Benchmarking evaluation of five PHMB-based multi-purpose solutions and a silicone hydrogel contact lens

2020 ◽  
Vol 1 (1) ◽  
pp. 47-51
Author(s):  
Martin Ming-Leung Ma ◽  
◽  
Daniel Tilia ◽  
Varghese Thomas ◽  
◽  
...  
Keyword(s):  
Contact Lens ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Rating Scale ◽  
Clinical Performance ◽  
Numeric Rating Scale ◽  
Open Label ◽  
Silicone Hydrogel ◽  
Ocular Comfort ◽  
Corneal Staining

AIM: To evaluate and compare the clinical performance of 5 kinds of polyhexamethylene biguanide (PHMB) based multi-purpose solutions (MPS) manufactured in China when used with a commercially available silicone hydrogel contact lens in terms of solution-induced corneal staining (SICS), ocular response (corneal staining and ocular hyperemia), corneal infiltrative event (CIEs) and ocular comfort. METHODS: This was a prospective, open label, randomized, parallel group clinical trial. Totally 162 participants (Pxs) who were at least 18y were enrolled and randomized into 5 groups of PHMB-based MPS made in China: Complete® MPS, Hydron® Aqua-shining moist, Baoshining™, Weicon® Fresh, Weicon® 2000 MPS (abbreviated as C, H, B, W, and W2). All participants wore balafilcon A contact lenses with monthly disposal (Bausch & Lomb Purevision®) in conjunction with the designated MPS on a daily wear for 3mo. Clinical visits were at baseline, 2wk, 1mo and 3mo. SICS and CIE were reported as first event incidence per 100 Px-months. Ocular response was graded on 0-4 scale in 0.5 steps (0=none, 4=severe) and ocular comfort was assessed via a numeric rating scale (1-10 in 1-point steps, 1=poor, 10=excellent). Ocular comfort and ocular response variables were analysed using linear mixed model. CIE and SICS were analysed using Fisher’s exact test and logistic regression. RESULTS: There were 36 (22%) Pxs who dropped out. SICS incidence for each MPS were: H (26.3%), B (20.8%), W (19.4%), W2 (13.4%), C (12.8%). The SICS rate of H was significantly different to W2 (P=0.012) and C (P=0.005). There were no significant differences in ocular response, CIE incidence and ocular comfort between different MPSs (P>0.05). Pxs with SICS had significantly lower comfort during the day and at the end of than those who did not have SICS. CONCLUSION: Differences in SICS incidence are found between MPSs but not for CIE incidence, ocular response or ocular comfort. SICS in PHMB-based MPS is found to be associated with ocular discomfort. More MPS/lens combinations should be studied in the future.

scholarly journals Accuracy of BIS monitoring using a novel interface device connecting conventional needle-electrodes and BIS sensors during frontal neurosurgical procedures

PLoS ONE ◽  
2021 ◽  
Vol 16 (10) ◽  
pp. e0258647
Author(s):  
Hideki Harada ◽  
Seiya Muta ◽  
Tatsuyuki Kakuma ◽  
Misa Ukeda ◽  
So Ota ◽  
...  
Keyword(s):  
Mixed Model ◽  
Linear Mixed Model ◽  
Clinical Performance ◽  
Clinical Situation ◽  
Electrode Placement ◽  
Neurosurgical Procedures ◽  
Non Invasive ◽  
Invasive Method ◽  
Data Points ◽  
Interface Device

Background Bispectral index (BIS) monitoring is a widely used non-invasive method to monitor the depth of anesthesia. However, in the event of surgeries requiring a frontal approach, placement of the electrode may be impossible at the designated area to achieve a proper BIS measurement. Methods We developed an investigational interface device to connect needle-electrodes to BIS sensors. The safety and clinical performance were investigated in patients who underwent surgery. Direct BIS values from a disposable BIS electrode and indirect values via the interface device were simultaneously recorded from the same areas of electrode placement in a single patient. The agreement between the direct and indirect BIS values was statistically analyzed. Results The interface device with a silver electrode demonstrated sufficient electric conduction to transmit electroencephalogram signals. The overall BIS curves were similar to those of direct BIS monitoring. Direct and indirect BIS values from 18 patients were statistically analyzed using a linear mixed model and a significant concordance was confirmed (indirect BIS = 7.0405 + 0.8286 * direct BIS, p<0.0001). Most observed data (2582/2787 data points, 92.64%) had BIS unit differences of 10 or less. Conclusions The interface device provides an opportunity for intraoperative BIS monitoring of patients, whose clinical situation does not permit the placement of conventional adhesive sensors at the standard location.

scholarly journals Dose-dependent progression of parkinsonism in manganese-exposed welders

Neurology ◽  
2016 ◽  
Vol 88 (4) ◽  
pp. 344-351 ◽  
Author(s):  
Brad A. Racette ◽  
Susan Searles Nielsen ◽  
Susan R. Criswell ◽  
Lianne Sheppard ◽  
Noah Seixas ◽  
...  
Keyword(s):  
Facial Expression ◽  
Upper Limb ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Rating Scale ◽  
Welding Fume ◽  
Confined Space ◽  
Annual Change ◽  
Disease Rating ◽  
Dose Dependent

Objective:To determine whether the parkinsonian phenotype prevalent in welders is progressive, and whether progression is related to degree of exposure to manganese (Mn)-containing welding fume.Methods:This was a trade union–based longitudinal cohort study of 886 American welding-exposed workers with 1,492 examinations by a movement disorders specialist, including 398 workers with 606 follow-up examinations up to 9.9 years after baseline. We performed linear mixed model regression with cumulative Mn exposure as the independent variable and annual change in Unified Parkinson Disease Rating Scale motor subsection part 3 (UPDRS3) as the primary outcome, and subcategories of the UPDRS3 as secondary outcomes. The primary exposure metric was cumulative Mn exposure in mg Mn/m3-year estimated from detailed work histories.Results:Progression of parkinsonism increased with cumulative Mn exposure. Specifically, we observed an annual change in UPDRS3 of 0.24 (95% confidence interval 0.10–0.38) for each mg Mn/m3-year of exposure. Exposure was most strongly associated with progression of upper limb bradykinesia, upper and lower limb rigidity, and impairment of speech and facial expression. The association between welding exposure and progression appeared particularly marked in welders who did flux core arc welding in a confined space or workers whose baseline examination was within 5 years of first welding exposure.Conclusions:Exposure to Mn-containing welding fume may cause a dose-dependent progression of parkinsonism, especially upper limb bradykinesia, limb rigidity, and impairment of speech and facial expression.

scholarly journals Micronized Palmitoylethanolamide-Polydatin Reduces the Painful Symptomatology in Patients with Interstitial Cystitis/Bladder Pain Syndrome

2019 ◽  
Vol 2019 ◽  
pp. 1-6 ◽  
Author(s):  
M. Cervigni ◽  
L. Nasta ◽  
C. Schievano ◽  
N. Lampropoulou ◽  
E. Ostardo
Keyword(s):  
Interstitial Cystitis ◽  
Pelvic Pain ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Pain Syndrome ◽  
Bladder Pain Syndrome ◽  
Symptom Scale ◽  
Open Label ◽  
Bladder Pain ◽  
Over Time

Aims. To assess the efficacy of a micronized-palmitoylethanolamide-polydatin (m-PEA-Pol) based product on chronic pelvic pain and severity of other symptoms in interstitial cystitis/bladder pain syndrome (IC/BPS) patients refractory to conventional therapies. Methods. A pilot, open-label bicentric study was carried out involving 32 IC/BPS patients. Chronic, oral m-PEA-Pol treatment lasted 6 months. Bladder pain was evaluated using the visual analog scale, while changes from baseline in other urinary symptoms were evaluated by means of the O’Leary-Sant Interstitial Cystitis Symptom and Problem Index and the Pelvic Pain and Urgency/Frequency (PUF) symptom scale questionnaires. The generalized linear mixed model was used to evaluate significant mean changes across time. Results. A significant and progressive reduction of pain intensity was observed during m-PEA-Pol treatment (p<0.0001 for reduction over time). The effect was associated with a reduction in severity of patients’ symptoms evaluated with the O’Leary-Sant questionnaire (p=0.0110 and p=0.0014 for cystitis symptoms and problem mean scores, respectively) and the PUF scale (p=0.0163 and p=0.0005 for symptom and bother mean scores, respectively). m-PEA-Pol therapy elicited a significant reduction over time in the urinary frequency evaluated with voiding diary (p=0.0005) and a small but not significant improvement of bladder capacity. Conclusions. These data highlight the potential benefit of m-PEA-Pol in patients with rare pathology such as IC/BPS and confirm the good safety profile of micronized PEA-based products.

scholarly journals Performance of Three Multipurpose Disinfecting Solutions with a Silicone Hydrogel Contact Lens

2015 ◽  
Vol 2015 ◽  
pp. 1-13 ◽  
Author(s):  
Nery García-Porta ◽  
Laura Rico-del-Viejo ◽  
Helena Ferreira-Neves ◽  
Sofia C. Peixoto-de-Matos ◽  
Antonio Queirós ◽  
...  
Keyword(s):  
Contact Lens ◽  
Clinical Performance ◽  
The Other ◽  
Soft Contact ◽  
Silicone Hydrogel ◽  
Soft Contact Lens ◽  
Comfort Rating ◽  
Analogue Scales ◽  
Lens Wear

Purpose. To evaluate the clinical performance of a silicone hydrogel (Si-Hy) soft contact lens (CL) in combination with three different multipurpose disinfecting solutions (MPDSs).Methods. This was a prospective, randomized, single-masked, crossover, and comparative study in which 31 habitual soft CL wearers were randomly assigned to one of the three MPDSs (Synergi, COMPLETE RevitaLens, and OPTI-FREE PureMoist) for 1 month with a 1-week wash-out period between each exposure. All subjects were successfully refitted with a Si-Hy CL (Biofinity). Subjects were then scheduled for follow-up visits after 1 month of lens wear, being evaluated at 2 and 8 hours after lens insertion. Visual Analogue Scales (VAS) were used to gauge comfort rating.Results. The tarsal conjunctiva showed a significantly different degree of lid redness between the MPDSs at the 2-hour visit (P<0.05, Kruskal-Wallis test), being lower for COMPLETE RevitaLens compared to the other two MPDSs (Mann-WhitneyUtest). Furthermore, a significantly different degree of lid roughness at the 8-hour visit was seen (P<0.05, Kruskal-Wallis test), being higher for Synergi (Mann-WhitneyUtest). The subjective comfort was similar with the three MPDSs.Conclusion.Tarsal conjunctival response should be also considered in the context of the clinical performance of MPDs at the ocular surface.

Comparison of Ocular Comfort, Vision, and SICS During Silicone Hydrogel Contact Lens Daily Wear

2012 ◽  
Vol 38 (1) ◽  
pp. 2-6 ◽  
Author(s):  
Jennie Diec ◽  
Victoria E Evans ◽  
Daniel Tilia ◽  
Thomas Naduvilath ◽  
Brien A Holden ◽  
...  
Keyword(s):  
Contact Lens ◽  
Silicone Hydrogel ◽  
Ocular Comfort

scholarly journals Multimodal Balance Training Supported by Rhythmic Auditory Stimuli in Parkinson Disease: Effects in Freezers and Nonfreezers

2020 ◽  
Vol 100 (11) ◽  
pp. 2023-2034
Author(s):  
Tamine T C Capato ◽  
Nienke M de Vries ◽  
Joanna IntHout ◽  
Jordache Ramjith ◽  
Egberto R Barbosa ◽  
...  
Keyword(s):  
Parkinson Disease ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Rating Scale ◽  
Balance Training ◽  
Auditory Stimuli ◽  
Control Group ◽  
Multimodal Training ◽  
Regular Training

Abstract Objective To fulfill the potential of nonpharmacological interventions for people with Parkinson disease (PD), individually tailored treatment is needed. Multimodal balance training supported by rhythmic auditory stimuli (RAS) can improve balance and gait in people with PD. The purpose of this study was to determine whether both freezers and nonfreezers benefit. Methods A secondary analysis was conducted on a large randomized controlled trial that included 154 patients with PD (Hoehn & Yahr Stages 1–3 while ON-medication) who were assigned randomly to 3 groups: (1) multimodal balance training with RAS delivered by a metronome (RAS-supported multimodal balance training); (2) regular multimodal balance training without rhythmic auditory cues; and (3) a control intervention (involving an educational program). Training was performed for 5 weeks, twice per week. The primary outcome was the Mini-BESTest score directly after the training period. Assessments were performed by a single, masked assessor at baseline, directly postintervention, and after 1-month and 6-month follow-up. Outcomes were analyzed in 1 analysis, and the results were presented separately for freezers and nonfreezers with a linear mixed model, adjusted for baseline Mini-BESTest scores, Unified Parkinson’s Disease Rating Scale scores, and levodopa equivalent dose. Results In both freezers and nonfreezers, both RAS-supported multimodal training and regular training significantly improved the Mini-BESTest scores compared with baseline scores and with the control group scores. The improvement was larger for RAS-supported training compared with regular training, for both freezers and nonfreezers. Only the RAS-supported training group retained the improvements compared with baseline measurements at 6-month follow-up, and this was true for both freezers and nonfreezers. Conclusions RAS-supported multimodal training is effective in improving balance performance in both freezers and nonfreezers. Impact Until this study, it was unknown whether both freezers and nonfreezers could benefit from multimodal balance training. With this information, clinicians who work with people with PD will be better able to apply personalized gait rehabilitation. Lay Summary Adding rhythmic auditory stimuli (RAS) to balance training is beneficial for both freezers and nonfreezers, at least in persons with mild to moderate disease stages. This RAS-supported multimodal training has good potential for a wider clinical implementation with good long-term effects.

scholarly journals Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Jae Hyup Lee ◽  
Jin-Hyok Kim ◽  
Jin-Hwan Kim ◽  
Hak-Sun Kim ◽  
Woo-Kie Min ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Spinal Surgery ◽  
Rating Scale ◽  
Medication Compliance ◽  
Pain Reduction ◽  
Numeric Rating Scale ◽  
Persistent Pain ◽  
Efficacy And Safety ◽  
Open Label ◽  
Persistent Postoperative Pain

Purpose. Control of persistent pain following spinal surgery is an unmet clinical need. This study compared the efficacy and safety of buprenorphine transdermal system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with persistent, moderate pain following spinal surgery.Methods. Open-label, interventional, randomized multicenter study. Adults with persistent postoperative pain (Numeric Rating Scale [NRS] ≥ 4 at 14–90 days postsurgery) were enrolled. Patients received once-weekly BTDS (n=47; 5 μg/h titrated to 20 μg/h) or twice-daily TA (n=40; tramadol 37.5 mg/acetaminophen 325 mg, one tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, medication compliance, and adverse events (AEs) were assessed.Findings. At week 6, both groups reported significant pain reduction (mean NRS change: BTDS −2.02; TA −2.76, bothP<0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; TA 0.19, bothP<0.05). The BTDS group achieved better medication compliance (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug reactions (20.3% versus 16.9%) were comparable between groups.Implications. For patients with persistent pain following spinal surgery, BTDS is an alternative to TA for reducing pain and supports medication compliance. This trial is registered with Clinicaltrials.gov:NCT01983111.

TPExtreme randomized trial: Quality of Life (QoL) and survival according to second-line treatments in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6507-6507 ◽  
Author(s):  
Joel Guigay ◽  
Jerome Fayette ◽  
Ricard Mesia ◽  
Esma Saada-Bouzid ◽  
Cedrik Lafond ◽  
...  
Keyword(s):  
Health Status ◽  
Global Health ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Global Health Status ◽  
Open Label ◽  
Trial Quality ◽  
Significant Difference ◽  
Health Status Score

6507 Background: TPExtreme trial comparing EXTREME regimen to the taxane-based TPEx confirmed the encouraging survival results of the TPEx regimen, despite lack of significant overall survival (OS) increase, with a significantly lower toxicity than the EXTREME regimen. Herein, the QoL and exploratory analyses of survival according to 2nd line treatments focusing on immunotherapy (IO) are presented. Methods: Randomized (1:1), open-label trial. Main inclusion criteria were R/M HNSCC not suitable for loco-regional treatment, age 18-70 years, PS < 2, creatinin clearance > 60ml/min, prior cisplatin < 300 mg/m². 539 pts were enrolled over a period of 37 months (mo). QoL was evaluated with QLQ-C30 questionnaire at baseline, week(W)12, W18, W26 and analyzed by linear mixed model. The primary QoL endpoint was the Global Health Status score. 2nd line treatments were collected for 501 (93%) patients (pts), 256 in the EXTREME arm and 245 in the TPEx arm. Results: The percentage of QLQ-C30 questionnaires filled at baseline, W12, W18 and W26 were similar in the 2 arms, 89%, 52%, 43%, and 39% in the EXTREME arm and 91%, 59%, 40%, and 37% in the TPEx arm, respectively.. Higher scores of Global Health Status (p = 0.02), physical functioning (p = 0.009) and role functioning (p = 0.013) and lower scores of appetite loss (p = 0.041) were observed in the TPEx arm than in the EXTREME arm. No significant difference was observed for the other scores. In 2nd line treatment, 120 (47%) pts in the EXTREME arm and 109 (44%) in the TPEx arm received chemotherapy +/- cetuximab (CT); 41 (16%) pts in the EXTREME arm and 41 (17%) in the TPEx arm received IO, mainly anti-PD-1/PD-L1. 79% and 85% of these 2nd line treatments were given after progression in EXTREME and TPEx arms respectively. Median OS (95%CI) since randomization was 17.6 (15.2 – 19.5) mo with CT and 19.4 (13.4 – 22.3) mo with IO in the EXTREME arm vs 14.9 (13.0 – 16.3) and 21.9 (15.9 – 35.0) mo in the TPEx arm (interaction test p = 0.077) respectively. Median OS since start of 2nd line was 9.3 mo with CT and 8.3 mo with IO in the EXTREME arm, and 7.1 and 11.6 mo respectively in the TPEx arm. Conclusions: An improvement in the QoL of patients was observed in the TPEx arm compared to that of the EXTREME arm. Exploratory analysis showed that the taxane-based TPEx regimen followed by IO in 2nd line could provide interesting median OS for pts who need CT in 1st line, with less toxicity than EXTREME. This sequential treatment deserves to be compared to a strategy that starts with Platinum+5FU+pembrolizumab. Clinical trial information: NCT02268695 .

scholarly journals Efficacy and safety of rilonacept for recurrent pericarditis: results from a phase II clinical trial

Heart ◽  
2020 ◽  
pp. heartjnl-2020-317928 ◽  
Author(s):  
Allan L Klein ◽  
David Lin ◽  
Paul C Cremer ◽  
Saifullah Nasir ◽  
Sushil Allen Luis ◽  
...  
Keyword(s):  
Phase Ii ◽  
Rating Scale ◽  
Interleukin 1 ◽  
Numeric Rating Scale ◽  
Efficacy And Safety ◽  
Recurrent Pericarditis ◽  
Open Label ◽  
Related Quality ◽  
Background Therapy ◽  
Registration Number

ObjectiveRecurrent pericarditis (RP) incurs significant morbidity. Rilonacept inhibits both interleukin-1 alpha (IL-1α) and IL-1β; these cytokines are thought to play a major role in RP. This phase II study evaluated rilonacept efficacy and safety in RP.MethodsThis multicentre, open-label study enrolled adult patients with idiopathic or postpericardiotomy RP, symptomatic (≥2 pericarditis recurrences) or corticosteroid (CS) dependent (≥2 recurrences prior).Patients received rilonacept 320 mg SC load/160 mg SC weekly maintenance in a 6-week base treatment period (TP) followed by an optional 18-week on-treatment extension period (EP) (option to wean background therapy).ResultsOutcomes: pericarditis pain (numeric rating scale (NRS)) and inflammation (C reactive protein (CRP)) for symptomatic patients; disease activity after CS taper for CS-dependent patients. Secondary outcomes: health-related quality of life (HRQOL), pericarditis manifestations and additional medications. 25 unique patients enrolled, while 23 completed the EP (seven colchicine failures and five CS failures). In symptomatic patients, NRS and CRP decreased; response was observed after first rilonacept dose. NRS decreased from 4.5 at baseline to 0.7, and CRP decreased from 4.62 mg/dL at baseline to 0.38 mg/dL at end of TP. Median time to CRP normalisation: 9 days. Pericarditis manifestations resolved. 13 patients on CS at baseline completed the EP; 11 (84.6%) discontinued CS, and 2 tapered; CRP and NRS remained low without recurrence. Mean HRQOL scores improved in symptomatic patients. One serious adverse event (SAE) resulted in discontinuation of rilonacept.ConclusionsRilonacept led to rapid and sustained improvement in pain, inflammation (CRP and pericarditis manifestations) and HRQOL. CSs were successfully tapered or discontinued; safety was consistent with known rilonacept safety profile.Trial registration numberNCT03980522.

scholarly journals PREST: Pain REduction with bone metastases STereotactic radiotherapy: A phase III randomized multicentric trial

2019 ◽  
Author(s):  
Francesco Cellini ◽  
Stefania Manfrida ◽  
Francesco Deodato ◽  
Savino Cilla ◽  
Ernesto Maranzano ◽  
...  
Keyword(s):  
Bone Metastases ◽  
Rating Scale ◽  
Prognostic Score ◽  
Progression Free Survival ◽  
Pain Reduction ◽  
Numeric Rating Scale ◽  
Phase Iii ◽  
Open Label ◽  
Free Survival ◽  
Numeric Rating

Abstract Background Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBRT) were largely investigated in several phase 2 studies with good symptom response, becoming widely adopted. Still is lacking evidence from randomized, direct comparison of RT and SBRT. Methods/Design The PREST trial was designed as an interventional study without medicinal, randomized 1:1, open-label, multicentric, phase 3. Inclusion criteria: painful spinal bone metastases presenting pain level >4 (or >1 if assuming analgesic) at numeric rating scale (NRS); expected intermediate/high prognosis (superior to 6 months) according to the Mizumoto prognostic score; low spine instability neoplastic score (SINS) sores (<7); magnetic resonance imaging (MRI) assessment of the bulky lesion. Patients will be assigned to either standard conventional radiotherapy administering 4 Gy x5 fractions (fx) to whole involved vertebra or SBRT by intensity modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) administering 7 Gy x3 fx (to the whole involved vertebra) + 10 Gy x3 fx on the macroscopic disease (Gross Tumor Volume -GTV). In the experimental arm, the GTV will be contoured by registration with baseline MRI. Discussion Primary endpoint is overall pain reduction, defined in term of variation between baseline and 1-month evaluation; pain will be measured by Numeric Rating Scale (NRS) score. Secondary endpoints include: pain control duration; retreatment rates (after a minimum interval of 1 month); local control assessed with RECIST Criteria; symptom progression free survival; progression free survival; overall survival and quality of life (at 0, 30 and 90 days). Accrual of 330 lesions is planned. Experimental arm is expected to improve overall pain response rates of 15% respect to standard arm (60% according to Chow et al 2012).

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