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NCT ID: NCT04833998 Recruiting - Hand-foot Syndrome Clinical Trials

Hydration Based on Thoitaine, Aloe Vera and Calendula, in the Prevention of Hand-Foot Syndrome in Patients Using Capecitabine

TACX Care
Start date: August 2, 2019
Phase: Phase 2
Study type: Interventional

Hand-foot syndrome (HFS) is a very common adverse event of many chemotherapeutic agents, especially capecitabine. The HFS can considerably interfere patient quality of life (QoL). The current treatments for hand-foot symptoms no have demonstrated 100% efficacy. And, the dose reduction and treatment interruption are recommended for treatment of HFS. It is known that hydration improves the degree of hand-foot syndrome, as it improves moisture retention and maintain hydration, thereby reducing further desquamation and decreasing infection risks. But so far there is no evidence of a cream that improves incidence. Besides that, clinical trials evaluating the use of urea-based moisturizer in patients treated with capecitabine have not shown efficacy in preventing hand-foot syndrome. The purpose of this study is to evaluate the effectiveness of moisturizer based on Thoitaine, Aloe Vera and Calendula compared to placebo in the prevention of SMP of any degree, in patients using Capecitabine.

NCT ID: NCT04832126 Recruiting - Channelopathies Clinical Trials

Genetic Analysis of Heart Channelopathies in Brazilian Patients and Their Relatives

Start date: January 1, 2018
Phase:
Study type: Observational

several genes have been associated with ion channel diseases, but a large number of families do not yet have an identified genetic cause. There is a lack of information on the genetic characteristics of channelopathies in Brazilians affected by these diseases. This study aims to carry out a comprehensive genetic analysis of cardiac channelopathies in Brazilian patients and their families. The study will involve 20 patients and 80 family members (a total of 100 individuals) accompanied by the Rede D'Or arrhythmia group in Rio de Janeiro. Individuals will be recruited and subjected to DNA sequencing and phenotypic evaluation, including clinical evaluation, echocardiography, 24-hour Holter or longer electrocardiographic monitoring. An integrated analysis of phenotype-genotype will be made in all individuals included in the study. Patients and their families will be followed up annually for 2 to 5 years through clinical evaluations and the same complementary methods described. The DNA sequencing of patients and their families may contribute to improve the diagnosis of channelopathies and allow the determination of the pattern of occurrence of the disease in the cases involved. Besides, this study may lead to the discovery of new genetic variants associated with channelopathies that will serve as a basis for designing and carrying out broader molecular epidemiological studies. The study of the molecular genetics of channelopathies is important mainly so that patients can avoid sudden death, but also for the medical community, researchers, laboratories, companies involved in the production of medical devices, and public health authorities

NCT ID: NCT04831567 Withdrawn - Clinical trials for Neuroendocrine Tumors

Study of MIBG-I131 in Patients With Well Differentiated Neuroendocrine Tumors

MIBNET
Start date: February 4, 2021
Phase: Phase 2
Study type: Interventional

This is a single-arm, unicentric, single-stage, phase 2 clinical study of therapeutic metaiodobenzylguanidine (MIBG) for patients with metastatic well-differentiated neuroendocrine tumors and radiological progression or intolerance after standard lines of treatment and with MIBG positive scan.

NCT ID: NCT04830319 Completed - Balance Clinical Trials

Pilates Method in People With HAM/TSP

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

Individuals with HTLV-1 secondary myelopathy (HAM/TSP) may have motor and sensory alterations, which may result in reduced functional performance and consequent risk of falls. The aim of the study is to verify the therapeutic effect of a Pilates exercise program on functional performance and risk of falls, when compared to task-oriented training, of people with HAM / TSP. This is a randomized, crossover clinical trial performed with individuals with HAM / TSP who are attended at a referral center who is able to perform gait whether or not to use a walking aid. Amputees, with psychiatric disorders, rheumatic or orthopedic diseases and other associated neurological disorders, which could influence the balance and functional mobility, as well as pregnant women, were excluded. Participants will be submitted to the initial evaluation of functional mobility, balance, gait balance, fatigue, gait endurance, sphincter changes and questioned about the occurrence of falls in the last three months and will answer a semi-structured questionnaire about their conjugality. They will be allocated randomly to two groups. One will perform the Pilates Method protocol and the other task-oriented training. The first group, called test-control group (GTC), will initiate the protocol with exercises of the Pilates method; the control-test group (GCT) will initiate the task-oriented training protocol. A p <0.05 will be considered a statistically significant difference.

NCT ID: NCT04829734 Recruiting - Clinical trials for Lateral Epicondylitis

Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With Lateral Epicondylitis

Start date: April 12, 2021
Phase: N/A
Study type: Interventional

Lateral epicondylitis (LE) is one of the most frequently encountered lesions affecting the upper extremity and is the most common cause of elbow pain in adults. It occurs on the lateral side of the elbow where the common extensors originate from the lateral epicondyle. LE can be considered an overuse injury which occurs on the lateral side of the elbow in the extensor tendons with repetitive micro-trauma. The clinical presentation of LE involves a painful or burning sensation over the humeral insertion of the common extensor tendons. Despite the high incidence of LE, optimal treatment has not been established. Treatment options include therapeutic exercise, bracing, shock wave or ultrasound therapy , but many of them lack sufficient evidence of beneficial effects. Photobiomodulation therapy (PBMT) alone or combined with static magnetic field (PBMT-sMF) has been shown to stimulate tendon healing, this suggests that therapy using laser or light-emitting diodes (LEDs) is efficacious for the symptoms associated with epicondylitis. According to the favorable results of PBMT-sMF in tendons repair processes, this type of therapy can be used as a therapeutic tool for management in epicondylitis, therefore, more investigations are necessary to establish the ideal parameters. Therefore, the aim of this project is to investigate the effects of PBMT-sMF, in the appropriate parameters, on degree of pain and quality of life of patients with lateral epicondylitis.

NCT ID: NCT04827251 Recruiting - Clinical trials for Coronary Artery Disease

Effects of Espresso on Platelet Aggregability in Patients With Coronary Artery Disease

Start date: September 1, 2022
Phase: N/A
Study type: Interventional

Discovered thousands of years ago, coffee is among the most consumed beverages in the world. The relationship between coffee and cardiovascular risk, more specifically coronary artery disease, is controversial. Platelet aggregation and its relationship with coffee is also controversial. The investigators propose this study to evaluate the relationship between coffee and platelet aggregability in patients with coronary artery disease.

NCT ID: NCT04825184 Completed - Body Image Clinical Trials

The Impact of an Artificial Intelligence Chatbot on Brazilian Adolescents' Body Image

Start date: April 6, 2021
Phase: N/A
Study type: Interventional

High prevalence of body and eating concerns in Brazilian populations is well-documented, with risk observed across the lifespan. Prevalence rates of body dissatisfaction range between 26.6 - 56% and 10.7- 36% for adolescent girls and boys, respectively (1, 2, 3). The prevalence of these disordered attitudes and behaviours are mirrored in older populations, and have shown to manifest within family units (6). Further, Brazilian consumer trends reflect these attitudes and behaviours, with it being the leading country in diet pill consumption and aesthetic surgeries, and second in the world for total aesthetic procedures (i.e., surgical and non-surgical), with 2.27 million procedures conducted annually (8). Despite the scope of body and eating concerns, few evidence-based interventions have been developed and tested for Brazilian populations and even fewer are accessible, scalable or cost-effective. Harnessing technology to deliver evidence-based care is a key focus for researchers. Micro-interventions (brief, low intensity, self-administered interventions), offer an alternative to traditional, intense interventions that may be unsuitable for milder concerns. Body image micro-interventions have proven effective at providing immediate and short-term improvements in body image among women (9). To date, body image micro-interventions have been developed and evaluated among high-income, White, English-speaking samples, with little research exploring how this intervention model may cater to other cultures and countries. The aim of the present study is to conduct a randomised controlled trial (RCT) to evaluate the immediate and short-term impact of a chatbot on Brazilian adolescents' body image, affect and body image self-efficacy. Primary outcomes include immediate and short-term changes in state- and trait-based body image, respectively. Secondary outcomes include immediate changes in state-based affect and short-term changes in trait affect and body image self-efficacy. The chatbot intervention is designed to target sociocultural risk and protective factors for body image using eight, brief therapeutic techniques derived from several evidence-based theories, including media literacy, cognitive behaviour theory and positive body image. The chatbot was developed through a collaboration between Dove (Unilever), United Nations Children's Fund (UNICEF), The Centre for Appearance Research, and Talk 2 U. The comparison control condition will be assessment only. This is informed by a care as usual framework; whereby, Brazilian adolescents are not currently offered body image prevention or intervention resources at school or within the community. To undertake this project, 2800 adolescent girls and boys will be recruited through an external research agency. Participants will be randomised to either the chatbot or assessment only conditions. Those in the intervention condition, will be encouraged to engage with the chatbot over a 72-hour period, where they will be assessed on state-body satisfaction and affect immediately before and after completing an intervention technique. All participants will be assessed on trait body image, affect and body image self-efficacy at baseline, post-intervention (72-hours) and at one-week and one-month follow-ups. At completion of the one-month follow-up, all participants will receive a debrief form, outlining the study aims and objectives, and additional resources for body and eating concerns. Those in the assessment only condition will be invited to engage with the chatbot; however, their engagement will not be monitored or assessed. Lastly, to compensate participants for their time, they will receive an electronic voucher to the value of approx. US$25 and US$21, for the intervention and control condition, respectively.

NCT ID: NCT04824612 Enrolling by invitation - Keloid Clinical Trials

Photobiomodulation and the Intralesional Administration of Corticoid in the Keloid Surgery.

Start date: August 30, 2021
Phase: N/A
Study type: Interventional

A randomized, controlled, double-blind, clinical trial will be conducted to study the evaluate the effect of blue light combined with corticoid treatment in the preoperative and postoperative period of keloid removal surgery.

NCT ID: NCT04822181 Recruiting - Clinical trials for Non-alcoholic Steatohepatitis

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

ESSENCE
Start date: April 1, 2021
Phase: Phase 3
Study type: Interventional

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

NCT ID: NCT04819321 Not yet recruiting - Metabolic Disease Clinical Trials

Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

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

The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.