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NCT ID: NCT05517447 Recruiting - Thyroid Eye Disease Clinical Trials

Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease

Start date: November 6, 2023
Phase: Phase 3
Study type: Interventional

This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.

NCT ID: NCT05516498 Recruiting - Liver Cirrhosis Clinical Trials

Zibotentan and Dapagliflozin Combination, EvAluated in Liver Cirrhosis (ZEAL Study)

ZEAL
Start date: October 31, 2022
Phase: Phase 2
Study type: Interventional

This is a two part Phase IIa/b multicentre, randomised, double-blind, placebo-controlled, parallel group dose-ranging study to assess the efficacy, safety, and tolerability of the combination of zibotentan and dapagliflozin, and dapagliflozin monotherapy versus placebo in participants with cirrhosis with features of portal hypertension.

NCT ID: NCT05514054 Recruiting - Breast Neoplasms Clinical Trials

A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer

EMBER-4
Start date: October 4, 2022
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

NCT ID: NCT05512377 Recruiting - Bladder Cancer Clinical Trials

Brightline-2: A Study to Test Whether Brigimadlin (BI 907828) Helps People With Cancer in the Biliary Tract, Pancreas, Lung or Bladder

Start date: November 25, 2022
Phase: Phase 2
Study type: Interventional

This study is open to adults with advanced cancer in the biliary tract, pancreas, lung, or bladder. This is a study for people for whom previous treatment was not successful or no treatment exists. The purpose of this study is to find out whether a medicine called BI 907828 helps people with cancer in the biliary tract, pancreas, lung, or bladder. BI 907828 is a so-called MDM2 inhibitor that is being developed to treat cancer. All participants take BI 907828 as a tablet once every 3 weeks. Participants may continue to take BI 907828 as long as they benefit from treatment and can tolerate it. They visit the study site regularly. At the study site, doctors regularly check the size of the tumour and whether it has spread to other parts of the body. The doctors also regularly check participants' health and take note of any unwanted effects.

NCT ID: NCT05512364 Recruiting - Clinical trials for HER2-negative Breast Cancer

Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)

TREAT ctDNA
Start date: December 15, 2023
Phase: Phase 3
Study type: Interventional

This is an international, multi-center, randomised, open label, superiority phase III trial of elacestrant vs standard endocrine therapy in patients with ER+/HER2- breast cancer and ctDNA relapse. During the ctDNA screening phase, patients will be tested at different timepoints to detect the presence of ctDNA in their blood. Patients who are found to be ctDNA-positive and have no evidence of distant metastasis, will be randomised 1:1 between standard endocrine treatment (the same they were receiving when tested ctDNA positive) versus elacestrant, provided they meet all eligibility criteria. After completion of the protocol treatment period, treatment will be left at the discretion of the treating physician.

NCT ID: NCT05510817 Recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Multiparametric Assessment to Investigate Prognostic Factors for Disease Evolution a nd Evolutionary Patterns of Cognitive Status in RRMS

COGNIT-MS
Start date: June 6, 2022
Phase: N/A
Study type: Interventional

This prospective study combining non conventional MRI techniques, neuropsychological screening tools, and a neurophysiological work-up using a sensitive and validated battery, will evaluate the predictive value of these measures and will explore the changes of the cognitive scores from baseline.

NCT ID: NCT05509777 Recruiting - Crohn's Disease Clinical Trials

A Study of Mirikizumab (LY3074828) in Pediatric Participants With Crohn's Disease

AMAY
Start date: March 13, 2024
Phase: Phase 3
Study type: Interventional

Study participants will be screened during the platform study and randomly assigned to receive mirikizumab or another intervention. The purpose of the mirikizumab study is to evaluate efficacy, safety, tolerability, and how well mirikizumab absorbs into the body of pediatric participants with Crohn's disease. Study periods for the intervention-specific appendix (ISA) will be as follows: - A 12-week induction period - A maintenance period from Week 12 to Week 52, and - A safety follow-up period up to 16 weeks. The study will last about 74 weeks and may include up to 19 visits.

NCT ID: NCT05509400 Recruiting - Migraine Clinical Trials

Efficacy and Tolerability of Rimegepant for the Acute Treatment of Migraine in Adults Unsuitable for Triptan Use

Start date: October 18, 2022
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate the efficacy and tolerability of rimegepant in a population of adults that are unsuitable for triptan medications due to a previous intolerance, lack of efficacy, or contraindication (including a history of clinically-relevant cardiovascular disease).

NCT ID: NCT05508867 Recruiting - Hodgkin Lymphoma Clinical Trials

A Study of Coformulated Favezelimab/Pembrolizumab (MK-4280A) Versus Physician's Choice Chemotherapy in PD-(L)1-refractory, Relapsed or Refractory Classical Hodgkin Lymphoma (MK-4280A-008)

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

The purpose of this study is to compare efficacy of coformulated favezelimab/pembrolizumab (MK-4280A) with physician's choice chemotherapy of bendamustine or gemcitabine in participants with PD-(L)1-refractory, relapsed or refractory classical Hodgkin Lymphoma. The study will also assess the safety and tolerability of coformulated favezelimab/pembrolizumab. The primary study hypotheses are that coformulated favezelimab/pembrolizumab is superior to physician's choice chemotherapy with respect to progression-free survival (PFS) and overall survival (OS).

NCT ID: NCT05508321 Recruiting - Telomere Shortening Clinical Trials

Nasal Brushing for the Diagnosis and Understanding of Telomeropathies

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

To date, the diagnosis of telomeropathies is based on telomere length measured in blood cells. However, this type of analysis is not always sufficient because some mutations underlying the development of telomeropathies are not associated with abnormal shortened telomeres. Since telomere dysfunction analysis cannot be performed on blood cells, it is mandatory to have access to another cellular material. To date, skin biopsies are performed to obtain fibroblasts. However, this technique is relatively invasive. The aim of this project is to assess whether nasal epithelial cells obtained through nasal brushing could offer the opportunity to detect cellular alterations and mutations involved in telomeropathies, in a mildly invasive way. If successful, this technique could become a non-invasive clinical tool for the diagnosis work-up of telomeropathies. Moreover, investigators aim to assess whether olfactory function is impaired in patients with telomeropathies.