the end of trial. The magnitude of reductions in total BDI-II score [-4.14 (-5.30 to -2.97)] as well as physical [-2.34 (-2.84 to -1.84)] and cognitive [-1.12 (-1.62 to -0.61)] subscales were significantly greater in the CVE versus control group, however, reduction of the affective symptoms was greater in the control compared with the CVE group [0.95 (0.18-0.72)]. Total HADS [-3.71 (-4.44 to -2.98)] as well as individual subscales of depression [-1.46 (-2.02 to -0.90)] and anxiety [-2.25 (-2.74 to -1.76)] were reduced to a greater degree in the CVE group. CVE was well tolerated and no serious adverse event was reported. This pilot exploratory trial provides the first clinical evidence on the efficacy and safety of adjunctive therapy with CVE in improving physical and cognitive symptoms of depression as well as anxiety symptoms in patients who are receiving standard antidepressant therapy. Copyright © 2015 Elsevier Ltd. All rights reserved.

Efficacy of standardized extract of Hibiscus sabdariffa L. (Malvaceae) in improving iron status of adults in malaria endemic area: A randomized controlled trial.

PubMed

Peter, Emanuel L; Rumisha, Susan F; Mashoto, Kijakazi O; Minzi, Omary Ms; Mfinanga, Sayoki

2017-09-14

Indigenous community of Mkuranga district have been using aqueous extract of H. sabdariffa L. for treating anemia. However, there have been neither safety nor efficacy studies to validate this medicinal product in anemia. The purpose of this study was to establish efficacy and safety of standardized aqueous extract of H. sabdariffa L. in anemic adults. This was a randomized controlled clinical trial in which 130 adults' men and women aged 18-50 years were involved after meeting the inclusion criteria. Initially, standardized aqueous extract of H. sabdariffa L. was prepared using optimized extraction parameters. Stratified randomization was used to randomize participants into four fixed dose groups. The first group received oral dose of 1000ml while the 2nd group was randomized to receive 1500ml orally. The last two groups were given a dose of 2000ml of extract and 200mg ferrous sulphate tablet respectively. Primary endpoint was the actual change of iron status indicators at the end of 30 days follow up period as compared to those recorded at baseline. Adverse effects were assessed at every 10th day scheduled visit. In all arms, HB and hematopoietic parameters were measured using HemoCue hemoglobinometer® (HemoCue, Ängelholm, Sweden) and hematology analyzer® respectively at the trial site. Follow up was done for 30 days. A total of 82 participants were included for analysis. A standardized aqueous extract of H. sabdariffa L. did not improve iron status in anemic adults in malaria endemic region (P>0.005). However, there was evidence to support the safety of the extract for human consumptions as herbal supplement. Iron and organic acids contents of H. sabdariffa L. extract showed the potential of improving hematopoietic parameters. Studies with bigger sample size are therefore needed to establish the efficacy of the extract when concurrently used with malaria chemoprophylaxis in malaria endemic areas. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

A randomized controlled trial of comprehensive early intervention care in patients with first-episode psychosis in Japan: 1.5-year outcomes from the J-CAP study.

PubMed

Nishida, Atsushi; Ando, Shuntaro; Yamasaki, Syudo; Koike, Shinsuke; Ichihashi, Kayo; Miyakoshi, Yuji; Maekawa, Sanae; Nakamura, Tomohisa; Natsubori, Tatsunobu; Ichikawa, Eriko; Ishigami, Hiroki; Sato, Kojiro; Matsunaga, Asami; Smith, Jo; French, Paul; Harima, Hirohiko; Kishi, Yoshiki; Fujita, Izumi; Kasai, Kiyoto; Okazaki, Yuji

2018-04-08

The first episode of psychosis represents a critical period wherein comprehensive early intervention in psychosis (EIP) may alter the course of illness. However, evidence from randomized controlled trials that have examined the impact of comprehensive EIP care on clinical and functional recovery assessed by independent blinded raters is limited. The objective of this study was to conduct a single-blinded multicenter trial comparing comprehensive EIP care and standard care in young patients with first-episode psychosis (FEP) in Japan (J-CAP Study). A total of 77 participants with FEP (aged 15-35 years) were randomized to receive standard care or specialized comprehensive EIP care and were followed up for 1.5 years (trial no.: UMIN000005092). Function (measured with the Global Assessment of Functioning) and clinical remission (defined by internationally standardized criteria proposed by the Remission in Schizophrenia Working Group) were evaluated by independent raters who were blinded to group assignment. Dropout rate and other secondary outcomes were also examined. The specialized EIP care group had a higher clinical remission rate (odds ratio, 6.3; 95% confidence interval, 1.0-37.9) and lower treatment dropout rate (odds ratio, 0.038; 95% confidence interval, 0.002-0.923) than the standard care group, even after adjusting for baseline characteristics. Functional improvement in the specialized EIP care group was slightly higher than that in the standard care group, but this difference was not statistically significant (p = 0.195). From the results, we conclude that comprehensive EIP care may provide advantages over standard care in patients with FEP. Copyright © 2018. Published by Elsevier Ltd.

Morinda citrifolia Linn. for prevention of postoperative nausea and vomiting.

PubMed

Prapaitrakool, Sunisa; Itharat, Arunporn

2010-12-01

To be a preliminary, prospective, randomized double blinded, placebo-controlled trial to evaluate the efficacy of Morinda citrifolia Linn or noni for the prevention of postoperative nausea and vomiting (PONV) in patients considered high risk for PONV after various types of surgery. The plant extract was prepared by boiling of dried noni fruit (maturity stage 3-4) then evaporated under standard procedure and processed into capsules. The doses were 150 mg, 300 mg and 600 mg which are equivalent to 5, 10 and 20 g of dried noni fruit, respectively. One hundred patients of ASA physical status I or II, aged 18-65 years, and considered at risk for PONV, were randomized to receive 150, 300, 600 mg of noni extract or a placebo orally 1 hours before surgery. Standard general anesthetic technique and postoperative analgesia were employed. Significantly fewer patients who had received the 600 mg noni extract experienced nausea during the first 6 hours compared to the placebo group (48% for the 600 mg noni group and 80% for the placebo group, p-value = 0.04). The incidence of PONV in other time periods was not statistically different for all three noni doses compared to the placebo group. No side effects were reported in all groups. Morinda citrifolia Linn. has an antiemetic property and prophylactic noni extract at 600 mg (equivalent to 20g of dried noni fruit or scopoletin 8.712 microg) effectively reduces the incidence of early postoperative nausea (0-6 hours).

ARBOOK: Development and Assessment of a Tool Based on Augmented Reality for Anatomy

NASA Astrophysics Data System (ADS)

Ferrer-Torregrosa, J.; Torralba, J.; Jimenez, M. A.; García, S.; Barcia, J. M.

2015-02-01

The evolution of technologies and the development of new tools with educational purposes are growing up. This work presents the experience of a new tool based on augmented reality (AR) focusing on the anatomy of the lower limb. ARBOOK was constructed and developed based on TC and MRN images, dissections and drawings. For ARBOOK evaluation, a specific questionnaire of three blocks was performed and validated according to the Delphi method. The questionnaire included motivation and attention tasks, autonomous work and three-dimensional interpretation tasks. A total of 211 students from 7 public and private Spanish universities were divided in two groups. Control group received standard teaching sessions supported by books, and video. The ARBOOK group received the same standard sessions but additionally used the ARBOOK tool. At the end of the training, a written test on lower limb anatomy was done by students. Statistically significant better scorings for the ARBOOK group were found on attention-motivation, autonomous work and three-dimensional comprehension tasks. Additionally, significantly better scoring was obtained by the ARBOOK group in the written test. The results strongly suggest that the use of AR is suitable for anatomical purposes. Concretely, the results indicate how this technology is helpful for student motivation, autonomous work or spatial interpretation. The use of this type of technologies must be taken into account even more at the present moment, when new technologies are naturally incorporated to our current lives.

The effect of primary midwife-led care on women's experience of childbirth: results from the COSMOS randomised controlled trial.

PubMed

McLachlan, H L; Forster, D A; Davey, M-A; Farrell, T; Flood, M; Shafiei, T; Waldenström, U

2016-02-01

To determine the effect of primary midwife-led care ('caseload midwifery') on women's experiences of childbirth. Randomised controlled trial. Tertiary care women's hospital in Melbourne, Australia. A total of 2314 low-risk pregnant women. Women randomised to caseload care received antenatal, intrapartum and postpartum care from a primary midwife, with some care provided by a 'back-up' midwife. Women in standard care received midwifery-led care with varying levels of continuity, junior obstetric care or community-based medical care. The primary outcome of the study was caesarean section. This paper presents a secondary outcome, women's experience of childbirth. Women's views and experiences were sought using seven-point rating scales via postal questionnaires 2 months after the birth. A total of 2314 women were randomised between September 2007 and June 2010; 1156 to caseload and 1158 to standard care. Response rates to the follow-up questionnaire were 88 and 74%, respectively. Women in the caseload group were more positive about their overall birth experience than women in the standard care group (adjusted odds ratio 1.50, 95% CI 1.22-1.84). They also felt more in control during labour, were more proud of themselves, less anxious, and more likely to have a positive experience of pain. Compared with standard maternity care, caseload midwifery may improve women's experiences of childbirth. Primary midwife-led care ('caseload midwifery') improves women's experiences of childbirth. © 2015 Royal College of Obstetricians and Gynaecologists.

Effects of a hospital-based education programme on self-care behaviour, care dependency and quality of life in patients with heart failure--a randomised controlled trial.

PubMed

Köberich, Stefan; Lohrmann, Christa; Mittag, Oskar; Dassen, Theo

2015-06-01

To evaluate the effects of a nurse-led, hospital-based heart failure specific education session with a three-month telephone follow-up on self-care behaviour, care dependency and quality of life for patients with chronic heart failure. Patient education in patients with heart failure is able to promote heart failure-specific self-care, to reduce mortality, morbidity and rehospitalisation rates and to enhance quality of life, especially if heart failure education is embedded in a multidisciplinary approach. Evidence of the effect of a nurse-led self-care education, quality of life and care dependency in addition to standard medical treatment in Germany is lacking. Nonblinded, prospective, single-centre, randomised controlled trial. Sixty-four patients were allocated either to the intervention group or to the control group. Patients in the intervention group received education about heart failure self-care with a consecutive telephone follow-up over three months in addition to standard medical treatment. Patients in the control group received standard medical treatment only. Data of 110 patients (58 in the intervention group and 52 in the control group) with a mean age of 62 years and mean left ventricular ejection fraction of 28·2% could be analysed. Self-care education had a significant influence on overall heart failure self-care but not on quality of life and care dependency. A single education session with a consecutive telephone follow-up is able to improve overall self-care behaviours but not quality of life. Care dependency was not influenced by the education session. The easy to implement and short educational intervention has a positive effect on self-care behaviour for patients with heart failure. However, there was no effect on quality of life and care dependency. To improve quality of life and to influence care dependency, different measures have to be applied. © 2015 John Wiley & Sons Ltd.

Efficacy and Safety of Individualized Coaching After Stroke: the LAST Study (Life After Stroke): A Pragmatic Randomized Controlled Trial.

PubMed

Askim, Torunn; Langhammer, Birgitta; Ihle-Hansen, Hege; Gunnes, Mari; Lydersen, Stian; Indredavik, Bent

2018-02-01

The evidence for interventions to prevent functional decline in the long term after stroke is lacking. The aim of this trial was to evaluate the efficacy and safety of an 18-month follow-up program of individualized regular coaching on physical activity and exercise. This was a multicentre, pragmatic, single-blinded, randomized controlled trial. Adults (age ≥18 years) with first-ever or recurrent stroke, community dwelling, with modified Rankin Scale <5, and no serious comorbidities were included 10 to 16 weeks poststroke. The intervention group received individualized regular coaching on physical activity and exercise every month for 18 consecutive months. The control group received standard care. Primary outcome was the Motor Assessment Scale at end of intervention (18-month follow-up). Secondary measures were Barthel index, modified Rankin Scale, item 14 from Berg Balance Scale, Timed Up and Go test, gait speed, 6-minute walk test, and Stroke Impact Scale. Other outcomes were adverse events and compliance to the intervention assessed by training diaries and the International Physical Activity Questionnaire. Three hundred and eighty consenting participants were randomly assigned to individualized coaching (n=186) or standard care (n=194). The mean estimated difference on Motor Assessment Scale in favor of control group was -0.70 points (95% confidence interval, -2.80, 1.39), P =0.512. There were no differences between the groups on Barthel index, modified Rankin Scale, or Berg Balance Scale. The frequency of adverse events was low in both groups. Results from International Physical Activity Questionnaire and training diaries showed increased activity levels but low intensity of the exercise in the intervention group. The regular individualized coaching did not improve maintenance of motor function or the secondary outcomes compared with standard care. The intervention should be regarded as safe. Despite the neutral results, the health costs related to the intervention should be investigated. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01467206. © 2017 American Heart Association, Inc.

Comparison of the WarmCloud and Bair Hugger Warming Devices for the Prevention of Intraoperative Hypothermia in Patients Undergoing Orthotopic Liver Transplantation: A Randomized Clinical Trial

PubMed Central

Pearce, Brett; Mattheyse, Linda; Ellard, Louise; Desmond, Fiona; Pillai, Param; Weinberg, Laurence

2018-01-01

Background The avoidance of hypothermia is vital during prolonged and open surgery to improve patient outcomes. Hypothermia is particularly common during orthotopic liver transplantation (OLT) and associated with undesirable physiological effects that can adversely impact on perioperative morbidity. The KanMed WarmCloud (Bromma, Sweden) is a revolutionary, closed-loop, warm-air heating mattress developed to maintain normothermia and prevent pressure sores during major surgery. The clinical effectiveness of the WarmCloud device during OLT is unknown. Therefore, we conducted a randomized controlled trial to determine whether the WarmCloud device reduces hypothermia and prevents pressure injuries compared with the Bair Hugger underbody warming device. Methods Patients were randomly allocated to receive either the WarmCloud or Bair Hugger warming device. Both groups also received other routine standardized multimodal thermoregulatory strategies. Temperatures were recorded by nasopharyngeal temperature probe at set time points during surgery. The primary endpoint was nasopharyngeal temperature recorded 5 minutes before reperfusion. Secondary endpoints included changes in temperature over the predefined intraoperative time points, number of patients whose nadir temperature was below 35.5°C and the development of pressure injuries during surgery. Results Twenty-six patients were recruited with 13 patients randomized to each group. One patient from the WarmCloud group was excluded because of a protocol violation. Baseline characteristics were similar. The mean (standard deviation) temperature before reperfusion was 36.0°C (0.7) in the WarmCloud group versus 36.3°C (0.6) in the Bairhugger group (P = 0.25). There were no statistical differences between the groups for any of the secondary endpoints. Conclusions When combined with standardized multimodal thermoregulatory strategies, the WarmCloud device does not reduce hypothermia compared with the Bair Hugger device in patients undergoing OLT. PMID:29707629

Can organic and transgenic soy be used as a substitute for animal protein by rats?

PubMed

Soares, L L; Lucas, A M M; Boaventura, G T

2005-04-01

We evaluated the protein quality of organic and transgenic soy fed to rats throughout life. Thirty female Wistar rats were divided into three groups (N = 10): organic soy group (OSG) receiving organic soy-based diet, genetically modified soy group (GMSG) receiving transgenic soy-based diet, and a control group (CG) receiving casein-based diet. All animals received water and isocaloric diet (10% protein), ad libitum for 291 days. After this, the weight of GMSG animals (290.9 +/- 9.1 g) was significantly lower (P <= 0.04) than CG (323.2 +/- 7.9 g). The weight of OSG (302.2 +/- 8.7 g) was between that of the GMSG and the CG. Protein intake was similar for OSG (308.4 +/- 6.8 g) and GMSG (301.5 +/- 2.5 g), and significantly lower (P <= 0.0005) than the CG (358.4 +/- 8.1 g). Growth rate was similar for all groups: OSG (0.80 +/- 0.02 g), GMSG (0.81 +/- 0.03 g) and CG (0.75 +/- 0.02 g). In addition to providing a good protein intake and inducing less weight gain, both types of soy were utilized in a manner similar to that of casein, suggesting that the protein quality of soy is similar to that of the standard protein casein. The groups fed soy-based diet gained less weight, which may be considered to be beneficial for health. We conclude that organic and transgenic soy can be fed throughout life to rats in place of animal protein, because contain high quality protein and do not cause a marked increase in body weight.

Effects of third generation mobile phone-emitted electromagnetic radiation on oxidative stress parameters in eye tissue and blood of rats.

PubMed

Demirel, Soner; Doganay, Selim; Turkoz, Yusuf; Dogan, Zümrüt; Turan, Bahadir; Firat, Penpe Gul Bozgul

2012-06-01

To investigate the effects of electromagnetic radiation (EMR) emitted by a third generation (3G) mobile phone on the antioxidant and oxidative stress parameters in eye tissue and blood of rats. Eighteen Wistar albino rats were randomly assigned into two groups: Group I (n = 9) received a standardized a daily dose of 3G mobile phone EMR for 20 days, and Group II served as the control group (n = 9), receiving no exposure to EMR. Glutathione peroxidase (GSH-Px) and catalase (CAT) levels were measured in eye tissues; in addition, malondialdehyde (MDA) and reduced GSH levels were measured in blood. There was no significant difference between groups in GSH-Px (p = 0.99) and CAT (p = 0.18) activity in eye tissue. There was no significant difference between groups in MDA (p = 0.69) and GSH levels (p = 0.83) in blood. The results of this study suggest that under a short period of exposure, 3G mobile phone radiation does not lead to harmful effects on eye tissue and blood in rats.

Effectiveness of music therapy as an aid to neurorestoration of children with severe neurological disorders

PubMed Central

Bringas, Maria L.; Zaldivar, Marilyn; Rojas, Pedro A.; Martinez-Montes, Karelia; Chongo, Dora M.; Ortega, Maria A.; Galvizu, Reynaldo; Perez, Alba E.; Morales, Lilia M.; Maragoto, Carlos; Vera, Hector; Galan, Lidice; Besson, Mireille; Valdes-Sosa, Pedro A.

2015-01-01

This study was a two-armed parallel group design aimed at testing real world effectiveness of a music therapy (MT) intervention for children with severe neurological disorders. The control group received only the standard neurorestoration program and the experimental group received an additional MT “Auditory Attention plus Communication protocol” just before the usual occupational and speech therapy. Multivariate Item Response Theory (MIRT) identified a neuropsychological status-latent variable manifested in all children and which exhibited highly significant changes only in the experimental group. Changes in brain plasticity also occurred in the experimental group, as evidenced using a Mismatch Event Related paradigm which revealed significant post intervention positive responses in the latency range between 308 and 400 ms in frontal regions. LORETA EEG source analysis identified prefrontal and midcingulate regions as differentially activated by the MT in the experimental group. Taken together, our results showing improved attention and communication as well as changes in brain plasticity in children with severe neurological impairments, confirm the importance of MT for the rehabilitation of patients across a wide range of dysfunctions. PMID:26582974

Letter-Sound Reading: Teaching Preschool Children Print-to-Sound Processing

PubMed Central

2015-01-01

This intervention study investigated the growth of letter sound reading and growth of consonant–vowel–consonant (CVC) word decoding abilities for a representative sample of 41 US children in preschool settings. Specifically, the study evaluated the effectiveness of a 3-step letter-sound teaching intervention in teaching pre-school children to decode, or read, single letters. The study compared a control group, which received the preschool’s standard letter-sound instruction, to an intervention group which received a 3-step letter-sound instruction intervention. The children’s growth in letter-sound reading and CVC word decoding abilities were assessed at baseline and 2, 4, 6 and 8 weeks. When compared to the control group, the growth of letter-sound reading ability was slightly higher for the intervention group. The rate of increase in letter-sound reading was significantly faster for the intervention group. In both groups, too few children learned to decode any CVC words to allow for analysis. Results of this study support the use of the intervention strategy in preschools for teaching children print-to-sound processing. PMID:26839494

Effectiveness of music therapy as an aid to neurorestoration of children with severe neurological disorders.

PubMed

Bringas, Maria L; Zaldivar, Marilyn; Rojas, Pedro A; Martinez-Montes, Karelia; Chongo, Dora M; Ortega, Maria A; Galvizu, Reynaldo; Perez, Alba E; Morales, Lilia M; Maragoto, Carlos; Vera, Hector; Galan, Lidice; Besson, Mireille; Valdes-Sosa, Pedro A

2015-01-01

This study was a two-armed parallel group design aimed at testing real world effectiveness of a music therapy (MT) intervention for children with severe neurological disorders. The control group received only the standard neurorestoration program and the experimental group received an additional MT "Auditory Attention plus Communication protocol" just before the usual occupational and speech therapy. Multivariate Item Response Theory (MIRT) identified a neuropsychological status-latent variable manifested in all children and which exhibited highly significant changes only in the experimental group. Changes in brain plasticity also occurred in the experimental group, as evidenced using a Mismatch Event Related paradigm which revealed significant post intervention positive responses in the latency range between 308 and 400 ms in frontal regions. LORETA EEG source analysis identified prefrontal and midcingulate regions as differentially activated by the MT in the experimental group. Taken together, our results showing improved attention and communication as well as changes in brain plasticity in children with severe neurological impairments, confirm the importance of MT for the rehabilitation of patients across a wide range of dysfunctions.

Effects of Prophylactic Foscarnet on Human Herpesvirus-6 Reactivation and Encephalitis in Cord Blood Transplant Recipients: A Prospective Multicenter Trial with an Historical Control Group.

PubMed

Ogata, Masao; Takano, Kuniko; Moriuchi, Yukiyoshi; Kondo, Tadakazu; Ueki, Toshimitsu; Nakano, Nobuaki; Mori, Takehiko; Uoshima, Nobuhiko; Nagafuji, Koji; Yamasaki, Satoshi; Shibasaki, Yasuhiko; Sakai, Rika; Kato, Koji; Choi, Ilseung; Jo, Yumi; Eto, Tetsuya; Kako, Shinichi; Oshima, Kumi; Fukuda, Takahiro

2018-06-01

Cord blood transplantation (CBT) is a distinct risk factor for human herpesvirus-6 (HHV-6) reactivation and HHV-6 encephalitis. In a prospective multicenter trial we investigated the effects of prophylactic foscarnet (90 mg/kg i.v. infusion from days 7 to 27 after CBT) on the occurrence of HHV-6 reactivation, HHV-6 encephalitis, and acute graft-versus-host disease (aGVHD) in CBT recipients. Between 2014 and 2016, 57 patients were included in a foscarnet-prophylaxis group. Outcomes were compared with an historical control group who received CBT between 2010 and 2014 (standard-treatment group, n = 63). The cumulative incidence of high-level HHV-6 reactivation, defined as plasma HHV-6 DNA ≥ 10 4 copies/mL, at 60 days after CBT was significantly lower in the foscarnet-prophylaxis group than in the standard-treatment group (18.3% versus 57.3%, P < .001). Multivariate analysis revealed that myeloablative preconditioning and standard treatment were significant risk factors for high-level HHV-6 reactivation. The cumulative incidence of HHV-6 encephalitis at 60 days after CBT was not different between the groups (foscarnet-prophylaxis group, 12.4%; standard-treatment group, 4.9%; P = .14). The cumulative incidences of grades II to IV and grades III to IV aGVHD at 60 days after CBT were not different between the groups (grades II to IV aGVHD: foscarnet-prophylaxis group, 42.0%; standard-treatment group, 40.5%; P = .96; grades III to IV aGVHD: foscarnet-prophylaxis group, 14.5%; standard-treatment group, 14.5%; P = 1.00). In the setting of this study foscarnet significantly suppressed systemic HHV-6 reactivation in CBT recipients but failed to prevent the development of HHV-6 encephalitis. Suppression of HHV-6 reactivation by foscarnet did not show any effects against the incidence of aGVHD. Copyright © 2018 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Contingency Management is Effective in Promoting Abstinence and Retention in Treatment Among Crack Cocaine Users in Brazil: A Randomized Controlled Trial

PubMed Central

Miguel, André Q. C.; Madruga, Clarice S.; Cogo-Moreira, Hugo; Yamauchi, Rodolfo; Simões, Viviane; da Silva, Claudio J.; McPherson, Sterling; Roll, John M.; Laranjeira, Ronaldo R.

2016-01-01

BACKGROUND Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. AIMS To evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. METHODS We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. RESULTS The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p < 0.01). Those in the STCM group were 3.8, 4.6, and 68.9 times more likely to be retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < 0.05). Compared to the STA group, the STCM group submitted a significantly higher proportion of crack cocaine, THC, and alcohol negative samples (p < 0.001) when all expected samples were included in the denominator, but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. CONCLUSIONS Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds promise for broader application in international settings. PMID:27442691

Contingency management is effective in promoting abstinence and retention in treatment among crack cocaine users in Brazil: A randomized controlled trial.

PubMed

Miguel, André Q C; Madruga, Clarice S; Cogo-Moreira, Hugo; Yamauchi, Rodolfo; Simões, Viviane; da Silva, Claudio J; McPherson, Sterling; Roll, John M; Laranjeira, Ronaldo R

2016-08-01

Crack cocaine dependence has become a severe public health problem in Brazil, and current psychosocial approaches to this problem have shown little or no effectiveness. Although contingency management is among the most effective behavioral treatments for substance use disorders, it has never been applied in the treatment of crack cocaine-dependent individuals in Brazil. The aim of this study was to evaluate the efficacy of incorporating contingency management into standard outpatient treatment for crack cocaine dependence, as well as the impact that doing so has on treatment attendance, retention in treatment, maintenance of abstinence, and the frequency of substance use. We evaluated 65 treatment-seeking, crack cocaine-dependent individuals, randomized to receive 12 weeks of standard treatment plus contingency management (STCM; n = 33) or 12 weeks of standard treatment alone (STA; n = 32). Those in the STCM group received monetary incentives for being abstinent, earning up to US$235.50 if they remained abstinent throughout the entire treatment period. The STCM group participants attended a mean of 19.5 (SD = 14.9) treatment sessions, compared with 3.7 (SD = 5.9) for the STA group participants (p < .01). Those in the STCM group were 3.8, 4.6, and 68.9 times more likely to be retained in treatment at weeks 4, 8, and 12 than were those in the STA group. The likelihood of detecting 4, 8, and 12 weeks of continuous abstinence was 17.7, 9.9, and 18.6 times higher in the STCM group than in the STA group (p < .05). Compared to the STA group, the STCM group submitted a significantly higher proportion of negative samples for crack cocaine, delta-9-tetrahydrocannabinol, and alcohol (p < .001) when all expected samples were included in the denominator but not when only submitted samples were considered. The average monthly cost/participant for incentives was $29.00. Contingency management showed efficacy in a sample of Brazilian crack cocaine users. The intervention holds promise for broader application in international settings. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

The value of perioperative antibiotics on the success of oral free flap reconstructions.

PubMed

Mücke, Thomas; Rohleder, Nils H; Rau, Andrea; Ritschl, Lucas M; Kesting, Marco; Wolff, Klaus-Dietrich; Mitchell, David A; Loeffelbein, Denys J

2015-10-01

The subject of the presented study was to monitor and compare problems and outcomes of reconstructive surgery with microvascular free flaps in the head and neck region between groups of patients treated with perioperative antibiotics and a group of patients without antibiotics. Patients requiring oral reconstructive surgery following cancer resections with microvascular free flaps were prospectively evaluated (2007-2012). Antibiotic therapy was started 30 min before the operation and administered for 10 days. Three hundred and fifty patients were included (208 male, 59.4%; 142 female, 40.6%; mean age 59.8 ± 13.2 years). 330 patients received perioperative antibiotics. Twenty patients (5.7%) who received no antibiotics for specific reasons served as the control group. Wound infections developed in 33 of 122 patients (27%) who received benzylpenicillin, 17 of 88 patients (19.3%) who received amoxicillin combined with sulbactam and 25 of 120 patients (20.8%) who received cefuroxime. Ten patients (50%) who did not receive antibiotics developed wound infections. Receiving no antibiotics or penicillin showed no benefit (P = 0.11). Those receiving cefuroxime showed significantly lower incidence of wound infections (P = 0.034; risk decreased by the factor 2.88). The use of amoxicillin combined with sulbactam showed the lowest rate of wound infections (P = 0.018; risk decreased by the factor 3.46). The use of amoxicillin combined with sulbactam appears to be the most appropriate prophylactic antibiotic followed by cefuroxime in oral microsurgical free flap reconstructions. These data may serve as a guide until a controlled multicenter prospective trial is performed comparing newer antibiotics against current standards. © 2015 Wiley Periodicals, Inc.

Development and evaluation of a self care program on breastfeeding in Japan: A quasi-experimental study.

PubMed

Awano, Masayo; Shimada, Keiko

2010-08-23

Although the importance of breastfeeding is well known in Japan, in recent years less than 50% of mothers were fully breastfeeding at one month after birth. The purpose of this study was to develop a self-care program for breastfeeding aimed at increasing mothers' breastfeeding confidence and to evaluate its effectiveness. A quasi-experimental pretest-posttest design was conducted in Japan. The intervention, a breastfeeding self-care program, was created to improve mothers' self-efficacy for breastfeeding. This Breastfeeding Self-Care Program included: information on the advantages and basics of breastfeeding, a breastfeeding checklist to evaluate breastfeeding by mothers and midwives, and a pamphlet and audiovisual materials on breastfeeding. Mothers received this program during their postpartum hospital stay.A convenience sample of 117 primiparous women was recruited at two clinical sites from October 2007 to March 2008. The intervention group (n = 55), who gave birth in three odd-numbered months, received standard care and the Breastfeeding Self-Care Program while the control group (n = 62) gave birth in three even numbered months and received standard breastfeeding care.To evaluate the effectiveness of the Breastfeeding Self-Care Program, breastfeeding self-efficacy and breastfeeding rate were measured early postpartum, before the intervention, and after the intervention at one month postpartum. The study used the Japanese version of The Breastfeeding Self-Efficacy Scale Short Form (BSES-SF) to measure self-efficacy. The BSES-SF score of the intervention group rose significantly from 34.8 at early postpartum to 49.9 at one month after birth (p < 0.01). For the control group, the score rose from 39.5 at early postpartum to 46.5 at one month after birth (p = 0.03). The early postpartum fully breastfeeding rate was 90% for the intervention group and 89% for the control group. At one month postpartum, the fully breastfeeding rate declined significantly to 65% for the control group compared to 90% for the intervention group (p = 0.02). Results indicate that the Breastfeeding Self-Care Program increased mothers' self-efficacy for breastfeeding and had a positive effect on the continuation of breastfeeding. UMIN000003517.

Short-term balance training with computer-based feedback in children with cerebral palsy: A feasibility and pilot randomized trial.

PubMed

Saxena, Shikha; Rao, Bhamini K; Senthil, Kumaran D

2017-04-01

To assess the feasibility of using short-term balance training with computer-based visual feedback (BTVF) and its effect on standing balance in children with bilateral spastic cerebral palsy (BSCP). Out of the fourteen children with BSCP (mean age = 10.31 years), seven children received four sessions of BTVF (two such sessions/day, each session = 15 min) in comparison to the control group that received standard care. Feasibility was measured as percentages of recruitment, retention and safety and balance was measured using a posturography machine as sway velocity (m/s) and velocity moment (m/s 2 ) during quiet standing. No serious adverse events occurred in either group. There were no differences in the retention percentages and in any clinical outcome measure between both groups. Use of BTVF is feasible in children with BSCP but further investigation is required to estimate a dose-effect relationship.

Effect of adrenaline on survival in out-of-hospital cardiac arrest: A randomised double-blind placebo-controlled trial.

PubMed

Jacobs, Ian G; Finn, Judith C; Jelinek, George A; Oxer, Harry F; Thompson, Peter L

2011-09-01

There is little evidence from clinical trials that the use of adrenaline (epinephrine) in treating cardiac arrest improves survival, despite adrenaline being considered standard of care for many decades. The aim of our study was to determine the effect of adrenaline on patient survival to hospital discharge in out of hospital cardiac arrest. We conducted a double blind randomised placebo-controlled trial of adrenaline in out-of-hospital cardiac arrest. Identical study vials containing either adrenaline 1:1000 or placebo (sodium chloride 0.9%) were prepared. Patients were randomly allocated to receive 1 ml aliquots of the trial drug according to current advanced life support guidelines. Outcomes assessed included survival to hospital discharge (primary outcome), pre-hospital return of spontaneous circulation (ROSC) and neurological outcome (Cerebral Performance Category Score - CPC). A total of 4103 cardiac arrests were screened during the study period of which 601 underwent randomisation. Documentation was available for a total of 534 patients: 262 in the placebo group and 272 in the adrenaline group. Groups were well matched for baseline characteristics including age, gender and receiving bystander CPR. ROSC occurred in 22 (8.4%) of patients receiving placebo and 64 (23.5%) who received adrenaline (OR=3.4; 95% CI 2.0-5.6). Survival to hospital discharge occurred in 5 (1.9%) and 11 (4.0%) patients receiving placebo or adrenaline respectively (OR=2.2; 95% CI 0.7-6.3). All but two patients (both in the adrenaline group) had a CPC score of 1-2. Patients receiving adrenaline during cardiac arrest had no statistically significant improvement in the primary outcome of survival to hospital discharge although there was a significantly improved likelihood of achieving ROSC. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

A randomized, controlled trial of interactive, multimedia software for patient colonoscopy education.

PubMed

Shaw, M J; Beebe, T J; Tomshine, P A; Adlis, S A; Cass, O W

2001-02-01

The purpose of our study was to assess the effectiveness of computer-assisted instruction (CAI) in patients having colonoscopies. We conducted a randomized, controlled trial in large, multispecialty clinic. Eighty-six patients were referred for colonoscopies. The interventions were standard education versus standard education plus CAI, and the outcome measures were anxiety, comprehension, and satisfaction. Computer-assisted instruction had no effect on patients' anxiety. The group receiving CAI demonstrated better overall comprehension (p < 0.001). However, Comprehension of certain aspects of serious complications and appropriate postsedation behavior were unaffected by educational method. Patients in the CAI group were more likely to indicate satisfaction with the amount of information provided when compared with the standard education counterparts (p = 0.001). Overall satisfaction was unaffected by educational method. Computer-assisted instruction for colonoscopy provided better comprehension and greater satisfaction with the adequacy of education than standard education. Computer-assisted instruction helps physicians meet their educational responsibilities with no decrement to the interpersonal aspects of the patient-physician relationship.

Efficacy of the Get Ready to Learn yoga program among children with autism spectrum disorders: a pretest-posttest control group design.

PubMed

Koenig, Kristie Patten; Buckley-Reen, Anne; Garg, Satvika

2012-01-01

Occupational therapists use school-based yoga programs, but these interventions typically lack manualization and evidence from well-designed studies. Using an experimental pretest-posttest control group design, we examined the effectiveness of the Get Ready to Learn (GRTL) classroom yoga program among children with autism spectrum disorders (ASD). The intervention group received the manualized yoga program daily for 16 wk, and the control group engaged in their standard morning routine. We assessed challenging behaviors with standardized measures and behavior coding before and after intervention. We completed a between-groups analysis of variance to assess differences in gain scores on the dependent variables. Students in the GRTL program showed significant decreases (p < .05) in teacher ratings of maladaptive behavior, as measured with the Aberrant Behavior Checklist, compared with the control participants. This study demonstrates that use of daily classroomwide yoga interventions has a significant impact on key classroom behaviors among children with ASD. Copyright © 2012 by the American Occupational Therapy Association, Inc.

Randomized trial of intensive motivational interviewing for methamphetamine dependence.

PubMed

Polcin, Douglas L; Bond, Jason; Korcha, Rachael; Nayak, Madhabika B; Galloway, Gantt P; Evans, Kristy

2014-01-01

An intensive, 9-session motivational interviewing (IMI) intervention was assessed using a randomized clinical trial of 217 methamphetamine (MA) dependent individuals. Intensive motivational interviewing (IMI) was compared with a single standard session of MI (SMI) combined with eight nutrition education sessions. Interventions were delivered weekly over 2 months. All study participants also received standard outpatient group treatment three times per week. Both study groups showed significant decreases in MA use and Addiction Severity Index drug scores, but there were no significant differences between the two groups. However, reductions in Addiction Severity Index psychiatric severity scores and days of psychiatric problems during the past 30 days were found for clients in the IMI group but not the SMI group. SMI may be equally beneficial to IMI in reducing MA use and problem severity, but IMI may help alleviate co-occurring psychiatric problems that are unaffected by shorter MI interventions. Additional studies are needed to assess the problems, populations, and contexts for which IMI is effective.

[Analysis of drug resistance to antituberculosis drugs of the first time retreated pulmonary tuberculosis patients in Shanghai].

PubMed

Fan, Yu-mei; Xiao, He-ping; Mei, Jian

2006-10-01

To investigate antituberculosis drug resistance among the first time retreated pulmonary tuberculosis patients in Shanghai, and therefore to provide evidence for establishing retreatment regimen. Analysis was conducted retrospectively on drug susceptibility tests to isoniazid, rifampin, streptomycin, ethambutol and para-aminosalicylates of the first time retreated pulmonary tuberculosis patients with a positive sputum culture in Shanghai Center for Disease Control from January 2002 to December 2004. The total drug resistance rate was 39.6%. The drug resistance rate in male and female patients was 38.5% and 44.4% respectively, the difference being not significant. The drug resistance rate in the young age group, the middle age group and the old age group were 50.0%, 41.6% and 34.6% respectively, the difference being not significant. The total drug resistance rates in the treatment failure group with standard initial chemotherapy and in the relapse group with standard regimen were both higher than in the relapse group with non-standard regimen (70.0%, 47.5%, 28.2%). So do the drug resistance rates of more than two drugs (70.0%, 18.3%, 6.4%). The multi-drug resistance rate of the failures with standard regimen was 70.0%, much higher than the relapses with standard regimen and the relapses with non-standard regimen. In relapses with non-standard initial therapy, the drug resistance rate of patients who received medications > or = 12 months was 55.0%, significantly higher than those treated for 1 - 5 months (13.0%). The drug resistance rate of patients who were treated with one to two drugs was lower than those treated with > or = 3 drugs, but no significant difference was observed (24.4% and 30.8%). Drug resistance rate varies in different types of the first time retreated pulmonary tuberculosis patients due to the history of drug use, which indicates that the current standard retreatment regimen is probably ineffective for some patients.

Esmolol is noninferior to metoprolol in achieving a target heart rate of 65 beats/min in patients referred to coronary CT angiography: a randomized controlled clinical trial.

PubMed

Maurovich-Horvat, Pál; Károlyi, Mihály; Horváth, Tamás; Szilveszter, Bálint; Bartykowszki, Andrea; Jermendy, Ádám L; Panajotu, Alexisz; Celeng, Csilla; Suhai, Ferenc I; Major, Gyöngyi P; Csobay-Novák, Csaba; Hüttl, Kálmán; Merkely, Béla

2015-01-01

Coronary CT angiography (CTA) is an established tool to rule out coronary artery disease. Performance of coronary CTA is highly dependent on patients' heart rates (HRs). Despite widespread use of β-blockers for coronary CTA, few studies have compared various agents used to achieve adequate HR control. We sought to assess if the ultrashort-acting β-blocker intravenous esmolol is at least as efficacious as the standard of care intravenous metoprolol for HR control during coronary CTA. Patients referred to coronary CTA with a HR >65 beats/min despite oral metoprolol premedication were enrolled in the study. We studied 412 patients (211 male; mean age, 57 ± 12 years). Two hundred four patients received intravenous esmolol, and 208 received intravenous metoprolol with a stepwise bolus administration protocol. HR and blood pressure were recorded at arrival, before, during, immediately after, and 30 minutes after the coronary CTA scan. Mean HRs of the esmolol and metoprolol groups were similar at arrival (78 ± 13 beats/min vs 77 ± 12 beats/min; P = .65) and before scan (68 ± 7 beats/min vs 69 ± 7 beats/min; P = .60). However, HR during scan was lower in the esmolol group vs the metoprolol group (58 ± 6 beats/min vs 61 ± 7 beats/min; P < .0001), whereas HRs immediately and 30 minutes after the scan were higher in the esmolol group vs the metoprolol group (68 ± 7 beats/min vs 66 ± 7 beats/min; P = .01 and 65 ± 8 beats/min vs 63 ± 8 beats/min; P < .0001; respectively). HR ≤ 65 beats/min was reached in 182 of 204 patients (89%) who received intravenous esmolol vs 162 of 208 of the patients (78%) who received intravenous metoprolol (P < .05). Of note, hypotension (systolic BP <100 mm Hg) was observed right after the scan in 19 patients (9.3%) in the esmolol group and in 8 patients (3.8%) in the metoprolol group (P < .05), whereas only 5 patients (2.5%) had hypotension 30 minutes after the scan in the esmolol group compared to 8 patients (3.8%) in the metoprolol group (P = .418). Intravenous esmolol with a stepwise bolus administration protocol is at least as efficacious as the standard of care intravenous metoprolol for HR control in patients who undergo coronary CTA. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Effects of substituting a portion of standard physiotherapy time with virtual reality games among community-dwelling stroke survivors

PubMed Central

2013-01-01

Background Evidence indicates that the continuation of therapy among community-dwelling stroke survivors improves physical function. Community rehabilitation programmes often face limitations in terms of resources. It is imperative to include new motivational interventions to encourage some level of non-clinician management. The aim of this study was to determine whether there were any changes in physical function and activities of daily living when substituting a portion of the standard physiotherapy time with virtual reality games among community-dwelling stroke survivors. Methods In this controlled trial, the experimental group received 30 minutes of virtual reality balance games in addition to 90 minutes of standard physiotherapy. The control group continued with their two hours of routine standard physiotherapy. Both groups received 12 therapy sessions: two-hour sessions twice per week for six continuous weeks. Changes in physical function, activities of daily living and balance ability were assessed using the Timed Up and Go test, 30-second Sit to Stand test, Timed Ten-Metre Walk test, Six-Minute Walk test and the Barthel Index, and static balance was assessed using a probalance board. Results Twenty-eight participants completed post-intervention assessments. The results showed a significant within-subject effect on the Timed Up and Go test: F (1, 26) = 5.83, p = 0.02; and the 30-second Sit to Stand test; F (1, 26) = 13.50, p = 0.001. The between-subject effect was not significant (p > 0.05) for any of the outcome measurements. Conclusion Substituting a portion of the standard physiotherapy time with virtual reality games was equally effective in maintaining physical function outcomes and activities of daily living among community-dwelling stroke survivors. Trial Registration Australia and New Zealand Clinical Trials Register, ACTRN12613000478718 PMID:24330250

The effects of a video-based education in women with newly diagnosed breast cancer in Singapore.

PubMed

Tan, May Leng; Lee, Kim Hua; Yong, Wei Sean; Rodgers, Cheryl

2018-05-18

The purpose of this study was to evaluate the impact of an educational video among women who were newly diagnosed with breast cancer on knowledge, anxiety, and satisfaction with their surgical decision. A pre-post-test design was used to evaluate knowledge, anxiety, and satisfaction levels with decision-making regarding surgery among women with breast cancer. A purposive sampling strategy was implemented to compare outcomes of newly diagnosed breast cancer women who received standard of care that included breast care nurse counseling sessions and written materials to women who received standard of care plus a supplement educational video. Knowledge and anxiety scores were collected at baseline and 2 weeks post-operatively. Satisfaction with decision (SWD) on the nature of surgery was gathered 2 weeks after surgery. Sixty-two subjects were recruited in a Singapore tertiary cancer center with a cohort of 32 women in the non-video group and 30 women in the video group. There was a statistically significant interaction effect of group and time (p = .008), wherein knowledge increased for both groups, although the increase was steeper for the video group. Both groups had significantly lower anxiety at post-implementation compared to pre-implementation (p < .001). There were no differences in SWD scores in both groups. Use of an additional video-based education significantly increased breast cancer knowledge levels among women in the educational video group. Nurses and healthcare professionals should focus on identifying individual informational needs based on surgical options to provide personalize care and transfer the necessary knowledge in empowering woman's decision-making process on her nature of breast surgery.

Effect of Calcium β-Hydroxy-β-Methylbutyrate (CaHMB), Vitamin D, and Protein Supplementation on Postoperative Immobilization in Malnourished Older Adult Patients With Hip Fracture: A Randomized Controlled Study.

PubMed

Ekinci, Osman; Yanık, Serhat; Terzioğlu Bebitoğlu, Berna; Yılmaz Akyüz, Elvan; Dokuyucu, Ayfer; Erdem, Şevki

2016-12-01

Nutrition support in orthopedic patients with malnutrition shortens the immobilization period. The efficacy of calcium β-hydroxy-β-methylbutyrate (CaHMB), vitamin D, and protein intake on bone structure is studied and well known; however, there is no evidence supporting the effect of combined use in orthopedic conditions. We investigated the effects of CaHMB, vitamin D, and protein supplementation on wound healing, immobilization period, muscle strength, and laboratory parameters. This randomized controlled study included 75 older female patients with a hip fracture admitted to orthopedic clinics. The control group received standard postoperative nutrition. The study group received an enteral product containing 3 g CaHMB, 1000 IU vitamin D, and 36 g protein, in addition to standard postoperative nutrition. Anthropometric, laboratory, wound-healing, immobilization period, and muscle strength assessments were evaluated preoperatively and on postoperative days 15 and 30. Wound-healing period was significantly shorter in the CaHMB/vitamin D/protein group than in the control group ( P < .05). The number of patients in the CaHMB/vitamin D/protein group who were mobile on days 15 and 30 (81.3%) was significantly higher than patients in the control group, who were mobile on days 15 and 30 (26.7%) ( P = .001). Muscle strength on day 30 was significantly higher in the CaHMB/vitamin D/protein group vs the control group. Nutrition of elderly patients with a CaHMB/vitamin D/protein combination led to acceleration of wound healing, shortening of immobilization period, and increased muscle strength without changing body mass index. It also reduced dependence to bed and related complications after an orthopedic operation.

A Comparison of Hospital Versus Outpatient Parenteral Antibiotic Therapy at Home for Pyelonephritis and Meningitis.

PubMed

Hensey, Conor C; Sett, Arun; Connell, Tom G; Bryant, Penelope A

2017-09-01

Despite the benefits of home treatment with outpatient parenteral antimicrobial therapy (OPAT), children with pyelonephritis and meningitis are rarely included. We aimed to compare clinical characteristics and outcomes between hospital and home treatment for these conditions and to identify factors influencing home treatment. Children admitted to the hospital with pyelonephritis or proven and presumed bacterial meningitis from January 1, 2012, to December 31, 2013 were identified retrospectively. Patients who received any OPAT (home group) received daily visits via our Hospital-in-the-Home (HITH) program; inpatients (hospital group) received standard care. Clinical and demographic features, length of stay, readmission rate and cost were compared between hospital and home groups. One hundred thirty-nine children with pyelonephritis and 70 with meningitis were identified, of which 127 and 44 were potentially suitable for OPAT, respectively. Of these, 12 (9%) with pyelonephritis received OPAT, contrasting with 29 (66%) with meningitis. Clinical features did not differ between hospital- and home-treated patients for either condition. Patients with meningitis in the hospital group were younger than those transferred to HITH (1 vs. 2 months; P = 0.01). All patients were afebrile before transfer to HITH. Admissions for pyelonephritis were brief with inpatients having a shorter length of stay than home patients (median: 3 vs. 4.5 days; P = 0.002). Unplanned readmission rates were comparable across all groups. Transfer to HITH resulted in a saving of AU$178,180. Children with pyelonephritis and meningitis can feasibly receive OPAT. Age, treatment duration and fever influence this decision. None of these should be barriers to OPAT, and the cost savings support change in practice.

Neuropeptide Y stimulation as primary target for preventive measures of maladaptative cardiovascular reactions in occupational chronic stress exposure.

PubMed

Ciumaşu-Rîmbu, Mălina; Popa, Livia; Vulpoi, Carmen

2012-01-01

Chronic stress may produce a decrease in central NPY expression and subjects exposed to it may prove hypersensitivity to a novel stressor with dysfunctions in the NPY system and cardiovascular maladaptation to stress, even hypertension. Upregulation of NPY expression may contribute to successful behavioral adaptation to stress by reducing cardiovascular tone and suppressing anxious behaviors. Adaptogens, a new class of metabolic regulators stimulate NPY expression and release. The aim of this study is to increase tolerance and adaptation to stress of hypersensitive to novel stressor, occupational chronic stress exposed subjects with cardiovascular maladaptation to mild new stressor using adaptogens as part of prevention protocol. 40 military personnel with known cardiostressor reactional mode and occupational chronic stress exposure were exposed to mild novel stressor: occupational medicine routine evaluation and clinically assessed for maladaptative cardiovascular response prior and before application of 30 day prevention protocol. Employees were randomly split in two groups, one receiving standard prevention protocol (lifestyle counseling) plus adaptogens in multiple dose administration, twice daily and the other receiving only standard prevention protocol. We found significant statistic differences in all cardiovascular parameters in adaptogen group and only in diastolic blood pressure in control group. Adaptogens could be an important factor in successful prevention protocols of chronic occupational stress dysfunctions involving NPY systems.

Comparison of palanosetron, granisetron and ondansetron as anti-emetics for prevention of postoperative nausea and vomiting in patients undergoing middle ear surgery.

PubMed

Basu, Anjana; Saha, Debdas; Hembrom, Bani P; Roy, Amit; Naaz, Anjum

2011-05-01

The objective of the study was to compare the efficacy of palanosetron (0.25 mg), granisetron (3.0 mg) and ondansetron (8.0 mg) used as anti-emetics for the prevention of postoperative nausea/vomiting in patients undergoing middle ear surgery. The study was done among 75 adult patients (age group 30-45 years) of which 50 were males and rest (25) females, all of ASA I and ASA II. The patients were randomly allocated into 3 equal groups: Group I (n = 25) received injection palanosetron (0.25 mg) IV, group II (n = 25) received injection granisetron (3 mg) IV and group III (n = 25) received injection ondansetron (8.0 mg) IV at the end of the surgical procedure. A standard general anaesthesia technique was employed. Emetic episodes and safety assessments were performed during two periods of 0-6 hours in the postanaesthesia care unit and 6-24 hours in the ward after anaesthesia. The incidence of emesis-free patients during the 0-6 hours period was 100% for group I; 72% for group II and 56% for group III. During the 6-24 hours period incidence of emesis-free patients were 96% for group I; 56% for group II and 32% for group III. So to conclude, a single dose of palanosetron (0.25 mg) is a superior anti-emetic to granisetron (3.0 mg) or ondansetron (8.0 mg) in complete prevention of postoperative nausea and vomiting after middle ear surgery during the first 24 hours period.

Evaluation of Pharmacist-Initiated Interventions on Vaccination Rates in Patients with Asthma or COPD.

PubMed

Klassing, Haley M; Ruisinger, Janelle F; Prohaska, Emily S; Melton, Brittany L

2018-04-01

To determine if pharmacy-initiated interventions improved the rate of influenza and pneumococcal vaccinations in adult patients with asthma and/or chronic obstructive pulmonary disease (COPD). Adult patients who filled prescriptions at one of three community pharmacies, who had a dispensing history indicative of an asthma and/or COPD diagnosis were randomized to receive a personal phone call or standardized mailed letter recommending influenza and pneumococcal vaccinations, or control with no vaccination information. The rate of influenza and pneumococcal vaccinations was measured for each group and measured using Chi square. Of 831 eligible participants, 210 patients completed the study, and self-reported a diagnosis of asthma and/or COPD. The influenza vaccine was administered to 56 (72.7%), 55 (87.3%), and 62 (88.6%) patients (p = 0.019); pneumococcal vaccine was administered to 46 (59.7%), 39 (61.9%), and 39 (55.7%) patients in the phone call, letter, and control groups, respectively. While the control group had significantly more influenza vaccinations, between the interventions the letter showed a higher rate of influenza vaccination over the phone call. Reviewing patients under age 65, the letter had a significantly higher rate of influenza vaccination than the phone call (p = 0.021). No significant improvement was found for the pneumococcal vaccination. Patients under age 65 who received a mailed letter had a significantly higher rate of influenza vaccination than those who received a phone call, and had a higher rate of pneumococcal vaccination. A standardized, mailed letter may help community pharmacists improve vaccination rates in patients with asthma and/or COPD.

Pilot study of dornase alfa (Pulmozyme) therapy for acquired ventilator-associated infection in preterm infants.

PubMed

Scala, Melissa; Hoy, Deborah; Bautista, Maria; Palafoutas, Judith Jones; Abubakar, Kabir

2017-06-01

Evaluate the feasibility, safety, and efficacy of adjunctive treatment with dornase alfa in preterm patients with ventilator-associated pulmonary infection (VAPI) compared to standard care. We hypothesize that therapy with dornase alfa will be safe and well tolerated in the preterm population with no worsening of symptoms, oxygen requirement, or need for respiratory support. Prospective, randomized, blinded, pilot study comparing adjunctive treatment with dornase alfa to sham therapy. In addition to standard care, infants were randomized to receive dornase alfa 2.5 mg nebulized via endotracheal tube (ETT) every 12 hr for 7 days or sham therapy. ETT secretion gram stain and culture and chest X-ray (CXR) findings were evaluated. Respiratory support data were downloaded from the ventilator. Fourteen infants developed VAPI between 2012 and 2014; 11 enrolled in the study. Six received dornase alfa and five received sham therapy. Average gestational age at birth was 25 weeks and age at study entry was 31 days. There were no differences in demographics, ETT white blood cell count (WBC), CXR, or mean airway pressure (MAP) between the two groups. There was a trend towards decreased oxygen requirement (FiO2) in the treatment group that did not reach statistical significance. No side effects were observed in the treatment group. Treatment with dornase alfa is safe and treated infants had some improvement in FiO 2 requirement but no improvement in MAP. A larger randomized trial is needed to evaluate the efficacy of this therapy. Pediatr Pulmonol. 2017; 52:787-791. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Effect of preemptive analgesia with intravenous oxycodone in the patients undergoing laparoscopic resection of ovarian tumor

PubMed Central

Wang, Na; Wang, Yuantao; Pang, Lei; Wang, Jinguo

2015-01-01

Objective: To evaluate the efficacy of preemptive intravenous oxycodone in the patients undergoing laparoscopic resection of ovarian tumor. Methods: Sixty ASA I or II patients undergoing elective laparoscopic resection of ovarian tumor were randomly allocated to one of two groups: Group O (n=30) received intravenous oxycodone (0.1 mg·kg-1) 10 minutes before surgery over 2 minutes, and Group N (n=30) received an equivalent volume of normal saline. All patients received a standardized general anesthesia. MBP and HR at the time of arrival of the operating room (T1), 5 min before pneumoperitoneum (T2), 5 minutes (T3), 10 minutes (T4), and 15 minutes after pneumoperitoneum (T5), and VAS scores at postoperative 2, 4, 8, 12 and 24 hour were recorded. The tramadol consumption and side effects in 24 h after surgery were recorded. Results: VAS pain scores at 2, 4, 8 and 12 hour after operation were significantly lower in Group O (P<0.05). MBP and HR increased significantly due to pneumoperitoneum at T3, T4 and T5, compared with T1 and T2 within Group N, and were higher at T3, T4 and T5 in Group N than at the same time points in Group O. Tramadol consumption was statistically lower in Group O (P=0.0003). Conclusions: Preemptive intravenous oxycodone was an efficient and safe method to reduce intraoperative haemodynamic effect and postoperative pain. PMID:26101479

A randomized trial of the effect of prayer on depression and anxiety.

PubMed

Boelens, Peter A; Reeves, Roy R; Replogle, William H; Koenig, Harold G

2009-01-01

To investigate the effect of direct contact person-to-person prayer on depression, anxiety, positive emotions, and salivary cortisol levels. Cross-over clinical trial with depression or anxiety conducted in an office setting. Following randomization to the prayer intervention or control groups, subjects (95% women) completed Hamilton Rating Scales for Depression and Anxiety, Life Orientation Test, Daily Spiritual Experiences Scale, and underwent measurement of cortisol levels. Individuals in the direct person-to-person prayer contact intervention group received six weekly 1-hour prayer sessions while those in the control group received none. Rating scales and cortisol levels were repeated for both groups after completion of the prayer sessions, and a month later. ANOVAs were used to compare pre- and post-prayer measures for each group. At the completion of the trial, participants receiving the prayer intervention showed significant improvement of depression and anxiety, as well as increases of daily spiritual experiences and optimism compared to controls (p < 0.01 in all cases). Subjects in the prayer group maintained these significant improvements (p < 0.01 in all cases) for a duration of at least 1 month after the final prayer session. Participants in the control group did not show significant changes during the study. Cortisol levels did not differ significantly between intervention and control groups, or between pre- and post-prayer conditions. Direct contact person-to-person prayer may be useful as an adjunct to standard medical care for patients with depression and anxiety. Further research in this area is indicated.

Metoprolol improves survival in severe traumatic brain injury independent of heart rate control.

PubMed

Zangbar, Bardiya; Khalil, Mazhar; Rhee, Peter; Joseph, Bellal; Kulvatunyou, Narong; Tang, Andrew; Friese, Randall S; O'Keeffe, Terence

2016-02-01

Multiple prior studies have suggested an association between survival and beta-blocker administration in patients with severe traumatic brain injury (TBI). However, it is unknown whether this benefit of beta-blockers is dependent on heart rate control. The aim of this study was to assess whether rate control affects survival in patients receiving metoprolol with severe TBI. Our hypothesis was that improved survival from beta-blockade would be associated with a reduction in heart rate. We performed a 7-y retrospective analysis of all blunt TBI patients at a level-1 trauma center. Patients aged >16 y with head abbreviated injury scale 4 or 5, admitted to the intensive care unit (ICU) from the operating room or emergency room (ER), were included. Patients were stratified into two groups: metoprolol and no beta-blockers. Using propensity score matching, we matched the patients in two groups in a 1:1 ratio controlling for age, gender, race, admission vital signs, Glasgow coma scale, injury severity score, mean heart rate monitored during ICU admission, and standard deviation of heart rate during the ICU admission. Our primary outcome measure was mortality. A total of 914 patients met our inclusion criteria, of whom 189 received beta-blockers. A propensity-matched cohort of 356 patients (178: metoprolol and 178: no beta-blockers) was created. Patients receiving metoprolol had higher survival than those patients who did not receive beta-blockers (78% versus 68%; P = 0.04); however, there was no difference in the mean heart rate (89.9 ± 13.9 versus 89.9 ± 15; P = 0.99). Nor was there a difference in the mean of standard deviation of the heart rates (14.7 ± 6.3 versus 14.4 ± 6.5; P = 0.65) between the two groups. In Kaplan-Meier survival analysis, patients who received metoprolol had a survival advantage (P = 0.011) compared with patients who did not receive any beta-blockers. Our study shows an association with improved survival in patients with severe TBI receiving metoprolol, and this effect appears to be independent of any reduction in heart rate. We suggest that beta-blockers should be administered to all severe TBI patients irregardless of any perceived beta-blockade effect on heart rate. Published by Elsevier Inc.

Evaluating the impact of a ‘virtual clinic’ on patient experience, personal and provider costs of care in urinary incontinence: A randomised controlled trial

PubMed Central

2018-01-01

Objective To evaluate the impact of using a ‘virtual clinic’ on patient experience and cost in the care of women with urinary incontinence. Materials and methods Women, aged > 18 years referred to a urogynaecology unit were randomised to either (1) A Standard Clinic or (2) A Virtual Clinic. Both groups completed a validated, web-based interactive, patient-reported outome measure (ePAQ-Pelvic Floor), in advance of their appointment followed by either a telephone consultation (Virtual Clinic) or face-to-face consultation (Standard Care). The primary outcome was the mean ‘short-term outcome scale’ score on the Patient Experience Questionnaire (PEQ). Secondary Outcome Measures included the other domains of the PEQ (Communications, Emotions and Barriers), Client Satisfaction Questionnaire (CSQ), Short-Form 12 (SF-12), personal, societal and NHS costs. Results 195 women were randomised: 98 received the intervention and 97 received standard care. The primary outcome showed a non-significant difference between the two study arms. No significant differences were also observed on the CSQ and SF-12. However, the intervention group showed significantly higher PEQ domain scores for Communications, Emotions and Barriers (including following adjustment for age and parity). Whilst standard care was overall more cost-effective, this was minimal (£38.04). The virtual clinic also significantly reduced consultation time (10.94 minutes, compared with a mean duration of 25.9 minutes respectively) and consultation costs compared to usual care (£31.75 versus £72.17 respectively), thus presenting potential cost-savings in out-patient management. Conclusions The virtual clinical had no impact on the short-term dimension of the PEQ and overall was not as cost-effective as standard care, due to greater clinic re-attendances in this group. In the virtual clinic group, consultation times were briefer, communication experience was enhanced and personal costs lower. For medical conditions of a sensitive or intimate nature, a virtual clinic has potential to support patients to communicate with health professionals about their condition. PMID:29346378

Survival after recurrence in patients with gastric cancer who receive S-1 adjuvant chemotherapy: exploratory analysis of the ACTS-GC trial.

PubMed

Ito, Seiji; Ohashi, Yasuo; Sasako, Mitsuru

2018-04-20

Some patients develop recurrence after curative resection and adjuvant chemotherapy. S-1, an oral fluoropyrimidine, is one of the standard regimens in adjuvant chemotherapy, and is also used in first-line treatment for advanced/metastatic gastric cancer. It is controversial as to whether the same treatment strategy can be applied for patients who develop recurrence after adjuvant chemotherapy and those who did not receive adjuvant chemotherapy. To investigate this issue, we compared the outcomes of patients who developed recurrences after treatment with or without adjuvant chemotherapy using the results of the Adjuvant Chemotherapy Trial of S-1 for Gastric Cancer (ACTS-GC). Patients who had confirmed recurrence in the ACTS-GC trial were analyzed. We defined 2 independent cohorts. Cohort 1 patients were divided by whether they received adjuvant chemotherapy (adjuvant S-1 group and surgery-only group). Cohort 2 patients were divided by whether they received a regimen including S-1 (IS) or not including S-1 (NIS) after recurrence. A total of 375 patients experienced recurrence (160 in the adjuvant S-1 group and 215 in the surgery-only group). In cohort 1, the median time from recurrence to death (TFRD) was 11.4 months (95% confidence interval [CI], 8.4-13.9) in the adjuvant S-1 group and 11.3 months (95% CI, 9.7-13.1) in the surgery-only group (hazard ratio [HR], 1.05; 95% CI, 0.84-1.31). In cohort 2, 292 patients received chemotherapy after recurrence and were divided into the IS (n = 189) or the NIS group (n = 103). The median TFRD was 13.9 months (95% CI, 12.7-15.6) in the IS group and 8.1 months (95% CI, 6.6-9.7) in the NIS group (HR, 0.59; 95% CI, 0.45-0.76), and there was no significant interaction between the adjuvant S-1 group and surgery-only group. Adjuvant chemotherapy with S-1 prolonged overall survival without influencing the TFRD. The same treatment strategy may be applied for patients who develop recurrence after adjuvant chemotherapy and those who did not receive adjuvant chemotherapy. NCT00152217 . First Posted on September 9, 2005.

Red blood cell alloimmunization among sickle cell Kuwaiti Arab patients who received red blood cell transfusion.

PubMed

Ameen, Reem; Al Shemmari, Salem; Al-Bashir, Abdulaziz

2009-08-01

Sickle cell disease (SCD) is common in the Arabian Gulf region. Most cases require a red blood cell (RBC) transfusion, increasing the potential for RBC alloantibody development. The incidence of RBC alloimmunization among Kuwaiti Arab SCD patients is not yet known. This study retrospectively assessed the effect of using two different matching protocols on the incidence of alloimmunization among multiply transfused Kuwaiti Arab SCD patients. A total of 233 Kuwaiti Arab SCD patients were divided into two groups: Group 1 (n = 110) received RBC transfusion through standard ABO- and D-matched nonleukoreduced blood; Group 2 (n = 123) received RBCs matched for ABO, Rh, and K1 poststorage-leukoreduced blood. Multivariate analysis was performed on the factors associated with RBC alloimmunization and antibody specificity. Sixty-five percent of patients in Group 1 developed clinically significant RBC alloantibody with an increased prevalence in females; in patients in Group 2, 23.6% developed RBC alloantibodies (p = 0.01). In Group 1, 72 patients (65.5%) had alloantibodies directed against Rh and Kell systems (p = 0.01). Multivariate analysis further confirmed the results, showing that blood transfusion type and sex have significant effects on the rate of alloimmunizations. This study confirms the importance of selecting RBCs matched for Rh and Kell to reduce the risk of alloimmunizations among Kuwaiti Arab SCD patients.

A randomized, comparative study of dual therapy (doxycycline-rifampin) versus triple therapy (doxycycline-rifampin-levofloxacin) for treating acute/subacute brucellosis.

PubMed

Hasanain, Ahmad; Mahdy, Reem; Mohamed, Asmaa; Ali, Mostafa

2016-01-01

The aim of this study was to compare both the efficacy and safety profile of the WHO-recommended, dual therapy (doxycycline-rifampin) to a quinolone-based, triple therapy (doxycycline-rifampin-levofloxacin) for treating acute/subacute brucellosis. We studied 107 consecutive, naïve patients with acute/subacute brucellosis admitted to Assiut University Hospital. Patients were randomly allocated to receive the dual therapy of doxycycline-rifampin (group-A) or to receive the triple therapy of doxycycline-rifampin-levofloxacin (group-B). Acute/subacute brucellosis was diagnosed based on the presence of: (1) contact with animals or fresh animal products, (2) suggestive clinical manifestations of less than one-year duration, and (3) positive antibody titer (1:160) by standard tube agglutination test. There was no significant difference between the two groups regarding their demographic data. Fever was the most frequent manifestation (96.3%). Epigastric pain was the most frequent adverse effect of treatment (12.1%). Group-A patients had a significantly higher relapse rate compared to group-B patients (22.6% versus 9.3%, p-value=0.01). The rate of treatment adverse effects was higher among group-B patients, although not reaching statistical significance (20.4% versus 11.3%, p-value=0.059). Adding levofloxacin to the dual therapy for acute/subacute brucellosis (doxycycline-rifampin) may increase its efficacy in terms of lowering the relapse rate of the disease. Further, larger scale studies are needed before considering modifying the standard, dual therapy for brucellosis. Copyright © 2016 Elsevier Editora Ltda. All rights reserved.

Virtual reality exercise improves mobility after stroke: an inpatient randomized controlled trial.

PubMed

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-06-01

Exercise using virtual reality (VR) has improved balance in adults with traumatic brain injury and community-dwelling older adults. Rigorous randomized studies regarding its efficacy, safety, and applicability with individuals after stroke are lacking. The purpose of this study was to determine whether an adjunct VR therapy improves balance, mobility, and gait in stroke rehabilitation inpatients. A blinded randomized controlled trial studying 59 stroke survivors on an inpatient stroke rehabilitation unit was performed. The treatment group (n=30) received standard stroke rehabilitation therapy plus a program of VR exercises that challenged balance (eg, soccer goaltending, snowboarding) performed while standing. The control group (n=29) received standard stroke rehabilitation therapy plus exposure to identical VR environments but whose games did not challenge balance (performed in sitting). VR training consisted of 10 to 12 thirty-minute daily sessions for a 3-week period. Objective outcome measures of balance and mobility were assessed before, immediately after, and 1 month after training. Confidence intervals and effect sizes favored the treatment group on the Timed Up and Go and the Two-Minute Walk Test, with both groups meeting minimal clinical important differences after training. More individuals in the treatment group than in the control group showed reduced impairment in the lower extremity as measured by the Chedoke McMaster Leg domain (P=0.04) immediately after training. This VR exercise intervention for inpatient stroke rehabilitation improved mobility-related outcomes. Future studies could include nonambulatory participants as well as the implementation strategies for the clinical use of VR. http://www.ANZCTR.org.au/. Unique identifier: ACTRN12613000710729. © 2014 American Heart Association, Inc.

Visual Schedule System in Dental Care for Patients with Autism: A Pilot Study.

PubMed

Mah, Janet Wt; Tsang, Phoebe

A pilot study to test whether a visual schedule system using picture communication symbols can help children with autism have successful routine dental cleaning visits. 14 boys with autism between three- to eight-years-old presented to the dental clinic for four weekly consecutive dental appointments. Patients were randomly assigned to either the control group who received the tell-show-do method (i.e., standard of care), or the test group who received the tell-show-do method plus the visual schedule system. Patients in the test group completed an average of 1.38 more steps, at 35.52 seconds per step faster, and with 18.7% lower levels of behavioral distress than those in the control group. The use of a visual schedule system, along with repeated weekly visits, showed some promise in helping children with autism successfully complete more steps, progress at a quicker rate, and exhibit lower levels of behavioral distress within a dental appointment, compared to a traditional tell-show-do approach.

Active for Life After Cancer: a randomized trial examining a lifestyle physical activity program for prostate cancer patients.

PubMed

Carmack Taylor, Cindy L; Demoor, Carl; Smith, Murray A; Dunn, Andrea L; Basen-Engquist, Karen; Nielsen, Ingrid; Pettaway, Curtis; Sellin, Rena; Massey, Pamela; Gritz, Ellen R

2006-10-01

Active for Life After Cancer is a randomized trial evaluating the efficacy of a 6-month group-based lifestyle physical activity program (Lifestyle) for prostate cancer patients to improve quality of life (QOL) including physical and emotional functioning compared to a group-based Educational Support Program and a Standard Care Program (no group). A total of 134 prostate cancer patients receiving continuous androgen-ablation were randomly assigned to one of the three study conditions. Results indicated no significant improvements in QOL at 6 or 12 months. Both group-based programs were positively received and yielded good attendance and retention. Lifestyle participants demonstrated significant improvements in most theoretical mediators proposed by the Transtheoretical Model and Social Cognitive Theory to affect physical activity. Despite these improvements, no significant changes were found for most physical activity measures. Results suggest a lifestyle program focusing on cognitive-behavioral skills training alone is insufficient for promoting routine physical activity in these patients.

Efficacy of intravenous fluid warming during goal-directed fluid therapy in patients undergoing laparoscopic colorectal surgery: a randomized controlled trial.

PubMed

Choi, Ji-Won; Kim, Duk-Kyung; Lee, Seung-Won; Park, Jung-Bo; Lee, Gyu-Hong

2016-06-01

To evaluate the clinical efficacy of intravenous (IV) fluid warming in patients undergoing laparoscopic colorectal surgery. Adult patients undergoing laparoscopic colorectal surgery were randomly assigned to receive either IV fluids at room temperature (control group) or warmed IV fluids (warm fluids group). Each patient received a standardized goal-directed fluid regimen based on stroke volume variances. Oesophageal temperature was measured at 15 min intervals for 2 h after induction of anaesthesia. A total of 52 patients were enrolled in the study. The drop in core temperature in the warm fluids group was significantly less than in the control group 2 h after the induction of anaesthesia. This significant difference was seen from 30 min after induction. IV fluid warming was associated with a smaller drop in core temperature than room temperature IV fluids in laparoscopic colorectal surgery incorporating goal-directed fluid therapy. © The Author(s) 2016.