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3,361 results for “Randomized Controlled Trial”
A feasibility randomized controlled superiority trial of fluticasone-vilanterol once daily use for the treatment of mild asthma in adults
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RNA seq data from: A randomized, placebo-controlled trial shows that nicotinamide riboside reduces airway inflammation in COPD
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Medical publications with information as to whether a publication reports a randomized controlled trial and/or if it covers an oncology topic
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Data from: Evaluation of a community health worker home visit intervention to improve child development in South Africa: A cluster-randomized controlled trial
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A randomized clinical trial to compare P. falciparum gametocytaemia and infectivity following blood-stage or mosquito bite induced controlled malaria infection
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Physical activity is associated with exercise capacity among patients undergoing chemotherapy: a pilot randomized controlled trial
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Remodeling dental anatomy vs sham therapy for chronic temporomandibular disorders: A placebo-controlled randomized clinical trial
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The Effects of Tramadol and Paracetamol on Physical Performance, Brain Dynamics and Sustained Attention During Cycling Exercise: A Double Blind Randomized Placebo-Controlled Clinical Trial
<p>The purposes of the current project are: 1) to investigate further the effect of Tramadol on cycling (at the physical, cognitive and brain levels) on the basis of the preliminary results of the TRAWADA2015 study (<a href="https://zenodo.org/deposit/1308615">https://zenodo.org/deposit/1308615</a>); 2) to study the effect of paracetamol at the physical, cognitive and brain levels during an aerobic and anaerobic exercise on cycle-ergometer, and compare it to that of tramadol</p>
Effects of Lactobacillus plantarum Q180 on blood lipid levels and intestinal microbiota : a double-blind, randomized, placebo-controlled, parallel trial
<p>Probiotics can improve the intestinal environment by enhancing beneficial bacteria to potentially regulate lipid levels; however, the underlying mechanisms remain unclear. The aim of this study was to investigate the effect of <em>Lactobacillus plantarum</em> Q180 (LPQ180) on blood lipid levels and the intestinal microbiome environment from a clinical perspective. A double-blind, randomized, placebo-controlled study was conducted including 70 participants of both sexes, 20 years of age and older, with blood triacylglyceride (TG) levels below 200 mg/dL. Treatment with LPQ180 for 12 weeks significantly decreased LDL-cholesterol (<em>p</em> = 0.042) and apolipoprotein (Apo)B-100 (<em>p</em> = 0.003) levels, and decreased postprandial maximum concentrations (C<sub>max</sub>) and areas under the curve (AUC) of TG, chylomicron TG, ApoB-48, and ApoB-100. LPQ180 treatment significantly decreased total indole and phenol levels (<em>p</em> = 0.019). In addition, there was a negative correlation between baseline microbiota abundance and lipid marker change, which was negatively correlated with metabolites related to harmful bacteria. LPQ180 treatment may help prevent hypertriglyceridemia by improving fasting and postprandial blood lipid levels. In addition, LPQ180 effectively prevented the growth of harmful bacteria, particularly in subjects with higher baseline levels of harmful gut microbiota. Probiotics can improve the intestinal environment by enhancing beneficial bacteria to potentially regulate lipid levels; however, the underlying mechanisms remain unclear. The aim of this study was to investigate the effect of <em>Lactobacillus plantarum</em> Q180 (LPQ180) on blood lipid levels and the intestinal microbiome environment from a clinical perspective. A double-blind, randomized, placebo-controlled study was conducted including 70 participants of both sexes, 20 years of age and older, with blood triacylglyceride (TG) levels below 200 mg/dL. Treatment with LPQ180 for 12 weeks significantly decreased LDL-cholesterol (<em>p</em> = 0.042) and apolipoprotein (Apo)B-100 (<em>p</em> = 0.003) levels, and decreased postprandial maximum concentrations (C<sub>max</sub>) and areas under the curve (AUC) of TG, chylomicron TG, ApoB-48, and ApoB-100. LPQ180 treatment significantly decreased total indole and phenol levels (<em>p</em> = 0.019). In addition, there was a negative correlation between baseline microbiota abundance and lipid marker change, which was negatively correlated with metabolites related to harmful bacteria. LPQ180 treatment may help prevent hypertriglyceridemia by improving fasting and postprandial blood lipid levels. In addition, LPQ180 effectively prevented the growth of harmful bacteria, particularly in subjects with higher baseline levels of harmful gut microbiota.</p>
Randomized control trial of SMS for postpartum behaviors and family planning in Kiambu County, Kenya
<p><strong>Background </strong></p> <p>It is estimated that one third of maternal deaths in Kenya in 2014 could have been prevented by more timely care-seeking. Mobile health interventions are increasingly being recognized as tools for the delivery of health education and promotion. Many maternal deaths occur in the first few weeks after delivery and mothers who are given adequate care in the postpartum period have better health outcomes. Kiambu County, Kenya has a high level of literacy and phone ownership amongst mothers delivering in public hospitals and was chosen as a site for a postpartum short message service intervention. </p> <p><strong>Methods </strong></p> <p>Women were recruited after delivery and randomized to receive a package of mobile messages or standard of care only. Messages covered danger signs, general postpartum topics, and family planning. Endline phone surveys were conducted at 8 weeks postpartum to assess knowledge, care seeking behavior and family planning uptake. Analysis was conducted using Stata and is presented in odds ratios. </p> <p><strong>Results </strong></p> <p>Women who received the danger sign messages were 1.6 times more likely to be able to list at least 1 danger sign and 3.51 times more likely to seek treatment if they experienced postpartum danger signs. There was no significant difference in routine postpartum care seeking or care seeking behaviors concerning newborns. Women who received family planning messages were 1.85 times more likely to uptake family planning services compared to controls and 2.1 times more likely to choose a longacting method.</p> <p><strong>Conclusions </strong></p> <p>Simple, low-cost mobile interventions can support women in the early postpartum period when the information is targeted to particular points in the postpartum continuum. Additional research is needed to understand the interplay between healthcare providers and mobile health interventions. Health policy makers should consider direct mobile interventions for women as an option for supporting positive maternal health outcomes in certain populations.</p>
Data from: Scrambler therapy improves pain in neuromyelitis optica: a randomized controlled trial
<p>Objective: The primary objective aimed to determine if Scrambler therapy is an effective, acceptable and feasible treatment of persistent central neuropathic pain in patients with neuromyelitis optica spectrum disorder (NMOSD). The secondary objective explored the effect of Scrambler therapy on co-occurring symptoms.</p> <p>Methods: We conducted a randomized single blind, sham-controlled trial in patients with NMOSD who have central neuropathic pain using Scrambler therapy for 10 consecutive weekdays. Pain severity, pain interference, anxiety, depression and sleep disturbance were assessed at baseline, end of treatment, and at 30- and 60-day follow-up.</p> <p>Results: Twenty-two patients (11 per arm) were enrolled into and completed this trial. The median baseline NRS pain score decreased from 5.0 to 1.5 following 10 days of treatment with Scrambler therapy, whereas the median NRS score did not significantly decrease in the sham arm. Depression was also reduced in the treatment arm, and anxiety was decreased in a subset of patients who responded to treatment. These symptoms were not impacted in the sham arm. The safety profiles were similar between groups.</p> <p>Conclusions: Scrambler therapy is an effective, feasible and safe intervention for central neuropathic pain in patients with NMOSD. Decreasing pain with Scrambler therapy may additionally improve depression and anxiety. Clinicaltrials.gov identifier NCT03452176 Classification of Evidence This study provides Class II evidence for patients with NMOSD and persistent central neuropathic pain that Scrambler therapy significantly reduces pain.</p>
Data from: Initiating Antiretroviral Therapy for HIV at a Patient's First Clinic Visit: The RapIT Randomized Controlled Trial
<p><strong>Background:</strong> High rates of patient attrition from care between HIV testing and antiretroviral therapy (ART) initiation have been documented in sub-Saharan Africa, contributing to persistently low CD4 cell counts at treatment initiation. One reason for this is that starting ART in many countries is a lengthy and burdensome process, imposing long waits and multiple clinic visits on patients. We estimated the effect on uptake of ART and viral suppression of an accelerated initiation algorithm that allowed treatment-eligible patients to be dispensed their first supply of antiretroviral medications on the day of their first HIV-related clinic visit.</p> <p><strong>Methods and Findings: </strong>RapIT was an unblinded randomized controlled trial of single-visit ART initiation in two public sector clinics in South Africa (a primary health clinic (PHC) and a hospital-based HIV clinic). Adult (≥18), non-pregnant patients receiving a positive HIV test or first treatment-eligible CD4 count were randomized to standard or rapid initiation. Rapid arm patients received a point-of-care (POC) CD4 count if needed; those ART-eligible received a POC TB test if symptomatic, POC blood tests, physical exam, education, counseling, and ARV dispensing. Standard arm patients followed standard clinic procedures (3-5 additional clinic visits over 2-4 weeks prior to ARV dispensing). Follow up was by record review only. The primary outcome was viral suppression, defined as initiated, retained in care, and suppressed (<=400 copies/ml) ≤ 10 months of study enrollment. Secondary outcomes included initiation of ART ≤ 90 days of study enrollment; retention in care; time to ART initiation; patient-level predictors of primary outcomes; prevalence of TB symptoms; and the feasibility and acceptability of the intervention. A survival analysis was conducted comparing attrition from care after ART initiation between the groups among those who initiated within 90 days. 377 patients were enrolled in the study between May 8, 2013 and August 29, 2014 (median CD4 count 210 cells/mm<sup>3</sup>). In the rapid arm, 119/187 patients (64%) initiated and were suppressed at 10 months, compared to 96/190 (51%) in the standard arm (RR 1.26 [1.05-1.50]. In the rapid arm 182/187 (97%) initiated ART ≤ 90 days, compared to 136/190 (72%) in the standard arm (relative risk [95% CI] 1.36 [1.24-1.49]. Among 318 patients who did initiate ART within 90 days, the hazard of attrition within the first 10 months did not differ between the treatment arms (HR 1.06; 95% CI 0.61-1.84). The study was limited by the small number of sites and small sample size and the generalizability of the results to other settings and to non-research conditions is uncertain.</p> <p><strong>Conclusions: </strong>Offering single-visit ART initiation to adult patients in South Africa increased uptake of ART by 36% and viral suppression by 26%. It should be considered for adoption in the public sector in Africa.</p>
Effect of vitamin D supplementation in patients with chronic hepatitis C after direct-acting antiviral treatment: a randomized, double-blind, placebo-controlled trial
<p><b>Background: </b>Replacement of vitamin D (VD) among patients with chronic hepatitis C (CHC) before viral eradication has demonstrated a protective effect on serum markers associated with hepatic fibrogenesis. We therefore hypothesized that VD may facilitate further fibrosis amelioration following curative treatment with direct-acting antivirals (DAA). </p> <p><b>Methods: </b>This study was a randomized, double-blind, placebo-controlled trial conducted between February 2018 and August 2018. Patients with CHC and VD deficiency were randomized in a 1:1 ratio to either receive ergicalciferol or placebo over 6 weeks. Biochemical analysis indicators, including 25-hydroxyvitamin D (25(OH)D), fibrogenic markers [(transforming growth factor beta 1 (TGF-β1) and tissue inhibitors of matrix metalloproteinases 1 (TIMP-1)], and fibrolytic markers [matrix metalloproteinase 9 (MMP-9) and amino terminal type III procollagen peptide (P3NP)], were assessed at baseline and at 6 weeks. Serum 25(OH)D was analyzed by a chemiluminescence immunoassay. Serum hepatic fibrogenesis markers were measured using a quantitative sandwich enzyme-linked immunosorbent assay.</p> <p><b>Results: </b>Seventy-five patients with CHC and VD deficiency were randomly assigned to VD (n=37) and placebo (n=38) groups. At the end of the study, the mean serum 25(OH)D level had risen to a normal level in the VD group, but was still deficient in the placebo group (41.8±9.1 vs. 18.1±4.6 ng/mL, p<0.001). Upon restoration of the VD level, there were no significant mean differences in the change from baseline for TGF-β1 (-0.6 ng/mL (95% confidence interval (95%CI) -2.8 – 1.7), p=0.63), TIMP-1 (-5.5 ng/mL (95%CI -26.4 – 15.3), p=0.60), MMP-9 (122.9 ng/mL (95%CI -69.0 – 314.8), p=0.21), and P3NP (-0.1 ng/mL (95%CI -2.4 – 2.2), p=0.92) between the VD and placebo groups. </p> <p><b>Conclusion: </b>Short-term VD supplementation after DAA treatment in patients with CHC does not improve serum fibrogenesis markers and may not expedite the residual liver fibrosis healing process. Future studies are warranted to evaluate the long-term effect of VD supplementation on hepatic fibrosis regression.</p>
Data from: The impact of hotspot-targeted interventions on malaria transmission in Rachuonyo south district in the western Kenyan highlands: a cluster-randomized controlled trial
Background: Malaria transmission is highly heterogeneous, generating malaria hotspots that can fuel malaria transmission across a wider area. Targeting hotspots may represent an efficacious strategy for reducing malaria transmission. We determined the impact of interventions targeted to serologically defined malaria hotspots on malaria transmission both inside hotspots and in surrounding communities. Methods and Findings: Twenty-seven serologically defined malaria hotspots were detected in a survey conducted from 24 June to 31 July 2011 that included 17,503 individuals from 3,213 compounds in a 100-km2 area in Rachuonyo South District, Kenya. In a cluster-randomized trial from 22 March to 15 April 2012, we randomly allocated five clusters to hotspot-targeted interventions with larviciding, distribution of long-lasting insecticide-treated nets, indoor residual spraying, and focal mass drug administration (2,082 individuals in 432 compounds); five control clusters received malaria control following Kenyan national policy (2,468 individuals in 512 compounds). Our primary outcome measure was parasite prevalence in evaluation zones up to 500 m outside hotspots, determined by nested PCR (nPCR) at baseline and 8 wk (16 June–6 July 2012) and 16 wk (21 August–10 September 2012) post-intervention by technicians blinded to the intervention arm. Secondary outcome measures were parasite prevalence inside hotpots, parasite prevalence in the evaluation zone as a function of distance from the hotspot boundary, Anopheles mosquito density, mosquito breeding site productivity, malaria incidence by passive case detection, and the safety and acceptability of the interventions. Intervention coverage exceeded 87% for all interventions. Hotspot-targeted interventions did not result in a change in nPCR parasite prevalence outside hotspot boundaries (p ≥ 0.187). We observed an average reduction in nPCR parasite prevalence of 10.2% (95% CI −1.3 to 21.7%) inside hotspots 8 wk post-intervention that was statistically significant after adjustment for covariates (p = 0.024), but not 16 wk post-intervention (p = 0.265). We observed no statistically significant trend in the effect of the intervention on nPCR parasite prevalence in the evaluation zone in relation to distance from the hotspot boundary 8 wk (p = 0.27) or 16 wk post-intervention (p = 0.75). Thirty-six patients with clinical malaria confirmed by rapid diagnostic test could be located to intervention or control clusters, with no apparent difference between the study arms. In intervention clusters we caught an average of 1.14 female anophelines inside hotspots and 0.47 in evaluation zones; in control clusters we caught an average of 0.90 female anophelines inside hotspots and 0.50 in evaluation zones, with no apparent difference between study arms. Our trial was not powered to detect subtle effects of hotspot-targeted interventions nor designed to detect effects of interventions over multiple transmission seasons. Conclusions: Despite high coverage, the impact of interventions targeting malaria vectors and human infections on nPCR parasite prevalence was modest, transient, and restricted to the targeted hotspot areas. Our findings suggest that transmission may not primarily occur from hotspots to the surrounding areas and that areas with highly heterogeneous but widespread malaria transmission may currently benefit most from an untargeted community-wide approach. Hotspot-targeted approaches may have more validity in settings where human settlement is more nuclear. Trial registration: ClinicalTrials.gov NCT01575613.
Data from: Effect of ecological momentary assessment, goal-setting and personalized phone-calls on adherence to interval walking training using the InterWalk application among patients with type 2 diabetes – a pilot randomized controlled trial
Objectives: The objective was to investigate the feasibility and usability of structured text-messages, goal-setting and phone-calls on adherence to a 12-week self-conducted interval walking training (IWT) program, delivered by the InterWalk smartphone among patients with type 2 diabetes (T2D). Methods: In a two-arm pilot randomized controlled trial (Denmark, March 2014 to February 2015), patients with T2D (18-80 years with a Body Mass Index of 18 and 40 kg/m2) were randomly allocated to 12 weeks of IWT with (intervention) or without additional support (control). The primary outcome was the difference between groups in accumulated time of interval walking training across 12 weeks. All patients were encouraged to use the InterWalk application to perform IWT for ≥90 minute/week. Patients in the intervention group made individual goals regarding lifestyle change, received automated text-messages once a week, inquiring about exercise adherence. In case of consistent non-adherence, the patients would receive a phone-call inquiring about the reason for non-adherence. The control group did not receive additional support. Information about training adherence was assessed objectively. Usability of structured text-messages was assessed based on response rates and self-reported satisfaction after 12-weeks. Results: Thirty-seven patients with T2D (66 years, 65% female, hemoglobin 1Ac 50.3 mmol/mol) where included (n=18 and n=19 in intervention and control group, respectively). The retention rate was 83%. The intervention group accumulated [95%CI] 345 -7, 698 minutes of IWT more than the control group. The response rate for the text-messages was 83% (68% for males and 90% for females). Forty-one percent of the intervention and 25% of the control group were very satisfied with their participation. Conclusion: The combination of structured text-messages, goal-setting with the possibility of follow-up phone calls are considered feasible interventions to attain training adherence when using the InterWalk app during a 12-week period in patients with T2D. Some uncertainty about the effect size of adherence remains.
Data from: Improving rational use of ACTs through diagnosis-dependent subsidies: evidence from a cluster-randomized controlled trial in western Kenya
Background: More than half of artemisinin combination therapies (ACTs) consumed globally are dispensed in the retail sector where diagnostic testing is uncommon, leading to overconsumption and poor targeting. In many malaria-endemic countries, ACTs sold over-the-counter are available at heavily subsidized prices, further contributing to their misuse. Inappropriate use of ACTs can have serious implications for the spread of drug resistance and leads to poor outcomes for non-malaria patients treated with incorrect drugs. We evaluated the public health impact of an innovative strategy that targets ACT subsidies to confirmed malaria cases by coupling free diagnostic testing with a diagnosis-dependent ACT subsidy. Methods and Findings: We conducted a cluster-randomized controlled trial in 32 community clusters in western Kenya (population ~160,000). Eligible clusters had retail outlets selling ACTs and existing community health worker (CHW) programs and were randomly assigned 1:1 to control and intervention arms. In intervention areas, CHWs were available in their villages to perform malaria rapid diagnostic tests on demand for any individual >1 year of age experiencing a malaria-like illness. Malaria RDT positive individuals received a voucher for a discount on a quality-assured ACT, redeemable at a participating retail medicine outlet. In control areas, CHWs offered a standard package of health education, prevention and referral services. We conducted four population-based surveys, at baseline, 6 months, 12 months and 18 months, of a random sample of households with fever in the last 4 weeks to evaluate predefined, individual-level outcomes. The primary outcome was uptake of malaria diagnostic testing at 12 months. The main secondary outcome was rational ACT use, defined as the proportion of ACTs used by test-positive individuals. Analyses followed the intention-to-treat principle using generalized estimating equations to account for clustering with pre-specified adjustment for gender, age, education and wealth. All descriptive statistics and regressions were weighted to account for sampling design. Between July 2015 and May 2017, 32,404 participants were tested for malaria and 10,870 vouchers were issued. 7416 randomly-selected participants with recent fever from all 32 clusters were surveyed. The majority of recent fevers were in children under 18 years (62.9%, n=4653). The gender of enrolled participants was balanced in children (50.0%, n=2318 v 50.2%, n=2335), but more adult women were enrolled than men (78.0%, n=2139 v 22.0%, n=604). At baseline, 67.6% (n=1362) of participants took an ACT for their illness and 40.3% (n=810) of all participants took an ACT purchased from a retail outlet. At 12 months, 50.5% (n=454) in the intervention arm and 43.4% (n=389) in the control arm had a malaria diagnostic test for their recent fever (Adjusted Risk Difference=9 percentage points [pp], 95%CI: 2-15pp, p=0.015; Adjusted Risk Ratio=1.20, 95%CI:1.05-1.38, p=0.015). By 18-months, the ARR had increased to 1.25 (95%CI:1.09-1.44, p=0.005). Rational use of ACTs in the intervention area increased from 41.7% (n=279) at baseline to 59.6% (n=403) and was 40% higher in the intervention arm at 18 months (Adj RR 1.40, 95%CI: 1.19-1.64). While intervention effects increased between 12 and 18 months, we were not able to estimate longer-term impact of the intervention and could not independently evaluate the effects of the free testing and the voucher on uptake of testing. Conclusions: Diagnosis-dependent ACT subsidies and community-based interventions that include the private sector can have an important impact on diagnostic testing and population-wide rational use of ACTs. Targeting of the ACT subsidy itself to those with a positive malaria diagnostic test may also improve sustainability and reduce the cost of retail sector ACT subsidies.
Data from: A single session of hyperbaric oxygen therapy demonstrates acute and long-lasting neuroplasticity effects in humans: a replicated, randomized controlled clinical trial
Purpose: Animal studies have demonstrated anti-inflammatory, and anti-nociceptive properties of hyperbaric oxygen therapy (HBOT). However, physiological data are scarce in humans. In a recent experimental study, the authors used the burn injury (BI) model observing a decrease in secondary hyperalgesia area (SHA) in the HBOT-group compared to a control-group.Surprisingly, a long-lasting neuroplasticity effect mitigating the BI-induced SHA-response was seen in the HBOT-preconditioned group. The objective of the present study, therefore, was to confirm our previous findings using an examiner-blinded, block-randomized, controlled, crossover study design. Patients and methods: Nineteen healthy subjects attended two BI-sessions with an inter-session interval of ≥28 days. The BIs were induced on the lower legs by a contact thermode (12.5 cm2, 47C°, 420 s). The subjects were block-randomized to receive HBOT (2.4 ATA, 100% O2, 90 min) or ambient conditions ([AC]; 1 ATA, 21% O2), dividing cohorts equally into two sequence allocations: HBOT-AC or AC-HBOT. All sensory assessments performed during baseline, BI, and post-intervention phases were at homologous time points irrespective of sequence allocation. The primary outcome was SHA, comparing interventions and sequence allocations. Data are mean (95% CI). Results: During HBOT-sessions a mitigating effect on SHAs was demonstrated compared to AC-sessions, ie, 18.8 (10.5–27.0) cm2 vs 32.0 (20.1–43.9) cm2 (P=0.021), respectively. In subjects allocated to the sequence AC-HBOT a significantly larger mean difference in SHA in the AC-session vs the HBOT-session was seen 25.0 (5.4–44.7) cm2 (P=0.019). In subjects allocated to the reverse sequence, HBOT-AC, no difference in SHA between sessions was observed (P=0.55), confirming a preconditioning, long-lasting (≥28 days) effect of HBOT. Conclusion: Our data demonstrate that a single HBOT-session compared to control is associated with both acute and long-lasting mitigating effects on BI-induced SHA, confirming central anti-inflammatory, neuroplasticity effects of hyperbaric oxygen therapy.
Data from: Adjunctive use of modified Yunu-Jian in the non-surgical treatment of male smokers with chronic periodontitis: a randomized double-blind, placebo-controlled clinical trial
Background: Yunu-Jian (YJ) is a Chinese medicine (CM) heat purging formula, which is used to reduce wei huo (stomach-heat, SH) and enrich shen yin (kidney-yin, KY). This formula is also commonly used to manage diabetes mellitus and gum/oral inflammation. The activity of YJ can be modified or refined by the addition of other CM herbs and/or minor changes to one of its five key ingredients. The aim of this study was to evaluate the adjunctive use of modified YJ (mYJ) or YJ containing additional osteoblast-stimulating and inflammation-modulating CM herbs in the non-surgical periodontal treatment of smokers with chronic periodontitis in a randomized, double-blind, prospective, placebo-controlled study. Methods: Healthy adult male smokers with untreated chronic periodontitis who showed CM syndrome of SH and KY deficiency (KYD) whilst attending a dental teaching hospital from October to December, 2005, were invited to participate in a randomized double-blind, placebo-controlled clinical trial. The trial itself involved the once-daily oral administration of a placebo or mYJ for 3 months as an adjunct to non-surgical periodontal therapy. Several periodontal parameters, including radiographic alveolar bone density, were measured by computer-assisted densitometric image analysis (CADIA) on selected sites, and CM signs of SH and KYD were followed from their baseline values to various time points up to 12 months or the end of study. Results: Twenty-five smokers (consumed 25.0 ± 15.3 smoking-pack years, ranged 7.5–80; aged 46.3 ± 6.8 years) with periodontitis and SH and KYD were recruited (Placebo, n = 14; mYJ, n = 11). All of the participants showed good tolerance towards the CM recipe. All of the periodontal parameters had improved after 12-month follow-up, and no statistically significant differences were detected between the control group and test group, except for the higher CADIA values observed compared with the baseline at 12 months for test sites (P = 0.025). 4/3/3 test vs 14/13/13 control participants had persisting SH and KYD at 6, 9 and 12 months (P < 0.001), respectively. Conclusions: The adjunctive use of mYJ preserved the post-treatment increases in the radiographic alveolar bone density at the study sites and led to an overall improvement in SH and KYD compared with the controls.
Data from: Ambulatory versus inpatient management of severe nausea and vomiting of pregnancy: a randomized control trial with patient preference arm
ABSTRACT Objective To determine whether ambulatory (outpatient, OP) treatment of severe nausea and vomiting of pregnancy (NVP) is as effective as inpatient (IP) care. Design Non-blinded randomized control trial (RCT) with patient preference arm Setting Multi-center Participants Women less than 20 weeks pregnant with severe NVP and associated ketonuria Methods Women participating in the RCT were randomized via web-based application to either ambulatory or IP treatment. Women declining randomisation entered the patient preference trial (PPT) arm. Protocols, data collection and follow-up were the same for all participants. Main Outcome Measures Primary outcome was reduction in Pregnancy Unique Quantification of Emesis (PUQE) score at 48 hours. Secondary outcomes were duration of treatment; improvement in symptom scores and ketonuria at 48 hours; re-attendances within 7 days of discharge; and comparison of symptoms at 7 days post discharge Results 152/174 eligible women agreed to participate with 77/152 (51%) recruited to the RCT and 79/152 (49%) to the PPT. Patients were initially compared in 4 groups (randomized IP, randomized OP, non-randomized IP and non-randomized OP). Comprehensive cohort analysis of participants in the (RCT) and (PPT) did not demonstrate any differences in patient demographics or baseline clinical characteristics. Pooled analysis of IP versus OP groups showed no difference in reduction in PUQE score at 48 hours (p=0.86). There was no difference in change in eating score (p=0.69), drinking score (p=0.77), wellbeing rating (p=0.64) or reduction in ketonuria (p=0.47) at 48 hours, with no difference in duration of index treatment episode (p=0.83) or re-attendances within 7 days (p=0.52). Conclusions Ambulatory management is an effective alternative to inpatient management of severe NVP. The trial also demonstrated that many women requiring treatment for HG have a strong preferences regarding treatment setting, which needs to be considered by care providers, especially given the psychological impact of HG.
Data from: First-in-human randomized controlled trial of an oral, replicating Adenovirus 26 vector vaccine for HIV-1
Background: Live, attenuated viral vectors that express HIV-1 antigens are being investigated as an approach to generating durable immune responses against HIV-1 in humans. We recently developed a replication-competent, highly attenuated Ad26 vector that expresses mosaic HIV-1 Env (rcAd26.MOS1.HIV-Env, "rcAd26"). Here we present the results of a first-in-human, placebo-controlled clinical trial to test the safety, immunogenicity and mucosal shedding of rcAd26 given orally. Methods: Healthy adults were randomly assigned to receive a single oral dose of vaccine or placebo at 5:1 ratio in a dosage escalation of 10^8 to 10^11 rcAd26 VP (nominal doses) at University of Rochester Medical Center, Rochester, NY, USA. Participants were isolated and monitored for reactogenicity for 10 days post-vaccination, and adverse events were recorded up to day 112. Rectal and oropharyngeal secretions were evaluated for shedding of the vaccine. Humoral and cellular immune responses were measured. Household contacts were monitored for secondary vaccine transmission. Results: We enrolled 22 participants and 11 household contacts between February 7 and June 24, 2015. 18 participants received one dose of HIV-1 vaccine and 4 participants received placebo. The vaccine caused only mild to moderate adverse events. No vaccine-related SAEs were observed. No infectious rcAd26 viral particles were detected in rectal or oropharyngeal secretions from any participant. Env-specific ELISA and ELISPOT responses were undetectable. No household contacts developed vaccine-induced HIV-1 seropositivity or vaccine-associated illness. Conclusions: The highly attenuated rcAd26.MOS1.HIV-Env vaccine was well tolerated up to 10^11 VP in healthy, HIV-1-uninfected adults, though the single dose was poorly immunogenic suggesting the replicative capacity of the vector was too attenuated. There was no evidence of shedding of infectious virus or secondary vaccine transmission following the isolation period. These data suggest the use of less attenuated viral vectors in future studies of live, oral HIV-1 vaccines. Clinical Trials Registration: NCT02366013
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Allen Brain Atlas
Allen Brain Atlas is an Allen Institute collection of brain map atlases, datasets, APIs, and analysis tools covering mouse, human, and non-human primate brain resources.
Annotated Behaviour and Observability Dataset (ABODe)
ABODe is a University of Edinburgh DataShare dataset for behavior classification in group-housed mice using home-cage video, identities, bounding boxes, ground-plate positions, and annotator labels.
DANDI Archive for NWB datasets
DANDI is a BRAIN Initiative archive for publishing and sharing neurophysiology data, including electrophysiology, optophysiology, and behavioral data packaged as NWB and related standards.
International Brain Laboratory public data
The International Brain Laboratory public data releases expose standardized mouse decision-making experiments, including Neuropixels recordings, widefield calcium imaging, behavior, and session metadata accessed through the ONE API.
OpenNeuro
OpenNeuro is a free, open platform for sharing neuroimaging datasets, with public search, dataset pages, and download paths for web, S3, DataLad, and the OpenNeuro CLI.