A randomized open-label active controlled left/right clinical trial to evaluate the use of topical emulsion cream versus standard care in subjects with actinic keratosis post cryotherapy

2007 ◽  
Vol 56 (2) ◽  
pp. AB152
Keyword(s):  
Clinical Trial ◽  
Actinic Keratosis ◽  
Standard Care ◽  
Open Label

scholarly journals Ciclesonide Inhaler Treatment for Mild-to-Moderate COVID-19: A Randomized, Open-Label, Phase 2 Trial

2021 ◽  
Vol 10 (16) ◽  
pp. 3545
Author(s):  
Joon-Young Song ◽  
Jin-Gu Yoon ◽  
Yu-Bin Seo ◽  
Jacob Lee ◽  
Joong-Sik Eom ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Standard Care ◽  
Eradication Rate ◽  
Clinical Status ◽  
Antiviral Agents ◽  
Outpatient Setting ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Viral Shedding ◽  
Phase 2 Trial

Although some intravenous drugs have been used to treat coronavirus disease 2019 (COVID-19), no effective antiviral agents are currently available in the outpatient setting. We aimed to evaluate the efficacy and adverse events of 14-day ciclesonide treatment vs. standard care for patients with mild-to-moderate COVID-19. A randomized, open-label, multicenter clinical trial of ciclesonide inhalers was conducted in patients with mild-to-moderate COVID-19. Patients were enrolled within 3 days of diagnosis or within 7 days from symptom onset and randomly assigned to receive either ciclesonide (320 µg inhalation twice per day for 14 days) or standard care. The primary endpoint was the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) eradication rate on day 14 from study enrollment. Clinical status was assessed once daily, and serial nasopharyngeal viral load was evaluated by quantitative reverse transcription polymerase chain reaction. There were 35 and 26 patients in the ciclesonide and standard care groups, respectively. The SARS-CoV-2 eradication rate at day 14 was significantly higher in the ciclesonide group (p = 0.021). In multivariate analysis, SARS-CoV-2 negative conversion within 14 days was 12 times more likely in the ciclesonide group (95% confidence interval, 1.187–125.240). Additionally, the clinical failure rate (high-flow nasal oxygen therapy or mechanical ventilation) was significantly lower in the ciclesonide group (p = 0.034). In conclusion, ciclesonide inhalation shortened SARS-CoV-2 viral shedding duration, and it may inhibit the progression to acute respiratory failure in patients with mild-to-moderate COVID-19. Clinical Trial Registration NCT04330586.

scholarly journals A 2x2 factorial, randomised, open-label trial to determine the clinical and cost- effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care over 52 weeks in adults with bronchiectasis: A protocol for the CLEAR clinical trial

2019 ◽  
Author(s):  
Judy Bradley ◽  
Rohan Anand ◽  
Brenda O'Neill ◽  
Kathryn Ferguson ◽  
Mike Clarke ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cost Effectiveness ◽  
Usual Care ◽  
Hypertonic Saline ◽  
Standard Care ◽  
Open Label ◽  
Double Blind ◽  
Airway Clearance ◽  
Health And Social Care ◽  
Open Label Trial

Abstract Background: Current guidelines for the management of bronchiectasis (BE) highlight the lack of evidence to recommend mucoactive agents, such as hypertonic saline (HTS) and carbocisteine, to aid sputum-removal as part of standard care. We hypothesise that mucoactive agents (HTS or cabocisteine, or a combination) are effective in reducing exacerbations over a 52-week period, compared to usual care. Methods: A 52-week, 2x2 factorial randomised open label trial to determine the clinical and cost-effectiveness of HTS 6% and carbocisteine for airway clearance versus usual care: CLEAR (clinical and cost-effectiveness of hypertonic saline (HTS 6%) and carbocisteine for airway clearance versus usual care). Patients will be randomised to either (i) Standard care and twice daily nebulised HTS (6%), (ii) Standard care and carbocisteine (750mg three times per day until visit 3 reducing to 750mg twice per day), (iii) Standard care and combination of twice-daily nebulised HTS and carbocisteine, or (iv) Standard care. The primary outcome is the mean number of exacerbations over 52 weeks. Key inclusion criteria: adults with a diagnosis of BE on computed tomography scans, BE as the primary respiratory diagnosis, two or more pulmonary exacerbations in the last year requiring antibiotics and production of daily sputum. Discussion: This trial’s pragmatic research design avoids the significant costs associated with double-blind trials whilst optimising rigor in other areas of trial-delivery. CLEAR will provide evidence as to whether HTS, carbocisteine or both are effective and cost-effective for BE patients. Trial registration: EudraCT Number: 2017-000664-14. (Date on which this record was first entered in the database 20/10/2017). ISRCTN89040295. (Date assigned 06/07/2018). Funder: National Institute for Health Research, Health Technology Assessment Programme (15/100/01). Sponsor: Belfast Health and Social Care Trust. Ethics Reference Number: 17/NE/0339. Protocol version: v3.0 Final_14052018. Keywords: Clinical trial protocol, factorial design, bronchiectasis, hypertonic saline, carbocisteine, exacerbation, SWAT.

scholarly journals COpenhagen Neuroplastic TRaining Against Contractures in Toddlers (CONTRACT): protocol of an open-label randomised clinical trial with blinded assessment for prevention of contractures in infants with high risk of cerebral palsy

BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044674
Author(s):  
Maria Willerslev-Olsen ◽  
Jakob Lorentzen ◽  
Katrine Røhder ◽  
Anina Ritterband-Rosenbaum ◽  
Mikkel Justiniano ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cerebral Palsy ◽  
High Risk ◽  
Standard Care ◽  
Muscle Growth ◽  
Randomised Clinical Trial ◽  
Triceps Surae ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Open Label

IntroductionContractures are frequent causes of reduced mobility in children with cerebral palsy (CP) already at the age of 2–3 years. Reduced muscle use and muscle growth have been suggested as key factors in the development of contractures, suggesting that effective early prevention may have to involve stimuli that can facilitate muscle growth before the age of 1 year. The present study protocol was developed to assess the effectiveness of an early multicomponent intervention, CONTRACT, involving family-oriented and supervised home-based training, diet and electrical muscle stimulation directed at facilitating muscle growth and thus reduce the risk of contractures in children at high risk of CP compared with standard care.Methods and analysisA two-group, parallel, open-label randomised clinical trial with blinded assessment (n=50) will be conducted. Infants diagnosed with CP or designated at high risk of CP based on abnormal neuroimaging or absent fidgety movement determined as part of General Movement Assessment, age 9–17 weeks corrected age (CA) will be recruited. A balanced 1:1 randomisation will be made by a computer. The intervention will last for 6 months aiming to support parents in providing daily individualised, goal-directed activities and primarily in lower legs that may stimulate their child to move more and increase muscle growth. Guidance and education of the parents regarding the nutritional benefits of docosahexaenic acid (DHA) and vitamin D for the developing brain and muscle growth will be provided. Infants will receive DHA drops as nutritional supplements and neuromuscular stimulation to facilitate muscle growth. The control group will receive standard care as offered by their local hospital or community. Outcome measures will be taken at 9, 12, 18, 24, 36 and 48 months CA. Primary and secondary outcome measure will be lower leg muscle volume and stiffness of the triceps surae musculotendinous unit together with infant motor profile, respectively.Ethics and disseminationFull approval from the local ethics committee, Danish Committee System on Health Research Ethics, Region H (H-19041562). Experimental procedures conform with the Declaration of Helsinki.Trial registration numberNCT04250454.Expected recruitment period1 January 2021–1 January 2025.

REGOMA: A Randomized, Multicenter, Controlled Open-Label Phase II Clinical Trial of Regorafenib Compared to Lomustine in Relapsed Glioblastoma Patients

2018 ◽  
Author(s):  
Giuseppe Lombardi ◽  
Gian Luca De Salvo ◽  
Alba Ariela Brandes ◽  
Marica Eoli ◽  
Roberta Rudà ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase Ii ◽  
Phase Ii Clinical Trial ◽  
Open Label ◽  
Open Label Phase
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