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NCT ID: NCT06218251 Recruiting - Upper Facial Lines Clinical Trials

A Study to Evaluate Participant Satisfaction and Natural Outcomes Following Administration of BOTOX Cosmetic Injections in Adult Participants for Treatment of Upper Facial Lines

Start date: February 5, 2024
Phase: Phase 4
Study type: Interventional

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), lateral canthal lines (LCL), and forehead lines (FHL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate participant satisfaction and natural outcomes following the administration of BOTOX Cosmetic in adult participants with upper facial lines (GL, LCL, and FHL). This is an open-label study in which all participants will receive active study treatment. Around 100 adult participants with an assessment of moderate to severe GL, LCL, and FHL, will be enrolled at approximately 10 sites in the United States and Canada. Participants will receive BOTOX Cosmetic as intramuscular injections to the glabellar lines, lateral canthal lines, and forehead lines at Day 1. Participants will attend regular visits during the study. The effect of the treatment will be checked by medical assessments for side effects and questionnaires will be completed during regular study visits.

NCT ID: NCT06217822 Recruiting - Clinical trials for Advanced Metastatic Castration-resistant Prostate Cancer

First-in-human Study of 225Ac-PSMA-Trillium (BAY 3563254) in Participants With Advanced Metastatic Castration-resistant Prostate Cancer (mCRPC)

PAnTHA
Start date: March 7, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat men who have metastatic castration-resistant prostate cancer (mCRPC). mCRPC is a cancer of the prostate (male reproductive gland found below the bladder) that has spread to other parts of the body. This type of prostate cancer does not respond to hormone treatment used to lower the level of testosterone, a male sex hormone, to prevent cancer from growing. The study treatment 225Ac-PSMA-Trillium, also called BAY3563254, is under development to treat advanced metastatic castration-resistant prostate cancer. It works by binding to PSMA and giving off radiation that can damage cancer cells and stop them from growing. The main purpose of this first-in-human study is to learn: - How safe is BAY3563254 in participants. - What is the recommended dose of BAY3563254 that is safe and works well that will be further tested in Part 2 of the study. - How well does BAY3563254 work in participants. To answer this, the researchers will look at: - The number and severity of medical problems including serious medical problems that participants experience after taking BAY3563254 - The number of dose-limiting toxicities (DLT) at each dose level. A DLT is a medical problem caused by a drug that is too severe to continue the use of that specific dose. - The number of participants whose cancer completely disappears (complete response) or reduces by at least 30% (partial response) after taking the treatment (also known as objective response rate (ORR)) - The number of participants who have a decrease in the levels of PSA* by at least 50% in their blood (also known as PSA50). PSA is a protein made by the prostate gland. High levels of PSA may indicate the presence of prostate cancer. - Participants' best response to treatment based on their PSA levels (also known as the best overall PSA response). The study will have two parts. The first part, called dose escalation, is done to find the most appropriate dose of BAY3563254 for use in the second part of the study. For this, each participant will receive one of different increasing amounts of BAY3563254. They will take BAY3563254 as an injection into a vein. All participants in the second part of the study, called dose expansion, will receive the most appropriate dose of BAY3563254 that was identified from the first part of the study. Participants in this study will take the study treatment once every 6 weeks, which is known as a treatment cycle. Each participant will have up to 4 of these treatment cycles, if the participant benefits from the treatment. Each participant will be in the study for approximately 6 years, including a screening phase of up to 30 days, 6 months of treatment depending on the participant's benefit, and a follow up phase of 60 months after the end of treatment. In addition, substudies performed during both dose escalation and dose expansion parts of the study will evaluate: - the clearance of radioactivity from the body over time - the doses of radiation that are delivered to normal organs and tumors - the ability of an experimental agent (Tris-POC) to decrease the amount of radiation absorbed by normal organs. During the study, the doctors and their study team will: - take blood and urine samples - check vital signs such as blood pressure, heart rate, and body temperature - examine heart health using electrocardiogram (ECG) - take tumor samples if required - check if the participants' cancer has grown and/or spread using CT (computed tomography) or MRI (magnetic resonance imaging) and bone scan - check the tumor status using PET (positron emission tomography) - check the amount of radiation absorbed by tumors and normal organs using SPECT/CT (single-photon emission tomography and computed tomography scan) - ask the participants questions about how they are feeling and what adverse events they are having. An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective if they think it is related or not to the study treatments. In addition, the participants will be asked to complete a questionnaire on quality of life at certain time points during the study. The treatment period ends with a visit in 6-12 weeks after the last BAY3563254 dose. About 6-12 weeks after the last dose and every 6 weeks thereafter, the study doctors and their team will check the participants' health and any changes in their cancer. This active follow-up period ends after 18 months. The long-term follow-up period will start after the end of the active follow-up visit and will continue for up to 60 months after the the last BAY3563254 dose. Participants will be contacted, typically by phone call or clinic visit, approximately every 12 weeks after the end of active follow-up.

NCT ID: NCT06217367 Recruiting - Allergic Rhinitis Clinical Trials

Over-the-Counter Antihistamines & Heat Stress

Start date: December 5, 2023
Phase: Phase 4
Study type: Interventional

Allergic rhinitis (AR) currently affects ~25% of Canadians, and due to factors of climate change, this number is expected to increase over the coming decade. AR symptoms can significantly impact individuals' quality of life by compromising sleep, productivity, and social interactions. To alleviate AR symptoms, North Americans tend to rely on H1 antihistamine medications available over-the-counter (OTC) at most pharmacies. However, public health authorities currently suggest restraining all antihistamines during heat waves due to beliefs that M3 muscarinic receptor and H1 receptor antagonism, independent pharmacological mechanisms of H1 antihistamines, might suppress thermoregulatory responses to heat stress and increase individuals' susceptibility to heat-related illness/injury. To date, studies using supramaximal doses of antihistamines have demonstrated reductions in sweating, however these doses and administration routes are not the typical use case. Additional studies utilizing fexofenadine, a second-generation H1 antihistamine, have linked H1 receptor antagonism to reductions in skin blood flow, potentially impacting thermoregulation by reducing peripheral blood redistribution. Empirical evidence supporting OTC H1 antihistamines impacting thermoregulatory control at recommended doses is scarce. Thus, this study aims to systematically assess whether three common OTC H1 antihistamines, taken as prescribed, alter thermoregulatory responses during thermal stress.

NCT ID: NCT06217159 Recruiting - Cerebral Blood Flow Clinical Trials

Mechanistic Effect of Ketones on Cerebral Blood Flow

MEKC
Start date: January 19, 2024
Phase: N/A
Study type: Interventional

Oral supplements containing exogenous ketones have recently become available and represent a novel tool for increasing plasma ketone bodies without the need for dietary restriction. Early evidence suggests that oral ketone supplements may enhance cerebral blood flow (CBF). However, a higher dose of a ketone monoester has been shown to slightly lower blood pH and reduce end-tidal CO2 (PetCO2) due to compensatory hyperventilation, which is accompanied by parallel reductions in CBF. Whether reductions in PetCO2 causes reductions in CBF is currently unknown. The purpose of this study is to investigate the effect of manipulating PetCO2 at normocapnia (PetCO2 maintained at baseline) or poikilocapnia (no PetCO2 targeting; breathing room air), following the ingestion of a dose of a ketone monoester on CBF and cerebrovascular reactivity to CO2 in young adults.

NCT ID: NCT06216899 Recruiting - Crohn Disease Clinical Trials

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

mRE-EEN
Start date: March 11, 2024
Phase: N/A
Study type: Interventional

This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.

NCT ID: NCT06216470 Recruiting - Clinical trials for Hepatitis B, Chronic

Vaccinal Effect of HBsAg Monoclonal Ab VIR-3434 in Chronic Hepatitis B Infection [VISION]

Start date: March 13, 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II Investigator-Initiated Study to understand the vaccinal effect of HBsAg monoclonal Ab VIR-3434 in chronic hepatitis B infection. The purpose of this study is to test VIR-3434, an experimental drug that specifically targets the HBsAg of hepatitis B virus, to clear it from the body. This is an open label study and there is no placebo used in this study. All participants will receive the VIR-3434 for 48 weeks and then follow up in the study for 48 weeks. A total duration of approximately 104 weeks including screening period for the entire study.

NCT ID: NCT06215963 Recruiting - Clinical trials for Opioid-Related Disorders

A4i-O: A Platform for Complex Behavioral Health to Address OUD

Start date: February 5, 2024
Phase: N/A
Study type: Interventional

For the purposes of beta testing the first version of A4i-O, 15 individuals with OUD will use the platform for one month. From a design perspective this sample size is viewed as being sufficient to answer questions regarding app functionality and feasibility before moving to larger trials. Additionally, 15 individuals is a larger sample size than in the A4i pilot. This is an open label pilot with a primary objective of troubleshooting and providing early feedback on the beta version of the technology. To that end, 15 participants are anticipated to be sufficient to provide robust, early feedback. As with the focus groups, through sampling an effort will be made to secure a diverse group. Any individuals who might be declined in that effort at this stage (e.g., it is determined that no more male identifying participants are needed but they were interested) would be invited to take part in the subsequent RCT.

NCT ID: NCT06215755 Recruiting - Clinical trials for Amyotrophic Lateral Sclerosis

A Study of VRG50635 in Participants With Amyotrophic Lateral Sclerosis (ALS)

Start date: January 15, 2024
Phase: Phase 1
Study type: Interventional

The primary purpose of this study is to evaluate the safety and tolerability of VRG50635 in participants with ALS.

NCT ID: NCT06215716 Recruiting - NASH With Fibrosis Clinical Trials

A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis

Start date: December 1, 2023
Phase: Phase 3
Study type: Interventional

This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3.

NCT ID: NCT06215534 Recruiting - Glycemic Response Clinical Trials

Glin3: Assessment of the Glycemic Responses to Nutritional Products

GLIN#3
Start date: February 7, 2024
Phase: N/A
Study type: Interventional

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.