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NCT ID: NCT04176965 Active, not recruiting - Cataract Clinical Trials

Investigation of the Safety and Effectiveness of a Trifocal IOL

Start date: May 30, 2022
Phase: N/A
Study type: Interventional

This study is a prospective, multicenter, randomized, double masked confirmatory trial comparing an investigational trifocal intraocular lens (IOL) and a commercially available monofocal IOL.

NCT ID: NCT04176783 Active, not recruiting - Pain Management Clinical Trials

Opioid-Free Orthopaedic Surgery

CORE
Start date: March 26, 2018
Phase: N/A
Study type: Interventional

To compare the safety and effectiveness of two pain control pathways following routine orthopaedic surgical procedures (single level or two-level ACDF/ACDA, 1st CMC arthroplasty, Hallux Valgus/Rigidus corrections, diagnostic knee arthroscopies, total hip arthroplasty, and total shoulder arthroplasty / reverse total shoulder arthroplasty). The control group will undergo surgery with an opioid-based pain protocol and the intervention group will undergo surgery with a multimodal, opioid-free protocol. Patients will have data collected with respect to pain scores, overall comfort level, overall satisfaction with the surgical experience and recovery, constipation, falls, and overall satisfaction with pain control, in addition to procedure-specific outcome scores and patient-specific metrics.

NCT ID: NCT04176497 Active, not recruiting - Prostate Cancer Clinical Trials

PSMA-PET/MRI Unfavorable-Risk Target Volume Pilot Study

Start date: July 16, 2020
Phase: Phase 2
Study type: Interventional

The goal of this study is to investigate the feasibility and toxicity of using prostate-specific membrane antigen-positron emission tomography (PSMA-PET) and multi-parametric magnetic resonance imagining (mpMRI) with PET-MR technology to define radiotherapy targets, while meeting all the current planning criteria.

NCT ID: NCT04176419 Active, not recruiting - Opioid Consumption Clinical Trials

Perioperative Analgesia on Postoperative Opioid Usage and Pain Control in H&N Cancer Surgery

Start date: January 17, 2020
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine how a non-opioid pain control regimen, administered before and during surgery, will affect postoperative pain control and total opioid consumption in head and neck cancer participants undergoing cancer surgery with free flap reconstruction.

NCT ID: NCT04176354 Active, not recruiting - Clinical trials for Metastatic Breast Cancer

Real-world Treatment Patterns and Effectiveness of Palbociclib and AI Therapy

Start date: January 25, 2019
Phase:
Study type: Observational

A retrospective observational analysis of de-identified Flatiron Health Analytic Database to describe patient characteristics, treatment patterns and effectiveness of Palbociclib + AI as first-line therapy in HR+/HER2- metastatic breast cancer (MBC) in the US clinical practices.

NCT ID: NCT04175977 Active, not recruiting - Dementia Clinical Trials

The Hospice Advanced Dementia Symptom Management and Quality of Life Trial (HAS-QOL)

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

The Aliviado Dementia Care Program (formerly known as the Dementia Symptom Management at Home Program, or DSM-H) was developed to implement dementia friendly care for persons with Dementia and their caregivers living in the community. Aliviado Dementia Care-Hospice Edition is a systems level quality assurance performance improvement program that includes interdisciplinary team training, validated assessment instruments, patient-centered care plans, treatment algorithms for behavioral and psychological symptoms of dementia and terminal delirium, and caregiver education pamphlets. Utilizing the R61/R33 mechanism, the Aliviado Dementia Care-Hospice Edition was successfully implemented in 2 sequential pilot trials in the hospice setting in 2019 (R61 phase). Following the successful pilot trials and the attainment of the R61 milestones, the investigators now seek to test the effectiveness of Aliviado Dementia Care-Hospice Edition in a pragmatic RCT in 25 hospice agencies across the nation (R33 phase) on its ability to reduce antipsychotic use (primary outcome) and effect quality (secondary and exploratory outcomes).

NCT ID: NCT04175912 Active, not recruiting - Clinical trials for Unresectable Hepatocellular Carcinoma

Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver

Start date: March 16, 2020
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.

NCT ID: NCT04175743 Active, not recruiting - Surgery Clinical Trials

Double-blind, Placebo-control, Study to Evaluate the Safety and Pharmacokinetics of CT-044 HCl, in Healthy Volunteers

Start date: December 4, 2019
Phase: Phase 1
Study type: Interventional

This study will be conducted to assess safety, tolerability, and PK of CT-044 HCl in normal healthy volunteers, in a traditional sequential multiple ascending dose paradigm. The multiple-dose escalation is designed to mimic the manner in which the product (CT-044 HCl) would be used to manage ongoing pain in patients (i.e., multiple dosing).

NCT ID: NCT04175639 Active, not recruiting - Breast Cancer Clinical Trials

mHealth Behavioral Cancer Pain Intervention for Medically Undeserved Patients

ICAN-NC
Start date: October 20, 2021
Phase: N/A
Study type: Interventional

The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients in medically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention - a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas. mPCST-Community addresses intervention barriers for patients in medically underserved areas as it is delivered with video-conferencing in the patients' community based oncology clinic by a remote therapist, is extended to the patients' home environment using simple mHealth technology, and is low-literacy adapted. The central hypothesis is that mPCST-Community will result in decreased pain compared to a mHealth education attention control group (mHealth-Ed). The rationale of this proposal is that if mPCST-Community is shown to be efficacious it will rapidly increase intervention access for individuals who receive their oncology care in medically underserved areas and ultimately reduce pain-related suffering. Guided by strong preliminary data, a randomized controlled trial will be used to pursue three specific aims: 1) Test the extent to which the mPCST-Community intervention reduces pain, fatigue, disability, and distress, 2) Examine self-efficacy and pain catastrophizing as mediators through which the mPCST-Community leads to reductions in pain, fatigue, disability, and distress, and 3) To evaluate the cost-effectiveness of mPCST-Community. For Aim 1, based on the study team's extensive work demonstrating the efficacy of in-person pain coping skills training protocols and pilot work showing promise for mPCST-Community, it is expected that mPCST-Community will lead to decreased pain as well as fatigue, disability, and distress compared to mHealth-Ed. For Aim 2, it is expected that the effects of mPCST-Community will be mediated by increased self-efficacy for pain control and decreased pain catastrophizing. For Aim 3, it is expected that mPCST-Community will demonstrate cost-effectiveness as assessed by all-cause medical resource use, participant and therapist time, and health utilities as well as successful overall accrual, high subject retention, and high intervention adherence.

NCT ID: NCT04175626 Active, not recruiting - Clinical trials for Coronary Artery Disease

Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions

BIOFLOW-VII
Start date: January 24, 2020
Phase:
Study type: Observational

The objective of this post-approval study is to confirm that the clinical performance of the Orsiro stent in a real-world setting is similar to the clinical performance observed for Orsiro in the BIOFLOW-V Investigational Device Exemption pivotal trial, as a condition of the US Food and Drug Administration (FDA) approval (P170030).