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NCT ID: NCT05152290 Recruiting - Clinical trials for Spinal Cord Injuries

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for SCI

Start date: July 6, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Spinal Cord Injury.

NCT ID: NCT05152147 Recruiting - Clinical trials for Esophageal Adenocarcinoma

A Study of Zanidatamab in Combination With Chemotherapy Plus or Minus Tislelizumab in Patients With HER2-positive Advanced or Metastatic Gastric and Esophageal Cancers

HERIZON-GEA-01
Start date: December 2, 2021
Phase: Phase 3
Study type: Interventional

This study is being done to find out if zanidatamab, when given with chemotherapy plus or minus tislelizumab, is safe and works better than trastuzumab given with chemotherapy. The patients in this study will have advanced human epidermal growth factor 2 (HER2)-positive stomach and esophageal cancers that are no longer treatable with surgery (unresectable) or chemoradiation, and/or have grown or spread to other parts of the body (metastatic).

NCT ID: NCT05151744 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Combination With Ranibizumab in Diabetic Macular Edema

Start date: December 17, 2021
Phase: Phase 2
Study type: Interventional

Study BP43464 is a phase II, multicenter, randomized, double-masked active comparator-controlled study designed to assess the efficacy, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of vamikibart in combination with, anti-vascular endothelial growth factor (VEGF) inhibitor, ranibizumab compared with ranibizumab alone in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be 76 weeks.

NCT ID: NCT05151731 Active, not recruiting - Clinical trials for Diabetic Macular Edema

A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema

Start date: December 31, 2021
Phase: Phase 2
Study type: Interventional

Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.

NCT ID: NCT05149430 Completed - Clinical trials for Post-intensive Care Syndrome

Quality of Life and Functional Capacity in Post Intensive Care Unit

Start date: August 1, 2019
Phase:
Study type: Observational

BACKGROUND. Staying in an intensive care unit can lead to physical and cognitive complications and post-traumatic stress. Currently, the aim is to find out the level of quality of life, functional capacity and cognitive status post intensive care unit. Describe the evolution of the quality of life, functional capacity and cognitive status of a cohort of patients admitted to the ward room after discharge from the intensive care unit, with subsequent follow-up at 3, 6 and 12 months of his discharge. METHODS. Prospective, observational, analytical cohort study. Subjects over 18 years of age with at least 48 hours of confinement in a closed area were included. Demographic variables, quality of life, functional capacity and cognitive status were recorded. A telephone follow-up was carried out three, six and twelve months after institutional discharge. For the evaluation of the primary variables, Euroqol 5d-5L (Eq5d - Eq5d-VAS), Barthel Index and Fototest were used.

NCT ID: NCT05147805 Recruiting - Clinical trials for Pulmonary Arterial Hypertension

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Treprostinil Palmitil Inhalation Powder in Participants With Pulmonary Arterial Hypertension

Start date: August 24, 2022
Phase: Phase 2
Study type: Interventional

The main objective of the study is to assess the effect of treprostinil palmitil inhalation powder (TPIP) compared with placebo on pulmonary vascular resistance.

NCT ID: NCT05147766 Recruiting - Clinical trials for Congestive Heart Failure

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Heart Disease

Start date: February 1, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of congestive heart failure and angina

NCT ID: NCT05147701 Recruiting - Glaucoma Clinical Trials

Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Eye Diseases

Start date: February 1, 2022
Phase: Phase 1
Study type: Interventional

This trial will study the safety and efficacy of intravenous and sub-tenon delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Eye diseases

NCT ID: NCT05147662 Active, not recruiting - Hemophilia A Clinical Trials

A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood

Alfa-PROTECT
Start date: March 23, 2022
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat hemophilia A. Hemophilia A is a genetic disorder where the body does not create enough of a protein called clotting factor 8 (FVIII) present in the blood. People with hemophilia A may bleed for a long time from minor wounds, have painful bleeding into joints, or have internal bleeding. In severe hemophilia A (clotting factor 8 levels less than 1%) bleedings are more likely to happen. In this study researchers want to learn more about the treatment called BAY94-9027. BAY94-9027 is an injectable medicine used to replace missing clotting factor 8. In BAY94-9027 the clotting factor 8 has been pegylated (combined with a substance called polyethylene glycol (PEG)). This is to make the treatment last longer in the body so that less injections are required. BAY94-9027 is already available for the prevention and treatment of bleeding in adults and children who are 12 years and older. BAY 94-9027 is also called Jivi. BAY94-9027 is not yet available for children aged 7 to less than 12 years. One potential specific risk of pegylated drugs is that proteins in the blood called antibodies are built. These may attach to the pegylation part of the drug and this in turn may lead to allergic reactions and the drug not working as well as it should during first 4 infusions. In studies that have been done so far, this has been seen in some children younger than six years, but not in 29 children aged 6 to less than 12 years treated with BAY94-9027. Further safety information related to how the body reacts to BAY94-9027 is however still needed for this age group. The main purpose of this study is to learn how safe BAY94-9027 is (safety) and how it affects the body (tolerability) in previously treated children with severe hemophilia A who are between 7 to less than 12 years. To answer this question, the researchers will study information about two medical problems of special interest, if allergic reactions occur (also called hypersensitivity) and if the drug is not working as well as it should (also called loss of efficacy) during the first 4 infusions. Allergic reactions may range from mild local reactions to widespread effects such as shortness of breath, skin rashes and low blood pressure. Only allergic reactions related to the study treatment will be considered. The assessment if loss of efficacy occurred will be based on the occurrence of bleeding, the clotting factor 8 level in blood after injection called recovery, clotting factor 8 inhibitor tests and measurement of antibodies against the PEG. The study has two parts, A and B. Part A takes 6 months and part B takes 18 months. In part A the participants will receive two injections of BAY94-9027 per week. In part B, the number of injections may be decreased, with up to five days between the injections. The participants in this study will visit the study site around 14 times and will have 15 phone visits. In part A, visit 1 is for screening. Visits 2 to 5 take place twice a week for two weeks. Visit 6 two weeks after visit 5, visits 7 to 10 take place monthly with visit 11 six weeks after visit 10. In part B, site visits will occur on month 9, 12, 18 and 24 and phone calls every month between the site visits. The participants' and their caregivers will record in an electronic patient diary information about when the study treatment was given and bleeding episodes that have happened. During the study, the study doctors and their team will - take blood samples, - do physical examinations, - review the participants' electronic diary - ask questions about the participants' quality of life, - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is a medical problem that happens during the study. Doctors keep track of all adverse events that happen in study, even if they do not think the adverse events might be related to the study treatments.

NCT ID: NCT05147220 Recruiting - Clinical trials for Relapsing Multiple Sclerosis

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)

REMODEL-1
Start date: December 16, 2021
Phase: Phase 3
Study type: Interventional

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)