Clinical Trials in Dentistry: A Cross-sectional Analysis of World Health Organization-International Clinical Trial Registry Platform

2016 ◽  
Vol 16 (2) ◽  
pp. 90-95
Author(s):  
Gowri Sivaramakrishnan ◽  
Kannan Sridharan
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
World Health Organization ◽  
World Health ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Health Organization ◽  
Sectional Analysis

scholarly journals Characteristics of COVID-19 Clinical Trials in India Based on the Registration Data on CTRI (Clinical Trials Registry- India): a cross-sectional analysis

2020 ◽  
Author(s):  
P Sathiyarajeswaran ◽  
MS Shree Devi ◽  
K Kanakavalli ◽  
NP Vinod
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Multiple Drug ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Registration Data ◽  
Post Marketing Surveillance ◽  
Sectional Analysis

AbstractObjectivesThe 2019 pandemic of coronavirus disease (COVID-19) has prompted several efforts to find safe and effective drugs, but little is understood as to where early efforts were centered. Several clinical trials, both Allopathy and AYUSH medicines have been registered in the Clinical Trial Registry of India (CTRI). We aimed to characterize and extract relevant data registered under CTRI for COVID-19.Materials and MethodsA cross-sectional analysis was performed of clinical trials for the treatment of COVID-19 that were registered in the Clinical Trial Registry of India (CTRI) from 1st March 2020 to 22nd June 2020. Relevant trial records were downloaded, deduplicated, and independently analyzed by three reviewers.Main outcomesTrial intervention, design, sponsorship, phase of the trial, and indicated outcomes.Results233 COVID-19 clinical trials, was registered from India in CTRI. Out of these, 146 were Interventional trials, 84 Observational trials, and three Post-marketing surveillance. Questionnaire and survey-based intervention occupy a significant portion. Randomized control trials are large in number 37.8% than non-randomized. 20% of the trials were recruiting patients, and the Research institution (34%) sponsored more than half of the trials. Global trials are minimal, occupying 3% of total trials and Indian trials were 97%. In most of the trials, the interventional agent is either multiple drug combinations or compound drug formulations compared to single drug administration. Among the trials, 46 Allopathic interventions, 41 Ayurveda interventions, 14 Homeopathy interventions, one in Unani, and 2 in yoga and Naturopathy.ConclusionThis study will provide a background of COVID-19 clinical trials registered in CTRI and provide specific issues observed related to clinical trial designs, which offer information to perform clinical trials on COVID-19

scholarly journals Delays in reporting and publishing trial results during pandemics: cross sectional analysis of 2009 H1N1, 2014 Ebola, and 2016 Zika clinical trials

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Christopher W. Jones ◽  
Amanda C. Adams ◽  
Elizabeth Murphy ◽  
Rachel P. King ◽  
Benjamin Saracco ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
H1n1 Influenza ◽  
World Health ◽  
Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
2009 H1n1 ◽  
Study Completion ◽  
Sectional Analysis

Abstract Background Pandemic events often trigger a surge of clinical trial activity aimed at rapidly evaluating therapeutic or preventative interventions. Ensuring rapid public access to the complete and unbiased trial record is particularly critical for pandemic research given the urgent associated public health needs. The World Health Organization (WHO) established standards requiring posting of results to a registry within 12 months of trial completion and publication in a peer reviewed journal within 24 months of completion, though compliance with these requirements among pandemic trials is unknown. Methods This cross-sectional analysis characterizes availability of results in trial registries and publications among registered trials performed during the 2009 H1N1 influenza, 2014 Ebola, and 2016 Zika pandemics. We searched trial registries to identify clinical trials testing interventions related to these pandemics, and determined the time elapsed between trial completion and availability of results in the registry. We also performed a comprehensive search of MEDLINE via PubMed, Google Scholar, and EMBASE to identify corresponding peer reviewed publications. The primary outcome was the compliance with either of the WHO’s established standards for sharing clinical trial results. Secondary outcomes included compliance with both standards, and assessing the time elapsed between trial completion and public availability of results. Results Three hundred thirty-three trials met eligibility criteria, including 261 H1N1 influenza trials, 60 Ebola trials, and 12 Zika trials. Of these, 139 (42%) either had results available in the trial registry within 12 months of study completion or had results available in a peer-reviewed publication within 24 months. Five trials (2%) met both standards. No results were available in either a registry or publication for 59 trials (18%). Among trials with registered results, a median of 42 months (IQR 16–76 months) elapsed between trial completion and results posting. For published trials, the median elapsed time between completion and publication was 21 months (IQR 9–34 months). Results were available within 24 months of study completion in either the trial registry or a peer reviewed publication for 166 trials (50%). Conclusions Very few trials performed during prior pandemic events met established standards for the timely public dissemination of trial results.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

scholarly journals Clinical trial reporting performance of thirty UK universities on ClinicalTrials.gov—evaluation of a new tracking tool for the US clinical trial registry

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sarai Mirjam Keestra ◽  
Florence Rodgers ◽  
Daphne Lenz ◽  
Rhiannon Osborne ◽  
Till Bruckner ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Median Number ◽  
World Health ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Link Type ◽  
The Us ◽  
Health Organization ◽  
The Uk

AbstractClinical trial transparency forms the foundation of evidence-based medicine, and trial sponsors, especially publicly funded institutions such as universities, have an ethical and scientific responsibility to make the results of clinical trials publicly available in a timely fashion. We assessed whether the thirty UK universities receiving the most Medical Research Council funding in 2017–2018 complied with World Health Organization best practices for clinical trial reporting on the US Clinical Trial Registry (ClinicalTrials.gov). Firstly, we developed and evaluated a novel automated tracking tool (clinical-trials-tracker.com) for clinical trials registered on ClinicalTrials.gov. This tracker identifies the number of due trials (whose completion lies more than 395 days in the past) that have not reported results on the registry and can now be used for all sponsors. Secondly, we used the tracker to determine the number of due clinical trials sponsored by the selected UK universities in October 2020. Thirdly, using the FDAAA Trials Tracker, we identified trials sponsored by these universities that are not complying with reporting requirements under the Food and Drug Administration Amendments Act 2007. Finally, we quantified the average and median number of days between primary completion date and results posting. In October 2020, the universities included in our study were sponsoring 1634 due trials, only 1.6% (n = 26) of which had reported results within a year of completion. 89.8% (n = 1468) of trials remained unreported, and 8.6% (n = 140) of trials reported results late. We also identified 687 trials that contained inconsistent data, suggesting that UK universities often fail to update their data adequately on ClinicalTrials.gov. The mean reporting delay after primary completion for trials that posted results was 981 days, the median 728 days. Only four trials by UK universities violated the FDAAA 2007. We suggest a number of reasons for the poor reporting performance of UK universities on ClinicalTrials.gov: (i) efforts to improve clinical trial reporting in the UK have to date focused on the European clinical trial registry (EU CTR), (ii) the absence of a tracking tool for timely reporting on ClinicalTrials.gov has limited the visibility of institutions’ reporting performance on the US registry and (iii) there is currently a lack of repercussions for UK sponsors who fail to report results on ClinicalTrials.gov which should be addressed in the future.

scholarly journals Searching clinical trial registries in interventional physical therapy systematic reviews: A Pilot Cross-sectional Analysis

2018 ◽  
Author(s):  
Alaa Abou Khzam
Keyword(s):  
Clinical Trial ◽  
Physical Therapy ◽  
Systematic Reviews ◽  
Trial Registry ◽  
Inclusion Criteria ◽  
Clinical Trial Registry ◽  
Cross Sectional ◽  
Cross Sectional Analysis ◽  
Clinical Trial Registries ◽  
Sectional Analysis

Background. Studies with positive findings are more likely to be published compared to those with negative findings. Therefore the latter studies are often disregarded in systematic reviews. This causes an overestimation of a treatment effect size which leads to a misinterpretation of the evidence. Searching clinical trial registries in systematic reviews is a useful source to retrieve unpublished clinical trials leading to the reduction of publication bias. Previous studies in the literature reported inconsistent searching of clinical trial registries in systematic reviews published in several medical fields. Searching clinical trial registries in physical therapy is still unknown. The aim of this cross-sectional analysis is to evaluate the extent of clinical trial registry searching in physical therapy interventional systematic reviews. Methods. Systematic reviews published between January 2017 and January 2018 were retrieved from five reputable physical therapy journals. Interventional systematic reviews that were coherent with the inclusion criteria were included in the analysis. Results. The search yielded 40 systematic reviews. Among these 19 were interventional systematic reviews as well as being consistent with the inclusion criteria and thus were considered for the analysis. After reviewing their search methodology, only two reviews (10.5%) reported searching at least one clinical trial registry. Discussion. The results of this study suggest poor searching of clinical trial registries in physical therapy systematic reviews. Due to the limitations of this study, further research analyzing large samples of interventional physical therapy systematic reviews is required.

Obesity, abdominal obesity and migraine: A cross-sectional analysis of ELSA-Brasil baseline data

Cephalalgia ◽  
2014 ◽  
Vol 35 (5) ◽  
pp. 426-436 ◽  
Author(s):  
Itamar S Santos ◽  
Alessandra C Goulart ◽  
Valeria M Passos ◽  
Maria del Carmen Molina ◽  
Paulo A Lotufo ◽  
...  
Keyword(s):  
Abdominal Obesity ◽  
International Headache Society ◽  
World Health ◽  
Cross Sectional ◽  
Logistic Regression Models ◽  
Cross Sectional Analysis ◽  
Validated Questionnaire ◽  
Health Organization ◽  
Sectional Analysis ◽  
Standard Techniques

Background and aim: Most studies assessing the association between migraine and obesity have shown conflicting results. We aimed to evaluate the association between obesity and migraine in ELSA-Brasil, a cohort study of 15,105 individuals aged 35–74 years. Methods: We assessed migraine using a validated questionnaire based on International Headache Society criteria and anthropometric measurements using standard techniques. Migraine was categorized as daily and non-daily. World Health Organization criteria were used to categorize overweight, obesity and abdominal obesity (AbO). We performed a cross-sectional analysis using multivariate logistic regression models to study the association between migraine and obesity (body mass index (BMI) ≥ 30 kg/m2), compared to controls without migraine. Results: We found an association between daily migraine and obesity (odds ratio (OR) 1.86; 95% confidence interval (95% CI): 1.12–3.09). Although the presence of AbO was not associated with migraine, interaction models showed that the association between obesity and daily migraine remained strong only in the absence of AbO diagnosis, notably in individuals aged 35–49 years. Discussion: In our large sample of individuals aged 35 years or older, obesity, but not AbO, was associated with daily migraine. AbO influenced the association between BMI and daily migraine in migraineurs aged 35–49 years.

HUBUNGAN TINGKAT STRES DENGAN SIKLUS MENSTRUASI PADA MAHASISWA KEBIDANAN TINGKAT I DI STIKES KUNINGAN TAHUN 2019

2020 ◽  
Vol 1 (1) ◽  
pp. 8
Author(s):  
Fera Riswidautami Herwandar ◽  
Russiska Russiska ◽  
Intan Maharani Fakhrudin
Keyword(s):  
World Health Organization ◽  
World Health ◽  
P Value ◽  
Cross Sectional ◽  
Health Organization

Permasalahan kesehatan pada remaja yang menduduki persentasi terbesar dibanding yang lainnya adalah gangguan menstruasi. Gangguan pada siklus menstruasi (durasi perdarahan yang lebih lama dan ketidakteraturan siklus) disebabkan oleh beberapa faktor, salah satunya ialah stres. Stres diketahui sebagai faktor-faktor penyebab (etiologi) terjadinya gangguan siklus menstruasi. Stres akan memicu pelepasan hormon kortisol dimana hormon kortisol ini dijadikan tolak ukur untuk melihat derajat stres seseorang. Hormon kortisol diatur oleh hipotalamus otak dan kelenjar pituitari, dengan dimulainya aktivitas hipotalamus, hipofisis mengeluarkan FSH dan proses stimulus ovarium akan menghasilkan estrogen. Penelitian yang dilakukan oleh Pelayanan Kesehatan Peduli Remaja (PKPR) dibawah naungan World Health Organization (WHO) menyebutkan bahwa permasalahan remaja di Indonesia adalah seputar permasalahan yang mengenai gangguan menstruasi. Tujuan penelitian ini adalah untuk mengetahui hubungan tingkat stres dengan siklus menstruasi pada mahasiswa kebidanan tingkat I di STIKES Kuningan tahun 2019. Penelitian ini menggunakan desain penelitian kuantitatif dengan pendekatan Cross Sectional. Populasi dalam penelitian ini adalah mahasiswa kebidanan tingkat I di STIKES Kuningan tahun 2019 sebanyak 41 responden. Analisis yang digunakan analisis univariat dan bivariat dengan menggunakan uji Rank Spearman. Hasil penelitian menunjukkan adanya hubungan tingkat stres dengan siklus menstruasi pada mahasiswa kebidanan tingkat I di STIKES Kuningan, dari 41 responden terdapat 18 (44%) responden yang mengalami stres sedang, pada siklus menstruasi yang tidak teratur terdapat 25 (61%) responden. Hasil uji rank spearman,  yakni p value = 0,01 (<0,05) yang ada hubungan antara tingkat stres dengan siklus menstruasi. Berdasarkan hasil penelitian penulis dapat menyimpulkan bahwa terdapat hubungan yang signifikan antara tingkat stres dengan siklus menstruasi pada mahasiswa kebidanan tingkat I di STIKES Kuningan tahun 2019. Bagi institusi Pendidikan khususnya Program Studi Diploma III Kebidanan diharapkan dapat membuat sebuah program edukasi mengenai manajemen stres pada remaja yang bisa dilakukan secara rutin di luar jadwal perkuliahan.  

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