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Sample records for controlled prospective study

  1. Asthma control measurement using five different questionnaires: a prospective study.

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    Vermeulen, Francois; de Meulder, Isabelle; Paesmans, Marianne; Muylle, Inge; Bruyneel, Marie; Ninane, Vincent

    2013-09-01

    Questionnaires play a key place in the assessment of asthma control. Different questionnaires have been developed. However, it remains largely unknown whether they can be used interchangeably. We wondered whether the panel of frequently used scores would give similar measurement of asthma control. The present study aimed to assess the agreement between five specific questionnaires. In this prospective study, ninety-nine patients completed five commonly used asthma control scores: the GINA, the Asthma Control Test™, the Royal College of Physician score, the Asthma Therapy Assessment Questionnaire (ATAQ), and the Asthma Control Questionnaire(©) (ACQ). The kappa coefficient was used to assess the agreement between questionnaires. The agreement between the GINA and other scores was only moderate (kappa coefficients amounted from 0.41 to 0.60). With respect to the "controlled" level, all the other scores gave higher results than GINA. All other scores also tended to underestimate GINA "uncontrolled level". For the "partly controlled level" defined by 3 of the 5 questionnaires, ACQ identified the same percentage of patients than GINA while ATAQ overestimated this percentage. This study shows only moderate agreement between five commonly used asthma control scores. The GINA score showed the lowest percentage of controlled and the highest percentage of uncontrolled asthma. As a consequence, all these scores do not seem to evaluate the same symptoms. NCT01350661. © 2013 Elsevier Ltd. All rights reserved.

  2. Hepatic Dysfunction in Asphyxiated Neonates: Prospective Case-Controlled Study

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    Mukesh Choudhary

    2015-01-01

    Full Text Available Objective This study was performed to determine the occurrence of hypoxic hepatitis in full-term neonates after perinatal asphyxia and to correlate between the rise in enzymes and severity of asphyxia with Apgar score and hypoxic ischemic encephalopathy (HIE grading of the neonates. Method and Material This prospective case-controlled study was conducted in a tertiary-level hospital in India for a period of 12 months. The study group A comprised 70 newborns suffering from birth asphyxia, while 30 healthy neonates were included in group B (control. All biochemical parameters of liver function, ie, serum alanine transferase (ALT, aspartate transferase (AST, alkaline phosphatase (ALP, lactate dehydrogenase (LDH, total protein, serum albumin, bilirubin (total and direct, and international normalized ratio (INR, were measured on postnatal days 1, 3, and 10 in both study and control groups. Results In group A, 22.8% newborns had severe (Apgar score 0–3, 47.1% had moderate (Apgar score 4–5, and 30% had mild (Apgar score 6–7 birth asphyxia at five minutes. In all, 14.28% babies were in HIE stage I, 25.73% babies were in HIE stage II, and 11.42% babies were in HIE stage III. The rest of the newborns, 48.57%, were normal. The prevalence of liver function impairment was seen in 42.85% of asphyxiated neonates. On day 1, ALT, AST, ALP, LDH, PT, and INR were significantly higher, and total protein and serum albumin were significantly lower in group A than in group B. However, ALT and AST correlated well with increasing severity of HIE score. On day 3, there was a rising trend observed in the concentration of mean LDH as HIE staging of neonates progressed from stage 0 to stage III, and among various HIE stages, the difference in LDH was statistically significant. Conclusion We concluded that AST, ALT at 24 hours, and LDH at 72 hours of animation can be a utilitarian diagnostic tool to differentiate asphyxiated neonates from non-asphyxiated neonates and

  3. Hypnosis and dental anesthesia in children: a prospective controlled study.

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    Huet, Adeline; Lucas-Polomeni, Marie-Madeleine; Robert, Jean-Claude; Sixou, Jean-Louis; Wodey, Eric

    2011-01-01

    The authors of this prospective study initially hypothesized that hypnosis would lower the anxiety and pain associated with dental anesthesia. Thirty children aged 5 to 12 were randomly assigned to 2 groups receiving hypnosis (H) or not (NH) at the time of anesthesia. Anxiety was assessed at inclusion in the study, initial consultation, installation in the dentist's chair, and at the time of anesthesia using the modified Yale preoperative anxiety scale (mYPAS). Following anesthesia, a visual analogue scale (VAS) and a modified objective pain score (mOPS) were used to assess the pain experienced. The median mYPAS and mOPS scores were significantly lower in the H group than in the NH group. Significantly more children in the H group had no or mild pain. This study suggests that hypnosis may be effective in reducing anxiety and pain in children receiving dental anesthesia.

  4. Development of visual motion perception for prospective control: Brain and behavioural studies in infants

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    Seth B. Agyei

    2016-02-01

    Full Text Available During infancy, smart perceptual mechanisms develop allowing infants to judge time-space motion dynamics more efficiently with age and locomotor experience. This emerging capacity may be vital to enable preparedness for upcoming events and to be able to navigate in a changing environment. Little is known about brain changes that support the development of prospective control and about processes, such as preterm birth, that may compromise it. As a function of perception of visual motion, this paper will describe behavioural and brain studies with young infants investigating the development of visual perception for prospective control. By means of the three visual motion paradigms of occlusion, looming, and optic flow, our research shows the importance of including behavioural data when studying the neural correlates of prospective control.

  5. Myocardial function at the early phase of traumatic brain injury: a prospective controlled study

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    Cuisinier, Adrien; Maufrais, Claire; Payen, Jean-François; Nottin, Stephane; Walther, Guillaume; Bouzat, Pierre

    2016-01-01

    Background The concept of brain-heart interaction has been described in several brain injuries. Traumatic brain injury (TBI) may also lead to cardiac dysfunction but evidences are mainly based upon experimental and clinical retrospective studies. Methods We conducted a prospective case-control study in a level I trauma center. Twenty consecutive adult patients with severe TBI were matched according to age and gender with 20 control patients. The control group included adult patients undergoin...

  6. Prospective, Controlled, Multicentre Study of Loperimide in Pregnancy

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    A Einarson

    2000-01-01

    Full Text Available BACKGROUND: Loperamide is a synthetic piperidine derivative used for the treatment of both acute and chronic diarrhea. Little is known about its safety and risk in pregnancy. Human data are limited to one surveillance study of Michigan Medicaid patients, with 108 women exposed in the first trimester. In this study there were six major birth defects, three of which were cardiovascular anomalies.

  7. Motivational and control mechanisms underlying adolescent cannabis use disorders: A prospective study

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    Janna Cousijn

    2015-12-01

    Full Text Available Cannabis use disorders (CUDs are the most prevalent substance use disorders among adolescents in treatment. Yet, little is known about the neuropsychological mechanisms underlying adolescent CUDs. Studies in adult cannabis users suggest a significant role for cognitive control and cannabis-oriented motivational processes, such as attentional bias, approach bias, and craving in CUDs. The current 6-month prospective study investigated the relationships between attentional bias, approach bias, craving, cognitive control, and cannabis use in adolescent patients in treatment for a primary or secondary CUD. Moreover, we investigated if these motivational processes and cognitive control could predict treatment progression after 6 months. Adolescents with a CUD had an attentional but no approach bias towards cannabis. In contrast to adult findings on the role of attentional bias, approach bias and cognitive control, only cannabis craving significantly correlated with current cannabis use and predicted cannabis use-related problems and abstinence from cannabis 6 months later. These findings identify craving as a predictor of treatment outcome, thereby supporting an important role for craving in the course of adolescent cannabis use and dependence. This prospective study is among the first to investigate neuropsychological mechanisms underlying adolescent CUDs, warranting future longitudinal studies.

  8. Serum Taurine and Stroke Risk in Women: A Prospective, Nested Case-Control Study.

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    Wu, Fen; Koenig, Karen L; Zeleniuch-Jacquotte, Anne; Jonas, Saran; Afanasyeva, Yelena; Wójcik, Oktawia P; Costa, Max; Chen, Yu

    2016-01-01

    Taurine (2-aminoethanesulfonic acid), a conditionally essential sulfur-containing amino acid, is mainly obtained from diet in humans. Experimental studies have shown that taurine's main biological actions include bile salt conjugation, blood pressure regulation, anti-oxidation, and anti-inflammation. We conducted a prospective case-control study nested in the New York University Women's Health Study, a cohort study involving 14,274 women enrolled since 1985. Taurine was measured in pre-diagnostic serum samples of 241 stroke cases and 479 matched controls. There was no statistically significant association between serum taurine and stroke risk in the overall study population. The adjusted ORs for stroke were 1.0 (reference), 0.87 (95% CI, 0.59-1.28), and 1.03 (95% CI, 0.69-1.54) in increasing tertiles of taurine (64.3-126.6, 126.7-152.9, and 153.0-308.5 nmol/mL, respectively). A significant inverse association between serum taurine and stroke risk was observed among never smokers, with an adjusted OR of 0.66 (95% CI, 0.37-1.18) and 0.50 (95% CI, 0.26-0.94) for the second and third tertile, respectively (p for trend = 0.01), but not among past or current smokers (p for interaction taurine and stroke risk, although a protective effect was observed in never smokers, which requires further investigation. Taurine, Stroke, Epidemiology, Prospective, Case-control study, NYUWHS.

  9. Telomere length in prospective and retrospective cancer case-control studies

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    Pooley, Karen A.; Sandhu, Manjinder S.; Tyrer, Jonathan; Shah, Mitul; Driver, Kristy E.; Luben, Robert N.; Bingham, Sheila A.; Ponder, Bruce A.J.; Pharoah, Paul D.P.; Khaw, Kay-Tee; Easton, Douglas F.; Dunning, Alison M.

    2010-01-01

    Previous studies have reported that shorter mean telomere length in lymphocytes is associated with increased susceptibility to common diseases of aging, and may be predictive of cancer risk. However, most analyses have examined retrospectively-collected case-control studies. Mean telomere length was measured using high-throughput quantitative Real Time PCR. Blood for DNA extraction was collected after cancer diagnosis in the East Anglian SEARCH Breast (2243 cases, 2181 controls) and SEARCH Colorectal (2249 cases, 2161 controls) studies. Prospective case-control studies were conducted for breast cancer (199 cases) and colorectal cancer (185 cases), nested within the EPIC-Norfolk cohort. Blood has been collected at least 6 months prior to diagnosis, and was matched to DNA from two cancer-free controls per case. In the retrospective, SEARCH studies, the age-adjusted Odds Ratios for shortest (Q4) vs. longest (Q1) quartile of mean telomere length was 15.5 (95%CI 11.6–20.8), p-het=5.7×10−75; with a ‘per quartile’ p-trend=2.1×10−80 for breast cancer, and 2.14 (95%CI 1.77–2.59), p-het=7.3×10−15; with a ‘per quartile’ p-trend=1.8×10−13 for colorectal cancer. In the prospective, EPIC study, the comparable Odds Ratios [Q4 vs. Q1] were 1.58 (95%CI 0.75–3.31), p-het=0.23 for breast cancer, and 1.13 (95%CI 0.54–2.36), p-het=0.75 for colorectal cancer risk. Mean telomere length was shorter in retrospectively-collected cases than in controls but the equivalent association was markedly weaker in the prospective studies. This suggests that telomere shortening largely occurs after diagnosis, and may not, therefore, be of value in cancer prediction. PMID:20395204

  10. A Prospective Controlled Study of Living Kidney Donors: Three-Year Follow-up

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    Kasiske, Bertram L.; Anderson-Haag, Teresa; Israni, Ajay K.; Kalil, Roberto S.; Kimmel, Paul L.; Kraus, Edward S.; Kumar, Rajiv; Posselt, Andrew A.; Pesavento, Todd E.; Rabb, Hamid; Steffes, Michael W.; Snyder, Jon J.; Weir, Matthew R.

    2015-01-01

    Background There have been few prospective controlled studies of kidney donors. Understanding the pathophysiological effects of kidney donation is important for judging donor safety and for improving our understanding of the consequences of reduced kidney function in chronic kidney disease. Study Design Prospective, controlled, observational cohort study. Setting & Participants Three-year follow-up of kidney donors and paired controls suitable for donation at their donor’s center. Predictor Kidney donation. Outcomes Medical history, vital signs, glomerular filtration rate and other measurements at 6, 12, 24 and 36 months after donation. Results At 36 months, 182 of 203 (89.7%) original donors and 173 of 201 (86.1%) original controls continue to participate in follow-up visits. The linear slope of the glomerular filtration rate measured by plasma iohexol clearance declined 0.36±7.55 mL/min per year in 194 controls, but increased 1.47±5.02 mL/min per year in 198 donors (P = 0.005) between 6 and 36 months. Blood pressure was not different between donors and controls at any visit, and at 36 months all 24-hour ambulatory blood pressure parameters were similar in 126 controls and 135 donors (mean systolic: 120.0±11.2 [SD] v. 120.7±9.7 mmHg [P=0.6]; mean diastolic: 73.4±7.0 v. 74.5±6.5 mmHg [P=0.2]). Mean arterial pressure nocturnal dipping was manifest in 11.2%±6.6% of controls and 11.3%±6.1% donors (P=0.9). Urinary protein-creatinine and albumin-creatinine ratios were not increased in donors compared to controls. From 6 to 36 months post-donation, serum parathyroid hormone, uric acid, homocysteine and potassium levels were higher, whereas hemoglobin was lower in donors compared to controls. Limitations Possible bias resulting from an inability to select controls screened to be as healthy as donors, short follow-up duration, and drop-outs. Conclusions Kidney donors manifest several of the findings of mild chronic kidney disease. However, at 36 months after

  11. a prospective study

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    Rörster, Elisa geb. Pätel

    2012-01-01

    Bulk fractures only occur on very rare occasions in bilayered all-ceramic crowns, where as veneer fractures, above all chippings, still present a frequent amount of clinical complications. The purpose of the current prospective study was to examine the clinical performance of an anatomically modified framework for a period of two years. All crowns were manufactured following the Cercon process (DeguDent GmbH, Hanau). As is common practice, the frameworks for the control group were made of ...

  12. Multilocus genetic risk score associates with ischemic stroke in case-control and prospective cohort studies

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    Malik, R; Bevan, S; Nalls, MA; Holliday, EG; Devan, WJ; Cheng, YC; Ibrahim-Verbaas, CA; Verhaaren, BF; Bis, JC; Joon, AY; de Stefano, AL; Fornage, M; Psaty, BM; Ikram, MA; Launer, LJ; van Duijn, CM; Sharma, P; Mitchell, BD; Rosand, J; Meschia, JF; Levi, C; Rothwell, PM; Sudlow, C; Markus, HS; Seshadri, S; Dichgans, M

    2014-01-01

    BACKGROUND AND PURPOSE Genome-wide association studies have revealed multiple common variants associated with known risk factors for ischemic stroke (IS). However, their aggregate effect on risk is uncertain. We aimed to generate a multilocus genetic risk score (GRS) for IS based on genome-wide association studies data from clinical-based samples and to establish its external validity in prospective population-based cohorts. METHODS Three thousand five hundred forty-eight clinic-based IS cases and 6399 controls from the Wellcome Trust Case Control Consortium 2 were used for derivation of the GRS. Subjects from the METASTROKE consortium served as a replication sample. The validation sample consisted of 22 751 participants from the Cohorts for Heart and Aging Research in Genomic Epidemiology consortium. We selected variants that had reached genome-wide significance in previous association studies on established risk factors for IS. RESULTS A combined GRS for atrial fibrillation, coronary artery disease, hypertension, and systolic blood pressure significantly associated with IS both in the case-control samples and in the prospective population-based studies. Subjects in the top quintile of the combined GRS had >2-fold increased risk of IS compared with subjects in the lowest quintile. Addition of the combined GRS to a simple model based on sex significantly improved the prediction of IS in the combined clinic-based samples but not in the population-based studies, and there was no significant improvement in net reclassification. CONCLUSIONS A multilocus GRS based on common variants for established cardiovascular risk factors was significantly associated with IS both in clinic-based samples and in the general population. However, the improvement in clinical risk prediction was found to be small. PMID:24436234

  13. Correlation of Serum Zinc Level with Simple Febrile Seizures: A Hospital based Prospective Case Control Study

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    Imran Gattoo

    2015-04-01

    Full Text Available Background: Febrile seizures are one of the most common neurological conditions of childhood. It seems that zinc deficiency is associated with increased risk of febrile seizures.Aim: To estimate the serum Zinc level in children with simple Febrile seizures and to find the correlation between serum zinc level and simple Febrile seizures.Materials and Methods: The proposed study was a hospital based prospective case control study which included infants and children aged between 6 months to 5 years, at Post Graduate Department of Pediatrics, (SMGS Hospital, GMC Jammu, northern India. A total of 200 infants and children fulfilling the inclusion criteria were included. Patients were divided into 100(cases in Group A with simple febrile seizure and 100(controls in Group B of children with acute febrile illness without seizure. All patients were subjected to detailed history and thorough clinical examination followed by relevant investigations.Results: Our study had slight male prepondance of 62% in cases and 58% in controls . Mean serum zinc level in cases was 61.53±15.87 ugm/dl and in controls it was 71.90+18.50 ugm/dl .Serum zinc level was found significantly low in cases of simple febrile seizures as compaired to controls ,with p value of

  14. A Prospective Controlled Study of Kidney Donors: Baseline and 6-Month Follow-up

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    Kasiske, Bertram L.; Anderson-Haag, Teresa; Ibrahim, Hassan N.; Pesavento, Todd E.; Weir, Matthew R.; Nogueira, Joseph M.; Cosio, Fernando G.; Kraus, Edward S.; Rabb, Hamid H.; Kalil, Roberto S.; Posselt, Andrew A.; Kimmel, Paul L.; Steffes, Michael W.

    2013-01-01

    Background Most previous studies of living kidney donors have been retrospective and have lacked suitable healthy controls. Needed are prospective controlled studies to better understand the effects of a mild reduction in kidney function from kidney donation in otherwise normal individuals. Study Design Prospective, controlled, observational cohort study. Setting & Participants Consecutive patients approved for donation at 8 transplant centers in the US were asked to participate. For every donor enrolled, an equally healthy control with 2 kidneys who theoretically would have been suitable to donate a kidney was also enrolled. Predictor Kidney donation. Measurements At baseline pre-donation and at 6 months after donation, a medical history, vital signs, measured (iohexol) glomerular filtration rate and other measurements were collected. There were 201 donors and 198 controls that completed both baseline and 6 month visits and form the basis of this report. Results Compared to controls, donors had 28% lower glomerular filtration rate at 6 months (94.6±15.1 [SD] v. 67.6±10.1 mL/min/1.73m2; P<0.001), associated with a 23% greater parathyroid hormone (42.8±15.6 v. 52.7±20.9 pg/mL; P<0.001), 5.4% lower serum phosphate (3.5±0.5 v. 3.3±0.5 mg/dL; P<0.001), 3.7% lower hemoglobin (13.6±1.4 v. 13.1±1.2 g/dL; P<0.001), 8.2% greater uric acid (4.9±1.2 v. 5.3±1.1 mg/dL; P<0.001), 24% greater homocysteine (1.20±0.34 v. 1.49±0.43 mg/L; P<0.001), and 1.5% lower high density lipoprotein cholesterol (54.9±16.4 v. 54.1±13.9 mg/dL; P=0.03) level. There were no differences in albumin-creatinine ratios (5.0 [IQR, 4.0-6.6] v. 5.0 [IQR, 3.3-5.4] mg/g; P=0.5), office blood pressure, or glucose homeostasis. Limitations Short duration of follow-up and possible bias resulting from an inability to screen controls with kidney and vascular imaging performed in donors. Conclusions Kidney donors have some, but not all, abnormalities typically associated with mild chronic kidney

  15. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

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    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (panesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

  16. Obesity, inflammatory markers, and endometrial cancer risk: a prospective case–control study

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    Dossus, Laure; Rinaldi, Sabina; Becker, Susen; Lukanova, Annekatrin; Tjonneland, Anne; Olsen, Anja; Stegger, Jakob; Overvad, Kim; Chabbert-Buffet, Nathalie; Jimenez-Corona, Aida; Clavel-Chapelon, Francoise; Rohrmann, Sabine; Teucher, Birgit; Boeing, Heiner; Schütze, Madlen; Trichopoulou, Antonia; Benetou, Vassiliki; Lagiou, Pagona; Palli, Domenico; Berrino, Franco; Panico, Salvatore; Tumino, Rosario; Sacerdote, Carlotta; Redondo, Maria-Luisa; Travier, Noémie; Sanchez, Maria-Jose; Altzibar, Jone M; Chirlaque, Maria-Dolores; Ardanaz, Eva; Bueno-de-Mesquita, H Bas; van Duijnhoven, Fränzel J B; Onland-Moret, N Charlotte; Peeters, Petra H M; Hallmans, Goran; Lundin, Eva; Khaw, Kay-Tee; Wareham, Nicholas; Allen, Naomi; Key, Tim J; Slimani, Nadia; Hainaut, Pierre; Romaguera, Dora; Norat, Teresa; Riboli, Elio; Kaaks, Rudolf

    2010-01-01

    Obesity, a major risk factor for endometrial cancer, is a low-grade inflammatory state characterized by elevated concentrations of cytokines and acute phase reactants. The current study had two aims: first to investigate the associations of C-reactive protein (CRP), interleukin 6 (IL6), and IL1 receptor antagonist (IL1Ra) with endometrial cancer risk and second to examine to which extent these markers can influence the association between obesity and endometrial cancer. We conducted a case–control study, nested within the European Prospective Investigation into Cancer and Nutrition, which comprised 305 incident cases of endometrial cancer and 574 matched controls. CRP, IL6, and IL1Ra were measured in prospectively collected blood specimens by immunoassays. Data were analyzed using conditional logistic regression. All statistical tests were two-sided, and P values <0.05 were considered statistically significant. We observed a significant increase in risk of endometrial cancer with elevated levels of CRP (odds ratio (OR) for top versus bottom quartile: 1.58, 95% confidence interval (CI): 1.03–2.41, Ptrend=0.02), IL6 (OR for top versus bottom quartile: 1.66, 95% CI: 1.08–2.54, Ptrend=0.008), and IL1Ra (OR for top versus bottom quartile: 1.82, 95% CI: 1.22–2.73, Ptrend=0.004). After adjustment for body mass index (BMI), the estimates were strongly reduced and became non-significant. The association between BMI and endometrial cancer was also substantially attenuated (∼10–20%) after adjustment for inflammatory markers, even when the effects of C-peptide or estrone had already been taken into account. We provided epidemiological evidence that chronic inflammation might mediate the association between obesity and endometrial cancer and that endometrial carcinogenesis could be promoted by an inflammatory milieu. PMID:20843938

  17. Influence of defective complete dentures renewal on TMD; an MRI and clinical controlled prospective study.

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    Abdelnabi, Mohamed H; Swelem, Amal A

    2015-09-01

    The influence of complete denture occlusion on temporomandibular disorder (TMD) is controversial. Some studies found that defective occlusion contributes to the development of TMD, while others found no correlation. This prospective controlled study evaluated the relationship between renewal of old defective complete dentures and TMD as evidenced both by clinical examination and magnetic resonance imaging (MRI) findings. The study included 25 complete denture patients with signs and symptoms of TMD and 21 asymptomatic controls. Clicking was a common finding in all symptomatic joints. All selected participants needed complete denture renewal. MRI and clinical assessment following research diagnostic criteria for TMD guidelines (RDC/TMD) were carried out at baseline and 2 years after new complete denture insertion. Temporomandibular joint (TMJ) pain, muscle pain, clicking and movement limitation were the assessed signs and symptoms. MRIs were conducted to evaluate the TMJs for disc displacement, disc morphology and joint effusion. Complete denture renewal significantly improved the signs and symptoms of TMD in symptomatic group (p dentures did not affect disc morphology in both groups (p = 0.5 for both groups) but significantly reduced joint effusion in the symptomatic group (symptomatic p complete dentures had a positive impact on TMD signs and symptoms, disc position and joint effusion but not on disc morphology. © 2013 John Wiley & Sons A/S and The Gerodontology Society. Published by John Wiley & Sons Ltd.

  18. Advancement of physical process by mental activation: A prospective controlled study

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    S. Lehrl, PhD

    2012-12-01

    Full Text Available According to the literature, patients who are significantly impaired by physical mobility limitations can be rehabilitated if the patient’s working memory is used to capacity. The conclusion that periodic mental activity improves physical rehabilitation should be evaluated. This is a prospective, controlled, and randomized open study of patients who underwent a total hip arthroplasty (THA. Sixteen patients who played the video game Dr. Kawashima’s Brain Training: How Old Is Your Brain? were compared in terms of rehabilitation progress to 16 individuals who did not play. Harris Hip and Merle d’Aubigné scores were evaluated 1 d preoperation and again 12 +/– 1 d postoperation. Preoperation, no significant differences in hip scores between the gaming and control groups were found (median Harris Hip score: 39 vs 33, respectively, p = 0.304; median Merle D’Aubigné score: 12 vs 9, respectively, p = 0.254. Postoperation, there were significant differences between the gaming and control groups (median Harris Hip score: 76.0 vs 56.5, respectively, p = 0.001; median Merle D’Aubigné score: 16.0 vs 13.5, respectively, p = 0.014. Within both groups, the posttest scores significantly improved; however, the increase for the gaming group was greater for both measures. Because the influence of age, sex, and level of education can be excluded, it can be assumed that mental activities can improve physical rehabilitation after THA.

  19. Food acceptance and neophobia in children with phenylketonuria: a prospective controlled study.

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    Evans, S; Daly, A; Chahal, S; MacDonald, J; MacDonald, A

    2016-08-01

    In phenylketonuria (PKU), little is known about the effect of bitter-tasting phenylalanine-free l-amino acid exposure on taste preference development. The present prospective study aimed to determine the flavour preferences of children with PKU versus healthy control children. Thirty-five children with PKU and 35 age/gender-matched controls, aged 4-13 years, tasted 10 blinded puree foods in random order. They were rated using a seven-point pictorial hedonic scale (super yummy to super yucky) and ranked in preferential order. Caregivers completed a neophobia and food frequency questionnaire on behalf of their children. Both PKU and control groups rated sweet foods higher than savoury, bitter and sour foods. However, control children ranked fruits as a group higher than PKU children (mean 3.7 versus 4.6; P = 0.03), whereas PKU children ranked vegetables as a group higher than controls (mean 5.6 versus 6.3; P = 0.05). Children with PKU had more neophobia and were untrusting/fearful of new foods. Although there was some evidence to suggest that children with PKU aged ≥4 years prefer savoury foods (vegetables) more than control children, they did not prefer bitter-tasting foods, and so early and persistent administration of bitter-tasting l-amino acids was not associated with apparent taste imprinting. Neophobia appears to play significant part in food refusal in PKU, perhaps more so than taste preferences. © 2015 The British Dietetic Association Ltd.

  20. Testosterone treatment and MMPI-2 improvement in transgender men: a prospective controlled study.

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    Keo-Meier, Colton L; Herman, Levi I; Reisner, Sari L; Pardo, Seth T; Sharp, Carla; Babcock, Julia C

    2015-02-01

    Most transgender men desire to receive testosterone treatment in order to masculinize their bodies. In this study, we aimed to investigate the short-term effects of testosterone treatment on psychological functioning in transgender men. This is the 1st controlled prospective follow-up study to examine such effects. We examined a sample of transgender men (n = 48) and nontransgender male (n = 53) and female (n = 62) matched controls (mean age = 26.6 years; 74% White). We asked participants to complete the Minnesota Multiphasic Personality Inventory (2nd ed., or MMPI-2; Butcher, Graham, Tellegen, Dahlstrom, & Kaemmer, 2001) to assess psychological functioning at baseline and at the acute posttreatment follow-up (3 months after testosterone initiation). Regression models tested (a) Gender × Time interaction effects comparing divergent mean response profiles across measurements by gender identity; (b) changes in psychological functioning scores for acute postintervention measurements, adjusting for baseline measures, comparing transgender men with their matched nontransgender male and female controls and adjusting for baseline scores; and (c) changes in meeting clinical psychopathological thresholds. Statistically significant changes in MMPI-2 scale scores were found at 3-month follow-up after initiating testosterone treatment relative to baseline for transgender men compared with female controls (female template): reductions in Hypochondria (p < .05), Depression (p < .05), Hysteria (p < .05), and Paranoia (p < .01); and increases in Masculinity-Femininity scores (p < .01). Gender × Time interaction effects were found for Hysteria (p < .05) and Paranoia (p < .01) relative to female controls (female template) and for Hypochondria (p < .05), Depression (p < .01), Hysteria (p < .01), Psychopathic Deviate (p < .05), Paranoia (p < .01), Psychasthenia (p < .01), and Schizophrenia (p < .01) compared with male controls (male template). In addition, the proportion of

  1. Calcium and Bone Turnover Markers in Acromegaly: A Prospective, Controlled Study.

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    Constantin, Tina; Tangpricha, Vin; Shah, Reshma; Oyesiku, Nelson M; Ioachimescu, Octavian C; Ritchie, James; Ioachimescu, Adriana G

    2017-07-01

    Acromegaly has been associated with calcium-phosphate and bone turnover alterations. Controlled studies of these interactions are sparse. To evaluate calcium and bone metabolism in active and treated acromegaly. We conducted a controlled, prospective study at a tertiary referral center. We studied 22 patients with acromegaly referred for surgical or medical therapy (ACM) and 22 with nonfunctioning pituitary adenomas referred for surgery (control). Calcium (serum and urine), phosphorus, parathyroid hormone (PTH), 25-hydroxy- and 1,25-dihydroxy-vitamin D, bone turnover markers [serum C-terminal telopeptide of type 1 collagen (CTX) and procollagen type 1 N-terminal propeptide (P1NP)], and cytokines [receptor activator of nuclear factor κB ligand (RANK-L) and osteoprotegerin (OPG)] at baseline and 3 to 6 months after treatment. At baseline, the ACM group had lower PTH levels than controls (36.3 ± 13.9 pg/mL vs 56.0 ± 19.9 pg/mL) and higher phosphorus (4.34 ± 0.71 mg/dL vs 3.55 ± 0.50 mg/dL) (P acromegaly, serum calcium (9.52 ± 0.43 mg/dL to 9.26 ± 0.28 mg/dL), phosphorus (4.34 ± 0.71 mg/dL to 3.90 ± 0.80 mg/dL), and CTX (0.91 ± 0.75 ng/mL to 0.63 ± 0.68 ng/mL) decreased, while PTH increased (36.3 ± 13.9 pg/mL to 48.9 ± 16.7 pg/mL) (P Acromegaly patients exhibited PTH-independent calcium-phosphate alterations and enhanced coupled bone formation and resorption. Within 6 months of treatment, bone resorption decreased, whereas RANK-L/OPG changes were inconsistent.

  2. Impact of an exercise program on acylcarnitines in obesity: a prospective controlled study

    Science.gov (United States)

    2012-01-01

    Background Acylcarnitine (AC) transport dysfunction into the mitochondrial matrix is one of the pathophysiological mechanisms of type 2 diabetes mellitus (DM). The effect of an aerobic exercise (AE) program on this condition in obese subjects without DM is unclear. Methods A prospective, randomized, longitudinal, interventional study in a University Research Center involved a 10-week AE program in 32 women without DM and a body mass index (BMI) greater than 27 kg/m2. (Cases n = 17; Controls n = 15). The primary objective was to evaluate the influence of a controlled AE program on beta-oxidation according to modifications in short, medium, and long-chain ACs. Secondary objectives were to define the behavior of amino acids, and the correlation between these modifications with metabolic and anthropometric markers. Results The proportion of dropouts was 17% and 6% in controls and cases, respectively. In cases there was a significant reduction in total carnitine (30.40 [95% CI 28.2 to 35.6]) vs. (29.4 [CI 95% 25.1 to 31.7]) p = 0.0008 and long-chain AC C14 (0.06 [95% CI 0.05 to 0.08]) vs. (0.05 [95% CI 0.05 to 0.09]) p = 0.005 and in C18 (0.31 [95% CI 0.27 to 0.45]) vs. (0.28 [95% CI 0.22 to 0.32]) p = 0.03. Free fatty acid levels remained without change during the study in both groups. Conclusion In conclusion, a controlled 10-week AE program improved beta-oxidation by reducing long-chain ACs. This finding highlights the importance that AE might have in avoiding or reverting lipotoxicity, and in consequence, improving insulin sensitivity and pancreatic beta cell functional reserve. PMID:22574901

  3. Impact of an exercise program on acylcarnitines in obesity: a prospective controlled study

    Directory of Open Access Journals (Sweden)

    Rodríguez-Gutiérrez René

    2012-05-01

    Full Text Available Abstract Background Acylcarnitine (AC transport dysfunction into the mitochondrial matrix is one of the pathophysiological mechanisms of type 2 diabetes mellitus (DM. The effect of an aerobic exercise (AE program on this condition in obese subjects without DM is unclear. Methods A prospective, randomized, longitudinal, interventional study in a University Research Center involved a 10-week AE program in 32 women without DM and a body mass index (BMI greater than 27 kg/m2. (Cases n = 17; Controls n = 15. The primary objective was to evaluate the influence of a controlled AE program on beta-oxidation according to modifications in short, medium, and long-chain ACs. Secondary objectives were to define the behavior of amino acids, and the correlation between these modifications with metabolic and anthropometric markers. Results The proportion of dropouts was 17% and 6% in controls and cases, respectively. In cases there was a significant reduction in total carnitine (30.40 [95% CI 28.2 to 35.6] vs. (29.4 [CI 95% 25.1 to 31.7] p = 0.0008 and long-chain AC C14 (0.06 [95% CI 0.05 to 0.08] vs. (0.05 [95% CI 0.05 to 0.09] p = 0.005 and in C18 (0.31 [95% CI 0.27 to 0.45] vs. (0.28 [95% CI 0.22 to 0.32] p = 0.03. Free fatty acid levels remained without change during the study in both groups. Conclusion In conclusion, a controlled 10-week AE program improved beta-oxidation by reducing long-chain ACs. This finding highlights the importance that AE might have in avoiding or reverting lipotoxicity, and in consequence, improving insulin sensitivity and pancreatic beta cell functional reserve.

  4. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

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    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  5. Lipid profile in nonobese pregnant women with polycystic ovary syndrome: a prospective controlled clinical study.

    Science.gov (United States)

    Palomba, Stefano; Falbo, Angela; Chiossi, Giuseppe; Muscogiuri, Giovanna; Fornaciari, Eleonora; Orio, Francesco; Tolino, Achille; Colao, Annamaria; La Sala, Giovanni Battista; Zullo, Fulvio

    2014-10-01

    Alterations in lipid pattern and increased risk for obstetric/neonatal complications have been observed in patients with polycystic ovary syndrome (PCOS). Pregnancy leads to physiologic changes in lipoprotein metabolism, and alterations in lipid profile have been related with adverse pregnancy outcomes. Based on these considerations, the aim of the present prospective controlled clinical study was to test the hypothesis that the changes in the lipid profile in patients with PCOS during pregnancy are characteristic and potentially related to the increased risk of obstetric/neonatal complications. One hundred and fifty nonobese PCOS women and 150 age- and body mass index (BMI)-matched healthy controls were enrolled. Serum lipids, glucose, insulin, and androgens levels were serially assayed in all subjects before and throughout pregnancy. Serum low-density lipoprotein (LDL) and triglyceride (TG) concentrations were significantly (Plipid levels, body weight gain, and insulin-resistance markers, serum TG concentrations during pregnancy were directly and independently associated with obstetric complications in both groups, whereas serum LDL levels only in PCOS patients. We can conclude that nonobese PCOS patients had specific changes in lipid profile during pregnancy, and that the lipid pattern typical of PCOS may account for the more frequent adverse pregnancy outcomes. PCOS-related hormonal and metabolic features, such as insulin resistance and high androgen levels, may mediate this phenomenon. Copyright © 2014 Elsevier Inc. All rights reserved.

  6. Anxiety and Depressed Mood in Obese Pregnant Women: A Prospective Controlled Cohort Study

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    Annick.F.L. Bogaerts

    2013-04-01

    Full Text Available Background: The psychological health in obese women during pregnancy has been poorly studied. Objective: To compare levels of anxiety and depressed mood during pregnancy in obese versus normal-weight women. Methods: 63 obese pregnant women and 156 normal-weight controls were included prospectively before 15 weeks of gestation. Levels of state and trait anxiety and depressed mood were measured during the first, second and third trimester of pregnancy. A linear mixed-effect model with repeated measures was used to evaluate group differences. Results: The levels of state anxiety significantly increased from trimester 1 to trimester 3 in obese pregnant women (beta = 3.70; p = 0.007, while this parameter remained constant throughout pregnancy in normal-weight women. Levels of trait anxiety and depressed mood significantly decreased from trimester 1 to trimester 2 in controls, but not in obese pregnant women. Variables such as maternal education, ethnicity, marital state, psychological history and miscarriages, parity and smoking behaviour had significant effects on anxiety and/or depressed moods during pregnancy. Obese pregnant women show higher levels of anxiety and depressive symptomatology compared to normal-weight pregnant women. Conclusion: Interventional programmes aiming at preventing the deleterious influence of maternal obesity on perinatal outcomes should include a psycho-educational program specifically tailored to this high-risk group.

  7. Control of Intraoperative Shivering Under Spinal Anaesthesia- A Prospective Randomized Comparative Study of Butorphanol with Tramadol

    Directory of Open Access Journals (Sweden)

    Astha Palan

    2017-01-01

    Full Text Available Background: Shivering is very uncomfortable and distressing for the patient, anaesthesiologist and the surgeon, especially when the patient is under regional anaesthesia. Aim and Objectives: The present study was designed to evaluate the efficacy of butorphanol and tramadol in the control of shivering under spinal anaesthesia and to compare their side effects. To compare the efficacy, potency, response time, hemodynamic alterations, and adverse effects of intravenously administered tramadol and butorphanol for relief of shivering occurring during spinal anaesthesia. Material and Methods: This randomized prospective study was conducted in 100 patients who developed shivering under spinal anaesthesia during various abdominal, orthopaedic, urological and gynaecological procedures. Patients with fever, acute infections, drug allergy and compromised cardiorespiratory functions were not included in the study. On shivering, patients were randomly allocated in two groups of 50 patients each who received intravenously 1mg of butorphanol or 50 mg of tramadol in a double blinded manner. Control of shivering, time taken for cessation, recurrence, hemodynamic changes, axillary temperatures and side effects were noted and compared for both the groups. Collected data were analysed using Chi square test and Student's unpaired t test. Results: All patients were relieved of shivering after butorphanol, 58% within 1 min, 82% within 3min and 100% within 5 min. Tramadol relieved shivering in 98% of patients, 32% within 1 min, 60% within 3 min, 98% within 5 mins (p<0.05. There was higher incidence of side effects like nausea and vomiting with tramadol (16% and 12% respectively as compared to butorphanol. Conclusion: Both the drugs, tramadol and butorphanol are effective to control shivering after spinal anaesthesia. Butorphanol is better as compared to tramadol in treating shivering under spinal anaesthesia because of its quicker onset of action, higher success rate

  8. Ascorbic acid is lower during pregnancy in diabetic women compared to controls: A prospective study

    DEFF Research Database (Denmark)

    Juhl, B.; Lauszus, Finn; Lykkesfeldt, Jens

    2017-01-01

    Abstract.Few studies have examined how vitamin C status is affected in diabetic pregnancy and no comparison between normal and diabetic pregnancies has been found. This study evaluated vitamin C status prospectively during pregnancy in women with type 1 diabetes mellitus (n=76), in non-diabetic w...

  9. Ascorbic acid is lower during pregnancy in diabetic women compared to controls: A prospective study

    DEFF Research Database (Denmark)

    Juhl, B.; Lauszus, Finn; Lykkesfeldt, Jens

    2016-01-01

    Few studies have examined how vitamin C status is affected in diabetic pregnancy and no comparison between normal and diabetic pregnancies has been found. This study evaluated vitamin C status prospectively during pregnancy in women with type 1 diabetes mellitus (n=76), in non-diabetic women (n=6...

  10. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

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    Moretti Biagio

    2012-06-01

    Full Text Available Abstract Background Total knee arthroplasty (TKA is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value  Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I-ONE group, NSAID use was

  11. Current asthma control predicts future risk of asthma exacerbation: a 12-month prospective cohort study

    Institute of Scientific and Technical Information of China (English)

    WEI Hua-hua; ZHOU Ting; WANG Lan; ZHANG Hong-ping; FU Juan-juan; WANG Lei; JI Yu-lin; WANG Gang

    2012-01-01

    Background The performance of asthma control test (ACT) at baseline for predicting future risk of asthma exacerbation has not been previously demonstrated.This study was designed to explore the ability of the baseline ACT score to predict future risk of asthma exacerbation during a 12-month follow-up.Methods This post hoc analysis included data from a 12-month prospective cohort study in patients with asthma (n=290).The time to the first asthma exacerbation was analyzed and the association between baseline ACT scores and future risk of asthma exacerbation was calculated as adjusted odds ratio (OR) using Logistic regression models.Further,sensitivity and specificity were estimated at each cut-point of ACT scores for predicting asthma exacerbations.Results The subjects were divided into three groups,which were uncontrolled (U,n=128),partly-controlled (PC,n=111),and well controlled (C,n=51) asthma.After adjustment,the decreased ACT scores at baseline in the U and PC groups were associated with an increased probability of asthma exacerbations (OR 3.65 and OR 5.75,respectively),unplanned visits (OR 8.03 and OR 8.21,respectively) and emergency visits (OR 20.00 and OR 22.60,respectively) over a 12-month follow-up period.The time to the first asthma exacerbation was shorter in the groups with U and PC asthma (all P<0.05).The baseline ACT of 20 identified as the cut-point for screening the patients at high risk of asthma exacerbations had an increased sensitivity of over 90.0% but a lower specificity of about 30.0%.Conclusion Our findings indicate that the baseline ACT score with a high sensitivity could rule out patients at low risk of asthma exacerbations and oredict future risk of asthma exacerbations in clinical practice.

  12. Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

    Science.gov (United States)

    Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

    2013-03-01

    Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

  13. Serum taurine and risk of coronary heart disease: a prospective, nested case-control study

    Science.gov (United States)

    Wójcik, Oktawia P.; Koenig, Karen L.; Zeleniuch-Jacquotte, Anne; Pearte, Camille; Costa, Max; Chen, Yu

    2013-01-01

    Purpose Taurine (2-aminoethanesulfonic acid), a molecule obtained from diet, is involved in bile acid conjugation, blood pressure regulation, anti-oxidation and anti-inflammation. We performed the first prospective study of taurine and CHD risk. Methods We conducted a case-control study nested in the New York University Women’s Health Study to evaluate the association between circulating taurine levels and risk of coronary heart disease (CHD). Taurine was measured in two yearly pre-diagnostic serum samples of 223 CHD cases and 223 matched controls and averaged for a more reliable measurement of long-term taurine levels. Results Mean serum taurine was positively related to age and dietary intake of poultry, niacin, vitamin B1, fiber, and iron, and negatively related to dietary intake of saturated fat (all p values ≤ 0.05). There was no statistically significant association between the risk of CHD and serum taurine levels. The adjusted ORs for CHD in increasing taurine tertiles were 1.0 (reference), 0.85 (95% CI, 0.51–1.40), and 0.66 (0.39–1.13; p for trend = 0.14). There was a significant inverse association between serum taurine and CHD risk among women with high total serum cholesterol (>250 mg/dl) (adjusted OR = 0.39 (0.19–0.83) for the third vs. first tertile; p for trend = 0.02) but not among those with low total serum cholesterol (p for interaction = 0.01). The data suggest a possible inverse association of serum taurine with diabetes and hypertension risk. Conclusions The findings suggest that high levels of taurine may be protective against CHD among individuals with high serum cholesterol levels. PMID:22322924

  14. Major dietary factors and prostate cancer risk: a prospective multicenter case-control study.

    Science.gov (United States)

    Salem, Sepehr; Salahi, Mona; Mohseni, Mona; Ahmadi, Hamed; Mehrsai, Abdolrasoul; Jahani, Yunes; Pourmand, Gholamreza

    2011-01-01

    The association between diet and prostate cancer (PC) risk, although suggestive, still remains largely elusive particularly in the Asian population. This study sought to further evaluate the possible effects of different dietary factors on risk of PC in Iran. Using data from a prospective hospital-based multicenter case-control study, dietary intakes of red meat, fat, garlic, and tomato/tomato products, as well as thorough demographic and medical characteristics, were determined in 194 cases with the newly diagnosed, clinicopathologically confirmed PC and 317 controls, without any malignant disease, admitted to the same network of hospitals. Odds ratios (ORs) and corresponding 95% confidence intervals (CIs) were obtained after adjustment for major potential confounders, including age, body mass index, smoking, alcohol, education, occupation, family history of PC, and total dietary calories. Comparing the highest with the lowest tertile, a significant trend of increasing risk with more frequent consumption was found for dietary fat (OR: 1.79, 95% CI: 1.71-4.51), whereas inverse association was observed for tomato/tomato products (OR: 0.33, 95% CI: 0.16-0.65). A nonsignificant increase in PC risk was revealed for dietary red meat (OR: 1.69, 95% CI: 0.93-3.06). For garlic consumption, a borderline reduction in risk was observed (OR: 0.58, 95% CI: 0.32-1.01; P = 0.05). In conclusion, our study supports the hypothesis that total fat may increase PC risk and tomatoes/tomato products and garlic may protect patients against PC.

  15. Bringing explicit insight into cognitive psychology features during clinical reasoning seminars: a prospective, controlled study.

    Science.gov (United States)

    Nendaz, Mathieu R; Gut, Anne M; Louis-Simonet, Martine; Perrier, Arnaud; Vu, Nu V

    2011-04-01

    Facets of reasoning competence influenced by an explicit insight into cognitive psychology features during clinical reasoning seminars have not been specifically explored. This prospective, controlled study, conducted at the University of Geneva Faculty of Medicine, Switzerland, assessed the impact on sixth-year medical students' patient work-up of case-based reasoning seminars, bringing them explicit insight into cognitive aspects of their reasoning. Volunteer students registered for our three-month Internal Medicine elective were assigned to one of two training conditions: standard (control) or modified (intervention) case-based reasoning seminars. These seminars start with the patient's presenting complaint and the students must ask the tutor for additional clinical information to progress through case resolution. For this intervention, the tutors made each step explicit to students and encouraged self-reflection on their reasoning processes. At the end of their elective, students' performances were assessed through encounters with two standardized patients and chart write-ups. Twenty-nine students participated, providing a total of 58 encounters. The overall differences in accuracy of the final diagnosis given to the patient at the end of the encounter (control 63% vs intervention 74%, p = 0.53) and of the final diagnosis mentioned in the patient chart (61% vs 70%, p = 0.58) were not statistically significant. The students in the intervention group significantly more often listed the correct diagnosis among the differential diagnoses in their charts (75% vs 97%, p = 0.02). This case-based clinical reasoning seminar intervention, designed to bring students insight into cognitive features of their reasoning, improved aspects of diagnostic competence.

  16. Is air transport of stroke patients faster than ground transport? A prospective controlled observational study.

    Science.gov (United States)

    Hesselfeldt, Rasmus; Gyllenborg, Jesper; Steinmetz, Jacob; Do, Hien Quoc; Hejselbæk, Julie; Rasmussen, Lars S

    2014-04-01

    Helicopters are widely used for interhospital transfers of stroke patients, but the benefit is sparsely documented. We hypothesised that helicopter transport would reduce system delay to thrombolytic treatment at the regional stroke centre. In this prospective controlled observational study, we included patients referred to a stroke centre if their ground transport time exceeded 30 min, or they were transported by a secondarily dispatched, physician-staffed helicopter. The primary endpoint was time from telephone contact to triaging neurologist to arrival in the stroke centre. Secondary endpoints included modified Rankin Scale at 3 months, 30-day and 1-year mortality. A total of 330 patients were included; 265 with ground transport and 65 with helicopter, of which 87 (33%) and 22 (34%), received thrombolysis, respectively (p=0.88). Time from contact to triaging neurologist to arrival in the regional stroke centre was significantly shorter in the ground group (55 (34-85) vs 68 (40-85) min, pground group (67 (42-136) km) than in the helicopter group (83 (46-143) km) (pground and helicopter transport. We found significantly shorter time from contact to triaging neurologist to arrival in the regional stroke centre if stroke patients were transported by primarily dispatched ground ambulance compared with a secondarily dispatched helicopter.

  17. Ovarian and Adrenal Androgens and Their Link to High Human Chorionic Gonadotropin Levels: A Prospective Controlled Study

    OpenAIRE

    2014-01-01

    Background. Although the association between human chorionic gonadotropin (hCG) and hyperandrogenism was identified more than 40 years ago, relevant questions remain unanswered. Design and Methods. We conducted a prospective, longitudinal, and controlled study in 23 women with a diagnosis of a complete hydatidiform mole (HM). Results. All participants completed the study. Before HM evacuation mean hCG was markedly higher in the cases than in the control group (P ≤ 0.001). Free testosterone (T...

  18. Paracervical block with 1% lidocaine for pain control during intrauterine device insertion: a prospective, single-blinded, controlled study

    Directory of Open Access Journals (Sweden)

    Derya Akdag Cirik

    2013-06-01

    Full Text Available In this prospective controlled study we aimed to investigate efficacy of paracervical block with 1% Lidocaine for pain control and demographic variables which may affect pain perception during intrauterine device insertion in Turkish women. Data from 95 women assigned to paracervical block (n=34, placebo (n=30 and no treatment (n=31 arms and asked to grade the pain level they felt during tenaculum placement, intrauterine device insertion and 5 minutes after the procedure using a visual pain scale. Demographic variables were also recorded. Pain scores were found to be lower in paracervical block group when compared to other 2 groups during tenaculum placement (p=0.00, intrauterine device insertion (p=0.00 and 5 minutes after the procedure (p=0.00. Level of pain was unrelated to mode of previous deliveries and current breastfeeding. Paracervical block is an easy, safe and effective way of pain control during intrauterine device insertion. Lack of vaginal birth history is not a reason to draw back from intrauterine device use. [Int J Reprod Contracept Obstet Gynecol 2013; 2(3.000: 263-267

  19. Is the routine pressure dressing after thyroidectomy necessary? A prospective randomized controlled study

    Directory of Open Access Journals (Sweden)

    Phuttharak Warinthorn

    2008-03-01

    Full Text Available Abstract Background An acute complication of thyroidectomy is fatal hematoma, which can produce an upper airway obstruction needing immediate intubation or tracheostomy. After neck surgery, we usually apply a pressure dressing with a non-woven, adhesive fabric to reduce bleeding and fluid collection at the operative bed. We conducted a prospective, randomized, controlled study to evaluate a pressure vs. a non-pressure dressing after thyroid surgery by monitoring blood and serum in the operative bed. Methods We studied 108 patients who underwent 116 thyroid surgeries at Srinagarind Hospital, Khon Kaen University, between December 2006 and September 2007. The patients were randomized to either the pressure dressing or non-pressure dressing group. Ultrasound of the neck was performed 24 ± 3 hours after surgery. The volume of fluid collection in the operative bed was calculated. All patients were observed for any post-operative respiratory distress, wound complications, tingling sensation or tetany. Results The distributions of age, sex, surgical indications and approaches were similar between the two groups. There was no statistically significant difference in the volume of fluid collection in the operative bed (p = 0.150 and the collected drained content (p = 0.798. The average time a drain was retained was 3 days. One patient in the pressure dressing group suffered cutaneous bruising while one patient in the non-pressure dressing group developed immediate hemorrhage after the skin sutures. Conclusion Pressure dressing after thyroidectomy does not have any significant impact on decreasing fluid collection at the operative bed. The use of pressure dressing after thyroidectomy may not therefore be justified. Trial Registration NCT00400465, ISRCTN52660978

  20. Helicobacter pylori infection amongst Arab Israeli women with hyperemesis gravidarum—a prospective, controlled study

    OpenAIRE

    Doron Boltin; Tsachi Tsadok Perets; Sami Abu Elheiga; Asher Sharony; Yaron Niv; Hussein Shamaly; Ram Dickman

    2014-01-01

    Objective: Helicobacter pylori has been associated with hyperemesis gravidarum in some geographical regions. The prevalence of H. pylori in Arab Israeli women in the Upper Galilee and its association with hyperemesis gravidarum has not been studied previously. We aimed to examine if hyperemesis gravidarum is associated with H. pylori in this population. Methods: Subjects with hyperemesis gravidarum carrying a singleton fetus were recruited prospectively. Women with an uncomplicated pregnan...

  1. [Explore objective clinical variables for detecting delirium in ICU patients: a prospective case-control study].

    Science.gov (United States)

    Liu, Xiaojiang; Lyu, Jie; An, Youzhong

    2017-04-01

    The aim of this case-control study is to explore clinical objective variables for diagnosing delirium of intensive care unit (ICU) patients. According to the method of prospective case-control study, critical adult postoperative patients who were transferred to ICU of Peking University People's Hospital from October 2015 to May 2016 and needed mechanical ventilation were included. After evaluating the Richmond agitation sedation scale score (RASS), the patients whose score were -2 or greater were sorted into two groups, delirium and non-delirium, according to the confusion assessment method for the ICU (CAM-ICU). Then these patients were observed by domestic multifunctional detector for electroencephalographic (EEG) variables such as brain lateralization, brain introvert, brain activity, brain energy consumption, focus inward, focus outward, cerebral inhibition, fatigue, sleep severity, sedation index, pain index, anxiety index, fidgety index, stress index and the cerebral blood flow (CBF) index which was named of perfusion index. Other variables including indexes of ICU blood gas analysis, which was consisted of variables of blood gas analysis, routine blood test and biochemistry, previous history and prognostic outcome was recorded. Binary logistic regression was used for multivariate analysis. Forty-three postoperative patients, who needed intensive care, were included. Eighteen were in delirium group and twenty-five in control group. Excluding the trauma, variables like gender, age, temperature, heart rate, respiratory rate, mean arterial pressure, acute physiology and chronic health evaluationII(APACHEII) score, organ failure, dementia and emergency surgery didn't show any statistical significance between two groups. The trauma in delirious patients increased obviously compared with the control group (33.3% vs. 4.0%, P = 0.031). Except for the brain activity [122.47 (88.62, 154.21) vs. 89.40 (86.27, 115.97), P = 0.034], there were no statistical differences in

  2. PROspective MEmory Training to improve HEart failUre Self-care (PROMETHEUS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Cameron, Jan; Rendell, Peter G; Ski, Chantal F; Kure, Christina E; McLennan, Skye N; Rose, Nathan S; Prior, David L; Thompson, David R

    2015-04-29

    Cognitive impairment is seen in up to three quarters of heart failure (HF) patients and has a significant negative impact on patients' health outcomes. Prospective memory, which is defined as memory to carry out future intentions, is important for functional independence in older adults and involves application of multiple cognitive processes that are often impaired in HF patients. The objective of this study is to examine the effects of prospective memory training on patients' engagement in HF self-care and health outcomes, carer strain and quality of life. The proposed study is a randomised, controlled trial in which 200 patients diagnosed with HF, and their carers will be recruited from 3 major hospitals across Melbourne. Eligible patients with HF will be randomised to receive either: 1) The Virtual Week Training Program - a computerised prospective memory (PM) training program (intervention) or 2) non-adaptive computer-based word puzzles (active control). HF patients' baseline cognitive function will be compared to a healthy control group (n = 60) living independently in the community. Patients will undergo a comprehensive assessment of PM, neuropsychological functioning, self-care, physical, and emotional functioning. Assessments will take place at baseline, 4 weeks and 12 months following intervention. Carers will complete measures assessing quality of life, strain, perceived control in the management of the patients' HF symptoms, and ratings of the patients' level of engagement in HF self-care behaviours. If the Virtual Week Training Program is effective in improving: 1) prospective memory; 2) self-care behaviours, and 3) wellbeing in HF patients, this study will enhance our understanding of impaired cognitive processes in HF and potentially is a mechanism to reduce healthcare costs. Australian New Zealand Clinical Trials Registry #366376; 27 May 2014. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366376&isClinicalTrial=False .

  3. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study

    Directory of Open Access Journals (Sweden)

    Angsuwatcharakon Phonthep

    2012-08-01

    Full Text Available Abstract Background ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP. Methods ERCP patients were randomized into 2 groups; the cocktail group (n = 103 and the controls (n = 102. For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation. Results In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients’ satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045, 93.1and 87.6 (P P Conclusions Cocktail sedation containing propofol provides faster recovery time and better patients’ satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop. Trial registration ClinicalTrials.gov, NCT01540084

  4. Patterns, predictors and outcomes of asthma control and exacerbations during pregnancy: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Luke E. Grzeskowiak

    2016-02-01

    Full Text Available There exists a paucity of data for socially disadvantaged populations describing patterns and predictors of asthma control status and exacerbations during pregnancy, and their relationship to adverse perinatal outcomes. Asthmatic women (n=189 were followed prospectively during pregnancy, with visits at 12, 20, 28 and 36 weeks gestation. Data on loss of control, recurrent uncontrolled asthma and moderate/severe exacerbations were collected at each visit and their relationship to perinatal outcomes examined following stratification for fetal sex. 50% of asthmatic women experienced a loss of control or moderate/severe exacerbation during pregnancy, with 22% of women experiencing a moderate/severe exacerbation. Factors associated with an increased risk of women experiencing recurrent uncontrolled asthma during pregnancy included smoking (relative risk 2.92, 95% CI 1.53–5.58, inhaled corticosteroid use at the beginning of pregnancy (relative risk 2.40, 95% CI 1.25–4.60 and increasing maternal age (relative risk 1.06, 95% CI 1.01–1.11. No factors were associated with moderate/severe exacerbations. Asthma control rather than exacerbations during pregnancy appeared to be most strongly correlated with perinatal outcomes. Following stratification by fetal sex, the presence of recurrent uncontrolled asthma was associated with an increased risk of being small for gestational age in women pregnant with females (33.3% versus 9.5%; p=0.018. In contrast, there was a nonsignificant increased risk of preterm birth in women with recurrent uncontrolled asthma that were pregnant with males (25.0% versus 11.8%; p=0.201 These results suggest that the key to improving perinatal outcomes lies in improving asthma control as early as possible in pregnancy and monitoring throughout pregnancy, rather than focusing on preventing exacerbations alone.

  5. Sexual functioning in women after mastectomy versus breast conserving therapy for early-stage breast cancer: a prospective controlled study.

    Science.gov (United States)

    Aerts, L; Christiaens, M R; Enzlin, P; Neven, P; Amant, F

    2014-10-01

    Breast cancer (BC) and/or its treatments may affect sexual functioning based on physiological and psychosocial mechanisms. The aim of this study was to prospectively investigate sexual adjustment of BC patients during a follow-up period of one year after mastectomy (ME) or breast conserving therapy (BCT). In this prospective controlled study, women with BC and an age-matched control group of healthy women completed the Beck Depression Inventory Scale, World Health Organization 5 Well-being scale, Body Image Scale, EORTC QLQ questionnaire, Dyadic Adjustment Scale, Short Sexual Functioning Scale and Specific Sexual Problems Questionnaire to assess various aspects of sexual and psychosocial functioning before surgery, six months and one year after surgical treatment. In total, 149 women with BC and 149 age-matched healthy controls completed the survey. Compared to the situation before surgery, significantly more BCT women reported problems with sexual arousal six months after surgery and significantly more women of the ME group reported problems with sexual desire, arousal and the ability to achieve an orgasm six months and one year after surgery. While in comparison with healthy controls, no significant differences in sexual functioning were found after BCT surgery, significantly more women who underwent ME reported problems with sexual desire, arousal, the ability to achieve an orgasm and intensity of the orgasm. Although little differences were seen in sexual functioning in the BCT group during prospective analyses and in comparison with healthy controls, analyses revealed that women who underwent a ME were at risk for post-operative sexual dysfunctions. Copyright © 2014. Published by Elsevier Ltd.

  6. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    Science.gov (United States)

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  7. Nurse led, primary care based antiretroviral treatment versus hospital care: a controlled prospective study in Swaziland

    Directory of Open Access Journals (Sweden)

    Bailey Kerry A

    2010-08-01

    Full Text Available Abstract Background Antiretroviral treatment services delivered in hospital settings in Africa increasingly lack capacity to meet demand and are difficult to access by patients. We evaluate the effectiveness of nurse led primary care based antiretroviral treatment by comparison with usual hospital care in a typical rural sub Saharan African setting. Methods We undertook a prospective, controlled evaluation of planned service change in Lubombo, Swaziland. Clinically stable adults with a CD4 count > 100 and on antiretroviral treatment for at least four weeks at the district hospital were assigned to either nurse led primary care based antiretroviral treatment care or usual hospital care. Assignment depended on the location of the nearest primary care clinic. The main outcome measures were clinic attendance and patient experience. Results Those receiving primary care based treatment were less likely to miss an appointment compared with those continuing to receive hospital care (RR 0·37, p p = 0·001. Those receiving primary care based, nurse led care were more likely to be satisfied in the ability of staff to manage their condition (RR 1·23, p = 0·003. There was no significant difference in loss to follow-up or other health related outcomes in modified intention to treat analysis. Multilevel, multivariable regression identified little inter-cluster variation. Conclusions Clinic attendance and patient experience are better with nurse led primary care based antiretroviral treatment care than with hospital care; health related outcomes appear equally good. This evidence supports efforts of the WHO to scale-up universal access to antiretroviral treatment in sub Saharan Africa.

  8. Intraoperative assistive technologies and extent of resection in glioma surgery: a systematic review of prospective controlled studies.

    Science.gov (United States)

    Barbosa, Breno José Alencar Pires; Mariano, Eric Domingos; Batista, Chary Marquez; Marie, Suely Kazue Nagahashi; Teixeira, Manoel Jacobsen; Pereira, Carlos Umberto; Tatagiba, Marcos Soares; Lepski, Guilherme Alves

    2015-04-01

    Several studies published to date about glioma surgery have addressed the validity of using novel technologies for intraoperative guidance and potentially improved outcomes. However, most of these reports are limited by questionable methods and/or by their retrospective nature. In this work, we performed a systematic review of the literature to address the impact of intraoperative assistive technologies on the extent of resection (EOR) in glioma surgery, compared to conventional unaided surgery. We were also interested in two secondary outcome variables: functional status and progression-free survival. We primarily used PubMed to search for relevant articles. Studies were deemed eligible for our analysis if they (1) were prospective controlled studies; (2) used EOR as their primary target outcome, assessed by MRI volumetric analysis; and (3) had a homogeneous study population with clear inclusion criteria. Out of 493 publications identified in our initial search, only six matched all selection criteria for qualitative synthesis. Currently, the evidence points to 5-ALA, DTI functional neuronavigation, neurophysiological monitoring, and intraoperative MRI as the best tools for improving EOR in glioma surgery. Our sample and conclusions were limited by the fact that studies varied in terms of population characteristics and in their use of different volumetric analyses. We were also limited by the low number of prospective controlled trials available in the literature. Additional evidence-based high-quality studies assessing cost-effectiveness should be conducted to better determine the benefits of intraoperative assistive technologies in glioma surgery.

  9. Clinical assessment of a new anaesthetic drug administration system: a prospective, controlled, longitudinal incident monitoring study.

    Science.gov (United States)

    Webster, C S; Larsson, L; Frampton, C M; Weller, J; McKenzie, A; Cumin, D; Merry, Alan F

    2010-05-01

    A safety-orientated system of delivering parenteral anaesthetic drugs was assessed in a prospective incident monitoring study at two hospitals. Anaesthetists completed an incident form for every anaesthetic, indicating if an incident occurred. Case mix data were collected and the number of drug administrations made during procedures estimated. From February 1998 at Hospital A and from June 1999 at Hospital B, until November 2003, 74,478 anaesthetics were included, for which 59,273 incident forms were returned (a 79.6% response rate). Fewer parenteral drug errors occurred with the new system than with conventional methods (58 errors in an estimated 183,852 drug administrations (0.032%, 95% CI 0.024-0.041%) vs 268 in 550,105 (0.049%, 95% CI 0.043-0.055%) respectively, p = 0.002), a relative reduction of 35% (difference 0.017%, 95% CI 0.006-0.028%). No major adverse outcomes from these errors were reported with the new system while 11 (0.002%) were reported with conventional methods (p = 0.055). We conclude that targeted system re-design can reduce medical error.

  10. Rapid relief of signs/symptoms in chronic venous microangiopathy with pycnogenol: a prospective, controlled study.

    Science.gov (United States)

    Cesarone, M R; Belcaro, G; Rohdewald, P; Pellegrini, L; Ledda, A; Vinciguerra, G; Ricci, A; Gizzi, G; Ippolito, E; Fano, F; Dugall, M; Acerbi, G; Cacchio, M; Di Renzo, A; Hosoi, M; Stuard, S; Corsi, M

    2006-01-01

    The aim of this study was to investigate the clinical efficacy of oral Pycnogenol (Horphag Research Ltd, UK) in patients with severe chronic venous insufficiency. Patients with severe venous hypertension (chronic venous insufficiency, ankle swelling) and history of venous ulcerations were treated with Pycnogenol. Patients received oral Pycnogenol (50 mg capsules, 3 times daily for a total of 150 mg daily) for 8 weeks. A group of 21 patients was included in the treatment group and 18 equivalent patients were observed as controls (no treatment during the observation period). All 21 patients (age 53 years; range, 42-60 years; M:F=11:10) in the treatment group completed the 8-week study. Also the 18 controls completed the follow-up period. There were no drop-outs. The average ambulatory venous pressure was 59.3 (SD 7.2; range 50-68) with a refilling time shorter than 10 seconds (average 7.6; SD 3). There were no differences in ambulatory venous pressure or refilling time between the treatment and control patients. The duration of the disease-from the first signs/symptoms-was on average 5.7 years (SD 2.1). At 4 and 8 weeks, in all Pycnogenol-treated subjects, microcirculatory and clinical evaluations indicated a progressive decrease in skin flux, indicating an improvement in the level of microangiopathy; a significant decrease in capillary filtration; a significant improvement in the symptomatic score; and a reduction in edema. There were no visible effects in controls. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol in the management, treatment and control of this common clinical problem. The treatment may be also useful to prevent ulcerations by controlling the level of venous microangiopathy.

  11. Naproxen prevention of heterotopic ossification after hip arthroplasty. A prospective control study of 55 patients

    DEFF Research Database (Denmark)

    Gebuhr, Peter Henrik; Soelberg, M; Orsnes, T

    1991-01-01

    The effect of naproxen on heterotopic ossification after total hip replacement was studied in a randomized, double-blind trial. Twenty-eight patients received 250 mg naproxen thrice daily for 4 weeks postoperatively starting on the morning of the operation while 27 control patients received a pla...

  12. Motivational and control mechanisms underlying adolescent cannabis use disorders: a prospective study

    NARCIS (Netherlands)

    Cousijn, J.; van Benthem, P.; van der Schee, E.; Spijkerman, R.

    2015-01-01

    Cannabis use disorders (CUDs) are the most prevalent substance use disorders among adolescents in treatment. Yet, little is known about the neuropsychological mechanisms underlying adolescent CUDs. Studies in adult cannabis users suggest a significant role for cognitive control and cannabis-oriented

  13. Neutrophil-to-lymphocyte ratio in patients with peripheral vertigo: a prospective controlled clinical study.

    Science.gov (United States)

    Ozbay, Isa; Kahraman, Cuneyt; Balikci, Hasan Huseyin; Kucur, Cuneyt; Kahraman, Nilufer Kuzeyli; Ozkaya, Derya Pınar; Oghan, Fatih

    2014-01-01

    We aimed to investigate the relationship between peripheral vertigo and inflammation by using the neutrophil-to-lymphocyte ratio (NLR) as an inflammatory marker. We recruited 103 patients with peripheral vertigo (71 women, 32 men; mean age, 39.8 ± 14.7 years) who presented to the Otolaryngology Department of Dumlupinar University Hospital. Vertigo patients with systemic diseases, neurological disorders, malignancy or any inflammatory disease that could alter the NLR were excluded from the study. We also enrolled 103 age- and sex-matched healthy subjects (controls; 82 women, 21 men; mean age, 36.7 ± 13.5 years) who underwent routine checkups in our hospital. The vertigo patients underwent full otolaryngologic and neurologic examinations and audiometric tests to rule out any other pathology causing the peripheral vertigo. NLR was calculated in all subjects and was compared between the patient and control groups. There were no significant differences between the study and control groups in terms of lipid profiles, liver-function tests, white blood cell (WBC) count, hemoglobin level, mean platelet volume, and vitamin B12 and folate levels. The mean NLR was significantly higher in the patients than in the controls (Pvertigo, found that the NLR is significantly higher among peripheral vertigo patients than among healthy controls. This result suggests that the NLR is a novel potential marker of stress in peripheral vertigo patients. Copyright © 2014 Elsevier Inc. All rights reserved.

  14. Oral status in patients with early rheumatoid arthritis: a prospective, case-control study.

    Science.gov (United States)

    Wolff, Björn; Berger, Timo; Frese, Cornelia; Max, Regina; Blank, Norbert; Lorenz, Hanns-Martin; Wolff, Diana

    2014-03-01

    Patients with RA suffer from a higher risk of periodontal attachment loss and increased oral inflammation. We hypothesize that there are pathogenetic and immunological interactions between these diseases that go beyond impaired manual dexterity accompanying advanced RA. The primary objective of the present study was to determine whether a loss of alveolar bone can be detected in RA patients during the early course of the disease. In this cross-sectional, epidemiological case-control study, 22 patients with early RA (ERA) were compared with 22 matched healthy controls. Oral and periodontal status, clinical activity, and socio-demographic parameters were determined. Oral microbiota were analysed using real-time quantitative PCR specific for leading oral pathogens. More advanced forms of periodontitis were found in ERA patients compared with controls. ERA patients had a greater number of missing teeth [ERA 5.7 (s.d. 5.0), controls 1.9 (s.d. 1.0), P = 0.002], deeper periodontal pockets [clinical attachment level: ERA 3.4 (s.d. 0.5 mm), controls 2.7 (s.d. 0.3 mm), P periodontal attachment and alveolar bone can be detected in patients with ERA, therefore we propose that the consulting rheumatologists inform the patients that they have a higher risk of periodontal disease. It would be beneficial if these patients were referred directly for intensive dental care.

  15. Applicability of Proposed Diagnostic Criteria of Pityriasis Rosea: Results of a Prospective Case-Control Study in India

    Science.gov (United States)

    Zawar, Vijay; Chuh, Antonio

    2013-01-01

    Background: The diagnosis of pityriasis rosea (PR) is generally clinical. Previous studies usually recruited relatively small numbers of patients and control subjects, leading to low power of study results. Systematic reviews and meta-analyses cannot be readily performed, as the inclusion and exclusion criteria of these studies were not uniform. We have previously validated a set of diagnostic criteria (DC) in Chinese patients with PR. Aim: Our aim is to evaluate the validity and applicability of the DC of PR in Indian patients with PR. Study Design: Prospective unblinded pair-matched case-control study. Materials and Methods: The setting is a dermatology clinic in India served by one board-certified dermatologist. We recruited all 88 patients seen by us during five years diagnosed to have PR to join our study. For each study subject, we recruited the next patient who consulted us with differential diagnoses of PR as control subjects. We applied the DC of PR on all study and control subjects. Result: The sensitivity, specificity, positive predictive value, and negative predictive value of the DC were all 100%. Two-tailed Fisher's exact probability test result was 0.036. Φ was 1.00. Conclusion: The set of DC can be validly applied to Indian patients with PR. PMID:24249894

  16. Telemonitoring in fasting individuals with Type 2 Diabetes Mellitus during Ramadan: A prospective, randomised controlled study.

    Science.gov (United States)

    Lee, Jun Yang; Wong, Chee Piau; Tan, Christina San San; Nasir, Nazrila Hairizan; Lee, Shaun Wen Huey

    2017-08-31

    We determined the impact of a remote blood glucose telemonitoring program with feedback in type 2 diabetes mellitus patients fasting during Ramadan compared to conventional self-monitoring method. A twelve-week cluster randomised study, with 85 participants who wish to fast for at least 15 days during Ramadan was conducted. Self-measurement and transmission of blood glucose results were performed six times daily during Ramadan. Results were transmitted to a secure website for review with feedback from case manager if necessary. The control group received usual care. The main outcome was the number of participants experiencing hypoglycaemia during Ramadan and at the end of the study. During Ramadan, the number of participants reporting hypoglycaemia was significantly lower in the telemonitoring group [Odds ratio (OR): 0.186, 95% confidence interval: 0.04-0.936; p = 0.04]. Similarly, the proportion of participants reporting symptomatic hypoglycaemia at the end of the study was significantly lower in the telemonitoring group (OR: 0.257, 95% CI: 0.07-0.89; p = 0.03). A reduction of 1.07% in glycated haemoglobin levels was observed in the telemonitoring group compared to 0.24% in the control group (p telemonitoring was a useful adjunct to reduce the risk of hypoglycaemia during Ramadan with no deterioration in glycaemic control.

  17. Written Educational Material Relieves Anxiety after Endoscopic Biopsy: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kim, Hae Won; Jung, Da Hyun; Youn, Young Hoon; Kim, Jie-Hyun; Kim, Jae Jin; Park, Hyo Jin

    2016-02-01

    Patients who undergo endoscopic biopsy suffer anxiety until results are confirmed. This study assesses the effects of written educational material on the anxiety level of patients following endoscopic biopsy. This study was a randomized controlled study trial with 83 patients divided into the following three groups: a biopsy group given written educational material prepared by our institution following the biopsy (intervention group, n=28), a biopsy group without written material (biopsy only group, n=25), and a control group without biopsy (control group, n=30). The anxiety level of each patient was evaluated three times using Spielberger's State-Trait Anxiety Inventory (STAI): for baseline at the first visit to our institution, at the day of endoscopy, one day later, and one week after the procedure. We compared baseline characteristics, STAI scores at each visit, and differences in STAI scores among the three groups. No difference was found in STAI score among groups at baseline and before and after the endoscopic procedure. However, the STAI-state score of the intervention group was slightly lower than biopsy only group one day post-procedure (40.3 ± 7.7 vs. 43.9 ± 7.1, p=0.135). The STAI-state score significantly decreased from pre- to post-procedure only in the intervention group (-2.75 ± 6.1 vs. 0.92 ± 4.0, pmaterial for patients having biopsy might lessen their anxiety level.

  18. Sentinel lymph node detection after transaxillary augmentation mammoplasty: a prospective controlled study utilizing lymphoscintigraphy in 43 breasts

    Energy Technology Data Exchange (ETDEWEB)

    Sado, Heitor Naoki; Yamada, Airton Seiji [Centro de Radioimunoensaio e Medicina Nuclear do Parana (CERMEN), Curitiba, PR (Brazil)]. E-mail: heitor@cermen.com.br; Graf, Ruth Maria; Timi, Jorge Rufino Ribas; Matias, Jorge Eduardo Fouto [Universidade Federal do Parana (UFPR), Curitiba, PR (Brazil). Hospital de Clinicas. Cirurgia Plastica; Urban, Cicero Andrade [Universidade Posotivo (UnicenP), Curitiba, PR (Brazil). Centro Universitario Positivo; Woellner, Luiz Carlos [Universidade Federal do Parana (UFPR), Curitiba, PR (Brazil). Hospital de Clinicas. Medicina Nuclear; Ferreira, Eduardo de Castro [Universidade Federal do Maranhao (UFMA), Sao Luis, MA (Brazil). Hospital Universitario

    2008-09-15

    Objective: To evaluate the potential influence of transaxillary augmentation mammoplasty on future detection of sentinel lymph node. Materials and methods: Prospective controlled study where 22 patients were selected and divided into two groups (post-mammoplasty and control) corresponding to 43 breasts (22 in the post-mammoplasty group and 21 in the control group) evaluated by lymphoscintigraphy immediately after periareolar {sup 99m}Tc-phytate injections. In the statistical analysis, p values < 0.05 were considered as significant. Results: All the breasts in the post-mammoplasty group presented lymphatic drainage to the axillary chain, with no difference as compared with the control group (p 0.488). The average number of hot lymph nodes was 1.27 {+-} 0.46 in the post-mammoplasty group, and 1.33 {+-} 0.58 in the control group (p = 0.895). The mean time required to visualize the first lymph node was 3.14 {+-} 4.42 minutes in the post mammoplasty group, and 5.48 {+-} 5.06 minutes in the control group (p 0.136). Conclusion: Transaxillary augmentation mammoplasty did not affect the future detection of sentinel lymph node. (author)

  19. Sentinel lymph node detection after trans axillary augmentation mammoplasty: a prospective controlled study utilizing lymphoscintigraphy in 43 breasts

    Energy Technology Data Exchange (ETDEWEB)

    Sado, Heitor Naoki; Timi, Jorge Rufino Ribas; Matias, Jorge Eduardo Fouto [Universidade Federal do Parana (UFPR), Curitiba, PR (Brazil). Program of Post-Graduation in Surgical Practice]. E-mail: heitor@cermen.com.br; Graf, Ruth Maria [Universidade Federal do Parana (UFPR), Curitiba, PR (Brazil). Hospital de Clinicas; Urban, Cicero Andrade [UnicenP, Curitiba, PR (Brazil); Yamada, Airton Seiji [CERMEN - Centro de Radioimunoensaio e Medicina Nuclear de Curitiba, PR (Brazil); Woellner, Luiz Carlos [Universidade Federal do Parana (UFPR), Curitiba, PR (Brazil). Hospital de Clinicas. Unit of Nuclear Medicine; Ferreira, Eduardo de Castro [Universidade Federal do Maranhao (UFMA), Sao Luis, MA (Brazil). Hospital de Clinicas

    2008-09-15

    Objective: to evaluate the potential influence of trans axillary augmentation mammoplasty on future detection of sentinel lymph node. Materials and methods: prospective controlled study where 22 patients were selected and divided into two groups (post-mammoplasty and control) corresponding to 43 breasts (22 in the post-mammoplasty group and 21 in the control group) evaluated by lymphoscintigraphy immediately after periareolar {sup 99m}Tc-phytate injections. In the statistical analysis, p values < 0.05 were considered as significant. Results: all the breasts in the post-mammoplasty group presented lymphatic drainage to the axillary chain, with no difference as compared with the control group (p 0.488). The average number of hot lymph nodes was 1.27 {+-} 0.46 in the post-mammoplasty group, and 1.33 {+-} 0.58 in the control group (p = 0.895). The mean time required to visualize the first lymph node was 3.14 {+-} 4.42 minutes in the post mammoplasty group, and 5.48 {+-} 5.06 minutes in the control group (p 0.136). Conclusion: transaxillary augmentation mammoplasty did not affect the future detection of sentinel lymph node. (author)

  20. Combination treatment of physical modalities in the treatment of musculoskeletal pain syndromes: a prospective-controlled study

    Directory of Open Access Journals (Sweden)

    Karin Pieber

    2010-12-01

    Full Text Available The aim of the study was to evaluate the effect of combinations of several physical therapies in the treatment of musculoskeletal pain syndromes by a prospective, controlled study. Forty patients (5 men and 35 women, 18-80 years with musculoskeletal pain syndrome were included. Thirty patients were assigned to the intervention group and 10 patients to the control group. The intervention group received a combination of physical therapies according to the clinical needs (electrotherapy, fango packs, mud packs, ultrasound, massage, exercise therapy. Treatment consisted of 10 sessions. The control group did not receive any physical therapy in the waiting period. The intervention group was examined at the beginning and the end of the treatment period. The control group was evaluated at the beginning and the end of the waiting period (before their physical therapy treatment started. Main outcome measurements were: Visual analogue scale for pain (VAS; Timed Get up and Go Test (TUG; Functional Reach Test (FRT. In addition bodily, emotional and social functioning was accessed by selected ICF-Items and items of the SF-36 health survey (SF-36. The main outcome measures showed significant improvement in the intervention group compared to the control group. Furthermore, ICF- and SF-36-Items also improved. In conclusion significant pain relief and improvement of function was achieved by a combination treatment of physical therapies in patients with musculoskeletal pain syndromes.

  1. Current state of concussion prevention strategies: a systematic review and meta-analysis of prospective, controlled studies.

    Science.gov (United States)

    Schneider, Daniel K; Grandhi, Ravi K; Bansal, Purnima; Kuntz, George E; Webster, Kate E; Logan, Kelsey; Barber Foss, Kim D; Myer, Gregory D

    2017-10-01

    The aim of the current review was to systematically identify, evaluate and synthesise trials that examine concussion prevention via equipment, educational programmes and training programmes. PubMed and EBSCO host (CINAHL, MEDLINE, SPORTDiscus). The electronic databases PubMed and EBSCO were searched using the phrases: concussion prevention equipment, concussion prevention training and concussion prevention education. Included studies utilised a prospective study design to evaluate the preventative effect of: (1) equipment, (2) training or (3) educational programmes on the incidence of concussions in comparison to a control group. Demographic data and intervention methods were recorded. Intervention and control group concussion rates and superficial head injury rates were extracted and combined using random-effects relative risk meta-analysis. 14 studies evaluated interventions of novel protective equipment. One prospective investigation evaluated an educational programme. The relative risk of concussion for participants enrolled in the interventional arms of trials was not significantly different from that in standard practice arms (RR=0.78, 95% CI 0.55 to 1.11, χ(2)=1.8, p=0.17; I(2)=85.3%, 95% CI 71.5% to 90.8%). The relative risk of concussion for participants wearing protective equipment (ie, headgear, full face shields) relative to their counterparts wearing standard or no equipment, calculated from seven available reports, showed no effect of intervention (RR=0.82, 95% CI 0.56 to 1.20, χ(2)=1.06, p=0.30; I(2)=86.7%, 95% CI 73.3% to 91.8%). The relative risk of superficial head injury for participants wearing protective equipment relative to their counterparts, calculated from three reports, showed a significant risk reduction (RR=0.41, 95% CI 0.31 to 0.56, χ(2)=34.13, p<0.0001; I(2)=53.1%, 95% CI 0% to 85.2%). Prospective controlled studies indicate that certain protective equipment may prevent superficial head injury, but these items are suboptimal for

  2. Examination of the diagnostic validity of 'headache attributed to whiplash injury': a controlled, prospective study.

    Science.gov (United States)

    Schrader, H; Stovner, L J; Obelieniene, D; Surkiene, D; Mickeviciene, D; Bovim, G; Sand, T

    2006-11-01

    Acute and chronic headache attributed to whiplash injury are new diagnostic entities in the International Classification of Headache Disorders, second edition. A main objective of the present study was to assess the validity of these nosologic entities by studying the headache pattern in an inception cohort of 210 rear-end car collision victims and in 210 matched controls. Consecutive drivers involved in rear-end collisions were identified from the daily records of the Traffic Police Department of Kaunas, Lithuania. A standard self-report questionnaire was sent to the drivers between 2 and 7 days after the collision, and their passengers were recruited as well. Headache and neck pain were evaluated within 7 days of the collision, at 2 months and 1 year after the collision. A control group of non-traumatized subjects received questionnaires at the time of the selection and 1 year later. Of the 75 collision victims who developed headache within the first 7 days of the collision, 37 had a clinical picture in accordance with the criteria for acute whiplash headache (i.e., concomitant neck pain) and 38 did not. For acute headache after collision, concomitant neck pain was of no relevance to the headache type or its course. In both these subgroups, migraine and tension-type headache could be diagnosed in similar proportions and the prognosis after 2 months and 1 year was also similar. Preexisting headache was a strong prognostic factor in both groups for both acute and chronic pain. Compared with the non-traumatized control group, the 1-year incidence of new or worsened headache, or of headache improvement, was the same. A likely interpretation of the data is that acute headaches after rear-end car collisions mainly represent episodes of a primary headache precipitated by the stress of the situation. We conclude that the nosologic validity of both acute and chronic whiplash headache is poor as the headaches, in accordance with the criteria lack distinguishing clinical

  3. Stop of loss of cognitive performance during rehabilitation after total hip arthroplasty-Prospective controlled study

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    Matthias H. Brem, MD, MHBA

    2010-12-01

    Full Text Available Prolonged hospitalization is known to be associated with a loss of cognitive performance. Does playing video games (VGs developed to improve cognitive properties delay this loss or even lead to an increase in cognitive performance? We performed a 10-day longitudinal study of patients who received total hip arthroplasty. We compared 16 patients (6 male aged 66 ± 9 years (mean ± standard deviation who played Dr. Kawashima's Brain Training: How Old Is Your Brain? (Nintendo; Redmond, Washington on a Nintendo DS handheld console with 16 control patients (6 male aged 69 ± 14 years. We measured cognitive performance 1 day preoperation, as well as on days 2 and 9 postoperation. With the daily exercise of a specific VG by the play group, the patients' fluid intelligence (median intelligence quotient 99-106, working memory capacity, and rate of information processing significantly improved over the course of 7 postoperative days. The cognitive performance of the control group did not increase. However, the memory spans of both groups did not systematically change. Exercise with VGs can prevent the loss of cognitive performance during prolonged hospitalization.

  4. Oxidative stress markers in intrahepatic cholestasis of pregnancy: a prospective controlled study.

    Science.gov (United States)

    Hu, Y-Y; Liu, J-C; Xing, A-Y

    2015-09-01

    Intrahepatic cholestasis of pregnancy (ICP), characterized by skin pruritus and elevation of serum aminotransferase activity and bile acid concentration in the mother, is one of the most common liver disorders in pregnancy. It was proved that ICP might lead to fetal distress by triggering oxidative damage. Total bile acids (TBA) are an established marker for assessment of the severity of ICP. The aim of this study was to explore associations of TBA levels with levels of the oxidative stress markers 8-epimer of prostaglandin F2alpha (8-iso-PGF2α), superoxide dismutase (SOD) and glutathione peroxidase (Gpx) in ICP. Maternal plasma levels of 8-iso-PGF2α, SOD and Gpx were examined in ICP patients (n=40) and normal pregnancy controls (n=47) using an enzyme-linked immunosorbent assay (ELISA) analysis. Plasma levels of 8-iso-PGF2α and Gpx were significantly lower in ICP patients than in controls (p = 0.006 and 0.002, respectively), while no significant difference was observed in SOD levels between the two groups. Levels of 8-iso-PGF2α and TBA were negatively correlated (r = -0.277, p = 0.01, Spearman's correlation coefficient). The clinical severity of ICP is closely related to the degree of lipid peroxidation, and the natural antioxidant system might fail to work effectively in the presence of lipid peroxidation damage in ICP.

  5. Force-controlled balance perturbations associated with falls in older people: a prospective cohort study.

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    Daina L Sturnieks

    Full Text Available Balance recovery from an unpredictable postural perturbation can be a challenging task for many older people and poor recovery could contribute to their risk of falls. This study examined associations between responses to unpredictable perturbations and fall risk in older people. 242 older adults (80.0 ± 4.4 years underwent assessments of stepping responses to multi-directional force-controlled waist-pull perturbations. Participants returned monthly falls calendars for the subsequent 12 months. Future falls were associated with lower force thresholds for stepping in the posterior and lateral but not anterior directions. Those with lower posterior force thresholds for stepping were 68% more likely to fall at home than those with higher force thresholds for stepping. These results suggest that amount of force that can be withstood following an unpredictable balance perturbation predicts future falls in community-dwelling older adults. Perturbations in the posterior direction best discriminated between future fallers and non-fallers.

  6. CONTROLLED HYPOTENSIVE ANAESTHESIA WITH DEXMEDETOMIDINE FOR FUNCTIONAL ENDOSCOPIC SINUS SURGERY: A PROSPECTIVE RANDOMIZED DOUBLE BLIND STUDY

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    Sunil

    2014-08-01

    Full Text Available : OBJECTIVE: Controlled hypotension is commonly used to achieve a bloodless operative field which is needed for successful FESS. This study was carried out to assess the hypotensive effect of dexmedetomidine (DEX during FESS. METHODS: Fifty ASA grades I and II patients of either sex aged 20–50 years undergoing FESS were randomly divided into two groups of 25 each. Group D received 10–15 min prior to induction of anesthesia 1 μg/kg IV bolus DEX diluted in 10 ml of normal saline over 10 min. Immediately thereafter an infusion of 0.4 μg/kg/hr of DEX commenced. Group C received placebo bolus and infusion of saline at a rate similar to DEX in Group D. Standard anesthetic technique was used. The surgical field was assessed using Average Category Scale and average blood loss was calculated. Hemodynamic variables (MAP and HR; emergence time and total recovery from anesthesia (Aldrete score ≥9 were recorded. RESULT: Group D reached the desired MAP (55-65 mmHg. In group D patients the average MAP was 55.9±5.3 mm of Hg, where as in group C it was 86.2±11.4 mm of Hg. Patients in group D had a better surgical field, and the duration of surgery was significantly reduced(78.34±16.7mins in group D vs 103.2±113.1 mins in group C The mean awakening time was significantly reduced in patients of Group D (9.1±2.7 mins in group D vs12.8±2.2 mins in group C when compared to patients of Group C. CONCLUSION: This study demonstrated that dexmedetomidine is a safe agent for controlled hypotension and is effective in providing ideal surgical field during FESS.

  7. Molecular and epidemiological characterization of canine Pseudomonas otitis using a prospective case-control study design.

    Science.gov (United States)

    Morris, Daniel O; Davis, Meghan F; Palmeiro, Brian S; O'Shea, Kathleen; Rankin, Shelley C

    2017-02-01

    Pseudomonas aeruginosa is an opportunistic pathogen of the canine ear canal and occupies aquatic habitats in the environment. Nosocomial and zoonotic transmission of P. aeruginosa have been documented, including clonal outbreaks. The primary objective of this study was to assess various environmental exposures as potential risk factors for canine Pseudomonas otitis. It was hypothesized that isolates derived from infected ears would be clonal to isolates derived from household water sources and the mouths of human and animal companions of the study subjects. Seventy seven privately owned dogs with otitis were enrolled, along with their human and animal household companions, in a case-control design. Data on potential risk factors for Pseudomonas otitis were collected. Oral cavities of all study subjects, their human and animal companions, and household water sources were sampled. Pulsed field gel electrophoresis was used to estimate clonal relatedness of P. aeruginosa isolates. In a multivariate model, visiting a dog park was associated with 77% increased odds of case status (P = 0.048). Strains clonal to the infection isolates were obtained from subjects' mouths (n = 18), companion pets' mouths (n = 5), pet owners' mouths (n = 2), water bowls (n = 7) and water taps (n = 2). Clonally related P. aeruginosa isolates were obtained from dogs that had no clear epidemiological link. Genetic homology between otic and environmental isolates is consistent with a waterborne source for some dogs, and cross-contamination with other human and animal members within some households. © 2016 ESVD and ACVD.

  8. Microorganisms Associated With Pneumonia in Children Emerging Countries: The GABRIEL Pneumonia Multicenter, Prospective, Case-Control Study.

    Science.gov (United States)

    Bénet, Thomas; Sánchez Picot, Valentina; Messaoudi, Mélina; Chou, Monidarin; Eap, Tekchheng; Wang, Jianwei; Shen, Kunling; Pape, Jean-William; Rouzier, Vanessa; Awasthi, Shally; Pandey, Nitin; Bavdekar, Ashish; Sanghavi, Sonali; Robinson, Annick; Rakoto-Andrianarivelo, Mala; Sylla, Maryam; Diallo, Souleymane; Nymadawa, Pagbajabyn; Naranbat, Nymadawaagiin; Russomando, Graciela; Basualdo, Wilma; Komurian-Pradel, Florence; Endtz, Hubert; Vanhems, Philippe; Paranhos-Baccalà, Gláucia

    2017-06-12

    Pneumonia, the leading infectious cause of child mortality globally, mainly afflicts developing countries. This prospective observational study aimed to assess the microorganisms associated with pneumonia in children aged emerging countries. A multicenter, case-control study by the GABRIEL (Global Approach to Biological Research, Infectious diseases and Epidemics in Low-income countries) network was conducted between 2010 and 2014 in Cambodia, China, Haiti, India (2 sites), Madagascar, Mali, Mongolia, and Paraguay. Cases were hospitalized children with radiologically confirmed pneumonia; controls were children from the same setting without any features suggestive of pneumonia. Nasopharyngeal swabs were collected from all subjects; 19 viruses and 5 bacteria were identified by reverse-transcription polymerase chain reaction. Associations between microorganisms and pneumonia were quantified by calculating the adjusted population attributable fraction (aPAF) after multivariate logistic regression analysis adjusted for sex, age, time period, other pathogens, and site. Overall, 888 cases and 870 controls were analyzed; ≥1 microorganism was detected in respiratory samples in 93.0% of cases and 74.4% of controls (P emerging countries. Increasing S. pneumoniae vaccination coverage may substantially reduce the burden of pneumonia among children in developing countries.

  9. Ultrasound features of carpal tunnel syndrome: a prospective case-control study

    Energy Technology Data Exchange (ETDEWEB)

    Sernik, Renato A.; Abicalaf, Claudia A.; Cerri, Giovanni G. [University of Sao Paulo, Department of Radiology, Sao Paulo (Brazil); Pimentel, Benedito F. [University of Taubate, Department of Orthopedics, Sao Paulo (Brazil); Braga-Baiak, Andresa [University of Sao Paulo, Post Graduation Program, Department of Radiology, Sao Paulo (Brazil); Braga, Larissa [University of Nebraska Medical Center, Omaha, NE (United States)

    2008-01-15

    The purpose of the study was to examine the most adequate cut-off point for median nerve cross-sectional area and additional ultrasound features supporting the diagnosis of carpal tunnel syndrome (CTS). Forty wrists from 31 CTS patients and 63 wrists from 37 asymptomatic volunteers were evaluated by ultrasound. All patients were women. The mean age was 49.1 years (range: 29-78) in the symptomatic and 45.1 years (range 24-82) in the asymptomatic group. Median nerve cross-sectional area was obtained using direct (DT) and indirect (IT) techniques. Median nerve echogenicity, mobility, flexor retinaculum measurement and the anteroposterior (AP) carpal tunnel distance were assessed. This study was IRB-approved and all patients gave informed consent prior to examination. In CTS the median nerve cross-sectional area was increased compared with the control group. Median nerve cross-sectional area of 10 mm{sup 2} (DT) and 9 mm{sup 2} (IT) had high sensitivity (85% and 88.5%, respectively), specificity (92.1% and 82.5%) and accuracy (89.3% and 82.5%) in the diagnosis of CTS. CTS patients had an increased carpal tunnel AP diameter, flexor retinaculum thickening, reduced median nerve mobility and decreased median nerve echogenicity. Ultrasound assists in the diagnosis of CTS using the median nerve diameter cut-off point of 10 mm{sup 2} (DT) and 9 mm{sup 2} (IT) and several additional findings. (orig.)

  10. Hyperbaric oxygen therapy as salvage treatment for sudden sensorineural hearing loss: a prospective controlled study.

    Science.gov (United States)

    Pezzoli, M; Magnano, M; Maffi, L; Pezzoli, L; Marcato, P; Orione, M; Cupi, D; Bongioannini, G

    2015-07-01

    The most commonly used treatment for sensorineural sudden hearing loss (SSHL) in clinical practice is the administration of steroids; however, a favorable result is not always obtained. We studied 58 patients who failed to recover after primary treatment with IV steroids, 44 of these met our inclusion criteria (mean age 50.7, 27 males, range 30-74). We treated 23 patients (mean age 47.3, 16 males, age range 22-74) with hyperbaric oxygen therapy (HBO) (2.5 ATA for 60 min for 15 treatments), while 21 (mean age 54.5, 11 males, age range 22-71) patients refused to be treated and served as a non-randomized control group. Patients treated with HBO had a mean improvement of 15.6 dB (SD ± 15.3), with 1 of them completely healed, 5 with a good recovery, 10 with a fair recovery and 7 unchanged. Patients who were not treated had a spontaneous mean improvement of 5.0 dB (SD ± 11.4) with 3 patients with a good recovery, 1 patient with a fair recovery and 17 patients unchanged. Mean improvement was significantly better in patients treated with HBO compared to controls (p = 0.0133). Patients with worst hearing had the greater degree of improvement whether or not they were treated in the first 10 days after the onset of the hearing loss or between 11 and 30 days. In conclusion, hyperbaric oxygen therapy can lead to significant improvement of pure tone hearing thresholds in patients with SSHL who failed primary corticosteroid treatment and are within 4 weeks of the onset of deafness.

  11. Management of dental extraction in patients undergoing anticoagulant treatment. Results from a large, multicentre, prospective, case-control study.

    Science.gov (United States)

    Bacci, Christian; Maglione, Michele; Favero, Lorenzo; Perini, Alessandro; Di Lenarda, Roberto; Berengo, Mario; Zanon, Ezio

    2010-11-01

    Following favourable results from a previous study, a large, multicentre, prospective, case-control study was performed to further assess the incidence of bleeding complications after dental extraction in patients taking oral anticoagulant therapy (OAT). Four hundred fifty-one patients being treated with warfarin who required dental extraction were compared with a control group of 449 non-anticoagulated subjects undergoing the same procedure. In the warfarin-treated group, the oral anticoagulant regimen was maintained unchanged, such that the patients had an International Normalised Ratio ranging between 1.8 and 4, and local haemostatic measures (i.e. fibrin sponges, silk sutures and gauzes saturated with tranexamic acid) were adopted. All the procedures were performed in an outpatient setting. Seven bleeding complications occurred in the OAT group and four in the control group; the difference in the number of bleeding events between the two groups was not statistically significant (OR=1.754; 95% CI 0.510 - 6.034; p=0.3727). No post-operative late bleeds requiring hospitalisation and/or blood transfusions were recorded, and the adjunctive local haemostatic measures were adequate to stop the bleeding. The results of our protocol applied in this large, multicenter study show that dental extractions can be performed easily and safely in anticoagulated outpatients without any modification of the ongoing anticoagulant therapy, thus minimising costs and reducing discomfort for patients.

  12. Efficacy of low dose gabapentin in acute herpes zoster for preventing postherpetic neuralgia: a prospective controlled study.

    Science.gov (United States)

    Lee, Eo G; Lee, Hee J; Hyun, Dong J; Min, Kyunghoon; Kim, Dong H; Yoon, Moon S

    2016-05-01

    Postherpetic neuralgia (PHN) is a sequela of herpes zoster that adversely affects quality of life seriously. The risk factors for PHN are well known but the effective interventions that reduce the incidence of PHN are less studied. The objective of this study is to evaluate the efficacy of treatment with gabapentin in patients with acute herpes zoster for preventing PHN. We performed a prospective randomized controlled study of 120 participants diagnosed with acute herpes zoster, aged 50 and over and complaining moderate to severe pain. All patients were treated with valacyclovir and acetaminophen. Half of the participants were assigned to the gabapentin group and received gabapentin 300 mg three times a day additionally. The intensity of pain at every visit and the incidence of PHN in both groups were measured. Total 52 and 49 patients in the gabapentin group and the control group, respectively, had completed 12 weeks of follow-up period. Although the incidence of PHN was higher in the control group, the difference was not statistically significant (6.1% vs. 3.8%, p = 0.67). Our results indicate that the use of low-dose gabapentin in acute herpes zoster seems not effective in the prevention of PHN.

  13. Association of low levels of vitamin D with chronic stable angina: A prospective case-control study

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    Ab Hameed Raina

    2016-01-01

    Full Text Available Background: Coronary artery disease (CAD is a major cause of death and disability in developed countries. Chronic stable angina is the initial manifestation of CAD in approximately 50% of the patients. Recent evidence suggests that vitamin D is crucial for cardiovascular health. The prevalence of vitamin D deficiency in our region is 83%. A low level of vitamin D is associated with chronic stable angina. Aim: This study was aimed at supporting or refuting this hypothesis in our population. Materials and Methods: The study was a prospective case-control study. We studied 100 cases of chronic stable angina and compared them with 100 matched controls. Vitamin D deficiency was defined as <20 ng/mL, vitamin D insufficiency as 20-30 ng/mL and normal vitamin D level as 31-150 ng/mL. Results: The prevalence of vitamin D deficiency among cases and controls was 75% and 10%, respectively. 75% of the cases were vitamin D-deficient (<20 ng/mL; 12% were vitamin D-insufficient (20-30 ng/mL, and 13% had normal vitamin D levels (31-150 ng/mL. None had a toxic level of vitamin D. Among the controls, 10% were vitamin D-deficient, 33% were vitamin D-insufficient, and 57% had normal vitamin D levels. The mean vitamin level among cases and controls was 15.53 ng/mL and 40.95 ng/mL, respectively, with the difference being statistically significant (P ≤ 0.0001. There was no statistically significant relation between the disease severities, i.e., on coronary angiography (CAG with vitamin D level. Among the cases, we found that an increasing age was inversely related to vitamin D levels (P = 0.027. Conclusion: Our study indicates a correlation between vitamin D deficiency and chronic stable angina. Low levels may be an independent, potentially modifiable cardiovascular risk factor.

  14. SPINAL ANAESTHESIA VERSUS GENERAL ANAESTHESIA FOR LAPAROSCOPIC CHOLECYSTECTOMY - A PROSPECTIVE RANDOMIZED CONTROLLED STUDY

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    Prasad

    2014-02-01

    Full Text Available INTRODUCTION: Combining minimal invasive surgical and lesser invasive anesthesia technique reduces morbidity and mortality. The aim of the study is to compare spinal anesthesia with the gold standard general anesthesia for elective laparoscopic cholecystectomy. MATERIALS & METHODS: 60 healthy patients were randomized under spinal anesthesia (n=30 & General Anesthesia (n=30 . Hyperbaric 3ml bupivacaine plus 25mcg fenta nyl was administered for spinal group and conventional general anesthesia for GA group. Intraoperative parameters and post - operative pain and recovery were noted. Under spinal group any intraoperative discomfort were taken care by reassurance , drugs or con verted to GA. Questionnaire forms were provided for patients and surgeons to comment about the operation. RESULTS: None of the patients had significant hemodynamic and respiratory disturbance except for transient hypotension and bradycardia. Operative time was comparable. 6patients under spinal anesthesia had right shoulder pain , 2 patients were converted to GA and 4 patients were managed by injection midazolam and infiltration of lignocaine over the diaphragm. There was significant post - operative pain reli ef in spinal group. All the patients were comfortable and surgeons satisfied. CONCLUSION: Spinal anesthesia is adequate and safe for laparoscopic cholecystectomy in otherwise healthy patients and offers better postoperative pain control than general anesth esia without limiting recovery , but require cooperative patient , skilled surgeon , a gentle surgical technique and an enthusiastic anesthesiologist

  15. Effectiveness of intermittent diazepam prophylaxis in febrile seizures: long-term prospective controlled study.

    Science.gov (United States)

    Pavlidou, Efterpi; Tzitiridou, Maria; Panteliadis, Christos

    2006-12-01

    The efficacy of intermittent rectal diazepam prophylaxis is assessed in the prevention of febrile seizures. In a prospective randomized cohort trial, 139 children (77 girls, 62 boys) who experienced a first febrile seizure were allocated to two groups: group A, which received intermittent diazepam (n = 68), and group B, which received no prophylaxis (n = 71). All children had a 3-year follow-up. The inclusion criteria were no personal history of afebrile seizures, normal neurodevelopment, no previous anticonvulsant therapy, and age between 6 months and 3 years. Each group was stratified to low, intermediate, and high risk according to the available clinical data. The 36-month recurrence rates in the no-prophylaxis group were 83% in high-risk patients, 55% in intermediate-risk patients, and 46% in low-risk patients. In the prophylaxis group, the recurrence rates were reduced in all risk groups: 38%, 35%, and 33%, respectively. Intermittent diazepam prophylaxis reduces the recurrence rate mainly in high-risk children provided that sufficient doses are given on time and adequately.

  16. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    Science.gov (United States)

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  17. Risk Factors for Sporadic Domestically Acquired Campylobacter Infections in Norway 2010-2011: A National Prospective Case-Control Study.

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    Emily MacDonald

    Full Text Available Campylobacteriosis is the most frequently reported food- and waterborne infection in Norway. We investigated the risk factors for sporadic Campylobacter infections in Norway in order to identify areas where control and prevention measures could be improved.A national prospective case-control study of factors associated with Campylobacter infection was conducted from July 2010 to September 2011. Cases were recruited from the Norwegian Surveillance System of Communicable Diseases (MSIS. Controls were randomly selected from the Norwegian Population Registry. Cases and controls were mailed a paper questionnaire with a prepaid return envelope. Univariable analyses using logistic regression were conducted for all exposures. A final parsimonious multivariable model was developed using regularized/penalized logistic regression, and adjusted odds ratios were calculated.A total of 995 cases and 1501 controls were included in the study (response proportion 55% and 30%, respectively. Exposures that had significant increases in odds of Campylobacter infection in multivariable analysis were drinking water directly from river, stream, or lake (OR: 2.96, drinking purchased bottled water (OR: 1.78, eating chicken (1.69, eating meat that was undercooked (OR: 1.77, eating food made on a barbecue (OR: 1.55, living on a farm with livestock (OR: 1.74, having a dog in the household (OR: 1.39, and having household water supply serving fewer than 20 houses (OR: 1.92.Consumption of poultry and untreated water remain important sources of Campylobacter infection in Norway, despite ongoing control efforts. The results justify the need for strengthening education for consumers and food handlers about the risks of cross-contamination when preparing poultry and with consuming raw or undercooked chicken. The public should also be reminded to take precautions when drinking untreated water in nature and ensure continued vigilance in order to protect and maintain the quality of

  18. EFFICACY OF TRANEXAMIC ACID IN DECREASING BLOOD LOSS DURING AND AFTER CAESAREAN SECTION: A RANDOMIZED CASE CONTROL PROSPECTIVE STUDY

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    Tullika

    2014-03-01

    Full Text Available : INTRODUCTION: To reduce maternal mortality and morbidity caused by bleeding, it is important to reduce the amount of bleeding during and after lower segment caesarean section (LSCS. Tranexamic acid helps to reduce bleeding during and after LSCS. OBJECTIVES: To study the efficacy and safety of Tranexamic acid in reducing blood loss during and after Lower segment Caesarean Section (LSCS. METHODS: A randomized case controlled prospective study was conducted on 200 women undergoing lower segment cesarean section. Hundreds of them that were given tranexamic acid immediately before LSCS were compared to hundred others to whom tranexamic acid was not given. Blood loss was collected and measured during the two periods, from plancental delivery to end of LSCS and second from end of LSCS to two hours postpartum. RESULTS: Tranexamic acid significantly reduced the quantity of blood loss from placental delivery to end of LSCS, 202.25ml in the study group vs392.20 ml in the control group (p<0.001; from the end of LSCS, to 2 hours postpartum 3.80ml in the study group versus 112.25ml in the control group (p<0.001; In totality, it significantly reduced the quantity of blood loss from placental delivery to two hours postpartum i.e. 27.05ml in the study group versus 510.45ml in the control group (p < 0.001. No complications or side effects were noted. CONCLUSION: Tranexamic acid significantly reduced the amount of blood loss during and after LSCS. Tranexamic acid can be used prophylactically; moreover it is safer and effective in women undergoing LSCS.

  19. Circulating C-Reactive Protein Concentrations and Risks of Colon and Rectal Cancer : A Nested Case-Control Study Within the European Prospective Investigation into Cancer and Nutrition

    NARCIS (Netherlands)

    Aleksandrova, Krasimira; Jenab, Mazda; Boeing, Heiner; Jansen, Eugene; Bueno-de-Mesquita, H. Bas; Rinaldi, Sabina; Riboli, Elio; Overvad, Kim; Dahm, Christina C.; Olsen, Anja; Tjonneland, Anne; Boutron-Ruault, Marie-Christine; Clavel-Chapelon, Francoise; Morois, Sophie; Palli, Domenico; Krogh, Vittorio; Tumino, Rosario; Vineis, Paolo; Panico, Salvatore; Kaaks, Rudolf; Rohrmann, Sabine; Trichopoulou, Antonia; Lagiou, Pagona; Trichopoulos, Dimitrios; van Duijnhoven, Fraenzel J. B.; Leufkens, Anke M.; Peeters, Petra H.; Rodriguez, Laudina; Bonet, Catalina; Sanchez, Maria-Jose; Dorronsoro, Miren; Navarro, Carmen; Barricarte, Aurelio; Palmqvist, Richard; Hallmans, Goran; Khaw, Kay-Tee; Wareham, Nicholas; Allen, Naomi E.; Spencer, Elizabeth; Romaguera, Dora; Norat, Teresa; Pischon, Tobias

    2010-01-01

    The authors investigated associations between serum C-reactive protein (CRP) concentrations and colon and rectal cancer risk in a nested case-control study within the European Prospective Investigation into Cancer and Nutrition (1992-2003) among 1,096 incident cases and 1,096 controls selected using

  20. Factors influencing asthma control: results of a real-life prospective observational asthma inhaler treatment (ASIT study

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    Yıldız

    2013-07-01

    Full Text Available Füsun Yildiz, On behalf of the ASIT Study Group Department of Pulmonary Disease, Kocaeli University School of Medicine, Kocaeli, Turkey Background: Despite the availability of new pharmacological options and novel combinations of existing drug therapies, the rate of suboptimal asthma control is still high. Therefore, early identification of the clinical and behavioral factors responsible for poor asthma control, and interventions during routine outpatient visits to improve asthma trigger management, are strongly recommended. This study was designed to evaluate the profiles of asthmatic patients and their inhaler treatment devices in relation to asthma control in Turkey. Methods: A total of 572 patients with persistent asthma (mean [standard deviation] age: 42.7 [12.1] years; 76% female were included in this prospective observational study. A baseline visit (0 month, visit 1 and three follow-up visits (1, 3 and 6 months after enrolment were conducted to collect data on demographics, past medical and asthma history, and inhaler device use. Results: Asthma control was identified in 61.5% of patients at visit 1 and increased to 87.3% at visit 4 (P < 0.001, regardless of sociodemographics, asthma duration, body mass index or smoking status. The presence of asthma-related comorbidity had a significantly negative effect on asthma control (P = 0.004. A significant decrease was determined, in the rate of uncontrolled asthma, upon follow-up among patients who were using a variety of fixed dose combination inhalers (P < 0.001 for each. Logistic regression analysis was used to show that the presence of asthma-related comorbidity (odds ratio [OR], 0.602; 95% confidence interval [CI], 0.419; 0.863, P = 0.006 and active smoking (OR, 0.522; 95% CI, 0.330; 0.825, P = 0.005 were significant predictors of asthma control. Conclusion: Our findings indicate that, despite ongoing treatment, asthma control rate was 61.5% at visit 1 in adult outpatients with persistent

  1. Betulin-Based Oleogel to Improve Wound Healing in Dystrophic Epidermolysis Bullosa: A Prospective Controlled Proof-of-Concept Study

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    Agnes Schwieger-Briel

    2017-01-01

    Full Text Available Introduction. Skin fragility and recurrent wounds are hallmarks of hereditary epidermolysis bullosa (EB. Treatment options to accelerate wound healing are urgently needed. Oleogel-S10 contains a betulin-rich triterpene extract from birch bark. In this study, we tested the wound healing properties of topical Oleogel-S10 in patients with dystrophic EB. Methods. We conducted an open, blindly evaluated, controlled, prospective phase II pilot trial in patients with dystrophic EB (EudraCT number 2010-019945-24. Healing of wounds treated with and without topical Oleogel-S10 was compared. Primary efficacy variable was faster reepithelialization as determined by 2 blinded experts. The main secondary outcome variable of the study was percentage of wound epithelialization. Results. Twelve wound pairs of 10 patients with dystrophic EB were evaluated. In 5 of 12 cases, both blinded reviewers considered epithelialization of the intervention wounds as superior. In 3 cases, only one reviewer considered Oleogel-S10 as superior and the other one as equal to control. Measurements of wound size showed a trend towards accelerated wound healing with the intervention but without reaching statistical significance. Conclusion. Our results indicate a potential for faster reepithelialization of wounds in patients with dystrophic EB when treated with Oleogel-S10 but larger studies are needed to confirm significance.

  2. Reducing radiation exposure during kyphoplasty with the use of a remote control injection system: a prospective study.

    Science.gov (United States)

    Wang, Jianru; Liu, Hui; Zhang, Kuibo; Li, Bingxue; Yang, Hao; Wang, Hua; Zheng, Zhaomin

    2015-01-15

    A prospective study. To compare surgeons' radiation exposure during kyphoplasty with and without the use of a remote control injection system. Distance from radiation sources is a critical factor for reducing radiation exposure during spine surgery. A newly designed device was used to minimize operators' radiation exposure during kyphoplasty. Forty-four patients admitted for single-level osteoporotic vertebral compression fracture were randomly divided into 2 groups (groups A and B) and treated with kyphoplasty. The remote control injection system was used only in group B. The radiation doses to the surgeon's eyes, thyroid, chest, and right wrist were recorded with 4 unprotected radiometers simultaneously. Operation time, fluoroscopic time, cement amount, patient-reported pre- and postoperative visual analogue scale scores for pain, and complications were recorded. For group A, the radiation doses at the eyes, thyroid, and right wrist were 1.132 ± 0.104 mSv, 0.647 ± 0.049 mSv, 0.578 ± 0.056 mSv, and 1.877 ± 0.214 mSv, respectively; for Group B, these doses were 0.257 ± 0.067 mSv, 0.201 ± 0.049 mSv, 0.145 ± 0.033 mSv, and 0.353 ± 0.046 mSv, respectively (P remote control injection system can significantly reduce surgeons' radiation exposure without affecting the efficiency of procedures.

  3. Risk of Coronary Heart Disease in Men With Poor Emotional Control : A Prospective Study

    NARCIS (Netherlands)

    Potijk, Marieke R.; Janszky, Imre; Reijneveld, Sijmen A.; Falkstedt, Daniel

    2016-01-01

    Objective Many psychosocial factors have been associated with coronary heart disease (CHD), including hostility, anger, and depression. We tested the hypothesis that these factors may have their basis in emotion regulation abilities. Our aim was to determine whether poor emotional control predicted

  4. Risk of Coronary Heart Disease in Men With Poor Emotional Control : A Prospective Study

    NARCIS (Netherlands)

    Potijk, Marieke R.; Janszky, Imre; Reijneveld, Sijmen A.; Falkstedt, Daniel

    Objective Many psychosocial factors have been associated with coronary heart disease (CHD), including hostility, anger, and depression. We tested the hypothesis that these factors may have their basis in emotion regulation abilities. Our aim was to determine whether poor emotional control predicted

  5. Association of severe intrahepatic cholestasis of pregnancy with adverse pregnancy outcomes: a prospective population-based case-control study.

    Science.gov (United States)

    Geenes, Victoria; Chappell, Lucy C; Seed, Paul T; Steer, Philip J; Knight, Marian; Williamson, Catherine

    2014-04-01

    Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy-specific liver disease, characterized by maternal pruritus and raised serum bile acids. Our objectives were to describe the epidemiology and pregnancy complications associated with severe ICP and to test the hypothesis that adverse perinatal outcomes are increased in these women. A prospective population-based case-control study with national coverage was undertaken using the UK Obstetric Surveillance System (UKOSS). Control data for comparison were obtained from women with healthy pregnancy outcome through UKOSS (n = 2,232), St Mary's Maternity Information System (n = 554,319), and Office for National Statistics (n = 668,195). The main outcome measures investigated were preterm delivery, stillbirth, and neonatal unit admission. In all, 713 confirmed cases of severe ICP were identified, giving an estimated incidence of 9.2 per 10,000 maternities. Women with severe ICP and a singleton pregnancy (n = 669) had increased risks of preterm delivery (164/664; 25% versus 144/2200; 6.5%; adjusted odds ratio [OR] 5.39, 95% confidence interval [CI] 4.17 to 6.98), neonatal unit admission (80/654; 12% versus 123/2192; 5.6%; adjusted OR 2.68, 95% CI 1.97 to 3.65), and stillbirth (10/664; 1.5% versus 11/2205; 0.5%; adjusted OR 2.58, 95% CI 1.03 to 6.49) compared to controls. Seven of 10 stillbirths in ICP cases were associated with coexisting pregnancy complications. These differences remained significant against national data. Risks of preterm delivery, meconium-stained amniotic fluid, and stillbirth rose with increasing maternal serum bile acid concentrations. In the largest prospective cohort study in severe ICP to date, we demonstrate significant increased risks of adverse perinatal outcomes, including stillbirth. Our findings support the case for close antenatal monitoring of pregnancies affected by severe ICP. © 2014 The Authors. Hepatology published by Wiley on behalf of the American Association for the Study of

  6. Factors associated with Clostridium difficile infection: A nested case-control study in a three year prospective cohort.

    Science.gov (United States)

    Khanafer, Nagham; Vanhems, Philippe; Barbut, Frédéric; Luxemburger, Christine

    2017-04-01

    Clostridium difficile infection (CDI) is a serious medical condition that is associated with substantial morbidity and mortality. Identification of risk factors associated with CDI and prompt recognition of patients at risk is key to successfully preventing CDI. A 3-year prospective, observational, cohort study was conducted in a French university hospital and a nested case-control study was performed to identify risk factors for CDI. Inpatients aged 18 years or older, suffering from diarrhea suspected to be related to CDI, were asked to participate. A total of 945 patients were included, of which 233 cases had a confirmed CDI. CDI infection was more common in men (58.4%) (P = 0.04) compared with patients with diarrhea not related to C. difficile. Previous hospitalization (P predictors of CDI. Patients at high risk of acquiring CDI at the time of admission may benefit from careful monitoring of antibiotic prescriptions and early attention to infection control issues. In future, these "high-risk" patients may benefit from novel agents being developed to prevent CDI. Copyright © 2017 Elsevier Ltd. All rights reserved.

  7. Improving oral presentation skills with a clinical reasoning curriculum: a prospective controlled study.

    Science.gov (United States)

    Wiese, Jeff; Varosy, Paul; Tierney, Lawrence

    2002-02-15

    The oral case presentation is an essential part of clinical medicine, but teaching medical students to present clinical data remains difficult. Presentation skills depend on the ability to obtain, process, and organize patient data. Clinical reasoning is fundamental to the development of these skills. We compared a clinical reasoning curriculum with standard ward instruction for improving presentation skills and clinical performance. Between October 1998 and May 1999, 62 third-year medical students at three hospitals were assigned to a 4-week clinical reasoning curriculum (n = 27) or a control group (n = 35) that underwent routine instruction. The curriculum consisted of four 1-hour group sessions and 1 hour of individual videotaped instruction, and taught students to use the principles of clinical reasoning, such as generation and refinement of diagnostic hypothesis, interpretation of diagnostic tests, and causal reasoning, to determine data for inclusion in the oral presentation. We videotaped students presenting two standardized case histories; one at baseline and a second 4 weeks later. Two independent evaluators who were blinded to the group assignments reviewed the videotapes and scored them for presentation quality and efficiency, and general speaking ability. Mean (+/- SD) presentation times at baseline were similar in the two groups (intervention group: 8 +/- 2 minutes; control group: 8 +/- 2 minutes; P = 0.74). Presentation time in students who were taught clinical reasoning decreased by 3 +/- 2 minutes, but increased by 2 +/- 2 minutes in control students. The difference in the changes between the groups was statistically significant (mean difference = 4 minutes; 95% confidence interval [CI]: 3 to 5 minutes; P Presentation quality scores at baseline were similar in both groups (intervention group: 17 +/- 8 points; control group: 20 +/- 7 points; P = 0.11). Students who were taught the clinical reasoning curriculum had an improvement of 9 +/- 6 points in

  8. The Sforzesco brace can replace cast in the correction of adolescent idiopathic scoliosis: A controlled prospective cohort study

    Directory of Open Access Journals (Sweden)

    Zaina Fabio

    2008-10-01

    Full Text Available Abstract Background The conservative treatment of adolescent idiopathic scoliosis (AIS has traditionally been divided into two phases–correction and stabilisation–and casts, even if less used today, can be considered the best standard in the correction phase. Till the present, however, no comparison between cast and brace efficacy has been proposed. Methods This is a prospective cohort study with a retrospective control group. The aim was to verify if it is possible to obtain with a specifically developed rigid brace results comparable to a cast. We considered fifty AIS patients who had refused surgery, aged 14.1 ± 1.5 years, with 46.7 ± 7.8° Cobb scoliosis. Thirty-two consecutive patients (with no drop-outs were prospectively followed up with the Sforzesco brace (SBG, and compared against a retrospective group of eighteen patients treated with the Risser cast (RCG. The treatment time (the total correction phase was 19 ± 3 months. Out-of-brace x-rays were compared, as well as clinical results. Results Compliance and hours of treatment were higher in the RCG while all the other parameters were not different. We observed a reduction of 6° Cobb and an important aesthetic gain in both groups (P Conclusion In the corrective phase of AIS treatment it is possible with a specific rigid brace (Sforzesco – SPoRT concept to obtain scoliosis correction similar to cast. Due to the human and social costs of casting, and worst sagittal profile results, Sforzesco brace should be the preferred method wherever possible.

  9. [A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

    Science.gov (United States)

    Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

    2017-05-22

    Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg(-1), Group C getting clonidine 1mcg.kg(-1) and Group D patients receiving dexmedetomidine 0.5mcg.kg(-1). The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  10. Histologic Evidence of New Collagen Formulation Using Platelet Rich Plasma in Skin Rejuvenation: A Prospective Controlled Clinical Study

    Science.gov (United States)

    Abuaf, Ozlem Karabudak; Baloglu, Hüseyin; Bilgili, Memet Ersan; Simsek, Hasan Aktug; Dogan, Bilal

    2016-01-01

    Background Platelet-rich plasma (PRP) is an autologous concentration of human platelets contained in a small volume of plasma and has recently been shown to accelerate rejuvenate aging skin by various growth factors and cell adhesion molecules. Objective This study was conducted to evaluate the efficacy and safety of intradermal injection of PRP in the human facial rejuvenation. Methods This study was a prospective, single-center, single-dose, open-label, non-randomized controlled clinical study. PRP injected to the upper site of this right infra-auricular area and all face. Saline was injected to the left infra-auricular area. Histopathological examinations were performed before PRP treatment, 28 days after the PRP, and saline (control) treatments. Results Twenty women ranging in age from 40 to 49 years (mean age, 43.65±2.43 years) were enrolled in the study. The mean optical densities (MODs) of collagen in the pre-treatment, control, and PRP-treated area were measured. They were 539±93.2, 787±134.15, 1,019±178, respectively. In the MOD of PRP, 89.05 percent improvement was found when MOD of PRP was compared with MOD of pre-treatment. The mean MOD of collagen fibers was clearly highest on the PRP side (p<0.001). The PRP-to-saline improvement ratio (89.05% to 46.01%) was 1.93:1. No serious side effects were detected. Conclusion PRP increases dermal collagen levels not only by growth factors, but also by skin needling (the mesotherapy technique 'point by point'). PRP application could be considered as an effective (even a single application) and safety procedure for facial skin rejuvenation. PMID:27904271

  11. Skin-impedance in Fabry Disease: A prospective, controlled, non-randomized clinical study

    Directory of Open Access Journals (Sweden)

    Lidicker Jeffrey R

    2008-11-01

    Full Text Available Abstract Background We previously demonstrated improved sweating after enzyme replacement therapy (ERT in Fabry disease using the thermo-regularity sweat and quantitative sudomotor axon reflex tests. Skin-impedance, a measure skin-moisture (sweating, has been used in the clinical evaluation of burns and pressure ulcers using the portable dynamic dermal impedance monitor (DDIM system. Methods We compared skin impedance measurements in hemizygous patients with Fabry disease (22 post 3-years of bi-weekly ERT and 5 ERT naive and 22 healthy controls. Force compensated skin-moisture values were used for statistical analysis. Outcome measures included 1 moisture reading of the 100th repetitive reading, 2 rate of change, 3 average of 60–110th reading and 4 overall average of all readings. Results All outcome measures showed a significant difference in skin-moisture between Fabry patients and control subjects (p Conclusion The instrument portability, ease of its use, a relatively short time required for the assessment, and the fact that DDIM system was able to detect the difference in skin-moisture renders the instrument a useful clinical tool.

  12. Acute effects of remote ischemic preconditioning on cutaneous microcirculation - a controlled prospective cohort study

    OpenAIRE

    Kraemer Robert; Lorenzen Johan; Kabbani Mohammad; Herold Christian; Busche Marc; Vogt Peter M; Knobloch Karsten

    2011-01-01

    Abstract Background Therapeutic strategies aiming to reduce ischemia/reperfusion injury by conditioning tissue tolerance against ischemia appear attractive not only from a scientific perspective, but also in clinics. Although previous studies indicate that remote ischemic intermittent preconditioning (RIPC) is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action especially in the clinical setting. Therefore, the aim of this study is to evaluate...

  13. Helicobacter pylori infection amongst Arab Israeli women with hyperemesis gravidarum—a prospective, controlled study

    Directory of Open Access Journals (Sweden)

    Doron Boltin

    2014-12-01

    Conclusion: H. pylori does not seem to increase the likelihood of hyperemesis gravidarum in Arab Israeli women. However, given the high background prevalence of H. pylori in this population, a larger study is required to corroborate these findings. (MOH20110066

  14. Male condom use, multiple sexual partners and HIV: a prospective case-control study in Kinshasa (DRC).

    Science.gov (United States)

    Carlos, Silvia; Lopez-Del Burgo, Cristina; Burgueño, Eduardo; Martinez-Gonzalez, Miguel Angel; Osorio, Alfonso; Ndarabu, Adolphe; Passabosc, Clément; de Irala, Jokin

    2016-11-16

    In the Democratic Republic of Congo no previous studies have assessed the factors associated with different patterns of condom use and with multiple sexual partners, and the association between condom use simultaneously taking into account multiple sexual partnerships, and HIV infection. We carried out a prospective case-control study. From December 2010 until June 2012, 1630 participants aged 15-49 getting HIV Voluntary Counseling and Testing in a hospital in Kinshasa were selected. Cases were new HIV diagnosis and controls were HIV-negative participants detected along the study period. We recruited 274 cases and 1340 controls that were interviewed about HIV-related knowledge, attitudes and behaviours. Among cases there was a high prevalence of multiple lifetime and concurrent sexual partnerships (89.8% and 20.4%, respectively) and most cases never used condoms with only 1.5% using them consistently. Condom use and multiple partnerships were associated with male, single and high-educated participants. An association was found between multiple lifetime partners and 'any condom use' (OR = 2.99; 95%CI: 2.14-4.19) but not with consistent use. Both having two or more multiple concurrent sexual partners or not using condoms were variables similarly and highly associated to HIV risk. The association found between having two or more concurrent sexual partners and HIV was slightly higher (OR = 3.58, 95%CI:2.31-5.56) than the association found between never condom use and HIV (OR = 3.38, 95%CI:1.15-9.93). We found a high prevalence of multiple lifetime sexual partners and an extremely high prevalence of inconsistent condom use, both strongly associated with HIV seropositivity. Local programmes would benefit from comprehensive interventions targeting all behavioural and sociocultural determinants.

  15. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Institute of Scientific and Technical Information of China (English)

    Yu Zhang; Hao-Ping Zhu; Jian-Xia Fan; Hong Yu; Li-Zhou Sun; Lian Chen; Qing Chang

    2015-01-01

    Background:In China,no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now.This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women.Methods:This was a double-blinded,prospective randomized controlled study including nulliparous women from 6 university hospitals across China.Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2.Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction.Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h.Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes.Results:A total of 173 women for misoprostol group and 49 women for placebo were analyzed.The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs.22.5%,relative risk [RR]:2.9,95% confidence interval [CI]:1.4-6.0).The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs.18.4%,RR:2.6,95% CI:1.2-5.7);and the induction-onset of labor interval was significantly shorter in the misoprostol group (P =0.0003).However,there were no significant differences in the median process time of vaginal labor (6.4 vs.6.8 h;P =0.695),incidence (39.3% vs.49.0%,RR:0.8,95% CI:0.4-1.5) and indications (P =0.683) of cesarean section deliveries,and frequencies of maternal,fetal/neonatal adverse events between the groups.Conclusion:Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

  16. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    Science.gov (United States)

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  17. Dietary Vitamin K intake and anticoagulation control during the initiation phase of warfarin therapy: A prospective cohort study

    Science.gov (United States)

    The effect of varying levels of dietary vitamin K intake on therapeutic International Normalized Ratio (INR) values among patients starting warfarin therapy has not been well studied. We performed a prospective cohort study among 282 patients to explore the independent associations between usual in...

  18. Plasma 25(OH)vitamin D and the risk of breast cancer in the european prospective investigation into cancer and nutrition (EPIC): A nested case-control study

    NARCIS (Netherlands)

    Kühn, T.; Kaaks, R.; Becker, S.; Eomois, P.P.; Clavel-Chapelon, F.; Kvaskoff, M.; Dossus, L.; Duijnhoven, van F.J.B.

    2013-01-01

    Experimental evidence suggests that vitamin D might play a role in the development of breast cancer. Although the results of case–control studies indicate that circulating 25-hydroxyvitamin D [25(OH)D] is inversely associated with the risk of breast cancer, the results of prospective studies are

  19. Oxidative stress influence on renal dysfunction in patients with obstructive jaundice: A case and control prospective study

    Directory of Open Access Journals (Sweden)

    David Martínez-Cecilia

    2016-08-01

    Full Text Available Background: Obstructive Jaundice (OJ is associated with a significant risk of developing acute renal failure (ARF. The involvement of oxidative stress in the development of cholestasis has been demonstrated in different experimental models. However, its role in the morbidity of human cholestasis is far to be elucidated. The aim of the study was the evaluation of oxidative stress markers in blood from patients with OJ and its relation to complications and benign/malignant evolution of cholestasis. Methods: A prospective cross-sectional study of 105 patients with OJ and 34 control subjects were included. Several markers of liver function and oxidative stress, such as lipoperoxides (LPO, as well as reduced glutathione (GSH, catalase (CAT, superoxide dismutase (SOD and glutathione peroxidase (GSH-Px activities were assessed. Results: The patients with OJ showed a marked increase in plasma levels of LPO, SOD and GSH, while GSH-Px levels were decreased. The increase in lipid peroxidation products and the depletion of SOD activity in blood were also related to renal dysfunction. The highest level of LPO was associated with malignant etiology of the disease. The logistic regression analysis showed that the age of the patient and the levels of LPO in blood were predictors of renal dysfunction in OJ patients. Conclusions: This study demonstrates a correlation between oxidative stress and renal dysfunction patients with OJ.

  20. Possible role of apoptosis in pathogenesis of adenoid hypertrophy and chronic adenoiditis: Prospective case-control study.

    Science.gov (United States)

    Önal, Merih; Yılmaz, Taner; Bilgiç, Elif; Müftüoğlu, Sevda; Sözen, Tevfik; Bajin, Münir Demir

    2015-12-01

    Apoptosis is a programmed cell death; it provides an important balance between lymphocytes in adenoid tissue. The aim of this study is to investigate the role of apoptosis in chronic adenoiditis and adenoid hypertrophy. This is the first study in the literature about apoptosis in adenoid hypertrophy and chronic adenoiditis. Prospective case-control study in a tertiary referral university hospital was conducted. 46 patients who had chronic adenoiditis and adenoid hypertrophy underwent adenoidectomy. Adenoids were evaluated for apoptosis and assembled into groups according to their size. Apoptotic cells were counted in three different microscopic fields and their average was taken for every microcompartment. As a result of immunohistochemical staining, specimens were compared for their apoptotic cell rate. The difference in apoptosis of chronic adenoiditis and adenoid hypertrophy groups is statistically significant (phypertrophy groups revealed significant differences for intrafollicular and intraepithelial areas, and insignificant differences for interfollicular and subepithelial areas. Although apoptosis could not totally explain the pathogenesis of chronic adenoiditis and adenoid hypertrophy, it appeared to play an important role in it. Apoptosis functions to limit adenoid hypertrophy. Adenoid apoptosis appears to be age-dependent. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  1. Controlled Prospective Longitudinal Study of Women with Cancer: I. Sexual Functioning Outcomes.

    Science.gov (United States)

    Andersen, Barbara L.; And Others

    1989-01-01

    Studied 47 women treated for early gynecologic cancer, 18 women treated for benign gynecologic disease, and 57 gynecologically healthy women. Found that frequency of intercourse declined for women treated for disease, whether malignant or benign. Diminution of sexual excitement was pronounced for women with disease; more severe and distressing for…

  2. Obesity, inflammatory markers, and endometrial cancer risk : a prospective case-control study

    NARCIS (Netherlands)

    Dossus, Laure; Rinaldi, Sabina; Becker, Susen; Lukanova, Annekatrin; Tjonneland, Anne; Olsen, Anja; Stegger, Jakob; Overvad, Kim; Chabbert-Buffet, Nathalie; Jimenez-Corona, Aida; Clavel-Chapelon, Francoise; Rohrmann, Sabine; Teucher, Birgit; Boeing, Heiner; Schuetze, Madlen; Trichopoulou, Antonia; Benetou, Vassiliki; Lagiou, Pagona; Palli, Domenico; Berrino, Franco; Panico, Salvatore; Tumino, Rosario; Sacerdote, Carlotta; Redondo, Maria-Luisa; Travier, Noemie; Sanchez, Maria-Jose; Altzibar, Jone M.; Chirlaque, Maria-Dolores; Ardanaz, Eva; Bueno-de-Mesquita, H. Bas; van Duijnhoven, Franzel J. B.; Onland-Moret, N. Charlotte; Peeters, Petra H. M.; Hallmans, Goran; Lundin, Eva; Khaw, Kay-Tee; Wareham, Nicholas; Allen, Naomi; Key, Tim J.; Slimani, Nadia; Hainaut, Pierre; Romaguera, Dora; Norat, Teresa; Riboli, Elio; Kaaks, Rudolf

    2010-01-01

    Obesity, a major risk factor for endometrial cancer, is a low-grade inflammatory state characterized by elevated concentrations of cytokines and acute phase reactants. The current study had two aims: first to investigate the associations of C-reactive protein (CRP), interleukin 6 (IL6), and IL1 rece

  3. The risk behaviors and mental health of detained adolescents: a controlled, prospective longitudinal study.

    Directory of Open Access Journals (Sweden)

    Zhenhua Zhou

    Full Text Available BACKGROUND: To assess the behavioral risk factors and mental health needs of adolescents in juvenile detention centers (JDC. METHOD: A total of 238 boys aged 12-17 years was surveyed who had been admitted to a detention center and compared them with boys from the community (n = 238 matched for sex and age. We assessed behavioral risk factors and mental health problems by using the Youth Risk Behavior Survey questionnaire (YRBS and the Youth Self-Report questionnaire (YSR. RESULTS: Young offenders had significantly higher YRBS scores than controls for drug use (odds ratio (OR 5.16, 95% CI 2.27-7.84, sexual intercourse (OR, 2.51; 95% CI 1.55-2.90, irregular diet (4.78, 2.11-7.51, suicide attempts (1.96, 1.32-5.85, and physical fighting behavior (3.49, 1.60-7.07, but not for tobacco use, alcohol use, and high-risk cycling. Young offenders at the time of admission (6.61, 2.58-15.2, at 6 months (3.12, 1.81-10.1, and at 12 months (5.29, 1.98-13.3 reported statistically higher levels of total mental health problems than adolescents in a community sample. CONCLUSIONS: Young offenders have a high rate of mental and behavioral disorders. In the detention period, aggressive behavior, self-destructive/identity, and externalizing of problems improved while withdrawn, anxious or depressed, and internalizing of problems worsened.

  4. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies

    Science.gov (United States)

    Azad, Meghan B.; Abou-Setta, Ahmed M.; Chauhan, Bhupendrasinh F.; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M.; Reid, Ashleigh E.; Fiander, Michelle; MacKay, Dylan S.; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

    2017-01-01

    BACKGROUND Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. METHODS We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. RESULTS From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference −0.37 kg/m2; 95% confidence interval [CI] −1.10 to 0.36; I2 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I2 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. INTERPRETATION Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with

  5. Stop of loss of cognitive performance during rehabilitation after total hip arthroplasty-Prospective controlled study

    OpenAIRE

    Matthias H. Brem, MD, MHBA; Siegfried Lehrl, PhD; Anna K. Rein, MD; Sylvia Massute, BS; Stefan Schulz-Drost, MD; Kolja Gelse, MD; Phillip M. Schlechtweg, MD, MHBA; Friedrich F. Hennig, MD, PhD; Alexander Olk, MD; Harald J. Jacob, MD; Johannes Gusinde, MD

    2010-01-01

    Prolonged hospitalization is known to be associated with a loss of cognitive performance. Does playing video games (VGs) developed to improve cognitive properties delay this loss or even lead to an increase in cognitive performance? We performed a 10-day longitudinal study of patients who received total hip arthroplasty. We compared 16 patients (6 male) aged 66 ± 9 years (mean ± standard deviation) who played Dr. Kawashima's Brain Training: How Old Is Your Brain? (Nintendo; Redmond, Washingto...

  6. Reconstruction of large iliac crest defects after graft harvest using autogenous rib graft: a prospective controlled study.

    Science.gov (United States)

    Bapat, Mihir R; Chaudhary, Kshitij; Garg, Hitesh; Laheri, Vinod

    2008-11-01

    Prospective controlled study analyzing the donor site morbidity after reconstruction of full thickness iliac crest defects, using autologous rib grafts. To compare the pain and cosmetic outcomes of patients with iliac crest reconstruction with those who have had no reconstruction of the iliac crest. Chronic donor site pain and poor cosmesis have been the major deterrents in using iliac crest for long-segment spinal reconstructions. Iliac crest reconstruction with rib has been reported but most studies are uncontrolled and retrospective. Patients with iliac defects rib graft harvested during the anterolateral approach to spine. Rib graft of the appropriate contour was impacted into the notches created in the iliac crest defect. The control group comprised 16 patients without reconstruction of the iliac crest. The pain, cosmesis, and functional disability were assessed on the basis of visual analog scores and a predesigned questionnaire. Judet iliac views were used to assess the incorporation of the rib graft. Evaluation was performed at 1.5, 3, 6, and 12 months, respectively. Intensity and incidence of pain was significantly lower in the reconstructed group. Cosmetic outcome was also significantly better in this group. Patients in control group had significant complications related to the tenting of skin over the defect such as bursitis and skin necrosis. Radiologic incorporation was documented in 95% of patients with 1 patient having resorption of the rib graft. Rib graft reconstruction provides a cheap and effective alternative for iliac crest reconstruction. Patients undergoing thoracotomy or thoraco-phrenico-lumbotomy for spinal reconstruction, the unutilized rib graft should be used to reconstruct the iliac defect. Reduced donor site morbidity and better cosmesis are the major benefits of reconstruction.

  7. Neuroendocrine regulation and metabolism of glucose and lipids in primary chronic insomnia: a prospective case-control study.

    Directory of Open Access Journals (Sweden)

    Eleonora Seelig

    Full Text Available OBJECTIVES: To investigate the relation between primary chronic insomnia and insulin sensitivity, visceral adiposity, non alcoholic fatty liver disease and neuroendocrine hormones. MATERIALS AND METHODS: In a case-controlled, prospective clinical trial 13 women with primary chronic insomnia according to DSM-IV criteria were compared to 12 healthy controls matched for age, sex, BMI, body composition and menopausal status. All participants had a sleep assessment including polysomnographic studies and neuropsychiatric evaluation. Insulin sensitivity was evaluated using the euglycaemic hyperinsulinemic clamp. Hepatic fat content, visceral adipose tissue and intramyocellular lipid accumulation were assessed using magnetic resonance imaging and spectroscopy. The hormonal stress axis was evaluated by measurements of midnight and early morning salivary cortisol, urinary catecholamines and plasma metanephrines. Body composition was determined using body impedance analysis and indirect calorimetry. RESULTS: Although the diagnosis of primary chronic insomnia was made by established clinical criteria, standard polysomongraphic studies failed to identify altered sleep continuity and architecture when compared to matched controls. However, women with primary chronic insomnia showed significantly higher midnight salivary cortisol concentrations (1.46 vs. 0.76 nmol/l, p = 0.02, indicating dysregulation of the hypothalamo-pituitary-adrenal (HPA axis. Plasma glucose and lipid concentrations, insulin sensitivity, hepatic and intramyocellular fat content, visceral adipose tissue mass and body composition did not differ between the two groups. CONCLUSION: Healthy women with clinically diagnosed primary chronic insomnia demonstrate a dysregulation of circadian cortisol secretion despite normal sleep continuity and architecture. Increased midnight cortisol levels, however, were not associated with impaired metabolism of glucose and lipids.

  8. Occupational lead exposure and severe CKD: a population-based case-control and prospective observational cohort study in Sweden.

    Science.gov (United States)

    Evans, Marie; Fored, Carl Michael; Nise, Gun; Bellocco, Rino; Nyrén, Olof; Elinder, Carl-Gustaf

    2010-03-01

    The role of low-level lead exposure in the cause of chronic kidney disease (CKD) is unsettled. Case-control study and prospective observational cohort study. 926 cases with incident severe CKD (serum creatinine > 3.4 mg/dL for men and > 2.8 mg/dL for women for the first time) and 998 population controls were included. Cases represented nearly all patients with incident severe CKD in Sweden during 2 years. Cases also were followed up prospectively for 7-9 years. Exposed and nonexposed cases were compared with regard to rate of change in estimated glomerular filtration rate (eGFR) and renal survival. Lead exposure was assessed using the expert rating method. Associations between lead exposure and risk of CKD, adjusted for factors associated with this outcome, were analyzed using multivariable logistic regression modeling, whereas links to the rate of change in eGFR were analyzed in mixed-effects multivariable models based on up to 6 measurements. Renal survival in relation to lead exposure was analyzed in a Cox proportional hazards model. The adjusted OR for incident severe CKD was 0.97 (95% CI, 0.68-1.38) in lead-exposed compared with nonexposed participants. The OR for individuals with the highest average exposure (>0.0075 mg/m(3)) was 1.09 (95% CI, 0.64-1.85). ORs for CKD caused by glomerulonephritis, nephrosclerosis, and diabetic nephropathy did not differ importantly. In patients with CKD ever exposed and most exposed to lead, eGFRs changed by -4.27 and -3.39 mL/min/1.73 m(2)/y compared with -4.55 mL/min/1.73 m(2)/y in nonexposed patients, respectively. Only native Swedes were included, which may limit generalizability. Blood lead was not measured to confirm the validity of the expert rating method. Our data provide no evidence of an important role of low-level occupational lead exposure in the cause or progression of severe CKD. Copyright 2010 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

  9. Acute effects of remote ischemic preconditioning on cutaneous microcirculation - a controlled prospective cohort study

    Directory of Open Access Journals (Sweden)

    Kraemer Robert

    2011-11-01

    Full Text Available Abstract Background Therapeutic strategies aiming to reduce ischemia/reperfusion injury by conditioning tissue tolerance against ischemia appear attractive not only from a scientific perspective, but also in clinics. Although previous studies indicate that remote ischemic intermittent preconditioning (RIPC is a systemic phenomenon, only a few studies have focused on the elucidation of its mechanisms of action especially in the clinical setting. Therefore, the aim of this study is to evaluate the acute microcirculatory effects of remote ischemic preconditioning on a distinct cutaneous location at the lower extremity which is typically used as a harvesting site for free flap reconstructive surgery in a human in-vivo setting. Methods Microcirculatory data of 27 healthy subjects (25 males, age 24 ± 4 years, BMI 23.3 were evaluated continuously at the anterolateral aspect of the left thigh during RIPC using combined Laser-Doppler and photospectrometry (Oxygen-to-see, Lea Medizintechnik, Germany. After baseline microcirculatory measurement, remote ischemia was induced using a tourniquet on the contralateral upper arm for three cycles of 5 min. Results After RIPC, tissue oxygen saturation and capillary blood flow increased up to 29% and 35% during the third reperfusion phase versus baseline measurement, respectively (both p = 0.001. Postcapillary venous filling pressure decreased statistically significant by 16% during second reperfusion phase (p = 0.028. Conclusion Remote intermittent ischemic preconditioning affects cutaneous tissue oxygen saturation, arterial capillary blood flow and postcapillary venous filling pressure at a remote cutaneous location of the lower extremity. To what extent remote preconditioning might ameliorate reperfusion injury in soft tissue trauma or free flap transplantation further clinical trials have to evaluate. Trial registration ClinicalTrials.gov: NCT01235286

  10. Psychological change after aesthetic plastic surgery: a prospective controlled outcome study.

    Science.gov (United States)

    Moss, Timothy P; Harris, David L

    2009-10-01

    Aesthetic plastic surgery has been long practiced for primarily psychological rather than physical benefit to patients. However, evaluation of the psychological impact of aesthetic plastic surgery has often been of limited methodological rigor in both study design and appropriate measurement. This study is intended to evaluate the psychological impact of aesthetic surgery on patients seeking such intervention in regard to concerns about breasts, nose or upper limbs using standardised psychometric instruments. Participants were recruited through the Plastic Surgery Unit (Patients) and general surgery, ENT surgery and Maxillo-facial surgery (Comparisons) at a UK General Hospital. Outcome measures included the Crown-Crisp Experiential Inventory anxiety scale, Beck Depression Inventory and Derriford Appearance Scale-24, a valid and reliable measure of distress and dysfunction in relation to self-consciousness of appearance. Data were collected pre-operatively (T1) and 3 months post-operatively (T2) for both groups. Longitudinal appearance adjustment for the plastic surgery group was also assessed at 12 months (T3). Both groups were less depressed and anxious post-operatively. The improvement in anxiety was significantly greater in the plastic surgery group. Body site specific appearance distress was significantly improved for the plastics group only, and the level of improvement was related to the body site affected.

  11. Carboprost Versus Oxytocin for Active Management of Third Stage of Labor: A Prospective Randomized Control Study.

    Science.gov (United States)

    Sunil Kumar, K S; Shyam, Sundar; Batakurki, Pavitra

    2016-10-01

    Postpartum hemorrhage is the single largest and leading cause of maternal morbidity and mortality not only in developing countries but also in developed countries. The present study is an attempt to evaluate the scope of using prophylactic intramuscular carboprost tromethamine 125 μg in comparison with intramuscular oxytocin 10 units for the active management of third stage of labor. Two hundred pregnant women at term with spontaneous onset of labor were included in the study and were randomly divided into 2 groups of 100 women each. Group A and group B were given injection oxytocin 10 units and injection carboprost tromethamine 125 μg intramuscularly, respectively, at the time of delivery of anterior shoulder. The main outcome measures with respect to third stage of labor were: duration, blood loss by volume, difference in hemoglobin, need for additional oxytocics and side effects. Subjects who received carboprost tromethamine 125 μg showed a significant reduction in duration of third stage of labor (p oxytocin 10 units. Likelihood of occurrence of postpartum hemorrhage was reduced without significant side effects except for diarrhea. Additional need for other uterotonics after carboprost was significantly less compared to oxytocin. Intramuscular carboprost 125 μg is a better cost-effective alternative as compared to 10 units intramuscular oxytocin in active management of third stage of labor.

  12. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study

    Directory of Open Access Journals (Sweden)

    Nada AM

    2017-07-01

    insignificant (P=0.069, 0.376, 0.058, respectively. FI decreased by 22%, HOMA-IR by 27.6%, and c-peptide by 1.83%. Total cholesterol, low-density lipoprotein cholesterol, parathyroid hormone, alkaline phosphatase, serum creatinine, and pulse rate significantly decreased (4.3±0.9 vs 4.0±0.9 mmol/L, P=0.036; 2.5±0.8 vs 2.2±0.8 mmol/L, P=0.018; 4.6±2.1 vs 3.5±1.8 pmol/L, P=0.001; 82.1±26.2 vs 66.2±19.5 U/L, P<0.001; 74.6±15.6 vs 70.7±14.7 µmol/L, P=0.047; and 81.6±11.9 vs 77.5±12.0 bpm, P=0.045, respectively. Triglycerides and high-density lipoprotein cholesterol, both systolic and diastolic BP, and BMI did not show significant change.Conclusion: Cholecalciferol helps improve blood glucose control and cholesterol profile in vitamin D3-deficient type 2 diabetic patients. Keywords: vitamin D, type 2 diabetes, HbA1c, cholesterol, creatinine, parathyroid hormone

  13. Cholecalciferol improves glycemic control in type 2 diabetic patients: a 6-month prospective interventional study.

    Science.gov (United States)

    Nada, Aml Mohamed; Shaheen, Dalia A

    2017-01-01

    significantly decreased (4.3±0.9 vs 4.0±0.9 mmol/L, P=0.036; 2.5±0.8 vs 2.2±0.8 mmol/L, P=0.018; 4.6±2.1 vs 3.5±1.8 pmol/L, P=0.001; 82.1±26.2 vs 66.2±19.5 U/L, P<0.001; 74.6±15.6 vs 70.7±14.7 μmol/L, P=0.047; and 81.6±11.9 vs 77.5±12.0 bpm, P=0.045, respectively). Triglycerides and high-density lipoprotein cholesterol, both systolic and diastolic BP, and BMI did not show significant change. Cholecalciferol helps improve blood glucose control and cholesterol profile in vitamin D3-deficient type 2 diabetic patients.

  14. Routine enema before urodynamics has no impact on the quality of abdominal pressure curves: Results of a prospective controlled study.

    Science.gov (United States)

    Rigole, H; Senal, N; Damphousse, M; Brochard, C; Manunta, A; Kerdraon, J; Tondut, L; Alimi, Q; Hascoet, J; Siproudhis, L; Peyronnet, B; Bonan, I

    2016-12-01

    The presence of stools in the rectum might affect the quality of the abdominal pressure curve during filling cystometry, but, to date, no study has evaluated the impact of bowel preparation before urodynamics. We evaluated the influence of a sodium phosphate enema before urodynamics on the quality of the abdominal pressure curve. A prospective, controlled, single-blind study was conducted in a single center from May to June 2013. The patients were divided into 2 consecutive groups: patients seen in outpatient clinics during the first 6 weeks (group A) who underwent urodynamics without bowel preparation and patients seen in outpatient clinics during the second 6 weeks (group B) who had a prescription of sodium phosphate enema before urodynamics. The primary endpoint was the quality of the abdominal pressure curve evaluated independently by three physicians who were blinded to the study group. The following data were also collected: age, gender, the presence of a neurological disorder, complicated nature of urodynamics and bother related to preparation for it, assessed using a Likert scale (0 to 10), and the equipment used. A per protocol analysis and an intent-to-treat analysis were conducted. One hundred and thirty-nine patients were included: 54 in group A and 85 in group B. One-third of patients had neurological conditions. 14 patients in group B did not perform their scheduled enema. Thus, 68 patients performed an enema before urodynamics and 71 did not. There was no difference between groups A and B regarding the complicated nature of urodynamics (Likert scale: 3.12 vs. 3.18; P=0.91) or bother related to preparation for it (Likert scale: 3.46 vs. 2.97; P=0.43). In the per protocol analysis, the abdominal pressure curve was considered perfectly interpretable (PI) in 69% of patients who did not receive an enema before urodynamics and in 65% of patients who did (P=0.61). The between-group difference was not statistically significant in intent-to-treat analysis (P

  15. Regenerative Endodontics Versus Apexification in Immature Permanent Teeth with Apical Periodontitis: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Lin, Jiacheng; Zeng, Qian; Wei, Xi; Zhao, Wei; Cui, Minyi; Gu, Jing; Lu, Jiaxuan; Yang, Maobin; Ling, Junqi

    2017-08-29

    The aim of the study was to compare the outcomes of regenerative endodontic treatment (RET) and apexification on immature permanent teeth with pulp necrosis and apical periodontitis. A total of 118 patients (118 teeth) were recruited and randomly assigned to either RET or apexification treatment. Each treatment group was divided into 2 subgroups according to the etiology: dens evaginatus or trauma. Clinical symptoms and complications were recorded, and cone-beam computed tomographic imaging with a limited field of view was used to measure the change of root length, root thickness, and apical foramen size at the 12-month follow-up. The t test/rank sum test and Fisher exact test were applied to compare the change of root morphology between RET and apexification. One hundred three of 118 cases were completed at the 12-month follow-up. The survival rate was 100% for both treatment groups. All cases were asymptomatic with apical healing. The RET group showed a significant increase in root length and root thickness compared with the apexification group (P < .05). In the RET group, the cases caused by dens evaginatus achieved increased root length and root thickness compared with those caused by trauma (P < .05). RET and apexification achieved a comparable outcome in regard to the resolution of symptoms and apical healing. RET showed a better outcome than apexification regarding increased root thickness and root length. The etiology had an impact on the outcome of RET. Dens evaginatus cases showed better prognoses than trauma cases after RET. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  16. Tramadol vs dexmedetomidine for emergence agitation control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: prospective randomized controlled clinical study.

    Science.gov (United States)

    Bedirli, Nurdan; Akçabay, Mehmet; Emik, Ulku

    2017-03-11

    This study was designed to compare the efficacy of an intraoperative single dose administration of tramadol and dexmedetomidine on hemodynamics and postoperative recovery profile including pain, sedation, emerge reactions in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia. Seventy-seven patient, aged 2-12, undergoing adenotonsillectomy with sevoflurane anesthesia was enrolled in this study. Patients were randomly assigned to receive either intravenous 2 mg/kg tramadol (Group T; n = 39) or 1 μg/kg dexmedetomidine (Group D; n = 38) after intubation. Heart rates (HR), mean arterial pressure (MAP) were recorded before induction, at induction and every 5 min after induction. Observational pain scores (OPS), pediatric anesthesia emergence delirium (PAED) scores, percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4, and Ramsay sedation scores (RSS) were recorded on arrival to the postoperative care unit (PACU) and at 5, 10, 15, 30, 45, 60 min. Extubation time and time to reach Alderete score > 9 were recorded. Dexmedetomidine significantly decreased the HR and MAP 10 and 15 min after induction; increased the RSS 15, 30 and 45 min after arrival to PACU. OPS and PAED scores and percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4 in both groups did not show any significant difference. Extubation time and time to have Alderete score > 9 was significantly longer in Group D. Both tramadol and dexmedetomidine were effective for controlling pain and emergence agitation. When compared with tramadol intraoperative hypotension, bradycardia and prolonged sedation were problems related with dexmedetomidine administration. Retrospectively registered, registration number: ISRCTN89326952 registration date: 14.07.2016.

  17. Pulmonary infection control window in treatment of severe respiratory failure of chronic obstructive pulmonary diseases: a prospective, randomized controlled, multi-centred study

    Institute of Scientific and Technical Information of China (English)

    Collaborating Research Group for Noninvasive Mecha

    2005-01-01

    Background Early withdraw from invasive mechanical ventilation (MV) followed by noninvasive MV is a new strategy for changing modes of treatment. This study was conducted to estimate the feasibility and the efficacy of early extubation and sequential noninvasive MV commenced at beginning of pulmonary infection control window in patients with exacerbated hypercapnic respiratory failure caused by chronic obstructive pulmonary diseases (COPD). Methods A prospective, randomized controlled study was conducted in eleven teaching hospitals' respiratory or medical intensive care units in China. Ninety intubated COPD patients with severe hypercapnic respiratory failure triggered by pulmonary infection (pneumonia or purulent bronchitis) were involved in the study. When the pulmonary infection had been controlled by antibiotics and comprehensive therapy, the "pulmonary infection control window (PIC window)" has been reached. Each case was randomly assigned to study group (extubation and noninvasive MV via facial mask immediately) or control group (invasive MV was received continuously after PIC window by using conventional weaning technique).Results Study group (n=47) and control group (n=43) had similar clinical characteristics initially and at the time of PIC window. Compared with control group, study group had shorter duration of invasive MV [(6.4±4.4) days vs (11.3±6.2) days, P=0.000], lower rate of ventilator associated pneumonia (VAP) (3/47 vs 12/43, P=0.014), fewer days in ICU [(12±8) days vs (16±11) days, P=0.047] and lower hospital mortality (1/47 vs 7/43, P=0.025).Conclusions In COPD patients requiring intubation and invasive MV for hypercapnic respiratory failure, which is exacerbated by pulmonary infection, early extubation followed by noninvasive MV initiated at the start of PIC window may decrease significantly the duration of invasive MV, the risk of VAP and hospital mortality.

  18. Labour: A Prospective, Descriptive Study

    African Journals Online (AJOL)

    Symphysis Fundus Height Measurements during Labour: A Prospective, Descriptive Study 49. Introduction ... 800g in about 50% of cases,2 and in term preg- nancies to be as .... Discussion. Prematurity and low birthweight are major causes.

  19. Topical treatment of CIN 2+ by cidofovir: results of a phase II, double-blind, prospective, placebo-controlled study.

    Science.gov (United States)

    Van Pachterbeke, C; Bucella, D; Rozenberg, S; Manigart, Y; Gilles, C; Larsimont, D; Vanden Houte, K; Reynders, M; Snoeck, R; Bossens, M

    2009-10-01

    Randomized controlled trial evaluating a topical treatment for cervical intraepithelial neoplasia 2 and 3 (CIN 2+) using cidofovir. Fifty-three women with a biopsy-proven CIN 2+ were randomly assigned, 6 weeks before their planned conisation, either 3 applications of 3 ml 2% cidofovir in Intrasite gel in a cervical cap or a placebo (the same volume of Intrasite alone). A cervical sample for high-risk types of human papillomaviruses (HPV) (Hybrid Capture 2 or HC2) was taken before treatment and before conisation. The cone was submitted for pathological examination, and subsequently, along with the initial biopsy, to in situ hybridization (ISH) for high-risk HPV. Forty-eight patients were treated and followed according to the protocol, (23 cidofovir, and 25 placebo). Fourteen of the 23 cones were free of any CIN (60.8%) in the cidofovir group. Only 5 of 25 cones were free of any CIN (20%) in the placebo group (ptreatment with cidofovir, at this point, cannot replace conisation, but it is a promising candidate for topical chemotherapy of CIN 2+ lesions; a larger prospective randomized study is needed to confirm our results.

  20. Patient-controlled hospital admission for patients with severe mental disorders: study protocol for a nationwide prospective multicentre study

    Science.gov (United States)

    Thomsen, Christoffer Torgaard; Benros, Michael Eriksen; Hastrup, Lene Halling; Andersen, Per Kragh; Giacco, Domenico; Nordentoft, Merete

    2016-01-01

    Introduction Patient-controlled hospital admission for individuals with severe mental disorders is a novel approach in mental healthcare. Patients can admit themselves to a hospital unit for a short stay without being assessed by a psychiatrist or contacting the emergency department. Previous studies assessing the outcomes of patient-controlled hospital admission found trends towards reduction in the use of coercive measures and length of hospital stay; however, these studies have methodological shortcomings and small sample sizes. Larger studies are needed to estimate the effect of patient-controlled hospital admission on the use of coercion and of healthcare services. Design and methods We aim to recruit at least 315 patients who are offered a contract for patient-controlled hospital admissions in eight different hospitals in Denmark. Patients will be followed-up for at least 1 year to compare the use of coercive measures and of healthcare services, the use of medications and suicidal behaviour. Descriptive statistics will be used to investigate hospitalisations, global assessment of functioning (GAF) and patient satisfaction with treatment. To minimise selection bias, we will match individuals using patient-controlled hospital admission and controls with a 1:5 ratio via a propensity score based on the following factors: sex, age group, primary diagnosis, substance abuse as secondary diagnosis, coercion, number of psychiatric bed days, psychiatric history, urbanity and suicidal behaviour. Additionally, a historical control study will be undertaken in which patients serve as their own control group prior to index date. Ethics and dissemination The study has been approved by The Danish Health and Medicines Authority (j.nr.: 3-3013-934/1/) and by The Danish Data Protection Agency (j.nr.: 2012-58-0004). The study was categorised as a register study by The Danish Health Research Ethics Committee and therefore no further approval was needed (j.nr.: H-2-2014-FSP70

  1. The effect of topically applied tissue expanders on radial forearm skin pliability: a prospective self-controlled study

    Science.gov (United States)

    2014-01-01

    Background The use of pre-operatively applied topical tissue expansion tapes have previously demonstrated increased rates of primary closure of radial forearm free flap donor sites. This is associated with a reduced cost of care as well as improved cosmetic appearance of the donor site. Unfortunately, little is known about the biomechanical changes these tapes cause in the forearm skin. This study tested the hypothesis that the use of topically applied tissue expansion tapes will result in an increase in forearm skin pliability in patients undergoing radial forearm free flap surgery. Methods Twenty-four patients scheduled for head and neck surgery requiring a radial forearm free flap were enrolled in this prospective self-controlled observational study. DynaClose tissue expansion tapes (registered Canica Design Inc, Almonte, Canada) were applied across the forearm one week pre-operatively. Immediately prior to surgery, the skin pliability of the dorsal and volar forearm sites were measured with the Cutometer MPA 580 (registered Courage-Khazaka Electronic GmbH, Cologne, Germany) on both the treatment and contralateral (control) arms. Paired t-tests were used to compare treatment to control at both sites, with p < 0.025 defined as statistically significant. Results There was a statistically significant increase in pliability by a mean of 0.05 mm (SD = 0.09 mm) between treatment and control arms on the dorsal site (95% CI [0.01, 0.08], p = 0.018). This corresponded to an 8% increase in pliability. In contrast, the volar site did not show a statistically significant difference between treatment and control (mean difference = 0.04 mm, SD = 0.20 mm, 95% CI [−0.04, 0.12], p = 0.30). Conclusions This result provides evidence that the pre-operative application of topical tissue expansion tapes produces measurable changes in skin biomechanical properties. The location of this change on the dorsal forearm is consistent with the method of tape

  2. Vertebral fractures in patients with inflammatory bowel disease COMPARED with a healthy population: a prospective case-control study

    Directory of Open Access Journals (Sweden)

    Vázquez Ma

    2012-05-01

    Full Text Available Abstract Background A prospective study was performed to compare the prevalence of morphometric vertebral fractures (MVF between patients with inflammatory bowel disease (IBD and healthy subjects and to identify predictive factors of fracture. Methods A total of 107 patients with IBD (53 with Crohn’s disease and 54 with ulcerative colitis and 51 healthy subjects participated in the study. Information about anthropometric parameters, toxins, previous fractures, and parameters related to this disease were evaluated. The index of vertebral deformity, bone mass density (BMD, and biochemical parameters were calculated. Results A total of 72 fractures were detected in 38.32% of patients with IBD, and 10 fractures were detected in 13.73% of healthy subjects; the risk of fracture in patients with IBD was higher than that in control subjects (OR, 4.03; 95% CI, 1.652–9.847; p p = 0.17 and femoral neck, r = −0.138, p = 0.07. Corticosteroid treatment was not associated with prevalent vertebral fractures nor with taking corticosteroids (r = 0.135, p = 0.14 or the duration for which they were taken (r = 0.08, p = 0.38, whereas this relationship was present in the controls (r = −0.365, p = 0.01. In the multivariate analysis, none of the measured parameters were significantly predictive of fracture, only to manifested IBD. Hypovitaminosis D was observed in 55.14% of patients with IBD. Conclusions The prevalence of morphometric vertebral fractures is higher in patients with IBD than in the healthy population, without association with BMD or corticoid treatment. Simply having IBD was proven to be a predictive factor of fracture. We observed a high incidence of hypovitaminosis D in patients with IBD.

  3. Campylobacter jejuni infection in Guillain-Barré syndrome: a prospective case control study in a tertiary care hospital.

    Science.gov (United States)

    Sharma, A; Lal, V; Modi, M; Vaishnavi, C; Prabhakar, S

    2011-01-01

    Guillain-Barré syndrome (GBS), is a common post-infectious polyradiculoneuropathy worldwide. The commonest implicated causative organism the world over is Campylobacter jejuni (C. jejuni). This study was carried out to determine the relationship between C. jejuni infection and GBS in an Indian setting. This prospective study was carried out on a cohort of 50 patients with GBS who were treated in a tertiary care hospital in India. Based on electrophysiological findings the patients were divided into various subtypes. Serology for C. jejuni (Immunoglogulin G, IgG and Immunoglogulin, IgM) using an enzyme-linked immunosorbent assay method (ELISA) was done both in patients and 40 age, sex and geographically matched controls. Evidence of recent C. jejuni infection was present in 30% of GBS patients compared to 8% of controls (15/50 vs. 3/40 P<0.005). Eight (47%) C. jejuni-positive patients reported symptoms of gastroenteritis 4-30 days (mean 13 days) prior to onset of GBS. Of the 15 patients with evidence of C. jejuni infection, 10 (67%) patients had axonal type of GBS. Axonal variety of GBS presented in a younger age group compared to acute inflammatory demyelinating polyradiculoneuropathy (AIDP) patients (mean age: axonal vs. AIDP: 30.11 + 13.73 vs. 40.2 + 18.77). C. jejuni-positive patients presented mainly in spring and winter and had a similar age and sex incidence as compared to the rest of the GBS patients. Preceding C. jejuni infection is common among GBS patients and is often associated with the axonal variety of GBS. Axonal variety of GBS generally presents in a younger age group as compared to AIDP.

  4. Ovarian and Adrenal Androgens and Their Link to High Human Chorionic Gonadotropin Levels: A Prospective Controlled Study

    Directory of Open Access Journals (Sweden)

    René Rodríguez-Gutiérrez

    2014-01-01

    Full Text Available Background. Although the association between human chorionic gonadotropin (hCG and hyperandrogenism was identified more than 40 years ago, relevant questions remain unanswered. Design and Methods. We conducted a prospective, longitudinal, and controlled study in 23 women with a diagnosis of a complete hydatidiform mole (HM. Results. All participants completed the study. Before HM evacuation mean hCG was markedly higher in the cases than in the control group (P≤0.001. Free testosterone (T and dehydroepiandrosterone sulfate (DHEA-S were found to be higher in the cases (2.78 ± 1.24 pg/mL and 231.50 ± 127.20 μ/dL when compared to the control group (1.50 ± 0.75 pg/mL and 133.59 ± 60.69 μ/dL (P=0.0001 and 0.001, respectively. There was a strong correlation between hCG and free T/total T/DHEA-S concentrations (r=0.78; P≤0.001, r=0.74;  P≤0.001, and r=0.71;  P≤0.001, respectively. In the cases group 48 hours after HM evacuation, hCG levels were found to be significantly lower when compared to initial levels (P=0.001 and free T and DHEA-S declined significantly (P=0.0002 and 0.009. Conclusion. Before uterus evacuation, hCG, free T, and DHEA-S levels were significantly higher when compared with controls finding a strong correlation between hCG and free T/DHEA-S levels. Forty-eight hours after HM treatment hCG levels declined and the difference was lost. A novel finding of our study is that in cases, besides free T, DHEA-S was also found to be significantly higher and both the ovaries and adrenal glands appear to be the sites of this androgen overproduction.

  5. Protocol for a prospective, controlled, observational study to evaluate the influence of hypoxia on healthy volunteers and patients with inflammatory bowel disease: the Altitude IBD Study

    Science.gov (United States)

    Vavricka, Stephan; Ruiz, Pedro A; Scharl, Sylvie; Biedermann, Luc; Scharl, Michael; de Vallière, Cheryl; Lundby, Carsten; Wenger, Roland H; Held, Leonhard; Merz, Tobias M; Gassmann, Max; Lutz, Thomas; Kunz, Andres; Bron, Denis; Fontana, Adriano; Strauss, Laura; Weber, Achim; Fried, Michael; Rogler, Gerhard

    2017-01-01

    Introduction Inflammatory bowel disease (IBD) is a chronic intestinal disorder, often leading to an impaired quality of life in affected patients. The importance of environmental factors in the pathogenesis of IBD, including their disease-modifying potential, is increasingly recognised. Hypoxia seems to be an important driver of inflammation, as has been reported by our group and others. The aim of the study is to evaluate if hypoxia can alter disease activity of IBD measured by Harvey-Bradshaw Activity Index in Crohn's disease (increase to ≥5 points) and the partial Mayo Score for ulcerative colitis (increase to ≥2 points). To test the effects of hypoxia under standardised conditions, we designed a prospective and controlled investigation in healthy controls and patients with IBD in stable remission. Methods and analysis This is a prospective, controlled and observational study. Participants undergo a 3-hour exposure to hypoxic conditions simulating an altitude of 4000 metres above sea level (m.a.s.l.) in a hypobaric pressure chamber. Clinical parameters, as well as blood and stool samples and biopsies from the sigmoid colon are collected at subsequent time points. Ethics and dissemination The study protocol was approved by the Ethics Committee of the Kanton Zurich (reference KEK-ZH-number 2013-0284). The results will be published in a peer-reviewed journal and shared with the worldwide medical community. Trials registration number NCT02849821; Pre-results. PMID:28057654

  6. A case-control study of non-AIDS-defining cancers in a prospective cohort of HIV-infected patients.

    Science.gov (United States)

    Rodríguez Arrondo, Francisco; von Wichmann, Miguel Ángel; Camino, Xabier; Goenaga, Miguel Ángel; Ibarguren, Maialen; Azcune, Harkaitz; Bustinduy, María Jesús; Ferrero, Oscar; Muñoz, Josefa; Ibarra, Sofía; Aguirrebengoa, Koldo; Goicoetxea, Josune; Bereciartua, Elena; Montejo, Miguel; García, M Asunción; Martínez, Eduardo; Portu, Joseba; Metola, Luis; Silvariño, Rafael; Sarasqueta, Cristina; Arrizabalaga, Julio; Iribarren, Jose Antonio

    2017-05-18

    We present a case-control study of non-AIDS-defining cancers (NADCs) in a cohort of HIV-infected patients where we value the incidence, survival and prognostic factors of mortality. All NADCs diagnosis conducted from 2007 to 2011 in 7 hospitals were collected prospectively, with a subsequent follow up until December 2013. A control group of 221 HIV patients without a diagnosis of cancer was randomly selected. Two hundred and twenty-one NADCs were diagnosed in an initial cohort of 7,067 HIV-infected patients. The most common were: hepatocellular carcinoma 20.5%, lung 18.7%, head and neck 11.9% and anal 10.5%. The incidence rate of NADCs development was 7.84/1,000 people-year. In addition to aging and smoking, time on ART (OR 1.11; 95% CI 1.05-1.17) and PI use (OR 1.72; 95% CI 1.0-2.96) increased the risk of developing a NADC. During follow-up 53.42% died, with a median survival time of 199.5 days. In the analysis of the prognostic factors of mortality the low values of CD4 at tumour diagnosis (OR 0.99; 95% CI 0.99-1.0; P=.033), and the previous diagnosis of AIDS (OR 2.06; 95% CI 1.08-3.92) were associated with higher mortality. Predictors of NADCs in our cohort were age, smoking, CD4 lymphocytes and time on ART. Mortality is high, with NADC risk factors being low CD4 count and previous diagnosis of AIDS. Copyright © 2017 Elsevier España, S.L.U. All rights reserved.

  7. Effects of gastric irrigation on bacterial counts before endoscopic submucosal dissection: a randomized case control prospective study.

    Directory of Open Access Journals (Sweden)

    Hirohito Mori

    Full Text Available OBJECTIVE: The antiseptic effect of gastric irrigation before endoscopic submucosal dissection (ESD has not yet been reported. The aim of the randomized prospective study is to evaluate the antiseptic effects of gastric irrigation of saline solution before ESD by evaluating bacterial count. METHODS: This prospective randomized controlled trial included 50 patients diagnosed with early gastric cancer who were randomly divided into 2 groups (25 patients in each group by using the opaque envelope method: the clean group (irrigation with 2 L saline solution before ESD and the regular group (no irrigation. The gastric juice was collected and cultured before ESD. The entire stomach was irrigated using a water jet attached to an endoscope. After ESD with resection and removal of the tumor specimen, a postoperative culture of the gastric juice was obtained using the same method as the preoperative culture. RESULTS: The mean log bacterial count of the post-gastric irrigation gastric juice was 5.08±0.75 in the regular group and 1.86±0.86 in the clean group. The difference in the bacterial counts was significant between the groups (P = 0.0004. The difference in the white blood cells (WBC count on POD 1 was significant (P = 0.044. WBC count on POD 2 did not significantly differ between the groups (P = 0.3. The difference in the body temperature (BT on POD 1 was significant (P = 0.017, On POD 2 the BT was not significant between the groups (P = 0.5. On POD 1, 88% of the patients in the regular group and 16% of the patients in the clean group had mild to moderate spontaneous pain (P = 0.0026. On POD 2 the proportion with mild to moderate spontaneous pain was 36% and 24% in the regular group and the clean group, respectively (P = 0.1. CONCLUSION: Pre-ESD gastric irrigation with saline solution is effective and feasible for suppressing infection during the ESD procedure with favorable clinical outcomes. TRIAL REGISTRATION

  8. Cognitive cooperation groups mediated by computers and internet present significant improvement of cognitive status in older adults with memory complaints: a controlled prospective study

    OpenAIRE

    Rodrigo de Rosso Krug; Anna Quialheiro Abreu da Silva; Ione Jayce Ceola Schneider; Luiz Roberto Ramos; Eleonora d’Orsi; André Junqueira Xavier

    2017-01-01

    ABSTRACT Objective To estimate the effect of participating in cognitive cooperation groups, mediated by computers and the internet, on the Mini-Mental State Examination (MMSE) percent variation of outpatients with memory complaints attending two memory clinics. Methods A prospective controlled intervention study carried out from 2006 to 2013 with 293 elders. The intervention group (n = 160) attended a cognitive cooperation group (20 sessions of 1.5 hours each). The control group (n = 133)...

  9. The effects of parental presence in the postanesthetic care unit on children's postoperative behavior: a prospective, randomized, controlled study.

    Science.gov (United States)

    Lardner, David R; Dick, Bruce D; Crawford, Susan

    2010-04-01

    The effects on children of parental presence in the postanesthesia care unit (PACU) have not been extensively studied. The few published studies are retrospective, nonrandomized, or lack adequate controls. They suggest that parental presence in the PACU decreases crying and negative behavior change postoperatively. We performed this prospective, randomized, controlled study to determine whether the presence of a parent affected crying behaviors in the PACU and behavior change 2 weeks postoperatively. Randomly selected patients, aged 2.0 to 8 years 11 months, ASA physical status I or II, and scheduled for elective outpatient surgery with an anticipated PACU stay of >10 minutes were randomly assigned to the parent present group (n = 150) or parent absent group (n = 150) in the PACU. All parents underwent the same preparation program. Reunification occurred once children's eyes had opened for the parent present group. In the PACU, crying was scored each minute after eye opening using a 5-point scale. Negative behavior change 2 weeks after discharge was determined using the Post Hospitalization Behavior Questionnaire. Because the anesthesia technique to be used was not determined a priori, data on the technique used were collected to ensure that groups were similar. Multiple and logistic regression techniques were used to determine predictors of crying in the PACU and behavior change 2 weeks postoperatively. Parental presence in the PACU made no difference in crying in the PACU. Negative behavior change 2 weeks postoperatively occurred more frequently in the parent absent group than the parent present group (45.8% vs 29.3%; P = 0.007). Multiple regression identified the following significant factors as predictive of larger proportion of time spent crying in the PACU (R(2) = 0.256, F[5, 273] = 15.66, P < 0.001): age <5 years (P < 0.001) and higher Children's Hospital of Eastern Ontario Pain Scale score at 15 minutes after arrival in day surgery (P < 0.001). Parental

  10. Risk of heart failure after community acquired pneumonia: prospective controlled study with 10 years of follow-up.

    Science.gov (United States)

    Eurich, Dean T; Marrie, Thomas J; Minhas-Sandhu, Jasjeet K; Majumdar, Sumit R

    2017-02-13

    Objective To determine the attributable risk of community acquired pneumonia on incidence of heart failure throughout the age range of affected patients and severity of the infection.Design Cohort study.Setting Six hospitals and seven emergency departments in Edmonton, Alberta, Canada, 2000-02.Participants 4988 adults with community acquired pneumonia and no history of heart failure were prospectively recruited and matched on age, sex, and setting of treatment (inpatient or outpatient) with up to five adults without pneumonia (controls) or prevalent heart failure (n=23 060).Main outcome measures Risk of hospital admission for incident heart failure or a combined endpoint of heart failure or death up to 2012, evaluated using multivariable Cox proportional hazards analyses.Results The average age of participants was 55 years, 2649 (53.1%) were men, and 63.4% were managed as outpatients. Over a median of 9.9 years (interquartile range 5.9-10.6), 11.9% (n=592) of patients with pneumonia had incident heart failure compared with 7.4% (n=1712) of controls (adjusted hazard ratio 1.61, 95% confidence interval 1.44 to 1.81). Patients with pneumonia aged 65 or less had the lowest absolute increase (but greatest relative risk) of heart failure compared with controls (4.8% v 2.2%; adjusted hazard ratio 1.98, 95% confidence interval 1.5 to 2.53), whereas patients with pneumonia aged more than 65 years had the highest absolute increase (but lowest relative risk) of heart failure (24.8% v 18.9%; adjusted hazard ratio 1.55, 1.36 to 1.77). Results were consistent in the short term (90 days) and intermediate term (one year) and whether patients were treated in hospital or as outpatients.Conclusion Our results show that community acquired pneumonia substantially increases the risk of heart failure across the age and severity range of cases. This should be considered when formulating post-discharge care plans and preventive strategies, and assessing downstream episodes of

  11. Boussignac continuous positive airway pressure for the management of acute cardiogenic pulmonary edema: prospective study with a retrospective control group

    Directory of Open Access Journals (Sweden)

    Aarts Leon PHJ

    2007-12-01

    Full Text Available Abstract Background Continuous positive airway pressure (CPAP treatment for acute cardiogenic pulmonary edema can have important benefits in acute cardiac care. However, coronary care units are usually not equipped and their personnel not adequately trained for applying CPAP with mechanical ventilators. Therefore we investigated in the coronary care unit setting the feasibility and outcome of the simple Boussignac mask-CPAP (BCPAP system that does not need a mechanical ventilator. Methods BCPAP was introduced in a coronary care unit where staff had no CPAP experience. All consecutive patients transported to our hospital with acute cardiogenic pulmonary edema, a respiratory rate > 25 breaths/min and a peripheral arterial oxygen saturation of Results During the 2-year prospective BCPAP study period 108 patients were admitted with acute cardiogenic pulmonary edema. Eighty-four of these patients (78% were treated at the coronary care unit of which 66 (61% were treated with BCPAP. During the control period 66 patients were admitted over a 1-year period of whom 31 (47% needed respiratory support in the intensive care unit. BCPAP treatment was associated with a reduced hospital length of stay and fewer transfers to the intensive care unit for intubation and mechanical ventilation. Overall estimated savings of approximately € 3,800 per patient were achieved with the BCPAP strategy compared to conventional treatment. Conclusion At the coronary care unit, BCPAP was feasible, medically effective, and cost-effective in the treatment of acute cardiogenic pulmonary edema. Endpoints included mortality, coronary care unit and hospital length of stay, need of ventilatory support, and cost (savings.

  12. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study

    Science.gov (United States)

    Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Doria, Carlo

    2016-01-01

    Summary Background Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. Purpose The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. Results 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. Conclusions Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment. PMID:28228788

  13. Acute and long-term dysphagia in critically ill patients with severe sepsis: results of a prospective controlled observational study.

    Science.gov (United States)

    Zielske, Joerg; Bohne, Silvia; Brunkhorst, Frank M; Axer, Hubertus; Guntinas-Lichius, Orlando

    2014-11-01

    Dysphagia is a major risk factor for morbidity and mortality in critically ill patients treated in intensive care units (ICUs). Structured otorhinolaryngological data on dysphagia in ICU survivors with severe sepsis are missing. In a prospective study, 30 ICU patients with severe sepsis and thirty without sepsis as control group were examined using bedside fiberoptic endoscopic evaluation of swallowing after 14 days in the ICU (T1) and 4 months after onset of critical illness (T2). Swallowing dysfunction was assessed using the Penetration-Aspiration Scale (PAS). The Functional Oral Intake Scale was applied to evaluate the diet needed. Primary endpoint was the burden of dysphagia defined as PAS score >5. At T1, 19 of 30 severe sepsis patients showed aspiration with a PAS score >5, compared to 7 of 30 in critically ill patients without severe sepsis (p = 0.002). Severe sepsis and tracheostomy were independent risk factors for severe dysphagia with aspiration (PAS > 5) at T1 (p = 0.042 and 0.006, respectively). 4-month mortality (T2) was 57 % in severe sepsis patients compared to 20 % in patients without severe sepsis (p = 0.006). At T2, more severe sepsis survivors were tracheostomy-dependent and needed more often tube or parenteral feeding (p = 0.014 and p = 0.040, respectively). Multivariate analysis revealed tracheostomy at T1 as independent risk factor for severe dysphagia at T2 (p = 0.030). Severe sepsis appears to be a relevant risk factor for long-term dysphagia. An otorhinolaryngological evaluation of dysphagia at ICU discharge is mandatory for survivors of severe critical illness to plan specific swallowing rehabilitation programs.

  14. In vitro thrombotic tendency of reactive thrombocytosis in critically ill patients: a prospective case-control study.

    Science.gov (United States)

    Duff, O C; Ho, K M; Maybury, S M

    2012-05-01

    It is uncertain whether reactive thrombocytosis is associated with an increased risk of thrombosis. This prospective case-control study assessed the in vitro thrombotic tendency of patients with reactive thrombocytosis. Forty-eight patients with reactive thrombocytosis, defined by platelet count >500x10(9)/l and 55 similar, randomly selected critically ill patients who did not have reactive thrombocytosis were considered. In vitro thrombotic tendency in both groups of patients was assessed using maximal amplitude (normal range 54 to 72 mm) and alpha angle (normal range 47 to 74°) on the thromboelastograph. The associations between reactive thrombocytosis and C-reactive protein, the coagulation profile and Sequential Organ Failure Assessment score were also evaluated. Patients with reactive thrombocytosis had an associated increased in vitro thrombotic tendency (maximal amplitude 77 vs 69 mm, mean difference 8 mm, 95% confidence interval 4.9 to 10.9, P=0.001), a higher fibrinogen concentration (7.2 vs 5.8 g/l, P=0.003), and a higher incidence of infection requiring antibiotics (50 vs 27%, P=0.025) compared to patients without thrombocytosis. Platelet count had a relatively linear relationship with the maximal amplitude and the alpha angle of the thromboelastograph tracing (Pearson correlation coefficient: 0.53, P=0.001). In the multivariate analysis, only reactive thrombocytosis (odds ratio 5.9, 95% confidence interval 1.3-27.8, P=0.025) and activated partial thromboplastin time (odds ratio 0.93 per second increment, 95% confidence interval 0.87 to 0.99, P=0.016) were significantly associated with a strong in vitro thrombotic tendency. In summary, reactive thrombocytosis was associated with infection requiring antibiotics and evidence of increased in vitro thrombotic tendency in critically ill patients.

  15. Treatment of patients with severe sepsis using Ulinastatin and Thymosin α1: a prospective, randomized, controlled pilot study

    Institute of Scientific and Technical Information of China (English)

    CHEN Hao; HE Ming-yan; LI Yu-min

    2009-01-01

    Background Tradition treatment of sepsis and new therapies, including high dose corticosteroids and non-steroidal anti-inflammatory drugs, have proven unsuccessful in improving survival. This study aimed to evaluate the potential efficacy of immunomodulating therapy using Ulinastatin (UTI) plus Thymosin α1 (Tα1) for improving organ function and reducing mortality in patients with severe sepsis.Methods A prospective study was carried out with randomized and controlled clinical analysis of 114 patients conforming to the enrollment standard. All patients had severe sepsis and received standard supportive care and antimicrobial therapy. Fifty-nine patients were also administered UTI plus Tα1 (defined as Group A), 55 patients were given a placebo (defined as Group B). Clinical parameters were determined by evaluation with the Acute Physiology and Chronic Health Evaluation Ⅱ (APACHE Ⅱ), multiple organ failure (MOF) and the Glasgow Coma Scores (GCS) on entry and after therapy on the 3rd, 8th, and 28th day. By flow cytometery and ELISA lymphocyte subsets and cytokines were analyzed. Survival analysis was determined by the Kaplan-Meier method at 28, 60, and 90 days. Results Based on comparison of the two groups, patients in Group A exhibited a better performance in organ failure scores which was noticeable soon after initiation of treatment. Patients in Group A also demonstrated a better resolution of pre-existing organ failures during the observation period. After initiation of treatment, significant improvements in the CD4+/CD8+ ratio, a quicker balance between proinflammatory mediators such as tumor necrosis factor a, interleukin 6 and anti-inflammatory cytokines including interleukin 4 and interleukin 10 were found. This was followed by cumulative survival increases of 17.3% at 28 days, 28.9% at 60 days, and 31.4% at 90 days in Group A. The reduction in mortality was accompanied by a considerably shorter stay in the ICU and a shorter length of supportive

  16. The UK Prospective Diabetes Study

    DEFF Research Database (Denmark)

    Olivarius, Niels de Fine; Andreasen, A.H.

    1998-01-01

    Læserbrev, som kritiserer det store UK Prospective Diabetes Study's forfattere for at overfortolke deres fund, idet marginalt signifikante p-værdier tages som udtryk for slående effekt (af at sænke blodsukkeret). Det sker selvom der f.eks. indgår effektvariabler, som kunne påvirkes af patienternes...

  17. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

  18. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    Science.gov (United States)

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  19. A PROSPECTIVE, RANDOMIZED CONTROL STUDY EVALUATING THE POSTOPERATIVE ANALGESIA USING RECTAL DICLOFENAC IN PATIENTS UNDERGOING ELECTIVE LAPAROSCOPIC CHOLECYSTECTOMY SURGERIES

    Directory of Open Access Journals (Sweden)

    Padmaja

    2015-05-01

    Full Text Available BACKGROUND: To assess the efficacy of rectal diclofenac suppository in patients undergoing elective laparoscopic cholecystectomy surgeries in management of postoperative pain, in reduction of intra operative opioid requirement and in prolongation of postoperative anal gesic initiation time. OBJECTIVES: This prospective randomized single blinded clinical trial evaluates the efficacy of rectal diclofenac suppository for the management of postoperative pain. MATERIALS AND METHODS: 100 patients undergoing elective laparosco pic cholecystectomy surgeries were randomized into two groups, Group 1 patients receiving 100mg diclofenac rectal suppository after induction of general anaesthesia, Group 2 patients does not receive any diclofenac rectal suppository. Intra operative hemod ynamic monitoring, post - operative VAS score and adverse reactions were recorded over period of 24 hrs. Intra operative opioid (fentanyl was repeated when heart rate and blood pressure variability of more than 20% from base line are noted. Post operatively if VAS score is more than 4 rescue analgesia with inj. Tramadol is given intramuscularly. RESULTS: Administration of single dose of rectal diclofenac had statistically significant reduction in VAS score post operatively compared to control group, reduced requirement of intra operative opioids (fentanyl. Post - operative rescue analgesia initiation time is prolonged in group 1 mean 9.56 hrs compared to group 2, mean 0.72 hrs (p - 0.000. CONCLUSION: Rectal Diclofenac used in laparoscopic cholecystectomy cases provide adequate, effective prolonged analgesia in the post - operative period with good safety profile

  20. Serum uric acid and coronary heart disease in 9,458 incident cases and 155,084 controls: prospective study and meta-analysis.

    Directory of Open Access Journals (Sweden)

    Jeremy G Wheeler

    2005-03-01

    Full Text Available BACKGROUND: It has been suggested throughout the past fifty years that serum uric acid concentrations can help predict the future risk of coronary heart disease (CHD, but the epidemiological evidence is uncertain. METHODS AND FINDINGS: We report a "nested" case-control comparison within a prospective study in Reykjavik, Iceland, using baseline values of serum uric acid in 2,456 incident CHD cases and in 3,962 age- and sex-matched controls, plus paired serum uric acid measurements taken at baseline and, on average, 12 y later in 379 participants. In addition, we conducted a meta-analysis of 15 other prospective studies in eight countries conducted in essentially general populations. Compared with individuals in the bottom third of baseline measurements of serum uric acid in the Reykjavik study, those in the top third had an age- and sex-adjusted odds ratio for CHD of 1.39 (95% confidence interval [CI], 1.23-1.58 which fell to 1.12 (CI, 0.97-1.30 after adjustment for smoking and other established risk factors. Overall, in a combined analysis of 9,458 cases and 155,084 controls in all 16 relevant prospective studies, the odds ratio was 1.13 (CI, 1.07-1.20, but it was only 1.02 (CI, 0.91-1.14 in the eight studies with more complete adjustment for possible confounders. CONCLUSIONS: Measurement of serum uric acid levels is unlikely to enhance usefully the prediction of CHD, and this factor is unlikely to be a major determinant of the disease in general populations.

  1. [Prospective observational study of insulin detemir in patients with poorly controlled type 2 diabetes mellitus initiating insulin therapy for the first time (SOLVE Study)].

    Science.gov (United States)

    Orozco-Beltrán, Domingo; Artola-Menéndez, Sara

    2016-02-01

    Describe the experience in the primary care setting with insulin detemir in patients with poorly controlled type2 diabetes mellitus that need to add-on insulin to their oral antidiabetic drug therapy. Prospective observational study of 6 months of follow up, performed in 10 countries. In Spain, participating sites were only from the primary care setting. Eligible patients were those with poorly controlled type2 diabetes mellitus adding-on once-daily insulin detemir to their existing oral antidiabetic therapy in the month prior to their enrollment. The change of Hb1Ac and of weight at the end of the study and the incidence of hypoglycemia and adverse reactions, were analyzed. We report the results obtained in the Spanish cohort. Overall 17,374 patients were included, 973 in Spain [mean age 64.8 years (SE 12); duration of diabetes 9.4 years (SE 6.2); Hb1Ac 8.9% (DE 1.4)]. In the sample analyzed for efficacy (n=474) the mean change of Hb1Ac was -1.6% (95%CI: -1.75 to -1.42; P<.001), mean change of weight was -2.9 kg (95%CI: -3.72 to -2.08; P<.001). Only one episode of severe hypoglycemia was reported, which was also the only serious adverse reaction reported in the study. The incidence rate of non-severe hypoglycemia was 2.44 events/patient-year. In this cohort of patients with type 2 diabetes mellitus receiving newly initiated insulin therapy, once-daily detemir improved the glycemic control, with low incidence of hypoglycemia and a significant reduction of the weight. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

  2. The mediating effects of situational control on social support and mood following a stressor: a prospective study of dementia caregivers in their natural environments.

    Science.gov (United States)

    Atienza, A A; Collins, R; King, A C

    2001-05-01

    The present study examined, prospectively and within the context of stress experienced in the natural environment, whether situational control served as a mediator between perceived social support and caregiver's mood. Data came from baseline assessments of individuals participating in health promotion interventions for women caregivers. Participants were 49 female caregivers of dementia patients who monitored their own acute psychological states during the day. Results revealed that although the occurrence of a situational stressor increased negative mood, greater perceived support reduced the detrimental impact of a stressor on negative mood. Moreover, path analyses revealed that changes in situational control partially mediated the relationship between perceived support and stress-induced negative mood changes. However, changes in control did not serve as a mediator in analyses focused on happiness. Results suggest that caregivers with greater perceived support were less emotionally reactive to stress occurring in their natural environments because of, in part, sustained or increased situational control.

  3. Does Cytoreductive Prostatectomy Really Have an Impact on Prognosis in Prostate Cancer Patients with Low-volume Bone Metastasis? Results from a Prospective Case-Control Study.

    Science.gov (United States)

    Steuber, Thomas; Berg, Kasper D; Røder, Martin A; Brasso, Klaus; Iversen, Peter; Huland, Hartwig; Tiebel, Anne; Schlomm, Thorsten; Haese, Alexander; Salomon, Georg; Budäus, Lars; Tilki, Derya; Heinzer, Hans; Graefen, Markus; Mandel, Philipp

    2017-07-08

    The impact of cytoreductive radical prostatectomy (CRP) on oncological outcomes in patients with prostate cancer (PCa) and distant metastases has been demonstrated by retrospective data with their potential selection bias. Using prospective institutional data, we compared the outcomes between 43 PCa patients with low-volume bone metastases (1-3 lesions) undergoing CRP (median follow-up 32.7 mo) and 40 patients receiving best systemic therapy (BST; median follow-up 82.2 mo). The inclusion criteria for both cohorts were identical. So far, no significant difference in castration resistant-free survival (p=0.92) or overall survival (p=0.25) has been detected. Compared to recent reports, the outcomes for our control group are more favorable, indicating a potential selection bias in the previous retrospective studies. Therefore, the unclear oncological effect has to be weighed against the potential risks of CRP. However, patients benefit from a significant reduction in locoregional complications (7.0% vs 35%; p<0.01) when undergoing CRP. In this study we analyzed the impact of surgery in patients with prostate cancer and bone metastases. Using prospective data, we could not show a significant benefit of surgery on survival, but the rate of locoregional complications was lower. Therefore, patients should be treated within prospective trials evaluating the role of cytoreductive prostatectomy in low-volume, bone metastatic prostate cancer. Copyright © 2017 European Association of Urology. Published by Elsevier B.V. All rights reserved.

  4. Clinical patterns of vitiligo and its associated co morbidities: A prospective controlled cross-sectional study in South India

    Directory of Open Access Journals (Sweden)

    D S Krupa Shankar

    2012-01-01

    Full Text Available Aim: The purpose of this study is to assess the clinical patterns and associations of vitiligo, audiometric functions, and ocular involvement and to correlate the morphology, clinical behaviour and comorbidities associated with vitiligo. Settings and Design: For this prospective and cross-sectional study 80 self-reporting patients in the age group 7-75 years with vitiligo attending the outpatient department of Manipal hospital during the period August 2008 to February 2010 were selected and the data was analysed. Materials and Methods: The patients were subjected to detailed history, clinical examination and investigations [complete blood count (CBC, absolute eosinophil count (AEC, erythrocyte sedimentation rate (ESR, thyroid stimulating hormone (TSH, vitamin B12 estimation, fasting blood sugar (FBS, and post prandial blood sugar (PPBS,antibody titre estimations that is antithyroid peroxidase (ATPA, antithyroglobulin (ATA, antinuclear antibodies (ANA,urine analysis], audiometric evaluation and ophthalmic examination. Statistical Analysis Used: The Fisher exact test has been used to find the significance of study parameters on categorical scale between two or more groups. Results: In the present series of 80 cases, 41 (51.25% were males and 39 (48.75% were females. The male to female ratio was 1.05:1. In our study 20% cases gave definite family history of vitiligo and patients in the age group of 20 - 30 years were the most commonly affected. Generalized vitiligo (31.3% was the most common type followed by segmental (30%, focal (18.8%, acrofacial (8.8%, and mucosal vitiligo (11.3%. In the present study there was a high incidence of autoantibodies (22.5%, vitamin B12 deficiency (30%, hypothyroidism (11.3%, elevated absolute eosinophil count (16.3%, hypoacusis (10% and retinal changes (8.8%. This suggests multisystem autoimmunity in vitiligo.

  5. Clinical tolerability of perioperative tenoxicam in 1001 patients--a prospective, controlled, double-blind, multi-centre study.

    Science.gov (United States)

    Merry, Alan F; Webster, Craig S; Holland, Robin L; Middleton, Neil G; Schug, Stephan A; James, Margaret; McGrath, Ken A

    2004-10-01

    We investigated adverse events (AEs) associated with perioperative tenoxicam in a double-blind, prospective, randomised study. Patients undergoing surgery, screened for contraindications to non-steroidal anti-inflammatory drug, received tenoxicam (n=750) on 2843 days or placebo (n=251) on 988 days, in courses of 1-12 days. There was no increase in the overall incidence of side effects with tenoxicam (33 vs 38% with placebo: P=0.15), or in major side effects (3.9 vs 2.0% with placebo: P=0.11). Of major side effects possibly or probably related to tenoxicam (2.1 vs 1.2% with placebo: P=0.26), all but one involved post-operative surgical site bleeding. However, in the subgroup of patients undergoing otorhinolaryngology surgery, surgical site bleeding occurred in 18 of 171 (10.5%) patients on tenoxicam and one of 57 (1.8%) on placebo (P=0.026); of these, nine in the tenoxicam group and 0 in the placebo were classified as major (P=0.07). One patient on tenoxicam experienced endoscopically proven duodenal ulceration with malaena. In conclusion, perioperative tenoxicam is well tolerated in comparison with placebo and the incidence of drug-related major AEs (other than post-operative bleeding) is no greater than 1 in 150 in low risk patients, but in patients undergoing otorhinolaryngological surgery there may be an increased risk of post-operative bleeding.

  6. Emerging risk factors and the dose-response relationship between physical activity and lone atrial fibrillation: a prospective case-control study.

    Science.gov (United States)

    Calvo, Naiara; Ramos, Pablo; Montserrat, Silvia; Guasch, Eduard; Coll-Vinent, Blanca; Domenech, Mònica; Bisbal, Felipe; Hevia, Sara; Vidorreta, Silvia; Borras, Roger; Falces, Carles; Embid, Cristina; Montserrat, Josep Maria; Berruezo, Antonio; Coca, Antonio; Sitges, Marta; Brugada, Josep; Mont, Lluís

    2016-01-01

    The role of high-intensity exercise and other emerging risk factors in lone atrial fibrillation (Ln-AF) epidemiology is still under debate. The aim of this study was to analyse the contribution of each of the emerging risk factors and the impact of physical activity dose in patients with Ln-AF. Patients with Ln-AF and age- and sex-matched healthy controls were included in a 2:1 prospective case-control study. We obtained clinical and anthropometric data transthoracic echocardiography, lifetime physical activity questionnaire, 24-h ambulatory blood pressure monitoring, Berlin questionnaire score, and, in patients at high risk for obstructive sleep apnoea (OSA) syndrome, a polysomnography. A total of 115 cases and 57 controls were enrolled. Conditional logistic regression analysis associated height [odds ratio (OR) 1.06 [1.01-1.11

  7. Prevalence and risk factors of Helicobacter pylori infection in Saudi children: a three-year prospective controlled study.

    Science.gov (United States)

    Hasosah, Mohammed; Satti, Mohammed; Shehzad, Amir; Alsahafi, Ashraf; Sukkar, Ghassan; Alzaben, Abdullah; Sunaid, Areej; Ahmed, Abdullah; AlThubiti, Sami; Mufti, Areej; Jacobson, Kevan

    2015-02-01

    Helicobacter pylori (H. pylori) infection is the most common chronic infections. The risk factors for H. pylori infection in both developing and developed countries are closely related to poor living conditions in childhood. This study aimed to establish the prevalence of H. pylori infection and its associated risk factors among children in the western and central regions of Saudi Arabia. A prospective cross-sectional study was performed among symptomatic children in National Guard hospitals who underwent esophagogastroduodenoscopy from 2010 to 2013. The gold standard diagnosis of H. pylori infection was histologic presence of the bacteria in the gastric biopsy. The variables analyzed as possible risk factors included demographic and living characteristics, socioeconomic status, potential mode of transmission, and clinical indications of H. pylori infection. A total of 303 children were included in the study. The overall prevalence of H. pylori infection was 49.8%. Among the studied variables, the following were positively associated with the presence of H. pylori in multivariable analyses: age above 10 years(OR = 11.84, 95% CI = 3.90-35.94, p pylori infection (p = .005 and .009, respectively). Helicobacter pylori infection had a high prevalence among Saudi children in the cities of Jeddah and Riyadh. It was a relatively common cause of abdominal pain and anorexia. In this cohort of children, H. pylori infection was associated with variables indicative of a crowded environment and poor living conditions, further supporting the conclusion that improving socioeconomic conditions and designing a preventive health strategy in Saudi Arabia will likely protect children against this infection. © 2014 John Wiley & Sons Ltd.

  8. Cost of dengue and other febrile illnesses to households in rural Cambodia: a prospective community-based case-control study

    OpenAIRE

    Margolis Harold S; Duong Socheat; Ngan Chantha; Beatty Mark; Wichmann Ole; Huy Rekol; Vong Sirenda

    2009-01-01

    Abstract Background The average annual reported dengue incidence in Cambodia is 3.3/1,000 among children < 15 years of age (2002–2007). To estimate the economic burden of dengue, accurate cost-of-illness data are essential. We conducted a prospective, community-based, matched case-control study to assess the cost and impact of an episode of dengue fever and other febrile illness on households in rural Cambodia. Methods In 2006, active fever surveillance was conducted among a cohort of 6,694 c...

  9. Restoring vaginal microbiota: biological control of bacterial vaginosis. A prospective case-control study using Lactobacillus rhamnosus BMX 54 as adjuvant treatment against bacterial vaginosis.

    Science.gov (United States)

    Recine, Nadia; Palma, Ettore; Domenici, Lavinia; Giorgini, Margherita; Imperiale, Ludovica; Sassu, Carolina; Musella, Angela; Marchetti, Claudia; Muzii, Ludovico; Benedetti Panici, Pierluigi

    2016-01-01

    Bacterial vaginosis (BV) is the most prevalent lower genital tract infection in reproductive-age women worldwide. BV is an ecological disorder of the vaginal microbiota characterized microbiologically by replacement of the lactobacilli, predominant vaginal microbiota. It is characterized by a high rate of relapse in sexual active women, and these patients show three or more relapses each year. A healthy vagina is characterized by hydrogen peroxide and acid-producing lactobacilli, which are crucial to maintain the physiological vaginal ecosystem and their depletion speeds up bacterial overgrowth with pH elevation, salidase and amine production, leading to the observed signs and symptoms of BV. The aim of this study is to evaluate the efficacy of long-term vaginal lactobacilli's implementation in restoring and maintaining vaginal microflora and pH and to collect data about prophylactic approach based on probiotics supplementation with lactobacilli. This is a prospective case-control study, performed between January 2013 and September 2014 at Department of Gynecological Obstetrics and Urologic Sciences of "Sapienza" University of Rome. 250 non-pregnant sexually active women with diagnoses of BV were collected. Patients selected were divided in Group A (125 patients assigned to standard treatment for BV-metronidazole 500 mg orally twice a day for 7 days) and Group B (125 women undergoing the same standard antibiotic regimen followed by vaginal tablets containing Lactobacillus rhamnosus BMX 54). Patients were evaluated after 2, 6, and 9 months (T0, T2, T6, and T9) in term of recurrences rates of BV, vaginal symptoms, re-establishment of healthy vaginal flora, vaginal pH, and treatment tolerability. Vaginal flora was significantly replaced in Group B patients after 2 months comparing with Group A (p = 0.014). These data were confirmed at 6 and 9 months follow-up: patients that underwent prophylactic therapy with NORMOGIN(®) experienced significantly low rate of

  10. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2016-01-01

    Full Text Available Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG and beta-tricalcium phosphate (β-TCP alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05. Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials.

  11. Relationship between tea consumption and pancreatic cancer risk: a meta-analysis based on prospective cohort studies and case-control studies.

    Science.gov (United States)

    Chen, Ke; Zhang, Qi; Peng, Min; Shen, Yanping; Wan, Peng; Xie, Guoming

    2014-09-01

    The aim of this study was to evaluate the relationship between regular tea consumption and the risk of pancreatic cancer by a meta-analysis. Two investigators independently performed a computer retrieve on the electronic databases of Embase, PubMed, and Ovidsp for prospective cohort studies and case-control studies on regular tea consumption and the risk of pancreatic cancer incidence. The keywords using for search were ('Pancreas' OR 'pancreatic') AND ('neoplasms' OR 'carcinoma' OR 'cancer') AND 'tea'. Risk ratios (RRs) and 95% confidence interval (CI) were used to determine the effect of tea consumption on pancreatic cancer. A total of 14 studies were included (8078 pancreatic cancer patients, with a total of 859 783 patients) in the present meta-analysis. The pooled results of effect size indicated that tea consumption has no significant relationship with risk of pancreatic cancer (RR=0.99, 95% CI: 0.89-1.11, P=0.922). However, the subgroup analysis of different countries showed a statistical decrease in pancreatic cancer risk by high consumption of tea in a Chinese population (RR=0.76, 95% CI: 0.59-0.98, P=0.036). Similar results were found in the elderly (>60 years old) (RR=0.76, 95% CI: 0.60-0.96, P=0.023). In conclusion, the present meta-analysis of 14 studies suggests that the correlation between tea consumption and the risk of pancreatic cancer in the general population is not significant, but an increase in tea consumption can reduce the risk of pancreatic cancer disease in Chinese populations and in individuals older than 60 years of age. It is necessary to formulate more rigorous designs of regional studies to further confirm the relationship between tea consumption and pancreatic cancer.

  12. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies123

    Science.gov (United States)

    Miller, Paige E; Perez, Vanessa

    2014-01-01

    Background: Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. Objective: The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. Design: A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. Results: In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (−0.80 kg; 95% CI: −1.17, −0.43), body mass index [BMI (in kg/m2): −0.24; 95% CI: −0.41, −0.07], fat mass (−1.10 kg; 95% CI: −1.77, −0.44), and waist circumference (−0.83 cm; 95% CI: −1.29, −0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). Conclusions: The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve

  13. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies.

    Science.gov (United States)

    Miller, Paige E; Perez, Vanessa

    2014-09-01

    Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (-0.80 kg; 95% CI: -1.17, -0.43), body mass index [BMI (in kg/m²): -0.24; 95% CI: -0.41, -0.07], fat mass (-1.10 kg; 95% CI: -1.77, -0.44), and waist circumference (-0.83 cm; 95% CI: -1.29, -0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans. © 2014 American Society

  14. DEXMEDETOMIDINE AND CLONIDINE AS ADJUVANTS TO LEVOBUPIVACAINE IN SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK: A COMPARATIVE RANDOMISED PROSPECTIVE CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Karthik

    2015-03-01

    Full Text Available BACKGROUND: There are always efforts to find better and safer local anaesthetics along with adjuvants for supraclavicular brachial plexus block. Levobupivacaine, has strongly emerged as a safer alternative for regional anesthesia than its racemic sibling, bupivacaine. Alpha 2 agonists are combined with local anaesthetics to improve the quality of regional anesthesia. AIMS AND OBJECTIVES: This study was conducted to evaluate and compare the onset, duration of sensory and motor blockade along with the duration of analges ia between dexmedetomidine and clonidine when administered along with 0.5% levobupivacaine in supraclavicular brachial plexus block for upper limb orthopaedic surgeries. MATERIALS AND METHODS: A prospective randomized study was carried out in the departmen t of Anaesthesia at Rajarajeswari Medical College and Hospital which included 50 adult patients between the ages of 20 and 50 years (of ASA I/II grade who underwent upper limb orthopaedic surgeries. The patients were randomly allocated into two groups; le vobupivacaine + dexmedetomidine (LD and levobupivacaine + clonidine (LC, comprising of 25 patients each. Group LD was administered 30 ml of 0.5% levobupivacaine and 1μg/kg of dexmedetomidine, while group LC received admixture of 30 ml of 0.5% levobupivac aine and 1 μg/kg of Clonidine. Onset, duration of sensory and motor blockade and duration of analgesia were observed. STATISTICAL ANALYSIS: Statistical analysis was done using student t test, chi - square test and Fisher Exact test. The Statistical Software namely SAS 9.2, SPSS 15.0, Stata 10.1, MedCalc 9.0.1, Sysatat 12.0 and R environment ver.2.11.1 were also used for the analysis of the data and Microsoft word and Excel have been used to generate graphs, tables etc. The value of P <0.05 was considered significant and P < 0.001 as highly significant. RESULTS: The onset of sensory and motor blockade was faster in Group LD when compared to Group LC. The duration of sensory

  15. Early crisis nontechnical skill teaching in residency leads to long-term skill retention and improved performance during crises: A prospective, nonrandomized controlled study.

    Science.gov (United States)

    Doumouras, Aristithes G; Engels, Paul T

    2017-07-01

    Medical error is common in crises, and the majority of observed errors are nontechnical in nature. The long-term impact of teaching crisis nontechnical skills to residents has not been evaluated. The objective of this study was to determine the effect of simulation-based teaching of crisis nontechnical skills compared to controls one year after initial teaching. This was a prospective study using both historical controls and a before-and-after methodology to evaluate the effect of a high-fidelity simulation curriculum that used crisis resource management principles to teach nontechnical skills. Postgraduate year 2 and 3 residents were invited to take part in a prospective training course over 2 years. The primary outcome was leader performance evaluated by expert raters using the previously validated 7-point Ottawa Global Rating Scale. Overall, 23 residents performed 30 simulations over the 2 years with the intervention group of 7 residents being assessed in both years. After adjustment, the postgraduate year 3 intervention group who received training the previous year had significantly higher overall performance scores than all postgraduate year 2 scores (1.09 95% confidence interval 0.70-1.47, P < .001) and the historical postgraduate year 3 cohort who received no prior training (1.20, 95% confidence interval 0.37-2.03, P = .005). There was no decay of skills noted over the course of the study. Postgraduate year 3 residents who had prior training had significantly improved crisis performance compared to historical postgraduate year 3 controls and untrained postgraduate year 2 residents. There were no significant differences between the crisis performance of postgraduate year 2 residents and the untrained postgraduate year 3 controls. This confirms the beneficial effect and long-term retention after crisis nontechnical skill training. Copyright © 2016 Elsevier Inc. All rights reserved.

  16. A prospective randomised controlled study on efficacies of acupuncture and steroid in treatment of idiopathic peripheral facial paralysis.

    Science.gov (United States)

    Tong, Fu Man; Chow, Shun Kit; Chan, Patrick Yiu Bong; Wong, Alex Kam Wah; Wan, Sambo Shuk Ying; Ng, Rebecca Ka Wah; Chan, Geoffrey; Chan, Wing Shan; Ng, Angela; Law, Chi Keung

    2009-12-01

    A randomised controlled trial was undertaken to evaluate the efficacy of acupuncture in comparison with steroid in treatment of idiopathic peripheral facial paralysis (Bell's palsy). A total of 119 patients attending Ear, Nose and Throat Clinic of Pamela Youde Nethersole Eastern Hospital from February 2003 to December 2005 were randomly allocated to groups of acupuncture, steroid and control (conventional expectant treatment). There were 53 in the steroid group, 28 in the acupuncture group and 38 in the control group. Patients were assessed weekly by blinded assessors, using the House-Brackmann facial nerve grading system. The efficacy of treatment in three groups was compared, in terms of degree of recovery and speed of recovery. Intention-to-treat analyses were performed. Results were analysed with SPSS software. Distribution of initial grade on presentation was analysed with the Pearson chi-square test and showed uneven distribution in the three groups in the intention-to-treat analysis. The overall improvement (grade 3 or better) was 86.9% in the steroid group, 96.4% in the acupuncture group and 89.5% in the control group respectively. However, the difference in degree of recovery and speed of recovery in the three groups was not statistically significant. The efficacies of acupuncture, steroid and conventional expectant treatment (natural course of recovery) in idiopathic peripheral facial palsy (Bell's palsy) in the study were the same with respect to the degree of recovery and speed of recovery.

  17. EFFECT OF NEBULIZED COLISTIN ON THE VENTILATOR CIRCUIT: A PROSPECTIVE PILOT CASE-CONTROL STUDY FROM A SINGLE CANCER CENTER

    Directory of Open Access Journals (Sweden)

    Iyad M Ghonimat

    2015-04-01

    Full Text Available Nebulized colistin (NC is used for the treatment of pneumonia due to multidrug-resistant Gram-negative bacteria. In this one-year case-control study, our objective was to evaluate the effect of NC on the ventilator circuit (VC components. The case group consisted of 25 mechanically-ventilated patients who received NC, while the control group was 25 mechanically-ventilated patients who did not receive NC. Respiratory therapists inspected the VC every 4 hrs and whenever a ventilator alarm was reported. The VC component was changed if the alarm did not subside after necessary measures were performed. Patients from both groups were treated at the adult ICU in King Hussein Cancer Center (KHCC. In the case group, 22(88% patients required changing at least one of the circuit components (flow sensor, exhalation membrane, or nebulizer kit. The median number of changes (range per patient of the flow sensor, exhalation membrane, and nebulizer kit were: 2(1-3, 2(1-6, and 1(1-2, respectively. Large amounts of white crystals, which resembled the colistin powder, were reported on the replaced VC components. The flow sensor was changed in 2 control patients, but white crystals were absent. Crystals obtained from one case subject were confirmed to be colistin by chromatographic mass spectroscopy. Further studies are needed to evaluate the effect of crystal formation on the efficacy of NC and clinical outcomes.

  18. Return to work after a workplace-oriented intervention for patients on sick-leave for burnout - a prospective controlled study

    Directory of Open Access Journals (Sweden)

    Larsson Britt

    2010-06-01

    Full Text Available Abstract Background In the present study the effect of a workplace-oriented intervention for persons on long-term sick leave for clinical burnout, aimed at facilitating return to work (RTW by job-person match through patient-supervisor communication, was evaluated. We hypothesised that the intervention group would show a more successful RTW than a control group. Methods In a prospective controlled study, subjects were identified by the regional social insurance office 2-6 months after the first day on sick leave. The intervention group (n = 74 was compared to a control group who had declined participation, being matched by length of sick leave (n = 74. The RTW was followed up, using sick-listing register data, until 1.5 years after the time of intervention. Results There was a linear increase of RTW in the intervention group during the 1.5-year follow-up period, and 89% of subjects had returned to work to some extent at the end of the follow-up period. The increase in RTW in the control group came to a halt after six months, and only 73% had returned to work to some extent at the end of the 1.5-year follow-up. Conclusions We conclude that the present study demonstrated an improvement of long-term RTW after a workplace-oriented intervention for patients on long-term sick leave due to burnout. Trial registration Current Controlled Trials NCT01039168.

  19. PROSPECTIVE RANDOMISED CONTROL STUDY OF POST OP EPIDURAL ANALGESIA WITH BUPIVACAINE AND FENTANYL VS. BUPIVACAINE AND CLONIDINE

    Directory of Open Access Journals (Sweden)

    Rachana

    2014-07-01

    Full Text Available The aim of the study was to compare the relative potencies and clinical characteristics of epidural Clonidine and Fentanyl with Bupivacaine in lower limb and lower abdominal surgeries using patient-controlled analgesia. In a randomised double-blinded study, 60 ASA I or II patients requiring epidural analgesia for post- operative pain relief were allocated to receive either 0.125% Bupivacaine with Clonidine 1µg/kg or 0.125% Bupivacaine with Fentanyl 1µg/kg via a sterile syringe by trained anaesthesiologists. Analgesia was established with 10-15 ml bolus of study solution. There were significant differences in onset time, duration and quality of analgesia, local anaesthetic consumption, between the two groups. We conclude that 0.125% Bupivacaine with Clonidine 1µg/kg group of patients clinically had better quality of analgesia and for a longer duration in comparison with patients receiving 0.125% Bupivacaine with Fentanyl 1µg/kg.

  20. Moist wound healing compared with standard care of treatment of primary closed vascular surgical wounds: a prospective randomized controlled study

    DEFF Research Database (Denmark)

    Vogt, Katja C; Uhlyarik, M; Schroeder, Torben V

    2007-01-01

    This study was a randomized-controlled trial comparing the standard type of dry dressing, Mepore, with moist wound healing, using a hydrofiber dressing, Aquacel, in primary closed wounds after vascular surgery. The endpoints were patient comfort, cost-effectiveness, infections, wound complications....... No difference in the infection rate (13% vs. 11%, p=0.73), length of hospital stay, or wound complications was noted between the two groups. We conclude that although the Aquacel dressing needed significantly fewer changes than the conventional dressing, this did not influence the patient comfort. Moreover...

  1. Effect of intravenous GLutamine supplementation IN Trauma patients receiving enteral nutrition study protocol (GLINT Study): a prospective, blinded, randomised, placebo-controlled clinical trial.

    Science.gov (United States)

    Al Balushi, Ruqaiya M; Paratz, Jennifer D; Cohen, Jeremy; Banks, Merrilyn; Dulhunty, Joel; Roberts, Jason A; Lipman, Jeffrey

    2011-01-01

    Background Trauma patients are characterised by alterations in the immune system, increased exposure to infectious complications, sepsis and potentially organ failure and death. Glutamine supplementation to parenteral nutrition has been proven to be associated with improved clinical outcomes. However, glutamine supplementation in patients receiving enteral nutrition and its best route are still controversial. Previous trials have been limited by a small sample size, use of surrogate outcomes or a limited period of supplementation. The aim of this trial is to investigate if intravenous glutamine supplementation to trauma patients receiving enteral nutrition is associated with improved clinical outcomes in terms of decreased organ dysfunction, infectious complications and other secondary outcomes. Methods/design Eighty-eight critically ill patients with multiple trauma receiving enteral nutrition will be recruited in this prospective, triple-blind, block-randomised, placebo-controlled clinical trial to receive either 0.5 g/kg/day intravenous undiluted alanyl-glutamine or intravenous placebo by continuous infusion (24 h/day). Both groups will be receiving the same standard enteral nutrition protocol and the same standard intensive care unit care. Supplementation will continue until discharge from the intensive care unit, death or a maximum duration of 3 weeks. The primary outcome will be organ-dysfunction evaluation assessed by the pattern of change in sequential organ failure assessment score over a 10-day period. The secondary outcomes are: the changes in total sequential organ failure assessment score on the last day of treatment, infectious complications during the ICU stay, 60-day mortality, length of stay in the intensive care unit and body-composition analysis. Discussion This study is the first trial to investigate the effect of intravenous alanyl-glutamine supplementation in multiple trauma patients receiving enteral nutrition on reducing severity of organ

  2. Alloplastic total temporomandibular joint replacements: do they perform like natural joints? Prospective cohort study with a historical control.

    Science.gov (United States)

    Wojczyńska, A; Leiggener, C S; Bredell, M; Ettlin, D A; Erni, S; Gallo, L M; Colombo, V

    2016-10-01

    The aim of this study was to qualitatively and quantitatively describe the biomechanics of existing total alloplastic reconstructions of temporomandibular joints (TMJ). Fifteen patients with unilateral or bilateral TMJ total joint replacements and 15 healthy controls were evaluated via dynamic stereometry technology. This non-invasive method combines three-dimensional imaging of the subject's anatomy with jaw tracking. It provides an insight into the patient's jaw joint movements in real time and provides a quantitative evaluation. The patients were also evaluated clinically for jaw opening, protrusive and laterotrusive movements, pain, interference with eating, and satisfaction with the joint replacements. The qualitative assessment revealed that condyles of bilateral total joint replacements displayed similar basic motion patterns to those of unilateral prostheses. Quantitatively, mandibular movements of artificial joints during opening, protrusion, and laterotrusion were all significantly shorter than those of controls. A significantly restricted mandibular range of motion in replaced joints was also observed clinically. Fifty-three percent of patients suffered from chronic pain at rest and 67% reported reduced chewing function. Nonetheless, patients declared a high level of satisfaction with the replacement. This study shows that in order to gain a comprehensive understanding of complex therapeutic measures, a multidisciplinary approach is needed. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  3. Blood fatty acid patterns are associated with prostate cancer risk in a prospective nested case-control study

    Science.gov (United States)

    Yang, Meng; Ayuningtyas, Azalea; Kenfield, Stacey A.; Sesso, Howard D.; Campos, Hannia; Ma, Jing; Stampfer1, Meir J.; Chavarro, Jorge E.

    2016-01-01

    Background Circulating fatty acids are highly correlated with each other and analyzing fatty acid patterns could better capture their interactions and their relation to prostate cancer. We aimed to assess the associations between data-derived blood fatty acid patterns and prostate cancer risk. Methods We conducted a nested case-control study in the Physicians’ Health Study. Fatty acids levels were measured in whole blood samples of 476 cases and their matched controls by age and smoking status. Fatty acid patterns were identified using principal component analysis. Conditional logistic regression was used to estimate odds ratio (OR) and 95% confidence interval (CI). Results Two patterns explaining 40.9% of total variation in blood fatty acid levels were identified. Pattern 1, which mainly reflects polyunsaturated fatty acid metabolism, was suggestively positively related to prostate cancer risk (ORquintile 5 vs. quintile 1=1.37, 95%CI=0.91–2.05, Ptrend=0.07). Pattern 2, which largely reflects de novo lipogenesis, was significantly associated with higher prostate cancer risk (ORquintile5 vs quintile1=1.63, 95%CI=1.04–2.55, Ptrend=0.02). This association was similar across tumor stage, grade, clinical aggressiveness categories and follow-up time. Conclusion The two patterns of fatty acids we identified were consistent with known interactions between fatty acid intake and metabolism. A pattern suggestive of higher activity in the de novo lipogenesis pathway was related to higher risk of prostate cancer. PMID:27488836

  4. A prospective study of anxiety in ICD patients with a pilot randomized controlled trial of cognitive behavioral therapy for patients with moderate to severe anxiety

    DEFF Research Database (Denmark)

    Qintar, Mohammed; George, Jason J; Panko, Melanie

    2015-01-01

    consisted of two parts: part 1 (N = 690) was a prospective cross-sectional observational study of consecutive ICD patients. Patients completed the Beck Anxiety Inventory (BAI), Generalized Anxiety Disorder Scale (GAD-7), Florida Shock Anxiety Scale (FSAS), and Florida Patient Acceptance Survey (FPAS......PURPOSE: Stress and anxiety are potential consequences from arrhythmias and implantable cardioverter defibrillator (ICD) shocks that can contribute to substantial morbidity. We assessed anxiety associated with an ICD and whether cognitive behavioral therapy (CBT) reduces anxiety. METHODS: The study......) psychometric tests. Part 2 (N = 29) was a pilot randomized controlled trial of CBT (three sessions in 3 months) vs. usual care (UC) in patients with BAI ≥ 19 from part 1. RESULTS: The median BAI and GAD-7 scores were 5 and 2, respectively. By BAI scores, 64.5 % had minimal and 3.9 % had severe anxiety. By GAD...

  5. Effects of interleukin-3 following chemotherapy of non-Hodgkin's lymphoma. A prospective, controlled phase I/II study.

    Science.gov (United States)

    Hovgaard, D J; Nissen, N I

    1995-02-01

    The effect of rhIL-3 was investigated in 32 patients with newly diagnosed non-Hodgkin lymphoma in a phase I/II trial. All patients received 6 cycles of standard CHOP chemotherapy, and each patient was his own control where rhIL-3 was given as a daily s.c. injection for 14 days (day 2-15) in cycle 2 and 4, while cycle 1 and 3 were control cycles. Five dose levels were examined (0.5 - 1 - 5 - 7.5 - 10 micrograms/kg). Compared to the other more lineage-specific hemopoietic growth factors G- and GM-CSF, the effect of rhIL-3 on the hemopoiesis was less dramatic and more delayed, i.e. the most apparent effect was observed in the 2 weeks of treatment. Thus, the neutrophil counts from days 15 to 22 following CHOP were significantly raised and the duration of neutropenia was shorter (significantly only at 10 micrograms/kg), while the nadir values were unaffected. Platelet recovery from days 12-22 was significantly increased and nadir values occurred earlier compared to control cycles, but were only increased in some subsets. Other cell populations affected moderately in the recovery period were eosinophils and monocytes. Reticulocytes increased, but no effect on hemoglobin or RBC transfusion requirement was noted. Only moderate adverse reactions occurred such as fever, chills, flushing of the face and flu-like symptoms. There was no evidence of stimulation of tumor growth. Most significant, the rhIL-3 treatment at all but the lowest dose levels led to an improved tolerance to chemotherapy, as indicated by a decline in number of delayed cycles. A conclusion concerning the role of rhIL-3 as post-chemotherapy adjuvant should await studies using rhIL-3 in combination with more lineage-restricted hemopoietic growth factors.

  6. [Prospective study in 2 hospitals].

    Science.gov (United States)

    Jiménez-Buñuales, M T; Martínez-Sáenz, M S; González-Diego, P; Vallejo-García, M; Gallardo-Anciano, J; Cestafe-Martínez, A

    2016-06-01

    The purpose of this study is to know the incidence rate of medication reconciliation at admission and discharge in patients of La Rioja and to improve the patient safety on medication reconciliation. An observational prospective study, part of the Joint Action PaSQ, Work Package 5, European Union Network for Patient Safety and Quality of Care. The study has taken into account the definitions of the Institute for Safe Medication Practices. Any unintended discrepancy in medication between chronic treatment and the treatment prescribed in the hospital was considered as a reconciliation error. A total of 750 patients were included, 9 (1.2%) of whom showed at least one discrepancy. The patients had a total of 3,156 mediations registered: 2,313 prescriptions (73.4%) showed no differences, while 821 prescriptions (26%) were intended discrepancies and 21 prescriptions (0.6%) unintended discrepancies were considered by the physician as reconciliation errors. A percentage of 1.2 of the patients, which represents 0.6% of the medicines (one in 166 medications registered) had reconciliation errors during their hospital stay. A proceeding has been implemented by means of the physician doing the medication reconciliation and reviewing it with the help of a medication reconciliation form. The medication reconciliation is a priority strategic objective to improve the safety of patients. Copyright © 2016 SECA. Published by Elsevier Espana. All rights reserved.

  7. Auricular acupressure reduces anxiety levels and improves outcomes of in vitro fertilization: a prospective, randomized and controlled study.

    Science.gov (United States)

    Qu, Fan; Zhang, Dan; Chen, Lu-Ting; Wang, Fang-Fang; Pan, Jie-Xue; Zhu, Yi-Min; Ma, Chun-Mei; Huang, Yi-Ting; Ye, Xiao-Qun; Sun, Sai-Jun; Zheng, Wen-Jun; Zhang, Run-Ju; Xu, Jian; Xing, Lan-Feng; Huang, He-Feng

    2014-05-22

    The study was to explore whether auricular acupressure (AA) can relieve anxiety during the period from trans-vaginal oocyte retrieval to the embryo transfer in IVF treatment and whether AA can improve the outcomes of IVF. 305 infertile patients with tubal blockage who were referred for IVF were included. The women were randomized into a control group with 102 cases, a Sham-AA group with 102 cases and an AA group with 101 cases. The anxiety levels were rated with Spielberger's State Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale. Data of clinical pregnancy rate (CPR), implantation rate (IR) and live birth rate (LBR) were obtained. The levels of neuropeptide Y (NPY) and transforming growth factor alpha (TGF-alpha) in the follicular fluids were detected with ELISA. After treatment, in AA group, the levels of state anxiety, preoperative anxiety and need-for-information were significantly lower, whereas CPR, IR, LBR and NPY levels in the follicular fluids were markedly higher than Sham-AA group and control group. We concluded that AA could help to reduce anxiety levels associated with IVF and improves the outcomes of IVF partly through increasing the levels of NPY in the follicular fluids.

  8. The effect of personal, familial, and environmental characteristics on acne vulgaris: a prospective, multicenter, case controlled study from Turkey.

    Science.gov (United States)

    Karadağ, Ayşe S; Balta, İlknur; Saricaoğlu, Hayriye; Kiliç, Selim; Kelekçi, Kıymet H; Yildirim, Mehmet; Arica, Deniz A; Öztürk, Savaş; Karaman, Göksun; Çerman, Aslı A; Bilgili, Serap G; Turan, Enver; Demirci, Mustafa M; Uzunçakmak, Tuğba K; Güvenç, Serdar C; Ataseven, Arzu; Ferahbaş, Ayten; Aksoy, Berna; Çölgeçen, Emine; Ekiz, Özlem; Topaloğlu Demir, Filiz; Bilgiç, Özlem; Çakmak, Seray; Uçmak, Derya; Özuğuz, Pınar; Kaymak Konkuralp, Yeşim; Ermertcan, Aylin T; Gökdemir, Gonca; Bülbül Başkan, Emel; Alyamaç, Gökçen; Şanli, Hatice

    2017-07-11

    There are only a few studies about epidemiological features of acne vulgaris in the literature. The aim of this study was to analyze demographic, clinical, familial and environmental characteristics of acne, the role of diet and aggravating factors and association of these factors with acne severity. Patients with a diagnosis of mild-moderate to severe acne were consecutively interviewed at the participating centers during the study period. A total of 3826 patients and 759 control patients were involved in this study. Mild acne was the most common type of acne, and most of the lesions were localized on face followed by the trunk. The severity of acne was worse in patients who had a positive family history of acne. The most common triggering factor was psychological stress. We found a positive correlation with chocolate, bread, green tea, milk, white sugar, ripe banana, ice cream, apple, orange, and red meat consumption. As we compare the acne severity according to geographical features we detected mildmoderate acne was more common in Mediterrenean region and severe acne was more common in East Anatolian region. Family history positivity was more common in Aegean region and least common in Middle Anatolian region. There was statistically significant relationship as we compare acne severity and dietary factors such as chocolate, dairy products such as milk, sunflower seed consumption within the geographical regions. This study presents the demographic and clinical characteristics of acne patients in Asian and the European parts of Turkey. We believe that this study will provide a useful overview of acne in Turkey.

  9. Improvement of signs and symptoms of chronic venous insufficiency and microangiopathy with Pycnogenol: a prospective, controlled study.

    Science.gov (United States)

    Cesarone, M R; Belcaro, G; Rohdewald, P; Pellegrini, L; Ledda, A; Vinciguerra, G; Ricci, A; Ippolito, E; Fano, F; Dugall, M; Cacchio, M; Di Renzo, A; Hosoi, M; Stuard, S; Corsi, M

    2010-09-01

    The aim of this study was to evaluate the clinical efficacy of standardized French maritime pine bark extract Pycnogenol in patients with severe chronic venous insufficiency (CVI). 98 subjects with symptomatic CVI and edema were randomly assigned to one group treated with 150 mg Pycnogenol a day only, another group with stockings only and a third group with both Pycnogenol and elastic stockings. The average ambulatory venous pressure (AVP) at inclusion was 58+/-7 mm Hg (range 48-60 mm Hg) with a refilling time (RT)Pycnogenol alone was more effective than compression alone for all parameters (pPycnogenol in the management, treatment and control of CVI also in combination with compression.

  10. Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

    Science.gov (United States)

    Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

    2017-04-01

    Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m(2) and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  11. Cistus incanus (CYSTUS052) for treating patients with infection of the upper respiratory tract. A prospective, randomised, placebo-controlled clinical study.

    Science.gov (United States)

    Kalus, Ulrich; Grigorov, Alexandre; Kadecki, Oliver; Jansen, Jan-Peter; Kiesewetter, Holger; Radtke, Hartmut

    2009-12-01

    In this prospective, randomized, placebo-controlled clinical study we aimed to investigate the clinical effect of a Cistus extract (CYSTUS052) in 160 patients with infections of the upper respiratory tract. The extract contains a high percentage of highly polymeric polyphenols. In cell culture and in a mouse model it exerts antiviral and antimicrobial activities. Principal active constituents of the genus Cistus are polyphenolic compounds. Plant-derived polyphenols have been shown to be strong antioxidants with potential health benefits. Various reports have appeared on the antiviral and antibacterial potential, including several reports describing the antiviral activity of polyphenols against influenza virus. Clinical studies on the effectiveness of Cistus incanus are scarce. Only one controlled application observation study demonstrated the effectiveness of a Cistus extract. The present randomised, placebo-controlled clinical study was designed to compare the symptom scores in patients with common cold treated either with CYSTUS052 or with placebo. A score of subjective symptoms decreased significantly over the course of treatment with Cistus, whereas treatment with placebo resulted in a less distinct decrease of symptoms. Among the inflammatory markers investigated, the C-reactive protein was mostly affected by Cistus and decreased significantly in the treatment group.

  12. Comparison of effectiveness of different surgical treatments for meralgia paresthetica: Results of a prospective observational study and protocol for a randomized controlled trial.

    Science.gov (United States)

    de Ruiter, Godard C W; Kloet, Alfred

    2015-07-01

    Various surgical procedures can be applied in the treatment of meralgia paresthetica. The two main ones are neurolysis and neurectomy of the lateral femoral cutaneous nerve. To date, no prospective or randomized controlled trial has compared the effectiveness of these procedures with standardized outcome measures. In this study we present our results for two prospectively followed cohorts and we present the protocol for a double blind randomized controlled trial (RCT). All patients that had an indication for surgical treatment of idiopathic meralgia paresthetica between August 2012 and April 2014 were included in the study. The patient decided on the type of treatment (neurolysis or neurectomy) after informed consent had been given. Primary outcome was measured using the Likert scale obtained 6 weeks after the surgery. Successful pain reduction was defined as Likert 1 or 2. Secondary outcome measures were the Numeric Rating Scale (NRS) and Bothersomeness Index (BSI). In case of neurectomy the BSI for numbness was also obtained. A total of 22 consecutive patients were included: neurolysis was performed in 8 patients and neurectomy in 14 patients (one bilateral case). Successful pain reduction was observed more frequently after neurectomy (93.3%) than after neurolysis (37.5%, P<0.05). Secondary outcome scores (NRS and BSI pain) were also better after neurectomy, although not significantly (respectively P=0.07 and 0.05). Paired analysis of the scores before and after the surgery showed an improvement in both the NRS and BSI after the neurectomy procedure (both P<0.001), while scores were not significantly different before and after the neurolysis procedure. Patient's scores for the BSI numbness after the neurectomy procedure were low (mean 1.4, SD±1.0, range 0-3). The results of our prospective study confirm results previous studies reported in the literature in that the percentage pain relief was better after neurectomy than after neurolysis. A RCT is needed to

  13. Three to four years after diagnosis: cognition and behaviour in children with 'epilepsy only'. A prospective, controlled study.

    Science.gov (United States)

    Oostrom, K J; van Teeseling, H; Smeets-Schouten, A; Peters, A C B; Jennekens-Schinkel, A

    2005-07-01

    A 3.5-year follow-up study of cognition and behaviour in 42 children with newly diagnosed idiopathic or cryptogenic epilepsy ('epilepsy only') attending mainstream education and 30 healthy gender-matched classmate controls was carried out to identify differences between groups, to detect factors that contribute to the difference and its change over time, and to establish the proportion of poorly performing children. The neuropsychological battery covered the major domains of cognition, mental and motor speed and academic language skills. Children were tested at the time of diagnosis (before any anti-epileptic drug treatment started) and 3, 12 and approximately 42 months later. Parents and teachers completed behaviour checklists, for which the scoring was adapted to prevent any influence of epilepsy-related ambiguity. Based on parental interviews at the time of diagnosis, children with epilepsy were categorized as having longstanding behavioural and/or learning problems, as belonging to a troubled family, as being exposed to 'off-balance' parenting starting at the time of epilepsy onset and/or as reacting maladaptively to the changes in relation to the onset of epilepsy. Throughout follow-up, the group of children with epilepsy only performed less well than healthy classmates on measures of learning, memory span for words, attention and behaviour. After controlling for school delay, proactive interference (number of responses to the same images as in the learning trials, but now presented in reordered locations) was the only remaining variable that distinguished the group of children with epilepsy only. Group-wise, no changes in cognitive and behavioural differences over time were found, but instability in individual performances appeared to characterize children with epilepsy only. Rather than intrinsically epilepsy-related variables, such as idiopathic versus cryptogenic aetiology, seizure control or anti-epileptic drug treatment, the child's prediagnostic

  14. Prospective randomized controlled study of prophylaxis with cefamandole in high risk patients undergoing operations upon the biliary tract.

    Science.gov (United States)

    Cáinzos, M; Potel, J; Puente, J L

    1985-01-01

    In this study, 52 high risk patients who underwent operations upon the biliary tract were assigned to receive either antibiotic prophylaxis or no treatment with antibiotics. Twenty-seven patients were given 2 grams of cefamandole intramuscularly 30 minutes before operation and 2 grams every eight hours for two days postoperatively. The remaining patients were in the control group and did not receive antibiotics. Surgical wounds were inspected daily by a surgeon while the patients were in the hospital and a follow-up revision was done four weeks after discharge from the hospital. Samples of exudate or pus were taken when the wound appeared infected and cultures of aerobic and anaerobic organism done. Chi-square affinity test with Yate's correction was used for statistical results; only p values more than or equal to 0.5 were considered significant. Seven patients (28 per cent) in the control group had complications develop postoperatively; seven surgical wound infections, one of which included a subphrenic abscess. Postoperatively, there were no septic complications in the group who received cefamandole as a prophylaxis. The incidence of infection was higher for females than males. The organisms most frequently isolated were Escherichia coli and Klebsiella; only in one instance was Clostridum sporogenes found. Polymicrobial infections accounted for 42.8 per cent of the infections. No incidences were reported with the use of cefamandole in those patients who were treated prophylactically. In view of these results, we believe that cefamandole is an ideal antibiotic to be used in the prophylactic treatment of infections of high risk patients who undergo operations upon the biliary tract.

  15. Follow-up MR imaging of the alar and transverse ligaments after whiplash injury: a prospective controlled study.

    Science.gov (United States)

    Vetti, N; Kråkenes, J; Ask, T; Erdal, K A; Torkildsen, M D N; Rørvik, J; Gilhus, N E; Espeland, A

    2011-01-01

    The cause and clinical relevance of upper neck ligament high signal intensity on MR imaging in WAD are controversial. The purpose of this study was to explore changes in the signal intensity of the alar and transverse ligaments during the first year after a whiplash injury. Dedicated high-resolution upper neck proton attenuation-weighted MR imaging was performed on 91 patients from an inception WAD1-2 cohort, both in the acute phase and 12 months after whiplash injury, and on 52 controls (noninjured patients with chronic neck pain). Two blinded radiologists independently graded alar and transverse ligament high signal intensity 0-3, compared initial and follow-up images to assess alterations in grading, and solved any disagreement in consensus. The Fisher exact test was used to compare proportions. Alar and transverse ligament grading was unchanged from the initial to the follow-up images. The only exceptions were 1 alar ligament changing from 0 to 1 and 1 ligament from 1 to 0. The prevalence of grades 2-3 high signal intensity in WAD was thus identical in the acute phase and after 12 months, and it did not differ from the prevalence in noninjured neck pain controls (alar ligaments 33.0% versus 46.2%, P = .151; transverse ligament 24.2% versus 23.1%, P = 1.000). Alar and transverse ligament high signal intensity in patients with WAD1-2 observed within the first year after injury cannot be explained by the trauma. Dedicated upper neck MR imaging cannot be recommended as a routine examination in these patients.

  16. The role of parental control and modelling in predicting a child's diet and relationship with food after they leave home. A prospective study.

    Science.gov (United States)

    Dickens, Emma; Ogden, Jane

    2014-05-01

    Research indicates that parental control and parental modelling are key factors in shaping a child's eating behaviour. To date, however, little is known about how these factors influence a child's diet once they have left home. This prospective study evaluated the extent to which a parent's own behaviour and their use of control over food whilst their child was still living at home predicted their child's relationship with food once they had begun to live independently. Parent/child dyads (n=93) took part in the study. Parents completed baseline measures of parental control practices (overt control, covert control and pressure to eat), their own diet (unhealthy snacks, unhealthy meals, healthy foods) and eating behaviours (emotional, uncontrolled and restrained eating). At one year follow up, once their child had left home, the child completed measures of their own diet and eating behaviours. The results showed a clear role for modelling with concordance between a child's intake of unhealthy snacks and emotional eating and their parents' own reports of these behaviours. Furthermore, the child's intake of healthy foods was also predicted by their parent's behaviour although there was both concordance and discordance between parents and their children. No role for parental control was found for any measure of diet or eating behaviour. It is concluded that a parent's own behaviour rather than parental control has a stronger longer lasting influence once a child has left home and that although this mostly involves a child copying their parent's behaviour (action) at times it also involves the opposite (reaction). Copyright © 2014 Elsevier Ltd. All rights reserved.

  17. [Analgesic efficacy of TENS therapy in patients with gonarthrosis. A prospective, randomised, placebo-controlled, double-blind study].

    Science.gov (United States)

    Gschiel, B; Kager, H; Pipam, W; Weichart, K; Likar, R

    2010-09-01

    The goal of the study was to substantiate the influence of TENS on pain development and medication needs of patients with proven gonarthrosis and chronic pain. The study included a 3-week stimulation period and 2-week observation period after the end of stimulation. Patients (at least 20 per group) were assigned to either an active treatment group or placebo group in a randomised, double-blind, placebo-controlled trial. For the active treatment group the TENS therapy device with HAN stimulation (alternating phase of stimulation) was used (TENStem eco).Total length of time: 30 min at least two times a day. The length of therapy was 3 weeks (therapy), followed by an observation period of 2 weeks (follow-up). The total length of the study was 5 weeks, whereby at the beginning and at the end of weeks 1, 3 and 5 the SF-36, WOMAC score and Lysholm score were documented; the pain score was documented daily. There are no significant demographic differences between the groups. In the active treatment group there was clear relief in pain intensity in the morning, midday and evening over the 3-week period of therapy. The Lysholm score in the active treatment group was 53.4 at the beginning, 90 after 1 week, 94.5 after the third week and 91 by the fifth week (significant difference). There were no side effects. TENS therapy with HAN stimulation resulted in pain relief in patients with gonarthrosis during the therapy period with TENS, but the pain relief did not last beyond the end of the TENS therapy. There was an improvement in the Lysholm score and the WOMAC score during the therapy. This improvement remained over the following 2-week period of observation without further TENS therapy. TENS therapy is a simple and effective method to treat gonarthrosis with very few side effects.

  18. Electroacupuncture-reduced sedative and analgesic requirements for diagnostic EUS: a prospective, randomized, double-blinded, sham-controlled study.

    Science.gov (United States)

    Bun Teoh, Anthony Yuen; Ning Chong, Charing Ching; Wa Leung, Wing; Cheong Chan, Simon Kin; Kit Tse, Yee; Wai Ng, Enders Kwok; San Lai, Paul Bo; Yuen Wu, Justin Che; Wong Lau, James Yun

    2017-07-24

    The role of electroacupuncture (EA) in reducing sedative and analgesic requirements during EUS is uncertain. The aim of the current study is to investigate the efficacy of EA in reducing procedure-related pain and discomfort during EUS. This was a double-blinded randomized controlled study conducted between March 2014 and July 2016. Consecutive patients who were scheduled for diagnostic EUS were recruited and randomized to receive electroacupuncture (EA) or sham-electroacupuncture (SA). The primary outcome was the dosage of propofol used. Other outcome measurements included pain scores, anxiety scores, satisfaction scores, patients' willingness to repeat the procedure, total procedure time, and adverse events. One hundred twenty-eight patients were recruited to the study. The patients that received EA had significantly fewer PCA requirements. The median (IQR range) number of demands for PCA (2 [1 - 5] vs 16.5 [8.5 - 33.8], P<0.001), the number of successful demands (2 [1 - 4] vs 9 [5.3 - 13], P<0.001), the total dose of propofol (0.15 [0.08 - 0.34] vs 0.77 [0.38 - 1.09], P<0.001) and alfentanil (0.38 [0.20 - 0.86] vs 1.92 [0.94 - 2.72], P<0.001) were all significantly less. Patients that received EA also had significantly less procedural pain scores and anxiety scores (P<0.001), higher satisfaction scores (P<0.001), and they are more willing to repeat the procedure (P<0.001). Both being in the SA group and the procedural time were significant predictors to increased PCA demands (P < 0.001 and P = 0.009 respectively). In conclusion, the use of EA reduced sedative and analgesic demands, improved patient experience, and was associated with low risk of adverse events during diagnostic EUS. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

  19. Cognitive cooperation groups mediated by computers and internet present significant improvement of cognitive status in older adults with memory complaints: a controlled prospective study

    Directory of Open Access Journals (Sweden)

    Rodrigo de Rosso Krug

    Full Text Available ABSTRACT Objective To estimate the effect of participating in cognitive cooperation groups, mediated by computers and the internet, on the Mini-Mental State Examination (MMSE percent variation of outpatients with memory complaints attending two memory clinics. Methods A prospective controlled intervention study carried out from 2006 to 2013 with 293 elders. The intervention group (n = 160 attended a cognitive cooperation group (20 sessions of 1.5 hours each. The control group (n = 133 received routine medical care. Outcome was the percent variation in the MMSE. Control variables included gender, age, marital status, schooling, hypertension, diabetes, dyslipidaemia, hypothyroidism, depression, vascular diseases, polymedication, use of benzodiazepines, exposure to tobacco, sedentary lifestyle, obesity and functional capacity. The final model was obtained by multivariate linear regression. Results The intervention group obtained an independent positive variation of 24.39% (CI 95% = 14.86/33.91 in the MMSE compared to the control group. Conclusion The results suggested that cognitive cooperation groups, mediated by computers and the internet, are associated with cognitive status improvement of older adults in memory clinics.

  20. Cognitive cooperation groups mediated by computers and internet present significant improvement of cognitive status in older adults with memory complaints: a controlled prospective study.

    Science.gov (United States)

    Krug, Rodrigo de Rosso; Silva, Anna Quialheiro Abreu da; Schneider, Ione Jayce Ceola; Ramos, Luiz Roberto; d'Orsi, Eleonora; Xavier, André Junqueira

    2017-04-01

    To estimate the effect of participating in cognitive cooperation groups, mediated by computers and the internet, on the Mini-Mental State Examination (MMSE) percent variation of outpatients with memory complaints attending two memory clinics. A prospective controlled intervention study carried out from 2006 to 2013 with 293 elders. The intervention group (n = 160) attended a cognitive cooperation group (20 sessions of 1.5 hours each). The control group (n = 133) received routine medical care. Outcome was the percent variation in the MMSE. Control variables included gender, age, marital status, schooling, hypertension, diabetes, dyslipidaemia, hypothyroidism, depression, vascular diseases, polymedication, use of benzodiazepines, exposure to tobacco, sedentary lifestyle, obesity and functional capacity. The final model was obtained by multivariate linear regression. The intervention group obtained an independent positive variation of 24.39% (CI 95% = 14.86/33.91) in the MMSE compared to the control group. The results suggested that cognitive cooperation groups, mediated by computers and the internet, are associated with cognitive status improvement of older adults in memory clinics.

  1. Vacuum-assisted closure versus conventional dressings in the management of diabetic foot ulcers: a prospective case–control study

    Directory of Open Access Journals (Sweden)

    Ali M. Lone

    2014-04-01

    Full Text Available Objective: To compare the effectiveness of vacuum-assisted closure (VAC versus conventional dressings in the healing of diabetic foot ulcerations (DFUs in terms of healing rate (time to prepare the wound for closure either spontaneously or by surgery, safety, and patient satisfaction. Methods: Randomized case–control study enrolling 56 patients, divided into two groups. Group A (patients treated with VAC and Group B (patients treated with conventional dressings, with an equal number of patients in each group. DFUs were treated until wound closure, either spontaneously, surgically, or until completion of the 8-week period. Results: Granulation tissue appeared in 26 (92.85% patients by the end of Week 2 in Group A, while it appeared in 15 (53.57% patients by that time in Group B. 100% granulation was achieved in 21 (77.78% patients by the end of Week 5 in Group A as compared to only 10 (40% patients by that time in Group B. Patients in Group A had fewer number of positive blood cultures, secondary amputations and were satisfied with treatment as compared to Group B. Conclusion: VAC appears to be more effective, safe, and patient satisfactory compared to conventional dressings for the treatment of DFUs.

  2. Tenoxicam 20 mg or 40 mg after thoracotomy: a prospective, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Merry, A F; Sidebotham, D A; Middleton, N G; Calder, M V; Webster, C S

    2002-04-01

    Forty-five adults undergoing thoracotomy were randomized to receive placebo, tenoxicam 20 mg or tenoxicam 40 mg IV during chest wall closure. All patients received intraoperative fentanyl and intercostal blocks followed by morphine by patient-controlled analgesia. Patient numbers 13 to 45 also received thoracic epidural analgesia by continuous infusion of bupivacaine 0.125%, patient numbers 25 to 45 having fentanyl 2 microg/ml added to the epidural infusion. Efficacy parameters and adverse reactions were assessed over the first 24 hours postoperatively. On a 100 mm visual analogue scale, mean (SD) pain at rest (adjusted area under curve for hours 1 to 24) was 25.8 (12.5), 17.4 (14.8) and 16.5 (13.3) mm for groups receiving placebo, 20 mg and 40 mg tenoxicam, respectively (ANOVA: P<0.05). There were no significant differences between study groups postoperatively in pain on coughing, opioid consumption, blood gas measurements, nausea, vomiting, sedation, blood loss, haemoglobin or serum creatinine. One patient in each tenoxicam group reported epigastric pain, rated moderate. These data support the inclusion of tenoxicam 20 mg IV in the management of pain at rest for patients undergoing thoracotomy, but do not show additional benefit for a higher dose.

  3. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

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    Andrzej Kotela

    2015-01-01

    Full Text Available Total knee arthroplasty (TKA is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA.

  4. Evaluation of a diclofenac transdermal patch for the attenuation of venous cannulation pain: a prospective, randomised, double-blind, placebo-controlled study.

    Science.gov (United States)

    Agarwal, A; Dhiraaj, S; Kumar, A; Singhal, V; Singh, U

    2006-04-01

    Venous cannulation, although a minor procedure, is often painful. The present study was planned to evaluate the efficacy of a diclofenac transdermal patch placed over the venepuncture site in decreasing the pain of cannulation. Seventy-two adults undergoing elective surgery were included in this randomised, prospective, double-blind, placebo-controlled study. Patients were divided into three equal groups. The Control group had a placebo adhesive patch placed on the both the dorsum of hand and the buttock; the Diclofenac-Buttock group had a placebo patch placed on the dorsum of the hand and a diclofenac transdermal patch on the buttock; the Diclofenac-Hand group had a diclofenac transdermal patch placed on the dorsum of hand and a placebo patch on the buttock. The patches were applied 1 h before cannulation. An 18G cannula was used for all venous cannulations. Pain during cannulation was assessed on a non-graduated 10-cm visual analogue scale. Median [interquartile range] pain scores were 3.0 [2.0-4.0] in the Diclofenac-Hand group, 5.0 [4.3-7.8] in the Diclofenac-Buttock group and 6.5 [4.5-7.0] in the Control group, p Diclofenac-Buttock and Diclofenac-Hand groups, respectively. The application of a diclofenac transdermal patch at the cannulation site appears to be effective in decreasing cannulation pain.

  5. A prospective randomized controlled study of erythromycin on gastric and small intestinal distention: Implications for MR enterography

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    Bharucha, Adil E., E-mail: bharucha.adil@mayo.edu [Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Fidler, Jeff L., E-mail: fidler.jeff@mayo.edu [Department of Radiology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Huprich, James E., E-mail: huprich@mayo.edu [Department of Radiology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Ratuapli, Shiva K., E-mail: ratuapli.shiva@mayo.edu [Clinical Enteric Neuroscience Translational and Epidemiological Research (C.E.N.T.E.R.) Program, Division of Gastroenterology and Hepatology, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Holmes, David R., E-mail: holmes.david3@mayo.edu [Biomedical Imaging Resource, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Riederer, Stephen J., E-mail: riederer@mayo.edu [MR Research Laboratory, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States); Zinsmeister, Alan R., E-mail: zinsmeis@mayo.edu [Division of Biomedical Statistics and Informatics, College of Medicine, Mayo Clinic, 200 First St. S.W., Rochester, MN 55905 (United States)

    2014-11-15

    Highlights: • Suboptimal small intestinal distention limits jejunal visualization during MRI. • In this controlled study, erythromycin increased gastric emptying measured with MRI. • However, effects on small intestinal dimensions were variable. - Abstract: Objectives: To assess if erythromycin increases gastric emptying and hence improves small intestinal distention during MR enterography. Methods: Gastric, small intestinal, and large intestinal volumes were assessed with MR after neutral oral contrast (1350 ml in 45 min) and balanced randomization to erythromycin (200 mg i.v., age 31 ± 3y, 13 females), or placebo (37 ± 3y, 13 females) in 40 healthy asymptomatic volunteers. Fat-suppressed T2-weighted MR images of the abdomen were acquired on a 1.5 T magnet at standard delay times for enterography. Gastric, small, and large intestinal volumes were measured by specialized software. In addition, two radiologists manually measured diameters and percentage distention of jejunal and ileal loops. Treatment effects were evaluated by an ITT analysis based on ANCOVA models. Results: All subjects tolerated erythromycin. MRI scans of the stomach and intestine were obtained at 62 ± 2 (mean ± SEM) and 74 ± 2 min respectively after starting oral contrast. Gastric volumes were lower (P < 0.0001) after erythromycin (260 ± 49 ml) than placebo (688 ± 63 ml) but jejunal, ileal, and colonic volumes were not significantly different. However, maximum (76–100%) jejunal distention was more frequently observed (P = 0.03) after erythromycin (8/20 subjects [40%]) than placebo (2/20 subjects [10%]). The diameter of a representative ileal loop was greater (P = 0.001) after erythromycin (18.8 ± 4.3 mm) than placebo (17.3 ± 2.8 mm) infusion. Conclusions: After ingestion of oral contrast, erythromycin accelerated gastric emptying but effects on small intestinal dimensions were variable. In balance, erythromycin did not substantially enhance small intestinal distention during

  6. Biolarvicides in vector control : challenges and prospects

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    P.K. Mittal

    2003-03-01

    Full Text Available Biolarvicides, based on mosquitocidal toxins of certain strains of Bacillus sphaericus and Bacillusthuringiensis var israelensis H-14 (Bti are highly effective against mosquito larvae at very lowdoses and safe to other non-target organisms. During past two decades various biolarvicide formulationsproduced in India and abroad have been tested at Malaria Research Centre and some formulationshave undergone large-scale operational trials. Biolarvicide formulations of B. sphaericusare useful in the control of Culex and certain Anopheles spp, such as An. stephensi and An. subpictus,but not much effective against An. culicifacies and almost ineffective against Aedes aegypti.Repeated application of B. sphaericus in the same habitat, however, results in the developmentof resistance in larvae of target mosquitoes. In view of its low specificity for An. culicifacies andthe potential for resistance in An. stephensi, B. sphaericus has limited prospects for control of malariavectors. However, with some resistance management, B. sphaericus can still be used againstCulex mosquitoes. On the other hand Bti formulations, which have broader spectrum of activityagainst Aedes, Culex and Anopheles spp, have not shown significant development of resistance inmosquitoes but their activity in field, particularly against surface feeding anopheline larvae is affectedby various bioenvironmental factors, thus requiring weekly application in most habitats. Toovercome this problem development of slow release formulations and genetically engineered biolarvicidesby transplanting mosquitocidal toxin genes of Bti and B. sphaericus in some other environmentallycompatible organisms have been investigated by different scientists.

  7. Povidone-Iodine-Based Solutions for Decolonization of Nasal Staphylococcus aureus: A Randomized, Prospective, Placebo-Controlled Study.

    Science.gov (United States)

    Rezapoor, Maryam; Nicholson, Thema; Tabatabaee, Reza Mostafavi; Chen, Antonia F; Maltenfort, Mitchell G; Parvizi, Javad

    2017-09-01

    Nasal Staphylococcus aureus decolonization reduces the risk of surgical site infections after orthopedic procedures. Povidone-iodine (PI)-based solutions have shown promising results in bacteria decolonization. The unique physiology of the nose may pose challenges for the bioactivity profiles of PI solutions. This study compared the antibacterial efficacy of an off-the-shelf PI product with a specifically manufactured PI-based skin and nasal antiseptic (SNA). This randomized, placebo-controlled study was conducted at a single institution between April 2014 and July 2015. Four hundred and twenty-nine patients undergoing primary or revision total joint arthroplasty, femoroacetabular osteoplasty, pelvic osteotomy, or total shoulder arthroplasty were included. 10% off-the-shelf PI, 5% PI-based SNA, or saline (placebo) were used for nasal decolonization. Baseline cultures were taken immediately preoperatively, followed by treatment of both nares twice for 2 minutes with 4 applicators. Reculturing of the right nostril occurred at 4 hours and the left at 24 hours. Ninety-five of the 429 patients (22.1%) had a positive culture result for S. aureus; 13 (3.03%) were methicillin-resistant S. aureus. Of these 95, 29 were treated with off-the-shelf PI, 34 with SNA, and 32 with saline swabs. At 4 hours post-treatment, S. aureus culture was positive in 52% off-the-shelf PI patients, 21% SNA patients, and 59% saline patients. After 24 hours posttreatment, S. aureus culture was positive in 72% off-the-shelf PI patients, 59% SNA patients, and 69% saline group. SNA was significantly more effective at decolonizing S. aureus over the 4-hour time interval (P = .003); no significant difference was observed over the 24-hour time interval between the 3 groups. A single application of PI-based SNA before surgery may be effective in eliminating nasal S. aureus in over two-thirds of patients. Off-the-shelf PI swabs were not as effective at 4 hours as the specifically manufactured product

  8. Extracorporeal shock wave treatment for non-inflammatory chronic pelvic pain syndrome: a prospective, randomized and sham-controlled study

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    ZENG Xiao-yong; LIANG Chen; YE Zhang-qun

    2012-01-01

    Background Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a clinical syndrome characterized by pain in the perineum,pelvis,suprapubic area,or external genitalia and variable degrees of voiding and ejaculatory disturbance.The analgesic effect of extracorporeal shock wave treatment (ESWT) was an interesting phenomenon with an unclear mechanism discovered by chance in the applications for urolithiasis,on which ESWT has become an increasingly popular therapeutic approach as an alternative option for the treatment of a number of soft tissue complaints.In this study,we aimed to evaluate the feasibility and efficacy of ESWT in non-inflammatory (ⅢB) CP/CPPS.Methods Men diagnosed with ⅢB CP/CPPS were randomized to either ESWT (group 1,n=40) or the control (group 2,n=40).Group 1 received 20 000 shock wave impulses in 10 sessions over a two-week period,whereas group 2 received only a sham procedure.The total scores and sub-domain scores of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) for both groups were assessed at baseline,mid-treatment,end-point,and 4-week and 12-week follow-up visits.Results The mean total NIH-CPSI score of group 1 was significantly decreased from baseline at all post-treatment time points (P <0.01 for all).Decreases in pain domain and quality of life (QOL) scores were also significant.In group 2,no significant decreases of total NIH-CPSI score and pain domain score were found at all post-treatment time points.At the end-point of treatment,71.1% of group 1 exhibited perceptible improvement in total NIH-CPSI compared with 27.0% of group 2 (P <0.001); additionally,28.9% of group 1 exhibited clinically significant improvement compared with 10.8% of group 2 (P <0.01).Moreover,a greater number of patients in group 1 at 4-week and 12-week follow-up were rated as responders (perceptible and clinically significant response) compared with group 2.Conclusion ESWT exhibits a potentially therapeutic

  9. ATTENUATION OF HEMODYNAMIC STRESS RESPONSE DURING EMERGENCE FROM GENERAL ANAESTHESIA: A PROSPECTIVE RANDOMIZED CONTROLLED STUDY COMPARING FENTANYL AND DEXMEDETOMIDINE

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    Liyakhath

    2014-11-01

    Full Text Available : BACKGROUND: Tracheal extubation and emergence is associated with significant haemodynamic alterations and is poorly tolerated by patients with co-morbid conditions. We compared the efficacy of fentanyl and dexmedetomidine in mitigating haemodynamic stress response and assessed extubation quality in study groups. MATERIALS AND METHODS: One fifty patients of either sex, ASA grade I & II normotensive patients, aged 18-55 years undergoing elective surgeries under general anaesthesia were randomized into 3 equal groups. Anaesthetic technique was standardized. 10 minutes prior to extubation, patients in Group N, F and D received intravenous bolus infusion of 0.9% normal Saline, Fentanyl 1μg /kg and Dexmedetomidine 1μg /kg respectively over 10 minutes period. Heart Rate (HR, Systolic BP (SBP, Diastolic BP (DBP and Mean Arterial Pressure (MAP were noted at extubation, 2, 4, 6, 8, 10 min and at regular interval thereafter for a period of two hours. Extubation quality was evaluated on 5-point extubation quality scale [ scale 1 = no coughing, 2 = smooth extubation, minimal coughing (1 or 2 times, 3 = moderate coughing (3 or 4 times, 4 = severe coughing (5-10 times and straining, 5 = poor extubation, very uncomfortable (laryngospasm and coughing >10 times]. Ramsay sedation score and Aldrete’s recovery score were recorded. Any adverse events, use of rescue drugs and postoperative analgesics were noted. RESULTS: All the measured haemodynamic parameters were significantly elevated at extubation and at various points of observation in normal saline group than fentanyl and dexmedetomidine group (p=0.000. Tachycardia response was seen in 84% patients in group N, compared to 36% and 8% in group F & D respectively (p=0.000. Statistically significant hypertensive response was noticed in 43(86% patients of group N, 9(18% of group F and 3(6% of group D (p=0.000. Duration of tachycardia and hypertensive response was significantly longer in control group. Three

  10. Virtual reality robotic surgery warm-up improves task performance in a dry laboratory environment: a prospective randomized controlled study.

    Science.gov (United States)

    Lendvay, Thomas S; Brand, Timothy C; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina D; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M

    2013-06-01

    Preoperative simulation warm-up has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized that a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. In a 2-center randomized trial, 51 residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot (Intuitive Surgical Inc). Once they successfully achieved performance benchmarks, surgeons were randomized to either receive a 3- to 5-minute VR simulator warm-up or read a leisure book for 10 minutes before performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical, and cognitive errors. Task time (-29.29 seconds, p = 0.001; 95% CI, -47.03 to -11.56), path length (-79.87 mm; p = 0.014; 95% CI, -144.48 to -15.25), and cognitive errors were reduced in the warm-up group compared with the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32; p = 0.020; 95% CI, 0.06-0.59) were reduced after the dissimilar VR task. When surgeons were stratified by earlier robotic and laparoscopic clinical experience, the more experienced surgeons (n = 17) demonstrated significant improvements from warm-up in task time (-53.5 seconds; p = 0.001; 95% CI, -83.9 to -23.0) and economy of motion (0.63 mm/s; p = 0.007; 95% CI, 0.18-1.09), and improvement in these metrics was not statistically significantly appreciated in the less-experienced cohort (n = 34). We observed significant performance improvement and error reduction rates among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on

  11. Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

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    Valentina Forni Ogna

    2013-01-01

    Full Text Available Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT is patient’s poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC or usual care approach (UC. In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (. The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (. Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (. Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet.

  12. Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

    Science.gov (United States)

    Forni Ogna, Valentina; Pruijm, Menno; Zweiacker, Carole; Wuerzner, Grégoire; Tousset, Eric; Burnier, Michel

    2013-01-01

    Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT) is patient's poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC) or usual care approach (UC). In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (P = 0.04). The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (P = 0.02). Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (P = 0.03). Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet. PMID:23971019

  13. Effectiveness of CO2-insufflated endoscopic submucosal dissection with the duodenal balloon occlusion method for early esophageal or gastric cancer: a randomized case control prospective study

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    Mori Hirohito

    2012-04-01

    Full Text Available Abstract Background Endoscopic submucosal dissection (ESD has typically been performed using air insufflation. Recently, however, insufflation of CO2 has been increasingly used to avoid complications. This prospective study was designed to compare the CO2 concentration, intestinal volume, and acid–base balance using the duodenal balloon procedure. Methods From June 2010 to February 2011, we enrolled 44 patients with esophageal or gastric cancer and randomly allocated them into two groups. We compared 22 patients undergoing CO2-insufflated ESD with a balloon placed into the duodenal bulb (duodenal balloon group and 22 patients undergoing regular CO2-insufflated ESD (regular group. Three-dimensional computed tomography was performed before and after the procedure to measure intestinal volume. CO2 concentrations were measured every 10 minutes. The visual analogue system (VAS scores for postoperative symptoms were recorded, and pH was measured immediately after the procedure. This was a prospective case control study randomized by the sealed envelope method. Results Intestinal CO2 gas volume before and after ESD was lower in the duodenal balloon group than in the regular group (P = 0.00027. The end-tidal CO2 level was significantly lower in the duodenal balloon group than in the regular group (P = 0.0001. No significant differences in blood ΔpH were found between the two groups. The VAS score for the occurrence of nausea due to abdominal distension after ESD indicated a significant difference (P = 0.031. Conclusions ESD using the duodenal balloon occlusion method is effective for reduction of post-ESD intestinal CO2 gas volume, resulting in a lower total amount of CO2 insufflation during ESD and reducing harmful influences on the human body to some extent.

  14. Neurocutaneous syndrome: A prospective study

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    Radheshyam Purkait

    2011-01-01

    Full Text Available Background: Neurocutaneous syndromes (NCS are a group of genetic disorders that produce a variety of developmental abnormalities of the skin along with an increased risk of neurological complications. Cutaneous manifestations usually appear early in life and progress with time, but neurological features generally present at a later age. There is a paucity of data regarding the evolution of skin lesions and their correlation with the central nervous system involvement in children. Aim: The primary objective was to track the course of skin lesions in various forms of NCS in the pediatric age group. Our secondary aim was to assess whether there was any predictive value of the lesions in relation to the neurological manifestations. Materials and Methods: This prospective longitudinal study was conducted at a tertiary care pediatric dermatology referral clinic of the Institute of Child Health, Kolkata, West Bengal. Children between the age group 0 and 12 years were included in the study on the basis of standard diagnostic criteria for different NCS, during the period from March, 2000 to February, 2004, and each of the enrolled cases were followed up for a duration of six years. Results: The study population comprised of 67 children (35 boys, 32 girls.The mean age of presentation was 33.8±27.8 months (range 10 days to 111 months. The various forms of NCS observed was neurofibromatosis 1(NF1 (n=33, tuberous sclerosis complex (TSC (n=23, Sturge Weber syndrome (n=6, ataxia telangiectasia (n=2, PHACE syndrome (n=1, incontinentia pigmenti (n=1, and hypomelanosis of Ito (n=1. The presentations were varied, ranging from predominantly cutaneous to primarily neurological, depending on the disease entity and age group concerned. There was a significant increase in the number of café au lait macules (CALMs with time (P=0.0002 in NF1, unlike that of hypopigmented macules of TSC (P=0.15. Statistically, no relation was documented between the evolution of skin

  15. Circulating C-reactive protein concentrations and risks of colon and rectal cancer: a nested case-control study within the European Prospective Investigation into Cancer and Nutrition.

    Science.gov (United States)

    Aleksandrova, Krasimira; Jenab, Mazda; Boeing, Heiner; Jansen, Eugene; Bueno-de-Mesquita, H Bas; Rinaldi, Sabina; Riboli, Elio; Overvad, Kim; Dahm, Christina C; Olsen, Anja; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Clavel-Chapelon, Françoise; Morois, Sophie; Palli, Domenico; Krogh, Vittorio; Tumino, Rosario; Vineis, Paolo; Panico, Salvatore; Kaaks, Rudolf; Rohrmann, Sabine; Trichopoulou, Antonia; Lagiou, Pagona; Trichopoulos, Dimitrios; van Duijnhoven, Fränzel J B; Leufkens, Anke M; Peeters, Petra H; Rodríguez, Laudina; Bonet, Catalina; Sánchez, María-José; Dorronsoro, Miren; Navarro, Carmen; Barricarte, Aurelio; Palmqvist, Richard; Hallmans, Göran; Khaw, Kay-Tee; Wareham, Nicholas; Allen, Naomi E; Spencer, Elizabeth; Romaguera, Dora; Norat, Teresa; Pischon, Tobias

    2010-08-15

    The authors investigated associations between serum C-reactive protein (CRP) concentrations and colon and rectal cancer risk in a nested case-control study within the European Prospective Investigation into Cancer and Nutrition (1992-2003) among 1,096 incident cases and 1,096 controls selected using risk-set sampling and matched on study center, age, sex, time of blood collection, fasting status, menopausal status, menstrual cycle phase, and hormone replacement therapy. In conditional logistic regression with adjustment for education, smoking, nutritional factors, body mass index, and waist circumference, CRP showed a significant nonlinear association with colon cancer risk but not rectal cancer risk. Multivariable-adjusted relative risks for CRP concentrations of > or = 3.0 mg/L versus colon cancer and 1.02 (95% CI: 0.67, 1.57; P-trend = 0.65) for rectal cancer. Colon cancer risk was significantly increased in men (relative risk = 1.74, 95% CI: 1.11, 2.73; P-trend = 0.01) but not in women (relative risk = 1.06, 95% CI: 0.67, 1.68; P-trend = 0.13). Additional adjustment for C-peptide, glycated hemoglobin, and high density lipoprotein cholesterol did not attenuate these results. These data provide evidence that elevated CRP concentrations are related to a higher risk of colon cancer but not rectal cancer, predominantly among men and independently of obesity, insulin resistance, and dyslipidemia.

  16. Energy expenditure at rest and during walking in patients with chronic respiratory failure: a prospective two-phase case-control study.

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    Ernesto Crisafulli

    Full Text Available BACKGROUND: Measurements of Energy Expenditure (EE at rest (REE and during physical activities are increasing in interest in chronic patients. In this study we aimed at evaluating the validity/reliability of the SenseWear®Armband (SWA device in terms of REE and EE during assisted walking in Chronic Respiratory Failure (CRF patients receiving long-term oxygen therapy (LTOT. METHODOLOGY/PRINCIPAL FINDINGS: In a two-phase prospective protocol we studied 40 severe patients and 35 age-matched healthy controls. In phase-1 we determined the validity and repeatability of REE measured by SWA (REEa in comparison with standard calorimetry (REEc. In phase-2 we then assessed EE and Metabolic Equivalents-METs by SWA during the 6-minute walking test while breathing oxygen in both assisted (Aid or unassisted (No-Aid modalities. When compared with REEc, REEa was slightly lower in patients (1351±169 vs 1413±194 kcal/day respectively, p<0.05, and less repeatable than in healthy controls (0.14 and 0.43 coefficient respectively. COPD patients with CRF patients reported a significant gain with Aid as compared with No-Aid modality in terms of meters walked, perceived symptoms and EE. CONCLUSIONS/SIGNIFICANCE: SWA provides a feasible and valid method to assess the energy expenditure in CRF patients on LTOT, and it shows that aided walking results in a substantial energy saving in this population.

  17. [Effect of specific physiotherapy on chronic pain, functional level and quality of life in osteoporosis. A prospective randomized single-blind placebo-controlled study].

    Science.gov (United States)

    Malmros, B; Jensen, M B; Charles, P; Mortensen, L S

    1999-08-16

    Patients suffering from osteoporotic vertebral fractures are handicapped by pain and reduced quality of life. Our aim was to investigate the effect of a short training program for osteoporotic patients with regard to pain level, use of analgetics and quality of life. We performed a prospective randomized single-blinded placebo-controlled study. The training program included general training of balance and muscle strength and stabilization of the back. The participants were randomised to 10 weeks of ambulatory training. Controls and training participants were tested weekly by registration of pain level and analgetic intake. Questionnaires on daily level of function and quality of life were given at the start and after five and 10 weeks. After three months both groups filled out the questionnaires at home. The training group had a significant reduction in pain score and use of analgetics. The distribution of functional score improved during training. Quality of life score improved significantly throughout the study and after three months. In conclusion, this ambulatory training program is effective for training osteoporotic patients with moderately severe pain and the training should be continued.

  18. Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

    Science.gov (United States)

    Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

    2017-09-26

    The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events

  19. Plasma cytokines and future risk of non-Hodgkin lymphoma (NHL): a case-control study nested in the Italian European Prospective Investigation into Cancer and Nutrition.

    NARCIS (Netherlands)

    Saberi Hosnijeh, F.; Krop, E.J.M.; Scoccianti, C.; Krogh, V.; Palli, D.; Panico, S.; Tumino, R.; Sacredote, C.; Nawroly, N.; Portengen, L.; Linseisen, J.; Vineis, P.; Vermeulen, R.

    2010-01-01

    BACKGROUND: Recently, biological markers related to the immune system such as cytokines have been studied to further understand the etiology of non-Hodgkin Lymphoma (NHL). However, to date, there are no studies that have studied cytokine levels prospectively in relation to NHL risk in the general po

  20. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren;

    1978-01-01

    Twenty patients were included in a prospective otoneurological study performed to assess the ototoxicity in gentamicin therapy. Gentamicin was administered intravenously, and the serum level was currently determined. Audiographic and electronystagmographic studies were carried out at the institut...

  1. Head Trauma with or without Mild Brain Injury Increases the Risk of Future Traumatic Death: A Controlled Prospective 15-Year Follow-Up Study.

    Science.gov (United States)

    Vaaramo, Kalle; Puljula, Jussi; Tetri, Sami; Juvela, Seppo; Hillbom, Matti

    2015-10-15

    Patients who have recovered from traumatic brain injury (TBI) show an increased risk of premature death. To investigate long-term mortality rates in a population admitted to the hospital for head injury (HI), we conducted a population-based prospective case-control, record-linkage study, All subjects who were living in Northern Ostrobothnia, and who were admitted to Oulu University Hospital in 1999 because of HI (n=737), and 2196 controls matched by age, gender, and residence randomly drawn from the population of Northern Ostrobothnia were included. Death rate and causes of death in HI subjects during 15 years of follow-up was compared with the general population controls. The crude mortality rates were 56.9, 18.6, and 23.8% for subjects having moderate-to-severe traumatic brain injury (TBI), mild TBI, and head injury without TBI, respectively. The corresponding approximate annual mortality rates were 6.7%, 1.4%, and 1.9%. All types of index HI predicted a significant risk of traumatic death in the future. Subjects who had HI without TBI had an increased risk of both death from all causes (hazard ratio 2.00; 95% confidence interval 1.57-2.55) and intentional or unintentional traumatic death (4.01, 2.20-7.30), compared with controls. The main founding was that even HI without TBI carries an increased risk of future traumatic death. The reason for this remains unknown and further studies are needed. To prevent such premature deaths, post-traumatic therapy should include an interview focusing on lifestyle factors.

  2. Immunogenicity and Safety of the 13-Valent Pneumococcal Conjugate Vaccine versus the 23-Valent Polysaccharide Vaccine in Unvaccinated HIV-Infected Adults: A Pilot, Prospective Controlled Study.

    Directory of Open Access Journals (Sweden)

    Francesca Lombardi

    Full Text Available Definition of the optimal pneumococcal vaccine strategy in HIV-infected adults is still under evaluation. We aimed to compare immunogenicity and safety of the 13-valent pneumococcal conjugate vaccine (PCV13 versus the 23-valent polysaccharide vaccine (PPSV23 in HIV-infected adults.We performed a pilot, prospective controlled study enrolling HIV-infected pneumococcal vaccine-naïve outpatients, aged 18-65 years with CD4 counts ≥200 cells/μL. Eligible subjects were recruited into two parallel groups: group 1 (n = 50 received two doses of PCV13 eight weeks apart, and group 2 (n = 50 received one dose of PPSV23, as part of their standard of care. Anti-pneumococcal capsular polysaccharide immunoglobulin G concentrations were quantified by ELISA at baseline, 8, 24 and 48 weeks. Clinical and viro-immunological follow-up was performed at the same time points. Unvaccinated, age-matched HIV-negative adults (n = 100 were also enrolled as baseline controls.Pre-vaccination specific IgG titers for each pneumococcal antigen did not differ between study groups but they were constantly lower than those from the HIV-negative controls. After immunization, significant increases in IgG titers were observed in both study groups at each time point compared to baseline, but response to serotype 3 was blunted in group 1. Antibody titers for each antigen did not differ between study groups at week 48. Overall, the proportion of subjects achieving seroprotection and seroconversion to all serotypes was comparable between groups. A marked decrease in IgG levels over time was observed with both vaccines. No relevant adverse reactions were reported in either group.In this population with favorable immune profile, no relevant differences were observed in immunogenicity between PCV13 and PPSV23. Both vaccines were safe and well tolerated.ClinicalTrials.gov NCT02123433.

  3. Rheumatoid Arthritis Exacerbates the Severity of Osteonecrosis of the Jaws (ONJ) in Mice. A Randomized, Prospective, Controlled Animal Study.

    Science.gov (United States)

    de Molon, Rafael Scaf; Hsu, Chingyun; Bezouglaia, Olga; Dry, Sarah M; Pirih, Flavia Q; Soundia, Akrivoula; Cunha, Fernando Queiroz; Cirelli, Joni Augusto; Aghaloo, Tara L; Tetradis, Sotirios

    2016-08-01

    Rheumatoid arthritis (RA), an autoimmune inflammatory disorder, results in persistent synovitis with severe bone and cartilage destruction. Bisphosphonates (BPs) are often utilized in RA patients to reduce bone destruction and manage osteoporosis. However, BPs, especially at high doses, are associated with osteonecrosis of the jaw (ONJ). Here, utilizing previously published ONJ animal models, we are exploring interactions between RA and ONJ incidence and severity. DBA1/J mice were divided into four groups: control, zoledronic acid (ZA), collagen-induced arthritis (CIA), and CIA-ZA. Animals were pretreated with vehicle or ZA. Bovine collagen II emulsified in Freund's adjuvant was injected to induce arthritis (CIA) and the mandibular molar crowns were drilled to induce periapical disease. Vehicle or ZA treatment continued for 8 weeks. ONJ indices were measured by micro-CT (µCT) and histological examination of maxillae and mandibles. Arthritis development was assessed by visual scoring of paw swelling, and by µCT and histology of interphalangeal and knee joints. Maxillae and mandibles of control and CIA mice showed bone loss, periodontal ligament (PDL) space widening, lamina dura loss, and cortex thinning. ZA prevented these changes in both ZA and CIA-ZA groups. Epithelial to alveolar crest distance was increased in the control and CIA mice. This distance was preserved in ZA and CIA-ZA animals. Empty osteocytic lacunae and areas of osteonecrosis were present in ZA and CIA-ZA but more extensively in CIA-ZA animals, indicating more severe ONJ. CIA and CIA-ZA groups developed severe arthritis in the paws and knees. Interphalangeal and knee joints of CIA mice showed advanced bone destruction with cortical erosions and trabecular bone loss, and ZA treatment reduced these effects. Importantly, no osteonecrosis was noted adjacent to areas of articular inflammation in CIA-ZA mice. Our data suggest that ONJ burden was more pronounced in ZA treated CIA mice and that RA could

  4. A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits.

    Science.gov (United States)

    Housler, Greggory J; Cross, Sue; Marcel, Vanessa; Kennedy, Daniel O; Husband, Michael; Register, Andrew; Roberts, Thomas; Grubbs, Seth; Dudewicz, Douglas; Setka, Nathan; Bay, Curt; Wendelken, Martin E; Izadjoo, Mina J

    This study focused on a clinically relevant healthcare problem in the military: acute soft tissue wounds, or blisters. The trial was a prospective, controlled, randomized two-arm study evaluating the efficacy of a bioelectric dressing, Procellera®, applied topically two to three times per week for 2 weeks to blisters developed in Ranger trainees during training at Fort Benning, Georgia. A total of 80 US Army Ranger recruits with blister wounds below the knee were randomly assigned to one of two treatment groups (n = 40/group). The primary goal was to assess the clinical efficacy (rate of healing) of administered Procellera in conjunction with the standard-of-care (SOC) treatment, moleskin and Tegaderm ®, on the healing rate of blisters compared with the SOC treatment alone. The secondary end points for efficacy were the quantities of wound fluid biomarkers and bacterial bioburden. The tertiary end point was assessment of pain in the treatment group compared with that of the control group during the 2-week study. The results showed no statistical difference between the SOC and SOC+Procellera groups in wound healing and pain. Wound fluid was reported for 24 participants (64.9%) in the SOC group and 21 participants (56.8%) in SOC+Procellera group at the baseline measurement (ρ = .475); however, the wounds were devoid of fluid on follow-up visits. The mild nature of the wounds in this study was apparent by the low pain scores at the beginning of the study, which disappeared by the follow-up visits. The average wound sizes were 2.2cm2 and 1.5cm2 for the SOC and SOC+Procellera groups, respectively. This trial protocol should be conducted on open softtissue wounds in severe heat. To our knowledge, this is the first clinical study conducted within the US Army Rangers training doctrine. 2017.

  5. A prospective, randomized, placebo controlled, double blind study of silicone gel in prevention of hypertrophic scar at donor site of skin grafting

    Directory of Open Access Journals (Sweden)

    Ravi Kumar Chittoria

    2013-01-01

    Full Text Available Background: Hypertrophic scarring at donor site of skin grafting is prevalent among Asians. The effectiveness of silicone gel in scar prevention may influence the surgeons and patients regarding its routine use during the postoperative period. Aims and Objectives: To study the efficacy of silicone gel in prevention of hypertrophic scars at donor site of skin grafting. Design: Prospective randomized placebo controlled double blind study. Setting: The study was conducted in the department of Plastic Surgery, Sri Venkateswara Institute of Medical Sciences (SVIMS University, Tirupati, Andhra Pradesh, India from June 2007 to June 2009. Patients were recruited during follow-up in the OPD. Materials and Methods: The susceptibility to scar development varied among patients; therefore, donor site scars were divided into upper half and lower half. Two types of coded gel prepared by an independent pharmacist were used on either half. Thus, selection and assessment biases and confounders were eliminated. Results: 100 scars in 50 patients were randomized into two arms, 50 control and 50 silicone gel. The median age was 25.5 years and there were 30 men (60% and 20 women (40%. Thirty-seven patients (74% had good compliance. The overall incidence of donor site hypertrophic scar was 94% (47 out of 50. At the second month postoperatively, the silicone gel scars were scored lower when compared with the control scars. The differences were statistically significant in all parameters, including pigmentation ( P = 0.001, Vascularity ( P = 0.010, pliability ( P = 0.001, and height ( P = 0.010. Conclusion: The effect of silicone gel in prevention of hypertrophic scar development in donor site scars is promising. Success of silicone gel in its prophylactic role will create its routine use in all types of surgery to minimize the formation of hypertrophic scars in the early postoperative period.

  6. Prevalence of diabetes, prediabetes, and stress hyperglycemia: insulin therapy and metabolic control in patients on total parenteral nutrition (prospective multicenter study).

    Science.gov (United States)

    Study Group Of Hyperglycemia In Parenteral Nutrition Nutrition Area Of The Spanish Society Of Endocrinology And Nutrition Seen; Olveira, Gabriel; Tapia, María J; Ocón, Julia; Cabrejas-Gómez, Carmen; Ballesteros-Pomar, María D; Vidal-Casariego, Alfonso; Arraiza-Irigoyen, Carmen; Olivares, Josefina; Conde-García, María C; García-Manzanares, Álvaro; Botella-Romero, Francisco; Quílez-Toboso, Rosa P; Cabrerizo, Lucio; Matía, Pilar; Chicharro, Luisa; Burgos, Rosa; Pujante, Pedro; Ferrer, Mercedes; Zugasti, Ana; Petrina, Estrella; Manjón, Laura; Diéguez, Marta; Carrera, María J; Vila-Bundo, Anna; Urgelés, Juan R; Aragón-Valera, Carmen; Sánchez-Vilar, Olga; Bretón, Irene; García-Peris, Pilar; Muñoz-Garach, Araceli; Márquez, Efren; del Olmo, Dolores; Pereira, José Luis; Tous, María C

    2015-01-01

    The prevalence of carbohydrate metabolism disorders in patients who receive total parenteral nutrition (TPN) is not well known. These disorders can affect the treatment, metabolic control, and prognosis of affected patients. The aims of this study were to determine the prevalence in noncritically ill patients on TPN of diabetes, prediabetes, and stress hyperglycemia; the factors affecting hyperglycemia during TPN; and the insulin therapy provided and the metabolic control achieved. We undertook a prospective multicenter study involving 19 Spanish hospitals. Noncritically ill patients who were prescribed TPN were included, and data were collected on demographic, clinical, and laboratory variables (glycated hemoglobin, C-reactive protein [CRP], capillary blood glucose) as well as insulin treatment. The study included 605 patients. Before initiation of TPN, the prevalence of known diabetes was 17.4%, unknown diabetes 4.3%, stress hyperglycemia 7.1%, and prediabetes 27.8%. During TPN therapy, 50.9% of patients had at least one capillary blood glucose of >180 mg/dL. Predisposing factors were age, levels of CRP and glycated hemoglobin, the presence of diabetes, infectious complications, the number of grams of carbohydrates infused, and the administration of glucose-elevating drugs. Most (71.6%) patients were treated with insulin. The mean capillary blood glucose levels during TPN were: known diabetes (178.6 ± 46.5 mg/dL), unknown diabetes (173.9 ± 51.9), prediabetes (136.0 ± 25.4), stress hyperglycemia (146.0 ± 29.3), and normal (123.2 ± 19.9) (P<.001). The prevalence of carbohydrate metabolism disorders is very high in noncritically ill patients on TPN. These disorders affect insulin treatment and the degree of metabolic control achieved.

  7. Effectiveness of intravenous haemocoagulase on haemorrhage control in bi-maxillary orthognathic surgery-A prospective, randomised, controlled, double-blind study.

    Science.gov (United States)

    Shetty, Vikram; Sriram S, Ganapathy

    2015-12-01

    Haemocoagulase is a snake venom protein derivative that is known to possess haemostatic activity. It is reported to minimise blood loss in orthopaedic, otorhinolaryngologic, and abdominal surgeries. The use of intravenous haemocoagulase in orthognathic surgery is unknown and not yet reported. The purpose of this trial is to study the efficacy of haemocoagulase in haemorrhage control in orthognathic surgery. Forty-six consecutive patients scheduled to undergo bi-maxillary orthognathic surgery within the time period of the study were recruited and randomized. They received either the study drug or placebo. All patients underwent operation with hypotensive anaesthesia. Intraoperative blood loss, operating time, drop in haemoglobin and haematocrit were the variables analysed in the study. Haemocoagulase caused an 11% (52 ml) reduction in blood loss in the study group (p = 0.01). There was no adverse reaction in any of the patients.

  8. A prospective, randomized, controlled study of hyperbaric oxygen therapy: effects on healing and oxidative stress of ulcer tissue in patients with a diabetic foot ulcer.

    Science.gov (United States)

    Ma, Le; Li, Pingsong; Shi, Zehong; Hou, Tuanjie; Chen, Xiao; Du, Jin

    2013-03-01

    Although hyperbaric oxygen (HBO) therapy has been reported to help heal chronic foot ulcers in patients with diabetes mellitus (DM), production of HBO-related oxidative stress is a concern. To assess the therapeutic effect and oxidative stress of HBO, a 2-week, prospective, randomized, controlled clinical study was conducted from January 1, 2010 to January1, 2012 among 36 consecutively admitted patients with diabetic foot ulcers (DFU). Average patient age was 60.08 ± 5.97 years and average DM duration was 16.4 ± 11.3 years; 86.1% had type 2 DM, and 47.2% had Wagner grade-III foot ulcers. Patients randomized to the control group (n = 18) received standard care including offloading, wound debridement, and glucose control. HBO treatment group patients (n = 18) received standard care and twice-daily HBO sessions for 90 minutes at 2.5 atmospheres absolute (ATA) 5 days a week for 2 weeks. Transcutaneous oxygen pressure (TcPo2) at the edge of the ulcer and wound size were measured at baseline and after 7 and 14 days of treatment. Ulcer tissues were harvested on days 7 and 14 to determine oxidative stress by measuring malondialdehyde (MDA) and antioxidant enzyme (superoxide dismutase [SOD], catalase [CAT], and glutathione peroxidase [GPx]) levels. Compared to baseline, TcPo2 in the HBO group increased on day 7 (477.8 ± 118.2 mm Hg versus 37.06 ± 5.23 mm Hg, P Ulcer size reduction in the HBO group was greater than that of the control group (42.4% ± 20.0% versus 18.1% ± 6.5%, P ulcer tissue may offset this effect long-term. Until needed additional research has been conducted, prolonged and/or inappropriate HBO treatment should be avoided.

  9. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness

    Directory of Open Access Journals (Sweden)

    Avidan Michael S

    2009-11-01

    Full Text Available Abstract Background The incidence of intraoperative awareness with explicit recall is 1-2/1000 cases in the United States. The Bispectral Index monitor is an electroencephalographic method of assessing anesthetic depth that has been shown in one prospective study to reduce the incidence of awareness in the high-risk population. In the B-Aware trial, the number needed to treat in order to prevent one case of awareness in the high-risk population was 138. Since the number needed to treat and the associated cost of treatment would be much higher in the general population, the efficacy of the Bispectral Index monitor in preventing awareness in all anesthetized patients needs to be clearly established. This is especially true given the findings of the B-Unaware trial, which demonstrated no significant difference between protocols based on the Bispectral Index monitor or minimum alveolar concentration for the reduction of awareness in high risk patients. Methods/Design To evaluate efficacy in the general population, we are conducting a prospective, randomized, controlled trial comparing the Bispectral Index monitor to a non-electroencephalographic gauge of anesthetic depth. The total recruitment for the study is targeted for 30,000 patients at both low and high risk for awareness. We have developed a novel algorithm that is capable of real-time analysis of our electronic perioperative information system. In one arm of the study, anesthesia providers will receive an electronic page if the Bispectral Index value is >60. In the other arm of the study, anesthesia providers will receive a page if the age-adjusted minimum alveolar concentration is Discussion Awareness during general anesthesia is a persistent problem and the role of the Bispectral Index monitor in its prevention is still unclear. The Michigan Awareness Control Study is the largest prospective trial of awareness prevention ever conducted. Trial Registration Clinical Trial NCT00689091

  10. A prospective randomized controlled study comparing two doses of gestodene in cyclic combined HRT preparations on endometrial physiology.

    Science.gov (United States)

    Okon, M A; Lee, S; Laird, S M; Li, T C

    2001-06-01

    Postmenopausal women taking oestradiol 17-beta 2 mg daily were randomized to receive either 25 or 50 microg gestodene from day 17 to 28 of the cycle in a double-blind study. Placental protein P14 (PP14) and CA 125 concentrations in uterine flushing, endometrial morphology and irregular bleeding after 12 cycles of study were observed. Eleven and 12 women in the 25 and 50 microg groups respectively completed the study. There were no significant differences in pre-treatment biochemical and morphological indices between the groups. The median PP14 concentration increased from 332 to 5800 ng/ml (P gestodene groups respectively. No between-group significant rise of PP14 was observed. Similarly, no significant change was seen between the initial and post-treatment concentrations of CA 125 for either group. All biopsies were atrophic at inception of the study, and both regimens produced secretory endometrial transformation in the majority of biopsies. No between-group difference was observed in the morphometric indices measured, or any significant correlation between the concentrations of PP14 or CA 125 and morphology. The mean number of days of withdrawal bleeding (3.8 and 4.2 days for 25 and 50 microg respectively) were similar. In conclusion, both regimens produced a significant rise in uterine flushing concentrations of PP14, but not CA 125. PP14 is a sensitive biochemical marker in the assessment of endometrial response to hormone replacement therapy.

  11. Intra-articular sodium hyaluronate injections after arthroscopic debridement forosteoarthritis of the knee: a prospective, randomized, controlled study

    OpenAIRE

    Heybeli, Nurettin; Doral, Mahmut; Atay, Özgür; Leblebicioğlu, Gürsel

    2017-01-01

    Objectives: The purpose of this study was to evaluate the effect of intra-articular hyaluronic acid (HA) injections after arthroscopic debridement on pain and functional parameters in patients with mild-to-moderate knee osteoarthritis.Methods: Sixty-seven patients (21 men, 46 women; mean age 56 years; range 40 to 65 years) who underwent standard arthroscopic debridement for primary knee osteoarthritis of Kellgren-Lawrence grade II-III were randomly assigned to HA injections (n=33) or to only ...

  12. Topical permethrin and oral ivermectin in the management of scabies: A prospective, randomized, double blind, controlled study

    OpenAIRE

    Reena Sharma; Archana Singal

    2011-01-01

    Background: Scabies is a highly contagious and intensely pruritic parasitic infestation. It is a re-emerging infection in the new millennium especially with HIV pandemic and a significant health problem in developing countries. Various treatment modalities have been used since time immemorial but the search for an ideal scabicide is ongoing. Aims: In this study, we compared the therapeutic efficacy of single application of topical 5% permethrin with oral ivermectin (200 μg/kg/dose) in a singl...

  13. ULTRAPRO Hernia System versus lichtenstein repair in treatment of primary inguinal hernias: a prospective randomized controlled study.

    Science.gov (United States)

    Karateke, Faruk; Ozyazici, Sefa; Menekse, Ebru; Özdogan, Hatice; Kunt, Mevlüt; Bozkurt, Hilmi; Bali, İlhan; Özdogan, Mehmet

    2014-01-01

    The Lichtenstein repair has been recommended as the gold standard for inguinal hernia repair. However, postoperative discomfort still constitutes a concern and an area for improvement. New mesh materials have been continuously introduced to achieve this goal. The goal of the present study was to investigate the outcomes of ULTRAPRO Hernia System (UHS) compared with Lichtenstein mesh repair. A total of 99 male patients with primary unilateral inguinal hernia were included in the study during the period of September 2010-January 2012. Patients with body mass index>30, comorbid diseases, and anesthetic risk of ASA-III and ASA-IV were excluded. The patients were randomly allocated to operation with the Lichtenstein technique (group L) or UHS. Demographics, operative and postoperative/recovery data, and short- and medium-term outcomes of the patients were recorded. A total of 50 patients in group L and 49 patients in group UHS were analyzed. The median follow-up time for the study was 33 months. There were no significant differences regarding demographics, complications, and rehabilitation between the groups. Overall, there was a prolonged operation time in the UHS group compared with the L group (UHS: 53.7±5.7 minutes; L: 44.5±5.5 minutes; Phernias regarding perioperative course, complications, recovery, and recurrence rates. However, because of reduced costs and the lack of need for the exploration of the preperitoneal space, we conclude that the Lichtenstein technique should be recommended as the first choice.

  14. Prevalence of colorectal cancer and its precursor lesions in symptomatic and asymptomatic patients undergoing total colonoscopy: results of a large prospective, multicenter, controlled endoscopy study.

    Science.gov (United States)

    Blumenstein, Irina; Tacke, Wolfgang; Bock, Herbert; Filmann, Natalie; Lieber, Elena; Zeuzem, Stefan; Trojan, Jörg; Herrmann, Eva; Schröder, Oliver

    2013-05-01

    Colorectal cancer (CRC) is the second most common cancer in Germany. Screening colonoscopies have been offered in Germany since 2002. However, validation of screening programs for CRC relies on estimates up to date. The aim of this study was to analyze the influence of the risk factor tumor-suspicious symptoms on the prevalence of CRC and its precursor lesions in patients at least 55 years of age undergoing colonoscopy in comparison with an age-matched and sex-matched control population undergoing screening colonoscopy. Multicenter, prospective, controlled colonoscopy study. Integrated care program of 49 gastroenterological practices in collaboration with a health insurance company and the screening colonoscopy program in Hesse, Germany. In total, 1075 symptomatic and 5375 asymptomatic participants were matched for age and sex (1 : 5) from 1 October 2008 to 30 September 2010. Detection of CRC and its precursor lesions. Overall, the prevalence of CRC was significantly equivalent in both the symptomatic (n=13/1075, 1.21%) and the control group [n=55/5375, 1.02%, 95% confidence interval (CI) for the difference: [-0.46%, 0.83%], P=0.0002, equivalence test with δ=1.5%], respectively. Advanced adenomas were observed in significantly fewer symptomatic patients (61/1075, 5.67%) compared with 432/5375 matched asymptomatic screening participants (8.03%, 95% CI for the difference: [-3.98%, -0.74%], P=0.0094, difference test). Finally, polyps were found significantly less often in symptomatic patients (n=269/1075, 25.0%) than in matched screening participants (n=1807/5375, 33.6%, 95% CI for the difference: [-11.53%, -5.66%], P<0.0001, difference test). The results underline the importance of screening the symptom-free population at least 55 years of age to prevent CRC.

  15. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study

    Science.gov (United States)

    Jendoubi, Ali; Naceur, Imed Ben; Bouzouita, Abderrazak; Trifa, Mehdi; Ghedira, Salma; Chebil, Mohamed; Houissa, Mohamed

    2017-01-01

    Background: Recently, there has been increasing interest in the use of analgesic adjuncts such as intravenous (IV) ketamine and lidocaine. Objectives: To compare the effects of perioperative IV lidocaine and ketamine on morphine requirements, pain scores, quality of recovery, and chronic pain after open nephrectomy. Study Design: A prospective, randomized, placebo-controlled, double-blind trial. Settings: The study was conducted in Charles Nicolle University Hospital of Tunis. Methods: Sixty patients were randomly allocated to receive IV lidocaine: bolus of 1.5 mg/kg at the induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively or ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively or an equal volume of saline (control group [CG]). Measurements: Morphine consumption, visual analog scale pain scores, time to the first passage of flatus and feces, postoperative nausea and vomiting (PONV), 6-min walk distance (6MWD) at discharge, and the incidence of chronic neuropathic pain using the “Neuropathic Pain Questionnaire” at 3 months. Results: Ketamine and lidocaine reduced significantly morphine consumption (by about 33% and 42%, respectively) and pain scores compared with the CG (P Lidocaine and ketamine also significantly improved bowel function in comparison to the CG (P lidocaine group (P Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months (P lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic neuropathic pain at 3 months after open nephrectomy. PMID:28442956

  16. The usefulness of a magnetic endoscope locating device in colonoscopy in daily practice: a prospective case-controlled study

    DEFF Research Database (Denmark)

    Jess, Per; Bulut, Orhan; Almasi, Ahmad

    2009-01-01

    BACKGROUND: This study aimed to investigate the effects of magnetic endoscope imaging (MEI) regarding examination time, caecal intubation rate, and sedation and analgesic requirements during routine colonoscopy compared with earlier used X-ray imaging. METHODS: Consecutive outpatients undergoing ...... 50 microg phentanyle and 2 mg midazolam in both groups). Median X-ray dose was 150 cGy in the group using X-ray imaging. CONCLUSION: MEI is the imaging methodology of choice and should always be available in colonoscopy, especially for precise locating of colonic lesions....

  17. The effect of preoperative intravenous use of tenoxicam: a prospective, double-blind, placebo-controlled study.

    Science.gov (United States)

    Akca, Tamer; Colak, Tahsin; Kanik, Arzu; Yaylak, Faik; Caglikulekci, Mehmet; Aydin, Suha

    2004-01-01

    In this study, we aimed to investigate the postoperative pain relief effect of preoperative tenoxicam usage in patients who undergo elective laparoscopic cholecystectomy or groin hernia repair. Eighty patients undergoing laparoscopic cholecystectomy or groin hernia repair procedures were randomized to receive either physiologic serum at 100 mL (group I, n = 40) or 20 mg iv tenoxicam (group II, n = 40) immediately before induction. Postoperative analgesic requirement, peroperative side effects and complications of drugs, operating time, post-operative mobilization time and pain score, hospitalization time, and patient pleasure were recorded. Postoperative pain was assessed by the visual analogue scale (VAS) on the recovery unit (RU), at 4, 8, and 24 h and every day at the same times in the morning. The RU median VAS score was also not different when Group 1 was compared with Group 2 (p = .97). However, the postoperative 4-h and 8-h median VAS score was significantly less (p = .01 and p = .03, respectively); first postoperative mobilization time was earlier in group 2 (p = .32). The median pain score and intramuscular analgesic requirement of patients were also reduced in Group 2 in postoperative day 1 (p = .015). The median duration of intramuscular analgesic requirement and total amount of intramuscular analgesic used in patients were also significantly less in Group 2 (p = .0001 and p = .0001, respectively). Thus, this study showed that preoperative use of iv tenoxicam is safe, simple, and effective for postoperative pain relief after laparoscopic cholecystectomy or inguinal hernia repair.

  18. Anticoagulation therapy in Chinese patients with non-valvular atrial fibrillation: a prospective, multi-center, randomized,controlled study

    Institute of Scientific and Technical Information of China (English)

    CHEN Ke-ping; HUANG Cong-xin; HUANG De-jia; CAO Ke-jiang; MA Chang-sheng; WANG Fang-zheng; ZHANG Shu

    2012-01-01

    Background Non-valvular atrial fibrillation is associated with an increased risk of ischemic stroke; however,the appropriate intensity of anticoagulation therapy for Chinese patients has not been determined.The purpose of this study was to compare the safety and the efficacy of standard-intensity warfarin therapy,low-intensity warfarin therapy,and aspirin therapy for the prevention of ischemic events in Chinese patients with non-valvular atrial fibrillation (NVAF).Methods A total of 786 patients from 75 Chinese hospitals were enrolled in this study and randomized into three therapy groups:standard-intensity warfarin (international normalized ratio (INR) 2.1 to 2.5) group,low-intensity warfarin (INR 1.6 to 2.0) group and aspirin (200 mg per day) group.All patients were evaluated by physicians at 1,3,6,9,12,15,18,21 and 24 months after randomization to obtain a patient questionnaire,physical examination and related laboratory tests.Results The annual event rates of ischemic stroke,transient ischemic attack (TIA) or systemic thromboembolism were 2.6%,3.1% and 6.9% in the standard-intensity warfarin,low-intensity warfarin and aspirin groups,respectively (P=0.027).Thromboembolic event rates in both warfarin groups were significantly lower than that in the aspirin group (P=0.018,P=0.044),and there was no significant difference between the two warfarin groups.Severe hemorrhagic events occurred in 15 patients,7 (2.6%) in the standard-intensity warfarin group,7 (2.4%) in the low-intensity warfarin group and 1 (0.4%)in the aspirin group.The severe hemorrhagic event rates in the warfarin groups were higher than that in the aspirin group,but the difference did not reach statistical significance (P=0.101).The mild hemorrhagic and total hemorrhagic event rates in the warfarin groups (whether in the standard-intensity warfarin group or low-intensity warfarin group) were much higher than that in the aspirin group with the annual event rates of total hemorrhages of 10

  19. Using an ACTIVE teaching format versus a standard lecture format for increasing resident interaction and knowledge achievement during noon conference: a prospective, controlled study.

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    Sawatsky, Adam P; Berlacher, Kathryn; Granieri, Rosanne

    2014-07-01

    The traditional lecture is used by many residency programs to fulfill the mandate for regular didactic sessions, despite limited evidence to demonstrate its effectiveness. Active teaching strategies have shown promise in improving medical knowledge but have been challenging to implement within the constraints of residency training. We developed and evaluated an innovative structured format for interactive teaching within the residency noon conference. We developed an ACTIVE teaching format structured around the following steps: assemble (A) into groups, convey (C) learning objectives, teach (T) background information, inquire (I) through cases and questions, verify (V) understanding, and explain (E) answer choices and educate on the learning points. We conducted a prospective, controlled study of the ACTIVE teaching format versus the standard lecture format, comparing resident satisfaction, immediate knowledge achievement and long-term knowledge retention. We qualitatively assessed participating faculty members' perspectives on the faculty development efforts and the feasibility of teaching using the ACTIVE format. Sixty-nine internal medicine residents participated in the study. Overall, there was an improvement in perceived engagement using the ACTIVE teaching format (4.78 vs. 3.80, P lecture. A structured ACTIVE teaching format improved resident engagement and initial knowledge, and required minimal resources. The ACTIVE teaching format offers an exciting alternative to the standard lecture for resident noon conference and is easy to implement.

  20. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

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    Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

    2017-04-01

    To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, pgout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, pgout and hyperuricaemia in obese subjects. NCT01479452; 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/.

  1. Influenza vaccine effectiveness among healthcare workers in comparison to hospitalized patients: A 2004-2009 case-test, negative-control, prospective study.

    Science.gov (United States)

    Vanhems, P; Baghdadi, Y; Roche, S; Bénet, T; Regis, C; Lina, B; Robert, O; Voirin, N; Ecochard, R; Amour, S

    2016-01-01

    The objective of this study was to calculate Vaccine Effectiveness (VE) in healthcare workers (HCW) and to compare VE between patients and HCW. A case-control investigation based on the prospective study was conducted between 2004 and 2009 in a teaching hospital. All HCW with influenza-like illness (ILI) from participating units (n = 24) were included, and vaccination status was characterized by interview. A total of 150 HCW presented ILI; 130 (87%) were female, 27 (18%) were positive for influenza, and 42 (28%) were vaccinated. Adjusted VE was 89% (95% CI 39 to 98). Among patients, adjusted VE was 42% (95% CI -39 to 76). The difference of VE (VEhcw - VEpat) was 46.15% (95% CI 2.41 to 144). The VE ratio (VEhcw / VEpat) was 2.09 (95% CI -1.60 to 134.17). Influenza VE differed between HCW and patients when the flu season was taken into account. This finding confirms the major impact of host determinants on influenza VE.

  2. Influenza vaccine effectiveness among healthcare workers in comparison to hospitalized patients: A 2004-2009 case-test, negative-control, prospective study

    Science.gov (United States)

    Vanhems, P; Baghdadi, Y; Roche, S; Bénet, T; Regis, C; Lina, B; Robert, O; Voirin, N; Ecochard, R; Amour, S

    2016-01-01

    The objective of this study was to calculate Vaccine Effectiveness (VE) in healthcare workers (HCW) and to compare VE between patients and HCW. A case-control investigation based on the prospective study was conducted between 2004 and 2009 in a teaching hospital. All HCW with influenza-like illness (ILI) from participating units (n = 24) were included, and vaccination status was characterized by interview. A total of 150 HCW presented ILI; 130 (87%) were female, 27 (18%) were positive for influenza, and 42 (28%) were vaccinated. Adjusted VE was 89% (95% CI 39 to 98). Among patients, adjusted VE was 42% (95% CI −39 to 76). The difference of VE (VEhcw - VEpat) was 46.15% (95% CI 2.41 to 144). The VE ratio (VEhcw / VEpat) was 2.09 (95% CI −1.60 to 134.17). Influenza VE differed between HCW and patients when the flu season was taken into account. This finding confirms the major impact of host determinants on influenza VE. PMID:26327520

  3. A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA to epsilon aminocaproic acid (EACA for corrective spinal surgery

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    Vaz Kenneth M

    2010-04-01

    Full Text Available Abstract Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA to epsilon aminocaproic acid (EACA in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS, neuromuscular scoliosis (NMS, and adult deformity (AD via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581

  4. Rizatriptan for the acute treatment of ICHD-II proposed menstrual migraine: two prospective, randomized, placebo-controlled, double-blind studies.

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    Mannix, L K; Loder, E; Nett, R; Mueller, L; Rodgers, A; Hustad, C M; Ramsey, K E; Skobieranda, F

    2007-05-01

    These are the first prospective studies to use criteria for menstrual migraine proposed in the 2004 revision of the International Classification of Headache Disorders (ICHD-II) to examine the efficacy of rizatriptan for treatment of a menstrual attack. Two identical protocols (MM1 and MM2) were randomized, parallel, placebo-controlled, double-blind studies. Adult women with ICHD-II menstrual migraine were assigned to either rizatriptan 10-mg tablet or placebo in a 2 : 1 ratio. Patients treated a single menstrual migraine attack of moderate or severe pain intensity. The primary end-point was 2-h pain relief and the secondary end-point was 24-h sustained pain relief. A total of 707 patients (MM1 357, MM2 350) treated a menstrual migraine attack. The percentage of patients reporting 2-h pain relief was significantly greater for rizatriptan than for placebo (MM1 70% vs. 53%, MM2 73% vs. 50%), as was the percentage of patients reporting 24-h sustained pain relief (MM1 46% vs. 33%; MM2 46% vs. 33%). Rizatriptan 10 mg was effective for the treatment of ICHD-II menstrual migraine, as measured by 2-h pain relief and 24-h sustained pain relief.

  5. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double-blind prospective study

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    Sebnem Koldas Dogan

    2010-01-01

    Full Text Available OBJECTIVES: Conflicting results were reported about the effectiveness of Low level laser therapy on musculoskeletal disorders. The aim of this study was to investigate the effectiveness of 850-nm gallium arsenide aluminum (Ga-As-Al laser therapy on pain, range of motion and disability in subacromial impingement syndrome. METHODS: A total of 52 patients (33 females and 19 males with a mean age of 53.59±11.34 years with subacromial impingement syndrome were included. The patients were randomly assigned into two groups. Group I (n = 30, laser group received laser therapy (5 joule/cm² at each point over maximum 5-6 painful points for 1 minute. Group II (n = 22, placebo laser group received placebo laser therapy. Initially cold pack (10 minutes was applied to all of the patients. Also patients were given an exercise program including range of motion, stretching and progressive resistive exercises. The therapy program was applied 5 times a week for 14 sessions. Pain severity was assessed by using visual analogue scale. Range of motion was measured by goniometer. Disability was evaluated by using Shoulder Pain and Disability Index. RESULTS: In group I, statistically significant improvements in pain severity, range of motion except internal and external rotation and SPADI scores were observed compared to baseline scores after the therapy (p0.05. CONCLUSIONS: The Low level laser therapy seems to have no superiority over placebo laser therapy in reducing pain severity, range of motion and functional disability.

  6. Comparison of low-dose oxytocin and dinoprostone for labor induction in postterm pregnancies: a randomized controlled prospective study.

    Science.gov (United States)

    Akay, Nezahat Öztürk; Hızlı, Deniz; Yılmaz, Saynur Sarıcı; Yalvaç, Serdar; Kandemir, Omer

    2012-01-01

    The aim of this study was to compare the efficacy of oxytocin and dinoprostone in achieving successful labor induction and vaginal delivery in postterm women with an unfavorable cervix. Postterm women with an uncomplicated pregnancy and a Bishop score of ≤6 were randomized to receive either dinoprostone vaginal pessary (Propess®) or low-dose oxytocin. The primary outcomes were the length of the induction-to-delivery period and the incidence of vaginal delivery. A total of 144 women were available for the analysis. The overall vaginal delivery rates were 75% (54/72) for the dinoprostone group and 80.6% (58/72; p = 0.35) for the oxytocin group; the mean induction-to-vaginal delivery interval was 13.3 and 10.3 h in the dinoprostone and the oxytocin group, respectively (p = 0.003). Uterine hyperstimulation was 7.4% compared with 6.8% (p = 0.8), and abnormal fetal heart rate was 26.4% compared with 18% (p = 0.2), respectively. Both oxytocin and dinoprostone seem to have similar obstetric outcomes in postterm pregnancies with an unfavorable cervix, except for a significant superiority of oxytocin for delivery in a shorter period. Copyright © 2012 S. Karger AG, Basel.

  7. Treatment of Medial Tibial Stress Syndrome according to the Fascial Distortion Model: A Prospective Case Control Study

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    Christoph Schulze

    2014-01-01

    Full Text Available Medial tibial stress syndrome (MTSS is a common problem among athletes and soldiers. There is no proven theory that could explain the pathophysiology of shin splints. The therapies described so far are time-consuming and involve a high risk of relapse. The method according to the fascial distortion model (FDM addresses local changes in the area of the lower leg fascia. It is suited to reduce pain and functional impairments associated with this symptom complex by applying targeted manual techniques. 32 patients (male: 30; female: 2 participated in this study. Visual analogue scale (VAS was used for the quantification of pain. Scores were also given to rate the maximum painless exercise tolerance of the patients. Subsequently treatment of the crural fascia was performed. Patients retested ability of running and jumping. Therapy was continued until full exercise tolerance or painlessness was reached. A significant reduction of the VAS pain score from 5.2 to 1.1 could be achieved (P<0.001. The impairment of exercise tolerance could be reduced from 7 to 2 points (P<0.001. The duration of treatment was 6.3 (SD: 4.3 days on average. The FDM therapy is a potential effective method for acute treatment of MTSS.

  8. Evaluation of left ventricular mass and function, lipid profile, and insulin resistance in Egyptian children with growth hormone deficiency: A single-center prospective case-control study

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    Kotb Abbass Metwalley

    2013-01-01

    Full Text Available Background: Growth hormone deficiency (GHD in adults is associated with a cluster of cardiovascular risk factors that may contribute to an increased mortality for cardiovascular disease. In children, relatively few studies have investigated the effect of GHD and replacement therapy on cardiac performance and metabolic abnormalities that may place them at a higher risk of cardiovascular disease (CVD at an early age. Aim: This study was aimed to assess the left ventricular function, lipid profile, and degree of insulin resistance in Egyptian children with GHD before and after 1 year of GH replacement therapy. Settings and Design: Prospective case-control study, single-center study. Materials and Methods: Thirty children with short stature due to GHD were studied in comparison to 20 healthy age- and sex-matched children. All subjects were subjected to history, clinical examination, auxological assessment, and echocardiography to assess the left ventricular function. Blood samples were collected for measuring IGF-1, lipid profile (Total, LDL, HDL cholesterol, triglyceride, and atherogenic index (AI, fasting blood sugar, and fasting insulin levels. In addition, basal and stimulated GH levels were measured in children with suspected GHD. Statistical Analysis Used: Student′s t-test was used for parametric data, and the Mann-Whitney U-test was used for non-parametric data. Results: Total, LDL cholesterol, triglyceride, AI, and insulin were significantly higher in children with GHD than in healthy controls at baseline. After 12 months of GH replacement therapy, total, LDL cholesterol, triglyceride, AI and insulin were significantly decreased, while homeostatic model assessment for insulin resistance index (HOMA-IR was significantly increased compared to both pre-treatment and control values. At baseline, the left ventricular mass (LVM and left ventricular mass index (LVMi were significantly lower in GHD children than in controls. After 12 months of GH

  9. Effect of Supervised Students' Involvement on Diagnostic Accuracy in Hospitalized Medical Patients — A Prospective Controlled Study

    Science.gov (United States)

    Herter, Dorothea Adelheid; Wagner, Robert; Holderried, Friederike; Fenik, Yelena; Riessen, Reimer; Weyrich, Peter; Celebi, Nora

    2012-01-01

    Background During internships most medical students engage in history taking and physical examination during evaluation of hospitalized patients. However, the students' ability for pattern recognition is not as developed as in medical experts and complete history taking is often not repeated by an expert, so important clues may be missed. On the other hand, students' history taking is usually more extensive than experts' history taking and medical students discuss their findings with a Supervisor. Thus the effect of student involvement on diagnostic accuracy is unclear. We therefore compared the diagnostic accuracy for patients in the medical emergency department with and without student involvement in the evaluation process. Methodology/Principal Findings Patients in the medical emergency department were assigned to evaluation by either a supervised medical student or an emergency department physician. We only included patients who were admitted to our hospital and subsequently cared for by another medical team on the ward. We compared the working diagnosis from the emergency department with the discharge diagnosis. A total of 310 patients included in the study were cared for by 41 medical students and 21 emergency department physicians. The working diagnosis was changed in 22% of the patients evaluated by physicians evaluation and in 10% of the patients evaluated by supervised medical students (p = .006). There was no difference in the expenditures for diagnostic procedures, length of stay in the emergency department or patient comorbidity complexity level. Conclusion/Significance Involvement of closely supervised medical students in the evaluation process of hospitalized medical patients leads to an improved diagnostic accuracy compared to evaluation by an emergency department physician alone. PMID:22984578

  10. Effect of supervised students' involvement on diagnostic accuracy in hospitalized medical patients--a prospective controlled study.

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    Dorothea Adelheid Herter

    Full Text Available BACKGROUND: During internships most medical students engage in history taking and physical examination during evaluation of hospitalized patients. However, the students' ability for pattern recognition is not as developed as in medical experts and complete history taking is often not repeated by an expert, so important clues may be missed. On the other hand, students' history taking is usually more extensive than experts' history taking and medical students discuss their findings with a Supervisor. Thus the effect of student involvement on diagnostic accuracy is unclear. We therefore compared the diagnostic accuracy for patients in the medical emergency department with and without student involvement in the evaluation process. METHODOLOGY/PRINCIPAL FINDINGS: Patients in the medical emergency department were assigned to evaluation by either a supervised medical student or an emergency department physician. We only included patients who were admitted to our hospital and subsequently cared for by another medical team on the ward. We compared the working diagnosis from the emergency department with the discharge diagnosis. A total of 310 patients included in the study were cared for by 41 medical students and 21 emergency department physicians. The working diagnosis was changed in 22% of the patients evaluated by physicians evaluation and in 10% of the patients evaluated by supervised medical students (p = .006. There was no difference in the expenditures for diagnostic procedures, length of stay in the emergency department or patient comorbidity complexity level. CONCLUSION/SIGNIFICANCE: Involvement of closely supervised medical students in the evaluation process of hospitalized medical patients leads to an improved diagnostic accuracy compared to evaluation by an emergency department physician alone.

  11. Topical permethrin and oral ivermectin in the management of scabies: A prospective, randomized, double blind, controlled study

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    Reena Sharma

    2011-01-01

    Full Text Available Background: Scabies is a highly contagious and intensely pruritic parasitic infestation. It is a re-emerging infection in the new millennium especially with HIV pandemic and a significant health problem in developing countries. Various treatment modalities have been used since time immemorial but the search for an ideal scabicide is ongoing. Aims: In this study, we compared the therapeutic efficacy of single application of topical 5% permethrin with oral ivermectin (200 μg/kg/dose in a single-dose and a two-dose regimen in patients with scabies. Methods: 120 clinically diagnosed cases of scabies (>5 years of age and/or >15 kg were randomized into three treatment groups A, B, C of 40 patients each; receiving either topical 5% permethrin (group A or oral ivermectin (200 μg/kg/dose in a single dose (group B or double dose regimen (group C repeated at 2 weeks interval. Patients were followed up at 1, 2, and 4 weeks interval. At each visit, cure rate (>50% improvement in lesion count and pruritus and negative microscopy was assessed and compared. Results: Cure rate in three treatment groups at the end of 4 weeks was 94.7% (A, 90% (B, 89.7%(C, and thus all three treatment modalities were equally efficacious. However, at 1 week follow up, group A patients reported better improvement in both lesion count and pruritus. Conclusions: Both permethrin and ivermectin in both single and two dose regimen are equally efficacious and well tolerated in scabies. However, permethrin has a rapid onset of action.

  12. A prospective, randomized, blinded-endpoint, controlled study - continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia

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    Joana Nunes

    Full Text Available Abstract Background: There is evidence that administration of a programmed intermittent epidural bolus (PIEB compared to continuous epidural infusion (CEI leads to greater analgesia efficacy and maternal satisfaction with decreased anesthetic interventions. Methods: In this study, 166 women with viable pregnancies were included. After an epidural loading dose of 10 mL with Ropivacaine 0.16% plus Sufentanil 10 µg, parturient were randomly assigned to one of three regimens: A - Ropivacaine 0.15% plus Sufentanil 0.2 µg/mL solution as continuous epidural infusion (5 mL/h, beginning immediately after the initial bolus; B - Ropivacaine 0.1% plus Sufentanil 0.2 µg/mL as programmed intermittent epidural bolus and C - Same solution as group A as programmed intermittent epidural bolus. PIEB regimens were programmed as 10 mL/h starting 60 min after the initial bolus. Rescue boluses of 5 mL of the same solution were administered, with the infusion pump. We evaluated maternal satisfaction using a verbal numeric scale from 0 to 10. We also evaluated adverse, maternal and neonatal outcomes. Results: We analyzed 130 pregnants (A = 60; B = 33; C = 37. The median verbal numeric scale for maternal satisfaction was 8.8 in group A; 8.6 in group B and 8.6 in group C (p = 0.83. We found a higher caesarean delivery rate in group A (56.7%; p = 0.02. No differences in motor block, instrumental delivery rate and neonatal outcomes were observed. Conclusions: Maintenance of epidural analgesia with programmed intermittent epidural bolus is associated with a reduced incidence of caesarean delivery with equally high maternal satisfaction and no adverse outcomes.

  13. Is adjunctive naturopathy associated with improved glycaemic control and a reduction in need for medications among type 2 Diabetes patients? A prospective cohort study from India.

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    Bairy, Srinivas; Kumar, Ajay M V; Raju, Msn; Achanta, Shanta; Naik, Balaji; Tripathy, Jaya P; Zachariah, Rony

    2016-08-17

    With an estimated 65 million Diabetes Mellitus (DM) patients, India ranks second in the world in terms of DM burden. The emphasis of current medical practice has been on pharmacotherapy but, despite the best combination therapies, acheiving glycaemic control (reduction of blood sugar to desirable levels) is a challenge. 'Integrated Naturopathy and Yoga'(INY) is an alternative system of medicine that lays emphasis on the role of diet and physical exercise. We assessed the short term effect of INY as an adjunct to pharmacotherapy on glycaemic control among type 2 DM patients. In this prospective cohort study with a 3 month follow-up, DM patients consecutively admitted to a hospital in India from May-October 2014 for either 15 or 30 days were offered INY - a package of vegetarian diet with no added oil, sugar and salt, yoga-based exercise, patient counselling and rest. A 'favourable outcome' was defined as glycaemic control (glycosylated hemoglobin (HbA1c) < 7 % or absolute reduction by 1 %) along with at least 50 % reduction in antidiabetes medication at 3 months relative to baseline. Compliance to diet was scored by self-report on a scale of 0-10 and categorized into poor (0-5), moderate (6-8) and excellent (9-10). Of 101 patients with 3-month follow-up data, 65(65 %) achieved a favourable outcome - with 19(19 %) stopping medication while sustaining glycemic control. Factors associated with favourable outcome were baseline HbA1c and compliance to diet, which showed a significant linear relationship with mean HbA1c reductions of 0.4 %, 1.1 % and 1.7 % in relation to poor, moderate and excellent dietary compliance respectively. INY, adjunctive to pharmacotherapy, was associated with a significant beneficial effect on glycaemic control and reduced the overall need for antidiabetes medications. These early results are promising. Further studies with long-term follow-up and using more rigorous randomized controlled trial designs are needed.

  14. Longitudinal course of deficient emotional self-regulation CBCL profile in youth with ADHD: prospective controlled study

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    Biederman J

    2012-06-01

    Full Text Available Joseph Biederman,1,2 Thomas J Spencer,1,2 Carter Petty,1 Laran L Hyder,1 Katherine B O’Connor,1 Craig BH Surman,1,2 Stephen V Faraone31Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Pediatric Psychopharmacology Unit, Yawkey Center for Outpatient Care, Boston, MA, 2Department of Psychiatry, Harvard Medical School, Cambridge, MA, 3Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NYBackground: While symptoms of deficient emotional self-regulation (DESR have been long associated with attention-deficit/hyperactivity disorder (ADHD, there has been limited investigation of this aspect of the clinical picture of the disorder. The main aim of this study was to examine the predictive utility of DESR in moderating the course of ADHD children into adolescence.Methods: Subjects comprised 177 children with and 204 children without ADHD followed for an average of 4 years (aged 6–18 years at baseline, 54% male. Subjects were assessed with structured diagnostic interviews and measures of psychosocial functioning. DESR was defined by the presence (n = 79 or absence (n = 98 of Child Behavior Checklist (CBCL-DESR profile (score ≥ 180 < 210 total of Attention, Aggression, and Anxious/Depressed subscales at the baseline assessment.Results: Of subjects with DESR at baseline, 57% had DESR at follow-up. Persistent ADHD was significantly associated with DESR at follow-up (χ2(1 = 15.37, P < 0.001. At follow-up, ADHD + DESR subjects had significantly more comorbidities (z = 2.55, P = 0.01, a higher prevalence of oppositional defiant disorder (z = 3.01, P = 0.003, and more impaired CBCL social problems t-score (t(227 = 2.41, P = 0.02 versus ADHD subjects.Conclusion: This work suggests that a positive CBCL-DESR profile predicts subsequent psychopathology and functional impairments in children with ADHD suggesting that it has the potential to help

  15. Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

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    Sartory Gudrun

    2010-12-01

    Full Text Available Abstract Background It has been demonstrated that cognitive behavioural therapy (CBT has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST which does not implement CBT-techniques but provides comparable therapeutic attention. Methods/Design The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process, advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists. Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency. Discussion This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the

  16. Helicobacter pylori infection, chronic corpus atrophic gastritis and pancreatic cancer risk in the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort: A nested case-control study.

    Science.gov (United States)

    Huang, Jiaqi; Zagai, Ulrika; Hallmans, Göran; Nyrén, Olof; Engstrand, Lars; Stolzenberg-Solomon, Rachael; Duell, Eric J; Overvad, Kim; Katzke, Verena A; Kaaks, Rudolf; Jenab, Mazda; Park, Jin Young; Murillo, Raul; Trichopoulou, Antonia; Lagiou, Pagona; Bamia, Christina; Bradbury, Kathryn E; Riboli, Elio; Aune, Dagfinn; Tsilidis, Konstantinos K; Capellá, Gabriel; Agudo, Antonio; Krogh, Vittorio; Palli, Domenico; Panico, Salvatore; Weiderpass, Elisabete; Tjønneland, Anne; Olsen, Anja; Martínez, Begoña; Redondo-Sanchez, Daniel; Chirlaque, Maria-Dolores; Hm Peeters, Petra; Regnér, Sara; Lindkvist, Björn; Naccarati, Alessio; Ardanaz, Eva; Larrañaga, Nerea; Boutron-Ruault, Marie-Christine; Rebours, Vinciane; Barré, Amélie; Bueno-de-Mesquita, H B As; Ye, Weimin

    2017-04-15

    The association between H. pylori infection and pancreatic cancer risk remains controversial. We conducted a nested case-control study with 448 pancreatic cancer cases and their individually matched control subjects, based on the European Prospective Investigation into Cancer and Nutrition (EPIC) cohort, to determine whether there was an altered pancreatic cancer risk associated with H. pylori infection and chronic corpus atrophic gastritis. Conditional logistic regression models were applied to calculate odds ratios (ORs) and corresponding 95% confidence intervals (CIs), adjusted for matching factors and other potential confounders. Our results showed that pancreatic cancer risk was neither associated with H. pylori seropositivity (OR = 0.96; 95% CI: 0.70, 1.31) nor CagA seropositivity (OR = 1.07; 95% CI: 0.77, 1.48). We also did not find any excess risk among individuals seropositive for H. pylori but seronegative for CagA, compared with the group seronegative for both antibodies (OR = 0.94; 95% CI: 0.63, 1.38). However, we found that chronic corpus atrophic gastritis was non-significantly associated with an increased pancreatic cancer risk (OR = 1.35; 95% CI: 0.77, 2.37), and although based on small numbers, the excess risk was particularly marked among individuals seronegative for both H. pylori and CagA (OR = 5.66; 95% CI: 1.59, 20.19, p value for interaction < 0.01). Our findings provided evidence supporting the null association between H. pylori infection and pancreatic cancer risk in western European populations. However, the suggested association between chronic corpus atrophic gastritis and pancreatic cancer risk warrants independent verification in future studies, and, if confirmed, further studies on the underlying mechanisms.

  17. Medical and surgical treatments for obesity have opposite effects on peptide YY and appetite: a prospective study controlled for weight loss.

    Science.gov (United States)

    Valderas, Juan P; Irribarra, Verónica; Boza, Camilo; de la Cruz, Rolando; Liberona, Yessica; Acosta, Ana Maria; Yolito, Macarena; Maiz, Alberto

    2010-03-01

    The effects of medical and surgical treatments for obesity on peptide YY (PYY) levels, in patients with similar weight loss, remain unclear. The objective of the study was to assess PYY and appetite before and after Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), and medical treatment (MED). This was a prospective, controlled, nonrandomized study. The study was conducted at the Departments of Nutrition and Digestive Surgery at a university hospital. PARTICIPANTS included three groups of eight patients with similar body mass indexes (RYGB 37.8 +/- 0.8, SG 35.3 +/- 0.7, and MED 39.1 +/- 1.7 kg/m(2), P = NS) and eight lean controls (body mass index 21.7 +/- 0.7 kg/m(2)). Total plasma PYY, hunger, and satiety visual analog scales in fasting and after ingestion of a standard test meal were measured. At baseline there were no differences in the area under the curve (AUC) of PYY, hunger, or satiety in obese groups. Two months after the interventions, RYGB, SG, and MED groups achieved similar weight loss (17.7 +/- 3, 14.9 +/- 2.4, 16.6 +/- 4%, respectively, P = NS). PYY AUC increased in RYGB (P < 0.001) and SG (P < 0.05) and did not change in MED. PYY levels decreased at fasting, 30 min, and 180 min after a standard test meal in MED (P < 0.05). Hunger AUC decreased in RYGB (P < 0.05). Satiety AUC increased in RYGB (P < 0.05) and SG (P < 0.05). Appetite did not change in MED. PYY AUC correlated with satiety AUC (r = 0.35, P < 0.05). RYGB and SG increased PYY and reduced appetite. MED failed to produce changes. Different effects occur despite similar weight loss. This suggests that the weight-loss effects of these procedures are enhanced by an increase in PYY and satiety.

  18. Pain relief in day care arthroscopic knee surgery: A comparison between intra-articular ropivacaine and levobupivacaine: A prospective, double-blinded, randomized controlled study

    Directory of Open Access Journals (Sweden)

    Anjan Das

    2014-01-01

    Full Text Available Background: Post-operative pain frequently hampers implementation of day care arthroscopic knee surgery in spite of so many analgesic, local anesthetic drugs and routes of administration. Aims: The aim of the present study was carried out to compare the efficacy of ropivacaine and levobupivacaine when administered through intra-articular route in controlling pain after day care arthroscopic knee surgery. Setting and Design: It was a prospective, double-blinded and randomized controlled study. Materials and Methods: April 2008-December 2008, 60 patients of both sex, of American Society of Anesthesiologists physical status I and II, undergoing day care arthroscopic knee surgery were randomly assigned into two groups (R, L. Group R received 10 ml of 0.75% ropivacaine, whereas group L received 10 ml of 0.50% levobupivacaine through intra-articular route at the end of the procedure. Pain assessed using visual analog scale (VAS and diclofenac sodium given as rescue analgesia when VAS >3. Time of first analgesic request and total rescue analgesic were calculated. Statistical Analysis and Results: based on comparable demographic profiles; time for the requirement of first post-operative rescue analgesia (242.16 ± 23.86 vs. 366.62 ± 24.42 min and total mean rescue analgesic requirement was (104.35 ± 18.96 vs. 76.82 ± 14.28 mg in group R and L respectively. Group R had higher mean VAS score throughout the study period. No side effects found among the groups. These two results were clinically and statistically significant (P < 0.05. Conclusion: Hence, it was evident that intra-articular levobupivacaine give better post-operative pain relief, with an increase in time of first analgesic request and decreased need of total post-operative analgesia compared with ropivacaine.

  19. An ADAM33 polymorphism associates with progression of preschool wheeze into childhood asthma: a prospective case-control study with replication in a birth cohort study.

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    Ester M M Klaassen

    Full Text Available The influence of asthma candidate genes on the development from wheeze to asthma in young children still needs to be defined.To link genetic variants in asthma candidate genes to progression of wheeze to persistent wheeze into childhood asthma.In a prospective study, children with recurrent wheeze from the ADEM (Asthma DEtection and Monitoring study were followed until the age of six. At that age a classification (transient wheeze or asthma was based on symptoms, lung function and medication use. In 198 children the relationship between this classification and 30 polymorphisms in 16 asthma candidate genes was assessed by logistic regression. In case of an association based on a p<0.10, replication analysis was performed in an independent birth cohort study (KOALA study, n = 248 included for the present analysis.In the ADEM study, the minor alleles of ADAM33 rs511898 and rs528557 and the ORMDL3/GSDMB rs7216389 polymorphisms were negatively associated, whereas the minor alleles of IL4 rs2243250 and rs2070874 polymorphisms were positively associated with childhood asthma. When replicated in the KOALA study, ADAM33 rs528557 showed a negative association of the CG/GG-genotype with progression of recurrent wheeze into childhood asthma (0.50 (0.26-0.97 p = 0.04 and no association with preschool wheeze.Polymorphisms in ADAM33, ORMDL3/GSDMB and IL4 were associated with childhood asthma in a group of children with recurrent wheeze. The replication of the negative association of the CG/GG-genotype of rs528557 ADAM33 with childhood asthma in an independent birth cohort study confirms that a compromised ADAM33 gene may be implicated in the progression of wheeze into childhood asthma.

  20. Comparison of Mineral Trioxide Aggregate and iRoot BP Plus Root Repair Material as Root-end Filling Materials in Endodontic Microsurgery: A Prospective Randomized Controlled Study.

    Science.gov (United States)

    Zhou, Wei; Zheng, Qinghua; Tan, Xuelian; Song, Dongzhe; Zhang, Lan; Huang, Dingming

    2017-01-01

    This prospective randomized controlled study evaluated the clinical and radiographic outcome of endodontic microsurgery when using iRoot BP Plus Root Repair Material (BP-RRM; Innovative BioCeramix Inc, Vancouver, BC, Canada) or mineral trioxide aggregate (MTA) as the retrograde filling material and analyzed the relationship between some potential prognostic factors and the outcome of the surgery. By using strict inclusion and exclusion criteria, 240 teeth were successfully enrolled and randomly and equally allocated to either the MTA or BP-RRM treatment group. A standardized surgical procedure was performed by a single operator. The patients were followed up at 1 week, 3 months, 6 months, and 12 months; follow-up included clinical and radiographic examination. Clinical and radiographic evaluations acquired at the 12-month follow-up were taken as the primary outcome. For the identification of prognostic factors, the dichotomous outcome (success vs failure) was taken as the dependent variable. A total of 158 teeth were analyzed at the 12-month follow-up, including 87 teeth in the MTA group and 71 teeth in the BP-RRM group. The success rate in the MTA and BP-RRM groups was 93.1% (81/87 teeth) and 94.4% (67/71 teeth), respectively (P > .05). Three significant outcome predictors were identified: quality of root filling (P materials in endodontic microsurgery. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  1. Validation and usefulness of a computer-assisted cup-positioning system in total hip arthroplasty. A prospective, randomized, controlled study.

    Science.gov (United States)

    Parratte, Sebastien; Argenson, Jean-Noel A

    2007-03-01

    Malpositioning of the acetabular component during total hip arthroplasty increases the risk of dislocation, reduces the range of motion, and can be responsible for early wear and loosening. The purpose of this study was to compare computer-assisted with freehand insertion of the acetabular component. A randomized, controlled, matched prospective study of two groups of thirty patients each was performed. In the first group, cup positioning was assisted by an imageless computer-assisted surgical system based on bone morphing. In the control group, the cup was placed freehand. All of the patients were operated on by the same surgeon through an anterolateral approach. Cup anteversion and abduction angles were measured on three-dimensional computed tomography reconstructions postoperatively for each patient by an independent observer using special cup-evaluation software. There were sixteen men and fourteen women in each group, and the mean body-mass index was approximately 25 in each group. The computer-assisted procedure took a mean of twelve minutes longer than the freehand procedure. Fifty-seven percent (seventeen) of the thirty cups placed freehand and 20% (six) of the thirty in the computer-assisted group were outside of the defined safe zone (outliers). This difference was significant (p = 0.002). There were no differences between the computer-assisted group and the freehand-placement group with regard to the mean abduction and anteversion angles, but there was a significant heterogeneity of variances, with the lowest variations in the computer-assisted group. Use of an imageless navigation system can improve cup positioning in total hip arthroplasty by reducing the percentage of outliers.

  2. Comparative alveolar ridge preservation using allogenous tooth graft versus free-dried bone allograft: A randomized, controlled, prospective, clinical pilot study

    Directory of Open Access Journals (Sweden)

    Chaitanya Pradeep Joshi

    2017-01-01

    Full Text Available Background: For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA in alveolar ridge preservation. Materials and Methods: Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases. Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL, mineralized whole tooth allograft (WTA and dentin allograft (DA were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. Study Design: In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site. All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Results: Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05. Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Conclusions: Rather than disposing extracted human teeth as a biomedical waste (common practice, they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an

  3. Neonatal gram-negative bacillary late-onset sepsis: A case-control-control study on a prospectively collected database of 5,233 admissions.

    Science.gov (United States)

    Tsai, Ming-Horng; Wu, I Hsyuan; Lee, Chiang-Wen; Chu, Shih-Ming; Lien, Reyin; Huang, Hsuan-Rong; Chiang, Ming-Chou; Fu, Ren-Huei; Hsu, Jen-Fu; Huang, Yhu-Chering

    2016-02-01

    Gram-negative bacillary (GNB) bloodstream infections account for 20%-30% of neonatal late-onset sepsis (LOS). We aimed to identify the incidence, clinical characteristics, and risk factors for adverse outcomes in neonates with GNB LOS. All patients with GNB LOS admitted to the neonatal intensive care units (NICUs) of a university-affiliated teaching hospital in Taiwan from January 1, 2004-December 31, 2011, were enrolled. A case-control-control study was performed to evaluate risk factors for acquisition of neonatal GNB LOS. Of the 5,010 neonates, 290 (5.8%) had a total of 346 episodes of GNB LOS (36.7% of total LOS), with an incidence rate of 13.6 per 10,000 neonate hospital days. The overall mortality rate was 17.6% (51/290), and the sepsis attributable mortality rate was 9.8% (34/346 episodes). After multivariate logistic regression analysis, neonates with prolonged use of total parenteral nutrition (adjusted odds ratio [OR] = 1.53; 95% confidence interval [CI], 1.02-2.29; P = .041) were independently associated with acquisition of GNB LOS. The independent predictors of in-hospital mortality were Pseudomonas aeruginosa etiology (OR = 11.45; 95% CI, 2.83-46.24) and underlying secondary pulmonary hypertension (OR = 18.02; 95% CI, 3.28-98.89), renal disease (OR = 17.16; 95% CI, 2.96-99.38), and neuromuscular comorbidities (OR = 2.72; 95% CI, 1.06-7.00). Given the higher illness severity and sepsis-attributable mortality rate of neonatal GNB LOS in the NICU, strategies to reduce the incidence need to be addressed urgently. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

  4. Does the timed up and go test predict future falls among British community-dwelling older people? Prospective cohort study nested within a randomised controlled trial.

    Science.gov (United States)

    Kojima, Gotaro; Masud, Tahir; Kendrick, Denise; Morris, Richard; Gawler, Sheena; Treml, Jonathan; Iliffe, Steve

    2015-04-03

    Falling is common among older people. The Timed-Up-and-Go Test (TUG) is recommended as a screening tool for falls but its predictive value has been challenged. The objectives of this study were to examine the ability of TUG to predict future falls and to estimate the optimal cut-off point to identify those with higher risk for future falls. This is a prospective cohort study nested within a randomised controlled trial including 259 British community-dwelling older people ≥65 years undergoing usual care. TUG was measured at baseline. Prospective diaries captured falls over 24 weeks. A Receiver Operating Characteristic curve analysis determined the optimal cut-off point to classify future falls risk with sensitivity, specificity, and predictive values of TUG times. Logistic regression models examined future falls risk by TUG time. Sixty participants (23%) fell during the 24 weeks. The area under the curve was 0.58 (95% confidence interval (95% CI) = 0.49-0.67, p = 0.06), suggesting limited predictive value. The optimal cut-off point was 12.6 seconds and the corresponding sensitivity, specificity, and positive and negative predictive values were 30.5%, 89.5%, 46.2%, and 81.4%. Logistic regression models showed each second increase in TUG time (adjusted for age, gender, comorbidities, medications and past history of two falls) was significantly associated with future falls (adjusted odds ratio (OR) = 1.09, 95% CI = 1.00-1.19, p = 0.05). A TUG time ≥12.6 seconds (adjusted OR = 3.94, 95% CI = 1.69-9.21, p = 0.002) was significantly associated with future falls, after the same adjustments. TUG times were significantly and independently associated with future falls. The ability of TUG to predict future falls was limited but with high specificity and negative predictive value. TUG may be most useful in ruling in those with a high risk of falling rather than as a primary measure in the ascertainment of risk.

  5. P.O.P.A. study: prevention of postoperative abdominal adhesions by icodextrin 4% solution after laparotomy for adhesive small bowel obstruction. A prospective randomized controlled trial.

    Science.gov (United States)

    Catena, Fausto; Ansaloni, Luca; Di Saverio, Salomone; Pinna, Antonio D

    2012-02-01

    Adhesive small bowel obstruction (ASBO) is an important cause of hospital admission, is associated with significant morbidity and mortality, and therefore is a substantial burden for healthcare systems worldwide. Icodextrin 4% solution (Adept, Shire Pharmaceuticals, UK) is a high-molecular-weight a-1,4 glucose polymer approved in Europe for use as intraoperative lavage and postoperative instillation to reduce the occurrence of post-surgery intra-abdominal adhesions. The present clinical study aimed to evaluate the safety and effectiveness of icodextrin 4% in decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASBO. The study was a single-center prospective, randomized investigation. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. Safety and efficacy of icodextrin 4% in the study group are compared to no anti-adhesion treatment in a parallel control group with blinded evaluation of primary endpoints. Primary endpoints are the evaluation of the therapeutic role of icodextrin 4% in reducing ASBO recurrence incidence and the need of laparotomies for ASBO recurrence, as well as adhesion formation (with evaluation of their incidence, extent, and severity). A sum of 181 patients with ASBO and surgical indication to laparotomy were enrolled and randomized in two groups. Patients were submitted to adhesiolysis with bowel resection if required with or without anastomosis. The first group received traditional treatment (control group), whereas the second group was treated with the addition of icodextrin 4% solution before the abdominal closure. Ninety-one patients were randomized to have icodextrin 4% solution administered intraperitoneally, and 90 patients were randomized to have the traditional treatment. The two study groups were homogeneous regarding their baseline characteristics. The ASBO recurrence rate was 2.19% (2/91) in the icodextrin groups vs 11.11% (10

  6. A prospective nested case-control study of Dengue in infants: rethinking and refining the antibody-dependent enhancement dengue hemorrhagic fever model.

    Directory of Open Access Journals (Sweden)

    Daniel H Libraty

    2009-10-01

    Full Text Available Dengue hemorrhagic fever (DHF is the severe and life-threatening syndrome that can develop after infection with any one of the four dengue virus (DENV serotypes. DHF occurs almost exclusively in individuals with secondary heterologous DENV infections and infants with primary DENV infections born to dengue immune mothers. The widely accepted explanation for the pathogenesis of DHF in these settings, particularly during infancy, is antibody-dependent enhancement (ADE of DENV infection.We conducted a prospective nested case-control study of DENV infections during infancy. Clinical data and blood samples were collected from 4,441 mothers and infants in up to two pre-illness study visits, and surveillance was performed for symptomatic and inapparent DENV infections. Pre-illness plasma samples were used to measure the associations between maternally derived anti-DENV3 antibody-neutralizing and -enhancing capacities at the time of DENV3 infection and development of infant DHF. The study captured 60 infants with DENV infections across a wide spectrum of disease severity. DENV3 was the predominant serotype among the infants with symptomatic (35/40 and inapparent (15/20 DENV infections, and 59/60 infants had a primary DENV infection. The estimated in vitro anti-DENV3 neutralizing capacity at birth positively correlated with the age of symptomatic primary DENV3 illness in infants. At the time of symptomatic DENV3 infection, essentially all infants had low anti-DENV3 neutralizing activity (50% plaque reduction neutralizing titers [PRNT(50] 50 is associated with protection from symptomatic DENV3 illness. We did not find a significant association between DENV3 ADE activity at illness onset and the development of DHF compared with less severe symptomatic illness. The results of this study should encourage rethinking or refinement of the current ADE pathogenesis model for infant DHF and stimulate new directions of research into mechanisms responsible for the

  7. Etiology and Factors Associated with Pneumonia in Children under 5 Years of Age in Mali: A Prospective Case-Control Study.

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    Thomas Bénet

    Full Text Available There are very limited data on children with pneumonia in Mali. The objective was to assess the etiology and factors associated with community-acquired pneumonia in hospitalized children <5 years of age in Mali.A prospective hospital-based case-control study was implemented in the Pediatric department of Gabriel Touré University Hospital at Bamako, Mali, between July 2011-December 2012. Cases were children with radiologically-confirmed pneumonia; Controls were hospitalized children without respiratory features, matched for age and period. Respiratory specimens, were collected to identify 19 viruses and 5 bacteria. Whole blood was collected from cases only. Factors associated with pneumonia were assessed by multivariate logistic regression.Overall, 118 cases and 98 controls were analyzed; 44.1% were female, median age was 11 months. Among pneumonia cases, 30.5% were hypoxemic at admission, mortality was 4.2%. Pneumonia cases differed from the controls regarding clinical signs and symptoms but not in terms of past medical history. Multivariate analysis of nasal swab findings disclosed that S. pneumoniae (adjusted odds ratio [aOR] = 3.4, 95% confidence interval [95% CI]: 1.6-7.0, human metapneumovirus (aOR = 17.2, 95% CI: 2.0-151.4, respiratory syncytial virus [RSV] (aOR = 7.4, 95% CI: 2.3-23.3, and influenza A virus (aOR = 10.7, 95% CI: 1.0-112.2 were associated with pneumonia, independently of patient age, gender, period, and other pathogens. Distribution of S. pneumoniae and RSV differed by season with higher rates of S. pneumoniae in January-June and of RSV in July-September. Pneumococcal serotypes 1 and 5 were more frequent in pneumonia cases than in the controls (P = 0.009, and P = 0.04, respectively.In this non-PCV population from Mali, pneumonia in children was mainly attributed to S. pneumoniae, RSV, human metapneumovirus, and influenza A virus. Increased pneumococcal conjugate vaccine coverage in children could significantly reduce the

  8. Comparative Alveolar Ridge Preservation Using Allogenous Tooth Graft versus Free-dried Bone Allograft: A Randomized, Controlled, Prospective, Clinical Pilot Study.

    Science.gov (United States)

    Joshi, Chaitanya Pradeep; D'Lima, Cynthia Bernardo; Samat, Urmila Chandrashekhar; Karde, Prerna Ashok; Patil, Agraja Ganpat; Dani, Nitin Hemchandra

    2017-01-01

    For the first time in India, allografts from human extracted teeth were prepared. A randomized, prospective, clinicoradiographical, histological study was conducted to evaluate their efficacy in comparison with freeze-dried bone allograft (FDBA) in alveolar ridge preservation. Graft preparation: with written consent, teeth were collected from three donors (full mouth extraction cases). Once donors' serums were tested negative for HIV, HBV, HCV, and Venereal disease research laboratory (VDRL), mineralized whole tooth allograft (WTA) and dentin allograft (DA) were prepared using the standard protocol of Tissue Bank at Tata Memorial Hospital, Mumbai, India. In this randomized controlled trial, 15 patients undergoing extraction of at least four teeth were selected. In each patient after atraumatic extractions, one socket was grafted with WTA, second with DA, third with FDBA, and fourth was left ungrafted (control site). All the sites were covered with chorion membrane. To estimate three-dimensional alveolar crest changes, cone beam computed tomography scans were taken immediately after grafting and 4 months postoperatively. Bone biopsies using 3 mm trephine bur were obtained from four patients at the time of implant placement and evaluated histologically. Clinically uneventful healing was observed at all sites. Compared to other sites, WTA and DA consistently showed superior results demonstrating least reduction in alveolar crest height and width which was statistically significant (P < 0.05). Between WTA and DA sites, there was no statistically significant difference. Histological analysis also confirmed more new bone formation at WTA and DA sites. Rather than disposing extracted human teeth as a biomedical waste (common practice), they can be collected from suitable systemically healthy donors. With the help of tissue bank, they can be processed into an allograft, serving as an excellent alternative to conventional allografts.

  9. Effect of intermittent hepatic inflow occlusion with the Pringle maneuver during donor hepatectomy in adult living donor liver transplantation with right hemiliver grafts: a prospective, randomized controlled study.

    Science.gov (United States)

    Park, Jae Berm; Joh, Jae-Won; Kim, Sung-Joo; Kwon, Choon-Hyuck David; Chun, Jae Min; Kim, Jong Man; Moon, Ju Ik; Lee, Suk-Koo

    2012-01-01

    To evaluate the effects of intermittent hepatic inflow occlusion (IHIO) during donor hepatectomy for living donor liver transplantation (LDLT) in recipients and donors, we performed a single-center, open-label, prospective, parallel, randomized controlled study. Adult donor-recipient pairs undergoing LDLT with right hemiliver grafts were randomized into IHIO and control groups (1:1). In the IHIO group, IHIO was performed during donor hepatectomy. The primary endpoint was the peak serum alanine aminotransferase (ALT) concentration in the recipients within 5 days after the operation. Blood samples for measurements of interleukin-6 (IL-6), IL-8, tumor necrosis factor α (TNF-α), and hepatocyte growth factor (HGF) were taken from the donors and the recipients during the operation and postoperatively. Biopsy samples for measurements of caspase-3 and malondialdehyde (MDA) were taken from the donors and the recipients. In all, 50 donor-recipient pairs (ie, 25 pairs in each group) completed this study. The mean peak serum ALT levels within 5 days after the operation did not differ in the recipients between the 2 groups (P = 0.32) but were higher in the donors of the IHIO group (P = 0.002). There were no differences in the prothrombin times or total bilirubin levels in the recipients or donors between the 2 groups. The amount of blood loss during donor hepatectomy was significantly lower in the IHIO group versus the control group (P = 0.02). The mean hospital stay for donors was 19.3 ± 7.2 days in the control group and 15.8 ± 4.6 days in the IHIO group (P = 0.046). There were no in-hospital deaths within 1 month and no cases of primary nonfunction or initially poor function in the 2 groups. The concentrations of IL-6, IL-8, TNF-α, and HGF did not differ between the 2 groups, nor did the concentrations of caspase-3 and MDA. In conclusion, although we found differences in postoperative peak serum ALT levels in donors, donor hepatectomy with IHIO for LDLT using a right

  10. A prospective, randomized, double blind, placebo controlled clinical trial to study efficacy and safety of benzydamine 0.15% gargles in prevention of postoperative sore throat

    OpenAIRE

    Smita M Gaikwad; Kanchan R. Rupwate; Bharati A Tendolkar

    2016-01-01

    Background: Postoperative sore throat (POST) is an undesirable outcome of general anesthesia. The aim of the study was to evaluate the effectiveness of benzydamine preoperative gargles in reducing the incidence and severity of POST. Methods: A randomized double blind prospective study involving 200 adult male and female patients was performed to assess the incidence of sore throat, cough and hoarseness of voice following tracheal intubation. The patients were randomly divided into two gro...

  11. Diagnosis of asymptomatic common bile duct stones: preoperative endoscopic ultrasonography versus intraoperative cholangiography--a multicenter, prospective controlled study. French Associations for Surgical Research.

    Science.gov (United States)

    Montariol, T; Msika, S; Charlier, A; Rey, C; Bataille, N; Hay, J M; Lacaine, F; Fingerhut, A

    1998-07-01

    In patients with symptomatic cholelithiasis, preoperative diagnosis of common bile duct (CBD) stones can modify the therapeutic strategy. The aims of this prospective, controlled multicenter study were to assess the feasibility, concordance, discordance, and indexes such as sensitivity, specificity, positive and negative predictive values, and accuracy of preoperative endoscopic ultrasonography compared with those of intraoperative cholangiography (IOC) in the diagnosis of asymptomatic CBD stones (i.e., patients undergoing cholecystectomy with no clinical or biologic evidence of CBD stones). From October 1993 to October 1995, 240 consecutive patients with symptomatic cholelithiasis, scheduled for cholecystectomy in 14 surgical centers, were enrolled in this study. All patients were selected for this study according to a preoperative high-risk CBD stone predictive score. Each patient underwent both endoscopic ultrasonography and IOC, as well as surgical exploration of the CBD when stones were detected during one or both preoperative investigations. All patients were seen 1 months and 1 year after operation to check for residual stones. The feasibility of endoscopic ultrasonography was significantly higher overall than that of IOC (99% vs 90%; p stones of 19%, positive and negative predictive values of IOC were significantly higher than those of endoscopic ultrasonography (0.93 and 1.00 vs 0.75 and 0.96, respectively). Although endoscopic ultrasonography is feasible more often than IOC, IOC is associated with a slightly lower degree of discordance and better information indexes and remains an efficient method of investigation for CBD stones. Endoscopic ultrasonography can be suggested in preference to endoscopic retrograde cholangiography when postoperative residual stones are suspected but need not be performed routinely before cholecystectomy.

  12. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study.

    Science.gov (United States)

    Lindeboom, J A H; Frenken, J W H; Valkenburg, P; van den Akker, H P

    2005-12-01

    To determine the value of clindamycin prophylaxis in the prevention of postoperative wound infections in patients undergoing endodontic surgery. This study included 256 patients undergoing endodontic surgery in a prospective double-blind placebo-controlled trial comparing oral administration of an oral placebo versus a preoperative 600 mg dose of clindamycin. After randomization the study medication was administered orally 1 h before surgery in a double-blind fashion. For a period of 4 weeks the postoperative course was observed according to clinical parameters of infection. Primary end-point was infection at the surgical site. The mean age of the study population was 44.4 years (SD 11.4, range 18-82 years) with a sex distribution of 147 females (47.4%) and 109 males (42.6%). Mean age of the patients in the clindamycin group was 44.7 years (SD 12.0), and the mean age in the placebo group was 44.1 years (SD 10.8) (P = 0.49). In the clindamycin group, the mean duration of surgery was 32.3 min (SD 8.8) and in the placebo group the mean duration of surgery was 32.5 min (SD 8.4) (P = 0.89). Two infections [1.6%; 95 confidence interval (CI): 0.48-4.72] were identified in the clindamycin group and four (3.2%; 95 CI: 0.42-1.33) in the placebo group (P = 0.448). No statistically significant difference was found between clindamycin prophylaxis and placebo with regard to the prevention of postoperative infection in endodontic surgical procedures.

  13. Diuresis and inversion therapy to improve clearance of lower caliceal stones after shock wave lithotripsy: A prospective, randomized, controlled, clinical study

    Directory of Open Access Journals (Sweden)

    Abul-fotouh Ahmed

    2015-01-01

    Full Text Available Objective: To improve the clearance of lower caliceal stones (LCSs after shock wave lithotripsy (SWL using a combination of intra-operative forced diuresis and inversion therapy. Materials and Methods: One hundred and fifty-seven consecutive patients with symptomatic, single LCSs of 5-20 mm size were prospectively randomized into two groups. The first (study group, SG underwent SWL at the time of the maximum diuresis with the patient in the Trendelenburg position with an angle of 30 degree, while the second group (control group, CG underwent standard SWL. After the last SWL session, patients were followed-up regularly using plain abdominal X-ray and renal ultrasound. The primary endpoint of the study was the stone-free rate (SFR at 12 weeks. Results: A total of 141 patients completed the study treatment protocol and follow-up: 69 patients in SG and 72 patients in CG. Both groups were comparable in baseline data. SG showed significantly higher SFR at all follow-up time points. At week 12, 78.3% of SG were rendered stone free, whereas only 61.1% were stone free in CG (P = 0.030. Also, there was a significantly higher SFR for larger stones (>10 mm and stones with higher attenuation value (>500 Hounsfield units in SG than CG. Mild non-significant complications were reported in both groups. Conclusion: SWL with intraoperative forced diuresis and inversion seems to be an effective measure with minimal extra cost to improve LCS clearance post-SWL.

  14. A pollen extract (Cernilton) in patients with inflammatory chronic prostatitis-chronic pelvic pain syndrome: a multicentre, randomised, prospective, double-blind, placebo-controlled phase 3 study.

    Science.gov (United States)

    Wagenlehner, Florian M E; Schneider, Henning; Ludwig, Martin; Schnitker, Jörg; Brähler, Elmar; Weidner, Wolfgang

    2009-09-01

    National Institutes of Health (NIH) category III prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a prevalent condition for which no standardised treatment exists. To assess the safety and efficacy of a standardised pollen extract in men with inflammatory CP/CPPS. We conducted a multicentre, prospective, randomised, double-blind, placebo-controlled phase 3 study comparing the pollen extract (Cernilton) to placebo in men with CP/CPPS (NIH IIIA) attending urologic centres. Participants were randomised to receive oral capsules of the pollen extract (two capsules q8h) or placebo for 12 wk. The primary endpoint of the study was symptomatic improvement in the pain domain of the NIH Chronic Prostatitis Symptom Index (NIH-CPSI). Participants were evaluated using the NIH-CPSI individual domains and total score, the number of leukocytes in post-prostatic massage urine (VB3), the International Prostate Symptom Score (IPSS), and the sexuality domain of a life satisfaction questionnaire at baseline and after 6 and 12 wk. In the intention-to-treat analysis, 139 men were randomly allocated to the pollen extract (n=70) or placebo (n=69). The individual domains pain (p=0.0086) and quality of life (QoL; p=0.0250) as well as the total NIH-CPSI score (p=0.0126) were significantly improved after 12 wk of treatment with pollen extract compared to placebo. Response, defined as a decrease of the NIH-CPSI total score by at least 25% or at least 6 points, was seen in the pollen extract versus placebo group in 70.6% and 50.0% (p=0.0141), respectively. Adverse events were minor in all patients studied. Compared to placebo, the pollen extract significantly improved total symptoms, pain, and QoL in patients with inflammatory CP/CPPS without severe side-effects.

  15. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861

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    Theorell Töres

    2005-07-01

    Full Text Available Abstract Background The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. Methods A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23–64 from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. Results After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor α (TNFα decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference remained a significant factor in five out of nine predictive models. Conclusion The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  16. Care plans and care planning in the management of long-term conditions in the UK: a controlled prospective cohort study.

    Science.gov (United States)

    Reeves, David; Hann, Mark; Rick, Jo; Rowe, Kelly; Small, Nicola; Burt, Jenni; Roland, Martin; Protheroe, Joanne; Blakeman, Tom; Richardson, Gerry; Kennedy, Anne; Bower, Peter

    2014-09-01

    In the UK, the use of care planning and written care plans has been proposed to improve the management of long-term conditions, yet there is limited evidence concerning their uptake and benefits. To explore the implementation of care plans and care planning in the UK and associations with the process and outcome of care. A controlled prospective cohort study among two groups of patients with long-term conditions who were similar in demographic and clinical characteristics, but who were registered with general practices varying in their implementation of care plans and care planning. Implementation of care plans and care planning in general practice was assessed using the 2009-2010 GP Patient Survey, and relationships with patient outcomes (self-management and vitality) were examined using multilevel, mixed effects linear regression modelling. The study recruited 38 practices and 2439 patients. Practices in the two groups (high and low users of written documents) were similar in structural and population characteristics. Patients in the two groups of practices were similar in demographics and baseline health. Patients did demonstrate significant differences in reported experiences of care planning, although the differences were modest. Very few patients in the cohort reported a written plan that could be confirmed. Analysis of outcomes suggested that most patients show limited change over time in vitality and self-management. Variation in the use of care plans at the practice level was very limited and not related to patient outcomes over time. The use of written care plans in patients with long-term conditions is uncommon and unlikely to explain a substantive amount of variation in the process and outcome of care. More proactive efforts at implementation may be required to provide a rigorous test of the potential of care plans and care planning. © British Journal of General Practice 2014.

  17. EVALUATION OF CLINICAL EFFICACY OF CLONIDINE AS AN ADJUVANT TO GENERAL ANAESTHESIA IN ELECTIVE FACIOMAXILLARY AND AESTHETIC FACE SURGERY- THE PROSPECTIVE RANDOMIZED SINGLE BLIND CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Vartika

    2014-12-01

    Full Text Available AIM AND OBJECTIVES: The present study aims to evaluate the clinical efficacy of clonidine as an adjuvant to General anaesthesia in elective faciomaxillary surgery. Faciomaxillary surgery is generally long duration surgery. Bleeding is expected to be more. As an anesthetist our main aim is to reduce the bleeding and make the patient more hemodynamically stable, so there is always a need to decrease heart rate(H.R., blood pressure (B.P. and prevent hemodynamic stress response to intubation, extubation and intraoperatively. MATERIAL AND METHODS: This prospective, randomized, double-blind controlled study was conducted on 60 male adults of ASA Grade I & II scheduled for elective faciomaxillary surgery under General anaesthesia. After taking consent from the institutional ethical committee patients were divided into 2 groups comprising 30 patients in each group. Group I received 2µg/kg of clonidine in 100ml normal saline 30 min before surgery and Group II received 100ml normal saline. H.R., non-invasive B.P (N.I.B.P., oxygen saturation in arterial blood (SpO2 were recorded as base line, after induction, after intubation, then at 15 min internal intraoperatively and finally after extubation. H. R. and B. P. were assessed after 30 min, 2hr and 6hr postoperatively. Any complication, side effect and adverse effect upto 24 hrs postoperatively were noted. RESULTS AND CONCLUSION: In Group I, compared to Group II, there was significant decrease in B.P. and H.R. during intubation, intraoperatively, extubation and post operatively and the concentration of isoflurane used was also reduced. Blood loss and incidence of shivering was less and also tube tolerance ability was better when tube was left in situ after surgery Clonidine, 2µg/kg IV in 100ml normal saline, 30min before is safe and effective in preventing the hemodynamic surgical stress response as well as intubation, extubation stress response.

  18. A Prospective, Randomized, Masked and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

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    Robert J Harman

    2016-09-01

    Full Text Available Osteoarthritis (OA is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with osteoarthritis. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived mesenchymal stem cells in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2% versus 55.4%, p=0.029. The veterinary pain on manipulation score (92.8% versus 50.2%, p=0.017 and the veterinary global score (86.9% versus 30.8%, p= 0.009 were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy.

  19. Randomized, controlled, parallel-group prospective study to investigate the clinical effectiveness of early insulin treatment in patients with latent autoimmune diabetes in adults

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    Lloyd Janet

    2008-07-01

    Full Text Available Abstract Background Latent autoimmune diabetes in adults [LADA] is a type 1 diabetes that is slowly developing. This means many people are treated as having type 2 diabetes at diagnosis as they are adults who are not immediately insulin dependent. LADA can be distinguished from type 2 diabetes by antibody tests. Patients who are antibody positive have an autoimmune reaction which is similar to that of type 1 diabetes and is not found in type 2 diabetes. We would like to examine the best way of treating LADA in the early phase of the conditions, with tablets (similar to type 2 diabetes or with insulin (similar to type 1 diabetes. Methods/design This is an open parallel group prospective randomised trial. Participants need to have a GAD antibody test results of 101 WHO units or more and a diagnosis of diabetes not requiring insulin at diagnosis. Participants will need to have been diagnosed within 12 months and not treated with insulin at study entry. They will be randomised to receive either insulin (NovoMix 30 or tablets (diet treated followed by metformin followed by glitazone (with or without metformin followed by insulin. Primary outcome assessment will be for change in HbA1c and change in fasting C-peptide over 24 months. Secondary outcome measures will include Quality of life, GAD antibody levels, adverse events, inflammatory markers, insulin resistance, and markers of the metabolic syndrome. Discussion This study seeks the best treatment for early LADA in terms of maintaining glycaemic control and maintaining natural insulin production. Trial registration ISRCTN63815121

  20. The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Fleming, Jennifer; Ownsworth, Tamara; Doig, Emmah; Hutton, Lauren; Griffin, Janelle; Kendall, Melissa; Shum, David H K

    2017-01-05

    Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI. This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups. This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial

  1. Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

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    Kazon Soráia

    2012-05-01

    Full Text Available Abstract Background The use of botulinum toxin A (BT-A for the treatment of lower limb spasticity is common in children with cerebral palsy (CP. Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist. Neuromuscular electrical stimulation (NMES is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae. The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1 one week prior to the administration of BT-A; 2 one week after the administration of BT-A; and 3 four months after the administration of BT-A (end of intervention. Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior

  2. Prospective randomized controlled study on the effects of perioperative administration of a neutrophil elastase inhibitor to patients undergoing video-assisted thoracoscopic surgery for thoracic esophageal cancer.

    Science.gov (United States)

    Kawahara, Y; Ninomiya, I; Fujimura, T; Funaki, H; Nakagawara, H; Takamura, H; Oyama, K; Tajima, H; Fushida, S; Inaba, H; Kayahara, M

    2010-05-01

    Sivelestat sodium hydrate (Ono Pharmaceutical Co., Osaka, Japan) is a selective inhibitor of neutrophil elastase (NE) and is effective in reducing acute lung injury associated with systemic inflammatory response syndrome (SIRS). We conducted a prospective randomized controlled study to investigate the efficacy of perioperative administration of sivelestat sodium hydrate to prevent postoperative acute lung injury in patients undergoing thoracoscopic esophagectomy and radical lymphadenectomy. Twenty-two patients with thoracic esophageal cancer underwent video-assisted thoracoscopic esophagectomy with extended lymph node dissection in our institution between April 2007 and November 2008. Using a double-blinded method, these patients were randomly assigned to one of two groups preoperatively. The active treatment group received sivelestat sodium hydrate intravenously for 72 hours starting at the beginning of surgery (sivelestat-treated group; n= 11), while the other group received saline (control group; n= 11). All patients were given methylprednisolone immediately before surgery. Postoperative clinical course was compared between the two groups. Two patients (one in each group) were discontinued from the study during the postoperative period because of surgery-related complications. Of the remaining 20 patients, 2 patients who developed pneumonia within a week after surgery were excluded from some laboratory analyses, so data from 18 patients (9 patients in each group) were analyzed based on the arterial oxygen pressure/fraction of inspired oxygen ratio, white blood cell count, serum C-reactive protein level, plasma cytokine levels, plasma NE level, and markers of alveolar type II epithelial cells. In the current study, the incidence of postoperative morbidity did not differ between the two groups. The median duration of SIRS in the sivelestat-treated group was significantly shorter than that in the control group: 17 (range 9-36) hours versus 49 (15-60) hours

  3. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study.

    Science.gov (United States)

    Vlaar, Alexander P J; Hofstra, Jorrit J; Determann, Rogier M; Veelo, Denise P; Paulus, Frederique; Kulik, Wim; Korevaar, Johanna; de Mol, Bas A; Koopman, Marianne M W; Porcelijn, Leendert; Binnekade, Jan M; Vroom, Margreeth B; Schultz, Marcus J; Juffermans, Nicole P

    2011-04-21

    Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related morbidity and mortality. Both antibodies and bioactive lipids that have accumulated during storage of blood have been implicated in TRALI pathogenesis. In a single-center, nested, case-control study, patients were prospectively observed for onset of TRALI according to the consensus definition. Of 668 patients, 16 patients (2.4%) developed TRALI. Patient-related risk factors for onset of TRALI were age and time on the cardiopulmonary bypass. Transfusion-related risk factors were total amount of blood products (odds ratio [OR] = 1.2; 95% confidence interval [CI], 1.03-1.44), number of red blood cells stored more than 14 days (OR = 1.6; 95% CI, 1.04-2.37), total amount of plasma (OR = 1.2; 95% CI, 1.03-1.44), presence of antibodies in donor plasma (OR = 8.8; 95% CI, 1.8-44), and total amount of transfused bioactive lipids (OR = 1.0; 95% CI, 1.00-1.07). When adjusted for patient risk factors, only the presence of antibodies in the associated blood products remained a risk factor for TRALI (OR = 14.2; 95% CI, 1.5-132). In-hospital mortality of TRALI was 13% compared with 0% and 3% in transfused and nontransfused patients, respectively (P < .05). In conclusion, the incidence of TRALI is high in cardiac surgery patients and associated with adverse outcome. Our results suggest that cardiac surgery patients may benefit from exclusion of blood products containing HLA/HNA antibodies.

  4. Does endometrial injury enhances implantation in recurrent in-vitro fertilization failures? A prospective randomized control study from tertiary care center.

    Science.gov (United States)

    Singh, Neeta; Toshyan, Varnit; Kumar, Sunesh; Vanamail, Perumal; Madhu, Malti

    2015-01-01

    Though Assisted Reproductive Techniques have overcome many fertility disorders, implantation is still considered, the rate-limiting step for the success of IVF. The aim of this study was to evaluate the role of endometrial scratching in improving the implantation rate in patients undergoing IVF-ET cycles. Prospective randomized control trial. Sixty infertile women with a history of >1 previous failed IVF-ET cycles were randomizedinto two groups of 30 each. The patients in group 1 underwent endometrial scratching once between days 14-21 of menstrual cycle in the cycle prior to embryo transfer (ET), while in group 2scratching were not done. Implantation rate, ongoing pregnancy rate, abortion rate and live birth rate were comparedbetween both groups. Mean values were compared between two groups using Student's't' independent test. Frequency distributions of categorical variables were compared using Chi-Square/Fisher's exact test as appropriate. Implantation rate in group 1 was 19.4% whereas in group 2 it was 8.1%. Difference between two groups was statistically significant (P =0.028). The live birth rate was higher in the group 2 compared to group 1, however this difference was not statistically significant (3.3% vs 10%, P =0.612). No significant difference was observed between the two groups regarding the ongoing pregnancy rate (16.7% vs 0.0%; P =0.052), abortion rate (10.0% vs 3.3%, P =0.612) and miscarriage rate (6.7% vs 3.3%, P =0.99). Implantation rate increases significantly after endometrial scratching in patients with previous failed IVF-ET.

  5. THE EFFICACY OF PREGABALIN AS A PREMEDICANT IN ATTENUATING NEUROENDOCRINE STRESS RESPONSE DURING GENERAL ANAESTHESIA IN ELECTIVE SURGERIES: A PROSPECTIVE RANDOMISED PLACEBO CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Bhavani Muthukrishnan

    2016-06-01

    Full Text Available BACKGROUND The stress response to surgery is characterised by increased secretion of pituitary hormones and activation of the sympathetic nervous system. The changes triggered by the stress response are short-lived and well tolerated by normal healthy patients belonging to ASA 1 and 2. In patients with other comorbidities like myocardial ischaemia, renal insufficiency, uncontrolled diabetes, liver disease and cerebrovascular diseases, these changes can be life threatening. The recognition of the factors which initiate the stress response can be considered for modification in the preoperative period itself. Various anaesthetic techniques and pain management strategies have been put into use to control the stress response. AIM To study the rise in serum cortisol levels during surgery after administering oral pregabalin as a premedicant. SETTINGS AND DESIGN A Prospective Randomised Placebo Controlled Study. MATERIALS AND METHODS All consented patients were aged between 18 and 50 years belonging to ASA 1 & 2 undergoing elective surgical procedures under general anaesthesia of duration between 30 minutes and 180 minutes. Group A received oral placebo, Group B oral pregabalin 150 mg 60-90 minutes before surgery with sips of water. They were randomly allocated to a particular group using computer generated numbers. The ward staff nurse administered the drug kept in sealed envelopes. Both the patients and the person administering anaesthesia were unaware of the group. STATISTICAL ANALYSIS The results were analysed using SPSS Version 17 software with the help of the statistician. The students’ paired t-test was used to compare the mean change in the cortisol levels in the two groups. RESULTS There was a significant [p < 0.01] reduction in the intraoperative cortisol levels after premedication with pregabalin. There was an increase in serum cortisol levels after extubation in both the groups which was statistically significant (p < 0.01. CONCLUSION

  6. Inflammatory Bowel Disease Phenotype as Risk Factor for Cancer in a Prospective Multicentre Nested Case-Control IG-IBD Study.

    Science.gov (United States)

    Biancone, Livia; Armuzzi, Alessandro; Scribano, Maria Lia; D'Inca, Renata; Castiglione, Fabiana; Papi, Claudio; Angelucci, Erika; Daperno, Marco; Mocciaro, Filippo; Riegler, Gabriele; Fries, Walter; Meucci, Gianmichele; Alvisi, Patrizia; Spina, Luisa; Ardizzone, Sandro; Petruzziello, Carmelina; Ruffa, Alessandra; Kohn, Anna; Vecchi, Maurizio; Guidi, Luisa; Di Mitri, Roberto; Renna, Sara; Emma, Calabrese; Rogai, Francesca; Rossi, Alessandra; Orlando, Ambrogio; Pallone, Francesco

    2016-08-01

    Cancer risk in inflammatory bowel disease [IBD] is still debated. In a prospective, multicentre, nested case-control study, we aimed to characterise incident cases of cancer in IBD. The role of immunomodulators vs clinical characteristics of IBD as risk factors for cancer was also investigated. From January 2012 to December 2014, each IBD patient with incident cancer was matched with two IBD patients without cancer for: IBD type, gender, and age. Risk factors were assessed by multivariate regression analysis. IBD patients considered numbered 44619: 21953 Crohn's disease [CD], 22666 ulcerative colitis [UC]. Cancer occurred in 174 patients: 99 CD [CD-K], 75 UC [UC-K]. Controls included 198 CD [CD-C], 150 UC [UC-C]. Cancer incidence in IBD was 3.9/1000, higher in CD (4.5/1000 [99/21,953]) than in UC (3.3/1000 [75/22,666]; p = 0.042). Cancers involved: digestive system [36.8%], skin [13.2%], urinary tract [12.1%], lung [8.6%], breast [8%], genital tract [6.9%], thyroid [4.6%], lymphoma [3.5%], others [6.3%]. In CD, penetrating behaviour and combined thiopurines and tumour necrosis factor alpha [TNFα] antagonists were risk factors for cancer overall: odds ratio [OR] (95% confidence interval [CI] 2.33 [1.01-5.47]); 1.97 [1.1-3.5]; and for extracolonic cancers 3.9 [1.56-10.1]; 2.15 [1.17-4.1], respectively. In UC, risk factors were pancolitis and disease-related surgery for cancer overall (OR: 2.52 [1.26-5.1]; 5.09 [1.73-17.1]); disease-related surgery for colorectal cancer [CRC] (OR 3.6 [1.0-12]); and extensive and left-sided vs distal UC for extracolonic cancers (OR: 2.55 [1.15-5.9]; 2.6 [1.04-6.6]), respectively. In a multicentre study, penetrating CD and extensive UC were risk factors for cancer overall. Cancer incidence was higher in CD than in UC. Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

  7. Shevchenko Study: "Eternal" Development Prospects

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    Varenikova Olena

    2016-09-01

    Full Text Available The article describes the definitions of some Ukrainian researchers in the field of Shevchenko study during the 1st third of XX – the beginning of XXI centuries, concerning the unlimited subject of studies, analyses some social-scientific correlation that contributes to the phenomenon of "always new Shevchenko study".

  8. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT as tobacco cigarettes substitute: a prospective 12-month randomized control design study.

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    Pasquale Caponnetto

    Full Text Available BACKGROUND: Electronic cigarettes (e-cigarettes are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a 'smoking' experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ('Categoria'; Arbi Group Srl, Italy compared to its non-nicotine choice. GroupA (n = 100 received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100, a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100 received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. RESULTS: Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline, with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants' perception and acceptance of the product under investigation was satisfactory. CONCLUSION: In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption

  9. Efficacy of the natural antioxidant astaxanthin in the treatment of functional dyspepsia in patients with or without Helicobacter pylori infection: a prospective, randomized, double blind, and placebo-controlled study5

    DEFF Research Database (Denmark)

    Kupcinskas, L.; Lafolie, P.; Lignell, A.;

    2008-01-01

    OBJECTIVES: The aim of this study was to evaluate the efficacy of the natural antioxidant astaxanthin in functional dyspepsia in different doses and compared with placebo. DESIGN: The study was a controlled, prospective, randomized, and double blind trial. PARTICIPANTS: Patients with functional d...... greater reduction of reflux symptoms were detected in patients treated with the highest dose of the natural antioxidant astaxanthin. The response was more pronounced in H. pylori-infected patients Udgivelsesdato: 2008/6...

  10. Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial.

    Science.gov (United States)

    Kazemier, Brenda M; Koningstein, Fiona N; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M; de Miranda, Esteriek; Vogelvang, Tatjana E; Verhoeven, Corine J M; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A; van der Ven, Jeanine E M; Vlegels, Manita T W; Kuiper, Petra N; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J M; Mol, Ben W J; Geerlings, Suzanne E

    2015-11-01

    Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort study with an embedded randomised controlled trial, we screened women (aged ≥18 years) at eight hospitals and five ultrasound centres in the Netherlands with a singleton pregnancy between 16 and 22 weeks' gestation for asymptomatic bacteriuria. Screening was done with a single dipslide and two culture media. Dipslides were judged positive when the colony concentration was at least 1×10(5) colony-forming units (CFU) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1×10(5) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the randomised controlled trial comparing nitrofurantoin with placebo treatment. In this trial, participants were randomly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets, and were instructed to self-administer these tablets twice daily for 5 consecutive days. Randomisation was done by a web-based application with a computer-generated list with random block sizes of two, four, or six participants rendered by an independent data manager. 1 week after the end of treatment, they provided us with a follow-up dipslide. Women, treating physicians, and researchers all remained unaware of the bacteriuria status and treatment allocation. Women who refused to participate in the randomised controlled trial did not receive any antibiotics, but their outcomes were collected for analysis in the cohort study. We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women. The primary endpoint was a

  11. Methylenetetrahydrofolate reductase polymorphism (C677T), hyperhomocysteinemia, and risk of ischemic cardiovascular disease and venous thromboembolism: prospective and case-control studies from the Copenhagen City Heart Study

    DEFF Research Database (Denmark)

    Frederiksen, Jeppe; Juul, Klaus; Grande, Peer

    2004-01-01

    ) and 19% in ICD/VTE cases versus controls (P 1.0. Furthermore, MTHFR C677T homozygosity was not associated with increased risk of ICD or VTE in subgroups after stratification...... for sex, age, cholesterol, high-density lipoprotein cholesterol, lipoprotein(a), fibrinogen, triglycerides, body mass index, smoking, diabetes mellitus, hypertension, and factor V Leiden genotype. Finally, in case-control studies odds ratios for ischemic heart disease and ischemic cerebrovascular disease...... in homozygotes versus noncarriers did not differ from 1.0. In conclusion, MTHFR C677T homozygosity with hyperhomocysteinemia is not associated with ICD or VTE; however, ICD/VTE is associated with hyperhomocysteinemia. Therefore, ICD and VTE may cause hyperhomocysteinemia, rather than vice versa....

  12. A retro- and prospective study

    OpenAIRE

    Dettweiler, Alexandra

    2015-01-01

    The objective of the present study was to determine the reference ranges of hematological parameters in pet rabbits (Oryctolagus cuniculus) on the one hand. We especially looked at the automatically measured hematocrit and the absolute reticulocyte count. On the other hand the causes and the severity of anemia in pet rabbits were studied. The reference range for the automatically measured hematocrit of 68 healthy pet rabbits was between 0,33 and 0,45 l/l. The reference range for reticuloc...

  13. Active prospective control is required for effective sensorimotor learning.

    Directory of Open Access Journals (Sweden)

    Winona Snapp-Childs

    Full Text Available Passive modeling of movements is often used in movement therapy to overcome disabilities caused by stroke or other disorders (e.g. Developmental Coordination Disorder or Cerebral Palsy. Either a therapist or, recently, a specially designed robot moves or guides the limb passively through the movement to be trained. In contrast, action theory has long suggested that effective skill acquisition requires movements to be actively generated. Is this true? In view of the former, we explicitly tested the latter. Previously, a method was developed that allows children with Developmental Coordination Disorder to produce effective movements actively, so as to improve manual performance to match that of typically developing children. In the current study, we tested practice using such active movements as compared to practice using passive movement. The passive movement employed, namely haptic tracking, provided a strong test of the comparison, one that showed that the mere inaction of the muscles is not the problem. Instead, lack of prospective control was. The result was no effective learning with passive movement while active practice with prospective control yielded significant improvements in performance.

  14. Active prospective control is required for effective sensorimotor learning.

    Science.gov (United States)

    Snapp-Childs, Winona; Casserly, Elizabeth; Mon-Williams, Mark; Bingham, Geoffrey P

    2013-01-01

    Passive modeling of movements is often used in movement therapy to overcome disabilities caused by stroke or other disorders (e.g. Developmental Coordination Disorder or Cerebral Palsy). Either a therapist or, recently, a specially designed robot moves or guides the limb passively through the movement to be trained. In contrast, action theory has long suggested that effective skill acquisition requires movements to be actively generated. Is this true? In view of the former, we explicitly tested the latter. Previously, a method was developed that allows children with Developmental Coordination Disorder to produce effective movements actively, so as to improve manual performance to match that of typically developing children. In the current study, we tested practice using such active movements as compared to practice using passive movement. The passive movement employed, namely haptic tracking, provided a strong test of the comparison, one that showed that the mere inaction of the muscles is not the problem. Instead, lack of prospective control was. The result was no effective learning with passive movement while active practice with prospective control yielded significant improvements in performance.

  15. A retro- and prospective study

    OpenAIRE

    Madel, Anne

    2016-01-01

    The aim of this study was to evaluate clinical, laboratory, imaging and pathological findings of pet rabbits with azotemia (plasma creatinine concentration > 166 µmol/l) and to differentiate prerenal, renal [acute renal failure (ARF) and chronic renal failure (CRF)] and post renal azotemia using several criteria. In addition, the course and causes of azotemia were evaluated and compared between azotemia groups. In a period of 13 years (2000 to 2013), data from 161 pet rabbits (50 animals p...

  16. [Psychogenic paralysis. A prospective study].

    Science.gov (United States)

    Binzer, M N; Kullgren, G

    2000-10-16

    Patients with motor conversion disorder are frequently seen in neurological departments. Long term prognosis is usually considered to be good, although earlier research has been somewhat unsystematic and mostly retrospective. This study follows a well investigated sample of patients for two to five years and attempts to identify predictors associated with prognosis. Thirty patients with a recent onset of motor conversion disorder were assessed for key psychiatric and demographic variables. They were reassessed two to five years later. Nineteen patients had recovered completely and eight patients had improved, while only three patients were unchanged or worse. Contrary to other follow-up studies none of the patients received a rediagnosis of neurological disease. The presence of a personality disorder, concomitant somatic disease, and low DSM-IV axis V score proved to be associated with poor outcome. The results of this study stresses the need for careful and well-conducted neurological and psychiatric assessments in patients with psychogenic paralyses, bearing in mind the substantial possibility for coinciding illnesses. If this is ensured, it appears that the risk of subsequent neurological rediagnosis is negligible.

  17. Suction evacuation of hemothorax: A prospective study.

    Science.gov (United States)

    Savage, Stephanie A; Cibulas, George A; Ward, Tyler A; Davis, Corinne A; Croce, Martin A; Zarzaur, Ben L

    2016-07-01

    Although tube thoracostomy is a common procedure after thoracic trauma, incomplete evacuation of fluid places the patient at risk for retained hemothorax. As little as 300 to 500 cm of blood may result in the need for an additional thoracostomy tube or, in more severe cases, lung entrapment and empyema. We hypothesized that suction evacuation of the thoracic cavity before tube placement would decrease the incidence of late complications. Patients requiring tube thoracostomy within 96 hours of admission were prospectively identified and underwent suction evacuation of the pleural space (SEPS) before tube placement. These patients were compared to historical controls without suction evacuation. Demographics, admission vital signs, laboratory values, details of chest tube placement, and outcomes were collected on all patients. Multivariable logistic regression was used to compare outcomes between groups. A total of 199 patients were identified, consisting of 100 retrospective controls and 99 SEPS patients. There were no differences in age, sex, admission injury severity score or chest abbreviated injury score, admission laboratory values or vital signs, or hospital length of stay. Mean (SD) volume of hemothorax in SEPS patients was 220 (297) cm; with only 48% having a volume greater than 100 cm at the time of tube placement. Three patients developed empyema, and 19 demonstrated retained blood; there was no difference between SEPS and control patients. Suction evacuation of the pleural space was significantly protective against recurrent pneumothorax after chest tube removal (odds ratio, 0.332; 95% confidence interval, 0.148-0.745). Preemptive suction evacuation of the thoracic cavity did not have a significant impact on subsequent development of retained hemothorax or empyema. Suction evacuation of the pleural space significantly decreased incidence of recurrent pneumothorax after thoracostomy removal. Although the mechanism is unclear, such a benefit may make this

  18. A Nested Case-Control Study of Metabolically Defined Body Size Phenotypes and Risk of Colorectal Cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC.

    Directory of Open Access Journals (Sweden)

    Neil Murphy

    2016-04-01

    Full Text Available Obesity is positively associated with colorectal cancer. Recently, body size subtypes categorised by the prevalence of hyperinsulinaemia have been defined, and metabolically healthy overweight/obese individuals (without hyperinsulinaemia have been suggested to be at lower risk of cardiovascular disease than their metabolically unhealthy (hyperinsulinaemic overweight/obese counterparts. Whether similarly variable relationships exist for metabolically defined body size phenotypes and colorectal cancer risk is unknown.The association of metabolically defined body size phenotypes with colorectal cancer was investigated in a case-control study nested within the European Prospective Investigation into Cancer and Nutrition (EPIC study. Metabolic health/body size phenotypes were defined according to hyperinsulinaemia status using serum concentrations of C-peptide, a marker of insulin secretion. A total of 737 incident colorectal cancer cases and 737 matched controls were divided into tertiles based on the distribution of C-peptide concentration amongst the control population, and participants were classified as metabolically healthy if below the first tertile of C-peptide and metabolically unhealthy if above the first tertile. These metabolic health definitions were then combined with body mass index (BMI measurements to create four metabolic health/body size phenotype categories: (1 metabolically healthy/normal weight (BMI < 25 kg/m2, (2 metabolically healthy/overweight (BMI ≥ 25 kg/m2, (3 metabolically unhealthy/normal weight (BMI < 25 kg/m2, and (4 metabolically unhealthy/overweight (BMI ≥ 25 kg/m2. Additionally, in separate models, waist circumference measurements (using the International Diabetes Federation cut-points [≥80 cm for women and ≥94 cm for men] were used (instead of BMI to create the four metabolic health/body size phenotype categories. Statistical tests used in the analysis were all two-sided, and a p-value of <0.05 was

  19. A Nested Case-Control Study of Metabolically Defined Body Size Phenotypes and Risk of Colorectal Cancer in the European Prospective Investigation into Cancer and Nutrition (EPIC).

    Science.gov (United States)

    Murphy, Neil; Cross, Amanda J; Abubakar, Mustapha; Jenab, Mazda; Aleksandrova, Krasimira; Boutron-Ruault, Marie-Christine; Dossus, Laure; Racine, Antoine; Kühn, Tilman; Katzke, Verena A; Tjønneland, Anne; Petersen, Kristina E N; Overvad, Kim; Quirós, J Ramón; Jakszyn, Paula; Molina-Montes, Esther; Dorronsoro, Miren; Huerta, José-María; Barricarte, Aurelio; Khaw, Kay-Tee; Wareham, Nick; Travis, Ruth C; Trichopoulou, Antonia; Lagiou, Pagona; Trichopoulos, Dimitrios; Masala, Giovanna; Krogh, Vittorio; Tumino, Rosario; Vineis, Paolo; Panico, Salvatore; Bueno-de-Mesquita, H Bas; Siersema, Peter D; Peeters, Petra H; Ohlsson, Bodil; Ericson, Ulrika; Palmqvist, Richard; Nyström, Hanna; Weiderpass, Elisabete; Skeie, Guri; Freisling, Heinz; Kong, So Yeon; Tsilidis, Kostas; Muller, David C; Riboli, Elio; Gunter, Marc J

    2016-04-01

    Obesity is positively associated with colorectal cancer. Recently, body size subtypes categorised by the prevalence of hyperinsulinaemia have been defined, and metabolically healthy overweight/obese individuals (without hyperinsulinaemia) have been suggested to be at lower risk of cardiovascular disease than their metabolically unhealthy (hyperinsulinaemic) overweight/obese counterparts. Whether similarly variable relationships exist for metabolically defined body size phenotypes and colorectal cancer risk is unknown. The association of metabolically defined body size phenotypes with colorectal cancer was investigated in a case-control study nested within the European Prospective Investigation into Cancer and Nutrition (EPIC) study. Metabolic health/body size phenotypes were defined according to hyperinsulinaemia status using serum concentrations of C-peptide, a marker of insulin secretion. A total of 737 incident colorectal cancer cases and 737 matched controls were divided into tertiles based on the distribution of C-peptide concentration amongst the control population, and participants were classified as metabolically healthy if below the first tertile of C-peptide and metabolically unhealthy if above the first tertile. These metabolic health definitions were then combined with body mass index (BMI) measurements to create four metabolic health/body size phenotype categories: (1) metabolically healthy/normal weight (BMI BMI ≥ 25 kg/m2), (3) metabolically unhealthy/normal weight (BMI BMI ≥ 25 kg/m2). Additionally, in separate models, waist circumference measurements (using the International Diabetes Federation cut-points [≥80 cm for women and ≥94 cm for men]) were used (instead of BMI) to create the four metabolic health/body size phenotype categories. Statistical tests used in the analysis were all two-sided, and a p-value of BMI used to define adiposity, compared with metabolically healthy/normal weight individuals, we observed a higher colorectal cancer

  20. Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis

    Science.gov (United States)

    Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

    2016-01-01

    Introduction This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. Design A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Participants Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Interventions Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Analysis Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. Ethics and dissemination The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. Trial

  1. A Prospective Randomized Controlled Study of Laser-Assisted Hatching on the Outcome of First Fresh IVF-ET Cycle in Advanced Age Women.

    Science.gov (United States)

    Shi, Wenhao; Hongwei, Tan; Zhang, Wei; Li, Na; Li, Mingzhao; Li, Wei; Shi, Juanzi

    2016-10-01

    There is no sufficient data to conclude the benefit of assisted hatching (AH) for advanced age patients. However, AH is routinely performed for advanced age patients undergoing in vitro fertilization (IVF) in China based on some retrospective evidence. It is important to assess the benefit of AH procedure for advanced age patients, especially by analyzing the data from China. This is a prospective randomized controlled trial to evaluate the effect of laser AH in the advanced age patients undergoing IVF. A total of 256 patients conformed to the inclusion criteria, and 78 were excluded by exclusion criteria. A total of 178 patients were eligible and randomized to 2 groups (82 AH group and 96 control group). Laser AH (zona thinning) was performed in the AH group. There were no statistical significance in basic clinical parameters between the 2 groups. No difference was found in implantation rate (AH vs control, 32.45% vs 39.29%) and clinical pregnancy rate (AH vs control, 48.78% vs 59.38%). Our data did not find any benefit of laser AH in improving implantation or pregnancy rates in advanced age women. Due to the potential risk and increasing financial burden, AH should not be routinely performed in first fresh IVF embryo transfer cycle for advanced age women.

  2. Relation between psychosocial variables and the glycemic control of patients with type 2 diabetes: A cross-sectional and prospective study

    Directory of Open Access Journals (Sweden)

    Kawai Keisuke

    2009-03-01

    Full Text Available Abstract Background This cross-sectional and prospective study used a variety of psychological inventories to evaluate the relationship between psychosocial factors and the glycemic control of patients with type 2 diabetes. Methods Participants were 304 patients with type 2 diabetes who were treated as outpatients at diabetes clinics. All participants were assessed for HbA1c and completed the following self-report psychological inventories: 1 Diabetes Treatment Satisfaction Questionnaire (DTSQ, 2 Problem Areas in Diabetes Survey (PAID, 3 Well-being Questionnaire 12 (W-BQ12, 4 Self-Esteem Scale (SES, 5 Social Support Scale, and 6 Self-Efficacy Scale. HbA1c was again measured one year later. The relationships between the psychosocial variables obtained by analysis of the psychological inventories and baseline or one-year follow-up HbA1c were determined. Results Baseline HbA1cwas significantly correlated with age, diet treatment regimen, number of microvascular complication of diabetes, and the total scores of DTSQ, W-BQ12, PAID, SES and the Self-Efficacy Scale. Hierarchical stepwise multiple regression revealed that significant predictors of baseline HbA1c were total DTSQ and PAID scores, along with age, diet treatment regimen, and number of microvascular complication of diabetes after adjustment for demographic, clinical and other psychosocial variables. Two hundred and ninety patients (95.4% of 304 were followed and assessed one year after baseline. Hierarchical stepwise multiple regression analysis showed the significant predictors of follow-up HbA1c to be total DTSQ and PAID scores, along with age and diet treatment regimen. However, the correlation between baseline and follow-up HbA1c was so high that the only other variable to retain significance was diet treatment regimen once baseline HbA1c was included in the regression of follow-up HbA1c. Conclusion The DTSQ and the PAID predicted both current and future HbA1c to a similar and

  3. The causal nature of the association between neighborhood deprivation and drug abuse: a prospective national Swedish co-relative control study.

    Science.gov (United States)

    Kendler, K S; Ohlsson, H; Sundquist, K; Sundquist, J

    2014-09-01

    Risk for drug abuse (DA) is strongly associated with neighborhood social deprivation (SD). However, the causal nature of this relationship is unclear. Three Swedish population-based cohorts were followed up over 5 years for incident registration of DA in medical, legal or pharmacy records. In each cohort, we examined the SD-DA association, controlling carefully for individual socio-economic status (SES) with multiple measures, in the entire sample and among pairs of first cousins, paternal and maternal half-siblings, full siblings and monozygotic (MZ) twins discordant for SD exposure. The number of informative relative pairs ranged from 6366 to 166,208. In all cohorts, SD was prospectively related to risk for incident DA. In relative pairs discordant for SD exposure, the SD-DA association was similar to that seen in the entire population in cousins, half-siblings, full siblings and MZ twins. Eliminating subjects who were residentially unstable or had DA in the first two follow-up years did not alter this pattern. When divided by age, in the youngest groups, the SD-DA association was weaker in siblings than in the entire population. Across three cohorts, controlling for individual SES and confounding familial factors, SD prospectively predicted risk for incident DA registration. These results support the hypothesis that the SD-DA association is in part causal and unlikely to result entirely from personal attributes, which both increase risk for DA and cause selection into high SD environments. At least part of the SD-DA association arises because exposure to SD causes an increased risk of DA.

  4. Diagnosis of Non-ST-Elevation Acute Coronary Syndrome by the Measurement of Heart-Type Fatty Acid Binding Protein in Serum: A Prospective Case Control Study

    Directory of Open Access Journals (Sweden)

    Priscilla Abraham Chandran

    2014-01-01

    Full Text Available A prospective case control study was undertaken to evaluate the diagnostic performance of serum heart-type fatty acid binding protein (HFABP in comparison to cardiac TnT and TnI in 33 patients admitted with chest pain, diagnosed as NSTE-ACS (non ST elevation acute coronary syndrome and 22 healthy controls. Area under the receiver operating curve (AUC was highest for H-FABP (AUC 0.79; 95% CI 0.66–0.89 versus cTnI (AUC 0.73; 95% CI 0.59–0.84 and cTnT (AUC 0.71; 95% CI 0.57–0.83. The H-FABP level above 6.5 ng/mL showed 56.7% (CI 37.4–74.5 sensitivity, 0.5 (95% CI 0.3–0.7 negative likelihood ratio (−LR, 100% (CI 84.6–100.0 specificity, and 100% (CI 79.4–100.0 positive predictive value (PPV, 62.9% (CI 44.9–78.5 negative predictive value (NPV. cTnI level above 0.009 μg/L had 40% (CI 22.7–59.4 sensitivity, 0.6 (95% CI 0.4–0.8 −LR, 100% (CI 84.6–100.0 specificity, 100% (CI 73.5–100.0 PPV, and 55% (CI 38.5–70.7 NPV. cTnT showed 46.7% (CI 28.3–65.7 sensitivity, 0.5 (95% CI 0.4–0.7 −LR, 100% (CI 84.6–100.0 specificity, 100% (CI 76.8–100.0 PPV, and 57.9% (CI 40.8–73.7 NPV at level above 9 μg/L. +LR were 12.5 (95% CI 1.8–86.8, 1.7 (95% CI 1.0–3.0, and 1.2 (95% CI 0.8–1.9 for H-FABP, cTnI, and cTnT respectively. In conclusion measurement of H-FABP is a valuable tool in the early diagnosis of patients with chest pain (6–8 hrs and seems to be a preferred biomarker in the differential diagnosis of NSTE-ACS. More studies are needed to determine whether serum H-FABP further improves diagnostic performance.

  5. Prospective study on burns treated with Integra®, a cellulose sponge and split thickness skin graft: comparative clinical and histological study--randomized controlled trial.

    Science.gov (United States)

    Lagus, Heli; Sarlomo-Rikala, Maarit; Böhling, Tom; Vuola, Jyrki

    2013-12-01

    The aim of this study was to compare three different methods to cover excised burn wounds in a randomized controlled trial. Fascially excised burn wounds, measuring 10 cm × 5 cm, were covered with Integra(®), split thickness skin graft (STSG), and a viscose cellulose sponge Cellonex™ in each of ten adult patients. Integra(®) and Cellonex™ treated areas were covered with thin STSG on day 14. Biopsies were taken 3, 7, 14, and 21 days, 3 months, and 12 months after surgery, and samples were subjected to a range of immunohistochemical stains, in addition to hematoxylin and eosin (HE). Scar assessment was performed 3 and 12 months post-operatively with the Vancouver Scar Scale (VSS). Inflammation was not substantial in any of the study areas, but Cellonex™ had the most neutrophils, histiocytes, and lymphocytes with significant differences on days 7 and 14. Complete vascularization of Integra(®) seemed to occur later compared to the other materials. STSG had the most myofibroblasts on day 14 (p = 0.012). In VSS the quality of the scar improved in all materials from 3 to 12 months. The final results for all treatments after 12 months demonstrate equal clinical appearance, as well as histological and immunohistochemical findings. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  6. Quality control within the multicentre perfusion CT study of primary colorectal cancer (PROSPeCT): results of an iodine density phantom study

    Energy Technology Data Exchange (ETDEWEB)

    Lewis, Maria; Honey, Ian [Trust, Medical Physics Department, Guy' s and St. Thomas' NHS Foundation, London (United Kingdom); Goh, Vicky [King' s College London, St Thomas' Hospital, Division of Imaging Sciences and Biomedical Engineering, London (United Kingdom); Beggs, Shaun [Bradford Teaching Hospitals NHS Foundation Trust, Radiation Physics Services, Bradford (United Kingdom); Bridges, Andrew; Wayte, Sarah [Radiology Physics University Hospitals Coventry and Warwickshire NHS Trust, Coventry (United Kingdom); Clewer, Philip [Medical Physics Department, University Hospital Southampton NHS Foundation Trust, Southampton (United Kingdom); Davis, Anne [Portsmouth Hospitals NHS Trust, Medical Physics Department, Portsmouth (United Kingdom); Foy, Trevelyan [Royal Cornwall Hospital NHS Trust, Medical Physics Department, Truro (United Kingdom); Fuller, Karen [Sheffield Teaching Hospitals NHS Foundation Trust, Medical Physics Department, Sheffield (United Kingdom); George, Jennifer [University Hospital of North Staffordshire NHS Trust, Medical Physics Department, Stoke-on-Trent (United Kingdom); Higginson, Antony [Portsmouth Hospitals NHS Trust, Department of Radiology, Portsmouth (United Kingdom); Iball, Gareth [Leeds Teaching Hospitals NHS Trust, Department of Medical Physics and Engineering, Leeds (United Kingdom); Mutch, Steve [Oxford University Hospitals NHS Trust, Radiation Physics and Protection Department, Oxford (United Kingdom); Neil, Shellagh; Sutton, David [NHS Tayside, Medical Physics Department, Dundee, Scotland (United Kingdom); Rivett, Cat [Plymouth Hospitals NHS Trust, Clinical and Radiation Physics, Plymouth (United Kingdom); Slater, Andrew [Oxford University Hospitals NHS Trust, Department of Radiology, Oxford (United Kingdom); Weir, Nick [Queen' s Medical Research Institute, Clinical Research Imaging Centre, Edinburgh, Scotland (United Kingdom); Collaboration: on behalf of the PROSPeCT Investigators

    2014-09-15

    To assess the cross-centre consistency of iodine enhancement, contrast-to-noise ratio and radiation dose in a multicentre perfusion CT trial of colorectal cancer. A cylindrical water phantom containing different iodine inserts was examined on seven CT models in 13 hospitals. The relationship between CT number (Hounsfield units, HU) and iodine concentration (milligrams per millilitre) was established and contrast-to-noise ratios (CNRs) calculated. Radiation doses (CTDI{sub vol}, DLP) were compared across all sites. There was a linear relationship between CT number and iodine density. Iodine enhancement varied by a factor of at most 1.10, and image noise by at most 1.5 across the study sites. At an iodine concentration of 1 mg ml{sup -1} and 100 kV, CNRs ranged from 3.6 to 4.8 in the 220-mm phantom and from 1.4 to 1.9 in the 300-mm phantom. Doses varied by a factor of at most 2.4, but remained within study dose constraints. Iterative reconstruction algorithms did not alter iodine enhancement but resulted in reduced image noise by a factor of at most 2.2, allowing a potential dose decrease of at most 80 % compared to filtered back projection (FBP). Quality control of CT performance across centres indicates that CNR values remain relatively consistent across all sites, giving acceptable image quality within the agreed dose constraints. (orig.)

  7. A prospective study of gentamicin ototoxicity

    DEFF Research Database (Denmark)

    Winkel, O; Hansen, M M; Kaaber-Bühler, Søren

    2010-01-01

    Twenty patients were included in a prospective otoneurological study performed to assess the ototoxicity in gentamicin therapy. Gentamicin was administered intravenously, and the serum level was currently determined. Audiographic and electronystagmographic studies were carried out at the institut......Twenty patients were included in a prospective otoneurological study performed to assess the ototoxicity in gentamicin therapy. Gentamicin was administered intravenously, and the serum level was currently determined. Audiographic and electronystagmographic studies were carried out...... at the institution and discontinuation of the treatment and again a few weeks later. Ten patients exhibited ototoxic actions, predominantly cochlear, 4 of the cases being fully reversible. Two patients developed severe hearing loss, associated in one with bilateral extinction of vestibular function. Low serum levels...... of gentamicin did not rule out the possiblity of ototoxicity. These results urge the continuing of prospective studies and indicate that gentamicin should be used only as a link in the primary treatment of severe infection or in cases in which other, less toxic agents have failed....

  8. The associations of advanced glycation end products and its soluble receptor with pancreatic cancer risk: a case-control study within the prospective EPIC Cohort.

    Science.gov (United States)

    Grote, Verena A; Nieters, Alexandra; Kaaks, Rudolf; Tjønneland, Anne; Roswall, Nina; Overvad, Kim; Nielsen, Michael R Skjelbo; Clavel-Chapelon, Françoise; Boutron-Ruault, Marie Christine; Racine, Antoine; Teucher, Birgit; Lukanova, Annekatrin; Boeing, Heiner; Drogan, Dagmar; Trichopoulou, Antonia; Trichopoulos, Dimitrios; Lagiou, Pagona; Palli, Domenico; Sieri, Sabina; Tumino, Rosario; Vineis, Paolo; Mattiello, Amalia; Argüelles Suárez, Marcial Vicente; Duell, Eric J; Sánchez, María-José; Dorronsoro, Miren; Huerta Castaño, José María; Barricarte, Aurelio; Jeurnink, Suzanne M; Peeters, Petra H M; Sund, Malin; Ye, Weimin; Regner, Sara; Lindkvist, Björn; Khaw, Kay-Tee; Wareham, Nick; Allen, Naomi E; Crowe, Francesca L; Fedirko, Veronika; Jenab, Mazda; Romaguera, Dora; Siddiq, Afshan; Bueno-de-Mesquita, H Bas; Rohrmann, Sabine

    2012-04-01

    Advanced glycation end products (AGE) and their receptors (RAGE) have been implicated in cancer development through their proinflammatory capabilities. However, prospective data on their association with cancer of specific sites, including pancreatic cancer, are limited. Prediagnostic blood levels of the AGE product Nε-(carboxymethyl)lysine (CML) and the endogenous secreted receptor for AGE (esRAGE) were measured using ELISA in 454 patients with exocrine pancreatic cancer and individually matched controls within the European Prospective Investigation into Cancer and Nutrition (EPIC). Pancreatic cancer risk was estimated by calculating ORs with corresponding 95% confidence intervals (CI). Elevated CML levels tended to be associated with a reduction in pancreatic cancer risk [OR = 0.57 (95% CI, 0.32-1.01) comparing highest with lowest quintile), whereas no association was observed for esRAGE (OR = 0.98; 95% CI, 0.62-1.54). Adjustments for body mass index and smoking attenuated the inverse associations of CML with pancreatic cancer risk (OR = 0.78; 95% CI, 0.41-1.49). There was an inverse association between esRAGE and risk of pancreatic cancer for cases that were diagnosed within the first 2 years of follow-up [OR = 0.46 (95% CI, 0.22-0.96) for a doubling in concentration], whereas there was no association among those with a longer follow-up (OR = 1.11; 95% CI, 0.88-1.39; P(interaction) = 0.002). Our results do not provide evidence for an association of higher CML or lower esRAGE levels with risk of pancreatic cancer. The role of AGE/RAGE in pancreatic cancer would benefit from further investigations. ©2012 AACR

  9. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

    Science.gov (United States)

    Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

    2013-06-01

    Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

  10. Personality and substance use disorders: a prospective study.

    Science.gov (United States)

    Sher, K J; Bartholow, B D; Wood, M D

    2000-10-01

    The personality systems of Cloninger (as measured by the Tridimensional Personality Questionnaire [TPQ]) and Eysenck (as measured by the Eysenck Personality Questionnaire [EPQ]) both have been linked to substance use and abuse. The current study examined the predictive utility of both systems for substance use disorder (SUD) diagnoses, both cross-sectionally and prospectively. Participants (N = 489 at baseline) completed the EPQ and TPQ and were assessed via structured diagnostic interview at baseline and 6 years later (N = 457 at follow-up). Both the EPQ and TPQ scales demonstrated bivariate cross-sectional and prospective associations with SUDs. Within each system, those dimensions marking a broad impulsive sensation-seeking or behavioral disinhibition trait were the best predictors prospectively, although the 2 systems were differentially sensitive to specific diagnoses. These relations remained significant even with autoregressivity, other concurrent SUD diagnoses, and multiple personality dimensions statistically controlled.

  11. Cognitive and psychomotor development of 5- to 6-year-old singletons born after PGD: a prospective case-controlled matched study.

    Science.gov (United States)

    Winter, C; Van Acker, F; Bonduelle, M; Desmyttere, S; De Schrijver, F; Nekkebroeck, J

    2014-09-01

    Do preschool preimplantation genetic diagnosis (PGD) children differ in their cognitive and psychomotor development from children born after ICSI and spontaneous conception (SC)? The cognitive development of PGD pre-schoolers was comparable to children born after ICSI and SC but motor development differed between ICSI and SC groups. The cognitive abilities and motor skills of 5- to 6-year-old singletons born after PGD (n = 47) were assessed in comparison with 49 ICSI and 48 SC children in a prospective, case-controlled, matched follow-up study between April 2011 and May 2013. PGD singletons, ICSI and SC children of preschool age were examined with the Wechsler Preschool and Primary Scale of Intelligence (WPSSI-III-NL) and the Movement ABC (M ABC). The WPSSI-III-NL revealed scores for Full IQ, Verbal IQ and Performance IQ. The M ABC yields a total score and comprising scores for measurements of balance, dexterity and ball skills. Since embryo biopsy is the only technical difference between the PGD and ICSI procedures, ICSI children were included as controls. These children were part of a Dutch-speaking cohort of children conceived after assisted reproduction technology (ART) at the Universitair Ziekenhuis Brussel (UZ Brussel) who received longitudinal follow-up. The SC children acted as a second control group similar to the fertile PGD sample and in contrast to the ICSI group. The SC group was recruited through announcements in a variety of media. The children were matched for age, gender, birth order and educational level of the mother. The assessments carried out for the ART groups were blinded whenever possible. The data were analysed using analysis of covariance (ANCOVA) and partial eta squared (η(2)), which was used as a measurement of effect size. The overall cognitive development of PGD singletons did not differ from controls [P = 0.647, η(2) = 0.006; 95% confidence interval (CI) (0, 0.043)]. The partial IQ scores for Verbal and Performance intelligence

  12. No association between static and dynamic postural control and ACL injury risk among female elite handball and football players: a prospective study of 838 players.

    Science.gov (United States)

    Steffen, Kathrin; Nilstad, Agnethe; Krosshaug, Tron; Pasanen, Kati; Killingmo, Aleksander; Bahr, Roald

    2017-02-01

    Research on balance measures as potential risk factors for ACL injury is limited. To assess whether postural control was associated with an increased risk for ACL injuries in female elite handball and football players. Premier league players were tested in the preseason and followed prospectively for ACL injury risk from 2007 through 2015. At baseline, we recorded player demographics, playing experience, ACL and ankle injury history. We measured centre of pressure velocity in single-leg stabilisation tests and reach distances in the Star Excursion Balance Test. To examine the stability of postural control measures over time, we examined their short-term and long-term reproducibility. We generated logistic regression models, 1 for each of the proposed risk factors. A total of 55 (6.6%) out of 838 players (age 21±4 years; height 170±6 cm; body mass 66±8 kg) sustained a non-contact ACL injury after baseline testing (1.8±1.8 years). When comparing normalised balance measures between injured and uninjured players in univariate analyses, none of the variables were statistically associated with ACL injury risk. Short-term and long-term reproducibility of the selected variables was poor. Players with a previous ACL injury had a 3-fold higher risk of sustaining a new ACL injury compared with previously uninjured players (OR 2.9, CI 1.4 to 5.7). None of postural control measures examined were associated with increased ACL injury risk among female elite handball and football players. Hence, as measured in the current investigation, the variables included cannot be used to predict ACL injury risk. 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/.

  13. Methylenetetrahydrofolate reductase polymorphism (C677T), hyperhomocysteinemia, and risk of ischemic cardiovascular disease and venous thromboembolism: prospective and case-control studies from the Copenhagen City Heart Study

    DEFF Research Database (Denmark)

    Frederiksen, Jeppe; Juul, Klaus; Grande, Peer

    2004-01-01

    from the general population were followed for 23 years. Second, 2125 whites with ischemic heart disease and 836 whites with ischemic cerebrovascular disease were compared with 7568 controls from the general population. Plasma homocysteine was elevated 25% in homozygotes versus noncarriers (P

  14. Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opportunistic screening program.

    Science.gov (United States)

    Rubio-Briones, J; Casanova, J; Dumont, R; Rubio, L; Fernandez-Serra, A; Casanova-Salas, I; Domínguez-Escrig, J; Ramírez-Backhaus, M; Collado, A; Gómez-Ferrer, A; Iborra, I; Monrós, J L; Ricós, J V; Solsona, E; Salas, D; Martínez, F; Lopez-Guerrero, J A

    2014-05-01

    To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. We perform a prospective evaluation of PCA3 as a second line biomarker in an opportunistic screening for prostate cancer (PCa). From September-2010 until September-2012, 2,366 men, aged 40-74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA >3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12cores-. Men with PCA3 .5 ng/ml at 4-6 months or PSAv > .75 ng/ml/year. With median follow-up (FU) of 10.1 months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (P<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3- branches, respectively (P<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment. PCA3 as a second line biomarker within an opportunistic dual screening protocol, can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1 months, respectively, just missing around 3.2% of high grade PCa. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

  15. Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

    Science.gov (United States)

    Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

    2017-07-20

    To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

  16. The BEST study - a prospective study to compare business class ...

    African Journals Online (AJOL)

    ... a prospective study to compare business class versus economy class air travel as a cause of thrombosis. ... Patients/methods. ... Logistical regression analysis was used to determine the risk factors related to abnormally high D-dimer levels.

  17. Peri-articular local infiltration analgesia versus femoral nerve block for postoperative pain control following anterior cruciate ligament reconstruction: Prospective, comparative, non-inferiority study.

    Science.gov (United States)

    Lefevre, N; Klouche, S; de Pamphilis, O; Herman, S; Gerometta, A; Bohu, Y

    2016-11-01

    Femoral nerve block (FNB) is considered as a major advance in anterior cruciate ligament (ACL) reconstruction as it reduces the need for parenteral opioids. However, the incidence of transient or even permanent neurological deficits due to the FNB is estimated at 1.94% after knee surgery. The primary objective of this study was to compare local infiltration analgesia (LIA) to FNB during ACL reconstruction procedures. The study hypothesis was that LIA was not less effective than FNB on early postoperative pain. A retrospective analysis of data collected prospectively in the FAST cohort included a series of continuous patients who underwent primary repair for isolated ACL with a hamstring graft in 2013-2014. Changes in our anesthesia practices over time allowed us to form three successive groups: Group 1 - FNB, Group 2 - FNB+LIA, Group 3 - LIA only. Ultrasound-guided FNB was done pre-operatively. The LIA was done at the end of the procedure by the surgeon with systematic infiltration of all skin incisions and the hamstring donor site; no intra-articular injections were performed. The primary endpoint was the average early postoperative pain (Days 0-3) described by the patient on a visual analogue scale (0-10). Sample size calculation pointed to 36 subjects being needed per group for a non-inferiority study. The study involved 126 patients: G1=42, G2=38, G3=46. The patients were comparable at enrolment. The average early postoperative pain levels were 3.1±2.4, 2.8±2.0 and 2.5±2.2, respectively (P=0.66). A trend toward higher intake of tramadol was noted in the LIA group on D0 to D3, with a significant trend test on Day 1 (P=0.03) and Day 2 (P=0.02). After reconstruction of isolated ACL tears with a hamstring graft, FNB is not more effective than LIA on patients' early postoperative pain. Patients who received a FNB consumed significantly less opioid-like analgesics. III - Prospective, comparative, non-randomized study. Copyright © 2016 Elsevier Masson SAS. All

  18. Parathyroidectomy improves bone geometry and microarchitecture in female patients with primary hyperparathyroidism. A 1-year prospective controlled study using high resolution peripheral quantitative computed tomography

    DEFF Research Database (Denmark)

    Hansen, Stinus; Hauge, Ellen M; Rasmussen, Lars

    2012-01-01

    controlled study, high-resolution peripheral quantitative computed tomography (HR-pQCT) was used to evaluate changes in bone geometry, volumetric BMD (vBMD), microarchitecture, and estimated strength in female patients with PHPT before and 1 year after PTX, compared to healthy controls. Twenty-seven women...

  19. Biomarkers of Oxidative Stress and Risk of Developing Colorectal Cancer: A Cohort-nested Case-Control Study in the European Prospective Investigation Into Cancer and Nutrition

    National Research Council Canada - National Science Library

    Leufkens, Anke M; van Duijnhoven, Franzel J. B; Woudt, Sjoukje H. S; Siersema, Peter D; Jenab, Mazda; Jansen, Eugene H. J. M; Pischon, Tobias; Tjonneland, Anne; Olsen, Anja; Overvad, Kim; Boutron-Ruault, Marie Christine; Clavel-Chapelon, Francoise; Morois, Sophie; Palli, Domenico; Pala, Valeria; Tumino, Rosario; Vineis, Paolo; Panico, Salvatore; Kaaks, Rudolf; Lukanova, Annekatrin; Boeing, Heiner; Aleksanova, Krasimira; Trichopoulou, Antonia; Trichopouios, Dimitrios; Dilis, Vardis; Peeters, Petra H; Skeie, Guri; Gonzalez, Carlos A; Argueelles, Marcial; Sanchez, Maria-Jose; Dorronsoro, Miren; Huerta, Jose Maria; Ardanaz, Eva; Hallmans, Goran; Palmqvist, Richard; Khaw, Kay-Tee; Wareham, Nick; Allen, Naomi E; Crowe, Francesca L; Fedirko, Veronika; Norat, Teresa; Riboli, Elio; Bueno-de-Mesquita, H. Bas

    2012-01-01

    Oxidative stress has been shown to play an important role in carcinogenesis, but prospective evidence for an association between biomarkers of oxidative stress and colorectal cancer (CRC) risk is limited...

  20. [Prognostic factors of bacteremia: prospective study].

    Science.gov (United States)

    Pazos Añón, R; Fernández Rodríguez, R; Paz Vidal, I; Tinajas, A; Cantón, I; Abel, V; González, R; Martínez, R; Gayoso, P; Fernández Alvarez, O

    2001-08-01

    To identify the epidemiology and risk factors with influence in the outcome and mortality of a series of bacteriemic patients. A prospective study of bloodstream infections with clinical significance detected in a secondary hospital of 650 beds over period from May 1998 to May 1999. The true bacteriemia was defined in basis to the criteria both the physician and microbiologist. A total of 16 variables were defined and categorized such as clinical-epidemiologic, intrinsic risk factor, extrinsic risk factor, outcome and survival. We used SPSS statistical package: For cuantitative variables we carried out with the mean with confidence interval of 95%, for cualitative variables: number and %. Univariate analysis of the results was carried out with the X2 test and t Student, the survival was expressed with Kaplan Meyer graphics and the logistic regression model. A total of 320 positive blood cultures were studied but only 272 blood cultures were considered true bacteriemia in 259 patients. The calculated incidence of significant episodes of bacteriemia per 1000 admissions/year was 13. The overall mortality was 22% whereas death attributable to bacteriemia was 16%. The mean age was 66.9 years (IC 95% 65-69), 59% episodes occurred in men. The 78% episodes occurred in patients hospitalized in medical services. 52% episodes were of nosocomial infection and 48% of community acquired infection. According to the severity of the underlying disease, 15% had fatal diseases and 35% episodes occurred in patients without underlying disease. According to the univariant analysis, the variables which where significantly associated with greater risk death were: etiology (fungus), septic shock, the inadequate antibiotic therapy, presence of extrinsic factors (central intravenous catheter, performance of invasive procedures, previous antimicrobial therapy) and the hospital stay of less than 10 days. According to the multivariable analysis showed that the factors remaining independent

  1. Extracorporeal shock wave therapy in the treatment of primary bone marrow edema syndrome of the knee: a prospective randomised controlled study.

    Science.gov (United States)

    Gao, Fuqiang; Sun, Wei; Li, Zirong; Guo, Wanshou; Wang, Weiguo; Cheng, Liming; Yue, Debo; Zhang, Nianfei; Savarin, Amanda

    2015-12-05

    The aim of this prospective study was to evaluate the effectiveness of extracorporeal shock wave therapy (ESWT) in normalizing the symptoms and imaging features of primary bone marrow edema syndrome (BMES) of the knee. This study compared the outcomes of ESWT (Group A) (n = 20) and intravenously applied prostacyclin and bisphosphonate (Group B) (n = 20) in the treatment of BMES of the knee in our department between 2011 and 2013. The Visual Analog Scale for pain (VAS, 100 mm), the Western Ontario and McMaster University Osteoarthritis Index (WOMAC), the SF-36 scores and MRI scans as well as plain radiographs were obtained before and after therapy between two groups. Compared with Group B, we found greater improvement in VAS, the WOMAC Osteoarthritis Index and SF-36 score at 1, 3 and 6 months post-treatment in Group A (P edema at 6 months in Group A (95 vs. 65 %; P = 0.018). The MRI at 1 year follow-up showed complete regression in all patients in Group A. However, two cases in Group B continued to normalize over the subsequent follow-up period. ESWT can produce rapid pain relief and functional improvement. It may be an effective, reliable, and non-invasive technique for rapid treatment of BMES of the knee. Research Registry UIN 528, September 03, 2015.

  2. Clinical evaluation of double-bundle anterior cruciate ligament reconstruction procedure using hamstring tendon grafts:a prospective, randomized and controlled study

    Institute of Scientific and Technical Information of China (English)

    WANG Jian-quan; AO Ying-fang; YU Chang-long; LIU Ping; XU Yan; CHEN Lin-xin

    2009-01-01

    Background In clinical studies there is still a lot of controversy about the increased anterior and rotational stability between double-bundle (DB) and single-bundle (SB) anterior cruciate ligament (ACL) reconstruction. The aim of this study was to evaluate the clinical results of four-tunnel DB ACL reconstruction.Methods Sixty-four consecutive patients with ACL ruptures from May 2005 to May 2006 were randomly assigned into two groups: 32 cases for SB ACL reconstruction and 32 cases for DB ACL reconstruction. Clinical data, including KT 2000, Biodex test, Lysholm score, Tegner score and IKDC score, were prospectively collected until at least 10 months post-operative.Results The average values of KT 2000 were (1.47±1.17) mm and (1.68±1.14) mm for the SB and DB ACL reconstruction groups at 30° of knee flexion (P >0.05), and were (1.04±0.98) mm and (1.13±0.98) mm at 90° of knee flexion (P>0.05). There were also no significant differences in Lysholm score, Tegner score, IKDC score and Biodex test scores between the two groups (P>0.05). The operation time of DB ACL reconstruction was 20 minutes longer than the SB ACL reconstruction (P<0.05)Conclusion Double bundle ACL reconstructions have no obvious clinical advantages over single bundle ACL reconstructions.

  3. Combination of Palonosetron, Aprepitant, and Dexamethasone Effectively Controls Chemotherapy-induced Nausea and Vomiting in Patients Treated with Concomitant Temozolomide and Radiotherapy: Results of a Prospective Study

    Science.gov (United States)

    MATSUDA, Masahide; YAMAMOTO, Tetsuya; ISHIKAWA, Eiichi; AKUTSU, Hiroyoshi; TAKANO, Shingo; MATSUMURA, Akira

    2016-01-01

    Concomitant use of temozolomide (TMZ) and radiotherapy, which is the standard therapy for patients with high-grade glioma, involves a unique regimen with multiple-day, long-term administration. In a previous study, we showed not only higher incidence rates of chemotherapy-induced nausea and vomiting (CINV) during the overall study period, but also substantially higher incidence rates of moderate/severe nausea and particularly severe appetite suppression during the late phase of the treatment. Here, we prospectively evaluated the efficacy of a combination of palonosetron, aprepitant, and dexamethasone for CINV in patients treated with concomitant TMZ and radiotherapy. Twenty-one consecutive patients with newly diagnosed high-grade glioma were enrolled. CINV was recorded using a daily diary and included nausea assessment, emetic episodes, degree of appetite suppression, and use of antiemetic medication. The percentage of patients with a complete response in the overall period was 76.2%. The percentages of patients with no moderate/severe nausea were 90.5, 100, and 90.5% in the early phase, late phase, and overall period, respectively. Severe appetite suppression throughout the overall period completely disappeared. The combination of palonosetron, aprepitant, and dexamethasone was highly effective and well tolerated in patients treated with concomitant TMZ and radiotherapy. This combination of antiemetic therapy focused on delayed as well as acute CINV and may have the potential to overcome CINV associated with a multiple-day, long-term chemotherapy regimen. PMID:27666343

  4. Effect of body mass index on the outcomes of controlled ovarian hyperstimulation in Chinese women with polycystic ovary syndrome: a multicenter, prospective, observational study.

    Science.gov (United States)

    Sheng, Yan; Lu, Guangxiu; Liu, Jiayin; Liang, Xiaoyan; Ma, Yanping; Zhang, Xuehong; Zhang, Songying; Sun, Yingpu; Sun, Yun; Chen, Wenfeng; Fang, Wenhui; Chen, Zijiang

    2017-01-01

    The purpose of the present study is to explore the influence of body mass index (BMI) on outcomes of in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) techniques in Chinese women with polycystic ovary syndrome (PCOS). This was a multicenter, prospective, observational study that enrolled 800 subjects with PCOS from nine hospitals in China. Patients were categorized according to BMI categories: underweight, BMI categories. Hormone levels (estradiol, follicle-stimulating hormone (FSH), LH, testosterone, and progesterone) were measured using electrochemiluminescence assays. Among the 774 subjects, 27.3 % were overweight and 8.1 % were obese. The rFSH dose used differed significantly among BMI categories (P BMI categories (P = 0.033), but there was no difference for biochemical (P = 0.327) and ongoing (P = 0.084) pregnancy rates. The miscarriage rate was similar among BMI categories. More than one third of Chinese women with PCOS undergoing IVF/ICSI are overweight or obese. Elevated BMI is associated with reduced clinical pregnancy rate but similar ongoing pregnancy rates, suggesting that BMI has little impact on IVF outcomes.

  5. Serum levels of osteoprotegerin and receptor activator of nuclear factor -κB ligand in children with early juvenile idiopathic arthritis: a 2-year prospective controlled study

    Directory of Open Access Journals (Sweden)

    Godang Kristin

    2010-12-01

    Full Text Available Abstract Background The clinical relevance of observations of serum levels of osteoprotegerin (OPG and receptor activator of nuclear factor -κB ligand (RANKL in juvenile idiopathic arthritis (JIA is not clear. To elucidate the potential role of OPG and RANKL in JIA we determined serum levels of OPG and RANKL in patients with early JIA compared to healthy children, and prospectively explored changes in relation to radiographic score, bone and lean mass, severity of the disease, and treatment. Methods Ninety children with early oligoarticular or polyarticular JIA (ages 6-18 years; mean disease duration 19.4 months and 90 healthy children individually matched for age, sex, race, and county of residence, were examined at baseline and 2-year follow-up. OPG and RANKL were quantified by enzyme-immunoassay. Data were analyzed with the use of t-tests, ANOVA, and multiple regression analyses. Results Serum OPG was significantly lower in patients than controls at baseline, and there was a trend towards higher RANKL and a lower OPG/RANKL ratio. Patients with polyarthritis had significantly higher increments in RANKL from baseline to follow-up, compared to patients with oligoarthritis. RANKL was a significant negative predictor for increments in total body lean mass. Patients who were receiving corticosteroids (CS or disease-modifying antirheumatic drugs (DMARDs at follow-up had higher OPG/RANKL ratio compared with patients who did not receive this medication. Conclusions The data supports that levels of OPG are lower in patients with JIA compared to healthy children, and higher levels of RANKL is associated with more serious disease. RANKL was a significant negative predictor of lean mass in patients with JIA. The OPG/RANKL ratio was higher in patients on DMARDs or CS treatment.

  6. Lipid control and use of lipid-regulating drugs for prevention of cardiovascular events in Chinese type 2 diabetic patients: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Tong Peter CY

    2010-11-01

    Full Text Available Abstract Background Dyslipidaemia is an important but modifiable risk factor of cardiovascular disease (CVD in type 2 diabetes. Yet, the effectiveness of lipid regulating drugs in Asians is lacking. We examined the effects of lipid control and treatment with lipid regulating drugs on new onset of CVD in Chinese type 2 diabetic patients. Methods In this prospective cohort consisting of 4521 type 2 diabetic patients without history of CVD and naïve for lipid regulating treatment recruited consecutively from 1996 to 2005, 371 developed CVD after a median follow-up of 4.9 years. We used Cox proportional hazard regression to obtain the hazard ratios (HR of lipids and use of lipid regulating drugs for risk of CVD. Results The multivariate-adjusted HR (95% confidence interval of CVD in patients with high LDL-cholesterol (≥ 3.0 mmol/L was 1.36 (1.08 - 1.71, compared with lower values. Using the whole range value of HDL-cholesterol, the risk of CVD was reduced by 41% with every 1 mmol/L increase in HDL-cholesterol. Plasma triglyceride did not predict CVD. Statins use was associated with lower CVD risk [HR = 0.66 (0.50 - 0.88]. In sub-cohort analysis, statins use was associated with a HR of 0.60 (0.44 - 0.82 in patients with high LDL-cholesterol (≥ 3.0 mmol/L and 0.49 (0.28 - 0.88 in patients with low HDL-cholesterol. In patients with LDL-cholesterol Conclusions In Chinese type 2 diabetic patients, high LDL-cholesterol and low HDL-cholesterol predicted incident CVD. Overall, patients treated with statins had 40-50% risk reduction in CVD compared to non-users.

  7. Pain relief after Arthroscopic Knee Surgery: A comparison of intra-articular ropivacaine, fentanyl, and dexmedetomidine: A prospective, double-blinded, randomized controlled study

    Directory of Open Access Journals (Sweden)

    Mohammed Babrak Manuar

    2014-01-01

    Full Text Available Background: Postoperative pain is very common distressing symptom after any surgical procedure. Different drugs in different routes have been used for controlling post-arthroscopic pain. No one proved to be ideal. We have compared the analgesic effect of ropivacaine, fentanyl, and dexmedetomidine when administered through the intra-articular route in arthroscopic knee surgery. Materials and Methods: From March 2008 to July 2010, 99 patients undergoing arthroscopic knee surgery were randomly assigned into three groups (A,B,C in a prospective double-blinded fashion. Group A received 10 ml of 0.75% ropivacaine, where Group B received 50 μg fentanyl, and Group C received 100 μg of dexmedetomidine through the intra-articular route at the end of procedure. Pain assessed using visual analog scale and diclofenac sodium given as rescue analgesia when VAS >4. Time of first analgesia request and total rescue analgesic used in 24 hours were calculated. Results: Demographic profiles are quite comparable among the groups. Time for requirement of first postoperative rescue analgesia in Group A was 380.61 ± 22.973 min, in Group B was 326.82 ± 17.131 min and in Group C was 244.09 ± 20.096 minutes. Total rescue analgesia requirement was less in Group A (1.394 ± 0.496 compared to Group B (1.758 ± 0.435 and Group C (2.546 ± 0.546. Group A had higher mean VAS score at 6 th and 24 th postoperative hours. No side effects found among the groups. Conclusion: Therefore, it suggests that intra-articular ropivacaine gives better postoperative pain relief, with increased time of first analgesic request and decreased need of total postoperative analgesia compared to fentanyl and dexmedetomidine.

  8. The PRAISE study: a prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749).

    Science.gov (United States)

    Bärthel, Erik; Rauchfuss, Falk; Hoyer, Heike; Breternitz, Maria; Jandt, Karin; Settmacher, Utz

    2013-01-29

    Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level>2000 IU/ml within the first 7 postoperative days, bilirubine  ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

  9. Refractory status epilepticus: a prospective observational study.

    Science.gov (United States)

    Novy, Jan; Logroscino, Giancarlo; Rossetti, Andrea O

    2010-02-01

    Status epilepticus (SE) that is resistant to two antiepileptic compounds is defined as refractory status epilepticus (RSE). In the few available retrospective studies, estimated RSE frequency is between 31% and 43% of patients presenting an SE episode; almost all seem to require a coma induction for treatment. We prospectively assessed RSE frequency, clinical predictors, and outcome in a tertiary clinical setting. Over 2 years we collected 128 consecutive SE episodes (118 patients) in adults. Clinical data and their relationship to outcome (mortality and return to baseline clinical conditions) were analyzed. Twenty-nine of 128 SE episodes (22.6%) were refractory to first- and second-line antiepileptic treatments. Severity of consciousness impairment and de novo episodes were independent predictors of RSE. RSE showed a worse outcome than non-RSE (39% vs. 11% for mortality; 21% vs. 63% for return to baseline clinical conditions). Only 12 patients with RSE (41%) required coma induction for treatment. This prospective study identifies clinical factors predicting the onset of SE refractoriness. RSE appears to be less frequent than previously reported in retrospective studies; furthermore, most RSE episodes were treated outside the intensive care unit (ICU). Nonetheless, we confirm that RSE is characterized by high mortality and morbidity.

  10. Combined analysis of six lipoprotein lipase genetic variants on triglycerides, high-density lipoprotein, and ischemic heart disease: cross-sectional, prospective, and case-control studies from the Copenhagen City Heart Study

    DEFF Research Database (Denmark)

    Wittrup, HH; Andersen, RV; Tybjærg-Hansen, A

    2006-01-01

    CONTEXT: Genetic variants in lipoprotein lipase may affect triglycerides, high-density lipoprotein (HDL), and risk of ischemic heart disease (IHD). OBJECTIVE: The objective of this study was to investigate the influence of T(-93)G, G(-53)C, Asp9Asn, Gly188Glu, Asn291Ser, and Ser447Ter lipoprotein...... in plasma triglycerides greater than 1 mmol/liter and differences in HDL cholesterol greater than 0.5 mmol/liter. A 1.6-fold risk of IHD in 9Asn (with -93G) heterozygotes and homozygotes combined is influenced by apolipoprotein E genotype.......CONTEXT: Genetic variants in lipoprotein lipase may affect triglycerides, high-density lipoprotein (HDL), and risk of ischemic heart disease (IHD). OBJECTIVE: The objective of this study was to investigate the influence of T(-93)G, G(-53)C, Asp9Asn, Gly188Glu, Asn291Ser, and Ser447Ter lipoprotein...... lipase genotypes on triglycerides, HDL, and IHD. DESIGN: The cross-sectional study involved 9004 adults. The prospective study consisted of 8817 adults developing 1001 IHD events over 23 yr. The case-control study involved 7818 non-IHD individuals vs. cohorts of 915 and 1062 IHD patients, respectively...

  11. Discontinuation of long-term benzodiazepine use by sending a letter to users in family practice: a prospective controlled intervention study

    NARCIS (Netherlands)

    Gorgels, W.J.M.J.; Voshaar, R.C. Oude; Mol, A.J.J.; Lisdonk, van de E.H.; Balkom, van A.J.L.M.; Hoogen, van den H.J.M.; Mulder, J.; Breteler, M.H.M.; Zitman, F.G.

    2005-01-01

    Minimal intervention strategies to decrease long-term benzodiazepine use have not yet been evaluated in large primary care based studies with a blinded control condition and a long follow-up period. The purpose of this study was to assess the effects of a letter with a discontinuation advice sent to

  12. Discontinuation of long-term benzodiazepine use by sending a letter to users in family practice: a prospective controlled intervention study.

    NARCIS (Netherlands)

    Gorgels, W.J.M.J.; Oude Voshaar, R.C.; Mol, A.J.J.; Lisdonk, E.H. van de; Balkom, A.J.L.M. van; Hoogen, H.J.M. van den; Mulder, J.; Breteler, M.H.M.; Zitman, F.G.

    2005-01-01

    Minimal intervention strategies to decrease long-term benzodiazepine use have not yet been evaluated in large primary care based studies with a blinded control condition and a long follow-up period. The purpose of this study was to assess the effects of a letter with a discontinuation advice sent to

  13. Comparative study of two doses of intrathecal dexmedetomidine as adjuvant with low dose hyperbaric bupivacaine in ambulatory perianal surgeries: A prospective randomised controlled study

    Directory of Open Access Journals (Sweden)

    K Sudheesh

    2015-01-01

    Full Text Available Background and Aims: Dexmedetomidine (DMT, as intrathecal adjuvant has been shown to successfully prolong duration of analgesia but delay the motor recovery. Hence, this study was designed to find out the dose of DMT which can provide satisfactory analgesia without prolonging motor block. Methods: A total of 50 patients scheduled for elective perianal surgeries were randomly allocated to Groups C or D (n = 25. Group D received hyperbaric bupivacaine 0.5% 4 mg + DMT 5 μg and Group C received hyperbaric bupivacaine 0.5% 4 mg + DMT 3 μg intrathecally. Onset and duration of sensory and motor blockade, duration of analgesia, time for ambulation and first urination were recorded. Adverse effects if any were noted. Results: Demographic characters, duration of surgery were comparable. The onset of sensory block to S1 was 9.61 ± 5.53 min in Group C compared to 7.69 ± 4.80 min in Group D (P = 0.35. Duration of sensory (145.28 ± 83.17 min – C, 167.85 ± 93.75 min – D, P = 0.5 and motor block (170.53 ± 73.44 min – C, 196.14 ± 84.28 min, P = 0.39 were comparable. Duration of analgesia (337.86 ± 105.11 min – C, 340.78 ± 101.81 min – D, P = 0.9 and time for ambulation (252.46 ± 93.72 min – C, 253.64 ± 88.04 min – D, P = 0.97 were also comparable. One patient in each group had urinary retention requiring catheterization. No other side effects were observed. Conclusion: Intrathecal DMT 3 μg dose does not produce faster ambulation compared to intrathecal DMT 5 μg though it produces comparable duration of analgesia for perianal surgeries.

  14. The effects of rose hip (Rosa canina) on plasma antioxidative activity and C-reactive protein in patients with rheumatoid arthritis and normal controls: A prospective cohort study

    DEFF Research Database (Denmark)

    Kirkeskov, Bente; Christensen, Robin; Bügel, Susanne Gjedsted

    2011-01-01

    : In this open case-control study 20 female patients with RA and 10 female controls were given 10.5g rose hip powder daily (Litozin(®)) for 28 days. Blood samples were analysed at baseline and follow-up for the capacity of the antioxidant enzymes superoxide dismutase, glutathione peroxidase, glutathione...... reductase and catalase and the inflammatory marker C-reactive protein (CRP). The participants kept a food diary for the first 3 days and the last 3 days of the intervention period. The RA-patients completed The Stanford Health Assessment Questionnaire at baseline and follow-up. RESULTS: CRP...... symptoms or laboratory measurements in patients with RA or healthy controls. This is in contrast to previous intervention studies with rose hip powder that found a reduction in the concentration of CRP. The results of the present study indicate that a daily amount of approximately 10g rose hip powder...

  15. A combined crystalloid and colloid pd solution as a glucose-sparing strategy for volume control in high-transport apd patients: a prospective multicenter study.

    Science.gov (United States)

    Freida, Philippe; Issad, Belkacem; Dratwa, Max; Lobbedez, Thierry; Wu, Lieling; Leypoldt, John K; Divino-Filho, Jose Carolino

    2009-01-01

    Evidence is accumulating that the continuous exposure to high glucose concentrations during peritoneal dialysis (PD) is an important cause of ultrafiltration (UF) failure. The cornerstone of prevention and treatment of UF failure is reduction of glucose exposure, which will also alleviate the systemic impact of significant free glucose absorption. The challenge for the future is to discover new therapeutic strategies to enhance fluid and sodium removal while diminishing glucose load and exposure using combinations of available osmotic agents. To investigate in patients on automated PD (APD) with a fast transport pattern whether there is a glucose-sparing advantage to replacing 7.5% icodextrin (ICO) during the long dwell with a mixed crystalloid and colloid PD fluid (bimodal UF) in an attempt to promote daytime UF and sodium removal while diminishing the glucose strength of the dialysate at night. A 2 parallel arm, 4 month, prospective nonrandomized study. PD units or university hospitals in 4 French and Belgian districts. During the 4-month intervention period, net UF and peritoneal sodium removal during the long dwell when treated by bimodal UF was about 2-fold higher than baseline (with ICO). The estimated percent change (95% confidence interval) from baseline in net daytime UF for the bimodal solution was 150% (106% - 193%), versus 18% (-7% - 43%) for ICO (p ICO (p ICO. Prescription of bimodal UF during the day in APD patients offers the opportunity to optimize the long dwell exchange in a complete 24-hour APD cycle. The current study demonstrated that a bimodal solution based on the mixing of glucose (2.6%) and icodextrin (6.8%) achieved the double target of significantly improving UF and peritoneal sodium removal by exploring a new concept of glucose-sparing PD therapy.

  16. Efficacy and safety of micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological malignancies: a randomized, controlled, prospective, multicenter study.

    Science.gov (United States)

    Jeong, Seong Hyun; Kim, Dae Young; Jang, Jun Ho; Mun, Yeung-Chul; Choi, Chul Won; Kim, Sung-Hyun; Kim, Jin Seok; Park, Joon Seong

    2016-01-01

    Micafungin, a clinically important echinocandin antifungal drug, needs to be investigated as empirical therapy in febrile neutropenia in comparison with azole compounds. A prospective randomized study was conducted to compare clinical outcomes between micafungin and intravenous itraconazole as an empirical therapy for febrile neutropenia in hematological malignancies. The antifungal drug (micafungin 100 mg or itraconazole 200 mg IV once daily) was given for high fever that was sustained despite the administration of appropriate antibiotics. Treatment success was determined by composite end points based on breakthrough invasive fungal infection (IFI), survival, premature discontinuation, defervescence, and treatment of baseline fungal infection. Duration of fever, hospital stay, and overall survival (OS) were studied. A total of 153 patients were randomized to receive micafungin or itraconazole. The overall success rate was 7.1 % point higher in the micafungin group (64.4 vs. 57.3 %, p = 0.404), satisfying the statistical criteria for the non-inferiority of micafungin. The duration of fever and hospital stay were significantly shorter in the micafungin group (6 vs. 7 days, p = 0.014; 22 vs. 27 days, p = 0.033, respectively). Grade 3 adverse events including hyperbilirubinemia (2 vs. 7), elevation of transaminase levels (2 vs. 4), electrolyte imbalance (1 vs. 2), atrial fibrillation (1 vs. 0), and anaphylaxis (1 vs. 0) occurred in 7 and 13 patients in the micafungin (10.4 %) and itraconazole (18.8 %) groups, respectively. Micafungin, when compared with itraconazole, had favorably comparable success rate and toxicity profiles on febrile neutropenia in patients with hematological malignancies. In addition, it showed superior effect on shortening the hospital stay.

  17. Complications of ERCP: a prospective study

    DEFF Research Database (Denmark)

    Christensen, Merete; Matzen, Peter; Schulze, Svend;

    2004-01-01

    BACKGROUND: Studies of ERCP-related morbidity seldom include a sufficient patient follow-up. The aim of this study was to characterize and to evaluate the frequency of complications, cardiopulmonary untoward events in particular. METHODS: All patients undergoing ERCP during a 2-year period were...... included in this prospective study. Complications were assessed at the time of ERCP and by postal/telephone contact at 30-days after the procedure. RESULTS: A total of 1177 ERCPs were included in the analysis, of which 56.2% were therapeutic. The 30-day complication rate was 15.9%; the procedure...... occurred in relation to 5% of the ERCP procedures (3 deaths). Cardiorespiratory complications occurred in 2.3% (2 deaths). Dilated bile duct ( p = 0.0001), placement of stent ( p = 0.001), and use of more than 40 mg of hyoscine-N-butyl bromide ( p complications by multivariate...

  18. AN EPIDEMIOLOGICAL PROSPECTIVE STUDY OF POSTCHOLECYSTECTOMY SYNDROME

    Directory of Open Access Journals (Sweden)

    Sumit

    2015-11-01

    Full Text Available BACKGROUND AND AIMS Cholecystectomy is the standard treatment for symptomatic gall stone disease. This study is aimed to assess the effect of the surgery on patients' symptoms. MATERIALS AND METHODS Eighty patients undergoing Cholecystectomy between September 2013 to February 2015 were evaluated using standard questionnaires in Study conducted on patients admitted in Surgical units in Maharaja Yashwantrao Hospital and MGM Medical College, a tertiary level care centre in Central India. RESULTS In this prospective study of 80 symptomatic gallstone disease patients with two or more symptoms pre-operatively the incidence of Postcholecystectomy Syndrome was found out to be 30%. All pain and non-pain symptoms were significantly reduced post-operatively except diarrhea.

  19. Prospective dynamic balance control in healthy children and adults.

    Science.gov (United States)

    Austad, Hanne; van der Meer, Audrey L H

    2007-08-01

    Balance control during gait initiation was studied using center of pressure (CoP) data from force plate measurements. Twenty-four participants were divided into four age groups: (1) 2-3 years, (2) 4-5 years, (3) 7-8 years, and (4) adults. Movement in the antero-posterior (CoPy) direction during the initial step was tau-G analyzed, investigating the hypothesis that tau of the CoPy motion-gap (tau(CoPy)), i.e., the time it will take to close the gap at its current closure rate, is tau-coupled onto an intrinsic tau-G guide (tau(G)), by maintaining the relation tau(CoPy )= Ktau(G), for a constant K. Mean percentage of tau-guidance for all groups was >/=99%, resulting in all r(2) exceeding 0.95, justifying an investigation of the regression slope as an estimate of the coupling constant K in the tau-coupling equation. Mean K values decreased significantly with age and were for 2- to 3-year-olds 0.56, for 4- to 5-year-olds 0.50, for 7- to 8-year-olds 0.47, and for adults 0.41. Therefore, the control of dynamic balance develops from the youngest children colliding with the boundaries of the base of support (K > 0.5) to the older children and adults making touch contact (K prospective balance control, a helpful tool in assessing whether a child is following a normal developmental pattern.

  20. Initiation of insulin glargine in patients with Type 2 diabetes in suboptimal glycaemic control positively impacts health-related quality of life. A prospective cohort study in primary care

    DEFF Research Database (Denmark)

    Hajós, Tibor R S; Pouwer, F; de Grooth, R

    2011-01-01

    control (HbA(1c) > 53 mmol/mol; 7%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Patients started insulin glargine and were followed up for 6 months. At baseline (start insulin therapy), 3 and 6 months, HbA(1c) was measured and patients......AIMS: To study prospectively the impact of initiating insulin glargine in suboptimally controlled insulin-naïve patients with Type 2 diabetes on health-related quality of life in relation to glycaemic control. METHODS: Insulin-naïve Dutch patients with Type 2 diabetes in suboptimal glycaemic......-revised score decreased from 15 ± 14 to 10 ± 12 and 10 ± 13 (P up and 67 ± 21.8 at 6-month follow-up (P

  1. A Prospective Study of Pain Control by a Two-Step Irradiance Schedule During Topical Photodynamic Therapy of Non-melanoma Skin Cancer

    Science.gov (United States)

    Zeitouni, Nathalie C.; Sunar, Ulas; Rohrbach, Daniel J.; Paquette, Anne D.; Bellnier, David A.; Shi, Yi; Wilding, Gregory; Foster, Thomas H.; Henderson, Barbara W.

    2015-01-01

    Background Topical photodynamic therapy (PDT) for selected non-melanoma skin cancer, employing 5-aminolevulinic acid (ALA) or methyl aminolevulinate (MAL) has yielded high long-term complete response rates with very good cosmesis. Pain during light activation of the photosensitizer can be a serious adverse event. A two-step irradiance protocol has previously been shown to minimize ALA-PDT pain. Objectives To determine the irradiance-dependent pain threshold for MAL-PDT, to adapt the two-step protocol to an LED light source, and assess clinical response. Methods In this prospective study, 25 superficial basal cell carcinoma (sBCC) received an initial irradiance by laser at 40 or 50 mW/cm2, or LED at 35 mW/cm2 followed by an irradiance at 70 mW/cm2 for a total of 75 J/cm2. Pain levels were recorded for both irradiance steps. Efficacy was assessed at 6, 12 or 24 months. Results Pain was mild in the 40/70 mW/cm2 laser cohort. Three instances of irradiance-limiting pain occurred at 50/70 mW/cm2. Pain was minimal in the 35/70 mW/cm2 LED cohort. Clinical response rates were 80% in the 50/70 mW/cm2 laser cohort and 90% in the 35/70 mW/cm2 LED cohort. Conclusions Topical PDT can be effectively delivered to sBCC with minimal treatment related pain by a two-step irradiance protocol. PMID:25393353

  2. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study.

    NARCIS (Netherlands)

    Vlaar, A.P.J.; Hofstra, J.J.; Determann, R.M.; Veelo, D.P.; Paulus, F.; Kulik, W.; Korevaar, J.; Mol, B.A. de; Koopman, M.M.W.; Porcelijn, L.; Binnekade, J.M.; Vroom, M.B.; Schultz, M.J.; Juffermans, N.P.

    2011-01-01

    Transfusion-related acute lung injury (TRALI) is the leading cause of transfusion-related morbidity and mortality. Both antibodies and bioactive lipids that have accumulated during storage of blood have been implicated in TRALI pathogenesis. In a single-center, nested, case-control study, patients w

  3. The effect of low-dose acetylsalicylic acid on bleeding after transurethral prostatectomy--a prospective, randomized, double-blind, placebo-controlled study

    DEFF Research Database (Denmark)

    Nielsen, Jesper Dan; Holm-Nielsen, A; Jespersen, J

    2000-01-01

    OBJECTIVE: An increase in the loss of blood after ingestion of acetylsalicylic acid (ASA) has been reported after several types of surgery, but randomized placebo-controlled studies have exclusively been performed after coronary artery bypass surgery. The reported effects of ASA on bleeding after...

  4. Mood impairs time-based prospective memory in young but not older adults: the mediating role of attentional control.

    Science.gov (United States)

    Schnitzspahn, Katharina M; Thorley, Craig; Phillips, Louise; Voigt, Babett; Threadgold, Emma; Hammond, Emily R; Mustafa, Besim; Kliegel, Matthias

    2014-06-01

    The present study examined age-by-mood interactions in prospective memory and the potential role of attentional control. Positive, negative, or neutral mood was induced in young and older adults. Subsequent time-based prospective memory performance was tested, incorporating a measure of online attentional control shifts between the ongoing and the prospective memory task via time monitoring behavior. Mood impaired prospective memory in the young, but not older, adults. Moderated mediation analyses showed that mood effects in the young were mediated by changes in time monitoring. Results are discussed in relation to findings from the broader cognitive emotional aging literature.

  5. Histidinaemia. Part III: Impact; a prospective study.

    Science.gov (United States)

    Coulombe, J T; Kammerer, B L; Levy, H L; Hirsch, B Z; Scriver, C R

    1983-01-01

    We describe a prospective study of histidinaemia. Probands and siblings (n = 21) with typical histidinaemia in 16 families were ascertained by newborn screening; diagnosis was confirmed by appropriate investigations in each subject; none had been treated by low histidine diet. The median age of subjects with histidinaemia was 9.5 y (mean 10.0, SD 3.5, range 6-18). Age-matched sib-pairs and their mothers were studied. IQ scores (Full Scale, Verbal and Performance Scores), Visual-Motor Integration Performance (Bender Gestalt and Koppitz scores), Wide Range Achievement Test (Reading and Mathematics), school performance, and psychological history were evaluated, as well as the medical history (pregnancy, delivery, neonatal, post-natal development). Findings were correlated with biochemical phenotype. CNS development in histidinaemic subjects (mean and distribution of scores) was normal; outlier values did not correlate with degree of histidinaemia. We can conclude that histidinaemia detected by newborn screening is a non-disadaptive phenotype.

  6. Predicting residents' performance: A prospective study

    Directory of Open Access Journals (Sweden)

    Ozuah Philip O

    2002-07-01

    Full Text Available Abstract Background Objective criteria for predicting residents' performance do not exist. The purpose of this study was to test the hypothesis that global assessment by an intern selection committee (ISC would correlate with the future performance of residents. Methods A prospective study of 277 residents between 1992 and 1999. Global assessment at the time of interview was compared to subsequent clinical (assessed by chief residents and cognitive performance (assessed by the American Board of Pediatrics in-service training examination. Results ISC ratings correlated significantly with clinical performance at 24 and 36 months of training (r = 0.58, P st, 2nd, and 3rd years of training (r = 0.35, P = .0016; r = 0.39, P = 0.0003; r = 0.50, P = 0.005 respectively. Conclusions Global assessment by an ISC predicted residents' clinical and cognitive performances.

  7. Acquiring a pet dog significantly reduces stress of primary carers for children with autism spectrum disorder: a prospective case control study

    OpenAIRE

    Wright, H. F.; Hall, S; Hames, A.; Hardiman, J; Mills, R.; ,; Mills, D. S.

    2015-01-01

    This study describes the impact of pet dogs on stress of primary carers of children with Autism Spectrum Disorder (ASD). Stress levels of 38 primary carers acquiring a dog and 24 controls not acquiring a dog were sampled at: Pre-intervention (17 weeks before acquiring a dog), post-intervention (3–10 weeks after acquisition) and follow-up (25–40 weeks after acquisition), using the Parenting Stress Index. Analysis revealed significant improvements in the intervention compared to the control gro...

  8. Swiss prospective study on spider bites.

    Science.gov (United States)

    Gnädinger, Markus; Nentwig, Wolfgang; Fuchs, Joan; Ceschi, Alessandro

    2013-09-04

    Knowledge of spider bites in Central Europe derives mainly from anecdotal case presentations; therefore we aimed to collect cases systematically. From June 2011 to November 2012 we prospectively collected 17 cases of alleged spider bites, and together with two spontaneous notifications later on, our database totaled 19 cases. Among them, eight cases could be verified. The causative species were: Cheiracanthium punctorium (3), Zoropsis spinimana (2), Amaurobius ferox, Tegenaria atrica and Malthonica ferruginea (1 each). Clinical presentation was generally mild, with the exception of Cheiracanthium punctorium, and patients recovered fully without sequelae. In Switzerland, spider bites generally have a benign clinical course, which is characterised by minor effects, with rapid and complete recovery. Since only verified spider bites can be regarded as spider bites, in the case of clinically important arachnidism, the spider should be sent to an expert for identification. Our study may help to diminish spider fear and reassure people who have experienced a bite.

  9. A PROSPECTIVE, DOUBLE BLIND RANDOMIZED CONTROLLED STUDY COMPARING THE EFFECTS OF MAGNESIUM SULPHATE VERSUS CLONIDINE AS AN ADJUNCT TO BUPIVICAINE IN SUB UMBILICAL SURGERIES

    Directory of Open Access Journals (Sweden)

    Sadhana

    2015-07-01

    Full Text Available OBJECTIVE: Providing comfort to the patient by prevention/relief of pain using various combinations of drugs thus achieving maximal benefit with minimal adverse effects is the ultimate goal of the anesthesiologist in the peri - operative period. AIM OF STUDY: To eva luate the efficacy of Magnesium Sulphate Versus Clonidine as an adjunct to Bupivicaine in Epidural Analgesia. METHODS: A total of 90 patients of either gender with ASA Grade (I , II , aged between 18 to 60 years scheduled for elective sub umbilical surgeri es were randomly assigned in a prospective double blind study to three separate groups that received epidural 0.5% Bupivicaine (19ml with 1ml of 0.9% Normal Saline or 0.5% Bupivicaine (19ml with Magnesium sulphate 50mg (1ml or 0.5% Bupivicaine With Clon idine 150 micro gram (1ml. All Patients were administered Pre - medication as per Hospital Protocol night before and morning of Surgery. Intra operative monitoring of patients included Heart - rate , ECG , SPO2 , NIBP , RR as a Base Line and follow - up after Injec tion of assigned drug. Sensory blockade was evaluated by using bilateral pinprick method , motor blockade was estimated using modified Bromage scale at 5 , 10 , 15 , 20 , 25 and 30 Minutes Interval after Epidural Administration of drug. Pain perceived was asses sed with Visual Analog Scale (VAS 0 - 10 both Intra Operatively and Post Operatively. In the event of pain with VAS >5 , top - up of 0.5% Bupivicaine alone was added. The time from onset of blockade till need for 1st top - up was evaluated. CONCLUSION: Co - ad ministration of Magnesium Sulphate (50mg to Epidural 0.5% Bupivicaine provides a predictable and rapid onset of nerve blockade without any side effects whereas co - administration of clonidine (150 micro - grams to Epidural 0.5% Bupivacaine produced prolonge d duration of anesthesia. The use of adjuvants in Epidural Aneasthesia gives a scope to improve the quality of anesthesia while minimizing the adverse

  10. Remote-controlled magnetic pulmonary vein isolation combined with superior vena cava isolation for paroxysmal atrial fibrillation: a prospective randomized study.

    Science.gov (United States)

    Da Costa, Antoine; Levallois, Marie; Romeyer-Bouchard, Cécile; Bisch, Laurence; Gate-Martinet, Alexis; Isaaz, Karl

    2015-03-01

    Radiofrequency ablation (RFA) of paroxysmal atrial fibrillation (PAF) has focused on pulmonary vein isolation (PVI). However, despite initial positive results, significant recurrences have occurred, partly because of pulmonary vein (PV) reconnection or non-PV ectopic foci, including the superior vena cava (SVC). This prospective, randomized study sought to investigate the efficacy of additional SVCI combined with PVI in symptomatic PAF patients referred for ablation. From November 2011 to May 2013, RFA was performed remotely using a CARTO(®) 3 System in patients randomized to undergo PVI for symptomatic drug-refractory PAF, with (PVI+SVCI group) or without (PVI alone group) SVCI. PVI and SVCI were confirmed by spiral catheter recording during ablation. Procedural data, complications and freedom from atrial tachycardia (AT) and atrial fibrillation (AF) were assessed. Over an 18-month period, 100 consecutive patients (56±9years; 17 women) with symptomatic PAF were included in the study (PVI+SVCI, n=51; PVI, n=49); the CHA2DS2-VASc score was 0.9±1. Median duration of procedure (±interquartile), 2.5±1hours; total X-ray exposure, 13.3±8minutes; transseptal puncture and catheter positioning, 8±5minutes; left atrium electroanatomical reconstruction, 3±2minutes; and catheter ablation, 3.7±3minutes. After a median follow-up of 15±8months, and having undergone a single procedure, 84% of patients were symptom free, while 86% remained asymptomatic after undergoing two procedures. The cumulative risks of atrial arrhythmias (AT or AF) were interpreted using Kaplan-Meier curves and compared using the log-rank test. Long-term follow-up revealed no significant difference between groups, with atrial arrhythmias occurring in six (12%) patients in the PVI+SVCI group and nine (18%) patients in the PVI alone group (P=0.6). One transient phrenic nerve palsy and one phrenic nerve injury with partial recovery occurred in the PVI+SVCI group. SVCI combined with PVI did not reduce

  11. Postocclusive Hyperemia Measured with Laser Doppler Flowmetry and Transcutaneous Oxygen Tension in the Diagnosis of Primary Raynaud's Phenomenon: A Prospective, Controlled Study

    Science.gov (United States)

    Maga, Paweł; Henry, Brandon Michael; Kmiotek, Elizabeth K.; Gregorczyk-Maga, Iwona; Kaczmarczyk, Paweł; Niżankowski, Rafał

    2016-01-01

    The aim of this study was to measure the sensitivity and specificity of transcutaneous oxygen tension and postocclusive hyperemia testing using laser Doppler flowmetry in patients with primary Raynaud's phenomenon. One hundred patients and one hundred controls were included in the study. Baseline microvascular blood flow and then time to peak flow following occlusion were measured using laser Doppler flowmetry. Afterwards, the transcutaneous oxygen tension was recorded. The sensitivities of baseline microvascular blood flow, postocclusive time to peak flow, and transcutaneous oxygen tension were 79%, 79%, and 77%, respectively. The postocclusive time peak flow had a superior specificity of 90% and area under the curve of 0.92 as compared to 66% and 0.80 for baseline microvascular flow and 64% and 0.76 for transcutaneous oxygen tension. Time to postocclusive peak blood flow measured by laser Doppler flowmetry is a highly accurate test for differentiating patients with primary Raynaud's phenomenon from healthy controls. PMID:28101516

  12. Postocclusive Hyperemia Measured with Laser Doppler Flowmetry and Transcutaneous Oxygen Tension in the Diagnosis of Primary Raynaud's Phenomenon: A Prospective, Controlled Study.

    Science.gov (United States)

    Maga, Paweł; Henry, Brandon Michael; Kmiotek, Elizabeth K; Gregorczyk-Maga, Iwona; Kaczmarczyk, Paweł; Tomaszewski, Krzysztof A; Niżankowski, Rafał

    2016-01-01

    The aim of this study was to measure the sensitivity and specificity of transcutaneous oxygen tension and postocclusive hyperemia testing using laser Doppler flowmetry in patients with primary Raynaud's phenomenon. One hundred patients and one hundred controls were included in the study. Baseline microvascular blood flow and then time to peak flow following occlusion were measured using laser Doppler flowmetry. Afterwards, the transcutaneous oxygen tension was recorded. The sensitivities of baseline microvascular blood flow, postocclusive time to peak flow, and transcutaneous oxygen tension were 79%, 79%, and 77%, respectively. The postocclusive time peak flow had a superior specificity of 90% and area under the curve of 0.92 as compared to 66% and 0.80 for baseline microvascular flow and 64% and 0.76 for transcutaneous oxygen tension. Time to postocclusive peak blood flow measured by laser Doppler flowmetry is a highly accurate test for differentiating patients with primary Raynaud's phenomenon from healthy controls.

  13. Prospective controlled randomized trial on prevention of postoperative abdominal adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences [POPA study: Prevention of Postoperative Adhesions on behalf of the World Society of Emergency Surgery

    Directory of Open Access Journals (Sweden)

    D'Alessandro Luigi

    2008-12-01

    Full Text Available Abstract Background Adhesive small intestine occlusion [ASIO] is an important cause of hospital admission placing a substantial burden on healthcare systems worldwide. Often times, ASIO is associated with significant morbidity and mortality. Icodextrin 4% solution [Adept, Shire Pharmaceuticals, UK] is a high-molecular-weight a-1,4 glucose polymer that is approved in Europe for use as an intra-operative lavage and a post-operative instillate to reduce the occurrence of post-surgery intra-abdominal adhesions. There are no randomized trials on the use of this solution to prevent adhesions after ASIO operation in current medical literature. The current clinical study evaluates the safety and effectiveness of Icodextrin 4% for decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASIO. Design The study project is a prospective, randomized controlled investigation performed in the Department of Transplant, General and Emergency Surgery of St. Orsola-Malpighi University Hospital [Bologna, Italy]. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. The study compares the results of Icodextrin 4% against a control group who does not receive anti-adhesion treatment. This randomized study uses a double-blind procedure to evaluate efficacy end points. In other words, designated third party individuals who are unaware of the treatment assigned to the patients to assess adhesion formation. Trial Registration Number ISRCTN22061989 Prospective controlled randomized trial on Prevention of Postoperative Abdominal Adhesions by Icodextrin 4% solution after laparotomic operation for small bowel obstruction caused by adherences [POPA study: Prevention of Postoperative Adhesions

  14. Acquiring a Pet Dog Significantly Reduces Stress of Primary Carers for Children with Autism Spectrum Disorder: A Prospective Case Control Study

    Science.gov (United States)

    Wright, H. F.; Hall, S.; Hames, A.; Hardiman, J.; Mills, R.; Mills, D. S.

    2015-01-01

    This study describes the impact of pet dogs on stress of primary carers of children with Autism Spectrum Disorder (ASD). Stress levels of 38 primary carers acquiring a dog and 24 controls not acquiring a dog were sampled at: Pre-intervention (17 weeks before acquiring a dog), post-intervention (3-10 weeks after acquisition) and follow-up…

  15. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as Tobacco Cigarettes Substitute: A Prospective 12-Month Randomized Control Design Study

    OpenAIRE

    Pasquale Caponnetto; Davide Campagna; Fabio Cibella; Morjaria, Jaymin B; Massimo Caruso; Cristina Russo; Riccardo Polosa

    2013-01-01

    BACKGROUND: Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a 'smoking' experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-mont...

  16. The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749

    Directory of Open Access Journals (Sweden)

    Bärthel Erik

    2013-01-01

    Full Text Available Abstract Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

  17. The effect of chromosome 9p21 variants on cardiovascular disease may be modified by dietary intake: evidence from a case/control and a prospective study.

    Science.gov (United States)

    Do, Ron; Xie, Changchun; Zhang, Xiaohe; Männistö, Satu; Harald, Kennet; Islam, Shofiqul; Bailey, Swneke D; Rangarajan, Sumathy; McQueen, Matthew J; Diaz, Rafael; Lisheng, Liu; Wang, Xingyu; Silander, Kaisa; Peltonen, Leena; Yusuf, Salim; Salomaa, Veikko; Engert, James C; Anand, Sonia S

    2011-10-01

    One of the most robust genetic associations for cardiovascular disease (CVD) is the Chromosome 9p21 region. However, the interaction of this locus with environmental factors has not been extensively explored. We investigated the association of 9p21 with myocardial infarction (MI) in individuals of different ethnicities, and tested for an interaction with environmental factors. We genotyped four 9p21 SNPs in 8,114 individuals from the global INTERHEART study. All four variants were associated with MI, with odds ratios (ORs) of 1.18 to 1.20 (1.85×10(-8)≤p≤5.21×10(-7)). A significant interaction (p = 4.0×10(-4)) was observed between rs2383206 and a factor-analysis-derived "prudent" diet pattern score, for which a major component was raw vegetables. An effect of 9p21 on MI was observed in the group with a low prudent diet score (OR = 1.32, p = 6.82×10(-7)), but the effect was diminished in a step-wise fashion in the medium (OR = 1.17, p = 4.9×10(-3)) and high prudent diet scoring groups (OR = 1.02, p = 0.68) (p = 0.014 for difference). We also analyzed data from 19,129 individuals (including 1,014 incident cases of CVD) from the prospective FINRISK study, which used a closely related dietary variable. In this analysis, the 9p21 risk allele demonstrated a larger effect on CVD risk in the groups with diets low or average for fresh vegetables, fruits, and berries (hazard ratio [HR] = 1.22, p = 3.0×10(-4), and HR = 1.35, p = 4.1×10(-3), respectively) compared to the group with high consumption of these foods (HR = 0.96, p = 0.73) (p = 0.0011 for difference). The combination of the least prudent diet and two copies of the risk allele was associated with a 2-fold increase in risk for MI (OR = 1.98, p = 2.11×10(-9)) in the INTERHEART study and a 1.66-fold increase in risk for CVD in the FINRISK study (HR = 1.66, p = 0.0026). The risk of MI and CVD conferred by Chromosome 9p21 SNPs appears

  18. The importance of drug-induced sedation endoscopy (D.I.S.E.) techniques in surgical decision making: conventional versus target controlled infusion techniques-a prospective randomized controlled study and a retrospective surgical outcomes analysis.

    Science.gov (United States)

    De Vito, Andrea; Agnoletti, Vanni; Zani, Gianluca; Corso, Ruggero Massimo; D'Agostino, Giovanni; Firinu, Elisabetta; Marchi, Chiara; Hsu, Ying-Shuo; Maitan, Stefano; Vicini, Claudio

    2017-02-17

    Drug-Induced Sedation Endoscopy (DISE) consists of the direct observation of the upper airways during sedative-induced sleep, allowing the identification of the sites of pharyngeal collapse, which is the main pathological event in Obstructive Sleep Apnea (OSA). The Authors have compared Target Controlled Infusion (TCI) sedation endoscopy (TCI-DISE) technique to conventional DISE (CDISE), performed by a manual bolus injection of sedative agent, to recreate accurately and safely snoring and apnea patterns comparable to natural sleep. The authors conducted a prospective, randomized, long-term study and a retrospective analysis of surgical outcomes. The apnea-event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plan of DISE-TCI technique. From January 2009 to January 2011, OSA patients were included in the study and randomly allocated into two groups: the bolus injection conventional DISE group and the TCI-DISE group. Third endpoint is to compare the surgical outcomes enrolling OSA patients from January 2009 to June 2015. We recorded the complete apnea-event at oropharynx and hypopharynx levels in 15/50 pts in conventional DISE group (30%) and in 99/123 pts in TCI-DISE group (81%) (p DISE group because a severe desaturation occurred during the first bolus of propofol (1 mg/kg) (p = 0.4872 ns). We recorded instability of the sedation plan in 13 patients of conventional DISE group (65%) and 1 patient of the TCI-DISE group (5%) (p = 0.0001). In 37 TCI-DISE group surgical patients we reported a significant reduction of postoperative AHI (from 42.7 ± 20.2 to 11.4 ± 10.3) in comparison with postoperative AHI in 15 C-DISE group surgical patients (from 41.3 ± 23.4 to 20.4 ± 15.5) (p = 0.05). Our results suggest the DISE-TCI technique as first choice in performing sleep-endoscopy because of its increased accuracy, stability and

  19. ADOLESCENT GYNAECOLOGICAL PROBLEMS: A PROSPECTIVE STUDY

    Directory of Open Access Journals (Sweden)

    Prakriti

    2015-12-01

    Full Text Available CONTEXT/BACKGROUND Adolescence, meaning “To grow up,” is a transitional stage of physical, sexual and mental human development occurring between puberty and legal adulthood. The Government of India in National Youth Policy defines adolescents as individuals between 13 to 19 yrs. of age. AIMS To study the magnitude of different adolescent gynecological problems in patients attending OPD of GRMC, Gwalior, MP. SETTINGS AND DESIGN Prospective study in patients attending gynecological OPD of GRMC, Gwalior, MP. SAMPLE SIZE: 75 METHODS AND MATERIALS Seventy five adolescent girls in the age group of 13-19 yrs. attending gynecological OPD of GRMC, Gwalior, from November 2013 to October 2014 were included in the study. Detailed history, general examinations and investigations were done to evaluate their health. STATISTICAL ANALYSIS Was done using Microsoft Excel. RESULTS Incidence of gynecological problem in our study was 3.33%. Different gynecological problems were menstrual disorders (60%, leucorrhoea (10.66%, infections (8%, ovarian cyst (5.33%, sexual assault (2.66%, teenage pregnancy (10.66% and infertility (2.66%. Majority of girls with menstrual disorders suffered from puberty menorrhagia (55.55%. Dysfunctional uterine bleeding was diagnosed in 96% of girls suffering from puberty menorrhagia. Pelvic Inflammatory Disease was exclusively seen in married adolescent girls. Vaginal atresia and imperforate hymen were causes of primary amenorrhoea. PCOD was commonest cause of secondary amenorrhoea amongst adolescents. CONCLUSION Menstrual abnormalities are the most common problems of adolescent girls. Setting up adolescent clinics is desirable.

  20. Hyperhomocysteinemia, methylenetetrahydrofolate reductase c.677C>T polymorphism and risk of cancer: cross-sectional and prospective studies and meta-analyses of 75,000 cases and 93,000 controls

    DEFF Research Database (Denmark)

    Zacho, Jeppe; Yazdanyar, Shiva; Bojesen, Stig E

    2011-01-01

    and the association of the MTHFR c.677TC>T variant with hyperhomocysteinemia and with cancer. We performed a cross-sectional study of 5,949 Danish general population adults, a prospective study of 9,235 Danish general population adults with up to 60 years of registry surveillance, and meta-analyses of 231 studies...... including 74,671 cases and 93,344 controls. Cross-sectionally, plasma homocysteine levels were 12.9 and 11.6 μmol/L in those with and without cancer (p 12.4 versus ....4 μmol/L did not differ from 1.0. In cancer-free participants, plasma homocysteine levels were 14.7 and 11.7 μmol/L in MTHFR c.677C>T homozygtes and noncarriers (p T homozygotes versus noncarriers did not differ...

  1. A prospective randomized controlled trial to study the role of sulfasalazine in prevention of acute gastrointestinal toxicity associated with concurrent chemoradiation in carcinoma cervix

    Directory of Open Access Journals (Sweden)

    Santanu Pal

    2013-01-01

    Full Text Available Background: The primary aim of the study was to evaluate the effectiveness of sulfasalazine in reducing the incidence of acute radiation-induced enteritis in carcinoma cervix patients receiving pelvic external beam radiotherapy along with concurrent cisplatin-based chemotherapy. Materials and Methods: Between November 2011 and July 2012 a total of 98 patients of locoregionally advanced carcinoma of cervix (49 each in study and control arms were enrolled in this study. Patients in both the arms were treated with whole pelvis external beam radiotherapy with total dose of 50 Gy in conventional fractionation. Along with this inj. cisplatin was given concurrently at the dose of 40 mg/m 2 of body surface area every week during radiation for 5 weeks. Concurrent chemoradiation was followed by brachytherapy after a gap of 2 weeks. Patients in the study arm also received tablet sulfasalazine 1,000 mg orally twice daily from the day of starting of radiotherapy to 1 week after completion of treatment. Weekly follow-up of all patients to assess acute toxicities was done using common toxicity criteria version 4.0 (CTC v4.0 toxicity scores. Data analysis was carried out by SPSS version 20.0 software. Results: Incidence of grade II or higher grade, lower gastrointestinal toxicity was 19.14% (09/47 in study arm and 41.66% (20/48 in control arm which was statistically significant (P = 0.017. Conclusion: The study shows that sulfasalazine can significantly reduce the acute radiation-induced diarrhea (ARID in patients undergoing whole pelvis external beam radiotherapy for carcinoma cervix. The drug is safe, cheap, and readily available.

  2. A prospective clinical study of polycarboxylate cement in periapical surgery

    National Research Council Canada - National Science Library

    Peñarrocha-Diago, M-A; Ortega-Sánchez, B; García-Mira, B; Maestre-Ferrín, L; Peñarrocha-Oltra, D; Gay-Escoda, C

    .... A prospective clinical study was made of 25 patients subjected to periapical surgery with ultrasound and magnifying loupes, in which polycarboxylate cement was used as retrograde filling material...

  3. Chinese Herbal Medicine (Zi Shen Qing for Mild-to-Moderate Systematic Lupus Erythematosus: A Pilot Prospective, Single-Blinded, Randomized Controlled Study

    Directory of Open Access Journals (Sweden)

    Linda L. D. Zhong

    2013-01-01

    Full Text Available Objective. The aim of this study is to investigate the effectiveness and safety of a Chinese herbal formula Zi Shen Qing (ZSQ in the treatment of systematic lupus erythematosus (SLE in Chinese patients. Methods. A randomized controlled trial was conducted over 12 weeks in 84 Chinese patients who reported total scores of SLE Disease Activity Index-2000 (SLEDAI-2000 was from 5 to 14. The primary outcome was the changes of the SLEDAI-2000. The secondary outcomes included score changes of Chinese Medicine Syndromes (CMS, the changes of steroid dosage, the incidence of disease flare-up and biologic markers. Results. ZSQ significantly reduced SLEDAI-2000, the total scores of CMS in the treatment group compared with the controlled group (P<0.05. Superiority of ZSQ over controlled group was also observed with greater improvement in the withdrawal dosage of corticosteroids and the incidence of disease flare-up (P<0.05. There were no serious adverse events, and safety indices of whole blood counts, renal and liver functions were normal, both before and after the treatment. Conclusion. ZSQ is safe and effective for decreasing SLE disease activity and withdrawal dosage of corticosteroids in the mild to moderate SLE patients with “Deficiency of Qi and Yin” Pattern.

  4. Effects of testosterone replacement therapy on nocturia and quality of life in men with hypogonadism: a subanalysis of a previous prospective randomized controlled study in Japan.

    Science.gov (United States)

    Shigehara, Kazuyoshi; Konaka, Hiroyuki; Koh, Eitetsu; Izumi, Koji; Kitagawa, Yasuhide; Mizokami, Atsushi; Nakashima, Takao; Shimamura, Masayoshi; Iwamoto, Teruaki; Namiki, Mikio

    2015-01-01

    We investigated the effects of testosterone replacement therapy (TRT) on nocturia and general health among men with hypogonadism and nocturia. From our previous EARTH study population, 64 patients with a clinical diagnosis of nocturia (two or more times per one night) and hypogonadism, comprising the TRT group (n = 31) and controls (n = 33), were included in this analysis. The TRT group was administered 250 mg of testosterone enanthate as an intramuscular injection every 4 weeks for 6 months. All patients responded to the following questionnaires: International Prostatic Symptoms Score (IPSS), Aging Male Symptoms (AMS) score and Short Form-36 health survey at baseline and 6-month visit. These categories were compared based on changes from baseline to the 6-month visit between TRT and control groups. At the 6-month visit, the TRT group had a significant decrease in IPSS question no. 7 and AMS question no. 4, whereas no significant changes were observed in the control group. Additionally, role limitation because of health program, vitality and mental health domains were significantly improved in the TRT group. Six-month TRT may improve nocturia, sleep conditions and quality of life among men with hypogonadism and nocturia.

  5. Three-dimensional delayed gadolinium-enhanced magnetic resonance imaging of hip joint cartilage at 3 T: A prospective controlled study

    Energy Technology Data Exchange (ETDEWEB)

    Zilkens, Christoph, E-mail: christoph.zilkens@med.uni-duesseldorf.de [Univ. Dusseldorf, Medical Faculty, Department of Orthopaedic Surgery, Moorenstrasse 5, D-40225 Dusseldorf (Germany); Miese, Falk, E-mail: falk.miese@med.uni-duesseldorf.de [Univ. Dusseldorf, Medical Faculty, Department of Diagnostic and Interventional Radiology, Moorenstrasse 5, D-40225 Dusseldorf (Germany); Kim, Young-Jo, E-mail: young-jo.kim@childrens.harvard.edu [Department of Orthopaedic Surgery, The Children' s Hospital Boston, 300 Longwood Ave., Boston, MA 02115 (United States); Hosalkar, Harish, E-mail: hhosalkar@rchsd.org [Department of Orthopaedic Surgery, Rady Children' s Hospital San Diego, 3030 Childrens Way Ste 410, San Diego, CA 92123 (United States); Antoch, Gerald, E-mail: antoch@med.uni-duesseldorf.de [Univ. Dusseldorf, Medical Faculty, Department of Diagnostic and Interventional Radiology, Moorenstrasse 5, D-40225 Dusseldorf (Germany); Krauspe, Ruediger, E-mail: krauspe@med.uni-duesseldorf.de [Univ. Dusseldorf, Medical Faculty, Department of Orthopaedic Surgery, Moorenstrasse 5, D-40225 Dusseldorf (Germany); Bittersohl, Bernd, E-mail: bbittersohl@partners.org [Univ. Dusseldorf, Medical Faculty, Department of Orthopaedic Surgery, Moorenstrasse 5, D-40225 Dusseldorf (Germany)

    2012-11-15

    Purpose: To assess acetabular and femoral hip joint cartilage with three-dimensional (3D) delayed gadolinium-enhanced magnetic resonance imaging (dGEMRIC) in patients with degeneration of hip joint cartilage and asymptomatic controls with morphologically normal appearing cartilage. Methods and materials: A total of 40 symptomatic patients (18 males, 22 females; mean age: 32.8 {+-} 10.2 years, range: 18-57 years) with different hip joint deformities including femoroacetabular impingement (n = 35), residual hip dysplasia (n = 3) and coxa magna due to Legg-Calve-Perthes disease in childhood (n = 2) underwent high-resolution 3D dGEMRIC for the evaluation of acetabular and femoral hip joint cartilage. Thirty-one asymptomatic healthy volunteers (12 males, 19 females; mean age: 24.5 {+-} 1.8 years, range: 21-29 years) without underlying hip deformities were included as control. MRI was performed at 3 T using a body matrix phased array coil. Region of interest (ROI) analyses for T1{sub Gd} assessment was performed in seven regions in the hip joint, including anterior to superior and posterior regions. Results: T1{sub Gd} mapping demonstrated the typical pattern of acetabular cartilage consistent with a higher glycosaminoglycan (GAG) content in the main weight-bearing area. T1{sub Gd} values were significantly higher in the control group than in the patient group whereas significant differences in T1{sub Gd} values corresponding to the amount of cartilage damage were noted both in the patient group and in the control group. Conclusions: Our study demonstrates the potential of high-resolution 3D dGEMRIC at 3 T for separate acetabular and femoral hip joint cartilage assessment in various forms of hip joint deformities.

  6. Ossiculoplasty: A Prospective Study of 80 Cases

    Directory of Open Access Journals (Sweden)

    Shrinivas Shripatrao Chavan

    2014-07-01

    Full Text Available Introduction: The use of ossicular graft material in ossicular chain reconstruction has significantly improved hearing results hearing after tympanoplasty and tympanomastoid surgery for chronic otitis media. Today, otologists have a wide array of tools from which to choose, but may find it difficult to know which middle ear implant works best.   Materials and Methods: A prospective study of 80 patients who underwent ossiculoplasty was performed in the ear, nose, and throat (ENT department at a tertiary health care facility from 2011 to 2013. Patients with chronic suppurative otitis media with an air-bone gap (ABG of >25 dB with ossicular involvement were included in the study. Total ossicular replacement prosthesis (TORP, partial ossicular replacement prosthesis (PORP, and refashioned incus were used. Success was defined as ABG   Results: The majority patients were of middle age with moderate conductive hearing loss. Incus was the most susceptible ossicle. Overall success rate in this study was 80.0% with an average change of 15.76 dB in ABG.   Conclusion:  With continuing advances in our understanding of middle ear mechanics, the results of ossiculoplasty are improving and results can be very rewarding in experienced hands. Severity of preoperative ear discharge, preoperative mastoid cellularity, presence of disease, and surgical procedure proved to be significant prognostic factors. Autograft incus and PORP fared better when the malleus handle was present while TORP gave better results when the malleus handle was eroded.

  7. [Prospective study of patients with prolonged fever].

    Science.gov (United States)

    Calderón, E; Legorreta, J; Sztabinski, G; Hernández, M; Wilkins, A; Gómez, D; Dávila, A

    1975-01-01

    A prospective study was made in 283 patients who attended IMAN's Children's Hospital, with fever the main symptom. A clinical and paraclinical procedure was designed for the study of each patient. 112 patients were eliminated because they did not follow the established criteria. All patients had acute infectious diseases considered trivial; 85% were 3 weeks to 2 years of age. They all had an antibacterial treatment without precise diagnosis. It was considered that on admission the patients showed a normal course in the natural history of the basic disease. The study group included 171 patients 2 months to 13 years of age; 62.5% had fever due to infection, 12.2% to collagenopathies, 7% to neoplasias 5.2% to miscellaneous causes and 12.8% were not diagnosed. The most common infectious causes for prolonged fever were tuberculosis, upper respiratory infections, amoebic liver abscess, typhoid fever and malaria. Careful questioning and clinical examination were enough to enlighten diagnosis in more than 80% of the patients.

  8. Ossiculoplasty: A Prospective Study of 80 Cases

    Directory of Open Access Journals (Sweden)

    Shrinivas Shripatrao Chavan

    2014-07-01

    Full Text Available Introduction: The use of ossicular graft material in ossicular chain reconstruction has significantly improved hearing results hearing after tympanoplasty and tympanomastoid surgery for chronic otitis media. Today, otologists have a wide array of tools from which to choose, but may find it difficult to know which middle ear implant works best.   Materials and Methods: A prospective study of 80 patients who underwent ossiculoplasty was performed in the ear, nose, and throat (ENT department at a tertiary health care facility from 2011 to 2013. Patients with chronic suppurative otitis media with an air-bone gap (ABG of >25 dB with ossicular involvement were included in the study. Total ossicular replacement prosthesis (TORP, partial ossicular replacement prosthesis (PORP, and refashioned incus were used. Success was defined as ABG   Results: The majority patients were of middle age with moderate conductive hearing loss. Incus was the most susceptible ossicle. Overall success rate in this study was 80.0% with an average change of 15.76 dB in ABG.   Conclusion:  With continuing advances in our understanding of middle ear mechanics, the results of ossiculoplasty are improving and results can be very rewarding in experienced hands. Severity of preoperative ear discharge, preoperative mastoid cellularity, presence of disease, and surgical procedure proved to be significant prognostic factors. Autograft incus and PORP fared better when the malleus handle was present while TORP gave better results when the malleus handle was eroded.  

  9. Quality control of involved-field radiotherapy for patients with early stage Hodgkin's lymphoma based on a central prospective review. Comparison of the results between two study generations of the German Hodgkin Study Group

    Energy Technology Data Exchange (ETDEWEB)

    Kriz, J.; Haverkamp, U.; Eich, H.T. [Muenster Univ. (Germany). Dept. of Radiation Oncology; Bangard, C. [Koeln Univ. (Germany). Dept. of Radiology; Bongartz, R.; Baues, C.; Mueller, R.P. [Koeln Univ. (Germany). Dept. of Radiation Oncology; Engert, A. [Koeln Univ. (Germany). Dept. of Medical Oncology

    2012-08-15

    Purpose: Based on experience in trials HD10 and HD11 (1998-2003), the radiotherapy reference center of the German Hodgkin Study Group (GHSG) continued their central prospective radiation oncological review in trials HD13 and HD14. The purpose of this analysis was to identify the impact of this procedure on radiotherapeutic management and to compare findings with former trials. Methods: Between 2003 and 2009, 1,710 patients were enrolled in the HD13 trial (early favorable stages) and 2,039 patients in the HD14 trial (early unfavorable stages). All patients received a total of 30 Gy involved-field (IF) radiotherapy within a combined modality approach. Results: For patients in HD13, there was a correction of disease involvement in 847/1,518 patients (56%), and for patients in HD14 in 1,370/1,905 patients (72%). Most discrepancies were observed in the lower mediastinum (19.2%), infraclavicular (31.7%), upper cervical (12.7%), and supraclavicular (10.8%) lymph nodes. This resulted in a change of disease stage in 241 (7%) patients and a shift into another study protocol in 66 (2%) patients. Due to the incorrect lymph node documentation of the participating study centers, the IF radiotherapy volume had to be enlarged in 1,063/3,423 patients (31%) and reduced in 244/3,423 patients (7.1%). These findings are comparable to the results of the quality control in the trials HD10 and HD11 (2,611 patients reviewed). Conclusion: Central review of the diagnostic imaging and clinical findings of Hodgkin's lymphoma patients shows a considerable number of discrepancies compared with the local evaluation. Thus, meticulous evaluation of all imaging information in close collaboration between the radiation oncologist and diagnostic radiologist is mandatory. (orig.)

  10. Association of Serum Magnesium Level with Odds of Prediabetes and Diabetes in a Southern Chinese Population: a Prospective Nested Case-Control Study.

    Science.gov (United States)

    Fang, Chenchen; Wang, Xuebao; Wu, Wenjun; Gu, Xuejiang; Ye, Tingting; Deng, Huihui; Wang, Xianqin; Shen, Feixia

    2016-08-01

    Although emerging clinical evidence supports that magnesium deficiency is a risk factor for the development of type 2 diabetes, there are sparse studies concerning the dynamic change of serum magnesium with the risk of diabetes and its early stages. In this nested case-control study, we performed a 75-g oral glucose tolerance test or a standardized steamed bread meal test in 178 subjects with incident glucose metabolism impairment (33 with type 2 diabetes and 145 with prediabetes) and 178 matched controls at baseline and at 3-year follow-up and determined the associations between baseline serum magnesium levels as well as changes in serum magnesium levels at follow-up and odds of prediabetes and diabetes. After adjusting for potential confounders, the odds ratios of risk for prediabetes and type 2 diabetes in the highest quartile of serum magnesium levels were 0.22 (95 % confidence intervals [CI] 0.10-0.49; p for trend magnesium level was detected in type 2 diabetes cases (p = 0.015) at 3 years as compared with at baseline. These results suggest that a low magnesium level is an independent risk factor for prediabetes and type 2 diabetes, and that the reduction of serum magnesium is associated with type 2 diabetes in a southern Chinese population.

  11. Prospective randomized controlled study on the effects of Saccharomyces boulardii CNCM I-745 and amoxicillin-clavulanate or the combination on the gut microbiota of healthy volunteers

    Science.gov (United States)

    Kabbani, Toufic A.; Pallav, Kumar; Dowd, Scot E.; Villafuerte-Galvez, Javier; Vanga, Rohini R.; Castillo, Natalia E.; Hansen, Joshua; Dennis, Melinda; Leffler, Daniel A.; Kelly, Ciarán P.

    2017-01-01

    ABSTRACT Probiotics are believed to be beneficial in maintaining a healthy gut microbiota whereas antibiotics are known to induce dysbiosis. This study aimed to examine the effects of the probiotic Saccharomyces boulardii CNCM I-745 (SB), the antibiotic Amoxicillin-Clavulanate (AC) and the combination on the microbiota and symptoms of healthy humans. Healthy subjects were randomized to one of 4 study groups: SB for 14 days, AC for 7 days, SB plus AC, Control (no treatment). Participants gave stool samples and completed gastro-intestinal symptom questionnaires. Microbiota changes in stool specimens were analyzed using 16s rRNA gene pyrosequencing (bTEFAP). Only one subject withdrew prematurely due to adverse events. Subjects treated by S boulardii + AC had fewer adverse events and tolerated the study regimen better than those receiving the AC alone. Control subjects had a stable microbiota throughout the study period. Significant microbiota changes were noted in the AC alone group during antibiotic treatment. AC associated changes included reduced prevalence of the genus Roseburia and increases in Escherichia, Parabacteroides, and Enterobacter. Microbiota alterations reverted toward baseline, but were not yet completely restored 2 weeks after antibiotherapy. No significant shifts in bacterial genera were noted in the SB alone group. Adding SB to AC led to less pronounced microbiota shifts including less overgrowth of Escherichia and to a reduction in antibiotic-associated diarrhea scores. Antibiotic treatment is associated with marked microbiota changes with both reductions and increases in different genera. S. boulardii treatment can mitigate some antibiotic-induced microbiota changes (dysbiosis) and can also reduce antibiotic-associated diarrhea. PMID:27973989

  12. Delirium in Australian Hospitals: A Prospective Study

    Directory of Open Access Journals (Sweden)

    C. Travers

    2013-01-01

    Full Text Available Objectives. Australian data regarding delirium in older hospitalized patients are limited. Hence, this study aimed to determine the prevalence and incidence of delirium among older patients admitted to Australian hospitals and assess associated outcomes. Method. A prospective observational study (n=493 of patients aged ≥70 years admitted to four Australian hospitals was undertaken. Trained research nurses completed comprehensive geriatric assessments using standardized instruments including the Confusion Assessment Method to assess for delirium. Nurses also visited the wards daily to assess for incident delirium and other adverse outcomes. Diagnoses of dementia and delirium were established through case reviews by independent physicians. Results. Overall, 9.7% of patients had delirium at admission and a further 7.6% developed delirium during the hospital stay. Dementia was the most important predictor of delirium at (OR=3.18, 95% CI: 1.65–6.14 and during the admission (OR=4.82; 95% CI: 2.19–10.62. Delirium at and during the admission predicted increased in-hospital mortality (OR=5.19, 95% CI: 1.27–21.24; OR=31.07, 95% CI: 9.30–103.78. Conclusion. These Australian data confirm that delirium is a common and serious condition among older hospital patients. Hospital clinicians should maintain a high index of suspicion for delirium in older patients.

  13. Injuries in competitive boxing. A prospective study.

    Science.gov (United States)

    Siewe, J; Rudat, J; Zarghooni, K; Sobottke, R; Eysel, P; Herren, C; Knöll, P; Illgner, U; Michael, J

    2015-03-01

    Boxing remains a subject of controversy and is often classified as dangerous. But the discussion is based mostly on retrospective studies. This survey was conducted as a prospective study. From October 2012 to September 2013, 44 competitive boxers were asked to report their injuries once a month. The questionnaire collected general information (training, competition) and recorded the number of bouts fought, injuries and resulting lost days. A total of 192 injuries were recorded, 133 of which resulted in interruption of training or competition. Each boxer sustained 3 injuries per year on average. The injury rate was 12.8 injuries per 1 000 h of training. Boxers fighting more than 3 bouts per year sustain more injuries (p=0.0075). The injury rate does is not a function of age (age≤19 vs. > 19a, p=0.53). Injuries to the head and the upper limbs occur most frequently. The most common injuries are soft tissue lacerations and contusions. Head injuries with neurological symptoms rarely occur (4.2%). Boxing has a high injury rate that is comparable with other contact sports, but most injuries are minor. Injury frequency is not a function of whether the boxer competes in the junior or adult category. Athletes fighting many bouts per year have a greater risk of injury.

  14. Placebo-controlled, double-blind, randomized, prospective study of a glycerol-based emollient on eczematous skin in atopic dermatitis: biophysical and clinical evaluation.

    Science.gov (United States)

    Breternitz, M; Kowatzki, D; Langenauer, M; Elsner, P; Fluhr, J W

    2008-01-01

    Atopic dermatitis (AD) is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of AD are dry skin, intense pruritus and impaired epidermal barrier function. The therapeutic management of AD is difficult and needs individualized concepts. Moisturizing creams and emollients are useful and important treatment adjuncts for the daily skin care of patients with dry and inflamed skin, e.g. AD. Glycerol is known to increase stratum corneum (SC) hydration, improve epidermal barrier function and decrease clinical signs of inflammation. However, no controlled study on the efficacy of glycerol on barrier function and SC hydration in AD has been published. In the present study, a topical 20% glycerol preparation was compared with its vehicle in patients with AD. The aim of the present study was to evaluate the effect of a single emollient ingredient in AD within the full frame of a phase III drug study. 24 patients with AD were treated for 4 weeks twice daily with a glycerol-based emollient in a randomized, double-blind study. Transepidermal water loss, skin capacitance, erythema and skin surface pH were assessed with biophysical, non-invasive instruments. The SCORAD and a local severity score were evaluated. After a wash-out period of 2 weeks, these parameters were assessed in order to quantify the sustained effect of this treatment. SC hydration was significantly improved, and epidermal barrier function was restored under treatment with glycerol-containing cream compared to the glycerol-free placebo. No significant differences were detectable for erythema values, SCORAD and local severity between the glycerol-containing cream and placebo. However, an improvement over time was detectable in the assessed parameters in both groups indicating the importance of emollient treatment in AD. Glycerol-based emollients have a positive influence on the skin of patients with AD. They enhance the SC hydration

  15. Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

    Science.gov (United States)

    Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

    2017-09-01

    Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017

  16. Prospective 10-year cohort study based on a randomized, controlled trial (RCT) on implant-supported full-arch maxillary prostheses. part II: prosthetic outcomes and maintenance.

    Science.gov (United States)

    Fischer, Kerstin; Stenberg, Torsten

    2013-08-01

    Long-term follow-up studies (i.e., over 5 years), focusing on prosthetic outcomes and maintenance of implant-supported reconstructions in the edentulous maxilla, are scarce in the literature. The purpose of this study was to evaluate and report 10-year data on outcomes and maintenance of screw-retained implant-supported full-arch casted titanium-resin prostheses in the edentulous maxilla. In the randomized control trial cohort of 24 patients, the outcome and maintenance of 23 bridges were registered. One patient dropped out of the study prior to the 10-year control. Of the 23 remaining patients, 21 still had their original frameworks; one framework fractured after 8 years and one was remade after 7 years to create better support for the acrylic. The remaining 23 prostheses showed criteria of success, survival, and failure in 9, 82, and 9%, respectively. Tightening of two assembly screws was necessary in one patient. No detrimental effects were seen because of long cantilever extensions or opposing dentition. A total of 4.7 resin-related complications per prosthesis were observed; tooth fracture was the most common prosthetic complication. There was an indication of greater prevention in the number of resin-related complications with the use of lingual gold onlay compared with a resilient mouth guard, 0.71 and 1.67, respectively per bridge. The bridges were removed and reinserted 0.83 times per patient. No abutment or abutment screw fractures were registered. Fracture or wear of the reconstruction materials were considered predictable risks when using resin-based suprastructure materials. Status of opposing dentition and length of cantilevers did not confer additional risk. The use of a lingual gold onlay indicated prevention of resin-related complications. Future research should focus on the suprastructure materials to predict better overall treatment results of implant-supported full-arch bridges in the edentulous maxilla. © 2011 Wiley Periodicals, Inc.

  17. A Study of Prospective Teachers' Consumption Patterns on Special Days

    Science.gov (United States)

    Saglam, Halil Ibrahim

    2016-01-01

    The purpose of this study was to identify prospective teachers' consumption patterns on special days. The sample was comprised of 29 prospective teachers (22 females and 7 males) who studied Primary School Teaching in the Faculty of Education at Sakarya University during the 2014-2015 Academic Year. The study was designed as a phenomenological…

  18. A Prospective Case-Control Study of Radial Extracorporeal Shock Wave Therapy for Spastic Plantar Flexor Muscles in Very Young Children With Cerebral Palsy

    Science.gov (United States)

    Wang, Tiantian; Du, Lin; Shan, Ling; Dong, Hanyu; Feng, Junyan; Kiessling, Maren C.; Angstman, Nicholas B.; Schmitz, Christoph; Jia, Feiyong

    2016-01-01

    Abstract To assess the effects of radial extracorporeal shock wave therapy (rESWT) on plantar flexor muscle spasticity and gross motor function in very young patients with cerebral palsy (CP). The design was case-control study (level of evidence 3). The setting was the Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China. Those with a diagnosis of CP and spastic plantar flexor muscles were recruited between April 2014 and April 2015. According to the parents’ decision, patients received 1 ESWT session per week for 3 months, with 1500 radial shock waves per ESWT session and leg with positive energy flux density of 0.03 mJ/mm2, combined with traditional conservative therapy (rESWT group) or traditional conservative therapy alone (control group). The Modified Ashworth Scale (MAS) (primary outcome measure) and passive range of motion (pROM) measurements were collected at baseline (BL), 1 month (M1), and 3 months (M3) after BL. The Gross Motor Function Measure (GMFM)-88 was collected at BL and M3. Sixty-six patients completed the final review at 3 months and were included in the study. Subjects ranged in age from 12 to 60 months (mean age 27.0 ± 13.6 months; median age 22.0 months; 33.3% female). For the rESWT group (n = 34), mean MAS grades at BL, M1, and M3 were 2.6, 1.9, and 1.5 on the left side and 1.9, 1.7, and 1.2 on the right side. For the control group (n = 32), mean MAS grades at BL, M1, and M3 were 2.5, 2.4, and 2.1 on the left side and 1.8, 1.8, and 1.5 on the right side. The within-subject effects time × side and time × treatment were statistically significant (P < 0.01). Similar results were found for the improvement of mean pROM. GMFM-88 improved from BL to M3, but showed no statistically significant difference between the groups. There were no significant complications. This study demonstrates that the combination of rESWT and traditional conservative therapy is more

  19. Cost of dengue and other febrile illnesses to households in rural Cambodia: a prospective community-based case-control study

    Directory of Open Access Journals (Sweden)

    Margolis Harold S

    2009-05-01

    Full Text Available Abstract Background The average annual reported dengue incidence in Cambodia is 3.3/1,000 among children Methods In 2006, active fever surveillance was conducted among a cohort of 6,694 children aged ≤ 15 years in 16 villages in Kampong Cham province, Cambodia. Subsequently, a case-control study was performed by individually assigning one non-dengue febrile control from the cohort to each laboratory-confirmed dengue case. Parents of cases and controls were interviewed using a standardized questionnaire to determine household-level, illness-related expenditures for medical and non-medical costs, and estimated income loss (see Additional file 1. The household socio-economic status was determined and its possible association with health seeking behaviour and the ability to pay for the costs of a febrile illness. Additional File 1 2006 cost study survey questionnaire, Cambodia. the questionnaire represents the data collection instrument that was developed and used during the present study. Click here for file Results Between September and November 2006, a total of 60 household heads were interviewed: 30 with dengue-positive and 30 with dengue-negative febrile children. Mean total dengue-related costs did not differ from those of other febrile illnesses (31.5 vs. 27.2 US$, p = 0.44. Hospitalization almost tripled the costs of dengue (from 14.3 to 40.1 US$ and doubled the costs of other febrile illnesses (from 17.0 to 36.2 US$. To finance the cost of a febrile illness, 67% of households incurred an average debt of 23.5 US$ and higher debt was associated with hospitalization compared to outpatient treatment (US$ 23.1 vs. US$ 4.5, p Conclusion In Cambodia, dengue and other febrile illnesses pose a financial burden to households. A possible reason for a lower rate of hospitalization among children from poor households could be the burden of higher illness-related costs and debts.

  20. Prospective associations between bilingualism and executive function in Latino children: sustained effects while controlling for biculturalism.

    Science.gov (United States)

    Riggs, Nathaniel R; Shin, Hee-Sung; Unger, Jennifer B; Spruijt-Metz, Donna; Pentz, Mary Ann

    2014-10-01

    The study purpose was to test 1-year prospective associations between English-Spanish bilingualism and executive function in 5th to 6th grade students while controlling for biculturalism. Participants included 182 US Latino students (50 % female). Self-report surveys assessed biculturalism, bilingualism, and executive function (i.e., working memory, organizational skills, inhibitory control, and emotional control, as well as a summary executive function score). General linear model regressions demonstrated that bilingualism significantly predicted the summary executive function score as well as working memory such that bilingual proficiency was positively related to executive function. Results are the first to demonstrate (a) prospective associations between bilingualism to executive function while controlling for the potential third variable of biculturalism, and (b) a principal role for working memory in this relationship. Since executive function is associated with a host of health outcomes, one implication of study findings is that bilingualism may have an indirect protective influence on youth development.

  1. Lidocaine-prilocaine cream reduces catheter-related bladder discomfort in male patients during the general anesthesia recovery period: A prospective, randomized, case-control STROBE study.

    Science.gov (United States)

    Mu, Li; Geng, Li-Cheng; Xu, Hui; Luo, Man; Geng, Jing-Miao; Li, Li

    2017-04-01

    Urethral catheterization is a predictor of agitation during the general anesthesia recovery period. The aim of this study was to determine the effect of intraurethral 5% lidocaine and 25 mg/g prilocaine cream in reducing catheter-related bladder discomfort (CRBD) in male patients during the general anesthesia recovery period. Adult male patients undergoing elective operations that required urinary catheterization under general anesthesia were enrolled and assigned randomly to 2 groups. In the lidocaine-prilocaine cream group (n = 72), approximately 5 g of topical cream was spread in the preputial sac, the glans, the meatus, and on the urinary catheter surface before urinary catheterization. In the control group (n = 74), the urinary catheter was lubricated with lidocaine gel. The incidence and severity of CRBD were assessed 15, 30, 45, and 60 minutes postoperatively. We found that the incidence of CRBD in the lidocaine-prilocaine cream group was significantly lower than in the control group. Multivariate logistic regression analysis showed that lidocaine-prilocaine cream applications reduced moderate or severe CRBD. Thirty minutes postoperation was the most frequent time point for the incidence of CRBD. Application of lidocaine-prilocaine cream on the surface of the urinary catheter is an efficient and safe method to reduce the incidence and severity of CRBD.

  2. Effectiveness of various formulations of local anesthetics and additives for topical anesthesia – a prospective, randomized, double-blind, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Weilbach C

    2017-05-01

    Full Text Available Christian Weilbach,1 Christian Hoppe,2 Matthias Karst,3 Michael Winterhalter,4 Konstantinos Raymondos,3 Arthur Schultz,3 Niels Rahe-Meyer2 1Department of Anesthesiology, Intensive Care, Emergency Medicine and Pain Therapy, St. Josefs-Hospital Cloppenburg, Cloppenburg, 2Clinic for Anesthesiology and Operational Intensive Care, Franziskus Hospital Bielefeld, Bielefeld, 3Clinic for Anesthesiology and Intensive Care, Medizinische Hochschule Hannover, Hannover, 4Clinic for Anesthesiology and Pain Therapy, Klinikum Bremen-Mitte, Bremen, Germany Background: Topical anesthesia is used to control pain associated with many procedures in medicine. Today, the product most commonly applied for topical anesthesia in Germany is EMLA® (lidocaine/prilocaine. However, since prilocaine is a methemoglobin-inducing agent, there are limitations to its use, especially in neonates and infants. The aim of this study was to evaluate the effect of prilocaine and lidocaine as well as propylene glycol, a penetration enhancer, and trometamol, a buffer substance, in anesthetic creams.Patients and methods: Twenty-nine healthy adults participated in this study. Standardized creams with eight different compositions were applied and left for 20, 40 or 60 min. After exposure to standardized painful stimuli (blunt/sharp with pressures of 0.2, 0.4 or 0.8 N, subjects rated the experimental pain using a visual analog scale.Results: Significant results were only found with an exposure time of 60 min and a stamp pressure of 0.8 N. At a concentration of 20%, lidocaine was more effective compared to placebo and equally effective compared to lidocaine/prilocaine in controlling pain. The analgesic effect of the cream containing lidocaine 10% and additional trometamol was significantly superior to that of placebo and non-inferior to that of lidocaine/prilocaine. In this study, the penetration enhancer propylene glycol did not accelerate the onset of the analgesic effect. In contrast

  3. Child cyclist injuries: a prospective study.

    Science.gov (United States)

    Armson, C J; Pollard, C W

    1986-02-01

    A prospective study of pedalcycle accident morbidity and mortality was carried out from February to mid-November 1983 because of the high frequency of child cyclist injuries that were occurring on the relatively flat Redcliffe Peninsula. These injuries were apparently associated with the large number of young children who use a bicycle as their main mode of transport to and from school. The schools were surveyed for the extent of bicycle use and cyclists were surveyed for the amount of protective clothing that was worn while involved in cycling. It was found that a disturbingly large number of young children made regular bicycle trips on public roads with the minimal use of safety helmets or any other form of protective clothing. Nearly 40% of on-road accidents involved children of less than 12 years of age, and over 10% of these involved children of six years of age or less. No child in our series of on-road accidents was, at the time of injury, wearing a safety helmet or any other form of protective clothing. No bicycle accidents occurred on the exclusive cycle track of approximately 1 km in length on the Peninsula.

  4. Depression after CABG: a prospective study

    Science.gov (United States)

    Nunes, Joana Kátya Veras Rodrigues Sampaio; de Figueiredo Neto, José Albuquerque; de Sousa, Rosângela Maria Lopes; Costa, Vera Lívia Xavier de Castro; Silva, Flor de Maria Araújo Mendonça; da Hora, Ana Flávia Lima Teles; da Silva, Edna Lúcia Coutinho; Reis, Lívia Mariane Castelo Branco

    2013-01-01

    Introduction Depression during or shortly after hospitalization elevated two to three times the risk of mortality or nonfatal cardiac events, significantly increasing the morbidity and mortality of these patients. Objective To assess the impact of revascularization on symptoms of depression in patients with coronary artery disease. Methods A prospective cohort study of 57 patients of both sexes undergoing coronary artery bypass grafting between June 2010 and June 2011. We used the SF-36 to assess quality of life, and the Beck Depression Inventory to detect depressive symptoms, applied preoperatively and six months. Results The prevalence of patients aged 60-69 years was 22 patients (38.60%), 39 men (68.42%), 26 described themselves as mixed race (45.61%), 16 literate (28.07 %) and 30 married (52.63%). The beck depression inventory score demonstrated increased after revascularization: 15 patients mild (26.32%) at time zero to 17 (29.82%) after. And with moderate, seven patients (12.28%) before and 10 (17.54%) after. In the categories of individuals with decreased minimum degree of 32 (56.14%) to 28 (49.12%), and severe of three (5.26%) for two (3.51%) patients. Association was observed between beck depression inventory, gender, age, lifestyle, comorbidities and quality of life. Conclusion There was a high prevalence of elevated beck depression inventory scores, lowest scores of depressive symptoms among men and association between the improvement of quality of life scores and beck depression inventory. PMID:24598954

  5. Depression after CABG: a prospective study

    Directory of Open Access Journals (Sweden)

    Joana Kátya Veras Rodrigues Sampaio Nunes

    2013-12-01

    Full Text Available INTRODUCTION: Depression during or shortly after hospitalization elevated two to three times the risk of mortality or nonfatal cardiac events, significantly increasing the morbidity and mortality of these patients. OBJECTIVE: To assess the impact of revascularization on symptoms of depression in patients with coronary artery disease. METHODS: A prospective cohort study of 57 patients of both sexes undergoing coronary artery bypass grafting between June 2010 and June 2011. We used the SF-36 to assess quality of life, and the Beck Depression Inventory to detect depressive symptoms, applied preoperatively and six months. RESULTS: The prevalence of patients aged 60-69 years was 22 patients (38.60%, 39 men (68.42%, 26 described themselves as mixed race (45.61%, 16 literate (28.07 % and 30 married (52.63%. The beck depression inventory score demonstrated increased after revascularization: 15 patients mild (26.32% at time zero to 17 (29.82% after. And with moderate, seven patients (12.28% before and 10 (17.54% after. In the categories of individuals with decreased minimum degree of 32 (56.14% to 28 (49.12%, and severe of three (5.26% for two (3.51% patients. Association was observed between beck depression inventory, gender, age, lifestyle, comorbidities and quality of life. CONCLUSION: There was a high prevalence of elevated beck depression inventory scores, lowest scores of depressive symptoms among men and association between the improvement of quality of life scores and beck depression inventory.

  6. A Prospective Case-Control Study of Radial Extracorporeal Shock Wave Therapy for Spastic Plantar Flexor Muscles in Very Young Children With Cerebral Palsy.

    Science.gov (United States)

    Wang, Tiantian; Du, Lin; Shan, Ling; Dong, Hanyu; Feng, Junyan; Kiessling, Maren C; Angstman, Nicholas B; Schmitz, Christoph; Jia, Feiyong

    2016-05-01

    To assess the effects of radial extracorporeal shock wave therapy (rESWT) on plantar flexor muscle spasticity and gross motor function in very young patients with cerebral palsy (CP).The design was case-control study (level of evidence 3).The setting was the Department of Pediatric Neurology and Neurorehabilitation, First Hospital of Jilin University, Changchun, China.Those with a diagnosis of CP and spastic plantar flexor muscles were recruited between April 2014 and April 2015.According to the parents' decision, patients received 1 ESWT session per week for 3 months, with 1500 radial shock waves per ESWT session and leg with positive energy flux density of 0.03 mJ/mm, combined with traditional conservative therapy (rESWT group) or traditional conservative therapy alone (control group).The Modified Ashworth Scale (MAS) (primary outcome measure) and passive range of motion (pROM) measurements were collected at baseline (BL), 1 month (M1), and 3 months (M3) after BL. The Gross Motor Function Measure (GMFM)-88 was collected at BL and M3.Sixty-six patients completed the final review at 3 months and were included in the study. Subjects ranged in age from 12 to 60 months (mean age 27.0 ± 13.6 months; median age 22.0 months; 33.3% female). For the rESWT group (n = 34), mean MAS grades at BL, M1, and M3 were 2.6, 1.9, and 1.5 on the left side and 1.9, 1.7, and 1.2 on the right side. For the control group (n = 32), mean MAS grades at BL, M1, and M3 were 2.5, 2.4, and 2.1 on the left side and 1.8, 1.8, and 1.5 on the right side. The within-subject effects time × side and time × treatment were statistically significant (P therapy is more effective than traditional conservative therapy alone in the treatment of spasticity in very young patients with CP.

  7. Multicenter prospective study on device-associated infection rates and bacterial resistance in intensive care units of Venezuela: International Nosocomial Infection Control Consortium (INICC) findings.

    Science.gov (United States)

    Empaire, Gabriel D; Guzman Siritt, Maria E; Rosenthal, Victor D; Pérez, Fernando; Ruiz, Yvis; Díaz, Claudia; Di Silvestre, Gabriela; Salinas, Evelyn; Orozco, Nelva

    2017-01-01

    Device-associated healthcare-acquired infections (DA-HAI) pose a threat to patient safety in the intensive care unit (ICU). A DA-HAI surveillance study was conducted by the International Nosocomial Infection Control Consortium (INICC) in two adult medical/surgical ICUs at two hospitals in Caracas, Venezuela, in different periods from March 2008 to April 2015, using the US Centers for Disease Control and Prevention's National Healthcare Safety Network (CDC/NHSN) definitions and criteria, and INICC methods. We followed 1041 ICU patients for 4632 bed days. Central line-associated bloodstream infection (CLABSI) rate was 5.1 per 1000 central line days, ventilator-associated pneumonia (VAP) rate was 7.2 per 1000 mechanical ventilator days, and catheter-associated urinary tract infection (CAUTI) rate was 3.9 per 1000 urinary catheter days, all similar to or lower than INICC rates (4.9 [CLABSI]; 16.5 [VAP]; 5.3 [CAUTI]), and higher than CDC/NHSN rates (0.8 [CLABSI]; 1.1 [VAP]; and 1.3 [CAUTI]). Device utilization ratios were higher than INICC and CDC/NHSN rates, except for urinary catheter, which was similar to INICC. Extra length of stay was 8 days for patients with CLABSI, 9.6 for VAP and 5.7 days for CAUTI. Additional crude mortality was 3.0% for CLABSI, 4.4% for VAP, and 16.9% for CAUTI. DA-HAI rates in our ICUs are higher than CDC/NSHN's and similar to or lower than INICC international rates. © The Author 2017. Published by Oxford University Press on behalf of Royal Society of Tropical Medicine and Hygiene. All rights reserved.For permissions, please e-mail: journals.permissions@oup.com.

  8. A Study on Chocolate Consumption in Prospective Teachers

    Science.gov (United States)

    Ozgen, Leyla

    2016-01-01

    This study was planned and conducted to determine the chocolate consumption habits of prospective teachers. The study population was comprised of students attending the Faculty of Education at Gazi University in Ankara and the sample consisted of 251 prospective teachers selected with simple random sampling. 96.4% and 3.6% of the prospective…

  9. Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: a prospective, randomized, controlled trial

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    Leitao Filho Fernando SS

    2011-10-01

    Full Text Available Abstract Background Obesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option. Methods/Design The present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities, candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil. The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness. Discussion This paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery. Trial Registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv.

  10. Multimodal analgesia with pregabalin and dexmedetomidine in morbidly obese patients undergoing laparoscopic sleeve gastrectomy: A prospective randomized double blind placebo controlled study

    Directory of Open Access Journals (Sweden)

    Atef Kamel Salama

    2016-07-01

    Conclusions: The combination of preoperative oral pregabalin and intraoperative dexmedetomidine infusion decreased intraoperative fentanyl use and ensured postoperative better pain control and less postoperative opioid consumption.

  11. Premorbid personality in schizophrenia spectrum: a prospective study

    DEFF Research Database (Denmark)

    Ekstrøm, Morten; Lykke Mortensen, Erik; Sørensen, Holger J

    2006-01-01

    to these three diagnostic categories. Twelve-year-old children destined to develop a disorder in the schizophrenia spectrum deviated significantly from healthy controls on a number of personality characteristics: they were rated significantly lower than controls on intelligence, concentration, maturity......Schizophrenia has been linked with premorbid character anomalies since it was first described. However, few prospective studies of premorbid personality characteristics in schizophrenia and related disorders have been conducted. This study evaluates premorbid personality in children who developed...... schizophrenia spectrum disorder in adult life. In 1972, 265 children at an average age of 12 (90 with at least one schizophrenic parent) from the Copenhagen Perinatal Cohort participated in a 1-day follow-up during which they were in contact with seven examiners who rated their personality by means...

  12. Pre-surgical regional blocks in orthognathic surgery: prospective study evaluating their influence on the intraoperative use of anaesthetics and blood pressure control.

    Science.gov (United States)

    Chen, Y A; Rivera-Serrano, C M; Chen, C; Chen, Y R

    2016-06-01

    In orthognathic surgery, maxillary (CNV2) and mandibular (CNV3) divisions of the trigeminal nerve can be blocked successfully prior to surgery. In this study, it was hypothesized that regional blocks (nerve block over a particular region: bilateral CNV2 and CNV3 divisions of the trigeminal nerve) would decrease the total requirement for intraoperative anaesthetic agents and facilitate the process of hypotensive anaesthesia. Local anaesthesia containing 1/100,000 epinephrine and 10ml 0.5% levobupivacaine was injected into the planned incisions in 50 patients. Twenty-five patients (group A) underwent orthognathic surgery without regional blocks and another 25 patients (group B) underwent surgery with regional blocks. The anaesthetic protocol was the same in both groups and administered by a single anaesthesiologist. The mean arterial pressure was recorded at several points throughout the operation, as well as all the medications used. The blood loss and the amounts of medications administered were lower in group B than in group A. In patients receiving regional blocks, the amounts of fentanyl and nicardipine required were significantly lower. The use of pre-emptive anaesthesia in orthognathic surgery may reduce the overall amounts of medications required for hypotensive anaesthesia, facilitate the intraoperative control of blood pressure, and decrease intraoperative blood loss.

  13. Acetabular component positioning in total hip arthroplasty with and without a computer-assisted system: a prospective, randomized and controlled study.

    Science.gov (United States)

    Gurgel, Henrique M C; Croci, Alberto T; Cabrita, Henrique A B A; Vicente, José Ricardo N; Leonhardt, Marcos C; Rodrigues, João Carlos

    2014-01-01

    In a study of the acetabular component in total hip arthroplasty, 20 hips were operated on using imageless navigation and 20 hips were operated on using the conventional method. The correct position of the acetabular component was evaluated with computed tomography, measuring the operative anteversion and the operative inclination and determining the cases inside Lewinnek's safe zone. The results were similar in all the analyses: a mean anteversion of 17.4° in the navigated group and 14.5° in the control group (P=.215); a mean inclination of 41.7° and 42.2° (P=.633); a mean deviation from the desired anteversion (15°) of 5.5° and 6.6° (P=.429); a mean deviation from the desired inclination of 3° and 3.2° (P=.783); and location inside the safe zone of 90% and 80% (P=.661). The acetabular component position's tomography analyses were similar whether using the imageless navigation or performing it conventionally. Published by Elsevier Inc.

  14. [The application of n-acetylcysteine as an antioxidant and mucolytic in mechanical ventilation in intensive care patients. A prospective, randomized, placebo-controlled, double-blind study].

    Science.gov (United States)

    Konrad, F; Schoenberg, M H; Wiedmann, H; Kilian, J; Georgieff, M

    1995-09-01

    Oxygen radicals and oxygen radial mediators are thought to be important components in the development of acute lung injury, sepsis, and multiple organ failure. Injured patients, patients with pulmonary diseases, and multiple trauma patients also showed an elevated lipid peroxidation, indicating increased oxidant stress. N-Acetylcysteine (NAC) has been used as an antioxidant in a wide variety of experiments. NAC has been suggested to act by raising concentrations of cysteine, and hence glutathione, and by scavenging of oxidant species [1, 11, 17, 29]. The present study was designed to investigate whether the application of NAC in intubated patients has an effect on concentrations of reduced glutathione in plasma and bronchoalveolar lavage fluid (BAL) and on the lipid peroxidation products malondialdehyde and conjugated dienes. Because NAC has been widely used as a mucolytic drug for the treatment of lung diseases, the influence on tracheobronchial mucus was studied, too. METHODS. In a randomized, double-blind, placebo-controlled study, a total of 38 long-term ventilated patients of a surgical intensive care unit were investigated. Patients were treated for 5 days with either 3 g NAC/day or placebo. The plasma concentration of reduced glutathione, malondialdehyde, and conjugated dienes were measured on admission and on the 3rd and 5th days of treatment [8, 34, 48]. Additionally, the numbers of tracheobronchial suctionings were registered and chest radiographs were evaluated. A fibre-bronchoscopy was performed on admission and on the 3rd day of treatment. The amount and viscidity of tracheobronchial secretions were examined semiquantitatively, and glutathione levels were measured in the unconcentrated BAL. The study was approved by the ethics committee of the University of Ulm. RESULTS. The two groups were comparable with respect to age, sex, APACHE II score and diagnosis (Table 1). We found no significant differences in reduced glutathione levels in the plasma or in

  15. TO EVALUATE THE ANALGESIC EFFICACY OF IPSILATERAL TRANSVERSUS ABDOMINIS PLANE BLOCK FOR LOWER ABDOMINAL SURGERIES IN CHILDREN: A PROSPECTIVE RANDOMISED CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Paleti

    2014-07-01

    Full Text Available BACKGROUND: Appendectomies and lower abdominal surgeries are associated with significant postoperative pain in children. Transversus Abdominis Plane (TAP block provides effective analgesia for patients undergoing lower abdominal surgeries. Our aim is to evaluate its analgesic efficacy for lower abdominal surgeries in children when compared to standard systemic analgesia. METHODOLOGY: After institutional Ethics Committee approval, 50 children, ASA I/II 7-13 yrs. undergoing lower abdominal surgeries were randomized into groups A and B of 25 each. All patients received standard General Anesthetic with standard monitoring. In Group A, TAP block was performed under land mark technique with 2.5mg/kg of 0.5% ropivacaine which is equivalent to 0.3ml/kg after General Anesthesia. In Group B, standard systemic analgesia was given which served as the control group. In addition, patients of both groups received regular IV paracetamol 15mg/kg immediately after completion of surgery. STATISTICS AND RESULTS: Statistical analysis was performed with student’s t-test and Fisher’s exact test. P<0.05 was considered significant. TAP block with ropivacaine reduced mean tramadol requirements in the 1st 24hrs postoperative period [42+15.89 vs. 80.35+19.16mg; p<0.001]. Postoperative VAS scores significantly reduced in TAP block group until 24hrs after surgery. No complications were reported with TAP block in our study. CONCLUSION: Land mark based TAP block, as a part of balanced analgesia regimen provides superior analgesia than systemic analgesia alone in children undergoing lower abdominal surgeries.

  16. Deferasirox reduces iron overload significantly in nontransfusion-dependent thalassemia: 1-year results from a prospective, randomized, double-blind, placebo-controlled study.

    Science.gov (United States)

    Taher, Ali T; Porter, John; Viprakasit, Vip; Kattamis, Antonis; Chuncharunee, Suporn; Sutcharitchan, Pranee; Siritanaratkul, Noppadol; Galanello, Renzo; Karakas, Zeynep; Lawniczek, Tomasz; Ros, Jacqueline; Zhang, Yiyun; Habr, Dany; Cappellini, Maria Domenica

    2012-08-02

    Nontransfusion-dependent thalassemia (NTDT) patients may develop iron overload and its associated complications despite receiving only occasional or no transfusions. The present 1-year, randomized, double-blind, placebo-controlled THALASSA (Assessment of Exjade in Nontransfusion-Dependent Thalassemia) trial assessed the efficacy and safety of deferasirox in iron-overloaded NTDT patients. A total of 166 patients were randomized in a 2:1:2:1 ratio to starting doses of 5 or 10 mg/kg/d of deferasirox or placebo. The means ± SD of the actual deferasirox doses received over the duration of the study in the 5 and 10 mg/kg/d starting dose cohorts were 5.7 ± 1.4 and 11.5 ± 2.9 mg/kg/d, respectively. At 1 year, the liver iron concentration (LIC) decreased significantly compared with placebo (least-squares mean [LSM] ± SEM, -2.33 ± 0.7 mg Fe/g dry weight [dw], P = .001, and -4.18 ± 0.69 mg Fe/g dw, P deferasirox groups, respectively (baseline values [means ± SD], 13.11 ± 7.29 and 14.56 ± 7.92 mg Fe/g dw, respectively). Similarly, serum ferritin decreased significantly compared with placebo by LSM -235 and -337 ng/mL for the deferasirox 5 and 10 mg/kg/d groups, respectively (P deferasirox significantly reduces iron overload in NTDT patients with a frequency of overall adverse events similar to placebo.

  17. Efficacy of Ketamine as an Adjunct to Local Anesthesia in the Surgical Removal of Impacted Mandibular Third Molars – A Split Mouth Prospective Controlled Clinical Study

    Science.gov (United States)

    Shah, Anand; Halli, Rajshekhar; Kshirsagar, Rajesh; Khurana, Jyotsana

    2016-01-01

    Introduction The removal of impacted teeth is one of the most common procedures performed by oral and maxillofacial surgeons. Reduction of discomfort post-operatively and efficient local anesthesia are imperative for success in surgical practice. At sub-anesthetic doses, ketamine has a noticeable analgesic action, which can be used to supplement local anesthesia with minimal side effects. Aim To assess the efficacy of low-dose ketamine as an adjunct to local anesthesia in the management of pain, swelling and trismus after surgical removal of impacted mandibular third molars. Materials and Methods Twenty five patients with bilaterally symmetrical impacted mandibular third molars requiring surgical removal under local anesthesia were selected for the controlled clinical study. The third molar sites of all patients enrolled in the trial were randomly assigned into 2 groups: Local Anesthesia (Lignocaine) Alone [LAA] and Local Anesthesia plus ketamine [LAK]. 5ml of local anesthetic (Lignocaine Hydrochloride 2% with epinephrine 1:100,000) was injected in the ‘LAA’ group while the ‘LAK’ group received 5ml of local anesthetic plus 0.2mg/kg ketamine. Patients were blinded to the solution used and the operator recorded the group (LAA or LAK) and the respective site (Right or Left) for analysis. Bilaterally symmetrical impacted mandibular molars were removed at an interval of 15 days. Results Facial swelling on post-operative days was significantly lower in the LAK group than in the LAA group (pimpacted third molars provides good local anesthesia while alleviating post-operative sequelae for the patient by providing a degree of post-operative analgesia with less swelling. PMID:27891453

  18. Decision Making and Response Inhibition as Predictors of Heavy Alcohol Use: A Prospective Study

    NARCIS (Netherlands)

    A.E. Goudriaan; E.R. Grekin; K.J. Sher

    2011-01-01

    Background: Very few studies have investigated the "real world" prospective, predictive value of behavioral instruments used in laboratory studies to test decision-making abilities or impulse control. The current study examines the degree to which 2 commonly used decision-making/impulse control meas

  19. Effects of nutritional supplementation combined with conventional pulmonary rehabilitation in muscle-wasted chronic obstructive pulmonary disease: a prospective, randomized and controlled study.

    Science.gov (United States)

    Gurgun, Alev; Deniz, Sami; Argın, Mehmet; Karapolat, Hale

    2013-04-01

    Nutritional depletion in chronic obstructive pulmonary disease (COPD) adversely affects health status and mortality. We aimed to evaluate the effects of nutritional supplementation (NS) with pulmonary rehabilitation (PR) on body composition, mid-thigh cross-sectional area (CSA), dyspnoea, exercise capacity, health-related quality of life, anxiety and depression in advanced COPD patients. Forty-six patients were randomized to PR and nutritional support (PRNS), PR or the control group. Dyspnoea was measured with Medical Research Council and BORG scales. Exercise capacity was measured through 6-min walk test and shuttle tests; health-related quality of life was assessed with St. George's Respiratory Questionnaire. Psychological status was measured with Hospital Anxiety and Depression Scale. Body weight and body mass indexes (BMI) were also evaluated. Fat-free mass was measured through bioelectrical impedance analyser. The CSA of quadriceps was calculated in mid-level of the thigh with magnetic resonance imaging. Dyspnoea and total scores of St. George's Respiratory Questionnaire improved in both groups (P < 0.05). Six-minute walk test and incremental shuttle walk test distances in PRNS and PR patients increased significantly as (62.6 ± 42.4 m, 43.3 ± 59.2 m, both P = 0.001; and 63.3 ± 70.1 m and 69.3 ± 69.7 m, both P = 0.001). Although anxiety improved in both groups (P < 0.05), there was no change in depression. Body weight, BMI and fat-free mass index (FFMI) (1.1 ± 0.9 kg, 0.2 ± 1.4 kg/m(2) and 0.6 ± 0.5 kg/m(2), P < 0.05) in PRNS, whereas body weight and FFMI (0.6 ± 0.7 kg, 0.1 ± 0.6 kg/m(2) P < 0.05) increased in PR after the intervention. There was a significant increase in mid-thigh CSA (2.5 ± 4.1 cm(2)) only in PRNS (P = 0.04). The combination of NS with PR resulted in improvements particularly in lean body mass and mid-thigh CSA. This study suggests combining NS with PR in reversing

  20. Liver fibrosis regression and progression during controlled hepatitis B virus infection among HIV–HBV patients treated with tenofovir disoproxil fumarate in France: a prospective cohort study

    Directory of Open Access Journals (Sweden)

    Anders Boyd

    2017-01-01

    Conclusions: Liver fibrosis levels are stable for most coinfected patients undergoing TDF, despite control of HBV replication. Nevertheless, a concerning amount of liver fibrosis progression did occur, which could be partly explained by metabolic abnormalities and past severe immunosuppression and requires further evaluation.

  1. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Ali Jendoubi

    2017-01-01

    Conclusion: Ketamine and lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic neuropathic pain at 3 months after open nephrectomy.

  2. A Prospective Randomized Control Trial to Study the Role of Intraperitoneal Irrigation with Normal Saline in Reduction of Postoperative Pain In Patients Undergoing Laparoscopic Cholecystectomy

    Directory of Open Access Journals (Sweden)

    Pankaj Shivhare

    2014-08-01

    Results: Abdominal pain was worst during the first 24 hours after laparoscopic cholecystectomy. At 6, 12 and 24 hrs, group A exhibited significantly less abdominal pain than group B. Group A also experienced less shoulder tip pain during the first postoperative day as compared to the control group. Conclusion: Intraperitoneal irrigation with normal saline is effective in reducing postoperative abdominal and shoulder tip pain following laparoscopic cholecystectomy. [Arch Clin Exp Surg 2014; 3(4.000: 213-219

  3. The effects of screening and intervention of subclinical hypothyroidism on pregnancy outcomes: a prospective multicenter single-blind, randomized, controlled study of thyroid function screening test during pregnancy.

    Science.gov (United States)

    Ma, Liangkun; Qi, Hong; Chai, Xiaofeng; Jiang, Fang; Mao, Su; Liu, Juntao; Zhang, Shaoqin; Lian, Xiaolan; Sun, Xiujing; Wang, Danhua; Ren, Jie; Yan, Qi

    2016-01-01

    To evaluate the effect of subclinical hypothyroidism (SCH) screening and intervention on pregnancy outcomes and explore the significance of thyroid function during early pregnancy. Pregnant women were recruited from Peking Union Medical College Hospital (screening group for measuring thyroid function and thyroid antibody in early pregnancy) and Haidian Maternal & Child Health Hospital (control group whose serum was stored and measured shortly after delivery) from July 2011 to December 2012. Thyrotropin levels 2.5-10 mIU/L and free T4 levels in normal range were considered SCH. Some of the screening group were treated with levothyroxine and adjusted. The others did not take medicine but kept a regular follow-up visit to doctors after antenatal clinic. The pregnancy outcomes and complications were compared. 1671 women (675 in screening group and 996 in control group) were recruited. 419 (167 from screening group) women was diagnosed as SCH. In screening group, 105 SCH and 4 hypothyroid women received thyroid hormone replacement therapy. The miscarriage and fetal macrosomia risks were lower, and cesarean was higher in screening group than control. Screening and intervention of SCH can significantly reduce the incidence rate of miscarriage.

  4. Moderating effect of gender on the prospective relation of physical activity with psychosocial outcomes and asthma control in adolescents: a longitudinal study

    NARCIS (Netherlands)

    Tiggelman, D.; Ven, M.O.M. van de; Schayck, O.C.P. van; Engels, R.C.M.E.

    2014-01-01

    Objective: Adolescents with asthma experience more psychosocial and physiological problems compared to their healthy peers. Physical activity (PA) might decrease these problems. This study was the first observational longitudinal study to examine whether habitual PA could predict changes in psychoso

  5. Definitive surgery and intraoperative photodynamic therapy: a prospective study of local control and survival for patients with pleural dissemination of non-small cell lung cancer.

    Science.gov (United States)

    Simone, Charles B; Cengel, Keith A

    2014-02-01

    Patients with non-small cell lung cancer (NSCLC) with pleural dissemination have very limited survivals often of just 6-9 months. Prior reports of aggressive surgical resection of pleural metastases have shown no consistent improvements in overall survival and very high rates of local recurrences. Based on this and the generally very diffuse pleural dissemination seen in patients, chemotherapy and palliative interventions are standard of care. By attempting to sterile microscopic residual disease after surgical resection, intraoperative photodynamic therapy (PDT) could improve local pleural control and overall survival compared with surgery alone for patients with NSCLC with pleural metastasis. Prior attempts to demonstrate an improvement in clinical outcomes with PDT as an intraoperative adjuvant combined with definitive surgery to treat pleural malignancies have not been successful, perhaps due, in part, to limited ability to perform real-time dosimetry and ensure adequate and even light distribution throughout the chest cavity. A stratified phase II trial assessed the efficacy of definitive surgery and intraoperative PDT with real-time dosimetry in patients with NSCLC with pleural dissemination demonstrated prolonged local control and a higher than expected 21.7-month median survival from the time of surgery and PDT among 22 enrolled patients. This is the first ever report describing optimal methods, techniques, and dosimetry that could be used to safely and reproducibly deliver intraoperative PDT to the chest cavity as part of multimodality therapy for NSCLC with pleural metastasis.

  6. Bullying increased suicide risk: prospective study of Korean adolescents.

    Science.gov (United States)

    Kim, Young Shin; Leventhal, Bennett L; Koh, Yun-Joo; Boyce, W Thomas

    2009-01-01

    This study examines the independent impact of bullying on suicide risk. Bullying was assessed by peer nomination in a prospective study of 1,655 7th and 8th grade Korean students, and suicide by youth self-report. Odds Ratios (ORs) of bullying for suicidal risks were computed, controlling for other suicide risk factors. Victim-Perpetrators and female Victims at baseline showed increased risk for persistent suicidality (OR: 2.4-9.8). Male Incident Victims exhibited increased risk for suicidal behaviors and ideations (OR = 4.4, 3.6). Female Persistent Perpetrators exhibited increased risks for suicidal behaviors; male Incident Perpetrators had increased risk for suicidal ideations (OR = 2.7, 2.3). Baseline-only male Victim-Perpetrators showed increased risk for suicidal ideations. (OR = 6.4). Bullying independently increased suicide risks.

  7. Adhesive strip wound closure after thyroidectomy/parathyroidectomy: a prospective, randomized controlled trial.

    LENUS (Irish Health Repository)

    O'Leary, D Peter

    2013-03-01

    Conventional collar incision closure in thyroid and parathyroid surgery involves the insertion of an epidermal layer of subcutaneous absorbable sutures that are reinforced by a deep layer of sutures. Adhesive strips offer an alternative method to close the epidermal layer. The aim of this study was to compare adhesive strip closure with absorbable sutures for collar incisions in a prospective, single-blinded, randomized controlled trial.

  8. Calcium intake and risk of hip fracture in men and women a meta-analysis of prospective cohort studies and randomized controlled trials

    Science.gov (United States)

    The role of total calcium intake for the prevention of hip fracture risk has not been well established. The objective of this analysis was to assess the relation of calcium intake to risk of hip fracture based on meta-analyses of cohort studies and clinical trials. In cohort studies in women (7 stu...

  9. Prospects for study of tectono-geochemistry

    Institute of Scientific and Technical Information of China (English)

    2003-01-01

    Focusing on fault tectono-geochemistry, the authors will illustrate four aspects of the fault tectono-geochemistry and its research prospects: (1) the major elements, trace elements and rare earth elements and their differentiation and dissipation sequence; (2)mineral veins, secondary inclusions, sync-deformation fluids and their micro-kinetic analyses; (3) pressure intensity, temperature grads,solution concentration and their coupled correlation system; (4) tectonic stress fields, rheologic physical fields, geochemical fields and digital modeling of parameters. The four aspects are unique in their own systems and related to one another. A unified explanation of spatial and temporal evolution can be obtained in combination with the geodynamics and tectonic chronology.

  10. 中国控烟干预策略的研究综述%Review and Prospect of Studies on Intervention Strategy for Tobacco Control in China

    Institute of Scientific and Technical Information of China (English)

    黄弋冰; 郑频频; 傅华

    2011-01-01

    Nicotine in tobacco contributing to smoking addiction as well as the influence of psychological and social factors result in quite low rate of smoking cessation among smokers though the adverse health effects of smoking is propagated widely.Today researchers and practitioners in tobacco control field are paying more attention to improving smoking cessation rate, reducing risk of secondhand-smoking and keeping teenagers far away from tobacco through effective policy development, health promotion,social psychological and behavioral interventions. Key intervention strategies applied to tobacco control in China were reviewod and suggestions on researches in the future were proposed in this paper.%由于烟草中的尼古丁易使吸烟者成瘾,加之心理、社会等因素的影响,尽管吸烟的危害广为宣传,但吸烟人群中的戒烟率仍相当低.通过制定控烟政策、健康促进、社会心理和行为干预,提高戒烟率.减少二手烟危害,使青少年不吸第一支烟,已成为控烟工作者关注的重点领域.该研究就我国大陆过去控烟实践研究成果内涵的健康教育等主要干预策略进行回顾性分析,并对今后相关研究工作提出若干建议和设想.

  11. Study of various causes of defaulter among tuberculosis patients under revised national tuberculosis control programme: a prospective analysis of 5235 tuberculosis patients

    Directory of Open Access Journals (Sweden)

    B. B. Bhadke

    2016-07-01

    Conclusions: Present study concludes that the most common cause of defaulters amongst tuberculosis patients are adverse effects, feeling of early improvement and migration. [Int J Res Med Sci 2016; 4(7.000: 2619-2622

  12. A prospective, randomized multicenter study comparing APD and CAPD treatment

    DEFF Research Database (Denmark)

    Bro, S; Bjorner, J B; Tofte-Jensen, P

    2000-01-01

    OBJECTIVE: The goals for maintenance dialysis treatment are to improve patient survival, reduce patient morbidity, and improve patient quality of life. This is the first randomized prospective study comparing automated peritoneal dialysis (APD) and continuous ambulatory peritoneal dialysis (CAPD)...

  13. A prospective PET study of patients with glioblastoma multiforme

    DEFF Research Database (Denmark)

    Andersen, Preben B.; Blinkenberg, M; Lassen, U;

    2006-01-01

    OBJECTIVE: To study the post-surgical metabolic and structural cerebral changes in patients with glioblastoma multiforme (GBM). MATERIALS AND METHODS: We examined ten patients prospectively with newly diagnosed GBM. All patients were primarily treated with surgery, followed by chemotherapy...

  14. Prospects and challenges of CRISPR/Cas genome editing for the study and control of neglected vector-borne nematode diseases.

    Science.gov (United States)

    Zamanian, Mostafa; Andersen, Erik C

    2016-09-01

    Neglected tropical diseases caused by parasitic nematodes inflict an immense health and socioeconomic burden throughout much of the developing world. Current estimates indicate that more than two billion people are infected with nematodes, resulting in the loss of 14 million disability-adjusted life years per annum. Although these parasites cause significant mortality, they primarily cause chronic morbidity through a wide range of severe clinical ailments. Treatment options for nematode infections are restricted to a small number of anthelmintic drugs, and the rapid expansion of anthelmintic mass drug administration raises concerns of drug resistance. Preservation of existing drugs is necessary, as well as the development of new treatment options and methods of control. We focus this review on how the democratization of CRISPR/Cas9 genome editing technology can be enlisted to improve our understanding of the biology of nematode parasites and our ability to treat the infections they cause. We will first explore how this robust method of genome manipulation can be used to newly exploit the powerful model nematode Caenorhabditis elegans for parasitology research. We will then discuss potential avenues to develop CRISPR/Cas9 editing protocols in filarial nematodes. Lastly, we will propose potential ways in which CRISPR/Cas9 can be used to engineer gene drives that target the transmission of mosquito-borne filarial nematodes. © 2016 The Authors. The FEBS Journal published by John Wiley & Sons Ltd on behalf of Federation of European Biochemical Societies.

  15. A prospective randomized control study on patient’s recall of consent after hand surgery: how much they want to know?

    Directory of Open Access Journals (Sweden)

    Zeeshan Khan

    2013-11-01

    Full Text Available Informed consent implies that the person undergoing an intervention thoroughly understands its pros and cons. We conducted a randomized control trial to evaluate patients’ recall of complications after day case hand surgery and how this can be influenced by age and/or socioeconomic factors. Patients’ wishes on the extent and type of provided information were also evaluated. A total of 124 cases were recruited. Ten cases were excluded because they presented for follow up more than 2 weeks after surgery. The other patients were randomized into 2 groups: the first one (48 received only verbal information, while the second one (66 also received written information sheets. No statistically significant difference was noted in the recall between the two groups. No difference among gender, age or socioeconomic status was noted. Most patients preferred both written and verbal information. Preference for knowledge of rates of complications increased when surgery was dangerous. Our results don’t show any significant difference in patients’ recall depending on the type of consenting method. Nevertheless, we still propose that patients should receive as much information as possible before undergoing any intervention.

  16. Efficacy of Wobe-Mugos {sup registered} E for reduction of oral mucositis after radiotherapy. Results of a prospective, randomized, placebo-controlled, triple-blind phase III multicenter study

    Energy Technology Data Exchange (ETDEWEB)

    Doerr, W.; Herrmann, T. [Univ. of Technology, Dresden (Germany). Dept. of Radiotherapy and Radiooncology, Medical Faculty Carl Gustav Carus

    2007-03-15

    Purpose: To investigate the efficacy and safety of Wobe-Mugos {sup registered} E (proteolytic enzymes) for amelioration of early side effects of radiotherapy for head-and-neck tumors, particularly oral mucositis. Patients and Methods: The study was a prospective, randomized, multicenter, placebo-controlled, triple-blind phase III study with parallel groups. 69 patients with carcinomas of the oropharynx or the oral cavity were enrolled between 1996 and 2000 in five centers; 54 of these were recruited in Dresden. Of the 69 patients, 61 (Dresden: 46) were available for analysis. The proteolytic enzymes tested (Wobe-Mugos {sup registered} E) comprised papain 100 mg, trypsin 40 mg, and chymotrypsin 40 mg. Results: Wobe-Mugos {sup registered} E was well tolerated. For the maximum mucositis scores, no statistically significant differences were found between the placebo and the verum group. The average mucositis score over weeks 1-6 revealed a significant difference in favor of the placebo arm, based on an earlier onset of mucositis in the Wobe-Mugos {sup registered} E group. Conclusion: The present study failed to demonstrate any effect of treatment with Wobe-Mugos {sup registered} E on radiotherapy side effects in patients treated for head-and-neck tumors. In particular, there was no beneficial effect on radiation-induced early oral mucositis. (orig.)

  17. A prospective, randomised, placebo-controlled study to identify biomarkers associated with active treatment in psoriatic arthritis: effects of adalimumab treatment on synovial tissue

    NARCIS (Netherlands)

    A.W.R. van Kuijk; D.M. Gerlag; K. Vos; G. Wolbink; M. de Groot; M.A. de Rie; A.H. Zwinderman; B.A.C. Dijkmans; P.P. Tak

    2009-01-01

    OBJECTIVE: To determine which of the changes in synovial tissue correlates best with clinical response associated with effective therapy (adalimumab) to facilitate the planning of future studies with therapeutic agents for psoriatic arthritis (PsA). METHODS: A total of 24 patients with active PsA we

  18. Prostate-specific antigen reduction after empiric antibiotic treatment does not rule out biopsy in patients with lower urinary tract symptoms: prospective, controlled, single-center study

    Directory of Open Access Journals (Sweden)

    Hasan Anıl Atalay

    2017-06-01

    Conclusion: This study has shown that, use empirical antibiotic treatment decreased the PSA levels but did not have any effect on prostate cancer detection. In addition, prostate cancer detection rates were found to be higher in patients with reduced PSA levels after treatment. Therefore, it may not be safe to rule out biopsies in patients who achieve a satisfactory PSA response to antibiotics.

  19. Double sampling of a faecal immunochemical test is not superior to single sampling for detection of colorectal neoplasia: a colonoscopy controlled prospective cohort study

    NARCIS (Netherlands)

    F.A. Oort (Frank); S.T. Van Turenhout (Sietze T.); V.M.H. Coupé (Veerle); R.W.M. van der Hulst (René); E.I.C. Wesdorp (Eric); J.S. Terhaar sive Droste (Jochim); I.B. Larbi (Ilhame); S.L. Kanis (Shannon); E. Van Hengel (Edwin); A.A. Bouman (Anneke); C.J.L.M. Meijer (Chris); C.J.J. Mulder (Chris)

    2011-01-01

    markdownabstract__Background:__ A single sampled faecal immunochemical test (FIT) has moderate sensitivity for colorectal cancer and advanced adenomas. Repeated FIT sampling could improve test sensitivity. The aim of the present study is to determine whether any of three different strategies of doub

  20. Transcutaneous Electrical Acupoint Stimulation in Children with Autism and Its Impact on Plasma Levels of Arginine-Vasopressin and Oxytocin: A Prospective Single-Blinded Controlled Study

    Science.gov (United States)

    Zhang, Rong; Jia, Mei-Xiang; Zhang, Ji-Sui; Xu, Xin-Jie; Shou, Xiao-Jing; Zhang, Xiu-Ting; Li, Li; Li, Ning; Han, Song-Ping; Han, Ji-Sheng

    2012-01-01

    Acupuncture increases brain levels of arginine-vasopressin (AVP) and oxytocin (OXT), which are known to be involved in the modulation of mammalian social behavior. Transcutaneous electrical acupoint stimulation (TEAS) is often used clinically to produce a similar stimulation to that of acupuncture on the acupoints. In the present study, TEAS was…

  1. Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy : a prospective cohort study with an embedded randomised controlled trial

    NARCIS (Netherlands)

    Kazemier, Brenda M.; Koningstein, Fiona N.; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M.; de Miranda, Esteriek; Vogelvang, Tatjana E.; Verhoeven, Corine J. M.; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A.; van der Yen, Jeanine E. M.; Vlegels, Manita T. W.; Kuiper, Petra N.; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J. M.; Mol, Ben W. J.; Geerlings, Suzanne E.

    2015-01-01

    Background Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. Methods In this multicentre

  2. Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial

    NARCIS (Netherlands)

    Kazemier, B.M.; Koningstein, F.N.; Schneeberger, C.; Ott, A.; Bossuyt, P.M.; Miranda, E. de; Vogelvang, T.E.; Verhoeven, C.J.; Langenveld, J.; Woiski, M.D.; Oudijk, M.A.; Ven, J.E. van der; Vlegels, M.T.; Kuiper, P.N.; Feiertag, N.; Pajkrt, E.; Groot, C.J. de; Mol, B.W.; Geerlings, S.E.

    2015-01-01

    BACKGROUND: Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. METHODS: In this

  3. Removing dentine caries in deciduous teeth with Carisolv: a randomised, controlled, prospective study with six-month follow-up, comparing chemomechanical treatment with drilling.

    Science.gov (United States)

    Bergmann, Jørgen; Leitão, Jorge; Kultje, Christina; Bergmann, Dorte; Clode, Maria João

    2005-01-01

    Dental fear is often associated with experience of pain, unpleasant sounds and uncomfortable vibrations caused by dental drills. Therefore patients welcome alternative, less painful excavating methods such as lasers, sandblasters and chemomechanical systems. The aim of this study was to compare a chemomechanical caries removal system (Carisolv) to traditional drilling with regard to patient acceptance and time consumption as well as the six-month success rate of fillings. Ninety-two primary teeth in 46 children were included in the study. From this study, the following conclusions can be drawn: patient acceptance of Carisolv-treatment compared to drilling is excellent, since 65% would choose Carisolv and no one drilling when treated next time. The dentists rated patients' degree of pain significantly lower in Carisolv situations than in drill situations. Time consumption is significantly higher when excavating with Carisolv (6.7 min.) than with drill (3.3 min.). The durability of fillings six months after treatment is equal in the two groups.

  4. Children (10-12 years age) of women with epilepsy have lower intelligence, attention and memory: Observations from a prospective cohort case control study.

    Science.gov (United States)

    Gopinath, Neelima; Muneer, Anila K; Unnikrishnan, Syam; Varma, Ravi Prasad; Thomas, Sanjeev V

    2015-11-01

    To compare the cognitive outcome of children of women with epilepsy (CWE) with matched controls (CWO). CWE (10-12 years) under follow up in Kerala Registry of Epilepsy and Pregnancy (n=190) were evaluated with WISC-IV, Trail Making Test (TMT), Rey Auditory Verbal Learning Test (RAVLT) and compared with age and sex matched children of women without epilepsy - CWO (n=149) drawn from schools in the same region. The dosage was expressed as prescribed daily dose/daily-defined dose (PDD/DDD) ratio in order to make comparisons. The Full Scale IQ of CWE (77.9 ± 14.6) was 8.5 points lower than that of CWO (86.4 ± 13.4), which was statistically significant (p=0.001). They performed lower on TMT Part A & B and RAVLT. The FSIQ mean ± SD; PDD/DDD ratio and number of monotherapy exposure for different anti-epileptic drugs were phenobarbital: (74.5 ± 14; 1.1 ± 0.8; 22), valproate: (82.8 ± 12.4; 0.3 ± 0.1; 36), carbamazepine: (82.2 ± 13.9; 0.6 ± 0.3; 41), phenytoin: (82.6 ± 13.5; 0.8±0.3; 11). The FSIQ for those exposed to phenobarbital was significantly (p=0.01) lower than others. The significant predictors of FSIQ differed at lower and higher ends of its spectrum. These predictors were low body mass index and low maternal education for FSIQ<80 and low maternal education, low maternal IQ and high anti-epileptic drug dosage for FSIQ<86. High anti-epileptic drug dosage, low maternal IQ, and low paternal education were the predictors for FSIQ<92. The IQ, attention and memory were significantly lower for 10-12 year old CWE when compared to CWO. The important predictors of low FSIQ were antiepileptic drug dosage, maternal IQ, and parental education. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Protocol for a prospective observational study of cortical lower urinary tract control changes following intradetrusor injection of botulinum toxin-A in patients with multiple sclerosis

    Science.gov (United States)

    Elizondo, Rodolfo A; Karmonik, Christof; Boone, Timothy B; Khavari, Rose

    2017-01-01

    Introduction Multiple sclerosis (MS) is a severe debilitating disease that affects patients' quality of life. Up to 90% of patients with MS will develop lower urinary tract dysfunction within the first 18 years of the disease. If oral pharmacotherapy with anticholinergics, behavioural modifications and pelvic floor physical therapy are unsuccessful, intradetrusor injection of botulinum toxin-A (OnaBotA; Botox Allergan, Dublin, Ireland) is a highly effective option for these patients. The local effects of OnaBotA are well understood, but not much is known of its afferent/sensory effects while treating the end organ. Our study will use functional MRI (fMRI) and task-related blood oxygen level-dependent signals to evaluate patients with MS and neurogenic detrusor overactivity (NDO) prior to, and after, intradetrusor injection of OnaBotA with simultaneous urodynamic evaluation. Urinary concentration of brain-derived neurotrophic factor and nerve growth factor will also be collected since it has been shown that patients with an overactive bladder have higher concentrations of these neuropeptides. Methods and analysis Female patients with MS and lower urinary tract symptoms who previously have undergone urodynamic screening and are refractory to conservative and oral pharmacotherapy management for NDO and are interested in OnaBotA intradetrusor injection will be invited to participate in the study. An fMRI will be performed preintradetrusor injection and postintradetrusor injection of OnaBotA with simultaneous MRI compatible with material urodynamics. Images will be collected and analysed accordingly. Ethics and dissemination All of the patients are properly consented before enrolling in this study that has been previously approved by the Institutional Review Board. Results of neural connectivity activation will be presented at national and international meetings and published in scholarly journals. PMID:28159850

  6. Cognitive function in the affective disorders: a prospective study.

    Science.gov (United States)

    Bulbena, A; Berrios, G E

    1993-01-01

    A prospective, controlled study of 50 subjects confirmed claims that major depression or mania may cause temporary disorders of attention, memory, visuo-spatial function, and choice reaction time, and cause-independently of medication-the appearance of glabellar tap, positive hand-face test, nuchocephalic reflex, and graphesthesia. On follow-up, all these phenomena either disappeared or markedly improved. Age and age of onset, but not pre-morbid intelligence or history of ECT, seemed to modulate the severity of the cognitive impairment. Presence of delusions predicted poor (but reversible) visuo-spatial function. Cognitive impairment accompanied by reversible soft neurological signs was more marked but patients thus affected surprisingly showed lower depressive scores; this was interpreted as representing a secondary, 'organic' form of affective disorder (i.e. a behavioural phenocopy of depression) characterised by a reduced capacity to experience depressive symptoms and by little improvement at follow-up.

  7. Posttraumatic stress in intensive care unit survivors - a prospective study

    DEFF Research Database (Denmark)

    Ratzer, Mette; Brink, Ole; Knudsen, Linda

    2014-01-01

    Aims: This study aimed to estimate the prevalence of severe Posttraumatic Stress Disorder (PTSD) symptoms and to identify factors associated with PTSD in survivors of intensive care unit (ICU) treatment following traumatic injury. Methods: Fifty-two patients who were admitted to an ICU through...... the emergency ward following traumatic injury were prospectively followed. Information on injury severity and ICU treatment were obtained through medical records. Demographic information and measures of acute stress symptoms, experienced social support, coping style, sense of coherence (SOC) and locus...... of control were assessed within one-month post-accident (T1). At the six months follow-up (T2), PTSD was assessed with the Harvard Trauma Questionnaire (HTQ). Results: In the six months follow-up, 10 respondents (19.2%) had HTQ total scores reaching a level suggestive of PTSD (N = 52), and 11 respondents (21...

  8. Inspiratory Muscle Training and Functional Electrical Stimulation for Treatment of Heart Failure With Preserved Ejection Fraction: Rationale and Study Design of a Prospective Randomized Controlled Trial.

    Science.gov (United States)

    Palau, Patricia; Domínguez, Eloy; López, Laura; Heredia, Raquel; González, Jessika; Ramón, Jose María; Serra, Pilar; Santas, Enrique; Bodi, Vicente; Sanchis, Juan; Chorro, Francisco J; Núñez, Julio

    2016-08-01

    Heart failure with preserved ejection fraction (HFpEF) has become the most prevalent form of heart failure in developed countries. Regrettably, there is no evidence-based effective therapy for HFpEF. We seek to evaluate whether inspiratory muscle training, functional electrical stimulation, or a combination of both can improve exercise capacity as well as left ventricular diastolic function, biomarker profile, quality of life (QoL), and prognosis in patients with HFpEF. A total of 60 stable symptomatic patients with HFpEF (New York Heart Association class II-III/IV) will be randomized (1:1:1:1) to receive a 12-week program of inspiratory muscle training, functional electrical stimulation, a combination of both, or standard care alone. The primary endpoint of the study is change in peak exercise oxygen uptake; secondary endpoints are changes in QoL, echocardiogram parameters, and prognostic biomarkers. As of March 21, 2016, thirty patients have been enrolled. Searching for novel therapies that improve QoL and autonomy in the elderly with HFpEF has become a health care priority. We believe that this study will add important knowledge about the potential utility of 2 simple and feasible physical interventions for the treatment of advanced HFpEF.

  9. Response of feline eosinophilic plaques and lip ulcers to amoxicillin trihydrate-clavulanate potassium therapy: a randomized, double-blind placebo-controlled prospective study.

    Science.gov (United States)

    Wildermuth, Brett E; Griffin, Craig E; Rosenkrantz, Wayne S

    2012-04-01

    In this study, we evaluated the treatment of feline eosinophilic plaques and lip ulcers with amoxicillin trihydrate-potassium clavulanate (Clavamox(®); Pfizer Animal Health). Nineteen cats with clinical and cytological findings consistent with eosinophilic plaques and/or lip ulcers were enrolled. Lesions were photographed and their areas measured in square centimetres before and after 21 days of therapy with either flavoured amoxicillin-clavulanate suspension or flavoured placebo suspension. Sixteen cats completed the study, with nine plaque lesions (four treatment and five placebo) and eight lip ulcer lesions (four treatment and four placebo) included in the analysis. All lesions were shown to have infection, with bacterial phagocytosis present on cytological examination. Coagulase-positive staphylococci were the most commonly isolated bacteria. The amoxicillin-clavulanate-treated eosinophilic plaque group had a statistically significant 96.2% reduction in mean lesion size (-7.60 cm(2), P = 0.0078) and an 80% reduction in mean percentage of microscopic fields demonstrating evidence of bacterial infection (P feline eosinophilic plaques.

  10. Curative effects of microneedle fractional radiofrequency system on skin laxity in Asian patients: A prospective, double-blind, randomized, controlled face-split study.

    Science.gov (United States)

    Lu, Wenli; Wu, Pinru; Zhang, Zhen; Chen, Jinan; Chen, Xiangdong; Ewelina, Biskup

    2017-04-01

    To date, no studies compared curative effects of thermal lesions in deep and superficial dermal layers in the same patient (face-split study). To evaluate skin laxity effects of microneedle fractional radiofrequency induced thermal lesions in different dermal layers. 13 patients underwent three sessions of a randomized face-split microneedle fractional radiofrequency system (MFRS) treatment of deep dermal and superficial dermal layer. Skin laxity changes were evaluated objectively (digital images, 2 independent experts) and subjectively (patients' satisfaction numerical rating). 12 of 13 subjects completed a course of 3 treatments and a 1-year follow-up. Improvement of nasolabial folds in deep dermal approach was significantly better than that in superficial approach at three months (P=.0002) and 12 months (P=.0057) follow-up. Effects on infraorbital rhytides were only slightly better (P=.3531). MFRS is an effective method to improve skin laxity. Thermal lesion approach seems to provide better outcomes when applied to deep dermal layers. It is necessary to consider the skin thickness of different facial regions when choosing the treatment depth.

  11. Immediate breastfeeding and skin-to-skin contact during cesarean section decreases maternal oxidative stress, a prospective randomized case-controlled study.

    Science.gov (United States)

    Yuksel, Beril; Ital, Ilker; Balaban, Onur; Kocak, Emel; Seven, Ali; Kucur, Suna Kabil; Erbakirci, Mehmet; Keskin, Nadi

    2016-01-01

    Immediate skin-to-skin contact (ISSC) and early breastfeeding are recommended for the wellbeing of the neonate. In this study, we aimed to evaluate the effect of ISSC and early breastfeeding on maternal oxidative stress and postoperative pain. A total of 90 patients were randomized into two groups based on the timing of skin-to-skin contact and breastfeeding. Group 1 (n = 45) was provided ISSC and breastfeeding in the operating room during the cesarean section (C/S). Group 2 (n = 45) breastfed their babies 1 h after the C/S. As markers of oxidative stress, maternal serum levels of total antioxidant status (TAS), total oxidant status (TOS) and oxidative stress indices (OSI) were evaluated. Maternal oxytocin levels and the relation between these parameters and postoperative pain were also evaluated. The postoperative TAS levels were significantly higher, whereas TOS and OSI levels were lower in Group 1 than Group 2. Negative correlations between oxytocin level and postoperative TOS and OSI were observed, as was a positive correlation between oxytocin level and postoperative TAS. The effect of ISSC and early breastfeeding on mothers was documented for the first time in this study. Our results demonstrated ISSC and early breastfeeding during C/S reduce maternal oxidative stress.

  12. Does an Early and Aggressive Combined Wrapping and Dangling Procedure Affect the Clinical Outcome of Lower Extremity Free Flaps?-A Randomized Controlled Prospective Study Using Microdialysis Monitoring.

    Science.gov (United States)

    Neubert, Nils; Vogt, P M; May, M; Boyce, M; Koenneker, S; Budde, E; Jokuszies, A

    2016-05-01

    Background The ideal starting point for flap training (FT) with the combined wrapping and dangling procedure is still a question of debate. Most units follow their own established protocols and currently evidence of flap compromise due to FT is still lacking. The aim of this study was to prove if an early and "aggressive" wrapping and dangling protocol could lead to metabolic changes, measured by microdialysis, indicating ischemia resulting in compromised flap perfusion. Methods Between 2010 and 2014, 49 patients with microvascular free flap reconstruction of the lower limb were included in this study. Patients were randomized into two groups. Group I started FT on the 7th postoperative day, and group II started on day 3. FT consisted of a combined wrapping and dangling procedure doubling its duration daily and ending at day 5. Flaps were monitored clinically and by microdialysis for ischemia-induced changes and metabolic parameters in the flap tissue in respect to different starting points of FT. Results All 49 patients in both groups were able to complete the postoperative FT without complications. Noninferiority of the early group could be proven and microdialysis results showed no differences between both groups. Conclusion We could prove by microdialysis that an early start of FT does not lead to compromised flap perfusion. Moreover, an early start of FT can lead to a reduced length of hospital stay. Furthermore, a reduced risk for deep vein thrombosis, pulmonary embolism, and pneumonia due to earlier mobilization might be an appreciated side effect.

  13. Bone density in proton pump inhibitors users: a prospective study.

    Science.gov (United States)

    Ozdil, Kamil; Kahraman, Resul; Sahin, Abdurrahman; Calhan, Turan; Gozden, Erdem H; Akyuz, Umit; Erer, Burak; Sokmen, Mehmet H

    2013-09-01

    Patients with gastroesophageal reflux disease (GERD) receive long-term therapy with proton pump inhibitor (PPI) agents. Several studies have recently been published suggesting that treatment with PPI may cause bone fractures, although the number of prospective studies in this regard is limited. The aim of this study is to prospectively investigate the effect of PPIs on bone density. Between March 2009 and January 2011, 114 GERD patients (18-56 years) and 110 healthy controls were included in the present study. Bone mineral densitometry (BMD) by using dual-energy X-ray absorptiometry was assessed at lumbar spine and femur neck. BMD measurements were performed on all subjects at the beginning of the study. The patients were divided according to three drugs by their treatment with esomeprazole, lansoprazole, or pantoprazole. The study group was followed for at least 6 months on PPI therapy, and then BMD measurements were repeated. The mean duration of treatment with PPIs was 8.5 ± 2.3 months. In patients receiving PPIs, the mean reduction in total vertebra T score following treatment compared to pre-treatment values was 00.23 ± 0.42 units (95 % CI 0.15-0.30) (p < 0.01), while the mean reduction in the femur T score was 0.10 ± 0.40 units (95 % CI 0.03-0.18) (p = 0.03). Reduction following treatment in L4 and total vertebra T scores of lansoprazole group was significantly higher than of pantoprazole group (p = 0.04). Reduction in femur T score of esomeprazole group was higher than of lansoprazole group and pantroprazole group, but it is not statistically significant. Treatment with a PPI results in a significant reduction in bone density. Close monitoring is beneficial for patients who are to receive long-term treatment with PPI.

  14. Plasma carotenoids, vitamin C, retinol and tocopherols levels and pancreatic cancer risk within the European Prospective Investigation into Cancer and Nutrition: a nested case-control study: plasma micronutrients and pancreatic cancer risk.

    Science.gov (United States)

    Jeurnink, Suzanne M; Ros, Martine M; Leenders, Max; van Duijnhoven, Franzel J B; Siersema, Peter D; Jansen, Eugene H J M; van Gils, Carla H; Bakker, Marije F; Overvad, Kim; Roswall, Nina; Tjønneland, Anne; Boutron-Ruault, Marie-Christine; Racine, Antoine; Cadeau, Claire; Grote, Verena; Kaaks, Rudolf; Aleksandrova, Krasimira; Boeing, Heiner; Trichopoulou, Antonia; Benetou, Vasiliki; Valanou, Elisavet; Palli, Domenico; Krogh, Vittorio; Vineis, Paolo; Tumino, Rosario; Mattiello, Amalia; Weiderpass, Elisabete; Skeie, Guri; Castaño, José María Huerta; Duell, Eric J; Barricarte, Aurelio; Molina-Montes, Esther; Argüelles, Marcial; Dorronsoro, Mire; Johansen, Dorthe; Lindkvist, Björn; Sund, Malin; Crowe, Francesca L; Khaw, Kay-Tee; Jenab, Mazda; Fedirko, Veronika; Riboli, E; Bueno-de-Mesquita, H B

    2015-03-15

    Evidence of a protective effect of several antioxidants and other nutrients on pancreatic cancer risk is inconsistent. The aim of this study was to investigate the association for prediagnostic plasma levels of carotenoids, vitamin C, retinol and tocopherols with risk of pancreatic cancer in a case-control study nested within the European Prospective Investigation into Cancer and Nutrition (EPIC). 446 incident exocrine pancreatic cancer cases were matched to 446 controls by age at blood collection, study center, sex, date and time of blood collection, fasting status and hormone use. Plasma carotenoids (α- and β-carotene, lycopene, β-cryptoxanthin, canthaxanthin, zeaxanthin and lutein), α- and γ-tocopherol and retinol were measured by reverse phase high-performance liquid chromatography and plasma vitamin C by a colorimetric assay. Incidence rate ratios (IRRs) with 95% confidence intervals (95%CIs) for pancreatic cancer risk were estimated using a conditional logistic regression analysis, adjusted for smoking status, smoking duration and intensity, waist circumference, cotinine levels and diabetes status. Inverse associations with pancreatic cancer risk were found for plasma β-carotene (IRR highest vs. lowest quartile 0.52, 95%CI 0.31-0.88, p for trend = 0.02), zeaxanthin (IRR highest vs. lowest quartile 0.53, 95%CI 0.30-0.94, p for trend = 0.06) and α-tocopherol (IRR highest vs. lowest quartile 0.62, 95%CI 0.39-0.99, p for trend = 0.08. For α- and β-carotene, lutein, sum of carotenoids and γ-tocopherol, heterogeneity between geographical regions was observed. In conclusion, our results show that higher plasma concentrations of β-carotene, zeaxanthin and α-tocopherol may be inversely associated with risk of pancreatic cancer, but further studies are warranted.

  15. Antidepressant treatment-emergent affective switch in bipolar disorder: a prospective case-control study of outcome Ciclagem afetiva associada a tratamento com antidepressivo no transtorno bipolar: estudo caso-controle prospectivo

    Directory of Open Access Journals (Sweden)

    Renata Sayuri Tamada

    2006-12-01

    Full Text Available OBJECTIVE: Treatment-emergent affective switch has been associated to cycle acceleration and poorer outcome, but there are few studies addressing this issue. The aim of this study was to prospectively compare the outcome of patients presenting treatment-emergent affective switch with patients with spontaneous mania, regarding presence and polarity of a new episode and time to relapse. METHOD: Twenty-four patients with bipolar disorder according to the DSM-IV were followed for 12 months. Twelve patients had treatment-emergent affective switch and twelve had spontaneous mania. Patients were evaluated weekly with the Young Mania Rating Scale and the Hamilton Depression Scale until remission of the index episode, and monthly until completion of the 12-month follow-up. RESULTS: Eleven patients with treatment-emergent affective switch had a recurrence on follow-up, all of them with major depressive episodes. In the group with spontaneous mania, six patients had a recurrence: two had a depressive episode, and four had a manic episode (p = 0.069 for new episode, p = 0.006 for polarity of the episode. Patients with treatment-emergent affective switch relapsed in a shorter period than patients with spontaneous mania (p = 0.016. CONCLUSIONS: In this first prospective study, treatment-emergent affective switch patients were at greater risk of relapses, especially depressive episodes, and presented a shorter duration of remission when compared with patients with spontaneous mania.OBJETIVO: A ciclagem para mania associada ao antidepressivo tem sido relacionada à aceleração do ciclo e pior evolução, mas há poucos estudos na literatura sobre este assunto. O objetivo deste estudo foi comparar prospectivamente a evolução de pacientes com mania associada a antidepressivo com pacientes com mania espontânea, em relação a tempo para recaída e polaridade do novo episódio. MÉTODO: Vinte e quatro pacientes com transtorno bipolar, de acordo com os crit

  16. Effect of Low-Frequency Repetitive Transcranial Magnetic Stimulation on Naming Abilities in Early-Stroke Aphasic Patients: A Prospective, Randomized, Double-Blind Sham-Controlled Study

    Directory of Open Access Journals (Sweden)

    Konrad Waldowski

    2012-01-01

    Full Text Available Background and Purpose. Functional brain imaging studies with aphasia patients have shown increased cortical activation in the right hemisphere language homologues, which hypothetically may represent a maladaptive strategy that interferes with aphasia recovery. The aim of this study was to investigate whether low-frequency repetitive transcranial magnetic stimulation (rTMS over the Broca’s homologues in combination with speech/language therapy improves naming in early-stroke aphasia patients. Methods. 26 right-handed aphasic patients in the early stage (up to 12 weeks of a first-ever left hemisphere ischemic stroke were randomized to receive speech and language therapy combined with real or sham rTMS. Prior to each 45-minute therapeutic session (15 sessions, 5 days a week, 30 minutes of 1-Hz rTMS was applied. Outcome measures were obtained at baseline, immediately after 3 weeks of experimental treatment and 15 weeks; posttreatment using the Computerized Picture Naming Test. Results. Although both groups significantly improved their naming abilities after treatment, no significant differences were noted between the rTMS and sham stimulation groups. The additional analyses have revealed that the rTMS subgroup with a lesion including the anterior part of language area showed greater improvement primarily in naming reaction time 15 weeks after completion of the therapeutic treatment. Improvement was also demonstrated in functional communication abilities. Conclusions. Inhibitory rTMS of the unaffected right inferior frontal gyrus area in combination with speech and language therapy cannot be assumed as an effective method for all poststroke aphasia patients. The treatment seems to be beneficial for patients with frontal language area damage, mostly in the distant time after finishing rTMS procedure.

  17. Zika virus: History, emergence, biology, and prospects for control.

    Science.gov (United States)

    Weaver, Scott C; Costa, Federico; Garcia-Blanco, Mariano A; Ko, Albert I; Ribeiro, Guilherme S; Saade, George; Shi, Pei-Yong; Vasilakis, Nikos

    2016-06-01

    Zika virus (ZIKV), a previously obscure flavivirus closely related to dengue, West Nile, Japanese encephalitis and yellow fever viruses, has emerged explosively since 2007 to cause a series of epidemics in Micronesia, the South Pacific, and most recently the Americas. After its putative evolution in sub-Saharan Africa, ZIKV spread in the distant past to Asia and has probably emerged on multiple occasions into urban transmission cycles involving Aedes (Stegomyia) spp. mosquitoes and human amplification hosts, accompanied by a relatively mild dengue-like illness. The unprecedented numbers of people infected during recent outbreaks in the South Pacific and the Americas may have resulted in enough ZIKV infections to notice relatively rare congenital microcephaly and Guillain-Barré syndromes. Another hypothesis is that phenotypic changes in Asian lineage ZIKV strains led to these disease outcomes. Here, we review potential strategies to control the ongoing outbreak through vector-centric approaches as well as the prospects for the development of vaccines and therapeutics.

  18. A comparison of the effect of ramipril, felodipine and placebo on glomerular filtration rate, albuminuria, blood pressure and vasoactive hormones in chronic glomerulonephritis. A randomized, prospective, double-blind, placebo-controlled study over two years.

    Science.gov (United States)

    Pedersen, E B; Bech, J N; Nielsen, C B; Kornerup, H J; Hansen, H E; Spencer, E S; Sølling, J; Jensen, K T

    1997-12-01

    The effects of an ACE-inhibitor (ramipril), a calcium antagonist (felodipine) and placebo on glomerular filtration rate (GFR), urinary albumin/creatinine ratio, blood pressure (BP) and vasoactive hormones were investigated in a randomized, prospective, double-blind, placebo-controlled study of patients with chronic glomerulonephritis and hypertension, with measurements at entrance and after 12 and 24 months. In total, 33 patients were included: 21 completed the study with 7 patients in each group. GFR was measured as 51Cr-EDTA clearance and the vasoactive hormones with radioimmunoassays. The reduction in GFR was significantly more pronounced in the felodipine group (-7 ml/min) than in the ramipril group (0 ml/min) but the same as in the placebo group (-6 ml/min). The urinary albumin/creatinine ratio was significantly more reduced in the ramipril group (-74 mg/mmol) than in the placebo group (-11 mg/mmol), which did not deviate from the felodipine group (-10 mg/mmol). BP was significantly reduced by ramipril and felodipine, but not by placebo. Angiotensin II and aldosterone in plasma increased or tended to increase in the felodipine and placebo groups, but were unchanged in the ramipril group. Endothelin increased only in the placebo group, and vasopressin, atrial natriuretic peptide, and brain natriuretic peptide were not significantly changed in any of the groups. It is concluded that ramipril seems to be superior to felodipine in chronic glomerulonephritis owing to better preservation of GFR.

  19. A multicenter, prospective, randomized, controlled trial evaluating the safety and efficacy of intracoronary cell infusion mobilized with granulocyte colony-stimulating factor and darbepoetin after acute myocardial infarction: study design and rationale of the 'MAGIC cell-5-combination cytokine trial'

    Directory of Open Access Journals (Sweden)

    Yoon Jung-Han

    2011-02-01

    Full Text Available Abstract Background Bone marrow derived stem/progenitor cell transplantation after acute myocardial infarction is safe and effective for improving left ventricular systolic function. However, the improvement of left ventricular systolic function is limited. This study will evaluate novel stem/progenitor cell therapy with combination cytokine treatment of the long-acting erythropoietin analogue, darbepoetin, and granulocyte colony-stimulating factor (G-CSF in patients with acute myocardial infarction. Methods The 'MAGIC Cell-5-Combination Cytokine Trial' is a multicenter, prospective, randomized, 3-arm, controlled trial with blind evaluation of the endpoints. A total of 116 patients will randomly receive one of the following three treatments: an intravenous darbepoetin infusion and intracoronary infusion of peripheral blood stem cells mobilized with G-CSF (n = 58, an intracoronary infusion of peripheral blood stem cells mobilized with G-CSF alone (n = 29, or conventional therapy (n = 29 at phase I. Patients with left ventricular ejection fraction Discussion This is the first study to evaluate the safety and efficacy of combination cytokine based progenitor/stem cell treatment. Trial registration http://www.ClinicalTrials.gov identifier: NCT00501917.

  20. Effect of CRM team leader training on team performance and leadership behavior in simulated cardiac arrest scenarios: a prospective, randomized, controlled study.

    Science.gov (United States)

    Fernandez Castelao, Ezequiel; Boos, Margarete; Ringer, Christiane; Eich, Christoph; Russo, Sebastian G

    2015-07-24

    Effective team leadership in cardiopulmonary resuscitation (CPR) is well recognized as a crucial factor influencing performance. Generally, leadership training focuses on task requirements for leading as well as non-leading team members. We provided crisis resource management (CRM) training only for designated team leaders of advanced life support (ALS) trained teams. This study assessed the impact of the CRM team leader training on CPR performance and team leader verbalization. Forty-five teams of four members each were randomly assigned to one of two study groups: CRM team leader training (CRM-TL) and additional ALS-training (ALS add-on). After an initial lecture and three ALS skill training tutorials (basic life support, airway management and rhythm recognition/defibrillation) of 90-min each, one member of each team was randomly assigned to act as the team leader in the upcoming CPR simulation. Team leaders of the CRM-TL groups attended a 90-min CRM-TL training. All other participants received an additional 90-min ALS skill training. A simulated CPR scenario was videotaped and analyzed regarding no-flow time (NFT) percentage, adherence to the European Resuscitation Council 2010 ALS algorithm (ADH), and type and rate of team leader verbalizations (TLV). CRM-TL teams showed shorter, albeit statistically insignificant, NFT rates compared to ALS-Add teams (mean difference 1.34 (95% CI -2.5, 5.2), p = 0.48). ADH scores in the CRM-TL group were significantly higher (difference -6.4 (95% CI -10.3, -2.4), p = 0.002). Significantly higher TLV proportions were found for the CRM-TL group: direct orders (difference -1.82 (95% CI -2.4, -1.2), p team leaders in CRM improves performance of the entire team, in particular guideline adherence and team leader behavior. Emphasis on training of team leader behavior appears to be beneficial in resuscitation and emergency medical course performance.

  1. Combined use of hyperbaric and hypobaric ropivacaine significantly improves hemodynamic characteristics in spinal anesthesia for caesarean section: a prospective, double-blind, randomized, controlled study.

    Directory of Open Access Journals (Sweden)

    ZheFeng Quan

    Full Text Available To observe the hemodynamic changes of parturients in the combined use of hyperbaric (4 mg and hypobaric (6 mg ropivacaine during spinal anesthesia for caesarean section in this randomized double-blind study.Parturients (n = 136 undergoing elective cesarean delivery were randomly and equally allocated to receive either combined hyperbaric and hypobaric ropivacaine (Group A or hyperbaric ropivacaine (Group B. Outcome measures were: hemodynamic characteristics, maximum height of sensory block, time to achieve T8 sensory blockade level, incidence of complications, Apgar scores at 1 and 5 min, and neonatal blood gas analysis.Group A had a lower level of sensory blockade (T6 [T6-T7] and longer time to achieve T8 sensory blockade level (8 ± 1.3 min than did patients in Group B (T3 [T2-T4] and 5 ± 1.0 min, respectively; P < 0.001, both. The incidence rates for hypotension, nausea, and vomiting were significantly lower in Group A (13%, 10%, and 3%, respectively than Group B (66%, 31%, and 13%; P < 0.001, P = 0.003, P = 0.028.Combined use of hyperbaric (4 mg and hypobaric (6 mg ropivacaine significantly decreased the incidences of hypotension and complications in spinal anesthesia for caesarean section by extending induction time and decreasing the level of sensory blockade.Chinese Clinical Trial Register ChiCTR-TRC-13004622.

  2. Prospective randomized controlled study on small-window craniotomy versus ordinary large-window craniotomy in the evacuation of epidural hematoma

    Directory of Open Access Journals (Sweden)

    Lian-shui HU

    2014-05-01

    Full Text Available There is still controversy on the clinical efficacy of small-window craniotomy (SWCT for acute epidural hematoma with concurrent early-phase cerebral herniation. This study compared multiple surgical and prognostic parameters of SWCT versus ordinary large-window craniotomy (LWCT, which aimed at providing evidences for surgical decision. Compared with LWCT (N = 51, SWCT (N = 44 displayed shortened average operation time (P = 0.000, reduced intraoperative blood loss (P = 0.000 and lessened intraoperative blood transfusion (P = 0.031. Moreover, there was no differences of postoperative residual hematoma (P = 0.141, postoperative palinesthesia time (P = 0.201, the ratio of postoperative secondary ischemia (P = 0.865 or cerebral edema (P = 0.879, and 6-month Glasgow Outcome Scale (GOS score (P = 0.603 between the two surgical approaches.  Results suggested that, for patients with acute epidural hematoma and concurrent early-phase cerebral herniation, SWCT could effectively evacuate hematoma and relief brain herniation without significant differences of effect and prognosis from LWCT. In addition, SWCT has several advantages such as significantly reduced operation time, intraoperative blood loss and blood transfusion. doi: 10.3969/j.issn.1672-6731.2014.05.013

  3. DOES TRANEXEMIC ACID REDUCE BLOOD TRANSFUSION REQUIREMENTS PERIOPERATIVELY IN PATIENTS UNDERGOING SPINE STABILIZATION SURGERIES? A PROSPECTIVE RANDOMIZED DOUBLE BLINDED CONTROLLED STUDY

    Directory of Open Access Journals (Sweden)

    Pradeep

    2014-11-01

    Full Text Available BACKGROUND: Spine surgeries may involve uncontrolled bleeding, resulting primarily from large vein and persists even after the wound is closed. Proper patient positioning, use of hypotensive anaesthesia regimen and normothermia reduces blood loss, additional measures to reduce bleeding & transfusion requirement must be considered in spine surgery. MATERIALS AND METHODS: Forty patients of both sexes between the age group 21 to 60 years belonging to ASA I to III who were scheduled for spine stabilization surgeries was enrolled for the study were randomized into two groups with 20 in each. Anaesthetic technique was standardized. Group T received Tranexamic acid bolus of 10 mg/kg i.v. over 15 min. after patient positioning followed maintenance infusion of 1mg/kg/hr. And Group N Equivalent volume of Normal saline. Intra-operative blood losses was measured by weighing sponges, measuring suction drainage and estimates of blood loss on the surgical drapes and gowns by the attending anesthesiologist. Post-operative blood losses were assessed by measuring wound drainage until drains withdrawal. Investigations like Hb, Platelet, PT and APTT were done pre and post-operatively. Patients were assessed postoperatively daily for any clinical evidence of deep venous thrombosis.

  4. The prevention of contrast induced nephropathy by sarpogrelate in patients with chronic kidney disease: a study protocol for a prospective randomized controlled clinical trial

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    Kim Sang-Hyun

    2010-12-01

    Full Text Available Abstract Background Contrast-induced nephropathy (CIN is a serious clinical problem associated with increased morbidity and mortality, particularly in patients with chronic renal insufficiency. Although some agents including hydration with saline are being prescribed to prevent renal deterioration in these high risk patients, their efficacy is not clearly defined and debatable. Therefore additional prophylactic pretreatments are needed. Methods/Design The present study aims to investigate differences in occurrence of CIN after sarpogrelate premedication in patients with chronic kidney disease (CKD. 268 participants, aged 20-85 years with a clinical diagnosis of CKD will be recruited. They will be randomly allocated to one of two conditions: (i routine treatment without sarpogrelate, and (ii routine treatment with sarpogrelate (a fixed-flexible dose of 300 mg/day. The primary outcome is the occurrence of CIN during 4 weeks after receiving contrast agent. Discussion As of May 2010, there were no registered trials evaluating the therapeutic potentials of sarpogrelate in preventing for CIN. If sarpogrelate decreases the worsening of renal function and occurrence of CIN, it will provide a safe, easy and inexpensive treatment option. Trial registration NCT01165567

  5. Eletrencefalograma digital com mapeamento em demência de Alzheimer e doença de Parkinson: estudo prospectivo controlado Digital EEG with brain mapping in Alzheimer's dementia and Parkinson's disease: a prospective controlled study

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    Marcos C. Sandmann

    1996-03-01

    Full Text Available Com o intuito de estudar a atividade eletrencefalográfica em vigilia da demência senil de tipo Alzheimer (DA e da doença de Parkinson (DP foi iniciado estudo prospectivo e controlado. Foram comparados 6 pacientes com DA e 11 pacientes com DP, com um grupo controle composto por 12 pacientes com depressão maior crônica leve a moderada (DSM-III-R, 1987. Nos três grupos, através de análise espectral, foi obtida a mediana da frequência da energia da atividade dominante posterior. O grupo controle apresentou atividade posterior com frequência de 8,79 ± 0,52 (m±dp. No grupo com DA este valor foi 6,65 ± 0,80 (m±dp e no grupo com DP 7,69± 1,39 (m±dp. A hipótese experimental de que pacientes com DA e DP diferem dos controles em relação à atividade de fundo (definida como anormal sendo In order to evaluate the EEG activity during wakefulness in senile dementia of the Alzheimer type (AD and Parkinson's disease (PD, a prospective controlled study was performed. We compared 6 AD and 11 PD patients with a control group of 12 patients with mild to moderate major chronic depression (DSM-III-R 1987. The median of the frequencies and the power of the posterior dominant activity was obtained in the three groups using spectral analysis. The posterior activity had a frequency of 8.79±0.52 (mean±sd in the contrc group, 6.65+0.80 (mean+sd in the AD group and 7.69+1.39 (mean±sd in the PD group. The experimental hypothesis that patients with AD and PD differ from controls in relation to the background activity (defined a abnormal <8 was confirmed by the chi square test (p=0.0l and the t test showed that the mean of the frequency of the posterior power was significantly lower in AD (p=0.01 and PD (p=0.05 patients, compared with the controls. The results indicate that this abnormality could be correlated with the degree of cortical damage and natural history of these disorders.

  6. Assessment of the therapeutic benefit of dexamethasone cyclophosphamide pulse versus only oral cyclophosphamide in phase II of the dexamethasone cyclophosphamide pulse therapy: A preliminary prospective randomized controlled study

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    Nisha V Parmar

    2013-01-01

    Full Text Available Background: Dexamethasone cyclophosphamide pulse (DCP therapy is an established mode of treatment for pemphigus in India. Aims: To assess the therapeutic benefit of additional DCPs (phase II, consolidation phase versus immediate oral cyclophosphamide, usually used in phase III (maintenance phase, after initial DCP therapy (phase I and to assess which laboratory test (DIF or ELISA will reflect the clinical relapse best. Methods: Nineteen newly recruited patients of pemphigus vulgaris (PV received monthly DCPs in phase I and were then randomized into two groups. Group