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NCT ID: NCT04574596 Completed - E Coli Infection Clinical Trials

Multi-Drug Resistant Organism (MDRO): Study of Highly Resistant Escherichia Coli

SHREC
Start date: November 12, 2020
Phase:
Study type: Observational

This is a prospective, observational, multicenter, case-control study.

NCT ID: NCT04574583 Completed - Solid Tumors Clinical Trials

Phase I/II Trial Investigating the Safety, Tolerability, Pharmacokinetics, Immune and Clinical Activity of SX-682 in Combination With BinTrafusp Alfa (M7824 or TGF-beta "Trap"/PD-L1) With CV301 TRICOM in Advanced Solid Tumors (STAT)

Start date: November 24, 2020
Phase: Phase 1/Phase 2
Study type: Interventional

Background: Combination immunotherapy techniques are being explored to improve responses and enhance benefits in people with cancer. Researchers want to see if this type of treatment can help people with advanced solid tumors. Objective: To find a safe dose of SX-682 in combined treatment with Bintrafusp alfa and BN-CV301 vaccines and to see if this treatment will cause tumors to shrink. Eligibility: Adults age 18 and older with metastatic cancer may be eligible for the first part of the trial. Adults age 18 and older with metastatic triple negative breast cancer or p16 negative head and neck squamous cell cancer, and who are not candidates for curative surgery may be eligible for the second part of the trial. Design: Participants will be screened under a separate protocol. Participants may have tumor biopsies. They will have physical exams. Their symptoms and medicines will be reviewed. They will have blood tests. They will have electrocardiograms to evaluate their heart. Participants will have imaging scans of the chest, abdomen, and pelvis. They may have a procedure where a small tube with a tiny video camera is put into the nose to look at the throat if they have head and neck cancers. Participants will get bintrafusp alfa through an intravenous catheter. For this, a small tube is put into an arm vein. They will get BN-CV301 vaccines as injections in the arm or thigh. They will take SX-682 by mouth twice a day. They will take the study drugs up to 2 years. They will keep a medicine diary. Participants will have study visits every 2 weeks. They will have 1 or 2 follow-up visits within 30 days after they stop treatment. Then they will be monitored by phone or email for 2 years.

NCT ID: NCT04574401 Completed - Prostate Cancer Clinical Trials

A Phase 1 Study of IS-002 Injection in Patients Undergoing Robotic Prostatectomy

Start date: October 10, 2020
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-site, interventional clinical trial evaluating the safety and efficacy of IS-002 intravenous (IV) injection for fluorescent identification and delineation of the positive cancer margins and metastatic lymph nodes during prostatectomy surgery using the da Vinci® X/Xi Surgical System with Firefly® Fluorescent Imaging.

NCT ID: NCT04574388 Completed - Spine Surgery Clinical Trials

Evaluation of Open-Label Conditioned Placebo Analgesia for Postoperative Opioid Reduction Following Spinal Fusion

COLP
Start date: November 30, 2018
Phase: N/A
Study type: Interventional

This research aims to understand the impact of conditioned open label placebo (COLP) on opioid consumption and pain after surgery. The hypothesis being tested is that by pairing a non-deceptive placebo pill with regularly prescribed pain killers after surgery, will allow reduction in opioids taken while maintaining the same level of analgesia.

NCT ID: NCT04574219 Completed - Anxiety Clinical Trials

Virtual Parental Presence on Induction

VPPIA
Start date: November 3, 2020
Phase: N/A
Study type: Interventional

Our goal in this study is to investigate the feasibility and acceptability of virtual parental presence of parents on anxiety in children at induction of anesthesia at Cincinnati Children's Hospital, an institution whose use of parental presence on induction is deeply ingrained in our culture, and to determine the impact of coaching of parents either prior to arrival at the hospital vs. on the day of surgery on efficacy of virtual parental presence on induction. Our primary hypothesis is that virtual PPIA is both feasibile for the smooth induction of general anesthesia and is acceptable to parents, patients, and anesthesia providers at our isntutition. Our secondary hypothesis is that the coaching of parents prior to virtual PPIA enhances the effect of video parental presence at induction of anesthesia on children's anxiety and that coaching prior to arrival at the hospital will allow for increased ease and use of this technique.

NCT ID: NCT04574193 Completed - Clinical trials for Substance Use Disorders

Continuing Care App for Probationers and Parolees

Start date: March 8, 2021
Phase: N/A
Study type: Interventional

This project extends successful Phase I work that developed a Continuing Care mobile application (app) for probationers and parolees with SUDs who are at elevated risk of relapse, re-arrest, and incarceration. This Phase II STTR project will finalize app development and evaluate its efficacy in a randomized controlled trial. The project has high public health significance due to its potential to provide an accessible recovery support tool for individuals on probation or parole that could improve their substance use disorder treatment outcomes.

NCT ID: NCT04573972 Completed - Social Isolation Clinical Trials

Using Social Connectedness to Increase Physical Activity

Start date: September 30, 2020
Phase: N/A
Study type: Interventional

A randomized controlled trial will test the effectiveness of social incentives relative to traditional incentives in promoting walking behavior among college students (N=200). Participants who are rewarded for walking together will be compared to those who are rewarded for walking even when alone. Research participants will download activity tracking apps (Fitbit app and AWARE app) that provide activity and location data. Participants will be consented and then randomized to one of two incentive schemes for walking. Over a 2-week intervention period, the standard incentive group will earn $2 per day when they meet their walking goal regardless of whether they walk alone or with others. The social incentive group will earn $1 per day when they reach their walking goal plus an additional $1 when they walk at least 2000 steps with their walking partner. The incentive scheme will be in place for 2-weeks, preceded by a 1-week baseline period and followed by a 2-week follow-up period.

NCT ID: NCT04573959 Completed - Crohn Disease Clinical Trials

Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System

Start date: October 1, 2015
Phase: N/A
Study type: Interventional

To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam® SV-2 and SV-3 capsule endoscopy systems.

NCT ID: NCT04573595 Completed - Blood Pressure Clinical Trials

Fresenius Noninvasive Blood Pressure Validation

BPM2
Start date: September 17, 2020
Phase: N/A
Study type: Interventional

The purpose of this study to collect blood pressure measurement values from the blood pressure measurement device on the Fresenius machine as compared to the standard method.

NCT ID: NCT04573582 Completed - Hepatic Impairment Clinical Trials

Pharmacokinetics of Enasidenib (CC-90007) in Participants With Mild, Moderate and Severe Hepatic Impairment

Start date: November 13, 2020
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label study to assess the PK of single 100 mg oral doses of enasidenib (CC-90007) in subjects with mild, moderate, and severe hepatic impairment (HI), and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease. Subjects will be enrolled in 4 Groups as follows: - Group A: Approximately 8 subjects with mild hepatic impairment (with a Child-Pugh score of < 7) will be enrolled in Group A. - Group B: Approximately 8 subjects with moderate hepatic impairment (with a Child-Pugh score of ≥ 7 to ≤ 9) will be enrolled in Group B. - Group C: Approximately 8 subjects with severe hepatic impairment (with a Child-Pugh score of ≥ 10 to ≤ 15) will be enrolled in Group C. - Group D: Approximately 8-24 healthy subjects with normal hepatic function will be enrolled in Group D. Subjects in Group D will be matched to subjects in Groups A-C with respect to sex, age (± 10 years), and weight (± 30 pounds). More than 1 subject with differing degrees of HI can be matched to a single control; however, all subjects with HI must be matched to at least 1 healthy match subject.