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NCT ID: NCT03858036 Not yet recruiting - Keratoconus Clinical Trials

Corneal Collagen Cross-Linking (CXL) Performed With "Epi-ON" Versus "Epi-OFF" in Eyes With Keratoconus and Other Corneal Ectatic Disorders

Start date: March 8, 2019
Phase: Phase 3
Study type: Interventional

This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.

NCT ID: NCT03857581 Not yet recruiting - Clinical trials for Substance Use Disorders

Clozapine Versus Olanzapine as Treatment for Comorbid Psychotic Disorder and Substance Use Disorder

Start date: July 2020
Phase: Phase 4
Study type: Interventional

The purpose of this trial is to determine if patients with comorbid psychotic disorder and substance use disorder will continue in treatment longer if treated with clozapine than with olanzapine, and will have greater reductions in psychosis and in substance use if treated with clozapine than treated with olanzapine. The specific aims and hypotheses of this trial are: 1. To compare the enduring effectiveness and tolerability of clozapine and olanzapine, as measured by time to all-cause treatment discontinuation, over 12 weeks of follow-up; The investigators hypothesize that patients assigned to clozapine treatment will have significantly longer times to all cause treatment discontinuation, 2. To compare the total psychosis items scores between patients treated with clozapine and patients treated with olanzapine over 12 weeks of follow-up; The investigators hypothesize that patients treated with clozapine will have significantly lower total psychosis items scores than patients treated with olanzapine, and 3. To compare the frequencies of positive urine drug screens and blood alcohol levels (obtained weekly throughout 12 weeks of follow-up) between patients treated with clozapine and patients treated with olanzapine; The investigators hypothesize that patients treated with clozapine will have significantly fewer positive urine drug screens and blood alcohol levels than patients treated with olanzapine.

NCT ID: NCT03856567 Not yet recruiting - Anxiety Clinical Trials

Virtual Reality System for Anxiety and OCD

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

Cognitive Behavioral Therapy with fear provoking exposures is the most effective therapy for anxiety disorders. The investigators aim to enhance this therapy with the use of virtual reality exposures. The human subjects study will test the effects of using VR for exposures compared to traditional imaginal exposures on anxiety symptom improvement, functioning, child engagement in and response to exposures, completion of exposure homework between treatment sessions, and length of treatment in weeks and length of treatment among children with anxiety disorders and/or obsessive compulsive disorder. The funding award supports the development of the technology and the human subjects study. The subcontract to Mayo supports expert input to identify clinically relevant content for therapeutic videos on the VR system and the human subjects study to test the VR system.

NCT ID: NCT03852277 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Assess Safety, Tolerability, Pharmacodynamics, Immunogenicity, Exploratory Clinical Efficacy, and Pharmacokinetics of Intravenous Infusions of E2814 in Healthy Participants and Participants With Prodromal Alzheimer's Disease (AD) to Moderate AD With and Without Detectable Tau Pathology

Start date: February 26, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

The primary purpose of the study is to evaluate the safety and tolerability of single and multiple ascending doses in healthy participants and participants with prodromal to moderate AD, respectively, and to demonstrate slowing in progression of tau pathology in the brain as determined by tau-positron emission tomography (PET) in participants with prodromal to moderate AD.

NCT ID: NCT03848390 Not yet recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Effect of Modified Time-restricted Feeding in Preventing Progression of Non-Alcoholic Fatty Liver Disease (NAFLD).

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

The purpose of the study is to examine the effects of modified time-restricted feeding and conventional dietary approaches in motivated obese fatty liver patients on biochemical markers, imaging studies, and anthropometric measurements.

NCT ID: NCT03845036 Not yet recruiting - Clinical trials for Peripheral Artery Disease

The Effects of Diet and Exercise Interventions in Peripheral Artery Disease

Start date: June 3, 2024
Phase: N/A
Study type: Interventional

This study is a 3-month, prospective, randomized controlled clinical trial designed to address the efficacy of the DASH dietary program combined with a home-based exercise program, quantified by a step activity monitor, to improve exercise and vascular outcome measures in patients with PAD.

NCT ID: NCT03843671 Not yet recruiting - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

Hyperbaric Radiation Sensitization of Head and Neck Cancers

Start date: July 1, 2019
Phase: Phase 2
Study type: Interventional

There is reason to believe that hyperbaric oxygen administered immediately prior to radiotherapy will prove beneficial for this cancer type and stage. The basis for this hypothesis is a review of several decades of published work, the conclusion of a recent (2018) Cochrane Review, and results of a Phase I trial.

NCT ID: NCT03834818 Not yet recruiting - Surgery Clinical Trials

Collecting Outcomes and Managing Pain After Surgery

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

The primary aim of this study is to measure pain and psychosocial patient reported outcomes, objective functionality, and actual daily at home opioid usage in orthopedic patients. The study's goal following the data collection is to predict which patients are at high risk for chronic opioid use.

NCT ID: NCT03833206 Not yet recruiting - Clinical trials for Major Depressive Disorder

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients

Start date: July 15, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.

NCT ID: NCT03826758 Not yet recruiting - Clinical trials for Chronic Kidney Diseases

Enhanced Dynamic Clinical Decision Support System Pragmatic Trial (E-DYNAMIC)

E-DYNAMIC
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Chronic kidney disease (CKD) is a highly prevalent, poorly recognized and undertreated and increases risk of atherosclerotic cardiovascular disease (ASCVD) and mortality. ASCVD risk interventions such as statin medications are not effective if initiated when kidney disease is advanced. Thus, early recognition of CKD is important for effective ASCVD risk management. Patient centered medical homes (PCMH)s (clinics which include nurse educators, dietitians, pharmacists and social workers) were designed to address gaps in care for complex chronic diseases such as CKD by increasing availability of ancillary services for patients. However, PCMH models have not been shown to improve the recognition and treatment of CKD and its associated ASCVD risk. The E DYNAMIC CDS retrieves real-time patient data from the electronic health record (EHR) every 24 hours to help primary care providers (PCP) identify patients with CKD and assess ASCVD risk and provide appropriate treatment. E-DYNAMIC also delegates CKD care with utilization of an opt-out approach for nurse education and dietitian referral. The overall objective of this pragmatic trial is to examine whether the E-DYNAMIC CDS increases PCP recognition of CKD and use of ASCVD risk management interventions when implemented within a PCMH. This pragmatic trial will be conducted within the Hines VA Hospital and community-based outpatient clinics designed as PCMH called teamlets. Teamlets include several PCPs, a nurse educator, a dietitian, a pharmacist, and a social worker. We will randomize 51 teamlets to the E-DYNAMIC CDS or to standard care. This pragmatic trial will address the following aims: 1) Determine the difference in PCP diagnosis of CKD stage 3-5 non-dialysis dependent CKD by allocation to the E-DYNAMIC CDS; 2) Determine the difference in PCPs ASCVD risk management of patients with stage 3-5 non-dialysis dependent CKD by teamlet allocation to the E-DYNAMIC CDS; 3) Determine the difference in patient use of ASCVD risk interventions and patient activation measures by their teamlet allocation to the E-DYNAMIC CDS. The primary outcomes of the pragmatic trial will be ascertained from the EHR. The E-DYNAMIC CDS tool may be transferred into other health systems that utilize an EHR and improve the diagnosis and management of CKD.