GEM/cochrane-simplification huggingface dataset:
Abstract: We included three quasi-randomised controlled trials, with a total of 149 women and their babies. All three trials were at a high risk of bias. When comparing women receiving relaxin with those who did not receive relaxin, there was a significant reduction in birth within seven days of treatment in one trial of 30 women (risk ratio (RR) 0.50, 95% confidence interval (CI) 0.29 to 0.87), yet no significant difference was seen for perinatal mortality in this trial (RR 0.83, 95% CI 0.32 to 2.15). The second and third included trials did not report on any of the primary outcomes pre-specified in the review, including birth within 48 hours of treatment, birth within seven days of treatment, perinatal mortality, and serious neonatal adverse outcomes. One trial found a significant increase in pregnancy prolongation for women receiving relaxin (RR 8.00, 95% CI 1.14 to 56.33; 30 women). None of the three included trials found significant differences in the outcomes of fetal death, neonatal death, birthweight or preterm birth, and no trial reported on longer-term outcomes for the babies. There is limited randomised controlled trial evidence available on the effect of relaxin during pregnancy for preventing preterm birth for women in preterm labour. Evidence from one quasi-randomised trial suggested a reduction in birth within seven days of treatment for women receiving relaxin, compared with women in a control group, however this trial was at a high risk of bias and included only 30 women. There is thus insufficient evidence to support or refute the use of relaxin in women in preterm labour for preventing preterm birth.

Plain-language summary: We included three small randomised trials involving 149 women in preterm labour in the review. These trials were conducted in the 1950s and had a high risk of bias overall. We found no convincing evidence that relaxin (given by intravenous and intramuscular injection) can prevent preterm birth for women in preterm labour. Only one of the studies, involving 30 women (and at a high risk of bias), reported on birth within seven days of treatment and found that women who received relaxin were less likely to give birth preterm within seven days of treatment, and were more likely to have a longer pregnancy than women who did not receive relaxin. The risk of babies dying was not significantly different between the women who received relaxin and those who did not. Neither of the other two trials found clear differences in preterm birth, and no trial reported on longer-term outcomes for the babies. There is therefore insufficient evidence from this review to recommend relaxin as an intervention to prevent preterm birth for women in preterm labour.
Abstract: We included 38 studies (3679 women). Nine studies included pregnancies after intrauterine deaths, five studies included termination of pregnancies because of fetal anomalies when the fetus was still alive and the rest (24) presented the pooled data for intrauterine deaths, fetal anomalies and social reasons. When compared with agents that have traditionally been used to induce labour in this setting (for example, gemeprost, prostaglandin E2 and prostaglandin F2alpha), vaginal misoprostol is as effective in ensuring vaginal birth within 24 hours, with a similar induction to birth interval. Vaginal misoprostol is associated with a reduction in the occurrence of maternal gastrointestinal side effects such as nausea, vomiting and diarrhoea when compared with other prostaglandin preparations. While the different treatments involving various prostaglandin preparations appear comparable for the reported outcomes, the information available regarding rare maternal complications, such as uterine rupture, is limited. The use of vaginal misoprostol in the termination of second and third trimester of pregnancy is as effective as other prostaglandin preparations (including cervagem, prostaglandin E2 and prostaglandin F2alpha), and more effective than oral administration of misoprostol. However, important information regarding maternal safety, and in particular the occurrence of rare outcomes such as uterine rupture, remains limited. Future research efforts should be directed towards determining the optimal dose and frequency of administration, with particular attention to standardised reporting of all relevant outcomes and assessment of rare adverse events. Further information is required about the use of sublingual misoprostol in this setting.

Plain-language summary: This review included 38 randomised controlled studies, involving 3679 women. Vaginal misoprostol was as effective as other agents in inducing labour and achieving vaginal birth within 24 hours, with a reduction in the occurrence of maternal side effects. Side effects include gastrointestinal disturbance (nausea, vomiting, diarrhoea). The information on rare adverse events (including uterine rupture) is limited.
Abstract: Our search strategy yielded 2696 references. Two review authors independently assessed all references for inclusion. Two randomized controlled trials, for a total of 110 infants, met the inclusion criteria of this review. Both trials compared supine midline head position with the bed at 0° versus supine head rotated 90° with the bed at 0°. We found no trials that compared supine versus prone midline head position, and no trials that compared effects of head tilting. We found no significant differences in rates of GM-IVH (typical risk ratio [RR] 1.14, 95% confidence interval [CI] 0.55 to 2.35; typical risk difference [RD] 0.03, 95% CI -0.13 to 0.18; two studies, 110 infants; I2 = 0% for RR and I2 = 0% for RD), severe IVH (typical RR 1.57, 95% CI 0.28 to 8.98; typical RD 0.02, 95% CI -0.06 to 0.10; two studies, 110 infants; I2 = 0% for RR and I2 = 0% for RD), and neonatal mortality (typical RR 0.52, 95% CI 0.16 to 1.65; typical RD -0.07, 95% CI -0.18 to 0.05; two studies, 110 infants; I2 = 28% for RR and I2 = 44% for RD). Among secondary outcomes, we found no significant differences in terms of cystic periventricular leukomalacia (one study; RR 3.25, 95% CI 0.14 to 76.01; RD 0.04, 95% CI -0.07 to 0.15), retinopathy of prematurity (one study; RR 2.27, 95% CI 0.85 to 6.11; RD 0.25, 95% CI -0.02 to 0.53), and severe retinopathy of prematurity (one study; RR 2.73, 95% CI 0.31 to 24.14; RD 0.09, 95% CI -0.09 to 0.26). None of the included trials reported on the other specified outcomes of this review (i.e., cerebellar hemorrhage, brain magnetic resonance imaging abnormalities, impairment in cerebral hemodynamics, long-term neurodevelopmental outcomes, and major neurodevelopmental disability). The quality of evidence supporting these findings is limited owing to the imprecision of the estimates. We identified no ongoing studies. Given the imprecision of the estimate, results of this systematic review are consistent with beneficial or detrimental effects of a supine head midline position versus a lateral position and do not provide a definitive answer to the review question.

Plain-language summary: We included two studies comparing supine midline head position versus supine head rotated 90°. This review of trials found too little evidence to show positive or negative effects of supine (lying on the back) midline head position for prevention of intraventricular hemorrhage (i.e., bleeding within the brain), mortality, or any other relevant outcomes in very preterm neonates. More research is needed. We found no trials that compared supine (lying on the back) versus prone (lying on the stomach) midline head position, and no trials that compared effects of head tilting (elevating the head of the incubator upward). Results of this systematic review are consistent with beneficial or detrimental effects of a supine head midline position and do not provide a definitive answer to the review question.
Abstract: Brynskov 1989a found that patients receiving high dose cyclosporine (median 7.6 mg/kg/day) had statistically significant clinical improvement at 12 weeks compared to placebo patients. None of the other studies found any statistically significant benefit for clinical improvement or induction of remission for low dose cyclosporine treatment (5 mg/kg/day) used by itself or in combination with corticosteroids compared to placebo. Cyclosporine was associated with a significantly higher proportion of adverse events and withdrawals due to adverse events relative to placebo. Brynskov 1989a enrolled a small number of patients and the modified clinical grading scale used in the study has not been validated in other studies. Furthermore, statistically significant clinical improvement does not imply induction of clinical remission. Indeed, Brynskov 1989a found no statistically significant differences in the mean Crohn's Disease Activity Index score at 12 weeks indicating that cyclosporine was no more effective than placebo for induction of remission in Crohn's disease. The results of this review demonstrate that low dose (5 mg/kg/day) oral cyclosporine is not effective for the induction of remission in Crohn's disease. Patients treated with low dose oral cyclosporine are more likely than placebo treated patients to experience adverse events including renal dysfunction. The use of low dose oral cyclosporine for the treatment of chronic active Crohn's disease does not appear to be justified. Oral dosing at higher levels or parenteral administration of cyclosporine have not been adequately evaluated in controlled clinical trials. Higher doses of cyclosporine are not likely to be useful for the long-term management of Crohn's disease because of the risk of nephrotoxicity and the availability of other proven interventions.

Plain-language summary: The results of this review demonstrate that low dose oral cyclosporine is not effective for treatment of active Crohn's disease. Studies indicate that Crohn's patients treated with low dose (5 mg/kg/day) oral cyclosporine could experience side effects including kidney problems. Therefore the use of this medication for the treatment of chronic active Crohn's disease is not advisable. Higher oral doses and injections of cyclosporine have not been sufficiently evaluated. Larger doses of cyclosporine are not likely to be useful for the long-term management of Crohn's disease due to the risk of kidney damage and the availability of other proven medications.
Abstract: Nine studies were included representing 425 participants. All studies compared omega-3 fatty acid supplementation with placebo lasting from four weeks to two years. Three studies with long treatment periods administered additional substances, making any observed effects impossible to attribute to omega-3 fatty acids and were excluded from the statistical analyses. One study did not express any mean values and, therefore, could not be included in statistical analyses. No significant differences between intervention and control groups were observed in pain-free walking distance (mean difference (MD) 11.62 m, 95% confidence interval (CI) -67.74 to 90.98), maximal walking distance (MD 16.99 m, 95% CI -72.14 to 106.11), ankle brachial pressure index (MD -0.02, 95% CI -0.09 to 0.05), total cholesterol levels (MD 0.27 mmol/L, 95% CI -0.48 to 1.01), high-density lipoprotein cholesterol levels (MD 0.00 mmol/L, 95% CI -0.16 to 0.15), low-density lipoprotein cholesterol levels (MD 0.44 mmol/L, 95% CI -0.31 to 1.19), triglyceride levels (MD -0.39 mmol/L, 95% CI -1.10 to 0.33), systolic blood pressure (MD 5.00 mmHg, 95% CI -11.59 to 21.59) or plasma viscosity (MD 0.03 mPa/s, 95% CI -0.02 to 0.08). There was some limited evidence that blood but not plasma viscosity levels decreased with treatment and gastrointestinal side effects such as nausea, diarrhoea and flatulence were observed in two studies. Omega-3 fatty acids appear to have little haematological benefit in people with intermittent claudication and there is no evidence of consistently improved clinical outcomes (quality of life, walking distance, ankle brachial pressure index or angiographic findings). Supplementation may also cause adverse effects such as nausea, diarrhoea and flatulence. Further research is needed to evaluate fully short- and long-term effects of omega-3 fatty acids on the most clinically relevant outcomes in people with intermittent claudication before they can be recommended for routine use.

Plain-language summary: The review included nine randomised controlled trials with 425 participants, comparing omega-3 fatty acid supplementation with other fatty acids. On the basis of these studies, omega-3 fatty acid supplementation did not improve walking distance, blood pressure in the leg or any other measure of clinical benefit. There was some limited evidence to suggest that omega-3 fatty acid supplementation may reduce blood viscosity (the resistance of blood to flow), which when high could potentially contribute to intermittent claudication. There was no evidence to suggest that omega-3 fatty acid supplementation reduced plasma (the liquid component of blood) viscosity or improved the levels of different types of cholesterol or any other components of blood tested. Side effects such as nausea, diarrhoea and flatulence were observed in two studies.
Abstract: Fourteen studies with data from 672 participants met the inclusion criteria. Five different antiepileptic drugs were examined. Sodium valproate/divalproex was superior to placebo for outpatient men with recurrent impulsive aggression, for impulsively aggressive adults with cluster B personality disorders, and for youths with conduct disorder, but not for children and adolescents with pervasive developmental disorder. Carbamazepine was superior to placebo in reducing acts of self-directed aggression in women with borderline personality disorder, but not in children with conduct disorder. Oxcarbazepine was superior to placebo for verbal aggression and aggression against objects in adult outpatients. Phenytoin was superior to placebo on the frequency of aggressive acts in male prisoners and in outpatient men including those with personality disorder, but not on the frequency of 'behavioral incidents' in delinquent boys. The authors consider that the body of evidence summarised in this review is insufficient to allow any firm conclusion to be drawn about the use of antiepileptic medication in the treatment of aggression and associated impulsivity. Four antiepileptics (valproate/divalproex, carbamazepine, oxcarbazepine and phenytoin) were effective, compared to placebo, in reducing aggression in at least one study, although for three drugs (valproate, carbamazepine and phenytoin) at least one other study showed no statistically significant difference between treatment and control conditions. Side effects were more commonly noted for the intervention group although adverse effects were not well reported. Absence of information does not necessarily mean that the treatment is safe, nor that the potential gains from the medication necessarily balance the risk of an adverse event occurring. Further research is needed.

Plain-language summary: This review systematically examines the evidence supporting this practice. From the evidence available, we were unable to draw any firm conclusion about using these medicines to treat aggression. Four antiepileptic drugs (valproate/divalproex, carbamazepine, oxcarbazepine and phenytoin) helped to reduce aggression in at least one study. However, for three of these drugs (valproate, carbamazepine and phenytoin) we found at least one other study where there was no significant improvement. Further research is needed to clarify which antiepileptic drugs are effective for whom. Such research is best carried out using carefully designed clinical trials. Such trials need to take account of the type of aggression displayed, the severity of the aggression, and any other disorders experienced by the participants.
Abstract: We identified four studies meeting our inclusion criteria. Overall, trials were of poor to moderate methodological quality. Few trial authors responded to our written inquiries seeking to resolve controversial issues and to obtain individual patient data. Strong heterogeneity amongst the trials prompted discussion between the review authors as to whether the data should or should not be pooled; we decided in favour of a quantitative synthesis to provide a rough impression about the effect sizes achievable with US-based triage algorithms. We pooled mortality data from three trials involving 1254 patients; the RR in favour of the FAST arm was 1.00 (95% CI 0.50 to 2.00). FAST-based pathways reduced the number of CT scans (random-effects model RD -0.52, 95% CI -0.83 to -0.21), but the meaning of this result was unclear. The experimental evidence justifying FAST-based clinical pathways in diagnosing patients with suspected abdominal or multiple blunt trauma remains poor. Because of strong heterogeneity between the trial results, the quantitative information provided by this review may only be used in an exploratory fashion. It is unlikely that FAST will ever be investigated by means of a confirmatory, large-scale RCT in the future. Thus, this Cochrane Review may be regarded as a review which provides the best available evidence for clinical practice guidelines and management recommendations. It can only be concluded from the few head-to-head studies that negative US scans are likely to reduce the incidence of MDCT scans which, given the low sensitivity of FAST (or reliability of negative results), may adversely affect the diagnostic yield of the trauma survey. At best, US has no negative impact on mortality or morbidity. Assuming that major blunt abdominal or multiple trauma is associated with 15% mortality and a CT-based diagnostic work-up is considered the current standard of care, 874, 3495, or 21,838 patients are needed per intervention group to demonstrate non-inferiority of FAST to CT-based algorithms with non-inferiority margins of 5%, 2.5%, and 1%, power of 90%, and a type-I error alpha of 5%.

Plain-language summary: In this review, the authors looked for studies that compared death rates in patients with an abdominal injury where ultrasound was used to aid diagnosis with death rates where no ultrasound was used. They also looked for evidence that ultrasound use could reduce the need to carry out other more complex and more expensive diagnostic tests. However, very few trials have been done and the authors concluded that there is insufficient evidence to justify the use of ultrasound as part of the diagnosis of patients with abdominal injury. Given this degree of uncertainty, it is probably justified to ask doctors on duty for a confirmatory CT scan in patients who have sustained an injury with a high chance of major trauma (that is, head and brain injury, cervical spine fracture, thoraco-abdominal pelvic trauma, and other injuries).
Abstract: Twenty studies involving 1898 subjects were evaluated, including 4 studies with multiple comparisons. We found eight comparisons of TURP with contact lasers, eight with non-contact lasers, four with hybrid techniques, and one with interstitial laser coagulation (ILC). Two studies compared transurethral electrovaporization (TUVP) with contact lasers, one study compared interstitial laser coagulation with transurethral microwave thermotherapy (TUMT), and one study compared holmium contact lasers (HoLRP) with open prostatectomy. Among the studies comparing laser prostatectomy with TURP, follow-up duration ranged from 6 to 36 months. Mean age (67.2 yrs), mean baseline symptom score (20.2), and mean baseline peak urinary flow (9.2 mL/s) did not differ by treatment group. The pooled percentage improvements for mean urinary symptoms ranged from 59% to 68% with lasers and 63% to 77% with TURP. The improvements for mean peak urinary flow ranged from 56% to 119% with lasers and 96% to 127% with TURP. Overall, laser subjects were less likely to receive transfusions or develop strictures and their hospitalizations were shorter. Non-contact laser subjects were more likely to have dysuria, urinary tract infection, and retention. Re-operation occurred more often following laser procedures. Laser techniques are a useful alternative to TURP for treating BPO. Small sample sizes and differences in study design limit any definitive conclusions regarding the preferred type of laser technique. Data were insufficient to compare laser techniques with other minimally invasive procedures.

Plain-language summary: This review of 20 studies involving 1898 subjects found laser techniques to be useful and relatively safe alternatives to TURP. The small number of enrolled subjects and differences in study design limit any definitive conclusions regarding which type of laser technique is the most effective. Improvements in LUTS and urine flow slightly favored TURP, though laser procedures had fewer side effects and shorter hospitalization times. The follow-up durations of these studies ranged from 6 to 36 months and men with extremely large prostates were generally excluded from the trials. The risk of needing a reoperation for recurrent LUTS was higher following laser procedures. Study results were insufficient to adequately compare laser techniques with other minimally invasive procedures. More studies, using randomized treatment assignment, enrolling larger numbers of subjects, and comprehensive measures of treatment effectiveness and side events, are needed to better define the long-term safety and durability of laser techniques for treating LUTS associated BPO.
Abstract: Five trials, with a total of 336 randomised participants, were included. A total of 105 participants (31%) died. Of the five included trials, four (80%) had a high risk of bias. Meta-analysis using all five trials showed that pentoxifylline reduced mortality compared with control (RR 0.64; 95% CI 0.46 to 0.89). However, this result was not supported by trial sequential analysis, which adjusts for multiple testing on accumulating data. Furthermore, four of the five trials were judged to have a high risk of bias, thus risking an overestimated intervention effect. Meta-analysis showed that pentoxifylline reduced the hepatic-related mortality due to hepatorenal syndrome (RR 0.40; 95% CI 0.22 to 0.71), but trial sequential analysis did not support this result. Data from one trial suggests that pentoxifylline may increase the occurrence of serious and non-serious adverse events compared to control. The current available data may indicate a possible positive intervention effect of pentoxifylline on all-cause mortality and mortality due to hepatorenal syndrome, and conversely, an increase in serious and non-serious adverse events. However, the evidence is not firm; no conclusions can be drawn regarding whether pentoxifylline has a positive, negative, or neutral effect on participants with alcoholic hepatitis.

Plain-language summary: We found five randomised trials, which together included 336 participants; half received pentoxifylline, and the other half received placebo or no intervention. We performed this systematic review and statistical analyses but could not show firm evidence of beneficial effects of pentoxifylline on mortality or on complications of liver diseases in patients with alcoholic hepatitis. Pentoxifylline did appear to cause more serious and non-serious side effects. In order to help decide whether pentoxifylline should be used to treat alcoholic hepatitis or not, we need well-designed, well-conducted, large randomised clinical trials, with short-term (less than one month) and long-term (more than one month) data on benefits and harms.