• Despite decades of research, there's still considerable uncertainty about the comparative effectiveness and safety of analgesics for the treatment of acute low back pain, new research shows. (medscape.com)
  • To evaluate the safety and effectiveness of this modality for noninvasive fat reduction of the flanks. (lww.com)
  • To be included in the meta-analysis, studies were required to assess the safety and efficacy of FMT in patients with HIV and gastrointestinal intestinal dysbiosis with or without Clostridium difficile infection, use FMT to restore the disrupted microbiota, measure complications and effectiveness outcomes, and provide sufficient data for statistical analysis. (hcplive.com)
  • Dr. D'Adamo says those looking into the purity, safety, and effectiveness of their products are in the minority, but growing. (waer.org)
  • Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market. (mayo.edu)
  • Effectiveness and safety are two criteria that any treatment intervention must meet for it to continue being used. (articlebiz.com)
  • Lastly, efficacy or effectiveness and patient safety were selected as the outcomes of the study. (articlebiz.com)
  • SILVER SPRING, Maryland - A federal advisory panel has voted to support the effectiveness but not the safety of a novel hepatitis B vaccine for adults aged 18 to 70 years. (medscape.com)
  • Effectiveness also may be lower than efficacy if clinicians inadvertently prescribe the drug inappropriately (eg, giving a fibrinolytic drug to a patient thought to have an ischemic stroke, but who had an unrecognized cerebral hemorrhage on CT scan). (msdmanuals.com)
  • Thus, effectiveness tends to be lower than efficacy. (msdmanuals.com)
  • Patient-oriented outcomes, rather than surrogate or intermediate outcomes, should be used to judge efficacy and effectiveness. (msdmanuals.com)
  • Similar vaccine efficacy (generally 90 to 100%) was observed across subgroups defined by age, sex, race, ethnicity, baseline body-mass index, and the presence of coexisting conditions. (nih.gov)
  • Dr David W. Goodman reviews the efficacy and tolerability of different classes of medications for the management of ADHD. (chadd.org)
  • The safety and tolerability of filgotinib as a monotherapy and in combination with MTX or csDMARDs were found to be favorable in a pooled safety analysis across the randomized, multicenter Phase 3 FINCH 1, 2 and 3 studies at both the 200 mg and 100 mg doses. (gilead.com)
  • 2,3 Cellular therapy centers, manufacturers, payers, and policy makers will need to work together to address barriers to care as new CAR T-cell products with improved efficacy and tolerability are approved for use in more diverse malignancies. (ajmc.com)
  • We will continue our investigation of rodent-derived interneuron transplantation to obtain relevant preclinical data for dose response, safety and efficacy in animal models. (ca.gov)
  • These dosing and safety data will then serve as the baseline for comparison with human interneuron precursors and inform design of preclinical studies of these cells in immunosuppressed mice. (ca.gov)
  • This report evaluates G-protein-coupled receptor family C group 5 member D (GPRC5D) from an industry perspective for its suitability as a tumor-specific target for cancer therapy based on its expression profile and preclinical and clinical safety and efficacy data of the various drug modalities employed for discovery and development of GPRC5D-targeted therapy candidates. (bharatbook.com)
  • Preclinical characterization of the efficacy and safety of biologic N-001 as a novel pain analgesic for post-operative acute pain treatment. (iasp-pain.org)
  • Preclinical safety studies of N-001 indicated the drug produced no toxic or adverse immunological reactions over multiple doses in mice. (iasp-pain.org)
  • In his article, Frothingham reminds us that serious adverse drug effects in patients led to the withdrawal or restriction of 4 quinolones in the last decade and that safety may differ substantially among the quinolones discussed in Scheld's review (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) ( 2 ). (cdc.gov)
  • With respect to efficacy, Frothingham writes that ciprofloxacin and levofloxacin have been studied in patient populations with more severe illness, and trials of the newer quinolones have enrolled patients with predominantly mild or moderate community-acquired infections and low overall death rates in comparison. (cdc.gov)
  • The data demonstrate durable efficacy and safety results with filgotinib across multiple RA patient populations, from MTX-naïve patients to those who have had an inadequate response to two or more biologic disease-modifying antirheumatic drugs (bDMARDs). (gilead.com)
  • Results demonstrate that, compared with placebo, filgotinib consistently improved clinical outcomes in bDMARD-IR patients and that treatment efficacy was not impacted by any of these demographic and clinical baseline characteristics. (gilead.com)
  • Pooled safety results across groups indicate that the frequency of adjudicated positive major adverse cardiac events (MACE), herpes zoster virus, deep vein thrombosis (DVT) and pulmonary embolism (PE) was similar across groups for patients treated with filgotinib as monotherapy, in combination with MTX or in combination with csDMARDs. (gilead.com)
  • The efficacy and safety of ponatinib in CML and Ph+ ALL patients resistant or intolerant to dasatinib or nilotinib, or with the T315I mutation, were evaluated in the PACE trial. (businesswire.com)
  • Phase 2, multicenter, safety and efficacy study of pidilizumab in patients with metastatic melanoma. (bepress.com)
  • Nearly half of the patients in this trial responded to therapy, with one complete response showing possible long-term efficacy. (scienceboard.net)
  • Muñoz AE, Pollarsky FD, Marino M, Cartier M, Vázquez H, Salgado P, Romero G. Addition of statins to the standard treatment in patients with cirrhosis: Safety and efficacy. (wjgnet.com)
  • Bayer) highlight its long-term efficacy and safety profile in both adult and pediatric patients with solid tumors that have a NTRK gene fusion without a known acquired resistance mutation, are metastatic, or where surgical resection is likely to result in severe morbidity, and who have no satisfactory alternative treatments or have progressed following treatment. (pharmacytimes.com)
  • In the second analysis, investigators examined long-term efficacy and safety of larotrectinib in patients with TRK fusion lung cancer. (pharmacytimes.com)
  • In an expanded dataset with longer follow-up, the treatment demonstrated long-term efficacy and safety data in adult patients, including those with CNS metastases. (pharmacytimes.com)
  • Results from a prospective observational study of patients treated with washed microbiota transplantation (WMT) are highlighting its safety and efficacy for the treatment of Clotridoides difficile infection (CDI). (consultantlive.com)
  • The current study demonstrates the attractive efficacy and safety of WMT in patients with CDI. (consultantlive.com)
  • The use of drug-eluting stents (DES) in these patients is widespread, despite uncertain long-term safety and efficacy. (lu.se)
  • On December 28, 2012, on the basis of data from two Phase IIb trials (i.e., well-controlled trials to evaluate the efficacy and safety of drugs in patients with a disease or condition to be treated, diagnosed, or prevented), the Food and Drug Administration (FDA) approved use of bedaquiline under the provisions of the accelerated approval regulations for "serious or life-threatening illnesses" (21CFR314.500) (Cox EM. (cdc.gov)
  • Efficacy can be assessed accurately only in ideal conditions (ie, when patients are selected by proper criteria and strictly adhere to the dosing schedule). (msdmanuals.com)
  • Thus, efficacy is measured under expert supervision in a group of patients most likely to have a response to a drug, such as in a controlled clinical trial. (msdmanuals.com)
  • Efficacy and safety of single vs dual antiplatelet therapy in patients on anticoagulation undergoing percutaneous coronary intervention: A systematic review and meta-analysis. (bvsalud.org)
  • As the first clinical study to evaluate safety, immunogenicity, and efficacy of a COVID-19 vaccine when co-administered with a seasonal influenza vaccine, these results demonstrate the promising opportunity for concomitant vaccination, which may improve the uptake of both vaccines," he added. (pharmatimes.com)
  • Title : Work Group summary and interpretation of TAK-003 efficacy, efficacy, safety, and immunogenicity data Personal Author(s) : Paz-Bailey, Gabriela Corporate Authors(s) : National Center for Emerging and Zoonotic Infectious Diseases (U.S.). Division of Viral Diseases. (cdc.gov)
  • The purpose of this study is to perform a systematic review of the literature to evaluate efficacy and safety of the procedure. (sages.org)
  • To evaluate long-term safety and efficacy of ziprasidone. (psychiatrist.com)
  • Therefore, the purpose of this study was to evaluate the analgesic efficacy and safety of subcutaneously administered buprenorphine in chinchillas. (awionline.org)
  • Objectives: The objective of the study was to evaluate the efficacy and safety of a polyherbal Roop Mantra Ayurvedic Medicinal Cream in subjects with acne, facial scars, pimples, blemishes, dull and dry skin. (who.int)
  • Kimtata Vijay, Gupta Vishu, Singh Lakhbir, Ahmed Hasan Ali Ahmed Ali, Yogeesh H R. A Single Centre Open Label Non-Randomized Phase-IV Post Marketing Surveillance Study to Evaluate the Efficacy and Safety of Roop Mantra Ayurvedic Medicinal Cream. (who.int)
  • The primary outcomes were reductions in low back pain intensity (measured with a visual analogue scale), numerical rating scale or another ordinal scale, and safety as indicated by the number of participants who had any adverse event. (medscape.com)
  • Elewski followed up with speaking on the efficacy and safety of these therapies, as well as 1 biologic used that aided in treating psoriasis and preventing bad outcomes from COVID-19 infection. (hcplive.com)
  • Two authors reviewed the results from this search to exclude studies : a) without abstracts b) performed only in animals c) tutorial, narrative d) with less than 10 cases e) where achalasia and POEM terms were not mentioned f) that did not address efficacy and safety outcomes of interest. (sages.org)
  • Thus, surrogate outcomes are less desirable measures of efficacy than patient-oriented outcomes. (msdmanuals.com)
  • We searched relevant databases for all randomized controlled trials that reported the efficacy and or safety ofany anti-infective drugs published up to April 30, 2022 for different outcomes. (bvsalud.org)
  • As we get more data about the kind of efficacy that they have over the longer term, we may see those (efficacy) numbers come down significantly for the mRNA (Pfizer and Moderna) vaccines," says Thompson. (healthydebate.ca)
  • As a result of tens of millions of patient exposures, we now have more robust data to work with and are better able to make informed and meaningful safety comparisons, particularly with respect to torsades de pointes, a rare, life-threatening cardiac arrhythmia infrequently associated with quinolone therapy. (cdc.gov)
  • During this first year, we have made considerable headway in the optimization of the human interneuron precursor differentiation protocol, verified functional engraftment of these cells in mice, and begun to collect dose, safety and efficacy data for rodent-derived interneuron transplantation. (ca.gov)
  • Almost 2 decades of clinical data have consistently demonstrated high overall shock efficacy and spontaneous conversion rates for the S-ICD. (bostonscientific.com)
  • Data from the EFFORTLESS registry shows overall final shock efficacy of 98%, after 5 years of follow up. (bostonscientific.com)
  • New clinical data support the long-term safety and efficacy of ALPROLIX® [Coagulation Factor IX (Recombinant), Fc Fusion Protein] in people with severe hemophilia B treated for up to two years, Biogen announced on Monday, August 17, 2015. (hemophiliafed.org)
  • The FDA's Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual public listening meeting to solicit input on methods and approaches (e.g., use of real-world evidence (RWE), registries) for capturing post approval safety and efficacy data for cell and gene therapy products. (fda.gov)
  • This virtual listening meeting was an opportunity for stakeholders to provide input on methods, approaches, logistics, privacy concerns, and other aspects related to efficacy and safety data collection in the post-approval setting for cell and gene therapies. (fda.gov)
  • Under the Prescription Drug User Fee Act (PDUFA) VII, by the end of fiscal year 2024, FDA is required to convene a meeting to solicit input on methods and approaches (e.g., use of RWE, Deve) for capturing post-approval safety and efficacy data for cell and gene therapy products. (fda.gov)
  • 5 years' data on efficacy and safety shows substantial durability evidence and is more extensive than what is typically submitted in a data package for a gene therapy. (biospace.com)
  • "The data so far showing the sustained efficacy of LUMEVOQ ® , combined with a favorable safety profile, is fully consistent with clinical experts' belief that the gene therapy's effects will not wane after its administration" noted Magali TAIEL, MD, Chief Medical Officer of GenSight Biologics. (biospace.com)
  • Researchers presented phase I/II preliminary clinical trial data demonstrating the safety and efficacy of a new CAR T-cell therapy that can be used as either a monotherapy or a combination therapy to treat Claudin 6 (CLDN6)-positive solid tumors. (scienceboard.net)
  • CLDN6 was never targeted before with cellular therapy, but in our study, this approach is already showing efficacy that may be better than the data from other CAR T trials in solid tumors. (scienceboard.net)
  • Carol L. Armstrong, PhD, ABPN , and researchers at the Center for Childhood Cancer Research are comparing the efficacy and side effects of proton therapy with pre-existing historical data on conventional (photon) radiotherapy, particularly in the area of cognition. (chop.edu)
  • However, the panel voted 8 to 5 with 1 abstention that the safety data presented by the company were not adequate to support safety of the product. (medscape.com)
  • 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)
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. (mayo.edu)
  • To assess the relevance of N-001 for treatment of acute post-surgical pain, the current study evaluated the efficacy of N-001 in a mouse hind-paw incision model by peri-incisional and popliteal nerve block administration combined with mechanical testing. (iasp-pain.org)
  • We carried out a network meta-analysis to assess their relath'e efficacy and safety . (bvsalud.org)
  • The primary outcome of the study was to assess the efficacy of Roop Mantra Ayurvedic Medicinal Cream based on changes in parameters such as skin texture, skin health, global acne assessment parameters and an investigator assessment scale. (who.int)
  • We invite researchers to submit original research and review articles on efficacy/pharmacology and overall safety/toxicology of medicinal plants involved in the treatment and/or management of diabetes mellitus. (hindawi.com)
  • Analgesic efficacy and safety of buprenorphine in chinchillas (Chinchilla lanigera). (awionline.org)
  • The purpose of this single-center multidisciplinary review was to report on the long-term safety and efficacy of CITB in the treatment of 21 children with intractable severe spasticity of cerebral origin. (nih.gov)
  • Safety and Efficacy of 3,4-Methylenedioxymethamphetamine (MDMA) Assisted Psychotherapy in the Treatment of Chronic PTSD : Mithoefer MC, Brady K. (erowid.org)
  • They also compare the safety of the new treatment with that of current treatments. (mayo.edu)
  • 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)
  • Sodium Chloride spray had superior efficacy to 1% Permethrin Crème Rinse in treating head lice and is a safe and excellent alternative to the current recommended treatment. (scirp.org)
  • Safety, Stability, and Therapeutic Efficacy of Long-Circulating TQ-Incorporated Liposomes: Implication in the Treatment of Lung Cancer. (bvsalud.org)
  • This study indicates that the pharmacological and efficacy profile of PEG- lip -TQ is superior to free TQ, which will pave the way for an exploration of the effect of TQ formulation in the treatment of lung cancer in clinical settings. (bvsalud.org)
  • A great deal of safety research combined with decades of clinical experience has proven the efficacy and relative safety of silicone gel breast implants. (medscape.com)
  • Efficacy and Temporal Stability of Reduced Safety Margins for Ventricular Defibrillation: Primary Results From the Low Energy Safety Study (LESS). (bostonscientific.com)
  • The results have spurred on Lilly and Alkermes to enter Phase III trials where, unusually, safety will take precedence over efficacy. (pharmtech.com)
  • However, evidence for the comparative efficacy of these agents is limited. (medscape.com)
  • However, we should be cautious in comparing these trials since they used different ways to measure efficacy, says Alison Thompson, an associate professor who studies public health policy and ethics at the University of Toronto. (healthydebate.ca)
  • We should be cautious in comparing these trials since they used different ways to measure efficacy, says Alison Thompson, associate professor at University of Toronto. (healthydebate.ca)
  • The four-year follow-up and updated safety profile demonstrate durability of responses in this heavily pre-treated population. (businesswire.com)
  • 1 "Therefore, we conducted this real-word study in a more representative population with diverse clinical characteristics and medical settings, aiming to better demonstrate the true efficacy and safety of WMT for CDI. (consultantlive.com)
  • His letter to the editor emphasizing the paramount importance of a well-established safety profile and documented clinical efficacy in severe infections before a "wholesale change" to the newer quinolones is an appropriate response to Michael Scheld's essay on maintaining quinolone class efficacy in which a "correct spectrum" strategy of using the most potent quinolone to treat the presumed or confirmed pathogen was described and advocated ( 1 ). (cdc.gov)
  • The safety profile of BNT162b2 was characterized by short-term, mild-to-moderate pain at the injection site, fatigue, and headache. (nih.gov)
  • These results of the B-YOND study provide additional insights supporting the efficacy and safety profile of ALPROLIX in adults and children with hemophilia B. (hemophiliafed.org)
  • The safety profile of risperidone in this psychosis of AD population was similar to the more general BPSD population. (unboundmedicine.com)
  • Clinical Impact, Safety, and Efficacy of Single- versus Dual-Coil ICD Leads in MADIT-CRT. (bostonscientific.com)
  • A separate analysis of the FINCH 2 trial assessed the efficacy of once-daily filgotinib 200 mg or 100 mg versus placebo for 24 weeks across prespecified subgroup characteristics such as disease duration/activity, seropositivity and concurrent medication use. (gilead.com)
  • The search was carried out using key words that included Striae Distensae, treatments, non-ablative fractional lasers, efficacy, and safety (Munn et al. (articlebiz.com)
  • Led by Adnan Malik, MD, gastroenterology fellow at Mountain Vista Medical Center, the study assessed the safety and efficacy of FMT as a potential therapy for HIV-related gastrointestinal tract symptoms. (hcplive.com)
  • Consitent reporting of symptoms, manometric findings and efficacy is required in future study designs. (sages.org)
  • Grob 1995) This pilot study will gather preliminary information about the safety and efficacy of MDMA-assisted psychotherapy in stimulating therapeutic processing of traumatic experiences, with the goal of reducing or relieving symptoms of PTSD. (erowid.org)
  • Safety analyses showed no statistically significant differences between Heplisav and Engerix-B in local and systemic solicited adverse events or deaths, and laboratory investigations did not reveal any clinically significant differences between the 2 groups. (medscape.com)
  • L. Serrano, L. Decesar and L. Pham, "Evaluation of the Efficacy and Safety of 1% Sodium Chloride (LiceFreee Spray) against 1% Permethrin Crème Rinse on Head Lice Infested Individuals," Pharmacology & Pharmacy , Vol. 4 No. 2, 2013, pp. 266-273. (scirp.org)
  • To hear more of the safety and accessibility of developing psoriasis therapies, watch the video above. (hcplive.com)
  • The researchers called for large-scale studies to explore antiviral efficacy dosing and adverse events. (newswise.com)
  • The panel's main concerns were that the safety database was too small to detect rare adverse events, that the vaccine hadn't been studied in sufficient numbers of ethnic minority populations, and that it hadn't been studied in combination with the administration of other adult vaccines . (medscape.com)
  • Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律 Iyaku-hin, iryō-kiki tō no hinshitsu, yūkōsei oyobi anzensei no kakuho tō ni kansuru hō ritsu) is a law (wikipedia.org)
  • On May 24, 2013, the Government Cabinet approved a revision of Pharmaceutical Affairs Law to simplify the approval process for medical devices and regenerative medicine products, the safety of regenerative medicine using iPS cells (stem cells). (wikipedia.org)
  • Lower efficacy, in the 60 to 70 per cent range, was found for the AstraZeneca and Janssen products. (healthydebate.ca)
  • After application of the products at Day 1 and Day 8, pediculicidal efficacy and safety were assessed at Day 1, Day 8 and Day 15. (scirp.org)
  • The guidelines, which reflect the consensus reached by 17 experts in pharmacology, biochemistry, and traditional medicine, respond to the need to assure the safety of widely-used herbal medicines while also facilitating the search for new pharmaceutical products. (who.int)
  • With the exception of labeling changes regarding glucose homeostasis abnormalities associated with gatifloxacin therapy, the subject of quinolone safety is centered on torsades de pointes. (cdc.gov)
  • This current review is thereby necessary because it will provide better insight into the efficacy and safety of non-ablative fractional laser therapy. (articlebiz.com)
  • The aim was to get as many sources as possible that examine the efficacy and safety of non-ablative fractional lasers therapy in treating SD. (articlebiz.com)
  • Group A had a significantly better efficacy compared to the control group B, but the side effects need to be concerned. (wjgnet.com)
  • I think the Johnson and Johnson (Janssen) one had much better clinical endpoints in the trials … there was a pretty low bar for establishing efficacy in the other trials," she says. (healthydebate.ca)
  • The safety population included those subjects plus others from additional supportive trials, for 4425 participants randomly assigned to Heplisav and 1420 to Engerix-B. (medscape.com)
  • In an ongoing multinational, placebo-controlled, observer-blinded, pivotal efficacy trial, we randomly assigned persons 16 years of age or older in a 1:1 ratio to receive two doses, 21 days apart, of either placebo or the BNT162b2 vaccine candidate (30 μg per dose). (nih.gov)
  • In the Janssen trial, for example, efficacy was 74 per cent in the United States but dropped to 52 per cent in South Africa, where almost 95 per cent of cases were due to the B.1.351 variant. (healthydebate.ca)
  • Conclusions: Our findings highlight the potentially high prevalence and impact of PTSD among jail officers, and offer implications for public safety workplace health interventions. (cdc.gov)
  • Efficacy measures included change from initial study baseline in Mania Rating Scale (MRS) and Clinical Global Impressions-Severity of Illness scale (CGI-S) scores, as well as MRS responder rates (50% reduction from initial study baseline). (psychiatrist.com)
  • So, assessing antiviral efficacy in terms of symptom duration and severity was limited. (newswise.com)
  • At the annual World Congress on Endourology, several studies posted positive results on the safety and efficacy of this technique. (urologytimes.com)
  • Topics covered range from the information required to establish the identity and quality of plant materials or preparations, through the selection of appropriate test systems for pharmacodynamic studies, to detailed advice on the many different tests, examinations, observations, and experimental procedures required, in experimental animals and controls, to establish the safety of herbal medicines. (who.int)
  • The safety of FMT is still questionable due to the high variation in [gastrointestinal tract] microbiota between the healthy donor and the patient. (hcplive.com)
  • However, the National Advisory Committee on Immunization expects that short-term efficacy will likely remain high, even with an extended four-month interval between doses. (healthydebate.ca)
  • Safety results were typical of the hemophilia B populations studied. (hemophiliafed.org)
  • Efficacy measures how many vaccinated people contract COVID-19 compared with how many infections occur in the placebo or control group. (healthydebate.ca)
  • Several warnings have been issued over lack of quality control, scientific evidence for the efficacy, and potential adverse effects of herbal remedies including hepatotoxicity, nephrotoxicity, cardiotoxicity, and reproductive toxicity among others. (hindawi.com)
  • efficacy population n=151) were enrolled. (medpagetoday.com)
  • That said, I don't think the safety database is sufficiently large to support a recommendation for use in the general adult population, given that this vaccine contains a new adjuvant," she explained. (medscape.com)
  • Objective: The aim of this study was to explore posttraumatic stress disorder (PTSD) symptom prevalence and health characteristics among jail correctional officers, a generally understudied population of public safety workers. (cdc.gov)
  • Details for: Research guidelines for evaluating the safety and efficacy of herbal medicines. (who.int)
  • Sets out detailed guidelines for conducting scientific research on the safety and efficacy of herbal medicines. (who.int)
  • The study results, published on the pre-print server medRxiv, suggest that the efficacy of both the flu vaccine and the COVID-19 vaccine appeared to be preserved, with no additional safety concerns appearing with co-administration. (pharmatimes.com)
  • Safety evaluations included adverse event monitoring, electrocardiography, and standard laboratory assessments. (psychiatrist.com)
  • A capacity-building contract to investigate safety aspects of mine ventilation through technical development and training. (cdc.gov)