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NCT ID: NCT05285982 Active, not recruiting - Clinical trials for Lung Diseases, Interstitial

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD®-ON)

Start date: April 4, 2022
Phase: Phase 3
Study type: Interventional

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 1 year and 5 months or until nintedanib or other treatment options become available outside of this study. During the first 3 years, they visit the study site about 15 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

NCT ID: NCT05281913 Recruiting - Clinical trials for Internet-Based Intervention

Psychoeducational Simulation Game for Adults in Stepfamilies

GSteps
Start date: February 4, 2022
Phase: N/A
Study type: Interventional

Recent evidence has shown that intervention programs for remarried people are scarce. Furthermore, from what is known, no specific intervention models (traditional or web-based) has yet been developed for remarried Portuguese population. This study evaluates the efficacy of a web-based Psychoeducational Simulation Game on marital adjustment on marital social skills, on remarriage beliefs, on parenting attitudes, and on the stepfamily functioning.

NCT ID: NCT05279326 Recruiting - Diabetes Type 2 Clinical Trials

Virtual SMAs in Lifestyle Approach for Type 2 Diabetes

Start date: December 2023
Phase: N/A
Study type: Interventional

This study protocol presents the design of a randomized pragmatic trial. This study aims to determine the effectiveness of virtual shared medical appointments (SMAs) lifestyle approach in improving glycaemic control, compared to usual care in type 2 diabetes (T2D) subjects.

NCT ID: NCT05274269 Completed - Cystic Fibrosis Clinical Trials

Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation

Start date: May 9, 2022
Phase: Phase 3
Study type: Interventional

This study will evaluate the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR) mutation.

NCT ID: NCT05270044 Active, not recruiting - Melanoma Clinical Trials

Adjuvant Encorafenib and Binimetinib in High-risk Stage II Melanoma With a BRAF Mutation.

COLUMBUS-AD
Start date: May 2, 2022
Phase: Phase 3
Study type: Interventional

The purpose of the Columbus-AD study is to evaluate the efficacy and safety of 12 months of encorafenib in combination with binimetinib in adjuvant setting of BRAF V600E/K mutant stage IIB/C melanoma versus the current standard of care (surveillance).

NCT ID: NCT05269004 Active, not recruiting - Multiple Sclerosis Clinical Trials

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

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

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

NCT ID: NCT05268289 Recruiting - Lupus Nephritis Clinical Trials

Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V

Start date: August 10, 2022
Phase: Phase 2
Study type: Interventional

The overall purpose of this two-part study is to evaluate the efficacy, safety and tolerability of iptacopan (LNP023) in addition to standard of care treatment.

NCT ID: NCT05267613 Recruiting - Erosive Esophagitis Clinical Trials

Endoscopic Evidence of Maintenance of Healing With Oral NEXIUM in Patients 1 to 11 Years Old With Erosive Esophagitis.

EE
Start date: July 1, 2022
Phase: Phase 3
Study type: Interventional

The aim of the study is to compare the safety and efficacy of two doses of Nexium in maintaining healing of erosive esophagitis in patients 1 to 11 years of age.

NCT ID: NCT05267392 Recruiting - Clinical trials for Non-small Cell Lung Cancer

Neoadjuvant Immunotherapy With Durvalumab (MEDI4736) in Non-Surgical Early Stage or Locally Advanced Non-Small Cell Lung Cancer (NSCLC) Followed by Radical Radiotherapy or Chemoradiotherapy

IDEAR
Start date: February 16, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This study proposes to evaluate the safety and efficacy of an anti-PD-L1 (durvalumab) agent as neoadjuvant therapy in patients diagnosed with localized NSCLC who are planned to undergo radical RT or CRT. The hypothesis to be tested for the primary objective is that the treatment of durvalumab followed by RT/CRT will be safe and well tolerated in subjects with NSCLC.

NCT ID: NCT05263999 Recruiting - Clinical trials for Graft Versus Host Disease

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids