Comparing the efficacy and safetySelf-efficacySafety of ustekinumabVaccineClinical trialPhaseEarly efficacyEndpointOutcomesTherapeutic efficacyAssessAcceptabilityExaminePlacebo-controlledAnalysesStudyParticipantsToxicityConclusionsTrialsTreatmentAssessmentComparativeRCTsDoseSystematicPrimaryMethodsObjectiveProportionalReadinessBeliefTrial1986AnalysisHighParametersLong-termPatients with heart failureFoundSignificant
Comparing the efficacy and safety1
- SUNRISE LMS is an international, placebo-controlled, registration-directed study comparing the efficacy and safety of unesbulin and DTIC versus placebo and DTIC in patients with advanced LMS who have received ≥1 prior line of systemic therapy. (prnewswire.com)
Self-efficacy19
- Specifically, the present study evaluates the impact of stress, self-perceptions of health, and self-efficacy on physical activity engagement in a 10-week physical activity intervention program for African American women. (sc.edu)
- Participants ( N = 33) completed measures of stress, self-efficacy, and self-perceptions of health at a baseline assessment as part the Developing Real Incentives and Volition for Exercise (DRIVE) study. (sc.edu)
- A linear mixed effects model was used to test whether high stress, low self-efficacy, and low health-related quality of life was associated with lower daily steps across the 10-week intervention. (sc.edu)
- There was also a marginal interaction between self-efficacy and time ( B= -985.230 , SE = 498.090 , p = .052), such that there was an increase in daily steps across time for those with relatively low self-efficacy, but not for those with high self-efficacy. (sc.edu)
- The current study aimed to examine whether treatment self-efficacy (self-efficacy regarding the mastery of obstacles during treatment) in guided Internet-delivered therapy for anxiety disorders in adults could be a predictor of lower dropout rates and greater symptom reduction. (frontiersin.org)
- Treatment self-efficacy was measured at pre-treatment. (frontiersin.org)
- The results showed that high treatment self-efficacy was a predictor of both lower dropout rates and greater symptom reduction. (frontiersin.org)
- Significant interaction effects between time and treatment self-efficacy were found for several of the nine modules that constitutes the treatment program, suggesting that treatment self-efficacy could be a moderator of symptom reduction. (frontiersin.org)
- The results suggest that measuring treatment self-efficacy may be a valuable tool to identify patients at risk of dropping out, and that treatment self-efficacy could be a predictor and moderator of symptom reduction in guided Internet-delivered therapy. (frontiersin.org)
- The present study explored the relationship between international students' Third Language Anxiety (TLA) and self-efficacy. (frontiersin.org)
- The research data were collected through questionnaires involving 243 Chinese International students' L3 French Learning with L2 English and L3 French at one university in the U.K. Three of them were interviewed about their experience of anxiety and self-efficacy. (frontiersin.org)
- Major findings include four underlying factors correlated with TLA and two underlying factors correlated with self-efficacy. (frontiersin.org)
- Also, levels of these students' TLA were negatively correlated with the level of their self-efficacy, as shown in the correlational analysis. (frontiersin.org)
- Then, two linear regression models were built to contribute to the prediction of their self-efficacy levels. (frontiersin.org)
- These findings can provide educational implications for L3 teaching and learning, inspiring teachers to consider international students' TLA and self-efficacy and thus propose some coping strategies. (frontiersin.org)
- Previous research on anxiety and self-efficacy in language learning has demonstrated a significant correlation, mostly in the context of learning English as an L2. (frontiersin.org)
- Since international students cannot speak their L1 in their L3 classroom in a foreign country, they might encounter more anxiety and pressure during the L3 learning process, which, in turn, affect their self-efficacy. (frontiersin.org)
- Thus, their anxiety and self-efficacy in L3 learning should be considered. (frontiersin.org)
- Self-efficacy (B = -0.42, P (cdc.gov)
Safety of ustekinumab1
- Although efficacy and safety of ustekinumab (UST) in the treatment of inflammatory bowel disease have been demonstrated through randomized trials, data from real-life prospective cohorts are still of great interest. (ecco-ibd.eu)
Vaccine15
- 1 2 The Rubini strain is still widely used in Europe, 3 and we report here a large outbreak of mumps in a population with a high vaccination rate and examine the differential efficacy of the three vaccine strains. (bmj.com)
- The low vaccine efficacy of the Rubini strain was observed throughout all age groups. (bmj.com)
- 85%) vaccine efficacy. (bmj.com)
- From a public health perspective, immunisation against mumps with the Rubini strain should be strongly discouraged unless the field efficacy of this vaccine is convincingly shown. (bmj.com)
- RCTs measure vaccine efficacy. (cdc.gov)
- Vaccine efficacy in this case refers to the percent reduction in how often flu illness occurs among vaccinated people compared to people given placebo (i.e., unvaccinated people). (cdc.gov)
- How do vaccine effectiveness studies differ from vaccine efficacy studies? (cdc.gov)
- Results from vaccine effectiveness studies are potentially subject to biases that are much less likely to occur in vaccine efficacy studies, like selection bias and confounding, which is why licensure of vaccines depends upon data collected in RCTs. (cdc.gov)
- What factors can affect the results of flu vaccine efficacy and effectiveness studies? (cdc.gov)
- The measurement of flu vaccine efficacy and effectiveness can be affected by virus and host factors as well as the type of study used. (cdc.gov)
- Therefore, vaccine efficacy/effectiveness point estimates have varied among published studies. (cdc.gov)
- SINGAPORE - A few months after releasing its phase 1 and 2 data, OSE Immunotherapeutics, which is based in Nantes, France, has announced positive results for its therapeutic vaccine to treat cancer. (medscape.com)
- The results suggest that Tedopi is the most developmentally advanced therapeutic vaccine for cancer. (medscape.com)
- I'll go over the safety and efficacy of the Janssen COVID-19 vaccine. (cdc.gov)
- So I'll just go over a quick summary of the available evidence from the phase three trials, first on vaccine efficacy, then on safety and reactogenicity. (cdc.gov)
Clinical trial5
- Tokyo, Japan (July 15, 2015) - Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced that data from a post-hoc subset analysis of its Phase IIb clinical trial suggesting potential efficacy of delamanid for the treatment of extensively drug-resistant tuberculosis (XDR-TB) was reported in this week's New England Journal of Medicine. (fiercepharma.com)
- Clinical trial results demonstrated that adverse events were evenly distributed in the delamanid and placebo treatment groups with the exception of QT prolongation. (fiercepharma.com)
- Despite mainly focusing on the pharmacology of agomelatine, these narrative reviews extensively presented clinical trial data on efficacy and safety, making claims of efficacy in favour of agomelatine. (cambridge.org)
- In a recent study published in The Lancet Respiratory Medicine , researchers reported the TB-PRACTECAL clinical trial outcomes, which evaluated the efficacy and safety of oral bedaquiline, linezolid, and pretomanid (BPaL)-based regimens for pulmonary tuberculosis resistant to rifampicin. (news-medical.net)
- Efficacy of concentrated growth factor versus collagen membrane in reconstructive surgical therapy of peri-implantitis: 3-year results of a randomized clinical trial. (bvsalud.org)
Phase9
- PTCT ) today announced encouraging preliminary safety and efficacy results from its Phase 1B study of unesbulin (PTC596) in advanced leiomyosarcoma (LMS) patients. (prnewswire.com)
- Investigators aimed to determine the efficacy and safety of acalabrutinib and zanubrutinib using individual patient data from the phase 3 ASCEND trial (NCT02970318) and aggregate data from the phase 3 ALPINE trial (NCT03734016). (cancernetwork.com)
- The efficacy of delamanid was studied in a large, randomized, placebo-controlled phase 2 trial that included a 2-month treatment period and a 1-month follow-up of 481 MDR-TB patients (Trial 204), with 213 patients continuing to a 6-month open-label treatment trial (Trial 208), and concluding with a 24-month follow-up study of 421 out of the originally randomized 481 patients (Trial 116). (fiercepharma.com)
- We did a randomised, placebo-controlled, phase 3 trial to assess the safety and efficacy of ustekinumab in patients with active psoriatic arthritis. (nih.gov)
- The results of the study showed that out of the 76 patients recruited in this study, 60 completed both the lidocaine and placebo patch phases, while 12 completed only one phase (seven in the placebo patch group and five in the lidocaine patch group). (news-medical.net)
- Positive results from a Phase 3 trial demonstrated the efficacy and safety profile of Dupixent ® (dupilumab) for up to one year (52 weeks) in children aged 1 to 11 years with eosinophilic esophagitis (EoE) was consistent. (sanofi.com)
- Data from this Phase 3 trial support the potential of dupilumab to treat EoE in children, with sustained efficacy and safety, which is particularly critical for these children. (sanofi.com)
- The late-breaking data to be presented at ACG feature results from children enrolled in the extended active treatment period (Part B) of a Phase 3 trial, following 16 weeks of Dupixent treatment or placebo in Part A of the trial. (sanofi.com)
- This phase 3 trial assessed the long-term efficacy and safety of tenapanor 50 mg b.i.d. for the treatment of patients with irritable bowel syndrome with constipation (IBS-C). (lww.com)
Early efficacy1
- The preliminary results demonstrate promising early efficacy in patients with advanced leiomyosarcoma. (prnewswire.com)
Endpoint1
- however, the primary efficacy endpoint was not achieved. (bmj.com)
Outcomes5
- The interim results show an improvement in pain and disability across all six outcomes measures (Visual Analogue Scale (VAS) Low Back Pain (LBP) and Leg Pain, Oswestry Disability Index (ODI), Overall Health Status, and Patient and Clinician Global Impression of Change). (octaneoc.org)
- Secondary efficacy outcomes included death from all-causes, myocardial infarction, and the composite (and individual components) of stroke, systemic embolism, or vascular death. (acc.org)
- Intention-to-treat (ITT) analysis was used for all efficacy outcomes. (acc.org)
- Bias is an unintended systematic error in a study, which can include the way researchers select study participants, measure outcomes, or analyze data that can lead to inaccurate results. (cdc.gov)
- Efficacy estimates for severe outcomes assessed at 28 days or more post-vaccination were even higher at 83% for severe disease, and 100% for hospitalization. (cdc.gov)
Therapeutic efficacy2
- To assess the therapeutic efficacy of eosin 2% solution compared to the other treatment modalities for diaper dermatitis. (unboundmedicine.com)
- The purpose of this study is to examine the therapeutic efficacy of human umbilical cord mesenchymal stem/stromal cells (UMSCs) in treating congenital and acquired corneal opacity associated with the loss of collagen V. (molvis.org)
Assess3
- To assess the efficacy and safety of a heavy silicone oil (Densiron 68®), a mixture of perfluorohexyloctane (F 6 H 8 ) with silicone oil as temporary internal tamponade in selected retinal detachments treated with large inferior retinectomy. (springer.com)
- Objective To assess the safety and efficacy of secukinumab, a fully human monoclonal anti-interleukin-17A antibody, in patients with rheumatoid arthritis (RA). (bmj.com)
- A systematic review was undertaken to assess the efficacy of cytisine in smoking cessation. (bmj.com)
Acceptability4
- Agomelatine efficacy and acceptability revisited: systematic. (cambridge.org)
- The present study systematically reviewed published and unpublished evidence of the acute and long-term efficacy and acceptability of agomelatine compared with placebo in the treatment of major depression. (cambridge.org)
- Cognitive-behavioral therapy (CBT) and serotonin reuptake inhibitors (SRIs) are recommended treatments for pediatric obsessive-compulsive disorder (OCD), but their relative efficacy and acceptability have not been comprehensively examined. (lu.se)
- Network meta-analyses were conducted to examine efficacy (post-treatment Children's Yale-Brown Obsessive Compulsive Scale) and acceptability (treatment discontinuation). (lu.se)
Examine1
- Network meta-analyses were conducted to examine efficacy. (lu.se)
Placebo-controlled3
- The objective of this multicenter, randomized, placebo-controlled study was to evaluate the efficacy and safety of infliximab in patients with AS. (nih.gov)
- Objectives To determine the efficacy and tolerability of β blockers in a broad age range of women and men with heart failure with reduced ejection fraction (HFrEF) by pooling individual patient data from placebo controlled randomised trials. (bmj.com)
- TY - JOUR T1 - The efficacy and safety of risperidone in the treatment of psychosis of Alzheimer's disease and mixed dementia: a meta-analysis of 4 placebo-controlled clinical trials. (unboundmedicine.com)
Analyses2
- Secondary efficacy analyses showed a significant advantage of agomelatine over placebo in terms of response (with no effect for remission). (cambridge.org)
- Regression analyses resulted in two significant differences between intervention and control sites in changes from baseline to 15 months: (1) intervention sites exhibited significantly smaller change in context scores relative to control sites over time and (2) intervention sites exhibited significantly higher changes in wellness program effort relative to control sites. (cdc.gov)
Study12
- The results from the dose escalation study which evaluated unesbulin in combination with dacarbazine (DTIC), will be presented on Saturday, June 4 , during the Sarcoma Oral Abstract Session beginning at 1:15 p.m. (prnewswire.com)
- Interim results of the RE-VERSE AD study were first published in a 2015 edition of the New England Journal of Medicine . (ajmc.com)
- Follow-up results of the RE-VERSE AD study presented at the 2016 American Heart Association Scientific Sessions in New Orleans, Louisiana, further confirm the efficacy and safety of idarucizumab (Praxbind) in patients who require dabigatran reversal. (ajmc.com)
- This follow-up analysis includes 494 patients, 60% (n = 285) of whom required anticoagulant reversal for serious bleeding episodes (group A), and the remaining 40% (n = 196) of whom required reversal to undergo an urgent medical procedure (group B). As the RE-VERSE AD study was designed to include approximately 500 patients, these result mark near-completion of the study, which will be published when 503 patients are accrued. (ajmc.com)
- CARLSBAD, CA / ACCESSWIRE / May 26, 2020 / SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, announced today interim results of the DiscSeal pilot human clinical study in patients suffering from low back pain (LBP). (octaneoc.org)
- At the study mid-point of 90 days, the primary safety objective is being met and interim efficacy results show a clear trend in reduction of low back pain, leg pain and disability. (octaneoc.org)
- Based on results of the overall safety to date, interim MRI reviews, and study adverse events, there have been no product-related safety events or concerns. (octaneoc.org)
- Background: The aim of this pilot study was to compare the efficacy of hydroponically cultivated red Panax ginseng Meyer root preparation (HRG80) and traditionally harvested six-year-old white P. ginseng standard preparation (PGS) with placebo in preventing symptoms of stress. (mdpi.com)
- In a recent preprint study posted in Preprints with The Lancet , a team of researchers investigated the efficacy of lidocaine for the treatment of neck pain and assessed the need for additional research in this area. (news-medical.net)
- This study aimed to analyze the efficacy and toxicity of stereotactic body radiotherapy (SBRT) for locoregional recurrent pancreatic cancer after radical resection. (frontiersin.org)
- The RCT study design minimizes bias that could lead to invalid study results. (cdc.gov)
- As a result, the study was stopped after the enrollment of 219 patients. (medscape.com)
Participants1
- Interim results indicated full reversal of the anticoagulant effect of dabigatran (Pradaxa) within 4 hours of administration of idarucizumab for all 90 participants. (ajmc.com)
Toxicity1
- For all analyzed NRTIs and their combinations, model-predicted macroscopic parameters (efficacy, fitness and toxicity) were consistent with observations. (plos.org)
Conclusions1
- Conclusions Cytisine is an effective treatment for smoking cessation with efficacy comparable to that of other currently licensed treatments. (bmj.com)
Trials3
- None of the negative trials were published and conflicting results between published and unpublished studies were observed. (cambridge.org)
- Results Eight controlled trials were identified. (bmj.com)
- The efficacy of CBT appears conserved when delivered via webcam/telephone, while more trials evaluating ICBT are needed. (lu.se)
Treatment7
- Their discussion also centered on how clinical factors affect treatment selection, treatment sequencing in this population, and methods for evaluating available Bruton tyrosine kinase (BTK) inhibitors based on efficacy and safety profiles. (cancernetwork.com)
- In October 2014, the WHO released its interim policy guidance for the use of delamanid in the treatment of MDR-TB[ix] and in May 2015, the WHO added delamanid to its Essential Medicines List, which includes medicines based on the scientific evidence of their comparative efficacy, safety, and cost-effectiveness. (fiercepharma.com)
- Results of most other disease activity and patient-reported endpoints (including Ankylosing Spondylitis Disease Activity Score, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index, multiple quality of life measures and pain measures) showed greater improvement in the IFX+NPX group than the PBO+NPX group, with several measures demonstrating early and consistent improvement over 28 weeks of treatment. (bmj.com)
- Considering the potential hazards of topical corticosteroids and the greater overall efficacy of eosin 2% solution, we suggest that eosin is the preferred treatment for diaper dermatitis. (unboundmedicine.com)
- RESULTS: Following 5 days of treatment, the rate of complete healing in the group treated with eosin (61%) was significantly higher (p = 0.0479) than that in the zinc oxide paste and corticosteroid groups (22 and 33%, respectively). (unboundmedicine.com)
- This review aimed to evaluate the efficacy and safety of VNS as a novel treatment option for post-stroke recovery. (karger.com)
- Results Demographics and baseline characteristics were comparable across all treatment groups. (bmj.com)
Assessment1
- For the four patients infused in DL2, two patients were evaluable for efficacy assessment at day 42. (pipelinereview.com)
Comparative1
- Comparative efficacy. (bmj.com)
RCTs1
- RCTs investigating the efficacy or safety of VNS on post-stroke recovery were included. (karger.com)
Dose4
- During 2011, a dose of 500 mL/ ha resulted in a decline of 78% by 10 days and 90% by day 16, while at a dose of 250 mL/ha (containing 25 g M. acridum spores/ha in oil) declines were 69% and 71% by day 10 and 16, respectively. (bioone.org)
- Our aim was to evaluate the clinical efficacy, drug sustainability, frequency of dose intensification, and results from therapeutic drug monitoring in UST treated Crohn's disease (CD) patients using a prospective, nationwide, multicenter cohort from Hungary. (ecco-ibd.eu)
- Ustekinumab showed good drug sustainability and clinical efficacy in a population with severe disease phenotype and high rates of previous anti-TNF failure, however frequent and early dose intensification was required. (ecco-ibd.eu)
- We compared the in vivo efficacy of single 10 and 40 mg/kg of caspofungin (2.5× and 10× the normal humanized dose) to that of the same cumulative doses of daily 2 and 8 mg/kg doses for 5 days against 2 each of wild-type C. albicans and C. dubliniensis as well as echinocandin resistant C. albicans . (dovepress.com)
Systematic3
- Agomelatine is a novel antidepressant drug with narrative, non-systematic reviews making claims of efficacy. (cambridge.org)
- One review Reference Hickie and Rogers 4 was followed by a still ongoing debate regarding narrative v. systematic approaches to evidence synthesis, Reference Barbui and Cipriani 7 and the true clinical efficacy of agomelatine. (cambridge.org)
- We present a systematic review and meta-analysis of all existing cytisine studies, consider the drug's safety and present a verdict regarding its efficacy and recommendations concerning its licensing. (bmj.com)
Primary2
Methods1
- Before we present our results, it is illustrating to demonstrate the problems in estimation that arise from using more traditional methods. (rba.gov.au)
Objective1
- The results demonstrated that treated patients achieved an 18.2 percent objective response rate and a 51.5 percent disease control rate. (prnewswire.com)
Proportional1
- Proportional representation shows higher political efficacy compared to plurality and majoritarian systems.Wasted vote can reduce political efficacy. (wikipedia.org)
Readiness1
- Readiness to change over time: change commitment and change efficacy in a work place health -promotion trial. (cdc.gov)
Belief3
- In political science, political efficacy is the citizens' trust in their ability to change the government and belief that they can understand and influence political affairs. (wikipedia.org)
- There are two types of political efficacy: internal efficacy (the belief that one can understand politics and therefore participate in politics) and external efficacy (that the government will respond to one's demands). (wikipedia.org)
- and change efficacy (a belief in shared ability to implement health promotion). (cdc.gov)
Trial2
- Safety results in Part B of the trial were generally consistent with Part A and the known safety profile of Dupixent in its FDA-approved EoE indication for adult and adolescent patients aged 12 years and older who weigh at least 40 kg. (sanofi.com)
- Since 62.5% of patients in the ROCKET AF trial had a history of HF or a low ejection fraction (EF), this large subgroup (n=9033) allowed for exploration of the efficacy and safety of rivaroxaban in AF patients with HF. (acc.org)
19861
- Effects of an adjuvant (Triton XR) on efficacy of forest herbicides (A summary of greenhouse and field results 1986). (gc.ca)
Analysis3
- 1 Both clinicians spoke to the analysis' results and highlighted their typical approach to treating CLL. (cancernetwork.com)
- The analysis aimed to determine whether acalabrutinib or zanubrutinib had superior efficacy in the specified patient population. (cancernetwork.com)
- These results represent the first analysis of longer-term data in this age group and will be featured in a late-breaking session on October 25 at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting. (sanofi.com)
High3
- Table 3 presents the results from an EGARCH(1,1) model of log changes in the AUD/USD exchange rate over the full sample, and in each of the high- and low-bound regimes. (rba.gov.au)
- [ 3 ] which compared the efficacy and safety of VNS in patients who received high stimulation vs. low stimulation. (medscape.com)
- Efficacy against severe illness remained high across world regions, suggesting protection against severe illness even with the variant strains. (cdc.gov)
Parameters2
- It also pin-points important parameters that may impact clinical efficacy of NA s used to treat other viruses. (plos.org)
- von Kleist M, Metzner P, Marquet R, Schütte C (2012) HIV-1 Polymerase Inhibition by Nucleoside Analogs: Cellular- and Kinetic Parameters of Efficacy, Susceptibility and Resistance Selection. (plos.org)
Long-term2
- Abrams GW, Azen SP, McCuen BW II, Flynn HW Jr, Lai MY, Ryan SJ (1997) Vitrectomy with silicone oil or long-acting gas in eyes with severe proliferative vitreoretinopathy: results of additional and long-term follow-up. (springer.com)
- Lucke KH, Foerster MH, Laqua H (1987) Long-term results of vitrectomy and silicone oil in 500 cases of complicated retinal detachments. (springer.com)
Patients with heart failure1
- 4 The authors of "Efficacy and Safety of Rivaroxaban in Patients with Heart Failure and Non-Valvular Atrial Fibrillation: Insights from ROCKET-AF" postulated that the predictability of rivaroxaban made it a useful alternative to warfarin in patients with AF and HF. (acc.org)
Found3
- No results found. (prnewswire.com)
- NRTI efficacy was found to greatly vary between distinct target cells. (plos.org)
- Political efficacy was found to polarize policy preferences. (wikipedia.org)
Significant1
- Overall, the results weren't significant. (medscape.com)