10-Year Update on Study Results Submitted to ClinicalTrials.gov.
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ABSTRACT:
SUBMITTER: Zarin DA
PROVIDER: S-EPMC8591666 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe ClinicalTrials.gov trial registry was expanded in 2008 to include a database for reporting summary results. We summarize the structure and contents of the results database, provide an update of relevant policies, and show how the data can be used to gain insight into the state of clinical research.MethodsWe analyzed ClinicalTrials.gov data that were publicly available between September 2009 and September 2010.ResultsAs of September 27, 2010, ClinicalTrials.gov received approximately 330 new and 2000 revised registrations each week, along with 30 new and 80 revised results submissions. We characterized the 79,413 registry and 2178 results of trial records available as of September 2010. From a sample cohort of results records, 78 of 150 (52%) had associated publications within 2 years after posting. Of results records available publicly, 20% reported more than two primary outcome measures and 5% reported more than five. Of a sample of 100 registry record outcome measures, 61% lacked specificity in describing the metric used in the planned analysis. In a sample of 700 results records, the mean number of different analysis populations per study group was 2.5 (median, 1; range, 1 to 25). Of these trials, 24% reported results for 90% or less of their participants.ConclusionsClinicalTrials.gov provides access to study results not otherwise available to the public. Although the database allows examination of various aspects of ongoing and completed clinical trials, its ultimate usefulness depends on the research community to submit accurate, informative data.
| S-EPMC3066456 | biostudies-literature
Project description:ObjectiveTo describe the frequency of work-related asthma (WRA) and characteristics of individuals with exposure to cleaning products 1998 to 2012, compared with 1993 to 1997.MethodsCases of WRA from products used for cleaning or disinfecting surfaces were identified from California, Massachusetts, Michigan (1998 to 2012), New Jersey (1998 to 2011), and New York (2009 to 2012).ResultsThere were 1199 (12.4%) cleaning product cases among all 9667 WRA cases; 77.8% women, 62.1% white non-Hispanic, and average age of 43 years. The highest percentages worked in healthcare (41.1%), and were building cleaners (20.3%), or registered nurses (14.1%).ConclusionsThe percentage of WRA cases from exposure to cleaning products from 1998 to 2012 was unchanged from 1993 to 1997 indicating that continued and additional prevention efforts are needed to reduce unnecessary use, identify safer products, and implement safer work processes.
| S-EPMC7839059 | biostudies-literature
Project description:PurposeGM1 gangliosidosis (GM1) is an ultra-rare lysosomal storage disease caused by pathogenic variants in galactosidase beta 1 (GLB1; NM_000404), primarily characterized by neurodegeneration, often in children. There are no approved treatments for GM1, but clinical trials using gene therapy (NCT03952637, NCT04713475) and small molecule substrate inhibitors (NCT04221451) are ongoing. Understanding the natural history of GM1 is essential for timely diagnosis, facilitating better supportive care, and contextualizing the results of therapeutic trials.MethodsForty-one individuals with type II GM1 (n=17 late infantile and n=24 juvenile onset) participated in a single-site prospective observational study. Here, we describe the results of extensive multisystem assessment batteries, including clinical labs, neuroimaging, physiological exams, and behavioral assessments.ResultsClassification of 37 distinct variants in this cohort was performed according to ACMG criteria and resulted in the upgrade of six and the submission of four new variants to pathogenic or likely pathogenic. In contrast to type I infantile, children with type II disease exhibited normal or near normal hearing and did not have cherry red maculae or significant hepatosplenomegaly. Some older children with juvenile onset developed thickened aortic and/or mitral valves with regurgitation. Serial MRIs demonstrated progressive brain atrophy that were more pronounced in those with late infantile onset. MR spectroscopy showed worsening elevation of myo-inositol and deficit of N-acetyl aspartate that were strongly correlated with scores on the Vineland Adaptive Behavior Scale and progress more rapidly in late infantile than juvenile onset disease.ConclusionThe comprehensive serial phenotyping of type II GM1 patients expands the understanding of disease progression and clarifies some common misconceptions about type II patients. Findings from this 10-year endeavor are a pivotal step toward more timely diagnosis and better supportive care for patients. The wealth of data amassed through this effort will serve as a robust comparator for ongoing and future therapeutic trials.
| S-EPMC10836125 | biostudies-literature
Project description:The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of results of applicable clinical trials to ClinicalTrials.gov. We characterized the proportion of applicable clinical trials with publicly available results and determined independent factors associated with the reporting of results.Using an algorithm based on input from the National Library of Medicine, we identified trials that were likely to be subject to FDAAA provisions (highly likely applicable clinical trials, or HLACTs) from 2008 through 2013. We determined the proportion of HLACTs that reported results within the 12-month interval mandated by the FDAAA or at any time during the 5-year study period. We used regression models to examine characteristics associated with reporting at 12 months and throughout the 5-year study period.From all the trials at ClinicalTrials.gov, we identified 13,327 HLACTs that were terminated or completed from January 1, 2008, through August 31, 2012. Of these trials, 77.4% were classified as drug trials. A total of 36.9% of the trials were phase 2 studies, and 23.4% were phase 3 studies; 65.6% were funded by industry. Only 13.4% of trials reported summary results within 12 months after trial completion, whereas 38.3% reported results at any time up to September 27, 2013. Timely reporting was independently associated with factors such as FDA oversight, a later trial phase, and industry funding. A sample review suggested that 45% of industry-funded trials were not required to report results, as compared with 6% of trials funded by the National Institutes of Health (NIH) and 9% of trials that were funded by other government or academic institutions.Despite ethical and legal obligations to disclose findings promptly, most HLACTs did not report results to ClinicalTrials.gov in a timely fashion during the study period. Industry-funded trials adhered to legal obligations more often than did trials funded by the NIH or other government or academic institutions. (Funded by the Clinical Trials Transformation Initiative and the NIH.).
| S-EPMC4508873 | biostudies-literature
Project description:ObjectivesTo review the benefit of an endoscopic surveillance programme for patients with Barrett's oesophagus.DesignObservational study.SettingUniversity teaching hospital.Participants409 patients in whom Barrett's oesophagus was identified during 1984-94; 143 were entered into the annual surveillance programme.Main outcome measuresDevelopment of dysplasia and cancer and mortality.ResultsThe average period of surveillance was 4.4 years; 55 patients were reassessed in 1994 but only eight remained in the programme in 1999, withdrawal being due to death (not from carcinoma of the oesophagus), illness, or frailty. Five of the patients who entered surveillance developed carcinoma of the oesophagus. Only one cancer was identified as a result of a surveillance endoscopy, the others being detected during endoscopy to investigate altered symptoms. Of the 266 patients who were not suitable for surveillance, one died from oesophageal cancer and 103 from other causes. Surveillance has resulted in 745 endoscopies and about 3000 biopsy specimens.ConclusionThe current surveillance strategy has limited value, and it may be appropriate to restrict surveillance to patients with additional risk factors such as stricture, ulcer, or long segment (>80 mm) Barrett's oesophagus.
| S-EPMC27527 | biostudies-literature
Project description:Image-guided tumor ablation has become a well-established hallmark of local cancer therapy. The breadth of options available in this growing field increases the need for standardization of terminology and reporting criteria to facilitate effective communication of ideas and appropriate comparison among treatments that use different technologies, such as chemical (eg, ethanol or acetic acid) ablation, thermal therapies (eg, radiofrequency, laser, microwave, focused ultrasound, and cryoablation) and newer ablative modalities such as irreversible electroporation. This updated consensus document provides a framework that will facilitate the clearest communication among investigators regarding ablative technologies. An appropriate vehicle is proposed for reporting the various aspects of image-guided ablation therapy including classification of therapies, procedure terms, descriptors of imaging guidance, and terminology for imaging and pathologic findings. Methods are addressed for standardizing reporting of technique, follow-up, complications, and clinical results. As noted in the original document from 2003, adherence to the recommendations will improve the precision of communications in this field, leading to more accurate comparison of technologies and results, and ultimately to improved patient outcomes. Online supplemental material is available for this article .
| S-EPMC4263618 | biostudies-literature
Project description:Youth mental health problems is the leading cause of disability worldwide and a major public health concern. Prevalence rates are needed for planning preventive interventions and health care services. We here report Norwegian prevalence estimates for youth mental disorders based on findings from the Bergen Child Study cohort. A web-based psychiatric interview; the Development and Well-Being Assessment, was completed by parents and teachers of 2,043 10-14-year-olds from the city of Bergen, Norway. Post-stratification weights were used to account for selective participation related to parental educational in the estimation of prevalence rates. Prevalence rates are presented for the whole sample and stratified by gender and age. The overall population weighted estimate suggests that 6.93% (95% CI 5.06-9.41) of the children met DSM-IV diagnostic criteria for one or more psychiatric disorders. There were no robust indications of age- or gender-related differences in the prevalence. 11.4% of the children fulfilled criteria for more than one diagnosis. The most common comorbid conditions were ADHD and disruptive disorders. The prevalence of psychiatric disorders was relatively low among Norwegian 10-14-year-olds, compared to published worldwide prevalence estimates. This is in line with estimates from prior studies from the Nordic countries. These findings raise important questions about the origins of different prevalence rates for psychiatric disorders between societies. The findings also illustrate the importance of locally driven epidemiological studies for planning preventative efforts and appropriately scaling mental health services to meet the need of the population.
| S-EPMC7978367 | biostudies-literature
Project description:ImportanceUnreported clinical trial results represent a violation of human rights. Oncology trials account for nearly 30% of interventional biopharmaceutical clinical studies registered on ClinicalTrials.gov and are the most numerous among all disciplines.ObjectiveTo analyze the reporting of results among all interventional oncology trials registered on ClinicalTrials.gov from 2007 through 2017.Design, setting, and participantsThis cohort study analyzed all clinical studies registered between June 1, 2007, and May 8, 2017, on ClinicalTrials.gov, the largest public clinical trial registry in the world. Trials with a recruitment status of completed or terminated and a primary completion date of on or before September 30, 2017, were selected. Data were analyzed between February 20, 2021, and February 26, 2021.Main outcomes and measuresThe main outcome was the percentage of trials that reported results either on ClinicalTrials.gov or in journal publications within 24 months of the primary completion date. Journal publication was ascertained by searching ClinicalTrials.gov for a link to the publication, PubMed using national clinical trial number, and Embase using national clinical trial number and filters.ResultsOf the 12 240 clinical trials registered in ClinicalTrials.gov, 7425 trials (60.7%; 95% CI, 60.0%-61.5%) reported results, with a 34.0% (95% CI, 30.3%-37.7%) increase in 24-month reporting rate from 2007 to 2017. Multivariable analyses confirmed that more recent trials (adjusted hazard ratio [HR], 1.11 per year increase; 95% CI, 1.10-1.13) and trials with larger sample sizes (51-100 patients: adjusted HR, 1.17 [95% CI, 1.09-1.24]; >100 patients: adjusted HR, 1.43 [95% CI, 1.33-1.54]) were more likely to report results. Terminated trials were less likely to report results compared with completed trials (adjusted HR, 0.88; 95% CI, 0.83-0.93). Compared with trials funded by industry, those funded by the National Institutes of Health were more likely to report results (adjusted HR, 1.39; 95% CI, 1.29-1.49), whereas those funded by other academic or nonprofit organizations were less likely to report results (adjusted HR, 0.66; 95% CI, 0.62-0.70). Among all 7425 trials, the results of 2807 trials (37.8%; 95% CI, 36.7%-38.9%) were posted only on ClinicalTrials.gov. These trials tended to be terminated early and to have small sample sizes (≤50 patients) compared with trials that published results in journals.Conclusions and relevanceThis study found a gradual improvement in results reporting among oncology trials over a 10-year period. Trial registries could serve as a results reporting platform for unpublished trials and as a data source of trial outcomes for future studies.
| S-EPMC8144925 | biostudies-literature
Project description:Aims and objectivesThe aim of the study is to retrospectively analyse the incidence of facial fractures along with age, gender predilection, etiology, commonest site, associated dental injuries and any complications of paediatric patients operated in Craniofacial unit of SDM college of dental sciences and hospital.Materials and methodsThis retrospective study was conducted at the department of OMFS, SDM College of Dental Sciences, Dharwad from January 2003-December 2013. All the patients below 15 years of age were included in the study. Data were recorded for the cause of injury, age and gender distribution, frequency and type of injury, localization and frequency of soft tissue injuries, dentoalveolar trauma, facial bone fractures, complications, concomitant injuries and different treatment protocols.ResultsA total of 68 cases of paediatric fracture were treated during these 10 years. Boys were commonly injured than girls with a ratio of 2.9:1, the commonest cause of trauma was fall (59 %), mandible was the commonest bone to be fractured (83 %), treatment protocols were dependant on the age, region and type of fracture but in most of the cases closed reduction was the choice of treatment, dental injuries were seen in 26 % patients and the commonest injury was avulsion.ConclusionThis study was done not only to analyse the different types of facial fractures and the pattern of fracture of paediatric cases admitted at this centre, but also to act as a contributional data which will help us to take preventive measures to avoid such injuries and make the appropriate treatment plan and execute it to achieve the pre-injury status of form and function.
| S-EPMC5878159 | biostudies-literature
Project description:PurposeThis work aimed to evaluate genotype-phenotype associations in individuals carrying germline variants of transmembrane protein 127 gene (TMEM127), a poorly known gene that confers susceptibility to pheochromocytoma (PHEO) and paraganglioma (PGL).DesignData were collected from a registry of probands with TMEM127 variants, published reports, and public databases.Main outcome analysisClinical, genetic, and functional associations were determined.ResultsThe cohort comprised 110 index patients (111 variants) with a mean age of 45 years (range, 21-84 years). Females were predominant (76 vs 34, P < .001). Most patients had PHEO (n = 94; 85.5%), although PGL (n = 10; 9%) and renal cell carcinoma (RCC, n = 6; 5.4%) were also detected, either alone or in combination with PHEO. One-third of the cases had multiple tumors, and known family history was reported in 15.4%. Metastatic PHEO/PGL was rare (2.8%). Epinephrine alone, or combined with norepinephrine, accounted for 82% of the catecholamine profiles of PHEO/PGLs. Most variants (n = 63) occurred only once and 13 were recurrent (2-12 times). Although nontruncating variants were less frequent than truncating changes overall, they were predominant in non-PHEO clinical presentations (36% PHEO-only vs 69% other, P < .001) and clustered disproportionately within transmembrane regions (P < .01), underscoring the relevance of these domains for TMEM127 function. Integration of clinical and previous experimental data supported classification of variants into 4 groups based on mutation type, localization, and predicted disruption.ConclusionsPatients with TMEM127 variants often resemble sporadic nonmetastatic PHEOs. PGL and RCC may also co-occur, although their causal link requires further evaluation. We propose a new classification to predict variant pathogenicity and assist with carrier surveillance.
| S-EPMC7765648 | biostudies-literature