scholarly journals Supporting Older Family Caregivers of Young Adults with IDD: A Pilot Program with Socially Assistive Robotics

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 813-813
Author(s):  
Ling Xu ◽  
Julienne Greer ◽  
Noelle Fields ◽  
Priscila Tamplain ◽  
John Bricout ◽  
...  
Keyword(s):  
Family Caregivers ◽  
Phase Ii ◽  
Social Presence ◽  
Social Engagement ◽  
Mixed Methods Research ◽  
Program Design ◽  
Assistive Robotics ◽  
Care Recipient ◽  
Phase Iii ◽  
Interactive Engagement

Abstract Introduction The need for caregiver respite is well-documented for the care of persons with IDD. Social Assistive Robotics (SAR) offer promise in addressing the need for caregiver respite through ‘complementary caregiving’ activities that promote engagement and learning opportunities for a care recipient (CR) with IDD. This study explored the acceptability and usefulness of a SAR caregiver respite program responsive to feedback from both the CRs and their older family caregivers (age 55+). Methods Caregiver-CR dyads (N =11) were recruited. A mixed methods research design was deployed in three phases: Phase I with four focus groups to inform the program design; Phase II for program demonstration and evaluation with pre- and post-surveys; and Phase III with post-program interviews for feedback and suggestions. Results Quantitative data analysis in Phase II showed both caregivers and their CRs scored favorably the social presence of the robot (Pepper) and social engagement with Pepper. Caregivers also reported positive perceptions of Pepper in terms of anthropomorphism, animation, likeability, intelligence, and safety. Content analysis from Phase III interviews suggested that the SAR may offer physical/emotional respite to caregivers by providing companionship/friendship as well as promoting independence, safety/monitoring, and interactive engagement with children. Discussion SAR has potential in providing respite for older family caregiver demonstrated by the levels of CR engagement and learning with Pepper. Future studies need a longer program design and larger sample size to test the feasibility and efficacy of the intervention.

Bewegungstherapie und körperliche Aktivität bei Patienten mit Herzinsuffizienz

Praxis ◽  
2018 ◽  
Vol 107 (17-18) ◽  
pp. 951-958 ◽  
Author(s):  
Matthias Wilhelm
Keyword(s):  
Phase I ◽  
Phase Ii ◽  
Körperliche Aktivität ◽  
Phase Iii

Zusammenfassung. Herzinsuffizienz ist ein klinisches Syndrom mit unterschiedlichen Ätiologien und Phänotypen. Die überwachte Bewegungstherapie und individuelle körperliche Aktivität ist bei allen Formen eine Klasse-IA-Empfehlung in aktuellen Leitlinien. Eine Bewegungstherapie kann unmittelbar nach Stabilisierung einer akuten Herzinsuffizienz im Spital begonnen werden (Phase I). Sie kann nach Entlassung in einem stationären oder ambulanten Präventions- und Rehabilitationsprogramm fortgesetzt werden (Phase II). Typische Elemente sind Ausdauer-, Kraft- und Atemtraining. Die Kosten werden von der Krankenversicherung für drei bis sechs Monate übernommen. In erfahrenen Zentren können auch Patienten mit implantierten Defibrillatoren oder linksventrikulären Unterstützungssystemen trainieren. Wichtiges Ziel der Phase II ist neben muskulärer Rekonditionierung auch die Steigerung der Gesundheitskompetenz, um die Langzeit-Adhärenz bezüglich körperlicher Aktivität zu verbessern. In Phase III bieten Herzgruppen Unterstützung.

scholarly journals The 2020 Portrait of American Caregivers

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 681-681
Author(s):  
Regina Shih
Keyword(s):  
Family Member ◽  
Family Caregivers ◽  
Care Recipient ◽  
Health Conditions ◽  
Complex Care ◽  
The Past ◽  
Care Recipients ◽  
The Us ◽  
National Alliance

Abstract The prevalence of caregiving for an adult or child with special needs has increased significantly in the past five years (from 18.2% to over 21.3%), driven by an increase in the prevalence of caring for a family member or friend aged 50 and older. At the same time, care recipients have greater health and functional needs that necessitate care from others in comparison to 2015. These new 2020 data from the Caregiving in the US Survey by the National Alliance for Caregiving suggests that not only are more American adults taking on the role of caregiver, but they are doing so for increasingly complex care situations. This paper addresses the prevalence of caregiving including the demographics of family caregivers, relationship between the caregiver and the care recipient, health conditions of the care recipient, and living situations of care recipients and their caregivers.

scholarly journals AB0332 IMMUNOSUPPRESSIVE AND IMMONOMODULATING AGENTS IN RHEUMATOID ARTHRITIS: A SYSTEMATIC REVIEW OF CLINICAL TRIALS AND THEIR CURRENT DEVELOPMENT STAGE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1464.1-1465
Author(s):  
J. Blaess ◽  
J. Walther ◽  
J. E. Gottenberg ◽  
J. Sibilia ◽  
L. Arnaud ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
B Cells ◽  
Phase I ◽  
Phase Ii ◽  
Clinical Development ◽  
Phase Iii ◽  
Jak Inhibitors ◽  
Exclusion Criteria ◽  
Immunomodulating Drugs

Background:Rheumatoid arthritis (RA) is the most frequent chronic inflammatory diseases with an incidence of 0.5% to 1%. Therapeutic arsenal of RA has continuously expanded in recent years with the recent therapeutic progress with the arrival of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biological (bDMARDs) and targeted synthetic (tsDMARDs), JAK inhibitors. However, there are still some unmet needs for patients who do not achieve remission and who continue to worsen despite treatments. Of note, only approximately 40% of patients are ACR70 responders, in most randomized controlled trials. For these patients, finding new therapeutic avenues is challenging.Objectives:The objective of our study was to analyze the whole pipeline of immunosuppressive and immunomodulating drugs evaluated in RA and describe their mechanisms of action and stage of clinical development.Methods:We conducted a systematic review of all drug therapies in clinical development in RA in 17 databases of international clinical trials. Inclusion criterion: study from one of the databases using the keywords “Rheumatoid arthritis” (search date: June 1, 2019). Exclusion criteria: non-drug trials, trials not related to RA or duplicates. We also excluded dietary regimen or supplementations, cellular therapies, NSAIDs, glucorticoids or their derivatives and non-immunosuppressive or non-immunomodulating drugs. For each csDMARD, bDMARD and tsDMARD, we considered the study at the most advanced stage. For bDMARDs, we did not take into account biosimilars.Results:The research identified 4652 trials, of which 242 for 243 molecules met the inclusion and exclusion criteria. The developed molecules belong to csDMARDs (n=21), bDMARDs (n=117), tsDMARDs (n=105).Among the 21 csDMARDs molecules: 8 (38%) has been withdrawn, 4 (19%) are already labelled in RA (hydroxychloroquine, leflunomide, methotrexate and sulfasalazine) and 9 (43%) are in development: 1 (11%) is in phase I/II, 5 (56%) in phase II, 3 (33%) in phase IV.Among the 117 bDMARDs molecules: 69 (59%) has been withdrawn, 9 (8%) are labeled in RA (abatacept, adalimumab, anakinra, certolizumab, etanercept, golimumab, infliximab, rituximab, sarilumab, tocilizumab) and 39 (33%) are in development: 9 (23%) in phase I, 3 (8%) in phase I/II, 21 (54%) in phase II, 5 (12%) are in phase III, 1 (3%) in phase IV. bDMARDs currently under development target B cells (n=4), T cells (n=2), T/B cells costimulation (n=2),TNF alpha (n=2), Interleukine 1 or his receptor (n=3), Interleukine 6 or his receptor (n=7), Interleukine 17 (n=4), Interleukine 23 (n=1), GM-CSF (n=1), other cytokines or chemokines (n=5), integrins or adhesion proteins (n=3), interferon receptor (n=1) and various other targets (n=4).Among the 105 tsDMARDs molecules: 64 (61%) has been withdrawn, 6 (6%) JAK inhibitors, have just been or will probably soon be labelled (baricitinib, filgotinib, peficitinib, tofacitinib and upadacitinib), 35 (33%) are in development: 8 (24%) in phase I, 26 (74%) in phase II, 1 (3%) in phase III and. tsDMARDs currently under development target tyrosine kinase (n=12), janus kinase (JAK) (n=3), sphingosine phostate (n=3), PI3K pathway (n=1), phosphodiesterase-4 (n=3) B cells signaling pathways (n=3) and various other targets (n=10).Conclusion:A total of 242 therapeutic trials involving 243 molecules have been or are being evaluated in RA. This development does not always lead to new treatments since 141 (58%) have already been withdrawn. Hopefully, some of the currently evaluated drugs will contribute to improve the therapeutic management of RA patients, requiring a greater personalization of therapeutic strategies, both in the choice of molecules and their place in therapeutic sequences.Disclosure of Interests:Julien Blaess: None declared, Julia Walther: None declared, Jacques-Eric Gottenberg Grant/research support from: BMS, Pfizer, Consultant of: BMS, Sanofi-Genzyme, UCB, Speakers bureau: Abbvie, Eli Lilly and Co., Roche, Sanofi-Genzyme, UCB, Jean Sibilia: None declared, Laurent Arnaud: None declared, Renaud FELTEN: None declared

scholarly journals Positive Aspects of Caregiving Among Family Caregivers of Individuals With Dementia

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 358-359
Author(s):  
Mary Grace Asirot ◽  
Anna Papazyan ◽  
Yeonsu Song
Keyword(s):  
Mental Health ◽  
Sleep Quality ◽  
Family Caregivers ◽  
Care Recipient ◽  
Related Factors ◽  
Negative Experience ◽  
Care Recipients ◽  
Positive Aspects Of Caregiving ◽  
Positive Caregiving ◽  
And Behavior

Abstract Traditionally, caregiving for individuals with dementia has been viewed as a negative experience. Understanding positive aspect of caregiving and related factors is important to improve health among family caregivers. We analyzed baseline data from an ongoing dyadic sleep education trial for individuals with dementia and their caregivers (N=21 dyads; mean age 70.8± 11.1 for caregivers, 80.5± 8.3 for care-recipients). The Positive Aspects of Caregiving (PAC 9-item) was used to assess subjective satisfaction with caregiving. Other measures included Zarit Burden Interview (ZBI), SF-12 Health Survey (SF-12v2), Revised Memory and Behavior Problems Checklist (RMBPC), and Pittsburgh Sleep Quality Index (PSQI). Pearson correlations and t-tests were calculated for analyses. Caregivers most frequently endorsed that caregiving enabled them to appreciate life more (n=16 agreed a lot). Caregivers who began providing care within the first few months of the care-recipient needing care (n=16) had greater positive aspects of caregiving than those who started providing care sometime later (n=5) (36.37±7.33 versus 25.8±8.29, p=0.01). Caregivers with higher PAC scores had lower ZBI score (r=-0.49, p=0.02), better mental health on the SF-12v2 (r=0.53, p=0.01), less distress related to care-recipient behaviors on the RMBPC (r=-0.50, p=0.02), and lower PSQI subscale (perceived sleep quality) score (r= -0.46, p=0.04). Findings suggest that higher positive caregiving experience was associated with better mental health and sleep quality, and less burden and distress from the care-recipients behaviors. More research is needed to better understand this relationship and to determine possible interventions to increase positive aspects of caregiving.

scholarly journals Determination of Efficacy of Single and Double 4.7 mg Deslorelin Acetate Implant on the Reproductive Activity of Female Pond Sliders (Trachemys scripta)

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 660
Author(s):  
Edoardo Bardi ◽  
Martina Manfredi ◽  
Raffaella Capitelli ◽  
Emanuele Lubian ◽  
Alessandro Vetere ◽  
...  
Keyword(s):  
Phase Ii ◽  
Egg Production ◽  
Reproductive Activity ◽  
Trachemys Scripta ◽  
Phase Iii ◽  
Control Group ◽  
Sexual Hormones ◽  
Significant Difference ◽  
Group 6 ◽  
Plasmatic Concentration

The use of long-acting gonadotropin-releasing hormone (GnRH) agonists to suppress fertility has been poorly investigated in reptiles, and the few available studies show inconsistent results. The efficacy of single and double intramuscular 4.7 mg deslorelin acetate implants in captive pond sliders (Trachemys scripta) was investigated, with 20 animals divided into three groups: a single-implant group (6 animals), a double-implant group (6 animals), and a control group (no implant). During one reproductive season (March to October), plasmatic concentration of sexual hormones (estradiol, progesterone, and testosterone) and ovarian morphometric activity via computed tomography were monitored about every 30 days. A significative decrease in the number of phase II ovarian follicles was detected in the double-implant group compared with the control group, but no significant difference was noted in the number of phase III and phase IV follicles, egg production, and plasmatic concentration of sexual hormones. Results show that neither a single nor a double deslorelin acetate implant can successfully inhibit reproduction in female pond sliders during the ongoing season, but the lower number of phase II follicles in the double-implant group can possibly be associated with reduced fertility in the following seasons.

scholarly journals A phase II study of high-dose cisplatin and VP-16 in neuroblastoma: a report from the Société Française d'Oncologie Pédiatrique.

1987 ◽  
Vol 5 (6) ◽  
pp. 941-950 ◽  
Author(s):  
T Philip ◽  
R Ghalie ◽  
R Pinkerton ◽  
J M Zucker ◽  
J L Bernard ◽  
...  
Keyword(s):  
Hearing Loss ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Bone Marrow Involvement ◽  
Stage Iv ◽  
Observation Time ◽  
Phase Iii ◽  
High Dose ◽  
Initial Stage ◽  
Duration Of Response

Forty-seven children or adolescents with initial stage IV (42 patients) or stage III (five) advanced neuroblastoma (12 were progressing after relapse and 35 had never reached complete remission [CR] after conventional therapy) were included in a phase II study of the combination of high-dose VP-16 (100 mg/m2/d X 5) and high-dose cisplatin (CDDP) (40 mg/m2/d X 5). Twenty patients had received prior CDDP therapy (total dose, 100 to 640 mg/m2; median, 320 mg/m2) and 38 of 47 had bone marrow involvement when included in the study. The overall response rate was 55%, with 22% CR. Duration of response was 5 to 18 months, with a median of 10 months. Eight patients are still disease free, with a median observation time of 13 months, but all had received additional therapy after two courses of this regimen. Gastrointestinal toxicity was frequent but tolerable. Myelosuppression was severe but of brief duration, ie, nadir of neutrophils was observed at day 15 with 95% of the patients recovering a normal count before day 28, and nadir of platelet count was at day 17 with only two severe and reversible episodes of bleeding. The overall incidence of sepsis was 8% (seven of 92 courses), with no death related to infection. No acute renal failure was observed after two courses, and only three of 47 children experienced a clear reduction of renal function. After two courses, only two children showed a hearing loss in the 1,000 to 2,000 Hz range, although hearing loss above the 2,000 Hz level was frequently encountered. It is concluded that high-dose VP-16 and CDDP is an effective regimen in advanced neuroblastoma with acceptable toxicity. Phase III studies are needed in previously untreated patients. J Clin Oncol 5:941-950.

Trimodality bladder-sparing approach versus radical cystectomy for invasive bladder cancer

2014 ◽  
Vol 13 (4) ◽  
pp. 428-437 ◽  
Author(s):  
Samy M. AlGizawy ◽  
Hoda H. Essa ◽  
Mostafa E. Abdel-Wanis ◽  
Ahmed M. Abdel Raheem
Keyword(s):  
Bladder Cancer ◽  
Radical Cystectomy ◽  
Phase Ii ◽  
Transurethral Resection ◽  
Residual Disease ◽  
Bladder Tumour ◽  
Phase Iii ◽  
Invasive Bladder Cancer ◽  
Combined Modality ◽  
Combined Chemoradiotherapy

AbstractPurposeTo compare the outcome among patients with invasive bladder cancer treated with cystectomy alone with outcome among those treated with combined-modality treatment in a randomised phase III trial.Patients and methodsPatients with histologically confirmed invasive non-metastatic bladder cancer T2-3, N0 and M0 were randomly assigned to two arms: Arm 1: of which all patients underwent radical cystectomy (RC) alone; and Arm 2, of which all patients were subjected to maximal transurethral resection of bladder tumour, followed 2 weeks later by combined chemoradiotherapy. The whole pelvis received 46 Gy in 23 fractions over 4·5 weeks. Chemotherapy was administered concomitantly with radiotherapy with: cisplatin 70 mg/m2 q. 3 weeks and Gemcitabine 300 mg/m2 D 1, 8 and 15 q. 3 weeks for two cycles. Patients who had complete response were shifted to phase II treatment: 20 Gy/10 fractions/2 weeks to the bladder. Patients with residual tumour underwent RC.ResultsOf the 80 patients assigned Arm 2, a visibly completed transurethral resection of the bladder tumour was possible in 48 patients (60%). Phase I of combined chemoradiotherapy (CCRT) was accomplished in 74 patients. Post-induction urologic evaluation revealed no evidence of disease in 62 patients (83·8%) and residual disease in 12 patients (16·2%). Phase II of CCRT was completed in 58 of the 62 patients. The median follow-up for all patients is 27 months (range: 4–49). The 3-year overall survival (OS) for the combined-modality group and for the surgery group were 61 and 63%, respectively (p = 0·425), whereas the disease-specific survival (DSS) for each group was 69 and 73%, respectively (p = 0·714). The 3-year OS with bladder preservation for Arm 2 patients was 50%.Multivariate analysis for the whole series showed that tumour stage and performance status (PS) were the only factors independently associated with DSS, although PS was the only factor independently associated with OS. In addition, residual disease after transurethral resection of the bladder tumour in Arm 2 patients was independently associated with both DSS and OS.Acute toxicity was moderate and most of the late toxicities were grade 2 with no grade 4 toxicity and no treatment-related deaths, none required cystectomy for bladder contraction.ConclusionThis study demonstrates that trimodality bladder-preserving approach represents a valid alternative for suitable patients. The OS and DSS rates of patients treated with trimodality bladder-preserving protocol are comparable to the results reported on patients treated with immediate radical cystectomy.

scholarly journals Unconventional Anticancer Agents: A Systematic Review of Clinical Trials

2006 ◽  
Vol 24 (1) ◽  
pp. 136-140 ◽  
Author(s):  
Andrew J. Vickers ◽  
Joyce Kuo ◽  
Barrie R. Cassileth
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Phase Ii ◽  
Dose Finding ◽  
Phase Iii ◽  
High Dose ◽  
Free Text ◽  
Phase Ii Trials ◽  
Off Label

Purpose A substantial number of cancer patients turn to treatments other than those recommended by mainstream oncologists in an effort to sustain tumor remission or halt the spread of cancer. These unconventional approaches include botanicals, high-dose nutritional supplementation, off-label pharmaceuticals, and animal products. The objective of this study was to review systematically the methodologies applied in clinical trials of unconventional treatments specifically for cancer. Methods MEDLINE 1966 to 2005 was searched using approximately 200 different medical subject heading terms (eg, alternative medicine) and free text words (eg, laetrile). We sought prospective clinical trials of unconventional treatments in cancer patients, excluding studies with only symptom control or nonclinical (eg, immune) end points. Trial data were extracted by two reviewers using a standardized protocol. Results We identified 14,735 articles, of which 214, describing 198 different clinical trials, were included. Twenty trials were phase I, three were phase I and II, 70 were phase II, and 105 were phase III. Approximately half of the trials investigated fungal products, 20% investigated other botanicals, 10% investigated vitamins and supplements, and 10% investigated off-label pharmaceuticals. Only eight of the phase I trials were dose-finding trials, and a mere 20% of phase II trials reported a statistical design. Of the 27 different agents tested in phase III, only one agent had a prior dose-finding trial, and only for three agents was the definitive study initiated after the publication of phase II data. Conclusion Unconventional cancer treatments have not been subject to appropriate early-phase trial development. Future research on unconventional therapies should involve dose-finding and phase II studies to determine the suitability of definitive trials.

scholarly journals Protein misfolding, amyotrophic lateral sclerosis and guanabenz: protocol for a phase II RCT with futility design (ProMISe trial)

BMJ Open ◽  
2017 ◽  
Vol 7 (8) ◽  
pp. e015434 ◽  
Author(s):  
Eleonora Dalla Bella ◽  
Irene Tramacere ◽  
Giovanni Antonini ◽  
Giuseppe Borghero ◽  
Margherita Capasso ◽  
...  
Keyword(s):  
Endoplasmic Reticulum ◽  
Amyotrophic Lateral Sclerosis ◽  
Placebo Group ◽  
Phase Ii ◽  
Critical Role ◽  
Protein Translation ◽  
Phase Iii ◽  
Protein Accumulation ◽  
Neuroprotective Effects ◽  
Lateral Sclerosis

IntroductionRecent studies suggest that endoplasmic reticulum stress may play a critical role in the pathogenesis of amyotrophic lateral sclerosis (ALS) through an altered regulation of the proteostasis, the cellular pathway-balancing protein synthesis and degradation. A key mechanism is thought to be the dephosphorylation of eIF2α, a factor involved in the initiation of protein translation. Guanabenz is an alpha-2-adrenergic receptor agonist safely used in past to treat mild hypertension and is now an orphan drug. A pharmacological action recently discovered is its ability to modulate the synthesis of proteins by the activation of translational factors preventing misfolded protein accumulation and endoplasmic reticulum overload. Guanabenz proved to rescue motoneurons from misfolding protein stress both in in vitro and in vivo ALS models, making it a potential disease-modifying drug in patients. It is conceivable investigating whether its neuroprotective effects based on the inhibition of eIF2α dephosphorylation can change the progression of ALS.Methods and analysesProtocolised Management In Sepsis is a multicentre, randomised, double-blind, placebo-controlled phase II clinical trial with futility design. We will investigate clinical outcomes, safety, tolerability and biomarkers of neurodegeneration in patients with ALS treated with guanabenz or riluzole alone for 6 months. The primary aim is to test if guanabenz can reduce the proportion of patients progressed to a higher stage of disease at 6 months compared with their baseline stage as measured by the ALS Milano-Torino Staging (ALS-MITOS) system and to the placebo group. Secondary aims are safety, tolerability and change in at least one biomarker of neurodegeneration in the guanabenz arm compared with the placebo group. Findings will provide reliable data on the likelihood that guanabenz can slow the course of ALS in a phase III trial.Ethics and disseminationThe study protocol was approved by the Ethics Committee of IRCCS ‘Carlo Besta Foundation’ of Milan (Eudract no. 2014-005367-32 Pre-results) based on the Helsinki declaration.

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