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NCT ID: NCT04673890 Completed - Cancer Clinical Trials

Improving Cancer Survival and Reducing Treatment Variations With Protocols for Emergency Care

ICARE
Start date: August 6, 2020
Phase:
Study type: Observational

Significant challenges and gaps remain in navigating transitions between acute care and outpatient care for many cancer survivors. This study underscores 1) implementation of Emergency Department (ED) risk-stratified treatments protocols that standardize patient care and would allow for rapid re-assessment and access to specialist care with well-coordinated cancer care plans, and 2) the significant numbers of minority cancer survivors seeking episodic care in the ED that are at increased risk of not receiving recommended post cancer treatment surveillance.

NCT ID: NCT04673877 Completed - Infection Clinical Trials

Vancomycin Tissue Concentrations by Bier Block or Intravenous Administration

Start date: August 26, 2021
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine whether or not giving a lower dose of antibiotics (Vancomycin) in the area where it is needed (upper extremity) is more effective at preventing infection than the current standard dose which is given intravenously (IV).

NCT ID: NCT04673851 Completed - Schizophrenia Clinical Trials

Horyzons: Implementation in Clinical Practice

Start date: January 19, 2021
Phase: N/A
Study type: Interventional

A clinical trial investigating the feasibility and acceptability of implementing a moderated online social media platform with therapeutic content, Horyzons, as a part of care received at first-episode psychosis (FEP) clinics across North Carolina. Clients between the ages of 18 and 35 who are enrolled at one of the 4 FEP clinics in North Carolina will be considered for enrollment in the trial. Cohort 1 participants will have access to the platform for 3 months and cohort 2 participants will have access to the platform for 6 months. All interventions and assessments will be completed virtually/remotely due to the global pandemic.

NCT ID: NCT04673721 Completed - Obesity Clinical Trials

PROSPective Evaluation of Fortified Eggs Related to Improvement in The Biomarker Profile for Your Health

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

The objective of the study is to assess the effect of fortified eggs (compared to a non-egg supplemented diet) and intermittent fasting (IF) (compared to a usual care diet) on biomarker profile at 4 months. This will be a 140-participant, 2x2 factorial, randomized clinical trial comparing fortified eggs vs. a non-egg supplemented diet and IF vs. usual care diet through 4 months. Participants will be randomized 1:1:1:1 to the four treatment groups. Participants will have in-person follow-up visits at 1- and 4- months (inclusive of laboratory assessments) in addition to telephone calls at months 2 and 3. A subset of patients (~24 in each egg randomized strata) will undergo microbiome assessment at baseline and at 4 months.

NCT ID: NCT04673656 Completed - Type 2 Diabetes Clinical Trials

Dose-Response Study to Evaluate the Effect of BKR-017 on Insulin Resistance and Other Metabolic Parameters in Type 2 Diabetes Patients

Start date: April 18, 2021
Phase: N/A
Study type: Interventional

This study is a randomized, double-blind, placebo-controlled, dose-response study of BKR-017 and placebo that will be conducted at two investigative sites. The total duration of subject involvement is approximately 15 weeks; the screening period can be up to 3 weeks prior to the start of test period, followed by a 12-week test period. During the test period, subjects will self-administer three tablets of test product, two times daily: before breakfast and before bedtime.

NCT ID: NCT04673513 Completed - Depression Clinical Trials

Cognitive Behavioral Therapy for Depression: Helping Clients Learn New Skills

Start date: December 11, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to compare two psychological treatments for major depressive disorder (MDD): cognitive-behavioral therapy (CBT) and CBT-Skill Enhanced (CBT-SE). CBT is well-studied, research-supported treatment for depression. CBT-SE is a variant of CBT that places greater focus on helping clients to developing the skills of CBT. The study will enroll 150 participants with MDD. Participants will be randomized to CBT or CBT-SE, with 75 participants being assigned to each condition. For both conditions, treatment will be provided over 12 weeks, with a 6 month follow-up period. Potential participants are asked to complete an initial screening and an intake evaluation to determine eligibility. After entering the study, participants are asked to complete evaluations at 4 weeks and at 12 weeks. They are also asked to respond to self-report instruments before and after each session. Following the 12 week treatment, participants are asked to complete monthly follow-up surveys for 6 months. The primary objectives of this study are three-fold. The first is to compare the outcomes of the two treatments. The second is to evaluate potential mediators of any treatment differences. The third is to evaluate the process of change in these two versions of CBT.

NCT ID: NCT04673019 Completed - Clinical trials for Metastatic Breast Cancer

Nurse AMIE for Echo Show: Randomized Control Trial

Start date: February 2, 2021
Phase: N/A
Study type: Interventional

The Nurse AMIE platform has been modified for use as an Amazon Alexa skill for use on the Echo Show device. The investigators will recruit women receiving treatment for metastatic breast cancer and randomize patients to receive standard treatment (control) or the Nurse AMIE for Echo Show program. Nurse AMIE is a supportive care program for women undergoing chemotherapy and helps manage symptoms. The investigators will test the feasibility of using the Nurse AMIE program as well as its effectiveness at managing symptoms.

NCT ID: NCT04672798 Completed - Depression Clinical Trials

BRITEPath- Phase 2

Start date: November 5, 2020
Phase: N/A
Study type: Interventional

BRITEPath (BP) aims to support co-located mental health clinicians in the development of a high quality, effective, and personalized safety plan for referred patients who screen positive for depression and/or suicidal ideation. BRITEPath utilizes BRITE, a safety planning and emotion regulation app that is loaded on the patient's smart phone and has previously been shown to be well accepted and to reduce suicide attempts compared to usual care in psychiatric inpatients (HR = 0.49). To support mental health clinicians in the development of effective safety plans, study investigators will develop Guide2Brite (G2B), which provides step-by-step instructions for the mental health clinician on how to populate BRITE onto the patient's smartphone and BRITEBoard, a clinician dashboard that tracks patient symptoms, app use, and rating on helpfulness of different interventions assessed through BRITE.

NCT ID: NCT04672538 Completed - Anesthesia Clinical Trials

Fontan Physiology Ventilation Strategy

Start date: March 2, 2021
Phase: N/A
Study type: Interventional

This study will investigate the different tidal volume (Vt) strategies during a cardiac catheterization procedure to determine whether or not low or high Vt have an impact on cardiac output. Research question: While maintaining the same minute ventilation/PaCO2, does higher Vt (10 cc/kg)/lower rate vs. lower Vt (6 cc/kg)/higher rate (maintaining consistent PEEP) result in improved cardiac output?

NCT ID: NCT04672460 Completed - Breast Cancer Clinical Trials

A Bioequivalence Study Between the Proposed and Current Talazoparib Capsule Formulation and Food Effect Study for the Proposed Talazoparib Capsule Formulation in Participants With Advanced Solid Tumors

Start date: December 21, 2020
Phase: Phase 1
Study type: Interventional

This will be a Phase 1, open label, 2-sequence, crossover study to establish the BE of the current commercial formulation (Generation 3.1 talazoparib capsules) to the proposed talazoparib liquid-filled soft gelatin capsule (soft gel capsule) formulation after multiple dosing under fasting conditions in participants with advanced solid tumors. In addition, the effect of food on the PK of the proposed talazoparib soft gel capsule formulation will be evaluated in fixed sequence after the 2 BE assessment periods.