980 resultados para controlled study


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The objective of the investigation who gave as result this work was to investigate the effectiveness of kinaesthetic motor imagery in the activation of the hemiplegic hand muscles following stroke. The experiment consisted of two random groups. Movements were measured after treatment. The participants were ten patients with hemiplegic hands (men who mean age was 74.4 years; mean time since stroke 3.05 months). All patients received three sessions of physical treatment based on an identical treatment protocol. Five patients were randomly assigned to an experimental group practising kinaesthetic motor imagery of a grasp using the 'lumbrical action' (experimental group). The others five (control group) followed a relaxation script. All the patients were then asked to grasp an object using the 'lumbrical action'. The grasps were recorded using an optoelectronic motion capture system. The magnitude of the extension of the index finger and the correlation of the angular displacement of the proximal phalangeal joints and the metacarpophalangeal joints were calculated. The movement time for the whole grip was calculated. The experimental group demonstrated higher extension in the index finger (p = < 0.01) and they had a higher correlation coefficient (0.99) than the control group (0.77) for the displacement of the proximal interphalangeal joint and the metacarpophalangeal joints. The movement time for the experimental group was faster, although the difference was not significant.

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Flavonoid extracts derived from plant foods have been shown to benefit certain types of fluid retention. However, no studies have investigated these compounds for use in premenstrual fluid retention, a complaint common among women with otherwise normal menstrual cycles. Therefore, we conducted a double-blind, placebo-controlled, pilot study into the effect of a daily flavonoid extract (Colladeen(R), 320 mg oligomeric procyanidins) on premenstrual fluid retention. Fluid retention was assessed at baseline and throughout 4 menstrual cycles of the intervention using validated questionnaires. Leg girth was also measured at baseline and at the end of the study. Thirty subjects completed the study (n = 18 active treatment; n = 12 placebo). Although no significant changes in leg girth measurements were noted, there was a significant improvement in subjective "leg health" scores after flavonoid treatment compared to placebo (p = 0.013). Furthermore, this was accompanied by an improvement in reported premenstrual fluid retention nearing significance (p = 0.066). We conclude that flavonoids supplements may provide a new therapeutic direction to counter premenstrual fluid retention and improve leg health. A larger study is now warranted.

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Objective: To evaluate the bifidogenic efficacy of two inulin doses in healthy human adults. Design: A double-blind, placebo-controlled, crossover human study. Setting: Food Microbial Sciences Unit, The University of Reading, Reading, UK. Subjects: Thirty healthy volunteers, 15 men, 15 women ( age range 19-35). Interventions: Subjects consumed a chocolate drink containing placebo ( maltodextrin, 8 g/day), 5 g/day inulin and 8 g/day inulin for a 2-week treatment period. Each treatment was followed by a 1-week washout at the end of which volunteers progressed to the next treatment. Faecal samples were obtained at the start of the study ( baseline) and at the end of each treatment and washout period. Fluorescent in situ hybridization was used to monitor populations of Bifidobacterium genus, Bacteroides - Prevotella, Lactobacillus - Enterococcus and Clostridium perfringens - histolyticum subgroup. Results: Bifidobacterial levels increased significantly upon ingestion of both the low ( 9.78 +/- 0.29 log(10) cells/g faeces, P < 0.05) and the high inulin dose ( 9.79 +/- 0.38 log(10) cells/g faeces, P < 0.05) compared to placebo ( 9.64 +/- 0.23 log(10) cells/g faeces). Conclusions: Both inulin doses exhibited a bifidogenic effect but a higher volunteer percentage responded to the high dose. A dose response effect was not observed but the magnitude of increase in bifidobacteria levels depended on their initial numbers. The higher the initial concentrations the smaller was the increase upon ingestion of the active treatments. Sponsorship: Financial support for the completion of this project was provided by Sensus ( Roosendaal, The Netherlands).

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Flavonoid extracts derived from plant foods have been shown to benefit certain types of fluid retention. However, no studies have investigated these compounds for use in premenstrual fluid retention, a complaint common among women with otherwise normal menstrual cycles. Therefore, we conducted a double-blind, placebo-controlled, pilot study into the effect of a daily flavonoid extract (Colladeen(R), 320 mg oligomeric procyanidins) on premenstrual fluid retention. Fluid retention was assessed at baseline and throughout 4 menstrual cycles of the intervention using validated questionnaires. Leg girth was also measured at baseline and at the end of the study. Thirty subjects completed the study (n = 18 active treatment; n = 12 placebo). Although no significant changes in leg girth measurements were noted, there was a significant improvement in subjective "leg health" scores after flavonoid treatment compared to placebo (p = 0.013). Furthermore, this was accompanied by an improvement in reported premenstrual fluid retention nearing significance (p = 0.066). We conclude that flavonoids supplements may provide a new therapeutic direction to counter premenstrual fluid retention and improve leg health. A larger study is now warranted.

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BACKGROUND: Accelerated gastric emptying (GE) may lead to reduced satiation, increased food intake and is associated with obesity and type 2 diabetes. Domperidone is a dopamine 2 (D(2)) receptor antagonist with claims of gastrointestinal tract pro-kinetic activity. In humans, domperidone is used as an anti-emetic and treatment for gastrointestinal bloating and discomfort. AIM: To determine the effect of acute domperidone administration on GE rate and appetite sensations in healthy adults. METHODS: A single-blind block randomised placebo-controlled crossover study assessed 13 healthy adults. Subjects ingested 10 mg domperidone or placebo 30 min before a high-fat (HF) test meal. GE rate was determined using the (13)CO(2) octanoic acid breath test. Breath samples and subjective appetite ratings were collected in the fasted and during the 360 min postprandial period. RESULTS:Gastric emptying half-time was similar following placebo (254 ± 54 min) and 10 mg domperidone (236 ± 65 min). Domperidone did not change appetite sensations during the 360 min postprandial period (P > 0.05). CONCLUSIONS: In healthy adults, acute administration of 10 mg domperidone did not change GE or appetite sensations following a HF test meal.

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Background: The beneficial cardiovascular effects of vegetables may be underpinned by their high inorganic nitrate content. Objective: We sought to examine the effects of a 6-wk once-daily intake of dietary nitrate (nitrate-rich beetroot juice) compared with placebo intake (nitrate-depleted beetroot juice) on vascular and platelet function in untreated hypercholesterolemics. Design: A total of 69 subjects were recruited in this randomized, double-blind, placebo-controlled parallel study. The primary endpoint was the change in vascular function determined with the use of ultrasound flow-mediated dilatation (FMD). Results: Baseline characteristics were similar between the groups, with primary outcome data available for 67 patients. Dietary nitrate resulted in an absolute increase in the FMD response of 1.1% (an ∼24% improvement from baseline) with a worsening of 0.3% in the placebo group (P < 0.001). A small improvement in the aortic pulse wave velocity (i.e., a decrease of 0.22 m/s; 95% CI: −0.4, −0.3 m/s) was evident in the nitrate group, showing a trend (P = 0.06) to improvement in comparison with the placebo group. Dietary nitrate also caused a small but significant reduction (7.6%) in platelet-monocyte aggregates compared with an increase of 10.1% in the placebo group (P = 0.004), with statistically significant reductions in stimulated (ex vivo) P-selectin expression compared with the placebo group (P < 0.05) but no significant changes in unstimulated expression. No adverse effects of dietary nitrate were detected. The composition of the salivary microbiome was altered after the nitrate treatment but not after the placebo treatment (P < 0.01). The proportions of 78 bacterial taxa were different after the nitrate treatment; of those taxa present, 2 taxa were responsible for >1% of this change, with the proportions of Rothia mucilaginosa trending to increase and Neisseria flavescens (P < 0.01) increased after nitrate treatment relative to after placebo treatment. Conclusions: Sustained dietary nitrate ingestion improves vascular function in hypercholesterolemic patients. These changes are associated with alterations in the oral microbiome and, in particular, nitrate-reducing genera. Our findings provide additional support for the assessment of the potential of dietary nitrate as a preventative strategy against atherogenesis in larger cohorts. This trial was registered at clinicaltrials.gov as NCT01493752.

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Background: The aim of this study was to evaluate root coverage of gingival recessions and to compare graft vascularization in smokers and non-smokers. Methods: Thirty subjects, 15 smokers and 15 non-smokers, were selected. Each subject had one Miller Class I or II recession in a non-molar tooth. Clinical measurements of probing depth (PD), relative clinical attachment level (CAL), gingival recession (GR), and width of keratinized tissue (KT) were determined at baseline and 3 and 6 months after surgery. The recessions were treated surgically with a coronally positioned flap associated with a subepithelial connective tissue graft. A small portion of this graft was prepared for immunohistochemistry. Blood vessels were identified and counted by expression of factor VIII-related antigen-stained endothelial cells. Results: Intragroup analysis showed that after 6 months there a was gain in CAL, a decrease in GR, and an increase in KT for both groups (P<0.05), whereas changes in PD were not statistically significant. Smokers had less root coverage than non-smokers (58.02% +/- 19.75% versus 83.35% +/- 18.53%; P<0.05). Furthermore, the smokers had more GR (1.48 +/- 0.79 mm versus 0.52 +/- 0.60 mm) than the nonsmokers (P<0.05). Histomorphometry of the donor tissue revealed a blood vessel density of 49.01 +/- 11.91 vessels/200x field for non-smokers and 36.53 +/- 10.23 vessels/200x field for smokers (P<0.05). Conclusion: Root coverage with subepithelial connective tissue graft was negatively affected by smoking, which limited and jeopardized treatment results.

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Objectives: The aim of the present study was to examine neonatal symptoms previously reported to be associated with exposure to antidepressant medication in late pregnancy in a group of infants exposed to antidepressants, using a prospective and controlled design.

Method: A prospective case-control study recruited 27 pregnant women taking antidepressant medication and 27 matched controls who were not taking antidepressant medication in pregnancy. Of the 27 women taking medication, 25 remained on medication in the third trimester and, of these, 23 women had complete data available. In pregnancy and after delivery women were assessed with the Beck Depression Inventory-II and a purpose-designed questionnaire. After delivery mothers were asked a set of nine questions pertaining to symptoms of discontinuation in their newborn and questions about pregnancy and delivery complications.

Results: There was an increased risk of discontinuation symptoms in neonates exposed to antidepressant medication in late pregnancy and an association with higher dose medication. The study group were found to be significantly more likely to display behaviour such as crying, jitteriness, tremor, feeding, reflux and sneezing and sleep for <3 h after a feed. They also had significantly higher rates of jaundice and admissions to the special care nursery.

Conclusions: Exposure to antidepressants in late pregnancy is associated with a range of symptoms in the neonate that are consistent with the effects of exposure to antidepressants in late pregnancy. The clusters of symptoms most highly correlated are the gastrointestinal and central nervous system symptoms. These finding helps to identify the common symptoms associated with a neonatal serotonin discontinuation syndrome.

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The use of alternative medicines and herbal remedies is an increasing trend in Western societies. For years, people have taken products made of deer velvet for their alleged beneficial effects on sexual function. There has been no scientific investigation of the effects of deer velvet powder on the sexual functioning of human males. This study investigated sexual function in men during a 12-week double-blind, placebo-controlled trial of deer velvet. Thirty-two volunteer male participants, aged 45–65 years, and their partners, were randomly assigned to either the deer velvet or placebo study group. The males took capsules containing ground deer velvet or placebo everyday for 12 weeks. Two sexual function questionnaires (the International Index of Erectile Function and the Brief Index of Sexual Function for Women) used at pre- and posttreatment assessed changes in sexual functioning in males and their partners. Blood tests at baseline, and end of study, determined levels of sex-related hormones in male participants. There were no significant differences in the sexual behavior of the men taking deer velvet compared with the men taking placebo capsules. There were no significant hormone changes from baseline to the end of the study in either group of men. We conclude that in normal males there was no advantage in taking deer velvet to enhance sexual function. All alternative health products or nutritional supplements should be subjected to randomized placebo-controlled trials to determine efficacy.

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A pilot study was conducted to evaluate the usefulness of granisetron for the treatment of antidepressant induced sexual dysfunction in women. Twelve women with antidepressant induced sexual dysfunction (AISD) were assigned granisetron (n=5) or placebo (n=7) in a 14-day randomized, double-blind, placebo-controlled study. One participant in the granisetron group did not complete the study. Participants were assessed at baseline, day 7 and day 14 using the Feiger Sexual Function and Satisfaction Questionnaire and the Arizona Sexual Experience Scale. No statistical differences were measured at baseline or at endpoint between the granisetron or placebo group. This study did not produce evidence supporting the usefulness of granisetron in AISD.