AN OPEN LABEL SINGLE CENTRE PILOT STUDY TO CORRELATE THE PRETRANSPLANT C 2 BLOOD LEVEL (2HR POST SINGLE DOSE) OF TACROLIMUS AS A PREDICTOR OF POST TRANSPLANT TACROLIMUS DOSE IN DENOVO RENAL TRANSPLANTATION PATIENTS

2008 ◽  
Vol 86 (Supplement) ◽  
pp. 330
Author(s):  
A Sharma ◽  
M Minz ◽  
V Shetty
Keyword(s):  
Single Dose ◽  
Renal Transplantation ◽  
Pilot Study ◽  
Blood Level ◽  
Single Centre ◽  
Open Label ◽  
Post Transplant ◽  
Tacrolimus Dose

scholarly journals Prevention of Acute Radiation-Induced Skin Reaction with NPE® Camellia Sinensis Nonfermentatum Extract in Female Breast Cancer Patients Undergoing Postoperative Radiotherapy: A Single Centre, Prospective, Open-Label Pilot Study

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Gabriela Näf ◽  
Urs E. Gasser ◽  
Hans E. Holzgang ◽  
Sandra Schafroth ◽  
Christoph Oehler ◽  
...  
Keyword(s):  
Pilot Study ◽  
Skin Reaction ◽  
Camellia Sinensis ◽  
Acute Radiation ◽  
Control Group ◽  
Data Sets ◽  
Single Centre ◽  
Open Label ◽  
Whole Breast Radiotherapy ◽  
Radiation Induced

Background. To assess effectiveness of NPE, a proprietary Camellia sinensis nonfermentatum (CSNF) extract, in prevention and recovery of acute radiation-induced skin reaction (ARSR) and skin care during postoperative whole breast radiotherapy (RT). Methods. Twenty patients were enrolled in this single centre, prospective, open-label pilot study. The outcomes of 20 prospective data sets were compared with 100 retrospectively collected matched data sets derived from hospital records. The preventive CSNF gel (2.5%) was administered 1 to 2 hours before each session on the irradiated fields. The care CSNF lotion (0.4%) was administered as 7-day pretreatment after each RT session, twice daily between RT sessions, and 4 to 8 weeks thereafter. The control group was treated according to the hospital care guidelines. The primary endpoint was time to ARSR ≥ Grade 2 (CTCAE v4.03); secondary endpoints were frequencies of ARSR grades 1, 2, 3, and 4, recovery of ARSR, frequencies of interruption and RT stop, complications and required rescue interventions, and tolerability of CSNF. Results. Time to ARSR ≥ G2 (censoring) was significantly longer (p = 0.014) in the CSNF group. The hazard ratio was 2.33 (95% CI: 1.15–4.72), demonstrating a 50% decrease in the risk of developing ARSR ≥ G2. There was a trend to faster recovery from ARSR G2 in the CSNF group (100% versus 47%; p = 0.078). The proportion of patients requiring rescue treatment during RT and follow-up was markedly higher in the control compared to the CSNF group (1% to 51% versus 0% to 15%). CSNF gel and lotion were well tolerated both during and after RT. Conclusions. This pilot study provides the first evidence on the potential pharmacological effectiveness of CSNF extract in prevention of RT-induced ARSR and recovery of skin irritation in patients undergoing postoperative whole breast RT and may reflect a novel concept for prevention of RT-induced ARSR and care of irritated skin.

Pharmacokinetics and Tolerability of Nasal Versus Intravenous Midazolam in Healthy Dutch Volunteers: A Single-Dose, Randomized-Sequence, Open-Label, 2-Period Crossover Pilot Study

2011 ◽  
Vol 33 (12) ◽  
pp. 2022-2028 ◽  
Author(s):  
Nicole M.L. Veldhorst-Janssen ◽  
Audrey A.A. Fiddelers ◽  
Paul-Hugo M. van der Kuy ◽  
H. Maurice S. Theunissen ◽  
Marc C.T.F.M. de Krom ◽  
...  
Keyword(s):  
Single Dose ◽  
Pilot Study ◽  
Open Label

scholarly journals FLUID study: study protocol for an open-label, single-centre pilot study to investigate the efFect of Lemborexant on sleep management in Japanese sUbjects aged 50 years and older with Insomnia Disorder

BMJ Open ◽  
2021 ◽  
Vol 11 (11) ◽  
pp. e054885
Author(s):  
Ippei Okada ◽  
Kunihiro Iwamoto ◽  
Seiko Miyata ◽  
Akihiro Fujimoto ◽  
Masaki Tanaka ◽  
...  
Keyword(s):  
Pilot Study ◽  
Sleep Quality ◽  
Sleep Disturbance ◽  
Study Protocol ◽  
Single Centre ◽  
Open Label ◽  
Glymphatic System ◽  
Insomnia Disorder ◽  
Sleep Parameters ◽  
The Alps

IntroductionBidirectional associations have been reported between sleep disturbance and both cognitive impairment, including Alzheimer’s disease and amyloid beta-peptide (Aβ) accumulation. These relationships can be explained by the glymphatic system, which acts as a garbage drainage system in the brain. As interstitial fluid dynamics are suggested to increase during sleep, clearance of Aβ can be influenced by sleep disturbance or deprivation. We hypothesised that using lemborexant, an orexin receptor antagonist, to improve sleep quality would also improve the function of the glymphatic system. We plan to examine the effect of lemborexant on sleep quality and the glymphatic system among patients with insomnia disorder.Methods and analysisThis pilot study is designed as an open-label, single-arm, single-centre trial. Thirty patients aged 50 years and over with insomnia will be recruited. The participants will take lemborexant (5 mg) at bedtime for 12 weeks and undergo a home-based sleep study at baseline and weeks 4 and 12, as well as MRI examinations to evaluate the glymphatic system at baseline and week 12. The primary outcome will be changes in objective sleep parameters as evaluated using a sleep monitoring system. The secondary outcomes will be changes in subjective sleep parameters. The relationships between changes in sleep parameters and the glymphatic system will be evaluated using diffusion tensor image analysis along the perivascular space, which is called the ALPS-index. Sleep parameters and the ALPS-index will be analysed using a paired t-test or Pearson’s correlation coefficient.Ethics and disseminationThe study protocol was approved by Nagoya University Certified Review Board. The findings from this research will be published in peer-reviewed journals and be presented at local, national and international conferences.Trial registration numberjRCTs041210024.

scholarly journals Is the pretransplant C2 an optimum predictor of posttransplant dose for tacrolimus in renal transplantation patients?

2019 ◽  
Vol 4 (1) ◽  
pp. IPK03
Author(s):  
Smita Pattanaik ◽  
Ashish Sharma ◽  
Praveen Kumar-M ◽  
Sarbpreet Singh ◽  
Vikram Shetty ◽  
...  
Keyword(s):  
Single Dose ◽  
Renal Transplantation ◽  
Trough Concentration ◽  
Tacrolimus Concentration ◽  
Spearman Correlation ◽  
Dose Requirement ◽  
Post Transplantation ◽  
Dose Administration ◽  
Post Transplant ◽  
The Mean

Aim: The study evaluated whether a single dose pretransplant 2-h tacrolimus concentration (C2) could predict the post-transplantation trough concentration (C0). Materials & methods: C2 concentration of tacrolimus was measured after single-dose administration (0.1 mg/kg) in 20 patients, 4–7 days prior to renal transplantation. Tacrolimus C0 monitoring was done on post-transplant day 2, 5, 10, 15 and 30. Results: The mean C2 was 21.79 ± 16.83 ng/ml (4.25–69.46) and the mean C0 obtained 48 h after transplant was 10.2 ± 6.27 (1.63–22.07) ng/ml. The Spearman correlation between C2 and C0 was 0.71 (p < 0.01). Conclusion: Pretransplant C2 could explain only 50% of the total variation in the post-transplant dose requirement hence it may not be sole predictor of the post-transplant dose.

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