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NCT ID: NCT04658953 Completed - Clinical trials for Chronic Low-back Pain

Comparison of the Effectiveness of Ultrasound-guided Versus Radioguided Medial Lumbar Bundle Branch Block

Start date: January 6, 2021
Phase: N/A
Study type: Interventional

In adults with chronic low back pain, the investigators will compare the effectiveness of the medial bundle branch block on three lumbar levels (L3-L4, L4-L5 and L5-S1) performed either by radiographic guidance or by ultrasound approach according to a transverse approach. The objective of this study will be to evaluate the benefit of these both procedures on pain, on the practice of daily activities and the incidence of adverse events in order to show whether the two modalities are equivalent.

NCT ID: NCT04658940 Completed - Clinical trials for Typical Atrial Flutter

AcQBlate Force Sensing Ablation System US IDE for Atrial Flutter (AcQForce Flutter)

AcQForce AFL
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

The Acutus Medical AcQForce Flutter clinical study is a prospective, multi-center, non-randomized global study designed to demonstrate the safety and effectiveness of the AcQBlate Force Sensing Ablation System in the ablation management of symptomatic cavotricuspid isthmus dependent atrial flutter.

NCT ID: NCT04658641 Completed - Parkinson Disease Clinical Trials

Characterization of Complex Pulse Shapes in Deep Brain Stimulation for Movement Disorders Using EEG and Local Field Potential Recordings

CHANNEL DBS
Start date: December 14, 2020
Phase: N/A
Study type: Interventional

Parkinson's disease and essential tremor are chronic movement disorders for which there is no cure. When medication is no longer effective, deep brain stimulation (DBS) is recommended. Standard DBS is a neuromodulation method that uses a simple monophasic pulse, delivered from an electrode to stimulate neurons in a target brain area. This monophasic pulse spreads out from the electrode creating a broad, electric field that stimulates a large neural population. This can often effectively reduce motor symptoms. However, many DBS patients experience side effects - caused by stimulation of non-target neurons - and suboptimal symptom control - caused by inadequate stimulation of the correct neural target. The ability to carefully manipulate the stimulating electric field to target specific neural subpopulations could solve these problems and improve patient outcomes. The use of complex pulse shapes, specifically biphasic pulses and asymmetric pre-pulses, can control the temporal properties of the stimulation field. Evidence suggests that temporal manipulations of the stimulation field can exploit biophysical differences in neurons to target specific subpopulations. Therefore, our aim is to evaluate the direct neurophysiological effects of complex pulse shapes in DBS movement disorder patients. This will be achieved using a two-stage investigation: stage one will study the neural response to different pulse shapes using electroencephalography (EEG) recordings. Stage two will study the neural responses to different pulse shapes using intra-operative local field potential (LFP) recordings. This study only relates only to the collection of EEG and LFP recordings in DBS patients. The protocol does not cover any surgical procedures, which already take place as part of the patient's normal clinical care.

NCT ID: NCT04657198 Completed - Clinical trials for Respiratory Syncytial Virus Infections

Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

Start date: December 9, 2020
Phase: Phase 2
Study type: Interventional

Nine different formulations of the RSVPreF3 OA investigational vaccine were tested in the parent study (NCT03814590). Based on safety and immunogenicity data from the parent study, RSVPreF3 OA investigational vaccine will be evaluated in further clinical research. Participants in selected groups will be invited to participate in this extension study. All participants who will be enrolled in the current extension study will receive the RSV investigational vaccine approximately 18 months after they received their respective dose-2 in the parent study.

NCT ID: NCT04656288 Completed - Healthy Clinical Trials

A Study in Healthy Men to Test if Different Formulations of BI 764198 With or Without Food Influence the Amount of BI 764198 in the Blood

Start date: January 15, 2021
Phase: Phase 1
Study type: Interventional

BI 764198 is intended to be used in patients hospitalized for COVID-19 at risk of respiratory complications. The present trial will investigate the relative bioavailability of BI 764198 administered as capsules versus tablets in a first part, and the relative bioavailability and food effect of four oral formulations: the newly developed tablet formulation under fed and fasted conditions as well as suspension from capsules and suspension from tablets in a second part.

NCT ID: NCT04653766 Completed - Healthy Clinical Trials

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ir-CPI in Healthy Male Subjects

Start date: September 12, 2019
Phase: Phase 1
Study type: Interventional

The purpose of this First-in-Human study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Ir-CPI, a novel dual inhibitor of FXIIa and FXIa, following IV administration of single ascending doses in healthy male volunteers.

NCT ID: NCT04652102 Completed - Covid19 Clinical Trials

A Phase 2b/3, Randomized, Observer-Blinded, Placebo-Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older

Start date: December 11, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

The primary objective of the randomized observer-blinded phase 2b/3 part of this trial is to demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve participants.

NCT ID: NCT04647942 Completed - Meniscal Tear Clinical Trials

Is Meniscal Volume Critical to Post-meniscectomy Symptoms?

Start date: December 2013
Phase:
Study type: Observational

With this study we would like to investigate whether a certain, critical loss of meniscal volume, is critical to the development of pain.

NCT ID: NCT04647487 Completed - Breast Cancer Clinical Trials

A Study of LY3484356 in Women With Breast Cancer Before Having Surgery

EMBER-2
Start date: April 21, 2021
Phase: Phase 1
Study type: Interventional

The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage I-III) breast cancer, when given prior to surgery. Participation in this study could last up to 2.5 months.

NCT ID: NCT04646811 Completed - Clinical trials for Tricuspid Regurgitation

Evaluation of Tricuspid Valve Percutaneous Repair System in the Treatment of Severe Secondary Tricuspid Disorders

TRI-FR
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Tricuspid regurgitation (TR) is a long-overdue valvular pathology. Its prevalence is significant and increasing with the aging of the population. It is often a consequence of chronic left cardiac pathologies or atrial fibrillation. Surgical treatment is recommended in severe symptomatic TR or when the tricuspid annulus is dilated with TR identified prior to scheduled left heart valve surgery. TR are mainly secondary (complicating left heart disease, pulmonary hypertension, atrial fibrillation and atrial dilatation) and pose a difficult problem related to the prognosis. The risk of death or hospitalization is high under medical treatment. Nevertheless, the surgical results are disappointing with significant morbidity and mortality, which are increased by associated comorbidities that are frequent in these sorts of patients. The benefit-risk assessment of surgery is limited by multiple confounders. This justifies the evaluation of alternative methods aimed at correcting TR with less interventional risk. The Clip for the tricuspid valve has been evaluated in the TRILUMINATE trial (inclusion of 85 patients with moderate-to-severe symptomatic TR with a 6-month follow-up). The Triclip system appears to be safe and effective at reducing tricuspid regurgitation by at least one grade. This reduction could translate to significant clinical improvement at 6 months post-procedure. It justified the European Conformity (CE) mark obtention. A very similar system for the mitral valve (Mitraclip) was previously tested in the randomized EVEREST II study against conventional surgery. The results of the EVEREST II trial justified the recourse to percutaneous edge-to edge mitral repair in patients with primary mitral regurgitation when the patient is contraindicated to conventional surgery. The Mitra-FR study made it possible to study the role of Mitraclip for treating patient suffering from a secondary mitral insufficiency. It leads to the implementation of this technique in selected patients. For secondary TR, several series underscored its prevalence and its clinical consequences. TR treatment justifies the proposal for a randomized study. As a matter of fact, evidence for treating are seriously lacking. Surgical surveys report hospital mortality ~ 8.8%. It, therefore, seems necessary to conduct a study as robust as possible to evaluate the contribution of clip for the tricuspid valve (as an innovative percutaneous technique) compared to conventional pharmacological treatment in patients who are unsuitable for a surgical isolated correction of the TR and who has suitable anatomy for clip for the tricuspid valve. It will be necessary to demonstrate clinical, functional (quality of life), echocardiographic and biological benefit of the percutaneous treatment vs optimized medical treatment alone.