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Objective: We aimed to evaluate to what extent the results of registered randomized controlled trials (RCTs) assessing transarterial chemoembolization (TACE) for treating hepatocellular carcinoma (HCC) are publicly available.Methods: We searched the Cochrane Central Register of Controlled Trials, the International Clinical Trials Registry Platform, and primary registries for RCTs assessing TACE for treating HCC, registered between January 2008 and August 2018, that had exceeded their completion date by more than 1 year. We systematically searched PubMed, EMBASE, and Google Scholar for a publication as well as the registry for results. The main outcomes were the availability of results, and the time to the first availability of results (i.e., posted on the registry or published). Secondary outcomes were the proportion of results available at 12 and 36 months after completion.Results: Among 67 identified RCTs, including a total target number to 11,599 participants, 26 had publicly available results (39%; i.e., 42% of total target number of participants). Results of 25 RCTs (37%) were published, with only 3 having results posted on the registry and 2 with both published and posted results. The median (Q1-Q3) time from completion to the first public availability of results was 18 months (11-29). The cumulative percentages of RCTs with results available were 10% (95% CI, 3-17%) and 29% (95% CI, 17-39%) at 12 and 36 months, respectively, after completion.Conclusions: Despite the ethical commitments and societal expectations for disclosure of results, the availability of results of RCTs on TACE for treating HCC is very limited.Key Points: • Underreporting of trial results is a major cause of wasted medical research since inaccessible research results fail to help both patients and clinicians. • Transarterial chemoembolization (TACE) is the most common treatment for hepatocellular carcinoma (HCC) and has called for considerable research efforts. • Yet, almost two-thirds of randomized controlled trials assessing TACE for treating HCC did not yield any public results, either on the registry platform or in scientific journals. [ABSTRACT FROM AUTHOR]

Background: Vedolizumab is a gut-selective humanized antibody that binds the α4β7 integrin. We evaluated efficacy and safety of vedolizumab in Japanese patients with moderate-to-severe Crohn's disease (CD).Methods: In this Phase 3, double-blind study (NCT02038920), 157 patients were randomized to receive intravenous vedolizumab 300 mg (n = 79) or placebo (n = 78) at Weeks 0, 2, and 6 (induction phase). Patients with CD activity index (CDAI)-70 response at Week 10 were randomized to receive vedolizumab 300 mg (n = 12) or placebo (n = 12) at Week 14, then every 8 weeks until Week 54 (maintenance phase). Primary endpoints were ≥ 100-point reduction in CDAI (CDAI-100 response) at Week 10 for induction, and clinical remission (CR: CDAI ≤ 150) at Week 60 for maintenance.Results: At Week 10, 26.6% of patients who received vedolizumab and 16.7% who received placebo achieved CDAI-100 response (odds ratio [OR] [95% confidence interval (CI)] 1.80 [0.82-3.96]; p = 0.145). At Week 60, 41.7% of vedolizumab-treated patients and 16.7% of placebo-treated patients achieved CR (OR [95% CI] 3.57 [0.53-23.95]; p = 0.178). The incidence of adverse events was similar in both treatment groups in both induction and maintenance phases. In patients without prior anti-TNFα exposure or with inadequate response to anti-TNFα, vedolizumab showed improved outcomes over placebo in the induction phase. Age might be a possible predictive factor of CR for future research.Conclusion: Vedolizumab showed a numerically greater efficacy versus placebo as induction therapy, but the difference was not statistically significant. Vedolizumab also showed a numerically greater efficacy in maintenance therapy, and was well tolerated. [ABSTRACT FROM AUTHOR]

Background and Aims: Despite advances in pharmacological and endoscopic management of non-variceal upper gastrointestinal bleeding (NVUGIB), mortality is still relevant. TC-325 (Hemospray-Cook Medical) is a mineral powder with adsorptive properties, designed for endoscopic hemostasis. There are still no comparative trials studying this new hemostatic modality. The objective of this research was to compare the use of TC-325 (associated with epinephrine injection) with the combined technique of endoscopic clipping and epinephrine injection for the treatment of patients with NVUGIB.Methods: We conducted a pilot randomized controlled trial with patients that presented NVUGIB with an actively bleeding lesion at the endoscopic evaluation. Patients were randomized either to the Hemospray or Hemoclip group. The randomization list was generated by a computer program and remained unknown throughout the entire trial. All patients underwent second-look endoscopy.Results: Thirty-nine patients were enrolled. Peptic ulcer was the most frequent etiology. Primary hemostasis was achieved in all Hemospray cases and in 90% of Hemoclip group (p = 0.487). Five patients in Hemospray group underwent an additional hemostatic procedure during second-look endoscopy, while no patient in the Hemoclip group needed it (p = 0.04). Rebleeding, emergency surgery and mortality rates were similar in both groups. No toxicity, allergy events, or gastrointestinal obstruction signs were observed in Hemospray group.Conclusions: TC-325 presents similar hemostatic results when compared with conventional dual therapy for patients with NVUGIB. Hemospray's excellent primary hemostasis rate certifies it as a valuable tool in arduous situations of severe bleeding or difficult location site. [ABSTRACT FROM AUTHOR]

Summary: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial (the TWICE study) conducted in Japanese primary osteoporosis patients with a high risk of fractures demonstrated that a 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen of teriparatide, while also improving safety. Introduction: While a 56.5-μg once-weekly regimen of teriparatide has high efficacy for osteoporosis, treatment continuation rates are low, with one of the major causes being adverse drug reactions such as nausea or vomiting. The TWICE study was therefore conducted to investigate whether a twice-weekly regimen with 28.2-μg teriparatide can provide comparable efficacy to the 56.5-μg once-weekly regimen while improving safety. Methods: A 48-week, multicenter, randomized, double-blind, double-dummy, active-controlled, non-inferiority trial was conducted in Japan. Patients with primary osteoporosis aged ≥ 65 years at high risk of fractures (n = 553) were randomly allocated to the 28.2-μg twice-weekly group (n = 277) or the 56.5-μg once-weekly group (n = 276). The primary endpoint was the percentage change in lumbar spine (L2–L4) bone mineral density (BMD) at final follow-up. Results: The percentage changes in lumbar spine (L2–L4) BMD at final follow-up in the 28.2-μg twice-weekly and 56.5-μg once-weekly groups were 7.3% and 5.9%, respectively; the difference (95% confidence interval [CI]) in percentage change was 1.3% (0.400–2.283%). Since the lower limit of the 95% CI was above the pre-specified non-inferiority margin (− 1.6%), non-inferiority of the 28.2-μg twice-weekly group was demonstrated. Adverse drug reactions were significantly less frequent in the 28.2-μg twice-weekly group (39.7% vs 56.2%; p < 0.01); the incidence of major adverse drug reactions was lower, and the number of subjects who discontinued due to adverse drug reactions was less in the 28.2-μg twice-weekly group. Conclusions: A 28.2-μg twice-weekly regimen of teriparatide can provide comparable efficacy to a 56.5-μg once-weekly regimen while improving safety. Clinical trial registration: JapicCTI-163477. [ABSTRACT FROM AUTHOR]

Background: Persistent proteinuria seems to be a risk factor for progression of renal disease. Its reduction by angiotensin-converting inhibitors (ACEIs) or angiotensin II receptor blockers (ARBs) is renoprotective. Our previous pilot study showed that 2-year lisinopril therapy is effective and safe for children with mild IgA nephropathy. When combined with ACEI and ARB, reported results are of greater decrease in proteinuria than monotherapy in chronic glomerulonephritis, including IgA nephropathy. To date, however, there have been no randomized controlled trials in children.Methods: This is an open-label, multicenter, prospective, and randomized phase II controlled trial of 63 children with biopsy-proven proteinuric mild IgA nephropathy. We compared efficacy and safety between patients undergoing lisinopril monotherapy and patients undergoing combination therapy of lisinopril and losartan to determine better treatment for childhood proteinuric mild IgA nephropathy.Results: There was no difference in proteinuria disappearance rate (primary endpoint) between the two groups (cumulative disappearance rate of proteinuria at 24 months: 89.3% vs 89% [combination vs monotherapy]). Moreover, there were no significant differences in side effects between the two groups.Conclusions: We propose lisinopril monotherapy as treatment for childhood proteinuric mild IgA nephropathy as there are no advantages of combination therapy.Clinical trial registration: Clinical trial registry, UMIN ID C000000006, https://www.umin.ac.jp. [ABSTRACT FROM AUTHOR]

Purpose: Vena cava syndrome (VCS) from stenosis of the superior vena cava or inferior vena cava caused by compression from a malignant tumor is one of the typical clinical conditions in patients with advanced stage malignant disease. VCS is difficult to manage and painful, reducing patients' quality of life. Although several reports have investigated stent placement for VCS, this treatment has never been established as the standard because of the lack of evidence of the safety and efficacy. We conducted a phase II trial and a phase III randomized controlled trial to clarify the role of stent placement in managing patients with VCS.Methods: In the phase II trial, 28 eligible patients were treated with stent placement. The efficacy of stent placement for VCS was evaluated based on the reduction of patients' symptom scores during 14 days following treatment. Technical success, technical feasibility, overall survival, recurrence of symptoms, and adverse events were evaluated. In the phase III trial, 32 patients were enrolled and randomly assigned to the test (n = 16) and control groups (n = 16). The area under the symptom score curve was compared between the groups. The EQ-5D, SF-8, and adverse events were evaluated until discontinuation of the protocol treatment or 28 days after enrollment.Results: In the phase II trial, the median patients' symptom scores significantly decreased from 10.50 before the procedure to 3.00 after the procedure. Technical success and technical feasibility rates were 96.4% and 100%, respectively. The incidence of treatment-related grade 3 or higher adverse events was 14.3%. In the phase III trial, significant superiority of stent placement was observed in the test, compared to that in the control, group. There was no significant difference in most other evaluations between the groups.Conclusions: Stent placement significantly improved the symptoms of VCS; thus, it might be accepted as the standard treatment to manage the symptoms of VCS.Trial Registration: JIVROSG-0402, JIVROSG-0807. [ABSTRACT FROM AUTHOR]

Background: Fermented milk products containing Bifidobacterium breve strain Yakult (BFM) may improve clinical status in ulcerative colitis (UC) patients.Aims: To assess efficacy of BFM in maintaining remission in Japanese patients with quiescent UC.Methods: This double-blind study (B-FLORA) enrolled 195 patients with quiescent UC, randomized to receive one pack of BFM fermented milk per day [Bifidobacterium breve strain Yakult (10 billion bacteria) and Lactobacillus acidophilus (1 billion bacteria)] (n = 98) or matching placebo (n = 97) for 48 weeks. The primary efficacy endpoint was relapse-free survival (relapse: rectal bleeding score ≥ 2 on Sutherland disease activity index scale for 3 consecutive days and/or initiation of remission induction therapy for worsening of UC).Results: An interim analysis was conducted after inclusion and follow-up of one-third of patients for the first phase of the study (n = 195). Relapse-free survival was not significantly different between the BFM and placebo groups (P = 0.643; hazard ratio 1.16; 95% CI 0.63-2.14, log-rank test), nor was the incidence of relapse. Therefore, the study was discontinued for lack of efficacy. An exploratory analysis of fecal samples from a subgroup of patients revealed no effects of either study beverage on intestinal microbiota, but there was a significant decrease in Bifidobacterium species before relapse, regardless of treatment group. Three mild adverse events occurred for which a causal relationship with the study beverage could not be ruled out (placebo: abdominal bloating and stress in one patient; BFM: body odor in one patient).Conclusions: BFM had no effect on time to relapse in UC patients compared with placebo.Study Registration: UMIN000007593. [ABSTRACT FROM AUTHOR]

Objectives: We tested whether complementary use of the somatostatin analogue pasireotide would augment efficacy of aspiration sclerotherapy of hepatic cysts.Methods: We conducted a double-blind, placebo-controlled trial in patients who underwent aspiration sclerotherapy of a large (>5 cm) symptomatic hepatic cyst. Patients were randomized to either intramuscular injections of pasireotide 60 mg long-acting release (n = 17) or placebo (sodium chloride 0.9 %, n = 17). Injections were administered 2 weeks before and 2 weeks after aspiration sclerotherapy. The primary endpoint was proportional cyst diameter reduction (%) from baseline to 6 weeks. Secondary outcomes included long-term cyst reduction at 26 weeks, patient-reported outcomes including the polycystic liver disease-questionnaire (PLD-Q) and safety.Results: Thirty-four patients (32 females; 53.6 ± 7.8 years) were randomized between pasireotide or placebo. Pasireotide did not improve efficacy of aspiration sclerotherapy at 6 weeks compared to controls (23.6 % [IQR 12.6-30.0] vs. 21.8 % [9.6-31.8]; p = 0.96). Long-term cyst diameter reduction was similar in both groups (49.1 % [27.0-73.6] and 45.6 % [29.6-59.6]; p = 0.90). Mean PLD-Q scores improved significantly in both groups (p < 0.01) without differences between arms (p = 0.92).Conclusions: In patients with large symptomatic hepatic cysts, complementary pasireotide to aspiration sclerotherapy did not improve cyst reduction or clinical response.Key Points: • Complementary pasireotide treatment does not improve efficacy of aspiration sclerotherapy. • Cyst fluid reaccumulation after aspiration sclerotherapy is a transient phenomenon. • Aspiration sclerotherapy strongly reduces symptoms and normalizes quality of life. [ABSTRACT FROM AUTHOR]

Non-suicidal self-injury (NSSI) in childhood is not well documented, especially among youth with pediatric bipolar disorder (PBD). The current study evaluated prevalence and correlates of NSSI, and its impact on intervention response, in a randomized trial of Child- and Family-Focused Cognitive-Behavioral Therapy (CFF-CBT) versus Treatment As Usual (TAU), adjunctive to pharmacotherapy. This study included 72 children ages 7-13 (58% male) with PBD. NSSI and correlates were assessed at baseline; mood and psychiatric severity were measured longitudinally. NSSI was common: 31% endorsed NSSI behaviors; 10% reported thoughts of NSSI, in the absence of behaviors. Children engaging in NSSI reported higher depression, psychosis, suicidality, and hopelessness; lower self-esteem; and reduced family help-seeking in univariate analyses. In a multivariate logistic regression, high child depression and psychosis, and low family help-seeking, remained significantly associated with baseline NSSI. In mixed-effects regression models, presence of NSSI at baseline did not influence the response of depressive symptoms to treatment. Children who endorsed NSSI experienced steeper response trajectories for psychiatric severity, regardless of treatment group. Youth who denied NSSI showed poorer response to TAU for manic symptoms; mania trajectories in CFF-CBT were similar across youth. Thus, NSSI in PBD is common and associated with impairment. As children might engage in NSSI for different reasons, the function of NSSI should be considered in treatment. Since children without NSSI fared worse in TAU, it may be important to ensure that youth with PBD receive structured, intensive interventions. CFF-CBT was efficacious regardless of NSSI, and thus shows promise for high-risk children with PBD. [ABSTRACT FROM AUTHOR]

The aim of this study was to evaluate the safety and clinical effectiveness of rhBMP-7 (or osteogenic protein-1) versus that of autogenous iliac crest bone graft (ICBG) in single-level posterolateral fusion (PLF) of the lumbar spine. A systematic search of all articles published through July 1, 2016 was conducted in databases such as PubMed, EMBASE, Scopus, and the Cochrane Collaboration Library. Randomized controlled trials (RCTs) that compared rhBMP-7 with ICBG for the treatment of single-level degenerative spondylolisthesis, provided the fusion rate, clinical success rate, safety and adverse events report, operation time, and hospital stay durations as the outcome were assessed. As a result, a total of five RCTs involving 539 patients met the inclusion criteria. The outcomes of subgroup analysis demonstrated that when compared with autogenous ICBG, rhBMP-7 appear to yield lower fusion rates in instrumented posterolateral fusion patients (RR = 0.76, 95% CI [0.60, 0.98], P = 0.03), despite the test for overall fusion rates suggested that there was no significant difference between the two groups (RR = 0.89, 95% CI [0.78, 1.02], P = 0.09). Patients treated with OP-1 had shorter operation times versus those treated with ICBG (WMD = -16.70,95% CI [-25.83, -7.57], P = 0.0003). Additionally, the outcomes demonstrated a lack of significant differences between rhBMP-7 and ICBG in terms of clinical success of ODI, overall adverse events, revision rates and duration of hospitalization. In conclusion, with the exception of reducing the operation time, our review suggests that the use of the rhBMP-7 instead of ICBG produce no any additional beneficial effect on the fusion rates, clinical success of ODI, overall adverse events, revision rates and duration of hospitalization in single level PLF. On the contrary, it appeared to yield lower fusion rate in the instrumented posterolateral fusion patients and cannot be recommended as an effective tool for this set of patients. [ABSTRACT FROM AUTHOR]

This pilot randomized controlled trial (RCT) investigated benefits of omega-3 fatty acid supplementation and Individual-Family Psychoeducational Psychotherapy (PEP; a family-focused, cognitive-behavioral therapy) for behavior problems among youth with depression. Participants aged 7-14 with DSM-IV-TR depressive disorders (N = 72; 56.9 % male) were randomized to 1 of 4 treatment conditions: PEP + omega-3, PEP monotherapy (with pill placebo), omega-3 monotherapy, or placebo (without active intervention). At screen, baseline, and 2, 4, 6, 9, and 12 weeks post-baseline, parents completed the SNAP-IV, which assesses attention-deficit/hyperactivity disorder symptoms, oppositional defiant disorder symptoms, and overall behavior problems. At screen, baseline (randomization), 6 and 12 weeks, parents completed the Eyberg Child Behavior Inventory (ECBI), which includes Intensity and Problem scales for child behavior problems. Youth who had a completed SNAP-IV or ECBI for at least two assessments during treatment (n = 48 and 38, respectively) were included in analyses of the respective outcome. ClinicalTrials.gov.:NCT01341925. Linear mixed effects models indicated a significant effect of combined PEP + omega-3 on SNAP-IV Total (p = 0.022, d = 0.80) and Hyperactivity/Impulsivity trajectories (p = 0.008, d = 0.80), such that youth in the combined group saw greater behavioral improvement than those receiving only placebo. Similarly, youth in combined treatment had more favorable ECBI Intensity trajectories than youth who received no active treatment (p = 0.012, d = 1.07). Results from this pilot RCT suggest that combined PEP + omega-3 is a promising treatment for co-occurring behavior symptoms in youth with depression. [ABSTRACT FROM AUTHOR]

The aim of this study was to compare the efficacy of elcatonin injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with osteoporosis who have acute lumbar pain after experiencing new vertebral compression fractures. Two hundred twenty-eight Japanese female patients (mean age 77.3 years) with acute lumbar pain from osteoporotic vertebral fractures were randomly divided into two groups. Patients in one group were given an NSAID (NSAIDs group) and patients in the other group were given weekly intramuscular injections of 20 units of elcatonin (elcatonin group). All patients underwent follow-up examinations up to 6 weeks from the start of the trial. Outcome measures were the level of functional impairment according to the Japan Questionnaire for Osteoporotic Pain (JQ22), the Roland-Morris Disability Questionnaire (RDQ), and a visual analog scale (VAS) of pain intensity. Statistical analyses focused on (1) the time course of pain and functional level using linear mixed effects models to analyze the longitudinal data and (2) the effectiveness of elcatonin injection with mean difference values and 95 % confidence intervals. Significant differences were seen over time between the initial values and the postintervention values (4 and 6 weeks) in JQ22, RDQ, and VAS scores (effect size d > 0.4) in each group. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were -4.8 and -8.3 for the JQ22, -1.3 and -2.6 for the RDQ, and -11.3 and -11.5 for the VAS, shifted to elcatonin. Once weekly elcatonin injection was more effective than NSAIDs for treating acute lumbar pain and improving mobility in Japanese women with osteoporotic vertebral fractures. [ABSTRACT FROM AUTHOR]

Background: Single-port laparoscopic surgery as an alternative to conventional laparoscopic cholecystectomy for benign disease has not yet been accepted as a standard procedure. The aim of the multi-port versus single-port cholecystectomy trial was to compare morbidity rates after single-access (SPC) and standard laparoscopy (MPC).Methods: This non-inferiority phase 3 trial was conducted at 20 hospital surgical departments in six countries. At each centre, patients were randomly assigned to undergo either SPC or MPC. The primary outcome was overall morbidity within 60 days after surgery. Analysis was by intention to treat. The study was registered with ClinicalTrials.gov (NCT01104727).Results: The study was conducted between April 2011 and May 2015. A total of 600 patients were randomly assigned to receive either SPC (n = 297) or MPC (n = 303) and were eligible for data analysis. Postsurgical complications within 60 days were recorded in 13 patients (4.7 %) in the SPC group and in 16 (6.1 %) in the MPC group (P = 0.468); however, single-access procedures took longer [70 min (range 25-265) vs. 55 min (range 22-185); P < 0.001]. There were no significant differences in hospital length of stay or pain VAS scores between the two groups. An incisional hernia developed within 1 year in six patients in the SPC group and in three in the MPC group (P = 0.331). Patients were more satisfied with aesthetic results after SPC, whereas surgeons rated the aesthetic results higher after MPC. No difference in quality of life scores, as measured by the gastrointestinal quality of life index at 60 days after surgery, was observed between the two groups.Conclusions: In selected patients undergoing cholecystectomy for benign gallbladder disease, SPC is non-inferior to MPC in terms of safety but it entails a longer operative time. Possible concerns about a higher risk of incisional hernia following SPC do not appear to be justified. Patient satisfaction with aesthetic results was greater after SPC than after MPC. [ABSTRACT FROM AUTHOR]

Gambling disorder (GD) is a prevalent condition for which no pharmacological treatment has yet been approved, although there is evidence that topiramate can reduce impulsivity in GD and craving in various addictive behaviors. The goal of this study was to investigate the effectiveness of topiramate combined with cognitive restructuring for GD in a two-center, randomized, double-blind clinical trial. Participants were individuals seeking outpatient treatment for GD (n = 30), treated with either topiramate or placebo combined with a brief cognitive intervention, over a 12-week period, the dose of topiramate being tapered up during the first 8 weeks. The main outcome measures were gambling craving, behavior, and cognitive distortions; impulsivity; depression and social adjustment. Topiramate proved superior to placebo in reducing gambling craving (P = 0.017); time and money spent gambling (P = 0.007 and P = 0.047, respectively); cognitive distortions related to gambling (P = 0.003); and social adjustment (P = 0.040). We found no significant effects on impulsivity or depression. These findings are in contrast with data from a previous clinical trial with topiramate for GD. In the current study, we found that topiramate affects features specifically related to gambling addiction and had no significant effect on associated phenomena such as impulsiveness and depression. We believe that this response could be due to synergistic interaction between topiramate and the cognitive intervention. [ABSTRACT FROM AUTHOR]

Purpose: Nasal continuous positive airway pressure (nCPAP) is currently the gold standard for respiratory support for moderate to severe acute viral bronchiolitis (AVB). Although oxygen delivery via high flow nasal cannula (HFNC) is increasingly used, evidence of its efficacy and safety is lacking in infants.Methods: A randomized controlled trial was performed in five pediatric intensive care units (PICUs) to compare 7 cmH2O nCPAP with 2 L/kg/min oxygen therapy administered with HFNC in infants up to 6 months old with moderate to severe AVB. The primary endpoint was the percentage of failure within 24 h of randomization using prespecified criteria. To satisfy noninferiority, the failure rate of HFNC had to lie within 15% of the failure rate of nCPAP. Secondary outcomes included success rate after crossover, intubation rate, length of stay, and serious adverse events.Results: From November 2014 to March 2015, 142 infants were included and equally distributed into groups. The risk difference of -19% (95% CI -35 to -3%) did not allow the conclusion of HFNC noninferiority (p = 0.707). Superiority analysis suggested a relative risk of success 1.63 (95% CI 1.02-2.63) higher with nCPAP. The success rate with the alternative respiratory support, intubation rate, durations of noninvasive and invasive ventilation, skin lesions, and length of PICU stay were comparable between groups. No patient had air leak syndrome or died.Conclusion: In young infants with moderate to severe AVB, initial management with HFNC did not have a failure rate similar to that of nCPAP. This clinical trial was recorded in the National Library of Medicine registry (NCT 02457013). [ABSTRACT FROM AUTHOR]

Callous-unemotional (CU) traits and effortful control (EC) are personality and temperament traits implicated in early-onset antisocial trajectories. This secondary analysis of Hitkashrut's randomized controlled trial first tested parent training's effects on EC and CU traits while controlling for more general treatment effects on conduct problems (CP), and subsequently tested mediation by parenting. Prekindergarten teachers in three Israeli cities identified 209 3-5 year-old (163 boys; 46 girls) preschoolers with subclinical-clinical range conduct problems. All participants were Jewish ranging from ultra-orthodox to secular. They were assigned to 14-session co-parent training groups (n = 140 couples), or to minimal intervention control groups with referral to local services as necessary (n = 69 couples). We employed averaged indices of pre- and post-intervention questionnaires completed by both parents. The testing of all hypothesized models controlled for treatment effects on CP in order to strengthen the robustness of the analyses. We found significant concurrent treatment effects on CP and on either CU traits or EC. All effects were mediated by ineffective parenting (IP): a latent variable that was indicated by negative/inconsistent practices and perceived parenting inefficacy. This is the first demonstration of parenting mediated treatment effects on both EC and CU traits in a randomized controlled study conducted in everyday practice contexts. This finding supports a disruption model of change: the reduction of IP facilitates a caregiving environment that affects children's behavior and developing personality. The changing of personality and temperament characteristics implicated in early-onset pathways suggests an innovative prevention strategy for disruptive behavior disorders. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this post hoc analysis was to examine self-reported recovery following a post-discharge intervention and to focus on the moderators of this intervention programme.Methods: RCT using parallel group block randomisation, including 151 patients with ≤3 hospitalisations within the last 3 years, a GAF score ≤60, and aged 18-64 years, assessed at two psychiatric hospitals from Zurich, Switzerland, between September 2011 and February 2014. In the present study, the main outcome was the OQ-45 as assessed prior to discharge from the index hospitalisation and at 12-month follow-up. Participants received either the post-discharge intervention provided by a social worker or treatment as usual (TAU).Results: Patients in the intervention group showed substantially less recovery over the 12-month observation period than controls (d = 0.44). In the TAU group, 15.6 % remained clinically impaired at 12-month follow-up as opposed to 48.1 % in the intervention group (p = 0.001). Among participants in the intervention group, an interdisciplinary meeting of significant network members was associated with less recovery (d = 0.46). Involuntary index admission (d = 0.42) and high educational degree (d = 0.52) were significant moderators of the intervention. Both factors related to less recovery over time in the intervention group relative to TAU.Conclusions: According to the OQ-45, this psychosocial post-discharge intervention revealed an unintended negative effect on self-reported recovery over time. Specifically, the meeting of significant network members related to a moderate deteriorating effect, suggesting that the involvement of some carers, relatives, or friends may cause harm to the patient. Considering with reservation pending replication, these findings could have important implications for brief interventions targeted at patients' social networks.Funding: This study was supported by a private foundation.Trial Registration: ISRCTN58280620. [ABSTRACT FROM AUTHOR]

Background and Objective: Ultrasound-guided blocks of the cervical plexus are established anesthetic procedures for carotid endarterectomy. This randomized, double-blind, placebo-controlled study tested the hypothesis that an additional ultrasound-guided periarterial injection of local anesthetic leads to a lower frequency of periarterial supplementation by the surgeon.Methods: A total of 40 patients were randomly assigned to 1 of 2 groups. In both groups an ultrasound-guided intermediate cervical plexus block (20 ml of 0.75 % ropivacaine) at the level of the fourth cervical vertebra was performed. In a second step, the needle was inserted from posterolateral to anteromedial (in-plane technique) relative to the internal carotid artery and then, depending on the randomized group assignment, 5 ml of 0.75 % ropivacaine (group 2) or 5 ml of 0.9 % saline (group 1) was injected. The parameters investigated included the need for supplementation, patient comfort, the incidence of side effects and circulatory changes.Results: The two groups did not significantly differ (p = 0.459) in terms of the need for intraoperative supplementation with 1 % prilocaine with a mean (range) in group 2 of 4.9 ml (0-20 ml), in group 1 of 3.7 ml (0-16 ml) and patient comfort (p = 0.144). In addition, a trend towards a higher complication rate was observed in group 2.Conclusion: For ultrasound-guided intermediate blocks of the cervical plexus, an additional periarterial infiltration showed no advantage. Abandoning this technique leads to a relevant simplification of the blocking technique and tends to reduce block-related side effects. [ABSTRACT FROM AUTHOR]

Antiepileptic drug withdrawal may be an option for patients who have been seizure free for some years. The best withdrawal rate is questionable; in particular, it is unknown whether "rapid" withdrawal is associated with a higher risk of relapse as compared to "slow" withdrawal. We aim to establish if a slow or a rapid withdrawal schedule of antiepileptic monotherapy influences relapse rate in adult patients with focal or generalized epilepsy who have been seizure free for at least 2 years. This multicentre, prospective, randomized controlled study will enroll adult patients with focal or generalized epilepsy, who are seizure free on monotherapy. Patients will be randomized to a slow (160 days) or a rapid (60 days) schedule. Follow-up will last 1 year after randomization. The primary endpoint is the time to seizure relapse; secondary endpoints are compliance to the assigned schedule, occurrence of status epilepticus, of seizure-related injuries and mortality. A sample size of 350 patients has been planned. Univariate and multivariate analysis by Kaplan-Meier curves and Cox regression (primary endpoint) and by logistic regression (secondary endpoint) will be performed. The present study should contribute to better define the best withdrawal period for AED treatment in adult patients with epilepsy. [ABSTRACT FROM AUTHOR]

The article discusses research being done on cardiac arrest patients. It references the study "Vasopressin, steroids and Epinephrine and Neurologically Favorable Survival After In-Hospital Cardiac Arrest: A Randomized Clinical Trial," by S. Mentzelopoulos et al. in the 2013 issue of the "Journal of the American Medical Association."The use of vasopressin, steroid and epinephrine (VSE) protocol in cardiac arrest resuscitation and cardiopulmonary resuscitation (CPR) is assessed.

Background: Robotic technology represents the latest development in minimally-invasive surgery. Nevertheless, robotic-assisted surgery seems to have specific disadvantages such as an increase in costs and prolongation of operative time. A general clinical implementation of the technique would only be justified if a relevant improvement in outcome could be demonstrated. This is also true for laparoscopic fundoplication. The present study was designed to compare robotic-assisted (RALF) and conventional laparoscopic fundoplication (CLF) with the focus on operative time, costs und perioperative outcome.Methods: Forty patients with gastro-esophageal reflux disease were randomized to either RALF by use of the daVinci Surgical System or CLF. Nissen fundoplication was the standard anti-reflux procedure. Peri-operative data such as length of operative procedure, intra-and postoperative complications, length of hospital stay, overall costs and symptomatic short-term outcome were compared.Results: The total operative time was shorter for RALF compared to CLF (88 vs. 102 min; p = 0.033) consisting of a longer set-up (23 vs. 20 min; p = 0.050) but a shorter effective operative time (65 vs. 82 min; p = 0.006). Intraoperative complications included one pneumothorax and two technical problems in the RALF group and two bleedings in the CLF group. There were no conversions to an open approach. Mean length of hospital stay (2.8 vs. 3.3 days; p = 0.086) and symptomatic outcome thirty days postoperatively (10% vs. 15% with ongoing PPI therapy; p = 1.0 and 25% vs. 20% with persisting mild dysphagia; p = 1.0) was similar in both groups. Costs were higher for RALF than for CLF (3244 euros vs. 2743 euros, p = 0.003).Conclusion: In comparison with CLF, operative time can be shorter for RALF if performed by an experienced team. However, costs are higher and short-term outcome is similar. Thus, RALF can not be favoured over CLF regarding perioperative outcome. [ABSTRACT FROM AUTHOR]

The medial parapatellar approach has become the standard technique in total knee arthroplasty (TKA). However, recent studies have reported superior results regarding functional recovery when using the midvastus approach. It was the aim of this study to evaluate the early functional outcome of both surgical techniques. In a prospective, double-blinded, randomized study, 50 patients for TKA were consecutively operated on either by the medial parapatellar or the midvastus approach. Exclusion criteria were defined as previous open knee surgery and leg deformity of more than 10 degrees varus or valgus. TKA was performed in all patients by one surgeon using the same type of implants in both groups. Pain scores (VAS) were documented and follow-up data including quadriceps strength and proprioception were obtained 3 weeks and 6 weeks postoperatively. Both groups were comparable in preoperative demographic data. Postoperatively, patients in the midvastus group demonstrated significantly lower pain in rest (VAS: mean 2.25 vs. 3.03) and under movement (VAS: mean 2.92 vs. 3.13). Further, they showed superior isometric quadriceps strength at 3 weeks (41.4 vs. 27.6 Nm) and 6 weeks (47.6 vs. 35.5 Nm). Moreover, this group showed a superior postoperative proprioception, while the range of motion was similar in both groups. The midvastus approach offers advantages over the standard parapatellar arthrotomy, in the early rehabilitation period. No adverse effects were observed associated with this approach. Therefore, the midvastus approach should be considered as a valuable alternative in TKA. [ABSTRACT FROM AUTHOR]

Background: Cluster headache attacks can, in many patients, be successfully treated with oxygen via a non-rebreather mask. In previous studies oxygen at flow rates of both 7 L/min and 12 L/min was shown to be effective. The aim of this study was to compare the effect of 100% oxygen at different flow rates for the treatment of cluster headache attacks.Methods: In a double-blind, randomized, crossover study, oxygen naïve cluster headache patients, treated attacks with oxygen at 7 and 12 L/min. The primary outcome measure was the percentage of attacks after which patients (treating at least 2 attacks/day) were painfree after 15 min, in the first two days of the study. Secondary outcome measures were percentage of successfully treated attacks, percentage of attacks after which patients were painfree, drop in VAS score and patient preference in all treatment periods (14 days).Results: Ninety-eight patients were enrolled, 70 provided valid data, 56 used both flow rates. These 56 patients recorded 604 attacks, eligible for the primary analysis. An exploratory analysis was conducted using all eligible attacks of 70 patients who provided valid data. We could only include 5 patients, treating 27 attacks on the first two days of the study, for our primary outcome, which did not show a significant difference (p = 0.180). Patients tended to prefer 12 L/min (p = 0.005). Contradicting this result, more patients were painfree using 7 L/min (p = 0.039). There were no differences in side effects or in our other secondary outcome measures. The exploratory analysis showed an odds ratio of being painfree using 12 L/min of 0.73 (95% CI 0.52-1.02) compared to 7 L/min (p = 0.061) as scored on a 5-point scale. The average drop in score on this 5-point scale, however, was equal between groups. Also slightly more patients noticed, no or not much, relief on 7 L/min, and found 12 L/min to be effective in all their attacks.Conclusion: There is lack of evidence to support differences in the effect of oxygen at a flow rate of 12 L/min compared to 7 L/min. More patients were painfree using 7 L/min, but our other outcome measures did not confirm a difference in effect between flow rates. As most patients prefer 12 L/min and treatments were equally safe, this could be used in all patients. It might be more cost-effective, however, to start with 7 L/min and, if ineffective, to switch to 12 L/min.Trial registration: European Union Clinical Trials Register (2012-003648-59), registered 1 October 2012. Dutch Trial Register (NTR3801), registered 14 January 2013. [ABSTRACT FROM AUTHOR]