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NCT ID: NCT04961567 Recruiting - Clinical trials for Lupus Erythematosus, Systemic

A Study to Learn About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus

TOPAZ-2
Start date: July 16, 2021
Phase: Phase 3
Study type: Interventional

In this study, researchers will learn more about a study drug called litifilimab (BIIB059) in participants with systemic lupus erythematosus (SLE). The study will focus on participants who have active disease and are already taking standard of care medications. These may include antimalarials, steroids, and immunosuppressants. The main objective of the study is to learn about the effect litifilimab has on lowering the activity of the disease. The main question researchers want to answer is: - How many participants have an improvement in their symptoms after 52 weeks of treatment? Researchers will answer this and other questions by measuring the symptoms of SLE over time using a variety of scoring tools. These include the SLE Responder Index (SRI), the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K), and the Patient Global Assessment - Visual Analog Scale (PGA-VAS). Researchers will also learn more about the safety of litifilimab. They will study how participants' immune systems respond to litifilimab. Additionally, they will measure the effect litifilimab and SLE have on the quality of life of participants using a group of questionnaires. The study will be done as follows: - After screening, participants will be randomized to receive either a high or low dose of litifilimab, or placebo. A placebo looks like the study drug but contains no real medicine. - All participants will receive either litifilimab or placebo as injections under the skin once every 4 weeks. The treatment period will last 52 weeks. Participants will continue to take their standard of care medications. - Neither the researchers nor the participants will know if the participants are receiving litifilimab or placebo. - There will be a follow-up safety period that lasts up to 24 weeks. - In total, participants will have up to 22 study visits. The total study duration for participants will be up to 80 weeks.

NCT ID: NCT04959513 Recruiting - Clinical trials for Alveolar Ridge Augmentation

GBR With L-PRF Bone Block in Early Healing Phase After Extraction

LPRF-GBR
Start date: January 22, 2021
Phase: N/A
Study type: Interventional

When the practitioners have to place an implant, it is necessary to have a sufficient amount of bone. This study propose to manage clinical situations by an approach using guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction. Alveolar ridge changes will be evaluated regarding soft and hard tissues up to 6 months.

NCT ID: NCT04958265 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

COMMUTE-p
Start date: November 17, 2021
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.

NCT ID: NCT04958239 Recruiting - Neoplasms Clinical Trials

A Study to Test Different Doses of BI 765179 Alone and in Combination With Ezabenlimab in Patients With Advanced Cancer (Solid Tumors)

Start date: September 24, 2021
Phase: Phase 1
Study type: Interventional

This study is open to adults with advanced cancer (solid tumors). People for whom previous treatment was not successful can take part in this study. The purpose of this study is to find the highest dose of a medicine called BI 765179 that people with solid tumors can tolerate when taken alone or together with a medicine called ezabenlimab. Each participant is put into one of two groups. Participants get BI 765179 alone or in combination with ezabenlimab as infusion into a vein every 3 weeks. BI 765179 and ezabenlimab are antibodies that may help the immune system fight cancer. In this study, BI 765179 is given to people for the first time. Participants can stay in the study up to 3 years if they benefit from treatment and can tolerate it. The doctors regularly check the participants' health and note any health problems that could have been caused by the study treatment.

NCT ID: NCT04956185 Recruiting - Stroke Clinical Trials

Data Collection of Patients Admitted to the Stroke Unit

PRODA-STROKE
Start date: April 29, 2021
Phase:
Study type: Observational [Patient Registry]

The purpose of this prospective observational study is to create a database in which data will be collected from every patient admitted to the Stroke unit and who has explicitly given his or her informed consent for this data collection. The data that will be collected are part of the standard clinical data. No additional investigations, blood tests or any other tests will be performed. The purpose of this database is to conduct retrospective observational research in the future and will allow the hospital to keep track of some important quality indicators in stroke care.

NCT ID: NCT04954599 Recruiting - Clinical trials for Unspecified Adult Solid Tumor, Protocol Specific

Phase 1/2 Clinical Trial of CP-506 (HAP) in Monotherapy or With Carboplatin or ICI

Start date: April 25, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

A modular, first time in human, open label, multiple dose, accelerated escalation with cohort expansion study of the safety and pharmacokinetics of intravenous infusion of CP-506, a tumor agnostic Hypoxia Activated Prodrug in patients with HRD/FAD solid tumours or tumor types with high incidence of HRD/FAD in monotherapy or in combination with carboplatin or patients with solid tumour and oligoprogressive disease receiving immune checkpoint inhibitors (ICI): a phase I-IIa clinical trial

NCT ID: NCT04951622 Recruiting - Myasthenia Gravis Clinical Trials

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Start date: July 15, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG).

NCT ID: NCT04951323 Recruiting - Clinical trials for Hematopoietic Neoplasms

Impact of the Immune System on Response to Anti-Coronavirus Disease 19 (COVID-19) Vaccine in Allogeneic Stem Cell Recipients (Covid Vaccin Allo)

Start date: March 22, 2021
Phase: Phase 3
Study type: Interventional

The present study is a prospective phase IV study. All participants will receive the anti-Coronavirus Disease 2019 (COVID-19) Vaccine (messenger Ribonucleic acid-based vaccine, BNT162b2 or Comirnaty®, commercialized by Pfizer-BioNTech) being authorized in the European Union since December 2020. The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.

NCT ID: NCT04950517 Recruiting - Clinical trials for Autism Spectrum Disorder

Physical Activity and Cardiorespiratory Fitness in Adolescents With Autism Spectrum Disorder

PAASD
Start date: November 18, 2021
Phase:
Study type: Observational

The purpose of this study is to increase knowledge and insights with regard to physical activity behavior in adolescents with Autism Spectrum Disorder.

NCT ID: NCT04946448 Recruiting - Crohn Disease Clinical Trials

COmbinAtion Therapy of dieT With biologicalS for Crohn's Disease: the OATS Study

OATS
Start date: September 14, 2021
Phase: N/A
Study type: Interventional

This study is a randomised open label study, comparing the FIT diet with standard diet in patients with Crohn's disease treated with biologic therapy.