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4,266,769 | 25,516,773 |
BACKGROUND
Strong opioids in the home setting after ambulatory surgery have rarely been studied for fear of hazardous adverse effects such as respiratory depression.
OBJECTIVES
We compared the efficacy of paracetamol/controlled-release (CR) oxycodone and paracetamol/naproxen for treatment of acute postoperative pain at home after ambulatory surgery. Secondary outcomes were adverse effects of study medication, treatment satisfaction, and postoperative analgesic compliance.
METHODS
Patients undergoing ambulatory knee arthroscopy or inguinal hernia repair surgery (n = 105) were randomized into 3 groups: Group1 paracetamol/naproxen (n = 35), Group 2 paracetamol/CR oxycodone for 24 hours (n = 35), and Group 3 paracetamol/CR oxycodone for 48 hours (n = 35). Pain intensity at movement and at rest using a visual analog scale as well as satisfaction with postoperative analgesia and side effects were recorded for up to 48 hours postoperatively. Compliance with study medication was also assessed.
RESULTS
For pain at movement and at rest, no significant differences were found between the paracetamol/naproxen group and either the paracetamol/CR oxycodone for 24 hours group (β = 2.6 [4.9]; P = 0.597) or the paracetamol/CR oxycodone for 48 hours (β = -1.7 [5.1]; P = 0.736). No major adverse effects of study medication were registered and satisfaction with postoperative pain treatment was high in all groups. Compliance was comparable across the groups. Despite clear instructions, 8 patients with the lowest pain scores did not use any of the prescribed pain medication.
CONCLUSIONS
Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.
| 0no significant effect
|
4,511,304 | 26,221,523 |
INTRODUCTION
Two studies were carried out to investigate the efficacy and safety of luseogliflozin added to existing oral antidiabetic drugs (OADs) in Japanese type 2 diabetic patients inadequately controlled with OAD monotherapy.
MATERIALS AND METHODS
In the trial involving add-on to sulfonylureas (study 03-1), patients were randomly assigned to receive luseogliflozin 2.5 mg or a placebo for a 24-week double-blind period, followed by a 28-week open-label period. In the open-label trial involving add-on to other OADs; that is, biguanides, dipeptidyl peptidase-4 inhibitors, thiazolidinediones, glinides and α-glucosidase inhibitors (study 03-2), patients received luseogliflozin for 52 weeks.
RESULTS
In study 03-1, luseogliflozin significantly decreased glycated hemoglobin at the end of the 24-week double-blind period compared with the placebo (-0.88%, P < 0.001), and glycated hemoglobin reduction from baseline at week 52 was -0.63%. In study 03-2, luseogliflozin added to other OADs significantly decreased glycated hemoglobin from baseline at week 52 (-0.52 to -0.68%, P < 0.001 for all OADs). Bodyweight reduction was observed in all add-on therapies, even with agents associated with weight gain, such as sulfonylureas and thiazolidinediones. Most adverse events were mild in severity. When added to a sulfonylurea, incidences of hypoglycemia during the double-blind period were 8.7% and 4.2% for luseogliflozin and placebo, respectively, but no major hypoglycemic episodes occurred. The frequency and incidences of adverse events of special interest for sodium glucose cotransporter 2 inhibitors and adverse events associated with combined OADs were acceptable.
CONCLUSIONS
Add-on therapies of luseogliflozin to existing OADs improved glycemic control, reduced bodyweight and were well tolerated in Japanese type 2 diabetic patients. These trials were registered with the Japan Pharmaceutical Information Center (add on to sulfonylurea: JapicCTI-111507; add on to other OADs: JapicCTI-111508).
| 1significant effect
|
2,447,849 | 18,588,670 |
BACKGROUND
Self-administered questionnaires are becoming increasingly common in general practice. Much research has explored methods to increase response rates but comparatively few studies have explored the effect of questionnaire administration on reported answers.
METHODS
The aim of this study was to determine the effect on responses of returning patient questionnaires to the respondents' medical practice or an independent researcher to questions relating to adherence and satisfaction with a GP consultation. One medical practice in Waveney primary care trust, Suffolk, England participated in this randomised trial. Patients over 18 years initiated on a new long-term medication during a consultation with a GP were randomly allocated to return a survey from their medical practice to either their medical practice or an independent researcher. The main outcome measures were self reported adherence, satisfaction with information about the newly prescribed medicine, the consultation and involvement in discussions.
RESULTS
274 (47%) patients responded to the questionnaire (45% medical practice, 48% independent researcher (95% CI -5 to 11%, p = 0.46)) and the groups appeared demographically comparable, although the high level of non-response limits the ability to assess this. There were no significant differences between the groups with respect to total adherence or any of the satisfaction scales. Five (4%) patients reported altering doses of medication in the medical practice group compared with 18 (13%) in the researcher group (P = 0.009, Fisher's exact test). More patients in the medical practice group reported difficulties using their medication compared to the researcher group (46 (35%) v 30 (21%); p = 0.015, Fisher's exact test).
CONCLUSION
Postal satisfaction questionnaires do not appear to be affected by whether they are returned to the patient's own medical practice or an independent researcher. However, returning postal questionnaires relating to detailed patient behaviours may be subject to response biases and further work is needed to explore this phenomena.
| 0no significant effect
|
4,030,121 | 24,868,217 |
PURPOSE
This study aimed to evaluate the autonomic imbalance in syncope by comparing the baseline heart rate variability (HRV) between healthy children and those with vasovagal syncope.
METHODS
To characterize the autonomic profile in children experiencing vasovagal syncope, we evaluated the HRV of 23 patients aged 7-18 years and 20 healthy children. These children were divided into preadolescent (<12 years) and adolescent groups. The following time-domain indices were calculated: root mean square of the successive differences (RMSSD); standard deviation of all average R-R intervals (SDNN); and frequency domain indices including high frequency (HF), low frequency (LF), normalized high frequency, normalized low frequency, and low frequency to high frequency ratio (LF/HF).
RESULTS
HRV values were significantly different between healthy children and those with syncope. Student t test indicated significantly higher SNDD values (60.46 ms vs. 37.42 ms, P=0.003) and RMSSD (57.90 ms vs. 26.92 ms, P=0.000) in the patient group than in the control group. In the patient group, RMSSD (80.41 ms vs. 45.89 ms, P=0.015) and normalized HF (61.18 ms vs. 43.19 ms, P=0.022) were significantly higher in adolescents, whereas normalized LF (38.81 ms vs. 56.76 ms, P=0.022) and LF/HF ratio (0.76 vs. 1.89, P=0.041) were significantly lower in adolescents. In contrast, the control group did not have significant differences in HRV values between adolescents and preadolescents.
CONCLUSION
The results of this study indicated that children with syncope had a decreased sympathetic tone and increased vagal tone compared to healthy children. Additionally, more severe autonomic imbalances possibly occur in adolescents than in preadolescents.
| 1significant effect
|
5,325,897 | 28,286,835 |
INTRODUCTION
Evaluation of students' learning in clinical education system is one of the most important and challenging issues that facilities in this field have been facing. The present study aimed to evaluate the role of feedback during evaluation in increasing emergency medicine residents' clinical skills.
METHOD
The present experimental study was performed on all second year emergency medicine residents of two educational hospitals, Tehran, Iran, with switching replications design and before-after method. They were randomly allocated to two groups (with or without feedback) and evaluated three times regarding chest ultrasonography for trauma patients, using direct observation of procedural skills (DOPS) and valid and reliable checklist. Data were analyzed using SPSS 20.
RESULTS
30 emergency medicine residents with the mean age of 36.63 ± 30.30 years were allocated to two equal groups (56.7% male). Studied groups were similar regarding the baseline characteristics. In both groups, obtained scores showed a significant increase from the first to the third evaluation (p < 0.001). Mean scores of first and second evaluations were 10.24 ± 0.77, 17.73 ± 0.46 in feedback receivers and 9.73 ± 0.77 and 12.13 ± 0.47 in others (p < 0.001). Mean third score after switching groups were 18.53 ± 0.22 in feedback receivers and 18.99 ± 0.22 in others (p = 0.213).
CONCLUSION
Based on the findings of the present study, giving feedback after evaluating the second year emergency medicine residents regarding chest ultrasonography for trauma patients, led to a significant improvement in their scores in future evaluations and consequently their skill.
| 1significant effect
|
3,821,103 | 24,223,330 |
BACKGROUND
Intra-articular analgesia is a pain reliever that is frequently administered following arthroscopic knee surgery.
OBJECTIVES
The purpose of this study was to compare the efficacy of intra-articular application of morphine and tramadol on postoperative pain after arthroscopic knee surgery.
PATIENTS AND METHODS
For this randomized double blinded clinical trial, 132 patients undergoing minor arthroscopic knee surgery were randomly assigned to receive either; 5 mg morphine or 50 mg tramadol intra-articularly. Pain was evaluated by means of the verbal pain rating score (VRS) preoperatively (at rest and on movement of the knee joint) and postoperatively at 0, 1, 2, 3, 4, 6, 12 and 24 hours. Meanwhile, the time of the first analgesic request and need for supplemental analgesic were also recorded.
RESULTS
There was no statistically significant difference in VRS scoring between the two groups during the preoperative period either at rest or on knee movement. Meanwhile, VRS scores did not differ significantly between the morphine and tramadol treated groups postoperatively, except for in the one-hour post-operative scores in which the tramadol-treated group experienced less pain (P < 0.007). Post-operative VRS scores at 6, 12, and 24 hours were significantly decreased when compared with previous scores in both morphine and tramadol prescribed subjects (P < 0.001), hence, both local analgesics can significantly reduce pain after minor knee surgery.
CONCLUSIONS
We have found a postoperative analgesic effect of intra-articularly administered morphine and tramadol following minor arthroscopic knee surgeries with a maximum effect 6 hours post injection.
| 1significant effect
|
5,273,788 | 28,129,772 |
BACKGROUND
Concern exists about the safety of iron supplementation given to individuals in malarious areas. The possible unfavourable impact of iron supplementation on malaria might be less when slow-release iron compounds are used instead of ferrous salts, because no toxic non-transferrin bound iron is formed. The aim of this study was to determine the effect of iron supplementation using the slow-release iron compound iron polymaltose (IPM) on the acquisition of malarial parasitaemia.
METHODS
A randomized, placebo-controlled trial was performed in schoolchildren aged 5-18 years with mild or moderate anaemia on the Indonesian island Flores. Microscopic malaria-negative children were randomized to receive 8 weeks of IPM (6 mg elemental iron/kg/day) or placebo . The primary outcomes were the occurrence of microscopically detectable malarial parasitaemia at week 4, 8, 12 and 16 after start of treatment and the proportion of participants with real-time (RT) PCR positive malarial parasitaemia at week 16.
RESULTS
294 Children were assigned to the IPM group and 297 to the placebo group. Whereas IPM supplementation failed to increased haemoglobin or ferritin concentrations, the IPM group had a significantly higher rate of occurrence of microscopically detectable parasitaemia [hazard ratio 2.2, 95% C.I. 1.2-4.0; P = 0.01]. This higher rate was confined to iron-replete children. At the end of the study, 89% of the children in the IPM group had remained free from microscopically detectable parasitaemia vs 95% of children in the placebo group. The proportion of plasmodial RT-PCR positive children was similar in both groups at week 16 (IPM group 16.6% vs placebo group 14.3%; P = 0.47). When analysis was restricted to iron-replete children (serum ferritin ≥30 µg/l), there was a trend for a higher proportion being RT-PCR positive at week 16 in the IPM group compared with the placebo group (20 vs 13.3%; P = 0.07). Erythrocyte microcytosis was an independent risk factor for microscopically detectable malarial parasitaemia.
CONCLUSIONS
A short course of IPM should be used cautiously in anaemic children in malaria endemic areas, as it has limited efficacy in treating iron deficiency, while it increases the rate of microscopic malarial parasitaemia in those with replete iron stores. Trial registration ISRCTN 83091970. Registered 16 May 2012 (retrospectively registered).
| 0no significant effect
|
3,424,202 | 22,818,552 |
BACKGROUND
Resistance in Plasmodium falciparum to commonly used anti-malarial drugs, especially chloroquine, is being increasingly documented in India. By 2007, the first-line treatment for uncomplicated malaria has been revised to recommend artemisinin-based combination therapy (ACT) for all confirmed P. falciparum cases.
OBJECTIVE
The objective of this study was to compare the efficacy, safety and tolerability between dihydroartemisinin-piperaquine (DP) and artesunate plus mefloquine (A + M) drug combinations in the treatment of uncomplicated P. falciparum malaria in India.
METHODS
Between 2006 and 2007, 150 patients with acute uncomplicated P. falciparum malaria were enrolled, randomized to DP (101) or A + M (49) and followed up for 63 days as part of an open-label, non-inferiority, randomized, phase III multicenter trial in Asia.
RESULTS
The heterogeneity analysis showed no statistically significant difference between India and the other countries involved in the phase III study, for both the PCR-corrected and uncorrected cure rates. As shown at the whole study level, both forms of ACT were highly efficacious in India. In fact, in the per protocol population, the 63-day cure rates were 100% for A + M and 98.8% for DP. The DP combination exerted a significant post-treatment prophylactic effect, and compared with A + M a significant reduction in the incidence of new infections for DP was observed (respectively 17.1% versus 7.5% of patients experienced new infection within follow up). Parasite and fever clearance was rapid in both treatment arms (median time to parasite clearance of one day for both groups). Both DP and A + M were well tolerated, with the majority of adverse events of mild or moderate severity. The frequencies of individual adverse events were generally similar between treatments, although the incidence of post treatment adverse events was slightly higher in patients who received A + M with respect to those treated with DP.
CONCLUSION
DP is a new ACT displaying high efficacy and safety in the treatment of uncomplicated P. falciparum malaria and could potentially be considered for the first-line treatment of uncomplicated falciparum malaria in India.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN 81306618.
| 1significant effect
|
5,200,867 | 28,050,319 |
PURPOSE
The present study investigated the impact of 2 different suture techniques, the conventional crossed mattress suture (X suture) and the novel hidden X suture, for alveolar ridge preservation (ARP) with an open healing approach.
METHODS
This study was a prospective randomized controlled clinical trial. Fourteen patients requiring extraction of the maxillary or mandibular posterior teeth were enrolled and allocated into 2 groups. After extraction, demineralized bovine bone matrix mixed with 10% collagen (DBBM-C) was grafted and the socket was covered by porcine collagen membrane in a double-layer fashion. No attempt to obtain primary closure was made. The hidden X suture and conventional X suture techniques were performed in the test and control groups, respectively. Cone-beam computed tomographic (CBCT) images were taken immediately after the graft procedure and before implant surgery 4 months later. Additionally, the change in the mucogingival junction (MGJ) position was measured and was compared after extraction, after suturing, and 4 months after the operation.
RESULTS
All sites healed without any complications. Clinical evaluations showed that the MGJ line shifted to the lingual side immediately after the application of the X suture by 1.56±0.90 mm in the control group, while the application of the hidden X suture rather pushed the MGJ line slightly to the buccal side by 0.25±0.66 mm. It was demonstrated that the amount of keratinized tissue (KT) preserved on the buccal side was significantly greater in the hidden X suture group 4 months after the procedure ( P <0.05). Radiographic analysis showed that the hidden X suture had a significant effect in preserving horizontal width and minimizing vertical reduction in comparison to X suture ( P <0.05).
CONCLUSIONS
Our study provided clinical and radiographic verification of the efficacy of the hidden X suture in preserving the width of KT and the dimensions of the alveolar ridge after ARP.
| 1significant effect
|
4,482,193 | 26,062,731 |
INTRODUCTION
The worldwide shortage of donor livers has prompted the search for alternative cell therapies. Previous data from our laboratory proved a supportive role for stem cell therapy in the treatment of end-stage liver disease patients. Therefore; this study was conducted to assess the clinical and biochemical effects of repeated stem cell infusion.
METHODS
Ninety patients with liver cirrhosis were randomized to receive either one session treatment (G-I) or two sessions 4 months apart (G-II) of autologous haematopoietic stem cells (HSCs) transplantation and a control group (G-III) who received regular liver treatment. G-CSF was administered to transplanted patients before infusion; HSCs were isolated from 400 cc bone marrow (BM) aspirate. CD34+/CD133+ cells were purified: 50 % of the cells were infused locally in the portal vein on the same day and the other 50 % were differentiated to MSC and infused systemically in a peripheral vein (one session treatment G-I). In G-II, the same process was repeated after 4 months from the first treatment (two session's treatment G-II). Liver function was monitored for 12 months after stem cell therapy (SCT).
RESULTS
Statistically significant improvement was reported in the transplanted patients (G-1) as regards the mean serum albumin, bilirubin and INR levels which started to improve after 2 weeks of treatment and continued to improve till the 6(th) month in the single infusion group. The two sessions infused group (G-II) showed sustained response which continued throughout the all follow-up period (12 month). By the end of the study, 36.7 % of the patients in G-I and 66.7 % in G-II showed improvement in the degree of ascites compared to the control group (G-III). We also reported an improvement in the hepatic functional reserve as assessed by the Child-Pugh and MELD score. Safety of the procedure was evidenced by the low incidence of complications encountered.
CONCLUSION
In patients with end-stage liver disease, the repeated infusion with combined routes portal and peripheral veins has a beneficial effect on liver functions with minimal adverse events and more lasting clinical efficacy after repeated HSCs infusion.
| 1significant effect
|
4,173,360 | 25,885,300 |
BACKGROUND
Intubating Laryngeal Mask Airway (ILMA) is a relatively new device designed to have better intubating characteristics than the standard Laryngeal Mask Airway. This study was designed to compare Intubating Laryngeal Mask with standard Direct Laryngoscopy (DLS), taking into account ease of intubation, time taken for intubation, success rate of intubation, hemodynamic responses and upper airway morbidity.
MATERIALS AND METHODS
Sixty patients, ASA I or II, of age between 20 and 60 years, were enrolled in this prospective and randomized study. They were randomly allocated to one of the two groups: group ILMA, Intubating Laryngeal Mask Airway; group DLS, Direct Laryngoscopy. The patients were intubated orally using either equipment after induction of general anesthesia.
RESULTS AND CONCLUSIONS
DLS is comparatively a faster method to secure tracheal intubation than Intubating Laryngeal Mask. ILMA offers no advantage in attenuating the hemodynamic responses compared to direct laryngoscope. The success rate of intubation through Intubating Laryngeal Mask is comparable with that of DLS. The upper airway morbidity and mean oxygen saturation are comparable in both the groups.
| 0no significant effect
|
5,636,096 | 29,020,023 |
BACKGROUND
Minimal hepatic encephalopathy (MHE) is clinically undetectable and the diagnosis requires psychometric tests. However, a lack of clarity exists as to whether the tests are in fact able to detect changes in cognition.
AIM
To examine if the continuous reaction time test (CRT) can detect changes in cognition with anti-HE intervention in patients with cirrhosis and without clinically manifest hepatic encephalopathy (HE).
METHODS
Firstly, we conducted a reproducibility analysis and secondly measured change in CRT induced by anti-HE treatment in a randomized controlled pilot study: We stratified 44 patients with liver cirrhosis and without clinically manifest HE according to a normal (n = 22) or abnormal (n = 22) CRT. Each stratum was then block randomized to receive multimodal anti-HE intervention (lactulose+branched-chain amino acids+rifaximin) or triple placebos for 3 months in a double-blinded fashion. The CRT is a simple PC-based test and the test result, the CRT index (normal threshold > 1.9), describes the patient's stability of alertness during the 10-minute test. Our study outcome was the change in CRT index in each group at study exit. The portosystemic encephalopathy (PSE) test, a paper-and-pencil test battery (normal threshold above -5), was used as a comparator test according to international guidelines.
RESULTS
The patients with an abnormal CRT index who were randomized to receive the active intervention normalized or improved their CRT index (mean change 0.92 ± 0.29, p = 0.01). Additionally, their PSE improved (change 3.85 ± 1.83, p = 0.03). There was no such effect in any of the other study groups.
CONCLUSION
In this cohort of patients with liver cirrhosis and no manifest HE, the CRT identified a group in whom cognition improved with intensive anti-HE intervention. This finding infers that the CRT can detect a response to treatment and might help in selecting patients for treatment.
| 1significant effect
|
2,936,735 | 20,859,490 |
BACKGROUND
Despite remarkable progress that has been achieved in the recent years in the diagnosis, prevention, and therapy for ventilator-associated pneumonia (VAP), this disease continues to create complication during the course of treatment in a significant proportion of patients while receiving mechanical ventilation.
OBJECTIVE
This study was designed to evaluate the effect of multimodality chest physiotherapy in intubated and mechanically ventilated patients undergoing treatment in the intensive care units (ICUs) for prevention of VAP.
PATIENTS AND METHODS
A total of 101 adult intubated and mechanically ventilated patients were included in this study. Manual hyperinflation (MH) and suctioning were administered to patients in the control group (n = 51), and positioning and chest wall vibrations in addition to MH plus suctioning (multimodality chest physiotherapy) were administered to patients in the study group (n = 50) till they were extubated. Both the groups were subjected to treatment twice a day. Standard care in the form of routine nursing care, pharmacological therapy, inhalation therapy, as advised by the concerned physician/surgeon was strictly implemented throughout the intervention period.
RESULTS
Data were analyzed using SPSS window version 9.0. The Clinical Pulmonary infection Score (CPIS) Score showed significant decrease at the end of extubation/successful outcome or discharge in both the groups (P = 0.00). In addition, significant decrease in mortality rate was noted in the study group (24%) as compared to the control group (49%) (P = 0.007).
CONCLUSIONS
It was observed in this study that twice-daily multimodality chest physiotherapy was associated with a significant decrease in the CPIS Scores in the study group as compared to the control group suggesting a decrease in the occurrence of VAP. There was also a significant reduction in the mortality rates with the use of multimodality chest physiotherapy in mechanically ventilated patients.
| 0no significant effect
|
5,963,741 | 29,735,965 |
BACKGROUND Mild moxibustion has been reported to effectively treat menopausal syndrome. This study investigated the efficacy and safety of using mild moxibustion at Shenshu for treating sub-health states in perimenopausal women. MATERIAL AND METHODS Sixty participants were randomly assigned to moxibustion and control groups. Participants in the moxibustion group received mild moxibustion at bilateral Shenshu (BL23) for 15 min daily. A course was 5 days, with 2 days between courses; treatment was conducted for 4 courses. Participants in the control group were given vitamin E soft capsules for 28 days. Physical condition, living conditions, emotional status, and energy status scores were assessed, and serum sex hormone levels measured. RESULTS Mild moxibustion significantly improved physical condition, living conditions, and emotional status compared to the control group after treatment ([i]P[/i]<0.05). Physical condition ([i]P[/i]<0.01) and living conditions ([i]P[/i]<0.05) improved significantly in post-menopausal women, while living conditions and emotional status were improved in pre-menopausal women ([i]P[/i]<0.05). Serum estradiol level was significantly higher after moxibustion, especially for pre-menopausal women ([i]P[/i]<0.01). CONCLUSIONS Mild moxibustion is safe and effective for treating sub-health state in pre-menopausal and post-menopausal women. A study with larger sample size and longer-term treatment is needed for further assessment of this topic.
| 1significant effect
|
5,099,199 | 26,338,825 |
OBJECTIVE
Significant heterogeneity was observed in previous trials that assessed the efficacies of sequential therapy for 10 days (S10) versus triple therapy for 14 days (T14) in the first-line treatment of Helicobacter pylori. We aimed to compare the efficacy of S10 and T14 and assess the factors affecting their efficacies.
DESIGN
We conducted this open-label randomised multicentre trial in eight hospitals and one community in Taiwan. 1300 adult subjects with H pylori infection naïve to treatment were randomised (1:1) to receive S10 (lansoprazole and amoxicillin for the first 5 days, followed by lansoprazole, clarithromycin and metronidazole for another 5 days) or T14 (lansoprazole, amoxicillin and clarithromycin for 14 days). All drugs were given twice daily. Successful eradication was defined as negative 13 C-urea breath test at least 6 weeks after treatment. Our primary outcome was the eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. Antibiotic resistance was determined by agar dilution test.
RESULTS
The eradication rates of S10 and T14 were 87.2% (567/650, 95% CI 84.4% to 89.6%) and 85.7% (557/650, 95% CI 82.8% to 88.2%) in the ITT analysis, respectively, and were 91.6% (556/607, 95% CI 89.1% to 93.4%) and 91.0% (548/602, 95% CI 88.5% to 93.1%) in the PP analysis, respectively. There were no differences in compliance or adverse effects. The eradication rates in strains susceptible and resistant to clarithromycin were 90.7% and 62.2%, respectively, for S10, and were 91.5% and 44.4%, respectively, for T14. The efficacy of T14, but not S10, was affected by CYP2C19 polymorphism.
CONCLUSIONS
S10 was not superior to T14 in areas with low clarithromycin resistance.
TRIAL REGISTRATION NUMBER
NCT01607918.
| 0no significant effect
|
3,407,716 | 22,540,955 |
BACKGROUND
Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.
METHODS
We conducted a prospective randomised clinical trial on patients undergoing thyroid surgery. Patients were randomly assigned to a drain group (n = 49) or a no-drain group (n = 44) immediately prior to wound closure. Patients underwent a neck ultrasound on day 1 and day 2 postoperatively. After surgery, we evaluated visual analogue scale pain scores, postoperative analgesic requirements, self-reported scar satisfaction at 6 weeks and complications.
RESULTS
There was significantly less mean fluid accumulated in the drain group on both day 1, 16.4 versus 25.1 ml (P-value = 0.005), and day 2, 18.4 versus 25.7 ml (P-value = 0.026), following surgery. We found no significant differences between the groups with regard to length of stay, scar satisfaction, visual analogue scale pain score and analgesic requirements. There were four versus one wound infections in the drain versus no-drain groups. This finding was not statistically significant (P = 0.154). No life-threatening bleeds occurred in either group.
CONCLUSIONS
Fluid accumulation after thyroid surgery was significantly lessened by drainage. However, this study did not show any clinical benefit associated with this finding in the nonemergent setting. Drains themselves showed a trend indicating that they may augment infection rates. The results of this study suggest that the frequency of acute life-threatening bleeds remains extremely low following abandoning drains. We advocate abandoning routine use of thyroid drains.
TRIAL REGISTRATION
ISRCTN94715414.
| 1significant effect
|
5,412,886 | 27,869,354 |
BACKGROUND
Allergic conjunctivitis (AC) is a disease of various agents that affects the physical and mental health of children. Although the most effective therapy has not been found so far, it is essential to explore the considerable therapeutic method. We compared the clinical efficacy of olopatadine, emedastine, loteprednol etabonate (LE), and vehicle for treating seasonal allergic conjunctivitis (SAC) in Chinese children.
METHODS
Eighty cases of 160 eyes aged from 5 to 10 years with SAC were available and those subjects were randomly distributed into 4 groups. Both their eyes received olopatadine hydrochloride 0.1% twice a day, emedastine difumarate 0.05% twice a day, or LE 0.5% 4 times a day, respectively, whereas those of the control group received artificial tears (AT) 0.5% 3 times a day. This study was conducted successfully and the observations were collected before treatment and on day 8 (±1 day) and day 15 (±2 days) afterward. The principal measurement of efficacy was focused on the signs and symptoms of the subjects, evaluated before and after treatment, in addition to visual acuity (VA) and fundus oculi.
RESULTS
On day 8 (±1 day) and day 15 (±2 days), all the antiallergic agents were found to be more effective than vehicle (p < 0.05) in terms of all the symptoms and signs. However, there was no statistical significance (p ≥ 0.05) shown among the treatment groups. There were no evident changes in VA and no clinically significant changes were observed in fundus oculi.
CONCLUSION
After the treatment, the efficacy presented a similar distribution among the trial groups.
| 0no significant effect
|
4,845,107 | 26,486,166 |
BACKGROUND
Patients with diabetes mellitus and cardiovascular disease may not achieve adequate low-density lipoprotein cholesterol (LDL-C) lowering on statin monotherapy, attributed partly to atherogenic dyslipidemia. More intensive LDL-C-lowering therapy can be considered for these patients. A previous randomized, controlled study demonstrated greater LDL-C lowering in diabetic patients with symptomatic cardiovascular disease who switched from simvastatin 20 mg (S20) or atorvastatin 10 mg (A10) to combination ezetimibe/simvastatin 10/20 mg (ES10/20) therapy, compared with statin dose-doubling (to S40 or A20) or switching to rosuvastatin 10 mg (R10). The effect of these regimens on novel biomarkers of atherogenic dyslipidemia (low- and high-density lipoprotein particle number and lipoprotein-associated phospholipase A2 [Lp-PLA2]) was assessed.
METHODS AND RESULTS
Treatment effects on low- and high-density lipoprotein particle number (by NMR) and Lp-PLA2 (by ELISA) were evaluated using plasma samples available from 358 subjects in the study. Switching to ES10/20 reduced low-density lipoprotein-particle number numerically more than did statin dose-doubling and was comparable with R10 (-133.3, -94.4, and -56.3 nmol/L, respectively; P>0.05). Increases in high-density lipoprotein particle number were significantly greater with switches to ES10/20 versus statin dose-doubling (1.5 and -0.5 μmol/L; P<0.05) and comparable with R10 (0.7 μmol/L; P>0.05). Percentages of patients attaining low-density lipoprotein particle number levels <990 nmol/L were 62.4% for ES10/20, 54.1% for statin dose-doubling, and 57.0% for R10. Switching to ES10/20 reduced Lp-PLA2 activity significantly more than did statin dose-doubling (-28.0 versus -3.8 nmol/min per mL, P<0.05) and was comparable with R10 (-28.0 versus -18.6 nmol/min per mL; P>0.05); effects on Lp-PLA2 concentration were modest.
CONCLUSIONS
In diabetic patients with dyslipidemia, switching from statins to combination ES10/20 therapy generally improved lipoprotein subclass profile and Lp-PLA2 activity more than did statin dose-doubling and was comparable with R10, consistent with its lipid effects.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00862251.
| 1significant effect
|
3,517,358 | 22,873,635 |
BACKGROUND
At present, what students read after an outpatient encounter is largely left up to them. Our objective was to evaluate the education efficacy of a clinical education model in which the student moves through a sequence that includes immediately reinforcing their learning using a specifically designed computer tutorial.
METHODS
Prior to a 14-day Pediatric Emergency rotation, medical students completed pre-tests for two common pediatric topics: Oral Rehydration Solutions (ORS) and Fever Without Source (FWS). After encountering a patient with either FWS or a patient needing ORS, the student logged into a computer that randomly assigned them to either a) completing a relevant computer tutorial (e.g. FWS patient + FWS tutorial = "in sequence") or b) completing the non-relevant tutorial (e.g. FWS patient + ORS tutorial = "out of sequence"). At the end of their rotation, they were tested again on both topics. Our main outcome was post-test scores on a given tutorial topic, contrasted by whether done in- or out-of-sequence.
RESULTS
Ninety-two students completed the study protocol with 41 in the 'in sequence' group. Pre-test scores did not differ significantly. Overall, doing a computer tutorial in sequence resulted in significantly greater post-test scores (z-score 1.1 (SD 0.70) in sequence vs. 0.52 (1.1) out-of-sequence; 95% CI for difference +0.16, +0.93). Students spent longer on the tutorials when they were done in sequence (12.1 min (SD 7.3) vs. 10.5 (6.5)) though the difference was not statistically significant (95% CI diff: -1.2 min, +4.5).
CONCLUSIONS
Outpatient learning frameworks could be structured to take best advantage of the heightened learning potential created by patient encounters. We propose the Patient-Teacher-Tutorial sequence as a framework for organizing learning in outpatient clinical settings.
| 0no significant effect
|
5,358,282 | 28,357,010 |
BACKGROUND
Premedication with benzodiazepines has been thought to reduce patient anxiety, pain perception, and non-catheter-induced coronary spasms and may increase procedure-related complications. We used to routinely provide premedication with diazepam and chlorpheniramine before cardiac catheterization procedures. However the benefits of such a treatment are not well established here. Therefore, we designed this study to test whether the routine use of premedication during coronary angiography is needed.
METHODS
A total of 200 consecutive patients scheduled to undergo either diagnostic or therapeutic coronary angiographic procedures were randomized to receive either premedication with diazepam (5 mg) and chlorpheniramine (4 mg) 60 minutes prior to their procedures (n = 100) or no premedication (n = 100). The administration of intravenous midazolam during the procedures was permitted at the operator's discretion. The primary endpoints were anxiety and pain perception during the procedure.
RESULTS
A total of 200 patients with similar baseline characteristics were randomized into two groups. The first group received oral premedication with diazepam (5 mg) and chlorphenamine (4 mg) 60 minutes prior to their procedures, and the other group did not receive premedication. We observed no differences in periprocedural pain perception (31% in the premedicated group versus 29% in the non-premedicated group; P = 0.75) or anxiety (59% in the premedicated group versus 50% in the non-premedicated group; P = 0.2). Interestingly, local pain was more pronounced in the premedicated patients than in the non-premedicated patients (30% versus 16%, respectively; P = 0.018). There were no contrast-related reactions reported in either group.
CONCLUSION
Treatment with oral diazepam and chlorphenamine prior to cardiac catheterization and percutaneous coronary intervention does not alter rates of anxiety, periprocedural pain.
| 0no significant effect
|
5,976,903 | 29,861,803 |
Objectives
The pectoral nerve block type II (PECS II block) is widely used for postoperative analgesia after breast surgery. This study evaluated the analgesic efficacy of PECS II block in patients undergoing breast-conserving surgery (BCS) and sentinel lymph node biopsy (SNB).
Methods
Patients were randomized to the control group ( n =40) and the PECS II group ( n =40). An ultrasound-guided PECS II block was performed after induction of anesthesia. The primary outcome measure was opioid consumption, and the secondary outcome was pain at the breast and axillary measured using the Numerical Rating Scale (NRS) 24 hours after surgery. Opioid requirement was assessed according to tumor location.
Results
Opioid requirement was lower in the PECS II than in the control group (43.8 ± 28.5 µ g versus 77.0 ± 41.9 µ g, p < 0.001). However, the frequency of rescue analgesics did not differ between these groups. Opioid consumption in the PECS II group was significantly lower in patients with tumors in the outer area than that in patients with tumors in the inner area (32.5 ± 23.0 µ g versus 58.0 ± 29.3 µ g, p =0.007). The axillary NRS was consistently lower through 24 hr in the PECS II group.
Conclusion
Although the PECS II block seemed to reduce pain intensity and opioid requirements for 24 h after BCS and SNB, these reductions may not be clinically significant. This trial is registered with Clinical Research Information Service KCT0002509.
| 1significant effect
|
4,893,238 | 27,259,970 |
BACKGROUND
Rebamipide is a gastroprotective agent with promising results against gastric damage induced by non-steroidal anti-inflammatory drugs. The present study evaluated if rebamipide protects against naproxen-induced gastric damage in healthy volunteers. Changes in gastric PGE2 tissue concentration were also evaluated.
METHODS
After a preliminary endoscopy to rule out previous gastric macroscopic damage, twenty-four healthy volunteers of both sexes were divided into 2 groups. One group received sodium naproxen 550 mg b.i.d. plus placebo for 7 days, while the other group received sodium naproxen 550 mg b.i.d. plus rebamipide 100 mg b.i.d. At the end of treatment, a new endoscopy was performed. Gastric macroscopic damage was evaluated by the Cryer score and by the modified Lanza score. The primary outcome measure of the trial was the macroscopic damage observed in each treatment group at the end of treatment. Biopsies were collected at both endoscopies for PGE2 quantification and histopathological analysis (secondary outcomes). Tissue PGE2 was quantified by ELISA. The randomization sequence was generated using 3 blocks of 8 subjects each. Volunteers and endoscopists were blind to whether they were receiving rebamipide or placebo.
RESULTS
All recruited volunteers completed the trial. Sodium naproxen induced gastric damage in both groups. At the end of the study, median Cryer score was 4 in both groups (Difference = 0; 95%CI = -1 to 0; p = 0.728). In the placebo group, the mean tissue PGE2 concentration was 1005 ± 129 pg/mL before treatment and 241 ± 41 pg/mL after treatment (p < 0.001). In the rebamipide group, the mean tissue PGE2 concentration was 999 ± 109 pg/mL before treatment, and 168 ± 13 pg/mL after treatment (p < 0.001). There was no difference in mean tissue PGE2 between the two groups (difference = 5; 95%CI from -334.870 to 345.650; p = 0.975). No significant change was observed at the histopathological evaluation, despite the evident macroscopic damage induced by naproxen.
CONCLUSION
Rebamipide does not protect against naproxen-induced gastric damage in healthy volunteers.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02632812 . Registered 14 December 2015.
| 0no significant effect
|
5,136,709 | 27,130,927 |
OBJECTIVES
To evaluate whether a modified 'FIFA 11 for Health' programme for non-communicable diseases had effects on body composition, blood pressure and physical fitness of Danish schoolchildren aged 10-12 years.
DESIGN
A cluster-randomised controlled study with 7 intervention and 2 control schools.
PARTICIPANTS
546 Danish 5th grade municipal schoolchildren allocated to an intervention group (IG; n=402: 11.1±0.4 (±SD) years, 150.1±7.0 cm, 41.3±8.4 kg) and a control group (CG; n=144: 11.0±0.5 years, 151.2±7.8 cm, 41.3±9.0 kg).
INTERVENTION
As part of the physical education (PE) curriculum, IG carried out 2 weekly 45 min 'FIFA 11 for Health' sessions focusing on health issues, football skills and 3v3 games. CG continued regular school PE activities. Measurements of body composition, blood pressure at rest, Yo-Yo intermittent recovery level 1 children's test (YYIR1C), balance, jump and sprint performance were performed before and after the 11-week study period.
RESULTS
During the 11-week study period, systolic blood pressure (-3.5 vs 0.9 mm Hg), mean arterial blood pressure (-1.9 vs 0.4 mm Hg), body mass index (-0.02 vs 0.13 kg/m 2 ) and body fat percentage (-0.83% vs -0.04%) decreased more (p<0.05) in IG than in CG. Within-group improvements (p<0.05) were observed in IG for 20 m sprint (4.09±0.29 to 4.06±0.28 s) and YYIR1C performance (852±464 to 896±517 m), but these changes were not significantly different from CG, and balance or jump performance remained unchanged in both groups.
CONCLUSIONS
The modified 'FIFA 11 for Health' programme has beneficial effects on body composition and blood pressure for Danish schoolchildren aged 10-12 years, thereby providing evidence that this football-based health education programme can directly impact participants' cardiovascular health profile.
| 1significant effect
|
3,227,609 | 22,140,499 |
BACKGROUND
the addition of oligosaccharides to infant formula has been shown to mimic some of the beneficial effects of human milk. The aim of the study was to assess the tolerance and safety of a formula containing an innovative mixture of oligosaccharides in early infancy.
METHODOLOGY/PRINCIPAL FINDINGS
this study was performed as a multi-center, randomized, double-blind, placebo-controlled trial including healthy term infants. Infants were recruited before the age of 8 weeks, either having started with formula feeding or being fully breast-fed (breastfeeding group). Formula-fed infants were randomized to feeding with a regular formula containing a mixture of neutral oligosaccharides and pectin-derived acidic oligosaccharides (prebiotic formula group) or regular formula without oligosaccharides (control formula group). Growth, tolerance and adverse events were assessed at 8, 16, 24 and 52 weeks of age. The prebiotic and control groups showed similar mean weight, length and head circumference, skin fold thicknesses, arm circumference gains and stool frequency at each study point. As far as the anthropometric parameters are concerned, the prebiotic group and the control group did not attain the values shown by the breastfeeding group at any study point. The skin fold thicknesses assessed in the breastfeeding group at 8 weeks were strikingly larger than those in formula fed infants, whereas at 52 weeks were strikingly smaller. The stool consistency in the prebiotic group was softer than in the control group at 8, 16 and 24 weeks (p<0.001) and closer to that of the breastfeeding group. There was no difference in the incidence of adverse events between the two formula groups.
CONCLUSIONS
our findings demonstrate the tolerability and the long term safety of a formula containing an innovative mixture of oligosaccharides in a large cohort of healthy infants.
TRIAL REGISTRATION
drks-neu.uniklinik-freiburg.de DRKS 00000201.
| 0no significant effect
|
5,358,738 | 28,319,122 |
BACKGROUND
In Mexico, although the majority of births are attended in hospitals, reports have emerged of obstetric violence, use of unsafe practices, and failure to employ evidence-based practices (EBP). Recent attention has refocused global efforts towards provision of quality care that is both patient-centered and evidence-based. Scaling up of local interventions should rely on strong evidence of effectiveness.
OBJECTIVE
To perform a secondary analysis to evaluate the impact of a simulation and team-training program (PRONTO) on the performance of EBP in normal births.
METHODS
A pair-matched cluster randomized controlled trial of the intervention was designed to measure the impact of the program (PRONTO intervention) on a sample of 24 hospitals (12 hospitals received the PRONTO training and 12 served as controls) in the states of Chiapas, Guerrero, and Mexico. We estimated the impact of receiving the intervention on the probability of birth practices performance in a sample of 641 observed births of which 318 occurred in the treated hospitals and 323 occurred in control hospitals. Data was collected at 4 time points (baseline, 4th, 8th and 12th months after the training). Women were blinded to treatment allocation but observers and providers were not. Estimates were obtained by fitting difference-in-differences logistic regression models considering confounding variables. The trial is registered at clinicaltrials.gov: # NCT01477554.
RESULTS
Significant changes were found following the intervention. At 4 months post-intervention an increase of 20 percentage points (p.p.) for complete Active Management of Third Stage of Labor (AMTSL) (p = 0.044), and 16 p.p. increase for Skin-to-Skin Contact (p = 0.067); at 12 months a 25 p.p. increase of the 1st step of AMTSL (p = 0.026) and a 42 p.p. increase of Delayed Cord Clamping (p = 0.004); at 4 months a 30 (p = 0.001) and at 8 months a 22 (p = 0.010) p.p. decrease for Uterine Sweeping.
CONCLUSIONS
The intervention has an impact on adopting EBP at birth, contributing to an increased quality of care. Long lasting impacts on these practices are possible if there were to be a widespread adoption of the training techniques including simulation, team-training and facilitated discussions regarding routine care.
| 0no significant effect
|
2,765,950 | 19,807,926 |
BACKGROUND
Noni (Morinda citrifolia) juice has demonstrated antioxidant activity in vitro and in vivo. To evaluate this activity in humans, noni juice from Tahiti (TNJ) was evaluated in a 30 day, double-blind, and placebo controlled clinical trial with 285 current heavy smokers. Research participants were randomly assigned to three daily treatment groups: 118 mL placebo, 29.5 mL TNJ, and 118 mL TNJ. Plasma superoxide anion radicals (SAR) and lipid hydroperoxide (LOOH) levels were measured pre and post-intervention.
RESULTS
After 30 days, mean SAR decreased from 0.26 +/- 0.14 to 0.19 +/- 0.10 micromol/mL in the 29.5 mL dose group (P < 0.01) and from 0.26 +/- 0.22 to 0.18 +/- 0.11 micromol/mL in the 118 mL dose group (P < 0.001). LOOH levels decreased from 0.53 +/- 0.19 to 0.40 +/- 0.10 micromol/mL in the 29.5 mL dose group (P < 0.001) and from 0.55 +/- 0.21 to 0.40 +/- 0.14 micromol/mL in the 118 mL dose group (P < 0.001). No significant reductions in SAR or LOOH levels were observed in the placebo group.
CONCLUSION
The results suggest an antioxidant activity from noni juice in humans exposed to tobacco smoke, thereby replicating the results found previous chemical and in vivo tests.
| 1significant effect
|
3,132,856 | 21,753,896 |
OBJECTIVES
The aim of this study was to analyze the clinical efficacy and cytomorphologic changes of colon mucosa following the treatment of patients suffering from irritable bowel syndrome (IBS) with mesalazine (5-aminosalicylic acid [5-ASA]).
METHODS
In this controlled, randomized, blind clinical trial, a total of 360 patients with varying subtypes of IBS were randomly treated with 500 mg of mesalazine qid or by standard therapy without mesalazine for a period of 28 days. Pre- and post-treatment pain intensity, pain duration, meteorism, stool abnormalities and endoscopic parameters were monitored, and biopsies or brush biopsies were examined histologically.
RESULTS
Treatment of IBS patients with mesalazine significantly reduced intensity and duration of pain in all subtypes of IBS, except for duration of pain in the subtype "undifferentiated", where the difference was not significant. In addition, in patients with diarrhea type and undifferentiated type of IBS, mesalazine also significantly reduced the abnormal stool pattern. In comparison to the control group, administration of mesalazine reduced the incidence of endoscopic and cytomorphologic changes of the bowel mucosa, including changes in colon mucus, mucus production, cytologic or histologic parameters, epithelial cell degeneration, appearance of leukocytes and macrophages and cell infiltrations.
CONCLUSION
Mesalazine was effective in reducing several symptoms characteristic of IBS. It significantly reduced pain intensity and duration and improved cytohistologic parameters of the bowel mucosa.
| 0no significant effect
|
2,291,568 | 18,414,647 |
BACKGROUND
More than a third of the world's children are infected with intestinal nematodes. Current control approaches emphasise treatment of school age children, and there is a lack of information on the effects of deworming preschool children.
METHODOLOGY
We studied the effects on the heights and weights of 3,935 children, initially 1 to 5 years of age, of five rounds of anthelmintic treatment (400 mg albendazole) administered every 6 months over 2 years. The children lived in 50 areas, each defined by precise government boundaries as urban slums, in Lucknow, North India. All children were offered vitamin A every 6 months, and children in 25 randomly assigned slum areas also received 6-monthly albendazole. Treatments were delivered by the State Integrated Child Development Scheme (ICDS), and height and weight were monitored at baseline and every 6 months for 24 months (trial registration number NCT00396500). p Value calculations are based only on the 50 area-specific mean values, as randomization was by area.
FINDINGS
The ICDS infrastructure proved able to deliver the interventions. 95% (3,712/3,912) of those alive at the end of the study had received all five interventions and had been measured during all four follow-up surveys, and 99% (3,855/3,912) were measured at the last of these surveys. At this final follow up, the albendazole-treated arm exhibited a similar height gain but a 35 (SE 5) % greater weight gain, equivalent to an extra 1 (SE 0.15) kg over 2 years (99% CI 0.6-1.4 kg, p = 10(-11)).
CONCLUSIONS
In such urban slums in the 1990s, five 6-monthly rounds of single dose anthelmintic treatment of malnourished, poor children initially aged 1-5 years results in substantial weight gain. The ICDS system could provide a sustainable, inexpensive approach to the delivery of anthelmintics or micronutrient supplements to such populations. As, however, we do not know the control parasite burden, these results are difficult to generalize.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00396500.
| 1significant effect
|
2,759,981 | 19,538,406 |
OBJECTIVE
To examine the effects of antenatal education focussing on natural childbirth preparation with psychoprophylactic training versus standard antenatal education on the use of epidural analgesia, experience of childbirth and parental stress in first-time mothers and fathers.
DESIGN
Randomised controlled multicentre trial.
SETTING
Fifteen antenatal clinics in Sweden between January 2006 and May 2007.
SAMPLE
A total of 1087 nulliparous women and 1064 of their partners.
METHODS
Natural group: Antenatal education focussing on natural childbirth preparation with training in breathing and relaxation techniques (psychoprophylaxis). Standard care group: Standard antenatal education focussing on both childbirth and parenthood, without psychoprophylactic training. Both groups: Four 2-hour sessions in groups of 12 participants during third trimester of pregnancy and one follow-up after delivery.
MAIN OUTCOME MEASURES
Epidural analgesia during labour, experience of childbirth as measured by the Wijma Delivery Experience Questionnaire (B), and parental stress measured by the Swedish Parenthood Stress Questionnaire.
RESULTS
The epidural rate was 52% in both groups. There were no statistically significant differences in the experience of childbirth or parental stress between the randomised groups, either in women or men. Seventy percent of the women in the Natural group reported having used psychoprophylaxis during labour. A minority in the Standard care group (37%) had also used this method, but subgroup analysis where these women were excluded did not change the principal findings.
CONCLUSION
Natural childbirth preparation including training in breathing and relaxation did not decrease the use of epidural analgesia during labour, nor did it improve the birth experience or affect parental stress in early parenthood in nulliparous women and men, compared with a standard form of antenatal education.
| 0no significant effect
|
4,112,798 | 25,031,274 |
BACKGROUND
Median survival of non-small cell lung cancer (NSCLC) patients with brain metastases is poor. We examined concurrent erlotinib and whole brain radiotherapy (WBRT) followed by maintenance erlotinib in patients with untreated brain metastases, given the potential radiosensitizing properties of erlotinib and its direct effect on brain metastases and systemic activity.
METHODS
Eighty NSCLC patients with KPS of 70 and greater and multiple brain metastases were randomly assigned to placebo (n = 40) or erlotinib (100mg, n = 40) given concurrently with WBRT (20 Gy in 5 fractions). Following WBRT, patients continued with placebo or erlotinib (150 mg) until disease progression. The primary end point was neurological progression-free survival (nPFS); hazard ratios (HRs) were calculated using Cox regression. All P values were two-sided.
RESULTS
Fifteen patients (37.5%) from each arm were alive and without neurological progression 2 months after WBRT. Median nPFS was 1.6 months in both arms; nPFS HR 0.95 (95% CI = 0.59 to 1.54; P = .84). Median overall survival (OS) was 2.9 and 3.4 months in the placebo and erlotinib arms; HR 0.95 (95% CI = 0.58 to 1.55; P = .83). The frequency of epidermal growth factor receptor (EGFR) mutations was low with only 1 of 35 (2.9%) patients with available samples had activating EGFR-mutations. Grade 3/4 adverse event rates were similar between the two groups (70.0% in each arm), except for rash 20.0% (erlotinib) vs 5.0% (placebo), and fatigue 17.5% vs 35.0%. No statistically significant quality of life differences were found.
CONCLUSIONS
Our study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases compared to placebo. Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations.
| 0no significant effect
|
3,017,961 | 21,234,210 |
BACKGROUND/AIMS
To study the efficacy of yoga on Gunas (personality) and self esteem in normal adults through a randomized comparative study.
MATERIALS AND METHODS
Of the 1228 persons who attended motivational lectures, 226 subjects aged 18-71 years, of both sexes, who satisfied the inclusion and exclusion criteria, and who consented to participate in the study were randomly allocated into two groups. The Yoga (Y) group practised an integrated yoga module that included asanas, pranayama, meditation, notional correction, and devotional sessions. The comparison group practised mild to moderate physical exercises (PE). Both groups had supervised practices for one hour daily, six days a week, for eight weeks. Guna (personality) was assessed before and after eight weeks using the self-administered "The 'Gita" Inventory of Personality" (GIN) to assess Sattva, Rajas, and Tamas. Self esteem in terms of competency (COM), global self esteem (GSE), moral and self esteem (MSE), social esteem (SET), family self esteem (FSE), body and physical appearance (BPA), and the lie scale (LIS) were assessed using the self esteem questionnaire (SEQ).
RESULTS
The baseline scores for all domains for both the groups did not differ significantly (P > 0.05 independent samples t-test). There were significant pre-post improvements in all domains in both groups (P < 0.001 paired t-test). The number of persons who showed improvement in Sattva and decrease in Tamas was significant in the Y but not in the PE group (McNemar test). The effect size for self esteem in the Y group is greater than for the PE group in three out of seven domains.
CONCLUSIONS
This randomized controlled study has shown the influence of Yoga on Gunas and self esteem in comparison to physical exercise.
| 1significant effect
|
4,914,255 | 26,933,803 |
BACKGROUND
D-serine is an endogenous co-agonist of the N-Methyl D-Aspartate Receptor (NMDAR) that plays a crucial role in cognition including learning processes and memory. Decreased D-serine levels have been associated with age-related decline in mechanisms of learning and memory in animal studies. Here, we asked whether D-serine administration in older adults improves cognition.
RESULTS
D-serine administration improved performance in the Groton Maze learning test of spatial memory and learning and problem solving (F(3, 38)= 4.74, p = 0.03). Subjects that achieved higher increases in plasma D-serine levels after administration improved more in test performance (r2=-0.19 p = 0.009). D-serine administration was not associated with any significant changes in the other cognitive tests or in the mood of older adults (p > 0.05).
METHODS
Fifty healthy older adults received D-serine and placebo in a randomized, double blind, placebo-controlled, crossover design study. We studied the effect of D-serine administration on the performance of cognitive tests and an analogue mood scale. We also collected blood samples to measure D-serine, L-serine, glutamate and glutamine levels.
CONCLUSIONS
D-serine administration may be a strategy to improve spatial memory, learning and problem solving in healthy older adults. Future studies should evaluate the impact of long-term D-serine administration on cognition in older adults.
| 0no significant effect
|
3,533,739 | 23,146,114 |
UNLABELLED
BACKGROUND
Randomised controlled trials are widely accepted as the gold standard method to evaluate medical interventions, but they are still open to bias. One such bias is the effect of patient's preference on outcome measures. The aims of this study were to examine whether patients' treatment preference affected clearance of plantar warts and explore whether there were any associations between patients' treatment preference and baseline variables in the EverT trial.
METHODS
Two hundred and forty patients were recruited from University podiatry schools, NHS podiatry clinics and primary care. Patients were aged 12 years and over and had at least one plantar wart which was suitable for treatment with salicylic acid and cryotherapy. Patients were asked their treatment preference prior to randomisation. The Kruskal-Wallis test was performed to test the association between preference group and continuous baseline variables. The Fisher's exact test was performed to test the association between preference group and categorical baseline variables. A logistic regression analysis was undertaken with verruca clearance (yes or no) as the dependent variable and treatment, age, type of verruca, previous treatment, treatment preference as independent variables. Two analyses were undertaken, one using the health professional reported outcome and one using the patient's self reported outcomes. Data on whether the patient found it necessary to stop the treatment to which they had been allocated and whether they started another treatment were summarised by treatment group.
RESULTS
Pre-randomisation preferences were: 10% for salicylic acid; 42% for cryotherapy and 48% no treatment preference. There was no evidence of an association between treatment preference group and either patient (p=0.95) or healthcare professional (p=0.46) reported verruca clearance rates. There was no evidence of an association between preference group and any of the baseline variables except gender, with more females expressing a preference for salicylic acid (p=0.004). There was no evidence that the number of times salicylic acid was applied was different between the preference groups at one week (p=0.89) or at three weeks (p=0.24). Similarly, for the number of clinic visits for cryotherapy (p=0.71) CONCLUSIONS: This secondary analysis showed no evidence to suggest that patients' baseline preferences affected verruca clearance rates or adherence with the treatment.
TRIAL REGISTRATION
Current Controlled Trials ISRCTN18994246 and National Research Register N0484189151.
| 0no significant effect
|
3,307,993 | 22,130,826 |
PURPOSE
To study the therapeutic effects of probiotic Escherichia coli Nissle 1917 (EcN) in irritable bowel syndrome (IBS) and identify subgroups benefiting most.
BACKGROUND
Some trials investigating therapeutic effects in irritable bowel syndrome have shown benefits in IBS subgroups only. Probiotic treatment seems to be promising.
METHODS
Patients with irritable bowel syndrome (120; Rome II) were recruited to a prospective double-blind study and randomized to either EcN (n = 60) or placebo (n = 60) given for 12 weeks. Objectives were to describe efficacy and safety of EcN in different groups of irritable bowel syndrome. Outcome was assessed by 'Integrative Medicine Patient Satisfaction Scale'.
RESULTS
Altogether, the responder rate was higher in the EcN than in the placebo group. However, only after 10 and 11 weeks, the differences were significant (Δ 20.0% points [95% CI 2.6; 37.4], p = 0.01 and Δ 18.3% points [95% CI 1.0; 35.7], p = 0.02, respectively). The best response was observed in the subgroup of patients with gastroenteritis or antibiotics prior to irritable bowel syndrome onset (Δ 45.7% points, p = 0.029). No significant differences were observed in any other subgroup. Both treatment groups showed similar adverse events and tolerance.
CONCLUSIONS
Probiotic EcN shows effects in irritable bowel syndrome, especially in patients with altered enteric microflora, e.g. after gastroenterocolitis or administration of antibiotics.
| 1significant effect
|
4,119,301 | 24,995,473 |
OBJECTIVES
There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial.
METHODS
Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire.
RESULTS
Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, p<0.0001).
CONCLUSION
There is significant evidence that dentures made from silicone impressions were preferred by patients.
CLINICAL SIGNIFICANCE
Given the strength of the clinical findings within this paper, dentists should consider choosing silicone rather than alginate as their material of choice for secondary impressions for complete dentures.
TRIAL REGISTRATION
ISRCTN 01528038. This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014.
| 1significant effect
|
5,395,810 | 28,420,417 |
BACKGROUND
This randomised controlled study evaluated a computer-generated future self-image as a personalised, visual motivational tool for weight loss in adults.
METHODS
One hundred and forty-five people (age 18-79 years) with a Body Mass Index (BMI) of at least 25 kg/m 2 were randomised to receive a hard copy future self-image at recruitment (early image) or after 8 weeks (delayed image). Participants received general healthy lifestyle information at recruitment and were weighed at 4-weekly intervals for 24 weeks. The image was created using an iPad app called 'Future Me'. A second randomisation at 16 weeks allocated either an additional future self-image or no additional image.
RESULTS
Seventy-four participants were allocated to receive their image at commencement, and 71 to the delayed-image group. Regarding to weight loss, the delayed-image group did consistently better in all analyses. Twenty-four recruits were deemed non-starters, comprising 15 (21%) in the delayed-image group and 9 (12%) in the early-image group (χ 2 (1) = 2.1, p = 0.15). At 24 weeks there was a significant change in weight overall (p < 0.0001), and a difference in rate of change between groups (delayed-image group: -0.60 kg, early-image group: -0.42 kg, p = 0.01). Men lost weight faster than women. The group into which participants were allocated at week 16 (second image or not) appeared not to influence the outcome (p = 0.31). Analysis of all completers and withdrawals showed a strong trend over time (p < 0.0001), and a difference in rate of change between groups (delayed-image: -0.50 kg, early-image: -0.27 kg, p = 0.0008).
CONCLUSION
One in five participants in the delayed-image group completing the 24-week intervention achieved a clinically significant weight loss, having received only future self-images and general lifestyle advice. Timing the provision of future self-images appears to be significant, and promising for future research to clarify their efficacy.
TRIAL REGISTRATION
Australian Clinical Trials Registry, identifier: ACTRN12613000883718 . Registered on 8 August 2013.
| 1significant effect
|
3,515,466 | 23,145,504 |
BACKGROUND
There is some evidence that singing lessons may be of benefit to patients with chronic obstructive pulmonary disease (COPD). It is not clear how much of this benefit is specific to singing and how much relates to the classes being a group activity that addresses social isolation.
METHODS
Patients were randomised to either singing classes or a film club for eight weeks. Response was assessed quantitatively through health status questionnaires, measures of breathing control, exercise capacity and physical activity and qualitatively, through structured interviews with a clinical psychologist.
RESULTS
The singing group (n=13 mean(SD) FEV1 44.4(14.4)% predicted) and film group (n=11 FEV1 63.5(25.5)%predicted) did not differ significantly at baseline. There was a significant difference between the response of the physical component score of the SF-36, favouring the singing group +12.9(19.0) vs -0.25(11.9) (p=0.02), but no difference in response of the mental component score of the SF-36, breathing control measures, exercise capacity or daily physical activity. In the qualitative element, positive effects on physical well-being were reported in the singing group but not the film group.
CONCLUSION
Singing classes have an impact on health status distinct from that achieved simply by taking part in a group activity.
TRIALS REGISTRATION
Registration Current Controlled Trials - ISRCTN17544114.
| 0no significant effect
|
4,335,628 | 25,759,715 |
BACKGROUND
Physical exercise influences homocysteine (Hcy) concentrations, cognitive function and the metabolic profile. The purpose of this study was to investigate the influence of regular physical exercise on Hcy levels, the metabolic profile and cognitive function in healthy elderly males before and after an endurance exercise program.
METHODS
Forty-five healthy and sedentary volunteers were randomized into 2 groups: (1) a control group asked not to change their normal everyday activities and not to start any regular physical exercise program and (2) an experimental group trained at a heart rate intensity corresponding to ventilatory threshold 1 (VT-1) for 60 min/day 3 times weekly on alternate days for 6 months using a cycle ergometer. All volunteers underwent cognitive evaluations, blood sample analyses and ergospirometric assessments.
RESULTS
A significant improvement in cognitive function was observed in the experimental group compared with the control group (p < 0.05). No significant changes in Hcy levels were observed in the experimental group (p > 0.05), but there was a significant increase in peak oxygen consumption and workload at VT-1 as well as a significant improvement in cholesterol, triglycerides, HDL, glucose, alkaline phosphatase, urea, T3, T4 and prostate-specific antigen compared with the control group (p < 0.05).
CONCLUSION
The data suggest that a physical exercise program does not reduce Hcy levels in healthy elderly males, although it improves the cardiovascular and metabolic profile as well as cognitive function.
| 1significant effect
|
2,948,428 | 20,536,952 |
AIMS
The study objective was to investigate the safety and tolerability of up-titration to high doses of taspoglutide, a once-weekly human glucagon-like peptide-1 analogue, in subjects with Type 2 diabetes inadequately controlled on metformin alone.
METHODS
In this double-blind phase II trial, subjects were randomized to placebo or taspoglutide (20 mg; three separate groups) administered once weekly by subcutaneous injection for 4 weeks. This was followed by dose maintenance at 20 mg, or titration to 30 mg (20/30) or 40 mg (20/40) once weekly with matched placebo for an additional 4 weeks. Subjects were monitored for adverse events (AEs) throughout the study and 4-week follow-up.
RESULTS
One hundred and twenty-nine subjects were randomized and treated [mean age 57 years, mean baseline glycated haemoglobin (HbA(1c)), 7.9%]. The most frequently reported AEs were nausea and vomiting. The number of patients reporting gastrointestinal AEs did not increase following titration to higher doses of taspoglutide or when continuing the initial 20 mg regimen. Three subjects were withdrawn from the study as a result of gastrointestinal AEs (one before and two after titration to higher doses). Although not designed to investigate efficacy, improvement in glycaemic control was observed in all active arms of the study. The proportion of subjects achieving HbA(1c) < 7.0% after 8 weeks of treatment was 72, 53 and 70% in the 20/20-, 20/30- and 20/40-mg arms, respectively, vs. 19% for placebo.
CONCLUSIONS
Taspoglutide was safe, well tolerated at high doses and efficacious for lowering HbA(1c). Up-titration of dose was not associated with a worsening AE profile.
| 0no significant effect
|
3,730,064 | 23,908,568 |
PURPOSE
To compare the short term effects of bevacizumab and ranibizumab injections on the regression of corneal neovascularization (NV).
METHODS
Sixteen eyes of 16 patients with corneal NV were randomly assigned for an injection with 2.5 mg of bevacizumab (group 1, n = 8) or 1 mg of ranibizumab (group 2, n = 8) through subconjunctival and intrastromal routes. The patients were prospectively followed-up for one month after the injections. Corneal NV areas, as shown on corneal slit-lamp photographs stored in JPEG format, were calculated using Image J software before the injection, one week after the injection, and one month after the injection. The corneal NV areas were compared before and after the injections.
RESULTS
Seven women and nine men, with an average age of 51 years, presented with corneal NV secondary to herpetic keratitis (7 cases), graft rejection (6), chemical burn (1), pemphigoid (1), and recurrent ulcer (1). In group I, the preoperative corneal NV area (8.75 ± 4.33%) was significantly decreased to 5.62 ± 3.86% one week after the injection and to 6.35 ± 3.02% one month after the injection (p = 0.012, 0.012, respectively). The corneal NV area in group 2 also exhibited a significant change, from 7.37 ± 4.33% to 6.72 ± 4.16% one week after the injection (p = 0.012). However, no significant change was observed one month after the injection. The mean decrease in corneal NV area one month after injection in group 1 (28.4 ± 9.01%) was significantly higher than in group 2 (4.51 ± 11.64%, p = 0.001).
CONCLUSIONS
Bevacizumab injection resulted in a more effective and stable regression of corneal NV compared to the ranibizumab injection. The potency and dose of these two drugs for the regression of corneal NV require further investigation.
| 1significant effect
|
2,699,080 | 19,547,693 |
BACKGROUND
Ureteropelvic junction obstruction (UPJO) causes hydronephrosis and progressive renal impairment may ensue if left uncorrected. Open pyeloplasty remains the standard against which new technique must be compared. We compared laparoscopic (LP) and open pyeloplasty (OP) in a randomized prospective trial.
MATERIALS AND METHODS
A prospective randomized study was done from January 2004 to January 2007 in which a total of 28 laparoscopic and 34 open pyeloplasty were done. All laparoscopic pyeloplasties were performed transperitoneally. Standard open Anderson Hynes pyeloplasty, spiral flap or VY plasty was done depending on anatomic consideration. Patients were followed with DTPA scan at three months and IVP at six months. Perioperative parameters including operative time, analgesic use, hospital stay, and complication and success rates were compared.
RESULTS
Mean total operative time with stent placement in LP group was 244.2 min (188-300 min) compared to 122 min (100-140 min) in OP group. Compared to OP group, the post operative diclofenac requirement was significantly less in LP group (mean 107.14 mg) and OP group required mean of (682.35 mg). The duration of analgesic requirement was also significantly less in LP group. The postoperative hospital stay in LP was mean 3.14 Days (2-7 days) significantly less than the open group mean of 8.29 days (7-11 days).
CONCLUSION
LP has a minimal level of morbidity and short hospital stay compared to open approach. Although, laparoscopic pyeloplasty has the disadvantages of longer operative time and requires significant skill of intracorporeal knotting but it is here to stay and represents an emerging standard of care.
| 1significant effect
|
3,253,336 | 21,951,832 |
AIMS
To compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan.
METHODS
Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end-point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan.
RESULTS
Of the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel-Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan.
CONCLUSIONS
In Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin-based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea-based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.
| 1significant effect
|
5,762,965 | 29,340,322 |
INTRODUCTION
Secondary hyperparathyroidism (SHPT) and vitamin D deficiency are common at kidney transplantation and are associated with some early and late complications. This study was designed to evaluate whether paricalcitol was more effective than nutritional vitamin D for controlling SHPT in de novo kidney allograft recipients.
METHODS
This was a 6-month, investigator-initiated, multicenter, open-label, randomized clinical trial. Patients with pretransplantation iPTH between 250 and 600 pg/ml and calcium <10 mg/dl were randomized to paricalcitol (PAR) or calcifediol (CAL). The intention-to-treat population (PAR: n = 46; CAL: n = 47) was used for the analysis. The primary endpoint was the percentage of patients with serum iPTH >110 pg/ml at 6 months. Secondary endpoints were bone mineral metabolism, renal function, and allograft protocol biopsies.
RESULTS
The primary outcome occurred in 19.6% of patients in the PAR group and 36.2% of patients in the CAL group ( P = 0.07). However, there was a higher percentage of patients with iPTH <70 pg/ml in the PAR group than in the CAL group (63.4% vs. 37.2%; P = 0.03). No differences were observed in bone turnover biomarkers and bone mineral density. The estimated glomerular filtration rate was significantly higher in the CAL group than in the PAR group without differences in albuminuria. In protocol biopsies, interstitial fibrosis and tubular atrophy tended to be higher in the PAR group than in the CAL group (48% vs. 23.8%; P = 0.09). Both medications were well tolerated.
CONCLUSION
Both PAR and CAL reduced iPTH, but PAR was associated with a higher proportion of patients with iPTH <70 pg/ml. These results do not support the use of PAR to treat posttransplantation hyperparathyroidism.
| 0no significant effect
|
3,698,473 | 23,882,146 |
BACKGROUND
1,3-dimethylamylamine is a commonly used ingredient within dietary supplements. Our prior work with this agent indicates a transient increase in blood pressure (systolic in particular) following oral ingestion of a single dosage, but no significant increase in resting blood pressure following chronic ingestion. Moreover, intervention studies involving both two and eight weeks of treatment with finished products containing 1,3-dimethylamylamine indicate minimal or no change in bloodborne markers of health. The present study sought to extend these findings by using a 10-week intervention trial to determine the change in selected markers of health in a sample of men.
METHODS
25 healthy men were randomly assigned to either a placebo (n = 13) or to a supplement containing 1,3-dimethylamylamine (n = 12) for a period of 10 weeks. Before and after the intervention, resting blood pressure and heart rate were measured, and blood samples were collected for determination of complete blood count, metabolic panel, and lipid panel.
RESULTS
No significant differences were noted between conditions for blood pressure (P > 0.05), although systolic blood pressure increased approximately 6 mmHg with the supplement (diastolic blood pressure decreased approximately 4 mmHg). A main effect for time was noted for heart rate (P = 0.016), with values decreasing from pre to post intervention. There were significant main effects for time for creatinine (increased from pre to post intervention; P = 0.043) and alkaline phosphatase (decreased from pre to post intervention; P = 0.009), with no condition differences noted (P > 0.05). There was a significant interaction noted for low density lipoprotein cholesterol (LDL-C) (P = 0.043), with values decreasing in the supplement group from pre to post intervention approximately 7 mg · dL(-1) (P = 0.034). No other effects of significance were noted for bloodborne variables.
CONCLUSION
These data indicate that a dietary supplement containing 1,3-dimethylamylamine does not result in a statistically significant increase in resting heart rate or blood pressure (although systolic blood pressure is increased ∼6 mmHg with supplement use). The supplement does not negatively impact bloodborne markers of health. Further study is needed involving a longer intervention period, a larger sample size, and additional measures of health and safety.
| 0no significant effect
|
5,126,873 | 27,894,316 |
BACKGROUND
Understanding dietary patterns in obese pregnant women will inform future intervention strategies to improve pregnancy outcomes and the health of the child. The aim of this study was to investigate the effect of a behavioral intervention of diet and physical activity advice on dietary patterns in obese pregnant woman participating in the UPBEAT study, and to explore associations of dietary patterns with pregnancy outcomes.
METHODS
In the UPBEAT randomized controlled trial, pregnant obese women from eight UK multi-ethnic, inner-city populations were randomly assigned to receive a diet/physical activity intervention or standard antenatal care. The dietary intervention aimed to reduce glycemic load and saturated fat intake. Diet was assessed using a food frequency questionnaire (FFQ) at baseline (15 +0 -18 +6 weeks' gestation), post intervention (27 +0 -28 +6 weeks) and in late pregnancy (34 +0 -36 +0 weeks). Dietary patterns were characterized using factor analysis of the baseline FFQ data, and changes compared in the control and intervention arms. Patterns were related to pregnancy outcomes in the combined control/intervention cohort (n = 1023).
RESULTS
Four distinct baseline dietary patterns were defined; Fruit and vegetables, African/Caribbean, Processed, and Snacks, which were differently associated with social and demographic factors. The UPBEAT intervention significantly reduced the Processed (-0.14; 95% CI -0.19, -0.08, P <0.0001) and Snacks (-0.24; 95% CI -0.31, -0.17, P <0.0001) pattern scores. In the adjusted model, baseline scores for the African/Caribbean (quartile 4 compared with quartile 1: OR = 2.46; 95% CI 1.41, 4.30) and Processed (quartile 4 compared with quartile 1: OR = 2.05; 95% CI 1.23, 3.41) patterns in the entire cohort were associated with increased risk of gestational diabetes.
CONCLUSIONS
In a diverse cohort of obese pregnant women an intensive dietary intervention improved Processed and Snack dietary pattern scores. African/Caribbean and Processed patterns were associated with an increased risk of gestational diabetes, and provide potential targets for future interventions.
TRIAL REGISTRATION
Current controlled trials; ISRCTN89971375.
| 1significant effect
|
4,766,670 | 26,911,397 |
BACKGROUND
Current practice guidelines for schizophrenia care recommend that antipsychotic medication is essential for patients' long-term maintenance treatment but their non-adherence to this medication is still a main obstacle to relapse prevention. This study evaluated the effects of a motivational-interviewing-based adherence therapy for people with schizophrenia spectrum disorders.
METHODS
This randomised controlled trial was conducted with 134 outpatients with schizophrenia spectrum disorders; 67 of them received a six-session adherence therapy (in addition to usual care) and 67 received usual psychiatric care alone. Participants' outcome measures included symptom severity, medication adherence, hospitalisation rates, insight into illness/treatment, and functioning.
RESULTS
The adherence therapy group reported significantly greater improvements in symptom severity (p < 0.003), insight into illness/treatment (p < 0.001), functioning (p < 0.005), duration of re-hospitalisations (p < 0.005), and medication adherence (p < 0.005) over 18 months follow-up, when compared with usual care alone.
CONCLUSIONS
Motivational-interviewing-based adherence therapy can be an effective approach to treatment for people with early stage of schizophrenia who poorly adhere to medication regimen.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01780116, registration date January 29, 2013.
| 1significant effect
|
5,756,602 | 29,318,119 |
BACKGROUND
To study the nursing method of mild hypothermia therapy for moderate or severe hypoxic-ischemic encephalopathy (HIE) in neonates.
METHODS
According to the inclusion and exclusion criteria, 48 patients were selected from Nanfang Hospital from December 2015 to October 2016 and randomly divided into the control group (n=24) and observation group (n=24). The control group received routine treatment and nursing, while the observation group received the same treatment as the control group combined with mild hypothermia treatment and nursing. The clinical effects were compared.
RESULTS
The total effective rate in the observation group was increased and mortality was decreased, and the differences were statistically significant ( P =0.029 and 0.033, respectively). The 28 d neonatal behavioral neurological assessment and nursing satisfaction scores in the observation group were higher than those in the control group, and the differences were statistically significant ( P =0.017 and 0.008, respectively).
CONCLUSION
Mild hypothermia therapy for moderate or severe HIE in neonates is safe and effective, and the correct nursing method is important for guaranteeing proper clinical treatment.
| 1significant effect
|
4,059,969 | 23,263,227 |
PURPOSE
The purpose of this study was to assess whether intraoperative fluoroscopy assists in the restoration of the coronal limb alignment target in conventional total knee arthroplasty (TKA).
METHODS
One hundred and six patients undergoing conventional cemented TKA were randomly assigned to be operated on with or without intraoperative fluoroscopy. The image intensifier, together with customized manual instrumentation, was used for separately measuring the frontal alignment of the femoral and tibial resection surfaces. The surgeon adjusted the resection surfaces when a mechanical axis deviation error angle of ≥ 0.5° was observed on the fluoroscopic image. Coronal alignment was measured on standing long-leg digital radiographs.
RESULTS
Patients operated with fluoroscopy assistance had (1) a lower risk of malalignment at the threshold of >3° (risk ratio, 0.7; 95 % CI, 0.13-1.2), (2) a mean fluoroscopic time of 3 s, and (3) a longer operative time (69 vs. 60 min, p < 0.001). The American Knee Society Score was not different between the two groups at 1-year follow-up.
CONCLUSION
This new surgical intervention appears to offer an effective means for improving the precision of TKA alignment in the coronal plane.
| 1significant effect
|
4,377,530 | 25,830,158 |
BACKGROUND
Urinary catheterization is one of the main measures used to treat and care for hospitalized patients. Several complications have been attributed to the presence of latex with routine Foley catheters. Therefore, some studies have recommended that Nelatone catheters be substituted for the ordinary Foley catheters to prevent these complications.
OBJECTIVES
This study aimed to compare the rates of urinary tract infection (UTI) in rabbits catheterized either with Foley or with Nelatone catheters.
MATERIALS AND METHODS
A randomized controlled trial was conducted on 60 rabbits that were randomly assigned to three groups of twenty. The first group was catheterized using Nelatone catheter; the second group was catheterized using Foley catheter and the third group was studied without performing any catheterization. After seven days, urine samples were collected using suprapubic aspiration and were sent to the laboratory for culture. Descriptive statistics were calculated. Moreover, chi-square and Fisher's exact tests were used for data analysis.
RESULTS
At the end of the study, four cases in the Nelatone group and 12 cases in the Foley group presented with UTI (P = 0.01). No positive urine cultures were found in the control group.
CONCLUSIONS
The Nelatone catheters, compared with the Foley ones, had a lower risk of UTI in the long term use. Verifying this claim by further studies can have an important role in reducing UTIs in patients using urinary catheters.
| 1significant effect
|
2,853,089 | 20,197,767 |
BACKGROUND
Participants are showing great interest these days in obtaining the results of clinical trials. The aim of this study was to assess patients' uptake and understanding of the results of the trial in which they have participated and the impact of a letter offering patients the possibility of consulting the trial results on a specific website.
METHODS
Breast cancer patients participating in a trial on the efficacy of Trastuzumab were randomly subdivided into an Internet group (who received the letter of invitation) and a control group (who did not receive it). Among 115 HER2-positive women from 21 centres, 107 (93%) answered a self-administered questionnaire.
RESULTS
Most of the patients in both groups had access to the Internet (72.0%). The majority (97.2%) stated that receiving information about the trial results would be useful, and the oncologist was the most frequently preferred information provider. The Internet group's declared uptake of the trial results was only slightly higher (47.1% vs 33.9%; P=0.166); however, they understood the results significantly more accurately (18.8% vs 5.6%; P=0.039).
INTERPRETATION
Although Internet was not the respondents' preferred source of information, the possibility of using this source slightly increased the uptake and understanding of the results.
| 0no significant effect
|
3,233,513 | 22,085,439 |
BACKGROUND
This study evaluated the efficacy and safety of the long-acting β₂-agonist formoterol in patients with moderate-to-severe COPD.
METHODS
This double-blind, placebo-controlled, parallel-group, multinational phase III study randomized patients ≥ 40 years of age with moderate-to-severe COPD to inhaled formoterol 4.5 or 9 μg twice daily (bid) via Turbuhaler or placebo for 12 weeks. Salbutamol 100 μg/actuation via pMDI was permitted as reliever medication. The primary outcome variable was change (ratio) from baseline to treatment period in FEV1 60-min post-dose.
RESULTS
613 patients received treatment (formoterol 4.5 μg n = 206; 9 μg n = 199; placebo n = 208); 539 (87.9%) male; 324 (52.9%) Japanese and 289 (47.1%) European. End of study increases in FEV1 60-min post-dose were significantly greater (p < 0.001 for both) with formoterol 4.5 and 9 μg bid (113% of baseline for both) than with placebo, as were all secondary outcome measures. The proportion of patients with an improvement in St George's Respiratory Questionnaire score of ≥ 4 was 50.2% for formoterol 4.5 μg (p = 0.0682 vs. placebo), 59.2% (p = 0.0004) for 9 μg, and 41.3% for placebo. Reduction in reliever medication use was significantly greater with formoterol vs. placebo (9 μg: -0.548, p < 0.001; 4.5 μg: -0.274, p = 0.027), with 9 μg being significantly superior to 4.5 μg (-0.274, p = 0.029). Formoterol was well tolerated with the incidence and type of adverse events not being different for the three groups.
CONCLUSIONS
Formoterol 4.5 μg and 9 μg bid was effective and well tolerated in patients with COPD; there was no difference between formoterol doses for the primary endpoint; however, an added value of formoterol 9 μg over 4.5 μg bid was observed for some secondary endpoints.
TRIAL REGISTRATION
NCT00628862 (ClinicalTrials.gov); D5122C00001 (AstraZeneca Study code).
| 1significant effect
|
4,296,330 | 25,625,059 |
BACKGROUND
The i-gel™ is a new device introduced recently. It differs from other supraglottic airway devices. It has a non-inflatable, gel-made cuff. Previously used devices, have some disadvantages which are claimed to be absent in i-gel™. In this study we aimed to compare the performance of the laryngeal mask airway (LMA)-Classic™ and i-gel™ during anesthesia in paralyzed patients.
MATERIALS AND METHODS
A total of 64 anaesthetized patients with paralysis were enrolled in a single-blind, randomized control trial to be intubated with one of the devices. We compared the device insertion parameters, some ventilatory parameters, and adverse effects after device insertion.
RESULTS
Vital signs were not significantly different between groups. Regarding duration of insertion attempts, the difference between groups was significant (P < 0.05); while the number of insertion attempts was insignificant (P = 0.265). There was no significant difference between both groups regarding postoperative complications (cough, sore throat, and blood on the cuff) (P > 0.05). Airway leak was assessed in both groups and data showed no significant difference (P = 0.662). Additionally, end-tidal CO2 change regarding the baseline value was significantly different after 10 and 15 min of anesthesia (P < 0.05).
CONCLUSIONS
Successful insertion time was shorter significantly for i-gel™. As i-gel™ has easy application, it is advantageous to be used during cardiopulmonary resuscitation by non-anesthetists in which time is very important. We concluded that i-gel™ can be an alternative to LMA-Classic™ for controlled ventilation during anesthesia as it is easier to be placed.
| 0no significant effect
|
3,880,665 | 24,427,480 |
PURPOSE
The purpose of this study was to examine the effects of 8 weeks moderate intensity aerobic exercise on serum retinol binding protein 4 (RBP4) levels in female athletes.
METHODS
Twenty female karate athletics were randomly assigned to one of the exercise group (n = 10) or control group (n = 10). The training group performed endurance training 3 days a week for 8 weeks at an intensity corresponding to 50-60% individual maximum oxygen consumption for 45 min.
RESULTS
Body mass and body mass index increased (P < 0.05) after 8 weeks aerobic exercise compared to the control group. For waist to hip ratio (WHR), body fat percentage and maximal oxygen consumption there were no significant differences between the exercise group and the control group. There were virtually no changes in body fat percentage, fasting glucose, insulin, insulin resistance and RBP4 levels after 8 weeks training.
CONCLUSION
Serum RBP4 level was not affected by 8-week moderate aerobic exercise in female athletes.
| 1significant effect
|
4,359,791 | 25,890,082 |
BACKGROUND
Detection of olfactory dysfunction is important for fire and food safety. Clinical tests of olfaction have been developed for adults but their use in children has been limited because they were felt to be unreliable in children under six years of age. We therefore administered two olfactory tests to children and compared results across tests.
METHODS
Two olfactory tests (Sniffin' Sticks and University of Pennsylvania Smell Identification Test (UPSIT)) were administered to 78 healthy children ages 3 to 12 years. Children were randomized to one of two groups: Group 1 performed the UPSIT first and Sniffin' Sticks second, and Group 2 performed Sniffin' Sticks first and UPSIT second.
RESULTS
All children were able to complete both olfactory tests. Performance on both tests was similar for children 5 and 6 years of age. There was an age-dependent increase in score on both tests (p < .01). Children performed better on the Sniffin' Sticks than the UPSIT (65.3% versus 59.7%, p < .01). There was no difference in performance due to order of test presentation.
CONCLUSIONS
The Sniffin' Sticks and UPSIT olfactory tests can both be completed by children as young as 5 years of age. Performance on both tests increased with increasing age. Better performance on the Sniffin' Sticks than the UPSIT may be due to a decreased number of test items, better ability to maintain attention, or decreased olfactory fatigue. The ability to reuse Sniffin' Sticks on multiple children may make it more practical for clinical use.
| 1significant effect
|
4,867,750 | 27,098,111 |
BACKGROUND
Parent training programs are traditionally delivered in face-to-face formats and require trained facilitators and weekly parent attendance. Implementing face-to-face sessions is challenging in busy primary care settings and many barriers exist for parents to attend these sessions. Tablet-based delivery of parent training offers an alternative to face-to-face delivery to make parent training programs easier to deliver in primary care settings and more convenient and accessible to parents. We adapted the group-based Chicago Parent Program (CPP) to be delivered as a self-administered, tablet-based program called the ezParent program.
OBJECTIVE
The purpose of this study was to (1) assess the feasibility of the ezParent program by examining parent satisfaction with the program and the percent of modules completed, (2) test the efficacy of the ezParent program by examining the effects compared with a control condition for improving parenting and child behavior in a sample of low-income ethnic minority parents of young children recruited from a primary care setting, and (3) compare program completion and efficacy with prior studies of the group-based CPP.
METHODS
The study used a two-group randomized controlled trial (RCT) design with repeated measures follow up. Subjects (n=79) were randomly assigned to an intervention or attention control condition. Data collection was at baseline and 12 and 24 weeks post baseline. Parents were recruited from a large, urban, primary care pediatric clinic. ezParent module completion was calculated as the percentage of the six modules completed by the intervention group parents. Attendance in the group-based CPP was calculated as the percentage of attendance at sessions 1 through 10. Satisfaction data were summarized using item frequencies. Parent and child data were analyzed using a repeated measures analysis of variance (RM-ANOVA) with simple contrasts to determine if there were significant intervention effects on the outcome measures. Effect sizes for between group comparisons were calculated for all outcome variables and compared with CPP group based archival data.
RESULTS
ezParent module completion rate was 85.4% (34.2/40; 95% confidence interval [CI] = 78.4%-93.7%) and was significantly greater (P<.05) than face-to-face CPP group attendance (135.2/267, 50.6%) attendance of sessions; 95% CI = 46.8%-55.6%). ezParent participants reported the program as very helpful (35/40, 88.0%) and they would highly recommend the program (33/40, 82.1%) to another parent. ezParent participants showed greater improvements in parenting warmth (F1,77 = 4.82, P<.05) from time 1 to 3. No other significant differences were found. Cohen's d effect sizes for intervention group improvements in parenting warmth, use of corporal punishment, follow through, parenting stress, and intensity of child behavior problems were comparable or greater than those of the group-based CPP.
CONCLUSIONS
Data from this study indicate the feasibility and acceptability of the ezParent program in a low-income, ethnic minority population of parents and comparable effect sizes with face-to-face delivery for parents.
| 0no significant effect
|
4,877,819 | 27,215,274 |
BACKGROUND
Andrographis paniculata (A. paniculata), a medicinal plant, has shown anti-inflammatory, neuroprotective and antifibrotic effects in animal models as well as clinical efficacy in different studies, including an anti-fatigue effect in autoimmune diseases such as rheumatoid arthritis. In multiple sclerosis (MS), fatigue is rated as one of the most common and disabling symptoms. In the present trial, we investigated the effect of A. paniculata on relapse rate and fatigue in relapsing-remitting MS (RRMS) patients receiving interferon beta.
METHODS
A randomised double-blind placebo-controlled trial assessed the effects of 170 mg of A. paniculata dried extract tablet b.i.d. p.o. on relapse rate and fatigue using the Fatigue Severity Scores (FSS) over 12 months in RRMS patients receiving interferon. The Expanded Disability Status Scale (EDSS) score, inflammatory parameters and radiological findings were also investigated. Twenty-five patients were enrolled, and twenty-two patients were ultimately analysed and randomised to the active or placebo group.
RESULTS
Patients treated with A. paniculata showed a significant reduction in their FSS score as compared to the placebo, equivalent to a 44 % reduction at 12 months. No statistically significant differences were observed for relapse rate, EDSS or inflammatory parameters, with a trend in reducing new lesions among the A. paniculata group. One patient in the A. paniculata group presented with a mild and transient skin rash, which was alleviated with anti-histamine treatment for three weeks.
CONCLUSION
A. paniculata was well tolerated in patients and no changes in clinical parameters were observed. A. paniculata significantly reduces fatigue in patients with RRMS receiving interferon beta in comparison to placebo and only interferon beta treatment.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02280876 ; Trial registration date: 20.10.2014.
| 1significant effect
|
3,653,258 | 23,696,766 |
BACKGROUND
Citrus sinensis juice (CSJ) is a rich source of dietary flavonoids which reduce the risk of adverse cardiovascular events. This study aimed to examine the effects of four-week intake of natural and commercial orange (Citrus sinensis) juice on blood pressure in healthy volunteers.
METHODS
In this single-blind randomized crossover study, 22 healthy subjects (age: 18-59 years old) were included and randomly divided into two groups of 11. Group A consumed commercial CSJ during the first four-week period. After a two-week washout period, they consumed natural CSJ for another four weeks. The procedure was reversed in group B. The participants were asked to drink 500 ml/day of either natural or commercial CSJ twice a day with breakfast and dinner. The effects of orange juice on blood pressure were evaluated.
RESULTS
After drinking commercial CSJ, diastolic and systolic blood pressure were significantly decreased (5.13%; P = 0.03 and -5.91%; P = 0.003, respectively). However, consumption of natural CSJ did not have significant effects on either diastolic or systolic blood pressure.
CONCLUSION
Commercial CSJ significantly decreased blood pressure. Higher flavonoid, pectin, and essential oils content of concentrated products compared to natural juice might have been responsible for this finding. Nevertheless, further studies to focus on dose-response effects are recommended.
| 1significant effect
|
4,126,186 | 25,110,531 |
AIMS
Low 25-hydroxy-vitamin D [25(ΟΗ)D] levels have been associated with increased risk for cardiovascular disease. Conflicting data exist regarding the effect of statins on [25(OH)D] levels. The aim of this study was to compare the effect of atorvastatin and rosuvastatin on 25(OH)D levels in non-diabetic patients with dyslipidaemia.
METHODS
This was a prospective randomized open-label study. Patients were assigned to atorvastatin 20 mg⁄day (n=28, age: 56.1±2.2 years, 22 females) or rosuvastatin 10 mg⁄day (n=24, age: 57.4±1.9 years, 20 females). Total cholesterol (TC), low- (LDL-C) and high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), fasting plasma glucose, insulin, glycosylated haemoglobin A1c (HbA1c) and high sensitivity C-reactive protein (hsCRP) levels were measured, and homeostatic model of assessment insulin resistance (HOMA-IR) was calculated at baseline and 12 weeks post-treatment.
RESULTS
There were no within or between group significant differences in 25(OH)D levels (atorvastatin: 21.7±1.9 ng/ml at baseline and 23.5±2.3 ng/ml at week 12; rosuvastatin: 25.3±1.8 and 27.0±2.4 ng/ml, respectively; p=0.172 and p=0.306 for between groups, respectively). Both statins significantly reduced TC, TG and LDL-C levels, with a greater LDL-C reduction being observed by rosuvastatin.
CONCLUSION
Atorvastatin and rosuvastatin did not significantly affect 25(OH)D levels in this study.
| 0no significant effect
|
3,635,879 | 23,497,243 |
BACKGROUND
Electrocardiogram (ECG) interpretation is a core clinical skill that needs to be acquired during undergraduate medical education. Intensive teaching is generally assumed to produce more favorable learning outcomes, but recent research suggests that examinations are more powerful drivers of student learning than instructional format. This study assessed the differential contribution of teaching format and examination consequences to learning outcome regarding ECG interpretation skills in undergraduate medical students.
METHODS
A total of 534 fourth-year medical students participated in a six-group (two sets of three), partially randomized trial. Students received three levels of teaching intensity: self-directed learning (two groups), lectures (two groups) or small-group peer teaching facilitated by more advanced students (two groups). One of the two groups on each level of teaching intensity was assessed in a formative, the other in a summative written ECG examination, which provided a maximum of 1% credit points of the total curriculum. The formative examination provided individual feedback without credit points. Main outcome was the correct identification of ≥3 out of 5 diagnoses in original ECG tracings. Secondary outcome measures were time spent on independent study and use of additional study material.
RESULTS
Compared with formative assessments, summative assessments increased the odds of correctly identifying at least three out of five ECG diagnoses (OR 5.14; 95% CI 3.26 to 8.09), of spending at least 2 h/week extra on ECG self-study (OR 4.02; 95% CI 2.65 to 6.12) and of using additional learning material (OR 2.86; 95% CI 1.92 to 4.24). Lectures and peer teaching were associated with increased learning effort only, but did not augment examination performance.
CONCLUSIONS
Medical educators need to be aware of the paramount role of summative assessments in promoting student learning. Consequently, examinations within medical schools need to be closely matched to the desired learning outcomes. Shifting resources from implementing innovative and costly teaching formats to designing more high-quality summative examinations warrants further investigation.
| 1significant effect
|
4,168,417 | 25,019,632 |
BACKGROUND
The application of internet technology for telerehabilitation in patients with stroke has developed rapidly.
OBJECTIVE
The current study aimed to evaluate the effect of a bidirectional and multi-user telerehabilitation system on balance and satisfaction in patients with chronic stroke living in long-term care facilities (LTCFs).
METHOD
This pilot study used a multi-site, blocked randomization design. Twenty-four participants from three LTCFs were recruited, and the participants were randomly assigned into the telerehabilitation (Tele) and conventional therapy (Conv) groups within each LTCF. Tele group received telerehabilitation but the Conv group received conventional therapy with two persons in each group for three sessions per week and for four weeks. The outcome measures included Berg Balance Scale (BBS), Barthel Index (BI), and the telerehabilitation satisfaction of the participants.
SETTING
A telerehabilitation system included "therapist end" in a laboratory, and the "client end" in LTCFs. The conventional therapy was conducted in LTCFs.
RESULTS
Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI. No significant difference between groups could be demonstrated. The satisfaction of participants between the Tele and the Conv groups also did not show significant difference.
CONCLUSIONS
This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs.
| 0no significant effect
|
5,416,724 | 28,515,522 |
BACKGROUND AND AIMS
The study aimed at comparing the performance of the novel optical Airtraq™ laryngoscope with the McCoy™ and conventional Macintosh laryngoscopes for ease of endotracheal intubation in patients with neck immobilisation using manual inline axial cervical spine stabilisation (MIAS) technique.
METHODS
Ninety consenting American Society of Anaesthesiologist's physical status I-II patients, aged 18-60 years, scheduled for various surgeries requiring tracheal intubation were randomly assigned into three groups of thirty each to undergo intubation with Macintosh, Airtraq™, or McCoy™ laryngoscope with neck immobilisation by MIAS technique. The ease of intubation based on Intubation difficulty scale (IDS) score, Cormack-Lehane grade of glottic view, optimisation manoeuvres and impact on haemodynamic parameters were recorded. Statistical analysis was performed with ANOVA and Bonferroni correction for post hoc tests.
RESULTS
All patients in three groups had a comparable demographic profile and were successfully intubated. The Airtraq™ laryngoscope significantly reduced the IDS (mean - 0.43 ± 0.81) as compared with both McCoy™ (mean - 1.63 ± 1.49, P = 0.001) and Macintosh laryngoscope (mean -2.23 ± 1.92, P < 0.001) and improved the Cormack-Lehane glottic view (77% grade 1 view and no patients with grade 3 or 4 view). There were less haemodynamic variations during laryngoscopy with the Airtraq™ compared to the Macintosh laryngoscope, but there was not between the Airtraq™ and McCoy™ laryngoscope groups.
CONCLUSION
In patients undergoing endotracheal intubation with cervical immobilisation, Airtraq™ laryngoscope was superior to the McCoy™ and Macintosh laryngoscopes, with greater ease of intubation and lower impact on haemodynamic variables.
| 1significant effect
|
4,710,971 | 26,758,035 |
BACKGROUND
The objective of this study was to investigate neurological short-term effects of craniosacral therapy as an ideal form of osteopathic manipulative treatment (OMT) due to the soft kinaesthetic stimulation.
METHODS
Included were 30 preterm infants, with a gestational age between 25 and 33 weeks, who were admitted to the neonatal intensive care unit of the University Hospital of Graz, Austria. The infants were randomized either into the intervention group (IG) which received standardised craniosacral therapy, or the control group (CG) which received standard care. To guarantee that only preterm infants with subsequent normal neurodevelopment were included, follow up was done regularly at the corrected age (= actual age in weeks minus weeks premature) of 12 and 24 months. After 2 years 5 infants had to be excluded (IG; n = 12; CG: n = 13). General Movements (GMs) are part of the spontaneous movement repertoire and are present from early fetal life onwards until the end of the first half year of life. To evaluate the immediate result of such an intervention, we selected the General Movement Assessment (GMA) as an appropriate tool. Besides the global GMA (primary outcome) we used as detailed GMA, the General Movement Optimality Score (GMOS- secondary outcome), based on Prechtl's optimality concept. To analyse GMOS (secondary outcome) a linear mixed model with fixed effects for session, time point (time point refers to the comparisons of the measurements before vs. after each session) and intervention (IG vs. CG), random effect for individual children and a first order autoregressive covariance structure was used for calculation of significant differences between groups and interactions. Following interaction terms were included in the model: session*time point, session*intervention, time point*intervention and session*time point*intervention. Exploratory post hoc analyses (interaction: session*time point*intervention) were performed to determine group differences for all twelve measurement (before and after all 6 sessions) separately.
RESULTS
Between groups no difference in the global GMA (primary outcome) could be observed. The GMOS (secondary outcome) did not change from session to session (main effect session: p = 0.262) in the IG or the CG. Furthermore no differences between IG and CG (main effect group: p = 0.361) and no interaction of time*session could be observed (p = 0.658). Post hoc analysis showed a trend toward higher values before (p = 0.085) and after (p = 0.075) the first session in CG compared to IG. At all other time points GMOS were not significantly different between groups.
CONCLUSION
We were able to indicate that a group of "healthy" preterm infants undergoing an intervention with craniosacral therapy (IG) showed no significant changes in GMs compared to preterm infants without intervention (CG). In view of the fact that the global GMA (primary outcome) showed no difference between groups and the GMOS (detailed GMA-secondary outcome) did not deteriorate in the IG, craniosacral therapy seems to be safe in preterm infants.
TRIAL REGISTRATION
German Clinical Trials Register DRKS00004258 .
| 0no significant effect
|
4,917,725 | 27,122,359 |
BACKGROUND
Increasing physical activity is a viable strategy for improving both the health and quality of life of older adults.
OBJECTIVE
The aim of this study was to assess if an Internet-based intervention aimed to increase physical activity was effective in improving quality of life of inactive older adults. In addition, we analyzed the effect of the intervention on quality of life among those participants who successfully reached their individually targeted increase in daily physical activity as indicated by the intervention program, as well as the dose-response effect of increasing physical activity on quality of life.
METHODS
The intervention was tested in a randomized controlled trial and was comprised of an Internet program-DirectLife (Philips)-aimed at increasing physical activity using monitoring and feedback by accelerometry and feedback by digital coaching (n=119). The control group received no intervention (n=116). Participants were inactive 60-70-year-olds and were recruited from the general population. Quality of life and physical activity were measured at baseline and after 3 months using the Research ANd Development 36-item health survey (RAND-36) and wrist-worn triaxial accelerometer, respectively.
RESULTS
After 3 months, a significant improvement in quality of life was seen in the intervention group compared to the control group for RAND-36 subscales on emotional and mental health (2.52 vs -0.72, respectively; P=.03) and health change (8.99 vs 2.03, respectively; P=.01). A total of 50 of the 119 participants (42.0%) in the intervention group successfully reached their physical activity target and showed a significant improvement in quality of life compared to the control group for subscales on emotional and mental health (4.31 vs -0.72, respectively; P=.009) and health change (11.06 vs 2.03, respectively; P=.004). The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous physical activity (MVPA) and increase in quality of life.
CONCLUSIONS
Our study shows that an Internet-based physical activity program was effective in improving quality of life in 60-70-year-olds after 3 months, particularly in participants that reached their individually targeted increase in daily physical activity.
TRIAL REGISTRATION
Nederlands Trial Register: NTR 3045; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 (Archived by WebCite at http://www.webcitation.org/6fobg2sjJ).
| 1significant effect
|
4,744,782 | 26,077,904 |
OBJECTIVES
This study examined the differential impact of two telehealth programs for women caring for an older adult with a neurocognitive disorder. Outcomes examined were depressive symptoms, upset following disruptive behaviors, anxious and angry mood states, and caregiving self-efficacy.
METHODS
Women cohabitating with a family member diagnosed with a neurocognitive disorder were assigned via random allocation to either of the following: (1) a 14-week behavioral intervention using video instructional materials, workbook and telephone coaching in behavioral management, pleasant events scheduling, and relaxation or (2) a basic education guide and telephone support comparison condition. Telephone assessments were conducted by interviewers blind to treatment condition at pre-intervention, post-intervention, and 6 months following intervention.
RESULTS
For those providing in-home care at post-treatment, depressive symptoms, upset following disruptive behaviors, and negative mood states were statistically lower in the behavioral coaching condition than in the basic education and support condition. Reliable change index analyses for Beck Depression Inventory II scores favored the behavioral coaching condition. Caregiving self-efficacy scores for obtaining respite and for managing patient behavioral disturbances were significantly higher in the coaching condition. Effect sizes were moderate but not maintained at the 6-month follow-up.
CONCLUSIONS
This study provides some initial evidence for the efficacy of a telehealth behavioral coaching intervention compared with basic education and telephone support. Carers' abilities to maintain strategy use during progressive disorders such as Alzheimer's disease likely require longer intervention contact than provided in the current study. Dementia carers, including those living in rural areas, can benefit from accessible and empirically supported interventions that can be easily disseminated across distances at modest cost.
| 1significant effect
|
5,594,766 | 28,928,547 |
INTRODUCTION
The aim of the present study was to evaluate and compare the effect of clonidine 200 μg and gabapentin 900 mg and pregabalin 150 mg in attenuation of the hemodynamic response to laryngoscopy and intubation in normotensive patients undergoing elective surgery.
METHODS
Ninety adult patients between 18 and 60 years are enrolled in the study. Patients with American Society of Anesthesiologists Grade-I and Grade-II are included which are posted for elective surgery under general anesthesia. Patients were divided into three groups: A, B, and C and received oral drugs 90 min before induction of general anesthesia, pregabalin 150, gabapentin 900mg, and clonidine 200 μg, respectively. Hemodynamic parameters such as heart rate and blood pressure were noted just before the (basal) administration of the drug, and in operation room, readings were recorded before intubation (T0) and after intubation at 1, 3, 5, and 10 min. Sedation and anxiety score were noted after 1 h of oral administration of the drug.
RESULTS
Mean arterial pressure was well attenuated by pregabalin than others, and mean heart rate following laryngoscopy and intubation was attenuated by clonidine group significantly.
CONCLUSION
We conclude that oral pregabalin and gabapentin attenuate blood pressure response fairly well and heart rate significantly attenuated by clonidine. All three drugs are very effective for relieving anxiety and improving sedation.
| 1significant effect
|
2,845,036 | 20,067,954 |
OBJECTIVE
This trial tested whether mycophenolate mofetil (MMF) alone or with daclizumab (DZB) could arrest the loss of insulin-producing beta-cells in subjects with new-onset type 1 diabetes.
RESEARCH DESIGN AND METHODS
A multi-center, randomized, placebo-controlled, double-masked trial was initiated by Type 1 Diabetes TrialNet at 13 sites in North America and Europe. Subjects diagnosed with type 1 diabetes and with sufficient C-peptide within 3 months of diagnosis were randomized to either MMF alone, MMF plus DZB, or placebo, and then followed for 2 years. The primary outcome was the geometric mean area under the curve (AUC) C-peptide from the 2-h mixed meal tolerance test.
RESULTS
One hundred and twenty-six subjects were randomized and treated during the trial. The geometric mean C-peptide AUC at 2 years was unaffected by MMF alone or MMF plus DZB versus placebo. Adverse events were more frequent in the active therapy groups relative to the control group, but not significantly.
CONCLUSIONS
Neither MMF alone nor MMF in combination with DZB had an effect on the loss of C-peptide in subjects with new-onset type 1 diabetes. Higher doses or more targeted immunotherapies may be needed to affect the autoimmune process.
| 0no significant effect
|
3,961,020 | 24,660,155 |
BACKGROUND
Laryngoscopy and tracheal intubation lead to the alteration of hemodynamic parameters, including blood pressure and heart rate, in traumatic patients who sustain rapid sequence intubation (RSI). Various drugs such as fentanyl, alfentanil and sufentanil have been used to modify these hemodynamic responses.
OBJECTIVES
The aim of the present study is to compare the effects of fentanyl, sufentanil and alfentanil in trauma patients who require RSI in the emergency department (ED).
PATIENTS AND METHODS
This was a randomized double-blinded study conducted on 90 patients (18-65 years old, ASA I, II), who needed intubation following trauma. The patients were randomly divided into three groups, Group I, Group II and Group III, who have received alfentanil, fentanyl and sufentanil, respectively. Heart rate, blood pressure, saturation of peripheral oxygen and end-tidal carbon dioxide were measured 5 minutes before and 3, 5 and 10 minutes after intubation, respectively. The changes of the hemodynamic parameters were compared in between groups. Data were analyzed by One-way ANOVA, General Linear Model Repeated Measure and Mauchly's Sphericity Test. A P < 0.05 was considered statistically significant.
RESULTS
There was no significant statistical difference among groups with respect to hemodynamic parameters.
CONCLUSIONS
Alfentanil, fentanyl and sufentanil can be used safely as premedication drugs for trauma patients who need intubation.
| 0no significant effect
|
3,268,925 | 22,323,915 |
PURPOSE
Preoperative chemotherapy has been used to increase the rate of breast conserving surgery (BCS) in Caucasian women. However, whether it would also increase the rate of BCS in Korean women has not been verified. The aim of this study was to determine the effectiveness of preoperative chemotherapy to make BCS possible in Korean women who have locally advanced cancer without any increase of locoregional recurrence according to operation methods (BCS vs. mastectomy).
METHODS
From August 2002 to April 2005, 205 patients with stage II or III breast cancer were enrolled in a phase III randomized trial of preoperative chemotherapy. Surgeons decided on the type of surgery (mastectomy or BCS) at initial diagnosis. By randomization, patients received four cycles of either docetaxel/capecitabine or doxorubicin/cyclophosphamide followed by surgery and crossover to the other treatment as postoperative chemotherapy.
RESULTS
The mean tumor size was 3.29 cm and the mean breast volume was 489 cc at diagnosis. After preoperative chemotherapy, clinical response was shown in 76.0% of the patients. Of the 71 patients planned for a mastectomy at initial diagnosis, 27 patients underwent BCS (38.0%). Clinical T stage after preoperative chemotherapy, pathologic T size and lymphatic invasion were correlated with conversion to BCS. In multivariate analysis, only lymphatic invasion showed statistical significance. Locoregional disease-free survival did not statistically differ between the two operation methods for the patients who were planned for a mastectomy at the initial exam.
CONCLUSION
This study showed that preoperative chemotherapy also increased the rate of BCS, while avoiding any increase of locoregional recurrence in Korean women with locally advanced breast cancer.
| 0no significant effect
|
5,820,800 | 29,463,275 |
BACKGROUND
Children who have suffered from critical illnesses that required treatment in a paediatric intensive care unit (PICU) have long-term physical and neurodevelopmental impairments. The mechanisms underlying this legacy remain largely unknown. In patients suffering from chronic diseases hallmarked by inflammation and oxidative stress, poor long-term outcome has been associated with shorter telomeres. Shortened telomeres have also been reported to result from excessive food consumption and/or unhealthy nutrition. We investigated whether critically ill children admitted to the PICU have shorter-than-normal telomeres, and whether early parenteral nutrition (PN) independently affects telomere length when adjusting for known determinants of telomere length.
METHODS
Telomere length was quantified in leukocyte DNA from 342 healthy children and from 1148 patients who had been enrolled in the multicenter, randomised controlled trial (RCT), PEPaNIC. These patients were randomly allocated to initiation of PN within 24 h (early PN) or to withholding PN for one week in PICU (late PN). The impact of early PN versus late PN on the change in telomere length from the first to last PICU-day was investigated with multivariable linear regression analyses.
RESULTS
Leukocyte telomeres were 6% shorter than normal upon PICU admission (median 1.625 (IQR 1.446-1.825) telomere/single-copy-gene ratio (T/S) units vs. 1.727 (1.547-1.915) T/S-units in healthy children (P < 0.0001)). Adjusted for potential baseline determinants and leukocyte composition, early PN was associated with telomere shortening during PICU stay as compared with late PN (estimate early versus late PN -0.021 T/S-units, 95% CI -0.038; 0.004, P = 0.01). Other independent determinants of telomere length identified in this model were age, gender, baseline telomere length and fraction of neutrophils in the sample from which the DNA was extracted. Telomere shortening with early PN was independent of post-randomisation factors affected by early PN, including longer length of PICU stay, larger amounts of insulin and higher risk of infection.
CONCLUSIONS
Shorter than normal leukocyte telomeres are present in critically ill children admitted to the PICU. Early initiation of PN further shortened telomeres, an effect that was independent of other determinants. Whether such telomere-shortening predisposes to long-term consequences of paediatric critical illness should be further investigated in a prospective follow-up study.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT01536275 . Registered on 16 February 2012.
| 1significant effect
|
3,775,167 | 24,049,616 |
BACKGROUND
Chronic kidney disease (CKD) coexisting with type 2 diabetes mellitus (DM) leads to coronary artery disease. The present study compares clopidogrel and low-dose aspirin as prophylactic therapy against coronary events in patients with CKD with diabetes.
METHODS
Total 80 patients of CKD with type 2 DM were randomized and allocated to clopidogrel and aspirin groups to receive the drug at a dose of 75 mg and 150 mg once daily respectively for 8 weeks as add-on therapy. Main outcome was change in blood pressure, metabolic parameters, renal function, inflammatory biomarkers, platelet aggregability and (UKPDS) United Kingdom Prospective Diabetes Study risk scoring.
RESULTS
Significant decrease in blood pressure (P < 0.01), total cholesterol (P = 0.02), LDL (P < 0.01), triglyceride (P < 0.01) and a better glycemic control (P < 0.01) was found in clopidogrel group. Renal markers and electrolytes have been improved in clopidogrel group but in aspirin group there was deterioration (2.5%) of creatinine clearance. Clopidogrel group has shown a significant decrease in hsCRP (P < 0.01), UKPDS risk scoring (P < 0.01) and better anti-aggregatory effect.
CONCLUSIONS
Clopidogrel has prophylactic role in CKD with type 2 DM due to better control of metabolic parameters, renal function and inflammatory burden in comparison to aspirin.
| 1significant effect
|
5,518,918 | 28,534,417 |
Aim Although cardiac rehabilitation improves physical fitness after a cardiac event, many eligible patients do not participate in cardiac rehabilitation and the beneficial effects of cardiac rehabilitation are often not maintained over time. Home-based training with telemonitoring guidance could improve participation rates and enhance long-term effectiveness. Methods and results We randomised 90 low-to-moderate cardiac risk patients entering cardiac rehabilitation to three months of either home-based training with telemonitoring guidance or centre-based training. Although training adherence was similar between groups, satisfaction was higher in the home-based group ( p = 0.02). Physical fitness improved at discharge ( p < 0.01) and at one-year follow-up ( p < 0.01) in both groups, without differences between groups (home-based p = 0.31 and centre-based p = 0.87). Physical activity levels did not change during the one-year study period (centre-based p = 0.38, home-based p = 0.80). Healthcare costs were statistically non-significantly lower in the home-based group (€437 per patient, 95% confidence interval -562 to 1436, p = 0.39). From a societal perspective, a statistically non-significant difference of €3160 per patient in favour of the home-based group was found (95% confidence interval -460 to 6780, p = 0.09) and the probability that it was more cost-effective varied between 97% and 75% (willingness-to-pay of €0 and €100,000 per quality-adjusted life-years, respectively). Conclusion We found no differences between home-based training with telemonitoring guidance and centre-based training on physical fitness, physical activity level or health-related quality of life. However, home-based training was associated with a higher patient satisfaction and appears to be more cost-effective than centre-based training. We conclude that home-based training with telemonitoring guidance can be used as an alternative to centre-based training for low-to-moderate cardiac risk patients entering cardiac rehabilitation.
| 0no significant effect
|
5,056,957 | 27,430,652 |
BACKGROUND/OBJECTIVES
Obesity prevention during adolescence is a health priority. The 'Physical Activity 4 Everyone' (PA4E1) study tested a multi-component physical activity intervention in 10 secondary schools from socio-economically disadvantaged communities. This paper aimed to report the secondary outcomes of the study; to determine whether the intervention impacted on adiposity outcomes (weight, body mass index (BMI), BMI z-score), and whether any effect was moderated by sex, baseline BMI and baseline physical activity level, at 12 and 24 months.
SUBJECTS/METHODS
A cluster randomised controlled trial was conducted in New South Wales, Australia. The school-based intervention included seven physical activity strategies targeting the following: curriculum (strategies to maximise physical activity in physical education, student physical activity plans, an enhanced school sport programme); school environment (physical activity during school breaks, modification of school policy); and parents and the community (parent engagement, links with community physical activity providers). Students' weight (kg), BMI and BMI z-score, were collected at baseline (Grade 7), 12 and 24 months. Linear Mixed Models were used to assess between-group mean difference from baseline to 12 and 24 months. Exploratory sub-analyses were undertaken according to three moderators of energy balance.
RESULTS
A total of 1150 students (mean age=12 years) provided outcome data at baseline, 1051 (91%) at 12 months and 985 (86%) at 24 months. At 12 months, there were group-by-time effects for weight (mean difference=-0.90 kg (95% confidence interval (CI)=-1.50, -0.30), P<0.01) and BMI (-0.28 kg m -2 (-0.50, -0.06), P=0.01) in favour of the intervention group, but not for BMI z-score (-0.05 (-0.11; 0.01), P=0.13). These findings were consistent for weight (-0.62 kg (-1.21, 0.03), P=0.01) and BMI (-0.28 kg m -2 (-0.49, -0.06), P=0.01) at 24 months, with group-by-time effects also found for BMI z-score (-0.08 (-0.14; -0.02), P=0.02) favouring the intervention group.
CONCLUSION
The PA4E1 school-based intervention achieved moderate reductions in adiposity among adolescents from socio-economically disadvantaged communities. Multi-component interventions that increase adolescents' engagement in moderate-to-vigorous physical activity (MVPA) may assist in preventing unhealthy weight gain.
| 1significant effect
|
4,332,717 | 25,652,604 |
BACKGROUND
Few studies thus far have compared head-to-head different non-myelooablative conditioning regimens for allogeneic hematopoietic cell transplantation (allo-HCT).
METHODS
Here, we report the results of a phase II multicenter randomized study comparing non-myeloablative allo-HCT from HLA-identical siblings (n = 54) or from 10/10 HLA-matched unrelated donors (n = 40) with either fludarabine plus 2 Gy total body irradiation (Flu-TBI arm; n = 49) or 8 Gy TLI + anti-thymocyte globulin (TLI-ATG arm; n = 45) conditioning.
RESULTS
The 180-day cumulative incidences of grade II-IV acute GVHD (primary endpoint) were 12.2% versus 8.9% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Two-year cumulative incidences of moderate/severe chronic GVHD were 40.8% versus 17.8% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Five Flu-TBI patients and 10 TLI-ATG patients received pre-emptive DLI for low donor chimerism levels, while 1 Flu-TBI patient and 5 TLI-ATG patients (including 2 patients given prior pre-emptive DLIs) received a second HCT for poor graft function, graft rejection, or disease progression. Four-year cumulative incidences of relapse/progression were 22% and 50% in Flu-TBI and TLI-ATG patients, respectively (P = 0.017). Four-year cumulative incidences of nonrelapse mortality were 24% and 13% in Flu-TBI and TLI-ATG patients, respectively (P = 0.5). Finally, 4-year overall (OS) and progression-free survivals (PFS) were 53% and 54%, respectively, in the Flu-TBI arm, versus 54% (P = 0.9) and 37% (P = 0.12), respectively, in the TLI-ATG arm.
CONCLUSIONS
In comparison to patients included in the Flu-TBI arm, patients included in the TLI-ATG arm had lower incidence of chronic GVHD, higher incidence of relapse and similar OS.
TRIAL REGISTRATION
The study was registered on ClinicalTrial.gov ( NCT00603954 ) and EUDRACT (2010-024297-19) .
| 0no significant effect
|
2,818,614 | 20,056,003 |
BACKGROUND
In meta-analyses supplementation with vitamin D appears to reduce incidence of fractures, and in cross-sectional studies there is a positive association between serum 25-hydroxyvitamin D (25(OH)D) levels and bone mineral density (BMD). However, the effect of supplementation with high doses of vitamin D on BMD is more uncertain and could in theory have both positive and negative effects.
METHODS
The study was a one year, double blind placebo-controlled intervention trial performed at the University Hospital of North Norway. 421 subjects, 21 - 70 years old, were included and 312 completed the study. The subjects were randomized to vitamin D3 40.000 IU per week (DD group), vitamin D3 20.000 IU per week (DP group), or placebo (PP group). All subjects were given 500 mg calcium daily. Serum 25(OH)D, osteoprotegrin (OPG), receptoractivator of nuclear factor-kappaB ligand (RANKL), and BMD at the lumbar spine and the hip were measured before and at the end of the study.
RESULTS
At baseline the mean serum 25(OH)D levels were 58 nmol/L (all subjects) and increased to 141 and 100 nmol/L in the DD and DP groups, respectively. After one year, no significant differences were found between the three groups regarding change in BMD, serum OPG or RANKL.
CONCLUSIONS
Supplementation with high doses of vitamin D for one year does not appear to have a negative effect on BMD in healthy subjects. In order to disclose a positive effect, subjects with low BMD and/or low serum 25(OH)D levels need to be studied.
TRIAL REGISTRATION
The trial was registered at ClinicalTrials.gov (NCT00243256).
| 0no significant effect
|
3,292,461 | 22,176,722 |
BACKGROUND
Pregnancy and childbirth are associated with weight gain in women, and retention of weight gained during pregnancy can lead to obesity in later life. Diet and physical activity are factors that can influence the loss of retained pregnancy weight after birth. Exercise guidelines exist for pregnancy, but recommendations for exercise after childbirth are virtually nonexistent. The aim of this study was to evaluate the effect of physical activity intervention based on pedometer on physical activity level and anthropometric measures of women after childbirth.
METHODS
We conducted a randomized controlled trial in which 66 women who had given birth 6 weeks to 6 months prior were randomly assigned to receive either a 12 week tailored program encouraging increased walking using a pedometer (intervention group, n = 32) or routine postpartum care (control group, n = 34). During the 12-week study period, each woman in the intervention group wore a pedometer and recorded her daily step count. The women were advised to increase their steps by 500 per week until they achieved the first target of 5000 steps per day and then continued to increase it to minimum of 10,000 steps per day by the end of 12th week. Assessed outcomes included anthropometric measures, physical activity level, and energy expenditure per week. Data were analyzed using the paired t-test, independent t-test, Mann-Whitney, chi-square, Wilcoxon, covariance analysis, and the general linear model repeated measures procedure as appropriate.
RESULTS
After 12 weeks, women in the intervention group had significantly increased their physical activity and energy expenditure per week (4394 vs. 1651 calorie, p < 0.001). Significant differences between-group in weight (P = 0.001), Body Mass Index (P = 0.001), waist circumference (P = 0.001), hip circumference (P = 0.032) and waist-hip ratio (P = 0.02) were presented after the intervention. The intervention group significantly increased their mean daily step count over the study period (from 3249 before, to 9960 after the intervention, p < 0.001).
CONCLUSION
A physical activity intervention based on pedometer is an effective means to increase physical activity; reducing retention of weight gained during pregnancy and can improve anthropometric measures in postpartum women.
TRIAL REGISTRATION
ISRCTN: IRCT201105026362N1.
| 1significant effect
|
4,552,663 | 26,317,629 |
BACKGROUND
Numerous studies have demonstrated the beneficial effects of preoperative administration of oral carbohydrate (CHO) or oral rehydration solution (ORS). However, the effects of preoperative CHO or ORS on postoperative quality of recovery after anesthesia remain unclear. Consequently, the purpose of the current study was to evaluate the effect of preoperative CHO or ORS on patient recovery, using the Quality of Recovery 40 questionnaire (QoR-40).
METHODS
This prospective, randomized, controlled clinical trial included American Society of Anesthesiologists (ASA) physical status 1 and 2 adult patients, who were scheduled to undergo a surgical procedure of body surface. Subjects were randomized to one of the three groups: 1) preoperative CHO group, 2) preoperative ORS group, and 3) control group. The primary outcome was the global QoR-40 administered 24 h after surgery. Intraoperative use of vasopressor, intraoperative body temperature changes, and postoperative nausea and vomiting (PONV) were also evaluated.
RESULTS
We studied 134 subjects. The median [interquartile range (IQR)] global QoR-40 scores 24 h after the surgery were 187 [177-197], 186 [171-200], and 184 [171-198] for the CHO, ORS, and control groups, respectively (p = 0.916). No significant differences existed between the groups regarding intraoperative vasopressor use during the surgery (p = 0.475).
CONCLUSIONS
Results of the current study indicated that the preoperative administration of either CHO or ORS did not improve the quality of recovery in patients undergoing minimally invasive body surface surgery.
TRIAL REGISTRATION
www.umin.ac.jp UMIN000009388 https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000011029&language=E.
| 0no significant effect
|
3,599,938 | 23,399,518 |
BACKGROUND
Investigators often face challenges when recruiting participants into randomized controlled trials (RCTs). Some data suggest that telephone reminders may lead to greater participant enrollment.
METHODS
Patients aged 50 to 70 years from family practice rosters were initially mailed invitations to participate in an RCT of colorectal cancer screening. Patients who did not respond were randomly allocated to follow-up invitations by either telephone or mail four weeks after the initial invitation. The primary outcome was attendance for eligibility screening with the study nurse.
RESULTS
After mailing invitations to 1,348 patients, 104 patients were initially enrolled in the RCT of colon cancer screening. Of 952 patients who did not respond to the initial mailed invitation, we randomly allocated 480 to follow-up invitation by telephone and 472 to follow-up invitation by mail. Attendance for eligibility screening with the study nurse was more frequent when non-responders were followed-up by telephone (84/480, 17.5%) than by mail (43/472, 9.1%) (relative risk (RR) 1.92, 95% confidence interval (CI) 1.36 to 2.71, P < 0.001). Enrollment into the RCT was also greater among patients followed-up by telephone (59/480, 12.3%) compared to those followed-up by mail (35/472, 7.4%) (RR 1.66, 95% CI 1.11 to 2.47, P=0.01).
CONCLUSIONS
Telephone-based follow-up results in greater enrollment compared to a mail-based method. Our findings should be of interest to investigators conducting RCTs, particularly trials of screening interventions involving asymptomatic participants for which volunteer participation may be challenging.
TRIAL REGISTRATION
Clinicaltrials.gov NCT00865527.
| 1significant effect
|
4,018,592 | 24,829,731 |
BACKGROUND
Increased requirement and decreased dietary intakes of micronutrients during pregnancy might affect maternal health and pregnancy outcomes. This study was aimed to examine the effects of two types of multiple micronutrient supplementations on pregnancy outcomes in Kashan, Iran.
METHODS
In a randomized single-blind controlled clinical trial, 104 primigravid singleton pregnant women aged 18-30 years were randomly assigned to receive either a multivitamin (n = 51) or a multivitamin-mineral (n = 53) supplements for 20 weeks. Participants consumed supplements once a day at week 16 of gestation. Maternal anthropometric data as well as newborn's weight, height, head circumference and 5-min Apgar score were also determined. Independent samples t-test was used for comparing between-group means. Multivariate linear regression analysis was used to identify determinants of newborn's weight, height and head circumference.
RESULTS
Women taking multivitamin-mineral supplements gained marginally less weight until week 28 than those taking multivitamin supplements (weight at week 28 of gestation: 67.5 ± 11.4 vs. 71.6 ± 10.3 kg, P = 0.06). Mean body mass index at week 28 (25.8 ± 4.0 vs. 28.4 ± 3.7 kg/m(2), P = 0.001) as well as at delivery (28.0 ± 3.9 vs. 30.1 ± 3.8 kg/m(2), P = 0.006) was lower among women taking multivitamin-mineral supplements than those taking multivitamin supplements. Although no significant difference was seen in newborns' height and Apgar score between the two groups, mean birth weight (3.3 ± 0.4 vs. 3.1 ± 0.4 kg, P = 0.04) and head circumference (35 ± 1.4 vs. 34 ± 1.3 cm, P < 0.0001) of the infants whose mothers receiving multivitamin-mineral supplements were higher than those whose mothers received multivitamins. Multivitamin-mineral use by pregnant women was a significant predictor of infants' weight (β =0.191, P = 0.03) and head circumference (β =0.907, P = 0.005).
CONCLUSIONS
In conclusion, we found that birth weight and head circumference was increased in infants whose mothers received multivitamin-mineral supplements for 5 months during pregnancy compared with infants whose mothers received multivitamin supplements.
| 0no significant effect
|
5,341,634 | 28,298,754 |
BACKGROUND AND AIMS
Various opioid additives have been trialed to prolong brachial plexus block. We evaluated the effect of adding nalbuphine hydrochloride to levobupivacaine for supraclavicular brachial plexus blockade. The primary end-points were the onset and duration of sensory and motor blocks and duration of analgesia.
MATERIALS AND METHODS
Seventy-eight patients (aged 25-45 years) posted for ambulatory forearm and hand surgery under supraclavicular brachial plexus block were divided into two equal groups (Groups LN and LC) in a randomized, double-blind fashion. In Group LN ( n = 39), 30 ml 0.5% levobupivacaine + 10 mg (diluted in 2 ml 0.9% saline) nalbuphine hydrochloride, and in Group LC ( n = 39), 30 ml 0.5% levobupivacaine + 2 ml normal saline (0.9%) were administered in supraclavicular block. Sensory and motor block onset times and block durations, time to first analgesic use, total analgesic need, postoperative visual analog scale (VAS), hemodynamics, and side effects were recorded for each patient.
RESULTS
Although with similar demographic profile and block (sensory and motor) onset time, sensory and motor block duration and time to first analgesic use were significantly longer and the total need for rescue analgesics was lower in Group LN ( P < 0.05) than Group LC. Postoperative VAS value at 24 h was significantly lower in Group LN ( P < 0.05). Intraoperative hemodynamics was comparable between two groups, and no any appreciable side effect was noted throughout the study period.
CONCLUSION
It can be concluded that adding nalbuphine hydrochloride to supraclavicular brachial plexus block increases the sensory and motor block duration and time to first analgesic use, and decreases total analgesic use with no side effects.
| 1significant effect
|
1,896,161 | 17,543,129 |
AIM
We evaluated the use of computerized quantification of wheezing and crackles compared to a clinical score in assessing the effect of inhaled albuterol or inhaled epinephrine in infants with RSV bronchiolitis.
METHODS
Computerized lung sounds analysis with quantification of wheezing and crackles and a clinical score were used during a double blind, randomized, controlled nebulized treatment pilot study. Infants were randomized to receive a single dose of 1 mgr nebulized l-epinephrine or 2.5 mgr nebulized albuterol. Computerized quantification of wheezing and crackles (PulmoTrack) and a clinical score were performed prior to, 10 minutes post and 30 minutes post treatment. Results were analyzed with Student's t-test for independent samples, Mann-Whitney U test and Wilcoxon test.
RESULTS
15 children received albuterol, 12 received epinephrine. The groups were identical at baseline. Satisfactory lung sounds recording and analysis was achieved in all subjects. There was no significant change in objective quantification of wheezes and crackles or in the total clinical scores either within the groups or between the groups. There was also no difference in oxygen saturation and respiratory distress.
CONCLUSION
Computerized lung sound analysis is feasible in young infants with RSV bronchiolitis and provides a non-invasive, quantitative measure of wheezing and crackles in these infants.
| 0no significant effect
|
3,224,655 | 22,135,493 |
INTRODUCTION
Noninvasive ventilation (NIV) is a well-established treatment for acute-on- chronic respiratory failure in hypercapnic COPD patients. Less is known about the effects of a long-term treatment with NIV in hypercapnic COPD patients and about the factors that may predict response in terms of improved oxygenation and lowered CO(2) retention.
METHODS
In this study, we randomized 15 patients to a routine pharmacological treatment (n = 5, age 66 [standard deviation ± 6] years, FEV(1) 30.5 [±5.1] %pred, PaO(2) 65 [±6] mmHg, PaCO(2) 52.4 [±6.0] mmHg) or to a routine treatment and NIV (using the Synchrony BiPAP device [Respironics, Inc, Murrsville, PA]) (n = 10, age 65 [±7] years, FEV(1) 29.5 [±9.0] %pred, PaO(2) 59 [±13] mmHg, PaCO(2) 55.4 [±7.7] mmHg) for 6 months. We looked at arterial blood gasses, lung function parameters and performed a low-dose computed tomography of the thorax, which was later used for segmentation (providing lobe and airway volumes, iVlobe and iVaw) and post-processing with computer methods (providing airway resistance, iRaw) giving overall a functional image of the separate airways and lobes.
RESULTS
In both groups there was a nonsignificant change in FEV(1) (NIV group 29.5 [9.0] to 38.5 [14.6] %pred, control group 30.5 [5.1] to 36.8 [8.7] mmHg). PaCO(2) dropped significantly only in the NIV group (NIV: 55.4 [7.7] → 44.5 [4.70], P = 0.0076; control: 52.4 [6.0] → 47.6 [8.2], NS). Patients actively treated with NIV developed a more inhomogeneous redistribution of mass flow than control patients. Subsequent analysis indicated that in NIV-treated patients that improve their blood gases, mass flow was also redistributed towards areas with higher vessel density and less emphysema, indicating that flow was redistributed towards areas with better perfusion. There was a highly significant correlation between the % increase in mass flow towards lobes with a blood vessel density of >9% and the increase in PaO(2). Improved ventilation-perfusion match and recruitment of previously occluded small airways can explain the improvement in blood gases.
CONCLUSION
We can conclude that in hypercapnic COPD patients treated with long-term NIV over 6 months, a mass flow redistribution occurs, providing a better ventilation-perfusion match and hence better blood gases and lung function. Control patients improve homogeneously in iVaw and iRaw, without improvement in gas exchange since there is no improved ventilation/perfusion ratio or increased alveolar ventilation. These differences in response can be detected through functional imaging, which gives a more detailed report on regional lung volumes and resistances than classical lung function tests do. Possibly only patients with localized small airway disease are good candidates for long-term NIV treatment. To confirm this and to see if better arterial blood gases also lead to better health related quality of life and longer survival, we have to study a larger population.
| 0no significant effect
|
4,517,417 | 26,216,410 |
BACKGROUND
Meta-analysis revealed that embryo placement 20 mm from the fundal endometrial surface resulted in higher pregnancy rate, ongoing pregnancy rate, and live birth rate compared with placement 10 mm from the fundal endometrial surface. Pregnancy and implantation rates according to relative position were higher when the catheter tip was positioned close to the middle of the endometrial cavity. The aim of the current study is to evaluate differences in implantation and pregnancy rates if the site of embryo transfer is 2 cm distance from the fundal endometrium (DFE) compared to the midpoint of the endometrial cavity length (ECL).
METHODS
Patients were randomized to one of two groups: in group A (n = 98, 98 IVF-ET cycles), the embryo transfer catheter tip was positioned 2 cm DFE, while that in group B (n = 97, 97 IVF-ET cycles) was positioned at the midpoint of the ECL. We compared pregnancy outcomes of implantation rate, chemical pregnancy rate, clinical pregnancy rate, ongoing pregnancy rate, ectopic pregnancy rate, and miscarriage rate in the two groups.
RESULTS
Analysis of implantation rate (19.5 ± 27.7 vs. 21.7 ± 32.6; p = 0.6), chemical pregnancy rate (51 % vs. 50.5 %; p = 0.94), clinical pregnancy rate (35.7 % vs. 38.1 %; p = 0.73), ongoing pregnancy rate (31.6 % vs. 30.9 %; p = 0.92), ectopic pregnancy rate (8.6 % vs. 2.7 %; p = 0.35), and miscarriage rate (11.4 % vs. 16.2 %; 0.74) revealed comparable results for both groups.
CONCLUSIONS
Implantation and pregnancy rates were not influenced by the site of the ET catheter tip being 2 cm DFE compared to at the midpoint of the ECL.
TRIAL REGISTRATION
ISRCTN
ISRCTN15972342.
| 0no significant effect
|
5,324,269 | 28,231,782 |
BACKGROUND
Vitamin D (D) supplements are indispensable for its world-wide deficiency. Controversy continues on ergocalciferol (D2) and cholecalciferol (D3) relative potency as well as on dosing-schedule and sex role in raising 25-hydroxy D (25(OH)D) level, the best indicator of D status.
METHODS
We randomized 279 adults to daily D2, D3, D2/D3, or placebo; 2-weekly D2 or D3; or 4-weekly D2 or D3 (250,000 IU over/140 days). Randomization sequence, stratified by body-mass-index (BMI) and sex, was concealed from study coordinators and participants who were then blinded to capsules' content. D2, D3, 25(OH)D2, and 25(OH)D3 Serum levels were determined blindly on days 0,1,2,3,4,7,14, and 2-weekly thereafter by high performance liquid chromatography assay. The results of 269 participants were available for analysis. Primary endpoint was area-under-the-curve (AUC) of 25(OH)D (25(OH)D2 + 25(OH)D3) adjusted for sex, BMI, and baseline 25(OH)D level.
RESULTS
Mean(SD) age was 33.0(8.5) year, 41% were males, and 85% completed follow-up. Baseline 25(OH)D level was 39.8(11.9) and increased by 3.3(11.6) and 28.6(16.3) nmol/L, in the placebo and active-treatment groups, respectively. AUC from day 0 to 140 (AUC 140 ) of 25(OH)D was 40% (D3 daily) to 55% (D3 2-weekly) higher with active-treatment than placebo (p < 0.001). 25(OH)D2 AUC 140 was higher in daily than 2-weekly (17%, p = 0.006) and 4-weekly (20%, p = 0.001) D2-treated groups. 25(OH)D3 AUC 140 was lower in daily than 2-weekly (11%, p = 0.002) and 4-weekly D3-treated groups (10%, p = 0.008). In D2-treated groups, there was 16.4 nmol/L decrease in 25(OH)D3 level that correlated (p < 0.001) with 25(OH)D2 level increase (r = 0.48) and baseline 25(OH)D level (r = 0.58), in one participant with measurable baseline 25(OH)D2 level, D3 caused a similar decrease in 25(OH)D2 level, while in the D2/D3-treated group, 25(OH)D3 level didn't increase. Incremental AUC from day 0 to 7 (AUC 7 ) of D3 and 25(OH)D3 in D3-treated groups were 118-243% higher and 31-39% lower, respectively, than incremental AUC 7 of D2 and 25(OH)D2 in D2-treated groups. Incremental AUC 7 of D3 and 25(OH)D3 in D3-treated groups and D2 and 25(OH)D2 in D2-treated groups were higher in females than males (55, 13, 64, and 28%, respectively). Baseline 25(OH)D level predicted response to D2 and D3 (p < 0.001), whereas, BMI was significant predictor only for early response to D2.
CONCLUSIONS
Effects of D2 and D3 supplements on 25 (OH)D level may be dosing-schedule and sex-dependent. D2-associated reduction in 25(OH)D3 level may be related to total 25(OH)D level rather than being D2-specific. D2 may be 25-hydroxylated faster than D3.
TRIAL REGISTRATION
ClinicalTrial.gov identifier: NCT01170494 (registered July 25, 2010).
| 1significant effect
|
2,778,511 | 19,861,997 |
BACKGROUND
The aims of this study were to determine which consent procedure patients prefer for use of stored tissue for research purposes and what the effects of consent procedures on actual consenting behaviour are.
METHODS
We offered 264 cancer patients three different consent procedures: 'one-time general consent' (asked written informed consent), 'opt-out plus' (had the opportunity to opt out by a form), or the standard hospital procedure (control group). The two intervention groups received a specific leaflet about research with residual tissue and verbal information. The control group only received a general hospital leaflet including opt-out information, which is the procedure currently in use. Subsequently, all patients received a questionnaire to examine their preferences for consent procedures.
RESULTS
In all, 99% of patients consented to research with their residual tissue. In the 'one-time consent' group 85% sent back their consent form. Patients preferred 'opt-out plus' (43%) above 'one-time consent' (34%) or 'opt-out' (16%), whereas 8% indicated that they did not need to receive information about research with residual tissues or be given the opportunity to make a choice.
CONCLUSIONS
The 'opt-out plus' procedure, which places fewer demands on administrative resources than 'one-time consent', can also address the information needs of patients.
| 1significant effect
|
5,471,294 | 28,663,739 |
OBJECTIVE
To explore whether the addition of a mid-luteal bolus of GnRH agonist (GnRHa) improves the implantation rate (IR) in in vitro fertilization (IVF) cycles.
DESIGN
A randomized controlled trial.
SETTING
Private IVF center.
PATIENTS
328 IVF/intracytoplasmic sperm injection patients were triggered with GnRHa and received 1,500 IU HCG on the day of oocyte pick-up (OPU) in addition to a standard luteal phase support (LPS).
INTERVENTIONS
In addition, the study group received a bolus of GnRHa 6 days after OPU, whereas the control group did not.
MAIN OUTCOME MEASURE
Implantation rate.
SECONDARY OUTCOME MEASURES
Ongoing pregnancy (OP) and live birth (LB) rates.
RESULTS
Although serum concentrations of FSH, LH, E2, and P on day OPU + 7 were significantly higher in the study group compared to the control group, the IR was not statistically different between the treatment group (27%) and the control group (23%) [odds ratio (OR) 1.2 (95% CI 0.9-1.7), P < 0.27]. Similarly, the OP rate was 37% in the treatment group and 31% in the control group [OR 1.3 (95% CI 0.8-2.0), P < 0.23]. The LB rate was 36% in the treatment group and 31% in the control group [OR: 1.3 (95% CI 0.8-2.0), P < 0.27].
CONCLUSION
Although a trend toward a higher IR and pregnancy rate was observed in the treatment group, this difference was not statistically significant. However, the absolute risk difference of 5% found for LB is clinically relevant, warranting further investigation.
NCT
02053779.
| 0no significant effect
|
4,124,476 | 25,104,916 |
BACKGROUND
Craniotomy patients have a high incidence of postoperative nausea and vomiting (PONV). This prospective, randomized, double-blind, multi-center study was performed to evaluate the efficacy of prophylactic ramosetron in preventing PONV compared with ondansetron after elective craniotomy in adult patients.
METHODS
A total of 160 American Society of Anesthesiologists physical status I-II patients aged 19-65 years who were scheduled to undergo elective craniotomy for various intracranial lesions were enrolled in this study. All patients received total intravenous anesthesia (TIVA) with propofol and remifentanil. Patients were randomly allocated into three groups to receive ondansetron (4 mg; group A, n = 55), ondansetron (8 mg; group B, n = 54), or ramosetron (0.3 mg; group C, n = 51) intravenously at the time of dural closure. The incidence of PONV, the need for rescue antiemetics, pain score, patient-controlled analgesia (PCA) consumption, and adverse events were recorded 48 h postoperatively.
RESULTS
Among the initial 160 patients, 127 completed the study and were included in the final analysis. The incidences of PONV were lower (nausea, 14% vs. 59% and 41%, respectively; P < 0.001; vomiting, P = 0.048) and the incidence of complete response was higher (83% vs. 37% and 59%, respectively; P < 0.001) in group C than in groups A and B at 48 h postoperatively. There were no significant differences in the incidence of PONV or need for rescue antiemetics 0-2 h postoperatively, but significant differences were observed in the incidence of PONV and complete response among the three groups 2-48 h postoperatively. No statistically significant intergroup differences were observed in postoperative pain, PCA consumption, or adverse events.
CONCLUSION
Intravenous administration of ramosetron at 0.3 mg reduced the incidence of PONV and rescue antiemetic requirement in craniotomy patients. Ramosetron at 0.3 mg was more effective than ondansetron at 4 or 8 mg for preventing PONV in adult craniotomy patients.
TRIAL REGISTRATION
CLINICAL RESEARCH INFORMATION SERVICE (CRIS) IDENTIFIER: KCT0000320. Registered 9 January 2012.
| 0no significant effect
|
3,556,012 | 23,351,337 |
UNLABELLED
BACKGROUND
The prevalence of Pediatric Functional Constipation (FC) has been reported between 0.7% to 29.6%. This study was conducted to compare the laxative effect of cassia fistula emulsion (CFE) with mineral oil (MO) on FC. Cassia fistula is named in Traditional Iranian Medicine (TIM) as "Folus".
MATERIALS AND METHODS
A randomized clinical trial was carried on 81 children (age range: 4-13 years) with FC, according to Rome III criteria in Amirkola Children's Hospital, Babol, Iran. They received CFE or MO randomly for three weeks. CFE was produced according to the order of TIM references. Children were counted as improved when they exited from Rome III criteria of FC. Frequency of defecation, fecal incontinence, retentive posturing, severity of pain, consistency of stool and anal leakage of oily material were compared between the two groups and with baselines. An intent-to-treat analysis was used. Safety of drugs was assessed with the evaluation of clinical adverse effects.
RESULTS
41 children were assigned randomly to receive CFE and 40 children received MO. After three weeks of medication, 84% of children in CFE group and 50% in MO group (p = 0.002) exited from the criteria of FC, so called improved. All measurable criteria improved in both groups. The frequency of defecation in CFE group improved from 1.7 per week (before the study) to 10.6 per week (at the third week) while this parameter differed in MO group from 2 to 6.1 (p < 0.001). The severity of pain during defecation and consistency of stool improved significantly better in CFE group than MO group (p < 0.05), but there were not any significant differences between the two groups in fecal incontinence and retentive posturing. Anal leakage of oily material occurred as an important complication in MO group while the children in CFE group did not complaint it. Drug's compliances were not significantly different in the two groups. CFE and MO did not cause clinically significant side effects.
CONCLUSIONS
CFE was most effective than MO in the 3-week treatment of children with FC.
| 1significant effect
|
2,796,659 | 19,995,444 |
BACKGROUND
Many studies have reported beneficial effects from the application of near-infrared (NIR) light photobiomodulation (PBM) to the body, and one group has reported beneficial effects applying it to the brain in stroke patients. We have reported that the measurement of a patient's left and right hemispheric emotional valence (HEV) may clarify data and guide lateralized treatments. We sought to test whether a NIR treatment could 1. improve the psychological status of patients, 2. show a relationship between immediate psychological improvements when HEV was taken into account, and 3. show an increase in frontal pole regional cerebral blood flow (rCBF), and 4. be applied without side effects.
METHODS
We gave 10 patients, (5 M/5 F) with major depression, including 9 with anxiety, 7 with a past history of substance abuse (6 with an opiate abuse and 1 with an alcohol abuse history), and 3 with post traumatic stress disorder, a baseline standard diagnostic interview, a Hamilton Depression Rating Scale (HAM-D), a Hamilton Anxiety Rating Scale (HAM-A), and a Positive and Negative Affect Scale (PANAS). We then gave four 4-minute treatments in a random order: NIR to left forehead at F3, to right forehead at F4, and placebo treatments (light off) at the same sites. Immediately following each treatment we repeated the PANAS, and at 2-weeks and at 4-weeks post treatment we repeated all 3 rating scales. During all treatments we recorded total hemoglobin (cHb), as a measure of rCBF with a commercial NIR spectroscopy device over the left and the right frontal poles of the brain.
RESULTS
At 2-weeks post treatment 6 of 10 patients had a remission (a score </= 10) on the HAM-D and 7 of 10 achieved this on the HAM-A. Patients experienced highly significant reductions in both HAM-D and HAM-A scores following treatment, with the greatest reductions occurring at 2 weeks. Mean rCBF across hemispheres increased from 0.011 units in the off condition to 0.043 units in the on condition, for a difference of 0.032 (95% CI: -0.016, 0.080) units, though this result did not reach statistical significance. Immediately after treatment the PANAS improved to a significantly greater extent with NIR "on" relative to NIR "off" when a hemisphere with more positive HEV was treated than when one with more negative HEV was treated. We observed no side effects.
CONCLUSION
This small feasibility study suggests that NIR-PBM may have utility for the treatment of depression and other psychiatric disorders and that double blind randomized placebo-controlled trials are indicated.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00961454.
| 1significant effect
|
3,603,112 | 23,565,464 |
BACKGROUND
Elderly, obese women with diabetes who have limitations in mobility often are unable to walk for a sustained period of time. We need to find a way to increase physical activity in these subjects.
AIM
To evaluate the effect of low-intensity, repetitive, home-based walking regimen on glycemic control in elderly, obese women with diabetes.
RESEARCH DESIGN
A 24-week open, 2 arms, and prospective study.
MATERIALS AND METHODS
A total of 18 elderly people with type 2 diabetes were recruited. Nine subjects were instructed to walk for 5 minutes per hour for most waking hours for 24 weeks. The rest were given standard advice regarding diet and exercise. Glycemic control, HbA1c, weight, BMI, subjects' physical fitness, QOL, and distance walked in 6 minutes were determined before and after the intervention.
INTERVENTION
A mild physical activity of 5 minutes walking/hour everyday and antidiabetic medications prescribed as per clinic procedure.
RESULTS
There was a significant reduction in HbA1c within the study group (8.76% to 7.43%) (P = 0.08) vs rise in the control group (8.34% to 9.34%) (P = 0.07). There was a significant weight loss within the group which exercised (P = 0.01), but there was no significant difference between the groups.
CONCLUSION
Repetitive low-intensity activity is effective in improving glycemic control and weight management in elderly obese women.
| 1significant effect
|
2,784,472 | 19,922,649 |
BACKGROUND
This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms.
METHODS
Sixty-one adults were enrolled (age 36.5 +/- 12.6 years; height 165.1 +/- 9.2 cm; weight 75.4 +/- 17.3 kg) and randomized to either Digestive Advantage Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use.
RESULTS
Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables.
CONCLUSION
In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT00881322.
| 1significant effect
|
3,611,073 | 23,560,189 |
BACKGROUND
The purpose of this study is to compare the anesthetic characteristics in elderly patients who remain in sitting position for 2 min compared with patients that are placed in supine position after induction of spinal anesthesia.
METHODS
Fifty-seven patients scheduled for transurethral surgery were randomized to assume supine position immediately after 6.5 mg hyperbaric bupivacaine were injected (L group) or to remain in the sitting position for 2 minutes before they also assumed the supine position (S group). Analgesic levels were assessed bilaterally, using pin-prick. Motor block was scored using a 12-point scale. The mean arterial pressure and heart rate were also recorded.
RESULTS
Sensory block levels were significantly lower at all time points for the L group. However, there were no significant differences in the degree of the motor block and hemodynamic changes between the two groups. However, in the L group, ephedrine or atropine were administered to three patients.
CONCLUSIONS
We concluded that performing a spinal anesthesia in sitting position was technically easier and induced less hypotension.
| 1significant effect
|
3,996,149 | 24,495,354 |
BACKGROUND AND AIM
Altered glucose metabolism, oxidative stress, lipid levels and inflammatory markers are important risk factors in diabetes, cardiovascular, and many other diseases. Cocoa has been shown to exert antioxidant and anti-inflammatory effects. The aim of this study is twofold: to assess the effect of Cocoa on the lipid profile and peroxidation in addition to the inflammatory markers in type 2 diabetic patients, and to represent a virtual model of probable action mechanism of observed clinical effects of Cocoa consumption using in silico analysis and bioinformatics data.
METHODS
One hundred subjects with type 2 diabetes were included in a randomized clinical control trial. Fifty treatment subjects received 10 grams cocoa powder and 10 grams milk powder dissolved in 250 ml of boiling water, and the other fifty control subjects received only 10 grams milk powder dissolved in 250 ml boiling water. Both groups were on the mentioned regimen twice daily for 6 weeks. Blood samples were obtained prior to Cocoa consumption and 6 weeks after intervention. Serum lipids and lipoproteins profile, malondialdehyde and inflammatory markers including tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and high sensitive C-reactive protein (hs-CRP) were measured. For statistical analysis two independent and paired samples t-test and linear regression were used. Bioinformatics and virtual analysis were performed using string data base and Molegro virtual software.
RESULTS
Cocoa consumption lowered blood cholesterol,triglyceride, LDL-cholesterol, and TNF-α, hs-CRP, IL-6 significantly (P < 0.01). The results showed that the levels of HDL-cholesterol decreased significantly (P < 0.05) but Cocoa inhibited lipid peroxidation in treatment group than control group (P < 0.0001). Virtual analysis showed that the most frequent Cocoa ingredients, (+)-Catechin and (-)-Epicatechin, can dock to the enzyme COX-2.
CONCLUSION
These data support the beneficial effect of Cocoa on the lipid peroxidation prevention and inflammatory markers in type 2 diabetic patients. Cocoa ingredients block the Cox-2 activation and reduce inflammatory prostanoids synthesis according to virtual analysis.
| 1significant effect
|
4,314,171 | 25,685,078 |
INTRODUCTION
Arterial hypertension is the main independent risk factor for cardiovascular (CV) disease and death. It affects development and course of cerebrovascular insult (CVI) and chronic kidney disease (CKD). Balneotherapy with sulphide baths was administered to patients having stage I hypertension (BP values 140-159/90-99), with no arrhythmia or pronounced coronary disease. Baths also had advantage in patients having hypertension joined with obesity, diabetes, microangiopathy, and atherosclerosis of peripheral arteries.
GOAL
Determine the effects of sulphate-sulphide mineral baths on stage I hypertension after 10 days therapy.
MATERIALS AND METHODS
Patients having stage I hypertension were sent to "Mlječanica" Institute for rehabilitation. All subjects were treated with kinesitherapy and electrotherapy, while experimental group (n=30) was also treated with 20 minute baths, daily, for period of 10 days.
RESULTS
In experimental group BP level lowered in average 10 mmHg after 10-day therapy, and change was evident even after only 5 days.
CONCLUSION
Sulphate-sulphide mineral water "Mlječanica" caused significant (p<0.05) lowering of arterial BP level after 10 days of therapy in patients who had stage I hypertension.
| 1significant effect
|
4,207,147 | 24,271,093 |
BACKGROUND
The effects of physical therapy on heart rate variability (HRV), especially in children, are still inconclusive.
OBJECTIVE
We investigated the effects of conventional physical therapy (CPT) for airway clearance and nasotracheal suction on the HRV of pediatric patients with acute bronchiolitis.
METHOD
24 children were divided into two groups: control group (CG, n=12) without respiratory diseases and acute bronchiolitis group (BG, n=12). The heart rate was recorded in the BG at four different moments: basal recording (30 minutes), 5 minutes after the CPT (10 minutes), 5 minutes after nasotracheal suction (10 minutes), and 40 minutes after nasotracheal suction (30 minutes). The CG was subjected to the same protocol, except for nasotracheal suction. To assess the HRV, we used spectrum analysis, which decomposes the heart rate oscillations into frequency bands: low frequency (LF=0.04-0.15 Hz), which corresponds mainly to sympathetic modulation; and high frequency (HF=0.15-1.2 Hz), corresponding to vagal modulation.
RESULTS
Under baseline conditions, the BG showed higher values in LF oscillations, lower values in HF oscillations, and increased LF/HF ratio when compared to the CG. After CPT, the values for HRV in the BG were similar to those observed in the CG during basal recording. Five minutes after nasotracheal suction, the BG showed a decrease in LF and HF oscillations; however, after 40 minutes, the values were similar to those observed after application of CPT.
CONCLUSIONS
The CPT and nasotracheal suction, both used for airway clearance, promote improvement in autonomic modulation of HRV in children with acute bronchiolitis.
| 1significant effect
|
5,125,808 | 27,920,497 |
PURPOSE
To evaluate the blood pressure (BP) lowering efficacy and safety of CKD-828, a fixed-dose combination of S-amlodipine (the more active isomer of amlodipine besylate, which is calcium channel blocker) and telmisartan (long acting angiotensin receptor blocker), in patients with hypertension inadequately controlled with S-amlodipine monotherapy.
PATIENTS AND METHODS
Eligible patients (N=187) who failed to respond after 4-week S-amlodipine 2.5 mg monotherapy (sitting diastolic blood pressure [sitDBP] ≥90 mmHg) to receive CKD-828 2.5/40 mg (n=63), CKD-828 2.5/80 mg (n=63), or S-amlodipine 2.5 mg (n=61) for 8 weeks. The primary efficacy endpoint, mean sitDBP change from baseline to Week 8, was compared between the combination (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) and S-amlodipine monotherapy groups. The safety was assessed based on adverse events, vital signs, and physical examination findings.
RESULTS
After the 8-week treatment, changes in sitDBP/systolic BP (SBP) were -9.67±6.50/-12.89±11.78, -10.72±6.19/-13.79±9.41, and -4.93±7.26/-4.55±11.27 mmHg in the CKD-828 2.5/40 mg ( P <0.0001/ P <0.0001), CKD-828 2.5/80 mg ( P <0.0001/ P <0.0001), and S-amlodipine 2.5 mg ( P <0.0001/ P =0.0027) groups, respectively, which were all significant BP reductions. At Week 8, the CKD-828 2.5/40 mg (sitDBP/SBP: P =0.0002/ P <0.0001) and CKD-828 2.5/80 mg (sitDBP/SBP: P =0.0001/ P <0.0001) showed superior BP-lowering effects to S-amlodipine 2.5 mg ( P <0.001). At Week 4, all groups showed significant antihypertensive effects but both CKD-828 combinations (CKD-828 2.5/40 mg and CKD-828 2.5/80 mg) exhibited superior BP-lowering effects to that of S-amlodipine 2.5 mg (sitDBP/SBP: P =0.0028/ P =0.0001 and P <0.0001/ P =0.0012, respectively). The adverse event incidence was significantly lower in the CKD-828 2.5/40 mg (9.52%, P =0.0086) than in the S-amlodipine 2.5 mg group (27.87%) and increasing the telmisartan dose induced no unexpected adverse events, suggesting the safety of CKD-828.
CONCLUSION
CKD-828 is an effective and safe option for patients with inadequate responses to S-amlodipine monotherapy.
| 1significant effect
|
5,772,830 | 29,359,111 |
PURPOSE
Drivers with homonymous hemianopia (HH) were previously found to have impaired detection of blind-side hazards, yet in many jurisdictions they may obtain a license. We evaluated whether oblique 57Δ peripheral prisms (p-prisms) and perceptual-motor training improved blind-side detection rates.
METHODS
Patients with HH ( n = 11) wore p-prisms for 2 weeks and then received perceptual-motor training (six visits) detecting and touching stimuli in the prism-expanded vision. In a driving simulator, patients drove and pressed the horn upon detection of pedestrians who ran toward the roadway (26 from each side): (1) without p-prisms at baseline; (2) with p-prisms after 2 weeks acclimation but before training; (3) with p-prisms after training; and (4) 3 months later.
RESULTS
P-prisms improved blind-side detection from 42% to 56%, which further improved after training to 72% (all P < 0.001). Blind-side timely responses (adequate time to have stopped) improved from 31% without to 44% with p-prisms ( P < 0.001) and further improved with training to 55% ( P = 0.02). At the 3-month follow-up, improvements from training were maintained for detection (65%; P = 0.02) but not timely responses ( P = 0.725). There was wide between-subject variability in baseline detection performance and response to p-prisms. There were no negative effects of p-prisms on vehicle control or seeing-side performance.
CONCLUSIONS
P-prisms improved detection with no negative effects, and training may provide additional benefit.
TRANSLATIONAL RELEVANCE
In jurisdictions where people with HH are legally driving, these data aid in clinical decision making by providing evidence that p-prisms improve performance without negative effects.
| 1significant effect
|
5,771,357 | 29,387,316 |
BACKGROUND
Since there is a lack of research on postoperative anticoagulation protocol in patients undergoing coronary artery bypass graft (CABG) / coronary endarterectomy (CE), we recommend a new protocol for anticoagulation in these patients.
METHODS
In this double-blind randomized clinical trial study, 52 patients undergoing CABG / CE entered the study and were divided into two groups. In group 1, the patients were given warfarin(international normalized ratio (INR) between 2-3) together with 80 mg aspirin daily for 3 months. In group 2, the patients were given 75 mg plavix daily together with 80 mg aspirin daily for 3 months. We evaluated patients with electrocardiography, echocardiography and checking ceratin phosphokinase MB and troponin I in the several stages. The data were analysed SPSS Version18 software.
RESULTS
There was no significant difference between pre and post-operative Ejection fraction in patients with plavix (P=0.21) and warfarin (P=0.316) regimen. However, wall mrotion score was significantly better in clopidogrel - aspirin patients in late (3 months) post operation (p<0.001).
CONCLUSIONS
Since warfarin has serious hemorrhagic complications and requires closed monitoring of serum drug activity by serial INR checking, it is recommended that clopidogrel - aspirin can be the preferred alternative anticoagulation therapy in CABG / CE patients.
| 1significant effect
|
4,251,615 | 25,451,347 |
BACKGROUND
Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.
METHODS
This was a multicenter, double-blind, randomized, placebo-controlled study. Patients (aged ≥ 40 years with baseline FEV1 ≤ 65% predicted, FEV1 > 0.50 L, FEV1/FVC ≤ 70%, and ≥ 15 pack-year smoking history) received arformoterol (n = 420) or placebo (n = 421) for 1 year. The primary assessment was time from randomization to respiratory death or first COPD exacerbation-related hospitalization.
RESULTS
Among 841 patients randomized, 103 had ≥ 1 primary event (9.5% vs 15.0%, for arformoterol vs placebo, respectively). Patients who discontinued treatment for any reason (39.3% vs 49.9%, for arformoterol vs placebo, respectively) were followed for up to 1 year postrandomization to assess for primary events. Fewer patients receiving arformoterol than placebo experienced COPD exacerbation-related hospitalizations (9.0% vs 14.3%, respectively). Twelve patients (2.9%) receiving arformoterol and 10 patients (2.4%) receiving placebo died during the study. Risk for first respiratory serious adverse event was 50% lower with arformoterol than placebo (P = .003). Numerically more patients on arformoterol (13; 3.1%) than placebo (10; 2.4%) experienced cardiac serious adverse events; however, time-to-first cardiac serious adverse event was not significantly different. Improvements in trough FEV1 and FVC were greater with arformoterol (least-squares mean change from baseline vs placebo: 0.051 L, P = .030 and 0.075 L, P = .018, respectively). Significant improvements in quality of life (overall St. George's Hospital Respiratory Questionnaire and Clinical COPD Questionnaire) were observed with arformoterol vs placebo (P < .05).
CONCLUSIONS
Arformoterol demonstrated an approximately 40% lower risk of respiratory death or COPD exacerbation-related hospitalization over 1 year vs placebo. Arformoterol was well-tolerated and improved lung function vs placebo.
TRIAL REGISTRY
ClinicalTrials.gov; No.: NCT00909779; URL: www.clinicaltrials.gov.
| 1significant effect
|
5,453,890 | 28,580,079 |
BACKGROUND
Benzodiazepines have been used preoperatively as part of an anesthesia regimen to attenuate the anxiety of patients. In this study, we aimed to examine the effect of oral triazolam, a short-acting benzodiazepine, on anxiety, sedation, and amnesia.
METHODS
Ninety patients, aged 20-55 years, were randomly assigned to receive no premedication, or to receive triazolam 0.25 mg or 0.375 mg 1 h before anesthesia. Anxiety score, sedation score, blood pressure, heart rate and psychomotor performance were measured on the evening before surgery and on the day of surgery. Additional tests of psychomotor performance were performed in the postanesthesia care unit and on the next day of surgery. The occurrence of amnesia, bispectral index (BIS), recovery profiles and patient satisfaction with overall anesthesia care were also evaluated.
RESULTS
Changes in the anxiety and sedation scores on the day of surgery were not significantly different among groups, whereas the increases in systolic blood pressure and heart rate were significantly less in both triazolam groups. The triazolam groups both showed a higher incidence of high satisfaction scores (≥ 2). The two triazolam groups also showed similar outcomes, except for a dose-dependent increase in the number of patients with amnesia and BIS values < 90. Delayed recovery from general anesthesia and psychomotor impairment were not observed in the triazolam groups.
CONCLUSIONS
Triazolam 0.25 mg or 0.375 mg reduced the hemodynamic changes associated with anxiety, produced potent amnesia, and improved patient satisfaction. We suggest that triazolam can be used effectively as anesthetic premedication in adults.
| 0no significant effect
|
5,534,041 | 28,775,825 |
BACKGROUND
Working memory (WM) often is impaired in autism spectrum disorder (ASD). Such impairment may underlie core deficits in cognition and social functioning. Transcranial direct current stimulation (tDCS) has been shown to enhance WM in both healthy adults and clinical populations, but its efficacy in ASD is unknown. We predicted that bifrontal tDCS would improve WM performances of adults with high-functioning autism during active stimulation compared to sham stimulation and that such enhancement would generalize to an untrained task.
METHODS
Twelve adults with high-functioning ASD engaged in a battery of WM tasks that included backward spatial span, backward digit span, spatial n -back and letter n -back. While engaged, 40 min of 1.5 mA bifrontal stimulation was applied over the left and the right dorsolateral prefrontal cortices (DLPFC). Using a single-blind crossover design, each participant received left anodal/right cathodal stimulation, right anodal/left cathodal stimulation, or sham stimulation, in randomized counterbalanced order on three separate days. Following tDCS, participants again engaged in letter and spatial n -back tasks before taking the Brief Test of Attention (BTA). We used repeated-measures ANOVA to compare overall performance on the WM battery as measured by a composite of z -scores for all five measures. Post hoc ANOVAs, t tests, Friedman's tests, and Wilcoxon signed-rank tests were used to measure the online and offline effects of tDCS and to assess performances on individual measures.
RESULTS
Compared to sham stimulation, both left DLPFC anodal stimulation ( t 11 = 5.4, p = 0.0002) and right DLPFC anodal stimulation ( t 11 = 3.57, p = 0.004) improved overall WM performance. Left anodal stimulation ( t 11 = 3.9, p = 0.003) and right anodal stimulation ( t 11 = 2.7, p = 0.019) enhanced performances during stimulation. Enhancement transferred to an untrained task 50 min after right anodal stimulation (z 11 = 2.263, p = 0.024). The tasks that showed the largest effects of active stimulation were spatial span backward ( z 11 = 2.39, p = 0.017) and BTA ( z 11 = 2.263, p = 0.024).
CONCLUSIONS
In adults with high-functioning ASD, active bifrontal tDCS given during WM tasks appears to improve performance. TDCS benefits also transferred to an untrained task completed shortly after stimulation. These results suggest that tDCS can improve WM task performance and could reduce some core deficits of autism.
TRIAL REGISTRATION
NCT01602263.
| 1significant effect
|
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