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NCT ID: NCT05352672 Recruiting - Melanoma Clinical Trials

Clinical Study of Fianlimab in Combination With Cemiplimab Versus Pembrolizumab in Adolescent and Adult Patients With Previously Untreated Unresectable Locally Advanced or Metastatic Melanoma

Start date: July 14, 2022
Phase: Phase 3
Study type: Interventional

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called REGN2810, also known as cemiplimab (each individually called a "study drug" or called "study drugs" when combined). The study is focused on patients with a type of skin cancer known as melanoma. The aims of the study are to see how effective the combination of fianlimab and cemiplimab are in treating the melanoma skin cancer, in comparison with a medication, pembrolizumab, approved for the treatment of melanoma skin cancer in adults, and to observe any similarities, or differences, in how the study drugs work in adolescent participants compared with adult participants. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. - How administering the study drugs might improve quality of life

NCT ID: NCT05352178 Recruiting - Prostate Cancer Clinical Trials

Metastasis-directed Therapy for Oligorecurrent Prostate Cancer

SPARKLE
Start date: April 20, 2022
Phase: Phase 3
Study type: Interventional

The aim is to investigate whether the addition of short-term androgen deprivation therapy (ADT) during 1 month or short-term ADT during 6 months together with an androgen receptor targeted therapy (ARTA) to metastasis-directed therapy (MDT) significantly prolongs poly-metastatic free survival (PMFS) and/or metastatic castration-refractory prostate cancer free survival (mCRPC-FS) in patients with oligorecurrent hormone sensitive prostate cancer.

NCT ID: NCT05351684 Completed - HIV-1-infection Clinical Trials

Effect of Dolutegravir Intensification on HIV-1 Reservoirs

EDIT
Start date: January 1, 2019
Phase: Phase 2
Study type: Interventional

Persistent HIV viremia occurs in most ART-treated patients and could arise from reactivation of viral expression from latently-infected cells that constitute the viral latent reservoir (LR) and/or residual ongoing viral replication during cART, for instance in anatomical compartment where drug penetration is sub-optimal. The question of the sources of persistent viremia is of the utmost importance. If ongoing viral replication occurs, it could induce deleterious consequences on reservoirs size and immune activation.We propose to better characterize the role ongoing viral replication to HIV persistence under ART by undertaking a treatment intensification trial with high-dose dolutegravir. Tissue/blood samples and replication-competent reservoir measurements will be included as outcomes as well as immune activation markers.

NCT ID: NCT05350072 Active, not recruiting - Sjogren Syndrome Clinical Trials

Two-arm Study to Assess Efficacy and Safety of Ianalumab (VAY736) in Patients With Active Sjogren's Syndrome

NEPTUNUS-1
Start date: July 28, 2022
Phase: Phase 3
Study type: Interventional

A randomized, double-blind, placebo controlled, 2-arm multicenter phase 3 study to assess the efficacy and safety of ianalumab in patients with active Sjogren's syndrome (NEPTUNUS-1)

NCT ID: NCT05349838 Completed - HIV-1-infection Clinical Trials

An Open-Label, Multi-Centre, Randomised, Switch Study to Evaluate the Virological Efficacy Over 96 Weeks Of 2-Drug Therapy With DTG/RPV FDC in Antiretroviral Treatment-Experienced HIV-1 Infected Subjects Virologically Suppressed With NNRTIs Resistance Mutation K103N

WISARD
Start date: November 5, 2018
Phase: Phase 3
Study type: Interventional

HIV-1 infected subjects that experience virological failure while on non nucleoside reverse-transcriptase inhibitors (NNRTIs), including those with the K103N mutation, are usually switched to a boosted PI-based regimen or other antiretroviral (ARV) combinations. The same is true for subjects who need to start antiretroviral therapy and have acquired virus that is already resistant to antiretrovirals. These "second line" combinations are often associated with numerous issues that can have a potential impact on the quality of life (QoL) of these patients. Therefore a simpler and better tolerated alternative second line treatment option would be a useful tool for the clinical management of these patients. The aim of this study is to assess the efficacy and tolerability of a dual combined therapy of Dolutegravir (DTG) 50 mg OD + Rilpivirine (RPV) 25 mg OD in virologically suppressed participants with previous virological failure with NNRTIs and having the clinically significant mutation K103N. The secondary objective of the study is to assess whether a simplification of the treatment in terms of pill burden, long term metabolic toxicity and potential for drug interactions improves the QOL of the participants. The study will also evaluate DTG & RPV concentrations in the blood plus changes in cell associated virus. In order to compare the first line treatment (boosted PI and/or other antiretroviral combinations) and the DTG+RPV combination, two thirds of study participants will be switched to DTG+RPV immediately and receive DTG+RPV for 96 weeks. The other third will be switched after 48 weeks of continuing on their first line treatment and receive DTG+RPV for 48 weeks. All participants will then be followed up for a further 30 days. Participants will be recruited from sites across Europe, and randomised onto either arm of the study. After randomisation, participants will attend approximately 10 visits over the course of two years.

NCT ID: NCT05349721 Active, not recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

Study to Assess the Effects of PTC857 Treatment in Participants With Amyotrophic Lateral Sclerosis ALS

CARDINALS
Start date: May 15, 2022
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy and safety of PTC857 treatment in participants diagnosed with ALS.

NCT ID: NCT05349695 Recruiting - Chronic Pain Clinical Trials

Patient Profiling and Outcome Assessment in Spinal Cord Stimulation for Chronic Back and/or Leg Pain

PROSTIM
Start date: May 1, 2022
Phase:
Study type: Observational

The PROSTIM study is an ongoing prospective, multicentric and observational clinical study. Patients are recruited in three different centers in Eastern Belgium from May 2018 onwards. This real-world data collection approaches the outcome assessment of daily medical practice. A hierarchical cluster analysis is used to identify significant patient clusters based on the Visual Analogue Scale (VAS), Oswestry disability index (ODI), Pain Vigilance and Awareness Questionnaire (PVAQ), Pain Catastrophizing Scale (PCS) and EuroQol with five dimensions for health-related quality of life (EQ-5D). Patient clusters will be assessed on the change in biopsychosocial variables after six weeks, three and twelve months. Secondary outcomes include the comparison of pain medication use, SCS parameters, treatment satisfaction and return to work.

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: NCT05348720 Active, not recruiting - COVID-19 Clinical Trials

Impact of a COVID-19 Related ICU Stay on Mental Health for Patients and Their Relatives

PICOVIDS
Start date: March 1, 2020
Phase:
Study type: Observational

As ICU mortality has been significantly decreased over the last two decades, the focus has been shifting from short term (such as ICU and hospital mortality) to long-term outcome. This evolution has led to a new entity that has been established in 2012 at a stakeholder conference: the Post-Intensive Care Syndrome (PICS). It is defined as impairments in physical, cognitive and mental health status arising after critical illness and persisting beyond acute care hospitalisation. As family members of ICU patients may also be affected by mental health impairment, the PICS-F (F for Family) has been introduced simultaneously. It is expected that the COVID-19 pandemic will result in a significant increase of the proportion of patients and relatives suffering PICS and PICS-F, as there is during the COVID-19 related ICU-stay exposure to a high number of risk factors for developing these entities. This Post Intensive Care Syndrome in COVID-19 survivors (PICOVIDS) study is an observational, single-center exploratory follow-up cohort study that aims to get insight into the mental impact of a COVID-19 related ICU stay for COVID-19 ICU survivors and their family members, 18 months after ICU discharge. Specific research questions are: 1. What is the prevalence of symptoms of depression, anxiety and Post Traumatic Stress Disorder (PTSD) and what is the prevalence of these specific disorders in COVID-19 ICU-survivors and their relatives 18 months after ICU-discharge? 2. What are important risk factors for these symptoms and disorders? 3. What is the satisfaction level of patient and caregiver about the ICU care: How did they experience ICU stay?

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.