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NCT ID: NCT05069415 Completed - Cataract Clinical Trials

Monofocal IOL Visual Outcomes When Targeting Mini Monovision

Start date: October 4, 2021
Phase: N/A
Study type: Interventional

This study is a 3-month, prospective, up to 2 center, bilateral, randomized subject masked clinical evaluation of a monofocal intraocular lens (IOL) when both eyes are targeted for emmetropia and when the non-dominant eye is targeted for mini monovision (-0.75 D) in patients with or without astigmatism undergoing routine cataract surgery.

NCT ID: NCT05069155 Completed - Dementia Clinical Trials

The STEP 4Life Trial

Start date: November 1, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to test the feasibility of using behavioral economic interventions (gamification with social incentives) targeting daily step counts to prevent or delay the development of Alzheimer's Disease and Related Dementias (ADRD).

NCT ID: NCT05069012 Completed - Postoperative Pain Clinical Trials

Intrathecal Morphine for Cesarean Delivery

Start date: November 15, 2021
Phase: Phase 4
Study type: Interventional

This is a randomized double blinded non-inferiority study comparing the duration of pain relief when patients receive one of three doses of spinal morphine. Enrolled patients will be randomly assigned to receive either 50 mcg, 150 mcg, or 250 mcg. All patients will receive standardized postoperative care, including multimodal analgesia. The primary outcome will be the time until the patient requests additional opioid pain medications.

NCT ID: NCT05068947 Completed - Phase 1 Clinical Trials

Safety, Tolerability, and Pharmacokinetic Study of Single Ascending Dose of GV101 in Healthy Subjects

Start date: September 10, 2021
Phase: Phase 1
Study type: Interventional

This is a single center Phase 1, placebo-controlled, randomized, double blind, first-in-human (FIH), sequential single ascending dose (SAD) study.

NCT ID: NCT05068661 Completed - Labor Pain Clinical Trials

Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Start date: November 21, 2021
Phase: Phase 4
Study type: Interventional

The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.

NCT ID: NCT05068609 Completed - Clinical trials for Squamous Cell Carcinoma of the Head and Neck

A Study of Nivolumab in Participants With Squamous Cell Carcinoma of the Head & Neck (SCCHN) - Patient Reported Outcomes (PRO)

VOLUME-PRO
Start date: August 13, 2020
Phase:
Study type: Observational

The purpose of the study is to capture the utilization of nivolumab among participants with squamous cell carcinoma of the head and neck (SCCHN) since its approval, and to describe the health related quality of life (HRQoL) among participants treated with nivolumab in a real-world setting.

NCT ID: NCT05068245 Completed - Anxiety Clinical Trials

Music to Reduce Patient Reported Pain During Intrauterine Device (IUD) Placement in the Office

MIUD
Start date: August 28, 2020
Phase: N/A
Study type: Interventional

This study seeks to determine if music reduces pain and anxiety in comparison to routine pain control measures alone during insertion of intrauterine contraceptive devices (Mirena, Paragard)

NCT ID: NCT05067933 Completed - COVID-19 Clinical Trials

A Ph 2 Trial With an Oral Tableted COVID-19 Vaccine

Start date: October 1, 2021
Phase: Phase 2
Study type: Interventional

Part 1: An open label, dose and age escalation phase to evaluate the safety and immunogenicity of VXA-CoV2-1.1-S with a repeat-dose vaccination schedule in healthy adults aged 18 - 75 years old that are either vaccine naive or have received prior vaccination with an mRNA (messenger ribonucleic acid) vaccine for the prevention of COVID-19. Part 2: This phase will assess the efficacy of prophylactic VXA-CoV2-1.1-S against confirmed COVID-19 occurring from 7 days after second dose with a repeat-dose vaccination schedule in healthy adults compared to placebo. Safety and immunogenicity of VXA-CoV2-1.1-S will also be evaluated in this phase.

NCT ID: NCT05067725 Completed - Headache Clinical Trials

Evaluating the Effectiveness of a Headache Management Program in Primary Care Settings

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

Between January 2020 to August 2021, fifty percent of patients referred from Geisinger's primary care sites to Neurology for headaches did not trial appropriate first line therapy prior to referral, and there was limited access available at Geisinger's Neurology department. This project was initiated to improve patient experience, management of headache, and provider experience as it relates to headache management. Geisinger's Neurology department, pharmacy department, and Community Medicine Service Line (CMSL) sites have collaborated to develop a Headache CarePath (i.e., a best practice alert containing: an EPIC headache assessment, Express Lane for prescriptions, and Ask-a-doc button for Neurology consult) and piloted at 2 CMSL sites (Woodbine, Selinsgrove) to gain some initial feedback. The feedback has been incorporated into best practice alert (BPA) language and criteria. The project team now plans to implement this CarePath to half of CMSL sites first while the other half of CMSL sites will continue to practice the standard of care as of today. The team will evaluate the impact of this CarePath on patient outcomes [change in Headache Impact Test-6 (HIT-6) scores, change in the frequency of headaches, and change in pain intensity], emergency department (ED) visits, number of referrals to Neurology for headache, and prescribing of headache medications by comparing the measures in clinics that had the CarePath implemented to those that did not. Patient outcomes will be collected by Geisinger's Survey Core, which will reach out telephonically to patients to ask about the status of their headaches (HIT-6, frequency, intensity of headaches, M-TOQ-5). Other measures will be collected and analyzed using secondary data sources such as electronic health record (EHR) data. The initial implementation is planned for 6-9 months. The findings from this evaluation will help the CarePath team identify any remaining opportunities or guide the direction of its future enhancements of the CarePath tools. The results of this evaluation will be shared with the Geisinger leadership to demonstrate its value to the organization.

NCT ID: NCT05067647 Completed - Thoracic Procedure Clinical Trials

A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures

Start date: November 29, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).