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NCT ID: NCT04641871 Active, not recruiting - Solid Tumor Clinical Trials

Sym021 in Combination With Either Sym022 or Sym023 or Sym023 and Irinotecan in Patients With Recurrent Advanced Selected Solid Tumor Malignancies

Start date: October 12, 2020
Phase: Phase 1
Study type: Interventional

The study will evaluate the preliminary efficacy of 3 combinations (Sym021+Sym022, Sym021+Sym023 and Sym021+Sym023+irinotecan) in patients with biliary tract carcinomas (BTC) and with esophageal squamous cell carcinoma (ESCC) by assessing overall response rates (ORRs) per Investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 The study will also evaluate the safety and tolerability profile of the 3 combinations

NCT ID: NCT04641689 Active, not recruiting - Obesity Clinical Trials

Stand Up Kansas: An Intervention to Reduce Sedentary Behavior in the Home Work Environment

Start date: October 21, 2020
Phase: N/A
Study type: Interventional

This project will examine the effectiveness of an intervention to reduce sedentary behavior in Kansas State University employees who are primarily working from home. We will recruit 100 employees to participate. Participants will be randomly assigned to one of four conditions: desk only, program only, desk + program, or waitlist control. The program will consist of strategies to reduce sitting and increase physical activity in the home environment. We will assess whether the intervention successfully elicits reductions in sitting among employees, as well as changes in cardiometabolic and work-related outcomes.

NCT ID: NCT04641247 Active, not recruiting - Breast Neoplasms Clinical Trials

A Long-term Treatment Extension Study of Niraparib in Participants Who Completed a Prior GlaxoSmithKline/TESARO-sponsored Niraparib Study

Start date: April 16, 2021
Phase: Phase 2
Study type: Interventional

This is a global extension study to provide continued access to niraparib and further characterize the long-term safety of niraparib treatment in participants who are currently receiving treatment with niraparib within GlaxoSmithKline/TESARO-sponsored studies (NCT01847274, NCT02354586, NCT01905592, NCT03308942, NCT02657889) that has fulfilled the requirements for the primary objective.

NCT ID: NCT04641026 Active, not recruiting - Diet, Healthy Clinical Trials

Discovery of Biological Signatures for Cruciferous Vegetable Intake (Single Serving)

Start date: February 22, 2021
Phase: N/A
Study type: Interventional

The purpose of this project is to study the molecular and metabolic profiles in human plasma, urine and microbiome composition following the consumption of broccoli sprouts.

NCT ID: NCT04640636 Active, not recruiting - Suicidal Ideation Clinical Trials

IM Ketamine vs Midazolam for Suicidal ER Patients

Start date: January 2, 2021
Phase: Phase 4
Study type: Interventional

Rising US suicide rates and the increased risk of suicide among persons who visit an emergency department (ED) for suicidality make the ED an important site for interventions to prevent suicide. There is no approved treatment for rapid relief of suicidal thoughts although clinical trials, including ours, show relief of suicidal thoughts within hours of treatment with inexpensive, generic, sub-anesthetic ketamine. We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.

NCT ID: NCT04640597 Active, not recruiting - Clinical trials for Peripheral Arterial Disease

MIMICS-3D-USA Registry Study

Start date: December 18, 2020
Phase:
Study type: Observational [Patient Registry]

The MIMICS-3D-USA Study is a prospective, multicentre, observational study (non-investigational) of the BioMimics 3D Vascular Stent System that evaluates evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention for the treatment of peripheral artery disease.

NCT ID: NCT04640025 Active, not recruiting - Myelofibrosis Clinical Trials

A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib

Start date: March 10, 2021
Phase: Phase 2
Study type: Interventional

This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and 39110-309. Eligible participants will receive treatment with itacitinib as per the treatment dose and schedule they received in the study in which they were originally enrolled. The original study is referred to as the "parent protocol". Participants who receive itacitinib in this study may continue treatment as long as the regimen is tolerated, the participant is deriving clinical benefit (in the opinion of the investigator), and the participant does not meet discontinuation criteria.

NCT ID: NCT04639466 Active, not recruiting - COVID-19 Infection Clinical Trials

A Synthetic MVA-based SARS-CoV-2 Vaccine, GEO-CM04S1, for the Prevention of COVID-19 Infection

Start date: November 19, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I trial evaluates the side effects and best dose of GEO-CM04S1 (previously designated as COH04S1), a synthetic modified vaccinia Ankara (MVA)-based SARS-CoV-2 vaccine, for the prevention of COVID-19 infection. COVID-19 infection is caused by the SARS-CoV-2 virus. SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. GEO-CM04S1 was created by placing small pieces of SARS-CoV-2 DNA (the chemical form of genes) into synthetic MVA, which may be able to induce immunity (the ability to recognize and fight against an infection) to SARS-CoV-2. The purpose of the Phase 1 study is to determine the safety and the optimal dose of the GEO-CM04S1 vaccine. The Phase 2 study is designed as a multi-center, double-blind, randomized, parallel, study to evaluate the safety profile of 2 dose levels of GEO-CM04S1 as a single booster shot to assess the immune response measured by the fold-increase in antibody against SARS-CoV-2 Spike protein at day 28 post-injection among healthy adult volunteers.

NCT ID: NCT04639375 Active, not recruiting - SARS-CoV-2 Clinical Trials

Polio Vaccine (IPV) for SARS-CoV-2 and Prevention of Coronavirus Disease (COVID-19)

Start date: November 15, 2020
Phase: Phase 4
Study type: Interventional

A total of 300 healthy volunteers between the ages of 18 and 80 with no previous history of COVID-19 will be entered into the study and will receive IPV by injection on Day 1. Blood specimens collected pre-inoculation will be tested for cross-reactivity to poliovirus and SARS-CoV-2 by Western blot. An additional specimen will be collected on Day 28 post-inoculation and, likewise tested for cross-reactivity to poliovirus and SARS-CoV-2. The number of subjects with an immune response to SARS-CoV-2 antigens following inoculation with IPV will be summarized.

NCT ID: NCT04639219 Active, not recruiting - Clinical trials for Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast

A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations

DPT01
Start date: December 30, 2020
Phase: Phase 2
Study type: Interventional

This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless of tumor histology. The target population are patients who have progressed following prior treatment or who have no satisfactory alternative treatment options, including approved second line therapies in the specific tumor type. Pre-specified HER2 mutations will be locally assessed using NGS tests or alternative methods. Prior HER2 targeting therapy is permitted.