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NCT ID: NCT05100459 Completed - Muscle Damage Clinical Trials

The Effects of Whey Protein Supplements on Markers of Exercise-induced Muscle Damage in Resistance-trained Individuals

WheyProtein
Start date: November 15, 2021
Phase: N/A
Study type: Interventional

Intense exercise can bring about various side effects to one's body. Less range of motion, increased pain sensitivity, increased muscle swelling, and decreased muscle strength can occur immediately after exercise. These side effects can be referred to exercise induced muscle damage (EIMD) and can sometimes last many days. This study's goal is to evaluate the effects of various protein supplements on EIMD symptoms as well as on blood vessel health during the recovery period after muscle damaging exercise.

NCT ID: NCT05100199 Completed - Glabellar Lines Clinical Trials

A Study to the Assess the Change in Condition and Adverse Events of OnabotulinumtoxinA X Injection in Adult Participants With Glabellar Lines

Start date: October 6, 2021
Phase: Phase 2
Study type: Interventional

This is a Phase 2, dose ranging study to evaluate the safety of OnabotulinumtoxinA X and to compare the efficacy of OnabotulinumtoxinA X and placebo for the treatment of Glabellar Lines in adult participants with moderate to severe GL.

NCT ID: NCT05099991 Completed - Clinical trials for Abortion, Second Trimester

Transcervical Balloon Compared to Osmotic Dilators Prior to Surgical Abortion

Start date: February 8, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a Foley balloon is similar to osmotic dilators for preparing the cervix prior to a second trimester abortion. Procedure time will be used to compare the two different methods of cervical preparation, reflecting the ease at which the surgeon can perform through a prepared cervix. The aim is to expand effective options for cervical preparation that will can accommodate for varying patient characteristics and provider experiences.

NCT ID: NCT05099640 Completed - Phenylketonuria Clinical Trials

A Study of PTC923 in Participants With Phenylketonuria

Start date: September 30, 2021
Phase: Phase 3
Study type: Interventional

The main purpose of this trial is to evaluate the efficacy of PTC923 in reducing blood phenylalanine (Phe) levels in participants with phenylketonuria as measured by mean change in blood Phe levels from baseline to Weeks 5 and 6 (that is, the average of each respective treatment dose 2-week period of double-blind treatment).

NCT ID: NCT05099614 Completed - Overdose Antidote Clinical Trials

Naloxone Auto-injection in Healthy Volunteers

Start date: March 10, 2021
Phase: Early Phase 1
Study type: Interventional

This study continues the work to develop a mobile breathing monitoring system to detect slowed breathing and overdose events caused by opioid use. This is a single-site feasibility study designed to test the mobile application with a commercially available drug delivery device called the SmartDose by West Pharmaceuticals, Inc. The SmartDose is a wearable self-injection device that can deliver a drug under the skin with a push of a button. Naloxone is a drug used to reverse the effects of opioid drugs in the body. This study will evaluate if the mobile application can wireless trigger the delivery of a small dose of naloxone to a healthy adult volunteer.

NCT ID: NCT05099484 Completed - Pregnancy Related Clinical Trials

Medications in Breast Milk: A Convenience Pharmacokinetic Study

MedMilk
Start date: January 15, 2021
Phase:
Study type: Observational

The benefits of breastfeeding and human milk consumption by infants has been clearly demonstrated. Benefits to the infant include reduction of infant and childhood diseases and allergies. Benefits to the woman include more rapid return to pre-pregnancy weight and reduced risk of health problems such as cardiovascular disease and diabetes in the future. Many women take medications as part of their standard of care and for multiple medical reasons in the postpartum period, when breastfeeding occurs. This creates a need for information about the transfer of drugs taken by a woman into breast milk, and ultimately, to the infant. Unfortunately, there are limited pharmacokinetic (PK) data on many of the medications commonly taken by lactating women. Additionally, there are little data on how the PK of drugs are impacted by lactation, and how this may vary from woman to woman or with time throughout lactation. Uptake of drugs into breast milk can vary due to a number of factors, including drug lipophilicity; molecular weight; drug half-life; active transport in breast epithelial cells; protein binding in milk and plasma; and lipid composition of breast milk. In silico and animal models can provide some information on transfer of drugs into breast milk, however, there are large gaps remaining in our knowledge of drug transfer into human milk. This information is crucial to better inform providers and patients about the transfer of those drugs to human breast milk. The purpose of this study is to characterize the PK of specific drugs of interest taken by lactating women as part of their standard of care. The drugs of interest (DOI) will be based on medical relevance and availability throughout the course of the study. The purpose of this study is to characterize the PK of medications taken by lactating women as part of their standard of care.

NCT ID: NCT05099445 Completed - Hemodialysis Clinical Trials

Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of INCB000928 in Participants With Impaired Renal Function and Hemodialysis

Start date: December 14, 2021
Phase: Phase 1
Study type: Interventional

This is a multicenter, open-label parallel-group to evaluate single oral doses of INCB000928 in participants with varying level of renal function or impairment.

NCT ID: NCT05099380 Completed - Visual Acuity Clinical Trials

Validation of Senofilcon A With New UV / HEV Filter

Start date: October 5, 2021
Phase: N/A
Study type: Interventional

This is a bilateral, dispensing, randomized, controlled, subject-masked, 2-arm parallel study to evaluate safety and efficacy

NCT ID: NCT05099198 Completed - Diabetes Clinical Trials

Replication of the GRADE Diabetes Trial in Healthcare Claims Data

Start date: September 1, 2018
Phase:
Study type: Observational

Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

NCT ID: NCT05099159 Completed - Hot Flashes Clinical Trials

A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2)

Start date: October 29, 2021
Phase: Phase 3
Study type: Interventional

Researchers are looking for a better way to treat women who have hot flashes after women have been through the menopause. Hot flashes are caused by the hormonal changes that happen when a woman's body has been through the menopause. Menopause is when women stop having a menstrual cycle, also called a period. During the menopause, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. The study treatment, elinzanetant, was developed to treat symptoms caused by hormonal changes. It works by blocking a protein called neurokinin from sending signals to other parts of the body, which is thought to play a role in starting hot flashes. There are treatments for hot flashes in women who have been through the menopause, but may cause medical problems for some people. In this study, the researchers will learn how well elinzanetant works compared to a placebo in women who have been through the menopause and have hot flashes. A placebo looks like a treatment but does not have any medicine in it. To compare these study treatments, the doctors will ask the participants to record information about the participants' hot flashes in an electronic diary. The researchers will study the number of hot flashes the participants have and how severe the hot flashes are. The researchers will look at the results from before treatment, after 4 weeks, and after 12 weeks of treatment. The participants in this study will take two capsules of either elinzanetant or the placebo once a day. The participants who take elinzanetant will take it for 26 weeks. The participants who take the placebo will take it for 12 weeks and then take elinzanetant for the next 14 weeks. During the study, the participants will visit the site approximately 9 times and perform 1 visit by phone. Each participant will be in the study for approximately 36 weeks. The treatment duration will be 26 weeks. During the study, the participants will: - record information about the participants' hot flashes in an electronic diary - answer questions about the participants' symptoms The doctors will: - check the participants' health - take blood samples - ask the participants questions about what medicines the participants are taking and if the participants are having adverse events An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if doctors do not think the adverse events might be related to the study treatments.