• A single-blinded randomized controlled clinical trial was conducted on pregnant mothers with a gestational age of less than 34 weeks at risk of preterm delivery. (researchsquare.com)
  • Fig. 1: Forest plots of clinical outcomes. (nature.com)
  • To date, data on clinical outcomes are scarce and on biomechanical outcomes of the dynamic MPFL reconstruction are lacking. (springer.com)
  • Here, we present the protocol of a randomized clinical trial for comparing clinical and biomechanical outcomes of dynamic versus static medial patellofemoral ligament reconstruction. (springer.com)
  • Preoperative magnetic resonance imaging, upright radiographs, surgical reports and patient records will be evaluated, and clinical and functional outcomes will be measured. (springer.com)
  • Main outcomes and measures: Change in amyloid, tau, and clinical decline after donanemab treatment. (sens.org)
  • Secondary outcomes were clinical cure at Day 30, length of stay, time to clinical stability, defervescence, and C-reactive protein. (atsjournals.org)
  • That question lies at the heart of drug trial outcomes. (medscape.com)
  • In resolution WHA75.8 (2022) the Health Assembly requested the Director-General, inter alia, "to organize, in a transparent manner, stakeholder consultations, in line with the Framework of 1 "A clinical trial is defined by WHO as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. (who.int)
  • A randomized trial of medical care with and without physical therapy and chiropractic care with and without physical modalities for patients with low back pain: 6-month follow-up outcomes from the UCLA low back pain study. (cdc.gov)
  • The authors suggested that a translational research collaboration can be built onto well characterized populations with already available sequence data (in a biobank/research environment), risk factor information, intervention information, and clinical outcomes. (cdc.gov)
  • In addition to observational studies, randomized clinical trials can be designed to assess individual, family, system and population outcomes based on returning versus not returning the results of selected genes/variants for specific clinical scenarios, depending on existing level of evidence. (cdc.gov)
  • DESIGN, SETTING, AND PARTICIPANTS: This open-label randomized clinical trial enrolled adult patients with an operatively treated tibial plateau or pilon fracture who met the criteria for a high risk of infection from January 1, 2015, through June 30, 2017, with 12 months of follow-up (final follow-up assessments completed in April 2018) at 36 US trauma centers. (healthpartners.com)
  • DESIGN, SETTING, AND PARTICIPANTS The Conservative Treatment for Adolescent Idiopathic Scoliosis (CONTRAIS) randomized clinical trial was conducted from January 10, 2013, through October 23, 2018, in 6 public hospitals across Sweden. (lu.se)
  • Design, setting, and participants: The Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ) was a phase 2, placebo-controlled, randomized clinical trial conducted from December 18, 2017, to December 4, 2020, with a double-blind period of up to 76 weeks and a 48-week follow-up period. (sens.org)
  • Participants from six randomized clinical trials on root coverage procedures at the University of Michigan were re-invited for a longitudinal evaluation. (bvsalud.org)
  • For example, there has to be agreement on what genes/variants to return to participants and their providers and medical records, in the course of routine clinical practice. (cdc.gov)
  • Setting 20 primary care practices in New York City, Philadelphia, and Pittsburgh, USA, randomized to intervention or usual care. (bmj.com)
  • The effort compared patients with mild to moderate insomnia who listened to their own brain waves for 10 sessions of approximately an hour to those patients who were provided an active intervention using randomized tones for the same time. (azbio.org)
  • I have lead clinical studies of blood thinners and coronary intervention for heart attacks, stroke prevention in atrial fibrillation, and prevention of heart attack for patients with coronary artery disease. (duke.edu)
  • His clinical interests include diagnostic and interventional coronary angiography, peripheral angiography and endovascular intervention. (duke.edu)
  • Purpose: The objective of this paper is to describe standardized methods of applying TMS motor cortex assessments in an international clinical trial of a pharmacological intervention for stroke patients, which was conducted at 15 centers in three countries. (longdom.org)
  • Objective: to realize a systematic review about cognitive and psycho-social intervention strategies in patients with colorectal cancer in randomized clinical trials. (bvsalud.org)
  • Common sense and clinical observation fail for several reasons: incomplete understanding of pathophysiology, biases and unmeasured confounding in observational research, and failure to understand risks and benefits of treatments within complex systems. (duke.edu)
  • He is the Director of Cardiovascular Research at the Duke Clinical Research Institute where he oversees a large group of clinical research faculty and a broad portfolio of cardiovascular clinical trials and observational clinical research programs. (duke.edu)
  • Based on controlled efficacy trials conducted in the 1940s and on subsequent observational efficacy studies, a primary series comprising four doses of whole-cell DTP vaccine is considered 70%-90% effective in preventing serious pertussis disease (1-4). (cdc.gov)
  • Randomized control trial, with the enrollment of 263 patients underwent surgery for inguinal hernia randomized by randomization table. (scielo.br)
  • The objective of this trial is to test the efficacy of a 3-year extension of a SEI service (following 2 years of SEI prior to randomization) for the maintenance and consolidation of therapeutic gains as compared to regular care in the community. (biomedcentral.com)
  • In this 2-group, parallel, double-blind, randomized controlled trial, 74 women aged 20-65 years and Fitzpatrick skin phototypes I or II were recruited from the general community in Quebec City, for randomization to either HFC (n = 33) or low-flavanol chocolate (LFC) (n = 41). (biomedcentral.com)
  • This single-blind randomized controlled trial, using the randomization box, was conducted in the Department of Obstetrics and Gynecology and the Intensive Care Unit of Qaem Hospital, affiliated to Mashhad University of Medical Sciences, Mashhad, Iran, between January 21st, 2019 and August 23rd 2019. (researchsquare.com)
  • Randomization is the process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce the bias. (wikipedia.org)
  • Concerns about the external validity of traditional randomized clinical trials (RCTs), together with the widespread availability of real-world data and advanced data analytic tools, have led to claims that common sense and clinical observation, rather than RCTs, should be the preferred method to generate evidence to support clinical decision-making. (duke.edu)
  • However, over the past 4 decades, results from well-done RCTs have repeatedly contradicted practices supported by common sense and clinical observation. (duke.edu)
  • Public health programs use the results of randomized controlled trials (RCTs) in practical implementation for their population. (cdc.gov)
  • We describe and illustrate a method of using results from randomized control trials (RCTs) to estimate changes in rates of adverse asthma events (AAEs) that result from expanding access to asthma interventions. (cdc.gov)
  • Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures or other medical treatments. (wikipedia.org)
  • Not all RCTs are randomized controlled trials (and some of them could never be, as in cases where controls would be impractical or unethical to use). (wikipedia.org)
  • To improve the reporting of RCTs in the medical literature, an international group of scientists and editors published Consolidated Standards of Reporting Trials (CONSORT) Statements in 1996, 2001 and 2010, and these have become widely accepted. (wikipedia.org)
  • This phase 2 trial was a 24-week randomized, placebo-controlled, two-way crossover study in 30 adult male patients (age 18-41 years) with FXS. (nature.com)
  • All requests for raw and analyzed data will be promptly reviewed by the study sponsor, Tetra Therapeutics, and by the clinical site, Rush University Medical Center, to verify if the request is subject to any intellectual property or confidentiality obligations. (nature.com)
  • The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. (researchgate.net)
  • In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. (researchgate.net)
  • We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. (researchgate.net)
  • The results of the study will clarify whether the reported surgery success for patella stabilization via dynamic MPFL reconstruction is due to muscle contraction or to the passive tenodesis effect combined with clinical outcome measures. (springer.com)
  • Trial registration The study protocol was registered at clinicaltrials.gov (NCT04849130). (springer.com)
  • This randomized clinical study aimed to evaluate the proper timing of a VR tour of an OR (a few days before vs. immediately before anesthesia) to reduce the anxiety in a pediatric patient undergoing elective surgery. (frontiersin.org)
  • The study was conducted at the Massachusetts General Hospital Clinical Research Center between March 11, 2013, and February 26, 2015. (psychiatrist.com)
  • Three subjects randomized to relamorelin stopped use of the study medication due to reported feelings of increased hunger. (psychiatrist.com)
  • Danielsson p, Isacson S, Hansen MV. Randomized study of Lichtenstein compared with Shouldice inguinal hernia repair by surgeons in training. (scielo.br)
  • At the time they need cotrimoxazole prevention or/and receive antiretrovirals they would have reached a study endpoint and will be excluded from the trial though the follow up will continue. (druglib.com)
  • This study was performed to determine the effects of probiotic supplementation on clinical and metabolic status of patients with rheumatoid arthritis (RA). (eurekamag.com)
  • The study can be characterized as an open-labelled randomized controlled trial with two parallel groups. (biomedcentral.com)
  • Aim of this study was to assess the frequency with which registered and completed randomized trials in orthodontics are published. (uzh.ch)
  • From the 266 orthodontic trials registered up to January 2017, 80 trials had been completed and included in the present study. (uzh.ch)
  • The statistical power of a study is a measure of the ability of a randomized clinical trial (RCT) to detect a difference statistically significant of the treatment effect in the treatment arms. (stackexchange.com)
  • This was a randomized clinical trial study. (jpalliativecare.com)
  • METHODS/DESIGN: This multisite study utilizes a randomized, controlled experimental design with blinded assessors and investigators. (duke.edu)
  • REGISTRATION: The PACT study is registered at http://Clinicaltrials.govNCT03848312. (duke.edu)
  • A randomized controlled trial can provide compelling evidence that the study treatment causes an effect on human health. (wikipedia.org)
  • Methods: In a randomized, double-blind, placebo-controlled design, the effects of the ghrelin agonist relamorelin were studied in 22 outpatient women with anorexia nervosa, diagnosed using DSM-5 criteria. (psychiatrist.com)
  • In multi-site clinical trials, this technique has some advantages over other neuroimaging methods owing to its relatively low cost, low personnel and equipment infrastructure requirements, and greater ease in consistently applying technology to collect and analyze data. (longdom.org)
  • Limited published details exist regarding methods to deliver TMS and analyze data in a standardized and consistent manner as part of an international, multicenter, clinical trial. (longdom.org)
  • Materials and methods: A standardization process was developed to ensure TMS protocol adherence and data quality, and each clinical site was required to successfully complete standardization procedures prior to collecting patient data. (longdom.org)
  • We performed a phase 2 randomized clinical trial to evaluate the preliminary effectiveness of a clinic-based patellar mobilization therapy (PMT) in patients with knee osteoarthritis. (nih.gov)
  • This clinical trial aimed to evaluate the consequences of a single-course of antenatal intramuscular injection of 25(OH) D for pregnant women at risk of preterm delivery on the incidence and severity of neonatal respiratory distress syndrome. (researchsquare.com)
  • Clearly, however, a larger randomized, double-blind clinical trial with just FM patients is warranted. (hindawi.com)
  • 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)
  • We performed a single-center, rater-blinded, balanced (1:1), split-face, placebo-controlled, parallel-group randomized clinical trial at an urban academic institution. (nih.gov)
  • At the very top of the evidence-based hierarchy is the randomized clinical trial, which by its very design offers a parallel control group, and often masking and allocation concealment too. (hstalks.com)
  • We searched ClinicalTrials.gov and ISRCTN for registered randomized clinical trials in orthodontics that had been completed up to January 2017 and judged the publication status and date of registered trials using a systematic protocol. (uzh.ch)
  • https://clinicaltrials.gov/ , NCT03000985. (frontiersin.org)
  • Registered 19 April 2021, https://clinicaltrials.gov/ct2/show/NCT04849130 . (springer.com)
  • Sleep is foundational for optimal health, healing and well-being," said principal investigator Charles H. Tegeler, M.D ., chair of neurology at Atrium Health Wake Forest Baptist, who led the team to investigate Cereset Research in a randomized controlled clinical trial. (azbio.org)
  • 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)
  • To investigate, using a split-mouth randomized clinical design, the effect of micro-osteoperforation (MOP) on mini-implant supported canine retraction using fixed appliances. (allenpress.com)
  • This is a randomized placebo controlled trial. (druglib.com)
  • A total of 78 patients were randomized and allocated to glibenclamide (n = 38) or placebo (n = 40). (thejns.org)
  • Sixty patients with RA aged 25-70 years were assigned into two groups to receive either probiotic capsules (n = 30) or placebo (n = 30) in this randomized, double-blind, placebo-controlled trial. (eurekamag.com)
  • Hospitalized patients, clinically and radiologically diagnosed with CAP using standard clinical and radiological criteria, were randomized to receive 40 mg prednisolone for 7 days or placebo, along with antibiotics. (atsjournals.org)
  • Fifty-four (25.4%) patients had a CURB-65 score greater than 2, and 93 (43.7%) patients were in Pneumonia Severity Index class IV-V. Clinical cure at Days 7 and 30 was 84/104 (80.8%) and 69/104 (66.3%) in the prednisolone group and 93/109 (85.3%) and 84/109 (77.1%) in the placebo group ( P = 0.38 and P = 0.08). (atsjournals.org)
  • 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)
  • L'incidence des nausées en salle de réveil était de 44 % avec le placebo, 20 % avec le métoclopramide, 16 % avec la dexaméthasone et 8 % avec l'association des deux médicaments. (who.int)
  • Objective: To perform post hoc analyses of amyloid reduction after donanemab treatment and assess its association with tau pathology and clinical measures. (sens.org)
  • This might be on the use of antiretroviral drugs, the incidence of clinical (eventually severe) malaria and spread of antimalarial resistance through immune compromised HIV patients (with and without antimalarial treatment). (druglib.com)
  • Data from other trials will be important to confirm aforementioned observations, particularly treatment response by APOE ε4 status. (sens.org)
  • 2 Although the biological and clinical effects of surgical procedures on the alveolus during orthodontic treatment are poorly understood, surgery can induce a localized inflammatory response, which encourages local recruitment and stimulation of osteoclasts and increased remodeling. (allenpress.com)
  • Effect of Cognitive Bias Modification on Early Relapse Among Adults Undergoing Inpatient Alcohol Withdrawal Treatment: A Randomized Clinical Trial. (edu.au)
  • The terms "RCT" and "randomized trial" are sometimes used synonymously, but the latter term omits mention of controls and can therefore describe studies that compare multiple treatment groups with each other in the absence of a control group. (wikipedia.org)
  • The first reported clinical trial was conducted by James Lind in 1747 to identify treatment for scurvy. (wikipedia.org)
  • The first published Randomized Controlled Trial in medicine appeared in the 1948 paper entitled "Streptomycin treatment of pulmonary tuberculosis", which described a Medical Research Council investigation. (wikipedia.org)
  • however no randomized control trial (RCT) has evaluated this treatment approach among patients with comorbid PTSD and respiratory illness. (cdc.gov)
  • however, no randomized clinical trial (RCT) has evaluated this treatment approach among patients with these comorbidities. (cdc.gov)
  • Contemp Clin Trials 123 (December 2022): 106978. (duke.edu)
  • In May 2022, the Seventy-fifth World Health Assembly adopted resolution WHA75.8 on strengthening clinical trials1 to provide high-quality evidence on health interventions and to improve research quality and coordination. (who.int)
  • Many of the biases that can compromise the integrity of other designs are eliminated by randomized clinical trials, but some of these biases are eliminated by the add-ons of masking and allocation concealment, which do not necessarily apply to all randomized trials, or even to all randomized trials that are labeled as masked and with allocation concealment. (hstalks.com)
  • Its effectiveness has also been demonstrated for individuals at clinical high risk for psychosis although rigorous further studies are required ( 10 ). (frontiersin.org)
  • The median time from completion to publication was 20.1 months (interquartile range: 9.1 to 31.6 months), while survival analysis indicated that less than 10% of the trials were published after 5 years from their completion. (uzh.ch)
  • Publication rates of registered randomized trials in orthodontics remained low, even 5 years after their completion date. (uzh.ch)
  • Scholars@Duke publication: The Preventing Alzheimer's with Cognitive Training (PACT) randomized clinical trial. (duke.edu)
  • The publication mentions that "per regulatory feedback," the protocol was "amended to decrease" the sample size and "only power the trial for PFS," to "limit the overall number of patients treated with docetaxel. (medscape.com)
  • Design Long term follow-up of multi-site practice randomized controlled trial (PROSPECT-Prevention of Suicide in Primary Care Elderly: Collaborative Trial). (bmj.com)
  • Currently there is limited direct evidence of clinical utility of sequencing to guide clinical care and disease prevention at the population level. (cdc.gov)
  • In this cluster-randomized controlled trial conducted in primary care clinics, clinicians received targeted reminders within the existing electronic medical record prompting them to order laboratory tests to detect adverse medication effects. (ahrq.gov)
  • In this cluster randomized trial among 47 primary care practices, prompting clinicians to enter justifications for prescribing antibiotics in patients with antibiotic-inappropriate diagnoses or providing peer comparisons through emails decreased mean antibiotic prescribing rates compared to controls. (ahrq.gov)
  • The trial excluded 1683 of 1955 individuals screened. (sens.org)
  • Research: My primary research interest is in conduct and methodology of large randomized clinical trials in heart disease. (duke.edu)
  • The methodology described is potentially valuable to investigators who might construct future multi-site clinical trials using TMS. (longdom.org)
  • Trial registration Clinical trials NCT00000367 . (bmj.com)
  • TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02227446. (healthpartners.com)
  • A priori registration of randomized clinical trials is crucial to the transparency and credibility of their findings. (uzh.ch)
  • y Col.: Randomized Trial of Lichtenstein versus Shouldice hernia repair in general surgical practice, British Journal of Surgery. (scielo.br)
  • 2020 . A real-time dashboard of clinical trials for COVID-19 . (ajtmh.org)
  • A well-designed trial must also be practically feasible to conduct. (who.int)
  • However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. (researchgate.net)
  • Quality of outpatient clinical notes: a stakeholder definition derived through qualitative research. (ahrq.gov)
  • Financial support for this clinical trial was supported by a research grant from The Susanne Marcus Collins Foundation, Inc. Sean L. Simpson was supported by NIBIB R01EB024559 and Wake Forest Clinical and Translational Science Institute (WF CTSI) NCATS UL1TR001420. (azbio.org)
  • John H. Alexander, MD, MHS is a cardiologist and Professor of Medicine in the Department of Medicine, Division of Cardiology at Duke University School of Medicine, as well as the Vice Chief, Clinical Research in the Division of Cardiology. (duke.edu)
  • Nutritional photoprotection with flavanol-rich chocolate is a promising area for research, but double-blind clinical trials are required to confirm experimental findings. (biomedcentral.com)
  • Fisher's experimental research and his writings popularized randomized experiments. (wikipedia.org)
  • In addition to several requests to the Director-General, the Health Assembly identified several possible actions for clinical researchers, trial sponsors, research funders, research ethics committees and national regulatory authorities that are key elements of the clinical trials ecosystem. (who.int)
  • In CBPR, the community often comes up with the research question or issue of interest based on personal experience, but in a randomized controlled trial (RCT), the funding agency or investigator generally develops the question based on pressing health issues identified from surveillance or other data sources. (cdc.gov)
  • A major challenge in implementing this research collaboration is to have clear lines of demarcation will have to be drawn between the "research" and the "clinical practice" arms. (cdc.gov)
  • Patients with recurrent patella dislocation requiring isolated MPFL reconstruction will be recruited and randomized to the dynamic or static reconstruction technique. (springer.com)
  • One of the clinical applications of VR technology is to educate pediatric patients and address their preoperative anxiety before anesthesia and surgery ( 5 ). (frontiersin.org)
  • Results In baseline clinical interviews, 396 people were classified as having major depression, 203 had clinically significant minor depression, and 627 did not meet criteria for depression. (bmj.com)
  • Three years results of a randomized clinical trial of lightweight or standard polypropylene mesh in Lichtenstein repair of primary inguinal hernia. (scielo.br)
  • Some of these experts may be confusing excitement surrounding a scientific discovery with the need to celebrate trial results, even when they're not impressive. (medscape.com)
  • But sometimes those core goals get buried in the design and interpretation of drug trials. (medscape.com)
  • Trial design was further influenced by the large-scale ISIS trials on heart attack treatments that were conducted in the 1980s. (wikipedia.org)
  • Clinical trials may also be referred to as interventional trials. (who.int)
  • Effect of behavioral interventions on inappropriate antibiotic prescribing among primary care practices: a randomized clinical trial. (ahrq.gov)
  • Flanders WD, Nurmagambetov TA, Cornwell CR, Kosinski AS, Sircar K. Using Randomized Controlled Trials to Estimate the Effect of Community Interventions for Childhood Asthma. (cdc.gov)
  • Recognizing that "well-designed2 and well-implemented clinical trials are indispensable for assessing the safety and efficacy of health interventions" and acknowledging "the importance of promoting equity in clinical trial capability" the Health Assembly sought to improve the quality of evidence generated in clinical trials and their coordination. (who.int)
  • Vrijland WW, van den Tol MP, Luijendijk RW, y Col.: Randomized Clinical trial of non-mesh versus mesh repair of primary inguinal hernia. (scielo.br)
  • Primary outcome was clinical cure at Day 7. (atsjournals.org)
  • First, as discussed, in last-line therapy when median overall survival is already less than 1 year, PFS alone does not imply any clinical benefit, so why would the regulators recommend changing the protocol in a way that shifted the primary endpoint from overall survival to PFS? (medscape.com)
  • Sotorasib received accelerated approval for this indication based on objective response rate from a single-arm trial in 2021, but this phase 3 trial provides the first comparative progression-free and overall survival data. (medscape.com)
  • Similarly, the initialism is sometimes expanded as "randomized clinical trial" or "randomized comparative trial", leading to ambiguity in the scientific literature. (wikipedia.org)
  • A second approach tested is usually a gene transfer strategy in which adeno-associated computer virus (AAV)-derived vectors of serotype rh10 (AAVrh10) encoding for the sulfamidase and sulfatase-modifying 1 (SUMF1) transgenes are delivered through multiple direct injections to the brain parenchyma ("type":"clinical-trial","attrs":"text":"NCT01474343″,"term_id":"NCT01474343″NCT01474343, clinicaltrials.gov). (scapca.org)
  • Subanalysis of patients with severe pneumonia did not show differences in clinical outcome. (atsjournals.org)
  • I have led a number of large international clinical studies in heart attacks, unstable angina, heart failure, and atrial fibrillation. (duke.edu)
  • In order to generate evidence that is robust enough to support decision-making, such as widespread use of therapeutics or preventives, trials should be designed, conducted, analysed and reported appropriately. (who.int)
  • CodeBreaK is a phase 3 randomized controlled trial that evaluated the new targeted drug sotorasib against docetaxel chemotherapy in patients with KRAS G12C mutation positive non-small cell lung cancer (NSCLC) who have already progressed on both immunotherapy and chemotherapy - essentially a last-line therapy trial. (medscape.com)
  • By using data from a 2015 clinical trial on Ebola convalescent-phase plasma in Guinea, we assessed the prevalence of electrolyte and metabolic abnormalities at admission and their predictive value to stratify patients into risk groups. (cdc.gov)
  • This definition includes Phase I to Phase IV trials. (who.int)