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NCT ID: NCT04647760 Active, not recruiting - Pediatric Obesity Clinical Trials

Packaging and Disseminating the JOIN for ME Program in Low-Income Settings

Start date: January 25, 2021
Phase: N/A
Study type: Interventional

One in five children in the United States have obesity, and under-served populations are differentially impacted by both obesity and its related health consequences. Thus, community-based programs that improve the dissemination of effective obesity treatments are needed within low income settings. The current study aims to test the effectiveness of an evidence-based, community centered program, JOIN for ME, in two types of community settings: housing authorities and patient-centered medical homes. Children between the ages of 6-12 years old and who meet study eligibility criteria will be enrolled in the study and participate in the JOIN for ME weight control intervention. Participants will be assigned to active or delayed treatment conditions (4-month delay) but all participants will receive the JOIN for ME program. The program will be delivered in English or Spanish. Primary outcomes include change in child and parent weight status and health-related quality of life.

NCT ID: NCT04647526 Active, not recruiting - Clinical trials for Metastatic Castration-Resistant Prostate Cancer

Study Evaluating mCRPC Treatment Using PSMA [Lu-177]-PNT2002 Therapy After Second-line Hormonal Treatment

SPLASH
Start date: February 25, 2021
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of [Lu-177]-PNT2002 in patients with metastatic castration-resistant prostate cancer who have progressed following treatment with androgen receptor axis-targeted therapy (ARAT).

NCT ID: NCT04647253 Active, not recruiting - In-Stent Restenosis Clinical Trials

A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)

AGENT IDE
Start date: May 11, 2021
Phase: Phase 3
Study type: Interventional

AGENT IDE is a Prospective, Randomized (2:1), Multicenter Trial. The purpose of this study is to assess the safety and effectiveness of the Agent Paclitaxel Coated PTCA Balloon Catheter compared to balloon angioplasty (POBA) in patients with in-stent restenosis (ISR) of a previously treated lesion of up to 26 mm in length (by visual estimate) in a native coronary artery 2.0 mm to 4.0 mm in diameter.

NCT ID: NCT04646473 Active, not recruiting - Type 1 Diabetes Clinical Trials

Sweetgoals for Type 1 Diabetes

Start date: April 29, 2021
Phase: N/A
Study type: Interventional

The study will test an app and web-delivered intervention designed to improve glycemic control (HbA1c) among young adults with Type 1 diabetes. All participants will receive the "core" digital intervention, the SweetGoals app, focused on self-monitoring and goal setting. Efficacy of two independent intervention components (incentives for adherence and web health coaching) will be tested

NCT ID: NCT04646096 Active, not recruiting - Osteoarthritis, Hip Clinical Trials

Multicenter Study for Robotic Arm-assisted THA 4.0 System: Hip Spine Relationship

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The current study is a multi-center study to assess precision and accuracy of the robotic system with new software.

NCT ID: NCT04646057 Active, not recruiting - Clinical trials for Breast Reconstruction

DuraSorb® in Prosthetic Breast Reconstruction

Start date: January 15, 2021
Phase: N/A
Study type: Interventional

This study compares outcomes of prospective mesh-based breast reconstructions to historical control breast reconstructions with no mesh.

NCT ID: NCT04646005 Active, not recruiting - Cervical Cancer Clinical Trials

Cemiplimab and ISA101b Vaccine in Adult Participants With Recurrent/Metastatic Human Papillomavirus (HPV)16 Cervical Cancer Who Have Experienced Disease Progression After First Line Chemotherapy

Start date: June 28, 2021
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to estimate the clinical benefit of cemiplimab + ISA101b after progression on first line chemotherapy, as assessed by objective response rate (ORR). The secondary objectives of the study are: - To characterize the safety profile of cemiplimab + ISA101b - To assess preliminary efficacy of cemiplimab + ISA101b as measured by duration of response (DOR), progression-free survival (PFS), and overall survival (OS)

NCT ID: NCT04645212 Active, not recruiting - Clinical trials for Neovascular Age-related Macular Degeneration

Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]

Start date: December 14, 2020
Phase:
Study type: Observational

ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).

NCT ID: NCT04645147 Active, not recruiting - EBV Clinical Trials

Safety and Immunogenicity of an Epstein-Barr Virus (EBV) gp350-Ferritin Nanoparticle Vaccine in Healthy Adults With or Without EBV Infection

Start date: March 29, 2022
Phase: Phase 1
Study type: Interventional

Background: Epstein-Barr virus (EBV) causes most cases of infectious mononucleosis (mono). Up to 1 in 10 people who get mono can have fatigue that lasts more than 6 months. One out of 100 people can have severe complications. EBV is also associated with several types of cancer. Researchers want to test an EBV vaccine. Objective: To test the safety of and immune response to a new vaccine against EBV. Eligibility: Healthy adults ages 18-29 Design: Participants will be screened with a medical history and physical exam. They will give a blood sample. Screening tests will be repeated during the study. Participants will get a dose of the study vaccine as an injection in a muscle in the upper arm. They will be observed for 30 to 60 minutes. Blood pressure, heart rate, breathing rate, and temperature will be checked. The injection site will be examined. Participants will get a diary card. They will write down any side effects they have after the vaccine dose, or they may use an electronic diary card. Participants will be asked to write down or enter any important medical events that may occur at any time during the study. Participants will get a vaccine dose at 2 more study visits. They will have 4 follow-up visits at different times after a vaccine dose. Participants will have 6 telephone calls in between the in-person visits. They will also have 1 telephone call 1 year after the third dose of vaccine. If possible, this visit can occur in person. Participation will last about 18 months. There is an optional in-person visit or telephone call 2 years after the third dose of vaccine.

NCT ID: NCT04644575 Active, not recruiting - Hemophilia A Clinical Trials

Long-term Safety and Efficacy of Efanesoctocog Alfa (BIVV001) in Previously Treated Patients With Hemophilia A

XTEND-ed
Start date: February 23, 2021
Phase: Phase 3
Study type: Interventional

Primary Objective: - To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia A Secondary Objectives: - To evaluate the efficacy of BIVV001 as a prophylaxis treatment. - To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes. - To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes. - To evaluate the effect of BIVV001 prophylaxis on joint health outcomes. - To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes. - To evaluate the safety and tolerability of BIVV001 treatment. - To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time (aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B). - To evaluate the efficacy of BIVV001 for perioperative management