GEM/cochrane-simplification huggingface dataset:
Abstract: We did not find any studies fulfilling the inclusion criteria, therefore no outcome data are reported. We identified nine studies after initial screening and, after further evaluation, we excluded these. The excluded studies involved a total of 163 individuals aged two years to 18 years. We excluded studies for three main reasons: they were non-randomized or case series studies, they were studies of people over 18 years of age or even where the study was randomised, the study population was mixed and results pertaining to the visually impaired cohort could not be independently evaluated. No significant adverse effects of melatonin were reported in these excluded studies. There is currently no high quality data to support or refute the use of melatonin for sleep disorders in visually impaired children. Placebo-controlled trials examining important clinical outcomes such as sleep quality, sleep latency, duration of sleep and night-time awakenings are needed. As the numbers of children meeting study inclusion criteria are likely to be low at individual sites, multicentre collaboration between developmental paediatricians, sleep physicians and other health care professionals is essential to achieve sufficient sample size for controlled studies. Such collaboration would help facilitate local recruitment at multiple sites, with study oversight being provided by paediatricians with expertise in sleep disorders. Participation of collaborators with experience in evidence-based practice research is also desirable due to the lack of protocols on melatonin therapy in the target population.

Plain-language summary: The current review planned to examine studies on the use of melatonin in these children to determine whether this drug is effective for improving their sleep (safety is not mentioned in objectives or abstract and adverse effects is a secondary outcome). We only wanted to use studies where the children had been randomly allocated to a treatment group and a control group that got no treatment or another medication or a placebo. We did not find any of these studies that were suitable to be included in our review and so we are unable to draw any conclusions about whether or not melatonin improves sleep for visually impaired children. To find out, we need appropriately designed clinical trials. Due to lack of knowledge about best practice in the use of melatonin with these children, it would be useful to have researchers involved who are experienced in sleep disorders and in evidence-based practice research. In addition, studies involving more than one location would be beneficial to increase the number of children being evaluated and make it more likely we will reach solid conclusions about whether melatonin works for this group of children, as well as details about the most effective dosage and timing of the treatment.
Abstract: We identified 28 randomised trials including 8950 participants (newly incorporated in this update: 10 trials including 4227 participants). The overall quality of the evidence was generally low to moderate. Pooled estimates showed a reduction in thromboembolic events (RR 0.58, 95% CI 0.45 to 0.75; participants = 7594; studies = 18; moderate quality of evidence). Both, trials of self-management or self-monitoring showed reductions in thromboembolic events (RR 0.47, 95% CI 0.31 to 0.70; participants = 3497; studies = 11) and (RR 0.69, 95% CI 0.49 to 0.97; participants = 4097; studies = 7), respectively; the quality of evidence for both interventions was moderate. No reduction in all-cause mortality was found (RR 0.85, 95% CI 0.71 to 1.01; participants = 6358; studies = 11; moderate quality of evidence). While self-management caused a reduction in all-cause mortality (RR 0.55, 95% CI 0.36 to 0.84; participants = 3058; studies = 8); self-monitoring did not (RR 0.94, 95% CI 0.78 to 1.15; participants = 3300; studies = 3); the quality of evidence for both interventions was moderate. In 20 trials (8018 participants) self-monitoring or self-management did not reduce major haemorrhage (RR 0.95, 95% CI, 0.80 to 1.12; moderate quality of evidence). There was no significant difference found for minor haemorrhage (RR 0.97, 95% CI 0.67 to 1.41; participants = 5365; studies = 13). The quality of evidence was graded as low because of serious risk of bias and substantial heterogeneity (I2 = 82%). Participants who self-monitor or self-manage can improve the quality of their oral anticoagulation therapy. Thromboembolic events were reduced, for both those self-monitoring or self-managing oral anticoagulation therapy. A reduction in all-cause mortality was observed in trials of self-management but not in self-monitoring, with no effects on major haemorrhage.

Plain-language summary: This is an update of the original review published in 2010. We performed a new search and found 10 new studies (with 4227 participants) to add to the original review, which changed some of the findings. In total, we found 28 randomised trials including 8950 participants that compared self-monitoring and self-management with standard monitoring. The quality of the evidence was generally low to moderate. The combined results of the 28 trials showed a halving of thromboembolic events with self-monitoring and self-management and no reduction in the number of major bleeds. Self-management had similar reductions in thromboembolic events and mortality to the overall benefit, with no effect on major bleeds. Self-monitoring halved the number of major haemorrhages that occurred but did not significantly reduce the rates of thrombotic events or all-cause mortality. In conclusion, self-monitoring or self-management can improve the quality of oral anticoagulant therapy, leading to fewer thromboembolic events and lower mortality, without a reduction in the number of major bleeds. Self-monitoring and self-management are not feasible for all patients, which requires the identification and education of suitable patients.
Abstract: Twenty-six randomized clinical trials fulfilled entry criteria. No study assessed combined long-term morbidity. Routine vitamin E supplementation significantly increased hemoglobin concentration by a small amount. Vitamin E significantly reduced the risk of germinal matrix/intraventricular hemorrhage and increased the risk of sepsis; however, heterogeneity limits the strength of these latter two inferences. Vitamin E did not significantly affect other morbidity or mortality. In VLBW infants, vitamin E supplementation significantly increased the risk of sepsis, and reduced the risk of severe retinopathy and blindness among those examined.  Subgroup analyses demonstrated (1) an association between intravenous, high-dose vitamin E supplementation and increased risk of sepsis and of parenchymal cerebral hemorrhage; (2) an association between vitamin E supplementation by other than the intravenous route and reduced risk of germinal matrix-intraventricular hemorrhage and of severe intraventricular hemorrhage; and (3) an association between serum tocopherol levels greater than 3.5 mg/dl and increased risk of sepsis and reduced risk for severe retinopathy among those examined. Vitamin E supplementation in preterm infants reduced the risk of intracranial hemorrhage but increased the risk of sepsis. In very low birth weight infants, vitamin E increased the risk of sepsis, and reduced the risk of severe retinopathy and blindness among those examined. Evidence does not support the routine use of vitamin E supplementation by intravenous route at high doses or aiming at serum tocopherol levels greater than 3.5 mg/dl.

Plain-language summary: This review of studies of vitamin E supplements found that while extra vitamin E reduces the chances of some complications (including disease of the retina), the risk of life-threatening infection is increased. The risk of bleeding in the brain is increased when extra vitamin E is given by vein but decreased when the extra vitamin E is given by other routes.
Abstract: We included eight trials involving 5701 patients. Six trials tested ancrod and two trials tested defibrase (patients were treated for less than three hours to less than 48 hours). Allocation concealment was adequate in seven trials. Fibrinogen depleting agents marginally reduced the proportion of patients who were dead or disabled at the end of follow-up (risk ratio (RR) 0.95, 95% confidence Interval (CI) 0.90 to 0.99, 2P = 0.02). There was no statistically significant difference in death from all causes during the scheduled treatment or follow-up period. There were fewer stroke recurrences in the treatment group than in the control group (RR 0.67, 95% CI 0.49 to 0.92, 2P = 0.01). However, symptomatic intracranial haemorrhage was about twice as common in the treatment group compared with the control group (RR 2.42, 95% CI 1.65 to 3.56, 2P < 0.00001). The current evidence is promising but not yet sufficiently robust to support the routine use of fibrinogen depleting agents for the treatment of acute ischaemic stroke. Further trials are needed to determine whether there is worthwhile benefit, and if so, which categories of patients are most likely to benefit.

Plain-language summary: Evidence from this updated review, which includes eight trials involving 5701 participants, indicates that there is currently not sufficient evidence to support the routine use of fibrinogen depleting agents for the treatment of acute ischaemic stroke. Further trials are needed to determine reliably whether there is worthwhile benefit, and if so, which categories of patients are most likely to benefit.
Abstract: The search yielded 7057 references of which we identified three RCTs for inclusion, four ongoing trials and one study awaiting classification. All three included RCTs compared videolaryngoscopy with direct laryngoscopy during intubation attempts by trainees. Time to intubation was similar between videolaryngoscopy and direct laryngoscopy (mean difference (MD) -0.62, 95% confidence interval (CI) -6.50 to 5.26; 2 studies; 311 intubations) (very low quality evidence). Videolaryngoscopy did not decrease the number of intubation attempts (MD -0.05, 95% CI -0.18 to 0.07; 2 studies; 427 intubations) (very low quality evidence). Moderate quality evidence suggested that videolaryngoscopy increased the success of intubation at first attempt (typical risk ratio (RR) 1.44, 95% CI 1.20 to 1.73; typical risk difference (RD) 0.19, 95% CI 0.10 to 0.28; number needed to treat for an additional beneficial outcome (NNTB) 5, 95% CI 4 to 10; 3 studies; 467 intubation attempts). Desaturation episodes during intubation attempts were similar between videolaryngoscopy and direct laryngoscopy (MD -0.76, 95% CI -5.74 to 4.23; 2 studies; 359 intubations) (low quality evidence). There was no difference in the incidence of airway trauma due to intubation attempts (RR 0.10, 95% CI 0.01 to 1.80; RD -0.04, 95% CI -0.09 to -0.00; 1 study; 213 intubations) (low quality evidence). There were no data available on other adverse effects of videolaryngoscopy. Moderate to very low quality evidence suggests that videolaryngoscopy increases the success of intubation in the first attempt but does not decrease the time to intubation or the number of attempts for intubation. However, these studies were conducted with trainees performing the intubations and these results highlight the potential usefulness of the videolaryngoscopy as a teaching tool. Well-designed, adequately powered RCTs are necessary to confirm efficacy and address safety and cost-effectiveness of videolaryngoscopy for endotracheal intubation in neonates by trainees and those proficient in direct laryngoscopy.

Plain-language summary: We sought evidence for the usefulness of these video-assisted devices for the placement of breathing tubes in babies. We searched scientific databases for clinical trials of babies who needed intubation in the delivery room, operating room or intensive care unit. The studies could measure time to intubation, number of attempts at intubation, success rate of first intubation or side effects. The evidence is current to May 2017. We included three studies, which provided data on up to 467 intubation attempts in newborns by trainees. Data from three included studies suggest that videolaryngoscopy increases the success of intubation at first attempt but does not decrease the time to intubation, the number of attempts or side effects due to placement of the breathing tube. These studies were done with trainees and highlights the use of videolaryngoscopy as a teaching tool. We make a case for further research in evaluating the use of video-assisted devices in the placement of breathing tubes in newborns.
Abstract: We included four studies with a total of 115 patients randomised to undergo a vascular procedure with remote ischaemic preconditioning and 117 patients randomised to have the procedure without remote ischaemic preconditioning. None of the trials were of low risk of bias. There was no significant difference in mortality between the two groups (RR 1.70, 95% CI 0.51 to 5.72). Similarly, there was no statistically significant difference between the two groups for all other outcomes except reduced risk of myocardial infarction in the remote ischaemic preconditioning group, which was significant by the fixed-effect model (RR 0.31, 95% CI 0.10 to 0.90) but not by the random-effects model (RR 0.34, 95% CI 0.11 to 1.08). This positive effect was from the results of only one trial and was not consistently observed. Furthermore, it was noted that there was an observed trend of high incidence of unplanned critical care admission in the remote ischaemic preconditioning group, although this was not statistically significant (RR 2.15, 95% CI 0.87 to 5.33). Based on current evidence from small pilot trials, there are too few data to be able to say whether remote ischaemic preconditioning has any beneficial or harmful effects. The safety of this technique needs to be confirmed in adequately powered trials. Therefore, further randomised trials on this technique are required.

Plain-language summary: We performed a systematic search of the literature to identify all the randomised controlled trials conducted on this topic. A total of 232 patients in four trials were randomised to remote ischaemic preconditioning or no preconditioning for three different operations on blood vessels. Based on the evidence from these small trials, there were too few data to be able to say whether remote ischaemic preconditioning has any beneficial or harmful effects. The studies varied in the surgical procedures, outcome measures and the way remote ischaemia was induced. The number of deaths around the time of surgery was not clearly different between the two groups. Heart attacks (myocardial infarction) may have been reduced in the remote ischaemic preconditioning group but this was apparent in only one trial and was not consistent across the trials. Unplanned critical care admissions tended to increase in the remote ischaemic preconditioning group. All the trials had a high risk of bias and the safety of this technique needs to be confirmed in trials with adequate numbers of participants.
Abstract: Fourteen trials were included, but only 12 trials involving 910 women contributed data to outcome analysis. Women who exercised did not lose significantly more weight than women in the usual care group (two trials; n = 53; MD -0.10 kg; 95% confidence interval (CI) -1.90 to 1.71). Women who took part in a diet (one trial; n = 45; MD -1.70 kg; 95% CI -2.08 to -1.32), or diet plus exercise programme (seven trials; n = 573; MD -1.93 kg; 95% CI -2.96 to -0.89; random-effects, T² = 1.09, I² = 71%), lost significantly more weight than women in the usual care group. There was no difference in the magnitude of weight loss between diet alone and diet plus exercise group (one trial; n = 43; MD 0.30 kg; 95% CI -0.06 to 0.66). The interventions seemed not to affect breastfeeding performance adversely. Evidence from this review suggests that both diet and exercise together and diet alone help women to lose weight after childbirth. Nevertheless, it may be preferable to lose weight through a combination of diet and exercise as this improves maternal cardiorespiratory fitness and preserves fat-free mass, while diet alone reduces fat-free mass. This needs confirmation in large trials of high methodological quality. For women who are breastfeeding, more evidence is required to confirm whether diet or exercise, or both, is not detrimental for either mother or baby.

Plain-language summary: The review looked for randomised studies to assess the impact of dieting or exercise, or both, on women's weight loss in the months after giving birth. It paid particular attention to breastfeeding women to be sure that breastfeeding was not compromised. The review of trials found 14 studies, with 12 studies involving 910 women carrying excess weight after childbirth that contributed data for analysis. The findings suggest that diet combined with exercise or diet alone compared with usual care seemed to help with weight loss after giving birth. There is potential for these interventions to play a role in preventing future maternal obesity. There was not sufficient evidence to be sure that exercise or diet did not interfere with breastfeeding though it appeared not to in the included studies. It seems preferable to lose weight through a combination of dieting and exercise, compared to dieting alone, because exercise is thought to improve circulation and heart fitness, and to preserve lean body mass. Further research is needed.
Abstract: We included 20 trials involving 2527 patients. Concealment of allocation was poorly described. Different doses (of tissue plasminogen activator, urokinase, desmoteplase or tenecteplase) were compared in 13 trials (N = 1433 patients). Different agents (tissue plasminogen activator versus urokinase, tissue-cultured urokinase versus conventional urokinase, tenecteplase versus tissue plasminogen activator) were compared in five trials (N = 875 patients). Five trials (N = 485) compared different routes of administration. As some trials compared different agents and different doses, some patients contributed to two analyses. There was an approximately three-fold increase in fatal intracranial haemorrhages in patients allocated to higher than to lower doses of the same thrombolytic drug (odds ratio (OR) 2.71, 95% confidence interval (CI) 1.22 to 6.04). There was no difference in the number of patients who were dead or dependent at the end of follow-up between those allocated higher or lower doses of thrombolytic drug (OR 0.86, 95% CI 0.62 to 1.19). Higher versus lower doses of desmoteplase were associated with more deaths at the end of follow-up (OR 3.21, 95% CI 1.23 to 8.39). There was no evidence of any benefit for intra-arterial over intravenous treatment. These limited data suggest that higher doses of thrombolytic agents may lead to higher rates of bleeding. However, the evidence is inadequate to conclude whether lower doses of thrombolytic agents are more effective than higher doses, or whether one agent is better than another, or which route of administration is the best, for acute ischaemic stroke. At present, intravenous rt-PA at 0.9mg/kg as licensed in many countries appears to represent best practice and other drugs, doses or routes of administration should only be used in randomised controlled trials.

Plain-language summary: This review aimed to find out if there were important differences between different clot-dissolving drugs. It also aimed to find out if there were differences in effect when giving the same drug in different doses or by different routes (into an artery or a vein). The review, which included 20 studies involving 2527 participants, showed that there was some evidence that lower doses of thrombolytic agents led to serious bleeding in the brain less often. However, it was not clear if the benefit from lower doses was as big as with higher doses. There was no evidence to show that one thrombolytic agent was clearly better than another, or that intra-arterial treatment was better than intravenous treatment. Therefore, more larger randomised controlled trials are required to answer questions about which drug, or dose or route of administration is best for thrombolysis. At present, rt-PA as currently licensed in many countries, should be regarded as best practice.
Abstract: We identified only one randomized controlled trial that met our inclusion criteria and no further trials were identified in subsequent updates. The included study was a trial of moderate intensity, endurance type exercise versus 'usual activities' in 25 patients with amyotrophic lateral sclerosis. The risk of bias was high and no adverse events were reported. At three months patients performing the 15 minute twice daily exercises had significantly less spasticity overall (mean reduction of -0.43, 95% confidence interval (CI) -1.03 to +0.17 in the treatment group versus an increase of +0.25, 95% CI -0.46 to +0.96 in control) but the mean change between groups was not significant (-0.68, 95% CI -1.62 to +0.26), as measured by the Ashworth scale (possible scores 0 to 5, where higher is worse). The single trial performed was too small to determine whether individualized moderate intensity endurance type exercises for the trunk and limbs are beneficial or harmful. No other medical, surgical or alternative treatment and therapy has been evaluated in a randomized fashion in this patient population. More research is needed.

Plain-language summary: This review found only one randomized trial of treatment for spasticity in motor neuron disease, which involved 25 participants, and no further trials have been found in subsequent updates. There were a number of issues with the design of the study which unfortunately reduced the certainty of the findings. At three months participants performing the 15 minute twice daily exercises had significantly less spasticity overall than control participants (mean reduction of -0.43, 95% confidence interval (CI) -1.03 to +0.17 in the treatment group versus an increase of +0.25, 95% CI -0.46 to +0.96 in control) but the mean change between groups was not significant, as measured by the Ashworth scale (a scale of spasticity, with a range of 0 to 5, where higher is worse). The trial was too small to determine whether individualized moderate intensity endurance type exercises for the trunk and limbs are beneficial or harmful. No side effects from exercise were reported. No other randomized trials of different treatments or therapies were found. Further research is needed to determine if exercise or other therapies such as anti-spasticity medication are beneficial or harmful.