scholarly journals P602 Vedolizumab subcutaneous influencing disease course in Constant-care app solution

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S547-S548
Author(s):  
J Nørgaard ◽  
R Malte ◽  
P L Charlotte ◽  
B Mette ◽  
F Eva ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Adverse Events ◽  
Controlled Trial ◽  
Severe Disease ◽  
University Hospital ◽  
Sustained Remission ◽  
Serious Adverse Events ◽  
Crohns Disease

Abstract Background The Constant-care app solution (CC) has been shown to empower patients with mild-moderate Ulcerative Colitis (UC) in 5-ASA treatment and improve disease specific quality of life (1). Here we present preliminary data on our study to investigate the effects of CC on quality of life in patients with moderate-severe UC or Crohns Disease (CD) treated with s.c.vedolizumab, launched in June 2020 in Denmark. Methods The study is an ongoing non-interventional, observational study. Patients are homemonitored via CC for 24 months. CC shows data on patient’s disease status, grouping them into three: green (remission), yellow (worsening), red (severe disease). Patients were recruited from the outpatient clinic at the Department of Gastroenterology, North Zealand University Hospital, Greater Copenhagen. Simple Clinical Colitis Index (SCCAI), Harvey-Bradshaw Index (HB-I), Fecal calprotectin (FC) and short QoL (0–70) are measured every two months or during a flare up between fixed screenings. Serious adverse events (SAE) and adverse events (AE) are monitored. Results 19 patients out of 40 have been included, 8 with CD and 11 with UC. None experienced SAEs. Five experienced AEs, of which four discontinued treatment. One patient experienced treatment failure during this study. Of the 15 patients, two are in complete remission, (Q2 respectively Q3). Five of the remaining patients have not entered more than two data entries in CC (data not shown).All patients sustained remission based on FC, except for two data points for two individual patients. Good QoL ≥ 50 was almost unchanged for 6 patients. Conclusion IBD CC has proven a usefull tool for surveillance and maintenance of remission in IBD patients treated with s.c. vedolizumab. S.c. vedolizumab has in this patientgroup, shown to provide sustainable QoL, sustained remission, and to have few AEs. 1) Elkjaer M, Shuhaibar M, Burisch J, Bailey Y, Scherfig H, Laugesen B, et al. E-health empowers patients with ulcerative colitis: a randomised controlled trial of the web-guided ‘Constant-care’ approach. Gut. 2010;59(12):1652–61.

scholarly journals Bilateral hypoglossal nerve stimulation for treatment of adult obstructive sleep apnoea

2019 ◽  
Vol 55 (1) ◽  
pp. 1901320 ◽  
Author(s):  
Peter R. Eastwood ◽  
Maree Barnes ◽  
Stuart G. MacKay ◽  
John R. Wheatley ◽  
David R. Hillman ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Nerve Stimulation ◽  
Hypoglossal Nerve ◽  
Sleep Apnoea ◽  
Serious Adverse Events ◽  
Obstructive Sleep ◽  
Device Use ◽  
Post Implantation

Background and aimHypoglossal nerve stimulation (HNS) decreases obstructive sleep apnoea (OSA) severity via genioglossus muscle activation and decreased upper airway collapsibility. This study assessed the safety and effectiveness at 6 months post-implantation of a novel device delivering bilateral HNS via a small implanted electrode activated by a unit worn externally, to treat OSA: the Genio™ system.MethodsThis prospective, open-label, non-randomised, single-arm treatment study was conducted at eight centres in three countries (Australia, France and the UK). Primary outcomes were incidence of device-related serious adverse events and change in the apnoea–hypopnoea index (AHI). The secondary outcome was the change in the 4% oxygen desaturation index (ODI). Additional outcomes included measures of sleepiness, quality of life, snoring and device use. This trial was registered with ClinicalTrials.gov, number NCT03048604.Results22 out of 27 implanted participants (63% male, aged 55.9±12.0 years, body mass index (BMI) 27.4±3.0 kg·m−2) completed the protocol. At 6 months BMI was unchanged (p=0.85); AHI decreased from 23.7±12.2 to 12.9±10.1 events·h−1, a mean change of 10.8 events·h−1 (p<0.001); and ODI decreased from 19.1±11.2 to 9.8±6.9 events·h−1, a mean change of 9.3 events·h−1 (p<0.001). Daytime sleepiness (Epworth Sleepiness Scale; p=0.01) and sleep-related quality of life (Functional Outcomes of Sleep Questionnaire-10; p=0.02) both improved significantly. The number of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of participants reported device use >5 days per week, and 77% reported use for >5 h per night. No device-related serious adverse events occurred during the 6-month post-implantation period.ConclusionsBilateral HNS using the Genio™ system reduces OSA severity and improves quality of life without device-related complications. The results are comparable with previously published HNS systems despite minimal implanted components and a simple stimulation algorithm.

scholarly journals Quality-of-Life (QOL) during Screening for Phase 1 Trial Studies in Patients with Advanced Solid Tumors and Its Impact on Risk for Serious Adverse Events

Cancers ◽  
2017 ◽  
Vol 9 (12) ◽  
pp. 73 ◽  
Author(s):  
Sidra Anwar ◽  
Wei Tan ◽  
Chi-Chen Hong ◽  
Sonal Admane ◽  
Askia Dozier ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Solid Tumors ◽  
Phase 1 ◽  
Advanced Solid Tumors ◽  
Serious Adverse Events ◽  
Phase 1 Trial

scholarly journals Controlled Trial of a 5-Day Course of Telithromycin versus Doxycycline for Treatment of Mild to Moderate Scrub Typhus

2007 ◽  
Vol 51 (6) ◽  
pp. 2011-2015 ◽  
Author(s):  
Dong-Min Kim ◽  
Ki Dong Yu ◽  
Ji Hyun Lee ◽  
Hyun Kuk Kim ◽  
Seung-Hyun Lee
Keyword(s):  
Adverse Events ◽  
Scrub Typhus ◽  
Controlled Trial ◽  
Sensitivity Study ◽  
University Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Antibiotics

ABSTRACT New antibiotics are required to have the antibacterial activity against doxycycline-resistant Orientia tsutsugamushi. An in vitro sensitivity study showed that telithromycin was more effective than erythromycin for Rickettsia, Bartonella, and Coxiella burnetii. In this prospective, open-label, randomized trial, we enrolled patients with mild-to-moderate scrub typhus. We compared the efficacy and safety of a 5-day telithromycin therapy with those of a 5-day doxycycline therapy at Chosun University Hospital or one of its two community-based affiliated hospitals (Jangheung Hospital and Cheomdan Hospital), which are all located in southwestern Korea, between September and December 2005. A total of 92 patients were randomly assigned to either the telithromycin group (n = 47) or the doxycycline group (n = 45). After the treatment, fever control time was 20.45 ± 12.9 h in the telithromycin group and 22.60 ± 21.44 h in the doxycycline group (P > 0.05). After the treatment, the cure rate was 100% in the telithromycin group and 97.8% in the doxycycline group (P > 0.05). Furthermore, there were no significant differences in time elapsed until such symptoms as headache, myalgia, and rash disappeared. No serious adverse events or death were noted following the treatment in both groups. There were no significant differences in adverse events. In conclusion, the efficacy and safety of a 5-day once-a-day regimen of 800 mg telithromycin were equivalent to those of a 5-day twice-a-day regimen of 100 mg doxycycline in patients with mild-to-moderate scrub typhus. Telithromycin could be considered a promising new antibacterial agent for patients with scrub typhus.

scholarly journals Cannabis is associated with clinical but not endoscopic remission in ulcerative colitis: A randomized controlled trial

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246871
Author(s):  
Timna Naftali ◽  
Lihi Bar-Lev Schleider ◽  
Fabiana Scklerovsky Benjaminov ◽  
Fred Meir Konikoff ◽  
Shelly Tartakover Matalon ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Ulcerative Colitis ◽  
Placebo Group ◽  
Activity Index ◽  
Controlled Trial ◽  
Clinical Effects ◽  
Short Term Treatment ◽  
Double Blind ◽  
Endoscopic Score

Background Cannabis is often used by patients with ulcerative colitis, but controlled studies are few. We aimed to assess the effect of cannabis in improving clinical and inflammatory outcomes in ulcerative colitis patients. Methods In a double-blind, randomized, placebo-controlled trial, patients received either cigarettes containing 0.5 g of dried cannabis flowers with80mgTetrahydrocannabinol (THC)or placebo cigarettes for 8 weeks. Parameters of disease including Lichtiger disease activity index, C reactive protein (CRP), calprotectin, Mayo endoscopic score and quality of life (QOL) were assessed before, during and after treatment. Results The study included 32 patients. Mean age was 30 years, 14 (43%) females. Lichtiger index improved in the cannabis group from 10.9 (IQR 9–14) to5 (IQR 1–7), (p<0.000), and in the placebo group from 11 (IQR 9–13) to 8 (IQR 7–10)(p = 0.15, p between groups 0.001). QOL improved in the cannabis group from 77±4 to 98±20 (p = 0.000) but not in the placebo group (78±3 at week 0 and 78±17 at week 8;p = 0.459; p between groups 0.007). Mayo endoscopic score changed in the cannabis group from 2.13±1 to 1.25±2 (p = 0.015) and in the placebo group from 2.15±1to 1.69±1 (p = 0.367, p between groups 0.17). Conclusion Short term treatment with THC rich cannabis induced clinical remission and improved quality of life in patients with mild to moderately active ulcerative colitis. However, these beneficial clinical effects were not associated with significant anti-inflammatory improvement in the Mayo endoscopic score or laboratory markers for inflammation.(clinicaltrials.gov NCT01040910).

scholarly journals Safety of Denervation Following Targeted Lung Denervation Therapy for COPD: AIRFLOW-1 Three-year Outcomes

2020 ◽  
Author(s):  
Christophe Pison ◽  
Pallav Shah ◽  
Dirk-Jan Slebos ◽  
Vincent Ninane ◽  
Wim Janssens ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Lung Function ◽  
Adverse Events ◽  
Late Onset ◽  
Open Label ◽  
Serious Adverse Events ◽  
Copd Exacerbations ◽  
Clinical Consequences

Abstract Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.

scholarly journals The effectiveness of combination of 7% hypertonic saline and 0.1% natrii hyaluronas in patients with chronic obstructive pulmonary disease who have suffered a new coronavirus infection

2021 ◽  
pp. 85-91
Author(s):  
O. N. Titova ◽  
N. A. Kuzubova ◽  
D. B. Skliarova ◽  
A. L. Aleksandrov ◽  
N. V. Egorova
Keyword(s):  
Quality Of Life ◽  
Adverse Events ◽  
Hypertonic Saline ◽  
Chronic Obstructive ◽  
Hypertonic Solution ◽  
Shortness Of Breath ◽  
Serious Adverse Events ◽  
Obstructive Pulmonary Disease ◽  
Coronavirus Infection

Introduction. New coronavirus infection (COVID-19) contributes to the aggravation of respiratory symptoms in patients with COPD, including affecting the intensity and nature of cough. Hypertonic solution (HS) has a positive effect on the rheological properties of sputum and mucociliary clearance. However, there are no studies in the available literature on the use of HS in patients who have undergone COVID-19.Goal. To evaluate the effect of the combination of 7% hypertonic saline and 0.1% natrii hyaluronas on the intensity and productive nature of cough in patients with COPD who have undergone a new coronavirus infection and the safety of its use in this cohort of patients.Materials and methods. 50 patients with severe COPD in remission who suffered a new coronavirus infection were examined. The rehabilitation stage of treatment was carried out in the conditions of the pulmonology department. From the moment of receiving the last negative PCR result for SARS-CoV-2 to admission to the hospital for rehabilitation, it took from 2 to 3 weeks. The duration of follow-up of patients was 10 days. The patients were divided into two groups: group 1 (n = 25) – patients who received combination of 7% hypertonic saline and 0.1% natrii hyaluronas 7% by inhalation through a nebulizer; group 2 (n = 25) – patients who did not receive combination of 7% hypertonic saline and 0.1% natrii hyaluronas. The severity of cough was assessed (cough severity scale; shortness of breath, cough and sputum scale), clinical and biochemical blood tests, ECG, spirometry.Results. In patients treated with combination of 7% hypertonic saline and 0.1% natrii hyaluronas, a significant decrease in the severity of cough, the amount of sputum was revealed. The tendency to reduce shortness of breath and improve the quality of life is determined. No serious adverse events were detected when using the drug.Conclusions. The use of the combination of 7% hypertonic saline and 0.1% natrii hyaluronas in patients with COPD who have suffered a new coronavirus infection at the rehabilitation stage leads to a decrease in the intensity of cough and improved sputum discharge, which helps to reduce the severity of shortness of breath and improve the quality of life. The use of the drug is safe and does not lead to clinically significant adverse events.

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