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2,944,158 | 20,831,782 | BACKGROUND
Peripheral intravenous device (IVD) complications were traditionally thought to be reduced by limiting dwell time. Current recommendations are to resite IVDs by 96 hours with the exception of children and patients with poor veins. Recent evidence suggests routine resite is unnecessary, at least if devices are inserted by a specialised IV team. The aim of this study was to compare the impact of peripheral IVD 'routine resite' with 'removal on clinical indication' on IVD complications in a general hospital without an IV team.
METHODS
A randomised, controlled trial was conducted in a regional teaching hospital. After ethics approval, 362 patients (603 IVDs) were randomised to have IVDs replaced on clinical indication (185 patients) or routine change every 3 days (177 patients). IVDs were inserted and managed by the general hospital medical and nursing staff; there was no IV team. The primary endpoint was a composite of IVD complications: phlebitis, infiltration, occlusion, accidental removal, local infection, and device-related bloodstream infection.
RESULTS
IVD complication rates were 68 per 1,000 IVD days (clinically indicated) and 66 per 1,000 IVD days (routine replacement) (P = 0.86; HR 1.03; 95% CI, 0.74-1.43). Time to first complication per patient did not differ between groups (KM with log rank, P = 0.53). There were no local infections or IVD-related bloodstream infections in either group. IV therapy duration did not differ between groups (P = 0.22), but more (P = 0.004) IVDs were placed per patient in the routine replacement (mean, 1.8) than the clinical indication group (mean, 1.5), with significantly higher hospital costs per patient (P < 0.001).
CONCLUSIONS
Resite on clinical indication would allow one in two patients to have a single cannula per course of IV treatment, as opposed to one in five patients managed with routine resite; overall complication rates appear similar. Clinically indicated resite would achieve savings in equipment, staff time and patient discomfort. There is growing evidence to support the extended use of peripheral IVDs with removal only on clinical indication.
REGISTRATION NUMBER
Australian New Zealand Clinical Trials Registry (ANZCTR) Number ACTRN12608000421336. | 0no significant effect
|
2,871,176 | 19,317,822 | AIM
To compare the effects of combining liraglutide (0.6, 1.2 or 1.8 mg/day) or rosiglitazone 4 mg/day (all n >or= 228) or placebo (n = 114) with glimepiride (2-4 mg/day) on glycaemic control, body weight and safety in Type 2 diabetes.
METHODS
In total, 1041 adults (mean +/- sd), age 56 +/- 10 years, weight 82 +/- 17 kg and glycated haemoglobin (HbA(1c)) 8.4 +/- 1.0% at 116 sites in 21 countries were stratified based on previous oral glucose-lowering mono : combination therapies (30 : 70%) to participate in a five-arm, 26-week, double-dummy, randomized study.
RESULTS
Liraglutide (1.2 or 1.8 mg) produced greater reductions in HbA(1c) from baseline, (-1.1%, baseline 8.5%) compared with placebo (+0.2%, P < 0.0001, baseline 8.4%) or rosiglitazone (-0.4%, P < 0.0001, baseline 8.4%) when added to glimepiride. Liraglutide 0.6 mg was less effective (-0.6%, baseline 8.4%). Fasting plasma glucose decreased by week 2, with a 1.6 mmol/l decrease from baseline at week 26 with liraglutide 1.2 mg (baseline 9.8 mmol/l) or 1.8 mg (baseline 9.7 mmol/l) compared with a 0.9 mmol/l increase (placebo, P < 0.0001, baseline 9.5 mmol/l) or 1.0 mmol/l decrease (rosiglitazone, P < 0.006, baseline 9.9 mmol/l). Decreases in postprandial plasma glucose from baseline were greater with liraglutide 1.2 or 1.8 mg [-2.5 to -2.7 mmol/l (baseline 12.9 mmol/l for both)] compared with placebo (-0.4 mmol/l, P < 0.0001, baseline 12.7 mmol/l) or rosiglitazone (-1.8 mmol/l, P < 0.05, baseline 13.0 mmol/l). Changes in body weight with liraglutide 1.8 mg (-0.2 kg, baseline 83.0 kg), 1.2 mg (+0.3 kg, baseline 80.0 kg) or placebo (-0.1 kg, baseline 81.9 kg) were less than with rosiglitazone (+2.1 kg, P < 0.0001, baseline 80.6 kg). Main adverse events for all treatments were minor hypoglycaemia (< 10%), nausea (< 11%), vomiting (< 5%) and diarrhoea (< 8%).
CONCLUSIONS
Liraglutide added to glimepiride was well tolerated and provided improved glycaemic control and favourable weight profile. | 1significant effect
|
2,708,184 | 19,523,207 | BACKGROUND
While manually-assisted body-weight supported treadmill training (BWSTT) has revealed improved locomotor function in persons with post-stroke hemiparesis, outcomes are inconsistent and it is very labor intensive. Thus an alternate treatment approach is desirable. Objectives of this pilot study were to: 1) compare the efficacy of body-weight supported treadmill training (BWSTT) combined with the Lokomat robotic gait orthosis versus manually-assisted BWSTT for locomotor training post-stroke, and 2) assess effects of fast versus slow treadmill training speed.
METHODS
Sixteen volunteers with chronic hemiparetic gait (0.62 +/- 0.30 m/s) post-stroke were randomly allocated to Lokomat (n = 8) or manual-BWSTT (n = 8) 3x/wk for 4 weeks. Groups were also stratified by fast (mean 0.92 +/- 0.15 m/s) or slow (0.58 +/- 0.12 m/s) training speeds. The primary outcomes were self-selected overground walking speed and paretic step length ratio. Secondary outcomes included: fast overground walking speed, 6-minute walk test, and a battery of clinical measures.
RESULTS
No significant differences in primary outcomes were revealed between Lokomat and manual groups as a result of training. However, within the Lokomat group, self-selected walk speed, paretic step length ratio, and four of the six secondary measures improved (p = 0.04-0.05, effect sizes = 0.19-0.60). Within the manual group, only balance scores improved (p = 0.02, effect size = 0.57). Group differences between fast and slow training groups were not revealed (p > or = 0.28).
CONCLUSION
Results suggest that Lokomat training may have advantages over manual-BWSTT following a modest intervention dose in chronic hemiparetic persons and further, that our training speeds produce similar gait improvements. Suggestions for a larger randomized controlled trial with optimal study parameters are provided. | 0no significant effect
|
2,864,284 | 20,409,302 | BACKGROUND
Afghanistan's national guidelines recommend chloroquine for the treatment of Plasmodium vivax infection, the parasite responsible for the majority of its malaria burden. Chloroquine resistance in P. vivax is emerging in Asia. Therapeutic responses across Afghanistan have not been evaluated in detail.
METHODS
Between July 2007 and February 2009, an open-label, randomized controlled trial of chloroquine and dihydroartemisinin-piperaquine in patients aged three months and over with slide-confirmed P. vivax mono-infections was conducted. Consistent with current national guidelines, primaquine was not administered. Subjects were followed up daily during the acute phase of illness (days 0-3) and weekly until day 56. The primary endpoint was the overall cumulative parasitological failure rate at day 56 after the start of treatment, with the hypothesis being that dihydroartemisinin-piperaquine was non-inferior compared to chloroquine (Delta = 5% difference in proportion of failures).
RESULTS
Of 2,182 individuals with positive blood films for P. vivax, 536 were enrolled in the trial. The day 28 cure rate was 100% in both treatment groups. Parasite clearance was more rapid with dihydroartemisinin-piperaquine than chloroquine. At day 56, there were more recurrent infections in the chloroquine arm (8.9%, 95% CI 6.0-13.1%) than the dihydroartemisinin-piperaquine arm (2.8%, 95% CI 1.4-5.8%), a difference in cumulative recurrence rate of 6.1% (2-sided 90%CI +2.6 to +9.7%). The log-rank test comparing the survival curves confirmed the superiority of dihydroartemisinin-piperaquine over chloroquine (p = 0.003). Multivariate analysis showed that a lower initial haemoglobin concentration was also independently associated with recurrence. Both regimens were well tolerated and no serious adverse events were reported.
CONCLUSIONS
Chloroquine remains an efficacious treatment for the treatment of vivax malaria in Afghanistan. In a setting where radical therapy cannot be administered, dihydroartemisinin-piperaquine provides additional benefit in terms of post-treatment prophylaxis, reducing the incidence of recurrence from 4-8 weeks after treatment. | 1significant effect
|
3,187,863 | 21,749,629 | OBJECTIVE
To investigate possible differences in operative delivery rate among low-risk women, randomised to an alongside midwifery-led unit or to standard obstetric units within the same hospital.
DESIGN
Randomised controlled trial.
SETTING
Department of Obstetrics and Gynaecology, Østfold Hospital Trust, Tromsø, Norway.
POPULATION
A total of 1111 women assessed to be at low risk at onset of spontaneous labour.
METHODS
Randomisation into one of three birth units: the special unit; the normal unit; or the midwife-led unit.
MAIN OUTCOME MEASURES
Total operative delivery rate, augmentation, pain relief, postpartum haemorrhage, sphincter injuries and intrapartum transfer, Apgar score <7 at 5 minutes, metabolic acidosis and transfer to neonatal intensive care unit.
RESULTS
There were no significant differences in total operative deliveries between the three units: 16.3% in the midwife-led unit; 18.0% in the normal unit; and 18.8% in the special unit. There were no significant differences in postpartum haemorrhage, sphincter injuries or in neonatal outcomes. There were statistically significant differences in augmentation (midwife-led unit versus normal unit RR 0.73, 95% CI 0.59-0.89; midwife-led unit versus special unit RR 0.69, 95% CI 0.56-0.86), in epidural analgesia (midwife-led unit versus normal unit RR 0.68, 95% CI 0.52-0.90; midwife-led unit versus special unit RR 0.64, 95% CI 0.47-0.86) and in acupuncture (midwife-led unit versus normal unit RR 1.45, 95% CI 1.25-1.69; midwife-led unit versus special unit RR 1.45, 95% CI 1.22-1.73).
CONCLUSIONS
The level of birth care does not significantly affect the rate of operative deliveries in low-risk women without any expressed preference for level of birth care. | 0no significant effect
|
2,688,140 | 19,239,703 | INTRODUCTION
In acute respiratory distress syndrome (ARDS), adequate positive end-expiratory pressure (PEEP) may decrease ventilator-induced lung injury by minimising overinflation and cyclic recruitment-derecruitment of the lung. We evaluated whether setting the PEEP using decremental PEEP titration after an alveolar recruitment manoeuvre (ARM) affects the clinical outcome in patients with ARDS.
METHODS
Fifty-seven patients with early ARDS were randomly assigned to a group given decremental PEEP titration following ARM or a table-based PEEP (control) group. PEEP and inspired fraction of oxygen (FiO2) in the control group were set according to the table-based combinations of FiO2 and PEEP of the ARDS network, by which we aimed to achieve a PEEP level compatible with an oxygenation target. In the decremental PEEP titration group, the oxygen saturation and static compliance were monitored as the patients performed the ARM along with the extended sigh method, which is designed to gradually apply and withdraw a high distending pressure over a prolonged period, and the decremental titration of PEEP.
RESULTS
The baseline characteristics did not differ significantly between the control and decremental PEEP titration groups. Initial oxygenation improved more in the decremental PEEP titration group than in the control group. However, dynamic compliance, tidal volume and PEEP were similar in the two groups during the first week. The duration of use of paralysing or sedative agents, mechanical ventilation, stay in the intensive care unit and mortality at 28 days did not differ significantly between the decremental PEEP titration and control groups.
CONCLUSIONS
The daily decremental PEEP titration after ARM showed only initial oxygenation improvement compared with the table-based PEEP method. Respiratory mechanics and patient outcomes did not differ between the decremental PEEP titration and control groups.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: ISRCTN79027921. | 0no significant effect
|
2,517,154 | 18,556,683 | BACKGROUND
Endometriosis is associated with an inflammatory response. Hence infliximab, an anti-TNF-alpha monoclonal antibody, might relieve pain.
METHODS
A randomized placebo-controlled trial was designed with 21 women with severe pain and a rectovaginal nodule of at least 1 cm. After 1 month of observation, three infusions of infliximab (5 mg/kg) or placebo were given. Surgery was performed 3 months later and follow-up continued for 6 months. The primary end-point was pain (dysmenorrhea, deep dyspareunia and non-menstrual pain) rated at each visit by the clinician and on a daily basis by the patient who in addition scored pain by visual analog pain scale and analgesia intake. Secondary end-points included the volume of the endometriotic nodule, pelvic tenderness and the visual appearance of endometriotic lesions at laparoscopy.
RESULTS
Pain severity decreased during the treatment by 30% in both the placebo (P < 0.001) and infliximab groups (P < 0.001). However, no effect of infliximab was observed for any of the outcome measures. After surgery, pain scores decreased in both groups to less than 20% of the initial value.
CONCLUSIONS
Infliximab appears not to affect pain associated with deep endometriosis. Treatment is associated with an important placebo effect. After surgery, pain decreases to less than 20%. Trials registration number ClinicalTrials.gov: NCT00604864. | 0no significant effect
|
2,691,927 | 19,430,829 | BACKGROUND
Laparoscopic surgery has become popular during the last decade, mainly because it is associated with fewer postoperative complications than the conventional open approach. It remains unclear, however, if this benefit is observed after laparoscopic correction of perforated peptic ulcer (PPU). The goal of the present study was to evaluate whether laparoscopic closure of a PPU is as safe as conventional open correction.
METHODS
The study was based on a randomized controlled trial in which nine medical centers from the Netherlands participated. A total of 109 patients with symptoms of PPU and evidence of air under the diaphragm were scheduled to receive a PPU repair. After exclusion of 8 patients during the operation, outcomes were analyzed for laparotomy (n = 49) and for the laparoscopic procedure (n = 52).
RESULTS
Operating time in the laparoscopy group was significantly longer than in the open group (75 min versus 50 min). Differences regarding postoperative dosage of opiates and the visual analog scale (VAS) for pain scoring system were in favor of the laparoscopic procedure. The VAS score on postoperative days 1, 3, and 7 was significant lower (P < 0.05) in the laparoscopic group. Complications were equally distributed. Hospital stay was also comparable: 6.5 days in the laparoscopic group versus 8.0 days in the open group (P = 0.235).
CONCLUSIONS
Laparoscopic repair of PPU is a safe procedure compared with open repair. The results considering postoperative pain favor the laparoscopic procedure. | 1significant effect
|
1,468,428 | 16,545,140 | BACKGROUND
Enemas are used during labour in obstetric settings with the belief that they reduce puerperal and neonatal infections, shorten labour duration, and make delivery cleaner for attending personnel. However, a systematic review of the literature found insufficient evidence to support the use of enemas. The objective of this RCT was to address an identified knowledge gap by determining the effect of routine enemas used during the first stage of labour on puerperal and neonatal infection rates.
METHODS
DESIGN
RCT (randomised controlled trial; randomized clinical trial).
OUTCOMES
Clinical diagnosis of maternal or neonatal infections, labour duration, delivery types, episiotomy rates, and prescription of antibiotics.
SETTING
Tertiary care referral hospital at the Javeriana University (Bogotá, Colombia) that attended 3170 births during study period with a caesarean section rate of 26%.
PARTICIPANTS
443 women admitted for delivery to the obstetrics service (February 1997 to February 1998) and followed for a month after delivery. Inclusion criteria were women with: low risk pregnancy and expected to remain in Bogotá during follow up; gestational age > or = 36 weeks; no pelvic or systemic bacterial infection; intact membranes; cervix dilatation < or = 7 cm.
INTERVENTION
1 litre saline enema, versus no enema, allocated following a block random allocation sequence and using sealed opaque envelopes.
RESULTS
Allocation provided balanced groups and 86% of the participants were followed up for one month. The overall infection rate for newborns was 21%, and 18% for women. We found no significant differences in puerperal or neonatal infection rates (Puerperal infection: 41/190 [22%] with enema v 26/182 [14%] without enema; RR 0.66 CI 95%: 0.43 to 1.03; neonatal infection 38/191 [20%] with enema v 40/179 [22%] without enema; RR 1.12, 95% CI 95% 0.76 to 1.66), and median labour time was similar between groups (515 min. with enema v 585 min. without enema; P = 0.24). Enemas didn't significantly change episiorraphy dehiscence rates (21/182 [12%] with enema v 32/190 [17%] without enema; P = 0.30).
CONCLUSION
This RCT found no evidence to support routine use of enemas during labour. Although these results cannot rule out a small clinical effect, it seems unlikely that enemas will improve maternal and neonatal outcomes and provide an overall benefit. | 0no significant effect
|
2,690,844 | 19,259,615 | OBJECTIVES
To determine whether a transverse incision is an alternative to a midline incision in terms of incisional hernia incidence, surgical site infection, postoperative pain, hospital stay and cosmetics in cholecystectomy. Incisional hernias after midline incision are commonly underestimated but probably complicate between 2 and 20% of all abdominal wall closures. The midline incision is the preferred incision for surgery of the upper abdomen despite evidence that alternatives, such as the lateral paramedian and transverse incision, exist and might reduce the rate of incisional hernia. A RCT was preformed in the pre-laparoscopic cholecystectomy era the data of which were never published.
METHODS
One hundred and fifty female patients were randomly allocated to cholecystectomy through midline or transverse incision. Early complications, the duration to discharge and the in-hospital use of analgesics was noted. Patients returned to the surgical outpatient clinic for evaluation of the cosmetic results of the scar and to evaluate possible complications such as fistula, wound dehiscence and incisional hernia after a minimum of 12 months follow-up.
RESULTS
Two percent (1/60) of patients that had undergone the procedure through a transverse incision presented with an incisional hernia as opposed to 14% (9/63) of patients from the midline incision group (P = 0.017). Transverse incisions were found to be significantly shorter than midline incisions and associated with more pleasing appearance. More patients having undergone a midline incision, reported pain on day one, two and three postoperatively than patients from the transverse group. The use of analgesics did not differ between the two groups.
CONCLUSIONS
In light of our results a transverse incision should, if possible, be considered as the preferred incision in acute and elective surgery of the upper abdomen when laparoscopic surgery is not an option. | 1significant effect
|
3,090,298 | 21,573,091 | PURPOSE
To compare differences in visual acuity, contrast sensitivity, complications, and higher-order ocular aberrations (HOAs) in eyes with stable myopia undergoing either photo-refractive keratectomy (PRK) or thin-flap laser in situ keratomileusis (LASIK) (intended flap thickness of 90 μm) using the VISX Star S4 CustomVue excimer laser and the IntraLase FS60 femtosecond laser at 1, 3, and 6 months postoperatively.
METHODS
In this prospective, masked, and randomized pilot study, refractive surgery was performed contralaterally on 52 eyes: 26 with PRK and 26 with thin-flap LASIK. Primary outcome measures were uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), contrast sensitivity, and complications.
RESULTS
At 6 months, mean values for UDVA (logMAR) were -0.043 ± 0.668 and -0.061 ± 0.099 in the PRK and thin-flap LASIK groups, respectively (n = 25, P = 0.466). UDVA of 20/20 or better was achieved in 96% of eyes undergoing PRK and 92% of eyes undergoing thin-flap LASIK, whereas 20/15 vision or better was achieved in 73% of eyes undergoing PRK and 72% of eyes undergoing thin-flap LASIK (P > 0.600). Significant differences were not found between treatment groups in contrast sensitivity (P ≥ 0.156) or CDVA (P = 0.800) at postoperative 6 months. Types of complications differed between groups, notably 35% of eyes in the thin-flap LASIK group experiencing complications, including microstriae and 2 flap tears.
CONCLUSION
Under well-controlled surgical conditions, PRK and thin-flap LASIK refractive surgeries achieve similar results in visual acuity, contrast sensitivity, and induction of HOAs, with differences in experienced complications. | 0no significant effect
|
3,387,601 | 21,745,374 | INTRODUCTION
Respiratory failure is a life threatening complication of Guillain Barré syndrome (GBS). There is no consensus on the specific treatment for this subset of children with GBS.
METHODS
This was a prospective randomized study to compare the outcome of intravenous immunoglobulin (IVIG) and plasma exchange (PE) treatment in children with GBS requiring mechanical ventilation. Forty-one children with GBS requiring endotracheal mechanical ventilation (MV) within 14 days from disease onset were included. The ages of the children ranged from 49 to 143 months.Randomly, 20 children received a five-day course of IVIG (0.4 g/kg/day) and 21 children received a five-day course of one volume PE daily. Lumbar puncture (LP) was performed in 36 patients (18 in each group).
RESULTS
Both groups had comparable age (p = 0.764), weight (p = 0.764), duration of illness prior to MV (p = 0.854), preceding diarrhea (p = 0.751), cranial nerve involvement (p = 0.756), muscle power using Medical Research Council (MRC) sum score (p = 0.266) and cerebrospinal fluid (CSF) protein (p = 0.606).Children in the PE group had a shorter period of MV (median 11 days, IQR 11.0 to 13.0) compared to IVIG group (median 13 days, IQR 11.3 to 14.5) with p = 0.037.Those in the PE group had a tendency for a shorter Pediatric Intensive Care Unit (PICU) stay (p = 0.094).A total of 20/21 (95.2%) and 18/20 (90%) children in the PE and IVIG groups respectively could walk unaided within four weeks after PICU discharge (p = 0.606).There was a negative correlation between CSF protein and duration of mechanical ventilation in the PE group (p = 0.037), but not in the IVIG group (p = 0.132).
CONCLUSIONS
In children with GBS requiring MV, PE is superior to IVIG regarding the duration of MV but not PICU stay or the short term neurological outcome.The negative correlation between CSF protein values and duration of MV in PE group requires further evaluation of its clinical usefulness.
TRIAL REGISTRATION
Clinicaltrials.gov Identifier NCT01306578. | 1significant effect
|
2,447,617 | 18,447,940 | BACKGROUND
Severe traumatic brain injury (TBI) has been increasing with greater incidence of injuries from traffic or sporting accidents. Although there are a number of animal models of TBI using progesterone for head injury, the effects of progesterone on neurologic outcome of acute TBI patients remain unclear. The aim of the present clinical study was to assess the longer-term efficacy of progesterone on the improvement in neurologic outcome of patients with acute severe TBI.
METHODS
A total of 159 patients who arrived within 8 hours of injury with a Glasgow Coma Score </= 8 were enrolled in the study. A prospective, randomized, placebo-controlled trial of progesterone was conducted in the Neurotrauma Center of our teaching hospital. The patients were randomized to receive either progesterone or placebo. The primary endpoint was the Glasgow Outcome Scale score 3 months after brain injury. Secondary efficacy endpoints included the modified Functional Independence Measure score and mortality. In a follow-up protocol at 6 months, the Glasgow Outcome Scale and the modified Functional Independence Measure scores were again determined.
RESULTS
Of the 159 patients randomized, 82 received progesterone and 77 received placebo. The demographic characteristics, the mechanism of injury, and the time of treatment were compared for the two groups. After 3 months and 6 months of treatment, the dichotomized Glasgow Outcome Scale score analysis exhibited more favorable outcomes among the patients who were given progesterone compared with the control individuals (P = 0.034 and P = 0.048, respectively). The modified Functional Independence Measure scores in the progesterone group were higher than those in the placebo group at both 3-month and 6-month follow-up (P < 0.05 and P < 0.01). The mortality rate of the progesterone group was significantly lower than that of the placebo group at 6-month follow-up (P < 0.05). The mean intracranial pressure values 72 hours and 7 days after injury were lower in the progesterone group than in the placebo group, but there was no statistical significance between the two groups (P > 0.05). Instances of complications and adverse events associated with the administration of progesterone were not found.
CONCLUSION
Our data suggest that acute severe TBI patients with administration of progesterone hold improved neurologic outcomes for up to 6 months. These results provide information important for further large and multicenter clinical trials on progesterone as a promising neuroprotective drug.
TRIAL REGISTRATION
ACTRN12607000545460. | 1significant effect
|
1,187,893 | 15,924,620 | BACKGROUND
Studies on exercise in knee osteoarthritis (OA) have focused on elderly subjects. Subjects in this study were middle-aged with symptomatic and definite radiographic knee osteoarthritis. The aim was to test the effects of a short-term, high-intensity exercise program on self-reported pain, function and quality of life.
METHODS
Patients aged 36-65, with OA grade III (Kellgren & Lawrence) were recruited. They had been referred for radiographic examination due to knee pain and had no history of major knee injury. They were randomized to a twice weekly supervised one hour exercise intervention for six weeks, or to a non-intervention control group. Exercise was performed at > or = 60% of maximum heart rate (HR max). The primary outcome measure was the Knee injury and Osteoarthritis Outcome Score (KOOS). Follow-up occurred at 6 weeks and 6 months.
RESULTS
Sixty-one subjects (mean age 56 (SD 6), 51 % women, mean BMI 29.5 (SD 4.8)) were randomly assigned to intervention (n = 30) or control group (n = 31). No significant differences in the KOOS subscales assessing pain, other symptoms, or function in daily life or in sport and recreation were seen at any time point between exercisers and controls. In the exercise group, an improvement was seen at 6 weeks in the KOOS subscale quality of life compared to the control group (mean change 4.0 vs. -0.7, p = 0.05). The difference between groups was still persistent at 6 months (p = 0.02).
CONCLUSION
A six-week high-intensive exercise program had no effect on pain or function in middle-aged patients with moderate to severe radiographic knee OA. Some effect was seen on quality of life in the exercise group compared to the control group. | 1significant effect
|
1,831,737 | 17,388,666 | BACKGROUND
HIV-1 control in sub-Saharan Africa requires cost-effective and sustainable programmes that promote behaviour change and reduce cofactor sexually transmitted infections (STIs) at the population and individual levels.
METHODS AND FINDINGS
We measured the feasibility of community-based peer education, free condom distribution, income-generating projects, and clinic-based STI treatment and counselling services and evaluated their impact on the incidence of HIV-1 measured over a 3-y period in a cluster-randomised controlled trial in eastern Zimbabwe. Analysis of primary outcomes was on an intention-to-treat basis. The income-generating projects proved impossible to implement in the prevailing economic climate. Despite greater programme activity and knowledge in the intervention communities, the incidence rate ratio of HIV-1 was 1.27 (95% confidence interval [CI] 0.92-1.75) compared to the control communities. No evidence was found for reduced incidence of self-reported STI symptoms or high-risk sexual behaviour in the intervention communities. Males who attended programme meetings had lower HIV-1 incidence (incidence rate ratio 0.48, 95% CI 0.24-0.98), and fewer men who attended programme meetings reported unprotected sex with casual partners (odds ratio 0.45, 95% CI 0.28-0.75). More male STI patients in the intervention communities reported cessation of symptoms (odds ratio 2.49, 95% CI 1.21-5.12).
CONCLUSIONS
Integrated peer education, condom distribution, and syndromic STI management did not reduce population-level HIV-1 incidence in a declining epidemic, despite reducing HIV-1 incidence in the immediate male target group. Our results highlight the need to assess the community-level impact of interventions that are effective amongst targeted population sub-groups. | 0no significant effect
|
1,876,597 | 17,525,792 | OBJECTIVES
To compare the efficacy and safety of artemether-lumefantrine (AL) and dihydroartemisinin-piperaquine (DP) for treating uncomplicated falciparum malaria in Uganda.
DESIGN
Randomized single-blinded clinical trial.
SETTING
Apac, Uganda, an area of very high malaria transmission intensity.
PARTICIPANTS
Children aged 6 mo to 10 y with uncomplicated falciparum malaria.
INTERVENTION
Treatment of malaria with AL or DP, each following standard 3-d dosing regimens.
OUTCOME MEASURES
Risks of recurrent parasitemia at 28 and 42 d, unadjusted and adjusted by genotyping to distinguish recrudescences and new infections.
RESULTS
Of 421 enrolled participants, 417 (99%) completed follow-up. The unadjusted risk of recurrent falciparum parasitemia was significantly lower for participants treated with DP than for those treated with AL after 28 d (11% versus 29%; risk difference [RD] 18%, 95% confidence interval [CI] 11%-26%) and 42 d (43% versus 53%; RD 9.6%, 95% CI 0%-19%) of follow-up. Similarly, the risk of recurrent parasitemia due to possible recrudescence (adjusted by genotyping) was significantly lower for participants treated with DP than for those treated with AL after 28 d (1.9% versus 8.9%; RD 7.0%, 95% CI 2.5%-12%) and 42 d (6.9% versus 16%; RD 9.5%, 95% CI 2.8%-16%). Patients treated with DP had a lower risk of recurrent parasitemia due to non-falciparum species, development of gametocytemia, and higher mean increase in hemoglobin compared to patients treated with AL. Both drugs were well tolerated; serious adverse events were uncommon and unrelated to study drugs.
CONCLUSION
DP was superior to AL for reducing the risk of recurrent parasitemia and gametocytemia, and provided improved hemoglobin recovery. DP thus appears to be a good alternative to AL as first-line treatment of uncomplicated malaria in Uganda. To maximize the benefit of artemisinin-based combination therapy in Africa, treatment should be integrated with aggressive strategies to reduce malaria transmission intensity. | 1significant effect
|
3,446,002 | 23,056,681 | OBJECTIVE
This study was designed to determine the effect of clofibrate on neonatal uncomplicated jaundice treated with home phototherapy.
METHODS
This clinical trial study was performed on 60 newborns with jaundice that received home phototherapy. Inclusion criteria were body weight between 2500 to 4000 gr, breastfed, total serum bilirubin (TSB) between 14 to 20 mg/dl, aged over 72 hours. The neonates were randomly divided into two groups. All received home phototherapy. Group I received a single dose of 50 mg/kg clofibrate and the other group served as control group. Total serum bilirubin level was measured every 24 hours.
FINDINGS
Two groups were matched regarding weight, sex, age and first TSB. At 24 and 48 hours of treatment, the mean values of TSB in the clofibrate group were 13.72 (1.56), 9.5 (0.56) and in the control group 15.30 (1.44), 12.6 (1.44). The results show that TSB was significantly decreased after 24 and 48 hours in clofibrate group (P<0.001). The mean duration of phototherapy in group I was 72(0.0) hours and in the control group 76.80 (±9.76) hours. The duration of phototherapy was significantly shorter in clofibrate group (P<0.001).
CONCLUSION
Clofibrate is effective for outpatients with neonatal hyperbilirubinemia who are under home phototherapy. Of course, further studies are needed for approved routine use of this drug in the treatment of neonatal jaundice. | 1significant effect
|
1,913,177 | 17,372,669 | BACKGROUND
Reconstruction of giant midline abdominal wall hernias is difficult, and no data are available to decide which technique should be used. It was the aim of this study to compare the "components separation technique" (CST) versus prosthetic repair with e-PTFE patch (PR).
METHOD
Patients with giant midline abdominal wall hernias were randomized for CST or PR. Patients underwent operation following standard procedures. Postoperative morbidity was scored on a standard form, and patients were followed for 36 months after operation for recurrent hernia.
RESULTS
Between November 1999 and June 2001, 39 patients were randomized for the study, 19 for CST and 18 for PR. Two patients were excluded perioperatively because of gross contamination of the operative field. No differences were found between the groups at baseline with respect to demographic details, co-morbidity, and size of the defect. There was no in-hospital mortality. Wound complications were found in 10 of 19 patients after CST and 13 of 18 patients after PR. Seroma was found more frequently after PR. In 7 of 18 patients after PR, the prosthesis had to be removed as a consequence of early or late infection. Reherniation occurred in 10 patients after CST and in 4 patients after PR.
CONCLUSIONS
Repair of abdominal wall hernias with the component separation technique compares favorably with prosthetic repair. Although the reherniation rate after CST is relatively high, the consequences of wound healing disturbances in the presence of e-PTFE patch are far-reaching, often resulting in loss of the prosthesis. | 0no significant effect
|
2,720,945 | 19,624,838 | BACKGROUND
The clinical effects of mucolytics in patients with chronic obstructive pulmonary disease (COPD) are discussed controversially. Cineole is the main constituent of eucalyptus oil and mainly used in inflammatory airway diseases as a mucolytic agent. We hypothesised that its known mucolytic, bronchodilating and anti-inflammatory effects as concomitant therapy would reduce the exacerbation rate and show benefits on pulmonary function tests as well as quality of life in patients with COPD.
METHODS
In this double-blind, placebo-controlled multi-center-study we randomly assigned 242 patients with stable COPD to receive 200 mg of cineole or placebo 3 times daily as concomitant therapy for 6 months during winter-time. The frequency, duration and severity of exacerbations were combined as primary outcome measures for testing as multiple criteria. Secondary outcome measures included changes of lung function, respiratory symptoms and quality of life as well as the single parameters of the exacerbations.
RESULTS
Baseline demographics, lung function and standard medication of both groups were comparable. During the treatment period of 6 months the multiple criteria frequency, severity and duration of exacerbations were significantly lower in the group treated with cineole in comparison to placebo. Secondary outcome measures validated these findings. Improvement of lung function, dyspnea and quality of life as multiple criteria were statistically significant relative to placebo. Adverse events were comparable in both groups.
CONCLUSION
Concomitant therapy with cineole reduces exacerbations as well as dyspnea and improves lung function and health status. This study further suggests cineole as an active controller of airway inflammation in COPD by intervening in the pathophysiology of airway inflammation of the mucus membrane.
TRIAL REGISTRATION
ISRCTN07600011. | 1significant effect
|
2,922,723 | 19,703,826 | BACKGROUND
High frequency chest wall oscillation (HFCWO) is standard treatment for airway clearance in the USA and has recently been introduced in the UK and Europe. There is little published research comparing HFCWO with airway clearance techniques (ACTs) frequently used in the UK and Europe. The aim of this study was to compare the short-term effects of HFCWO with usual ACTs in patients with cystic fibrosis hospitalised with an infective pulmonary exacerbation.
METHODS
A 4-day randomised crossover design was used. Patients received either HFCWO on days 1 and 3 and usual ACTs on days 2 and 4 or vice versa. Wet weight of sputum, spirometry and oxygen saturation were measured. Perceived efficacy, comfort, incidence of urinary leakage and preference were assessed. Data were analysed by mixed model analysis.
RESULTS
29 patients (72% male) of mean (SD) age 29.4 (8.4) years and mean (SD) forced expiratory volume in 1 s (FEV(1)) percentage predicted (FEV(1)%) 38 (16.7) completed the study. Significantly more sputum was expectorated during a single treatment session and over a 24 h period (mean difference 4.4 g and 6.9 g, respectively) with usual ACTs than with HFCWO (p<0.001). No statistically significant change in FEV(1)% or oxygen saturation was observed after either HFCWO or usual ACTs compared with baseline. 17 patients (55%) expressed a preference for their usual ACT.
CONCLUSIONS
During both a finite treatment period and over 24 h, less sputum was cleared using HFCWO than usual ACT. HFCWO does not appear to cause any adverse physiological effects and may influence adherence. | 1significant effect
|
2,575,601 | 18,759,980 | INTRODUCTION
Experimental research has demonstrated that the level of neuroprotection conferred by the various barbiturates is not equal. Until now no controlled studies have been conducted to compare their effectiveness, even though the Brain Trauma Foundation Guidelines recommend that such studies be undertaken. The objectives of the present study were to assess the effectiveness of pentobarbital and thiopental in terms of controlling refractory intracranial hypertension in patients with severe traumatic brain injury, and to evaluate the adverse effects of treatment.
METHODS
This was a prospective, randomized, cohort study comparing two treatments: pentobarbital and thiopental. Patients who had suffered a severe traumatic brain injury (Glasgow Coma Scale score after resuscitation < or = 8 points or neurological deterioration during the first week after trauma) and with refractory intracranial hypertension (intracranial pressure > 20 mmHg) first-tier measures, in accordance with the Brain Trauma Foundation Guidelines.
RESULTS
A total of 44 patients (22 in each group) were included over a 5-year period. There were no statistically significant differences in ' baseline characteristics, except for admission computed cranial tomography characteristics, using the Traumatic Coma Data Bank classification. Uncontrollable intracranial pressure occurred in 11 patients (50%) in the thiopental treatment group and in 18 patients (82%) in the pentobarbital group (P = 0.03). Under logistic regression analysis--undertaken in an effort to adjust for the cranial tomography characteristics, which were unfavourable for pentobarbital--thiopental was more effective than pentobarbital in terms of controlling intracranial pressure (odds ratio = 5.1, 95% confidence interval 1.2 to 21.9; P = 0.027). There were no significant differences between the two groups with respect to the incidence of arterial hypotension or infection.
CONCLUSIONS
Thiopental appeared to be more effective than pentobarbital in controlling intracranial hypertension refractory to first-tier measures. These findings should be interpreted with caution because of the imbalance in cranial tomography characteristics and the different dosages employed in the two arms of the study. The incidence of adverse effects was similar in both groups.
TRIAL REGISTRATION
(Trial registration: US Clinical Trials registry NCT00622570.). | 1significant effect
|
2,430,614 | 18,575,626 | BACKGROUND
Artesunate+amodiaquine (AS+AQ) and artemether-lumefantrine (AL) are now the most frequently recommended first line treatments for uncomplicated malaria in Africa. Artesunate+chlorproguanil-dapsone (AS+CD) was a potential alternative for treatment of uncomplicated malaria. A comparison of the efficacy and safety of these three drug combinations was necessary to make evidence based drug treatment policies.
METHODS
Five hundred and thirty-four, glucose-6-phosphate dehydrogenase (G6PD) normal children were randomised in blocks of 15 to the AS+AQ, AL or AS+CD groups. Administration of study drugs was supervised by project staff and the children were followed up at r home on days 1,2,3,7,14 and 28 post treatment. Parasitological and clinical failures and adverse events were compared between the study groups.
MAIN FINDINGS
In a per-protocol analysis, the parasitological and clinical failure rate at day 28 post treatment (PCF28) was lower in the AS+AQ group compared to the AL or AS+CD groups (corrected for re-infections: 6.6% vs 13.8% and 13.8% respectively, p = 0.08; uncorrected: 14.6% vs 27.6% and 28.1% respectively, p = 0.005). In the intention to treat analysis, the rate of early treatment failure was high in all three groups (AS+AQ 13.3%; AL 15.2%; and AS+CD 9.3%, p = 0.2) primarily due to vomiting. However, the PCF28 corrected for re-infection was lower, though not significantly, in the AS+AQ group compared to the AL or the AS+CD groups (AS+AQ 18.3%; AL 24.2%; AS+CD 20.8%, p = 0.4) The incidence of adverse events was comparable between the groups.
CONCLUSIONS
AS+AQ is an appropriate first line treatment for uncomplicated malaria in Ghana and possibly in the neighbouring countries in West Africa. The effectiveness of AL in routine programme conditions needs to be studied further in West Africa.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00119145. | 0no significant effect
|
4,139,977 | 25,161,987 | BACKGROUND
Evidence has shown beneficial effects of probiotics in the treatment of irritable bowel syndrome (IBS); however, there is still a lack of data in this regard. We evaluated the efficacy of a multi-strain probiotic compound on IBS symptoms and quality-of-life (QOL).
MATERIALS AND METHODS
Adult IBS patients (n = 132) were randomized to receive a probiotic compound containing seven bacteria species including Lactobacillus strains, Bifidobacterium strains and Streptococcus thermophiles or similar placebo, twice daily after a meal for 14 consecutive days. Improvement of IBS symptoms was assessed in categories of abdominal pain and distension and improvement of bowel habit. Improvement in patients QOL was assessed by the IBS-QOL instrument. Patients were evaluated for symptoms and QOL at baseline and then 1 month after completion of the treatment.
RESULTS
After treatment, there was a decrease in abdominal pain and distension severity in both probiotic and the placebo groups (P<0.001), but there was no difference between the two groups in this regard (P>0.05). Improvement in bowel habit was observed in 33.3% of the probiotic and 36.5% of the placebo group (P = 0.910). There was no significant difference between the two groups in QOL after the treatment (P >0.05).
CONCLUSIONS
We found no beneficial effects over placebo for a 2-week treatment with the above mentioned multi-strain probiotic compound in the treatment of IBS. Further, trials are yet required before a clear conclusion in this regards. | 0no significant effect
|
4,819,709 | 26,805,720 | BACKGROUND
The aim of this study was to assess behavioural recovery from the patient's perspective as a prespecified secondary outcome in a multicentre parallel-group randomized clinical trial comparing ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA) and surgery for the treatment of primary varicose veins.
METHODS
Participants were recruited from 11 UK sites as part of the CLASS trial, a randomized trial of UGFS, EVLA or surgery for varicose veins. Patients were followed up 6 weeks after treatment and asked to complete the Behavioural Recovery After treatment for Varicose Veins (BRAVVO) questionnaire. This is a 15-item instrument that covers eight activity behaviours (tasks or actions an individual is capable of doing in an idealized situation) and seven participation behaviours (what the individual does in an everyday, real-world situation) that were identified to be important from the patient's perspective.
RESULTS
A total of 798 participants were recruited. Both UGFS and EVLA resulted in a significantly quicker recovery compared with surgery for 13 of the 15 behaviours assessed. UGFS was superior to EVLA in terms of return to full-time work (hazard ratio 1·43, 95 per cent c.i. 1·11 to 1·85), looking after children (1·45, 1·04 to 2·02) and walks of short (1·48, 1·19 to 1·84) and longer (1·32, 1·05 to 1·66) duration.
CONCLUSION
Both UGFS and EVLA resulted in more rapid recovery than surgery, and UGFS was superior to EVLA for one-quarter of the behaviours assessed. The BRAVVO questionnaire has the potential to provide important meaningful information to patients about their early recovery and what they may expect to be able to achieve after treatment. | 0no significant effect
|
2,888,205 | 20,353,551 | INTRODUCTION
Although exercise is therapeutic for adults with fibromyalgia (FM), its symptoms often create obstacles that discourage exercise. We evaluated the effects of accumulating at least 30 minutes of self-selected lifestyle physical activity (LPA) on perceived physical function, pain, fatigue, body mass index, depression, tenderness, and the six-minute walk test in adults with FM.
METHODS
Eighty-four minimally active adults with FM were randomized to either LPA or a FM education control (FME) group. LPA participants worked toward accumulating 30 minutes of self-selected moderate-intensity LPA, five to seven days per week, while the FME participants received information and support.
RESULTS
Seventy-three of the 84 participants (87%) completed the 12-week trial. The LPA group increased their average daily steps by 54%. Compared to FME, the LPA group reported significantly less perceived functional deficits (P = .032) and less pain (P = .006). There were no differences between the groups on the six-minute walk test (P = .067), fatigue, depression, body mass index, or tenderness.
CONCLUSIONS
Accumulating 30 minutes of LPA throughout the day produces clinically relevant changes in perceived physical function and pain in previously minimally active adults with FM.
TRIAL REGISTRATION
clinicaltrials.gov NCT00383084. | 0no significant effect
|
3,198,285 | 21,900,148 | OBJECTIVE
The prevalence of gestational diabetes mellitus (GDM) is rising. There is little evidence to demonstrate the effectiveness of one dietary therapy over another. We aimed to investigate the effect of a low-glycemic index (LGI) versus a conventional high-fiber diet on pregnancy outcomes, neonatal anthropometry, and maternal metabolic profile in GDM.
RESEARCH DESIGN AND METHODS
Ninety-nine women (age 26-42 years; mean ± SD prepregnancy BMI 24 ± 5 kg/m²) diagnosed with GDM at 20-32 weeks' gestation were randomized to follow either an LGI (n = 50; target glycemic index [GI] ~50) or a high-fiber moderate-GI diet (HF) (n = 49; target GI ~60). Dietary intake was assessed by 3-day food records. Pregnancy outcomes were collected from medical records.
RESULTS
The LGI group achieved a modestly lower GI than the HF group (mean ± SEM 47 ± 1 vs. 53 ± 1; P < 0.001). At birth, there was no significant difference in birth weight (LGI 3.3 ± 0.1 kg vs. HF 3.3 ± 0.1 kg; P = 0.619), birth weight centile (LGI 52.5 ± 4.3 vs. HF 52.2 ± 4.0; P = 0.969), prevalence of macrosomia (LGI 2.1% vs. HF 6.7%; P = 0.157), insulin treatment (LGI 53% vs. HF 65%; P = 0.251), or adverse pregnancy outcomes.
CONCLUSIONS
In intensively monitored women with GDM, an LGI diet and a conventional HF diet produce similar pregnancy outcomes. | 1significant effect
|
2,829,413 | 20,195,400 | BACKGROUND/AIMS
This multicenter, open-labeled, randomized trial was performed to compare the effects of rosuvastatin 10 mg and atorvastatin 10 mg on lipid and glycemic control in Korean patients with nondiabetic metabolic syndrome.
METHODS
In total, 351 patients who met the modified National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria for metabolic syndrome with low-density lipoprotein cholesterol (LDL-C) levels > or = 130 mg/dL were randomized to receive either rosuvastatin 10 mg (n = 173) or atorvastatin 10 mg (n = 178) for over 6 weeks.
RESULTS
After 6 weeks of treatment, greater reductions in total cholesterol (- 35.94 +/- 11.38 vs. - 30.07 +/- 10.46%, p < 0.001), LDL-C (48.04 +/- 14.45 vs. 39.52 +/- 14.42%, p < 0.001), non-high-density lipoprotein cholesterol (- 42.93 +/- 13.15 vs. - 35.52 +/- 11.76%, p < 0.001), and apolipoprotein-B (- 38.7 +/- 18.85 vs. - 32.57 +/- 17.56%, p = 0.002) levels were observed in the rosuvastatin group as compared to the atorvastatin group. Overall, the percentage of patients attaining the NCEP ATP III goal was higher with rosuvastatin as compared to atorvastatin (87.64 vs. 69.88%, p < 0.001). Changes in glucose and insulin levels, and homeostasis model assessment of insulin resistance index were not significantly different between the two groups. The safety and tolerability of the two agents were similar.
CONCLUSIONS
Rosuvastatin 10 mg was more effective than atorvastatin 10 mg in achieving NCEP ATP III LDL-C goals in patients with nondiabetic metabolic syndrome, especially in those with lower NCEP ATP III target level goals. | 1significant effect
|
5,577,662 | 28,854,973 | BACKGROUND
To determine the safety and efficacy of collagenase clostridium histolyticum (CCH) injection for the treatment of palmar Dupuytren disease nodules.
METHODS
In this 8-week, double-blind trial, palpable palmar nodules on one hand of adults with Dupuytren disease were selected for treatment. Patients were randomly assigned using an interactive web response system to receive a dose of 0.25 mg, 0.40 mg, or 0.60 mg (1:1:1 ratio) and then allocated to active treatment (CCH) or placebo (4:1 ratio). All patients and investigators were blinded to treatment. One injection was made in the selected nodule on Day 1. Caliper measurements of nodule length and width were performed at screening and at Weeks 4 and 8. Investigator-reported nodular consistency and hardness were evaluated at baseline and Weeks 1, 4, and 8. Investigator-rated patient improvement (1 [very much improved] to 7 [very much worse]) and patient satisfaction were assessed at study end.
RESULTS
In the efficacy population (n = 74), percentage changes in area were significantly greater with CCH 0.40 mg (-80.1%, P = 0.0002) and CCH 0.60 mg (-78.2%, P = 0.0003), but not CCH 0.25 mg (-58.3%, P = 0.079), versus placebo (-42.2%) at post-treatment Week 8. Mean change in nodular consistency and hardness were significantly improved with CCH versus placebo at Weeks 4 and 8 (P ≤ 0.0139 for all). At Week 8, investigator global assessment of improvement was significantly greater with CCH 0.40 mg and 0.60 mg (P ≤ 0.0014) but not statistically significant with CCH 0.25 mg versus placebo (P = 0.13). Most patients were "very satisfied" or "quite satisfied" with CCH 0.40 mg and 0.60 mg. Contusion/bruising (50.0% to 59.1%) was the most common adverse event with CCH treatment.
CONCLUSION
In patients with Dupuytren disease, a single CCH injection significantly improved palmar nodule size and hardness. The safety of CCH was similar to that observed previously in patients with Dupuytren contracture.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT02193828 . Date of trial registration: July 2, 2014 to December 5, 2014. | 1significant effect
|
1,475,568 | 16,533,388 | BACKGROUND
Self-management programs for patients with heart failure can reduce hospitalizations and mortality. However, no programs have analyzed their usefulness for patients with low literacy. We compared the efficacy of a heart failure self-management program designed for patients with low literacy versus usual care.
METHODS
We performed a 12-month randomized controlled trial. From November 2001 to April 2003, we enrolled participants aged 30-80, who had heart failure and took furosemide. Intervention patients received education on self-care emphasizing daily weight measurement, diuretic dose self-adjustment, and symptom recognition and response. Picture-based educational materials, a digital scale, and scheduled telephone follow-up were provided to reinforce adherence. Control patients received a generic heart failure brochure and usual care. Primary outcomes were combined hospitalization or death, and heart failure-related quality of life.
RESULTS
123 patients (64 control, 59 intervention) participated; 41% had inadequate literacy. Patients in the intervention group had a lower rate of hospitalization or death (crude incidence rate ratio (IRR) = 0.69; CI 0.4, 1.2; adjusted IRR = 0.53; CI 0.32, 0.89). This difference was larger for patients with low literacy (IRR = 0.39; CI 0.16, 0.91) than for higher literacy (IRR = 0.56; CI 0.3, 1.04), but the interaction was not statistically significant. At 12 months, more patients in the intervention group reported monitoring weights daily (79% vs. 29%, p < 0.0001). After adjusting for baseline demographic and treatment differences, we found no difference in heart failure-related quality of life at 12 months (difference = -2; CI -5, +9).
CONCLUSION
A primary care-based heart failure self-management program designed for patients with low literacy reduces the risk of hospitalizations or death. | 1significant effect
|
3,108,665 | 21,694,864 | BACKGROUND
Somatostatin has been found to be effective in the prevention of postoperative complications in pancreatic surgery. It can inhibit the pancreatic secretions that, quite often, are responsible for complications during the postoperative period.
METHODS
We randomized 67 patients in 2 groups. In the study group (n = 35), somatostatin was administered 30 minutes prior to surgery as well as intraoperatively and postoperatively. No medication was given to the control group (n = 32). Biopsies were taken and processed for electron microscopy and ultrastructural morphometric analysis.
RESULTS
Administration of somatostatin reduced the exocrine granule number, and the patients suffered from fewer postoperative complications.
CONCLUSIONS
Somatostatin reduces granule number and size of pancreatic cells, which can partially explain the prophylactic effect of the drug on early complications of pancreatic surgery, and which is confirmed by the clinical findings. | 1significant effect
|
1,261,533 | 16,179,089 | BACKGROUND
The use of antimalarial drug combinations with artemisinin derivatives is recommended to overcome drug resistance in Plasmodium falciparum. The fixed combination of oral artemether-lumefantrine, an artemisinin combination therapy (ACT) is highly effective and well tolerated. It is the only registered fixed combination containing an artemisinin. The trial presented here was conducted to monitor the efficacy of the six-dose regimen of artemether-lumefantrine (ALN) in an area of multi-drug resistance, along the Thai-Myanmar border.
METHODS
The trial was an open-label, two-arm, randomized study comparing artemether-lumefantrine and mefloquine-artesunate for the treatment of uncomplicated falciparum malaria with 42 days of follow up. Parasite genotyping by polymerase chain reaction (PCR) was used to distinguish recrudescent from newly acquired P. falciparum infections. The PCR adjusted cure rates were evaluated by survival analysis.
RESULTS
In 2001-2002 a total of 490 patients with slide confirmed uncomplicated P. falciparum malaria were randomly assigned to receive artemether-lumefantrine (n = 245) or artesunate and mefloquine (n = 245) and were followed for 42 days. All patients had rapid initial clinical and parasitological responses. In both groups, the PCR adjusted cure rates by day 42 were high: 98.8% (95% CI 96.4, 99.6%) for artemether-lumefantrine and 96.3% (95% CI 93.1, 98.0%) for artesunate-mefloquine. Both regimens were very well tolerated with no serious adverse events observed attributable to either combination.
CONCLUSION
Overall, this study confirms that these two artemisinin-based combinations remain highly effective and result in equivalent therapeutic responses in the treatment of highly drug-resistant falciparum malaria. | 0no significant effect
|
4,785,315 | 26,936,901 | OBJECTIVES
We sought evidence of effectiveness of lay support to improve maternal and child outcomes in disadvantaged families.
DESIGN
Prospective, pragmatic, individually randomised controlled trial.
SETTING
3 Maternity Trusts in West Midlands, UK.
PARTICIPANTS
Following routine midwife systematic assessment of social risk factors, 1324 nulliparous women were assigned, using telephone randomisation, to standard maternity care, or addition of referral to a Pregnancy Outreach Worker (POW) service. Those under 16 years and teenagers recruited to the Family Nurse Partnership trial were excluded.
INTERVENTIONS
POWs were trained to provide individual support and case management for the women including home visiting from randomisation to 6 weeks after birth. Standard maternity care (control) included provision for referring women with social risk factors to specialist midwifery services, available to both arms.
MAIN OUTCOME MEASURES
Primary outcomes were antenatal visits attended and Edinburgh Postnatal Depression Scale (EPDS) 8-12 weeks postpartum. Prespecified, powered, subgroup comparison was among women with 2 or more social risks. Secondary outcomes included maternal and neonatal birth outcomes; maternal self-efficacy, and mother-to-infant bonding at 8-12 weeks; child development assessment at 6 weeks, breastfeeding at 6 weeks, and immunisation uptake at 4 months, all collected from routine child health systems.
RESULTS
Antenatal attendances were high in the standard care control and did not increase further with addition of the POW intervention (10.1 vs 10.1 (mean difference; MD) -0.00, 95% CI (95% CI -0.37 to 0.37)). In the powered subgroup of women with 2 or more social risk factors, mean EPDS (MD -0.79 (95% CI -1.56 to -0.02) was significantly better, although for all women recruited, no significant differences were seen (MD -0.59 (95% CI -1.24 to 0.06). Mother-to-infant bonding was significantly better in the intervention group for all women (MD -0.30 (95% CI -0.61 to -0.00) p=0.05), and there were no differences in other secondary outcomes.
CONCLUSIONS
This trial demonstrates differences in depressive symptomatology with addition of the POW service in the powered subgroup of women with 2 or more social risk factors. Addition to existing evidence indicates benefit from lay interventions in preventing postnatal depression. This finding is important for women and their families given the known effect of maternal depression on longer term childhood outcomes.
TRIAL REGISTRATION NUMBER
ISRCTN35027323; Results. | 0no significant effect
|
5,062,194 | 27,746,564 | BACKGROUND
Anxiety is a concern in obstetrics, especially in preeclamptic mothers. Sedation is not commonly used in parturients for fear of adverse neonatal effect. We investigated maternal and neonatal outcome of midazolam as an adjuvant to spinal anesthesia for elective cesarean delivery.
METHODS
A prospective randomized controlled trial, in which eighty preeclamptic parturients received either an intravenous dose of 0.035 mg/kg of midazolam or an equal volume of normal saline, 30 min before spinal anesthesia. Maternal anxiety was assessed using Amsterdam Preoperative Anxiety and Information Scale (APAIS); postoperative maternal satisfaction was assessed using Maternal Satisfaction Scale for Cesarean Section (MSSCS). Newborns were assessed using Apgar score, Neonatal Neurologic and Adaptive Capacity Score (NACS), and umbilical artery blood gases.
RESULTS
Mothers premedicated with midazolam showed a lower level of preoperative anxiety and a higher degree of postoperative satisfaction than the control group. There were no between-group differences regarding the neonatal outcome.
CONCLUSION
Preeclamptic parturients premedicated with midazolam (0.035 mg/kg) before spinal anesthesia have lower anxiety and higher postoperative satisfaction levels, with no adverse effects on the newborns. | 1significant effect
|
4,794,897 | 26,983,672 | BACKGROUND
To compare the effects of resistance training versus passive physical therapy on bone turnover markers (BTM) in the metastatic bone during radiation therapy (RT) in patients with spinal bone metastases. Secondly, to evaluate an association of BTM to local response, skeletal-related events (SRE), and number of metastases.
METHODS
In this randomized trial, 60 patients were allocated from September 2011 to March 2013 into one of the two arms: resistance training (Arm A) or passive physical therapy (Arm B) with thirty patients in each arm during RT. Biochemical markers such as pyridinoline (PYD), desoxy-pyridinoline (DPD), bone alkaline phosphatase (BAP), total amino-terminal propeptide of type I collagen (PINP), beta-isomer of carboxy-terminal telopeptide of type I collagen (CTX-I), and cross-linked N-telopeptide of type I collagen (NTX) were analyzed at baseline, and three months after RT.
RESULTS
Mean change values of PYD and CTX-I were significantly lower at 3 months after RT (p = 0.035 and p = 0.043) in Arm A. Importantly, all markers decreased in both arms, except of PYD and CTX-I in arm B, although significance was not reached for some biomarkers. In arm A, the local response was significantly higher (p = 0.003) and PINP could be identified as a predictor for survivors (OR 0.968, 95%CI 0.938-0.999, p = 0.043). BAP (OR 0.974, 95%CI 0.950-0.998, p = 0.034) and PINP (OR 1.025, 95%CI 1.001-1.049, p = 0.044) were related with an avoidance of SRE.
CONCLUSIONS
In this group of patients with spinal bone metastases, we were able to show that patients with guided resistance training of the paravertebral muscles can influence BTM. PYD and CTX-I decreased significantly in arm A. PINP can be considered as a complementary tool for prediction of local response, and PINP as well as BAP for avoidance of SRE.
TRIAL REGISTRATION
Clinical trial identifier NCT 01409720. August 2, 2011. | 1significant effect
|
3,349,250 | 22,568,998 | BACKGROUND
In a randomised phase III trial of treatment-naive patients with metastatic renal cell carcinoma, sunitinib showed significant improvement in progression-free survival (PFS) compared with interferon (IFN)-α. We assessed between-treatment differences in overall benefit using a quality-adjusted Time Without Symptoms of disease progression or Toxicity of treatment (TWiST; Gelber and Goldhirsch) analysis.
METHODS
In this analysis, in which only grade 3/4 treatment-related toxicities were included, overall survival was partitioned into three health states: toxicity (time with toxicity after randomisation and before progression), time without symptoms of disease progression or toxicity, and time from progression until death. Between-treatment differences in the mean duration of each state were calculated. A threshold utility analysis was used to assess quality-adjusted TWiST (Q-TWiST) outcomes.
RESULTS
Q-TWiST scores showed that quality-adjusted survival time was greater with sunitinib than with IFN-α, even though certain grade 3/4 toxicities occurred more frequently with sunitinib. For both treatments, the mean number of days with toxicity was small compared with PFS. This effect was more pronounced with sunitinib in which time spent without progression or toxicity was 151 days greater than with IFN-α.
CONCLUSION
Patients randomised to sunitinib had longer clinical benefit, defined as Q-TWiST scores, than patients randomised to IFN-α. | 1significant effect
|
3,221,331 | 21,371,991 | BACKGROUND
Advances in technology allowed the development of a novel smoking cessation program delivered by video messages sent to mobile phones. This social cognitive theory-based intervention (called "STUB IT") used observational learning via short video diary messages from role models going through the quitting process to teach behavioral change techniques.
OBJECTIVE
The objective of our study was to assess the effectiveness of a multimedia mobile phone intervention for smoking cessation.
METHODS
A randomized controlled trial was conducted with 6-month follow-up. Participants had to be 16 years of age or over, be current daily smokers, be ready to quit, and have a video message-capable phone. Recruitment targeted younger adults predominantly through radio and online advertising. Registration and data collection were completed online, prompted by text messages. The intervention group received an automated package of video and text messages over 6 months that was tailored to self-selected quit date, role model, and timing of messages. Extra messages were available on demand to beat cravings and address lapses. The control group also set a quit date and received a general health video message sent to their phone every 2 weeks.
RESULTS
The target sample size was not achieved due to difficulty recruiting young adult quitters. Of the 226 randomized participants, 47% (107/226) were female and 24% (54/226) were Maori (indigenous population of New Zealand). Their mean age was 27 years (SD 8.7), and there was a high level of nicotine addiction. Continuous abstinence at 6 months was 26.4% (29/110) in the intervention group and 27.6% (32/116) in the control group (P = .8). Feedback from participants indicated that the support provided by the video role models was important and appreciated.
CONCLUSIONS
This study was not able to demonstrate a statistically significant effect of the complex video messaging mobile phone intervention compared with simple general health video messages via mobile phone. However, there was sufficient positive feedback about the ease of use of this novel intervention, and the support obtained by observing the role model video messages, to warrant further investigation.
TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry Number: ACTRN12606000476538; http://www.anzctr.org.au/trial_view.aspx?ID=81688 (Archived by WebCite at http://www.webcitation.org/5umMU4sZi). | 0no significant effect
|
4,078,386 | 25,002,886 | BACKGROUND
Lipid metabolism is one of the hepatitis C virus (HCV) life cycle steps. Statins can reduce cholesterol level and finally can decrease HCV replication. Thus, we assessed the effect of Statins in combination with standard antiviral treatment on hyperlipidemic genotype I HCV infected patients.
MATERIALS AND METHODS
This study was a prospective clinical trial. 40 patients were selected from those referred to educational and Therapeutic Centers of Isfahan University of Medical Sciences from 2009 to 2010 with confirmed HCV viremia. All patients received Peg-interferon-a2a and ribavirin. 20 hyperlipidemic Patients received 20 mg atorvastatin nightly for 3 months and placebo was prescribed for 20 normolipidemic HCV infected patients as a control group. Liver enzymes and complete blood count were checked monthly and thyroid stimulating hormone was checked every 3 months. We also performed quantitative HCV-ribonucleic acid (RNA) test in 12(th) week of therapy, at the end of treatment and 6 months after therapy for all samples.
RESULTS
We didn't find any significant differences in the mean of HCV-RNA numbers between statin and placebo groups in 12(th) week of treatment, in the end of treatment and 6 months after treatment (P > 0.05).
CONCLUSION
Atorvastatin has no effect on the mean of HCV viral load when we added it to standard treatment for hepatitis C infection. Further studies are necessary to examine the possible antiviral properties of statins and their potential role as adjuncts to standard HCV therapy. | 0no significant effect
|
5,729,252 | 29,237,441 | BACKGROUND
No drugs have been approved for the treatment of patients with pulmonary hypertension (PH) secondary to idiopathic pulmonary fibrosis (IPF), particularly those with idiopathic honeycomb lung. This study was conducted to investigate the long-term efficacy and safety of bosentan for PH based on changes in prognosis and respiratory failure.
METHODS
IPF patients with borderline or less severe PH and completely organized honeycomb lung were randomized (1:1) to bosentan or no treatment for PH for 2 years and assessed at baseline and every 6 months for respiratory failure, activities of daily living (ADL), lung and heart functions by right cardiac catheterization, and other parameters. An interim analysis was performed, however, following detection of a significant survival benefit favoring bosentan therapy.
RESULTS
Significant differences were noted for the bosentan-treated (n = 12) vs. untreated (n = 12) groups in hospital-free survival (603.44 ± 50.074 days vs. 358.87 ± 68.65 days; hazard ratio [HR], 0.19; P = 0.017) and overall survival (671 days vs. 433.78 ± 66.98 days; HR, 0.10; P = 0.0082). Again, significant improvements were noted for the bosentan-treated group from baseline to month 6 or 12 in several indices in ADL, pulmonary circulation, and %DLCO. Without requiring O 2 inhalation, bosentan was associated with no increase but a trend toward a decrease in adverse events and an improvement in respiratory status.
CONCLUSIONS
Bosentan tended to improve prognosis and ADL without worsening respiratory failure in IPF patients with borderline or less severe PH and completely organized honeycomb lung alone.
TRIAL REGISTRATION
This study was registered on December 18, 2010 with UMIN-CTR Clinical Trial as UMIN000004749 to investigate the long-term influence of bosentan on cardiac function, as well as its cardioprotective efficacy and safety, in patients with pulmonary hypertension secondary to concurrent COPD and IPF, respectively. | 1significant effect
|
2,974,815 | 21,049,213 | OBJECTIVES
To evaluate the importance of providing guidelines to patients via active telephone calls for blood pressure control and for preventing the discontinuation of treatment among hypertensive patients.
INTRODUCTION
Many reasons exist for non-adherence to medical regimens, and one of the strategies employed to improve treatment compliance is the use of active telephone calls.
METHODS
Hypertensive patients (n=354) who could receive telephone calls to remind them of their medical appointments and receive instruction about hypertension were distributed into two groups: a) "uncomplicated" - hypertensive patients with no other concurrent diseases and b) "complicated" - severe hypertensive patients (mean diastolic ≥ 110 mmHg with or without medication) or patients with comorbidities. All patients, except those excluded (n=44), were open-block randomized to follow two treatment regimens ("traditional" or "current") and to receive or not receive telephone calls ("phone calls" and "no phone calls" groups, respectively).
RESULTS
Significantly fewer patients in the "phone calls" group discontinued treatment compared to those in the "no phone calls" group (4 vs. 30; p<0.0094). There was no difference in the percentage of patients with controlled blood pressure in the "phone calls" group and "no phone calls" group or in the "traditional" and "current" groups. The percentage of patients with controlled blood pressure (<140/90 mmHg) was increased at the end of the treatment (74%), reaching 80% in the "uncomplicated" group and 67% in the "complicated" group (p<0.000001).
CONCLUSION
Guidance to patients via active telephone calls is an efficient strategy for preventing the discontinuation of antihypertensive treatment. | 1significant effect
|
4,320,624 | 25,398,689 | BACKGROUND
Long-acting β2-adrenergic agonists (LABAs) are recommended in combination with inhaled corticosteroids (ICSs) for asthma management. Abediterol is a novel, selective, potent, once-daily LABA in development for treatment of asthma and chronic obstructive pulmonary disease. This study aimed to determine abediterol doses with similar peak bronchodilatory effect to salbutamol 400 μg, and duration of action compatible with once-daily dosing in patients with persistent, stable asthma.
METHODS
This was a Phase II, randomized, double-blind, double-dummy, crossover, placebo-controlled, dose-ranging study (ClinicalTrials.gov NCT01425801) in 62 patients with mild-to-moderate asthma who were also receiving an ICS. Patients received single doses of abediterol 0.313, 0.625, 1.25, or 2.5 μg, salbutamol 400 μg, or placebo in the morning. Spirometry was performed up to 36 h post-dose; safety and tolerability were assessed throughout the study. The primary endpoint was change from baseline in peak forced expiratory volume in 1 s (FEV1). Additional endpoints included trough FEV1, normalized area under the FEV1 curve (FEV1 AUC) up to 24 h post-dose, and peak and trough forced vital capacity (FVC).
RESULTS
Abediterol produced dose-dependent improvements in peak FEV1 from baseline compared with placebo, from 0.274 (95% CI 0.221, 0.327) to 0.405 L (95% CI 0.353, 0.458) for abediterol 0.313 to 2.5 μg, respectively (p < 0.0001 all doses). Abediterol 0.625, 1.25, and 2.5 μg had similar magnitude of peak FEV1 effect to salbutamol. Dose-dependent changes from baseline in trough FEV1 versus placebo were 0.219 (95% CI 0.136, 0.302) to 0.400 L (95% CI 0.317, 0.483) for abediterol 0.313 to 2.5 μg, respectively (p < 0.0001). All abediterol doses achieved significant improvements versus placebo in FEV1 AUC 0-6, 0-12, and 0-24 h, and peak and trough FVC (p < 0.05). Less than 10% of patients experienced treatment-related adverse events for each dose of abediterol; most were mild to moderate in intensity and the most common were headache and nasopharyngitis. There were no clinically relevant changes in heart rate.
CONCLUSIONS
Abediterol 0.625-2.5 μg provided dose-dependent, clinically and statistically significant bronchodilation versus placebo in patients with asthma, with a peak effect similar to salbutamol and duration of action compatible with once-daily dosing. All doses of abediterol were well tolerated. | 1significant effect
|
3,278,655 | 22,206,447 | BACKGROUND AND PURPOSE
The trabecular metal tibial monoblock component (TM) is a relatively new option available for total knee arthroplasty. We have previously reported a large degree of early migration of the trabecular metal component in a subset of patients. These implants all appeared to stabilize at 2 years. We now present 5-year RSA results of the TM and compare them with those of the NexGen Option Stemmed cemented tibial component (Zimmer, Warsaw IN).
PATIENTS AND METHODS
70 patients with osteoarthritis were randomized to receive either the TM implant or the cemented component. RSA examination was done postoperatively and at 6 months, 1 year, 2 years, and 5 years. RSA outcomes were translations, rotations, and maximum total point motion (MTPM) of the components. MTPM values were used to classify implants as "at risk" or "stable".
RESULTS
At the 5-year follow-up, 45 patients were available for analysis. There were 27 in the TM group and 18 in the cemented group. MTPM values were similar in the 2 groups (p = 0.9). The TM components had significantly greater subsidence than the cemented components (p = 0.001). The proportion of "at risk" components at 5 years was 2 of 18 in the cemented group and 0 of 27 in the TM group (p = 0.2).
INTERPRETATION
In the previous 2-year report, we expressed our uncertainty concerning the long-term stability of the TM implant due to the high initial migration seen in some cases. Here, we report stability of this implant up to 5 years in all cases. The implant appears to achieve solid fixation despite high levels of migration initially. | 0no significant effect
|
4,889,691 | 27,279,849 | INTRODUCTION
Whether the AutoPulse automated chest compression device is worthy of clinical use for out-of-hospital cardiac arrest (OHCA) remains controversial. A prospective controlled study was conducted to evaluate the effect of AutoPulse versus manual chest compression for cardiopulmonary resuscitation (CPR) of OHCA patients in the northern district of Shanghai, China.
MATERIAL AND METHODS
A total of 133 patients with OHCA who were treated at the Emergency Medical Center of the Tenth People's Hospital Affiliated with Tongji University between March 2011 and March 2012 were included. The patients were randomly assigned to the Manual CPR (n = 64) and AutoPulse CPR groups (n = 69) in accordance with the approach of chest compression received. The primary outcome measure was return of spontaneous circulation (ROSC), and the secondary outcome measures included 24-h survival rate, hospital discharge rate, and neurological prognosis at hospital discharge.
RESULTS
The ROSC rate of patients with OHCA was significantly higher in the AutoPulse CPR group than in the Manual CPR group (44.9% vs. 23.4%; p = 0.009). The 24-h survival rate of OHCA patients was significantly higher in the AutoPulse CPR group than in the Manual CPR group (39.1% vs. 21.9%; p = 0.03). The hospital discharge rate of the patients with OHCA was significantly higher in the AutoPulse CPR group than in the Manual CPR group (18.8% vs. 6.3%; p = 0.03). The proportion of patients with OHCA and a cerebral performance category score of 1 or 2 points at hospital discharge was higher in the AutoPulse CPR group than in the Manual CPR group, but the difference was not statistically significant (16.2% vs. 13.4%, p = 1.00).
CONCLUSIONS
Use of the AutoPulse increases CPR success and survival rates in patients with OHCA, but its ability to improve cerebral performance requires further evaluation. | 1significant effect
|
1,198,254 | 16,080,791 | BACKGROUND
In persons without clinical symptom it is difficult to assess an impact of probiotics regarding its effect on health. We evaluated the functional efficacy of the probiotic Lactobacillus fermentum ME-3 in healthy volunteers by measuring the influence of two different formulations on intestinal lactoflora, fecal recovery of the probiotic strain and oxidative stress markers of blood and urine after 3 weeks consumption.
METHODS
Two 3-week healthy volunteer trials were performed. Open placebo controlled (OPC) study participants (n = 21) consumed either goat milk or by L. fermentum ME-3 fermented goat milk (daily dose 11.8 log CFU (Colony Forming Units). Double blind randomised placebo controlled (DBRP) study participants (n = 24) received either capsules with L. fermentum ME-3 (daily of dose 9.2 CFU) or placebo capsules. The faecal lactoflora composition, faecal ME-3 recovery, effect of the consumption on intestinal lactoflora, and oxidative stress markers of blood (total antioxidative activity; total antioxidative status and glutathione red-ox ratio) was measured.
RESULTS
ME-3 was well tolerated and a significant increase in total faecal lactobacilli yet no predominance of ME-3 was detected in all study groups. Faecal recovery of ME-3 was documented by molecular methods only in fermented milk group, however the significant improvement of blood TAA (Total Antioxidative Activity) and TAS (Total Antioxidative Status) indices was seen both in case of fermented goat milk and capsules", yet glutathione re-ox ratio values decreased only in case of fermented by ME-3 goat milk.
CONCLUSION
The functional efficacy of both consumed formulations of an antioxidative probiotic L. fermentum ME-3 is proved by the increase of the intestinal lactobacilli counts providing putative defence against enteric infections and by reduction of the oxidative stress indices of blood and urine of healthy volunteers. In non-diseased host the probiotic health claims can be assessed by improvement of some measurable laboratory indices of well-established physiological functions of host, e.g. markers of antioxidative defence system. | 1significant effect
|
5,551,012 | 28,808,578 | BACKGROUND
Babies are increasingly being exposed to antibiotics intrapartum in the bid to reduce neonatal and maternal deaths. Intrapartum antibiotic exposure, including even those considered safe in pregnancy, have been associated with childhood obesity and compromised immunity. Data on the extent of antibiotic use, safety and its impact on birth outcomes and neonatal health in Sub-Saharan Africa is very limited. This study sought to ascertain the extent of antibiotic use in pregnancy and its effects on birth outcomes in a rural hospital in Ghana.
METHODS
The study was a retrospective randomized study of mothers who delivered babies in a rural hospital between 2011 and 2015 in Ghana. A total of 412 mother/baby records out of 2100 pre-selected met the inclusion criteria of the study. Indicators of neonatal health used were birthweight, Apgar score, incidence of birth defects.
RESULTS
Sixty five percent of pregnant women were administered antibiotics at some stage during pregnancy. Beta Lactam antibiotics accounted for more than 67% of all antibiotics prescribed. There was a statistically significant association between antibiotic exposure and pregnancy factors such as stage of pregnancy, parity and mode of delivery but not with socio-economic status of the mother. Intrapartum antibiotic exposure did not significantly affect the birthweight, incidence of congenital birth defect and mean Apgar scores. After adjusting for method of delivery, however, perinatal antibiotic use (24 h to delivery) was associated with lower mean Apgar scores. Birth weight was affected significantly by maternal socio-economic factors such as age and marital status.
CONCLUSION
Sixty five percent of women attending the antenatal clinic received antibiotics. Intrapartum antibiotics did not affect early markers of neonatal health such as birthweight, congenital birth defect and mean Apgar scores. However, antibiotic use less than 24 h to delivery was associated with a decrease in mean APGAR score. | 0no significant effect
|
2,656,477 | 19,243,603 | BACKGROUND
To examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors.
METHODS
Early stage endometrial cancer survivors were randomized to intervention (n = 23) or usual care (n = 22) groups. Chi-square, Student's t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss.
RESULTS
Morbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03) and restraint (p = .02) in the LI group. There was a significant difference for emotional well-being quality of life (p = .02), self-efficacy related to negative emotions (p < .01), food availability (p = .03), and physical discomfort (p = .01) in women who lost weight as compared to women who gained weight. Improvement in restraint was also reported in women who lost weight (p < .01).
CONCLUSION
This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors.
TRIAL REGISTRATION
http://www.clinicaltrials.gov; NCT00420979. | 1significant effect
|
5,209,819 | 28,049,481 | BACKGROUND
Tanzania has seen a reduction in the fraction of fevers caused by malaria, likely due in part to scale-up of control measures. While national guidelines require parasite-based diagnosis prior to treatment, it is estimated that more than half of suspected malaria treatment-seeking in Tanzania initiates in the private retail sector, where diagnosis by malaria rapid diagnostic test (RDT) or microscopy is illegal. This pilot study investigated whether the introduction of RDTs into Accredited Drug Dispensing Outlets (ADDOs) under realistic market conditions would improve case management practices.
METHODS
Dispensers from ADDOs in two intervention districts in Tanzania were trained to stock and perform RDTs and monitored quarterly. Each district was assigned a different recommended retail price to evaluate the need for a subsidy. Malaria RDT and artemisinin-based combination therapy (ACT) uptake and availability were measured pre-intervention and 1 year post-intervention through structured surveys of ADDO owners and exiting customers in both intervention districts and one contiguous control district. Descriptive analysis and logistic regression were used to compare the three districts and identify predictive variables for testing.
RESULTS AND DISCUSSION
A total of 310 dispensers from 262 ADDOs were trained to stock and perform RDTs. RDT availability in intervention ADDOs increased from 1% (n = 172) to 73% (n = 163) during the study; ACT medicines were available in 75% of 260 pre-intervention and 68% of 254 post-intervention ADDOs. Pre-treatment testing performed within the ADDO increased from 0 to 65% of suspected malaria patients who visited a shop (95% CI 60.8-69.6%) with no difference between intervention districts. Overall parasite-based diagnosis increased from 19 to 74% in intervention districts and from 3 to 18% in the control district. Prior knowledge of RDT availability (aOR = 1.9, p = 0.03) and RDT experience (aOR = 1.9, p = 0.01) were predictors for testing. Adherence data indicated that 75% of malaria positives received ACT, while 3% of negatives received ACT.
CONCLUSIONS
Trained and supervised ADDO dispensers in rural Tanzania performed and sold RDTs under real market conditions to two-thirds of suspected malaria patients during this one-year pilot. These results support the hypothesis that introducing RDTs into regulated private retail sector settings can improve malaria testing and treatment practices without an RDT subsidy. Trial registration ISRCTN ISRCTN14115509. | 1significant effect
|
5,519,461 | 28,674,348 | Objective CYP2C19 metabolic activity influences the efficacy of Helicobacter pylori eradication therapies comprising PPIs. Rabeprazole (RPZ) and esomeprazole (EPZ) are PPIs not extensively metabolized by CYP2C19. The aim of this study was to elucidate whether or not first-line triple therapies using RPZ or EPZ are equally effective in Japanese patients with different CYP2C19 genotypes. Methods Two-hundred patients infected with H. pylori were randomized to receive one of the following regimens: amoxicillin (750 mg), clarithromycin (200 mg), and either esomeprazole (20 mg) (EAC group) or rabeprazole (10 mg) (RAC group), twice a day for one week. The CYP2C19 polymorphisms were determined by polymerase chain reaction and the serum level of pepsinogens was measured. Results The eradication rates of the EAC and RAC regimens were 79.8% (95% confidential interval: 71.7-89.0%) and 74.7% (66.0-83.4%), respectively, in a per protocol (PP) analysis (p=0.488). The eradication rates of the EAC and RAC regimens were not significantly different between patients with the homo EM genotype (p=0.999) or hetero IM or PM genotypes (p=0.286). A lower PG I/II ratio was associated with lower eradication rates (p=0.025). Conclusion Although the eradication rate was less than 80%, the EAC and RAC regimens were equally effective in each CYP2C19 genotype group. The PG I/II ratio was associated with the results of EAC and RAC therapy in this series of patients. | 0no significant effect
|
4,221,638 | 24,267,513 | BACKGROUND
Traumatic brain injury (TBI) is commonly accompanied by intracranial bleeding which can worsen after hospital admission. Tranexamic acid (TXA) has been shown to reduce bleeding in elective surgery and there is evidence that short courses of TXA can reduce rebleeding in spontaneous intracranial haemorrhage. We aimed to determine the effectiveness and safety of TXA in preventing progressive intracranial haemorrhage in TBI.
METHODS
This is a double blinded, placebo controlled randomized trial. We enrolled 238 patients older than 16 years with moderate to severe TBI (post-resuscitation Glasgow Coma Scale (GCS) 4 to 12) who had a computerized tomography (CT) brain scan within eight hours of injury and in whom there was no immediate indication for surgery. We excluded patients if they had a coagulopathy or a serum creatinine over than 2.0 milligrams%. The treatment was a single dose of 2 grams of TXA in addition to other standard treatments. The primary outcome was progressive intracranial haemorrhage (PIH) which was defined as an intracranial haemorrhage seen on the second CT scan that was not seen on the first CT scan, or an intracranial haemorrhage seen on the first scan that had expanded by 25% or more on any dimension (height, length, or width) on the second scan.
RESULTS
Progressive intracranial haemorrhage was present in 21 (18%) of 120 patients allocated to TXA and in 32 (27%) of 118 patients allocated to placebo. The difference was not statistically significant [RR = 0.65 (95% CI 0.40 to 1.05)]. There were no significant difference in the risk of death from all causes in patients allocated to TXA compared with placebo [RR = 0.69 (95% CI 0.35 to 1.39)] and the risk of unfavourable outcome on the Glasgow Outcome Scale [RR = 0.76 (95% CI 0.46 to 1.27)]. There was no evidence of increased risk of thromboembolic events in those patients allocated to TXA.
CONCLUSIONS
TXA may reduce PIH in patients with TBI; however, the difference was not statistically significant in this trial. Large clinical trials are needed to confirm and to assess the effect of TXA on death or disability after TBI. | 0no significant effect
|
4,138,383 | 25,127,539 | BACKGROUND
Several hospitals in Norway provide short self-referral inpatient treatment to patients with severe mental diagnosis. No studies have compared the experiences of patients who have had the opportunity to self-refer to inpatient treatment with patients who have received treatment as usual. This qualitative study was nested within a randomised controlled trial investigating the effect of self-referral to inpatient treatment. The aim was to explore how patients with severe mental diagnosis coped four months after signing a contract for self-referral, as compared to patients receiving treatment as usual.
METHODS
Data was collected using qualitative individual interviews with patients with severe mental diagnosis, conducted four months after being randomised either to a contract for self-referral (intervention group) or to treatment as usual (control group).
RESULTS
Twenty-five patients participated in interviews - 11 from the intervention group and 14 from the control group. Results four months after randomisation showed that patients with a contract for self-referral appeared to have more confidence in strategies to cope with mental illness and to apply more active cognitive strategies. Patients with a contract also expressed less resignation, hopelessness and powerlessness than patients without a contract. In addition, patients with a contract seemed to be closer to the ideal of living a "normal" life and being a "normal" person.
CONCLUSION
The results indicate that the patients who had a contract for self-referral had come further in the recovery process and should possibly be better off during treatment. | 1significant effect
|
4,748,685 | 26,861,865 | BACKGROUND
One of the most effective current approaches to preventing stroke events is the reduction of lifestyle risk factors, such as unhealthy diet, physical inactivity and smoking. In this study, we assessed the efficacy and usability of the phone-based Computer-aided Prevention System (CAPSYS) in supporting the reduction of lifestyle-related risk factors.
METHODS
A single-centre two-arm clinical trial was performed between January 2013 and February 2014, based on individual follow-up periods of six months with 94 patients at high risk of stroke, randomly assigned to an intervention group (IC: 48; advised to use the CAPSYS system) or a standard care group (SC: 46). Study parameters, such as blood pressure, blood values (HDL, LDL, HbA1c, glycaemia and triglycerides), weight, height, physical activity as well as nutrition and smoking habits were captured through questionnaires and medical records at baseline and post-intervention and analysed to detect significant changes. The usability of the intervention was assessed based on the standardised System Usability Scale (SUS) complemented by a more system-specific user satisfaction and feedback questionnaire.
RESULTS
The statistical evaluation of primary measures revealed significant decreases of systolic blood pressure (mean of the differences = -9 mmHg; p = 0.03; 95% CI = [-17.29, -0.71]), LDL (pseudo-median of the differences = -7.9 mg/dl; p = 0.04; 95% CI = [-18.5, -0.5]) and triglyceride values (pseudo-median of the differences = -12.5 mg/dl; p = 0.04; 95% CI = [-26, -0.5]) in the intervention group, while no such changes could be observed in the control group. Furthermore, we detected a statistically significant increase in self-reported fruit and vegetable consumption (pseudo-median of the differences = 5.4 servings/week; p = 0.04; 95% CI = [0.5, 10.5]) and a decrease in sweets consumption (pseudo-median of the differences = -2 servings/week; p = 0.04; 95% CI = [-4, -0.00001]) in the intervention group. The usability assessment showed that the CAPSYS system was, in general, highly accepted by the users (average SUS score: 80.1).
CONCLUSIONS
The study provided encouraging results indicating that a computerised phone-based lifestyle coaching system, such as CAPSYS, can support the usual treatment in reducing cerebro-cardiovascular risk factors and that such an approach is well applicable in practice.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02444715. | 1significant effect
|
3,224,529 | 21,955,588 | BACKGROUND
Mechanical ventilation seems to occupy a major source in alteration in the quality and quantity of sleep among patients in intensive care. Quality of sleep is negatively affected with frequent patient-ventilator asynchronies and more specifically with modes of ventilation. The quality of sleep among ventilated patients seems to be related in part to the alteration between the capacities of the ventilator to meet patient demand. The objective of this study was to compare the impact of two modes of ventilation and patient-ventilator interaction on sleep architecture.
METHODS
Prospective, comparative crossover study in 14 conscious, nonsedated, mechanically ventilated adults, during weaning in a university hospital medical intensive care unit. Patients were successively ventilated in a random ordered cross-over sequence with neurally adjusted ventilatory assist (NAVA) and pressure support ventilation (PSV). Sleep polysomnography was performed during four 4-hour periods, two with each mode in random order.
RESULTS
The tracings of the flow, airway pressure, and electrical activity of the diaphragm were used to diagnose central apneas and ineffective efforts. The main abnormalities were a low percentage of rapid eye movement (REM) sleep, for a median (25th-75th percentiles) of 11.5% (range, 8-20%) of total sleep, and a highly fragmented sleep with 25 arousals and awakenings per hour of sleep. Proportions of REM sleep duration were different in the two ventilatory modes (4.5% (range, 3-11%) in PSV and 16.5% (range, 13-29%) during NAVA (p = 0.001)), as well as the fragmentation index, with 40 ± 20 arousals and awakenings per hour in PSV and 16 ± 9 during NAVA (p = 0.001). There were large differences in ineffective efforts (24 ± 23 per hour of sleep in PSV, and 0 during NAVA) and episodes of central apnea (10.5 ± 11 in PSV vs. 0 during NAVA). Minute ventilation was similar in both modes.
CONCLUSIONS
NAVA improves the quality of sleep over PSV in terms of REM sleep, fragmentation index, and ineffective efforts in a nonsedated adult population. | 1significant effect
|
3,971,783 | 24,719,691 | BACKGROUND
The nocturnal enuresis is one of the most common complaints of childhood. Upper airway obstruction and nocturnal snoring affect the nocturnal enuresis in children.
OBJECTIVES
The aim of this study was to investigate the effects of breathing exercises on the nocturnal enuresis in the children with the sleep-disordered breathing.
PATIENTS AND METHODS
This study was conducted in year of 2011 by a semi-experimental design with the control group among 40 children, aged 6 - 12 years, who had the nocturnal enuresis. Participants were examined based on the criteria of nocturnal enuresis, oral breathing, and nocturnal snoring. Subsequently, they were randomly assigned to the case and control groups. In the case group, the breathing exercises were performed for 45 minutes, and were pursued for four weeks in the morning following and prior to sleeping, and subsequently the arterial blood gases were measured and the frequency of enuresis and the respiratory rates (RR) were recorded.
RESULTS
After intervention the means of PaCO2 and RR in the control group were significantly higher than the case group (P < 0.0001). Likewise, O2sat, PaO2 in the case group were higher than the control group (P < 0.0001). The nocturnal enuresis decreased significantly in the case group, compared to the control group (P < 0.0001).
CONCLUSIONS
This study suggests that the breathing exercises may reduce the frequency of nocturnal enuresis in the patients with the oral breathing and nocturnal snore. The clinical implications of these findings should be verified in the future longitudinal studies. | 1significant effect
|
5,122,238 | 27,904,586 | BACKGROUND
Post- and intra-operative shivering is one of the most complications of spinal anesthesia so recommend a suitable drug with at least complications for prevention and control of postoperative shivering. This current study aimed to compare the preventive effect of hydrocortisone on intra- and post-operative shivering in patients undergoing surgery with spinal anesthesia.
MATERIALS AND METHODS
In a clinical trial study, ninety patients who candidate for surgery with spinal anesthesia were selected and randomly divided into three groups. The first and second groups were received 1 mg/kg and 2 mg/kg hydrocortisone, respectively, and the third group was received normal saline, and postoperative shivering was compared between the three groups.
RESULTS
The investigation of the incidence of inter- and post-operative shivering in patients in the three groups revealed that within the study period, 31 patients suffered from shivering among which 9, 5, and 17 cases were in 1 mg/kg hydrocortisone group, 2 mg/kg hydrocortisone group, and placebo group, respectively, and according to the Chi-square test, the difference among the three groups was significant ( P = 0.004).
CONCLUSION
According to the obtained results, the overall conclusion of the study is that using hydrocortisone at least with the dose of 1 mg/kg as a preventive drug reduced the incidence of intra- and post-operative shivering with spinal anesthesia. | 1significant effect
|
4,667,210 | 26,634,058 | BACKGROUND/OBJECTIVES
Lactobacillus brevis G101 suppresses the absorption of monosodium glutamate (MSG) from the intestine into the blood in mice. Therefore, the attenuating effect of orally administered G101 on monosodium glutamate (MSG) symptom complex was investigated in humans.
MATERIALS/METHODS
Capsules (300 mg) containing Lactobacillus brevis G101 (1×10(10) CFU/individual) or maltodextrin (placebo) was orally administered in 30 respondents with self-recognized monosodium glutamate (MSG) symptom complex for 5 days and the rice with black soybean sauce containing 6 g MSG (RBSM) was ingested 30 min after the final administration. Thereafter, the MSG symptom complex (rated on a 5-point scale: 1, none; 5, strong) was investigated in a double blind placebo controlled study. The intensity of the MSG symptom complex was significantly reduced in respondents of the G101 intake group (2.87 ± 0.73) compared to that in those treated with the placebo (3.63 ± 1.03) (P = 0.0016). Respondents in the placebo group exhibited more of the various major conditions of the MSG symptom complex than in the G101 intake group. Although there was no significant difference in the appearance time of the MSG symptom complex between subjects orally administered G101 and those administered the placebo, its disappearance in < 3 h was observed in 69.9% of subjects in the G101 treatment group and in 38.0% of subjects in the placebo group (P = 0.0841).
CONCLUSIONS
Oral administration of Lactobacillus brevis G101 may be able to reduce the intensity of the MSG symptom complex. | 0no significant effect
|
5,610,854 | 29,082,039 | PURPOSE
To compare laser peripheral iridotomy (LPI) with trabeculectomy as an initial treatment for primary angle-closure glaucoma (PACG) with peripheral anterior synechiae (PAS) ≥ 6 clock hours.
METHODS
Patients were drawn from two randomized controlled trials. 38 eyes of 38 patients (PAS ≥ 6 clock hours) were treated with LPI (group 1) while 111 eyes of 111 PACG patients (PAS ≥ 6 clock hours) underwent primary trabeculectomy (group 2). All patients underwent a comprehensive ophthalmic examination at baseline and at postoperative visits and were followed up for a minimum of one year.
RESULTS
Group 2 had higher baseline IOP (45.7 ± 14.8 mmHg versus 34.3 ± 14.3 mmHg) than group 1 and more clock hours of PAS (10.4 ± 1.9 versus 9.0 ± 2.2). IOPs at all postoperative visits were significantly lower in group 2 than in group 1 ( p = 0.000). Five eyes in group 1 required trabeculectomy. 17 of the 38 eyes in group 1 (44.7%) required IOP-lowering medications as compared to seven of the 111 eyes in group 2 (6.3%). Cataract progression was documented in 2 eyes (5.3%) in group 1 and 16 eyes (14.4%) in group 2.
CONCLUSIONS
Primary trabeculectomy for PACG (PAS ≥ 6 clock hours) is more effective than LPI in lowering IOP. | 1significant effect
|
4,082,484 | 24,972,677 | BACKGROUND
Curry, one of the most popular foods in Japan, contains spices that are rich in potentially antioxidative compounds, such as curcumin and eugenol. Oxidative stress is thought to impair endothelial function associated with atherosclerosis, a leading cause of cardiovascular events. The aim of this study was to determine whether a single consumption of curry meal would improve endothelial function in healthy men.
METHODS
Fourteen healthy male subjects (BMI 23.7 ± 2.7 kg/m2; age 45 ± 9 years) were given a single serving of curry meal or spice-free control meal (180 g of curry or control and 200 g of cooked rice; approximately 500 kcal in total) in a randomized, controlled crossover design. Before and 1 hr after the consumption, fasting and postprandial flow-mediated vasodilation (FMD) responses and other parameters were measured.
RESULTS
The consumption of the control meal decreased FMD from 5.8 ± 2.4% to 5.1 ± 2.3% (P = 0.039). On the other hand, the consumption of the curry meal increased FMD from 5.2 ± 2.5% to 6.6 ± 2.0% (P = 0.001), and the postprandial FMD after the curry meal was higher than that after the control meal (P = 0.002). Presence of spices in the curry did not alter significantly the systemic and forearm hemodynamics, or any biochemical parameters including oxidative stress markers measured.
CONCLUSIONS
These findings suggest that the consumption of curry ameliorates postprandial endothelial function in healthy male subjects and may be beneficial for improving cardiovascular health.
TRIAL REGISTRATION
UMIN Clinical Trials Registry 000012012. | 1significant effect
|
3,491,047 | 23,061,875 | BACKGROUND
The implementation of evidence based clinical practice guidelines on self-management interventions to patients with chronic diseases is a complex process. A multifaceted strategy may offer an effective knowledge translation (KT) intervention to promote knowledge uptake and improve adherence in an effective walking program based on the Ottawa Panel Evidence Based Clinical Practice Guidelines among individuals with moderate osteoarthritis (OA).
METHODS
A single-blind, randomized control trial was conducted. Patients with mild to moderate (OA) of the knee (n=222) were randomized to one of three KT groups: 1) Walking and Behavioural intervention (WB) (18 males, 57 females) which included the supervised community-based aerobic walking program combined with a behavioural intervention and an educational pamphlet on the benefits of walking for OA; 2) Walking intervention (W) (24 males, 57 females) wherein participants only received the supervised community-based aerobic walking program intervention and the educational pamphlet; 3) Self-directed control (C) (32 males, 52 females) wherein participants only received the educational pamphlet. One-way analyses of variance were used to test for differences in quality of life, adherence, confidence, and clinical outcomes among the study groups at each 3 month assessment during the 12-month intervention period and 6-month follow-up period.
RESULTS
Short-term program adherence was greater in WB compared to C (p<0.012) after 3 months. No statistical significance (p> 0.05) was observed for long-term adherence (6 to 12 months), and total adherence between the three groups. The three knowledge translation strategies demonstrated equivalent long-term results for the implementation of a walking program for older individuals with moderate OA. Lower dropout rates as well as higher retention rates were observed for WB at 12 and 18 months.
CONCLUSION
The additional knowledge translation behavioural component facilitated the implementation of clinical practice guidelines on walking over a short-term period. More studies are needed to improve the long-term walking adherence or longer guidelines uptake on walking among participants with OA. Particular attention should be taken into account related to patient's characteristic and preference. OA can be managed through the implementation of a walking program based on clinical practice guidelines in existing community-based walking clubs as well as at home with the minimal support of an exercise therapist or a trained volunteer.
TRIAL REGISTRATION
Current Controlled Trials IRSCTNO9193542. | 0no significant effect
|
2,920,262 | 20,682,030 | BACKGROUND
Despite optimal pharmacological therapy and pulmonary rehabilitation, patients with COPD continue to be breathless. There is a need to develop additional strategies to alleviate symptoms. Learning to sing requires control of breathing and posture and might have benefits that translate into daily life.
METHODS
To test this hypothesis we performed a randomised controlled trial, comparing a six week course of twice weekly singing classes to usual care, in 28 COPD patients. The experience of singing was assessed in a qualitative fashion, through interviews with a psychologist. In addition, we surveyed patients with chronic respiratory conditions who participated in a series of open singing workshops.
RESULTS
In the RCT, the physical component score of the SF36 improved in the singers (n = 15) compared to the controls (n = 13); +7.5(14.6) vs. -3.8(8.4) p = 0.02. Singers also had a significant fall in HAD anxiety score; -1.1(2.7) vs. +0.8(1.7) p = 0.03. Singing did not improve single breath counting, breath hold time or shuttle walk distance. In the qualitative element, 8 patients from the singing group were interviewed. Positive effects on physical sensation, general well-being, community/social support and achievement/efficacy emerged as common themes. 150 participants in open workshops completed a questionnaire. 96% rated the workshops as "very enjoyable" and 98% thought the workshop had taught them something about breathing in a different way. 81% of attendees felt a "marked physical difference" after the workshop.
CONCLUSION
Singing classes can improve quality of life measures and anxiety and are viewed as a very positive experience by patients with respiratory disease; no adverse consequences of participation were observed.
TRIAL REGISTRATION
Current Controlled Trials--ISRCTN17544114. | 1significant effect
|
3,577,738 | 23,437,310 | OBJECTIVE
Internet-delivered interventions can effectively change health risk behaviors and their determinants, but adherence to intervention websites once they are accessed is very low. This study tests whether and how social presence elements can increase website use.
METHODS
A website about Hepatitis A, B, and C virus infections was used in a preparatory lab-based eye-tracking study assessing whether social presence elements attract participants' attention, because this is a prerequisite for affecting website use. In the following field study, 482 participants representative of the Dutch population were randomized to either a website with or a website without social presence elements. Participants completed a questionnaire of validated measures regarding user perceptions immediately after exposure to the website. Server registrations were used to assess website use.
RESULTS
Participants in the experimental condition focused on the social presence elements, both in terms of frequency (F(1, 98) = 40.34, p<.001) and duration (F(1, 88) = 39.99, p<.001), but did not differ in website use in comparison with the control condition; neither in terms of the number of pages visited (t(456) = 1.44, p = .15), nor in terms of time on the website (t(456) = 0.01, p = .99).
CONCLUSIONS
Adding social presence elements did not affect actual use of an intervention website within a public health context. Possible reasons are limited attention for these elements in comparison with the main text and the utilitarian value of intervention websites. | 0no significant effect
|
5,003,313 | 27,625,757 | BACKGROUND
The restless legs syndrome is a sensorimotor disorder that is very common in patients on hemodialysis. Due to pharmacological treatments which have their own side effects, nowadays, studies have turned to non-pharmacological treatments.
OBJECTIVES
The present study aims to assess the effect of stretching exercises on the severity of restless legs syndrome in patients on hemodialysis.
PATIENTS AND METHODS
This clinical trial study was conducted on 33 patients who had been identified using diagnostic criteria from the hemodialysis ward of Hasheminejad Hospital in Tehran. Participants were randomly divided into the intervention group (n = 17) and control group (n = 16). Stretching exercises were performed on legs during the dialysis for half an hour, three times a week for 8 weeks in intervention group. Data were collected by using the international restless legs syndrome study group scale.
RESULTS
The results showed that the majority of participants were suffering from moderate restless legs syndrome. The symptom severity of this syndrome meaningfully changed eight weeks after intervention in the intervention group compared to the control group (P < 0.001).
CONCLUSIONS
The results highlighted the significance of training and performing the stretching exercises during dialysis for the purpose of improving restless legs syndrome symptoms and the quality of care of hemodialysis patients. | 1significant effect
|
3,895,597 | 24,466,452 | BACKGROUND/AIMS
Antispasmodics such as octylonium are widely used to manage irritable bowel syndrome (IBS) symptoms. However, the efficacy and safety of another antispasmodic, tiropramide, remain uncertain. We aimed to evaluate the efficacy and safety of tiropramide compared with octylonium in patients with IBS.
METHODS
In this multicenter, randomized, non-inferiority trial, 287 patients with IBS (143 receiving tiropramide and 144 octylonium) were randomly allocated to either tiropramide 100 mg or octylonium 20 mg t.i.d (means 3 times a day) for 4 weeks. Primary endpoint was the mean change of abdominal pain from baseline assessed by visual analogue scales (VAS) score after 4 weeks of treatment. Secondary endpoints were the changes in abdominal pain from baseline at week 2 and in abdominal discomfort at weeks 2 and 4, using VAS scores, patient-reported symptom improvement including stool frequency and consistency, using symptom diaries, IBS-quality of life (IBS-QoL), and depression and anxiety, at week 4.
RESULTS
The VAS scores of abdominal pain at week 4, were significantly decreased in both tiropramide and octylonium groups, but the change from baseline did not differ between the 2 groups (difference,-0.26 mm; 95% CI,-4.33-3.82; P = 0.901). Abdominal pain and discomfort assessed using VAS scores, diaries, and IBS-QoL were also improved by both treatments, and the changes from baseline did not differ. The incidence of adverse events was similar in the 2 groups, and no severe adverse events involving either drug were observed.
CONCLUSIONS
Tiropramide is as effective as octylonium in managing abdominal pain in IBS, with a similar safety profile. | 0no significant effect
|
5,101,425 | 27,847,701 | BACKGROUND
Coronary artery bypass grafting (CABG) is a common surgical intervention at the end-stages of coronary artery occlusion disease. Despite the effectiveness of CABG, it may have particular complications, such as bleeding during and after surgery. So far, there have been many drugs used to reduce bleeding.
OBJECTIVES
This study aimed at investigating the effects of desmopressin on the amount of bleeding in patients undergoing CABG with a cardiopulmonary bypass pump (CPBP) who were taking anti-platelet medicine.
METHODS
One hundred patients scheduled for elective CABG with a CPBP were included in a prospective, placebo-controlled, double-blinded clinical trial study. They were randomly divided into two groups. One group received desmopressin (40 μg) and the other group received a placebo (isotonic saline). Seven patients were excluded from the study, and 47 and 46 patients participated in the desmopressin and control groups, respectively. The methods of monitoring and the anesthetic techniques were similar in both groups, and all surgeries were performed by one surgeon. Variables including age, gender, pump time, aortic clamp time, duration of surgery, complications (e.g., nausea and vomiting, blood pressure changes), the necessity to receive blood products, and coagulation tests (prothrombin time, partial thromboplastin time, international normalized ratio, and bleeding time) were assessed. Data were statistically analyzed with SPSS software version 17.
RESULTS
There was no significant difference between the groups regarding age, gender, pump time, clamp time, duration of surgery, complications, and the changes in hemoglobin and coagulation test measurements (P > 0.05). No significant difference was noted between the groups regarding the rate of bleeding after surgery (359.3 ± 266.2 in group D vs. 406.3 ± 341.6 in group P (control group); P = 0.208). However, the platelet changes after surgery in both groups were significantly different. The analysis revealed that the rate of thrombocytopenia after surgery was higher in the control group (P = 0.012).
CONCLUSIONS
Our study showed that desmopressin could not reduce the amount of blood loss after CABG. Also, desmopressin did not have a significant effect on coagulation status. Therefore, based on the results of our study, it seems that the use of this medication cannot be a helpful for patients with any indication for CABG. | 1significant effect
|
3,742,017 | 23,951,557 | BACKGROUND
By school age, even low risk moderately preterm-born children show more neuro-cognitive deficits, underachievement, behavioral problems, and poor social adaptation than full-term peers.
AIM
To evaluate the outcomes at school-age for moderately preterm-born children (29-33 weeks gestational age), appropriate in growth for gestational age (AGA) and medically at low-risk, randomized to Newborn Individualized Developmental Care and Assessment Program (NIDCAP) or standard care in the Newborn Intensive Care Unit. At school-age, the experimental (E) group will show better neuropsychological and neuro-electrophysiological function, as well as improved brain structure than the control (C) group.
MATERIALS AND METHODS
The original sample consisted of 30 moderately preterm-born infants (29 to 33 weeks), 23 (8C and 15E) of them were evaluated at 8 years of age, corrected-for-prematurity with neuropsychological, EEG spectral coherence, and diffusion tensor magnetic resonance imaging (DT MRI) measures.
RESULTS
E-performed significantly better than C-group children on the Kaufman Assessment Battery for Children-Second Edition (KABC-II) and trended towards better scores on the Rey-Osterrieth Complex Figure Test. They also showed more mature frontal and parietal brain connectivities, and more mature fiber tracts involving the internal capsule and the cingulum. Neurobehavioral results in the newborn period successfully predicted neuropsychological functioning at 8 years corrected age.
CONCLUSION
Moderately preterm infants cared for with the NIDCAP intervention showed improved neuropsychological and neuro-electrophysiological function as well as improved brain structure at school-age. | 1significant effect
|
5,100,099 | 27,821,162 | BACKGROUND
Neurally Adjusted Ventilatory Assist (NAVA) is a mode of assisted mechanical ventilation that delivers inspiratory pressure proportionally to the electrical activity of the diaphragm. To date, no pediatric study has focused on the effects of NAVA on hemodynamic parameters. This physiologic study with a randomized cross-over design compared hemodynamic parameters when NAVA or conventional ventilation (CV) was applied.
METHODS
After a baseline period, infants received NAVA and CV in a randomized order during two consecutive 30-min periods. During the last 10 min of each period, respiratory and hemodynamic parameters were collected. No changes in PEEP, FiO 2 , sedation or inotropic doses were allowed during these two periods. The challenge was to keep minute volumes constant, with no changes in blood CO 2 levels and in pH that may affect the results.
RESULTS
Six infants who had undergone cardiac surgery (mean age 7.8 ± 4.1 months) were studied after parental consent. Four of them had low central venous oxygen saturation (ScvO 2 < 65 %). The ventilatory settings resulted in similar minute volumes (1.7 ± 0.4 vs. 1.6 ± 0.6 ml/kg, P = 0.67) and in similar tidal volumes respectively with NAVA and with CV. There were no statistically significant differences on blood pH levels between the two modes of ventilation (7.32 ± 0.02 vs. 7.32 ± 0.04, P = 0.34). Ventilation with NAVA delivered lower peak inspiratory pressures than with CV: -32.7 % (95 % CI: -48.2 to -17.1 %, P = 0.04). With regard to hemodynamics, systolic arterial pressures were higher using NAVA: +8.4 % (95 % CI: +3.3 to +13.6 %, P = 0.03). There were no statistically significant differences on cardiac index between the two modes of ventilation. However, all children with a low baseline ScvO 2 (<65 %) tended to increase their cardiac index with NAVA compared to CV: 2.03 ± 0.30 vs. 1.91 ± 0.39 L/min.m 2 (median ± interquartile, P = 0.07).
CONCLUSIONS
This pilot study raises the hypothesis that NAVA could have beneficial effects on hemodynamics in children when compared to a conventional ventilatory mode that delivered identical PEEP and similar minute volumes.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01490710 . Date of registration: December 7, 2011. | 0no significant effect
|
4,940,009 | 27,462,175 | OBJECTIVE
Despite the many complications of succinylcholine, it is still widely used as a superior muscle relaxant for rapid sequence induction. One of these complications is postoperative myalgia (POM). The aim of this study was to investigate the prophylactic effect of low-dose ketamine on the incidence and severity of POM.
MATERIALS AND METHODS
In this double-blind clinical study, a total of 148 patients scheduled for general anesthesia were randomly divided into two equal groups. Initially, in Group K, 0.5 mg/kg of ketamine was injected intravenously, whereas in Group N, the same volume (5 mL) of normal saline was injected. Thereafter, anesthesia was induced in all patients, by injecting 1.5 mg/kg of fentanyl and 2 mg/kg of propofol intravenously. Following the loss of eyelid reflex, 1.5 mg/kg of succinylcholine was injected intravenously as a muscle relaxant and then the patients were intubated. POM was defined as a pain with no surgical interferences, and its intensity was graded based on a four-point scale. The incidence and severity of myalgia were assessed by a blinded observer 24 hours after surgery.
RESULTS
In terms of demographic data, the results of this study showed that there is no significant difference between patients in both groups (P>0.05). Overall, the incidence of POM in Group K was significantly less, when compared with Group N (P<0.05), but both groups were comparable based on the grade 2 of POM. After the induction of anesthesia, the systolic and diastolic blood pressure values were found to reduce in both groups (P<0.05). However, the changes were somehow similar, and repeated measures of variance analysis showed no significant difference in the two study groups (P>0.05).
CONCLUSION
The addition of 0.5 mg/kg of ketamine to propofol for the induction of anesthesia can be effective in reducing the incidence of low-grade POM. | 0no significant effect
|
5,489,138 | 28,680,915 | OBJECTIVE
To assess the comparative utility of disability progression measures in primary progressive MS (PPMS) using the PROMiSe trial data set.
METHODS
Data for patients randomized to placebo (n = 316) in the PROMiSe trial were included in this analysis. Disability was assessed using change in single (Expanded Disability Status Scale [EDSS], timed 25-foot walk [T25FW], and 9-hole peg test [9HPT]) and composite disability measures (EDSS/T25FW, EDSS/9HPT, and EDSS/T25FW/9HPT). Cumulative and cross-sectional unconfirmed disability progression (UDP) and confirmed disability progression (CDP; sustained for 3 months) rates were assessed at 12 and 24 months.
RESULTS
CDP rates defined by a ≥20% increase in T25FW were higher than those defined by EDSS score at 12 and 24 months. CDP rates defined by T25FW or EDSS score were higher than those defined by 9HPT score. The 3-part composite measure was associated with more CDP events (41.4% and 63.9% of patients at 12 and 24 months, respectively) than the 2-part measure (EDSS/T25FW [38.5% and 59.5%, respectively]) and any single measure. Cumulative UDP and CDP rates were higher than cross-sectional rates.
CONCLUSIONS
The T25FW or composite measures of disability may be more sensitive to disability progression in patients with PPMS and should be considered as the primary endpoint for future studies of new therapies. CDP may be the preferred measure in classic randomized controlled trials in which cumulative disability progression rates are evaluated; UDP may be feasible for cross-sectional studies. | 1significant effect
|
5,936,036 | 29,736,130 | BACKGROUND
We have developed a structured cognitive behavioral therapy manual for anxiety disorder in China, and the present study evaluated the applicability of simplified cognitive behavioral therapy based on our previous research.
AIMS
To evaluate the applicability of simplified cognitive behavioral therapy (SCBT) on generalized anxiety disorder (GAD) by conducting a multi-center controlled clinical trial.
METHODS
A multi-center controlled clinical trial of SCBT was conducted on patients with GAD, including institutions specializing in mental health and psychiatry units in general hospitals. The participants were divided into 3 groups: SCBT group, SCBT with medication group and medication group. The drop-out rates of these three groups, the therapy satisfaction of patients who received SCBT and the evaluation of SCBT from therapists were compared.
RESULTS
(1) There was no significant difference among the drop-out rates in the three groups. (2) Only the duration and times of therapy were significantly different between the two groups of patients who received the SCBT, and the therapy satisfaction of the SCBT group was higher than that of the SCBT with medication group. (3) Eighteen therapists who conducted the SCBT indicated that the manual was easy to comprehend and operate, and this therapy could achieve the therapy goals.
CONCLUSION
The applicability of SCBT for patients with GAD is relatively high, and it is hopeful that SCBT can become a psychological treatment which can be applied in medical institutions of various levels. | 0no significant effect
|
3,296,686 | 22,412,837 | BACKGROUND
Insulin resistance (IR) is induced by chronic hepatitis C virus (HCV) genotypes 1 and 4 infections. It is not known whether drugs that affect IR such as Pioglitazone and Prednisone also affect serum HCV RNA titers independently of PEG-Interferon-α2/ribavirin treatment. The primary aim was to assess whether Pioglitazone by improving IR and/or inflammation decreases HCV viral load independently of standard of care HCV treatment. A secondary aim was to assess whether Prednisone, a drug that induces insulin resistance and stimulates HCV viral entry and replication in replicon culture systems, increases HCV viral load in this population.
METHODOLOGY/PRINCIPAL FINDINGS
We designed a two-arm, parallel Pilot Study of overweight, treatment naïve genotype 4 HCV-infected patients at a public referral Liver Clinic in Giza, Egypt. The subjects received Pioglitazone (30 mg/day for 14 days) or Prednisone (40 mg/day for 4 days) in a randomized fashion, but the two arms can be considered independent pilot studies. Only changes from baseline within each arm were assessed and no contrasts of the interventions were made, as this was not an aim of the study. Among 105 consecutive HCV genotype 4 patients, 39 were enrolled based on the optimal sample size and power analysis according to the CONSORT statement; 20 to the Pioglitazone group and 19 to the Prednisone group. Pioglitazone was effective in decreasing serum HCV RNA at day-14 (n = 10; difference of means = 205,618 IU/ml; 95% CI 26,600 to 384,600; P<0.001). Although Prednisone did increase serum HCV RNA at day-4 (n = 10; change from baseline = -42,786 IU/ml; 95% CI -85,500 to -15,700; P = 0.049), the log(10) HCV RNA titers were statistically not different from baseline day-0.
CONCLUSION/SIGNIFICANCE
This is the first documentation that Pioglitazone decreases the serum HCV RNA titers independently of PEG-Interferon-α2/ribavirin treatment. The novel findings of our Study provide the foundation for basic and clinical investigations on the molecular mechanisms responsible for the Pioglitazone-induced decrease in HCV genotype 4 RNA titers.
TRIAL REGISTRATION
ClinicalTrials.gov NCT01157975. | 1significant effect
|
4,821,313 | 27,054,007 | INTRODUCTION
The rapid decline in renal function caused by radiographic contrast agents usually is transient, but it can result in chronic kidney disease. The pathophysiology of contrast-induced nephropathy (CIN) is poorly understood, but it may include acute hypoxia-induced oxidative stress and free radicals generated within the acid environment of the renal medulla. Thus, the alkalization of urine by sodium bicarbonate has been regarded as resulting in the reduction of CIN. The aim of this study was to determine whether a long-duration sodium bicarbonate regimen is more effective than a short-duration regimen in reducing CIN.
METHODS
One hundred patients were assigned randomly to treatment with sodium bicarbonate solution using either the short regimen (intravenous bolus 3 mL/kg/h of 166 mEq/L sodium bicarbonate for 1 hour immediately before radiocontrast) or the long regimen (initial intravenous bolus of 3 mL/kg/h of 166 mEq/L sodium bicarbonate for 6 hr). Patients with renal dysfunction (estimated glomerular filtration rate [eGFR], 60 mL/min/1.73 m(2) or less) who underwent elective or emergent coronary angiography (CAG) with/without percutaneous coronary intervention (PCI) at Nephrology Department (Theodor Bilharz Research Institute) were enrolled in the study. Data were analyzed by SPSS version 12, using Kruskal Wallis, ANOVA, Chi square test and Spearman rank correlation coefficient.
RESULTS
There was a significant increase in serum creatinine and a decrease in eGFR 48 hr post-intervention in group 1 (short regimen) with no statically difference regarding those parameters group 2 (long regimen). Serum potassium clearly was decreased significantly post procedure in both groups.
CONCLUSIONS
The results of our study indicated that the long regimen of bicarbonate supplementation was a more effective strategy to prevent CIN than the short regimen. | 1significant effect
|
5,002,324 | 27,568,011 | BACKGROUND
The present study examined the effects of a balance-based exergaming intervention using the Kinect sensor on postural stability and balance in people with Parkinson's disease (PD).
METHODS
We conducted a subject-blinded, randomized controlled study. Twenty people with PD (Hoehn and Yahr stages I through III) were recruited and randomly assigned to either a balance-based exergaming group (N = 10) or a balance training group (N = 10) for an 8-week balance training period. Postural stability was assessed using the limits of stability (LOS) and one-leg stance (OLS) tests. Balance was assessed using the Berg Balance Scale (BBS) and the timed up and go (TUG) test. Participants were assessed pre- and post-training.
RESULTS
After training, participants in the balance-based exergaming group showed significant improvements in LOS performance, and in the eyes-closed condition of the OLS test. Both training programs led to improvements in BBS and TUG performance. Furthermore, balance-based exergaming training resulted in significantly better performance in directional control in the LOS test (78.9 ± 7.65 %) compared with conventional balance training (70.6 ± 9.37 %).
CONCLUSIONS
Balance-based exergaming training resulted in a greater improvement in postural stability compared with conventional balance training. Our results support the therapeutic use of exergaming aided by the Kinect sensor in people with PD.
TRIAL REGISTRATION
ClinicalTrials.gov. NCT02671396. | 1significant effect
|
4,306,068 | 25,635,196 | BACKGROUND
Acute pain assessment in the emergency department (ED) is important in particular during the triage process. Early pain assessment and management improve outcome. The objective of this study was to determine the effects of documentation and display of patient's self-assessment of pain using numerical rating scale (NRS) on analgesic use among adult trauma patients in ED.
METHODS
A randomized control trial was conducted recruiting 216 trauma patients who presented to ED of two tertiary centers. Pain score was done using NRS for all patients. They were randomized into pain score display group or not displayed in the control. The outcome measured were proportion of patients receiving analgesics and timing from triage to analgesic administration.
RESULTS
The proportion of patients who received analgesics when pain score was displayed was 6.5% more than when pain score was not displayed. This difference was however not statistically significant. However, stratified categorical analysis using chi-square showed that the displayed severe pain group was 1.3 times more likely to receive analgesics compared to the non-displayed group. The mean timing to analgesic administration for the displayed and non-displayed groups were 81.3 ± 41.2 (95% C.I 65.9, 96.7) and 88.7 ± 45.4 (95% C.I 69.0, 108.3), respectively (p > 0.05).
CONCLUSIONS
The proportion of patients who received analgesics increased when NRS was displayed. However, the pain display has no significant effect on the timing of analgesics. | 0no significant effect
|
5,018,157 | 27,642,568 | BACKGROUND
Despite controversies about the safest anesthetic technique for cesarean delivery in severely preeclamptic women, there is evidence that supports the use of spinal anesthesia in this group of patients.
OBJECTIVES
This prospective randomized clinical trial was designed to determine the hemodynamic effects of low-dose spinal bupivacaine and the incidence of spinal anesthesia-associated hypotension in severely preeclamptic and healthy parturients undergoing cesarean sections.
PATIENTS AND METHODS
Spinal anesthesia was performed with 10 mg (= 2 mL) hyperbaric 0.5% bupivacaine plus 2.5 µg sufentanil in two groups of patients after they received 500 mL of IV lactated Ringer's solution. Heart rate and blood pressure were recorded before spinal anesthesia and at two minutes intervals for 15 minutes after the block, and then every five minutes until the end of the surgery. Hypotension was defined as more than 25% of decline in the mean arterial blood pressure compared to the baseline in both groups (or systolic blood pressure < 100 mmHg in healthy parturients) and was treated with 5 mg IV ephedrine. The total amounts of intravenous administered fluid and the total doses of ephedrine were recorded for each patient as well.
RESULTS
The incidence rate of hypotension among the preeclamptic patients was lower than that of the healthy parturients, despite the former group receiving smaller volumes of intravenous fluids (P < 0.05). The total doses of IV ephedrine for treating hypotension were significantly lower among the preeclamptic patients (3.2 mg in preeclamptic patients versus 7.6 mg in normotensive patients) (P = 0.02). The one-minute Apgar score was significantly lower for the preeclamptic parturients (8.4 ± 0.7 versus 7.2 ± 1.5) (P = 0.001), but there was no significant difference in the five-minute Apgar scores between the two groups.
CONCLUSIONS
Our results confirm that low-dose bupivacaine spinal anesthesia is associated with a lower risk of hypotension than previously believed, and it can therefore be safely used in severe preeclamptic women undergoing cesarean delivery. | 0no significant effect
|
4,895,766 | 27,313,426 | INTRODUCTION
Prevalence of diabetes and its complications have been a burden to the society from the ancient times, in the present and also will be in the future unless proper measures are taken to prevent its manifestation. There have been an increasing number of death associated-amputation cases which are mainly caused by nonhealing wounds. These facts urge researchers to develop new, more effective wound treatments for diabetic patients.
AIM
To evaluate and compare the effect of Katupila Kalka (Securinega leucopyrus [Willd.] Muell. leaf paste) and Tila Taila (Sesamum indicum oil) in Madhumehajanya Vrana (diabetic wounds/ulcers) with Betadine ointment.
MATERIALS AND METHODS
A total of 23 patients of Madhumehajanya Vrana were chosen and randomly divided into two groups (Group A and B). Patients of Group A were treated with local application of Katupila Kalka with Tila Taila, whereas, in Group B, Betadine ointment was applied on the affected parts, once a day in the morning for 30 days. The relief in signs and symptoms were assessed on scoring pattern.
RESULTS
In Group A, diabetic wounds treated with Katupila paste got healed within 28 days with minimal scar formation without any complications, whereas in Group B, wound was healed completely only in two patients within 28 days. In both the groups, no patients reported any adverse drug reaction during the entire course of treatment as well as in follow-up period.
CONCLUSION
Study concluded that the drug Katupila Kalka possesses Vrana Ropana (wound healing) activity with fine scaring. | 1significant effect
|
5,626,376 | 29,026,341 | PURPOSE
To assess the effectiveness of viscosupplementation or platelet-rich plasma (PRP), compared to standard care, for pain relief after knee arthroscopic debridement in patients with meniscal pathology and osteoarthritis (OA), under normal clinical practice conditions.
PATIENTS AND METHODS
We conducted a prospective, randomized, evaluator-blind, pilot study. After arthroscopy, patients were randomized to receive 1) five injections of HA1 (Suprahyal ® /Adant ® ); 2) four injections of HA2 (Orthovisc ® ); 3) three injections of HA3 (Synvisc ® ); 4) a single injection of PRP (GPS™ II); or 5) standard care (control). Patients were followed up for 18 months. Clinical outcomes were evaluated using the Western Ontario and McMaster Universities Arthritis Index (WOMAC) at 3, 6, 12, and 18 months. Minimally Clinical Important Improvement (MCII), as relative improvement ≥20 for pain and function, was also calculated.
RESULTS
Fifty patients were included. At early follow-up (3 months), total WOMAC scores improved in all groups compared to baseline with reductions of 44.79% (HA1), 24.02% (HA2), 40.38% (HA3), 39.77% (PRP), and 27.64% (control) ( p =0.002 HA1 compared to HA2). At 18 months, the higher improvement in total WOMAC was in HA1 with a 65.20% reduction, followed by PRP (55.01%), HA3 (49.57%), and HA2 (29.82%), whereas the control group had a 14.55% increase over baseline ( p =0.001 control compared to HA1 and HA3). The percentage of patients achieving the MCII for both pain and function at 18 months was 100% (HA1), 80% (HA3), 60% (HA2), and 60% (PRP), whereas, in the control group, all patients returned to pre-arthroscopy levels. There were no adverse events attributable to surgery or to intraarticular administration.
CONCLUSION
Viscosupplementation following arthroscopy is more effective than PRP in adequately selected patients with meniscal lesions occurring concomitantly with OA. Further controlled studies with a larger sample size and/or alternative regimens would be of interest for the scientific community. | 1significant effect
|
4,713,214 | 26,816,685 | BACKGROUND
Resiniferatoxin (RTX) has been shown to have variable efficacy in the treatment of intractable lower urinary tract symptoms and symptoms associated with neurogenic detrusor overactivity. It has also been used successfully in treating overactive bladder (OAB). In order to evaluate the potential and efficiency of RTX in treatment of catheter related bladder discomfort (CRBD) over post-operative period of transurethral resection of the prostate (TURP), we conducted the current pilot, randomized open study.
METHODS
The study was comprised of 48 patients undergoing TURP in a single institute from September 2007 to September 2008. Patients were randomly divided into Group-RTX and Group-control. CRBD was classified into 4 degrees: degree 0, 1, 2, and 3. Patients with the most severed CRBD (degree-3) were treated with tolterodine.
RESULTS
There were no statistical difference of patients' age, prostate volume, IPSS score, storage score and void score in IPSS, and QOL score between the two study groups(P=0.213, 0.356, 0.471, 0.554, 0.055 and 0.380, respectively). RTX pre-treatment reduced incidence of CRBD. 25% of the patients in RTX group had CRBD, at 6 hours/1 day and 3 days after TURP, significantly lower than the control group in which 75% of the patients during the same period (P=0.001). During the three days post-operative period, RTX also reduced severity of CRBD, compared with the control group. No patient in Group RTX sufferred CRBD of degree 3, a clear contrast to the control group in which 7 patients had degree 3 CRBD, during three days post-operative. Finally, less patients in RTX group required tolterodine, compared with control, P=0.009. Interestingly, the difference of CRBD incidence between Group RTX (50%) and control (75%) diminished 5 days after TURP, P=0.135.
CONCLUSIONS
Pretreatment with intravesical resiniferatoxin significantly reduces the incidence and severity of catheter related bladder discomfort in patients after TURP. | 1significant effect
|
3,597,472 | 23,516,656 | INTRODUCTION
More than 80% of schistosomiasis patients in China live in the lake and marshland regions. The purpose of our study is to assess the effect of a comprehensive strategy to control transmission of Schistosoma japonicum in marshland regions.
METHODOLOGY/PRINCIPAL FINDINGS
In a cluster randomized controlled trial, we implemented an integrated control strategy in twelve villages from 2009 through 2011 in Gong'an County, Hubei Province. The routine interventions included praziquantel chemotherapy and controlling snails, and were implemented in all villages. New interventions, mainly consisting of building fences to limit the grazing area for bovines, building safe pastures for grazing, improving the residents' health conditions and facilities, were only implemented in six intervention villages. Results showed that the rate of S. japonicum infection in humans, bovines, snails, cow dung and mice in the intervention group decreased from 3.41% in 2008 to 0.81% in 2011, 3.3% to none, 11 of 6,219 to none, 3.9% to none and 31.7% to 1.7%, respectively (P<0.001 for all comparisons). In contrast, there were no statistically significant reductions of S. japonicum infection in humans, bovines and snails from 2008 to 2011 in the control group (P>0.05 for all comparisons). Moreover, a generalized linear model showed that there was a higher infection risk in humans in the control group than in the intervention group (OR = 1.250, P = 0.001) and an overall significant downward trend in infection risk during the study period.
CONCLUSIONS/SIGNIFICANCE
The integrated control strategy, designed to reduce the role of bovines and humans as sources of S. japonicum infection, was highly effective in controlling the transmission of S. japonicum in marshland regions in China.
TRIAL REGISTRATION
Chinese Clinical Trial Registry ChiCTR-PRC-12002405. | 1significant effect
|
4,803,984 | 26,493,430 | BACKGROUND & OBJECTIVES
Prolonged labor leads to increase of cesarean deliveries, reduction of fetal heart rate, and maternal as well as infantile complications. Therefore, many women tend to use pharmacological or non-pharmacological methods for reduction of labor length. The present study aimed to compare the effects of maternal supportive care and acupressure (at BL32 acupoint) on labor length and infant's Apgar score.
METHODS
In this clinical trial, 150 women with low-risk pregnancy were randomly divided into supportive care, acupressure, and control groups each containing 50 subjects. The data were collected using a questionnaire including demographic and pregnancy characteristics. Then, the data were analyzed using Chi-square test and one-way ANOVA.
RESULTS
The mean length of the first and second stages of labor was respectively 157.0±29.5 and 58.9±5.8 minutes in the supportive care group, 161.7±37.3 and 56.1±31.4 minutes in the acupressure group, ad 281.0±9.8 and 128.4±44.9 minutes in the control group. The difference between the length of labor stages was significant in the three study groups (P<0.001). Moreover, the frequency of Apgar score>8 in the first and 5th minutes was higher in the supportive care and acupressure groups compared to the control group, and the difference was statistically significant (P<0.001).
CONCLUSION
Continuous support and acupressure could reduce the length of labor stages and increase the infants' Apgar scores. Therefore, these methods, as effective non-pharmacological strategies, can be introduced to the medical staff to improve the delivery outcomes. | 1significant effect
|
4,132,637 | 24,727,884 | AIMS
The optimal platelet inhibition strategy for ACS patients managed without revascularization is unknown. We aimed to evaluate efficacy and safety of ticagrelor vs. clopidogrel in the non-ST-elevation acute coronary syndrome (NSTE-ACS) subgroup of the PLATO trial, in the total cohort, and in the subgroups managed with and without revascularization within 10 days of randomization.
METHODS AND RESULTS
We performed a retrospective analysis of the primary endpoint of cardiovascular death/myocardial infarction/stroke. Among 18 624 PLATO patients, 11 080 (59%) were categorized as NSTE-ACS at randomization. During the initial 10 days, 74% had angiography, 46% PCI, and 5% CABG. In NSTE-ACS patients, the primary endpoint was reduced with ticagrelor vs. clopidogrel [10.0 vs. 12.3%; hazard ratio (HR) 0.83; 95% confidence interval (CI) = 0.74-0.93], as was myocardial infarction (6.6 vs. 7.7%; HR 0.86; 95% CI = 0.74-0.99), cardiovascular death (3.7 vs. 4.9%; HR 0.77; 95% CI = 0.64-0.93), and all-cause death (4.3 vs. 5.8%; HR 0.76; 95% CI = 0.64-0.90). Major bleeding rate was similar between treatment groups (13.4 vs. 12.6%; HR 1.07; 95% CI = 0.95-1.19), but ticagrelor was associated with an increase in non-CABG major bleeding (4.8 vs. 3.8%; HR 1.28; 95% CI = 1.05-1.56). Within the first 10 days, 5366 (48.4%) patients were managed without revascularization. Regardless of revascularization or not, ticagrelor consistently reduced the primary outcome (HR 0.86 vs. 0.85, interaction P = 0.93), and all-cause death (HR 0.75 vs. 0.73, interaction P = 0.89) with no significant increase in overall major bleeding.
CONCLUSION
In patients with NSTE-ACS, benefit of ticagrelor over clopidogrel in reducing ischaemic events and total mortality was consistent with the overall PLATO trial, independent of actually performed revascularization during the initial 10 days. | 0no significant effect
|
3,636,800 | 23,563,184 | BACKGROUND
Mobile phone-based assessment may represent a cost-effective and clinically effective method of monitoring psychotic symptoms in real-time. There are several software options, including the use of native smartphone applications and text messages (short message service, SMS). Little is known about the strengths and limitations of these two approaches in monitoring symptoms in individuals with serious mental illness.
OBJECTIVE
The objective of this study was to compare two different delivery modalities of the same diagnostic assessment for individuals with non-affective psychosis-a native smartphone application employing a graphical, touch user interface against an SMS text-only implementation. The overall hypothesis of the study was that patient participants with sewrious mental illness would find both delivery modalities feasible and acceptable to use, measured by the quantitative post-assessment feedback questionnaire scores, the number of data points completed, and the time taken to complete the assessment. It was also predicted that a native smartphone application would (1) yield a greater number of data points, (2) take less time, and (3) be more positively appraised by patient participant users than the text-based system.
METHODS
A randomized repeated measures crossover design was employed. Participants with currently treated Diagnostic and Statistical Manual (Fourth Edition) schizophrenia or related disorders (n=24) were randomly allocated to completing 6 days of assessment (four sets of questions per day) with a native smartphone application or the SMS text-only implementation. There was then a 1-week break before completing a further 6 days with the alternative delivery modality. Quantitative feedback questionnaires were administered at the end of each period of sampling.
RESULTS
A greater proportion of data points were completed with the native smartphone application in comparison to the SMS text-only implementation (β = -.25, SE=.11, P=.02), which also took significantly less time to complete (β =.78, SE= .09, P<.001). Although there were no significant differences in participants' quantitative feedback for the two delivery modalities, most participants reported preferring the native smartphone application (67%; n=16) and found it easier to use (71%; n=16). 33% of participants reported that they would be willing to complete mobile phone assessment for 5 weeks or longer.
CONCLUSIONS
Native smartphone applications and SMS text are both valuable methods of delivering real-time assessment in individuals with schizophrenia. However, a more streamlined graphical user interface may lead to better compliance and shorter entry times. Further research is needed to test the efficacy of this technology within clinical services, to assess validity over longer periods of time and when delivered on patients' own phones. | 1significant effect
|
4,124,480 | 25,088,030 | BACKGROUND
The effectiveness of clinic-based pulmonary rehabilitation in advanced COPD is well established, but few data exist for less severe patients treated in alternative settings. The purpose of this study was to investigate whether a novel, community-based exercise program (CBE) was feasible and effective for patients with moderate COPD.
METHODS
Nineteen patients with moderate COPD (mean FEV1 62%) and self-reported exercise impairment were randomized to 12-weeks of progressive endurance and strength training at a local health club under the guidance of a certified personal trainer, or to continuation of unsupervised habitual physical activity. Outcomes assessed at baseline and 12 weeks included session compliance, intensity adherence, treadmill endurance time, muscle strength, dyspnea, and health status.
RESULTS
Compliance was 94% and adherence was 83%. Comparisons between CBE and control groups yielded the following mean (SEM) differences in favor of CBE: endurance time 134 (74) seconds versus -59 (49) seconds (P=0.041) and TDI 5.1 (0.8) versus -0.2 (0.5) (P<0.001). The CBE group increased muscle strength (weight lifted) by 11.8 kilograms per subject per week of training (P<0.001). SGRQ was not significantly changed.
CONCLUSIONS
We demonstrated the feasibility and effectiveness of a novel community-based exercise program involving health clubs and personal trainers for patients with moderate COPD.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier NCT01985529. | 0no significant effect
|
5,673,730 | 29,142,561 | OBJECTIVE
To evaluate and compare feto-maternal outcomes and glycemic control in metformin versus insulin treated gestational diabetics.
METHODS
The study was conducted in 2010- 2012 as a part of M. Phil at Civil hospital, Lyari General Hospital and Mamji Hospital in Karachi. After written informed consent, 71 GDM diagnosed females with WHO criteria were enrolled. They were divided into two groups. Group-A, 32 females were given oral metformin 500 mg TDS while Group-B, 39 females were given insulin 0.8-0.9 mg/kg/day in two divided doses subcutaneously. Patients were followed till term. Feto-maternal outcomes were evaluated in 25 patients in each group who completed the study.
RESULTS
When groups were compared, newborns in Group-B were significantly more in weight (p=0.01). Significant numbers of babies were delivered after 38 weeks of pregnancy in Group-B (P=0.021). There were two intrauterine deaths and significantly higher HbA 1 C at term in Group-B. (P=0.03). FBS at term was non-significant (p=0.079) and there was more number of cesarean sections due to feto-maternal disproportion in Group-B (28% vs.2%). Results analyzed for glycemic control before and after the treatment revealed that FBS was statistically less in Group-A (p=0.00) whereas for Group-B the value of FBS and HbA 1 C was statistically high. (p=0.002 & 0.04 respectively).
CONCLUSION
Metformin has produced better effects on feto-maternal outcomes and glycemic control in comparison to Insulin in GDM. | 1significant effect
|
2,694,465 | 19,488,583 | OBJECTIVES
To evaluate the effects of intrathecal morphine on pulmonary function, analgesia, and morphine plasma concentrations after cardiac surgery.
INTRODUCTION
Lung dysfunction increases morbidity and mortality after cardiac surgery. Regional analgesia may improve pulmonary outcomes by reducing pain, but the occurrence of this benefit remains controversial.
METHODS
Forty-two patients were randomized for general anesthesia (control group n=22) or 400 microg of intrathecal morphine followed by general anesthesia (morphine group n=20). Postoperative analgesia was accomplished with an intravenous, patient-controlled morphine pump. Blood gas measurements, forced vital capacity (FVC), forced expiratory volume (FEV), and FVC/FEV ratio were obtained preoperatively, as well as on the first and second postoperative days. Pain at rest, profound inspiration, amount of coughing, morphine solicitation, consumption, and plasma morphine concentration were evaluated for 36 hours postoperatively. Statistical analyses were performed using the repeated measures ANOVA or Mann-Whiney tests (*p<0.05).
RESULTS
Both groups experienced reduced FVC postoperatively (3.24 L to 1.38 L in control group; 2.72 L to 1.18 L in morphine group), with no significant decreases observed between groups. The two groups also exhibited similar results for FEV1 (p=0.085), FEV1/FVC (p=0.68) and PaO2/FiO2 ratio (p=0.08). The morphine group reported less pain intensity (evaluated using a visual numeric scale), especially when coughing (18 hours postoperatively: control group= 4.73 and morphine group= 1.80, p=0.001). Cumulative morphine consumption was reduced after 18 hours in the morphine group (control group= 20.14 and morphine group= 14.20 mg, p=0.037). The plasma morphine concentration was also reduced in the morphine group 24 hours after surgery (control group= 15.87 ng.mL-1 and morphine group= 4.08 ng.mL-1, p=0.029).
CONCLUSIONS
Intrathecal morphine administration did not significantly alter pulmonary function; however, it improved patient analgesia and reduced morphine consumption and morphine plasma concentration. | 1significant effect
|
5,506,592 | 28,699,550 | BACKGROUND
Dengue is a serious public health issue that affects households in endemic areas in terms of health and also economically, imposing costs for prevention and treatment of cases. The Camino Verde cluster-randomised controlled trial in Mexico and Nicaragua assessed the impact of evidence-based community engagement in dengue prevention. The Mexican arm of the trial was conducted in 90 randomly selected communities in three coastal regions of Guerrero State. This study reports an analysis of a secondary outcome of the trial: household use of and expenditure on anti-mosquito products. We examined whether the education and mobilisation activities of the trial motivated people to spend less on anti-mosquito products.
METHODS
We carried out a household questionnaire survey in the trial communities in 2010 (12,312 households) and 2012 (5349 households in intervention clusters, 5142 households in control clusters), including questions about socio-economic status, self-reported dengue illness, and purchase of and expenditure on insecticide anti-mosquito products in the previous month. We examined expenditures on anti-mosquito products at baseline in relation to social vulnerability and we compared use of and expenditures on these products between intervention and control clusters in 2012.
RESULTS
In 2010, 44.2% of 12,312 households reported using anti-mosquito products, with a mean expenditure of USD4.61 per month among those who used them. Socially vulnerable households spent less on the products. In 2012, after the intervention, the proportion of households who purchased anti-mosquito products in the last month was significantly lower in intervention clusters (47.8%; 2503/5293) than in control clusters (53.3%; 2707/5079) (difference - 0.05, 95% CIca -0.100 to -0.010). The mean expenditure on the products, among those households who bought them, was USD6.43; 30.4% in the intervention clusters and 36.7% in the control clusters spent more than this (difference - 0.06, 95% CIca -0.12 to -0.01). These expenditures on anti-mosquito products represent 3.3% and 3.8% respectively of monthly household income for the poorest 10% of the population in 2012.
CONCLUSIONS
The Camino Verde community mobilisation intervention, as well as being effective in reducing dengue infections, was effective in reducing household use of and expenditure on insecticide anti-mosquito products.
TRIAL REGISTRATION
( ISRCTN27581154 ). | 1significant effect
|
3,466,198 | 23,056,520 | BACKGROUND
Acidform gel, an acid-buffering product that inactivates spermatozoa, may be an effective topical non-hormonal contraceptive. This study was designed to evaluate the safety of vaginal dosing and effects of Acidform on mucosal immune mediators, antimicrobial properties of genital secretions, and vaginal microbiota.
METHODS
Thirty-six sexually abstinent U.S. women were randomized to apply Acidform or hydroxyethylcellulose (HEC) placebo gel twice daily for 14 consecutive days. Safety was assessed by symptoms and pelvic examination. The impact of gel on mucosal immunity was assessed by quantifying cytokines, chemokines, antimicrobial proteins and antimicrobial activity of genital secretions collected by cervicovaginal lavage (CVL) at screening, 2 hours after gel application, and on days 7, 14 and 21. Vaginal microbiota was characterized at enrollment and day 14 using species-specific quantitative PCR assays.
RESULTS
The median vaginal and cervical pH was significantly lower 2 hours after application of Acidform and was associated with an increase in the bactericidal activity of CVL against E. coli. However, 65% of women who received Acidform had at least one local adverse event compared with 11% who received placebo (p = 0.002). While there was no increase in inflammatory cytokines or chemokines, CVL concentrations of lactoferrin and interleukin-1 receptor antagonist (IL-1ra), an anti-inflammatory protein, were significantly lower following Acidform compared to HEC placebo gel application. There were no significant changes in Lactobacillus crispatus or Lactobacillus jensenii in either group but there was a decrease in Gardnerella vaginalis in the Acidform group (p = 0.08).
CONCLUSIONS
Acidform gel may augment mucosal defense as evidenced by an increase in bactericidal activity of genital secretions against E. coli and a decrease in Gardnerella vaginalis colonization. However, Acidform was associated with more irritation than placebo and lower levels of antimicrobial (lactoferrin) and anti-inflammatory (IL-1ra) proteins. These findings indicate the need for additional safety studies of this candidate non-hormonal contraceptive.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00850837. | 0no significant effect
|
3,056,193 | 21,431,013 | INTRODUCTION
This paper describes a fictitious study of a fictitious drug. A companion paper in this issue of the Indian J Psychiatry critically examines this paper and provides author, reader, reviewer, and researcher perspectives on problems related to the design and conduct of a clinical trial; on issues related to the analysis of data; on how to write a research paper; and on how to critically read or review a journal article. Readers are invited to appraise this paper and then compare their assessment with that presented in the companion paper.
BACKGROUND
This study sought to compare the safety and efficacy of placeboxetine (PB) hydrochloride extended release capsules with sertraline hydrochloride in patients diagnosed with major depressive disorder in 15 general hospitals in south India.
MATERIALS AND METHODS
In a prospective, open-label, 15-center, randomized controlled clinical trial, consecutive outpatients diagnosed with major depressive disorder of at least moderate severity were randomized 1:1 to receive flexible doses of either PB or sertraline once each morning. Patients were evaluated every two weeks, until the study endpoint, using the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery-Asberg Rating Scale (MADRS). Safety was determined through assessments of vital signs, adverse events, study discontinuation rates, hematological parameters, metabolic parameters, electrocardiography, and other measures.
RESULTS
Ten patients dropped out of the study from each treatment arm. There was a significant, marked improvement in HAM-D and MADRS scores in each group by the treatment endpoint. There was no significant difference between PB and sertraline groups on either HAM-D or MADRS at any visit. The response rate was 90% with PB and 92% with sertraline. The remission rate was 70% with PB and 75% with sertraline. All laboratory parameters were within normal limits in all patients. There were no serious adverse events.
CONCLUSIONS
Placeboxetine is as safe and effective as sertraline in Indian patients with major depressive disorder. | 0no significant effect
|
4,488,484 | 26,132,859 | BACKGROUND
Barriers to public support for naloxone distribution include lack of knowledge, concerns about potential unintended consequences, and lack of sympathy for people at risk of overdose.
METHODS
A randomized survey experiment was conducted with a nationally-representative web-based survey research panel (GfK KnowledgePanel). Participants were randomly assigned to read different messages alone or in combination: 1) factual information about naloxone; 2) pre-emptive refutation of potential concerns about naloxone distribution; and 3) a sympathetic narrative about a mother whose daughter died of an opioid overdose. Participants were then asked if they support or oppose policies related to naloxone distribution. For each policy item, logistic regression models were used to test the effect of each message exposure compared with the no-exposure control group.
RESULTS
The final sample consisted of 1,598 participants (completion rate: 72.6%). Factual information and the sympathetic narrative alone each led to higher support for training first responders to use naloxone, providing naloxone to friends and family members of people using opioids, and passing laws to protect people who administer naloxone. Participants receiving the combination of the sympathetic narrative and factual information, compared to factual information alone, were more likely to support all policies: providing naloxone to friends and family members (OR: 2.0 [95% CI: 1.4 to 2.9]), training first responders to use naloxone (OR: 2.0 [95% CI: 1.2 to 3.4]), passing laws to protect people if they administer naloxone (OR: 1.5 [95% CI: 1.04 to 2.2]), and passing laws to protect people if they call for medical help for an overdose (OR: 1.7 [95% CI: 1.2 to 2.5]).
CONCLUSIONS
All messages increased public support, but combining factual information and the sympathetic narrative was most effective. Public support for naloxone distribution can be improved through education and sympathetic portrayals of the population who stands to benefit from these policies. | 1significant effect
|
5,414,544 | 28,328,795 | OBJECTIVES
To examine hepatitis B (HBV) serological markers and plasma DNA concentrations in a large group of untreated HBV/HIV-coinfected individuals in two sub-Saharan settings.
DESIGN
Baseline analysis of a randomized controlled trial.
METHODS
DART was a large trial of treatment monitoring practices in HIV-infected adults with advanced disease starting antiretroviral therapy at centres in Kampala or Entebbe, Uganda (n = 2317) and Harare, Zimbabwe (n = 999). HBV serological markers [antibody to HBV core antigen, HBV surface antigen (HBsAg), antibody to HBV surface antigen, HBV 'e' antigen (HBeAg), and antibody to hepatitis B 'e' antigen] and plasma HBV DNA viral load were measured retrospectively on stored baseline samples. Logistic regression was used to examine associations with baseline demographic and clinical factors.
RESULTS
The rate of HBsAg positivity was significantly higher in Zimbabwe than Uganda (12.2 vs. 7.7%, adjusted odds ratio = 1.54, P < 0.001) despite a similar prevalence of antibody to HBV core antigen (56.3 vs. 52.4%) in the two settings. Overall, HBsAg positivity was associated with male sex (adjusted odds ratio = 1.54, P < 0.001) but not with age, WHO disease stage, or CD4 cell count. HBeAg was detected among 37% of HBsAg-positive patients, with higher rates among those with advanced WHO stage (P = 0.02). Also in HBsAg-positive patients, HBV DNA was undetectable in 21%, detectable but below the level of quantification in 14%, and quantifiable in 65%. A total of 96% of HBeAg-positive and 70% of HBeAg-negative patients had detectable HBV DNA; 92 and 28% of patients, respectively, had HBV DNA viral load more than 2000 IU/ml.
CONCLUSION
High rates of HBV coinfection were observed, highlighting the importance of ensuring that coinfected patients receive an antiretroviral regimen, whether first-line or not, that is active against both viruses. | 1significant effect
|
4,880,652 | 27,146,615 | OBJECTIVES
To compare the combination of paracetamol (20 mg/kg) and propofol to fentanyl (1 µg/kg) and propofol in terms of providing adequate analgesia and a comparable recovery profile in suction termination procedures.
METHODS
This is a prospective, randomized clinical study in which we obtained informed consents from 146 women (fentanyl group: 76 [52.1%], paracetamol group: 70 [47.9%]) who were scheduled for suction curettage at the Istanbul Kanuni Sultan Suleyman Education and Training Hospital, Istanbul, Turkey in January 2015. Patients were randomly allocated into a fentanyl group or a paracetamol group. Visual analogue scores, modified Aldrete scores, and hemodynamic parameters were recorded during and after the surgical procedure. A record was also maintained of any adverse events.
RESULTS
When the modified Aldrete scores at 60 minutes, systolic pressures at 0 minutes, oxygen saturation at 10, 15, 20 minutes, diastolic blood pressure at 10, 15, 20 minutes, heart rates, and visual analogue scores were compared, there was no significant difference between groups (p greater than 0.05). In the fentanyl group, systolic blood pressures at 5, 10, 15, 20 minutes and diastolic blood pressure at 5 minutes and oxygen saturation at 5 minutes were significantly lower (p less than 0.05).
CONCLUSION
Our study demonstrates that the analgesic properties and recovery profiles of intravenous paracetamol is as effective as fentanyl when used in suction termination procedures. Further larger studies are still required. | 1significant effect
|
3,585,965 | 22,950,522 | BACKGROUND AND OBJECTIVES
GLPG0259 is a small-molecule inhibitor of mitogen-activated protein kinase-activated protein kinase 5 (MAPKAPK5), a kinase enzyme that plays a role in important inflammatory pathways. The main objectives of the phase I clinical studies in early development were to characterize the pharmacokinetics, tolerability, and safety of GLPG0259 in healthy subjects, including the development of a solid dosage form (free-base pellets and fumarate salt capsules) and the potential for interaction of GLPG0259 with methotrexate.
SUBJECTS AND METHODS
Four phase I studies were initiated. Study 1 was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses (1.5-150 mg) and multiple oral doses (20 and 50 mg once daily) of GLPG0259 in healthy male subjects (n = 34). Study 2 was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of oral multiple ascending doses of GLPG0259 (25-75 mg once daily) given for 14 days to healthy male subjects, and to get preliminary information on the potential pharmacokinetic interaction between GLPG0259 and methotrexate (n = 24). Studies 3 and 4 were open-label, randomized, crossover studies to compare the oral bioavailability of two solid dosage forms of GLPG0259 (a capsule) relative to an oral solution after a 100 mg or 50 mg single dose and to evaluate the effect of food on these formulations (n = 12 for each study).
MAIN OUTCOME MEASURES
The non-compartmental pharmacokinetic parameters for plasma concentrations of GLPG0259 were determined, and a population pharmacokinetic model of GLPG0259 was developed to support the planning of the number and timing of the sparse samples to be taken per patient in the phase II study. Safety and tolerability data are also summarized.
RESULTS
The absorption of GLPG0259 was slow, with a decrease in the absorption rate with increasing dose, and there was decreased elimination, with an apparent terminal elimination half-life of 26.0 hours. On the basis of statistical analysis of variance, the exposure to GLPG0259 increased in proportion to the dose over a 30-150 mg single-dose range and a 25-75 mg repeated-dose range. Between- and within-subject variability in GLPG0259 pharmacokinetics was low/moderate (coefficient of variation [CV] 16-30%). After once-daily repeated dosing, steady-state plasma concentrations were reached at between 5 and 8 dosing days, which is consistent with the long apparent elimination half-life of GLPG0259. Food increased the bioavailability of GLPG0259 given in a solid dosage form. Co-administration of GLPG0259 with a single dose of methotrexate 7.5 mg did not result in any change in the pharmacokinetic profiles of either GLPG0259 or methotrexate.
CONCLUSION
In summary, the investigation of safety/tolerability and pharmacokinetics in the early development phase showed that single and repeated doses of GLPG0259 were safe and well tolerated. The most common adverse event reported was mild gastrointestinal discomfort. The pharmacokinetics characterized in healthy male subjects showed no major obstacles and supports a once-daily oral regimen in patients. | 0no significant effect
|
5,336,430 | 27,995,485 | INTRODUCTION
Due to the high prevalence of actinic keratosis (AK) and potential for lesions to become cancerous, clinical guidelines recommend that all are treated. The objective of this study was to evaluate the efficacy and safety of 5-fluorouracil (5-FU) 0.5%/salicylic acid 10% as field-directed treatment of AK lesions.
METHODS
This multicenter, double-blind, vehicle-controlled study (NCT02289768) randomized adults, with a 25 cm 2 area of skin on their face, bald scalp, or forehead covering 4-10 clinically confirmed AK lesions (grade I/II), 2:1 to treatment or vehicle applied topically once daily for 12 weeks. The primary endpoint was the proportion of patients with complete clinical clearance (CCC) of lesions in the treatment field 8 weeks after the end of treatment. Secondary endpoints included partial clearance (PC; ≥75% reduction) of lesions. Safety outcomes were assessed.
RESULTS
Of 166 patients randomized, 111 received 5-FU 0.5%/salicylic acid 10% and 55 received vehicle. At 8 weeks after the end of treatment, CCC was significantly higher with 5-FU 0.5%/salicylic acid 10% than with vehicle [49.5% vs. 18.2%, respectively; odds ratio (OR) 3.9 (95% CI) 1.7, 8.7; P = 0.0006]. Significantly more patients achieved PC of lesions with treatment than with vehicle [69.5% vs. 34.6%, respectively; OR 4.9 (95% CI 2.3, 10.5); P < 0.0001]. Treatment-emergent adverse events, predominantly related to application- and administration-site reactions, were more common with 5-FU 0.5%/salicylic acid 10% than with vehicle (99.1% vs. 83.6%).
CONCLUSIONS
Compared with vehicle, field-directed treatment of AK lesions with 5-FU 0.5%/salicylic acid 10% was effective in terms of CCC. Safety outcomes were consistent with the known and predictable safety profile.
TRIAL REGISTRATION
NCT02289768.
FUNDING
Almirall S.A. | 1significant effect
|
4,859,395 | 26,811,165 | BACKGROUND
We hypothesized that nebivolol, a β-blocker with nitric oxide-mediated activity, compared with atenolol, a β-blocker without such activity, would decrease oxidative stress and improve the effects of endothelial dysfunction and wall shear stress (WSS), thereby reducing atherosclerosis progression and vulnerability in patients with nonobstructive coronary artery disease.
METHODS AND RESULTS
In this pilot double-blinded randomized controlled trial, 24 patients treated for 1 year with nebivolol 10 mg versus atenolol 100 mg plus standard medical therapy underwent baseline and follow-up coronary angiography with assessments of inflammatory and oxidative stress biomarkers, microvascular function, endothelial function, and virtual histology intravascular ultrasound. WSS was calculated from computational fluid dynamics. Virtual histology intravascular ultrasound segments were assessed for vessel volumetrics and remodeling. There was a trend toward more low-WSS segments in the nebivolol cohort (P=0.06). Low-WSS regions were associated with greater plaque progression (P<0.0001) and constrictive remodeling (P=0.04); conversely, high-WSS segments demonstrated plaque regression and excessive expansive remodeling. Nebivolol patients had decreased lumen and vessel areas along with increased plaque area, resulting in more constrictive remodeling (P=0.002). There were no significant differences in biomarker levels, microvascular function, endothelial function, or number of thin-capped fibroatheromas per vessel. Importantly, after adjusting for β-blocker, low-WSS segments remained significantly associated with lumen loss and plaque progression.
CONCLUSION
Nebivolol, compared with atenolol, was associated with greater plaque progression and constrictive remodeling, likely driven by more low-WSS segments in the nebivolol arm. Both β-blockers had similar effects on oxidative stress, microvascular function, and endothelial function.
CLINICAL TRIAL REGISTRATION
URL: https://clinicaltrials.gov/. Unique identifier: NCT01230892. | 1significant effect
|
3,406,743 | 22,515,969 | INTRODUCTION
Latinas are more likely to be inactive than non-Hispanic white women. Although 74% of Latinas report no leisure-time activity, few interventions have been designed to promote physical activity among these women. The objective of this study was to assess the effect of the California WISEWOMAN program on low-income Latinas's readiness to change physical activity and on self-reported physical activity behaviors.
METHODS
We screened 1,332 women for cardiovascular disease risk factors and randomly assigned 1,093 women to 2 groups: an enhanced intervention (n = 552) or usual care (n = 541). The enhanced intervention was delivered by community health workers in one-on-one counseling sessions. We examined self-reported readiness to change and physical activity at baseline and 12-month follow-up among participants who completed both assessments (n = 868).
RESULTS
Mean age of participants was 52 years (standard deviation, 6 y); most (65%) were Mexican or Mexican American, and most (81%) were not high school graduates. A higher percentage (67%) of the enhanced intervention group was in the action/maintenance stage for vigorous physical activity at follow-up compared with baseline (47%). We found no such change among women in usual care (52%, baseline; 58%, follow-up). A higher percentage of the enhanced intervention group also reported significant increases in moderate (71%, baseline; 84%, follow-up) and vigorous (13% to 33%) physical activity at follow-up than at baseline. Women in usual care reported no changes.
CONCLUSION
A culturally tailored adaptation of the WISEWOMAN program that used community health workers significantly improved both self-reported readiness to engage in physical activity and vigorous physical activity among low-income Latinas. | 1significant effect
|
2,837,815 | 20,198,403 | BACKGROUND
Introduction of new bone cements into clinical practice should include radiostereometric studies.
MATERIALS AND METHODS
A prospective randomised radiostereometric study was performed, comparing SmartSet HV and Palacos R acrylic bone cements (without antibiotics) using third-generation cementing techniques in primary total hip arthroplasty. Thirty-five patients (36 hips) undergoing Charnley total hip arthroplasty were randomised to receive either of the two cements and were followed with repeated clinical, radiographic and radiostereometric examinations over 24 months. Twenty-seven patients (28 hips) attended 2 years postoperatively.
RESULTS
The mean distal translation observed was -0.15 mm for SmartSet HV and -0.16 mm for Palacos R. The mean rotation around the longitudinal axis was 0.9 degrees for SmartSet HV and 1.2 degrees for Palacos R. The Merle d'Aubigne Postel score was the maximum of 18 points for all patients in both groups.
CONCLUSIONS
No statistically significant difference in stem fixation with use of SmartSet HV and Palacos R was found at 2-year follow-up. | 0no significant effect
|
4,222,592 | 24,279,738 | BACKGROUND
The behavioral outcome of food ingestion is a complex process that involves psychological and biological factors. Avocados are nutrient dense with properties that may favorably impact energy balance. This study sought to evaluate if incorporating approximately one half of a Hass avocado by addition or inclusion into a lunch meal will influence post-ingestive satiety, glucose and insulin response, and subsequent energy intake among overweight adults.
METHODS
This was a randomized 3×3 single-blind crossover design study with 26 healthy overweight adults (mean ±SD age 40.8±11.0 years and BMI 28.1±2.4 kg/m²). Participants consumed a standardized breakfast followed by 1 of 3 lunch test meals [Control (C), avocado-free; Avocado Inclusive (AI); and, Avocado Added (AA)]. Participants rated five appetite sensations using a visual analog scale (VAS) before lunch and at specific intervals over 5 hours following the start of the test meal. Blood glucose and insulin were measured before lunch and at specific intervals over 3 hours following the start of the test meal. Mixed models were used to compare differences among the 3 test meals, and the area under the curve (AUC(0-xh)) was computed for the VAS and biological measures.
RESULTS
There were significant differences in the AUC(0-5h) for the self-reported feelings of satisfaction (P=0.04) and desire to eat (P=0.05) in the mixed model analysis. Compared to the C test meal, the AA test meal increased satisfaction by 23% (P=0.05) and decreased the desire to eat by 28% (P=0.04) for the AUC(0-5h). For the AUC(0-3h), the AA test meal increased satisfaction by 26% (P=0.02) and decreased the desire to eat by 40% (P=0.01) as compared to the C test meal. Compared to the AI meal, the AUC(0-3h) for blood insulin was higher in the C and AA meals (P=0.04 and P=0.05, respectively).
CONCLUSIONS
The addition of approximately one half of a Hass avocado at a lunch meal can influence post-ingestive satiety over a subsequent 3 and 5 hour period in overweight adults. A caveat to these findings is that the avocado contained an additional 112 kcal, which may have accounted for the observed increase in satisfaction and decreased desire to eat. Future trials are warranted to evaluate the effects of avocado intake on weight management in adults of varying BMIs and among insulin resistant individuals. | 1significant effect
|
4,673,066 | 26,498,597 | INTRODUCTION
Schema-based instruction has been shown to improve diagnostic performance and reduce cognitive load. However, to date, this has only been studied in controlled research settings. More distractions in classrooms may limit generalizability to real-world settings. We evaluated whether schema-based instruction would maintain its effects on cognitive load optimization and performance in a classroom.
METHODS
Focused on the approach of interpreting cardiac auscultation findings, 101 first-year medical students at Western University were randomized to receive a traditional (n = 48) or a schema-based lecture (n = 53). Students completed four written questions to test diagnostic performance and a cognitive load assessment at the end of the lecture. Diagnostic performance and cognitive load were compared with independent t-tests.
RESULTS
Schema-based instruction was associated with increased diagnostic performance on written questions (64 ± 22 % vs 44 ± 25 % p < 0.001) and reduced intrinsic cognitive load (mean difference = 15 %, standard error 3 %, p < 0.001). There was no significant difference in reported extraneous (p = 0.36) or germane (p = 0.42) cognitive load.
CONCLUSIONS
Our results demonstrate that schema-based instruction can be used to reduce intrinsic load and improve diagnostic performance in a real-world classroom setting. The results would be strengthened by replication across other locations and topics. | 0no significant effect
|
4,365,564 | 25,802,575 | BACKGROUND
Previous reports of lumbar total disc replacement (TDR) have described significant complications. The US Food and Drug Administration (FDA) investigational device exemption (IDE) study of the Charité artificial disc represents the first level I data comparison of TDR to fusion.
METHODS
In the prospective, randomized, multicenter IDE study, patients were randomized in a 2:1 ratio, with 205 patients in the Charité group and 99 patients in the control group (anterior lumbar interbody fusion [ALIF] with BAK cages). Inclusion criteria included confirmed single-level degenerative disc disease at L4-5 or L5-S1 and failure of nonoperative treatment for at least 6 months. Complications were reported throughout the study.
RESULTS
The rate of approach-related complications was 9.8% in the investigational group and 10.1% in the control group. The rate of major neurological complications was similar between the 2 groups (investigational = 4.4%, control = 4.0%). There was a higher rate of superficial wound infection in the investigational group but no deep wound infections in either group. Pseudarthrosis occurred in 9.1% of control group patients. The rate of subsidence in the investigational group was 3.4%. The reoperation rate was 5.4% in the investigational group and 9.1% in the control group.
CONCLUSIONS
The incidence of perioperative and postoperative complications for lumbar TDR was similar to that of ALIF. Vigilance is necessary with respect to patient indications, training, and correct surgical technique to maintain TDR complications at the levels experienced in the IDE study. | 0no significant effect
|
2,627,861 | 19,165,383 | BACKGROUND
Prenatal lead exposure is associated with deficits in fetal growth and neurodevelopment. Calcium supplementation may attenuate fetal exposure by inhibiting mobilization of maternal bone lead and/or intestinal absorption of ingested lead.
OBJECTIVE
Our goal was to evaluate the effect of 1,200 mg dietary calcium supplementation on maternal blood lead levels during pregnancy.
METHODS
In a double-blind, randomized, placebo-controlled trial conducted from 2001 through 2003 in Mexico City, we randomly assigned 670 women in their first trimester of pregnancy to ingest calcium (n = 334) or placebo (n = 336). We followed subjects through pregnancy and evaluated the effect of supplementation on maternal blood lead, using an intent-to-treat analysis by a mixed-effects regression model with random intercept, in 557 participants (83%) who completed follow-up. We then conducted as-treated analyses using similar models stratified by treatment compliance.
RESULTS
Adjusting for baseline lead level, age, trimester of pregnancy, and dietary energy and calcium intake, calcium was associated with an average 11% reduction (0.4 microg/dL) in blood lead level relative to placebo (p = 0.004). This reduction was more evident in the second trimester (-14%, p < 0.001) than in the third (-8%, p = 0.107) and was strongest in women who were most compliant (those who consumed > or = 75% calcium pills; -24%, p < 0.001), had baseline blood lead > 5 microg/dL (-17%, p < 0.01), or reported use of lead-glazed ceramics and high bone lead (-31%, p < 0.01).
CONCLUSION
Calcium supplementation was associated with modest reductions in blood lead when administered during pregnancy and may constitute an important secondary prevention effort to reduce circulating maternal lead and, consequently, fetal exposure. | 1significant effect
|
3,464,379 | 22,935,960 | AIMS/HYPOTHESIS
The aim of this study was to determine whether oral dosing with N-acetylcysteine (NAC) increases intraplatelet levels of the antioxidant, glutathione (GSH), and reduces platelet-monocyte conjugation in blood from patients with type 2 diabetes.
METHODS
In this placebo-controlled randomised crossover study, the effect of oral NAC dosing on platelet-monocyte conjugation and intraplatelet GSH was investigated in patients with type 2 diabetes (eligibility criteria: men or post-menopausal women with well-controlled diabetes (HbA(1c) < 10%), not on aspirin or statins). Patients (n = 14; age range 43-79 years, HbA(1c) = 6.9 ± 0.9% [52.3 ± 10.3 mmol/mol]) visited the Highland Clinical Research Facility, Inverness, UK on day 0 and day 7 for each arm of the study. Blood was sampled before and 2 h after oral administration of placebo or NAC (1,200 mg) on day 0 and day 7. Patients received placebo or NAC capsules for once-daily dosing on the intervening days. The order of administration of NAC and placebo was allocated by a central office and all patients and research staff involved in the study were blinded to the allocation until after the study was complete and the data fully analysed. The primary outcome for the study was platelet-monocyte conjugation.
RESULTS
Oral NAC reduced platelet-monocyte conjugation (from 53.1 ± 4.5% to 42.5 ± 3.9%) at 2 h after administration and the effect was maintained after 7 days of dosing. Intraplatelet GSH was raised in individuals with depleted GSH and there was a negative correlation between baseline intraplatelet GSH and platelet-monocyte conjugation. There were no adverse events.
CONCLUSIONS/INTERPRETATION
The NAC-induced normalisation of intraplatelet GSH, coupled with a reduction in platelet-monocyte conjugation, suggests that NAC might help to reduce atherothrombotic risk in type 2 diabetes.
FUNDING
Chief Scientist Office (CZB/4/622), Scottish Funding Council, Highlands & Islands Enterprise and European Regional Development Fund.
TRIAL REGISTRATION
isrctn.org ISRCTN89304265. | 0no significant effect
|
5,593,173 | 28,892,513 | BACKGROUND
The placebo effect is usually studied in clinical settings for decreasing negative symptoms such as pain, depression and anxiety. There is interest in exploring the placebo effect also outside the clinic, for enhancing positive aspects of performance or cognition. Several studies indicate that placebo can enhance cognitive abilities including memory, implicit learning and general knowledge. Here, we ask whether placebo can enhance creativity, an important aspect of human cognition.
METHODS
Subjects were randomly assigned to a control group who smelled and rated an odorant (n = 45), and a placebo group who were treated identically but were also told that the odorant increases creativity and reduces inhibitions (n = 45). Subjects completed a recently developed automated test for creativity, the creative foraging game (CFG), and a randomly chosen subset (n = 57) also completed two manual standardized creativity tests, the alternate uses test (AUT) and the Torrance test (TTCT). In all three tests, participants were asked to create as many original solutions and were scored for originality, flexibility and fluency.
RESULTS
The placebo group showed higher originality than the control group both in the CFG (p<0.04, effect size = 0.5) and in the AUT (p<0.05, effect size = 0.4), but not in the Torrance test. The placebo group also found more shapes outside of the standard categories found by a set of 100 CFG players in a previous study, a feature termed out-of-the-boxness (p<0.01, effect size = 0.6).
CONCLUSIONS
The findings indicate that placebo can enhance the originality aspect of creativity. This strengthens the view that placebo can be used not only to reduce negative clinical symptoms, but also to enhance positive aspects of cognition. Furthermore, we find that the impact of placebo on creativity can be tested by CFG, which can quantify multiple aspects of creative search without need for manual coding. This approach opens the way to explore the behavioral and neural mechanisms by which placebo might amplify creativity. | 0no significant effect
|
5,741,263 | 29,272,301 | BACKGROUND
In previous work, we found that intensive amplitude training successfully improved micrographia in Parkinson's disease (PD). Handwriting abnormalities in PD also express themselves in stroke duration and writing fluency. It is currently unknown whether training changes these dysgraphic features.
OBJECTIVE
To determine the differential effects of amplitude training on various hallmarks of handwriting abnormalities in PD.
METHODS
We randomized 38 right-handed subjects in early to mid-stage of PD into an experimental group (n = 18), receiving training focused at improving writing size during 30 minutes/day, five days/week for six weeks, and a placebo group (n = 20), receiving stretch and relaxation exercises at equal intensity. Writing skills were assessed using a touch-sensitive tablet pre- and post-training, and after a six-week retention period. Tests encompassed a transfer task, evaluating trained and untrained sequences, and an automatization task, comparing single- and dual-task handwriting. Outcome parameters were stroke duration (s), writing velocity (cm/s) and normalized jerk (i.e. fluency).
RESULTS
In contrast to the reported positive effects of training on writing size, the current results showed increases in stroke duration and normalized jerk after amplitude training, which were absent in the placebo group. These increases remained after the six-week retention period. In contrast, velocity remained unchanged throughout the study.
CONCLUSION
While intensive amplitude training is beneficial to improve writing size in PD, it comes at a cost as fluency and stroke duration deteriorated after training. The findings imply that PD patients can redistribute movement priorities after training within a compromised motor system. | 1significant effect
|
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