scholarly journals Zytux in Refractory Myasthenia Gravis: A Multicenter, Open-Labeled, Clinical Trial Study of Effectiveness and Safety of a Rituximab Biosimilar

2021 ◽  
Vol 12 ◽  
Author(s):  
Farzad Fatehi ◽  
Kamyar Moradi ◽  
Ali Asghar Okhovat ◽  
Ghazaleh Shojatalab ◽  
Behnaz Sedighi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Myasthenia Gravis ◽  
Clinical Status ◽  
Neuromuscular Disorder ◽  
Clinical Trial Registration ◽  
Prednisolone Dose ◽  
Immune Mediated ◽  
Post Infusion

Objectives: Myasthenia gravis (MG) is an immune-mediated neuromuscular disorder responsive to immunomodulatory treatments. 10–20% of MGs are not responsive to conventional first-line therapies. Here, we sought to investigate the efficacy and safety of rituximab therapy in the treatment of patients with refractory MG.Methods: In a 48-week, multicenter, open-labeled, prospective cohort setting, 34 participants with refractory MG were assigned to receive infusions of Zytux, which is a rituximab biosimilar, according to a validated protocol. Clinical, functional, and quality of life (QoL) measurements were recorded at baseline, and seven further visits using the Myasthenia Gravis Foundation of America (MGFA), Myasthenia Gravis Composite (MGC), Myasthenia Gravis Activities of Daily Living profile (MG-ADL), and Myasthenia Gravis Quality of Life (MGQoL-15) scales. Besides, the post-infusion side effects were systematically assessed throughout the study.Results: The correlation analysis performed by generalized estimating equations analysis represented a significant reduction of MGC, MG-ADL, and MGQoL-15 scores across the trial period. The subgroup analysis based on the patients' clinical status indicated a significant effect for the interaction between time and MGFA subtypes on MG-ADL score, MGC score, and pyridostigmine prednisolone dose, reflecting that the worse clinical condition was associated with a better response to rituximab. Finally, no serious adverse event was documented.Conclusions: Rituximab therapy could improve clinical, functional, and QoL in patients with refractory MG in a safe setting. Further investigations with larger sample size and a more extended follow-up period are warranted to confirm this finding.Clinical Trial Registration: The study was registered by the Iranian Registry of Clinical Trials (IRCT) (Code No: IRCT20150303021315N18).

Rest or 30-Min Walk as Exercise Intervention (RESTOREX) in Myasthenia Gravis: A Randomized Controlled Trial

2021 ◽  
pp. 1-7
Author(s):  
Usha K. Misra ◽  
Jayantee Kalita ◽  
Varun K. Singh ◽  
Aditya Kapoor ◽  
Abhilasha Tripathi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Controlled Trial ◽  
Myasthenia Gravis ◽  
Controlled Trial ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Randomized Controlled ◽  
Secondary Endpoints

<b><i>Introduction:</i></b> There is a lack of evidence about the usefulness of exercise or rest in myasthenia gravis (MG). This study is aimed to evaluate the efficacy and safety of exercise or rest in MG. <b><i>Methods:</i></b> In a single-center open-labeled randomized controlled trial, the patients with mild to moderate MG were randomized to 30-min walk or rest in addition to the standard treatment. The primary endpoint was 50% improvement in the MG Quality of Life (MG-QOL15), and secondary endpoints were change in the Myasthenic Muscle Score (MMS), MG Activities of Daily Living (MGADL), grip strength, dose of acetylcholine esterase inhibitor and prednisone, 6-min walk test (6MWT), decrement in trapezius on the low-rate repetitive nerve stimulation test, and adverse events. The outcomes were defined at 3 months, by &#x3e;50% improvement in these outcome parameters. <b><i>Results:</i></b> Forty patients with MG were randomized to the exercise or rest arm. The 2 arms were matched for demographic and clinical parameters. The patients in the exercise arm had significantly better QOL evidenced by MG-QOL15 (<i>p =</i> 0.02). The secondary endpoints, distance covered in 6MWT (<i>p =</i> 0.007), were also better in the exercise arm without any adverse event. <b><i>Conclusion:</i></b> Regular exercise for 30 min in mild and moderate MG improves quality of life and walking distance compared to rest and is safe. <b><i>Clinical Trial Registration:</i></b> The clinical trial registration number is CTRI/2019/11/021869.

scholarly journals A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nancy A. Hodgson ◽  
Nalaka Gooneratne ◽  
Adriana Perez ◽  
Sonia Talwar ◽  
Liming Huang
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Trial Registration ◽  
Phase Iii ◽  
Poor Sleep ◽  
Sleep Wake Disorders ◽  
Clinical Trial Registration ◽  
Link Type ◽  
Home Based

Abstract Background Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders. Methods A definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms. Discussion The results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia. Clinical trial registration Clinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.

scholarly journals Cognitive Behavioral Approach to Treat Obesity: A Randomized Clinical Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Amanda dos Santos Moraes ◽  
Ricardo da Costa Padovani ◽  
Cauê Vazquez La Scala Teixeira ◽  
Maria Gabriela Soria Cuesta ◽  
Silvandro dos Santos Gil ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Physical Training ◽  
Eating Behaviors ◽  
Behavioral Therapy ◽  
Behavioral Approach ◽  
Cognitive Behavioral ◽  
Total Quality ◽  
Clinical Trial Registration

Our aim was to analyze and compare the effects of three different long-term treatments on anthropometric profiles, eating behaviors, anxiety and depression levels, and quality of life of groups of adults with obesity.Methods: The 43 participants in the study were randomly assigned to one of three groups: the education and health group (EH, n = 12), which received lectures on health topics; the physical exercise group (PE, n = 13), which underwent physical training; and the interdisciplinary therapy plus cognitive behavioral therapy (IT + CBT) (n = 18) group, which received physical training, nutritional advice, and physical and psychological therapy.Results: Total quality of life increased significantly in the EH group (△ = 2.00); in the PE group, body weight significantly decreased (△ = −1.42) and the physical domain of quality of life improved (△ = 1.05). However, the most significant changes were seen in the IT + CBT group, in which the anthropometric profile improved; there were an increase in quality of life in all domains (physical, psychological, social, and environmental), an improvement in eating behaviors [Dutch Eating Behavior Questionnaire (DEBQ), total △ = −8.39], and a reduction in depression [Beck Depression Inventory (BDI), △ = −10.13).Conclusion: The IT + CBT program was more effective than the PE and EH programs.Clinical Trial Registration Number:NCT02573688.

scholarly journals Pens versus syringes to deliver insulin among elderly patients with type 2 diabetes: a randomized controlled clinical trial

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Rafael Vaz Machry ◽  
Gustavo Fonseca Cipriani ◽  
Henrique Umpierre Pedroso ◽  
Rafaela Ramos Nunes ◽  
Thayme Luisa Souza Pires ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Glycemic Control ◽  
Controlled Clinical Trial ◽  
Clinical Trial Registration ◽  
Bolus Insulin ◽  
The Impact

Abstract Background Diabetes mellitus (DM) is a prevalent disease among elderly population. As the disease progresses, insulin may become necessary. The use of pens application seems to be more practical. However, the influence of this method on glycemic control needs to be defined in elderly people. Methods Randomized clinical trial comparing pens and syringes for insulin application among patients with type 2 DM over 60 years old and Glycated Hemoglobin > 8.5% at baseline. The follow-up was 24 weeks, with monthly medical visits to adjust the treatment. All patients received insulin NPH and, if necessary, insulin Regular. We assessed glycemic control, adherence to treatment, hypoglycemia occurrence, need for adjustment in treatment and impact on quality of life, Results We included 121 patients with mean age of 65.75 years. Sixty-one were randomized for pen group (PG) and 60 patients for syringe group (SG). At baseline, mean HbA1c was 10.34 ± 1.66% and 9.90 ± 1.25% (p = 0.103) in PG and SG respectively. Mean HbA1c was 8.39 ± 1.28% in PG and 8.85 ± 1.74% in SG (p = 0.101) at 24 weeks. However, there was a more significant reduction in PG (− 1.94 ± 1.93% in PG and − 1.04 ± 1.46% in SG, p < 0.05) during follow-up. We found no difference in treatment adherence rates, hypoglycemia, greater need for insulin doses or oral medication, and progression to basal-bolus insulin scheme. We also found no difference in the impact of the disease on quality of life between groups. Conclusion Although we did not find any difference in the impact on quality of life, frequency of hypoglycemia or adherence, the PG showed a reduction in HbA1c higher in 24 weeks of follow-up. Clinical trial registration: NCT02517242

scholarly journals The use of Lactobacillus casei DG® prevents symptomatic episodes and reduces the antibiotic use in patients affected by chronic bacterial prostatitis: results from a phase IV study

2021 ◽  
Author(s):  
Tommaso Cai ◽  
Luca Gallelli ◽  
Erika Cione ◽  
Gianpaolo Perletti ◽  
Francesco Ciarleglio ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Symptoms ◽  
Clinical Status ◽  
Well Being ◽  
Antibiotic Use ◽  
Chronic Bacterial Prostatitis ◽  
Symptomatic Recurrence ◽  
Bacterial Prostatitis ◽  
Phase Iv

Abstract Purpose To evaluate the efficacy of Lactobacillus paracasei CNCM I-1572 (L. casei DG®) in both prevention of symptomatic recurrences and improvement of quality of life in patients with chronic bacterial prostatitis (CBP). Methods Patients with CBP attending a single Urological Institution were enrolled in this phase IV study. At enrollment, all patients were treated with antibiotics in agreement with EAU guidelines and then were treated with L. casei DG® (2 capsules/day for 3 months). Clinical and microbiological analyses were carried out before (enrollment, T0) and 6 months (T2) after the treatment. Both safety and adherence to the treatment were evaluated 3 months (T1) after the enrollment. NIH Chronic Prostatitis Symptom Index (CPSI), International Prostate Symptom Score (IPSS) and Quality of Well-Being (QoL) questionnaires were used. The outcome measures were the rate of symptomatic recurrence, changes in questionnaire symptom scores and the reduction of antibiotic use. Results Eighty-four patients were included. At T2, 61 patients (72.6%) reported a clinical improvement of symptoms with a return to their clinical status before symptoms. A time dependent improvement in clinical symptoms with significant changes in NIH-CPSI, IPSS and QoL (mean difference T2 vs T0: 16.5 ± 3.58; − 11.0 ± 4.32; + 0.3 ± 0.09; p < 0.001), was reported. We recorded that L. casei DG® treatment induced a statistically significant decrease in both (p < 0.001) symptomatic recurrence [1.9/3 months vs 0.5/3 months] and antibiotic use [− 7938 UDD]. No clinically relevant adverse effects were reported. Conclusions L. casei DG® prevents symptomatic recurrences and improves the quality of life in patients with CBP, reducing the antibiotic use.

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