scholarly journals Acoustic Coordinated Reset Neuromodulation in a Real Life Patient Population with Chronic Tonal Tinnitus

2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Christian Hauptmann ◽  
Armin Ströbel ◽  
Mark Williams ◽  
Nitesh Patel ◽  
Hannes Wurzer ◽  
...  
Keyword(s):  
Real Life ◽  
Negative Influence ◽  
Tinnitus Questionnaire ◽  
Open Label ◽  
Safety And Efficacy ◽  
Life Conditions ◽  
Real Life Setting ◽  
Clinically Significant ◽  
Coordinated Reset

Purpose. Primary tinnitus has a severe negative influence on the quality of life of a significant portion of the general population. Acoustic coordinated reset neuromodulation is designed to induce a long-lasting reduction of tinnitus symptoms. To test acoustic coordinated reset neuromodulation as a treatment for chronic, tonal tinnitus under real life conditions, an outpatient study “RESET Real Life” was commissioned by ANM GmbH. Herein we present the results of this study.Methods. In a prospective, open-label, nonrandomized, noncontrolled multicenter clinical study with 200 chronic tinnitus patients, tinnitus questionnaire TBF-12 and Global Clinical Improvement-Impression Scale (CGI-I7) are used to study the safety and efficacy of acoustic coordinated reset neuromodulation. 189 patients completed the last 12-month visit, 11 patients dropped out (8 because of nontreatment related reasons; 2 because tinnitus did not change; and 1 because tinnitus got louder).Results. Acoustic coordinated reset neuromodulation caused a statistically and clinically significant decrease in TBF-12 scores as well as in CGI-I7 after 12 months of therapy under real life conditions. There were no persistent adverse events reported that were related to the therapy.Conclusion. The field study “RESET Real Life” provides evidence for safety and efficacy of acoustic coordinated reset neuromodulation in a prospective, open-label, real life setting.

Ziv-aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Interim safety data from the global aflibercept safety and quality-of-life program in pts pretreated with bevacizumab (B).

2014 ◽  
Vol 32 (3_suppl) ◽  
pp. 556-556 ◽  
Author(s):  
David Raymond Ferry ◽  
Alberto F. Sobrero ◽  
Roberto Bordonaro ◽  
Salvatore Siena ◽  
Filippo Pietrantonio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Safety Data ◽  
Real Life ◽  
The United States ◽  
Open Label ◽  
Real Life Setting ◽  
Safety Population ◽  
Previously Treated ◽  
Initial Starting

556 Background: In the VELOUR study, adding Z (known as aflibercept outside the United States) to FOLFIRI resulted in improved OS, PFS, and RR in mCRC pts who had received prior oxaliplatin. Prior treatment with B (~30% of the ITT population) did not appear to impact the safety profile of Z. Results from VELOUR supported initiation of the global Aflibercept Safety and Quality-of-Life (QoL) Program composed of two clinical studies (ASQoP [NCT01571284]; AFEQT [NCT01670721]) to capture QoL and safety data from a population similar to that of VELOUR in a real-life setting. We report early safety data from this interim analysis in pts pretreated with B. Methods: ASQoP and AFEQT are single-arm, open-label trials evaluating safety and QoL of Z in mCRC pts previously treated with an oxaliplatin-containing regimen. Eligible pts receive Z (4 mg/kg) q2wks on day 1 of each cycle followed by FOLFIRI until disease progression, unacceptable toxicity, death, or investigator/pt decision. Initial starting doses and subsequent modifications are at treating physicians’ discretion. The percentage of pts with grade (G) 3/4 adverse events (AEs) in the combined safety population of ASQoP and AFEQT in B-pretreated pts is compared with that of B-pretreated pts in VELOUR. Results: At data cut-off, the safety population comprised 116 pts with ≥1 completed treatment cycle; 67 (57.8%) were pretreated with B. At least 1 G3/4 AE was experienced by 49.3% of pts vs 82.5% in VELOUR. Most G3/4 AEs were G3. There were no reports of G4 hypertension or proteinuria. Conclusions: Thisinterim safety analysis from ASQoP/AFEQT in pts pretreated with B has identified no new safety signals for Z and a trend toward decreased incidence of G3/4 events. The early analysis provides additional safety data and suggests an acceptable toxicity profile in this real-life setting. Clinical trial information: NCT01571284. [Table: see text]

Aflibercept (Z) in combination with FOLFIRI for second-line treatment of patients (pts) with metastatic colorectal cancer (mCRC): Safety and quality of life (QoL) data from the Spanish subgroup of the Aflibercept Safety and Quality-of-Life Program (ASQoP).

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 751-751
Author(s):  
Fernando Rivera ◽  
Eduardo Polo Marques ◽  
Enrique Aranda ◽  
Carlos Fernandez-Martos ◽  
Adelaida La Casta Munoa ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Real Life ◽  
Open Label ◽  
Utility Index ◽  
Real Life Setting ◽  
Safety Population ◽  
Eortc Qlq C30 ◽  
Report Data ◽  
Eortc Qlq

751 Background: In the VELOUR trial, adding Z to FOLFIRI improves OS, PFS and RR in mCRC pts progressing after oxaliplatin ±biologic agents. The ASQoP trial (NCT01571284) was designed to gather safety and QoL data from mCRC in real-life setting. We report data collected by the Spanish investigators. Methods: ASQoP is single-arm, open-label trial evaluating safety and QoL of Z in mCRC pts as 2nd line. Eligible pts received Z (4mg/kg) q2wks on day 1/cycle, followed by FOLFIRI (dosing was at physician’s discretion) until disease progression, unacceptable toxicity, death, or investigator/pt decision. The EQ-5D was used for utility index (UI) measure and the EORTC QLQ-C30 as generic cancer instrument. QoL population consisted of pts completing the questionnaire at baseline and ≥1 assessment post-baseline and received ≥1 part of 1 dose of study treatment. Results: The safety population comprised 77 pts with ≥1 completed cycle of treatment. Grade (G)3/4 AEs were reported in 72.7% of pts (vs 83.5% in VELOUR), being G3 most commonly reported. There was no G4 hypertension, stomatitis, or proteinuria. G4 Diarrhea was found in 1.3% of pts. Mean baseline UI was 0.7 (95% CI, 0.63-0.78) in 51 pts, and remained relatively stable at cycles 3 (n=39) and 7 (n=24), with a mean (±SD) change from baseline of 0.03 (±0.26) and -0.06 (±0.35), respectively. Mean baseline global health status score was 63.1 (95% CI, 55.8-70.4) in 54 pts, and remained stable up to cycle 9 with a mean (±SD) change from baseline of 4.17 (±38). Conclusions: Thisanalysis has identified no new safety signals and suggests an acceptable toxicity profile with a relatively stable UI and QoL in Spanish mCRC pts in the real-life setting. [Table: see text]

scholarly journals Technical Feasibility of Acoustic Coordinated Reset Therapy for Tinnitus Delivered via Hearing Aids: A Case Study

2017 ◽  
Vol 2017 ◽  
pp. 1-6
Author(s):  
Christian Hauptmann ◽  
Mark Williams ◽  
Federica Vinciati ◽  
Markus Haller
Keyword(s):  
Hearing Aids ◽  
Hearing Aid ◽  
Treatment Protocol ◽  
Negative Influence ◽  
Sound Therapy ◽  
First Case ◽  
Clinically Significant ◽  
Coordinated Reset

Primary tinnitus has a severe negative influence on the quality of life of a substantial portion of the general population. When acoustic coordinated reset (CR) neuromodulation stimuli are delivered for several hours per day over several weeks a clinically significant symptom reduction in patients with primary tonal tinnitus has been reported by several clinical sites. Here, we reported the first case where CR neuromodulation was delivered through a hearing aid. A 52-year-old man with chronic primary tonal tinnitus was previously considered untreatable with sound therapy. He initially received the classic CR treatment protocol with signals delivered with the separate proprietary device with his hearing aids removed during treatment. He was subsequently treated with the therapy being deployed through a set of contemporary hearing aids. After 5 months of classic CR treatment with the separate custom device, the THI and VASL/Ascores worsened by 57% and 13%/14%, respectively. Using the hearing aid without CR treatment for 5 months no change in tinnitus symptoms was observed. However, after three months of CR treatment delivered through the hearing aids, the THI and VASL/Ascores were reduced by 70% and 32%/32%, respectively.

Open-Label Study of the Stability of Sublingual Nitroglycerin Tablets in Simulated Real-Life Conditions

2018 ◽  
Vol 122 (12) ◽  
pp. 2151-2156 ◽  
Author(s):  
James J. Nawarskas ◽  
Jason Koury ◽  
David A. Lauber ◽  
Linda A. Felton
Keyword(s):  
Real Life ◽  
Sublingual Nitroglycerin ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Life Conditions ◽  
The Stability

scholarly journals Experience of patisiran with transthyretin stabilizers in patients with hereditary transthyretin-mediated amyloidosis

2020 ◽  
Vol 10 (5) ◽  
pp. 289-300 ◽  
Author(s):  
Hollis Lin ◽  
Madeline Merkel ◽  
Cecilia Hale ◽  
Jing L Marantz
Keyword(s):  
Quality Of Life ◽  
Diabetic Neuropathy ◽  
Phase Ii ◽  
Phase Iii ◽  
Open Label ◽  
Safety And Efficacy ◽  
Impairment Score ◽  
Open Label Extension ◽  
Post Hoc

Aim: Examine safety and pharmacodynamics of patisiran alone or with concomitant transthyretin stabilizers from the Phase II open-label extension study and safety and efficacy of patisiran in patients with prior transthyretin stabilizer use from the Phase III APOLLO study. Patients & methods: Post hoc analyses in patients with hereditary transthyretin-mediated amyloidosis with polyneuropathy. Results: Patisiran safety was consistent regardless of concomitant or prior transthyretin stabilizers. In the Phase II open-label extension (n = 27), transthyretin reduction was similar over 24 months, regardless of concomitant transthyretin stabilizers. In APOLLO (n = 225), patisiran-treated groups showed stabilization or improvements in neurological function (modified Neuropathy Impairment Score +7) and quality of life (Norfolk Quality of Life-Diabetic Neuropathy questionnaire) at 18 months, regardless of prior transthyretin stabilizers. Conclusion: Patients benefit from patisiran regardless of transthyretin stabilizer use.

Effectiveness and Safety of Rizatriptan Benzoate 10 mg in the Treatment of Migraine Headaches

2010 ◽  
Vol 2 ◽  
pp. CMT.S4670
Author(s):  
Michel Aubé ◽  
Fridon Chouha ◽  
Julie Vaillancourt ◽  
John Sampalis
Keyword(s):  
Adverse Events ◽  
Real Life ◽  
Study Drug ◽  
Pain Severity ◽  
Open Label ◽  
Serious Adverse Events ◽  
Over The Counter ◽  
Rizatriptan Benzoate ◽  
Migraine Headaches ◽  
Real Life Setting

Background Patients that do not achieve therapeutic response with over the counter non-triptan medications may benefit from triptan-based treatments. Objective Phase I V, open-label, multi-center, prospective cohort study assessing the effectiveness of rizatriptan in the management of migraines for patients that have not responded to non-triptan treatment. Methods Patients were treated with one rizatriptan (MAXALT RPD®) 10 mg wafer at the onset of each migraine attack and were assessed after a minimum of one and a maximum of two consecutive headache episodes. Outcome measures included self-reported assessments (severity and duration of migraine headache) and the Migraine ACT questionnaire. Results A total of 369 patients were enrolled, of which 291 and 215 reported one and two attacks, respectively. For the first and second attacks, 47.2% and 53.9% of patients reported complete resolution of pain while 73.6% and 77.0% reported pain severity reduction within two hours of onset. Mean (SD) pain severity score (four-point Likert scale) during the 488 migraine episodes was reduced significantly ( P < 0.001) from 2.56 (0.49) at onset to 1.91 (0.85) at 30, 1.31 (1.00) at 60 and 0.84 (1.00) at 120 minutes. Similar improvements were observed for changes in Migraine ACT questionnaire scores. No treatment-related serious adverse events were reported. The most frequently reported non-serious adverse events that were attributed to the study drug were dizziness (2.2%), chest discomfort (1.1%), nausea (1.1%), and somnolence (0.8%). Conclusion In a real-life setting, rizatriptan benzoate 10 mg is effective and safe in the treatment of acute migraine headaches in patients who do not respond to non-triptan treatment.

Impact on OS of 2nd and 3rd generation TKI in EGFR mt+ and ALK+ patients: Results of the NOWEL network.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e20560-e20560 ◽  
Author(s):  
Julia Roeper ◽  
Maria Netchaeva ◽  
Anne Christina Lueers ◽  
Ursula Stropiep ◽  
Cora Hallas ◽  
...  
Keyword(s):  
Real Life ◽  
Stage Iv ◽  
Cancer Centers ◽  
Real Life Setting ◽  
Effective Choice ◽  
Detection Of Mutations ◽  
The Impact ◽  
Choice Of Therapy ◽  
Generation Sequencing

e20560 Background: Available clinical research data shows that early mutation testing for patients with NSCLC stage IV could lead to an effective choice of therapy for patients with proven mutations. Targeted therapies achieve a higher ORR, PFS, OS and a better quality of life than chemotherapy in mt+ patients. With the advent of 2nd and 3rd generation TKI´s effective in 1st generation TKI resistant tumors, we wanted to study the impact of these drugs on the outcome of patients in a real life setting in 3 lung cancer centers. Methods: 1383 patients from the three cancer centers diagnosed with NSCLC stage IV (UICC 7) were examined. Methods for the detection of mutations included Sanger Sequencing, hybridization based COBAS testing as well as hybrid cage next generation sequencing. Results: 880/1383 (64%) consecutive patients with non-squamous cell NSCLC from the cancer centers were studied for the presence of tumor mutations, especially for EGFR and ALK mutations. The EGFR mutation rate was 16.6% (141/880), and the ALK-translocation rate 3.8% (24/635). Median OS in EGFR mt+ patients was 31 (n = 78) vs. 32 (n = 38) vs. 16 (n = 14) months respectively (center 1 vs. center 2 vs. center 3). Median OS in ALK mt+ patients was 25 (n = 17) months in center 1 and 11 (n = 5) months in center 2 (p < 0.05). Use of 3rd generation TKI Osimertinib (n = 17) lead to a significantly higher OS (n = 17, median OS 67 mo) than the use of only 1st and 2nd generation TKI (n = 113, median OS 24 mo, p < 0.000). Similarly, use of 2nd and 3rd generation ALKi impacted significantly on median OS: Crizotinib alone n = 7, 17 months, Crizotinib followed by Ceritinib and/or Brigatinib (n = 9) median OS not reached, p < 0.001. Conclusions: Smalldifferences in OS were observed, depending on the treatment centers, but the use of multiple EGFR and ALK-I impacted highly significantly on the outcome of patients with EGFR and ALK-alterations in a real life setting.

Long-term treatment of chronic migraine with OnabotulinumtoxinA: efficacy, quality of life and tolerability in a real-life setting

2016 ◽  
Vol 123 (5) ◽  
pp. 533-540 ◽  
Author(s):  
Katja Kollewe ◽  
Claus M. Escher ◽  
Dirk U. Wulff ◽  
Davood Fathi ◽  
Lejla Paracka ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Chronic Migraine ◽  
Real Life ◽  
Term Treatment ◽  
Real Life Setting ◽  
Long Term Treatment
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