• Blinding patients in clinical trials is a key methodological procedure, but the expected degree of bias due to nonblinded patients on estimated treatment effects is unknown. (nih.gov)
  • Systematic review of randomized clinical trials with one sub-study (i.e. experimental vs control) involving blinded patients and another, otherwise identical, sub-study involving nonblinded patients. (nih.gov)
  • Two of the 12 trials also used observer-reported outcomes, showing no indication of exaggerated effects due lack of patient blinding. (nih.gov)
  • This study provides empirical evidence of pronounced bias due to lack of patient blinding in complementary/alternative randomized clinical trials with patient-reported outcomes. (nih.gov)
  • The primary outcome is nerve conduction velocity (NCV), and the secondary outcomes include Michigan Neuropathy Screening Instrument (MNSI) scores, Diabetes-Specific Quality of Life (DSQL) scores, blood rheology parameters, and assessments of safety and blinding. (biomedcentral.com)
  • Conclusions: The outcomes of the 2-year study confirmed that a short cycle of intra-articular treatment (3 weekly double-blind injections) with polynucleotides (long-acting viscosupplementation properties, pro-trophic activity on chondrocytes, pain-relieving properties) in fixed combination with high molecular weight hyaluronic acid is more effective in improving knee function and pain in knee OA patients than HA alone. (researchsquare.com)
  • The results of this trial should provide valuable information regarding a novel approach to improve biological, and potentially clinical, outcomes post CABG. (frontiersin.org)
  • While the magnitude of the observed outcomes differed between these trials, altogether, their findings suggest that a conventional management coupled with inflammation inhibition could maximize vascular benefit and clinical outcomes ( 6 - 8 ). (frontiersin.org)
  • Secondary outcomes (efficacy) will be measured by assessing clinical, analytical, and imaging-test parameters. (unav.edu)
  • The aim of this study is to explore the potential benefits of the IL-1β antibody, Canakinumab, in the treatment of AH.Methods: This is multicentre, double-blind, randomised placebo-controlled trial. (imperial.ac.uk)
  • Methods: A phase I multicentre clinical trial (ClinicalTrials.gov NCT01919827) with a single endobronchial administration of autologous adult BM-MSCs in patients diagnosed with mild-to-moderate IPF. (unav.edu)
  • ROCCELLA is a multinational 52-week, multicentre randomized double-blind placebo-controlled dose-ranging phase 2 trial for the treatment of OA ( NCT03595618 ). (bmj.com)
  • The primary outcome measure is anti-double stranded DNA (anti-dsDNA) antibody levels at 52 weeks. (ucl.ac.uk)
  • The primary outcome measure was the Clinical Global Impressions-Improvement (CGI-I) scale, and secondary measures of efficacy included the Yale-Brown Obsessive Compulsive Scale for Trichotillomania (TTM-YBOCS) and the Clinical Global Impressions-Severity of Illness (CGI-S) scale. (psychiatrist.com)
  • Conclusion It seems that continuous topical GTN treatment in addition to an eccentric exercise programme does not improve clinical outcome compared to placebo patches and an eccentric exercise programme in patients with chronic patellar tendinopathy. (bmj.com)
  • Additional secondary structural and clinical efficacy objectives are based on changes from baseline in the target knee: cartilage thickness and bone area on qMRI, KOA "progressor" rates, Joint Space Width on X-ray, pain VAS, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total and sub scores, Patient Global Assessment VAS and the proportion of Outcome Measures in Rheumatology (OMERACT)-OARSI responders. (bmj.com)
  • It has been suggested that inhibition of MMPs may stabilize vulnerable atherosclerotic plaques and improve clinical outcome. (edu.au)
  • This is a protocol for a randomized, double-blind, sham-controlled trial. (biomedcentral.com)
  • METHODS AND RESULTS: Single-center prospective registry including 1304 consecutive patients undergoing coronary CT angiography for suspected CAD. (who.int)
  • A prospective, randomized, double-blinded, multi-center trial was conducted in a 6-month study. (dovepress.com)
  • OPUS at UTS: Prospective, randomized, double-blind trial investigating the effect of doxycycline on matrix metalloproteinase expression within atherosclerotic carotid plaques. (edu.au)
  • METHODS: The study design was a prospective, double-blind randomized trial. (edu.au)
  • Methods In this cross-sectional study, taken. (researchgate.net)
  • Methods The present case-control study carried out on 85 patients who. (researchgate.net)
  • This study aimed to evaluate the clinical efficacy of probiotic and prebiotic supplementation on the metabolic parameters, liver enzymes, and inflammation in patients with nonalcoholic fatty liver disease (NAFLD). (researchgate.net)
  • Methods A randomised, double-blind, placebo-controlled study was carried out. (bmj.com)
  • 9-11 We aimed to study the effect of melatonin in a double-blind, placebo controlled trial with an active comparator. (bmj.com)
  • Methods Retrospective observational descriptive study during one year. (scielo.br)
  • The authors of this letter to the editor discuss a study of the adult clinical trajectories of a cohort of adolescents diagnosed with conduct disorder after referral to an urgent psychiatry service using a retrospective record-linkage approach. (psychiatrist.com)
  • METHODS: This phase 1, double-blind, placebo-controlled, first-in-human study (NCT03809052) included a single ascending-dose phase (with a food-effect cohort) where participants across seven sequential cohorts were randomized 3:1 to receive oral GB1211 (5, 20, 50, 100, 200 or 400 mg) or placebo. (lu.se)
  • CLINICAL TRIAL REGISTRATION: The study was registered with ClinicalTrials.gov (identifier: NCT03809052). (lu.se)
  • The study population included patients undergoing bronchoscopy for appropriate clinical indications. (druglib.com)
  • MATERIALS AND METHODS: Natural and semi-natural mouthrinses included in this study were herbal mix mouthrinse, cranberry mouthrinse, chlorhexidine digluconate mouthrinse, cranberry extract mixed with chlorhexidine digluconate mouthrinse, chlorhexidine digluconate mouthrinse with alcohol (positive control), and distilled water (negative control). (cranberryinstitute.org)
  • CLINICAL SIGNIFICANCE: Different mouthrinses proposed in this study showed antimicrobial effects against the tested oral pathogens, and possibly the tested mouthrinses will lead for future formulation of natural or semi-natural pharmaceutical mouthrinses. (cranberryinstitute.org)
  • METHODS: Randomized, double-blind, placebo-controlled, clinical study was conducted at 19 U.S. clinical sites. (omega-research.com)
  • A cross-sectional, double-blind study analysed 49 individuals admitted for emergency dental care. (uwi.edu)
  • Methods: It was a randomized, double-blind, placebo-controlled study. (cranberryinstitute.org)
  • Since 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy shows promise as a treatment for other anxiety disorders, a blinded, placebo-controlled pilot study was conducted. (erowid.org)
  • Methods: Randomised, double-blind, HA-controlled clinical trial in 100 knee OA patients (98 randomised, 69 completing the study) in a high-specialisation tertiary care setting. (researchsquare.com)
  • This study aims to evaluate the clinical efficacy between patients undergoing a Lichtenstein's hernioplasty with a new biologic mesh derived from porcine small intestine submucosal (SIS) extracellular matrix versus a standard SIS mesh. (dovepress.com)
  • Cinromide was evaluated versus placebo as add‐on therapy in a double‐blind crossover study in epileptic outpatients with partial seizures at three sites. (mcmaster.ca)
  • We present the results of a double blind, placebo controlled, crossover study of ghrelin in gastric emptying in patients with diabetic gastroparesis. (bmj.com)
  • Methods In this double-blind randomised controlled phase III study, 755 MTX-naïve patients with active RA were randomly assigned to MTX alone, rituximab 2×500 mg + MTX or rituximab 2×1000 mg + MTX. (bmj.com)
  • In this study, the established similarity evaluation methods based on the CQAs were convenient and reliable, which can be utilized to evaluate the similarity of TCM granule and their placebo at granule and solution status, and demonstrated to be well applied in placebo-controlled trials. (hindawi.com)
  • To present the study design of ROCCELLA, a large Phase 2 clinical trial in knee OA (KOA) patients, evaluating the efficacy and safety of GLPG1972/S201086 in reducing cartilage loss in OA. (bmj.com)
  • This clinical trial was designed with a combination of two radiological selection criteria to ensure sufficient structural progression (cartilage loss) in the study population. (bmj.com)
  • In this replication and extension study of a previous clinical trial, we tested the impact of low‐dose naltrexone on daily self‐reported pain. (ldnresearchtrust.org)
  • Methods: A double-blinded controlled clinical study was conducted. (bvsalud.org)
  • More precise and comparable data about the risk of poliomyelitis could be obtained in future surveys by incorporating a standard case definition, by using house- to- house case- finding methods in representative community- based samples, by analyzing and presenting rates in more clearly defined ways, and by selecting stable populations for study. (who.int)
  • In this study, QoL, IPSS, and uroflowmetry tests will be used for evaluation, Blinding description: This study will be conducted as a double-blind clinical trial, in which patients with membranous urethral stricture of maximum length 15 millimeters who undergo internal urethrotomy surgery will be selected to participate in the study. (who.int)
  • The surgeon and the surgical method for all patients in the study will be the same. (who.int)
  • The article chronicles the results of the phase III clinical trial on 10,077 healthy infants and young children in China (six to 35 months of age) with a randomized, double-blind, placebo-controlled, multicenter trial method. (centerwatch.com)
  • Methods: A multicenter, randomized double-blind, placebo-controlled trial has been designed. (unav.edu)
  • The present double-blind, randomized, placebo-controlled clinical trial intended to test whether ingestion of a natural combination medicine (Tr14 tablets) affects serum muscle damage and inflammatory immune response after downhill running. (hindawi.com)
  • Methods Randomised double-blind, placebo-controlled clinical trial comparing a 12-week programme of using a GTN or placebo patch in combination with eccentric squats on a decline board. (bmj.com)
  • The purpose of this sham controlled clinical trial is to determine the effect and safety of 10.6-μm LM as adjuvant therapy in patients with DPN. (biomedcentral.com)
  • Q-CABG is a phase II, prospectively registered, randomized, double-blind and placebo-controlled clinical trial. (frontiersin.org)
  • In order to further verify the ameliorative effect of HLG on ALS patients, a double-blind, placebo-controlled clinical trial would be conducted, while the placebo control implementation is an effective guarantee for blindness and clinical efficacy. (hindawi.com)
  • A randomized placebo-controlled clinical trial. (bvsalud.org)
  • A double-blind, controlled clinical trial. (bvsalud.org)
  • Methods: Stool samples were collected from 78 Swedish children with celiac disease autoimmunity participating in a randomized, double-blind, placebo-controlled clinical trial to either receive a mixture of supplementation with L. plantarum HEAL9 and L. paracasei 8700:2 (n = 38) or placebo (n = 40). (lu.se)
  • It was an interventional double‐blind placebo‐controlled randomized stu. (researchgate.net)
  • Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The method of randomization is Permutation block randomization. (who.int)
  • 4) during two 8-h psychotherapy sessions (experimental sessions) in a controlled clinical setting. (erowid.org)
  • Double-blinded experimental sessions were spaced approximately 1 month apart with 3 non-drug psychotherapy sessions following each. (erowid.org)
  • Aunque los placebos eran originalmente preparados medicinales que no tenían una actividad farmacológica específica frente a una enfermedad diana, se ha ampliado el concepto para incluir tratamientos o procedimientos, especialmente los administrados a grupos de control en ensayos clínicos, con el fin de proporcionar determinaciones basales en relación con el protocolo experimental. (bvsalud.org)
  • Although placebos originally were medicinal preparations having no specific pharmacological activity against a targeted condition, the concept has been extended to include treatments or procedures, especially those administered to control groups in clinical trials in order to provide baseline measurements for the experimental protocol. (bvsalud.org)
  • http://orcid.org/0000-0003-4461-0145 grupo experimental y 56 en el grupo de control. (bvsalud.org)
  • In this population of patients with early, aggressive RA, combination therapy with adalimumab plus MTX was significantly superior to either MTX alone or adalimumab alone in improving signs and symptoms of disease, inhibiting radiographic progression, and effecting clinical remission. (nih.gov)
  • Treatment recommendations for the management of early arthritis concluded that the main goal of treatment is clinical remission, in order to prevent structural joint damage and long-term disability. (bmj.com)
  • These findings support further clinical development of GB1211. (lu.se)
  • These findings suggest that there is no benefit of high-dose vitamin D supplementation for bone health, a finding that has been evidenced in other studies such as the clinical trial by Burt et al [3], which was designed to investigate the effects of daily supplementation of vitamin D in high doses on bone density and strength. (imsociety.org)
  • A review of surveys conducted to date reveals considerable variation in both the choice and use of survey methods and in the assumptions made in the analysis and interpretation of findings. (who.int)
  • Humans understand that both these views are real, even if in order to be communicated they need different methods. (cia.gov)
  • Controlled clinical intervention studies have demonstrated that cocoa flavanols (CF) can decrease blood pressure and arterial stiffness in healthy humans, although a large variability in the effect size across trials has been reported. (frontiersin.org)
  • In total, eleven healthy young humans participated in a repeated crossover randomized controlled double-blind n-of-1 trial. (frontiersin.org)
  • METHODS: In a double-blind, crossover trial, children with Rome III IBS completed a 1-week baseline period. (medscape.com)
  • Biologic mesh is a newly developed material for hernia repairs which has been successfully used in clinical practices. (dovepress.com)
  • The method is to reinforce the inguinal floor with a large sheet of mesh, with adequate mesh tissue interface beyond the boundary of the inguinal floor and creation of a new internal ring made of prosthesis. (dovepress.com)
  • Method: randomized, double-blind clinical trial, Isaac Gonçalves da Silva3 conducted with people with type 2 diabetes, in primary health care units. (bvsalud.org)
  • In a double-blind, randomized, placebo-controlled trial, 107 patients were prospectively evaluated for efficacy of a novel compound, pirfenidone. (atsjournals.org)
  • 8 - 12 A recent review of placebo controlled homoeopathic clinical trials in general concluded that the effects of treatment cannot be attributed entirely to a placebo response but that there was insufficient evidence to support the use of homoeopathic treatment for any single disease. (bmj.com)
  • Given that the current treatment is not established in daily clinical practice, it is essential to provide evidence-based data that allow taking a step forward in its clinical development. (unav.edu)
  • Patients are allocated to two treatment groups using a random permutation block method. (who.int)
  • The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. (centerwatch.com)
  • Cette étude clinique en double aveugle évaluait l'incidence des nausées et des vomissements après une chirurgie de la cataracte avec anesthésie par voie intraveineuse chez 100 patients auxquels un placebo (eau saline), du métoclopramide (10 mg), de la dexaméthasone (8 mg) ou les deux médicaments associés avaient été administrés de manière randomisée avant l'opération. (who.int)
  • La cinromide a étéévaluée dans une étude en double‐aveugle versus placebo en adjonction au traitement en cours chez des patients épileptiques ambulatoires ayant des crises partielles de 3 types. (mcmaster.ca)
  • The main clinical manifestations of DPN are numbness or pain in both extremities, as well as paresthesia such as formication or burning sensation. (biomedcentral.com)
  • Melioidosis is a severe disease that can be difficult to di- agnose because of its diverse clinical manifestations and Melioidosis is a frequently fatal infection caused by the gram-negative bacillus Burkholderia pseudomal- a lack of adequate diagnostic capabilities for suspected lei (1). (cdc.gov)
  • The 'gold standard' method to assess humoral antibody responses fol owing vaccination is the neutralization assay. (who.int)
  • A controlled, randomized, clinical trial to evaluate the safety and efficacy of this combination in treating obesity should be considered. (researchgate.net)
  • To evaluate the similarity of Huoling Shengji granule (HLG) and its placebo at both granules and solution status, the innovative methods that consist of intelligent sensory evaluation technologies and human sensory evaluation methods were developed based on critical quality attributes (CQAs) of granule. (hindawi.com)
  • Although the term "placebo" was first introduced into medical jargon and gradually applied controversially in clinical trials in the late eighteenth century, the studies of TCM placebo that meet the requirements of similarity are poor [ 3 ]. (hindawi.com)
  • The clinical studies have shown that HLG could effectively prolong the lifespan and extend the disease duration in ALS patients. (hindawi.com)
  • Two controlled and blinded studies have confirmed benefit of plasma exchange. (medscape.com)
  • Bias due to lack of patient blinding in clinical trials. (nih.gov)
  • Lack of patient blinding also increased attrition and use of co-interventions: ratio of control group attrition risk 1.79 (1.18 to 2.70), and ratio of control group co-intervention risk 1.55 (0.99 to 2.43). (nih.gov)
  • Weidong Yin, chairman, president and CEO, said, "The peer-reviewed publication in NEJM of our phase III clinical trial results shows that our scientific contribution is acknowledged by the academia. (centerwatch.com)
  • Double blind randomised controlled trial. (bmj.com)
  • Therefore, the TCM placebo may play a key role in evaluating the effectiveness of TCM compound formulations in clinical trials. (hindawi.com)
  • Moreover, evaluating and developing placebos for clinical trials is more challenging, particularly when the TCM compound formulations that contain rich color, special appearance, complex taste, and smell are different from the chemical drugs. (hindawi.com)
  • All reviews included key questions (KQs) or subquestions on how benefits and harms varied according to demographic (age, sex, race), clinical (severity and duration of pain, medical and psychiatric comorbidities, concomitant medications), and intervention (dose, duration, intensity) characteristics. (cdc.gov)
  • Randomised clinical trial: gut microbiome biomarkers are associated with clinical response to a low FODMAP diet in children with the irritable bowel syndrome. (medscape.com)
  • Twenty-five participants with DSM-IV trichotillomania participated in a 12-week, randomized, double-blind, placebo-controlled trial of flexible-dose olanzapine for trichotillomania. (psychiatrist.com)
  • Participants will be diagnosed with AH using clinical criteria. (imperial.ac.uk)
  • Any detectable titer of neutralizing antibody against poliovirus is considered protective against clinical paralytic diseases. (who.int)
  • The clinical presentation includes a peripheral facial palsy, pain in the ear and face, and vesicles in the external ear canal. (medscape.com)
  • Methods and analysis: BEAT Lupus is a double-blind, randomised, placebo controlled, phase II clinical trial. (ucl.ac.uk)
  • Patients whose veins are not large enough for repeated needle insertions have double-lumen catheter placed, either Quinton catheter (can be kept in for few weeks) or Permacath (can remain inserted indefinitely). (medscape.com)
  • This 6-week, randomized, double-blind, placebo-controlled trial used simultaneous depression and mania criteria to compare a single mood stabilizer, divalproex, with and without adjunctive olanzapine in patients with bipolar I disorder experiencing acute mixed episodes. (psychiatrist.com)
  • High levels of inflammatory markers, such as C-reactive protein, were associated with left ventricular dysfunction ( 2 ), higher cardiovascular event rates ( 3 ) and worse clinical prognosis ( 4 ) following an acute myocardial infarction, independent of traditional risk factors. (frontiersin.org)
  • Although widely used to treat lupus, the efficacy of B cell depletion therapy using rituximab has not been demonstrated in randomised clinical trials. (ucl.ac.uk)
  • This double-blind clinical trial assessed the incidence of nausea and vomiting after cataract surgery with intravenous anaesthesia in 100 patients randomly assigned to preinduction placebo (saline), metoclopramide (10 mg), dexamethasone (8 mg) or the 2 drugs combined. (who.int)
  • Patellar tendinopathy (PT) (jumper's knee) is a clinical condition characterised by activity-related patellar tendon pain, most commonly at the insertion at the inferior pole of the patella. (bmj.com)
  • The serum test may offer advantages over skin prick testing when skin testing is limited by dermatographism, generalized dermatitis, or a clinical history of severe anaphylactic reactions to a given food. (medscape.com)
  • This clinical trial focuses on evaluating the effects of supplementation with a dry extract of cranberry on plasma levels of LPS and uremic toxins in non-dialysis CKD patients. (cranberryinstitute.org)
  • Also, the multidisciplinary coordination exercise needed to develop this clinical trial protocol will undoubtfully be useful to conduct academic clinical trials in the field of cell therapy in the near future. (unav.edu)
  • Included were admissions associated with odontogenic infection identified by clinical examination, establishing a relation to pain through a survey. (uwi.edu)