GEM/cochrane-simplification huggingface dataset:
Abstract: We included four trials involving 1365 participants. Three trials compared the intravenous GP IIb-IIIa inhibitor Abciximab with intravenous placebo (1215 participants) and one trial compared the intravenous GP IIb-IIIa inhibitor Tirofiban with intravenous aspirin (150 participants). Treatment with either of these GP IIb-IIIa inhibitors did not significantly reduce long-term death or dependency (odds ratio (OR) 0.97, 95% confidence interval (CI) 0.77 to 1.22, for the comparison between Abciximab and placebo; OR 1.00, 95% CI 0.52 to 1.92, for the comparison between Tirofiban and aspirin) and had no effect on deaths from all causes (OR 1.08, 95% CI 0.77 to 1.53, for the comparison between Abciximab and placebo; OR 1.00, 95% CI 0.35 to 2.82, for the comparison between Tirofiban and aspirin). Abciximab was associated with a significant increase in symptomatic intracranial haemorrhage (OR 4.6, 95% CI 2.01 to 10.54) and with a non-significant increase in major extracranial haemorrhage (OR 1.81, 95% CI 0.96 to 3.41), whereas the only small trial comparing Tirofiban with aspirin showed no increased risk of bleeding complications with Tirofiban (OR 0.32, 95% CI 0.03 to 3.19, for symptomatic intracranial haemorrhage; OR 3.04, 95% CI 0.12 to 75.83, for major extracranial haemorrhages). There was no significant inconsistency across the studies. The available trial evidence showed that, for individuals with acute ischaemic stroke, GP IIb-IIIa inhibitors are associated with a significant risk of intracranial haemorrhage with no evidence of any reduction in death or disability in survivors. These data do not support their routine use in clinical practice. The conclusion is driven by trials of Abciximab, which contributed 89% of the total number of study participants considered.

Plain-language summary: We identified four trials with a total of 1365 participants in searches conducted up to June 2013: three trials compared the intravenous GP IIb-IIIa inhibitor Abciximab with intravenous placebo and one trial compared the intravenous GP IIb-IIIa inhibitor Tirofiban with intravenous aspirin. The results showed that GP IIb-IIIa inhibitors cause bleeding in the brain, and that this complication offset any benefits. Therefore, GP IIb-IIIa inhibitors should be avoided in people with acute ischaemic stroke. Overall, the studies were considered at low risk of bias.
Abstract: We included two RCTs with 81 participants. One RCT involved 14 critically ill children with ARDS (very low quality of evidence), and one RCT involved 67 critically ill adults (very low quality evidence). Only one RCT (paediatric trial) provided data on mortality and found no difference between intervention and control. However, this trial was eligible for meta-analysis due to a cross-over design. We assessed the benefits and harms of aerosolized prostacyclin. One RCT found no difference in improvement of partial pressure of oxygen in arterial blood/fraction of inspired oxygen (PaO2/FiO2) ratio (mean difference (MD) -25.35, 95% confidence interval (CI) -60.48 to 9.78; P = 0.16; 67 participants, very low quality evidence). There were no adverse events such as bleeding or organ dysfunction in any of the included trials. Due to the limited number of RCTs, we were unable to perform the prespecified subgroup and sensitivity analyses or trial sequential analysis. We are unable to tell from our results whether the intervention has an important effect on mortality because the results were too imprecise to rule out a small or no effect. Therefore, no current evidence supports or refutes the routine use of aerosolized prostacyclin for people with ARDS. There is an urgent need for more RCTs.

Plain-language summary: This review was updated in 2017. We included two randomized controlled trials (RCT; clinical studies where people are randomly put into one of two or more treatment groups), one involving 14 critically ill children with ARDS and one involving 67 critically ill adults with ARDS. The trials did not measure severity of illness, resolution of organ dysfunction, length of stay in intensive care unit or hospital, and quality of life. The study authors did not report side effects such as bleeding, organ dysfunction, airway reactivity or side effects unrelated to the intervention. None of the included trials reported receiving money from drug companies. Only the RCT involving children provided data on deaths, with no clear difference with and without prostacyclin. The RCT in adults reported a trend towards improved blood oxygen levels, for participants who were treated with alprostadil (prostaglandin E1). Therefore, we could not identify a clear advantage of the use of aerosolized prostacyclin in critically ill children or adults with low blood oxygen levels. The quality of the evidence was very low because of the limited number of participants and poor trial design. The RCT involving children used a cross-over design where one group received aerosolized prostacyclin first and the other group received saline (salt solution). They then changed over to the alternate treatment. There was insufficient information on the effect on death in both trials. We conclude that there is a need for a large-scale clinical trial with low risk of misleading information to investigate the advantages and harms of prostacyclin for critically ill people.
Abstract: The search identified two randomized controlled trials for inclusion. One trial included 47 hypertensive patients and showed that garlic significantly reduces mean supine systolic blood pressure by 12 mmHg (95% CI 0.56 to 23.44 mmHg, p=0.04) and mean supine diastolic blood pressure by 9 mmHg (95% CI 2.49 to 15.51 mmHg, p=0.007) versus placebo. The authors state that garlic was "free from side effects" and that no serious side effects were reported. There were 3 cases "where a slight smell of garlic was noted." The second trial could not be meta-analysed as they did not report the number of people randomized to each treatment group. They did report that 200 mg of garlic powder given three times daily, in addition to hydrochlorothiazide-triamterene baseline therapy, produced a mean reduction of systolic blood pressure by 10-11 mmHg and of diastolic blood pressure by 6-8 mmHg versus placebo. Neither trial reported clinical outcomes and insufficient data was provided on adverse events. There is insufficient evidence to determine if garlic provides a therapeutic advantage versus placebo in terms of reducing the risk of mortality and cardiovascular morbidity in patients diagnosed with hypertension. There is also insufficient evidence to determine the difference in withdrawals due to adverse events between patients treated with garlic or placebo. Based on 2 trials in 87 hypertensive patients, it appears that garlic reduces mean supine systolic and diastolic blood pressure by approximately 10-12 mmHg and 6-9 mmHg, respectively, over and above the effect of placebo but the confidence intervals for these effect estimates are not precise and this difference in blood pressure reduction falls within the known variability in blood pressure measurements. This makes it difficult to determine the true impact of garlic on lowering blood pressure.

Plain-language summary: In this analysis, we reviewed the currently available evidence to determine the impact of garlic on cardiovascular events and mortality in patients with hypertension. Based on data from two randomized controlled trials that compared garlic to placebo in patients with hypertension it appears that garlic may have some blood pressure lowering effect, as compared to placebo but the evidence currently available is insufficient to determine whether garlic provides a therapeutic advantage versus placebo in terms of reducing the risk of cardiovascular morbidity and mortality. Data on the safety of garlic, as a therapeutic entity, in this population is also lacking. More (and large enough) trials comparing several doses of garlic with placebo are needed to detect possible differences in mortality, serious adverse events, and cardiovascular morbidity.
Abstract: Nine studies were identified, five of which met the inclusion criteria. A meta-analysis of two trials in which 71 patients were randomized to nicotine and 70 to placebo showed a statistically significant benefit for nicotine treatment. After four to six weeks of treatment 19 of 71 patients treated with transdermal nicotine were in clinical remission compared to 9 of 70 treated with placebo (OR=2.56, 95% CI 1.02-6.45). In the same group of patients improvement or remission was noted in 29 of the 71 patients assigned to nicotine compared to 14 of 70 patients assigned to placebo (OR=2.72, 95% CI 1.28 - 5.81). For patients with left sided colitis the odds ratio was 2.31 (95% CI 1.05-5.10). When transdermal nicotine was compared to standard medical therapy no significant benefit for nicotine was observed. After four to six weeks of standard therapy (oral prednisone or mesalamine), 34 of 63 patients were in clinical or sigmoidoscopic remission compared to 33 of 66 patients treated with transdermal nicotine (OR=0.77, 95% CI 0.37-1.60). A meta-analysis of all five studies which included 137 patients treated with transdermal nicotine and 133 patients treated with a placebo or standard therapy demonstrated no statistically significant benefit of nicotine therapy (OR=1.23; 95% CI 0.71-2.14). Patients treated with transdermal nicotine were significantly more likely to withdrawal due to adverse events than patients treated with placebo or standard medical therapy (OR=5.82, 95% CI, 1.66 - 20.47) and were significantly more likely to suffer from an adverse event than patients treated with placebo or standard medical therapy (OR=3.54, 95% CI, 2.07 - 6.08). The results of this review provide evidence that transdermal nicotine is superior to placebo for the induction of remission in patient's with ulcerative colitis. The review did not identify any significant advantage for transdermal nicotine therapy compared to standard medical therapy. Adverse events associated with transdermal nicotine are significant and limit its use in some patients.

Plain-language summary: Randomised controlled trials were therefore developed to test the hypothesis that nicotine patches can induce remission of a flare of ulcerative colitis. This review provides evidence that transdermal nicotine is superior to placebo (fake patch) for the treatment of active ulcerative colitis. However, patients treated with transdermal nicotine were significantly more likely to experience side effects than patients receiving placebo or standard medical therapy. Its use is therefore limited in some patients. The review did not identify any significant advantage for transdermal nicotine therapy compared to standard medical therapy.
Abstract: One trial, which included 49 infants, met the inclusion criteria. The trial compared the use of inhaled corticosteroids (budesonide) with placebo. We found no differences between groups in terms of need for nasal continuous positive airway pressure (risk ratio (RR) 1.27, 95% confidence interval (CI) 0.65 to 2.51; 1 study, 49 participants) and need for mechanical ventilation (RR 0.52, 95% CI 0.05 to 5.38; 1 study, 49 participants). The type of mechanical ventilation used in the included study was high-frequency oscillation. Tests for heterogeneity were not applicable for any of the analyses as only one study was included. Out of the secondary outcomes we deemed to be of greatest importance to patients, the study only reported on duration of hospital stay, which was no different between groups. The quality of the evidence is very low, due to the imprecision of the estimates and indirectness. We identified no ongoing trials. Given the paucity and very low quality of the available evidence, we are unable to determine the benefits and harms of postnatal administration of either inhaled or systemic corticosteroids for the management of TTN.

Plain-language summary: We identified and included one study, which compared steroids with placebo (dummy pill) in 49 newborns. The steroids were given to babies by inhalation. We found no ongoing studies. The evidence is up to date as of February 2019. Steroids did not improve lung function or reduce the need for breathing support. Overall, we are uncertain as to whether steroids have an important effect on rapid breathing because the results are imprecise and based on only one small study.
Abstract: Four trials were included. These involved a total of 278, mainly adult, participants with 283 mallet finger injuries. All four trials were methodologically flawed, including inadequate outcome assessment. Three trials compared different types of finger splints versus a standard Stack splint. One trial found a lower incidence of treatment failure in participants treated with a perforated custom-made splint. One trial found there were fewer complications in participants treated with a padded aluminium-alloy malleable finger splint; however, the incidence of treatment failure was similar in the two treatment groups. One trial evaluating the Abouna splint found a similar incidence of treatment failure in the two groups. However, the Abouna splint often needed replacing due to disintegration of its rubber cover and rusting of the exposed wires and was also less popular with participants. The fourth trial found no statistically significant differences between participants whose mallet finger was treated with Kirschner wire fixation and those with a Pryor and Howard splint. Similar numbers had complications in the two groups. There was insufficient evidence from comparisons tested within randomised controlled trials to establish the relative effectiveness of different, either custom-made or off-the-shelf, finger splints used for treating mallet finger injury. There was a useful reminder that splints used for prolonged immobilisation should be robust enough for everyday use, and of the central importance of patient adherence to instructions for splint use. There was insufficient evidence to determine when surgery is indicated.

Plain-language summary: Four randomised trials were included in the review. These involved a total of 278, mainly adult, participants with 283 mallet finger injuries. The methods of all four trials were flawed leading to concerns about bias. There was no pooling of data. Three trials compared different types of finger splints versus a standard Stack splint. One trial found less treatment failure in participants treated with a perforated custom-made splint. A second trial found there were fewer complications in participants treated with a padded aluminium-alloy malleable finger splint. However, the incidence of treatment failure was similar in the two treatment groups of this trial. The third trial evaluated the Abouna splint and found a similar incidence of treatment failure in the two groups. However, the Abouna splint often needed replacing due to disintegration of its rubber cover and rusting of the exposed wires and was also less popular with participants. The fourth trial in the review found no significant differences between participants whose mallet finger was treated with Kirschner wire fixation and those with a Pryor and Howard splint. Similar numbers had complications in the two groups. The review concluded that there was not enough evidence to show which is the best way to treat mallet finger injury. It noted, however, that splints used for prolonged immobilisation should be robust enough for everyday use.
Abstract: We included a total of 13 randomised trials with 790 patients. Loss of hepatitis B 'e' antigen (OR 1.41, 95% confidence interval 1.03 to 1.92, P = 0.03) and hepatitis B virus DNA (OR = 1.51, 95% confidence interval 1.12 to 2.05, P = 0.008) were significantly more frequent among patients treated with the sequential combination of glucocorticosteroids and alfa interferon than among patients treated with alfa interferon alone. Glucocorticosteroid pretreatment did not significantly influence seroconversion from hepatitis B 'e' antigen to antibodies to hepatitis B 'e' antigen, loss of hepatitis B surface antigen, normalisation of alanine aminotransferase/aspartate aminotransferase activities, and severity of adverse events. Glucocorticosteroid pretreatment did not significantly affect mortality and adverse events. The effect of glucocorticosteroid pretreatment on liver histology and quality of life could not be assessed due to insufficient data. Pretreatment with glucocorticosteroids before treatment with alfa interferon in patients with hepatitis B 'e' antigen positive chronic hepatitis B may be more effective than treatment with alfa interferon alone with regard to loss of hepatitis B 'e' antigen and hepatitis B virus DNA, but evidence for effect on clinical outcomes is lacking.

Plain-language summary: The objectives of this review were to assess the effects of the sequential combination of glucocorticosteroids and interferon compared to interferon alone in the treatment of chronic hepatitis B. Glucocorticosteroid pretreatment was associated with a significantly higher frequency of loss of hepatitis B markers (HBeAg and HBV DNA), but had no significant effect on clinical outcomes.
Abstract: Six studies found since 2004 were originally viewed as possible inclusions, but when the family-centred score assessment was tested, only one met the minimum score of family-centredness and was included in this review. This was an unpublished RCT involving 288 children post-tonsillectomy in a care-by-parent unit (CBPU) compared with standard inpatient care.The study used a range of behavioural, economic and physical measures. It showed that children in the CBPU were significantly less likely to receive inadequate care compared with standard inpatient admission, and there were no significant differences for their behavioural outcomes or other physical outcomes. Parents were significantly more satisfied with CBPU care than standard care, assessed both before discharge and at 7 days after discharge. Costs were lower for CPBU care compared with standard inpatient care. No other outcomes were reported. The study was rated as being at low to unclear risk of bias. This update of a review has found limited, moderate-quality evidence that suggests some benefit of a family-centred care intervention for children's clinical care, parental satisfaction, and costs, but this is based on a small dataset and needs confirmation in larger RCTs. There is no evidence of harms. Overall, there continues to be little high-quality quantitative research available about the effects of family-centred care. Further rigorous research on the use of family-centred care as a model for care delivery to children and families in hospitals is needed. This research should implement well-developed family-centred care interventions, ideally in randomised trials. It should investigate diverse participant groups and clinical settings, and should assess a wide range of outcomes for children, parents, staff and health services.

Plain-language summary: This review has tried to do that by examining research about family-centred care. We looked for randomised trials of family-centred care interventions for children aged 0-12 years, in hospitals. We assessed potentially-relevant studies against criteria that identify important parts of family-centred care. Despite extensive searching we identified only one moderate-quality study (Bolton 2004) for inclusion. This study, from a doctoral thesis, showed that the family-centred care model had a positive effect on the adequacy of children's care, parental satisfaction, and costs. For other indicators such as clinical outcomes and children's behaviour there was no significant difference between the family-centred care model and standard inpatient care. There were no harms reported. In this searches for this update, we also found 25 qualitative studies which described aspects of family-centred care, and a review of these will be published by the Joanna Briggs Institute. Our main conclusion from this Cochrane review update, however, is that further, rigorous research is needed to assess the effects of family-centred care on children's experience of hospitalisation, as well as on their parents, hospital staff, and service delivery outcomes such as costs.
Abstract: Only one study met the inclusion criteria, an RCT conducted in Tanzania between May 2003 and October 2004. Women in the intervention group (n=760) received a letter for their male partners, which invited them to return together to receive Couple Voluntary Counselling and Testing (CVCT) for HIV. Women in the control group (n=761) received individual HIV VCT during their first ANC visit and then usual care. The percentages of women who received HIV VCT and collected their results were 48%, 45% and 39% in the intervention group and 93%, 78% and 71% in the control group (p <0,001). Only 33% of women in the intervention group returned with their male partners and only 47% of them went through the whole CVCT process. The proportion of women who received HIV prophylaxis at delivery was not different between the two arms (27% in the intervention and 22% in the control group). The study had a high risk of bias. We found only one eligible study that assessed the effectiveness of male involvement in improving women’s uptake of PMTCT services, which only focused on one part of the perinatal PMTCT cascade. We urgently need more rigorously designed studies assessing the impact of male engagement interventions on women’s uptake of PMTCT services to know if this intervention can contribute to improve uptake of PMTCT services and reduce vertical transmission of HIV in children.

Plain-language summary: We undertook a comprehensive search to identify relevant studies. We found 3,072 references, but only one study that met our criteria. The study was performed in 2003-2004 in Tanzania. Pregnant women in the intervention group were provided with a letter inviting their male partners to accompany them to their next visit, in which they were offered voluntary HIV counselling and testing (VCT) together or separately. Women in the control group received the VCT individually during their first visit. The proportions of women that received VCT and collected their HIV test results were significantly lower in the intervention group than in the control group. Most of the women in the intervention group did not return to the clinic for the subsequent visit and most of those that returned accompanied refused to receive VCT together with their male partners. The invitation letter had a negative impact on the PMTCT uptake in that setting. We urgently need more studies assessing different interventions to improve male engagement in PMTCT to identify the most successful approach for women to safely access health care for their own health and to deliver HIV negative children.