scholarly journals An Investigation Comparing the Efficacy of Topical Ocular Application of Tacrolimus and Cyclosporine in Dogs

2011 ◽  
Vol 2011 ◽  
pp. 1-5 ◽  
Author(s):  
Diane V .H. Hendrix ◽  
Elizabeth A. Adkins ◽  
Daniel A. Ward ◽  
Jamie Stuffle ◽  
Brian Skorobohach
Keyword(s):  
Keratoconjunctivitis Sicca ◽  
Phase 1 ◽  
Phase 2 ◽  
Efficacy And Safety ◽  
Two Phase ◽  
Topical Tacrolimus ◽  
Randomized Controlled ◽  
Schirmer Tear Test ◽  
Significant Difference ◽  
Trial Phase

The purpose of this paper was to determine the efficacy and safety of topical tacrolimus, compared to cyclosporine, for treating keratoconjunctivitis sicca (KCS) in dogs. This study was a two-phase, randomized, controlled, masked clinical trial. Phase 1 evaluated ophthalmic 0.03% tacrolimus in normal dogs. Ocular examinations were performed daily. Phase 2 evaluated the efficacy of tacrolimus in treating KCS. Half the dogs received 2% cyclosporine A; the others received 0.03% tacrolimus, both diluted in olive oil. Four ophthalmic examinations were done over 12 weeks. There was no significant difference between groups in phase I. In phase 2, there was no significant difference in Schirmer tear test I (STT) results between the two groups, and both groups had a significant increase in STT over time. Both drugs were effective in increasing the STT in dogs naïve to lacrimostimulants. Tacrolimus was effective in increasing the STT in 4 dogs currently nonresponsive to cyclosporine.

Effects of Aerosolized Dexamethasone on Acute Subglottic Injury

1992 ◽  
Vol 101 (1) ◽  
pp. 95-99 ◽  
Author(s):  
Thomas C. Kryzer ◽  
Carlos Gonzalez ◽  
Lawrence P. A. Burgess
Keyword(s):  
Phase 1 ◽  
Control Group ◽  
Phase 2 ◽  
Histomorphometric Analysis ◽  
Untreated Control Group ◽  
Phase 1 Study ◽  
Two Phase ◽  
Phase Study ◽  
Significant Difference ◽  
Made In

Aerosolized dexamethasone was used in a two-phase study to determine the possible effects on acute subglottic injury in the ferret animal model. In phase 1, equivalent subglottic injuries were made in 10 animals by using the brush technique, and the animals were divided into two groups. The treatment group received aerosolized dexamethasone at 2, 4, and 6 hours postinjury. All animals were examined 2, 4, 6, and 24 hours after the injury. The clinical condition of each animal was evaluated and their airways were measured. The animals were then painlessly killed and the larynges were frozen, sectioned, and photographed at 1-mm intervals. A computer-linked digitizer pad was used to measure the subglottic dimensions. The results show a trend for the treated animals to have a larger subglottic airway as compared to the untreated (control) group. The phase 1 study suggests that there may be an improvement in the subglottic airway when treated acutely with aerosolized dexamethasone. In phase 2, 20 additional animals were studied by using the same methods of injury and treatment as in phase 1. The subglottic airways of these animals were evaluated with histomorphometric analysis on fixed histologic sections. A statistically significant difference was found between the subglottic airways of the treated and untreated animals favoring treatment with aerosolized dexamethasone. Aerosolized dexamethasone appears to be beneficial in preserving the subglottic airway after injury, possibly secondary to decreasing the edema associated with injury.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

scholarly journals A phase 1 and randomized controlled phase 2 trial of the safety and efficacy of the combination of gemcitabine and docetaxel with ontuxizumab (MORAb‐004) in metastatic soft‐tissue sarcomas

Cancer ◽  
2019 ◽  
Vol 125 (14) ◽  
pp. 2445-2454 ◽  
Author(s):  
Robin L. Jones ◽  
Sant P. Chawla ◽  
Steven Attia ◽  
Patrick Schöffski ◽  
Hans Gelderblom ◽  
...  
Keyword(s):  
Soft Tissue ◽  
Phase 1 ◽  
Soft Tissue Sarcomas ◽  
Phase 2 ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Phase 2 Trial

Endometrial Adenocarcinoma in SurePath™ Cervical Samples: Cytological Features Revisited

2016 ◽  
Vol 60 (1) ◽  
pp. 46-52 ◽  
Author(s):  
Nalini Gupta ◽  
John Crossley ◽  
Nick Dudding ◽  
John H.F. Smith
Keyword(s):  
Phase 1 ◽  
Endometrial Adenocarcinoma ◽  
Nuclear Chromatin ◽  
Phase 2 ◽  
Cervical Lesions ◽  
Two Phase ◽  
Endometrial Cells ◽  
Phase Study ◽  
Cytological Features ◽  
Liquid Based Cytology

Objective: The cytomorphological criteria of malignant endometrial lesions in cervical samples are less well described than those of cervical lesions. We wished to investigate if there were features in SurePath™ liquid-based cytology samples that would facilitate more accurate differentiation between benign and malignant endometrial cells. Study Design: This was a two-phase study, with a review of all SurePath™ samples reported as endometrial adenocarcinoma (n = 42) evaluating 12 cytological features in the first phase. In phase 2 (test set), all initial cases plus an additional 83 cases were reviewed using these 12 cytological features to predict the outcome. Results: Out of 12 cytological features evaluated in phase 1 (training set), nuclear chromatin pattern, apoptotic bodies and tingible body macrophages were found to be the most significant features determining malignant histological outcome. These 12 cytological features were re-evaluated in phase 2 (n = 125). Of 125 cases, 54 had a benign and 71 had a malignant or premalignant histological outcome, with a positive predictive value of 56.8%. Conclusion: Granular nuclear chromatin, tingible body macrophages and apoptosis in the background are the most significant factors in determining whether endometrial cells present in cervical samples represent malignancy or are benign. Using these features, relatively accurate predictions of endometrial pathology can be made.

scholarly journals A Randomized Controlled Two-Stage Trial in the Treatment of Bulimia Nervosa, Comparing CBT Versus Motivational Enhancement in Phase 1 Followed by Group Versus Individual CBT in Phase 2

2010 ◽  
Vol 72 (7) ◽  
pp. 656-663 ◽  
Author(s):  
Melanie A. Katzman ◽  
Nuria Bara-Carril ◽  
Sophia Rabe-Hesketh ◽  
Ulrike Schmidt ◽  
Nicholas Troop ◽  
...  
Keyword(s):  
Bulimia Nervosa ◽  
Phase 1 ◽  
Group Versus ◽  
Phase 2 ◽  
Two Stage ◽  
Motivational Enhancement ◽  
Randomized Controlled

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Developing a realist theory of psychosocial rehabilitation: the Clubhouse model

2021 ◽  
Author(s):  
Christina Mutschler ◽  
Jen Rouse ◽  
Kelly McShane ◽  
Criss Habal-Brosek
Keyword(s):  
Phase 1 ◽  
Psychosocial Rehabilitation ◽  
Theory Development ◽  
Realist Evaluation ◽  
Self Determination ◽  
Phase 2 ◽  
Two Phase ◽  
Realist Theory ◽  
Clubhouse Model ◽  
Two Phases

Background Psychosocial rehabilitation is a service that supports recovery from mental illness by providing opportunities for skill development, self-determination, and social interaction. One type of psychosocial rehabilitation is the Clubhouse model. The purpose of the current project was to create, test, and refine a realist theory of psychosocial rehabilitation at Progress Place, an accredited Clubhouse. Method Realist evaluation is a theory driven evaluation that uncovers contexts, mechanisms, and outcomes, in order to develop a theory as to how a program works. The current study involved two phases, encompassing four steps: Phase 1 included (1) initial theory development and (2) initial theory refinement; and Phase 2 included (3) theory testing and (4) refinement. Results The data from this two-phase approach identified three demi-regularities of recovery comprised of specific mechanisms and outcomes: the Restorative demi-regularity, the Reaffirming demi-regularity, and the Re-engaging demi-regularity. The theory derived from these demi-regularities suggests that there are various mechanisms that produce outcomes of recovery from the psychosocial rehabilitation perspective, and as such, it is necessary that programs promote a multifaceted, holistic perspective on recovery. Conclusions The realist evaluation identified that Progress Place promotes recovery for members. Additional research on the Clubhouse model should be conducted to further validate that the model initiates change and promotes recovery outcomes.

scholarly journals Methylene Blue for Treatment of Hospitalized COVID-19 Patients: A Randomized, Controlled, Open-Label Clinical Trial, Phase 2

2021 ◽  
Vol 73 (3) ◽  
Author(s):  
Daryoush Hamidi-Alamdari ◽  
Saied Hafizi-Lotfabadi ◽  
Ahmad Bagheri-Moghaddam ◽  
Hossin Safari ◽  
Mahnaz Mozdourian ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Methylene Blue ◽  
Phase 2 ◽  
Open Label ◽  
Randomized Controlled ◽  
Trial Phase

The Efficacy and Safety of Coenzyme Q10 in Preventing the Progression of Early Parkinson’s Disease: A Meta-Analysis

2017 ◽  
Vol 51 (2) ◽  
Author(s):  
Ranhel C. De Roxas ◽  
Roland Dominic G. Jamora
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Coenzyme Q10 ◽  
Meta Analysis ◽  
P Value ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Early Parkinson’S Disease

Introduction. Coenzyme Q10, also known as Ubiquinone, is a substance now being used as a dietary supplement in many countries including the Philippines. It has also been the focus of several researches as treatment for several diseases including Parkinson’s Disease. Several studies have shown that Coenzyme Q10 inhibits mitochondrial dysfunction in Parkinson’s Disease, hence delaying its progression. Objectives. The objective of this study is to assess and summarize the available evidence on the efficacy and safety of Coenzyme Q10 administration in the prevention of the progression of early Parkinson’s Disease. Methods. This is meta-analysis of randomized controlled trials on the use of Coenzyme Q10 in Parkinson’s Disease. A literature search in several databases was conducted for relevant studies. Three randomized controlled trials met the inclusion criteria. The efficacy of Coenzyme Q10 were measured using the total and the component scores of the Unified Parkinson Disease Rating Scale on follow-up. On the other hand, safety were measured using the withdrawal rate and the associated adverse reactions during the therapy of CoQ10. The Review Manager Software was utilized for the meta-analysis. Results. Compared to Placebo, treatment of CoQ10 did not show any significant difference in the mean scores of the UPDRS mental and ADL scores. Interestingly, the UPDRS motor score showed a significant difference between Coenzyme Q10 and placebo, but no significant difference when a subgroup analysis between high-dose (-4.03 [-15.07-7.01], p-value 0.47, I2 67%, P for heterogeneity 0.08) and low-dose Coenzyme Q10 (0.53 [-0.891.94], p-value 0.47, I2 34%, P for heterogeneity 0.22) was done. Overall, there was no significant difference in the total UPDRS score (0.68 [-0.61-1.97], p-value 0.30, I2 0%, P for heterogeneity 0.70). The most common side effects of the use of Coenzyme Q10 are anxiety, back pain, headache, sore throat, nausea, dizziness and constipation. Conclusion. Contrary to some animal and human studies, this meta-analysis showed that the use of CoQ10 results to nonsignificant improvement in all components of the UPDRS scores as opposed to placebo. However, the use of CoQ10 is tolerated and seems to be safe but further studies are needed to validate this finding.

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