scholarly journals Effect of Facial Cosmetic Acupuncture on Facial Elasticity: An Open-Label, Single-Arm Pilot Study

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Younghee Yun ◽  
Sehyun Kim ◽  
Minhee Kim ◽  
KyuSeok Kim ◽  
Jeong-Su Park ◽  
...  
Keyword(s):  
Pilot Study ◽  
Large Scale ◽  
Muscle Tone ◽  
Common Adverse Event ◽  
University Hospital ◽  
Secondary Outcome ◽  
Open Label ◽  
Self Assessment ◽  
Before And After ◽  
Moiré Topography

Background. The use of acupuncture for cosmetic purposes has gained popularity worldwide. Facial cosmetic acupuncture (FCA) is applied to the head, face, and neck. However, little evidence supports the efficacy and safety of FCA. We hypothesized that FCA affects facial elasticity by restoring resting mimetic muscle tone through the insertion of needles into the muscles of the head, face, and neck.Methods. This open-label, single-arm pilot study was implemented at Kyung Hee University Hospital at Gangdong from August through September 2011. Participants were women aged 40 to 59 years with a Glogau photoaging scale III. Participants received five treatment sessions over three weeks. Participants were measured before and after FCA. The primary outcome was the Moire topography criteria. The secondary outcome was a patient-oriented self-assessment scale of facial elasticity.Results. Among 50 women screened, 28 were eligible and 27 completed the five FCA treatment sessions. A significant improvement after FCA treatment was evident according to mean change in Moire topography criteria (from 1.70 ± 0.724 to 2.26 ± 1.059,P<0.0001). The most common adverse event was mild bruising at the needle site.Conclusions. In this pilot study, FCA showed promising results as a therapy for facial elasticity. However, further large-scale trials with a controlled design and objective measurements are needed.

scholarly journals THU0642-HPR EVOLUTION OF THE PERCEPTIONS OF RA PATIENTS AFTER EDUCATION PATIENT SESSION TEACHING METHOTREXATE SELF-INJECTION A PROSPECTIVE PILOT STUDY

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 566.1-566
Author(s):  
S. Afilal ◽  
H. Rkain ◽  
B. Berchane ◽  
J. Moulay Berkchi ◽  
S. Fellous ◽  
...  
Keyword(s):  
Pilot Study ◽  
Patient Education ◽  
Median Duration ◽  
Large Scale ◽  
Education Session ◽  
Prospective Pilot Study ◽  
Mean Delay ◽  
Lack Of Information ◽  
Level Of Satisfaction ◽  
Before And After

Background:Methotrexate is a gold standard for treatment of RA. In our context, RA patients prefer to be injected by paramedics rather than self-injecting. This can be explained by patients’ bad perceptions of self-injection or lack of information. Appropriate self-injection education can therefore be an important element in overcoming these obstacles and improving disease self-management.Objectives:Compare the RA patients’ perceptions on methotrexate self-injection before and after a patient education session.Methods:Prospective pilot study that included 27 consecutive patients (81.5% female, mean age 44.4 years, illiteracy rate 40.7%) with RA (median duration of progression of 4 years, mean delay in referral for specialist of 6 months, median duration of methotrexate use of 1 year). The patients benefited from an individual patient education session to learn how to self-inject with methotrexate subcutaneously. The patient education session was supervised by a nurse and a rheumatologist with a control a week later. Perceptions of the reluctance to self-inject and the difficulties encountered by patients were assessed before the patient education session, after the 1st and 2nd self-injection of methotrexate using a 10 mm visual analog scale. Patients also reported their level of satisfaction (10 mm VAS) after the 1st and 2nd self-injection.Results:The mean duration of patient education session is 13 min.Table I compares the evolution of the degrees of reluctance to self-injection, the difficulties encountered, and the satisfaction experienced by the patients.Table 1.Evolution of RA patients’ perceptions on the methotrexate self-injection. (N = 27)BeforeAfter the 1stself-injectionAfter the 2end self-injectionpVAS reluctance (0-10mm)6,5 ± 3,62,2 ± 2,91,0 ± 2,3<0,0001VAS difficulty (0-10mm)7,5 ± 2,62,5 ± 2,71,0 ± 1,9<0,0001VAS satisfaction (0-10mm)-8,9 ± 1,89,5 ± 1,50,002Conclusion:This study suggests the effectiveness of a methotrexate self-injection patient education session in RA patients. It also highlights the value of patient education in rheumatologic care. A large-scale study is necessary to better interpret and complete these preliminary results from this pilot study.Disclosure of Interests:None declared

scholarly journals Pharmacokinetic and safety study of co-administration of albendazole, diethylcarbamazine, Ivermectin and azithromycin for the integrated treatment of Neglected Tropical Diseases

2020 ◽  
Author(s):  
Lucy N John ◽  
Catherine Bjerum ◽  
Pere Millat Martinez ◽  
Rhoda Likia ◽  
Linda Silus ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Large Scale ◽  
Neglected Tropical Diseases ◽  
Pharmacokinetic Interaction ◽  
Integrated Treatment ◽  
Secondary Outcome ◽  
Pharmacokinetic Data ◽  
Tropical Diseases ◽  
Open Label ◽  
Significant Difference

Abstract Background Pharmacokinetic data are a pre-requisite to integrated implementation of large-scale mass drug administration (MDA) for neglected tropical diseases (NTDs). We investigated the safety and drug interactions of a combination of azithromycin (AZI) targeting yaws and trachoma, with the newly approved ivermectin, albendazole, diethylcarbamazine (IDA) regime for Lymphatic Filariasis. Methodology An open-label, randomized, 3-arm pharmacokinetic interaction study in adult volunteers was carried out in Lihir Island, Papua New Guinea. Healthy adult participants were recruited and randomized to (I) IDA alone, (II) IDA combined with AZI, (III) AZI alone. The primary outcome was lack of a clinically relevant drug interaction. The secondary outcome was the overall difference in the proportion of AEs between treatment arms. Results Thirty-seven participants, eighteen men and nineteen women, were randomized and completed the study. There were no significant drug-drug interactions between the study arms. The GMR of Cmax, AUC0–t, and AUC0–∞ for IVM, DEC, ALB-SOX, and AZI were within the range of 80–125% (GMR for AUC0–∞ for IVM, 87.9; DEC, 92.9; ALB-SOX, 100.0; and AZI, 100.1). There was no significant difference in the frequency of AEs across study arms (AZI and IDA alone arms 9/12 (75%), co-administration arm 12/13 (92%); p = 0.44). All AEs were grade 1 and self-limiting. Conclusions Co-administration of AZI with IDA did not show evidence of significant drug-interactions. There were no serious AEs in any of the study arms. Our data support further evaluation of the safety of integrated MDA for NTDs. Clinical Trials Registration. NCT03664063

scholarly journals OC 8489 CLINICAL DEVELOPMENT OF A THERAPEUTIC VACCINE FOR PREVENTION OF POST KALA AZAR DERMAL LEISHMANIASIS

2019 ◽  
Vol 4 (Suppl 3) ◽  
pp. A9.2-A9
Author(s):  
Paul Kaye ◽  
Ahmed Musa ◽  
Joseph Olobo ◽  
Margaret Mbuchi ◽  
Asrat Hailu Mekuria ◽  
...  
Keyword(s):  
East Africa ◽  
Therapeutic Vaccine ◽  
Clinical Development ◽  
Secondary Outcome ◽  
Therapeutic Trial ◽  
Secondary Outcome Measure ◽  
Open Label ◽  
Kala Azar ◽  
Before And After ◽  
Open Label Phase

BackgroundThe leishmaniases represent a complex of human diseases, with 350 million people at risk of infection worldwide. Although the potential benefits of vaccination have been well-recognised, no human vaccine is registered. Post-kala azar dermal leishmaniasis (PKDL) is a chronic skin disease often following treatment for visceral leishmaniasis (VL). In addition to affecting quality of life, evidence suggests that PKDL patients may also act as reservoirs for VL transmission. Hence, PKDL vaccines may have a significant impact on disease burden. We recently developed a third-generation adenoviral vaccine for leishmaniasis (ChAd63-KH) that has been evaluated for safety and immunogenicity in healthy volunteers (Osman et al,2017). ChAd63-KH is currently being evaluated for safety as a therapeutic in Sudanese PKDL patients, with a phase IIb RCT starting in late 2018. With EDCTP funding, we are initiating a new phase IIa/IIb study (PREV_PKDL) to’determine whether ChAd63-KH can prevent PKDL development.MethodsIn PREV_PKDL, we will conduct an open-label phase IIa safety study, followed by a placebo blinded, phase IIb RCT. Safety and clinical response represent primary outcome measures, and immunogenicity is a secondary outcome measure. In addition, working across the four countries of Leishmaniasis East Africa Platform (LEAP), we will use deep phenotyping methods to study the immune status of patients before and after treatment for VL to understand why PKDL development is limited to specific geographic regions. This work, and other research in the region, will be supported by the creation of a new flow cytometry ‘centre of excellence’ within LEAP.ResultsAn update on the progress of our current therapeutic trial in PKDL patients will be provided.ConclusionPREV_PKDL represents an important step in the clinical development of ChAd63-KH and will help develop capacity to support future vaccine and drug trials for leishmaniasis in the East Africa Region.

scholarly journals Douching With Water Works Device for Perceived Vaginal Odor With or Without Complaints of Discharge in Women With No Infectious Cause of Vaginitis: A Pilot Study

2006 ◽  
Vol 2006 ◽  
pp. 1-4 ◽  
Author(s):  
Ashwin J. Chatwani ◽  
Sarmina Hassan ◽  
Salma Rahimi ◽  
Stacey Jeronis ◽  
Vani Dandolu
Keyword(s):  
Pilot Study ◽  
Outcome Measures ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Open Label ◽  
Significant Change

Objective. To determine if douching with Water Works device for 1 month can (1) lower or eliminate perceived vaginal odor by subject; (2) have any effects on vaginal ecosystem.Methods. Ten women with perceived vaginal odor with or without discharge, douched every day for 4 weeks in an open-label, nonrandomized pilot study. Primary outcome measures included perceived vaginal odor by subject, lactobacilli score from Nugent slide, and acceptance of the Water Works douching system. Secondary outcome included the safety of using this douching device.Results. At week 4, there was improvement in vaginal odor (P=.0006) and there was no significant change in lactobacilli score.Conclusion. Douching with Water Works device is associated with reduction or elimination of vaginal odor without adversely affecting the vaginal ecosystem.

scholarly journals Hemodynamic effects of fluoxetine in pulmonary arterial hypertension: an open label pilot study

2020 ◽  
Vol 10 (4) ◽  
pp. 204589402097195
Author(s):  
Adetoun Sodimu ◽  
Sonja Bartolome ◽  
Oluwatosin P. Igenoza ◽  
Kelly M. Chin
Keyword(s):  
Pilot Study ◽  
Pulmonary Arterial Hypertension ◽  
Arterial Hypertension ◽  
Therapeutic Potential ◽  
Hemodynamic Effects ◽  
Open Label ◽  
Before And After ◽  
Secondary Endpoints ◽  
Pulmonary Arterial ◽  
Fluoxetine Therapy

In order to evaluate the therapeutic potential of fluoxetine in pulmonary arterial hypertension, 13 patients with pulmonary arterial hypertension underwent catheterization before and after 12 (N = 5) or 24 (N = 8) weeks fluoxetine therapy. No change was seen in the primary endpoint of pulmonary vascular resistance, other hemodynamic values, or any secondary endpoints.

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.

Vortioxetine in the Treatment of Mood Disorders Associated with Burning Mouth Syndrome: Results of an Open-Label, Flexible-Dose Pilot Study

Pain Medicine ◽  
2019 ◽  
Author(s):  
Daniela Adamo ◽  
Giuseppe Pecoraro ◽  
Massimo Aria ◽  
Gianfranco Favia ◽  
Michele Davide Mignogna
Keyword(s):  
Pilot Study ◽  
Rating Scales ◽  
Nonparametric Test ◽  
Burning Mouth Syndrome ◽  
University Hospital ◽  
Open Label ◽  
Paired Samples ◽  
Total Pain ◽  
Burning Mouth ◽  
Flexible Dose

Abstract Objective To evaluate the efficacy of a new multimodal antidepressant, vortioxetine (VO), in the management of burning mouth syndrome (BMS). Design Longitudinal single-assessment open-label pilot study. Setting University hospital. Subjects. Thirty BMS patients were enrolled. Methods BMS patients were treated with topical clonazepam and a flexible dose of VO (10 mg, 15 mg, or 20 mg). The visual analog scale (VAS), the Total Pain Rating Index (T-PRI), the Hamilton Rating Scales for Depression (HAM-D) and Anxiety (HAM-A), and the Pittsburgh Sleep Quality Index (PSQI) were performed at baseline (time 0) and after two (time 1), four (time 2), six (time 3), and 12 months (time 4) of treatment. Descriptive statistics and the Wilcoxon nonparametric test for two paired samples were used. Results The BMS patients showed a statistically significant improvement in VAS and T-PRI scores from baseline (median [interquartile range {IQR}] = 10.0 [10–10] and 22.0 [20–24], respectively) to time 4 (median [IQR] = 0.0 [0–0] and 8.0 [7–9], P < 0.001, respectively). Similarly, the HAM-A and HAM-D and PSQI scores showed an improvement from time 0 (median [IQR] = 20 [15.8–22], 19 [16–20.3], and 4.0 [4–7.3], respectively) to time 4 (median [IQR] = 6.0 [6–7], 6.0 [6–7], and 3.0 [3–4], respectively, P < 0.001). Conclusions VO is efficacious and well tolerated in the treatment of BMS in firstline therapy on account of its better receptor pharmacological profile and in second-line treatment for patients who have only partially responded or have reported adverse effects to previous treatments.

scholarly journals A pilot study of a neuroscience-based, harm minimisation programme in schools and youth centres in Australia

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033337 ◽  
Author(s):  
Jennifer Debenham ◽  
Louise Birrell ◽  
Katrina Champion ◽  
Mina Askovic ◽  
Nicola Newton
Keyword(s):  
Pilot Study ◽  
Health Professionals ◽  
School Environment ◽  
Large Scale ◽  
Harm Minimisation ◽  
Older Adolescents ◽  
Before And After ◽  
Evaluation Trial ◽  
The Impact ◽  
Youth Centre

ObjectivesThe primary aim is to evaluate the feasibility of a newly developed, neuroscience-based, alcohol and other drug (AOD) use prevention programme, ‘The Illicit Project’, in Australian older adolescents. The secondary aim is to investigate the impact of the programme on students’ drug literacy levels (a combination of knowledge, attitudes and skills).DesignA pilot study examining the feasibility of The Illicit Project in Australian schools was conducted.ParticipantsStudents aged 15–19 years from two secondary schools and a youth centre and 11 teachers and health professionals from various organisations in Sydney were recruited.InterventionThe intervention consisted of three 90 min workshops delivered by trained facilitators within a month.Primary and secondary measuresStudents completed a drug literacy questionnaire before and after intervention. All participants (students, teachers and health professionals) completed an evaluation questionnaire postprogramme delivery. A paired-sample t-test and descriptive analytics were performed.ResultsStudents (n=169) demonstrated a significant increase in drug literacy levels from preintervention to postintervention (t(169) = −13.22, p<0.0001). Of students evaluating the programme (n=252), over threequarters agreed that The Illicit Project was good or very good (76%), that the neuroscience content was interesting (76%) and relevant (81%), and that they plan to apply the concepts learnt to their own lives (80%). In addition, all teachers and health professionals (n=11) agreed that the programme was feasible and valid for schools and perceived the programme to be effective in reducing the harms and use of AOD.ConclusionsThere is evidence to suggest that The Illicit Project is credible and feasible in the school environment and there are preliminary data to suggest it may help to improve drug literacy levels in young people. A large-scale evaluation trial of the intervention will be conducted to determine the programme’s effectiveness in minimising the harms of AOD in older adolescents.

scholarly journals The Institutional Logic of Digitalism: Exploring The Aftermath of Large-Scale Technology In Healthcare Organisations

2021 ◽  
Author(s):  
Lars Erik Kjekshus ◽  
Bendik Bygstad
Keyword(s):  
Large Scale ◽  
Enterprise Architecture ◽  
Organisational Change ◽  
Healthcare Management ◽  
University Hospital ◽  
Institutional Logic ◽  
Systems Research ◽  
Information Systems Research ◽  
Before And After ◽  
Source Case

Abstract Background: Healthcare organisations experience organisational difficulties and inertia in the implementation of large-scale information and communication technology (ICT). The ongoing discussion concerns the full understanding of these changes and the interplay between ICT, innovation and organisational change.Methods: We introduce ‘digitalism’ as a new institutional logic in healthcare organisations, alongside managerialism and professionalism. To develop our argument, we combine organisational and institutional logic theory with information systems research into enterprise architecture and large-scale ICT systems. We illustrate our arguments with a multi-source case study of a process of organisational development before and after the implementation of centralised large-scale ICT systems at a large Norwegian university hospital in 2015. Conclusion: Understanding of digitalism, blending and competing with traditional institutional logics in healthcare organisations, gives insight into how large-scale technology and organisations are tied together and can contribute to effective healthcare management and prevent organisational inertia.

scholarly journals Pilot Study of Silymarin as Supplementation to Reduce Toxicities in Metastatic Colorectal Cancer Patients Treated with First-Line FOLFIRI Plus Bevacizumab

2021 ◽  
Author(s):  
Tsung-Kun Chang ◽  
Tzu-Chieh Yin ◽  
Wei-Chih Su ◽  
Hsiang-Lin Tsai ◽  
Ching-Wen Huang ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Pilot Study ◽  
Metastatic Colorectal Cancer ◽  
Underlying Mechanism ◽  
Mucosal Damage ◽  
Common Adverse Event ◽  
Control Group ◽  
Study Group ◽  
First Line ◽  
Open Label

Irinotecan, a topoisomerase inhibitor, is a common cytotoxic agent prescribed for metastatic colorectal cancer (mCRC) patients. Diarrhea is the most common adverse event (AE). The underlying mechanism of irinotecan-induced diarrhea is intestinal mucosal damage caused by SN-38 (active metabolite of irinotecan) hydrolyzed from SN-38G (inactive metabolite) by bacterial β-glucuronidase (βG). According to an animal study, silymarin reduces the activity of bacterial βG without impairing antitumor efficacy. We conducted a prospective open-label pilot study to evaluate the effect of silymarin as supplementation in reducing toxicities of mCRC patients undergoing irinotecan-based chemotherapy. We enrolled and randomized seventy mCRC patients receiving first-line FOLFIRI (5-fluorouracil/leucovorin/irinotecan) plus bevacizumab. In each treatment cycles, the study group was administered silymarin capsules (150 mg) three times daily for 7 days. The study group experienced less AEs in diarrhea (5.7% vs. 14.6%, P = 0.002) and nausea (27.0% vs. 40.2%, P = 0.005) in the comparison with the control group, but no significant differences in hepatic toxicities were observed. In conclusion, Simultaneous administration of silymarin is a potential effective supplementation for reducing toxicities in mCRC patients undergoing first-line 53 FOLFIRI plus bevacizumab, especially in diarrhea and nausea.

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