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Quality of Life clinical trials

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NCT ID: NCT05007444 Recruiting - Breast Cancer Clinical Trials

Safety and Efficacy Evaluation of the P2Et Extract in Patients With Breast Cancer

Start date: March 1, 2022
Phase: Phase 2
Study type: Interventional

Currently, the study of many extracts in different types of cancer has allowed the validation of scientific knowledge either as a therapy that reduces the size of the tumor or that helps to improve the quality of life of the patient by reducing the associated effects of the treatment. In the Immunobiology and Cell Biology group of the Pontificia Universidad Javeriana, a standardized extract of Caesalpinia spinosa (Dividivi) called P2Et has been obtained. This extract has been shown to have cytotoxic activity in different human and murine tumor cell lines, favoring the induction of immunogenic cell death with the release of danger signals such as calreticulin, HMGB1 and ATP. Additionally, treating mice with murine melanoma and sinus tumors significantly reduces tumor size and metastases. On the other hand, induction of complete autophagic flux and synergistic effects with anthracycline-type chemotherapeutics have been shown in human cell lines and in animal models of breast cancer. With this background, and the results of the Phase I clinical study carried out in healthy volunteers that showed that the extract is safe, the investigators propose that treatment with the P2Et extract in patients with breast cancer could improve their general condition, impacting their quality of life. , and induce antitumor immune response, improving the immune infiltrate and acting as a transforming agent from a cold tumor to a warm tumor. This would lead to an improvement in the long-term survival of patients treated with the phytomedicine in conjunction with the chemotherapeutic treatment selected by the treating oncologist. In order to advance on this path, and responding to the adjustments suggested in the phase I study in healthy individuals, it is proposed to carry out a clinical study that allows determining the optimal biological dose of the P2Et extract in a design based on randomized simulations of adaptive form and considering the safety of the extract as an objective in patients with breast cancer. Additionally, those parameters that allow defining the best indicators of effectiveness of P2Et in this group of patients will be evaluated, such as modulation of the immune response, quality of life, reduction of adverse effects and progression-free survival.

NCT ID: NCT05007041 Completed - Pain Clinical Trials

Simultaneous RZV and aIIV4 Vaccination

Start date: September 21, 2021
Phase: Phase 4
Study type: Interventional

The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.

NCT ID: NCT05004558 Not yet recruiting - Obesity Clinical Trials

Effects of Remote-based Resistance Training on Cardiometabolic Risk Factors, Cognitive Function, and Quality of Life in Adults Living With Alzheimer's Disease and/or Related Dementias

Start date: September 1, 2021
Phase: N/A
Study type: Interventional

The investigators aim to study the effects of a 24-week remote-based resistance exercise training program on cardiovascular disease risk factors, cognitive function, and quality of life in older adults living with mild cognitive impairment or Alzheimer's Disease and/or a related dementia. Data for this study will be collected at the beginning, middle, and end of the resistance training program. Participants of this study will receive a baseline health-fitness assessment at the beginning of the study. Measurements of resting blood pressure, fasting blood glucose and lipids, waist and hip circumferences, height and weight, cognitive function and quality of life will be collected at the health-fitness assessment. Participants will then receive supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a second 12-week health-fitness assessment in the middle of the intervention. Participants will then receive 12 additional weeks of supervised remote-based resistance exercise training with Therabands, 3 days per week for 12 weeks before receiving a third 24-week health fitness assessment at the end of the study.

NCT ID: NCT05000424 Recruiting - Quality of Life Clinical Trials

Clary Sage Essential Oil & Pregnancy

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the potential for clary sage essential oil to support overall health, wellbeing, and quality of life during the third trimester of pregnancy among otherwise healthy adult women.

NCT ID: NCT04998734 Terminated - Quality of Life Clinical Trials

Validation of the ASI-SR Form in a Population of Chronic Non-cancer Pain Patients

ASI-SR
Start date: August 5, 2021
Phase:
Study type: Observational

The Swedish version of ASI-SR has shown good feasibility in assessment of addiction patients functioning compare to long and time-consuming ASI, which is upp to date golden standard in Sweden. This study investigate if ASI-SR is suitable instrument for the assessment of the chronic pain patient addicted to opioids. The validation process is designed according to the COSMIN guidelines. Preliminary results are expected by December 2022.

NCT ID: NCT04995237 Completed - Quality of Life Clinical Trials

RHWP Prescription Produce Plan

PPP
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The purpose of this research study is to find out if access to fresh produce along with individual goal setting and education influences vegetable consumption, self-management [self-efficacy], resilience, or quality of life. Researcher think access to fresh produce along with individual goal setting and education, may improve all of the above. This study will allow them to learn more about it.

NCT ID: NCT04989894 Recruiting - Quality of Life Clinical Trials

Quality of Recovery After Childbirth

Start date: December 20, 2021
Phase:
Study type: Observational

In this proposed study, the investigators hope to assess the quality of recovery after delivery in a local population that would take into account physiological and psychological parameters to better understand the recovery process after delivery. The investigators will identify risk factors, especially those that are modifiable and associated with a poorer ObsQoR score and hence a poor quality of recovery after delivery. This data may then be used to educate women and manage expectations in the postpartum period, and help develop potential therapeutic interventions.

NCT ID: NCT04988880 Active, not recruiting - Multiple Sclerosis Clinical Trials

Territorial Implementation and Evaluation of a Multiple Sclerosis Expert Patient Program

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

Introduction: Multiple sclerosis (MS) affects about 50,000 people in Spain, so it is essential to implement health interventions that meet their needs and demands. Expert patient programs facilitate health-related empowerment through peer learning. From a study of focus groups that identified the characteristics and contents of an expert patient program for MS and the ongoing pilot tests, the need for implementation in the different reference units of Catalonia is established. Hypothesis: The territorial implementation in Catalonia of a Catalonia® Expert Patient Program for people with MS (PPEC-EM) based on peer learning will improve the quality of life, knowledge and self-management related to the health process of the participants. Objective: To deploy and evaluate the territorial implementation of a PPEC-EM based on peer learning regarding the quality of life, knowledge and self-management related to the health process of the participants. Methodology: Pre-post intervention multicenter clinical study. This study will begin after the approval of the respective Ethics Committees. The deployment will consist of 12 groups of patients (2 per unit): 6 groups with people with recurrent MS and 6 groups with people with progressive MS. A patient with MS previously trained by a team of health professionals will lead 9 educational group sessions (1 weekly session for 9 weeks) with 12 people with the same disease in order to improve the impact and self-management according to the health process. The main variable is the improvement of the quality of life and the secondary ones are the emotional impact, activation of the person, knowledge on the MS, fatigue, habits and lifestyles, use of the sanitary services and program-related experience of participants. All variables will be measured before and after the intervention and after 6 and 12 months. A pre-post comparability analysis will be developed in relation to the variables studied.

NCT ID: NCT04988724 Recruiting - Pain Clinical Trials

Impact of Physical Exercise at a Hospital

Start date: April 16, 2022
Phase: N/A
Study type: Interventional

Aims and Hypotheses Aims - to investigate associations between an intelligent exercise training intervention and clinical health parameters, well-being, sick leave and productivity at Nordsjællands Hospital (NOH) - to generate data and experiences to a larger cluster randomized trial with more included departments at NOH - to analyze how the intervention could be successfully implemented in the organization to ensure long-term effects Outcomes - Aerobic capacity (Åstrand's ergometer test) - Blood pressure and heart rate - Physical activity (steps measured by tracker) - Self-reported health (questionnaire EQ-5D) - Self-reported physical activity (questionnaire IPAQ) - Well-being (questions from the Danish Health and Morbidity Survey) - Musculoskeletal pain and use of anti-pain medications (Numeric Rating Scale) - Monetized value of productivity loss - Productivity using an employer´s perspective (scale 1-10) - Sick leave (days in short term (≤14 days) and long term (>14 days), data will be delivered by The Department of HR) - Muscle strength in knee extension (dynamometer) Intervention The concept of intelligent training at the worksite is an individualized exercise training where the exercises are: 1) balanced to the physiological capacity of the employees relative to their occupational exposure, 2) tailored to the individual capacities and disorders to improve employees' health, 3) motivating by offering evidence based and enjoyable programs implemented with care, and 4) cost-effective for the company. The intervention period is 20 weeks of intelligent exercise training. Every week, several exercise sessions will be offered to the participants in the intervention group during the working hours. The exercise sessions will be of 30 min durations twice a week and include aerobic exercise with high intensity (≥16 on the Borg scale, rate of perceived exhaustion), resistance training and/or functional training. In addition, there will be a number of intelligent exercise sessions of 30 min durations before and after the most common working hours with a primary focus on aerobic exercise. The exercise sessions will be supervised by exercise experts (education in sport or physiotherapy). The intelligent exercise interventions will be adjusted to the individual participant's physical capacity and limitations; thus, as one participant may perform aerobic exercise, another person may perform resistance training.

NCT ID: NCT04988126 Recruiting - Pain Clinical Trials

Pain, Fatigue and Life Quality in COVID-19 Patients

Start date: February 1, 2021
Phase:
Study type: Observational

The aim in this study is to evaluate pain, fatigue and quality of life in patients with Covid-19 pneumonia in long-term follow-up and to investigate their relationship with pneumonia severity, age, presence of comorbidity and depression level.