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NCT ID: NCT05006157 Recruiting - Pericardial Access Clinical Trials

Pericardial Access With ViaOne Device

Start date: July 10, 2021
Phase: N/A
Study type: Interventional

ViaOne device is a tool designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac. In this study ViaOne will be used to obtain pericardial access in patients in whom electrophysiological diagnostic (mapping) and/or therapeutic (ablation) of epicardial sites via percutaneous subxiphoid approach to the to the normal, non-distended pericardial space is indicated.

NCT ID: NCT05005403 Recruiting - Clinical trials for Non-Small Cell Lung Cancer

Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of ABBV-514 Alone or in Combination With Budigalimab

Start date: November 1, 2021
Phase: Phase 1
Study type: Interventional

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-Small Cell Lung Cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of ABBV-514 as a monotherapy and in combination with Budigalimab. Budigalimab and ABBV-514 are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of ABBV-514 will be explored. Each treatment arm receives a different dose of ABBV-514 in monotherapy and in combination with Budigalimab. Approximately 268 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive ABBV-514 as a monotherapy or in combination with Budigalimab as an Intravenous (IV) Infusion for an estimated treatment period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT05000710 Recruiting - Clinical trials for Metastatic or Locally Advanced NSCLC

Concomitant Radiotherapy, Tremelimumab & Durvalumab for Advanced NSCLC Patients Progressing on First-line Immunotherapy

CORAL-Lung
Start date: December 9, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm, phase 2a trial with a safety run-in cohort followed by a Simon two-step design expansion cohort, of two checkpoint blockage treatments and radiotherapy in the treatment of locally advanced or metastatic NSCLC who have failed first-line immunotherapy (alone or as a combination regimen with chemotherapy). Study objectives: Objective of the safety run-in phase: • To evaluate safety of the triple combination of irradiation -Durvalumab - Tremelimumab Co-Primary objectives of the entire study: - To evaluate safety of the triple combination (as for the run-in phase). - To evaluate response rate on study drug compared to historical data of response to first-line platinum-doublet chemotherapy and 2nd-line docetaxel. Secondary objective: • To evaluate PFS and OS compared to historical data . Exploratory objectives: - Examine the mechanism of resistance to first-line immunotherapy . - Examine the immune response in irradiation -Durvalumab - Tremelimumab treated patients and identify potential predictors of clinical benefit.

NCT ID: NCT04998084 Recruiting - Ulcerative Colitis Clinical Trials

Advanced Therapy Registry of IBD Patients

Start date: February 28, 2019
Phase:
Study type: Observational

The study is aim to detect common microbial profiles and metabolic pathways throughout IBD diagnosis and treatment with biological therapy.

NCT ID: NCT04997226 Recruiting - Clinical trials for Transcranial Direct Current Stimulation

Cognitive Enhancement in Healthy Elderly People

Pro-Cog
Start date: September 1, 2020
Phase: N/A
Study type: Interventional

According to the European Commission Special Report, till 2030 it is expected ca. 40% increase of population aged 66-79. Increasing population of elderly people in modern society has suggested that more individuals are expected to suffer from cognitive deficits, as chronological aging is usually accompanied by declined cognition, in particular memory functions. The cognitive decline reaches medical attention for about 5-25% of the elderly population (over 65 years of age) as they suffer from Mild Cognitive Impairment (MCI). MCI is usually referred to as an intermediate phase between the expected cognitive decline of normal aging and the pathological cognitive decline linked to dementia. In recent years, a new viewpoint argues that substantial improvement in cognitive function may be possible even in older age, using appropriately designed training programs. In the current project the investigators propose a potential intervention that might delay the onset of dementia by maintaining cognitive performance in general and improving in MCI in particular. The current approach is to employ cognitive enhancement protocols, such as the combination of non-invasive, low intensity electrical stimulation and memory training aiming to preserve and ultimately improve cognitive abilities in MCI and healthy elderly.

NCT ID: NCT04994795 Recruiting - Clinical trials for Non-small Cell Lung Cancer Metastatic

Predictive Multimodal Signatures Associated With Response to Treatment and Prognosis of Patients With Stage IV Non-small Cell Lung Cancer

DEEP-Lung-IV
Start date: August 21, 2021
Phase:
Study type: Observational

Predicting response to therapy and disease progression in stage IV NSCLC patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.

NCT ID: NCT04994015 Recruiting - Parkinson's Disease Clinical Trials

Parkinson's Foundation PD GENEration Genetic Registry

Start date: December 20, 2020
Phase:
Study type: Observational [Patient Registry]

Development of a central repository for PD-related genomic data for future research.

NCT ID: NCT04993924 Recruiting - IVF Clinical Trials

GnRH Antagonist Pre-treatment in the Early Follicular Phase for Resolution of a Baseline Functional Ovarian Cyst

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

In this study we would like to examine the effect of GnRH antagonist administration at the beginning of the follicular phase in patient presenting with a simple ovarian cyst 25-50 mm. The aim of this intervention is to allow a spontaneous regression of the ovarian cyst (if in nature) while ensuring a pituitary downregulation to prevent the beginning of a leading follicle recruitment. As previous studies using GnRH antagonist pre-treatment prior to GT initiation for other purposes demonstrated positive results (including different patient population) , no deleterious effects are expected.

NCT ID: NCT04991935 Recruiting - Clinical trials for Eosinophilic Esophagitis

Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis

Start date: September 14, 2021
Phase: Phase 3
Study type: Interventional

This study is an open-label, uncontrolled study design to evaluate the long-term safety and tolerability of treatment with CC-93538. The study will enroll participants who participated in the CC-93538-EE-001 or CC-93538-DDI-001 studies.

NCT ID: NCT04990739 Recruiting - Clinical trials for Advanced Solid Tumor

Study of MTB-9655, an Inhibitor of ACSS2, in Patients With Advanced Solid Tumors

Start date: June 30, 2021
Phase: Phase 1
Study type: Interventional

MetaboMed is developing MTB-9655, an orally bioavailable, first-in-class small molecule inhibitor of the human Acetyl coenzyme A (Acyl-CoA) synthetase short chain family member 2 (ACSS2) enzyme, as a potential treatment for patients with cancer. This study is a Phase 1,First-in-Human (FIH), open-label dose-escalation study of MTB-9655 given daily as a single oral (PO) agent. Up to 30 patients with locally advanced, unresectable and/or metastatic solid tumor(s) are expected to be enrolled in the dose-escalation portion (Part A). The study will be conducted at 1 to 2 sites in the United States and Israel.