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NCT ID: NCT04011722 Active, not recruiting - Clinical trials for Symptomatic Severe Aortic Stenosis

Portico NG Approval Study

Start date: September 17, 2019
Phase: N/A
Study type: Interventional

The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Porticoâ„¢ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the rate of moderate or greater paravalvular leak at 30 days in a high or extreme surgical risk patient population to support CE (Conformité Européenne) Mark and FDA approval.

NCT ID: NCT04011410 Active, not recruiting - Clinical trials for Prostate Cancer Recurrent

Hydroxychloroquine to Increase Tumor Suppressor PAR-4 Levels in Oligometastatic Prostate Cancer

Start date: December 3, 2019
Phase: Phase 2
Study type: Interventional

Treatment of recurrent oligometastatic prostate cancer may be enhanced by the addition of Hydroxychloroquine to the current treatment regimens. Potential benefits of Hydroxychloroquine include delayed disease progression and delayed initiation of androgen deprivation therapy (ADT), thus lessening morbidity, distressing side effects, and improving functioning and quality of life in men with recurrent prostate cancer. Building on prior research at Markey, patients recently diagnosed with recurrent oligometastatic prostate cancer will be approached about participating in this study. Per standard of care, these patients undergo either surgery or radiation, in addition participants of this clinical trial will also receive Hydroxychloroquine (400 mg per day, oral medication) for 3 months. It is expected that a participant will exhibit a 50% increase of tumor suppressor PAR-4, as well as few, if any, negative side effects from Hydroxychloroquine.

NCT ID: NCT04010656 Active, not recruiting - Voiding Disorders Clinical Trials

Optimization of Spontaneous Postoperative Trial of Void Among Women

OPTION
Start date: September 10, 2018
Phase: N/A
Study type: Interventional

Trial of void (TOV) is a diagnostic test performed on all women who undergo prolapse repair or incontinence surgery, due to the importance of diagnosing postoperative urinary retention (POUR). Incidence of POUR may be as high as 62% in some studies. Timely and accurate diagnosis is important to avoid complications such as urinary tract infection, bladder overdistension, and permanent bladder injury. Despite the frequent use of TOV, there is no gold standard for the test, and it likely has poor specificity, leading to discharge of more patients with catheter than required. This prospective cohort study will seek to establish evidence-based optimal parameters for spontaneous trial of void, a TOV modality that has merit for further evaluation given lower theoretical risk of urinary tract infection.

NCT ID: NCT04009512 Active, not recruiting - Clinical trials for Thoracoabdominal Aortic Aneurysm

Endovascular Repair of Thoracoabdominal Aortic Aneurysms

Start date: October 6, 2020
Phase: N/A
Study type: Interventional

The primary objective of this study is to assess the use of the thoracic bifurcation and the visceral manifold devices in the repair thoracoabdominal aortic aneurysms in patients with appropriate anatomy. The primary intent of the study is to assess safety and preliminary effectiveness of the device. Additionally, the study will assess technical success and treatment success at each follow-up interval.

NCT ID: NCT04009499 Active, not recruiting - Psoriatic Arthritis Clinical Trials

A Study to Assess the Long-term Safety, Tolerability, and Efficacy of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis

BE VITAL
Start date: August 13, 2019
Phase: Phase 3
Study type: Interventional

This is a study to assess the long-term safety, long-term efficacy and tolerability of bimekizumab administered subcutaneously (sc) in adult subjects with psoriatic arthritis (PsA).

NCT ID: NCT04009447 Active, not recruiting - Hypertension Clinical Trials

Sleep Quality and Mechanisms of Cardiovascular Risks in Adults With Hypertension

Start date: February 14, 2020
Phase: N/A
Study type: Interventional

The objective of this study is to elucidate the potential mechanisms responsible for the increased risk of cardiovascular disease among patients with hypertension and comorbid insomnia.

NCT ID: NCT04009291 Active, not recruiting - Clinical trials for Endocrine System Diseases

A Trial Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism

PaTH Forward
Start date: August 27, 2019
Phase: Phase 2
Study type: Interventional

During the first four weeks of the trial, participants will be randomly assigned to one of four groups: three groups will receive fixed doses of TransCon PTH and one group will receive placebo. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the four weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs. This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, Denmark, and Norway.

NCT ID: NCT04009109 Active, not recruiting - Myeloma, Multiple Clinical Trials

Study of Lenalidomide/Ixazomib/Dexamethasone/Daratumumab in Transplant-Ineligible Patients With Newly Diagnosed MM

Start date: October 21, 2020
Phase: Phase 2
Study type: Interventional

A randomized Phase II clinical trial will be conducted to assess the impact on progression free survival (PFS) with the addition of ixazomib and daratumumab to lenalidomide as a maintenance treatment following induction with lenalidomide, ixazomib, dexamethasone, and daratumumab. Patients will be randomized to either: Arm A: 12 cycles of lenalidomide, ixazomib, daratumumab, and dexamethasone followed by lenalidomide until disease progression or unacceptable toxicity or a maximum of 2 years of maintenance therapy. Arm B: 12 cycles of lenalidomide, ixazomib, daratumumab and dexamethasone, followed by lenalidomide, ixazomib, and daratumumab until disease progression or unacceptable toxicity or a maximum of 2 years maintenance therapy.

NCT ID: NCT04009005 Active, not recruiting - Clinical trials for Relapsing Remitting Multiple Sclerosis

Clinically Isolated Syndrome and Relapsing-Remitting Multiple Sclerosis

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

A key question in efforts to reduce symptoms and improve quality of life for multiple sclerosis (MS) patients is whether a therapeutic lifestyle (diet, stress reduction and exercise) is inferior to disease-modifying drug treatments in terms of reducing multiple sclerosis related symptoms, improving function and quality of life, and reducing the number of acute inflammatory lesions and loss of brain volume. This study will prospectively assess the changes in quality of life and clinical outcomes in two cohorts of patients who are recently diagnosed with clinically isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS) to begin answering that question. The goal of this project is to compare a diet and therapeutic lifestyle only treatment usual care in the setting of newly diagnosed individuals with RRMS or CIS, which is the precursor to the development of MS. Due to the COVID 19 Pandemic, the study was redesigned from an in-person study to a virtual visit only study prior to enrolling study subjects.

NCT ID: NCT04008940 Active, not recruiting - Clinical trials for Distal Femur Fracture

Locking Plates for Distal Femur Fractures - a Multicenter Case Review

VA_LCP
Start date: January 2012
Phase:
Study type: Observational

In order to assess the rate and mode of failure cases observed in patients with distal femur fractures treated with a distal femur plates, anonymized radiographs from those patients will be collected retrospectively. All available images will reviewed by an expert review board in regards to fracture classification, implant and surgery details, quality of initial reduction and plate positioning as well as the occurrence of mechanical complications and the outcome in terms of fracture healing (if available). Additionally, age and gender as basic demographical data will be collected in a de-identified way..