scholarly journals A Clinical Trial for the Identification of Metabolic Biomarkers in Hashimoto’s Thyroiditis and in Psoriasis: Study Protocol

2021 ◽  
Vol 28 (2) ◽  
pp. 291-306
Author(s):  
Evangelia Sarandi ◽  
Sabine Kruger Kruger Krasagakis ◽  
Dimitris Tsoukalas ◽  
Gottfried Rudofsky ◽  
Aristides Tsatsakis
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Mediterranean Diet ◽  
Hashimoto’S Thyroiditis ◽  
Dietary Factors ◽  
Hashimoto's Thyroiditis ◽  
Control Group ◽  
The Mediterranean ◽  
Metabolic Biomarkers

Hashimoto’s thyroiditis and psoriasis are inflammatory disorders that significantly impact patients’ quality of life, stressing the need for novel biomarkers of early diagnosis. This randomized clinical trial (NCT04693936) aims to identify Hashimoto’s thyroiditis’ and psoriasis’ metabolic biomarkers and to investigate the effect of environmental factors on the disease-related metabolic imprint and quality of life. Patients with Hashimoto’s thyroiditis, patients with psoriasis, and healthy individuals aged 18–60 will be recruited, enrolled according to eligibility criteria (medical history, clinical thyroid markers and the PASI score) and randomized to two groups. The intervention group will receive a combination of nutraceuticals for 6 months as part of a Mediterranean diet, and the control group will follow their usual diet. Data will be collected at baseline and the end of the study, including metabolite levels, lifestyle and anthropometric measurements, adherence to the Mediterranean diet (through the Mediterranean Diet Score) and disease-specific quality of life (through the Thyroid Patient Report Outcome for Hashimoto’s group, and the Dermatology Life Quality Index for the psoriasis group). This study will investigate metabolic biomarkers and related changes in Hashimoto’s thyroiditis and psoriasis and evaluate the association of metabolic changes with dietary factors and quality of life.

scholarly journals Surgical Treatment of Hashimoto’s Thyroiditis – Pros and Cons from the Perspective of Clinical Results

2020 ◽  
Vol 9 (3) ◽  
pp. 1208-1216 ◽  
Keyword(s):  
Quality Of Life ◽  
Surgical Treatment ◽  
Hashimoto’S Thyroiditis ◽  
Clinical Results ◽  
Hashimoto's Thyroiditis ◽  
Control Group ◽  
Quality Of Life Indicators ◽  
Sf 36 ◽  
Pros And Cons

Patients with Hashimoto’s thyroiditis have hypothyroidism, goiter, and extrathyroidal lesions. Substitution therapy with thyroxine drugs in some cases is not effective. The work studies the feasibility of using surgical treatment – removal of the active site of autoimmune aggression. To study the effect of thyroidectomy on the quality of life of patients with Hashimoto’s thyroiditis with extrathyroidal manifestations. Sixty-one patients with Hashimoto’s thyroiditis were examined. Among them 29 patients were treated with drugs (control group) and 32 with surgery (main group). The quality of life was studied using the SF-36 questionnaire. TSH levels within euthyroidism were controlled and the level of antibodies to thyroperoxidase was determined. Two years after the surgical treatment, the studied quality of life indicators was improved significantly. The growth in individual indicators ranged from 34 (role-functioning, conditioned by emotional state) to 57 % (vital activity), and the overall health indicator increased by 52 %. The level of antibodies to peroxidase decreased almost to the norm. In the group of patients receiving drug treatment, overall quality of life indicators did not change significantly, but there was a tendency to worsen. The level of antibodies to peroxidase remained at high rates without significant changes. Surgical treatment of patients with Hashimoto’s thyroiditis improves the quality of life. The level of antibodies to thyroperoxidase after thyroidectomy is reduced to almost physiologically significant indicators.

scholarly journals Effect of Baduanjin exercise intervention on cognitive function and quality of life in women with breast cancer receiving chemotherapy: study protocol of a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Xiao-Lin Wei ◽  
Ru-Zhen Yuan ◽  
Yong-Mei Jin ◽  
Shu Li ◽  
Ming-Yue Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Cognitive Function ◽  
Exercise Intervention ◽  
Early Stage ◽  
Early Stage Breast Cancer ◽  
Pharmacological Intervention ◽  
Control Group

Abstract Background More than 50% cognitive impairment was reported by cancer patients before and after medical treatment. However, there are no effective interventions to manage the cognitive problem in women with breast cancer. This pilot study was designed to evaluate the protective effect of Baduanjin exercise on cognitive function and cancer-related symptoms in women with early-stage breast cancer undergoing chemotherapy. Method A single-blinded, randomized control trial was designed. The trial will recruit 70 patients with early-stage breast cancer scheduled to receive chemotherapy from Shanghai in China. All participants will be randomly assigned to (1:1) the supervised Baduanjin group (5 times/week, 30 min each time) or the wait-list control group for 3 months. The effect of Baduanjin exercise intervention will be evaluated by outcome measures including subjective and objective cognitive function, symptoms (fatigue, depression, and anxiety), and health-related quality of life at pre-intervention (T0), 8 weeks (T1), and 12 weeks (T2). The PCI score in the FACT-Cog as the primary cognitive outcome will be reported descriptively, while effect sizes and 95% confidence intervals (CIs) will be calculated. The collected data will be analyzed by using an intention-to-treat principle and linear mixed-effects modeling. Discussion This is the first randomized clinical trial to investigate whether Baduanjin exercise will have a positive role in improving cognitive function in women with breast cancer receiving chemotherapy. If possible, Baduanjin exercise will be a potential non-pharmacological intervention to manage cognitive dysfunction and promote survivorship care among breast cancer survivors. Trial registration Chinese Clinical Trial Registry (ChiCTR) ChiCTR2000033152. Registered on 22 May 2020

scholarly journals FRI0233 IMPACT AND ADHERENCE TO THE MEDITERRANEAN DIET IN SYSTEMIC SCLEROSIS ITALIAN PATIENTS: CORRELATION WITH GASTROINTESTINAL SYMPTOMS, MOOD DISTURBANCES AND QUALITY OF LIFE

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 700.2-700
Author(s):  
G. De Luca ◽  
G. Natalello ◽  
G. Abignano ◽  
C. Campochiaro ◽  
D. Temiz Karadağ ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systemic Sclerosis ◽  
Mediterranean Diet ◽  
Dietary Habits ◽  
Anxiety And Depression ◽  
Research Support ◽  
Work Impairment ◽  
Gi Symptoms ◽  
The Mediterranean

Background:Gastrointestinal involvement(GI) is a common feature of systemic sclerosis(SSc) and can be highly disabling, representing a major cause of morbidity and reduced quality of life(QoL). The impact of dietary habits on GI symptoms, mood and QoL has not been extensively evaluated.Objectives:To evaluate the adherence to the Mediterranean Diet(MD) in an Italian multicenter cohort of SSc patients, and its impact on GI symptoms and other disease features, depression, anxiety and overall QoL.Methods:Consecutive SSc(ACR/EULAR2013) patients from 4 Italian cohorts were enrolled. Dietary habits and adherence to the MD were assessed using the 14-item MEDAS and QueMD questionnaires. Presence and severity of depressive/anxious symptoms and QoL were evaluated with the Hospital Anxiety and Depression Scale(HADS) and the SSc-HAQ(S-HAQ). GI symptoms were assessed with the Reflux Disease Questionnaire(RDQ) and the UCLA SCTC GI Tract 2.0 questionnaire(USG). Associations with patients’ lifestyle, disease characteristics, and nutritional status were explored.Results:265 patients (94.7% females; age 55.8±13.6years; disease duration 9.1±7.0years; diffuse SSc 31.8%; Scl70 + 35.8%;ulcers 23.4%;ILD 29.4%;BMI 23.7±4.4 Kg/m2; obese 11.3%,overweight 23.4%,underweight 4.9%) were enrolled.Overall MD adherence was moderate(7.5±1.9) according to MEDAS and it correlated with QueMD score(4.53±1.96)(R=.371,p<0.001). MD adherence was optimal in 39 patients(14.7%), more frequently from Central-Southern Italy(p=0.036); 189 patients(71.3%) had a good and 37(14.0%) a poor MD adherence.GI symptoms were moderate/severe according to USG in 37(14.0%) patients(USG:0.41±0.40), and heartburn was the most common GI symptom(35.2%). The prevalence of significant anxiety and depression was 24.1% and 17.0%.An inverse correlation was found between MD adherence and mood disturbances at HADS(MEDAS; R=-0.181,p=0.04), work impairment(QueMD;R=-0.247,p=0.005) and reduced QoL, both for GI (constipation at USG: R=-0.133,p=0.032) and general S-HAQ items(bowel:R=-0.181,p=0.04;severity R=-0.202,p=0.01;Raynaud:R=-0.217,p<0.001;ulcers: R=-0.207,p=0.01). MD adherence directly correlated with lung function(MEDAS;R=0.181,p=0.023 for FVC and R=0.170,p=0.03 for DLCO). Patients with MD optimal adherence had lower HADS depression(p=0.04) and S-HAQ scores(HAQ,p=0.04; Raynaud,p=0.005; ulcers,p=0.02) and lower work impairment and lost work time(p=0.03). No significant correlation emerged between MD adherence and BMI, or specific symptoms. Depression and anxiety directly correlated with the severity of reported upper GI symptoms according to both scales (RDQ-GERD:R=0.261,p=0.001; USG:R=0.263,p<0.001) and general S-HAQ items (HAQ: R=0.136,p=0.032;severity R=0.233,p<0.001;bowel: R=0.135,p=0.04;breath: R=0.133,p=0.03; ulcers: R=0.132,p=0.037). Results were confirmed after exclusion of psychiatric(11.7%) and fibromyalgic(15.5%) patients.Conclusion:Unsatisfactory MD adherence is associated with a low mood, impaired QoL, work impairment, GI and vascular symptoms in Italian SSc patients. The promotion of a healthy lifestyle could positively impact on QoL and disease status of SSc patients.References:[1]Gnagnarella P, et a. NMCD 2018. DOI: 10.1016/j.numecd.2018.06.006[2]Jaeger VK et al. PLoS One, 2016.[3]Dinu M et al. Eur J Clin Nutr 2018. doi: 10.1038/ejcn.2017.58.[4]Khanna D, et al.Arthritis Rheum. 2009. doi: 10.1002/art.24730.Acknowledgments:GILSDisclosure of Interests:Giacomo De Luca Grant/research support from: SOBI, Speakers bureau: SOBI, Novartis, Pfizer, MSD, Celgene, Gerlando Natalello: None declared, Giuseppina Abignano: None declared, Corrado Campochiaro Speakers bureau: Novartis, Pfizer, Roche, GSK, SOBI, Duygu Temiz Karadağ: None declared, Maria De Santis: None declared, Elisa Gremese Speakers bureau: Abbvie, BMS, Celgene, Jannsen, Lilly, MSD, Novartis, Pfizer, Sandoz, UCB, Silvia Laura Bosello Speakers bureau: Abbvie, Pfizer, Boehringer, Lorenzo Dagna Grant/research support from: Abbvie, BMS, Celgene, Janssen, MSD, Mundipharma Pharmaceuticals, Novartis, Pfizer, Roche, SG, SOBI, Consultant of: Abbvie, Amgen, Biogen, BMS, Celltrion, Novartis, Pfizer, Roche, SG, and SOBI

scholarly journals Intravesical Instillation of Sodium Hyaluronate (Cystistat®) for the Treatment of Patients with Radiation Cystitis-Randomized Clinical Trial

2020 ◽  
Vol 13 (11) ◽  
Author(s):  
Farzad Allameh ◽  
Abbas Basiri ◽  
Saleh Ghiasy ◽  
Atefeh Javadi ◽  
Seyyed Ali Hojjati ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Hyaluronic Acid ◽  
Sodium Hyaluronate ◽  
Intravesical Instillation ◽  
Control Group ◽  
Radiation Cystitis ◽  
Vas Score ◽  
The Mean

Background: Radiotherapy (RT) is a choice to manage pelvic organ malignancies that can affect bladder; therefore, it causes radiation cystitis with some bothering urinary symptoms and decreasing the patient’s quality of life. Intravesical hyaluronic acid (HA) is an agent with promising results in some studies for cystitis, and Cystistat is a derivative of hyaluronic acid. Objectives: This clinical trial aimed at evaluating the effects of intravesical instillation of Cystistat on symptoms of radiation cystitis and quality of life (QOL). Methods: A total of 58 patients with radiation cystitis were randomized in 2 groups (case: 30, control: 28). One group received intravesical Cystistat, the other received normal saline weekly for up to 4 weeks and then monthly for up to 2 months. Hematuria, Visual Analog scale (VAS) and QOL based on King’s Health questionnaire were compared before and 3, 6 and 9 months after intravesical instillation. Results: The mean age of the patients was 63.93 ± 10.89 years old. The mean of each sub-category of QOL and total score of QOL, as well as, VAS score were significantly improved in comparison to the control group at each time of follow-ups (P < 0.05). Hematuria was significantly different in the 3rd, 6th and 9th month of follow-ups (P < 0.05). Conclusions: Findings showed that patients with radiation cystitis could significantly benefit from intravesical instillation of HA, their hematuria would be successfully resolved rather than control group in addition to lowering the VAS score, so their QOL would be improved.

Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study

2018 ◽  
Vol 132 (3) ◽  
pp. 202-206 ◽  
Author(s):  
J S Phillips ◽  
J Fitzgerald ◽  
D Phillis ◽  
A Underwood ◽  
I Nunney ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Pilot Study ◽  
Vestibular Rehabilitation ◽  
University Hospital ◽  
Control Group ◽  
Rehabilitation Protocol ◽  
Wii Fit ◽  
Significant Difference

AbstractObjective:To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness.Methods:A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires.Results:Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified.Conclusion:This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

scholarly journals Influence of a Multidisciplinary Program of Diet, Exercise, and Mindfulness on the Quality of Life of Stage IIA-IIB Breast Cancer Survivors

2020 ◽  
Vol 19 ◽  
pp. 153473542092475
Author(s):  
Julia Ruiz-Vozmediano ◽  
Sarah Löhnchen ◽  
Lucas Jurado ◽  
Rosario Recio ◽  
Andrea Rodríguez-Carrillo ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Cancer Survivors ◽  
Mediterranean Diet ◽  
Breast Cancer Survivors ◽  
Intervention Program ◽  
Intervention Group ◽  
Control Group ◽  
Cancer Symptoms

Background: Integrative oncology has proven to be a useful approach to control cancer symptoms and improve the quality of life (QoL) and overall health of patients, delivering integrated patient care at both physical and emotional levels. The objective of this randomized trial was to evaluate the effects of a triple intervention program on the QoL and lifestyle of women with breast cancer. Methods: Seventy-five survivors of stage IIA-IIB breast cancer were randomized into 2 groups. The intervention group (IG) received a 6-month dietary, exercise, and mindfulness program that was not offered to the control group (CG). Data were gathered at baseline and at 6 months postintervention on QoL and adherence to Mediterranean diet using clinical markers and validated questionnaires. Between-group differences at baseline and 3 months postintervention were analyzed using Student’s t test for related samples and the Wilcoxon and Mann-Whitney U tests. Results: At 6 months postintervention, the IG showed significant improvements versus CG in physical functioning ( p = .027), role functioning ( p = .028), and Mediterranean diet adherence ( p = .02) and a significant reduction in body mass index ( p = .04) and weight ( p = .05), with a mean weight loss of 0.7 kg versus a gain of 0.55 kg by the CG ( p = .05). Dyspnea symptoms were also increased in the CG versus IG ( p = .066). Conclusions: These results demonstrate that an integrative dietary, physical activity, and mindfulness program enhances the QoL and healthy lifestyle of stage IIA-IIB breast cancer survivors. Cancer symptoms may be better managed by the implementation of multimodal rather than isolated interventions.

scholarly journals Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-13
Author(s):  
Xiaolin Li ◽  
Ying Gao ◽  
Chi Zhang ◽  
Qingsu Zhang ◽  
Xiyan Xin ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Acupuncture Therapy ◽  
Long Term Results ◽  
Control Group ◽  
Acupuncture Points ◽  
Term Efficacy ◽  
Secondary Outcomes

Background. Poststroke aphasia (PSA) is a disabling condition that decreases the quality of life, and the duration of the disease harms the quality of life of PSA patients. Acupuncture has been widely employed for PSA. There is some evidence for the immediate treatment efficacy of acupuncture for PSA; however, long-term results after acupuncture may be poorer. Methods. This is a multicentre, randomized, blinded, nonacupoint (NA) acupuncture controlled, multimodal neuroimaging clinical trial. A total of 48 subjects with subacute PSA will be randomly assigned to an acupoint group or an NA control group. The acupoint group will receive acupuncture with normal needling at DU20, EX-HN1, HT5, GB39, EX-HN12, EX-HN13, and CV23. The NA control group will receive acupuncture in locations not corresponding to acupuncture points as sham acupoints. Both groups will receive identical speech and language therapy thrice a week for four weeks. The primary outcome will be the change in the aphasia quotient (AQ) score measured by the Western Aphasia Battery (WAB) test during the 12th week after randomization. Participants will be blindly assessed at prerandomization (baseline) and 4 weeks, 12 weeks, and 24 weeks after randomization. The secondary outcomes include the Boston Diagnostic Aphasia Examination (BDAE) score, the Disease Prognosis Scale score for ischaemic stroke, etc. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at 4-time intervals as secondary outcomes. All scores and image evaluations will be taken at the same point as the linguistic evaluation. The multilevel evaluation technique will be used to assess the long-term efficacy of acupuncture therapy. MRI scans and EEG will be used to assess acupuncture-related neuroplasticity changes. Discussion. The results from our trial will help to supply evidence for the long-term acupuncture effects for PSA over a long follow-up period. It will provide valuable information for future studies in the field of PSA treatment. The trial was registered at the Chinese Clinical Trial Registry on 16 March 2020 (ChiCTR2000030879).

scholarly journals The Efficacy and Safety of Acupuncture for Prophylaxis of Vestibular Migraine: A Study Protocol for a Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Tianye Hu ◽  
Hantong Hu ◽  
Feng Chen ◽  
Bin Jiang ◽  
Fengfei Shen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Outcome Measures ◽  
Vestibular Migraine ◽  
Secondary Outcome ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled

Introduction: With a high incidence rate and low diagnosis rate, vestibular migraine (VM) can seriously affect the quality of life of patients, but it remains difficult to manage by current treatment options. Acupuncture may be a potential treatment option for VM prophylaxis, but the currently available evidence is still uncertain. Therefore, this trial aims to evaluate the efficacy and safety of acupuncture for VM prophylaxis.Methods: This is a 28-week parallel, randomized, controlled clinical trial including 4 weeks of baseline, 8 weeks of treatment, and 16 weeks of follow-up. A total of 72 participants will be randomly assigned to two groups. The participants will receive acupuncture in the experimental group, while the participants in the control group will be treated with venlafaxine. The primary outcome measures are change in vertigo/migraine days and vertigo/migraine attacks, vertigo severity, and migraine intensity per 4 weeks from baseline. The secondary outcome measures are change in doses of rescue medication, anxiety level, depression level, and quality of life per 4 weeks from baseline. Adverse events will be recorded for safety evaluation.Discussion: This study will investigate the efficacy and safety of acupuncture for VM prophylaxis. The results will contribute to determining whether acupuncture can serve as an optional treatment strategy for treating VM.Clinical Trial Registration:www.ClinicalTrials.gov, identifier: NCT0464088.

scholarly journals PENGARUH PEMBERIAN INHALASI KOMBINASI SALMETEROL/FLUTIKASON PROPIONAT TERHADAP KUALITAS HIDUP PENDERITA PENYAKIT PARU OBSTRUKTIF KNONIK STABIL

2019 ◽  
Vol 1 (2) ◽  
pp. 28-33
Author(s):  
Refi Sulistiasari
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Treatment Group ◽  
Control Group ◽  
Copd Assessment Test ◽  
Copd Patients ◽  
Significant Difference ◽  
Inhaled Therapy ◽  
St George's Respiratory Questionnaire

It is known that inflammation is the underlying cause of COPD, and this affects to quality of life of the patient. Provision of inhaled therapy combination of LABA and corticosteroids is one of therapy in pharmacology of stable PPOK patients. The aim of this study was to know the benefits of inhalation of 50 g / fluticasone propionate 500 g inhibition in stable COPD patients. The research design is clinical trial. The study was conducted for 3 months and was performed on 26 stable COPD patients divided into two groups: 15 patients for the treatment group and 15 patients for the control group. After the measurements were obtained, there was a significant difference in the quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) (p = 0.001) and COPD Assessment Test (CAT) (0.001) measurements were made twice on the first and thirtieth days.

Sign in / Sign up

Export Citation Format

Share Document