Randomised, multicentre, prospective interventional study to evaluate the efficacy of immediate diet in addition to standard mouth rinsing in reducing local adverse events of inhaled corticosteroid among asthmatic patients: a pilot study

2021 ◽  
Author(s):  
Yee Mei Ng ◽  
Yen Ping Ng ◽  
Wei Kai Heng ◽  
Habshoh Bt Hat ◽  
Ahmad Kamal Ariffin bin Abdul Jamil ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Inhaled Corticosteroid ◽  
Interventional Study ◽  
Asthmatic Patients ◽  
Mouth Rinsing

scholarly journals The Efficacy of Immediate Diet for Reducing Local Adverse Events of Inhaled Corticosteroid: A Pilot Study

2012 ◽  
Vol 73 (2) ◽  
pp. 93
Author(s):  
Myoung Kyu Lee ◽  
Won Yeon Lee ◽  
Suk Joong Yong ◽  
Kye Chul Shin ◽  
Chong Whan Kim ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Inhaled Corticosteroid

Safety of Vinflunine in Patients with Advanced Urothelial Carcinoma Refractory to Platinum-based Chemotherapy: A Prospective Pilot Study

2019 ◽  
Vol 14 (1) ◽  
pp. 31-36
Author(s):  
Raafat Abdel-Malek ◽  
Kyrillus S. Shohdy ◽  
Noha Abbas ◽  
Mohamed Ismail ◽  
Emad Hamada ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Urothelial Carcinoma ◽  
Transitional Cell ◽  
Chemotherapeutic Agents ◽  
Serious Adverse Events ◽  
Platinum Based Chemotherapy ◽  
Number Of Patients ◽  
Advanced Urothelial Carcinoma ◽  
Grade 3

Background: Several single chemotherapeutic agents have been evaluated as the second-line treatment of advanced urothelial carcinoma. Despite encouraging efficacy outcomes, toxicity has often led to dose modifications or discontinuation. We aimed to assess the safety of vinflunine in a particular population of advanced transitional cell carcinoma of urothelium (TCCU), that were exposed to the previous toxicity of chemotherapy. Methods: This is an open-label, prospective, single-center pilot study to evaluate the response rate and safety profile of vinflunine in patients with advanced TCCU. It was planned to enroll 25 evaluable patients. Eligible patients are those with progressive disease after first-line platinum-based regimen for advanced or metastatic disease. Results: The study was prematurely closed due to two sudden deaths that were judged by the review board as treatment-related. Only ten patients were evaluated and received at least one cycle of vinflunine. All but one were male and seven underwent radical surgery. Eight had a distant metastasis (mainly lung and/or liver). Disease control rate was 40%, four patients had a partial response with median duration of response of 3.5 months. The median overall survival was 3.2 months (95% CI:1.67- 4.73). There were three serious adverse events namely two sudden deaths and one grade 4 thrombocytopenia. Nine grade 3/4 adverse events occurred. The most common all-grade adverse events were fatigue (50%), constipation (40%) and vomiting (40%). Moreover, grade 3 fatigue occurred in 30% of patients. Only one patient, who achieved PR for 5 months, was fit to receive further cytotoxic chemotherapy. Conclusion: The activity of vinflunine in advanced urothelial carcinoma came at the expense of its safety. The use of vinflunine has to be limited to the selected group of patients. However, this is a single institute experience in a limited number of patients.

scholarly journals The Use of the Oxygenated AirdriveTM Machine Perfusion System in Kidney Graft Preservation: A Clinical Pilot Study

2020 ◽  
Vol 61 (6) ◽  
pp. 153-162
Author(s):  
Julia H.E. Houtzager ◽  
Sebastiaan David Hemelrijk ◽  
Ivo C.J.H. Post ◽  
Mirza M Idu ◽  
Frederike J. Bemelman ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
Pilot Study ◽  
Adverse Events ◽  
Deceased Donor ◽  
Kidney Graft ◽  
Machine Perfusion ◽  
End Points ◽  
Viable Solution ◽  
Technical Failures

Background: The shortage of donor kidneys has led to the use of marginal donors, e.g., those whose kidneys are donated after circulatory death. Preservation of the graft by hypothermic machine perfusion (HMP) provides a viable solution to reduce warm ischemic damage. This pilot study was undertaken to assess the feasibility and patient safety of the AirdriveTM HMP system in clinical kidney transplantation. Methods: Five deceased-donor kidneys were preserved using the oxygenated Airdrive HMP system between arrival at the recipient center (Amsterdam UMC) and implantation in the patient. The main study end-points were adverse effects due to the use of Airdrive HMP. Secondary end-points were clinical outcomes and perfusion parameters. All events occurring during the transplantation procedure or within 1 month of follow-up were monitored. Results: Five patients were included in this pilot study. No technical failures were observed during the preservation period using the Airdrive HMP. Mean perfusion parameters were: duration 8.5 h (3–15 h), pressure 25 mm Hg (18–25 mm Hg), flow 49.77 mL/min (19–58 mL/min), resistance 0.57 mm Hg/min/mL (0.34–1.3 mm Hg/min/mL), and temperature 8.2 °C (2–13°C). Mean cold ischemia time (CIT) was 20.2 h (11–29.5 h). No adverse events or technical failures were observed during preservation and transplantation or during the 1-month follow-up. Conclusions: This pilot study showed the feasibility of the use of the Airdrive HMP system with no adverse events in clinical kidney transplantation.

scholarly journals Paliperidone ER in the Treatment of Borderline Personality Disorder: A Pilot Study of Efficacy and Tolerability

2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Silvio Bellino ◽  
Paola Bozzatello ◽  
Camilla Rinaldi ◽  
Filippo Bogetto
Keyword(s):  
Borderline Personality Disorder ◽  
Pilot Study ◽  
Personality Disorder ◽  
Adverse Events ◽  
Mechanism Of Action ◽  
Severity Index ◽  
Borderline Personality ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Dsm Iv

Antipsychotics are recommended for the treatment of impulsive dyscontrol and cognitive perceptual symptoms of borderline personality disorder (BPD). Three reports supported the efficacy of oral risperidone on BPD psychopathology. Paliperidone ER is the metabolite of risperidone with a similar mechanism of action, and its osmotic release reduces plasmatic fluctuations and antidopaminergic effects. The aim of this study is to evaluate efficacy and safety of paliperidone ER in BPD patients. 18 outpatients with a DSM-IV-TR diagnosis of BPD were treated for 12 weeks with paliperidone ER (3–6 mg/day). They were assessed at baseline, week 4, and week 12, using the CGI-Severity item, the BPRS, the HDRS, the HARS, the SOFAS, the BPD Severity Index (BPDSI), and the Barratt Impulsiveness Scale (BIS-11). Adverse events were evaluated with the DOTES. Paliperidone ER was shown to be effective and well tolerated in reducing severity of global symptomatology and specific BPD symptoms, such as impulsive dyscontrol, anger, and cognitive-perceptual disturbances. Results need to be replicated in controlled trials.

scholarly journals Percutaneous administration of allogeneic bone-forming cells for the treatment of delayed unions of fractures: a pilot study

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Marc Jayankura ◽  
Arndt Peter Schulz ◽  
Olivier Delahaut ◽  
Richard Witvrouw ◽  
Lothar Seefried ◽  
...  
Keyword(s):  
Pilot Study ◽  
Adverse Events ◽  
Phase I ◽  
Bone Fractures ◽  
Fracture Site ◽  
Post Treatment ◽  
Long Bone ◽  
Allogeneic Bone ◽  
Hla Antibodies ◽  
Long Bone Fractures

Abstract Background Overall, 5–10% of fractures result in delayed unions or non-unions, causing major disabilities and a huge socioeconomic burden. Since rescue surgery with autologous bone grafts can cause additional challenges, alternative treatment options have been developed to stimulate a deficient healing process. This study assessed the technical feasibility, safety and preliminary efficacy of local percutaneous implantation of allogeneic bone-forming cells in delayed unions of long bone fractures. Methods In this phase I/IIA open-label pilot trial, 22 adult patients with non-infected delayed unions of long bone fractures, which failed to consolidate after 3 to 7 months, received a percutaneous implantation of allogeneic bone-forming cells derived from bone marrow mesenchymal stem cells (ALLOB; Bone Therapeutics) into the fracture site (50 × 106 to 100 × 106 cells). Patients were monitored for adverse events and need for rescue surgery for 30 months. Fracture healing was monitored by Tomographic Union Score (TUS) and modified Radiographic Union Score. The health status was evaluated using the Global Disease Evaluation (GDE) score and pain at palpation using a visual analogue scale. The presence of reactive anti-human leukocyte antigen (HLA) antibodies was evaluated. Results During the 6-month follow-up, three serious treatment-emergent adverse events were reported in two patients, of which two were considered as possibly treatment-related. None of the 21 patients in the per-protocol efficacy population needed rescue surgery within 6 months, but 2/21 (9.5%) patients had rescue surgery within 30 months post-treatment. At 6 months post-treatment, an improvement of at least 2 points in TUS was reached in 76.2% of patients, the GDE score improved by a mean of 48%, and pain at palpation at the fracture site was reduced by an average of 61% compared to baseline. The proportion of blood samples containing donor-specific anti-HLA antibodies increased from 8/22 (36.4%) before treatment to 13/22 (59.1%) at 6 months post-treatment, but no treatment-mediated allogeneic immune reactions were observed. Conclusion This pilot study showed that the percutaneous implantation of allogeneic bone-forming cells was technically feasible and well tolerated in patients with delayed unions of long bone fractures. Preliminary efficacy evidence is supporting the further development of this treatment. Trial registration NCT02020590. Registered on 25 December 2013. ALLOB-DU1, A pilot Phase I/IIa, multicentre, open proof-of-concept study on the efficacy and safetyof allogeneic osteoblastic cells (ALLOB®) implantation in non-infected delayed-union fractures.

scholarly journals A Brief Review of Severe Asthma

2021 ◽  
Vol 6 (2) ◽  
pp. 4-12
Author(s):  
Muhammad Amin Ibrahim ◽  
Ahmad Izuanuddin Ismail ◽  
Mohammed Fauzi Abdul Rani
Keyword(s):  
Severe Asthma ◽  
Treatment Options ◽  
Oral Steroid ◽  
Inhaler Technique ◽  
Inhaled Corticosteroid ◽  
Asthma Care ◽  
Asthmatic Patients ◽  
Appropriate Treatment ◽  
Considerable Morbidity ◽  
The Cost

Severe asthma describes an asthma condition that requires a substantial amount of inhaled corticosteroid and bronchodilators to keep it under control including the frequent additional need for oral steroid to avoid exacerbations. The incidence of severe asthma in Malaysia is unknown but data elsewhere shows that it is around 5 to 10 % of asthmatics. This category of asthmatic patients has considerable morbidity, is disproportionate cost-wise to the number of sufferers and requires specialised and focused care. The management of severe asthma should be undertaken at a severe asthma clinic led by a physician with a special interest in its management. The diagnosis needs confirmation, comorbidities identified and triggering factors addressed. Inhaler technique and compliance are major contributing issues and must be addressed at all consultation opportunities. Once the diagnosis of severe asthma is confirmed, the disease needs phenotyping to plan for the most appropriate treatment, termed as a personalised approach to severe asthma care. The advances in biologics have changed the landscape of treatment of this disease but in Malaysia especially, there are many limitations namely the cost. This article briefly explores the current understanding of severe asthma, the assessment including phenotyping and possible treatment options.

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