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NCT ID: NCT05348915 Active, not recruiting - Sickle Cell Disease Clinical Trials

A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease

Start date: March 29, 2022
Phase: Phase 3
Study type: Interventional

This study is an open-label study to evaluate the safety of long-term administration of inclacumab in participants with sickle cell disease (SCD). Participants in this study will have completed a prior study of inclacumab.

NCT ID: NCT05348733 Recruiting - Clinical trials for Type 2 Diabetes Mellitus

A Study Called FINE-REAL to Learn More About the Use of the Drug Finerenone in a Routine Medical Care Setting

Start date: June 13, 2022
Phase:
Study type: Observational

This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: - Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants - Reasons for starting finerenone - Reasons for stopping finerenone early - How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) - Dosing of finerenone - Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: - Stopping finerenone treatment too early - Dialysis (a medical procedure to filter the blood of extra water and waste) - Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.

NCT ID: NCT05348577 Recruiting - Prostate Cancer Clinical Trials

Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)

CAPItello280
Start date: March 25, 2022
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel with steroid therapy and receive androgen deprivation therapy. The intention of the study is to demonstrate that the combination of capivasertib plus docetaxel is superior to placebo plus docetaxel with respect to the overall survival of study participants, when overall survival is defined as the time from randomization until the date of death due to any cause.

NCT ID: NCT05347862 Not yet recruiting - Type 2 Diabetes Clinical Trials

Remote and Intensive Program for Physical Activity Promotion for People With Type 2 Diabetes (The PRACTICE Trial)

PRACTICE
Start date: December 2, 2022
Phase: N/A
Study type: Interventional

The purpose of this trial is to evaluate the effects of a remote and intensive physical activity promotion program for people with Type 2 Diabetes (T2D), in comparison to a usual model of PA counseling, in glycemic levels, level of physical activity and quality of life in adults in elderly with T2D.

NCT ID: NCT05347316 Recruiting - Atherosclerosis Clinical Trials

Colchicine Effect on Perivascular Inflammation Index on Coronary CTA

COPIX
Start date: March 7, 2022
Phase: Phase 1
Study type: Interventional

Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.

NCT ID: NCT05345821 Recruiting - Quality of Life Clinical Trials

An Analysis of Adverse Events and Satisfaction Outcomes of Women Who Underwent Primary and Secondary Breast Augmentation Using Silimed® Breast Implants With Smooth Surface

STEPS S
Start date: November 21, 2022
Phase:
Study type: Observational

The study investigates the safety and performance of Silimed® brand smooth surface breast implants in women born with indication for primary and secondary (revision) augmentation to be followed up for 10 years. The safety of the smooth-surfaced Silimed® implant will be evaluated by estimating known and unexpected short-term and long-term risk/adverse event rates through patient reports of adverse events after implantation. The performance of using Silimed® brand smooth surface breast implants will be evaluated by evaluating satisfaction and quality of life after implantation.

NCT ID: NCT05345171 Recruiting - OTC Deficiency Clinical Trials

Clinical Study of DTX301 AAV- Mediated Gene Transfer for Ornithine Transcarbamylase(OTC) Deficiency

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

The primary objective is to evaluate the efficacy of DTX301 on the improvement of ornithine transcarbamylase (OTC) function by maintaining safe plasma ammonia levels with removal of dietary protein restriction and alternative pathway medication.

NCT ID: NCT05344222 Completed - Clinical trials for Impacted Third Molar Tooth

Effects of Photobiomodulation Conditioning in Impacted Third Molars

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

The removal of third molars should be considered to avoid problems such as cysts and other complications. Surgical intervention with the manipulation of oral tissues has the undesirable postoperative effects of pain, trismus (limited mouth opening) and edema. Photobiomodulation has also proved effective regarding reductions in pain, edema and trismus. The aim of the present study was to evaluate the effectiveness of photobiomodulation for the conditioning of tissues involved in the surgical removal of impacted mandibular third molars in terms of reducing or eliminating postoperative pain, trismus and edema.

NCT ID: NCT05344183 Active, not recruiting - Fatigue Clinical Trials

Immediate and Short-term Effects of Low-level Laser

Start date: September 3, 2022
Phase: N/A
Study type: Interventional

Athletes experience an exhaustive routine of training, associated with the reduced time of rest, facilitates the appearance of muscle fatigue, which increases the risk of muscle injuries, especially during the execution of the jump. Low Level Lasertherapy is a technique that has been increasingly improved due to the physiological effects it provides in the muscle recovery process. However, there is still a lack of studies focused on the use of this technique in functional improvement, especially in jumping sports. Objectives: To evaluate the immediate and short-term effects of low-level laser on the functional performance of lower limbs of jumping athletes and to evaluate the short-term effects of low-level laser on the activation of the gluteus medius and quadriceps muscles. Methods: This is a brief, double-blind, randomized, placebo-controlled clinical trial. Will be recruited 24 handball and volleyball players aged between 18 to 35 years. The primary outcome of our study is functional performance (modified hop test and modified SEBT), and as a secondary outcome (level of electromyographic activity). After the baseline assessments, the athletes will be randomized and allocated into two groups: Intervention Group (IG, n=12) and Control Group (CG, n=12) and submitted to a fatigue protocol, followed by laser therapy or placebo.

NCT ID: NCT05343936 Recruiting - Prostate Cancer Clinical Trials

Evaluation of an Active Surveillance Protocol for Prostate Cancer in the Brazilian Population

Start date: August 19, 2022
Phase:
Study type: Observational [Patient Registry]

In this study, the investigators aim to form a Brazilian national prospective active surveillance cohort of patients with low-risk prostate cancer in the public health system. The investigators aim to demonstrate data on the pathological reclassification rate, treatment-free survival, among others. This cohort aim to evaluate and validate the active surveillance strategy in Brazil.