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NCT ID: NCT05605093 Recruiting - COVID-19 Clinical Trials

Strategies and Treatments for Respiratory Infections & Viral Emergencies (STRIVE): Shionogi Protease Inhibitor (Ensitrelvir)

Start date: December 23, 2022
Phase: Phase 3
Study type: Interventional

Treatments are needed to improve outcomes among patients hospitalized for COVID-19, including direct-acting antiviral (DAA) agents to mitigate the pathology driven by ongoing viral replication. This trial will evaluate S-217622 (ensitrelvir), an anti-SARS-CoV2 3C-like protease inhibitor (PI) developed by Shionogi &; Co. Ltd. The study design is a randomized, placebo-controlled, multi-center international clinical trial that will evaluate the clinical efficacy of ensitrelvir when given in addition to standard of care (SOC) for inpatients with COVID-19. The SOC will be determined by local established guidelines and may include additional DAA (e.g., remdesivir) and immunomodulatory treatment strategies. Certain SOC treatments will be pre-specified prior to randomization.

NCT ID: NCT05600088 Recruiting - Clinical trials for Coronary Artery Disease

Intracoronary Cryotherapy Effect on Stabilization of Vulnerable Plaque in Patients With NSTEMI or Unstable Angina

POLARSTAR
Start date: October 18, 2022
Phase: N/A
Study type: Interventional

The POLARSTAR study is an early safety and feasibility study to evaluate the performance and safety of the CryoTherapy System (CTS) for the treatment of coronary plaque lesions that are not obstructing blood flow but are at high-risk of rupture which would cause a major heart attack. The CTS is used to apply local freezing of the lesion using a balloon catheter, controlled by a console that regulates in- and outflow of a cooling agent into the catheter. The treatment is expected to stabilize the lesion, diminishing the risk of rupture. The study will enrol subjects with acute coronary disease who have suitable coronary lesions. Subjects will be followed for 1 year after the CTS treatment. Baseline identification of lesions will be done using Coronary CT-angiography (CCTA), which will be repeated at 3 and 9 months after procedure.

NCT ID: NCT05600049 Completed - Lentigo Solar Clinical Trials

Tolerance and Performance of Cyto-selective Difluoroethane-based Cryotherapy in the Treatment of Brown Spots

Start date: October 21, 2022
Phase: N/A
Study type: Interventional

CS5_1 study aim to evaluate the tolerance and to adjust the mode of administration of 4 different conditions of cryotherapy treatments applied on the brown spots of the face and hand with 3 prototypes. Each treatment corresponds to a combination of a specific sequence of a cryogenic spray and of a frequency of application. The study will evaluate 3 prototypes : - Prototype 1 : from (815-v1 001) to (815-v1 100) - Prototype 2 : from (815-v1 101) to (815-v1 150) - Prototype 3 : from (815-v1 151) to (815-v1 200)

NCT ID: NCT05596409 Recruiting - Clinical trials for Metastatic Breast Cancer

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

ELCIN
Start date: May 19, 2023
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with ER+/HER2- advanced/metastatic breast cancer who received no prior CDK4/6i in the metastatic setting.

NCT ID: NCT05592392 Active, not recruiting - Clinical trials for Heart Failure With Reduced Ejection Fraction

RECOVER-HF Pilot Study of SDS in Heart Failure

Start date: August 23, 2022
Phase: N/A
Study type: Interventional

The RECOVER HF pilot is a feasibility study for evaluating a randomized, doubled-blinded study design to determine the benefits and risks of chronically delivering Synchronized Diaphragmatic Stimulation (SDS) in Heart Failure patients on GDMT with NYHA II/III, EF<=40% and QRSd,=130ms.

NCT ID: NCT05586321 Active, not recruiting - Solid Tumor, Adult Clinical Trials

Study of Safety and Antitumor Activity of GEN1056 in Participants With Advanced Solid Tumors

Start date: October 24, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this first-in-human study of GEN1056, is to evaluate safety. In addition, the study will determine the recommended dose and frequency for subsequent clinical studies and will assess the preliminary anti-tumor activity of GEN1056. GEN1056 will be studied in patients with advanced or metastatic solid cancer, for whom standard of care (SOC) therapy is not an option. All participants will get GEN1056.

NCT ID: NCT05577351 Completed - Clinical trials for Acute Ischemic Stroke

Feasibility Study of RapidPulseTM Aspiration System as Frontline Approach for Patients With Acute Ischemic Stroke

PULSE-F
Start date: April 23, 2023
Phase: N/A
Study type: Interventional

A feasibility study to evaluate the initial safety and performance of the RapidPulseTM Aspiration System in the treatment of patients with Acute Ischemic Stroke (AIS) due to Large Vessel Occlusion (LVO) in the intracranial ICA, M1, M2, basilar or vertebral arteries.

NCT ID: NCT05572047 Recruiting - Atrial Fibrillation Clinical Trials

Coherent Sine Burst (CSE) Electroporation System Pilot Study in Patients With Atrial Fibrillation

BURST-AF
Start date: October 11, 2022
Phase: N/A
Study type: Interventional

To evaluate the safety and efficiency of the Arga Medtech CSE Ablation System in the treatment of atrial fibrillation.

NCT ID: NCT05568095 Active, not recruiting - Clinical trials for Advanced Upper Gastrointestinal Tract Adenocarcinoma

A Clinical Trial of a New Combination Treatment, Domvanalimab and Zimberelimab, Plus Chemotherapy, for People With an Upper Gastrointestinal Tract Cancer That Cannot be Removed With Surgery That Has Spread to Other Parts of the Body

STAR-221
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This randomized Phase 3 open-label study will compare the efficacy of the T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) monoclonal antibody domvanalimab, the anti programmed cell death protein 1 (PD-1) monoclonal antibody zimberelimab, and multiagent chemotherapy versus the anti PD-1 monoclonal antibody nivolumab and multiagent chemotherapy in the first-line treatment of participants with locally advanced unresectable or metastatic gastric, gastroesophageal junction (GEJ), and esophageal adenocarcinoma.

NCT ID: NCT05557591 Recruiting - Clinical trials for Advanced Non-Small Cell Lung Cancer

A Trial to Learn How the Cancer Vaccine BNT116 in Combination With Cemiplimab Works and How Safe the Combination is in Adults With Advanced Non-small Cell Lung Cancer (EMPOWERVAX Lung 1)

Start date: April 21, 2023
Phase: Phase 2
Study type: Interventional

This study is researching an investigational drug, called BNT116, in combination with cemiplimab. BNT116 and cemiplimab will each be called a "study drug", and together be called "study drugs". The study is focused on patients who have advanced non-small cell lung cancer (NSCLC). The aims of this study are to see how safe and tolerable BNT116 is in combination with cemiplimab and to see how effective BNT116 in combination with cemiplimab is compared to cemiplimab by itself at treating cancer. The study is looking at several other research questions, including: - What side effects may happen from receiving the study drugs - How much study drug is in the blood at different times - Whether the body makes antibodies against the study drug(s) (which could make the drug less effective or could lead to side effects)