Seizure frequency, quality of life, behavior, cognition, and sleep in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol

2021 ◽  
Vol 124 ◽  
pp. 108325
Author(s):  
Christopher L. Anderson ◽  
Victoria Evans ◽  
Laura Gorham ◽  
Zhao Liu ◽  
Cynthia R. Johnson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Study ◽  
Seizure Frequency ◽  
Pediatric Patients ◽  
Open Label ◽  
Life Behavior

scholarly journals Quality of Life in Childhood Epilepsy in pediatric patients enrolled in a prospective, open-label clinical study with cannabidiol

Epilepsia ◽  
2017 ◽  
Vol 58 (8) ◽  
pp. e96-e100 ◽  
Author(s):  
Evan C. Rosenberg ◽  
Jay Louik ◽  
Erin Conway ◽  
Orrin Devinsky ◽  
Daniel Friedman
Keyword(s):  
Quality Of Life ◽  
Clinical Study ◽  
Pediatric Patients ◽  
Childhood Epilepsy ◽  
Open Label

scholarly journals Nine-year prospective efficacy and safety of brain-responsive neurostimulation for focal epilepsy

Neurology ◽  
2020 ◽  
Vol 95 (9) ◽  
pp. e1244-e1256 ◽  
Author(s):  
Dileep R. Nair ◽  
Kenneth D. Laxer ◽  
Peter B. Weber ◽  
Anthony M. Murro ◽  
Yong D. Park ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Seizure Frequency ◽  
Focal Epilepsy ◽  
Responder Rate ◽  
Seizure Freedom ◽  
Open Label ◽  
Cognitive Domains ◽  
Signed Rank

ObjectiveTo prospectively evaluate safety and efficacy of brain-responsive neurostimulation in adults with medically intractable focal onset seizures (FOS) over 9 years.MethodsAdults treated with brain-responsive neurostimulation in 2-year feasibility or randomized controlled trials were enrolled in a long-term prospective open label trial (LTT) to assess safety, efficacy, and quality of life (QOL) over an additional 7 years. Safety was assessed as adverse events (AEs), efficacy as median percent change in seizure frequency and responder rate, and QOL with the Quality of Life in Epilepsy (QOLIE-89) inventory.ResultsOf 256 patients treated in the initial trials, 230 participated in the LTT. At 9 years, the median percent reduction in seizure frequency was 75% (p < 0.0001, Wilcoxon signed rank), responder rate was 73%, and 35% had a ≥90% reduction in seizure frequency. We found that 18.4% (47 of 256) experienced ≥1 year of seizure freedom, with 62% (29 of 47) seizure-free at the last follow-up and an average seizure-free period of 3.2 years (range 1.04–9.6 years). Overall QOL and epilepsy-targeted and cognitive domains of QOLIE-89 remained significantly improved (p < 0.05). There were no serious AEs related to stimulation, and the sudden unexplained death in epilepsy (SUDEP) rate was significantly lower than predefined comparators (p < 0.05, 1-tailed χ2).ConclusionsAdjunctive brain-responsive neurostimulation provides significant and sustained reductions in the frequency of FOS with improved QOL. Stimulation was well tolerated; implantation-related AEs were typical of other neurostimulation devices; and SUDEP rates were low.ClinicalTrials.gov identifierNCT00572195.Classification of evidenceThis study provides Class IV evidence that brain-responsive neurostimulation significantly reduces focal seizures with acceptable safety over 9 years.

scholarly journals An Exploratory Study on the Anti-inflammatory Effects of Fucoidan in Relation to Quality of Life in Advanced Cancer Patients

2017 ◽  
Vol 17 (2) ◽  
pp. 282-291 ◽  
Author(s):  
Hidenori Takahashi ◽  
Mitsuhiko Kawaguchi ◽  
Kunihiro Kitamura ◽  
Seiji Narumiya ◽  
Munenori Kawamura ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Study ◽  
Side Effects ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
High Sensitivity ◽  
Advanced Cancer Patients ◽  
Open Label ◽  
Anti Inflammatory

Background. Conventional anticancer therapies still cause difficulties with selective eradication and accompanying side effects that reduce patients’ quality of life (QOL). Fucoidan is extracted from seaweeds and has already exhibited broad bioactivities, including anticancer and anti-inflammatory properties, in basic studies. It is expected to enhance therapeutic efficacy and minimize side effects in cancer patients; however, despite its potential benefits, there are very few clinical trials using fucoidans. Therefore, we performed an exploratory clinical study for advanced cancer patients to examine the efficacy of fucoidans, especially focusing on inflammation in relation to QOL scores. Methods. We conducted a prospective, open-label clinical study for advanced cancer patients using fucoidans via oral administration; 20 advanced cancer patients with metastases were recruited and were given 400 mL/d fucoidan (10 mg/mL) for at least 4 weeks. Inflammatory biomarkers, including high-sensitivity C-reactive protein and various cytokines, and QOL scores were monitored before treatment, after 2 weeks, and after 4 weeks of fucoidan ingestion. Results. The main proinflammatory cytokines, including interleukin-1β (IL-1β), IL-6, and tumor necrosis factor-α (TNF-α) were significantly reduced after 2 weeks of fucoidan ingestion. QOL scores, including fatigue, stayed almost stable without significant changes during the study period. The univariate and multivariate analyses revealed that the responsiveness of IL-1β was a significant independent prognostic factor. Conclusion. This is the first study providing evidence of the anti-inflammatory effects of fucoidans for advanced cancer patients. In future studies, larger blinded, controlled trials are required to establish the efficacy of fucoidan as supportive care for cancer patients, especially those undergoing chemotherapy.

Effectiveness of Individualised Homoeopathic Medicines versus Conventional Treatment in the Management of Primary Dysmenorrhoea in Young Unmarried Females: A Randomised, Open-Label, Clinical Study

2020 ◽  
Author(s):  
Lily Jain ◽  
C Nayak ◽  
M B. Sharma ◽  
Kushal Gehlot
Keyword(s):  
Quality Of Life ◽  
Clinical Study ◽  
Severe Pain ◽  
Conventional Treatment ◽  
Moderate Pain ◽  
Open Label ◽  
Primary Dysmenorrhoea ◽  
Group I ◽  
Group Ii

Abstract Background Primary dysmenorrhoea (PD) is a painful menstruation without any identifiable pelvic pathology. More than 70% of teenagers suffer from varying degrees of discomfort during menstruation. Effective conventional treatment of PD includes non-steroidal anti-inflammatory drugs or oral contraceptive pills that usually have adverse effects. Objective The objective of the present study was to compare the effectiveness of individualised homoeopathic medicines with symptomatic conventional treatment in management of PD in young unmarried females by using Visual Analogue Scale (VAS) for assessing intensity of pain and World Health Organization Quality of Life: Brief Version (WHOQOL-BREF) scale for assessing the quality of life (QoL). Materials and Methods In this randomised, open-label, clinical study, 80 patients were randomly allocated in two groups: one that were indicated homoeopathic medicines (Group I; N = 40) and the other with conventional treatment (Group II; N = 40). The selection of homoeopathic medicines was based on individualisation, and follow-up of cases was done every month for six cycles. VAS score was used to assess pain intensity and WHOQOL-BREF scale was used for assessing QoL, at 3 and 6 months of treatment. Results In Group I, out of 40 patients, 14 (35%) cases reported moderate pain and 26 (65%) reported severe pain before treatment, out of whom 29 (72.5%) patients had mild pain, 8 (20%) cases moderate pain and 3 (7.5%) cases severe pain, after homoeopathic treatment. In Group II, out of 40 patients, 11 (27.5%) reported moderate pain and 29 (72.5%) had severe pain before treatment, whereas 12 (30%) patients reported mild, 16 (40%) moderate pain and 12 (30%) severe pain, after conventional treatment. Independent t-test was applied to compare after treatment the score of VAS and WHOQOL-BREF mean transformed score in both groups, which showed that the difference was statistically significant. The t-value was –4.186 (p < 0.0001) for VAS and 3.988 (p < 0.0001) for overall domain WHOQOL-BREF mean transformed score. Conclusion It was concluded that intensity of pain during menses was reduced and QoL improved in patients with PD in homoeopathic intervention group, which proved the effectiveness of individualised homoeopathic medicines.

scholarly journals Glatiramer Acetate Treatment in Multiple Sclerosis-Associated Fatigue—Beneficial Effects on Self-Assessment Scales But Not on Molecular Markers

Biomolecules ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 393
Author(s):  
Oliver Neuhaus ◽  
Wolfgang Köhler ◽  
Florian Then Bergh ◽  
Wolfgang Kristoferitsch ◽  
Jürgen Faiss ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Multiple Sclerosis ◽  
Glatiramer Acetate ◽  
Neurotrophic Factors ◽  
Common Symptom ◽  
Mrna Levels ◽  
Open Label ◽  
Immunological Parameters ◽  
Beneficial Effects

Although fatigue is a common symptom in multiple sclerosis (MS), its pathomechanisms are incompletely understood. Glatiramer acetate (GA), an immunomodulatory agent approved for treatment of relapsing-remitting MS (RRMS), possesses unique mechanisms of action and has been shown to exhibit beneficial effects on MS fatigue. The objective of this study was to correlate clinical, neuropsychological, and immunological parameters in RRMS patients with fatigue before and during treatment with GA. In a prospective, open-label, multicenter trial, 30 patients with RRMS and fatigue were treated with GA for 12 months. Inclusion criterion was the presence of fatigue as one of the most frequent and disabling symptoms. Before and during treatment, fatigue was assessed using the Fatigue Severity Scale (FSS), the MS-FSS, and the Modified Fatigue Impact Scale (MFIS). In addition, fatigue and quality of life were assessed using the Visual Analog Scales (VAS). Laboratory assessments included screening of 188 parameters using real-time PCR microarrays followed by further analysis of several cytokines, chemokines, and neurotrophic factors. Fatigue self-assessments were completed in 25 patients. After 12 months of treatment with GA, 13 of these patients improved in all three scales (with the most prominent effects on the MFIS), whereas 5 patients had deteriorated. The remaining 7 patients exhibited inconsistent effects within the three scales. Fatigue and overall quality of life had improved, as assessed via VAS. Laboratory assessments revealed heterogeneous mRNA levels of cytokines, chemokines, and neurotrophic factors. In conclusion, we were not able to correlate clinical and molecular effects of GA in patients with RRMS and fatigue.

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