Comparison of efficacy and tolerability of oral desloratadine, rupatadine and ketotifen in seasonal allergic rhinitis

2021 ◽  
Vol 4 (3) ◽  
pp. 106-114
Author(s):  
Syed Khadeer ◽  
B Jagannath
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Nasal Congestion ◽  
Primary Outcome Measure ◽  
Nasal Symptom ◽  
Secondary Outcome ◽  
Open Label ◽  
Non Allergic Rhinitis ◽  
The Individual ◽  
Change In Mean

Rhinitis is inflammation of nasal mucosa which characteristically presents as running nose, blocked nose, itching on nose or sneezing. Allergic rhinitis is more common than non-allergic rhinitis. Anti-histamines are the mainstay of SAR treatment. Desloratadine, rupatadine and ketotifen are the commonly prescribed anti histamines in our region. In this study, we have compared efficacy and tolerability of desloratadine, rupatadine and ketotifen in SAR. This was a prospective, randomized, three arm, open label comparative study of desloratadine, rupatadine and ketotifen in SAR, conducted at Department of ENT, Kempegowda Institute of Medical Sciences, Bangalore; between January 2014 and December 2014. Patients’ severity of SAR symptoms were assessed by TNSS, QoL was measured using Medical Outcomes Study questionnaire (SF-12). SF-12 was administered at the start of study and then at the end of study. Adverse effects were monitored during clinical examination at each visit. Study subjects were systemically randomized into three groups – desloratadine (DES), rupatadine (RUP) and ketotifen (KET). Based on the assigned group; desloratadine was given orally in dose of 10mg OD, rupatadine orally 10 mg OD and ketotifen orally 1mg BD. All medications were given for 4 weeks. Follow up was done for all patients every week during treatment period of 4 weeks. The primary outcome measure was change in mean TNSS from baseline; secondary outcome measures were changes in the individual nasal symptom scores, change in the quality of life and tolerability to the study medications. Total 150 patients were recruited for this study, divided into 3 groups. DES and RUP were equally effective but significantly better than KET in improving rhinorrhea, nasal congestion, TNSS and AEC. (p=0.05). All the drugs were equally effective with no statistically significant intergroup difference in improving sneezing, nasal itching and QoL. RUP appeared to have better tolerability as the total number of adverse events were marginally less. DES and RUP are comparatively more effective and faster acting than KET. All the study medications were well tolerated with few mild, self-limiting, transient adverse events requiring no intervention.

scholarly journals TO EVALUATE EFFICACY AND SAFETY OF RUPATADINE, BILASTINE, AND LEVOCETRIZINE IN ALLERGIC RHINITIS AT TERITARY CARE HOSPITAL, TELANGANA

2021 ◽  
pp. 140-143
Author(s):  
NAGUR SHARONE GRACE ◽  
SYED ARSHADDUDDIN AHMED ◽  
BHUVANESWARI E ◽  
SYED HAMZA QUADRI ◽  
VEENA B ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Adverse Events ◽  
Nasal Congestion ◽  
Care Hospital ◽  
Efficacy And Safety ◽  
Open Label ◽  
Once Daily ◽  
Significant Difference ◽  
The Mean ◽  
The Government

Objective: Allergic rhinitis (AR) is a heterogeneous disorder characterized by symptoms – sneezing, itching, nasal congestion, and rhinorrhea. The aim of the study is to evaluate the efficacy and safety of rupatadine, bilastine, and levocetirizine in AR. Methods: A prospective, open-label, comparative study was conducted at the Government ENT Hospital, Hyderabad, Telangana. Ninety patients diagnosed with AR were randomized, of whom Group 1 received oral tab. bilastine 20 mg once daily, Group 2 received oral tab. levocetirizine 5 mg once daily, and Group 3 received oral tab. rupatadine with a dose of 10 mg once daily for 2 weeks. The reduction in total nasal symptom score (TNSS) and absolute eosinophil counts (AECs) was compared with baseline and at 2 weeks. Safety was assessed according to adverse events reported during the study period. An analysis of variance was used as a test of significance for the three groups. Results: Overall, 90 cases were included in the study, with 48% of males and 52% of females. All three drugs significantly reduced the TNSS and AEC after treatment compared to before treatment (p<0.05). The mean difference in TNSS and AEC showed no statistically significant difference among the three groups (TNSS: p>0.908 and AEC: p>0.967). In terms of safety, all three drugs showed nearly similar adverse events. Conclusion: In this study, after 2 weeks of follow-up, the three drugs (bilastine, levocetirizine, and rupatadine) showed significant improvement clinically, but the mean reduction in the score of symptoms and AEC was not statistically significant in the treatment of AR.

scholarly journals ACTR-69. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMA

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi29-vi29
Author(s):  
Garni Barkhoudarian ◽  
Nicholas Blondin ◽  
Sajeel Chowdhary ◽  
Ekokobe Fonkem ◽  
Brian Vaillant ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outcome Measure ◽  
Progression Free Survival ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Secondary Outcome Measure ◽  
Newly Diagnosed ◽  
Open Label ◽  
Serious Adverse Events ◽  
Radio Frequency Energy

Abstract BACKGROUND The EMulate Therapeutics Voyager system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. METHODS This open-label, multi-center study (NAT-109) enrolled adults newly diagnosed with GBM. Following surgical debulking, patients were enrolled and treated concurrently with temozolomide, radiotherapy, and Voyager. The objective of the study is to assess if the Voyager is a safe and feasible treatment for newly diagnosed GBM when combined with standard of care. The primary outcome measure is safety, assessed by the incidence and evaluation of any adverse events (AEs) associated with the Voyager. The secondary outcome measure is clinical utility, assessed by progression-free survival and overall survival. RESULTS Enrollment is closed, and treatment and long-term follow-up is ongoing. A total of 37 patients were enrolled and treated. 27 patients reported 282 AEs, none of which required withdrawal from the study. One AE was reported as probably related to the device - i.e., mild dysesthesia, which resolved without interruption or cessation of treatment with the device. 15 patients reported 28 SAEs, and none were reported as related to the device. 56% of patients were progression-free at 6 months, and 43% were progression-free at 12 months. 89% of patients were still alive after 6 months, 71% were still alive after 12 months. CONCLUSIONS The Voyager system appears to be safe and feasible for the treatment of newly diagnosed GBM. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is planned.

scholarly journals Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Paul Sondo ◽  
Marc Christian Tahita ◽  
Toussaint Rouamba ◽  
Karim Derra ◽  
Bérenger Kaboré ◽  
...  
Keyword(s):  
Vitamin A ◽  
Burkina Faso ◽  
Malaria Incidence ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Micronutrient Deficiencies ◽  
Open Label ◽  
Link Type ◽  
Potential Factors ◽  
Combined Strategy

Abstract Background Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing malaria incidence among children aged 3–59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. Malnutrition, in particular micronutrient deficiency, appears to be one of the potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the incidence of malaria in highly prevalent malaria zone such as rural settings. Therefore, we hypothesized that a combined strategy of SMC together with a daily oral nutrients supplement will enhance the immune response and decrease the incidence of malaria and malnutrition among children under SMC coverage. Methods Children (6–59 months) under SMC coverage receiving vitamin A supplementation will be randomly assigned to one of the three study arms (a) SMC + vitamin A alone, (b) SMC + vitamin A + zinc, or (c) SMC + vitamin A + Plumpy’Doz™ using 1:1:1 allocation ratio. After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed-up for 1 year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, haemoglobin measurement, and spotted onto filter paper for further PCR analyses. The primary outcome measure is the incidence of malaria in each arm. Secondary outcome measures will include mid-upper arm circumference and weight gain from baseline measurements, coverage and compliance to SMC, occurrence of adverse events (AEs), and prevalence of molecular markers of antimalarial resistance comprising Pfcrt, Pfmdr1, Pfdhfr, and Pfdhps. Discussion This study will demonstrate an integrated strategy of malaria and malnutrition programmes in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels. Trial registration ClinicalTrials.gov NCT04238845. Registered on 23 January 2020 https://clinicaltrials.gov/ct2/show/NCT04238845

scholarly journals Randomized controlled trial of convalescent plasma therapy against standard therapy in patients with severe COVID-19 disease

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Manaf AlQahtani ◽  
Abdulkarim Abdulrahman ◽  
Abdulrahman Almadani ◽  
Salman Yousif Alali ◽  
Alaa Mahmood Al Zamrooni ◽  
...  
Keyword(s):  
Standard Therapy ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Severe Disease ◽  
Pilot Trial ◽  
Standard Of Care ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Plasma Therapy

AbstractConvalescent plasma (CP) therapy in COVID-19 disease may improve clinical outcome in severe disease. This pilot study was undertaken to inform feasibility and safety of further definitive studies. This was a prospective, interventional and randomized open label pilot trial in patients with severe COVID-19. Twenty COVID-19 patients received two 200 ml transfusions of convalescent patient CP over 24-h compared with 20 who received standard of care. The primary outcome was the requirement for ventilation (non-invasive or mechanical ventilation). The secondary outcomes were biochemical parameters and mortality at 28 days. The CP group were a higher risk group with higher ferritin levels (p < 0.05) though respiratory indices did not differ. The primary outcome measure was required in 6 controls and 4 patients on CP (risk ratio 0.67, 95% CI 0.22–2.0, p = 0.72); mean time on ventilation (NIV or MV) did not differ. There were no differences in secondary measures at the end of the study. Two patients died in the control and one patient in the CP arm. There were no significant differences in the primary or secondary outcome measures between CP and standard therapy, although a larger definitive study is needed for confirmation. However, the study did show that CP therapy appears to be safe in hospitalized COVID-19 patients with hypoxia.Clinical trials registration NCT04356534: 22/04/2020.

Efficacy of Hypertonic Saline Irrigation for Nasal Symptoms in Children with Perennial Allergic Rhinitis: A Randomized Double-Blind Study

2021 ◽  
Vol 104 (10) ◽  
pp. 1570-1577
Keyword(s):  
Allergic Rhinitis ◽  
Side Effects ◽  
Hypertonic Saline ◽  
Symptom Score ◽  
Nasal Congestion ◽  
Nasal Symptom ◽  
Perennial Allergic Rhinitis ◽  
Saline Irrigation ◽  
Nasal Irrigation ◽  
Nasal Cytology

Background: Nasal saline irrigation was an adjunctive therapy of allergic rhinitis (AR). It has been suggested that the use of hypertonic saline (HS) is better than normal saline (NSS) in treatment of AR. Reduction of mucosal edema by hypertonicity induced water transport through nasal mucosa, nasal congestion reduction and mucociliary clearance improvement. Objective: To compare total nasal symptom score (TNSS) between 3% HS and NSS irrigation in perennial allergic rhinitis children. Materials and Methods: The present study was conducted at the Allergy Center of Bhumibol Adulyadej Hospital (BAH), Royal Thai Airforce, Bangkok, Thailand between January and March 2021. Sixty-two perennial AR children were enrolled and categorized in severity level, namely mild, moderate or severe. Subjects were randomized into two groups. Each participant was blind-randomized to nasal irrigation of either 3% HS or NSS twice-daily for 4 weeks by the same investigator. The primary outcome was TNSS improvement between both groups. Secondary outcomes were quality of life, nasal congestion severity improvement, nasal cytology change and side effects. Results: TNSS improvement of 3% HS was more than NSS group (4.03±2.36 versus 2.73±3.06, p=0.034). Nasal congestion was the only symptom that differed significantly between the two groups (1.32±1.01 in 3% HS versus 0.70±1.24 in NSS, p=0.024). Reduction of congestion severity by physical examination, nasal cytology changes and side effects were comparable. Conclusion: Nasal irrigation with 3% HS in children with perennial AR had more improvement than NSS in TNSS., especially nasal congestion. Keyword: Hypertonic saline; Nasal irrigation; Allergic rhinitis; Nasal symptom score

scholarly journals ACTR-68. FEASIBILITY STUDY OF THE EMULATE THERAPEUTICS™ VOYAGER SYSTEM IN PATIENTS WITH RECURRENT GLIOBLASTOMA (GBM)

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi29-vi29
Author(s):  
Garni Barkhoudarian ◽  
Michael Badruddoja ◽  
Nicholas Blondin ◽  
Ricky Chen ◽  
Sajeel Chowdhary ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Skin Irritation ◽  
Recurrent Glioblastoma ◽  
Secondary Outcome ◽  
Open Label ◽  
Serious Adverse Events ◽  
Radio Frequency Energy ◽  
Long Term Treatment ◽  
Recurrent Gbm

Abstract BACKGROUND The EMulate Therapeutics Voyager system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of brain cancer. METHODS This ongoing, open-label, multi-center study (NAT-101) is being conducted in the US and Australia in patients with recurrent GBM. There are 3 treatment groups: 32 patients treated with Voyager alone, 43 patients treated with Voyager + Investigator’s choice of anti-cancer therapy, and 21 patients treated with Voyager+lomustine+/-bevacizumab. The objective of the study is to assess if the Voyager is a safe and feasible treatment for recurrent GBM. The primary outcome measure is safety, assessed by the incidence and evaluation of adverse events (AEs) associated with the Voyager. The secondary outcome measures are progression-free survival and overall survival. RESULTS Enrollment is closed, and long-term treatment and follow-up is ongoing. 96 patients were enrolled and treated. 82 patients reported at least one AE, and 18 AEs were assessed as device-related (mild-moderate; 12 headache, 2 vomiting, 1 nausea, 1 confusion, 1 insomnia, and 1 skin irritation). 31 patients reported at least one serious AE, and none were assessed as device-related. 33% of patients treated with Voyager alone and 36% of patients treated with Voyager + chemotherapy were progression-free after 6 months. 58% of patients treated with Voyager alone and 60% of patients treated with Voyager + chemotherapy remained alive after 6 months; median overall survival is 7 months (95% CI=4.4±14.3) in patients treated with Voyager alone and 10 months (95% CI=6.7±11.5) in patients treated with Voyager + chemotherapy. CONCLUSIONS The Voyager system appears to be safe and feasible for the treatment of recurrent GBM. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is planned.

Treatment Emergent Sexual Dysfunction Related to Antidepressants: A Meta-analysis

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1
Author(s):  
A. Chiesa ◽  
A. Serretti ◽  
R. Calati ◽  
D. de Ronchi
Keyword(s):  
Sexual Dysfunction ◽  
Meta Analysis ◽  
Antidepressant Drugs ◽  
Cochrane Collaboration ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Difference ◽  
Total Treatment ◽  
The Cochrane Collaboration

Objective:Sexual dysfunction is an important under-estimated side effect of antidepressant drugs. Patients, in fact, if not directly questioned, tend to scarcely report them. Thus, the aim of the present meta-analysis is to quantify sexual dysfunction caused by antidepressants on the basis of studies where sexual functioning was purposely investigated through direct inquiry and specific questionnaires.Methods:A literature search was conducted using Medline, Isi web of Knowledge and references of selected articles. Selected studies performed on patients without previous sexual dysfunction were entered in the Cochrane Collaboration Review Manager Software (RevMan version 4.2). Our primary outcome measure was the rate of total treatment emergent sexual dysfunction. Our secondary outcome measures were the rates of treatment emergent desire, arousal and orgasm dysfunction.Results:Our analyses indicated significantly higher rates of treatment emergent sexual dysfunction as well as specific phases dysfunction compared to placebo for the following drugs: citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, duloxetine, venlafaxine, clomipramine, imipramine and phenelzine, whereas no significant difference with placebo was found for the following antidepressants: amineptine, bupropion, moclobemide, mirtazapine and nefazodone. Nonetheless sufficient evidences (>100 subjects) are available only for bupropion, citalopram, fluoxetine, paroxetine, sertraline and venlafaxine.Discussion:Present evidence on treatment emergent sexual dysfunction caused by antidepressant is sufficiently studied only for few drugs. Furthermore some statistical limiting assumptions, as the inclusion of open label or small studies and the presence of an evident publication bias, could reduce the significativity of our findings. Thus, treatment emergent sexual dysfunction should be more deeply investigated.

Lipid-based Nose Ointment for Allergic Rhinitis

2005 ◽  
Vol 133 (5) ◽  
pp. 754-761 ◽  
Author(s):  
Urban Wilhelm Geisthoff ◽  
Andreas Blum ◽  
Marianne Rupp-Classen ◽  
Peter-Karl Plinkert
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Tertiary Care ◽  
Control Group ◽  
Significant Drop ◽  
Intention To Treat ◽  
Study Results ◽  
Tertiary Care Centers ◽  
The Individual ◽  
Individual Scores

OBJECTIVE: To assess the efficacy of a lipid-based nose ointment in treating allergic rhinitis. STUDY DESIGN AND SETTING: Prospective, open, randomized, controlled clinical study in the outpatient departments of 2 tertiary care centers. RESULTS: No specific adverse effects were observed. The nose ointment under investigation led to a significant improvement in sneezing and nasal itching (17 patients). There was no significant change for nasal congestion and rhinorrhea in the intention-to-treat sets. However, there was still a significant drop of the mean relative total symptom score derived from the individual scores. All scores remained unchanged in the untreated control group (16 patients). CONCLUSION: Topical application of the nose ointment as a supportive treatment leads to a significant improvement of symptoms in allergic rhinitis. SIGNIFICANCE: The prevalence of allergic rhinitis is about 10% to 20% in the population. Our study results are encouraging and should be assessed in further research because changes in the therapeutic guidelines may be suggested.

scholarly journals Correlation of Features of Allergic Rhinitis and Allergic Conjunctivitis with Treatment Modalities

2019 ◽  
pp. 1-10 ◽  
Author(s):  
Shuaib Kayode Aremu ◽  
Tayo Ibrahim ◽  
Azeez Oyemomi Ibrahim ◽  
Popoola Tomilayo Ajoke
Keyword(s):  
Allergic Rhinitis ◽  
Allergic Conjunctivitis ◽  
Nasal Congestion ◽  
Nasal Symptom ◽  
Treatment Modalities ◽  
Nasal Discharge ◽  
Southwestern Nigeria ◽  
Cross Sectional ◽  
Female Ratio ◽  
Eye Pain

Introduction: Allergic Rhinitis (AR) is a chronic, symptomatic allergic disorder of the nose that is usually caused by IgE-mediated inflammatory response following exposure to an allergen. The allergen could be in the form of dust, pollen, flower, animal dander, mold, cold, food allergens or insect. Clinically, AR occurs when there are recurrent nasal symptoms which are reversible either spontaneously or with medication in the preceding one year. Such symptoms include at least two of the following; excessive sneezing, running nose, nasal itching, nasal discharge, nasal congestion or obstruction. Previous studies have linked AR to be co-existed with another form of allergic disorders including AC, Atopic dermatitis and Allergic Asthma. This study is aimed at assessing the feature of  AR patients with coexistent AC as well as evaluating the effectiveness of the treatments offered to them. Objectives: The study was aimed at finding the correlation between the nasal and eye features in a patient who has co-existing allergic rhinitis and allergic conjunctivitis. Methodology: This was a cross-sectional descriptive study conducted between August 2018 and November 2019 among 38 patients who presented to ENT and Ophthalmology departments of Federal Teaching Hospital Ido-Ekiti, Ekiti State, Southwestern Nigeria and was diagnosed with both allergic rhinitis and allergic conjunctivitis. Relevant data obtained were analyzed using SPSS version 20.  P ≤ 0.05 was taken as significant. Results: The patients’ age range between 8 and 81 years with a median age of 33 years. The majority were less than 45 years (63.2%) with the male to female ratio of almost. Eye pain, itching, and redness account for 97.4% of all the eye features, while the presence of Cobblestone-like papillae is the least and accounted for 5%. Nasal itching (92.1%) was the commonest nasal symptom. Sleep disturbance was found to be the most common among those with eye itching (29.7%). Conclusion: This research was conducted to correlate the features of allergic rhinitis with those of conjunctivitis and common management and preventive measures offered to the patients seen in our clinics. The majority of the patients were less than 45 years with almost equal sex ratio. Eye pain, itching, and redness account for the majority of all the eye features, while the presence of Cobblestone-like papillae is the least eye feature. Nasal itching was the commonest nasal symptom and this was seen in the majority of the patients with eye symptoms.

scholarly journals Use of a new transanal irrigation device for bowel disorder management by patients familiar with the irrigation technique: a prospective, interventional, multicenter pilot study

2020 ◽  
Vol 24 (7) ◽  
pp. 731-740
Author(s):  
K. Charvier ◽  
V. Bonniaud ◽  
D. Waz ◽  
C. Desprez ◽  
A.-M. Leroi
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Medical Device ◽  
Bowel Dysfunction ◽  
Secondary Outcome ◽  
Electric Pump ◽  
Open Label ◽  
Serious Adverse Events ◽  
New Device ◽  
Transanal Irrigation

Abstract Background The aim of this study was to evaluate the feasibility of transanal irrigation (TAI) with a new medical device incorporating an electric pump, the IryPump®R Set. Methods An interventional, prospective, open-label, non-comparative, multicenter pilot study on TAI was conducted at three French university hospitals. Patients with experience of TAI were enrolled for a 1-month period during which 5 consecutive TAIs were performed using the IryPump®R Set (B.Braun Melsungen AG Melsungen, Germany). The study’s primary efficacy criterion was successful TAI, defined as (i) use of the patient’s usual irrigation volume of water, (ii) stool evacuation, and (iii) the absence of leakage between TAIs. The first two TAIs were not taken into account in the main analysis. The secondary outcome measures were device acceptability, bowel dysfunction scores, tolerability, and safety. Results Fifteen patients were included between November 2016 and May 2017, and 14 were assessed in the main analysis. The TAI success rate was 72.4% (21 out of 29 procedures). The bowel dysfunction scores at the end of the study did not differ significantly from those recorded on inclusion. A high proportion of patients (> 70%) reported that TAI was feasible with the new medical device. There were no serious adverse events or device-related adverse events. At the end of the study, 50% of the participants were willing to consider further use of the new device. Conclusions In patients familiar with TAI, using a new medical device incorporating an electric pump was feasible. Levels of patient satisfaction were high, especially with regard to comfort of use and a feeling of security during TAI.

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