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NCT ID: NCT05563246 Completed - Clinical trials for Lipoprotein Disorder

A Study of LY3473329 in Adult Participants With Elevated Lipoprotein(a) at High Risk for Cardiovascular Events

KRAKEN
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of LY3473329 in adult participants with elevated Lp(a) at high risk for cardiovascular events.

NCT ID: NCT05561803 Withdrawn - Palliative Care Clinical Trials

The Use of Photobiomodulation in the Management of Radiodermatitis in Patients in Palliative Care. A Prospective Study.

Start date: April 8, 2024
Phase:
Study type: Observational

It is estimated that there will be 670,000 new cases of cancer worldwide in 2020-2022 and it is known that the most commonly instituted treatments in cancer are chemotherapy, radiotherapy and surgery. However, these treatments have undesirable side effects, such as Radiodermatitis after Radiotherapy (RD). In fact, the prevalence of possible side effects after radiotherapy is estimated to be 80 to 90%. Radiotherapy complications are associated with a negative impact on patients' quality of life and few supportive measures are available for such complications. Thus, the management of these side effects has been studied in the literature until the present day. On the other hand, Photobiomodulation (PBM) has an important role in wound repair and tissue regeneration, as it influences the different phases of lesion resolution, including the inflammatory phase, the proliferative phase and the remodeling phase. Thus, the aim of this study is to report a case series of Cancer Patients diagnosed with radiotherapy-induced acute radiodermatitis on Palliative Care, treated with PBM. This is a case series report and the study data will be extracted from the medical records of forty cancer patients with grade 2 or 3 RD followed up from September 2023 at the Laser Therapy Outpatient Clinic in a Universitary Hospital. The outcomes are the size of the lesion, the presence of pain assessed by the Visual Analogue Scale (VAS), the Portuguese Version of WHOQOL BREF Scale and the RTOG Scale (Radiation Therapy Oncology Group Scale) to assess the degree of Radiodermatitis before and after PBM therapy. The data will be subjected to a statistical analysis and will be discussed. Data with positive or negative results will be reported.

NCT ID: NCT05561140 Active, not recruiting - Sickle Cell Disease Clinical Trials

Resolution of Sickle Cell Leg Ulcers With Voxelotor

RESOLVE
Start date: May 30, 2022
Phase: Phase 3
Study type: Interventional

This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.

NCT ID: NCT05560243 Completed - HIV Infections Clinical Trials

Tobacco Cessation Tailored to Patients Living With HIV (PLWH) in Brazil

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

The overall goal of this feasibility study is to make adaptations to these evidence-based approaches in collaboration with PLWH and health care providers working with this population, and develop, implement, and evaluate the feasibility and scalability of a theory-based, culturally relevant tobacco cessation intervention for PLWH receiving care through the public health system in a southern town in Brazil (Londrina). This proposal will focus on the intervention development, pretesting, and feasibility testing. The primary outcome will be a 7-day point prevalence abstinence (defined as no tobacco use in the past 7 days and verified through measurement of salivary cotinine and exhaled carbon monoxide levels) at 6-month follow-up. We will also conduct detailed treatment fidelity and scalability assessments (acceptability, feasibility, potential reach and adoption, alignment with the strategic context) to inform a full-scale efficacy trial.

NCT ID: NCT05559580 Recruiting - Clinical trials for Scleroderma, Systemic

A Study in People With Systemic Sclerosis to Test Whether Avenciguat (BI 685509) Has an Effect on Lung Function and Other Systemic Sclerosis Symptoms

VITALISScEā„¢
Start date: November 24, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults aged 18 and older or above legal age who have systemic sclerosis. People can participate if they have a specific subtype called diffuse cutaneous systemic sclerosis. People with another subtype called limited cutaneous systemic sclerosis can also participate if they are anti Scl-70 antibody positive. Systemic sclerosis is also called scleroderma. The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) helps people with scleroderma who have symptoms due to lung fibrosis or vascular problems. Participants are put into 2 groups by chance. One group takes Avenciguat (BI 685509) tablets 3 times a day and the other group takes placebo tablets 3 times a day. Placebo tablets look like BI 685509 tablets but do not contain any medicine. Participants take the tablets for at least 11 months. Afterwards, participants can continue to take the tablets until the last participant has completed the 11-months treatment period. This means that the time in the study and duration of treatment is different for each participant, depending on when they start the study. At the beginning of the study, participants visit the study site every 2 weeks. The time between the visits to the study site gets longer over the course of the study. After the 11-months treatment period, participants visit the study site every 3 months. During the study, participants regularly do lung function tests. The results are compared between the 2 groups to see whether the treatment works. The participants also regularly fill in questionnaires about their scleroderma symptoms. The doctors regularly check participants' skin condition and general health and take note of any unwanted effects.

NCT ID: NCT05559528 Recruiting - Clinical trials for Metastatic Breast Cancer

BRaziLian outcomE for metAStatic breasT Cancer

BREAST
Start date: September 13, 2021
Phase:
Study type: Observational [Patient Registry]

Given the certain benefit in efficacy of adding CDK 4/6 inhibitor to first line endocrine therapy in metastatic breast cancer HR+ HER2- , the aim of this project is to evaluate whether patients without private health insurance may have worse outcomes than privately insured women due to limited access to such class of drugs during their treatments. Prospective observational study with 300 patients divided into two groups, one with patients from the public health system and the second with patients treated in the private service. Patients will be recruited in different regions of Brazil and will be followed for 24 months, stratified according to the use or not of the CDK 4/6 inhibitors.

NCT ID: NCT05559359 Recruiting - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab (LY3650150) in Participants 6 Months to <18 Years of Age With Moderate-to-Severe Atopic Dermatitis

ADorable-1
Start date: October 18, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to <18 years of age with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT05558397 Recruiting - Quality of Life Clinical Trials

Epidural Association of Morphine and Ropivacaine for Cancer Pain Treatment

Start date: April 1, 2018
Phase: Phase 4
Study type: Interventional

In 2012, more than 14 million cases of cancer were diagnosed worldwide, with the forecast for 2025 exceeding 20 million. Pain is the most critical symptom that accompanies cancer. The development of disease generates the need for oncological palliative care and adequacy of the structure by Public Health Care System. In this context, this study aims to evaluate an alternative to the treatment plans provided for in the Brazilian's Public Health Care System table. The objective is to carry out a cost-effectiveness analysis of the epidural administration of morphine and ropivacaine in patients with abdominal neoplasia, and pain that is difficult to clinically control, which leads to an improvement in the quality of life, functional conditions and survival of patients, and that reduces the cost to the Brazilian's Public Health Care System. This is a randomized clinical trial. Patients will be divided into two groups: control and intervention. The control group will receive oral treatment according to the Clinical Protocol and Therapeutic Guidelines for Chronic Pain of the Brazilian's Ministry of Health: morphine, pregabalin and duloxetine. The intervention group will receive an anesthetic solution containing morphine and ropivacaine for epidural administration through a surgically implanted catheter. Pain, quality of life, functional capacity and survival will be evaluated using the following instruments: Visual Analogue Scale; European Organization for Research and Treatment of Cancer Quality of Life Questionnaire "Core" 30; Karnofsky Performance Scale; Eastern Cooperative Oncology Group Scale; Palliative Performance Scale; and Palliative Prognosis Index. It is expected that, at the end of the study, the intervention group will represent a significant savings for the Public Health Care System, due to the decrease in the number of hospitalizations/day and the possible complications due to the lack of effectiveness of the oral treatment. It is expected that the results found will produce scientific support to disseminate the proposed treatment plan for Brazilian's Public Health Care System patients in palliative care.

NCT ID: NCT05558098 Completed - Sepsis Clinical Trials

Dapagliflozin in Patients With Critical Illness

DEFENDER
Start date: November 1, 2022
Phase: Phase 3
Study type: Interventional

To assess the effects of dapagliflozin on a composite hierarchical endpoint in critically ill patients.

NCT ID: NCT05558007 Recruiting - Prostate Cancer Clinical Trials

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients

Start date: November 22, 2023
Phase: Phase 2
Study type: Interventional

To determine efficacy, safety and tolerabiltiy of topically applied BZ371A in patients that experienced RP, in combination with daily tadalafil compared to placebo.