title stringlengths 1 1.19k | keywords stringlengths 0 668 | concept stringlengths 0 909 | paragraph stringlengths 0 61.8k | PMID stringlengths 10 11 |
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Protocol. | (DOCX)Click here for additional data file. | PMC10681230 | ||
Tianjin normal University scientific research ethics review form. | (DOCX)Click here for additional data file. | PMC10681230 | ||
Human research ethics approval. | (PDF)Click here for additional data file.(TIFF)Click here for additional data file. | PMC10681230 | ||
CONSORT 2010 checklist of information to include when reporting a randomised trial*. | (DOC)Click here for additional data file.The authors acknowledge the statistical support received through the Research and Statistical Support Service, Faculty of Medicine, The University of Queensland, Australia. | PMC10681230 | ||
References | PMC10681230 | |||
Keywords | hair loss | HAIR LOSS, ANDROGENETIC ALOPECIA | Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders with a higher psychological impact on females. Currently, topical minoxidil is the only FDA-approved treatment for female AGA and it needs life-long application and causes side effects. Cetirizine is an antihistamine that may be effective... | PMC10205881 |
Introduction | hair loss | HAIR LOSS, ANDROGENETIC ALOPECIA | Androgenetic alopecia (AGA) is the most common cause of hair loss in both genders [ | PMC10205881 |
Patients and methods | PMC10205881 | |||
Study design and study participants | hair loss, alopecia, hypersensitivity, FAGA | HAIR LOSS, ALOPECIA, HYPERSENSITIVITY, CARDIOVASCULAR DISEASE | This was a 24-week, double-blind (patient and outcome assessors), randomized, controlled, parallel study. Sixty-six patients were recruited from the Dermatology Clinic, Cairo University Teaching Hospital (Kasr- Al- Ainy), Egypt, after obtaining their written consent and after the approval of the Research Ethics Committ... | PMC10205881 |
Randomization | Patients were randomly assigned into 2 groups with a 1:1 allocation. A blocked size balanced randomization was done through the free online software “sealed envelope.” The software randomly generated numbers that indicated the specific group to which the research subject would be allocated [ | PMC10205881 | ||
Measurements | PMC10205881 | |||
Primary outcomes | hair loss rate | BALD | The changes from baseline in the terminal and vellus hairs percent and density, terminal to vellus ratio, mean hair shaft thickness and the average number of hairs per follicular unit in the frontal and vertex areas were measured at 12 and 24 weeks. Dermatoscopic examination was done using a digital dermatoscope (photo... | PMC10205881 |
Secondary outcomes | SIDE EFFECT | Global photographic assessment was conducted at baseline, 12 and 24 weeks at the clinic where standardized photographs of the scalp were taken. Then, a panel of 3 blinded dermatologists and the blinded outcome assessor compared baseline with follow-up photographs of each subject and used a 7-point scale to rate the hai... | PMC10205881 | |
Statistical analysis | ADVERSE EFFECTS | A priori sample size was calculated using G*Power 3.1.9.2 using the trichoscopic evaluation parameters as the primary outcome measure. A total sample size of (28) participants would be required to detect a statistically significant change using both mixed repeated measures ANOVA (RM-ANOVA) and one-way RM-ANOVA tests pr... | PMC10205881 | |
Results | PMC10205881 | |||
Global photographic assessment | The blinded outcome assessor (mean ranks: group 1 = 30.05 and The response rates to treatment based on the panel of dermatologists were measured where slight increase in hair growth = good response, moderate increase = very good and great increase = excellent. Group 1 showed excellent response in 16 patients, very good... | PMC10205881 | ||
Treatment safety | hair loss, itching, dandruff | HAIR LOSS, DANDRUFF | The reported side effects were itching, dry hair, initial hair loss and dandruff which are known side effects of minoxidil and the patients did not complain of any side effects after cetirizine application. There was no significant difference between groups in the number of patients with side effects ( | PMC10205881 |
Acknowledgements | We would like to thank Dr. Ashraf Wageeh, Managing Director Global Pharmaceutical Group, and Global Napi for providing us with the cetirizine powder. | PMC10205881 | ||
Author contributions | Research idea was given by HRN, conceptualization was done by all authors equally, medication preparation by EAB, random allocation, enrollment, assignment, patients questionnaires and follow-up by EAB, global photographic assessment and trichoscopic parameters outcome assessor by SIE-S, statistical analysis by EAB, ma... | PMC10205881 | ||
Funding | Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). None. | PMC10205881 | ||
Data availability | Data are available on request from the authors. | PMC10205881 | ||
Declarations | PMC10205881 | |||
Competing interests | The authors declare no competing interests. | PMC10205881 | ||
Conflict of interest | None declared. | PMC10205881 | ||
Ethics approval | This study was performed in line with the principles of the Declaration of Helsinki, and the study protocol (CL 2555) was approved by the Research Ethics Committee for Experimental and Clinical Studies, Faculty of Pharmacy, Cairo University. The study was registered in clinicaltrials.gov, identifier number NCT04481412. | PMC10205881 | ||
Consent | Oral and written informed consents were obtained from all patients before enrollment. | PMC10205881 | ||
References | PMC10205881 | |||
Background | Telerehabilitation has gained significance as a tool to deliver and supervise therapy and training as effective as traditional rehabilitation methods yet more accessible and affordable. An exergame-based telerehabilitation system has recently been developed within the scope of the international Continuum-of-Care (COCAR... | PMC10739244 | ||
Objective | SECONDARY | This study aims to analyze the usability, acceptance, and enjoyment of the COCARE system from the perspective of primary (older adults [OAs]) and secondary (HPs) end users. | PMC10739244 | |
Methods | At 3 trial sites (located in Switzerland, Italy, and Cyprus), participants engaged in a single-session trial of the COCARE system, including testing of exergames and assessments. Mixed methods encompassing qualitative approaches (eg, think aloud) and quantitative measures (eg, Exergame Enjoyment Questionnaire [EEQ], Sy... | PMC10739244 | ||
Results | SD | A total of 45 OAs and 15 HPs participated in this study. The COCARE system achieved good acceptance ratings (OAs: 83%, range 36%-100% and HPs: 81%, range 63.8%-93.3% of the maximum score), and OAs indicated high enjoyment (mean 73.3, SD 12.7 out of 100 points in the EEQ) during the exergame session. The system’s usabil... | PMC10739244 | |
Conclusions | The study’s findings will inform the further development of the COCARE system toward a user-friendly and widely accepted version, enhancing cognitive and physical functions in OAs. Future randomized controlled trials should evaluate the system’s feasibility and effectiveness. | PMC10739244 | ||
Introduction | PMC10739244 | |||
Background | -11 | In recent decades, the development of health technology systems to support patients and health care professionals (HPs) has increased dramatically. For instance, information and communications technologies (ICTs) have recently emerged as valuable tools for telerehabilitation in older adults (OAs) and various patient gr... | PMC10739244 | |
Objectives | SECONDARY | Thus, the primary aim of this study was to assess the usability, acceptance, enjoyment, and safety of the modified COCARE system for OAs (primary end users) and HPs (secondary end users) and identify facilitators of and barriers to its implementation at home. In addition, the study aimed to analyze potential associatio... | PMC10739244 | |
Methods | PMC10739244 | |||
Materials | The COCARE system as an exergame-based telerehabilitation tool consists of four subsystems: (1) Dividat Senso (The assessment system allows for a comprehensive analysis of a user’s functional status to generate training recommendations. A report on the assessment results is delivered directly to the HPs and to OAs (for... | PMC10739244 | ||
Study Design | This usability study was conducted as a cross-sectional study at 3 study sites (ETH Zürich, Switzerland; Materia Group, Cyprus; and Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Don Carlo Gnocchi, Italy) using a mixed methods design (ie, qualitative [think-aloud method and open questions] and quantita... | PMC10739244 | ||
Ethics Approval | The Ethics Commission of ETH Zürich (EK 2021-N-183); the Ethical Committee of Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione Don Carlo Gnocchi, Milan (ID 05_09/12/2021); and Cyprus National Bioethics Committee (ΕΕΒΚ/ΕΠ/2021/51) examined and approved the study confirming that it complies with the princi... | PMC10739244 | ||
Participants | psychiatric | RECRUITMENT, RECRUITMENT | We aimed to recruit 20 participants (15 OAs and 5 HPs) at each site, with a total sample size of 60 participants. To determine sample sizes, we considered studies recommending 3 to 5 [The inclusion criteria for OAs were (1) age of ≥60 years, (2) being community dwelling, and (3) being physically able to independently s... | PMC10739244 |
Study Procedure | Each participant underwent a single assessment session lasting approximately 90 minutes. During this session, the COCARE system components were presented to participants, who subsequently tried them out. Each session at each site followed a standardized protocol corresponding to the natural flow of the COCARE system.Fi... | PMC10739244 | ||
Outcome and Outcome Measures in OAs | PMC10739244 | |||
Primary Outcomes | PMC10739244 | |||
Usability | Usability was assessed quantitatively using the System Usability Scale (SUS) [For the qualitative analysis of usability, a usability protocol was created consisting of 5 categories (Dividat Senso, assessment system, Dividat Senso Flex, exergames, and rehabilitation cockpit) that incorporated observations by the investi... | PMC10739244 | ||
Acceptance | Adopting the definition of Peek et al [ | PMC10739244 | ||
Enjoyment | Enjoyment was measured using the Exergame Enjoyment Questionnaire (EEQ) [ | PMC10739244 | ||
Perceived Safety | dizziness, pain | The analysis of safety involved questions about dizziness or pain experienced during training. Moreover, critical moments such as tripping, slipping, swaying, or fear of falling were noted in the observation protocol. | PMC10739244 | |
Secondary Outcomes: Performance Parameters | One performance parameter for each exergame and assessment stored in the rehabilitation cockpit was collected for further analysis. | PMC10739244 | ||
Contextual Factors | The following factors, previously suggested to be determinants of OAs’ perceived usability and acceptance of technological (training) devices [Demographics (age, sex, and years of education)Training motivation, assessed using the Behavioral Regulation in Exercise Questionnaire–3 (BREQ-3) [ | PMC10739244 | ||
Outcomes and Outcome Measures in HPs | The outcomes and outcome measures for HPs were similar to those for OAs, with only slightly differing questions. While questions for OAs focused particularly on the comprehensibility of all components, HPs were also asked about their acceptance of the system as part of their therapies. Furthermore, exergame enjoyment, ... | PMC10739244 | ||
Statistical Analysis | SECONDARY | Potential differences in demographics between the different trial sites were tested using a 1-way ANOVA for continuous variables and a chi-square test for dichotomous variables.To quantitatively assess usability, descriptive statistics were generated for all quantitative data resulting from the primary outcomes (SUS, s... | PMC10739244 | |
Results | PMC10739244 | |||
Primary End Users (OAs) | PMC10739244 | |||
System Usability (OAs) | The overall SUS score was 68.1 (SD 18.8; n=45) and fell below the predefined 70-point score considered acceptable. When considering the individual countries, the scores differed, revealing acceptable usability in Switzerland (mean 81.5, SD 13.0), borderline acceptable usability in Cyprus (mean 69.3, SD 15.2), and unacc... | PMC10739244 | ||
Enjoyment (OAs) | Overall, participants from all 3 trial sites rated the enjoyment of playing the exergames with a mean score of 73.3 (SD 12.7) out of 100 points (range 34-96). Across the sites, participants in Switzerland reported the highest enjoyment (mean 82.8, SD 8.7), followed by Cyprus (mean 72.8, SD 8.4), whereas participants fr... | PMC10739244 | ||
Safety (OAs) | dizziness, ’ desire, pain | Most older participants (38/45, 84%) indicated no fear of falling while playing the exergames on the Senso Flex. In terms of safety measures, most participants reported no pain (38/45, 84%) or dizziness (41/45, 91%). Although some participants experienced moments of struggling to maintain balance during the assessments... | PMC10739244 | |
Perceived Usability of Single Components of the COCARE System (OAs) | The following results are based on the self-constructed questionnaire addressing various usability-related topics for each component of the COCARE system. | PMC10739244 | ||
Assessment System | The perceived usability of the assessments and the assessment report was evaluated very positively, with only 4% (2/45; question 2) to 16% (7/45; question 1) of neutral or negative ratings (Usability of (A) the assessment system, (B) the rehabilitation cockpit, and (C) the Senso Flex evaluated by older adults. | PMC10739244 | ||
Rehabilitation Cockpit | The rehabilitation cockpit also received positive ratings (As the rehabilitation cockpit is also intended to serve as a communication tool for HPs to provide training guidance, the concept of such a communication tool was explained to the participants, and they were further asked about their preferences regarding such ... | PMC10739244 | ||
Senso Flex and Exergames | The Senso Flex obtained mixed evaluations. Most participants (37/45, 82%) did not perceive any of the setup steps as difficult. Only a small number of participants experienced difficulties when unrolling the mat (1/45, 2%), connecting the mat to the computer (3/45, 7%), turning on the mat (2/45, 4%), turning on the com... | PMC10739244 | ||
Secondary Outcomes (OAs) | PMC10739244 | |||
Secondary End Users (HPs) | PMC10739244 | |||
System Usability (HPs) | The overall SUS score for HPs was 70.7 (SD 12.3; n=15), slightly surpassing the predefined acceptable threshold of 70 points. However, looking at site differences, participants from Cyprus and Italy rated the system with mean scores of 65.5 (SD 9.42) and 65.5 (SD 6.47) points, respectively, whereas in Switzerland, this... | PMC10739244 | ||
Safety (HPs) | The issue of safety for OAs when training independently using the Senso Flex sparked disagreements among HPs. A total of 33% (5/15) of HPs considered independent use safe, whereas 47% (7/15) remained uncertain and 20% (3/15) even perceived a significant lack of safety. The primary concern raised by HPs was the absence ... | PMC10739244 | ||
Usability of Single Components of the COCARE System (HPs) | PMC10739244 | |||
Assessment System | Overall, HPs provided favorable ratings for the assessment system (Usability of (A) the assessment system, (B) the rehabilitation cockpit, and (C) the Senso Flex evaluated by health care professionals. OA: older adult. | PMC10739244 | ||
Rehabilitation Cockpit | The rehabilitation cockpit received positive evaluations (In terms of future ways of communicating with their patients, most HPs would find it useful to send training reminders (14/15, 93%), motivational messages (13/15, 87%), and training feedback. A total of 87% (13/15) of HPs regarded messages on the system as a fav... | PMC10739244 | ||
Senso Flex and Exergames | Questions related to the Senso Flex primarily concerned its setup and navigation through the games. A total of 20% (3/15) of the participants would not expect any difficulties with any setup step. However, most HPs (9/15, 60%) found it challenging to connect the Senso Flex to the computer, unroll the mat (1/15, 7%), tu... | PMC10739244 | ||
Summary of the Usability Protocol (HPs) | HPs did not share many opinions or suggestions for further development of the Senso but focused more on the other components of the COCARE system. Regarding the assessment system, they found the UI and navigation easy and user-friendly, praising the warm-up feature as well as the possibility of repeating the warm-up as... | PMC10739244 | ||
Discussion | PMC10739244 | |||
Overview | SECONDARY | This study aimed to investigate the usability of the newly developed exergame-based COCARE system for telerehabilitation in OAs. Usability was assessed quantitatively and qualitatively, and valuable insights into the perspectives of OAs and HPs regarding the COCARE system was gained. Overall usability, enjoyment, accep... | PMC10739244 | |
Overall Usability | SD | The overall usability of the system, quantitatively assessed using the SUS, was rated with a mean score of 68.1 (SD 18.8; OAs) and 70.7 (SD 12.3; HPs) points. A score of 70 points has been defined as “fully acceptable” [It is worth noting that usability scores from previous studies on similar exergame systems vary, wit... | PMC10739244 | |
Usability of the Single Components of the COCARE System | PMC10739244 | |||
Assessment System | The assessment system received positive ratings in the questionnaire from both OAs and HPs. However, when asked to think aloud, participants indicated difficulties in understanding the instructions provided by the system, suggesting the integration of videos or pictures to visualize the instructions. These evaluations ... | PMC10739244 | ||
Senso Flex | Concerning the Senso Flex, a crucial aspect for OAs is its setup demands. Observations made by the investigators and the perceived level of difficulty reported by the OAs indicated that, on average, the older participants performed very well in setting up the system. However, it became evident that HPs significantly un... | PMC10739244 | ||
Exergames | Despite encountering several difficulties, both OAs and HPs expressed overall satisfaction with the exergames as they recognized the potential physical and cognitive benefits of the exergame training and awarded high exergame enjoyment scores. This is in line with previous literature, which indicates that exergames are... | PMC10739244 | ||
Rehabilitation Cockpit and Telerehabilitation | DISEASES | The rehabilitation cockpit, serving as a tool for telerehabilitation, garnered positive feedback from both OAs and HPs. Participants found it highly useful and interesting for patients as well as for HPs. These observations are in accordance with previous research, which highlighted that OAs recognize the value of mobi... | PMC10739244 | |
Enjoyment | The average EEQ scores point to a satisfying enjoyment of the exergames—a result supported by the qualitative analyses of satisfaction with the exergames. Manser et al [Drawing on this assumption, Sweetser and Wyeth [ | PMC10739244 | ||
Acceptance | The overall acceptance ratings based on the UTAUT were high among both OAs and HPs. These findings align with those of Baschung Pfister et al [Analyzing the UTAUT subcategories, Surprisingly, | PMC10739244 | ||
Safety | dizziness, pain | ADVERSE EVENTS | Despite momentary balance issues in a few participants, most OAs did not report fear of falling when using the Senso Flex, and only a small number of participants experienced pain or dizziness while playing the exergames, with no adverse events. This aligns with a review conducted by Valenzuela et al [ | PMC10739244 |
Influencing Factors | SECONDARY, DISORDERS | The secondary aim of this study was to analyze possible correlations among potential influencing factors, namely, age, sex, years of education, training motivation, game and assessment performance, and measures of usability. Except for sex and years of education, many significant correlations were found, with the SUS e... | PMC10739244 | |
Strength and Limitations | The strength of this study is that (contrary to previous usability studies) it not only directly compares the opinions and demands of HPs and OAs but also provides valuable insights into country- and culture-related differences within both participant groups. Moreover, this study points to future pathways for developin... | PMC10739244 | ||
Conclusions | This study revealed some differences between OAs and HPs in terms of their perception of usability and acceptance of the COCARE system. OAs demonstrated higher acceptance of the system and better performance on the Senso and Senso Flex and found the setup of the Senso Flex to be easier than expected by most HPs. Furthe... | PMC10739244 | ||
Abbreviations | Behavioral Regulation in Exercise Questionnaire–3Continuum-of-CareExergame Enjoyment Questionnairehealth care professionalinformation and communications technologyMini-Mental State Examinationolder adultStrengthening the Reporting of Observational Studies in EpidemiologySystem Usability ScaleTechnology Acceptance Model... | PMC10739244 | ||
Data Availability | The raw data supporting the conclusions of this study will be made available by the authors without undue reservation to any qualified researcher upon request. | PMC10739244 | ||
Subject terms | multiple myeloma | MULTIPLE MYELOMA | Patients with newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation (ASCT) have lower survival rates and may benefit from frontline regimens that include novel agents. This Phase 1b study (NCT02513186) evaluated preliminary efficacy, safety, and pharmacokinetics (PK) of isatuximab,... | PMC10264885 |
Introduction | transplant-ineligible, tumor | DISEASE PROGRESSION, MULTIPLE MYELOMA (MM), TUMOR | Despite treatment advances contributing to improved outcomes in patients with multiple myeloma (MM), those not eligible for autologous stem cell transplantation (ASCT) have lower survival rates partially due to receiving less-intensive therapy based on advanced age and/or comorbidities [Molecular and immunophenotypic t... | PMC10264885 |
Methods | PMC10264885 | |||
Study design | MM | ONCOLOGY, MAY, RECRUITMENT | This open-label, multicenter, Phase 1b study enrolled adults with measurable NDMM ineligible for (Part A and B) or without intent for (Part B) immediate transplantation. Patients with ultra-high–risk smoldering MM fulfilling IMWG criteria were also eligible. Patients were excluded if they had an Eastern Cooperative Onc... | PMC10264885 |
Treatments | toxicity | DISEASE PROGRESSION | Isa-VRd was administered for four 6-week cycles during the induction phase, followed by Isa-Rd (maintenance) until disease progression, unacceptable toxicity, or patient withdrawal. Based on previous findings in relapsed/refractory MM [ | PMC10264885 |
Assessments | Cancer | ADVERSE EVENT, T(4;14), EVENTS, DISEASE, T(14;16), CANCER | Disease assessments were performed by investigators every cycle based on local laboratory for serum, urine M-protein, and free light chain (FLC) parameters using IMWG criteria [For patients with suspected isatuximab interference on serum immunofixation (IFE), the Sebia HYDRASHIFT 2/4 Isatuximab IFE test was used by the... | PMC10264885 |
Pharmacokinetics | BLOOD | Blood samples were collected at predetermined time points. Isatuximab plasma concentrations were determined with a validated ELISA method (lower limit of quantification, 0.500 ng/mL). Lenalidomide and bortezomib plasma concentrations were determined using validated LC-MS/MS methods (lower limits of quantification, 1.00... | PMC10264885 | |
Immunophenotyping | BLOOD | Blood samples were taken at Day 1 of Cycles 1 and 3, and at the end of treatment to explore microenvironment changes. Immune cell populations (ie, CD3, CD4, and CD8 T cell, and NK-cell subsets) were characterized by multiparametric flow cytometry analysis for cell surface marker expression. | PMC10264885 | |
Statistical analysis | For Part A, Simon’s two-stage optimal design was used to determine the sample size. The null hypothesis that the true confirmed CR response rate is 16% was tested against a one-sided alternative. In the first stage, 13 patients were treated. If there were ≤2 confirmed CR response in these 13 patients, the study was to ... | PMC10264885 | ||
Results | PMC10264885 | |||
Patient disposition | Of the 27 patients treated in Part A, 13 discontinued treatment due to AEs ( | PMC10264885 | ||
Infusion duration | In Part A, median duration for the first infusion was 3 h 44 min for patients receiving the weight-based infusion and 3 h 25 min for patients who switched to the fixed-volume infusion method. The median duration decreased to 2 h 49 min and 1 h 48 min for the second infusion, 2 h 45 min and 1 h 18 min for the third infu... | PMC10264885 | ||
Stem cell mobilization (Part B) | In Part B, 13 (28.3%) patients were eligible but without immediate intent for ASCT and 7 (53.8%) proceeded to stem cell mobilization. Overall, 4 (30.8%) patients proceeded with ASCT: 3 discontinued study treatment to have immediate ASCT per protocol and 1 decided to discontinue study treatment (due to heavy study proce... | PMC10264885 | ||
Best overall response (BOR) | For the 71 patients in Parts A and B comprising the efficacy population, the ORR was 98.6% ( | PMC10264885 | ||
Minimal residual disease | BOR | MRD status was assessed in patients with VGPR or better as BOR. In the efficacy-evaluable population, 36/71 (50.7%) patients achieved MRD- (sensitivity 10 | PMC10264885 |
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