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NCT ID: NCT05248984 Completed - Post Cesarean Pain Clinical Trials

Dosing of Ketorolac Impacts Post-cesarean paiN manaGemenet (KING)

KING
Start date: June 8, 2022
Phase:
Study type: Observational

This is a randomized controlled single blinded trial to compare the morphine milligram equivalents (MME) use in the first 24 hours postoperatively after cesarean section in patients receiving a single dose of 30 mg intravenous ketorolac vs. 60 mg intravenous ketorolac in the operating room after the end of surgery.

NCT ID: NCT05248893 Completed - Glabellar Lines Clinical Trials

A Study to Assess Adverse Events of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Start date: February 25, 2022
Phase: Phase 3
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety of AGN-151586 over multiple repeat treatments of the study drug to improve the appearance of glabellar lines. AGN-151586 is an investigational product being developed for the treatment of GL. Around 940 to 1100 adult participants with moderate to severe GL will be enrolled in the study in approximately 45 sites in the United States. This is an open-label, 126 day study in which all participants will receive 5 intramuscular AGN-151586 injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive up to 2 additional cycles of treatment during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

NCT ID: NCT05248880 Completed - Glabellar Lines Clinical Trials

A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Toxin-Naïve Adult Participants With Glabellar Lines

Start date: March 8, 2022
Phase: Phase 3
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in toxin-naïve participants with moderate to severe GL. This is a 12 week study in which eligible subjects will be enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 300 adult participants with moderate to severe GL will be enrolled in the study in approximately 15 sites. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may receive an open-label treatment of AGN-151586 during the study. Participants will attend regular visits during the study at a study site. The effect of the treatment will be checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

NCT ID: NCT05248867 Completed - Glabellar Lines Clinical Trials

A Study to Assess Adverse Events and Change in Disease Activity of Intramuscular AGN-151586 Injection in Adult Participants With Glabellar Lines

Start date: March 16, 2022
Phase: Phase 3
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. AGN-151586 is an investigational product being developed for the treatment of GL. The purpose of this study was to evaluate the safety and efficacy of AGN-151586 for the treatment of GL in participants with moderate to severe GL. This was a 12-week study in which eligible subjects were enrolled into the study containing 2 treatment periods, double-blind period and open-label period. Participants were randomly assigned to receive AGN-151586 or placebo. There was 1 in a 4 chance that participants would receive placebo. Around 600 adult participants with moderate to severe GL were to be enrolled in the study in approximately 38 sites across the world. Participants received either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. Participants meeting retreatment criteria may have received an open-label treatment of AGN-151586 during the study. Participants attended regular visits during the study at a study site. The effect of the treatment was checked by medical assessments, blood tests, telephone calls, questionnaires and checking for side effects.

NCT ID: NCT05248828 Completed - Breast Pumping Clinical Trials

Testing of New Method in Sanitizing Breast Pump Equipment in the NICU

Start date: February 21, 2022
Phase:
Study type: Observational

This study will evaluate a newly developed device, Q. Basin. The Q. Basin is a multifunctional, single patient use device that can sanitize breast pump parts, bottles, and reusable feeding devices for patients admitted under one year of age. Improving the current sanitation method would provide a quick and efficient sanitation process for breast pump parts. This study will compare the Q. Basin to the current method of steam bag sanitation.

NCT ID: NCT05248672 Completed - Alzheimer Disease Clinical Trials

Study to Assess the Pharmacokinetics of CT1812 in Older Healthy Volunteers

COG0107
Start date: February 15, 2022
Phase: Phase 1
Study type: Interventional

This an open label study to assess the pharmacokinetics of CT1812 in normal healthy volunteers.

NCT ID: NCT05248399 Completed - COVID-19 Clinical Trials

Vale+ Tu Salud: Corner-Based Randomized Trial to Test a Latino Day Laborer Program Adapted to Prevent COVID-19

Start date: March 23, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to adapt and pilot test the feasibility of implementing a corner-based risk reduction program that aims to assist Latino day laborers (LDL) in their efforts to adhere to COVID-19 mitigation practices, including receiving the COVID-19 vaccine, using personal protective equipment (PPE), and practicing social distancing.

NCT ID: NCT05247970 Completed - Obesity Clinical Trials

A Study to Assess S-309309 in Healthy and Obese Participants

Start date: January 4, 2022
Phase: Phase 1
Study type: Interventional

The primary aim of the study is to assess the safety and tolerability of S-309309 after oral administration in healthy adult or obese but otherwise healthy adult participants. The secondary aim of the study is to assess the pharmacokinetics of S-309309 and the effects on ECG parameters after oral administration in healthy or obese but otherwise healthy participants.

NCT ID: NCT05247541 Completed - Clinical trials for Chronic Exertional Compartment Syndrome

Diagnosing Compartment Syndrome With SHAPE vs Elastography

Start date: July 1, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic exertional compartment syndrome (CECS) is an innocuous condition seen primarily in 10-60% of young active people with exercise induced leg pain. With an average delay in diagnosis of 2 years, early identification is crucial as delays have led to poor surgical outcomes after fasciotomy. Diagnosis is currently made by compartment pressure (CP) testing, which is invasive, painful and demonstrates variable accuracy. There is no literature on the role of shear wave elastography (SWE) and/or subharmonic assisted pressure estimation (SHAPE) with microbubbles in diagnosing CECS. Ultrasound contrast agents are FDA-approved and are extremely safe. In this single-blinded prospective pilot study, the accuracy of SHAPE and SWE will be evaluated and compared to the current gold standard of compartment testing in patients with suspected CECS. Muscle stiffness and record a quantitative assessment of enhancement and hydrostatic pressures will be documented and correlated with compartment testing results based on a reference standard modified Pedowitz criteria for CECS

NCT ID: NCT05247528 Completed - Clinical trials for Resistant Hypertension

Safety And Tolerability Of Subcutaneous MANP In Difficult To Control/Resistant Hypertensive Subjects

DTC/RHS
Start date: December 20, 2021
Phase: Phase 1
Study type: Interventional

A randomized, double-blind, placebo-controlled multiple ascending dose study in hypertensive subjects on stable doses of at least three hypertensive drugs for at least 6 weeks prior to Screening. The study will consist of screening, PK-unit admittance, and safety follow up periods. Subjects will be randomized at a 6:2 ratio of either MANP or placebo and will be stratified by race in each dosage cohort. The entire first Cohort will be given the lowest dosage with subsequent cohorts progressing sequentially to the higher doses depending on safety and tolerability of the previous cohort. Endpoints not related to the safety reviews will be analyzed after the last patient last visit (LPLV).