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NCT ID: NCT05349643 Recruiting - Clinical trials for Tenosynovial Giant Cell Tumor

A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

Start date: January 26, 2023
Phase: Phase 2
Study type: Interventional

AMB-051-07 is an Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension which will enroll approximately 48 adult subjects with TGCT for IA doses over a 24-week dosing period (Part 1) with a Part 2 OLE of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

NCT ID: NCT05349110 Recruiting - Clinical trials for Colorectal Neoplasms

Real-time Diagnosis of Diminutive Colorectal Polyps Using AI

COMET-OPTICAL
Start date: August 20, 2021
Phase:
Study type: Observational

Correct endoscopic prediction of the histopathology and differentiation between benign, pre-malignant, and malignant colorectal polyps (optical diagnosis) remains difficult. Artificial intelligence has great potential in image analysis in gastrointestinal endoscopy. Aim of this study is to investigate the real-time diagnostic performance of AI4CRP for the classification of diminutive colorectal polyps, and to compare it with the real-time diagnostic performance of commercially available CADx systems.

NCT ID: NCT05348785 Recruiting - Parkinson Disease Clinical Trials

A Study to Assess the Safety of BIIB122 Tablets and if it Can Slow the Worsening of Early-Stage Parkinson's Disease in Participants Between the Ages of 30 and 80

LUMA
Start date: April 19, 2022
Phase: Phase 2
Study type: Interventional

In this study, researchers will learn more about a study drug called BIIB122 in participants with early-stage Parkinson's disease (PD). In this study: - Participants will take 225 milligrams (mg) of BIIB122 or a placebo as tablets by mouth. A placebo looks like the study drug but has no real medicine in it. - Participants will take BIIB122 or placebo 1 time a day for up to a minimum of 48 weeks and a maximum of 144 weeks. - Certain medications for PD will be allowed at enrollment for a subset of participants. - Participants will have to visit at 2-week intervals between baseline and week 12 and at 4-week intervals between week 12 and week 48 and at 12 week intervals between week 48 and week 144. The main question researchers are trying to answer is if taking BIIB122 slows the worsening of symptoms more than placebo in the early stages of PD. To help answer this question, researchers will use a questionnaire called the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, also known as the MDS-UPDRS. Researchers will use the MDS-UPDRS to learn about participant PD symptoms and how they affect their daily life. Researchers will also learn more about the safety of BIIB122.

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: NCT05347927 Recruiting - Skin Microbiome Clinical Trials

Observational Study to Evaluate the Influence of Undercast Material Types on Skin Microbiome

Microbiome II
Start date: October 30, 2022
Phase:
Study type: Observational

This clinical study will evaluate the clinical performance and the safety of the CE-marked casting and padding materials when used in routine fracture care without any additional invasive methods and within the intended use. As primary objective the cast therapy´s influence on skin microbiome during fracture management will be investigated. Further, the influence of the padding material on the skin microbiome, device comfort, skin conditions, and impact on daily life activities as well as HCP´s and patient´s satisfaction and general product safety and performance are considered as secondary outcomes.

NCT ID: NCT05347693 Recruiting - Clinical trials for Chronic Kidney Disease

Continuing Sodium Zirconium Cyclosilicate (SZC) After Discharge Study

CONTINUITY
Start date: March 24, 2022
Phase: Phase 4
Study type: Interventional

This is an open-label, randomised study in participants with chronic kidney disease (CKD) treated for hyperkalaemia (HK) whilst in hospital. The study will compare SZC to standard of care (SoC) with the goal of determining: - If continued use of SZC maintains normokalaemia (NK) better than SoC after participant discharge from the hospital. - If continued use of SZC after discharge will reduce HK related healthcare resource utilisation compared to SoC.

NCT ID: NCT05347095 Recruiting - Clinical trials for Perianal Crohns Disease

A Study of Guselkumab in Participants With Fistulizing, Perianal Crohn's Disease

FUZION CD
Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study to evaluate the clinical efficacy of guselkumab in fistulizing, perianal Crohn's disease and to assess the overall safety of guselkumab.

NCT ID: NCT05346367 Recruiting - Brain Metastases Clinical Trials

Improving Therapeutic Ratio With Hypo Fractionated Stereotactic Radiotherapy for Brain Metastases

SAFESTEREO
Start date: July 18, 2022
Phase: N/A
Study type: Interventional

Randomized phase II trial. The study aims to investigate a different and potentially safer radio therapeutic treatment method for brain metastases. The current standard of stereotactic radiotherapy (SRT) in one or three fractions is compared to fractionated stereotactic radiotherapy (fSRT) in five fractions.

NCT ID: NCT05346042 Recruiting - COVID-19 Clinical Trials

Safe and Timely Cessation of Isolation of Patients With COVID-19 (The SCIP-COVID-19) Study

SCIP-COVID19
Start date: December 1, 2022
Phase:
Study type: Observational

Rationale: In the treatment, care and isolation of COVID-19 patients, one of the most important issues is determining the duration of infectiousness. The current Dutch guideline advises at least 14 days of isolation for seriously ill patients, which is the case for most admitted patients, and at least 21 days for intubated patients. It is believed that in most cases this isolation duration is too long, which is highly undesirable for patients staying in closed single-occupancy rooms. This is known to result in limited contact with healthcare workers (HCW) and to be associated with a higher level of depression among patients. The longer the isolation, the higher the workload for HCW and the higher the costs (e.g. with about 0.5 million admission days in the Netherlands, these work out at about €14 million on personal protective equipment [PPE] and cleaning alone). Additionally, isolation demands a larger healthcare workforce, yielding less capacity to provide other care to non-COVID-19 patients, with numerous other consequences. On the other hand, it is possible that some patients were discontinued from isolation too early, leading to a risk of transmission to other patients and to HCW. In conclusion, duration of isolation should be as short as possible for proper patient flow and to avoid unnecessary burden to patients and HCW, and thus to healthcare in general. Therefore, there is an urgent need to define the period of infectiousness of COVID-19. We will develop a safe and effective algorithm for decision on timely discontinuation of isolation of COVID-19 hospitalized patients. Objective: The ultimate goal of this project is to produce new evidence-based criteria for the termination of isolation of hospitalized COVID-19 patients that are safe (very low subsequent risk of transmission to other patients or healthcare workers) while reducing the number of unnecessary days in isolation (thereby improving quality of life of patients, reducing hospital costs, and making optimal use of the scarce number of isolation beds). Multiple sources of data and evidence will be integrated to arrive at these new criteria.