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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: NCT05361148 Recruiting - Diabetes Clinical Trials

Long-term Health After Severe Acute Malnutrition in Children and Adults: the Role of the Pancreas

SAMPA
Start date: October 12, 2021
Phase:
Study type: Observational

Whilst there is an increasing prevalence of overweight and obesity worldwide, malnutrition remains common. In addition, malnutrition, overweight, and infections often interact. The consequences of malnutrition after birth are little studied. Severe acute malnutrition in childhood remains common in Africa and Asia and many adult patients with tuberculosis or HIV, diseases which are common in Africa and Asia, may become malnourished. We are interested in diabetes, which in Africa and Asia affects people at younger age and lower weight than in Europe. There is evidence that severe postnatal malnutrition increases the risk of later diabetes but the evidence is piecemeal and there is little information as to the mechanisms involved. It is thus difficult to determine what treatments or preventative strategies are appropriate. We wish to focus on the pancreas which is a key organ in digestion and metabolic processes, especially in relation to diabetes. We will investigate pancreas size, microscopic structure, hormone and digestive enzyme production, and the body's response to these hormones among groups of people in Tanzania, Zambia, India and the Philippines. These groups have participated in the research team's previous studies of malnutrition and were malnourished before birth, as children, or as adults. They now live in places with a wide range of access to foods high in fat and sugar which could affect their risk of diabetes. We will compare their pancreas function to that of never-malnourished controls at each site. We will use advanced statistical methods to understand the links between early malnutrition and later diabetes, taking into account the factors often associated with diabetes such as age, current overweight and infection. Even if we find no important link between early malnutrition and later diabetes, the research will lead to improved understanding of the long-term consequences of malnutrition and the presentation and underlying metabolism of diabetes in Africa and Asia. Thus, the project will lead to improved health care for both malnourished and diabetic people.

NCT ID: NCT05352919 Enrolling by invitation - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Evaluate the Continuous Safety and Efficacy of Litifilimab (BIIB059) in Adults With Active Systemic Lupus Erythematosus

EMERALD
Start date: June 10, 2022
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long-term safety and tolerability of litifilimab in participants with active systemic lupus erythematosus (SLE). The secondary objectives of this study are to evaluate the long-term effect of litifilimab on disease activity in participants with SLE, to evaluate the long-term effect of litifilimab in participants with SLE in maintaining low disease activity, to evaluate the effect of litifilimab in participants with active SLE in preventing irreversible organ damage, to assess long-term use of oral corticosteroid (OCS) with participants receiving litifilimab treatment, to assess the impact of litifilimab on participant-reported Health-Related Quality-of-Life Questionnaire (HRQoL), symptoms, and impacts of SLE, to evaluate long-term effect of litifilimab on laboratory parameters, and to evaluate immunogenicity of litifilimab.

NCT ID: NCT05321420 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

ELEVATE
Start date: July 29, 2022
Phase: Phase 2
Study type: Interventional

This study a randomized, double-blind, four arm study to evaluate the safety and efficacy of LYT-100 compared to pirfenidone or placebo in adults with Idiopathic Pulmonary Fibrosis.

NCT ID: NCT05310396 Active, not recruiting - Infant Nutrition Clinical Trials

Efficacy of a Nutrient Blend in Improving Neurocognitive and Behavioral Outcomes in Infants: a Randomized, Controlled, Intervention Study

Start date: October 7, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the efficacy of the nutrient blend in a starter infant formula (IF) and follow up infant formula (FUF) in improving the neurocognitive and behavioural outcomes among formula-fed infants randomized to the experimental formula (EF) versus the control formula (CF).

NCT ID: NCT05306574 Recruiting - Clinical trials for Systemic Lupus Erythematosus

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

Start date: June 20, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

NCT ID: NCT05305547 Completed - Clinical trials for SARS-CoV-2 Infection

A Study to Compare S-217622 With Placebo in Non-Hospitalized Participants With COVID-19

SCORPIO-HR
Start date: August 3, 2022
Phase: Phase 3
Study type: Interventional

The main aim of this study is to evaluate the efficacy of S-217622 versus placebo among outpatient adults with mild and moderate COVID-19 starting intervention within 3 days of symptom onset.

NCT ID: NCT05301842 Recruiting - Clinical trials for Hepatocellular Carcinoma

Evaluate Durvalumab and Tremelimumab +/- Lenvatinib in Combination With TACE in Patients With Locoregional HCC

EMERALD-3
Start date: March 28, 2022
Phase: Phase 3
Study type: Interventional

A global study to evaluate transarterial chemoembolization (TACE) in combination with durvalumab, tremelimumab and lenvatinib therapy in patients with locoregional hepatocellular carcinoma

NCT ID: NCT05299905 Completed - Cerebral Palsy Clinical Trials

ImGTS for Patients With Cerebral Palsy and With Mobility Limitations

Start date: April 28, 2022
Phase: N/A
Study type: Interventional

The proposed research project aims to answer the question "Are immersive technology systems effective in the rehabilitation management of pediatric patients with cerebral palsy and with mobility limitations?". The current study is the first of three phases, and it aims to create an immersive gamification technology system for the management of patients with cerebral palsy and with mobility disorders and to determine its acceptability, usability, and safety in healthy children.

NCT ID: NCT05298423 Recruiting - Clinical trials for Carcinoma, Non-Small-Cell Lung

Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006/KEYVIBE-006)

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

This study is to evaluate the safety and efficacy of pembrolizumab/vibostolimab (MK-7684A) in combination with concurrent chemoradiotherapy (cCRT) followed by pembrolizumab/vibostolimab versus cCRT followed by durvalumab in participants with unresectable, locally advanced, stage III Non-small Cell Lung Cancer (NSCLC). The primary hypotheses are that pembrolizumab/vibostolimab with cCRT followed by pembrolizumab/vibostolimab is superior to cCRT followed by durvalumab with respect to the following: - progression free survival (PFS) per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) in participants with programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥1% and PD-L1 all comer participants. - overall survival (OS) in participants with PD-L1 TPS ≥1% and PD-L1 all comer participants.