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NCT ID: NCT03129295 Not yet recruiting - Clinical trials for Urinary Tract Infections

Phase II Proof of Concept Study in Uncomplicated UTI

Start date: April 2017
Phase: Phase 2
Study type: Interventional

A study of the efficacy and safety of MPC-SHRC for the relief of symptoms associated with uncomplicated urinary tract infections.

NCT ID: NCT03108261 Not yet recruiting - Clinical trials for Metastatic Urothelial Carcinoma

Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations

Start date: May 1, 2017
Phase: Phase 2
Study type: Interventional

This pilot phase II trial studies how well sapanisertib works in treating patients with bladder cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic) with tuberous sclerosis (TSC)1 and/or TSC2 mutations (changes in deoxyribonucleic acid [DNA]).Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

NCT ID: NCT03105258 Not yet recruiting - Clinical trials for Neurofibromatosis Type 1

Selumetinib Pilot Study for Cutaneous Neurofibromas

Start date: May 1, 2017
Phase: Phase 2
Study type: Interventional

This is a small study of the oral MEK1/2 inhibitor, selumetinib, to evaluate the potential utility of selumetinib in individuals ≥ 18 years old with Neurofibromatosis 1 (NF1) and cutaneous neurofibromas (cNFs). The study aims to determine whether selumetinib will result in shrinkage of existing cutaneous neurofibromas and if it prevents or delays the development of new cutaneous neurofibromas.

NCT ID: NCT03101917 Not yet recruiting - Clinical trials for Hearing Loss, Cochlear

Microtable® Method for Cochlear Implantation Investigational Device Exemption (IDE)

Start date: July 1, 2024
Phase: N/A
Study type: Interventional

The Microtable® Microstereotactic Frame and Drill Press and Associated Method for Cochlear Implantation consists of a patient-customized microstereotactic frame which targets the cochlea. The intended use of the device in this early feasibility study is to surgically access the cochlea, allowing placement of an intra-cochlear electrode array for cochlear implantation, thereby providing a less invasive surgical option than currently performed. Compared to traditional cochlear implantation (CI) surgery, the investigators hypothesize that the minimally invasive, image-guided approach may offer the following benefits: (1) shorter procedure time including shorter general anesthesia time, (2) less tissue removal potentially eliminating post-operative mastoid bone depression, decreased post-operative patient discomfort, and quicker wound healing, (3) better chance of preservation of taste secondary to preservation of the chorda tympani nerve, and (4) standardization of electrode placement potentially allowing more consistent placement within the scala tympani sub-compartment of the cochlea which has been shown to be associated with improved post-operative audiological performance. This early feasibility study will focus on the advantages of the new technology to the patient. Advantages to the healthcare delivery system will be examined during the pivotal study phase.

NCT ID: NCT03061344 Not yet recruiting - Urethral Stricture Clinical Trials

Liquid Buccal Mucosa Graft Urethroplasty

LBMG
Start date: February 2017
Phase: Phase 1
Study type: Interventional

Study Objectives The current definitive treatment options for urethral stricture disease include endoscopic urethrotomy known as Direct Vision Internal Urethrotomy (DVIU) or open reconstruction known as urethroplasty (1-6). The purpose of this study is to determine feasibility of endoscopic-only repair of urethral stricture or bladder neck contracture using a combination of existing surgical techniques of internal urethrotomy (or bladder neck incision) augmented by buccal mucosal graft.

NCT ID: NCT02996136 Not yet recruiting - Influenza, Human Clinical Trials

Assessment of the Clinical Performance of the ARROW-FLU System

Start date: December 2016
Phase: N/A
Study type: Interventional

The ARROW-FLU Influenza A&B Test is an in vitro diagnostic immuno-chromatographic assay intended for the qualitative detection of influenza A and influenza B viral nucleoprotein antigens from nasal or nasopharyngeal swab specimens in symptomatic patients. It is intended to aid in the rapid differential diagnosis of influenza A and/or B viral infections. This test is not intended for the detection of influenza C viruses. A negative test is presumptive and it is recommended these results be confirmed by cell culture of an FDA cleared molecular device. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

NCT ID: NCT02990416 Not yet recruiting - Stage IV Melanoma Clinical Trials

A-dmDT390-bisFv(UCHT1) Fusion Protein With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma

Start date: January 2017
Phase: Phase 1/Phase 2
Study type: Interventional

This study evaluates the effectiveness of adding a single four-day treatment of the fusion protein A-dmDT390-bisFv(UCHT1) — plus single palliative tumor radiation — with standard of care KEYTRUDA (Pembrolizumab) therapy for the treatment of metastatic melanoma. The results will be measured by comparing the combined therapy to historical data of KEYTRUDA alone.

NCT ID: NCT02988245 Not yet recruiting - Hypertension Clinical Trials

Investigating the Use of Genetics to Guide Pharmacologic Therapy for Hypertension

PGEN for HTN
Start date: June 2022
Phase: Phase 2
Study type: Interventional

Hypertension is one of the most important preventable contributors to disease and death in the United States and represents the most common condition seen in the primary care setting. Approximately 78 million adults living in the U.S. have hypertension with more than 5 million new diagnoses made each year. Unfortunately, despite a significant impulse in the medical community to move towards an "individualized medicine" approach to patient centered treatment, the current clinical treatment strategy is based on a set algorithm which does not take into account individual patient differences. As a result hypertension is often sub-optimally treated based on "population averages", rather than a person's genetic make-up, with significant burden on our health care system. In fact, 40% of patients who are adherent to their blood pressure therapy (taking their medicines as prescribed by their clinician) do not have their blood pressure under control. Previous work has demonstrated significant functional polymorphisms within the kidney, vessels, and heart that will likely predict a patient's response to blood pressure pharmacotherapy. Previous work by our group, utilizing a retrospective design, has determined that the addition of genetic knowledge to prescribing can improve therapeutic guidance and decrease the time to blood pressure control significantly. Despite this, to date, there are no prospective trials to guide blood pressure therapy using multiple organ systems that are important in the three most common classes of drugs: diuretics, vasodilators, and beta-blockers. The objective of this clinical trial is to determine the efficacy of genetically guided therapeutic options for pharmacologic treatment of essential hypertension in newly diagnosed patients.

NCT ID: NCT02985697 Not yet recruiting - Clinical trials for Safety and Efficacy of Intranasal Dexmedetomidine

Safety and Efficacy of Intranasal Dexmedetomidine

Start date: January 2017
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate the efficacy and safety of intranasal dexmedetomidine when used in combination with oral midazolam and/or nitrous oxide for moderate sedation during pediatric outpatient dental procedures.

NCT ID: NCT02968316 Not yet recruiting - Clinical trials for Pregnancy Complications

Bioelectric Impedance Analysis and Pregnancy Outcomes

Start date: January 2017
Phase: N/A
Study type: Observational

This is a prospective observational study correlating Body Impedance Analysis (BIA) with pregnancy outcomes.