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NCT ID: NCT04162860 Recruiting - Esophageal Cancer Clinical Trials

Preemptive Endoluminal Negative Pressure in Minimally Invasive Transthoracic Esophagectomy

Start date: December 4, 2019
Phase: N/A
Study type: Interventional

The primary objective of the preSponge randomized controlled trial (RCT) will be to assess the potential protective effects of preemptive endoscopic negative pressure therapy (ENP) on postoperative morbidity in high-risk patients undergoing total minimally invasive transthoracic esophagectomy with gastric pull-up reconstruction and high intrathoracic anastomosis (thoracoscopic and laparoscopic Ivor Lewis esophagectomy).

NCT ID: NCT04162509 Completed - Fear of Spiders Clinical Trials

Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders

GARET2019
Start date: October 7, 2019
Phase: N/A
Study type: Interventional

Investigation of the efficacy of a gamified augmented reality exposure app in individual with fear of spiders.

NCT ID: NCT04161963 Recruiting - Cataract Clinical Trials

Incidence of Sub-clinical Cystoid Macular Edema After Cataract Surgery

ICCME
Start date: March 4, 2019
Phase:
Study type: Observational

Cystoid macular edema (CME) can limit visual acuity after cataract surgery. Little is known whether the incidence is similar between standard ultrasound phacoemulsification cataract surgery (phaco), femtolaser assisted cataract surgery (FLACS), and combined phacoemulsification cataract surgery plus micro invasive glaucoma surgery (phaco+MIGS) procedures.

NCT ID: NCT04161885 Active, not recruiting - Cancer Clinical Trials

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

VIALE-T
Start date: February 26, 2020
Phase: Phase 3
Study type: Interventional

The main objective of this study is to evaluate the efficacy of venetoclax in combination with azacitidine to improve Overall Survival (OS) in Acute Myeloid Leukemia (AML) participants compared to Best Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell transplantation (SCT). This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who are greater than or equal to 18 years old; Part 2 (Randomization) which may include participants who are greater than or equal to 12 years old. During Part 1, recommended Phase 3 dose of venetoclax in combination with azacitidine will be determined and during Part 2, the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with BSC (Part 2 Arm B).

NCT ID: NCT04161235 Completed - Pulmonary Emphysema Clinical Trials

Post-Market Clinical Evaluation of the Zephyr Valve 5.5-LP EBV

Start date: February 5, 2020
Phase:
Study type: Observational [Patient Registry]

This is a Post-Market Evaluation of the Zephyr Valve 5.5-LP EBV to assess Treated Lobar Volume Reduction (TLVR), changes in lung function and the safety profile of the Zephyr Valve treatment with the use of at least one Zephyr Valve 5.5-LP EBV.

NCT ID: NCT04160793 Not yet recruiting - Bladder, Overactive Clinical Trials

Genital Nerve Stimulation - GNS - for Treatment of Non-neurogenic OAB

GNS
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

The Genital Nerve Stimulation - GNS - consists of a two-step procedure with a preoperative non-surgical test-phase and a final surgical implantation of the neuroprothesis. In contrast to the classical technique of transcutaneous lead electrode implantation for sacral or pudendal nerve stimulation, the GNS-test-phase does not require any interventional procedure: because the genital nerves are located just few millimeter below the skin, test-stimulation can be achieved using skin surface or needle electrodes. Stimulation is achieved using a battery powered hand-held stimulator . The effect of the stimulation can be tested by the patient in their daily, home and professional environment, or at the practice under urodynamic testing, or if required other electrophysio-logical testing. After confirmation of the effectiveness of GNS, implantation of a permanent neuroprothesis can be planned. The procedure is performed either under general or spinal anesthesia or using only local anesthesia with IV-sedation as in the classical tension-free vaginal tape procedure (TVT). Because the GNS does not require two surgical procedures for both the test- and the final-implantation but rather only one for the final implantation, the presented protocol allows considerable cost reduction in comparison to the usual procedures for sacral or pudendal nerve stimulation.

NCT ID: NCT04160130 Active, not recruiting - Clinical trials for Aortic Valve Stenosis

RHEIA (Randomized researcH in womEn All Comers With Aortic Stenosis)

RHEIA
Start date: November 29, 2019
Phase: N/A
Study type: Interventional

Purpose of this prospective, randomized, controlled, multi-center study is to evaluate the safety and efficacy of Transcatheter Aortic Valve Implantation (TAVI) as compared to surgical aortic valve replacement (SAVR) in female patients with severe symptomatic aortic stenosis. Patients will be randomized 1:1 to receive either TAVI or SAVR aortic valve replacement. For TAVI procedure, Edwards SAPIEN 3 THV system Model 9600 TFX (20, 23, 26 and 29 mm) or SAPIEN 3 Ultra THV system Model 9750 TFX (20, 23, 26) with the associated transfemoral delivery systems will be sued, for SAVR any commercially available surgical bioprosthetic valve. Patients will undergo the following visits: Screening, Procedure, Post Procedure, Discharge, 30 day, 6 months (telephone contact) and 1 year.

NCT ID: NCT04160000 Recruiting - Heart Failure Clinical Trials

Treatment Of Atrial Fibrillation In Preserved Cardiac Function Heart Failure

TAP-CHF
Start date: July 26, 2020
Phase: Phase 4
Study type: Interventional

Heart failure (HF) with preserved left ventricular function (pEF) is difficult clinical syndrome to treat effectively with few evidence based therapies. Atrial fibrillation (AF) is now an important co-morbidity being observed in 43% of patients with HFpEF. Rhythm control has not been studied in this population. Catheter ablation and antiarrhythmic drugs are rhythm control therapies that have been used for treatment of AF without HF or HF with reduced systolic function but have not been widely applied in HFpEF. No controlled comparative evaluation has been performed in HFpEF. The introduction of wireless pulmonary artery hemodynamic monitoring has permitted optimization of HF therapy in patients with chronic HF with reduced and preserved EF. Reduction in HF hospitalizations has been observed in post hoc analyses of HFpEF patients but has not been systematically applied in AF patients with HFpEF. In this study, we propose to study both rhythm control and optimized HF therapeutic approaches in an AF with HFpEF study population in a pilot study using a sequential two phase randomized controlled clinical trial design.

NCT ID: NCT04158869 Completed - Depression Clinical Trials

An Investigation of the Relationship Between Omega-3 Fatty Acid Nutrition and Mental Health in Children and Adolescents

Start date: September 16, 2019
Phase:
Study type: Observational

This is an observational case-control add-on study to an investigator-initiated clinical trial (IICT) (ClinicalTrials.gov Identifier: NCT03167307): Omega-3 fatty acids as firstline treatment in pediatric depression. A 36-week multi-centre, double-blind, placebo-controlled randomized superiority study. This project will recruit a healthy control group matched for age and sex to a sub-group of patients with diagnosed pediatric major depressive disorder (pMDD) enrolled in the IICT. The aim is to investigate the relationship of n-3 FA intake and status with mental health in children and adolescents with and without diagnosed pMDD, and explore potential biochemical mechanisms underlying this relationship by measuring biomarkers related to n-3 FA metabolism, mental health and cognitive function.

NCT ID: NCT04158596 Withdrawn - Clinical trials for Chronic Rhinosinusitis Without Nasal Polyps

Safety and Efficacy of SDX-3101 for the Treatment of Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

SDX-3101
Start date: June 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this clinical trial is to assess the safety and efficacy of SDX-3101 for treatment of adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) by investigating a vibration pattern of SDX-3101 compared to a control