Clinical Trials Logo

Filter by:
NCT ID: NCT05386550 Recruiting - Clinical trials for Head and Neck Cancer

Phase III Xevinapant (Debio 1143) and Radiotherapy in Resected LA SCCHN, High Risk, Cisplatin-ineligible Participants (XRAY VISION)

Start date: October 6, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to demonstrate the superior efficacy of Xevinapant (Debio 1143) versus placebo when added to radiotherapy in the treatment of high-risk participants with resected locally advanced squamous cell carcinoma of the head and neck (LA SCCHN) who are ineligible to receive cisplatin-based chemoradiation concurrently. Study details include: Study duration: Participants will be followed until the last on-study participant reaches his/her 60-month post-randomization visit, a decision to end the study has been triggered, or until premature discontinuation from study, whichever occurs first. Treatment duration: 18 weeks, consisting of six 3-week cycles. Health measurement/observation: Improved Disease-Free Survival. Visit frequency: Weekly visit during combination therapy period, once every 3 weeks during monotherapy period, and every 3, 4, or 6 months during the Disease-Free Survival Follow-up period in Year 1, 2 and 3, or 4 and 5 (with telephone contact in between), respectively, and every 3 months (telephone visits allowed) during the Overall Survival Follow-up period.

NCT ID: NCT05382299 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Patients With Previously Untreated Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-03
Start date: July 20, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) versus treatment of physician's choice (TPC) in participants with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express programmed cell death ligand 1 (PD-L1) or in participants previously treated with anti-programmed cell death (ligand or protein) 1 (Anti-PD-(L)1) Agents in the early setting whose tumors do express PD-L1.

NCT ID: NCT05382286 Recruiting - Clinical trials for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer

ASCENT-04
Start date: July 25, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1).

NCT ID: NCT05378529 Completed - Clinical trials for Atherosclerotic Cardiovascular Disease

A Cross-sectional Study of Lipoprotein(a) Levels in Patients With Documented History of Atherosclerotic Cardiovascular Disease (ASCVD)

Start date: April 19, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to characterize the distribution of lipoprotein(a) (Lp(a)) levels among participants with a history of ASCVD as defined by their medical history and is 2-fold: - Evaluate the distribution of Lp(a) value in the overall participants with documented history of ASCVD - Evaluate the distribution of Lp(a) value in participants with documented history of ASCVD by demographics and regions

NCT ID: NCT05374512 Recruiting - Breast Cancer Clinical Trials

A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Patients With Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer, Who Are Not Candidates for PD-1/PD-L1 Inhibitor Therapy (TROPION-Breast02)

Start date: May 16, 2022
Phase: Phase 3
Study type: Interventional

This is a Phase III, randomised, open-label, 2 arm, multicentre, international study assessing the efficacy and safety of Dato-DXd compared with ICC in participants with locally recurrent inoperable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

NCT ID: NCT05372445 Recruiting - Obesity Clinical Trials

Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention

MicrobiAr
Start date: May 30, 2022
Phase: N/A
Study type: Interventional

The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.

NCT ID: NCT05371613 Recruiting - Clinical trials for Mucopolysaccharidosis II

A Study to Determine the Efficacy and Safety of Tividenofusp Alfa (DNL310) vs Idursulfase in Pediatric Participants With Neuronopathic (nMPS II) or Non-Neuronopathic Mucopolysaccharidosis Type II (nnMPS II)

COMPASS
Start date: July 21, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

This is a Phase 2/3, multiregional, two-arm, double-blind, randomized, active (standard-of-care)-controlled study of the efficacy and safety of tividenofusp alfa (DNL310), an investigational central nervous system (CNS)-penetrant enzyme-replacement therapy (ERT) for mucopolysaccharidosis type II (MPS II). Participants may also qualify to enter an open-label treatment phase with DNL310 or idursulfase based on pre-specified criteria.

NCT ID: NCT05368649 Completed - Healthy Volunteers Clinical Trials

Sensory Processing and Musculoskeletal Shoulder Pain

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

The development of chronic pain is a common complication in shoulder pain conditions. Half of these type of patients exhibit persistent pain even after a period of six to twelve months from the start of their pain treatment. Persistent pain is most likely a result of different biological alterations, including but not limited to tissue damage. Another potential cause is neurogenic inflammation, which can be triggered by applying excessive mechanical stress to a structure or region. Neurogenic inflammation can lead to peripheral sensitization and sensitizing the musculoskeletal tissues in the process, and this sensitization will last until the input is removed. Nevertheless, even though peripheral factors are sufficient to perpetuate pain, the role of central mechanisms cannot be excluded as a potential cause of sensitization. Moreover, the evidence is not conclusive about deficiencies in pain modulation processes and presence of central mechanisms in chronic pain conditions. It is well known that chronic shoulder pain presents a multi-factorial nature. Hypersensitivity in this condition has been linked to persistent activation of peripheral nerves, which can result in an increased excitability of the sensory input and reduced inhibitory effect of pain modulatory mechanisms. On the other hand, the role the central sensitization plays is not completely clear in this type of patients, but could also contribute to the hypersensitivity in some patients.However, it has been shown that there is a remarkable variability in the presence of central effects among chronic patients. The aim of this study is to evaluate changes in sensory processing and in pain modulatory mechanisms in individuals with and without shoulder pain.

NCT ID: NCT05365009 Recruiting - Clinical trials for Interstitial Lung Disease Due to Systemic Disease

Registry of Autoimmune Interstitial Lung Disease

EPIMAR
Start date: April 10, 2022
Phase:
Study type: Observational [Patient Registry]

Interstitial lung diseases (ILD) constitute a group of entities characterized by inflammation and/or fibrosis of the lung parenchyma. In recent years, with the advent of new diagnostic tools and therapeutic options, multidisciplinary evaluation is essential, since it optimizes the interpretation of each case and the quality of care for these pathologies Consensus for the identification and management of ILD associated with SSc (ILD-SSc) is the only guideline published at present. In the others autoimmune ILD (Ai-ILD), screening, diagnosis, treatment and follow-up strategies are usually performed according to the criteria of the treating medical team. Guidelines regarding the follow-up and indication of immunosuppressive and antifibrotic treatment are lacking. Many questions on the horizon of the Ai-ILD should be answered as better quality evidence emerges from studies with a greater number of patients and better methodological design.

NCT ID: NCT05364931 Completed - Clinical trials for Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

A Study to Evaluate the Safety and Efficacy of Cotadutide Given by Subcutaneous Injection in Adult Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis

PROXYMO-ADV
Start date: July 14, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.