scholarly journals Changes in asthma and general health after Hurricane Harvey: A natural experiment utilizing an asthma clinical trial, Harris County, TX

2021 ◽  
Vol 2021 (1) ◽  
Author(s):  
Abiodun Oluyomi ◽  
Rebecca J. Bruhl ◽  
Danielle Guffey ◽  
Charles G. Minard ◽  
Ned Levine ◽  
...  
Keyword(s):  
Clinical Trial ◽  
General Health ◽  
Natural Experiment ◽  
Harris County

Clinical downstaging and quality of life after neoadjuvant chemotherapy in patients with locally advanced rectal cancer: Interim analysis from a phase II clinical trial.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e15178-e15178
Author(s):  
Ahmed Abdalla ◽  
Amr M. Aref ◽  
Amer Alame ◽  
Danny Ma ◽  
Mohammed Barawi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Rectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Phase Ii ◽  
General Health ◽  
Locally Advanced ◽  
Advanced Rectal Cancer ◽  
Locally Advanced Rectal Cancer

e15178 Background: The role of neoadjuvant FOLFOX in achieving clinical downstaging and improvement in quality of life (QOL) in patients with locally advanced rectal cancer (LARC) remains to be established. We are conducting a phase II prospective clinical trial to evaluate the use of six cycles of FOLFOX as neoadjuvant chemotherapy in patients with T2-T3/N0-N+ rectal cancer. We now report tumor clinical downstaging and patient-reported QOL in our first patient cohort. Methods: Eleven Patients enrolled in our phase II prospective trial. Patients received three months of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) administered every two weeks. After three weeks of recovery, each patient was treated with conventional chemo-radiotherapy (5FU or capecitabine) All patients had an MRI and endorectal ultrasound at baseline and after completion of FOLFOX. A compilation of validated QOL questionnaires were also administered before and after FOLFOX. Results: A total of 11 patients completed the chemotherapy regimen. Based on pelvic MRI, complete clinical response (T0N0) was achieved by seven patients (64%), one patient (9%) was clinically downstaged but three (27%) didn’t have any changes following FOLFOX. Importantly, we found no disease progression during the FOLFOX course. QOL assessment after FOLFOX regimen showed trend towards improvement in general health, mobility, bladder control and psychological health. These changes in QOL were not statistically significant due to the small sample size. Patients self-grading of their general health before starting FOLFOX was 50% compared to 75% after. Of the five patients with pain at time of diagnosis, four reported complete pain relief while the fifth reported improvement from extreme to moderate pain. Three patients reported improvement in their anxiety/depression. In terms of bowel function, although there was trend towards improvement in the urgency subscale, other bowel functions subscales were unchanged. In general, scores for mobility, selfcare, and bladder function were slightly better after FOLFOX. Conclusions: This study suggests that adding only six cycles of neoadjuvant FOLFOX before CRT not only resulted in clinical downstaging of (LARC) but showed a trend toward improved QOL. This result provides some reassurance for oncologists that this approach does not diminish QOL with no risk of disease progression during the time of neoadjuvant chemotherapy. These findings need to be validated in a larger phase III trial.

scholarly journals The Reduction of Distress Using Therapeutic Geothermal Water Procedures in a Randomized Controlled Clinical Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-10 ◽  
Author(s):  
Lolita Rapolienė ◽  
Artūras Razbadauskas ◽  
Antanas Jurgelėnas
Keyword(s):  
Clinical Trial ◽  
Health Risk ◽  
General Health ◽  
Geothermal Water ◽  
Mineral Waters ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Stress Symptoms ◽  
Distress Scale

Stress is an element of each human’s life and an indicator of its quality. Thermal mineral waters have been used empirically for the treatment of different diseases for centuries.Aim of the Study. To investigate the effects of highly mineralised geothermal water balneotherapy on distress and health risk.Methodology. A randomized controlled clinical trial was performed with 130 seafarers: 65 underwent 2 weeks of balneotherapy with 108 g/L full-mineralisation bath treatment; the others were in control group. The effect of distress was measured using the General Symptoms Distress Scale. Factorial and logistic regression analyses were used for statistical analysis.Results. A significant positive effect on distress (P<0.001) was established after 2 weeks of treatment: the number of stress symptoms declined by 60%, while the intensity of stress symptoms reduced by 41%, and the control improved by 32%. Health risks caused by distress were reduced, and resources increased, whereas the probability of general health risk decreased by 18% (P=0.01).Conclusion. Balneotherapy with highly mineralised geothermal water reduces distress, by reducing the health risk posed by distress by 26%, increasing the health resources by 11%, and reducing probability of general health risk by 18%. Balneotherapy is an effective preventive tool and can take a significant place in integrative medicine.

scholarly journals Effects of exergames and resistance training on well-being in older adults: a randomized clinical trial

2020 ◽  
Vol 14 (3) ◽  
pp. 152-159
Author(s):  
Vandrize Meneghini ◽  
Eduardo Hauser ◽  
Camilo Luis Monteiro Lourenço ◽  
Aline Rodrigues Barbosa
Keyword(s):  
Quality Of Life ◽  
Older Adults ◽  
Clinical Trial ◽  
Resistance Training ◽  
Randomized Clinical Trial ◽  
General Health ◽  
Training Group ◽  
Life Assessment ◽  
Symptoms Of Depression

OBJECTIVE: To analyze the effects of an exergame-based training compared to resistance training on the quality of life and symptoms of depression in older adults. METHODS: This was a two-arm, non-blinded, randomized clinical trial. Thirty-five participants (62.09 ± 7.11 years) were randomized either on the Exergame-based Training Group (n = 17) or the Resistance Training Group (n = 18). Sessions lasted 50 to 60 minutes, three times per week, for 13 weeks. For the Exergame-based Training Group, we used games that simulate sports and adventure activities through Xbox360 Kinect™. The Resistance Training Group performed ten exercises per session for upper and lower limbs using free weights and machines, following linear periodization and individualized loads. Quality of life and symptoms of depression were assessed using the World Health Organization Quality of Life assessment - an abbreviated version (WHOQOL-BREF) and the Geriatric Depression Scale, respectively. We performed a two-way analysis of variance (p ≤ 0.05). RESULTS: Only time effects were identified for overall quality of life, general health, and symptoms of depression. After the intervention, overall quality of life score increased (3.82 ± 0.95 versus 4.18 ± 0.53, p = 0.05), whereas symptoms of depression decreased (3.35 ± 1.73 versus 2.59 ± 1.54, p = 0.02) in the Exergame-based Training Group, and the general health improved in the Resistance Training Group (3.78 ± 0.81 versus 4.11 ± 0.68, p = 0.05) compared with the baseline scores. CONCLUSION: Both training groups improved different aspects of quality of life. The Exergaming-based Training Group improved the overall perception, whereas the Resistance Training Group improved the general health-related perception. Participants in the Exergame-based Training Group also decreased the number of symptoms of depression.

scholarly journals Health-Related Quality of Life in Postpartum Recovery of Women who Practice Hypopressive Physical Activity. Randomized Clinical Trial.

2020 ◽  
Author(s):  
Juan Carlos Sánchez-García ◽  
María josé Aguilar-Cordero ◽  
Maria Montiel-Troya ◽  
Ana Eugenia Marín-Jiménez ◽  
Elena Mellado-García ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Clinical Trial ◽  
General Health ◽  
Low Pressure ◽  
Health Related Quality ◽  
Emotional Role ◽  
Related Quality ◽  
Health Related

Abstract BackgroundPracticing physical exercise is a way of maintaining a healthy lifestyle and it has been demonstrated that it benefits and improves quality of life after labour. Aim To determine whether a workout programme using the Low-Pressure Fitness methodology has an impact on the Health-Related Quality of Life after labour.Material and MethodWe carried out a 12-weeks randomized clinical trial. It started at week 16 after labour and ended at postpartum week 28. Women followed a moderate intensity workout programme, using the Low-Pressure Fitness methodology in the treatment group, and we had a control group of sedentary women to perform a comparison. We used the SF-36v2 questionnaire at the postpartum weeks 16 and 28 to assess the Health-Related Quality of Life in women.ResultsWe found statistically significant differences (p<0.05) in general health components, vitality, emotional role, and mental health in the sample group of women under the Low-Pressure Fitness, who obtained a higher score. We found statistically significant differences in all aspects between the postpartum weeks 16 and 28. The interaction between time and group affect in general health components, vitality, emotional role and the score of mental component. In all of them the score is higher at week 28 and in the Low-Pressure Fitness group.ConclusionsPhysical exercise, following the Low-Pressure Fitness method, improves Health-Related Quality of Life after labour. We found that, when both the treatment and control groups are categorized by body-mass index, the Low-Pressure Fitness method was not determinant to improve the postpartum Health-Related Quality of Life. The trial is registered at the US National Institutes of Health (ClinicalTrials.gov), under the title “Physical Activity in Pregnancy and Postpartum Period, Effects on Women”. Number NCT02761967.

scholarly journals The effect of a care plan based on the Roy adaptation model on general health in hemodialysis patients; a randomized controlled clinical trial

2020 ◽  
Vol 9 (2) ◽  
pp. e11-e11
Author(s):  
Monir Nobahar ◽  
Mohadese Saffari ◽  
Hassan Babamohamadi ◽  
Nemat Sotodehasl ◽  
Majid Mirmohammadkhani
Keyword(s):  
Clinical Trial ◽  
General Health ◽  
Intervention Group ◽  
Hemodialysis Patients ◽  
Care Plan ◽  
Controlled Clinical Trial ◽  
Roy Adaptation Model ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Adaptation Model

Introduction: Evidence suggests that end-stage renal disease (ESRD) significantly affects general health in the patients, causing their general health to be poorer compared to the general population. The Roy adaptation model (RAM) is the best one for ESRD patients. Objectives: The present study aimed to determine the effect of a RAM-based care plan on general health in hemodialysis patients. Patients and Methods: This randomized controlled clinical trial conducted on 60 hemodialysis patients in Iran. The data collected using a demographic questionnaire and the general health questionnaire-28 (GHQ-28). In the intervention group, the Roy assessment form was completed and the RAM-based care plan was then trained in four group sessions over 4 weeks. Individual sessions were also held if required and patients followed-up for 2 weeks. The control group received only routine care. At the end of the follow-up, general health was re-assessed in the patients. The findings were analysed using t test, the chi-square test and the McNemar test. Results: Despite observing no significant differences between the two groups in terms of general health levels before the intervention (P=0.530), the difference was significant after the intervention (P=0.028), since the mean score of general health decreased by 4.07 in the intervention group compared to before the intervention (P=0.003). The intervention significantly affected the subscales of somatic symptoms (P=0.013), anxiety and insomnia (P=0.006), social dysfunction (P=0.016) and depression (P=0.031). Conclusion: The findings suggested the positive effects of using the RAM on general health in hemodialysis patients. The RAM is therefore recommended that be used as a holistic care approach to improving general health in these patients

scholarly journals Health-Related Quality of Life in Postpartum Recovery of Women who Practice Hypopressive Physical Activity. Randomized Clinical Trial

2020 ◽  
Author(s):  
Juan Carlos Sánchez-García ◽  
María José Aguilar-Cordero ◽  
Maria Montiel-Troya ◽  
Ana Eugenia Marín-Jiménez ◽  
Elena Mellado-García ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
General Health ◽  
Low Pressure ◽  
Health Related Quality ◽  
Emotional Role ◽  
Related Quality ◽  
Health Related

Abstract BackgroundPracticing physical exercise is a way of maintaining a healthy lifestyle and it has been demonstrated that it benefits and improves quality of life after labour.AimTo determine whether a workout programme using the Low-Pressure Fitness methodology has an impact on the Health-Related Quality of Life after labour.Material and MethodWe carried out a 12-weeks randomized clinical trial. It started at week 16 after labour and ended at postpartum week 28. Women followed a moderate intensity workout programme, using the Low-Pressure Fitness methodology in the treatment group, and we had a control group of sedentary women to perform a comparison. We used the SF-36v2 questionnaire at the postpartum weeks 16 and 28 to assess the Health-Related Quality of Life in women.ResultsWe found statistically significant differences (p<0.05) in general health components, vitality, emotional role, and mental health in the sample group of women under the Low-Pressure Fitness, who obtained a higher score.We found statistically significant differences in all aspects between the postpartum weeks 16 and 28.The interaction between time and group affect in general health components, vitality, emotional role and the score of mental component. In all of them the score is higher at week 28 and in the Low-Pressure Fitness group.ConclusionsPhysical exercise, following the Low-Pressure Fitness method, improves Health-Related Quality of Life after labour. We found that, when both the treatment and control groups are categorized by body-mass index, the Low-Pressure Fitness method was not determinant to improve the postpartum Health-Related Quality of Life.

scholarly journals The Clinical, Economic, and Humanistic Burden of Patients with β-Thalassemia: A US-Centric Review of the Literature

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5855-5855
Author(s):  
Elizabeth S. Mearns ◽  
Chuka Udeze ◽  
Ronda Copher ◽  
Sujit Sheth
Keyword(s):  
Clinical Trial ◽  
Iron Overload ◽  
Physical Functioning ◽  
Annual Cost ◽  
General Health ◽  
Short Form ◽  
Bodily Pain ◽  
Cochrane Library ◽  
Role Physical ◽  
Humanistic Burden

Introduction: β-thalassemia is a genetic blood disease characterized by ineffective erythropoiesis due to defective hemoglobin production that manifests as potentially fatal anemia. Patients with β-thalassemia rely on regular, lifelong red blood cell transfusions (RBCTs) for survival and suffer from multi-system complications, physical manifestations, and decreased health-related quality of life (HRQoL) due to iron overload and continual RBCTs. This literature review aims to describe the disease burden associated with β-thalassemia. Methods: Electronic databases (MEDLINE®, Embase®, Cochrane Library) were searched to identify articles in the English language assessing the clinical, economic, and humanistic burden of β-thalassemia in North America and Europe. Articles were selected based on predefined criteria including appropriate study design, disease state, country, and outcome measures. Results: Patients with β-thalassemia who received regular RBCTs were significantly more likely to develop ≥ 1 iron overload-related comorbidity than matched, non-thalassemia controls (P < 0.0001). Other iron-related issues included cardiac disease (observed in 13-30% of patients), hypogonadism (17-22%), diabetes (10-18%), osteoporosis (16%), hypothyroidism (12%), liver disease (4%), and hypoparathyroidism (2%). RBCTs also introduced the risk of transfusion reactions (48-50%), infections (24-65%), and development of alloantibodies (19-23%). Mortality rate for the US population was 1.9%. The direct annual cost per regularly transfused patient with β-thalassemia was significantly higher than in matched controls (USD 128,062 vs USD 5,438; P < 0.001; 2016 USD). The main annual cost drivers per patient were iron chelation therapy (48%; USD 61,974) and RBCTs (31%; USD 39,723). Indirect costs for β-thalassemia were impacted by unemployment, reported at 33% among patients with β-thalassemia versus 24% for the general US population. Patients scored significantly worse on 5 subdomains (physical functioning, role-physical, general health, social functioning, and role-emotional) of the Short Form-36 (SF-36) HRQoL questionnaire compared with the general US population (all P < 0.0001) with the greatest impairments seen in the general health subdomain (P < 0.0001). Clinically meaningful reductions in physical functioning, role-physical, and general health scores were observed for patients with β-thalassemia aged < 65 years with transfusion-related iron overload. Bodily pain was reported by 56-69% of patients with β-thalassemia, and pain interfered with patient physical and emotional functioning HRQoL outcomes. Increasing age correlated with higher numbers of pain responses (P < 0.001). Psychiatric comorbidities were found in 24% of patients with β-thalassemia, and mood disorders, including depression and anxiety, were associated with overall significantly poorer physical and mental HRQoL (P < 0.001). Conclusions: β-thalassemia is associated with a substantial clinical, economic, and humanistic burden in the USA. Patients with β-thalassemia experience reduced life expectancy, significant comorbidities, considerable direct healthcare costs, unemployment, and impaired HRQoL. There is a need for more effective management and therapeutic options for these patients. Disclosures Mearns: Celgene Corporation: Employment. Udeze:Celgene Corporation: Employment. Copher:Celgene Corporation: Employment. Sheth:CRSPR/Vertex: Other: Clinical Trial Steering committee; Apopharma: Other: Clinical trial DSMB; Celgene: Consultancy.

scholarly journals Diagonal Trunk Muscle Exercises in Peripartum Pelvic Pain: A Randomized Clinical Trial

2000 ◽  
Vol 80 (12) ◽  
pp. 1164-1173 ◽  
Author(s):  
Jan MA Mens ◽  
Chris J Snijders ◽  
Henk J Stam
Keyword(s):  
Clinical Trial ◽  
Pelvic Pain ◽  
General Health ◽  
Potential Benefit ◽  
Muscle Force ◽  
Trunk Muscle ◽  
Low Back ◽  
Individual Coaching ◽  
Additional Value ◽  
Exacerbation Of Symptoms

Abstract Background and Purpose. Exercises for low back and pelvic pain are supposed to increase muscle force to reduce symptoms, but they could exacerbate symptoms by loading of the spinal and pelvic structures. The purpose of this study was to investigate the value of graded exercises of the diagonal trunk muscle systems. Subjects. The subjects were 44 women with persistent pelvic pain after pregnancy (mean age=31.7 years, SD=3.2, range=23.6–37.5; mean period postpartum=4.1 months, SD=2.2, range=1.7–5.6). Methods. Subjects were randomly assigned to 1 of 3 groups: (1) a group that performed exercises to increase the force of the diagonal trunk muscle systems, (2) a group that received training of the longitudinal trunk muscle systems, and (3) a group that was instructed to refrain from exercises. Pain, fatigue, perceived general health, and mobility of the pelvic joints as measured with radiographs were the outcome measures. Results. After 8 weeks, no differences were found among the 3 groups. Conclusion and Discussion. In treating patients with persistent pelvic pain, training of the diagonal trunk muscle systems, without individual coaching, has no additional value above instructions and use of a pelvic belt without exercises. Whether the treatment is ineffective or whether exacerbation of symptoms due to loading of the spinal and pelvic structures obscures any potential benefit of increased muscle force cannot be determined from the study design.

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