|drug1420||Esophageal temperature monitoring probe Wiki||0.71|
|drug4474||ensoETM. Esophageal cooling during AF ablation Wiki||0.71|
|D004937||Esophageal Fistula NIH||0.71|
|D001281||Atrial Fibrillation NIH||0.35|
|D003424||Crohn Disease NIH||0.21|
There are 2 clinical trials
The purpose of this study is to evaluate the long-term safety and efficacy of repeat administration of darvadstrocel in participants with Crohn's Disease (CD) and complex perianal fistula by evaluation of adverse events (AEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and special situation reports (SSRs).
Description: An AE is any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. A TEAE is defined as an AE with an onset that occurs after receiving study drug.Measure: Percentage of Participants with at Least 1 Treatment-Emergent Adverse Event (TEAE) Time: From administration of repeat dose up to 156 weeks post-repeat administration
Description: An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.Measure: Percentage of Participants with at Least 1 Treatment Emergent Serious Adverse Event (TESAE) Time: From administration of repeat dose up to 156 weeks post-repeat administration
Description: An SSR includes pregnancy, any case in which a pregnant participant is exposed to a study product or in which a female participant or female partner of a male participant becomes pregnant following treatment with a study product. Exposure is considered either through maternal exposure or via semen following paternal exposure or infant exposure from breast milk.Measure: Percentage of Participants with Special Situation Reports (SSRs) Time: From administration of repeat dose up to 156 weeks post-repeat administration
Description: AESI includes immunogenicity/alloimmune reactions, hypersensitivity, transmission of infectious agents, tumorgenicity, ectopic tissue formation, medication errors.Measure: Percentage of Participants with Adverse Event of Special Interest (AESI) Time: From administration of repeat dose up to 156 weeks post-repeat administration
Description: Combined remission is defined as the closure of all treated external openings that were draining at baseline (i.e., baseline visit), despite gentle finger compression and absence of collection(s) >2 cm (in at least 2 dimensions) of the treated perianal fistula(s) confirmed by central magnetic resonance imaging (MRI) assessment.Measure: Percentage of Participants who Achieve Combined Remission of Perianal Fistula(s) Time: At Week 24 and at Week 156 post-repeat administration
Description: Clinical remission is defined as closure of all treated external fistula openings that were draining at baseline despite gentle finger compression.Measure: Percentage of Participants who Achieve Clinical Remission Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administration
Description: Clinical response is defined as closure of at least 50% of all treated external fistula openings that were draining at baseline despite gentle finger compression.Measure: Percentage of Participants who Achieve Clinical Response Time: At Weeks 6, 24, 52, 104, and 156 post-repeat administration
Description: Relapse is defined as reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed that were in the combined remission at Week 24 or the development of a collection >2 cm (in at least 2 dimensions) confirmed by centrally read MRI assessment.Measure: Percentage of Participants with Relapse From Week 24 Combined Remission Time: From Week 24 to Week 156 post-repeat administration
Description: Time to Relapse is defined as the time in days to reopening of any of the treated fistula(s) external openings with active drainage as clinically assessed, relative to Week 24.Measure: Time to Relapse Time: From Week 24 to the Day of relapse post-repeat administration
Description: The PDAI is a scoring system to evaluate the severity of perianal lesion associated with Crohn's disease. It includes the following 5 items: (a) discharge; (b) pain; (c) restriction of sexual activity; (d) type of perianal disease; and (e) degree of induration. Each item is graded on a 5-point scale ranging from no symptoms (score of 0) to severe symptoms (score of 4) and total range of score is from 0 to 20. Higher score means more severe disease.Measure: Change From Baseline in Score of Discharge and Pain Items of Perianal Disease Activity Index (PDAI) Score Time: Baseline to Weeks 6, 24, 52, 104, and 156 post-repeat administration
Atrial fibrillation (AF) is a common debilitating heart rhythm condition that can cause heart failure and negatively impact a patient's outlook in terms of symptoms and disability. It is an irregular fast heart rhythm disorder coming from the top chamber of the heart (left atrium). Catheter ablation treatment has been shown to be effective in controlling or eliminating AF and its associated symptoms. This is now a common and effective treatment option for patients suffering with AF. During ablation, thermal energy is applied in the top chamber of the heart (the left atrium) to abolish abnormal electrical signals that cause AF. It is generally a safe procedure, but one potential risk associated with this procedure is damage to the oesophagus caused by thermal energy being transmitted to the oesophagus from the heart. The oesophagus sits just behind the heart chamber where ablation work is performed, about 5mm away, so it is vulnerable to damage. Although the risk of severe oesophageal damage is low, if it occurs it can be serious as the patient may become very ill as a result. In a recent study, we have shown that a more advanced type of oesophageal probe that cools the oesophagus during ablation is better at protecting the oesophagus from ablation-related injury compared to the standard care probe currently used. As it was a single-centre study, more evidence is required before we can say that this type of probe is better in protecting the oesophagus. The purpose is to run a multi-centre randomized study to compare the safety of AF ablation when there is protection by the oesophageal cooling probe versus the standard of care oesophageal temperature monitoring probe. This means that there is a 50:50 chance of the new cooling probe being used during AF ablation for participants.
Description: An upper gastrointestinal endoscopy diagnostic camera is performed under local anaesthetic spray and sedation. This is to screen for ablation-related thermal injury, which is highly characteristic and separate from other pathologies. This is performed for ALL participants of the trial regardless of randomization to study or control group.Measure: Incidence and severity of endoscopically detected oesophageal thermal injury related to AF ablation. (Endoscopy at times 12-72 hours). Time: Performed once, at 12-72 hours post ablation
Description: A measure for procedure efficiencyMeasure: Procedure duration (minutes). Time: Measured once. At time of AF ablation procedure (day 0)
Description: A measure for procedure efficiencyMeasure: Fluoroscopy duration (minutes) Time: Measured once. At time of AF ablation procedure (day 0)
Description: A measure of safety of AF ablation across both randomized groups.Measure: Incidence of major adverse events (MACCE) at times 0, 3, 6, 12 months. Time: Measured 4 times, at times: 0, 3, 6, 12 months from time of ablation.
Description: A measure of efficacy and efficiency of the AF ablation procedure: Attainment of ablation targets, including isolation of all veins and production of proven bidirectional block across all lines attempted. Attainment of first-pass isolation for each set of veins Persistence of isolation through waiting period and adenosine test (if used at operator's discretion).Measure: Ability to attain procedural endpoints during AF ablation. Time: Measured once at time points: time of AF ablation procedure (day 0).
Description: Incidence of severe gastroenterological symptoms, indicative of oesophageal reflux or gastroparesis, from validated questionnaires (gastro-esophageal reflux disease score (GERDQ) and gastroparesis cardinal symptoms index (GCSI) score) administered >3 months from time of ablation.Measure: Incidence of clinically significant chest/gastroenterological symptoms post ablation Time: Measured once at time points: 3 months from AF ablation procedure
Description: Record any evidence of return of the treated arrhythmia at follow up cardiac monitoring: includes, 12 lead ECG, Holter, implantable loop recorders, non-invasive ECG monitors, mobile ECG apps. A return of AF (treated arrhythmia) must satisfy clear ECG/monitoring evidence of AF/related AT for >30 seconds. This is a measure of the success of the AF ablation procedure.Measure: Recurrence of treated atrial arrhythmia (AF or related AT) Time: Measured at these time points: 3, 6, 12, 24 months from time of ablation procedure.
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports