GEM/cochrane-simplification huggingface dataset:
Abstract: Ten efficacy trials of SPf66 involving 9698 participants were included. Results with SPf66 in reducing new episodes of P. falciparum malaria were heterogeneous: it was not effective in four African trials (RR 0.98, 95% CI 0.90 to 1.07; 2371 participants) or in one Asian trial (RR 1.06, 95% CI 0.90 to 1.25; 1221 participants). In four trials in South America the number of first attacks with P. falciparum was reduced by 28% (RR 0.72, 95% CI 0.63 to 0.82; 3807 participants). It did not reduce episodes of P. vivax malaria or admission to hospital with severe malaria. Trials have not indicated any serious adverse events with SPf66 vaccine. There is no evidence for protection by SPf66 vaccines against P. falciparum in Africa. There is a modest reduction in attacks of P. falciparum malaria following vaccination with SPf66 in South America. There is no justification for further trials of SPf66 in its current formulation. Further research with SPf66 vaccines in South America or with new formulations of SPf66 may be justified.

Plain-language summary: SPf66 has had 10 trials in Africa, Asia, and South America. Results were initially promising, but further trials showed only a small effect in some trials, and no effect in Africa. There is no evidence that SPf66 is effective enough to be introduced on a routine basis for prevention of malaria.
Abstract: There were a total of 19 trials that met inclusion criteria and that had data sufficient for analysis. Thirteen trials reported sufficient information to use a global rating of improvement and nine trials provided information on a comprehensive rating scale. Three trials provided both outcome measures. It was not possible to use many of the published results in a combined analysis owing to the lack of sufficient data to perform statistical analyses. For the 12 trials that used global ratings, there was a significant effect favouring hydergine (OR 3.78, 95% CI, 2.72 to 5.27). For the nine trials that used comprehensive ratings, there was a significant mean difference favouring hydergine (WMD 0.96, 95%CI, 0.54 to 1.37). Hydergine was well tolerated in these trials, with 78% of randomized subjects available for data analyses. Greater effect sizes on global ratings were associated with younger age, and possibly higher dose, although most of the subgroup analyses were statistically insignificant. As in an earlier systematic review, we found hydergine to show significant treatment effects when assessed by either global ratings or comprehensive rating scales (based here on a smaller set of trials than in the earlier published systematic review because trials were required to have data that could conform with MetaView, the Cochrane Collaboration statistics software). The small number of trials available for analysis, however, limited the ability of subgroup analyses to identify statistically significant moderating effects. Unfortunately, most of the randomized, double-blind, and placebo-controlled trials of hydergine were conducted and published before the advent of consensus-based diagnostic standards of dementia in 1984; therefore diagnostic criteria were less specific. As a result, uncertainty remains regarding hydergine's efficacy in dementia.

Plain-language summary: The statistical evidence for efficacy in 'possible or probable Alzheimer's disease' patients was so modest however that one additional statistically non-significant trial would have reduced the results to non significance; evidence for efficacy in vascular dementia rested on relatively stronger effects for hydergine on clinical ratings; and effective doses may be higher than 3 mg/d (i.e., than that currently approved in the USA). Despite its availability for 40 years, the circumstances of hydergine's efficacy in dementia syndromes have not been adequately researched, and have yet to be precisely defined.
Abstract: We included three trials with a total of 420 children; there were no trials in adult populations. The largest of the three trials was conducted in settings with high mortality rates and was judged to have low risk of bias for all domains, except performance bias which was high risk. The other two smaller trials were not of high quality.The meta-analysis found no significant difference between the maintenance-fluid and restricted-fluid groups in number of deaths (RR 0.82, 95% confidence interval (CI) 0.53 to 1.27; 407 participants; low quality of evidence) or acute severe neurological sequelae (RR 0.67, 95% CI 0.41 to 1.08; 407 participants; low quality of evidence). However, when neurological sequelae were defined further, there was a statistically significant difference in favour of the maintenance-fluid group for spasticity (RR 0.50, 95% CI 0.27 to 0.93; 357 participants); and seizures at both 72 hours (RR 0.59, 95% CI 0.42 to 0.83; 357 participants) and 14 days (RR 0.19, 95% CI 0.04 to 0.88; 357 participants). There was very low quality of evidence favouring maintenance fluid over restrictive fluid for chronic severe neurological sequelae at three months follow-up (RR 0.42, 95% CI 0.20 to 0.89; 351 participants). The quality of evidence regarding fluid therapy in children with acute bacterial meningitis is low to very low and more RCTs need to be conducted. There is insufficient evidence to guide practice as to whether maintenance fluids should be chosen over restricted fluids in the treatment of acute bacterial meningitis.

Plain-language summary: The evidence is current to March 2016. We did not find any trials in adult populations and included three trials involving 420 children. All trials were set in countries where death rates for meningitis are high. In one study no funding source was mentioned. The remaining two studies were funded jointly by pharmaceutical concerns with government agencies and a charitable agency. No studies reported important healthcare outcomes such as duration of hospital stay, raised intracranial pressure, or status epilepticus. An adverse effect in children with restricted fluid intake was that they were less likely to have low levels of sodium in their blood and therefore they would experience greater reductions in body fluids. An adverse effect of unrestricted fluid administration was reported in one study as short-term swelling of the face and low blood sodium levels one to two days after fluids were started, although the largest study found no difference in blood sodium levels. Quality of the evidenceAnalysis of available trials found low quality evidence that there is no significant difference between maintenance versus restrictive fluid regimens for the outcome of death and acute severe neurological complications. There was also some evidence favouring maintenance fluid therapy over restricted fluids for chronic severe neurological events at three months follow-up, but the quality was very low.
Abstract: A total of 4092 titles were screened and 14 full text reports reviewed; a single small study met the inclusion criteria. In the included RCT, 40 women (35 with ovarian cancer) had extensive elective surgery including bowel resection for treatment of gynaecological malignancy. Randomisation was made to either early oral feeding (oral fluids in the first 24 hours, solid foods on the following day) or to a 'traditional' feeding regimen where oral fluids and foods were delayed until there was evidence of bowel function. Most women in the early feeding group (14/18) were able to resume eating solid food one day after surgery. This resulted in a significantly shorter hospital stay with no increase in postoperative complications or change in quality of life measures in comparison with the women on the 'traditional' feeding regimen. The incidence of nausea and vomiting during the postoperative stay was similar in both groups and was noted in slightly more than half of the women. Overall survival was evaluated until 30 days following discharge from hospital; in this period, there was one death of a woman who had been in the 'traditional oral feeding' group, cause of death was not noted. We assessed risk of bias and found no high risk of bias was identified in the methodology and reporting of the included study, although there was an increased risk of bias due to the small size of the study in which not all of the women had ovarian cancer. Although women with ovarian cancer have been shown to be at risk of malnutrition, there is a lack of evidence derived from RCTs evaluating the identification, assessment and treatment of malnutrition during the perioperative phase of treatment. There is evidence from one small study that some women with ovarian cancer undergoing surgery with associated bowel resection may safely commence oral fluids within 24 hours of surgery and solid foods on the following day. Further research is required, including a RCT, to generate guidance concerning the treatment of malnutrition in this patient group.

Plain-language summary: In this review, the authors looked for studies (randomised controlled trials (RCTs)) from around the world to find out how women with ovarian cancer were assessed to see if they were eating and drinking well and what help they may be given with nutrition before or after surgery. A lack of information was found on this topic. One RCT was found where a small group of women (40 including 35 with ovarian cancer) requiring extensive elective surgery for gynaecological cancer including surgery to the gut, were able to restart eating normal foods on the day after surgery. They were able to leave hospital earlier and did not have more complications in the month after surgery than women who were not allowed to resume eating normal foods until at least three days after the operation. More studies are needed to confirm whether restarting normal eating one day after surgery can be recommended for women having surgery for ovarian cancer. More research is needed to provide information about how to identify and treat problems of malnutrition in women with ovarian cancer.
Abstract: Sixty-five (65) studies were identified for possible inclusion in this review. Fourteen published RCTs with a total of 1551 participants met the inclusion criteria. Duration of cry was significantly reduced in infants who were administered a sweet-tasting solution [MD -13.47 (95% CI -16.80 to -10.15)], P < 0.00001 compared with water. However, there was considerable heterogeneity between the studies (I2 = 94%) that we were unable to explain. Meta-analysis was not able to be undertaken for any of the other outcome measures, except for cry duration, because of differences in study design. However, most of the individual studies that measured pain found sucrose to significantly reduce pain compared with the control group. One study compared sucrose and Lidocaine-prilocaine cream and no significant difference was found between the two treatments for the outcomes pain and cry duration. Due to the differences between the studies, we were unable to identify the optimal concentration, volume or method of administration of sweet-tasting solutions in infants aged one to 12 months. Further large RCTs are needed. There is insufficient evidence to confidently judge the effectiveness of sweet-tasting solutions in reducing needle-related pain in infants (one month to 12 months of age). The treatments do, however, appear promising. Data from a series of individual trials are promising, as are the results from a subset meta-analysis of studies measuring duration of crying. Further well controlled RCTs are warranted in this population to determine the optimal concentration, volume, method of administration, and possible adverse effects.

Plain-language summary: In this review we were interested in whether giving babies sugar-based solutions to taste when the needle breaks the skin will help reduce their pain. We found 14 separate studies that had asked this question. However, the differences between the studies were often too great to let us combine their findings. Overall, the studies show that different types of sugar-based solutions were effective but we were not able to confidently assert that there is strong evidence for this treatment in reducing pain. We did find some evidence that babies may not cry for as long if given sugar-based solutions. This review is broadly in agreement with two other reviews, one asking this question in younger children, and one in older children. There is a need for better studies in this field.
Abstract: The search identified 3659 abstracts, but only 12 RCTs with a total of 929 participants could be included in the review. Because of clinical heterogeneity, few meta-analyses were possible. The main outcome was reduction of severity (response) of depression, not of psychosis. We found no evidence for the efficacy of monotherapy with an antidepressant or an antipsychotic. However, evidence suggests that the combination of an antidepressant plus an antipsychotic is more effective than antidepressant monotherapy (three RCTs; RR 1.49, 95% CI 1.12 to 1.98, P = 0.006), more effective than antipsychotic monotherapy (four RCTs; RR 1.83, 95% CI 1.40 to 2.38, P = 0.00001) and more effective than placebo (two identical RCTs; RR 1.86, 95% CI 1.23 to 2.82, P = 0.003). Risk of bias is considerable: there were differences between studies with regard to diagnosis, uncertainties around randomisation and allocation concealment, differences in treatment interventions (pharmacological differences between the various antidepressants and antipsychotics) and different outcome criteria. Psychotic depression is heavily understudied, limiting confidence in the conclusions drawn. Some evidence indicates that combination therapy with an antidepressant plus an antipsychotic is more effective than either treatment alone or placebo. Evidence is limited for treatment with an antidepressant alone or with an antipsychotic alone.

Plain-language summary: The aim of this review is to compare the efficacy of the various forms of drug treatment that have been used to treat psychotic depression. We did this by analysing all randomised controlled trials (RCTs) that investigated drug treatments for psychotic depression. We searched for these trials in a wide-ranging way. The search identified 3659 studies, but in the end, we found only 12 RCTs that met our inclusion criteria. These trials involved a total of 929 people. From these trials, we found evidence that the combination of an antidepressant plus an antipsychotic provides more effective treatment for psychotic depression than either treatment alone. However, our confidence in this conclusion is limited because the information came from only a small number of RCTs, which included small numbers of people. In addition, the types of people involved varied between RCTs, and the RCTs differed in design, which means that we cannot confidently generalise their findings.
Abstract: One trial involving 1639 women was included. It compared SFH measurement with clinical abdominal palpation. There was no difference in the two reported primary outcomes of incidence of small-for-gestational age (risk ratio (RR) 1.32; 95% confidence interval (CI) 0.92 to 1.90, low quality evidence) or perinatal death.(RR 1.25, 95% CI 0.38 to 4.07; participants = 1639, low quality evidence). There were no data on the neonatal detection of large-for-gestational age (variously defined by authors). There was no difference in the reported secondary outcomes of neonatal hypoglycaemia, admission to neonatal nursery, admission to the neonatal nursery for IUGR (low quality evidence), induction of labour and caesarean section (very low quality evidence). The trial did not address the other outcomes specified in the 'Summary of findings' table (intrauterine death; neurodevelopmental outcome in childhood). GRADEpro software was used to assess the quality of evidence, downgrading of evidence was based on including a small single study with unclear risk of bias and a wide confidence interval crossing the line of no effect. There is insufficient evidence to determine whether SFH measurement is effective in detecting IUGR. We cannot therefore recommended any change of current practice. Further trials are needed.

Plain-language summary: We wanted to know which of these two methods is more likely to detect poor growth. Ultrasound assessment can also be used to detect growth restriction but this is costly and not always available, and there are concerns about its unnecessary use. We found only one randomised trial (involving 1639 women at 20 weeks’ gestation and above) comparing repeated measures of SFH with abdominal palpation. The trial found no difference between the two approaches in detecting poor growth. With such limited evidence, it is still not known whether one method is more effective than the other, and how these methods compare with ultrasound measurement. The main findings from this review were assessed for quality using software called GRADEpro. The overall evidence was of low/very low quality.
Abstract: Seven studies were included in the review, including a total of 298 children in the out-patient/home group. The one high quality trial identified suggested that home-based management of children with newly diagnosed type 1 diabetes may lead to slightly improved long term metabolic control (at two and three years follow-up). No differences between comparison groups were found in any of the psychosocial and behavioural variables assessed or in rates of acute diabetic complications within two years. Parental costs were found to be decreased, while health system costs were increased, leaving total social costs virtually unchanged. None of the other studies assessing metabolic control found a difference between the comparison groups. There seemed to be no differences in hospitalisations or acute diabetic complications between the out-patient/home groups and the hospital groups. Due to the generally low quality or limited applicability of the studies identified, the results of this review are inconclusive. On the whole, the data seem to suggest that where adequate out-patient/home management of type 1 diabetes in children at diagnosis can be provided, this does not lead to any disadvantages in terms of metabolic control, acute diabetic complications and hospitalisations, psychosocial variables and behaviour, or total costs.

Plain-language summary: This review asked the question whether there are any benefits or dangers of using this type of care. We found only data of limited quality and or applicability, so no clear answers are possible. The seven studies we looked at suggested that home management of children newly diagnosed with type 1 diabetes does not lead to any disadvantages in terms of blood glucose, acute diabetic complications and hospitalisations, psychological variables and behaviour, or total costs. This would be particularly relevant for children not acutely ill, but also for children who require a short period of initial treatment in the hospital.
Abstract: Six trials including a total of 454 patients met our inclusion criteria. The methodological quality of most included trials was not high. It was shown that compared to placebo, Huperzine A had beneficial effects on the improvement of general cognitive function measured by MMSE (WMD 2.81; 95% CI 1.87 to 3.76; P < 0.00001) and ADAS-Cog at six weeks (WMD 1.91; 95% CI 1.27 to 2.55) and at 12 weeks (WMD 2.51; 95% CI 1.74 to 3.28), global clinical assessment measured by CDR (WMD -0.80; 95% CI -0.95 to -0.65) and CIBIC-plus (OR 4.32, 95% CI 2.37 to 7.90), behavioral disturbance measured by ADAS-non-Cog at six weeks (WMD -1.33, 95%CI -2.12 to -0.54) and at 12 weeks (WMD -1.52, 95% CI-2.39 to -0.65), and functional performance measured by ADL (WMD = -7.17; 95% CI -9.13 to -5.22; P < 0.00001). However, Huperzine A was not superior to placebo in the improvement of general cognitive function measured by Hasegawa Dementia Scale (HDS) (WMD: 2.78; 95% CI -0.17 to 5.73, P = 0.06) and specific cognitive function measured by Weshler Memory Scale (WMS) (WMD = 6.64; 95% CI -3.22 to 16.50; P = 0.19). No data were available on quality of life and caregiver burden. The adverse events of Huperzine A were mild and there were no significant differences of adverse events between Huperzine A groups and control groups. From the available evidence, Huperzine A seems to have some beneficial effects on improvement of general cognitive function, global clinical status, behavioral disturbance and functional performance, with no obvious serious adverse events for patients with AD. However, only one study was of adequate quality and size. There is therefore inadequate evidence to make any recommendation about its use. Rigorous design, randomized, multi-centre, large-sample trials of Huperzine A for AD are needed to further assess the effects.

Plain-language summary: This review looked for randomized trials comparing Huperzine A with control in patients with AD. Six trials were identified but most trials were of low methodological quality. Although Huperzine A seemed to have some beneficial effects on improvement of general cognitive function, global clinical status, behavioral disturbance and functional performance for patients with AD, the small trials with limited numbers of patients and the low methodological quality resulted in cautious assessment of the results. More large, high-quality randomized trials are needed.
Abstract: We included only one study in this review, which compared two surgical interventions: pedicled buccal fat pad flap and buccal flap for the treatment of oro-antral communications. The study involved 20 participants. The risk of bias was unclear. The relevant outcome reported in this trial was successful (complete) closure of oro-antral communication. The quality of the evidence for the primary outcome was very low. The study did not find evidence of a difference between interventions for the successful (complete) closure of an oro-antral communication (RR 1.00, 95% Cl 0.83 to 1.20) one month after the surgery. All oro-antral communications in both groups were successfully closed so there were no adverse effects due to treatment failure. We did not find trials evaluating any other intervention for treating oro-antral communications or fistulae due to dental procedures. We found very low quality evidence from a single small study that compared pedicled buccal fat pad and buccal flap. The evidence was insufficient to judge whether there is a difference in the effectiveness of these interventions as all oro-antral communications in the study were successfully closed by one month after surgery. Large, well-conducted RCTs investigating different interventions for the treatment of oro-antral communications and fistulae caused by dental procedures are needed to inform clinical practice.

Plain-language summary: We searched various databases until 23 May 2018. Only one study, which was conducted in Iran, is included in our review. The study ran for two years and involved 20 people with OAC aged between 25 and 56 years. Participants were divided into two groups and two surgical treatments were compared for treating oro-antral communications; one group was treated with pedicled buccal fat pad flap (PBFPF) and the other with buccal flap (BF). The study did not find evidence of a difference between PBFPF and BF in terms of successful (complete) closure of OAC. Both interventions resulted in successful closure by one month after surgery. The study did not therefore report any adverse effects of treatment failure. It may not be possible to generalise these findings because the quality of the evidence was very low, due to unclear risk of bias and the small numbers studied in the single included trial. The evidence currently available is insufficient to draw reliable conclusions regarding the effects of interventions used to treat OAC or fistulae due to dental procedures. More well-designed and well-reported trials evaluating different interventions are needed to provide reliable evidence to inform clinical decisions.