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4,596,416 | 26,448,861 |
BACKGROUND
The hands of the medical staff play an important role in transmission of pathogens in the health care environment. Hand hygiene is efficient, easy to perform and cost-effective. Safety, tolerability and acceptance of hand hygiene preparations play a major role in hand hygiene compliance, and apply, in particular, to formulations with high anti-viral activity.
AIM
Clinical trial to evaluate the safety and tolerability of different virucidal hand rubs.
METHODS
In a randomized, double-blind, four-period cross-over trial, healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of 4 days each with a washout period. The primary endpoint was skin barrier function measured by transepidermal water loss (TEWL) after application.
RESULTS
Twenty-two subjects (seven male, 15 female; median age 25, range 21-54) were randomized and started at least one period. TEWL was 22.5; 95 %-confidence interval (CI): 19.6-25.4 after P1, 16.3; 13.5-19.1 after P2, 16.4; 13.4-19.3 after P3, and 24.0; 21.1-27.0 after R; p < 0.0001. The percentage of subjects experiencing at least one adverse event (AE) was 86 % with P1, 25 % with P2, 89 % with P3 and 56 % with R. The majority of AEs were skin reactions classified as of mild severity. No serious AEs were observed.
CONCLUSIONS
Results were inconsistent. The number of AEs was higher than expected for all products. In summary, there is room for improvement both for hand rub development and the scientific approaches taken to practically and reproducibly evaluate hand rub safety and tolerability.
| 1significant effect
|
5,648,411 | 28,749,642 |
Purpose: Vascular Endothelial Growth Factor (VEGF) and interleukin-8 (IL-8) appear important in tumor growth. In
this study, we have investigated the effect of copper reduction along with gamma knife radiosurgery on IL-8 and VEGF
in patients with recurrent glioblastoma multiforme (GBM). Materials and Methods: In a 3-month randomized clinical
trial, patients with recurrent GBM were allocated randomly between intervention and placebo groups. Radiosurgery
was performed for both groups (Reference dose: 16-18 Gray, in one fraction). The intervention group received low
copper diet and penicillamine while the patients in the placebo group continued with their usual diet. VEGF and IL-8
were measured at baseline and the end of intervention. Results: VEGF in intervention group significantly reduced
compared to placebo group (Mean ± SD, 4.5±1.91 vs. 7.8±3.21; P<0.001). IL-8 in intervention group decreased
compared to placebo group but not significant (2.7±1.91 vs. 3.2±3.20; P=0.49). We also detected a significant positive
correlation between serum copper and VEGF (r=0.57; P<0.05) and a negative correlation between KPS and serum
copper. Discussion: Our results could reflect that low copper diet and penicillamine may decrease serum VEGF in
patients who underwent gamma knife radiosurgery for recurrent glioblastoma multiforme.
| 1significant effect
|
5,706,318 | 29,279,621 |
OBJECTIVE
The current study was intended to evaluate and compare the in vivo efficacy of Calotropis gigantea mouth rinse as anticariogenic agents with 0.2% chlorhexidine and Listerine mouth rinse.
MATERIALS AND METHODS
An experimental crossover study was conducted on sixty school children aged 14-15 years. Participants were divided into three Groups A, B, and C. In all children, baseline unstimulated saliva samples were collected and assessed for Streptococcus mutans counts. The study was conducted in three phases; each phase lasted for 8 days separated by a washout period of 15 days in between them. Groups A, B, and C were treated with 0.2% chlorhexidine, Listerine and C. gigantea extract mouth rinses, respectively, in the Phase I and assessed for salivary S. mutans counts. Subsequently, mouth rinses were crossed over as dictated by the Latin square design in Phase II and III.
RESULTS AND CONCLUSION
All the three mouth rinses have individually shown a statistically significant reduction in the salivary S. mutans counts.
| 1significant effect
|
5,116,111 | 27,475,700 |
BACKGROUND
Despite efforts to prevent postoperative discomfort, there are still many immediate side effects associated with the surgical extraction of impacted lower third molars. Cicatrization is a physiological process through which the loss of integrity of oral mucosa is recovered and damaged tissues are repaired. Bexident Post (ISDIN, Spain) is a topical gel that contains chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol. While this gel has many clinical indications, there are no published clinical trials evaluating its use in impacted mandibular third molar surgery. This study aims to clinically evaluate the efficacy of a gel containing chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol on wound healing and reduction of postoperative side effects and complications after extraction of an impacted mandibular third molar.
MATERIAL AND METHODS
A split-mouth design study was carried out on a total of 50 bilaterally and symmetrically impacted third molar extractions, which were randomly placed into either a control group (CG=25) or an experimental group (EG=25). Patients were all informed of the purpose of the study and provided written consent. All procedures were carried out by the same dental practitioner, in accordance with standard surgical protocol. A different dental practitioner, unaware of which treatment had been applied, provided follow-up care. The EG applied 10 ml of topical gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol to the surgical wound three times a day for 10 days, patients in the CG did not apply any gel.
RESULTS
The groups were homogeneous insofar as potentially confounding variables. No significant findings were found regarding postoperative swelling and pain. Neither of the groups displayed poor healing or infectious complications of the wound during the postoperative period. In all the recorded follow-ups (Day 7 p=0.001, and Day 14 p=0.01), the wound's aesthetic appearance was better in the EG. Overall treatment tolerance was satisfactory and similar in both groups.
CONCLUSIONS
The gel composed of chitosan, 0.2% chlorhexidine, allantoin and dexpanthenol did not aid in patients' postoperative comfort; however, improved wound healing was observed.
| 1significant effect
|
5,712,637 | 29,238,417 |
BACKGROUND
In order to minimize the possibility of unsuccessful dental extraction procedure due to dental anxiety, there are several approaches that can be used, including music intervention.
OBJECTIVE
The objective of this research was to investigate the effectiveness of classical and religious Islamic music on reducing dental anxiety.
MATERIALS AND METHODS
Two hundred and twenty-five muslim participants (105 males, 120 females) were recruited for this study and randomly assigned to three groups: classical music group, religious Islamic music group, and the group with no music intervention, equally in numbers. Participant's blood pressure (BP) and blood sample were taken prior to and after dental extraction to evaluate systolic and diastolic BP as well as nor-adrenaline plasma (NAP) level. All data were then analyzed by using t-test, ANOVA test, Mann-Whitney and Kruskawallis test.
RESULTS
There was a decrease in NAP level in the religious music group (0.110 ng/mL) and the control group (0.013 ng/mL) when initial NAP level was compared to post extraction NAP level, whilst the classical music group showed an increase of 0.053 ng/mL. There were significant differences found between the religious Islamic music group and the classical music group ( p = 0.041) as well as the control group ( p = 0.028) for the difference between pre and post NAP level, of which the NAP level of the religious Islamic group participants were lower.
CONCLUSION
Religious Islamic music was proven to be effective in reducing dental anxiety in Muslim participants compared to classical music. Despite, further evaluation in a more heterogenous population with various religious and cultural background is needed.
| 1significant effect
|
4,121,491 | 25,097,736 |
BACKGROUND
It has been known that positive end-expiratory pressure (PEEP) increases the vasoconstriction threshold by baroreceptor unloading. We compared the effect on the thermoregulatory responses according to anesthetic techniques between an inhalation anesthesia with desflurane and a total intravenous anesthesia (TIVA) with propofol and reminfentanil when PEEP was applied in patients undergoing tympanoplasty.
METHODS
Forty-six patients with a scheduled tympanoplasty were enrolled and the patients were divided in two study groups. Desflurane was used as an inhalation anesthetic in group 1 (n = 22), while TIVA with propofol and remifentanil was used in group 2 (n = 24). PEEP was applied by 5 cmH2O in both groups and an ambient temperature was maintained at 22-24℃ during surgery. The core temperature and the difference of skin temperature between forearm and fingertip were monitored for about 180 minutes before and after the induction of general anesthesia.
RESULTS
The final core temperature was significantly higher in group 2 (35.4 ± 0.7℃) than in group 1 (34.9 ± 0.5℃). Peripheral thermoregulatory vasoconstriction was found in 5 subjects (23%) in group 1 and in 21 subjects (88%) in group 2. The time taken for reaching the thermoregulatory vasoconstriction threshold was 151.4 ± 19.7 minutes in group 1 and 88.9 ± 14.4 minutes in group 2.
CONCLUSIONS
When PEEP will be applied, anesthesia with TIVA may have more advantages in core temperature preservation than an inhalation anesthesia with desflurane.
| 1significant effect
|
5,571,493 | 28,836,995 |
BACKGROUND
We aimed to quantify the glycemic effects of quinine in healthy individuals.
METHODS
We evaluated the glycemic profile in response to 4 h infusion of 500 ml of 0.9% saline versus 5% glucose solution with and without quinine at therapeutic dose (500 mg) in ten healthy volunteers (8 men) aged 28 ± 9 years. The order of the fourth explorations was randomly assigned. During these explorations, we measured blood glucose every 15 min for 4 h and compared the mean and glycemic fluctuations for each test. A resting ECG was performed before and after quinine infusion in each participant.
RESULTS
The mean glycemic level during the 4-h infusion was 83 ± 5 mg/dl without quinine versus 74 ± 5 mg/dl with quinine (p < 0.001) using saline solute versus 92 ± 7 mg/dl without quinine versus 82 ± 5 mg/dl with quinine (p < 0.001) when associated with the glucose solute. In isotonic dirty solute, quinine induces a cumulative glycemic decrease of 17.5% (p = 0.01) characterized by a nadir estimated at -26.5% at the 60th minute (65 ± 23 mg/dl), p <0.001 followed by a gradual increase until the 4th hour. There were no signs of hypoglycemia or significant prolongation of the QT interval at the ECG. Overall, quinine did not induce a significant change in blood glucose with glucose compared to saline.
CONCLUSION
The intravenous infusion of quinine at a therapeutic dose induces a light drop in blood glucose with a significant nadir at the 60th minute in the healthy subject without hypoglycemia. This suggests the need for close monitoring in patients at risk of hypoglycemia such as those with severe malaria especially during the first hour of quinine infusion.
| 1significant effect
|
4,837,818 | 25,563,312 |
BACKGROUND
Herpes simplex keratitis (HSK) caused by herpes simplex virus 1 (HSV-1), which has high recurrent rate and incidence of severe vision loss, is the leading cause of infectious blindness in the world. The aim was to explore the clinical efficacy of oral ganciclovir (GCV) in the prevention of recurrent HSK.
METHODS
A multicenter, prospective, randomized, single-blind, and controlled clinical trial was conducted from April 2010 to June 2013. One hundred seventy-three patients (173 eyes involved) who were diagnosed as recurrent HSK definitely, including stromal keratitis and corneal endotheliitis, were divided into three groups randomly: negative control (placebo) group was topically administered with 0.15% GCV ophthalmic gel, 4 times per day and 0.1% fluorometholone eye drops, 3 times per day until resolution of HSK; positive control acyclovir (ACV) group was topically adopted the same ophthalmic gel and eye drops and additionally received oral ACV 400 mg 5 times a day for 10 weeks and followed by 400 mg 2 times per day for 6 months; test GCV group was topically adopted the same treatment as negative control group and additionally received oral GCV 1000 mg 3 times per day for 8 weeks. The symptoms and signs were evaluated before and after the therapy 1 st week, 2 nd week and then followed up every 2 weeks until recovery. Furthermore, we followed up recurrence of HSK for every 3 months after recovery and then assessed the cure time, recurrent rate and adverse reactions.
RESULTS
One hundred and seventy-three patients were followed up 7-48 months (mean 32.1 ± 12.3 months), but 34 patients were failed to follow-up. The cure time was 12.1 ± 4.3, 11.9 ± 4.0 weeks in negative control (placebo) group and positive control ACV group respectively (P = 0.991), which was longer than that in test GCV group (8.6 ± 2.8 weeks) and there was a significant difference between test GCV group and negative control (placebo) group or positive control ACV group (P = 0.000). Furthermore, the recurrent rate was higher in negative control (placebo) group (47.3%) than that in positive control group ACV (26.7%) and test GCV group (17.2%), and there was a great significant difference among the three groups (P = 0.007), but there was no significant difference between positive control ACV group and test GCV group (P = 0.358). In addition, there was no obvious adverse reaction expect neutropenia (only one patient in test GCV group).
CONCLUSION
Short-term oral GCV could cure recurrent HSK and endotheliitis, shorten the course, reduce recurrent rate of HSK and have confirmed safety.
| 1significant effect
|
3,608,590 | 23,555,624 |
BACKGROUND AND AIM
Mild to moderate depression is common in those with cardiovascular disease and undertreated. We aimed to evaluate the effectiveness of internet-delivered Cognitive Behaviour Therapy (iCBT) on depressive symptom severity and adherence to medical advice and lifestyle interventions in adults with mild to moderate depression and high cardiovascular disease (CVD) risks.
METHODS
Randomised double-blind, 12 week attention-controlled trial comparing an iCBT programme (E-couch) with an internet-delivered attention control health information package (HealthWatch, n = 282). The primary outcome was depression symptom level on the nine-item Patient Health Questionnaire (PHQ-9) (trial registration: ACTRN12610000085077).
RESULTS
487/562 (88%) participants completed the endpoint assessment. 383/562 (70%) were currently treated for cardiovascular disease and 314/562 (56%) had at least one other comorbid condition. In ITT analysis of 562 participants iCBT produced a greater decline in the mean PHQ-9 score compared to the attention control of 1.06 (95% CI: 0.23-1.89) points, with differences between the two arms increasing over the intervention period (time by treatment effect interaction p = .012). There were also larger improvements in adherence (2.16 points; 95% CI: 0.33-3.99), reductions in anxiety (0.96 points; 95% CI: 0.19-1.73), and a greater proportion engaging in beneficial physical activity (Odds Ratio 1.91, 95%CI: 1.01-3.61) in the iCBT participants but no effect upon disability, or walking time/day. There were no withdrawals due to study related adverse events.
CONCLUSIONS
In people with mild to moderate depression and high levels of CVD risk factors, a freely accessible iCBT programme (http://www.ecouch.anu.edu.au) produced a small, but robust, improvement in depressive symptoms, adherence and some health behaviours.
TRIAL REGISTRATION
Australian and New Zealand Clinical Trials Registry ACTRN12610000085077.
| 0no significant effect
|
4,610,922 | 26,495,053 |
BACKGROUND
The purpose of this study was to evaluate the effect of intraoperative dexmedetomidine sedation on patient's and surgeon's satisfaction during retinal surgery under sub-tenon's anesthesia.
METHODS
Forty-four patients scheduled for elective retinal surgery under sub-tenon's anesthesia were enrolled in this randomized controlled trial. The patients were divided into Dexmedetomidine (n = 22) and Control (n = 22) groups. Intravenous dexmedetomidine or 0.9% saline via infusion pump were administered continuously to the dexmedetomidine or control group, respectively. Ramsay sedation scale with a target level of 3-4 was used to assess adequacy of sedation. Perioperative pain, hemodynamic and respiratory data were collected, while satisfaction from patients and surgeon were assessed post-surgery using a 5-point satisfaction scale.
RESULTS
Patient and surgeon satisfaction was higher in the dexmedetomidine group (P < 0.001, P = 0.002, respectively). The pain associated with sub-tenon's anesthesia and peripheral vitrectomy was lesser in the dexmedetomidine group than in the control group (P = 0.020). There was significant reduction of heart rate in the dexmedetomidine group (P = 0.001), but only one patient needed treatment with atropine. There was no respiratory effect on both groups.
CONCLUSIONS
Dexmedetomidine sedation during retinal surgery improved satisfaction from both patient and surgeon without respiratory complication. It is a safe and preferable choice of sedation for retinal surgery.
| 0no significant effect
|
4,782,022 | 26,998,426 |
BACKGROUND
The Ovarian Protection Trial In Premenopausal Breast Cancer Patients "OPTION" trial (NCT00427245) was a prospective, multicenter, randomised, open label study evaluating the frequency of primary ovarian insufficiency (POI) at 12 months in women randomised to 6-8 cycles of (neo)adjuvant chemotherapy (CT) +/- goserelin (G). Here we report the results of a secondary endpoint analysis of the effects of CT+/-G on markers of bone turnover.
METHODS
Serum for bone alkaline phosphatase (BALP) and urine for N-terminal telopeptide (NTX) were collected at baseline, 6, 12, 18, 24 and 36 months. Changes in median levels of bone turnover markers were evaluated for the overall population, according to age stratification at randomisation (≤40 vs >40 years) and with exploratory analysis according to POI rates at 12 months.
RESULTS
In the overall population, there was a significant increase in NTX at 6 months compared to baseline in patients treated with CT+G (40.81 vs 57.82 p=0.0074) with normalisation of levels thereafter. BALP was significantly increased compared to baseline at 6 months and 12 months in those receiving CT+G, but normalised thereafter. BALP remained significantly higher compared to baseline at 12, 24 and 36 months in patients receiving CT, resulting in a significant difference between treatment groups at 36 months (CT+G 5.845 vs CT 8.5 p=0.0006). These changes were predominantly seen in women >40 years. Women with POI at 12 months showed altered bone formation compared to baseline levels for a longer duration than women who maintained menses.
CONCLUSION
Addition of G to CT increases bone turnover during treatment with normalisation after cessation of treatment suggesting G may offer sufficient ovarian protection against CT induced POI to negate longstanding altered bone turnover associated with POI.
| 1significant effect
|
4,311,106 | 25,642,107 |
BACKGROUND
Many community dwelling individuals with schizophrenia do not take medications regularly and, thus, are prone to frequent relapses.
AIM
Evaluate the effectiveness of self-management training on adherence to medications and relapse among individuals with chronic schizophrenia living in the community.
METHODS
A total of 201 individuals with chronic schizophrenia living in the urban and rural communities of Shanghai Municipality were randomized into a treatment as usual control group (n=98) or a selfmanagement intervention group (n=103) that received weekly self-management skills training for 6 months followed by 24 months of monthly group booster sessions in which a community health worker reviewed patients' self-management checklists. Two psychiatrists blind to the treatment status of patients, assessed adherence to medications using the Morisky Medication Adherence Scale and patients' insight into their illness using the Scale to Assess Unawareness of Mental Disorders (SAUMD) at baseline and 30 months after baseline. A total of 194 individuals (95.6%) completed the study.
RESULTS
There were no differences between groups at baseline, but after 30 months the intervention group had significantly better medication compliance, significantly greater insight into their illness, and (by self-report) were using significantly higher dosages of antipsychotic medication. Only 2 (1.9%) of the 103 intervention group participants relapsed (i.e., experienced one or more re-hospitalizations) over the 30 months of follow-up, but 14 (14.3%) of the 98 control group subjects relapsed (X (2)=8.83, p=0.003).
CONCLUSIONS
Given the large sample size, relatively long follow-up, randomized design, and single-blind evaluation of outcomes the dramatic reduction in relapse and improvements in medication adherence and insight identified in this study are robust findings. These results extended our previous findings, which demonstrated the benefit of self-management training on improving the symptoms and social functioning of individuals with chronic schizophrenia living in the community. Cost-benefit studies are now needed to assess the feasibility of up-scaling this self-management intervention to a wide range of communities.
| 0no significant effect
|
4,173,506 | 25,885,715 |
BACKGROUND
Tramadol is licensed primarily as an analgesic, but has additional properties, one of which is the ability to increase gastric pH. However, it has not been established if this action is dose related, hence we set out to provide further evidence about this action of tramadol.
PATIENTS AND METHODS
Fifty-five female adult patients presenting for gynecological surgery were randomized into three groups. After induction, 2.5 ml of gastric juice was aspirated to determine baseline pH, after which groups 1, 2, and 3 received 50 mg, 75 mg, and 100 mg of IV tramadol, respectively. Gastric pH was subsequently assessed every 30 min for as long as the surgery lasted.
RESULTS
There was no significant difference in the pH of the three groups before anesthesia (3.88 ± 0.75, 3.54 ± 0.73, and 3.75 ± 0.70; P = 0.393). Similarly, no significant statistical difference was observed in the pH of the three tramadol groups during the subsequent three readings (pH1: 4.21 ± 0.93, 4.27 ± 0.95, 4.07 ± 0.82; pH2: 4.75 ± 1.00, 4.68 ± 0.94, 4.59 ± 0.78; pH3: 5.33 ± 0.86, 5.13 ± 0.95, 4.97 ± 0.78; P = 0.793, 0.876, and 0.490). There were statistically significant increases in the pH of each group when the baseline pH was compared with the subsequent three readings, with P values of 0.002, 0.0001, 0.001 in the 50 mg group, 0.0001, 0.0001, 0.0001 in the 75 mg group, and 0.008, 0.0001, 0.001 in the 100 mg group.
CONCLUSION
Our result further confirms that tramadol elevates gastric pH. However, the degree of elevation was not found to be dose dependent.
| 0no significant effect
|
3,017,527 | 21,122,147 |
BACKGROUND
Rapeseed oil is the principal dietary source of monounsaturated and n-3 polyunsaturated fatty acids in the Northern Europe. However, the effect of rapeseed oil on the markers of subclinical atherosclerosis is not known. The purpose of this study was to compare the effects of dietary intake of cold-pressed turnip rapeseed oil (CPTRO) and butter on serum lipids, oxidized LDL and arterial elasticity in men with metabolic syndrome.
METHODS
Thirty-seven men with metabolic syndrome completed an open and balanced crossover study. Treatment periods lasted for 6 to 8 weeks and they were separated from each other with an eight-week washout period. Subjects maintained their normal dietary habits and physical activity without major variations. The daily fat adjunct consisted either of 37.5 grams of butter or 35 mL of Virgino R CPTRO. Participants were asked to spread butter on bread on the butter period and to drink CPTRO on the oil period. The fat adjunct was used as such without heating or frying.
RESULTS
Compared to butter, administration of CPTRO was followed by a reduction of total cholesterol by 8% (p < 0.001) and LDL cholesterol by 11% (p < 0.001). The level of oxidized LDL was 16% lower after oil period (p = 0.024). Minimal differences in arterial elasticity were not statistically significant.
CONCLUSION
Cold-pressed turnip rapeseed oil had favourable effects on circulating LDL cholesterol and oxidized LDL, which may be important in the management of patients at high cardiovascular risk.
| 1significant effect
|
4,610,088 | 26,543,461 |
BACKGROUND
Availability of narcotics is an issue in developing countries, and low-dose ketamine offers an alternative to these drugs.
OBJECTIVE
The objective of this study is to evaluate the effect of a preemptive dose of low-dose ketamine on intra operative and the immediate postoperative analgesic requirements.
DESIGN
Randomized double-blind control trial.
SETTINGS
This study has been performed in the operating rooms and postanesthesia care unit at Aga Khan University Hospital, Karachi, Pakistan.
MATERIALS AND METHODS
Totally, 60 adult American Society of Anesthesiologists I and II patients undergoing day care surgery were randomly allocated into two groups, Group A (ketamine group) and Group B (saline group).
INTERVENTION
All patients underwent general anesthesia. Propofol 2 mg/kg was used as an induction agent; laryngeal mask airway (size 3 for females and 4 for males) was inserted. Following induction patients in Group A received ketamine 0.3 mg/kg and Group B saline bolus in a blinded manner. All patients were administered injection fentanyl 1 μg/kg as an analgesic and anesthesia was maintained with oxygen 40%, nitrous oxide 60% and isoflorane 1-2 minimum alveolar concentration. Patients breathed spontaneously on Lack circuit. Postoperatively rescue analgesia was provided with intravenous morphine 0.1 mg/kg when patient complained of pain.
MAIN OUTCOME MEASURES
We observed analgesic effects of low-dose ketamine intra operatively and narcotic requirements in immediate postoperative period for day care surgeries.
RESULTS
There was no significant difference in demographic data in between groups. Saline group required more rescue analgesia (morphine) postoperatively (P < 0.001). No significant psychotomimetic symptoms were noted in either group.
CONCLUSION
Low-dose ketamine 0.3 mg/kg provided adequate co-analgesia with fentanyl 1 μg/kg and was effective in a reduction of morphine requirement in the postoperative phase with minimal adverse effects.
| 1significant effect
|
5,299,497 | 28,130,918 |
OBJECTIVE
To assess the efficacy and safety of anifrolumab, a type I interferon (IFN) receptor antagonist, in a phase IIb, randomized, double-blind, placebo-controlled study of adults with moderate-to-severe systemic lupus erythematosus (SLE).
METHODS
Patients (n = 305) were randomized to receive intravenous anifrolumab (300 mg or 1,000 mg) or placebo, in addition to standard therapy, every 4 weeks for 48 weeks. Randomization was stratified by SLE Disease Activity Index 2000 score (<10 or ≥10), oral corticosteroid dosage (<10 or ≥10 mg/day), and type I IFN gene signature test status (high or low) based on a 4-gene expression assay. The primary end point was the percentage of patients achieving an SLE Responder Index (SRI[4]) response at week 24 with sustained reduction of oral corticosteroids (<10 mg/day and less than or equal to the dose at week 1 from week 12 through 24). Other end points (including SRI[4], British Isles Lupus Assessment Group [BILAG]-based Composite Lupus Assessment [BICLA], modified SRI[6], and major clinical response) were assessed at week 52. The primary end point was analyzed in the modified intent-to-treat (ITT) population and type I IFN-high subpopulation. The study result was considered positive if the primary end point was met in either of the 2 study populations. The Type I error rate was controlled at 0.10 (2-sided), within each of the 2 study populations for the primary end point analysis.
RESULTS
The primary end point was met by more patients treated with anifrolumab (34.3% of 99 for 300 mg and 28.8% of 104 for 1,000 mg) than placebo (17.6% of 102) (P = 0.014 for 300 mg and P = 0.063 for 1,000 mg, versus placebo), with greater effect size in patients with a high IFN signature at baseline (13.2% in placebo-treated patients versus 36.0% [P = 0.004] and 28.2% [P = 0.029]) in patients treated with anifrolumab 300 mg and 1,000 mg, respectively. At week 52, patients treated with anifrolumab achieved greater responses in SRI(4) (40.2% versus 62.6% [P < 0.001] and 53.8% [P = 0.043] with placebo, anifrolumab 300 mg, and anifrolumab 1,000 mg, respectively), BICLA (25.7% versus 53.5% [P < 0.001] and 41.2% [P = 0.018], respectively), modified SRI(6) (28.4% versus 49.5% [P = 0.002] and 44.7% [P = 0.015], respectively), major clinical response (BILAG 2004 C or better in all organ domains from week 24 through week 52) (6.9% versus 19.2% [P = 0.012] and 17.3% [P = 0.025], respectively), and several other global and organ-specific end points. Herpes zoster was more frequent in the anifrolumab-treated patients (2.0% with placebo treatment versus 5.1% and 9.5% with anifrolumab 300 mg and 1,000 mg, respectively), as were cases reported as influenza (2.0% versus 6.1% and 7.6%, respectively), in the anifrolumab treatment groups. Incidence of serious adverse events was similar between groups (18.8% versus 16.2% and 17.1%, respectively).
CONCLUSION
Anifrolumab substantially reduced disease activity compared with placebo across multiple clinical end points in the patients with moderate-to-severe SLE.
| 1significant effect
|
2,569,033 | 18,837,970 |
BACKGROUND
Plant sterols are an established non-pharmacological means to reduce total and LDL blood cholesterol concentrations and are therefore recommended for cholesterol management by worldwide-renown health care institutions. Their efficacy has been proven in many types of foods with the majority of trials conducted in spreads or dairy products. As an alternative to dairy products, soy based foods are common throughout the world. Yet, there is little evidence supporting the efficacy of plant sterols in soy-based foods. The objective of this study was to investigate the effect of a soy drink enriched with plant sterols on blood lipid profiles in moderately hypercholesterolemic subjects.
METHODS
In a randomized, placebo-controlled double-blind mono-centric study, 50 subjects were assigned to 200 ml of soy drink either enriched with 2.6 g plant sterol esters (1.6 g/d free plant sterol equivalents) or without plant sterols (control) for 8 weeks. Subjects were instructed to maintain stable diet pattern and physical activity. Plasma concentrations of lipids were measured at initial visit, after 4 weeks and after 8 weeks. The primary measurement was the change in LDL cholesterol (LDL-C). Secondary measurements were changes in total cholesterol (TC), non-HDL cholesterol (non-HDL-C), HDL cholesterol (HDL-C) and triglycerides.
RESULTS
Regular consumption of the soy drink enriched with plant sterols for 8 weeks significantly reduced LDL- C by 0.29 mmol/l or 7% compared to baseline (p < 0.05). TC and non-HDL-C concentrations decreased by 0.26 mmol/l and 0.31 mmol/l (each p < 0.05), respectively. Mean reductions in total, LDL and non-HDL cholesterol were significantly greater than in the placebo group (p < 0.05). HDL-C and triglycerides were not affected. Compliance was very high (>96%), and products were well tolerated.
CONCLUSION
Daily consumption of a plant sterol-enriched soy drink significantly decreased total, non-HDL and LDL cholesterol and is therefore an interesting and convenient aid in managing mild to moderate hypercholesterolemia.
| 1significant effect
|
5,135,478 | 27,932,894 |
OBJECTIVE
To examine the analgesic and opioid-sparing effects of parecoxib following major gynecologic surgery.
METHODS
This is a large subset analysis of patients from a multicenter, randomized, double-blind, placebo-controlled study of parecoxib/valdecoxib (PAR/VAL) for postoperative pain. Pain severity, pain interference with function, opioid use, occurrence of opioid-related symptoms, and Patient/Physician Global Evaluation of Study Medication were compared between placebo and PAR/VAL treatment groups in the days following surgery.
RESULTS
Pain scores were reduced in the PAR/VAL group (n=98), relative to placebo (n=97), on Day 2 (-21%, P <0.001) and Day 3 (-23%, P =0.004). Pain interference with function scores were also significantly lower in the PAR/VAL group, compared with placebo, on Day 2 (-29%, P <0.001) and Day 3 (-28%, P =0.013). Consumption of supplemental morphine was significantly lower in the PAR/VAL group relative to placebo at 24 hours (-37%, P =0.010) and trended lower at 48 (-28%) and 72 hours (-26%). Patients in the PAR/VAL group also had a reduced risk of experiencing specific opioid-related symptoms, including "inability to concentrate" (relative risk =0.53) and "nausea" (relative risk =0.60) on Day 2. Both Patient and Physician Global Evaluation of Study Medication scores were better in the PAR/VAL group than in the placebo group.
CONCLUSION
The current study adds support for the use of parecoxib in patients following major gynecologic surgery.
| 1significant effect
|
4,009,639 | 24,803,757 |
BACKGROUND
Facial nerve monitoring, often required during total parotidectomy, precludes use of long acting muscle relaxants and propofol infusion is used solely to ensure patient immobility. We aimed to compare intraoperative patient immobility, hemodynamic stability and propofol consumption during total parotidectomy following a transtracheal block.
MATERIAL AND METHODS
Forty patients were allocated to 2 equal groups. Preoperatively, group A patients received transtracheal block with 4 ml of 4% lidocaine, while no block was given to patients in group B. If there was patient movement, tachycardia or hypertension, group A patients received a bolus of propofol 30 mg and propofol infusion was started (100mg/hr). In group B, propofol infusion was started (100mg/hr) soon after intubation.
RESULT
Both group A and B were comparable with respect to patient immobility and hemodynamic stability. There was no intraoperative propofol requirement in group A.
CONCLUSION
Transtracheal block is a safe and successful alternative to propofol infusion during surgeries where muscle relaxants are to be avoided.
| 0no significant effect
|
5,630,558 | 28,921,310 |
INTRODUCTION
To investigate whether vildagliptin add-on insulin therapy improves glycemic variations in patients with uncontrolled type 2 diabetes (T2D) compared to patients with placebo therapy.
METHODS
This was a 24-week, single-center, double-blind, placebo-controlled trial. Inadequately controlled T2D patients treated with insulin therapy were recruited between June 2012 and April 2013. The trial included a 2-week screening period and a 24-week randomized period. Subjects were randomly assigned to a vildagliptin add-on insulin therapy group (n = 17) or a matched placebo group (n = 16). Scheduled visits occurred at weeks 4, 8, 12, 16, 20, and 24. Continuous glucose monitoring (CGM) was performed before and at the endpoint of the study.
RESULTS
A total of 33 subjects were admitted, with 1 patient withdrawing from the placebo group. After 24 weeks of therapy, HbA1c values were significantly reduced at the endpoint in the vildagliptin add-on group. CGM data showed that patients with vildagliptin add-on therapy had a significantly lower 24-h mean glucose concentration and mean amplitude of glycemic excursion (MAGE). At the endpoint of the study, patients in the vildagliptin add-on group had a significantly lower MAGE and standard deviation compared to the control patients during the nocturnal period (0000-0600). A severe hypoglycemic episode was not observed in either group.
CONCLUSION
Vildagliptin add-on therapy to insulin has the ability to improve glycemic variations, especially during the nocturnal time period, in patients with uncontrolled T2D.
| 1significant effect
|
5,264,222 | 26,150,601 |
OBJECTIVES
To compare the efficacy and safety of SB4 (an etanercept biosimilar) with reference product etanercept (ETN) in patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
METHODS
This is a phase III, randomised, double-blind, parallel-group, multicentre study with a 24-week primary endpoint. Patients with moderate to severe RA despite MTX treatment were randomised to receive weekly dose of 50 mg of subcutaneous SB4 or ETN. The primary endpoint was the American College of Rheumatology 20% (ACR20) response at week 24. Other efficacy endpoints as well as safety, immunogenicity and pharmacokinetic parameters were also measured.
RESULTS
596 patients were randomised to either SB4 (N=299) or ETN (N=297). The ACR20 response rate at week 24 in the per-protocol set was 78.1% for SB4 and 80.3% for ETN. The 95% CI of the adjusted treatment difference was -9.41% to 4.98%, which is completely contained within the predefined equivalence margin of -15% to 15%, indicating therapeutic equivalence between SB4 and ETN. Other efficacy endpoints and pharmacokinetic endpoints were comparable. The incidence of treatment-emergent adverse events was comparable (55.2% vs 58.2%), and the incidence of antidrug antibody development up to week 24 was lower in SB4 compared with ETN (0.7% vs 13.1%).
CONCLUSIONS
SB4 was shown to be equivalent with ETN in terms of efficacy at week 24. SB4 was well tolerated with a lower immunogenicity profile. The safety profile of SB4 was comparable with that of ETN.
TRIAL REGISTRATION NUMBERS
NCT01895309, EudraCT 2012-005026-30.
| 0no significant effect
|
4,810,948 | 27,073,307 |
BACKGROUND
Oxidative stress is a complicated process, which was defined as an increase in prooxidants and decrease in antioxidants caused by various mechanisms, including inflammation and surgical trauma. The association between acute appendicitis and oxidative stress has been showed in previous studies. However, comparison of oxidative stress in laparoscopic or open appendectomy (OA) has not been established.
PATIENTS AND METHODS
Patients who were diagnosed as acute appendicitis between October 2012 and January 2013 were randomized to open (OA, n = 50) and laparoscopic appendectomy (LA, n = 50). Blood samples for oxidative stress markers (total oxidant status [TOS] and total antioxidant status [TAS]), C-reactive protein (CRP) and white blood cells (WBC's) were collected just before the surgery and 24 h after surgery.
RESULTS
There were no differences in preoperative values of WBC and CRP between LA and OA groups (P = 0.523 and 0.424), however, in postoperative 24(th) h, CRP was reduced in LA group (P = 0.031). There were no differences in preoperative levels of TOS, TAS, and oxidative stress index (OSI) between LA and OA groups. In the postoperative 24(th) h, TOS and OSI were found to be significantly higher in OA group when compared to LA group (P = 0.017 and 0.002) whereas no difference was detected in TAS level in the postoperative 24(th) h (P = 0.172).
CONCLUSIONS
This double-blind, randomized clinical trial provides evidence that LA for uncomplicated appendicitis is associated with significantly lower oxidative stress compared with OA. Some of the advantages of LA may be attributed to the significant reduction of oxidative stress in these patients.
| 0no significant effect
|
3,276,927 | 22,346,061 |
BACKGROUND
Hernia is an abnormal protrusion of an organ or tissue through a defect in its surrounding walls which most commonly involves the abdominal wall, particularly the inguinal region. The treatment options for hernia ranges from simple exercises to modern surgeries. The effect of yoga therapy is not scientifically examined for reversible inguinal hernia and hence this study is undertaken with the aim to test the effect of selected asanas in reversible inguinal hernia.
MATERIALS AND METHODS
A quasi experimental trail of 19 males through consecutive sampling was done with selected asanas for three months and the outcome was measured by a questionnaire focusing on pain, aggravating factors, relieving factors and frequency of occurrence of symptoms of hernia.
RESULTS
The pre and post interventional data were compared statistically and found significant reduction of symptoms with P≤0.001 in pain, frequency of occurrence and aggravating factors. The relieving factors showed significant increase with P≤0.001.
CONCLUSION
Yoga therapy with selected asanas is effective in the treatment of reversible inguinal hernia.
| 1significant effect
|
4,173,437 | 25,885,506 |
BACKGROUND
The radical surgical procedures are associated with perioperative blood loss. This study was aimed to evaluate the clinical efficacy and safety of tranexamic acid in reducing perioperative blood loss in patients undergoing radical surgery.
MATERIALS AND METHODS
Sixty ASA class I and II adult consented female patients, scheduled for elective radical surgery and met the inclusion criterion, were blindly randomized into two groups to receive either intravenous 1 g tranexamic acid 20 min before skin incision or an equivalent volume of normal saline as placebo (P). All patient's total blood loss was measured and recorded perioperatively at the 12(th)h postoperatively. The preoperative and postoperative hemoglobin, hematocrit values, serum creatinine, activated thromboplastin time, prothombin time, thrombocyte count, fibrinogen, D-dimer, and symptoms of pulmonary embolism were comparatively evaluated.
RESULTS
The tranexamic acid significantly reduced the quantity of total blood loss, 576 ± 53 mL in study group as compared to 823 ± 74 mL in the control group (P<0.01). Postoperatively hematocrit values were higher in the tranexamic acid group. The coagulation profile did not differ between the groups, but D-dimer concentrations were increased in the control group. No complications or adverse effects were reported in the either group.
CONCLUSION
The prophylactic administration of tranexamic acid has effectively reduced theblood loss and transfusion needs during radical surgery without any adverse effects or complication of thrombosis.
| 1significant effect
|
5,595,267 | 27,989,693 |
PURPOSE
This study aimed to compare the efficacy of two sustained-release formulation of artificial tear drops.
PATIENTS AND METHODS
This is a randomized patient-masked clinical trial, a total 88 patients into two group A (n=41; with single dose of artificial tear, containing dextran 70, 1mg/ml and hypromellose, 3mg/ml hydroxypropyl methylcellulose (HPMC) and group B (n=47; with multidose of artificial tear, containing 0.3g HPMC and 0.1g of dextran 70, with 0.01% benzalkonium chloride (BAK) as preservative) were completed the study. The ocular surface disease index (OSDI) questionnaire, tear break up time (TBUT), corneal and conjunctival staining and Schirmer test, were performed. Repeated measures ANOVA was used to assess the differences among the two products. A p-value less than 0.05 was considered significant.
RESULTS
The mean of age of the participants in the Group A and B was 44.08±6.29 (range, 33-58 years) years and 45.83±8.42 (31-60 years), respectively. In comparing two groups before the intervention, the OSDI scores, the TBUT scores, the conjunctival and corneal staining scores and the Schirmer scores did not show statistically significant differences (p=0.339, p=0.640, p=0.334, p=0.807 and p=0.676, respectively). After 4 weeks, the OSDI scores, conjunctival and corneal staining scores showed improvement in compare to those before the intervention (p<0.001). But, the differences for the Schirmer test score and TBUT score was not significant (p=0.115, p=0.013, respectively).
CONCLUSION
Our outcomes indicated that improvement occurred with use of both products but there was no statistically significant difference between them.
| 0no significant effect
|
5,686,687 | 29,264,492 |
CONTEXT
Resveratrol has been used for the treatment of endometriosis.
OBJECTIVE
To compare resveratrol (40 mg/d) with monophasic contraceptive pill (COC) to COC with placebo for the reduction of pain scores.
DESIGN
A randomized clinical trial.
SETTING
University Hospital.
PATIENTS
Women (ages 20 to 50) with laparoscopic diagnosis of endometriosis were eligible for the study. Exclusion criteria: pregnancy, allergy to resveratrol, or contraindications to COC, use of agonists of gonadotropin release hormone or danazol in the last month, or had used depot medroxyprogesterone acetate or Mirena®.
INTERVENTION
Subjects were randomized using a computer-generated randomization list to receive COC for 42 days to be taken with identical capsules containing 40 mg of resveratrol or placebo in coded bottles (1:1 ratio). Allocation was concealed in coded, sequenced, opaque-sealed envelopes.
MAIN OUTCOME
Median pain scores measured with a visual analog scale on day 42.
RESULTS
Between 18 June and 6 November 2015, 44 subjects were enrolled. Mean [95% confidence interval (CI)] pain scores on day 0 were 5.4 (4.2 to 6.6) in the placebo group and 5.7 (4.8 to 6.6) in resveratrol groups. After treatment, pain values were [3.9 (2.2 to 5); n = 22] and [3.2 (2.1 to 4.3); n = 22] in the placebo and resveratrol groups, respectively ( P = 0.7; Mann-Whitney U test). Median (95% CI) difference between groups was 0.75 (-1.6 to 2.3).
CONCLUSION
Resveratrol is not superior to placebo for treatment of pain in endometriosis.
| 0no significant effect
|
3,559,346 | 23,383,037 |
BACKGROUND
Oral and vaginal preparations of tenofovir as pre-exposure prophylaxis (PrEP) for human immunodeficiency virus (HIV) infection have demonstrated variable efficacy in men and women prompting assessment of variation in drug concentration as an explanation. Knowledge of tenofovir concentration and its active form, tenofovir diphosphate, at the putative vaginal and rectal site of action and its relationship to concentrations at multiple other anatomic locations may provide key information for both interpreting PrEP study outcomes and planning future PrEP drug development.
OBJECTIVE
MTN-001 was designed to directly compare oral to vaginal steady-state tenofovir pharmacokinetics in blood, vaginal tissue, and vaginal and rectal fluid in a paired cross-over design.
METHODS AND FINDINGS
We enrolled 144 HIV-uninfected women at 4 US and 3 African clinical research sites in an open label, 3-period crossover study of three different daily tenofovir regimens, each for 6 weeks (oral 300 mg tenofovir disoproxil fumarate, vaginal 1% tenofovir gel [40 mg], or both). Serum concentrations after vaginal dosing were 56-fold lower than after oral dosing (p<0.001). Vaginal tissue tenofovir diphosphate was quantifiable in ≥90% of women with vaginal dosing and only 19% of women with oral dosing. Vaginal tissue tenofovir diphosphate was ≥130-fold higher with vaginal compared to oral dosing (p<0.001). Rectal fluid tenofovir concentrations in vaginal dosing periods were higher than concentrations measured in the oral only dosing period (p<0.03).
CONCLUSIONS
Compared to oral dosing, vaginal dosing achieved much lower serum concentrations and much higher vaginal tissue concentrations. Even allowing for 100-fold concentration differences due to poor adherence or less frequent prescribed dosing, vaginal dosing of tenofovir should provide higher active site concentrations and theoretically greater PrEP efficacy than oral dosing; randomized topical dosing PrEP trials to the contrary indicates that factors beyond tenofovir's antiviral effect substantially influence PrEP efficacy.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00592124.
| 1significant effect
|
4,881,703 | 26,139,740 |
BACKGROUND
Tapentadol is a relatively new analgesic. We decided to compare it with tramadol for their various effects after cardiac surgery.
SETTING
A study in a tertiary care hospital.
MATERIALS AND METHODS
Sixty adults undergoing cardiac surgery were divided into 2 groups of 30 each by computerized random allotment (Group X = tapentadol 50 mg oral and Group Y = tramadol 100 mg oral). Informed Consent and Institutional Ethics Committee approval were obtained. The patients were given either drug X or drug Y after extubation in this single blinded study, wherein the data collectors and analyzers were blinded to the study. All patients received oral paracetamol qds and either drug X or drug Y tds. The pain score was noted on a Visual Analog Scale before each drug dose, 3 h later and on coughing. Heart rate, respiratory rate, and blood pressure were recorded before the drug dose and 3 h later. Postoperative nausea or vomiting (PONV), temperature, and modified Glasgow Coma Scale readings were recorded. The above readings were obtained for 6 doses (up to 48 h after extubation).
STATISTICS
t-test, Pearson Chi-square test, Fisher exact test, and Mantel-Haenszel test were used for statistics.
RESULTS
Tapentadol group patients had significantly better analgesia 3 h after the drug and "on coughing" than tramadol group. The difference in their effects on blood creatinine levels, temperature, hemodynamics, oxygen saturation, and respiratory rate were not clinically significant. Tapentadol produced lesser drowsiness and lesser vomiting than tramadol.
CONCLUSIONS
Tapentadol, due to its norepinephrine reuptake inhibition properties, in addition to mu agonist, is a better analgesic than tramadol and has lesser PONV.
| 1significant effect
|
5,654,031 | 28,889,155 |
OBJECTIVES
To compare the analgesic efficiencies of caudal blocks, ultrasound (US)-guided transversus abdominis plane (TAP) blocks, and ilio-inguinal/ilio-hypogastric (II/IH) blocks performed to provide postoperative analgesia in pediatric patients undergoing unilateral lower abdominal surgery. Methods: This prospective, randomized, single-blinded study was conducted in the Department of Pediatric Surgery, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey from July 2013 to January 2015. The doses used were as follows: 0.5 ml/kg (group T), 0.3 ml/kg (group I), and 0.7 ml/kg (group C) of a 0.25% levobupivacaine solution with 1/200,000 adrenalin for the TAP block, II/IH block, and caudal block. The primary aim was to compare postoperative analgesic consumption within the first 24 hours after surgery. The secondary aim were to compare the mCHEOPS score, first analgesic requirement time, vital signs, and undesirable effects such as nausea and vomiting, which were recorded in the surgical ward at 1, 4, 8, 16, and 24 hours after surgery. Results: Ninety patients with American Society of Anesthesiology physical status class I-II were randomized into 3 groups (group I, group T, and group C). The total amount of analgesic consumption was significantly higher in Group I compared with Groups T and C (p=0.003). Pain scores at 1, 4, and 8 hours were significantly higher in Group I compared with the other 2 groups; however, pain scores in Group I at 16 hours were significantly higher only compared with Group C (p less than 0.05). Conclusion: Caudal and TAP blocks are more effective than II/IH nerve blocks in the early postoperative period.
| 1significant effect
|
4,006,208 | 24,795,515 |
BACKGROUND
Due to increasing resistance to antibiotics and rising incidence of oral diseases, there is a need for alternative treatment modalities to combat oral diseases. The aim of the present study was to access the effect of Aloe vera mouthwash on the dental plaque in the experimental period of 4 days and to compare it with the bench mark control chlorhexidine and placebo (saline water).
MATERIAL AND METHODS
A total of 300 systemically healthy subjects were randomly allocated into 3 groups: Aloe vera mouthwash group (n=100), control group (=100)-chlorhexidene group and saline water-Placebo (n=100). To begin with, Gingival index (GI) and plaque index (PI) were recorded. Then, baseline plaque scores were brought to zero by professionally cleaning the teeth with scaling and polishing. After randomization of the participants into three groups they were refrained from regular mechanical oral hygiene measures. Subjects were asked to swish with respective mouthwash (Aloe vera mouthwash, 0.2%chlorhexidine gluconate mouthwash, or normal saline) as per therapeutic dose for 4 days.
RESULTS
The results showed that Aloe vera mouthrinse is equally effective in reducing plaque as Chlorhexidine compared to placebo over a period of 4 days. There was a significant reduction on plaque in Aloe vera and chlorhexidine groups and no statistically significant difference was observed among them (p>0.05). Aloe vera mouthwash showed no side effects.
CONCLUSION
The results of the present study indicated that Aloe vera may prove an effective mouthwash due to its ability in reducing dental plaque.
| 1significant effect
|
4,416,300 | 25,937,837 |
BACKGROUND
Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking.
METHODS
We conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.0 mg oral melatonin or matching placebo nightly for 10 weeks. After a 6-week washout, subjects received the other treatment for 10 more weeks. We measured waist circumference, triglycerides, HDL cholesterol, fasting glucose, and blood pressure (BP) in each subject at the beginning and end of both 10-week treatment periods. The primary outcome was the mean 10-week change in each MetS component, and a secondary outcome was the proportion of subjects free from MetS, after melatonin versus placebo.
RESULTS
The mean 10-week change for most MetS components favored melatonin over placebo (except fasting glucose): waist circumference -0.9 vs. +1.0 cm (p = 0.15); triglycerides -66.3 vs. -4.2 mg/dL (p = 0.17); HDL cholesterol -0.2 vs. -1.1 mg/dL (p = 0.59); fasting glucose +0.3 vs. -3.1 mg/dL (p = 0.29); systolic BP -2.7 vs. +4.7 mmHg (p = 0.013); and diastolic BP -1.1 vs. +1.1 mmHg (p = 0.24). Freedom from MetS tended to be more common following melatonin versus placebo treatment (after the first 10 weeks, 35.3% vs. 15.0%, p = 0.25; after the second 10 weeks, 45.0% vs. 23.5%, p = 0.30). Melatonin was well-tolerated.
CONCLUSIONS
Melatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment.
TRIAL REGISTRATION
NCT01038921, clinicaltrials.gov.
| 0no significant effect
|
4,830,153 | 27,127,744 |
BACKGROUND AND AIM
One of the goals of health care team is to improve the quality of life of patients during and after hospitalization period. Therefore, this study aimed to examine the effect of performing discharge planning on ischemic heart disease patient's physical quality of life.
METHODS
This quasi-experimental study was performed on 74 ischemic heart disease patients which randomly allocated to discharge-planning group (n = 37) and usual care group (n = 37). The discharge-planning included the patients' educational needs, self-care instructions for patients, and caregivers. This program was performed through supporting patients during hospitalization and after discharge. The physical aspect of quality of life was assessed by standard questionnaire Short Form 36 and the data were analyzed through Mann-Whitney, independent t-test, variance analysis, Friedman and Wilcoxon.
RESULTS
There was no significant difference between intervention and control groups in physical aspects of the quality of life before intervention (P = 0.423) while two groups were significantly different after intervention (P = 0.000) and quality of life of patients in the case group improved significantly.
CONCLUSION
Applying the discharge-planning program as an effective, efficient, cost-effective, and noninvasive intervention on physical aspects of the quality of ischemic heart disease patients' lives is useful and helpful. Hence, it is recommended to use this program to promote and improve the quality of ischemic heart disease patients' lives.
| 1significant effect
|
3,696,875 | 23,811,172 |
OBJECTIVES
The effect of web-based interventions for depression on suicide ideation in callers to helplines is not known. The aim of this study was to determine if web-based Cognitive Behaviour Therapy (CBT) with and without telephone support is effective in reducing suicide ideation in callers to a helpline compared with treatment as usual (TAU). A secondary aim was to examine the factors that predict change in suicide ideation. Putative predictors included level of baseline depression, suicide behaviour, baseline anxiety and type of intervention.
DESIGN
Randomised controlled trial.
SETTING
Lifeline, Australia's 24 h telephone counselling service participants: 155 callers to a national helpline service with moderate-to-high psychological distress.
INTERVENTIONS
Participants were recruited and randomised to receive either 6 weeks of internet CBT plus weekly telephone follow-up; internet CBT only; weekly telephone follow-up only or a wait-list TAU control group.
PRIMARY AND SECONDARY OUTCOME MEASURES
Suicidal ideation was measured using four items from the 28-item General Health Questionnaire. Predictors of change in ideation were tested using logistic regression analysis.
RESULTS
Regardless of the intervention condition, participants showed significant reductions in suicidal ideation over 12 months (p<0.001). Higher baseline suicidal behaviour decreased the odds of remission of suicidal ideation at postintervention (OR 0.409, p<0.001). However, change in depression over the course of the interventions was associated with improvement in suicide ideation (OR 1.165, p<0.001).
CONCLUSIONS
Suicide ideation declines with and without proactive intervention. Improvements in depression are associated with the resolution of suicide ideation. Specific interventions focusing on suicide ideation should be further investigated.
TRIAL REGISTRATION
Controlled-Trials.com ISRCTN93903959.
| 0no significant effect
|
5,838,916 | 29,535,941 |
BACKGROUND
A large number of patients with diabetes mellitus are unaware of foot care and are at risk of developing foot ulcer and amputation. This increases healthcare burden due to preventable complication of diabetes.
AIMS
We conducted this study to assess the effectiveness of a foot care education module for diabetes developed by us.
MATERIALS AND METHODS
One hundred and twenty-seven patients with diabetes mellitus attending our outpatient were randomized into intervention ( n = 63) and control groups ( n = 64). At first visit, 1 and 3 months later, both groups filled a questionnaire regarding foot care knowledge and practice. The intervention group was administered foot care education module and the control group received routine care at baseline and 1 month. Patient education module consisted of an audio-visual display and a pamphlet on diabetes foot care. Change in score at 3 months was assessed by Student's t -test.
RESULTS
Knowledge scores in the intervention group at first, second, and third visits were 9.8 ± 1.8, 10.2 ± 1.6, and 11.0 ± 1.7, respectively. The knowledge scores in the control group at first, second, and third visits were 9.9 ± 1.7, 9.8 ± 1.6, and 10.0 ± 1.8, respectively. The change in knowledge score was statistically significant ( P < 0.001) at third visit compared to first in the intervention group but not in the control group ( P = 0.62). Practice score also improved significantly ( P < 0.001) in the intervention group in the second visit but not in the control group.
CONCLUSION
Audio-visual foot care patient education module in outpatient setting is an effective means to improve foot care knowledge and practice in patients with diabetes.
| 1significant effect
|
4,822,094 | 26,986,656 |
OBJECTIVES
Colon cleansing for flexible sigmoidoscopy using a standard fleet enema does not provide adequate cleansing in a significant number of patients. We tested whether the addition of a low-volume oral cleansing agent could mitigate this challenge without significantly compromising patient tolerance.
HYPOTHESIS
Oral picosulfate with magnesium citrate (P/MC) would enhance the colon cleansing of patients undergoing sigmoidoscopy, as assessed by the modified Ottawa Bowel Preparation Score.
METHODS
A randomized single blinded trial comparing (1) a single dose (i.e., one sachet) of oral sodium picosulfate plus magnesium citrate (P/MC) administered the night before, (2) a single dose oral P/MC the night before plus sodium phosphate enema 1 h before leaving home, and (3) sodium phosphate enema alone 1 h before leaving home for flexible sigmoidoscopy was conducted on outpatients referred for sigmoidoscopy for symptom assessment.
RESULTS
A total 120 patients were randomized to the study groups. The main indication for sigmoidoscopy was investigation of rectal bleeding (n=80). There was no significant difference in bowel cleansing quality, measured by the endoscopist blinded to preparation, between P/MC, P/MC plus enema, and enema alone as measured by the modified Ottawa Bowel Preparation Scale (P=0.34) or the Aronchick Scale (P=0.13). Both oral P/MC regimens were associated with higher incidence of nausea, abdominal pain, bloating, and interrupted sleep than enema alone (P<0.05).
CONCLUSIONS
A single dose of oral P/MC administered the night before did not result in better colon cleansing for sigmoidoscopy when used alone or with an enema and was associated with more side effects (NCT 01554111).
| 0no significant effect
|
5,731,010 | 29,284,961 |
BACKGROUND
The transalveolar extraction and the use of pharmacological antibiotic therapy following the surgical procedure in management of postoperative infection go hand in hand in minor oral surgery. Attention has often been focused on antibiotic therapy administered at different time schedules (before or after surgery or both). This investigation reveals how the use of different molecules and dosages is critical in the postoperative period and has always provided positive result.
METHODOLOGY
A prospective randomized study was carried out in 100 healthy controls of age group 20-50 years undergoing transalveolar extraction in the Department of Oral and Maxillofacial Surgery, Vivekanandha Dental College for Women. A 5-day regimen of amoxicillin or ciprofloxacin group of antibiotics along with regular analgesics was administered to the patients following transalveolar extraction. The patients were evaluated for postoperative infection, inflammation and wound care on postoperative days: day zero, day 2, day 5, day 7, day 15, day 30, and analyzed. A P < 0.05 was considered statistically significant.
RESULTS AND CONCLUSION
A total of 100 patients aged 23-50 years (24.6-4.43) met the inclusion criteria. Male accounted for 44, while female were 55, giving male:female ratio 1:1.4. Postoperative infection was minimum with ciprofloxacin group as compared to amoxicillin group and was more significant ( P < 0.005) on evaluation. A complete review has also been taken into an account, various strategies used such as surgical flaps, no traumatic osteotomy, and primary or secondary closure.
| 1significant effect
|
2,546,382 | 18,694,484 |
OBJECTIVE
Exenatide belongs to a new therapeutic class in the treatment of diabetes (incretin mimetics), allowing glucose-dependent glycaemic control in type 2 diabetes. Randomised controlled trial data suggest that exenatide is as effective as insulin glargine at reducing HbA1c in combination therapy with metformin and sulphonylureas; with reduced weight but higher incidence of adverse gastrointestinal events. The objective of this study is to evaluate the cost effectiveness of exenatide versus insulin glargine using RCT data and a previously published model of type 2 diabetes disease progression that is based on the United Kingdom Prospective Diabetes Study; the perspective of the health-payer of the United Kingdom National Health Service.
METHODS
The study used a discrete event simulation model designed to forecast the costs and health outcome of a cohort of 1,000 subjects aged over 40 years with sub-optimally-controlled type 2 diabetes, following initiation of either exenatide, or insulin glargine, in addition to oral hypoglycaemic agents. Sensitivity analysis for a higher treatment discontinuation rate in exenatide patients was applied to the cohort in three different scenarios; (1) either ignored or (2) exenatide-failures excluded or (3) exenatide-failures switched to insulin glargine. Analyses were undertaken to evaluate the price sensitivity of exenatide in terms of relative cost effectiveness. Baseline cohort profiles and effectiveness data were taken from a published randomised controlled trial.
RESULTS
The relative cost-effectiveness of exenatide and insulin glargine was tested under a variety of conditions, in which insulin glargine was dominant in all cases. Using the most conservative of assumptions, the cost-effectiveness ratio of exenatide vs. insulin glargine at the current UK NHS price was -29,149 pounds/QALY (insulin glargine dominant) and thus exenatide is not cost-effective when compared with insulin glargine, at the current UK NHS price.
CONCLUSION
This study evaluated the relative cost effectiveness of insulin glargine versus exenatide in the management of type 2 diabetes using a published model. Given no significant difference in glycaemic control and applying the additional effectiveness of exenatide over insulin glargine, with respect to weight loss, and using the current UK NHS prices, insulin glargine was found to be dominant over exenatide in all modelled scenarios. With current clinical evidence, exenatide does not appear to represent a cost-effective treatment option for patients with type 2 diabetes when compared to insulin glargine.
| 1significant effect
|
3,474,173 | 23,077,409 |
BACKGROUND
Patients with rare diseases often lack information about the disease itself and appropriate health care, leading to poor quality of life. Personal health records provide health information which can then be shared between multiple health care providers. Personal health records may also offer a tool for capturing patients' reported outcomes, thus enhancing their empowerment and improving communication with health care professionals. We conducted a pilot study to evaluate the usability of Sanoia, a freely accessible personal health record, which was customized for patients with the rare disease, idiopathic thrombocytopenic purpura (ITP).
METHODS
The Sanoia interface was expanded with ITP-specific tools. A prospective study was conducted at the referent center to evaluate the usability of this new interface (referred to here as the "tool") by patients. Forty-three patients were randomized into groups to use or to not use the tool. Its use was evaluated by a specific questionnaire and by surveying individual patient adherence profiles. Evaluation of health-related quality of life using the ITP patient assessment questionnaire, was performed at baseline and after 1, 3, and 6 months via postal mail.
RESULTS
The groups were similar at inclusion in terms of characteristics, including global quality of life. During the study period, the tool was used to update the personal records of 19/28 patients (68%), with a median of two connections to the tool (range 1-12) plus access by various health care professionals (n = 22). In addition, 15/19 (78%) patients used the "personal notes" section at least once. We observed no significant changes in quality of life between patients with or without the tool during the study period.
CONCLUSION
This pilot study demonstrates the good usability of the new customized Sanoia interface for patients with ITP. Additional studies will increase its usability further, and its interface could be adapted for use with other rare chronic diseases.
| 0no significant effect
|
5,294,435 | 28,216,860 |
BACKGROUND
Today, chronic low back pain is one of the special challenges in healthcare. There is no unique approach to treat chronic low back pain. A variety of methods are used for the treatment of low back pain, but the effects of these methods have not yet been investigated adequately.
AIM
The aim of this study was to compare the effects of Pilates and McKenzie training on pain and general health of men with chronic low back pain.
MATERIALS AND METHODS
Thirty-six patients with chronic low back pain were chosen voluntarily and assigned to three groups of 12 each: McKenzie group, Pilates group, and control group. The Pilates group participated in 1-h exercise sessions, three sessions a week for 6 weeks. McKenzie group performed workouts 1 h a day for 20 days. The control group underwent no treatment. The general health of all participants was measured by the General Health Questionnaire 28 and pain by the McGill Pain Questionnaire.
RESULTS
After therapeutic exercises, there was no significant difference between Pilates and McKenzie groups in pain relief ( P = 0.327). Neither of the two methods was superior over the other for pain relief. However, there was a significant difference in general health indexes between Pilates and McKenzie groups.
CONCLUSION
Pilates and McKenzie training reduced pain in patients with chronic low back pain, but the Pilates training was more effective to improve general health.
| 0no significant effect
|
3,503,752 | 22,958,541 |
BACKGROUND
Regular review and support for asthma self-management is promoted in guidelines. A randomised controlled trial suggested that unscheduled health care usage was similar when patients were offered self management support by a lay-trainer or practice nurses.
METHODS
Following the RCT, a costing study was undertaken using the trial data to account for the cost of delivery of the service under both strategies and the resulting impact on unscheduled healthcare (measure of effectiveness) in this trial.
RESULTS
One year data (n = 418) showed that 29% (61/205) of the nurse group required unscheduled healthcare (177 events) compared with 30.5% (65/213) for lay-trainers (178 events).The training costs for the lay-trainers were greater than nurses (£36 versus £18 respectively per patient, p<0.001), however, the consultation cost for lay-trainers were lower than nurses (£6 per patient versus £24, p<0.001). If the cost of unscheduled healthcare are accounted for then the costs of nurses is £161, and £135 for lay-trainers (mean difference £25, [95% CI = -£97, £149, p = 0.681]). The total costs (delivery and unscheduled healthcare) were £202 per patient for nurses versus £178 for lay-trainers, (mean difference £24, [95%CI = -£100, £147, p = 0.707]).
CONCLUSIONS
There were no significant differences in the cost of training and healthcare delivery between nurse and lay trainers, and no significant difference in the cost of unscheduled health care use.
| 1significant effect
|
5,296,807 | 28,216,703 |
BACKGROUND AND AIMS
Neuromuscular blocking agents have been one of the cornerstones of anaesthesia. With the advent of newer surgical, anaesthetic and neurological monitoring techniques, their utility in neuroanaesthesia practice seems dispensable. The aim of this prospective, comparative, randomised study was to determine whether neuromuscular blocking agents are required in patients undergoing supratentorial surgery when balanced anaesthesia with desflurane, dexmedetomidine and scalp block is used.
METHODS
Sixty patients with the American Society of Anesthesiologists physical status I or II, aged between 18 and 60 years were included in the study. All patients received anaesthesia including desflurane, dexmedetomidine and scalp block. The patients were randomly allocated to receive no neuromuscular blocking agent (Group A) or atracurium infusion to keep train-of-four count 2 (Group B). The two groups were compared with respect to haemodynamic stability, brain relaxation scores and recovery characteristics. Haemodynamic parameters and time taken to achieve Aldrete score >9 and other secondary outcomes were analysed using Student's t -test. Non-parametric data were analysed using the Mann-Whitney test.
RESULTS
The mean arterial pressure was comparable between the groups. The intraoperative heart rate was comparable; however, in the post-operative period, it remained higher in Group B for 30 min after extubation ( P = 0.02). The brain relaxation scores were comparable among the two groups ( P = 0.27). Tracheal extubation time, time taken for orientation and time required to reach Aldrete score ≥9 were comparable among the two groups.
CONCLUSION
The present study suggests that balanced anaesthesia using desflurane, dexmedetomidine and scalp block can preclude the use of neuromuscular blocking agents in patients undergoing supratentorial surgery under intense haemodynamic monitoring.
| 0no significant effect
|
4,018,698 | 24,904,789 |
BACKGROUND
Effective control of postoperative pain remains one of the most important and pressing issues in the field of surgery and has a significant impact on our health care system. In too many patients, pain is treated inadequately, causing them needless suffering and they can develop complications as an indirect consequence of pain. Analgesic modalities, if properly applied, can prevent or at least minimize this needless suffering and these complications.
OBJECTIVES
The aim of this study was to compare the efficacy of continuous infusions of local anesthetic drugs by paravertebral and epidural routes in controlling postoperative pain in patients undergoing hip surgeries.
PATIENTS AND METHODS
The study involved 60 patients who were undergoing hip surgery under the subarachnoid block. They were randomly divided into 2 groups of 30 patients. Group I (paravertebral group) received a single dose of spinal anesthesia with 2.5 mL 0.5% bupivacaine (heavy) + a continuous infusion of 0.125% bupivacaine at 5 mL/h in the paravertebral space. Group II (epidural group) received a single dose of spinal anesthesia with 0.5% bupivacaine (heavy) + a continuous infusion of 0.125% bupivacaine at a rate of 5 mL/hr in the epidural space for 48 hours in the postoperative period. Visual analogue scale (VAS) score, vital statistics, rescue analgesia, and procedure time were compared with the corresponding times between the 2 groups by student's t-test and repeated measures ANOVA with post hoc Bonferroni. P < 0.05 was considered significant. There were no statistically significant differences between the 2 groups regarding mean pain score in the first 48 hours.
RESULTS
Mean arterial pressure was significantly lower in the epidural group compared with the paravertebral group from 2 hours after start of the infusion until 48 hrs. Regional anesthesia procedure time was significantly longer in the epidural group (P < 0.001). There was no significant difference between the 2 groups regarding frequency of postoperative complications and catheter-related problems.
CONCLUSIONS
The results of our study indicate that for patients who are scheduled for hip surgery, both continuous paravertebral and continuous epidural analgesia are effective in controlling postoperative pain but that the former has several crucial advantages.
| 1significant effect
|
4,355,923 | 25,780,518 |
BACKGROUND
This research investigated the response of vascular active factors, vascular endothelial growth factor (VEGF) and angiotensin-II (AT-II) to ovarian stimulation during 24 hours in patients with polycystic ovary syndrome (PCOS).
MATERIALS AND METHODS
In this clinical trial study, 52 patients with PCOS and 8 control cases were stimulated with human chorionic gonadotropin (HCG) on the 4(th) to 7(th) day of the patients' natural or induced menstrual cycles. We measured VEGF and AT-II by radioimmunoassay before the injection (0 hour) and 3, 8, 12, 18 and 24 hours after the stimulation.
RESULTS
After ovarian stimulation, there was substantially higher level of VEGF in typical PCOS patients than the other three groups at the 3 hour time point (p<0.05), while there were no significant differences in VEGF at all the other time points among the four groups. As for AT-II, before and at all time points after the ovarian stimulation, it seemed that the AT-II levels in patients' sera with different phenotypes of PCOS by the Rotterdam criteria were all higher than in the control group although the differences were not statistically significant. The level of AT-II in typical PCOS patients was also significantly higher than the other three groups at the 3 hour time point (p<0.05), while no significant differences at all the other time points among the four groups were observed.
CONCLUSION
The response to the stimulation varied among patients with different phenotypes of PCOS according to the Rotterdam criteria. Serum VEGF and AT-II were possible contributors to an increased risk of developing ovarian hyperstimulation syndrome (OHSS) in patients with typical PCOS during the early follicular phase (3 hours) after ovarian stimulation (
REGISTRATION NUMBER
NCT02265861).
| 1significant effect
|
5,812,876 | 29,541,133 |
BACKGROUND/OBJECTIVE
Our study aimed to assess the effects of physical activity interventions via standing banners (point-of-decision prompt) and aerobics classes to promote physical activity among individuals with metabolic syndrome.
METHODS
We conducted a cluster randomized controlled intervention trial (16-week intervention and 8-week follow-up). Malaysian government employees in Putrajaya, Malaysia, with metabolic syndrome were randomly assigned by cluster to a point-of-decision prompt group (n = 44), an aerobics group (n = 42) or a control group (n = 103) based on sample size calculation formula. Step counts were evaluated by Lifecorder e-STEP accelerometers for all participants. Metabolic syndrome was defined according to the 'harmonizing' definition, in which individuals who have at least three of the five metabolic risk factors (waist circumference, high-density lipoprotein cholesterol, triglycerides, fasting glucose levels, systolic and diastolic blood pressure) will be classified as having metabolic syndrome. A total of 80% of the enrolled government employees with metabolic syndrome completed the programme. Data were analyzed using SPSS for Windows (version 20, SPSS, Chicago, IL).
RESULTS
There were significantly higher step counts on average in the aerobics group compared to the control group over assessments. Assessments at baseline, post-intervention and follow-up showed a significant difference in step counts between the intervention and control groups. The greatest reductions in the proportions of individuals with metabolic syndrome were observed in the aerobics group with a reduction of 79.4% in the post-intervention assessment compared to the assessment at baseline.
CONCLUSION
The findings of this study suggest that physical activity intervention via aerobics classes is an effective strategy for improving step counts and reducing the prevalence of metabolic syndrome.
| 1significant effect
|
4,026,398 | 24,872,682 |
BACKGROUND
Mixed venous and arterial ulcers account for approximately 15%-30% of all venous leg ulcerations. Several studies have shown that matrix metalloproteinases (MMPs) and neutrophil gelatinase-associated lipocalin (NGAL) play a central role in the pathophysiology of venous and arterial diseases. Some studies have shown the efficacy of glycosaminoglycans, such as sulodexide (SDX), in treating patients with leg ulcers. The aim of this study was to evaluate clinical effects of SDX and its correlation with MMPs and NGAL expression in patients with mixed arterial and venous leg ulcers.
METHODS
Patients eligible for this study were of both sexes, older than 20 years, and with a clinical and instrumental diagnosis of mixed ulcer.
RESULTS
Fifty-three patients of both sexes were enrolled and divided into two groups by means of randomization tables. Group A (treated group) comprised 18 females and ten males (median age: 68.7 years) treated with standard treatment (compression therapy and surgery) + SDX (600 lipoprotein lipase-releasing units/day intramuscularly) for 15 days followed by SDX 250 lipase-releasing units every 12 hours day orally for 6 months as adjunctive treatment. Group B (control group) comprised 17 females and eight males (median age: 64.2 years) treated with standard treatment only (compression therapy and surgery). The type of surgery was chosen according to anatomical level of vein incompetence: superficial venous open surgery and/or subfascial endoscopic perforating surgery. In all enrolled patients, blood samples were collected in order to evaluate the plasma levels of MMPs and NGAL through enzyme-linked immunosorbent assay. These results were compared to another control group (Group C) of healthy individuals. Moreover, biopsies of ulcers were taken to evaluate the tissue expression of MMPs and NGAL through Western blot analysis. Our results revealed that SDX treatment is able to reduce both plasma levels and tissue expression of MMPs improving the clinical conditions in patients with mixed ulcers.
CONCLUSION
Inhibition of MMPs could represent a possible therapeutic intervention to limit the progression of leg ulceration. In particular, our findings demonstrate the efficacy of SDX in patients with mixed arterial and venous chronic ulcers of the lower limbs.
| 1significant effect
|
4,871,204 | 27,231,549 |
OBJECTIVE
We compared a three-drug combination therapy (control group) consisting of tacrolimus, mycophenolate mofetil, and corticosteroids in living donor renal transplantation with a four-drug combination therapy (study group), in which the doses of tacrolimus and mycophenolate mofetil were halved and the immunosuppressive drug mizoribine was added, in order to determine whether the incidence rates of acute rejection after transplantation between the study group and the control group are similar, whether the study group regimen prevents the occurrence of calcineurin inhibitor-induced renal damage, and whether the study group regimen prevents adverse effects such as diarrhea caused by mycophenolate mofetil.
METHODS
We investigated the incidence of acute rejection, serum creatinine levels, and estimated glomerular filtration rate and the incidence of adverse effects such as diarrhea.
RESULTS
There was no significant difference between the two groups in the incidence of acute rejection. Renal function (estimated glomerular filtration rate and serum creatinine) was maintained in the control group whereas in the study group renal function gradually improved, with a statistical difference observed at 12 months. The incidence of gastrointestinal symptoms including diarrhea was significantly higher in the control group than in the study group. There was no significant difference in the incidence of cytomegalovirus infection and other adverse effects.
CONCLUSION
These results suggest the study group therapy is an effective regimen in preventing acute rejection and the deterioration of renal function. These results also show this therapy can reduce the incidence of adverse effects such as gastrointestinal symptoms.
| 1significant effect
|
4,951,371 | 27,446,789 |
OBJECTIVE
To investigate the effect of radial extracorporeal shock wave therapy (rESWT) on hemiplegic shoulder pain (HSP) syndrome.
METHODS
In this monocentric, randomized, patient-assessor blinded, placebo-controlled trial, patients with HSP were randomly divided into the rESWT (n=17) and control (n=17) groups. Treatment was administered four times a week for 2 weeks. The visual analogue scale (VAS) score and Constant-Murley score (CS) were assessed before and after treatment, and at 2 and 4 weeks. The Modified Ashworth Scale and Fugl-Meyer Assessment scores and range of motion of the shoulder were also assessed.
RESULTS
VAS scores improved post-intervention and at the 2-week and 4-week follow-up in the intervention group (p<0.05). Respective differences in VAS scores between baseline and post-intervention in the intervention and control groups were -1.69±1.90 and -0.45±0.79, respectively (p<0.05), between baseline and 2-week follow-up in the intervention and control groups were -1.60±1.74 and -0.34±0.70, respectively (p<0.05), and between baseline and 4-week follow-up in the intervention and control groups were -1.61±1.73 and -0.33±0.71, respectively (p<0.05). Baseline CS improved from 19.12±11.02 to 20.88±10.37 post-intervention and to 20.41±10.82 at the 2-week follow-up only in the intervention group (p<0.05).
CONCLUSION
rESWT consisting of eight sessions could be one of the effective and safe modalities for pain management in people with HSP. Further studies are needed to generalize and support these results in patients with HSP and a variety conditions, and to understand the mechanism of rESWT for treating HSP.
| 1significant effect
|
5,803,937 | 29,441,294 |
BACKGROUND
Psoriasis is one of the most common skin disorders with a prevalence rate of 0.1%-3%. Chronic nature, frequent relapses, absence of permanent cure, and the cosmetic disfigurement of psoriasis have a negative impact on quality of life (QoL) by causing psychological stress. Patients with psoriasis often have unambiguous ideas about the causes, controllability, consequences, and expected time-course of their disease.
AIM
The aim of this study is to assess the effectiveness of a video-assisted teaching program regarding psoriasis on the level of knowledge and relaxation therapy on QoL among patients with psoriasis.
MATERIALS AND METHODS
Experimental design was adapted. One hundred and four participants diagnosed with psoriasis were randomly allocated either to an experimental or to a control group. Fifty-two participants were included in each group by simple random sampling. A video-assisted teaching program on psoriasis and relaxation exercises was taught to the participants over a period of 3 months. The tools used were: Psoriasis Knowledge Assessment Questionnaire, modified psoriasis disability index, and modified psoriasis life stress inventory.
RESULTS
In the experimental group, the knowledge score was increased significantly from 9 ± 2.2 at baseline to 23.6 ± 1.5 after the intervention. The disability score was decreased from 15.6 to 9.9 and the stress score related to the illness was decreased from 22.8 to 16.9 after the intervention.
CONCLUSION
Educational intervention about disease process and relaxation exercises was effective in improving the knowledge and QoL of patients with psoriasis.
| 1significant effect
|
4,170,550 | 25,254,191 |
BACKGROUND AND OBJECTIVES
This study was conducted to evaluate the retention of various prefabricated posts and to compare them with that of the conventional cast post.
MATERIALS AND METHODS
A sample of 60 freshly extracted single-rooted human mandibular first premolars were sectioned horizontally, 1 mm coronal to the cemento-enamel junction and randomly divided into four groups consisting of carbon fiber posts, glass fiber posts, stainless steel posts and cast metal posts. Cast metal post was the control group. Each group contained 15 specimen. The post space of 9 mm depth was prepared using specific drill supplied by the manufacturer. Resin patterns of the prepared post spaces were fabricated for 15 specimen and were cast in nickel chromium base metal alloy. All the posts were cemented with self-adhesive resin cement and mounted in acrylic cylinders. The teeth were subjected to tensile pull-out test using a universal testing machine. The force required to dislodge each post from the teeth was recorded. The data was analyzed using one-way analysis of variance and Bonferroni test.
RESULTS
The bond strength of all the prefabricated posts was significantly lower than the conventional cast post. Among the prefabricated posts highest bond strength was obtained for prefabricated stainless steel post and lowest for carbon fiber posts. There was no significant difference in the mean bond strength obtained for stainless steel and glass fiber post.
CONCLUSION
Though no single prefabricated post could achieve results close to the control group, most retentive among the experimental group were the stainless steel posts. However, conditions where nonmetallic posts are indicated most preferred type of post can be the glass fiber posts.
| 1significant effect
|
3,284,878 | 22,226,127 |
BACKGROUND
Despite breast abscess becoming less common in developed countries, it has remained one of the leading causes of morbidity in women in developing countries. A randomized controlled trial was conducted at Mulago hospital complex in Kampala Uganda to establish whether ultrasound guided needle aspiration is a feasible alternative treatment option for breast abscesses.
RESULTS
A total of 65 females with breast abscess were analyzed, of these 33 patients were randomized into the ultrasound guided needle aspiration and 32 patients in the Incision and drainage arm. The mean age was 23.12, most of them were lactating (66.2%), primipararous (44.6%) with peripheral abscesses (73.8%) located in the upper lateral quadrant (56%).The mean breast size was 3.49 cm. The two groups were comparably in demographic characteristic and breast abscess size. Survival analysis showed no difference in breast abscess healing rate between the two groups (Log rank 0.24 df 1 and P = 0.63). Incision and drainage was found to be more costly than ultrasound guided aspiration (cost effective ratio of 2.85).
CONCLUSION
Ultrasound guided needle aspiration is therefore a feasible and cost effective treatment option for both lactating and non lactating breast abscesses with a diameter up to 5 cm by ultrasound in an immune competent patient.
| 0no significant effect
|
4,839,625 | 27,101,379 |
INTRODUCTION
The World Health Organisation recommends home visits conducted by Community Health Workers (in Uganda known as Village Health Teams--VHTs) in order to improve maternal and newborn health. This study measured the effect of home visits combined with mobile phone consultations on maternal and newborn care practices.
METHOD
In a community intervention trial design 16 health centres in Masindi and Kiryandongo districts, Uganda were randomly and equally allocated to one of two arms: control and intervention arms. Eight control health centres received the usual maternal and newborn educational messages offered by professional health workers and eight intervention health centres that received an intervention package for maternal care and essential newborn care practices. In the intervention arm VHTs made two prenatal and one postnatal home visit to households. VHTs were provided with mobile phones to enable them make regular telephone consultations with health workers at the health centre serving the catchment area. The primary outcome was health facility delivery. Other outcomes included antenatal attendances, birth preparedness, cord and thermal care and breastfeeding practices. Analysis was by intention-to-treat.
RESULTS
A total of 1385 pregnant women were analysed: 758 and 627 in the control and intervention arms respectively. Significant post-intervention differences were: delivery place [adjusted Odds Ratio aOR: 17.94(95%CI: 6.26-51.37); p<0.001], cord care [aOR: 3.05(95%CI: 1.81-5.12); p<0.001] thermal care [aOR: 7.58(95%CI: 2.52-22.82); p<0.001], and timely care-seeking for newborn illness [aOR: 4.93(95%CI: 1.59-15.31); p = 0.006].
CONCLUSION
VHTs can have an effect in promoting proper cord and thermal care for the newborn and improve timely care-seeking for health facility delivery and newborn illness, because they could answer questions and refer patients correctly. However, VHTs should be supported by professional health workers through the use of mobile phones.
TRIAL REGISTRATION
ClinicalTrials.gov NCT02084680.
| 1significant effect
|
5,711,682 | 29,035,435 |
BACKGROUND AND OBJECTIVES
This trial evaluated the safety and efficacy of the Genoss drug-eluting coronary stent.
METHODS
This study was a prospective, multicenter, randomized trial with a 1:1 ratio of Genoss drug-eluting stent (DES)™ and Promus Element™. Inclusion criteria were the presence of stable angina, unstable angina, or silent ischemia. Angiographic inclusion criteria were de novo coronary stenotic lesion with diameter stenosis >50%, reference vessel diameter of 2.5-4.0 mm, and lesion length ≤40 mm. The primary endpoint was in-stent late lumen loss at 9-month quantitative coronary angiography follow-up. Secondary endpoints were in-segment late lumen loss, binary restenosis rate, death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis during 9 months of follow-up.
RESULTS
We enrolled 38 patients for the Genoss DES™ group and 39 patients for the Promus Element™ group. In-stent late lumen loss at 9 months was not significantly different between the 2 groups (0.11±0.25 vs. 0.16±0.43 mm, p=0.567). There was no MI or stent thrombosis in either group. The rates of death (2.6% vs. 0%, p=0.494), TLR (2.6% vs. 2.6%, p=1.000), and TVR (7.9% vs. 2.6%, p=0.358) at 9 months were not significantly different.
CONCLUSION
This first-in-patient study of the Genoss DES™ stent showed excellent angiographic outcomes for in-stent late lumen loss and major adverse cardiac events over a 9-month follow-up.
| 0no significant effect
|
4,114,003 | 25,077,156 |
BACKGROUND
Neonatal conjunctivitis leads to several ocular consequences in the affected neonates such as blindness. Currently available therapeutic options include NaNO3, Gentamicin, Neomycin and so on, in which each of them has their own limitations. Regarding the immunologic content of colostrum and its safety and easy accessibility, we aimed to evaluate its preventive effects against neonatal conjunctivitis.
MATERIALS AND METHODS
In this clinical trial, conducted from November 2011 to July 2012, 300 preterm neonates, with culture negative eye swab, were enrolled and randomly assigned into three groups. The intervention group received two drops of colostrum. Control group received no treatment and other neonates were treated with topical Erythromycin ointment (0.5%). All neonates were followed for occurrence of clinical conjunctivitis for 28 days. Data analysis were performed by Chi-square test.
RESULTS
Our data demonstrate the beneficial preventive effects of Colostrum against neonatal conjunctivitis (P = 0.036).
CONCLUSION
Colostrum is suggested as an alternative prophylactic option for antibiotics against neonatal conjunctivitis. As colostrum is easily accessible without cost, potential hazards and side effects, public education about its topical favorable effects is worthwhile.
| 1significant effect
|
5,682,702 | 29,184,837 |
AIM AND OBJECTIVES
To assess Tufts Medical Center obstetrician/gynecologist (OB/GYN) residents' knowledge, beliefs, and previous training in oral health and to assess the effect of an oral health educational seminar on their knowledge and beliefs.
MATERIALS AND METHODS
A preseminar questionnaire was distributed to the residents. The same questionnaire was distributed immediately after the seminar and 3 months later. SPSS Version 21 was used for the data analysis.
RESULTS
Convenience sample of 25 residents were included in the study. The mean (standard deviation) age of participants was 29.08 (2.47) years. Only 1 (4%) participant reported receiving >8 h previous training in oral health and 7 (28%) reported receiving <1 h of training. The nonparametric Friedman test showed a statistically significant difference between administrations in terms of total score on knowledge-based questions ( P < 0.001) and some of the belief-based questions. The post hoc Wilcoxon signed-rank test with Bonferroni correction showed statistically significant improvement in the knowledge-based questions between pre- and post-seminar questionnaire ( P = 0.002) and between preseminar and 3-month follow-up ( P = 0.003).
CONCLUSIONS
OB/GYN residents at Tufts Medical Center received limited training in oral health. Their knowledge improved significantly following the oral health educational seminar. Similar training modules can be brought to other OB/GYN residencies and OB/GYNs in an effort to enhance the symbiotic relationship between medical and dental professionals.
| 1significant effect
|
3,228,981 | 22,148,110 |
BACKGROUND/AIMS
Antispasmodics including otilonium bromide (OB) are recommended to treat irritable bowel syndrome (IBS). However, reports about OB experience in Asia is sparse. The purpose of present study was to provide the efficacy of OB in treating Asian IBS patients.
METHODS
Overall, 117 IBS patients meeting Rome II criteria were enrolled in an 8-week, double-blind, active-controlled and single center trial. Randomized participants received either OB 40 mg or mebeverine 100 mg 3 doses daily. The primary endpoints were to evaluate the net changes of abdominal pain/discomfort frequency score (APDFS) and safety profile, while the secondary endpoints were to assess the changes in abdominal pain/discomfort intensity, flatulence, abdominal bloating, satisfied stool frequency etc.
RESULTS
Finally, 49 OB and 52 mebeverine subjects were eligible for efficacy analysis. Compared to baselines in per protocol populations, the reduced APDFSs in OB and mebeverine were 0.55 ± 1.20 (P = 0.011) and 0.37 ± 1.11 (P = 0.042), respectively, to show similarly reduced scores. The most reported side effects included dry mouth, nausea and dizziness. Besides, the improved APDFSs at 4th week visit, final alleviations in abdominal pain intensity, flatulence, abdominal bloating and satisfied stool frequency with global assessments filled by both patients and investigators were significantly achieved by both treatments, and OB was not inferior to mebeverine in treating these parameters.
CONCLUSIONS
In Orientals, OB is as effective as mebeverine for alleviating IBS symptoms in terms of abdominal pain, flatulence, abdominal bloating etc. However, obvious side effects are also observed. A large-scaled trial and post-marketing surveillance are recommended to confirm its efficacy and safety.
| 0no significant effect
|
5,863,413 | 29,599,587 |
INTRODUCTION
Lichen planus (LP) is a chronic inflammatory, autoimmune, mucocutaneous disease of unknown etiology. The first line of treatment for oral LP (OLP) has been corticosteroids, but because of their adverse effects, alternative therapeutic approaches are being carried out, of which the recent natural alternative is propolis.
AIM
This study aims to evaluate the efficacy of topical propolis in the management of OLP.
MATERIALS AND METHODS
The research group consisted of 27 patients diagnosed with symptomatic OLP, among which 15 patients were in the control group and the rest 12 were in the study group. The patients in the control group received triamcinolone acetonide 0.1% (topical application) while the patients in the study group received propolis gel. Both the groups were evaluated for pain and erythema at baseline (1 st visit), first follow-up (7 th day), and second follow-up (14 th day) using numerical rating scale and modified oral mucositis index.
RESULTS
The patients in both the study and control groups showed a statistically significant reduction ( P = 0.000 for the study group and P = 0.000 for the control group) in pain and erythema scores from baseline to second follow-up visit. However, on comparison of the reduction in pain and erythema scores between the two groups, the difference was found to be statistically insignificant ( P = 0.255).
STATISTICAL ANALYSIS USED
Chi-square and Cramer's V test were used.
CONCLUSION
The topical propolis was found to be of comparative effectiveness with respect to triamcinolone acetonide 0.1% in the management of OLP.
| 0no significant effect
|
5,702,778 | 29,291,188 |
OBJECTIVE
The purpose of this study was to determine the effects of carbonated water on etched or sealed enamel according to the carbonation level and the presence of calcium ions.
METHODS
Carbonated water with different carbonation levels was manufactured by a soda carbonator. Seventy-five premolar teeth were randomly divided into a control group and 4 experimental groups in accordance with the carbonation level and the presence of calcium ions in the test solutions. After specimen preparation of the Unexposed, Etched, and Sealed enamel subgroups, all the specimens were submerged in each test solution for 15 minutes three times a day during 7 days. Microhardness tests on the Unexposed and Etched enamel subgroups were performed with 10 specimens from each group. Scanning electron microscopy (SEM) tests on the Unexposed, Etched, and Sealed enamel subgroups were performed with 5 specimens from each group. Microhardness changes in different groups were statistically compared using paired t -tests, the Wilcoxon signed rank test, and the Kruskal-Wallis test.
RESULTS
The microhardness changes were significantly different between the groups ( p = 0.000). The microhardness changes in all experimental groups except Group 3 (low-level carbonated water with calcium ions) were significantly greater than those in the Control group. SEM showed that etched areas of the specimen were affected by carbonated water and the magnitude of destruction varied between groups. Adhesive material was partially removed in groups exposed to carbonated water.
CONCLUSIONS
Carbonated water has negative effects on etched or sealed enamel, resulting in decreased microhardness and removal of the adhesive material.
| 1significant effect
|
5,508,798 | 28,717,347 |
BACKGROUND
This study investigated the effect of supplementation with fish oil rich in eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) on the M-wave latency of biceps brachii and muscle damage after a single session of maximal elbow flexor eccentric contractions (ECC).
METHODS
Twenty-one men were completed the randomized, double-blind, placebo-controlled, and parallel-design study. The subjects were randomly assigned to the fish oil group ( n = 10) or control group ( n = 11). The fish oil group consumed eight 300-mg EPA-rich fish oil softgel capsules (containing, in total, 600 mg EPA and 260 mg DHA) per day for 8 weeks before the exercise, and continued this for a further 5 days. The control group consumed an equivalent number of placebo capsules. The subjects performed six sets of ten eccentric contractions of the elbow flexors using a dumbbell set at 40% of their one repetition maximum. M-wave latency was assessed as the time taken from electrical stimulation applied to Erb's point to the onset of M-wave of the biceps brachii. This was measured before and immediately after exercise, and then after 1, 2, 3, and 5 days. Changes in maximal voluntary isometric contraction (MVC) torque, range of motion (ROM), upper arm circumference, and delayed onset muscle soreness (DOMS) were assessed at the same time points.
RESULTS
Compared with the control group, M-wave latency was significantly shorter in the fish oil group immediately after exercise ( p = 0.040), MVC torque was significantly higher at 1 day after exercise ( p = 0.049), ROM was significantly greater at post and 2 days after exercise (post; p = 0.006, day 2; p = 0.014), and there was significantly less delayed onset muscle soreness at 1 and 2 days after exercise (day 1; p = 0.049, day 2; p = 0.023).
CONCLUSION
Eight weeks of EPA and DHA supplementation may play a protective role against motor nerve function and may attenuate muscle damage after eccentric contractions.
TRIAL REGISTRATION
This trial was registered on July 14th 2015 (https://upload.umin.ac.jp/cgi-open-bin/ctr/index.cgi).
| 1significant effect
|
5,808,274 | 29,440,956 |
BACKGROUND
The introduction of endourological procedures such as percutaneous nephrolithotomy and ureterorenoscopy have led to a revolution in the the management of urinary stone disease. The indications for open stone surgery have been narrowed significantly, making it a second- or third-line treatment option.
AIMS AND OBJECTIVES
To study the safety and efficacy of retroperitoneal laparoscopic pyelolithotomy in retroperitoneal renal stone. We compared the results of laparoscopic and open surgery in terms of easy accessibility, operative period, renal injuries, and early recovery.
METHODS
This prospective study was conducted on renal pelvic stone cases from January 2009 to February 2016 in Suchkhand Hospital, Agra, India. The study included a total of 1700 cases with the diagnosis of solitary renal pelvic stones. In group A - 850 cases - retroperitoneal laparoscopic pyelolithotomy was performed, while group B - 850 cases - underwent open pyelolithotomy.
RESULTS
The mean operative time was less in group B than group A (74.83 min vs. 94.43 min) which was significant (p<0.001). The blood loss was less in the laparoscopic group than in the open group (63 mL vs. 103mL). There were statistically significant differences in the post-operative pain scores, and postoperative complications compared to group B (p<0.001). The mean hospital stay was less in group A (p<0.03), which was significant.
CONCLUSION
Laparoscopic surgery reduces analgesic requirements, hospital stay, and blood loss. The disadvantages include the reduced working space, the cost of equipment and the availability of a trained surgeon.
| 1significant effect
|
4,166,382 | 25,237,447 |
BACKGROUND
The efficacy of palonosetron in preventing postoperative nausea and vomiting (PONV), as well as chemotherapy-induced nausea and vomiting, has already been demonstrated in multiple clinical studies. The purpose of this study was to determine whether continuous infusion of palonosetron following single injection could reduce PONV to a greater extent than single injection only of palonosetron.
METHODS
In total, 132 women were enrolled in the study. All subjects were over the age of 20 years and were scheduled to undergo gynecologic laparoscopic surgery. Patients were randomly allocated into two groups. In both groups, patients received 0.075 mg of palonosetron intravenously, immediately before induction of anesthesia. In the continuous palonosetron infusion group, 0.075 mg (1.5 ml) of palonosetron was added to the patient-controlled analgesia device. In the single-injection palonosetron group, 1.5 ml of normal saline was added.
RESULTS
The incidence of PONV 24 hours postoperatively was significantly lower in the continuous palonosetron infusion group than the single-injection palonosetron group (31.8 vs. 56.1%, P = 0.009).
CONCLUSIONS
Continuous palonosetron infusion, following single injection, reduces the incidence of PONV compared with single injection only.
| 1significant effect
|
3,504,298 | 22,579,509 |
BACKGROUND
Negative attentional biases are thought to increase the risk of recurrence in depression, suggesting that reduction of such biases may be a plausible strategy in the secondary prevention of the illness. However, no previous study has tested whether reducing negative attentional bias causally affects risk factors for depressive recurrence. The current experimental medicine study reports the effects of a computerized attentional bias modification (ABM) procedure on intermediate measures of the risk of depressive recurrence (residual depressive symptoms and the cortisol awakening response) in patients with recurrent depression.
METHODS
Sixty-one patients with at least two previous episodes of depression who were currently in remission were randomized to receive either an active (positive) or placebo computer-based ABM regime. The ABM regime presented either pictures of faces or words. Residual depressive symptoms, measured using the Beck Depression Inventory and the cortisol awakening response were measured immediately before and after completion of the bias modification and then again after 4 weeks' follow-up.
RESULTS
Positive, face-based ABM reduced both measures of recurrence risk (Beck Depression Inventory and cortisol awakening response). This effect occurred during the month following completion of bias modification. Word-based modification did not influence the outcome measures.
CONCLUSIONS
Positive face-based ABM was able to reduce intermediate measures of recurrence risk in previously depressed patients. These results suggest that ABM may provide a "cognitive vaccine" against depression and offer a useful strategy in the secondary prevention of the illness.
| 0no significant effect
|
5,892,275 | 29,780,415 |
OBJECTIVE
To compare the effect of the rapid-acting insulin analogues (RAIAs) aspart (NovoRapid) and lispro (Prandilin) on glycemic variations by continuous glucose monitoring system (CGMS) in patients within newly diagnosed type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) and metformin intensive therapy.
METHODS
This is a single-blind randomized controlled trial. A total of 110 patients with newly diagnosed T2DM and with hemoglobin A1c (HbA1c%) above 9% was hospitalized and randomly divided into two groups: group Asp (NovoRapid group) and group Lis (Prandilin group). They all received CSII and metformin therapy. Treatments were maintained for 2-3 weeks after the glycaemic target was reached. C-peptide and insulin and fructosamine were determined. CGMS was continuously applied for 4 days after reaching the glycemic target.
RESULTS
There were no significant differences in daily dosages of insulin, fasting plasma C-P and 2 h postprandial C-P and insulin, and fructosamine at the baseline and endpoint between the groups Asp and Lis. No significant differences were seen in the 24 h mean amplitude of glycemic excursions (MAGE), 24 h mean blood glucose (MBG), the standard deviation of the MBG (SDBG), fasting blood glucose, number of glycemic excursion (NGE), and the incidence of hypoglycemia between the two groups. Similarly, no significant differences were found in areas under the curve (AUC) of glucose above 10.0 mmol/L or the decremental area over the curve (AOC) of glucose below 3.9 mmol/L between the two groups.
CONCLUSIONS
Lispro and aspart had the similar ability to control the glycemic variations in patients with newly diagnosed T2DM. This study was registered with ClinicalTrials.gov, number ChiCTR-IPR-17010338.
| 0no significant effect
|
5,008,205 | 25,912,221 |
AIMS
To compare the once-weekly glucagon-like peptide-1 (GLP-1) receptor dulaglutide with the dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin after 104 weeks of treatment.
METHODS
This AWARD-5 study was a multicentre, double-blind trial that randomized participants to dulaglutide (1.5 or 0.75 mg) or sitagliptin 100 mg for 104 weeks or placebo (reported separately) for 26 weeks. Change in glycated haemoglobin (HbA1c) concentration from baseline was the primary efficacy measure. A total of 1098 participants with HbA1c concentrations ≥7.0% (≥53.0 mmol/mol) and ≤9.5% (≤80.3 mmol/mol) were randomized, and 657 (59.8%) completed the study. We report results for dulaglutide and sitagliptin at the final endpoint.
RESULTS
Changes in HbA1c at 104 weeks were (least squares mean ± standard error) -0.99 ± 0.06% (-10.82 ± 0.66 mmol/mol), -0.71 ± 0.07% (-7.76 ± 0.77 mmol/mol) and -0.32 ± 0.06% (-3.50 ± 0.66 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg and sitagliptin, respectively (p < 0.001, both dulaglutide doses vs sitagliptin). Weight loss was greater with dulaglutide 1.5 mg (p < 0.001) and similar with 0.75 mg versus sitagliptin (2.88 ± 0.25, 2.39 ± 0.26 and 1.75 ± 0.25 kg, respectively). Gastrointestinal adverse events were more common with dulaglutide 1.5 and 0.75 mg versus sitagliptin (nausea 17 and 15% vs 7%, diarrhoea 16 and 12% vs 6%, vomiting 14 and 8% vs 4% respectively). Pancreatic, thyroid, cardiovascular and hypersensitivity safety were similar across groups.
CONCLUSIONS
Dulaglutide doses provided superior glycaemic control and dulaglutide 1.5 mg resulted in greater weight reduction versus sitagliptin at 104 weeks, with acceptable safety.
| 1significant effect
|
3,441,280 | 22,510,240 |
BACKGROUND
Nutritional supplements designed to increase adenosine 5'-triphosphate (ATP) concentrations are commonly used by athletes as ergogenic aids. ATP is the primary source of energy for the cells, and supplementation may enhance the ability to maintain high ATP turnover during high-intensity exercise. Oral ATP supplements have beneficial effects in some but not all studies examining physical performance. One of the remaining questions is whether orally administered ATP is bioavailable. We investigated whether acute supplementation with oral ATP administered as enteric-coated pellets led to increased concentrations of ATP or its metabolites in the circulation.
METHODS
Eight healthy volunteers participated in a cross-over study. Participants were given in random order single doses of 5000 mg ATP or placebo. To prevent degradation of ATP in the acidic environment of the stomach, the supplement was administered via two types of pH-sensitive, enteric-coated pellets (targeted at release in the proximal or distal small intestine), or via a naso-duodenal tube. Blood ATP and metabolite concentrations were monitored by HPLC for 4.5 h (naso-duodenal tube) or 7 h (pellets) post-administration. Areas under the concentration vs. time curve were calculated and compared by paired-samples t-tests.
RESULTS
ATP concentrations in blood did not increase after ATP supplementation via enteric-coated pellets or naso-duodenal tube. In contrast, concentrations of the final catabolic product of ATP, uric acid, were significantly increased compared to placebo by ~50% after administration via proximal-release pellets (P = 0.003) and naso-duodenal tube (P = 0.001), but not after administration via distal-release pellets.
CONCLUSIONS
A single dose of orally administered ATP is not bioavailable, and this may explain why several studies did not find ergogenic effects of oral ATP supplementation. On the other hand, increases in uric acid after release of ATP in the proximal part of the small intestine suggest that ATP or one of its metabolites is absorbed and metabolized. Uric acid itself may have ergogenic effects, but this needs further study. Also, more studies are needed to determine whether chronic administration of ATP will enhance its oral bioavailability.
| 1significant effect
|
4,206,772 | 24,810,369 |
OBJECTIVE
To assess the efficacy and safety of enzyme replacement therapy (ERT) with BMN 110 (elosulfase alfa) in patients with Morquio A syndrome (mucopolysaccharidosis IVA).
METHODS
Patients with Morquio A aged ≥5 years (N = 176) were randomised (1:1:1) to receive elosulfase alfa 2.0 mg/kg/every other week (qow), elosulfase alfa 2.0 mg/kg/week (weekly) or placebo for 24 weeks in this phase 3, double-blind, randomised study. The primary efficacy measure was 6-min walk test (6MWT) distance. Secondary efficacy measures were 3-min stair climb test (3MSCT) followed by change in urine keratan sulfate (KS). Various exploratory measures included respiratory function tests. Patient safety was also evaluated.
RESULTS
At week 24, the estimated mean effect on the 6MWT versus placebo was 22.5 m (95 % CI 4.0, 40.9; P = 0.017) for weekly and 0.5 m (95 % CI -17.8, 18.9; P = 0.954) for qow. The estimated mean effect on 3MSCT was 1.1 stairs/min (95 % CI -2.1, 4.4; P = 0.494) for weekly and -0.5 stairs/min (95 % CI -3.7, 2.8; P = 0.778) for qow. Normalised urine KS was reduced at 24 weeks in both regimens. In the weekly dose group, 22.4 % of patients had adverse events leading to an infusion interruption/discontinuation requiring medical intervention (only 1.3 % of all infusions in this group) over 6 months. No adverse events led to permanent treatment discontinuation.
CONCLUSIONS
Elosulfase alfa improved endurance as measured by the 6MWT in the weekly but not qow dose group, did not improve endurance on the 3MSCT, reduced urine KS, and had an acceptable safety profile.
| 0no significant effect
|
5,773,988 | 29,386,817 |
BACKGROUND
The purpose of the present study was to envisage the effectiveness of demineralized freeze-dried bone allograft (DFDBA) and bovine bone graft (BBG) for promoting defect fill in periodontal intrabony defects using dentascan.
MATERIALS AND METHODS
A total of 13 subjects (15 intrabony defects) aged between 24 and 56 years affected by moderate to severe periodontitis were randomly divided into Control (CG) and Test groups (TG1 and TG2). In CG only debridement, TG1 debridement plus DFDBA, and TG2 debridement plus BBG were performed. The clinical parameters probing pocket depth (PPD), clinical attachment level (CAL) was used. The radiological analysis was done by dentascan, which is a single-slice spiral computed tomographic scanner. Six months after, regenerative treatment clinical measurements were recorded. The bone fill was assessed using Dentascan as previously mentioned.
RESULTS
PPD reduction and CAL gain were significant in all the groups after 6 months whereas, on intergroup comparisons, insignificant finding was observed both at baseline and after 6 months. Coronoapical bone status decreased significantly in all groups, buccolingual measurements decreased significantly in TG1 and TG2, but no such trend was seen in CG. Significant reduction in mesiodistal bone status was noticed only in TG1 whereas insignificant on intergroup comparisons.
CONCLUSION
Dentascan-based analysis attested that DFDBA was superior to BBG.
| 0no significant effect
|
5,761,719 | 29,249,436 |
BACKGROUND
The PROspective Multicenter Imaging Study for Evaluation of chest pain (PROMISE) minimal-risk tool was recently developed to identify patients with suspected stable angina at very low risk of coronary artery disease (CAD) and clinical events. We assessed the external validity of this tool within the context of the Scottish Computed Tomography of the HEART (SCOT-HEART) multicenter randomised controlled trial of patients with suspected stable angina due to coronary disease.
METHODS
The minimal-risk tool was applied to 1764 patients with complete imaging and follow-up data. External validity was compared with the guideline-endorsed CAD Consortium (CADC) risk score and determined through tests of model discrimination and calibration.
RESULTS
A total of 531 (30.1%, mean age 52.4years, female 62.0%) patients were classified as minimal-risk. Compared to the remainder of the validation cohort, this group had lower estimated pre-test probability of coronary disease according to the CADC model (30.0% vs 47.0%, p<0.001). The PROMISE minimal-risk tool improved discrimination compared with the CADC model (c-statistic 0.785 vs 0.730, p<0.001) and was improved further following re-estimation of covariate coefficients (c-statistic 0.805, p<0.001). Model calibration was initially poor (χ 2 197.6, Hosmer-Lemeshow [HL] p<0.001), with significant overestimation of probability of minimal risk, but improved significantly following revision of the PROMISE minimal-risk intercept and covariate coefficients (χ 2 5.6, HL p=0.692).
CONCLUSION AND RELEVANCE
Despite overestimating the probability of minimal-risk, the PROMISE minimal-risk tool outperforms the CADC model with regards to prognostic discrimination in patients with suspected stable angina, and may assist clinicians in decisions regarding non-invasive testing.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT01149590.
| 1significant effect
|
4,459,874 | 26,053,679 |
BACKGROUND
Helminth infections are a major public health problem, especially in the tropics. Infected individuals have an altered immune response with evidence that antibody response to vaccination is impaired. Hence, treatment of helminth infections before vaccination may be a simple intervention to improve vaccine immunogenicity. In the present study we investigated whether a single-dose antihelminthic treatment influences antibody responses to a seasonal influenza vaccine in primary school children living in Gabon, Central Africa.
METHODS
In this placebo-controlled double-blind trial conducted in Gabon the effect of a single-dose antihelminthic treatment with 400 mg albendazole versus a placebo one month prior to immunization with a seasonal influenza vaccine was investigated. Antiviral antibody titers against all three vaccine strains were assessed by haemagglutination inhibition (HI) test at baseline (Day 0; vaccination) and four weeks (Day 28) as well as 12 weeks (Day 84) following vaccination. Vaccine-specific memory B-cell response was measured at Day 0 and Day 84 by vaccine-specific Enzyme-linked Immunospot (ELISpot) assay. The trial is registered with the Pan African Clinical Trials Registry (PACTR) (PACTR201303000434188).
RESULTS
98 school children aged 6-10 years were randomly allocated to receive either antihelminthic treatment or placebo and were vaccinated one month after the treatment. The prevalence of helminths at baseline was 21%. Vaccine-specific HI titers against at least one of the three vaccine strains increased at Day 28 and Day 84 in all participants. HI titers against both influenza A strains as well as memory B-cell response were modestly higher in the antihelminthic treated group compared to the placebo group but the difference was not statistically significant. Total but not specific IgA was elevated in the antihelminthic treated group compared to the control group at Day 28.
CONCLUSION
In our setting antihelminthic treatment had no significant effect on influenza vaccine immunogenicity. A trend towards better antiviral and vaccine immunogenicity in the antihelminthic treated group encourages studies to be conducted with alternative treatment schedules or in populations with a higher helminth burden.
| 0no significant effect
|
2,409,966 | 18,560,581 |
BACKGROUND
Three randomized controlled trials (RCTs) have confirmed that male circumcision (MC) significantly reduces acquisition of HIV-1 infection among men. The objective of this study was to perform a comprehensive, prospective evaluation of risk compensation, comparing circumcised versus uncircumcised controls in a sample of RCT participants.
METHODS AND FINDINGS
Between March 2004 and September 2005, we systematically recruited men enrolled in a RCT of MC in Kenya. Detailed sexual histories were taken using a modified Timeline Followback approach at baseline, 6, and 12 months. Participants provided permission to obtain circumcision status and laboratory results from the RCT. We evaluated circumcised and uncircumcised men's sexual behavior using an 18-item risk propensity score and acquisition of incident infections of gonorrhea, chlamydia, and trichomoniasis. Of 1780 eligible RCT participants, 1319 enrolled (response rate = 74%). At the baseline RCT visit, men who enrolled in the sub-study reported the same sexual behaviors as men who did not. We found a significant reduction in sexual risk behavior among both circumcised and uncircumcised men from baseline to 6 (p<0.01) and 12 (p = 0.05) months post-enrollment. Longitudinal analyses indicated no statistically significant differences between sexual risk propensity scores or in incident infections of gonorrhea, chlamydia, and trichomoniasis between circumcised and uncircumcised men. These results are based on the most comprehensive analysis of risk compensation yet done.
CONCLUSION
In the context of a RCT, circumcision did not result in increased HIV risk behavior. Continued monitoring and evaluation of risk compensation associated with circumcision is needed as evidence supporting its' efficacy is disseminated and MC is widely promoted for HIV prevention.
| 0no significant effect
|
4,194,359 | 25,249,290 |
BACKGROUND
Breast cancer mortality steadily declined from the 1990s and this has been attributed to early detection and/or to improvements in therapy. Which of those two has had the greater impact is a subject of contention.
METHODS
A database of 386 patients, enrolled in a randomized clinical trial on the effect of adjuvant chemotherapy (CMF), was analysed. The probabilities of recurrence and death were estimated by the Fine and Gray's model and by the Cox model. Time dependent covariate and interaction effects were investigated by additive models. Absolute risk reductions (ARR) related to adjuvant treatment or to tumour size [diameter ≤ 2 cm (T1) or >2 cm (T2/T3)] were estimated.
RESULTS
CMF-related reduction in recurrence emerges early, reaches a maximum level at 3 years and persists at a constant level thereafter. Tumour-size-related recurrence reduction, after a maximum at 3 years, displays a progressive regular reduction approaching zero. Patients with any tumour size, when given CMF, exhibit mortality reduction that displays an early regular increase and continues to a persistent plateau. In contrast, tumour-size-related mortality reduction reaches a maximum at 5-7 years and then regularly drops to very low values for patients of both trial arms.
CONCLUSIONS
Findings reveal that there is a different time-dependent benefit from chemotherapy and from smaller tumour size at diagnosis. The benefit from adjuvant chemotherapy is long-lasting for patients with any tumour size while the early benefit of diagnosing smaller tumours substantially decreases afterwards. Treatment improvements have probably had greater impact on the mortality reduction than mammography screening.
| 0no significant effect
|
3,094,245 | 21,496,343 |
BACKGROUND
In Pakistan, only 59-73% of children 12-23 months of age are fully immunized. This randomized, controlled trial was conducted to assess the impact of a low-literacy immunization promotion educational intervention for mothers living in low-income communities of Karachi on infant immunization completion rates.
METHODS
Three hundred and sixty-six mother-infant pairs, with infants aged ≤ 6 weeks, were enrolled and randomized into either the intervention or control arm between August - November 2008. The intervention, administered by trained community health workers, consisted of three targeted pictorial messages regarding vaccines. The control group received general health promotion messages based on Pakistan's Lady Health Worker program curriculum. Assessment of DPT/Hepatitis B vaccine completion (3 doses) was conducted 4-months after enrollment. A Poisson regression model was used to estimate effect of the intervention. The multivariable Poisson regression model included maternal education, paternal occupation, ownership of home, cooking fuel used at home, place of residence, the child's immunization status at enrollment, and mother's perception about the impact of immunization on child's health.
RESULTS
Baseline characteristics among the two groups were similar. At 4 month assessment, among 179 mother-infant pairs in the intervention group, 129 (72.1%) had received all 3 doses of DPT/Hepatitis B vaccine, whereas in the control group 92/178 (51.7%) had received all 3 doses. Multivariable analysis revealed a significant improvement of 39% (adjusted RR = 1.39; 95% CI: 1.06-1.81) in DPT-3/Hepatitis B completion rates in the intervention group.
CONCLUSION
A simple educational intervention designed for low-literate populations, improved DPT-3/Hepatitis B vaccine completion rates by 39%. These findings have important implications for improving routine immunization rates in Pakistan.
| 1significant effect
|
4,984,916 | 27,092,784 |
BACKGROUND
In the United Kingdom, totally implantable venous access systems (TIVAS) are not routinely used. Compared with Hickman catheters, these devices are more expensive and complex to insert. However, it is unclear whether the higher costs may be offset by perceived greater health benefits. This pilot trial aimed to generate relevant data to inform the design of a larger definitive randomised controlled trial.
METHODS
This was a phase II prospective, randomised, open trial from two UK oncology centres. The primary end point was overall complication rate. Secondary end points included individual complication rates, time to first complication and quality of life. Analysis was by intention to treat. An economic evaluation was also carried out.
RESULTS
A total of 100 patients were randomised in a 3 : 1 ratio to receive a Hickman or a TIVAS. Overall, 54% of patients in the Hickman arm suffered one or more complications compared with 38% in the TIVAS arm (one-sided P=0.068). In the Hickman arm, 28% of the devices were removed prematurely due to a complication compared with 4% in the TIVAS arm. Quality of life based on the device-specific questionnaire was greater in the TIVAS arm for 13 of the 16 questions. The economic evaluation showed that Hickman arm was associated with greater mean cost per patient £1803 (95% CI 462, 3215), but similar quality-adjusted life years -0.01 (95% CI -0.15, 0.15) than the TIVAS arm. However, there is much uncertainty associated with the results.
CONCLUSIONS
Compared with Hickman catheters, TIVAS may be the cost-effective option. A larger multicentre trial is needed to confirm these preliminary findings.
| 0no significant effect
|
4,674,925 | 27,391,598 |
INTRODUCTION
Progression-free survival (PFS) and overall survival (OS) endpoints often only weakly correlate. This analysis investigates how different progression events impact on OS, using data from two phase 3 studies with eribulin in women with advanced/metastatic breast cancer (MBC).
METHODS
In Study 301, 1102 women with ≤2 prior chemotherapies for advanced/MBC were randomized to eribulin mesylate (1.4 mg/m(2) on days 1 and 8 every 21 days) or capecitabine (1.25 g/m(2) twice daily on days 1-14 every 21 days). Study 305/EMBRACE enrolled 762 patients following two to five prior chemotherapies for advanced/MBC, randomized to eribulin (as above) or treatment of physician's choice. We analyzed OS and PFS post hoc for patients whose disease progressed due to development of "new" metastases, growth of pre-existing lesions, and patients with no reported disease progression.
RESULTS
In both clinical studies, development of new metastases was associated with an increased risk of death (p < 0.0001). The time to development of new metastasis or death was significantly longer with eribulin than the comparator in Study 305 (p = 0.0017), but not in Study 301 (p = 0.46). Significantly longer OS was observed in the eribulin compared with the comparator arm for the new metastases subgroup in Study 301 (p = 0.008), but not in Study 305 (p = 0.16), compared with other progression subgroups.
CONCLUSIONS
Patients with MBC progressing with new metastases have a worse prognosis than those whose disease progresses due to growth of existing lesions or patients with no reported disease progression. These findings have potentially important implications for the interpretation of clinical study data and clinical practice.
TRIAL REGISTRATION
ClinicalTrials.gov registration IDs: Study 301: NCT00337103 ; Study 305: NCT00388726 .
| 0no significant effect
|
2,396,624 | 18,466,604 |
BACKGROUND
We report a patient-centered intervention study in 9 municipalities of rural Nicaragua aiming at a reduction of internalized social stigma in new AFB positive tuberculosis (TB) patients diagnosed between March 2004 and July 2005.
METHODS
Five out of 9 municipal teams were coached to tailor and introduce patient-centered package. New TB patients were assigned to the intervention group when diagnosed in municipalities implementing effectively at least TB clubs and home visits. We compared the changes in internalized stigma and TB treatment outcome in intervention and control groups. The internalized stigma was measured through score computed at 15 days and at 2 months of treatment. The treatment results were evaluated through classical TB program indicators. In all municipalities, we emphasized process monitoring to capture contextual factors that could influence package implementation, including stakeholders.
RESULTS
TB clubs and home visits were effectively implemented in 2 municipalities after June 2004 and in 3 municipalities after January 2005. Therefore, 122 patients were included in the intervention group and 146 in the control group. After 15 days, internalized stigma scores were equivalent in both groups. After 2 months, difference between scores was statistically significant, revealing a decreased internalized stigma in the intervention group and not in the control group.
CONCLUSION
This study provides initial evidences that it is possible to act on TB patients' internalized stigma, in contexts where at least patient centered home visits and TB clubs are successfully implemented. This is important as, indeed, TB care should also focus on the TB patient's wellbeing and not solely on TB epidemics control.
| 1significant effect
|
5,002,172 | 27,567,670 |
BACKGROUND
To assess the effectiveness of the new modified technique in order to control bleeding in women presenting with atonic, flabby uterus compared to the most commonly described technique of classic B-Lynch suture.
METHOD
This study included 160 women of uncontrolled atonic postpartum hemorrhage delivered by cesarean section at Ain Shams University Maternity Hospital between January 2013 and October 2015. Participants were randomly assigned following simple randomization procedures (computerized random numbers) and divided into two groups. Group, I (80 patients) operated upon by the modified (new technique) stitch while group II (80 patients) operated upon by the classic technique. The ultimate goals were to stop blood loss after placement of the sutures and avoid life-saving hysterectomy thus preserving the life and fertility of the patient.
RESULTS
The modified new technique was done in 80 patients with atonic postpartum hemorrhage and it was found to be superior to the classic technique with a success rate 95 % (4 cases needed hysterectomy as a lifesaving measure) compared to 85 % with the classic technique (in 12 cases, a life-saving hysterectomy was done).
CONCLUSIONS
This technique can replace the classic B-lynch in flabby unresponsive atonic uteri as it has 8 shaped placement of the stitch which causes more firm compression on the uterus and simultaneous bilateral uterine artery ligation. This technique was proved valuable and successful in many patients who suffer from uncontrolled massive postpartum hemorrhage (PPH).
| 1significant effect
|
4,625,433 | 26,510,621 |
BACKGROUND
Tourniquet use in total knee arthroplasty (TKA) surgery is applied to minimize blood loss thereby creating better overview of the surgical field. This induces ischemia in the skeletal muscle resulting in reperfusion injury. Our aim was to investigate the in vivo metabolic changes in the skeletal muscle during TKA surgery using microdialysis (MD).
METHODS
Seventy patients were randomly allocated to tourniquet group (n = 35) or non-tourniquet group (n = 35). Prior to surgery, catheters were inserted in the operated leg and non-operated leg. Interstitial dialysate was collected before and after surgery and at 20 min intervals during a 5 h reperfusion period. Main variables were ischemic metabolites: glucose, pyruvate, lactate and glycerol and L/P ratio.
RESULTS
Significant difference in all metabolites was detected between the two groups, caused by tourniquet application. Tourniquet induced ischemia resulted in decreased levels of glucose and pyruvate to 54 and 60 % respectively, compared to baseline. Simultaneously, accumulation of lactate to 116 % and glycerol to 190 % was observed. L/P ratio was elevated indicating ischemia. In the non-tourniquet group the metabolite changes were less profound and normalized within 60 min.
CONCLUSIONS
Microdialysis revealed that performing TKA with tourniquet is associated with increased ischemia. This affects all metabolites but the changes are normalized after 5 h.
| 1significant effect
|
2,908,852 | 17,302,204 |
PURPOSE
To compare the short-term effects of intravitreal versus posterior subtenon injection of triamcinolone acetonide for diabetic macular edema.
METHODS
This is a prospective and interventional study. Sixty eyes of 60 patients who had diffuse diabetic macular edema were assigned to receive a single intravitreal injection (4 mg) or a single posterior subtenon injection (40 mg) of triamcinolone acetonide. The central retinal thickness was measured using optical coherent tomography before injection and at 1 and 3 months after injection. Visual acuity and intraocular pressure (IOP) were also measured.
RESULTS
Both intravitreal and posterior subtenon injections of triamcinolone acetonide resulted in significant improvements in visual acuity at 1 month and 3 months after injection. Both groups resulted in a significant decrease in central macular thickness (CMT) at 1 month and 3 months post-injection. IOP in the intravitreal injection group was significantly higher than in the posterior subtenon injection group at 3 months after injection.
CONCLUSIONS
The posterior subtenon injection of triamcinolone acetonide had a comparable effect to the intravitreal triamcinolone injection and showed a lower risk of elevated IOP. Posterior subtenon injection of triamcinolone acetonide may be a good alternative for the treatment of diffuse diabetic macular edema.
| 1significant effect
|
5,971,505 | 29,239,259 |
Objective This study was performed to investigate the safety and efficacy of oral paracetamol versus oral ibuprofen in the treatment of patent ductus arteriosus (PDA) in premature infants. Methods Premature infants with PDA with a gestational age of ≤32 weeks or birth weight of ≤1500 g were included in this randomized study. Results A total of 120 premature infants fulfilled the inclusion criteria. Of these 120 infants, 34 fulfilled the treatment criteria and 22 were finally randomized. We found no significant difference in the mortality or primary closure rates between the two groups. We also found no significant difference in the short-term neonatal outcomes. Conclusions Either oral paracetamol or oral ibuprofen can be used safely and effectively to treat PDA in premature infants.
| 0no significant effect
|
2,039,813 | 17,657,599 |
BACKGROUND
ACE inhibition results in secondary prevention of coronary artery disease (CAD) through different mechanisms including improvement of endothelial dysfunction. The Perindopril-Function of the Endothelium in Coronary artery disease Trial (PERFECT) evaluated whether long-term administration of perindopril improves endothelial dysfunction.
METHODS
PERFECT is a 3-year double blind randomised placebo controlled trial to determine the effect of perindopril 8 mg once daily on brachial artery endothelial function in patients with stable CAD without clinical heart failure. Endothelial function in response to ischaemia was assessed using ultrasound. Primary endpoint was difference in flow-mediated vasodilatation (FMD) assessed at 36 months.
RESULTS
In 20 centers, 333 patients randomly received perindopril or matching placebo. Ischemia-induced FMD was 2.7% (SD 2.6). In the perindopril group FMD went from 2.6% at baseline to 3.3% at 36 months and in the placebo group from 2.8 to 3.0%. Change in FMD after 36 month treatment was 0.55% (95% confidence interval -0.36, 1.47; p = 0.23) higher in perindopril than in placebo group. The rate of change in FMD per 6 months was 0.14% (SE 0.05, p = 0.02) in perindopril and 0.02% (SE 0.05, p = 0.74) in placebo group (0.12% difference in rate of change p = 0.07).
CONCLUSION
Perindopril resulted in a modest, albeit not statistically significant, improvement in FMD.
| 0no significant effect
|
5,131,536 | 27,903,247 |
BACKGROUND
There still is no evidence which neoadjuvant therapy regimen for stage II-III rectal cancer is superior. The aim of this study was to compare results achieved after long-course chemoradiotherapy (CRT) with short-term radiotherapy (RT) followed by delayed surgery.
METHODS
A randomized trial was carried out between 2007-2013. One hundred fifty patients diagnosed with stage II-III rectal cancer were randomized into one of two neoadjuvant treatment arms: conventional chemoradiotherapy (CRT) and short-term radiotherapy (RT) followed by surgery after 6-8 weeks. Primary endpoints of this trial were downstaging and pathological complete response rate. Secondary endpoints were local recurrence rate and overall survival.
RESULTS
The pathological complete response was found in 3 (4.4%) cases after RT and 8 (11.1%) after CRT (P = 0.112). Downstaging (stage 0 and I) was observed in 21 (30.9%) cases in RT group vs. 27 (37.5%) cases in CRT group (P = 0.409). Median follow-up time was 39.7 (range 4.9-79.7) months. 3-years overall survival (OS) was 78% in RT group vs. 82.4% in CRT group (P = 0.145), while disease-free survival (DFS) differed significantly - 59% in RT group vs. 75.1% in CRT group (P = 0,022). Hazard ratio of cancer progression for RT patients was 1.93 (95% CI: 1.08-3.43) compared to CRT patients.
CONCLUSION
Three-years disease-free survival was better in CRT group comparing with RT group with no difference in overall survival.
TRIAL REGISTRATION
http://clinicaltrials.gov identifier NCT00597311. January 2008.
| 0no significant effect
|
5,742,508 | 29,375,198 |
AIM
To evaluate the effectiveness on tissue response of the new nutritional supplement made of oligomeric proanthocyanidins in induced gingivitis after 21 days of use.
MATERIAL AND METHODS
A prospective, double-blind, randomized, controlled clinical trial was carried out on 20 patients; it is divided into an experimental group and a control group after fulfilling the selection criteria. Patients had to come 4 times during the study to register the Silness and Löe index, the gingival bleeding index, the plaque index, the inflammatory crevicular fluid study (IL6), and the changes in the brightness of the gingiva. No complementary hygiene methods were allowed during the 21 days.
RESULTS
The Silness and Löe index was higher in the control group than in the experimental group, reaching a twofold difference between the groups ( p < 0.0001). The gingival bleeding index also supports this fact, since the bleeding was lower in the experimental group ( p < 0.005). However, the dental plaque on the tooth surface according to the plaque index was 33% higher in the experimental group ( p < 0.006). Some differences in the IL-6 were found in the crevicular fluid ( p < 0.0001).
CONCLUSION
Oligomeric proanthocyanidins have an effect on the periodontal tissue's health. No effects on the accumulation of plaque on the tooth surface were found, so further studies are needed to determine the nature of the plaque.
| 1significant effect
|
3,590,543 | 23,493,414 |
AIM
To compare insertion characteristics of 2 different supraglottic devices [I-gel and Proseal laryngeal mask airway (PLMA)] and to observe any associated complications.
STUDY DESIGN
This prospective, randomized study was conducted in 80 patients [Group I - I-gel insertion (n = 40) and Group P - LMA Proseal insertion (n =40)] of ASA grades I/II, of either sex in the age group 18-65 years. Both groups were compared with respect to ease of insertion, insertion attempts, fiberoptic assessment, airway sealing pressure, ease of gastric tube placement, and other complications.
MATERIALS AND METHODS
All patients were asked to fast overnight. Patients were given alprazolam 0.25 mg orally at 10 p.m. the night before surgery and again 2 hours prior to surgery with 1-2 sips of water. Glycopyrrolate 0.2 mg, metoclopramide 10 mg, and ranitidine 50 mg were administered intravenously to the patients 45 minutes prior to the surgery. Once adequate depth of anesthesia was achieved either of the 2 devices, selected using a random computerized table, was inserted by an experienced anesthesiologist. In group I, I-gel was inserted and in patients of group P, PLMA was inserted.
STATISTICAL ANALYSIS
Student t-test and Mann-Whitney test were employed to compare the means; for categorical variables, Chi-square test was used.
RESULT
Mean insertion time for the I-gel (11.12 ± 1.814 sec) was significantly lower than that of the PLMA (15.13 ± 2.91 sec) (P = 0.001). I-gel was easier to insert with a better anatomic fit. Mean airway sealing pressure in the PLMA group (29.55 ± 3.53 cm H2O) was significantly higher than in the I-gel group (26.73 ± 2.52 cm H2O; P = 0.001). Ease of gastric tube insertion was significantly higher in the I-gel group (P = 0.001). Incidence of blood staining of the device, sore throat and dysphagia were observed more in PLMA group. No other complications were observed in either of the groups.
| 1significant effect
|
4,689,520 | 26,698,120 |
BACKGROUND
Dietary nitrate supplementation can enhance exercise performance in healthy people, but it is not clear if it is beneficial in COPD. We investigated the hypotheses that acute nitrate dosing would improve exercise performance and reduce the oxygen cost of submaximal exercise in people with COPD.
METHODS
We performed a double-blind, placebo-controlled, cross-over single dose study. Subjects were randomised to consume either nitrate-rich beetroot juice (containing 12.9 mmoles nitrate) or placebo (nitrate-depleted beetroot juice) 3 hours prior to endurance cycle ergometry, performed at 70% of maximal workload assessed by a prior incremental exercise test. After a minimum washout period of 7 days the protocol was repeated with the crossover beverage.
RESULTS
21 subjects successfully completed the study (age 68 ± 7 years; BMI 25.2 ± 5.5 kg/m2; FEV1 percentage predicted 50.1 ± 21.6%; peak VO2 18.0 ± 5.9 ml/min/kg). Resting diastolic blood pressure fell significantly with nitrate supplementation compared to placebo (-7 ± 8 mmHg nitrate vs. -1 ± 8 mmHg placebo; p = 0.008). Median endurance time did not differ significantly; nitrate 5.65 (3.90-10.40) minutes vs. placebo 6.40 (4.01-9.67) minutes (p = 0.50). However, isotime oxygen consumption (VO2) was lower following nitrate supplementation (16.6 ± 6.0 ml/min/kg nitrate vs. 17.2 ± 6.0 ml/min/kg placebo; p = 0.043), and consequently nitrate supplementation caused a significant lowering of the amplitude of the VO2-percentage isotime curve.
CONCLUSIONS
Acute administration of oral nitrate did not enhance endurance exercise performance; however the observation that beetroot juice caused reduced oxygen consumption at isotime suggests that further investigation of this treatment approach is warranted, perhaps targeting a more hypoxic phenotype.
TRIAL REGISTRATION
ISRCTN Registry ISRCTN66099139.
| 0no significant effect
|
4,604,289 | 26,478,862 |
BACKGROUND
Because blood pressure and heart rate (HR) elevations during tracheal extubation are common, different medications have been studied to prevent such complications.
OBJECTIVES
To compare magnesium sulfate, remifentanil, and placebo regarding mean arterial pressure (MAP) and HR changes during/after tracheal extubation, in patients who underwent laparotomy.
MATERIALS AND METHODS
In this randomized double-blinded trial, 120 patients undergoing laparotomy were evenly divided into three groups, including remifentanil (1 mcg/kg), magnesium sulfate (50 mg/kg), or normal saline, as placebo. Hemodynamic responses (MAP and HR) were documented at different times (before operation, during medication administration, immediately before extubation, immediately after extubation, and also 3, 5, and 10 minutes after extubation). The double burst time (DBT) was determined using neuromuscular monitoring, as time interval, between administration of reverse medication and DBT of 100%.
RESULTS
The HR was significantly lower, immediately after extubation and 3, 5, and 10 minutes after extubation, in both magnesium and remifentanil groups, compared to normal saline (P < 0.001). The MAP was also lower in magnesium and remifentanil groups, immediately after extubation and 3 minutes after extubation, in comparison to the normal saline group (P < 0.001). Mean (± SD) DBT 100% was significantly higher in magnesium group (30.2 ± 15.3) vs. remifenatnil (13.6 ± 6.8) and normal saline (13.5 ± 8.2) groups (P < 0.001).
CONCLUSIONS
Both remifentanil and magnesium had favorable outcomes in preventing HR and MAP elevation after tracheal extubation. However, remifentanil was associated with more rapid regaining of consciousness and reversal of muscular relaxation.
| 1significant effect
|
5,536,558 | 27,688,685 |
Objective To compare the effects of saddle, lumbar epidural and caudal blocks on anal sphincter tone using anorectal manometry. Methods Patients undergoing elective anorectal surgery with regional anaesthesia were divided randomly into three groups and received a saddle (SD), lumbar epidural (LE), or caudal (CD) block. Anorectal manometry was performed before and 30 min after each regional block. The degree of motor blockade of the anal sphincter was compared using the maximal resting pressure (MRP) and the maximal squeezing pressure (MSP). Results The study analysis population consisted of 49 patients (SD group, n = 18; LE group, n = 16; CD group, n = 15). No significant differences were observed in the percentage inhibition of the MRP among the three regional anaesthetic groups. However, percentage inhibition of the MSP was significantly greater in the SD group (83.6 ± 13.7%) compared with the LE group (58.4 ± 19.8%) and the CD group (47.8 ± 16.9%). In all groups, MSP was reduced significantly more than MRP after each regional block. Conclusions Saddle block was more effective than lumbar epidural or caudal block for depressing anal sphincter tone. No differences were detected between lumbar epidural and caudal blocks.
| 0no significant effect
|
4,233,044 | 25,348,087 |
BACKGROUND
Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures.
METHODS
This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test.
RESULTS
Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%).
CONCLUSIONS
This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00813397. Registered 19 December 2008.
| 1significant effect
|
4,796,524 | 25,363,176 |
INTRODUCTION
There is debate on renal graft stenting during ureteroneocystostomy, patients with ureteral stents may encounter several complications such as encrustation, stent crustation which can lead to loss of kidney, and complications related to stent extraction: pain and UTI increasing related to cystoscopy for stent extraction accompanying excess expenses. This study designed to reduce complications related to stent extraction.
MATERIALS & METHODS
90 patients prepared for renal transplantation during 1 year randomly classified to groups, study group: patients with attached stent to Foley catheter, control group: patients with conventional technique (stent separated from Foley) then in their follow up; UTI, stent crustation, luts severity compared to each other.
RESULTS
Second week and fourth week UTI reported 25.6%, 2.3% in study group versus 34.9%, 4.7% in control group (P.value:0.48 and 0.5). Urinary leakage was 3.3% overall, that all of them occurred in separate stent group, 37.5% vs. 0% in the linked stent group. Stent crustation in separate stent was 25% compared with 0% in the linked stent.
CONCLUSION
Low complications rate in linked stent group, despite the lack of significant statistical differences, but indicate the effectiveness and success of the new technique.
| 1significant effect
|
3,087,029 | 21,541,835 |
BACKGROUND
Antithrombotic management in atrial fibrillation (AF) is currently based on clinical characteristics, despite evidence of potential fine-tuning with transoesophageal echocardiography (TEE). This open, randomised, multicentre study addresses the hypothesis that a comprehensive strategy of TEE-based aspirin treatment in AF patients is feasible and safe.
METHODS
Between 2005 and 2009, ten large hospitals in the Netherlands enrolled AF patients with a moderate risk of stroke. Patients without thrombogenic TEE characteristics were randomised to aspirin or vitamin K antagonists (VKA). The primary objective is to show that TEE-based aspirin treatment is safe compared with VKA therapy. The secondary objective tests feasibility of TEE as a tool to detect echocardiographic features of high stroke risk. This report compares randomised to non-randomised patients and describes the feasibility of a TEE-based approach.
RESULTS
In total, 310 patients were included. Sixty-nine patients were not randomised because of non-visualisation (n = 6) or TEE risk factors (n = 63). Compared with non-randomised patients, randomised patients (n = 241) were younger (65 ± 11 vs. 69 ± 9 years, p = 0.004), had less coronary artery disease (9 vs. 20%, p = 0.018), previous TIA (1.7 vs. 7.2%, p = 0.029), AF during TEE (25 vs. 54%, p < 0.001), mitral incompetence (55 vs. 70%, p = 0.038), VKA use (69 vs. 82%, p = 0.032), had a lower mean CHADS(2) score (1.2 ± 0.6 vs. 1.6 ± 1.0, p = 0.004), and left ventricular ejection fraction (59 ± 8 vs. 56 ± 8%, p = 0.016).
CONCLUSIONS
This study shows that a TEE-based approach for fine-tuning stroke risk in AF patients with a moderate risk for stroke is feasible. Follow-up data will address the safety of this TEE-based approach.
| 1significant effect
|
3,785,973 | 24,028,826 |
BACKGROUND
Long-term asthma management falls short of the goals set by international guidelines. The Internet is proposed as an attractive medium to support guided self-management in asthma. Recently, in a multicenter, pragmatic randomized controlled parallel trial with a follow-up period of 1 year, patients were allocated Internet-based self-management (IBSM) support (Internet group [IG]) or usual care (UC) alone. IBSM support was automatically terminated after 12 months of follow-up. In this study, IBSM support has been demonstrated to improve asthma-related quality of life, asthma control, lung function, and the number of symptom-free days as compared to UC. IBSM support was based on known key components for effective self-management and included weekly asthma control monitoring and treatment advice, online and group education, and communication (both online and offline) with a respiratory nurse.
OBJECTIVE
The objective of the study was to assess the long-term effects of providing patients 1 year of IBSM support as compared to UC alone.
METHODS
Two hundred adults with physician-diagnosed asthma (3 or more months of inhaled corticosteroids prescribed in the past year) from 37 general practices and 1 academic outpatient department who previously participated were invited by letter for additional follow-up at 1.5 years after finishing the study. The Asthma Control Questionnaire (ACQ) and the Asthma Quality of Life Questionnaire (AQLQ) were completed by 107 participants (60 UC participants and 47 IG participants). A minimal clinical important difference in both questionnaires is 0.5 on a 7-point scale.
RESULTS
At 30 months after baseline, a sustained and significant difference in terms of asthma-related quality of life of 0.29 (95% CI 0.01-0.57) and asthma control of -0.33 (95% CI -0.61 to -0.05) was found in favor of the IBSM group. No such differences were found for inhaled corticosteroid dosage or for lung function, measured as forced expiratory volume in 1 second.
CONCLUSIONS
Improvements in asthma-related quality of life and asthma control were sustained in patients who received IBSM support for 1 year, even up to 1.5 years after terminating support. Future research should be focused on implementation of IBSM on a wider scale within routine asthma care.
TRIAL REGISTRATION
International Standard Randomized Controlled Trial Number (ISRCTN): 79864465; http://www.controlled-trials.com/ISRCTN79864465 (Archived by WebCite at http://www.webcitation.org/6J4VHhPk4).
| 1significant effect
|
5,442,201 | 27,743,214 |
OBJECTIVES
The ultrasonic NO PAIN technology (Electro Medical Systems, Nyon, CH) promises minimal pain during debridement due to linear oscillating action combined with a sinusoidal power output and feedback control. The aim of the present study was to measure pain perception on a visual analogue scale (VAS) during supportive periodontal therapy including debridement of hypersensitive teeth. Two ultrasonic scalers were used, one with and one without NO PAIN technology.
MATERIAL AND METHODS
In a randomized-controlled clinical study with split-mouth design, 100 hypersensitive teeth matched for air blast hypersensitivity were either treated with the ultrasonic device Piezon Master 700 or the Mini Piezon (both EMS, Nyon, CH). Pain perception during debridement was assessed by a VAS (range 0-10).
RESULTS
The average VAS for the test device Piezon Master 700 with NO PAIN technology was 3.16 ± 2.10, and for the control device Mini Piezon without NO PAIN technology 3.40 ± 2.59 (p = 0.490). Placing an arbitrary threshold at the VAS score of 3 for significant pain experience, 60 % of the subjects experienced no significant pain with either instrument.
CONCLUSION
No statistically significant difference in perceived pain between the instruments used was found.
CLINICAL RELEVANCE
Both ultrasonic devices showed very small pain intensities during debridement of highly hypersensitive teeth and can therefore be recommended for supportive periodontal therapy.
| 0no significant effect
|
3,714,520 | 23,412,078 |
OBJECTIVE
Canagliflozin, a sodium glucose cotransporter (SGLT) 2 inhibitor, is also a low-potency SGLT1 inhibitor. This study tested the hypothesis that intestinal canagliflozin levels postdose are sufficiently high to transiently inhibit intestinal SGLT1, thereby delaying intestinal glucose absorption.
RESEARCH DESIGN AND METHODS
This two-period, crossover study evaluated effects of canagliflozin on intestinal glucose absorption in 20 healthy subjects using a dual-tracer method. Placebo or canagliflozin 300 mg was given 20 min before a 600-kcal mixed-meal tolerance test. Plasma glucose, (3)H-glucose, (14)C-glucose, and insulin were measured frequently for 6 h to calculate rates of appearance of oral glucose (RaO) in plasma, endogenous glucose production, and glucose disposal.
RESULTS
Compared with placebo, canagliflozin treatment reduced postprandial plasma glucose and insulin excursions (incremental 0- to 2-h area under the curve [AUC0-2h] reductions of 35% and 43%, respectively; P < 0.001 for both), increased 0- to 6-h urinary glucose excretion (UGE0-6h, 18.2 ± 5.6 vs. <0.2 g; P < 0.001), and delayed RaO. Canagliflozin reduced AUC RaO by 31% over 0 to 1 h (geometric means, 264 vs. 381 mg/kg; P < 0.001) and by 20% over 0 to 2 h (576 vs. 723 mg/kg; P = 0.002). Over 2 to 6 h, canagliflozin increased RaO such that total AUC RaO over 0 to 6 h was <6% lower versus placebo (960 vs. 1,018 mg/kg; P = 0.003). A modest (∼10%) reduction in acetaminophen absorption was observed over the first 2 h, but this difference was not sufficient to explain the reduction in RaO. Total glucose disposal over 0 to 6 h was similar across groups.
CONCLUSIONS
Canagliflozin reduces postprandial plasma glucose and insulin by increasing UGE (via renal SGLT2 inhibition) and delaying RaO, likely due to intestinal SGLT1 inhibition.
| 1significant effect
|
5,729,670 | 29,285,445 |
CONTEXT
There is limited literature focusing on the management of glucocorticoid-induced hyperglycemia (GCIH).
AIMS
The primary objective was to compare the mean blood glucose between the experimental group (new protocol) and the control group (standard protocol) in the management of GCIH. The secondary objective was to compare other parameters of glycemic efficacy, variability, and safety parameters.
METHODS
This was a randomized, open-labeled, parallel arm trial. Adult patients who were given glucocorticoid (minimum dose equivalent to prednisolone 10 mg) in the past 24 h and had 2 h postmeal plasma glucose ≥200 mg/dl were included in the study. Patients randomized to control group received standard basal-bolus insulin. In the experimental group, a "correctional insulin" matching the glycemic profile of the glucocorticoid administered was provided with or without "background" basal-bolus insulin. The parameters of glycemic efficacy, variability, and safety were compared. P < 0.05 was considered statistically significant.
RESULTS
Data of 67 patients included in the study were analyzed, of which 33 patients were in the experimental group and 34 patients in the control group. The mean blood glucose in the experimental and the control group was 170.32 ± 33.46 mg/dl and 221.05 ± 49.72, respectively ( P = 0.0001). The parameters for glycemic variability were all significantly lower in patients in the experimental group. The hypoglycemia event rate was low in both the groups.
CONCLUSION
When compared to the standard basal-bolus insulin protocol, the new protocol showed lower mean blood glucose and lower glycemic variability.
| 1significant effect
|
3,781,572 | 23,656,980 |
OBJECTIVE
To assess the success and baseline predictors of maintaining glycemic control for up to 5 years of therapy using basal insulin glargine or standard glycemic care in people with dysglycemia treated with zero or one oral glucose-lowering agents.
RESEARCH DESIGN AND METHODS
Data from 12,537 participants in the Outcome Reduction with Initial Glargine Intervention (ORIGIN) trial were examined by baseline glycemic status (with or without type 2 diabetes) and by therapeutic approach (titrated insulin glargine or standard therapy) using an intention-to-treat analysis. Median values for fasting plasma glucose (FPG) and A1C and percentages with A1C<6.5% (48 mmol/mol) during randomized treatment were calculated. Factors independently associated with maintaining updated mean A1C<6.5% were analyzed with linear regression models.
RESULTS
Median A1C in the whole population was 6.4% at baseline; at 5 years, it was 6.2% with glargine treatment and 6.5% with standard care. Of those with diabetes at baseline, 60% using glargine and 45% using standard care had A1C<6.5% at 5 years. Lack of diabetes and lower baseline A1C were independently associated with 5-year mean A1C<6.5%. Maintaining mean A1C<6.5% was more likely with glargine (odds ratio [OR] 2.98 [95% CI 2.67-3.32], P<0.001) than standard care after adjustment for other independent predictors.
CONCLUSIONS
Systematic intervention with basal insulin glargine or standard care early in the natural history of dysglycemia can maintain glycemic control near baseline levels for at least 5 years, whether diabetes is present at baseline or not. Keeping mean A1C<6.5% is more likely in people with lower baseline A1C and with the glargine-based regimen.
| 1significant effect
|
5,585,595 | 28,830,853 |
BACKGROUND
Raising a child with type 1 diabetes (T1D) means combining the demands of the disease management with everyday parenting, which is associated with increased levels of distress. A Web-based patient portal, Sugarsquare, was developed to support parents, by providing online parent-professional communication, online peer support and online disease information.
OBJECTIVE
The first aim of this study was to assess the feasibility of conducting a multicenter, randomized controlled trial in Dutch parents of a child with T1D. The second aim was to assess the feasibility of implementing Sugarsquare in clinical practice.
METHODS
The parents of 105 children (N=105) with T1D below the age of 13 participated in a 6-month multicenter randomized controlled feasibility trial. They were randomly assigned to an experimental (n=54, usual care and Sugarsquare) or a control group (n=51, usual care). Attrition rates and user statistics were gathered to evaluate feasibility of the trial and implementation. To determine potential efficacy, the parenting stress index (PSI-SF) was assessed at baseline (T0) and after 6 months (T1).
RESULTS
Of a potential population of parents of 445 children, 189 were willing to participate (enrollment refusal=57.5%, n=256), 142 filled in the baseline questionnaire (baseline attrition rate=25%, n=47), and 105 also filled in the questionnaire at T1 (post randomization attrition rate during follow-up=26%, n=32). As such, 24% of the potential population participated. Analysis in the experimental group (n=54) revealed a total of 32 (59%) unique users, divided into 12 (38%) frequent users, 9 (28%) incidental users, and 11 (34%) low-frequent users. Of the total of 44 professionals, 34 (77%) logged in, and 32 (73%) logged in repeatedly. Analysis of the user statistics in the experimental group further showed high practicability and integration in all users, moderate acceptability and demand in parents, and high acceptability and demand in health care professionals. Baseline parenting stress index scores were related to the parents' frequency of logging on (ρ=.282, P=.03) and page-views (ρ=.304, P=.01). No significant differences in change in parenting stress between experimental and control group were found (F 3,101 =.49, P=.49).
CONCLUSIONS
The trial can be considered feasible, considering the average enrollment refusal rate, baseline attrition rate and postrandomization attrition rate, compared to other eHealth studies, although lower than hypothesized. Implementing Sugarsquare in clinical practice was partly feasible, given moderate demand and acceptability in parent users and lack of potential efficacy. Parents who reported higher levels of parenting stress used Sugarsquare more often than other parents, although Sugarsquare did not reduce parenting stress. These results indicate that Web-based interventions are a suitable way of providing parents of children with T1D with additional support. Future studies should determine how Sugarsquare could reduce parenting stress, for instance by adding targeted interventions. Factors potentially contributing to successful implementation are suggested.
TRIAL REGISTRATION
Nederlands Trial Register Number: NTR3643; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3643 (Archived by WebCite at http://www.webcitation.org/6qihOVCi6).
| 0no significant effect
|
4,689,777 | 26,206,077 |
PURPOSE
We aimed to compare the preventive effect of 5-day administration of aprepitant with single administration of fosaprepitant meglumine against nausea and vomiting symptoms due to highly emetogenic chemotherapy regimens comprising cisplatin (CDDP).
METHODS
Subjects were inpatients who underwent chemotherapy for gastric cancer, esophageal cancer, lung cancer, or head and neck cancer with a regimen comprising 60 mg/m(2) or higher dose of CDDP. In this randomised, open-label, controlled study, the subjects were assigned to a group given aprepitant for 5 days or a group given a single administration of fosaprepitant meglumine. The nausea and vomiting symptoms that emerged within 7 days after the first CDDP administration were investigated with a questionnaire form; the results were compared between the two groups. Risk factors affecting nausea and vomiting symptoms were also investigated.
RESULTS
Of the 101 patients enrolled, 93 patients were included (48 in the 5-day aprepitant group and 45 in the single fosaprepitant meglumine group). No significant intergroup differences in the complete response rate or the complete control rate were found over the entire period. The nausea score tended to increase from day 3 in both groups, but no significant intergroup difference was observed. Furthermore, the investigation of risk factors affecting moderate or severe nausea symptoms indicated that the fosaprepitant meglumine administration was not a risk factor.
CONCLUSIONS
Single administration of fosaprepitant meglumine was not inferior to 5-day administration of aprepitant for preventing acute and delayed nausea and vomiting symptoms occurring after administration of CDDP (60 mg/m(2) or higher).
| 0no significant effect
|
4,994,121 | 27,583,039 |
OBJECTIVE
The aim of our study was to research the effects of levosimendan (LS) and sodium nitroprusside (SNP) combination on systolic and diastolic ventricular function after coronary artery bypass grafting (CABG) who required endoventricular patch repair (EVPR).
PATIENTS AND METHODS
We studied 70 patients with ischemic dilated cardiomyopathy. LS and SNP combination was administered in 35 patients (study group, SG). In the remaining patients, normal saline solution was given (placebo group, PG). Levosimendan (10µgr/kg) started 4 h prior to operation and we stopped LS before the initiation of extracorporeal circulation (ECC). During the rewarming period, we started again levosimendan (10µgr/kg) in combination with SNP (0.1-0.2 µgr/kg/min). If mean blood pressure decreased by more than 25% compared with pre-infusion values, for corrected of mean arterial pressure, the volume loading was performed using a 500 ml ringer lactate. Hemodynamic variables, inotrophyc requirement, and laboratory values were recorded.
RESULTS
Five patients died (7.14%) post-surgery (one from SG and 4 from PG) due to low cardiac out-put syndrome (LOS). At the postoperative period, cardiac output and stroke volume index was higher in SG (mean±sd;29.1±6.3 vs. 18.4±4.9 mL/min(-1)/m(-2) (P<0.0001)). Stroke volume index (SVI) decreased from 29±10mL/m(2) preoperatively to 22±14mL/m(2) in the early postoperative period in group 1. This difference was statistically significant (P=0.002). Cardiac index was higher in SG (320.7±37.5 vs. 283.0±83.9 mL/min(-1)/m-(2) (P=0.009)). The postoperative inotrophyc requirement was less in SG (5.6±2.7 vs. 10.4±2.0 mg/kg, P< 0.008), and postoperative cardiac enzyme levels were less in SG (P< 0.01). Ten patients (28.5%) in SG and 21 patients (60%) in PG required inotrophyc support (P<0.001). We used IABP in eight patients (22.8%) in SG and 17 patients (48.5%) in CG (P=0.0001).
CONCLUSION
This study showed that LS and SNP combination impressive increase in left ventricular systolic and diastolic functions including LVEF. The use of this combination achieved more less inotrophics and IABP requirement. We therefore suggest preoperative and peroperative levosimendan and SNP combination.
| 1significant effect
|
3,611,071 | 23,560,187 |
BACKGROUND
The aim of the study was to evaluate the comparative effects of propofol infusion versus sevoflurane for maintenance of anesthesia with respect to hemodynamics, recovery characteristics, nausea and vomiting in patients undergoing percutaneous nephrolithotomy.
METHODS
Forty American Society of Anesthesiologists physical status I-II patients, aged between 22 and 65 years were randomly divided to receive either intravenous anesthesia with propofol (group P) or sevoflurane (group S). Cardiovascular variables, peripheral oxygen saturation (SpO2), end-tidal carbon dioxide (ETCO2), bispectral index (BIS) and train-of-four (TOF) values were recorded at intervals throughout the procedure. Time to spontaneous respiration, eye opening, extubation, obey commands, hand squeezing, Aldrete Score > 9 and the incidence of postoperative nausea and vomiting were recorded.
RESULTS
Early recovery times [spontaneous respiration (P = 0.002), eye opening (P = 0.006), extubation (P = 0.013), obey commands (P < 0.05), hand squeezing (P = 0.005)] were significantly longer in group P. The incidence of vomiting was significantly higher in group S (P < 0.05). Hemodynamic parameters, levels of SpO2, ETCO2, and BIS and TOF values were not significantly different between the groups (P > 0.05).
CONCLUSIONS
The present study which adjusted sevoflurane concentration and propofol infusion rate according to BIS values revealed that maintenance of anesthesia with sevoflurane is associated with faster recovery than anesthesia with propofol. Propofol resulted in a significantly lower incidence of postoperative nausea and vomiting. Hemodynamic parameters and levels of SpO2 and ETCO2 were comparable between the groups during percutaneous nephrolithotomy.
| 1significant effect
|
5,643,294 | 29,085,218 |
AIM
To prospectively evaluate the effect of local wound infiltration with ropivacaine on postoperative pain relief and stress response reduction after open hepatectomy.
METHODS
A total of 56 patients undergoing open hepatectomy were randomly divided into two groups: a ropivacaine group (wound infiltration with ropivacaine solution) and a control group (infiltration with isotonic saline solution). A visual analog scale (VAS) at rest and on movement was used to measure postoperative pain for the first 48 h after surgery. Mean arterial pressure (MAP), heart rate (HR), time to bowel recovery, length of hospitalization after surgery, cumulative sufentanil consumption, and incidence of nausea and vomiting were compared between the two groups. Surgical stress hormones (epinephrine, norepinephrine, and cortisol) were detected using enzyme-linked immunosorbent assay, and the results were compared.
RESULTS
VAS scores both at rest and on movement at 24 h and 48 h were similar between the two groups. Significantly lower VAS scores were detected at 0, 6, and 12 h in the ropivacaine group compared with the control group ( P < 0.05 for all). MAP was significantly lower at 6, 12, and 24 h ( P < 0.05 for all); HR was significantly lower at 0, 6, 12, and 24 h ( P < 0.05 for all); time to bowel recovery and length of hospitalization after surgery ( P < 0.05 for both) were significantly shortened; and cumulative sufentanil consumption was significantly lower at 6, 12, 24, and 36 h ( P < 0.05 for all) in the ropivacaine group than in the control group, although the incidence of nausea and vomiting showed no significant difference between the two groups. The levels of epinephrine, norepinephrine, and cortisol were significantly lower in the ropivacaine group than in the control group at 24 and 48 h ( P < 0.01 for all).
CONCLUSION
Local wound infiltration with ropivacaine after open hepatectomy can improve postoperative pain relief, reduce surgical stress response, and accelerate postoperative recovery.
| 0no significant effect
|
3,726,903 | 23,919,026 |
BACKGROUND
Ingrown toenails (IT) is a very common problem leading to significant associated morbidity. The articles related to phenolization for matrix removal in teenagers with IT are not enough in the foot surgery literature.
AIMS
To compare the postoperative recovery periods, complication rate, and tolerability of partial matrix excision and segmental phenolization in teenagers with IT.
MATERIALS AND METHODS
Thirty-nine patients (13-17 years) with 48 IT were randomly divided into two groups and were treated with partial matrix excision (Group I) and segmental phenolization (Group II). We assessed the recurrence rates, postoperative complications, duration of analgesic usage, and time to return to daily activities.
RESULTS
There was no significant difference between the demographic and clinical data of the two groups. Three patients in Group I and two patients in Group II experienced moderate pain postoperatively. These patients used analgesics for 3 days. The rates of postoperative complications and recurrences between the two groups showed no statistically significant difference (P = 0.688). The time to return to normal daily activities was significantly shorter in Group II patients than in Group I patients (P < 0.05).
CONCLUSIONS
Partial matrix excision is a very safe model of therapy in the surgical treatment of teenagers with IT. It has low recurrence rate and minimal postoperative morbidity. We concluded that segmental phenolization is also as safe as partial matrix excision in the treatment of IT and patients return to their daily activities in less time with this treatment modality.
| 0no significant effect
|
4,206,289 | 25,338,053 |
OBJECTIVES
To evaluate the effects of a low-sodium and high-potassium salt-substitute on lowering blood pressure (BP) among Tibetans living at high altitude (4300 meters).
METHOD
The study was a patient-blinded randomized controlled trial conducted between February and May 2009 in Dangxiong County, Tibetan Autonomous Region, China. A total of 282 Tibetans aged 40 or older with known hypertension (systolic BP≥140 mmHg) were recruited and randomized to intervention (salt-substitute, 65% sodium chloride, 25% potassium chloride and 10% magnesium sulfate) or control (100% sodium chloride) in a 1: 1 allocation ratio with three months' supply. Primary outcome was defined as the change in BP levels measured from baseline to followed-up with an automated sphygmomanometer. Per protocol (PP) and intention to treat (ITT) analyses were conducted.
RESULTS
After the three months' intervention period, the net reduction in SBP/DBP in the intervention group in comparison to the control group was -8.2/-3.4 mmHg (all p<0.05) in PP analysis, after adjusting for baseline BP and other variables. ITT analysis showed the net reduction in SBP/DBP at -7.6/-3.5 mmHg with multiple imputations (all p<0.05). Furthermore, the whole distribution of blood pressure showed an overall decline in SBP/DBP and the proportion of patients with BP under control (SBP/DBP<140 mmHg) was significantly higher in salt-substitute group in comparison to the regular salt group (19.2% vs. 8.8%, p = 0.027).
CONCLUSION
Low sodium high potassium salt-substitute is effective in lowering both systolic and diastolic blood pressure and offers a simple, low-cost approach for hypertension control among Tibetans in China.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01429246.
| 1significant effect
|
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